Grand Duchy of Luxembourg |
2836 |
98-1629342 | ||
(Jurisdiction of Incorporation or Organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification Number) |
Michal Berkner, Esq. Nicolas H.R. Dumont, Esq. Divakar Gupta, Esq. Cooley (UK) LLP 22 Bishopsgate London EC2N 4BQ United Kingdom Tel: +44 (0) 20 7583 4055 Fax: +44 (0) 20 7785 9355 |
Christian O. Nagler, Esq. Peter Seligson, Esq. Allison Gallagher, Esq. Kirkland & Ellis LLP 601 Lexington Avenue New York, New York 10022 Tel: +1 (212) 446-4800 Fax: +1 (212) 446-4900 |
* |
Upon the closing of the Business Combination referred to in the proxy statement/prospectus within this registration statement, the name of the registrant is expected to change to Alvotech S.A. |
Sincerely, |
|
John Frank |
Chairman of the Board of Directors |
• |
Proposal No. 1—The Business Combination Proposal RESOLVED Business Combination Agreement ”), by and among OACB, Alvotech Holdings S.A., a public limited liability company (société anonyme L-1273 Luxembourg, Grand Duchy of Luxembourg and registered with the Luxembourg Register of Commerce and Companies (R.C.S. Luxembourg Alvotech ”) and Alvotech Lux Holdings S.A.S., a simplified joint stock (société par actions simplifiée L-1273 Luxembourg, Grand Duchy of Luxembourg and registered with the Luxembourg Register of Commerce and Companies (R.C.S. Luxembourg TopCo ”), a copy of which is attached to the proxy statement/prospectus as Annex A , pursuant to which, among other things, (a) on the date and time at which the notarial deed of the sole shareholder’s resolutions of TopCo approving the First Merger becomes effective, upon its publication in the Recueil Electronique des Sociétés et Associations Exhibit G of Annex A , the “Plan of First Merger”) and the filing and registration of such Plan of First Merger and such other documents as required under the Companies Act (as amended) of the Cayman Islands (the “First Merger Effective Time ”), OACB will merge with and into TopCo, whereby (i) all of the outstanding OACB Ordinary Shares will be exchanged for TopCo Ordinary Shares and (ii) all of the outstanding OACB Warrants will be converted into TopCo Warrants, with TopCo as the surviving company in the merger (the “First Merger ”); (b) immediately after the effectiveness of the First Merger, TopCo will redeem and cancel the initial shares held by the initial sole shareholder of TopCo pursuant to a share capital reduction of TopCo (the “Redemption ”); (c) immediately after the effectiveness of the First Merger and the Redemption, the legal form of TopCo shall be changed from a simplified joint stock company (société par actions simplifiée société anonyme Conversion ”); and (d) immediately following the effectiveness of the Conversion and the PIPE Financing, Alvotech will merge with and into TopCo, whereby all outstanding Alvotech Ordinary Shares will be exchanged for TopCo Ordinary Shares, with TopCo as the surviving company in the merger (the “Second Merger ”), and certain related agreements (including the Investor Rights and Lock-Up Agreement, the form of Support Agreements, the form of Subscription Agreements and the Sponsor Letter Agreement, each in the form attached to the proxy statement/prospectus as Exhibit A to the Business Combination Agreement, Annex D , Annex E , Annex F and Annex G , respectively), and the transactions contemplated thereby, be approved, ratified and confirmed in all respects. |
• |
Proposal No. 2—The First Merger Proposal RESOLVED |
as Exhibit G of Annex A, the “ Plan of First Merger ”) be authorized, approved and confirmed in all respects; and (c) OACB be authorized to enter into the Plan of First Merger. |
• | Proposal No. 3—The Adjournment Proposal RESOLVED |
(i) | (a) hold OACB Class A Ordinary Shares, or (b) if you hold OACB Class A Ordinary Shares through OACB Units, you elect to separate your OACB Units into the underlying OACB Class A Ordinary Shares and OACB Warrants prior to exercising your redemption rights with respect to the OACB Class A Ordinary Shares; |
(ii) | submit a written request to Continental, OACB’s transfer agent, in which you (a) request that OACB redeem all or a portion of your public shares for cash, and (b) identify yourself as the beneficial holder of the public shares and provide your legal name, phone number and address; and |
(iii) | deliver your public shares to Continental, OACB’s transfer agent, physically or electronically through The Depository Trust Company. |
|
John Frank |
Chairman of the Board of Directors |
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A-1 |
A. | OACB has entered into the Business Combination Agreement with TopCo and Alvotech, which provides for the Business Combination in which, among other transactions, each of Alvotech and OACB will merge with and into TopCo whereby, in each case, TopCo will be the surviving company. A copy of the Business Combination Agreement is attached to this proxy statement/prospectus as Annex A. |
A. | The OACB General Meeting will be held at , Eastern time, on , 2022, via live webcast at . The OACB General Meeting will be held virtually as well as at the offices of Kirkland & Ellis LLP, located at 601 Lexington Avenue, New York, New York 10022. |
A. | At the OACB General Meeting, OACB will ask its shareholders to vote in favor of the following proposals: |
A. | The First Merger Proposal is conditioned on the approval of the Business Combination Proposal. The Shareholder Adjournment Proposal does not require the approval of the Business Combination Proposal and Business Combination to be effective. It is important to note that in the event that the Business Combination Proposal is not approved, then OACB will not consummate the Business Combination. If OACB does not consummate the Business Combination and fails to complete an initial business combination by September 21, 2022, or amend the OACB Memorandum and Articles of Association to extend the date by which OACB must consummate an initial business combination, OACB will be required to dissolve and liquidate. |
A. | Pursuant to the Business Combination Agreement, each of the following transactions will occur in the following order: (i) on the First Merger Effective Time, OACB will merge with and into TopCo, whereby (i) all of the outstanding OACB Ordinary Shares will be exchanged for TopCo Ordinary Shares and (ii) all of the outstanding OACB Warrants will be converted into TopCo Warrants, with TopCo as the surviving company in the merger; (ii) immediately after the effectiveness of the First Merger, TopCo will redeem and cancel the initial shares held by the initial sole shareholder of TopCo pursuant to a share capital reduction of TopCo; (iii) immediately after the effectiveness of the First Merger and the Redemption, the legal form of TopCo shall be changed from a simplified joint stock company ( soci é t é par actions simplifi é e soci é t é anonyme |
• | the Alvotech Shareholders will receive an aggregate of 218,930,000 TopCo Ordinary Shares (38,330,000 of which will be subject to certain transfer restrictions, vesting and buyback conditions); |
• | each outstanding OACB Ordinary Share will be exchanged for one TopCo Ordinary Share; and |
• | each issued and outstanding OACB Warrant will cease to represent a right to acquire OACB Ordinary Shares and will instead represent the right to be issued the same number of TopCo Ordinary Shares, at the same exercise price and on the same terms as in effect immediately prior to the Closing. |
A. | OACB was organized for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. OACB is not limited to any particular industry or sector. |
A. | Alvotech is a highly integrated biopharmaceutical company committed to developing and manufacturing high quality biosimilar medicines for patients globally. Our purpose is to improve the health and quality of life of patients around the world by improving access to proven treatments for various diseases. Since our inception, we have built our company with key characteristics we believe will help us capture the substantial global market opportunity in biosimilars: a leadership team that has brought numerous successful biologics and biosimilars to market around the world; a purpose-built biosimilars R&D and manufacturing platform; top commercial partnerships in global markets; and a diverse, expanding pipeline addressing many of the biggest disease areas and health challenges globally. Alvotech is a company committed to constant innovation: we focus our platform, people and partnerships on finding new ways to drive access to more affordable biologic medicines. |
A. | It is anticipated that, upon completion of the Business Combination, (i) OACB’s existing shareholders, including the Sponsor, will own approximately 13% of the issued and outstanding TopCo Ordinary Shares, (ii) Alvotech’s existing shareholders will own approximately 79% of the issued and outstanding TopCo Ordinary Shares and (iii) the Subscribers in the PIPE Financing will own approximately 8% of the issued and outstanding TopCo Ordinary Shares. These relative percentages do not include Seller Earn Out Shares (as defined below), Sponsor Earn Out Shares (as defined below) or |
the shares underlying the TopCo Warrants, and assume that (i) none of OACB’s existing Public Shareholders exercise their redemption rights, and (ii) no additional equity securities of OACB are issued at or prior to Closing. If the actual facts are different than these assumptions, the percentage ownership retained by OACB’s existing shareholders will be different. Certain figures included in this section have been rounded for ease of presentation and, as a result, percentages may not sum to 100%. |
Amounts in thousands, except share amounts, per share amounts and percentages |
Assuming No Redemptions |
Assuming 25% of Maximum Redemptions |
Assuming 50% of Maximum Redemptions |
Assuming 75% of Maximum Redemptions |
Assuming Maximum Redemptions |
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Ownership in Shares |
% |
Ownership in Shares |
% |
Ownership in Shares |
% |
Ownership in Shares |
% |
Ownership in Shares |
% |
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Alvotech shareholders (1) |
180,600,000 | 79 | % | 180,600,000 | 80 | % | 180,600,000 | 81 | % | 180,600,000 | 83 | % | 180,600,000 | 84 | % | |||||||||||||||||||||||||
OACB shareholders (2) |
25,000,000 | 11 | % | 21,876,176 | 10 | % | 18,752,353 | 9 | % | 15,628,529 | 7 | % | 12,504,705 | 6 | % | |||||||||||||||||||||||||
Sponsor (3) |
5,000,000 | 2 | % | 5,000,000 | 2 | % | 5,000,000 | 2 | % | 5,000,000 | 2 | % | 5,000,000 | 2 | % | |||||||||||||||||||||||||
PIPE investors |
17,493,000 | 8 | % | 17,493,000 | 8 | % | 17,493,000 | 8 | % | 17,493,000 | 8 | % | 17,493,000 | 8 | % | |||||||||||||||||||||||||
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Pro Forma Ordinary Shares Outstanding |
228,093,000 |
224,969,176 |
221,845,353 |
218,721,529 |
215,597,705 |
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Pro Forma Book Value of Equity (4) |
$ | 63,357 | $ | 32,118 | $ | 879 | $ | (30,359 | ) | $ | (61,597 | ) | ||||||||||||||||||||||||||||
Pro Forma Book Value per Share (5) |
$ |
0.28 |
$ |
0.14 |
$ |
0.00 |
$ |
(0.14 |
) |
$ |
(0.29 |
) |
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Sources of Dilution (6) |
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Ownership in Shares |
% Dilution (7) |
Ownership in Shares |
% Dilution (7) |
Ownership in Shares |
% Dilution (7) |
Ownership in Shares |
% Dilution (7) |
Ownership in Shares |
% Dilution (7) |
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Alvotech Seller Earn Out Shares |
38,330,000 | 14 | % | 38,330,000 | 15 | % | 38,330,000 | 15 | % | 38,330,000 | 15 | % | 38,330,000 | 15 | % | |||||||||||||||||||||||||
OACB Shareholders |
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OACB Sponsor Earn Out Shares |
1,250,000 | 1 | % | 1,250,000 | 1 | % | 1,250,000 | 1 | % | 1,250,000 | 1 | % | 1,250,000 | 1 | % | |||||||||||||||||||||||||
Public OACB Warrants |
6,250,000 | 3 | % | 6,250,000 | 3 | % | 6,250,000 | 3 | % | 6,250,000 | 3 | % | 6,250,000 | 3 | % | |||||||||||||||||||||||||
Private OACB Warrants |
4,666,667 | 2 | % | 4,666,667 | 2 | % | 4,666,667 | 2 | % | 4,666,667 | 2 | % | 4,666,667 | 2 | % | |||||||||||||||||||||||||
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Adjusted Pro Forma Ordinary Shares Outstanding (8) |
278,589,667 |
275,465,843 |
272,342,020 |
269,218,196 |
266,094,372 |
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Per Share Impact from Sources of Dilution (9) |
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Proceeds |
$/Share |
Proceeds |
$/Share |
Proceeds |
$/Share |
Proceeds |
$/Share |
Proceeds |
$/Share |
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Alvotech Seller Earn Out Shares |
$ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||||||||||
OACB Shareholders |
Amounts in thousands, except share amounts, per share amounts and percentages |
Assuming No Redemptions |
Assuming 25% of Maximum Redemptions |
Assuming 50% of Maximum Redemptions |
Assuming 75% of Maximum Redemptions |
Assuming Maximum Redemptions |
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Proceeds |
$/Share |
Proceeds |
$/Share |
Proceeds |
$/Share |
Proceeds |
$/Share |
Proceeds |
$/Share |
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OACB Sponsor Earn Out Shares |
— | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||
Public OACB Warrants |
71,875 | 0.30 | 71,875 | 0.31 | 71,875 | 0.32 | 71,875 | 0.32 | 71,875 | 0.33 | ||||||||||||||||||||||||||||||
Private OACB Warrants |
53,667 | 0.22 | 53,667 | 0.23 | 53,667 | 0.24 | 53,667 | 0.24 | 53,667 | 0.25 | ||||||||||||||||||||||||||||||
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Adjusted Pro Forma Book Value of Equity (10) |
188,899 | 157,660 | 126,421 | 95,183 | 63,945 | |||||||||||||||||||||||||||||||||||
Adjusted Pro Forma Book Value per Share (11) |
$ |
0.68 |
$ |
0.57 |
$ |
0.46 |
$ |
0.35 |
$ |
0.24 |
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(1) | Excludes 38,330,000 Seller Earn Out Shares that are subject to certain transfer, vesting and buyback restrictions. Holders of the Seller Earn Out are entitled to the voting and dividend rights generally granted to holders of TopCo Ordinary Shares. |
(2) | Excludes 6,250,000 of Public OACB Warrants which will be converted into warrants for new TopCo Ordinary Shares. |
(3) | Excludes 1,250,000 Sponsor Earn Out Shares that are subject to certain transfer, vesting and buyback restrictions. Holders of the Sponsor Earn Out Shares are entitled to the voting and dividend rights generally granted to holders of TopCo Ordinary Shares. Also excludes 4,666,667 of Private OACB Warrants which will be converted into warrants for new TopCo Ordinary Shares. |
(4) | Reflects the pro forma book value of equity following the consummation of the Business Combination and all related pro forma adjustments as illustrated in the pro forma financial statements for the no and max redemption scenarios. For the 25%, 50%. and 75% redemption scenario and the purposes of the sensitivity analysis above, the change in net proceeds from the Trust Account to TopCo would be reflected as a reduction to the book value of equity. Please see “Unaudited Pro Forma Condensed Combined Financial Information” for additional information regarding the no redemption scenario and maximum redemption scenario. |
(5) | Calculated as Pro Forma Book Value of Equity divided by Pro Forma Ordinary Shares Outstanding. |
(6) | Represents the shares of TopCo issuable upon the exercise of all outstanding Earn Out Shares and OACB Warrants. |
(7) | To illustrate the potential dilutive impacts to non-redeeming shareholders of TopCo. The percentage dilution is calculated as the number of shares issued upon exercise of the dilutive instrument divided by the sum of Pro Forma Ordinary Shares outstanding and the shares issued upon exercise of the dilutive instrument. |
(8) | Reflects the pro forma TopCo Ordinary Shares outstanding on a fully diluted basis, reflecting the aggregate impacts of the potential sources of dilution. |
(9) | For the purposes of the sensitivity analysis and each potential source of dilution, the amount of proceeds from the exercise each dilutive instrument is shown. Proceeds are additive to the book value of equity of TopCo with no other adjustments assumed to TopCo book value equity in the analysis above. The dollar per share impact is calculated as the incremental impact to book value per equity of TopCo resulting from each potential source of dilution and related proceeds on an individual basis. For OACB’s Warrants, proceeds reflect receipt of the exercise price of $11.50 per share consistent with the warrant agreement. |
(10) | Reflects the pro forma TopCo book value of equity on a fully diluted basis, reflecting the aggregate impacts from recognizing the proceeds related to the potential sources of dilution. |
(11) | Calculated as Adjusted Pro Forma Book Value of Equity divided by Adjusted Pro Forma Ordinary Shares Outstanding reflecting the aggregate impacts from all potential sources of dilution on TopCo’s book value per share. |
A. | It is anticipated that, at the Closing, TopCo’s board of directors will be composed of nine directors who will be identified and appointed prior to the Closing. TopCo’s executive management team will be led by the current management of Alvotech. We are in the process of identifying one more individual who will be a member of the TopCo board of directors. The other eight directors have been identified in the section titled “ Management of TopCo After the Business Combination. |
A. | There are a number of closing conditions in the Business Combination Agreement, including that OACB’s shareholders have approved and adopted the Business Combination Agreement. For a |
summary of the conditions that must be satisfied or waived prior to completion of the Business Combination, please see the section entitled “ The Business Combination Agreement |
A. | The record date for the OACB General Meeting will be earlier than the date that the Business Combination is expected to be completed. If you transfer your OACB Ordinary Shares after the record date, but before the OACB General Meeting, unless the transferee obtains from you a proxy to vote those shares, you will retain your right to vote at the OACB General Meeting. However, you will not be entitled to receive any TopCo Ordinary Shares following the Closing because only OACB’s shareholders on the date of the Closing will be entitled to receive TopCo Ordinary Shares in connection with the Closing. |
A. | The approval of each of the Business Combination Proposal and the Shareholder Adjournment Proposal requires the affirmative vote of the holders of a majority of the OACB Ordinary Shares that are voted thereon at the OACB General Meeting. Accordingly, an OACB shareholder’s failure to vote by proxy or to vote in person at the OACB General Meeting, an abstention from voting, or a Broker Non-vote will have no effect on the outcome of any vote on the Business Combination Proposal or the Shareholder Adjournment Proposal. |
A. | It is a condition to Closing that Alvotech Shareholders approve the Second Merger. In addition, the prior consent of the two majority shareholders of Alvotech (i.e. Aztiq and Alvogen) is required with respect to the Business Combination. |
A. | In connection with the shareholder vote to approve the proposed Business Combination, OACB may privately negotiate transactions to purchase shares prior to the Closing from shareholders who would have otherwise elected to have their shares redeemed in conjunction with a proxy solicitation pursuant to the proxy rules for a per-share pro rata portion of the Trust Account without the prior written consent of Alvotech. None of the Sponsor or OACB’s directors, officers or advisors, or their respective affiliates, will make any such purchases when they are in possession of any material non-public information not disclosed to the seller. Such a purchase would include a contractual acknowledgement |
that such shareholder, although still the record holder of such shares, is no longer the beneficial owner thereof and therefore agrees not to exercise its redemption rights. In the event that the Sponsor or OACB’s directors, officers or advisors, or their affiliates, purchase shares in privately negotiated transactions from Public Shareholders who have already elected to exercise their redemption rights, such selling shareholders would be required to revoke their prior elections to redeem their shares. Any such privately negotiated purchases may be effected at purchase prices that are in excess of the per-share pro rata portion of the Trust Account. The purpose of these purchases would be to increase the amount of cash available to OACB for use in the Business Combination. |
A. | TopCo or OACB has entered into equity financings in connection with the proposed Business Combination with their respective affiliates or any third parties if OACB determines that the issuance of additional equity is necessary or desirable in connection with the consummation of the Business Combination. The purposes of any such financings may include increasing the likelihood of OACB meeting the minimum available cash condition to consummation of the Business Combination. Any equity issuances could result in dilution of the relative ownership interest of the non-redeeming Public Shareholders or the former equity holders of Alvotech. In connection with the Business Combination, OACB has obtained commitments from the Subscribers to subscribe to $174,930,000 in TopCo Ordinary Shares (the “Shares”), at a subscription price of $10.00 per share. In addition, TopCo will issue 38,330,000 TopCo Ordinary Shares to be issued to the Alvotech Shareholders at the Second Merger Effective Time (the “Seller Earn Out Shares”) and 1,250,000 TopCo Ordinary Shares issued to the Sponsor at the First Merger Effective Time (the “Sponsor Earn Out Shares”), that are subject to certain transfer, vesting and buyback restrictions. |
A. | OACB’s shareholders are entitled to one vote at the OACB General Meeting for each OACB Ordinary Share held of record as of the record date. As of the close of business on the record date, there were outstanding OACB Ordinary Shares. |
A. | In connection with OACB’s IPO, OACB entered into agreements with the Sponsor, officers and directors, pursuant to which each agreed to vote their OACB Class B Ordinary Shares and any other shares acquired during and after the IPO in favor of the Business Combination Proposal. Currently, the Sponsor holds approximately 20% of the issued and outstanding OACB Ordinary Shares. |
A. | OACB’s directors and executive officers may have interests in the Business Combination that are different from, in addition to, or in conflict with, yours. These interests include: |
• | the beneficial ownership of the Sponsor of an aggregate of 6,250,000 OACB Class B Ordinary Shares, which shares would become worthless if OACB does not complete a business combination within the applicable time period, as the Initial Shareholders have waived any right to redemption with respect to these shares for no consideration in return. Such shares have an aggregate market value of approximately $ based on the closing price of the OACB Class A Ordinary Shares of $ on the New York Stock Exchange on , 2022, the record date for the OACB General Meeting; |
• | OACB’s directors will not receive reimbursement for any out-of-pocket |
• | the potential continuation of certain of OACB’s directors as directors of TopCo; |
• | the continued indemnification of current directors and officers of OACB and the continuation of directors’ and officers’ liability insurance after the Business Combination; and |
• | certain of OACB’s officers and directors are employed by Oaktree. Certain affiliates of Oaktree have an approximately 1% equity stake in Alvotech and hold approximately 47.48% ($82,953,251 aggregate principal amount) of Alvotech’s Tranche A bonds and approximately 33.99% of Alvotech’s Tranche B bonds ($75,699,188 aggregate principal amount). Such affiliates’ equity stake, which was acquired after a conversion of a portion of the Alvotech debt securities, would be valued at approximately $1.5 million, assuming a value of $10.00 per share and the consummation of the Business Combination. The Tranche A bonds and Tranche B bonds will remain outstanding after the consummation of the Business Combination; |
• | the fact that the Sponsor (and OACB’s officers and directors who are members of the Sponsor) has invested an aggregate of $7,025,000 in OACB, comprised of the $25,000 purchase price of 6,250,000 OACB Class B Ordinary Shares and the $7,000,000 purchase price for 4,666,667 OACB Private Warrants. Assuming a trading price of $9.86 per OACB Class A Ordinary Share and $1.09 per OACB Public Warrant (based upon the respective closing prices of the OACB Class A Ordinary Shares and the OACB Public Warrants on the NYSE on January 31, 2022), the 6,250,000 Class B Ordinary Shares and 4,666,667 OACB Private Warrants would have an implied aggregate market value of approximately $66,711,667. Even if the trading price of the TopCo Ordinary Shares were as low as $1.12 per share, the aggregate market value of the OACB Class B Ordinary Shares alone (without taking into account the value of the OACB Private Warrants) would be approximately equal to the initial investment in OACB by the Initial Shareholders. As a result, the Initial Shareholders are likely to be able to make a substantial profit on their investment in OACB at a time when TopCo Ordinary Shares have lost significant value. On the other hand, if OACB liquidates without completing a business combination before September 21, 2022, the Initial Shareholders will likely lose their entire investment in OACB; |
• | the fact that the Sponsor and OACB’s officers and directors will benefit from the completion of a business combination and may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidate; and |
• | the fact that the Sponsor and its affiliates can earn a positive rate of return on their investment, even if Public Shareholders experience a negative rate of return in the post-business combination company. |
A. | OACB’s board of directors did not obtain a third-party valuation or fairness opinion in connection with its determination to approve the Business Combination. However, OACB’s management, the members of OACB’s board of directors and the other representatives of OACB have substantial experience in evaluating the operating and financial merits of companies similar to Alvotech and reviewed certain financial information of Alvotech and compared it to certain publicly traded companies, selected based on the experience and the professional judgment of OACB’s management team, which enabled them to make the necessary analyses and determinations regarding the Business Combination. Accordingly, investors will be relying solely on the judgment of OACB’s board of directors in valuing Alvotech’s business and assuming the risk that OACB’s board of directors may not have properly valued such business. |
A. | The OACB Private Placement Warrants are identical to the OACB Public Warrants in all material respects, except that the OACB Private Placement Warrants will not be transferable, assignable or salable until 30 days after the completion of the Business Combination and they will not be redeemable by OACB (except as described in the notes to OACB’s financial statements included elsewhere in this proxy statement/prospectus) so long as they are held by the Sponsor or its permitted transferees. The Sponsor, or its permitted transferees, has the option to exercise the OACB Private Placement Warrants on a cashless basis. If the OACB Private Placement Warrants are held by holders other than the Sponsor or its permitted transferees, the OACB Private Placement Warrants will be redeemable by OACB in all redemption scenarios and exercisable by the holders on the same basis as the OACB Public Warrants. |
A. | If the Business Combination Proposal is not approved and OACB does not consummate a business combination by September 21, 2022, or amend the Memorandum and Articles of Association to extend the date by which OACB must consummate an initial business combination, OACB will be required to dissolve and liquidate the Trust Account. |
A: | As discussed more fully under “U.S. Federal Income Tax Considerations”, it is the opinion of Kirkland & Ellis LLP that the First Merger, together with the Election, should constitute a tax-deferred reorganization within the meaning of Section 368(a)(l)(F) of the U.S. Internal Revenue Code of 1986, as amended (the “Code”). However, due to the absence of direct guidance on the application of these rules to a corporation holding only investment-type assets such as OACB, this result is not entirely free from doubt. In the case of a transaction, such as a First Merger (together with the Election), that should qualify as a tax-deferred reorganization within the meaning of Section 368(a)(1)(F), a U.S. Holder that exchanges its OACB securities in the First Merger for TopCo securities should not recognize any gain or loss on such exchange. |
A. | If you are a holder of Public Shares, you may redeem your Public Shares for cash equal to their pro rata share of the aggregate amount on deposit in the Trust Account, which holds the proceeds of OACB’s IPO, as of two business days prior to the consummation of the Business Combination, including interest earned on the funds held in the Trust Account and not previously released to OACB to pay its franchise and income taxes, upon the consummation of the Business Combination. The per-share amount OACB will distribute to holders who properly redeem their shares will not be reduced by the deferred underwriting commissions OACB will pay to the underwriters of its IPO if the Business Combination is consummated. Holders of the outstanding Public Warrants do not have redemption rights with respect to such warrants in connection with the Business Combination. All of the Initial |
Shareholders have agreed to waive their redemption rights with respect to their OACB Class B Ordinary Shares in connection with the completion of OACB’s initial business combination. The OACB Class B Ordinary Shares will be excluded from the pro rata calculation used to determine the per-share redemption price. For illustrative purposes, based on funds in the trust account of approximately $ on , 2022, the estimated per share redemption price would have been approximately $ . This is greater than the $10.00 IPO price of the OACB Units. Additionally, Public Shares properly tendered for redemption will only be redeemed if the Business Combination is consummated; otherwise, holders of such shares will only be entitled to a pro rata portion of the Trust Account, including interest earned on the funds held in the Trust Account and not previously released to OACB to pay franchise and income taxes (less $100,000 of interest to pay dissolution expenses), in connection with the liquidation of the Trust Account. |
Amounts in thousands, except per share amounts and percentages |
Assuming No Redemptions |
Assuming 25% of Maximum Redemptions |
Assuming 50% of Maximum Redemptions |
Assuming 75% of Maximum Redemptions |
Assuming Maximum Redemptions |
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Ownership in Shares |
Ownership in Shares |
Ownership in Shares |
Ownership in Shares |
Ownership in Shares |
||||||||||||||||
Deferred underwriting fee |
8,750 | 8,750 | 8,750 | 8,750 | 8,750 | |||||||||||||||
Proceeds from Trust Account |
250,023 | 218,785 | 187,546 | 156,308 | 125,069 | |||||||||||||||
Effective underwriting fee: |
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As % of Trust proceeds |
3 | % | 4 | % | 5 | % | 6 | % | 7 | % | ||||||||||
On Per Share Basis – Pro Forma Ordinary Shares Outstanding (1) |
$ | 0.04 | $ | 0.04 | $ | 0.04 | $ | 0.04 | $ | 0.04 | ||||||||||
On Per Share Basis – Adjusted Pro Forma Ordinary Shares Outstanding (2) |
$ | 0.03 | $ | 0.03 | $ | 0.03 | $ | 0.03 | $ | 0.03 |
(1) | Calculated as the deferred underwriting fee divided by the pro forma TopCo Ordinary Shares outstanding following the consummation of the Business Combination across each of the presented redemption scenarios. Refer to Q. What equity stake will current OACB shareholders and Alvotech Shareholders have in TopCo after the Closing? |
(2) | Calculated as the deferred underwriting fee divided by the adjusted pro forma TopCo Ordinary Shares outstanding following the consummation of the Business Combination across each of the presented redemption scenarios. Refer to Q. What equity stake will current OACB shareholders and Alvotech Shareholders have in TopCo after the Closing? |
A. | A Public Shareholder, together with any affiliate of his or any other person with whom he is acting in concert or as a “group” (as defined in Section 13(d)(3) of the Exchange Act) will be restricted from seeking redemption rights with respect to 15% or more of the Public Shares. Accordingly, all shares in |
excess of 15% of the Public Shares owned by a holder will not be redeemed. On the other hand, a Public Shareholder who holds less than 15% of the Public Shares may redeem all of the Public Shares held by him or her for cash. |
A. | No. You may exercise your redemption rights whether you vote your Public Shares for or against the Business Combination Proposal or any other proposal described in this proxy statement/prospectus, or do not vote your shares. As a result, the Business Combination Proposal and the First Merger Proposal can be approved by shareholders who will redeem their Public Shares and no longer remain shareholders, leaving shareholders who choose not to redeem their Public Shares holding shares in a company with a less liquid trading market, fewer shareholders, less cash and the potential inability to meet the listing standards of Nasdaq. |
A. | In order to exercise your redemption rights, you must, prior to p.m. Eastern time on , 2022 (two business days before the OACB General Meeting), (i) submit a written request to Continental Stock Transfer & Trust Company, OACB’s transfer agent, that OACB redeem your Public Shares for cash, and (ii) deliver your shares to OACB’s transfer agent physically or electronically through the Depository Trust Company (“DTC”). The address of OACB’s transfer agent is listed under the question “Who can help answer my questions?” below. OACB requests that any requests for redemption include the identity as to the beneficial owner making such request. Electronic delivery of your shares generally will be faster than delivery of physical share certificates. |
A. | Subject to the “passive foreign investment company” rules described below under “ U.S. Federal Income Tax Considerations U.S. Federal Income Tax Considerations—U.S. Holders U.S. Federal Income Tax Considerations. |
A: | No. There are no redemption rights with respect to the OACB Warrants. |
A: | OACB’s Public Shareholders are not required to vote “FOR” the Business Combination in order to exercise their redemption rights. Accordingly, the Business Combination may be consummated even though the funds available from the Trust Account and the number of Public Shareholders are reduced as a result of redemptions by Public Shareholders. |
Amounts in thousands, except share amounts, per share amounts and percentages |
Assuming No Redemptions |
Assuming 25% of Maximum Redemptions |
Assuming 50% of Maximum Redemptions |
Assuming 75% of Maximum Redemptions |
Assuming Maximum Redemptions |
|||||||||||||||||||||||||||||||||||
Ownership in Shares |
% |
Ownership in Shares |
% |
Ownership in Shares |
% |
Ownership in Shares |
% |
Ownership in Shares |
% |
|||||||||||||||||||||||||||||||
Alvotech shareholders (1) |
180,600,000 | 79 | % | 180,600,000 | 80 | % | 180,600,000 | 81 | % | 180,600,000 | 83 | % | 180,600,000 | 84 | % | |||||||||||||||||||||||||
OACB shareholders (2) |
25,000,000 | 11 | % | 21,876,176 | 10 | % | 18,752,353 | 9 | % | 15,628,529 | 7 | % | 12,504,705 | 6 | % | |||||||||||||||||||||||||
Sponsor (3) |
5,000,000 | 2 | % | 5,000,000 | 2 | % | 5,000,000 | 2 | % | 5,000,000 | 2 | % | 5,000,000 | 2 | % | |||||||||||||||||||||||||
PIPE investors |
17,493,000 | 8 | % | 17,493,000 | 8 | % | 17,493,000 | 8 | % | 17,493,000 | 8 | % | 17,493,000 | 8 | % | |||||||||||||||||||||||||
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|
|
|
|||||||||||||||||||||||||||||||
Pro Forma Ordinary Shares Outstanding |
228,093,000 |
224,969,176 |
221,845,353 |
218,721,529 |
215,597,705 |
|||||||||||||||||||||||||||||||||||
Pro Forma Book Value of Equity (4) |
$ | 63,357 | $ | 32,118 | $ | 879 | $ | (30,359 | ) | $ | (61,597 | ) | ||||||||||||||||||||||||||||
Pro Forma Book Value per Share (5) |
$ |
0.28 |
$ |
0.14 |
$ |
0.00 |
$ |
(0.14 |
) |
$ |
(0.29 |
) |
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Sources of Dilution (6) |
||||||||||||||||||||||||||||||||||||||||
Ownership in Shares |
% Dilution (7) |
Ownership in Shares |
% Dilution (7) |
Ownership in Shares |
% Dilution (7) |
Ownership in Shares |
% Dilution (7) |
Ownership in Shares |
% Dilution (7) |
|||||||||||||||||||||||||||||||
Alvotech Seller Earn Out Shares |
38,330,000 | 14 | % | 38,330,000 | 15 | % | 38,330,000 | 15 | % | 38,330,000 | 15 | % | 38,330,000 | 15 | % | |||||||||||||||||||||||||
OACB Shareholders |
||||||||||||||||||||||||||||||||||||||||
OACB Sponsor Earn Out Shares |
1,250,000 | 1 | % | 1,250,000 | 1 | % | 1,250,000 | 1 | % | 1,250,000 | 1 | % | 1,250,000 | 1 | % | |||||||||||||||||||||||||
Public OACB Warrants |
6,250,000 | 3 | % | 6,250,000 | 3 | % | 6,250,000 | 3 | % | 6,250,000 | 3 | % | 6,250,000 | 3 | % | |||||||||||||||||||||||||
Private OACB Warrants |
4,666,667 | 2 | % | 4,666,667 | 2 | % | 4,666,667 | 2 | % | 4,666,667 | 2 | % | 4,666,667 | 2 | % | |||||||||||||||||||||||||
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|
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|
|
|
|
|||||||||||||||||||||||||||||||
Adjusted Pro Forma Ordinary Shares Outstanding (8) |
278,589,667 |
275,465,843 |
272,342,020 |
269,218,196 |
266,094,372 |
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|
Per Share Impact from Sources of Dilution (9) |
||||||||||||||||||||||||||||||||||||||||
Proceeds |
$/ Share |
Proceeds |
$/ Share |
Proceeds |
$/ Share |
Proceeds |
$/ Share |
Proceeds |
$/ Share |
|||||||||||||||||||||||||||||||
Alvotech Seller Earn Out Shares |
$ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||||||||||
OACB Shareholders |
||||||||||||||||||||||||||||||||||||||||
OACB Sponsor Earn Out Shares |
— | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||
Public OACB Warrants |
71,875 | 0.30 | 71,875 | 0.31 | 71,875 | 0.32 | 71,875 | 0.32 | 71,875 | 0.33 | ||||||||||||||||||||||||||||||
Private OACB Warrants |
53,667 | 0.22 | 53,667 | 0.23 | 53,667 | 0.24 | 53,667 | 0.24 | 53,667 | 0.25 | ||||||||||||||||||||||||||||||
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|
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Adjusted Pro Forma Book Value of Equity (10) |
188,899 | 157,660 | 126,421 | 95,183 | 63,945 | |||||||||||||||||||||||||||||||||||
Adjusted Pro Forma Book Value per Share (11) |
$ |
0.68 |
$ |
0.57 |
$ |
0.46 |
$ |
0.35 |
$ |
0.24 |
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|
(1) | Excludes 38,330,000 Seller Earn Out Shares that are subject to certain transfer, vesting and buyback restrictions. Holders of the Seller Earn Out are entitled to the voting and dividend rights generally granted to holders of TopCo Ordinary Shares. |
(2) | Excludes 6,250,000 of Public OACB Warrants which will be converted into warrants for new TopCo Ordinary Shares. |
(3) | Excludes 1,250,000 Sponsor Earn Out Shares that are subject to certain transfer, vesting and buyback restrictions. Holders of the Sponsor Earn Out Shares are entitled to the voting and dividend rights generally granted to holders of TopCo Ordinary Shares. Also excludes 4,666,667 of Private OACB Warrants which will be converted into warrants for new TopCo Ordinary Shares. |
(4) | Reflects the pro forma book value of equity following the consummation of the Business Combination and all related pro forma adjustments as illustrated in the pro forma financial statements for the no and max redemption scenarios. For the 25%, 50%. and 75% redemption scenario and the purposes of the sensitivity analysis above, the change in net proceeds from the Trust Account to TopCo would be reflected as a reduction to the book value of equity. Please see “Unaudited Pro Forma Condensed Combined Financial Information” for additional information regarding the no redemption scenario and maximum redemption scenario. |
(5) | Calculated as Pro Forma Book Value of Equity divided by Pro Forma Ordinary Shares Outstanding. |
(6) | Represents the shares of TopCo issuable upon the exercise of all outstanding Earn Out Shares and OACB Warrants. |
(7) | To illustrate the potential dilutive impacts to non-redeeming shareholders of TopCo. The percentage dilution is calculated as the number of shares issued upon exercise of the dilutive instrument divided by the sum of Pro Forma Ordinary Shares outstanding and the shares issued upon exercise of the dilutive instrument. |
(8) | Reflects the pro forma TopCo Ordinary Shares outstanding on a fully diluted basis, reflecting the aggregate impacts of the potential sources of dilution. |
(9) | For the purposes of the sensitivity analysis and each potential source of dilution, the amount of proceeds from the exercise each dilutive instrument is shown. Proceeds are additive to the book value of equity of TopCo with no other adjustments assumed to TopCo book value equity in the analysis above. The dollar per share impact is calculated as the incremental impact to book value per equity of TopCo resulting from each potential source of dilution and related proceeds on an individual basis. For OACB’s Warrants, proceeds reflect receipt of the exercise price of $11.50 per share consistent with the warrant agreement. |
(10) | Reflects the pro forma TopCo book value of equity on a fully diluted basis, reflecting the aggregate impacts from recognizing the proceeds related to the potential sources of dilution. |
(11) | Calculated as Adjusted Pro Forma Book Value of Equity divided by Adjusted Pro Forma Ordinary Shares Outstanding reflecting the aggregate impacts from all potential sources of dilution on TopCo’s book value per share. |
A: | The Cayman Companies Act prescribes when OACB Shareholder appraisal rights will be available and sets the limitations on such rights. Where such rights are available, OACB Shareholders are entitled to receive fair value for their shares. However, regardless of whether such rights are or are not available, OACB Shareholders are still entitled to exercise the rights of redemption, as set out in the section of this proxy statement/prospectus entitled “ OACB General Meeting—Redemption Rights Appraisal Rights. |
A: | If the Business Combination is consummated, the funds held in the Trust Account will be released to pay (i) OACB shareholders who properly exercise their redemption rights and (ii) cash consideration |
pursuant to the Business Combination Agreement. Any additional funds available for release from the Trust Account will be used for general corporate purposes of TopCo following the Business Combination. |
A: | There are certain circumstances under which the Business Combination Agreement may be terminated. See the section entitled “ The Business Combination Agreement |
A: | It is currently anticipated that the Business Combination will be consummated promptly following the OACB General Meeting, provided that all other conditions to the consummation of the Business Combination have been satisfied or waived. |
A: | You are urged to carefully read and consider the information contained in this proxy statement/prospectus, including the financial statements and annexes attached hereto, and to consider how the Business Combination will affect you as a shareholder. You should then vote as soon as possible in accordance with the instructions provided in this proxy statement/prospectus on the enclosed proxy card or, if you hold your shares through a brokerage firm, bank or other nominee, on the voting instruction form provided by the broker, bank or nominee. |
A: | If you were a holder of record of OACB Ordinary Shares on , 2022, the record date for the OACB General Meeting, you may vote with respect to the applicable proposals in person at the OACB General Meeting or by completing, signing, dating and returning the enclosed proxy card in the postage-paid envelope provided. If you hold your shares in “street name,” which means your shares are held of record by a broker, bank or other nominee, you should contact your broker, bank or nominee to ensure that votes related to the shares you beneficially own are properly counted. In this regard, you must provide the record holder of your shares with instructions on how to vote your shares or, if you wish to attend the OACB General Meeting and vote virtually or in person, obtain a proxy from your broker, bank or nominee. |
A: | At the OACB General Meeting, OACB will count a properly executed proxy marked “ABSTAIN” with respect to a particular proposal as present for purposes of determining whether a quorum is present. For purposes of approval, an abstention or failure to vote will have no effect on the Business Combination Proposal, the First Merger Proposal or the Shareholder Adjournment Proposal. If you sign and return your proxy card without indicating how you wish to vote, your proxy will be voted in favor of each of the proposals presented at the OACB General Meeting. |
A: | Signed and dated proxies received by OACB without an indication of how the shareholder intends to vote on a proposal will be voted in favor of each proposal presented to the shareholders. |
A. | No. You are invited to attend the OACB General Meeting to vote on the proposals described in this proxy statement/prospectus. However, you do not need to attend the OACB General Meeting to vote your shares. Instead, you may submit your proxy by signing, dating and returning the applicable enclosed proxy card(s) in the pre-addressed postage-paid envelope. Your vote is important. OACB encourages you to vote as soon as possible after carefully reading this proxy statement/prospectus. |
A. | Yes. After carefully reading and considering the information contained in (and incorporated by reference into) this proxy statement/prospectus, please submit your proxy, as applicable, by completing, signing, dating and returning the enclosed proxy card in the postage-paid envelope provided. |
A. | No. If your broker holds your shares in its name and you do not give the broker voting instructions, under the applicable stock exchange rules, your broker may not vote your shares on any of the proposals. If you do not give your broker voting instructions and the broker does not vote your shares, this is referred to as a “Broker Non-vote.” Broker Non-votes will be counted for purposes of determining the presence of a quorum at the OACB General Meeting, and will have no effect on the Business Combination Proposal, the First Merger Proposal and the Shareholder Adjournment Proposal. However, in no event will a Broker Non-vote also have the effect of exercising your redemption rights |
for a pro rata portion of the Trust Account, and therefore no shares as to which a Broker Non-vote occurs will be redeemed in connection with the proposed Business Combination. |
A. | Yes. You may change your vote by sending a later-dated, signed proxy card to OACB prior to the vote at the OACB General Meeting, or attend the OACB General Meeting and vote virtually or in person. You also may revoke your proxy by sending a notice of revocation to OACB, provided such revocation is received prior to the vote at the OACB General Meeting. If your shares are held in street name by a broker or other nominee, you must contact the broker or nominee to change your vote. |
A. | You may receive more than one set of voting materials, including multiple copies of this proxy statement/prospectus and multiple proxy cards or voting instruction cards. For example, if you hold your shares in more than one brokerage account, you will receive a separate voting instruction card for each brokerage account in which you hold shares. If you are a holder of record and your shares are registered in more than one name, you will receive more than one proxy card. Please complete, sign, date and return each proxy card and voting instruction card that you receive in order to cast your vote with respect to all of your shares. |
A. | A quorum will be present at the OACB General Meeting if a majority of the OACB Ordinary Shares outstanding and entitled to vote at the meeting is represented in person or by proxy. In the absence of a quorum, the Memorandum and Articles of Association provide that the meeting shall stand adjourned to the same day in the next week, at the same time and place as the adjourned meeting. |
A. | Properly exercising your redemption rights as an OACB shareholder does not result in either a vote “FOR” or “AGAINST” the Business Combination Proposal or any of the other proposals described in this proxy statement/prospectus. If the Business Combination is completed, all of your OACB Warrants will automatically convert into warrants to be issued TopCo Ordinary Shares as described in this proxy statement/prospectus. If the Business Combination is not completed, you will continue to hold your OACB Warrants, and if OACB does not otherwise consummate an initial business combination by September 21, 2022, or amend the Memorandum and Articles of Association to extend the date by which OACB must consummate an initial business combination, OACB will be required to dissolve and liquidate, and your warrants will expire worthless. |
A. | OACB will pay the cost of soliciting proxies for the OACB General Meeting. OACB has engaged Morrow Sodali to assist in the solicitation of proxies for the OACB General Meeting. OACB has agreed to pay Morrow Sodali a fee of $ . OACB will reimburse Morrow Sodali for reasonable out-of-pocket |
custodians, nominees and fiduciaries representing beneficial owners of OACB Ordinary Shares for their expenses in forwarding soliciting materials to beneficial owners of OACB Ordinary Shares and in obtaining voting instructions from those owners. OACB’s directors, officers and employees may also solicit proxies by telephone, by facsimile, by mail, on the Internet or in person. They will not be paid any additional amounts for soliciting proxies. |
A. | If you have questions about the shareholder proposals, or if you need additional copies of this proxy statement/prospectus, or the proxy cards you should contact Morrow Sodali, the proxy solicitation agent for OACB, toll-free at (800) 662-5200 (banks and brokers call (203) 658-9400) or email OACB.info@investor.morrowsodali.com. |
• | the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; |
• | the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and |
• | the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified significant events. |
• | the beneficial ownership of the Sponsor of an aggregate of 6,250,000 OACB Class B Ordinary Shares, which shares would become worthless if OACB does not complete a business combination within the |
applicable time period, as the Initial Shareholders have waived any right to redemption with respect to these shares for no consideration in return. Such shares have an aggregate market value of approximately $ based on the closing price of OACB Class A Ordinary Shares of $ on the New York Stock Exchange on , 2022 the record date for the OACB General Meeting; |
• | OACB’s directors will not receive reimbursement for any out-of-pocket |
• | the potential continuation of certain of OACB’s directors as directors of TopCo; |
• | the continued indemnification of current directors and officers of OACB and the continuation of directors’ and officers’ liability insurance after the Business Combination; |
• | certain of OACB’s officers and directors are employed by Oaktree. Certain affiliates of Oaktree have an approximately 1% equity stake in Alvotech and hold approximately 47.48% ($82,953,251 aggregate principal amount) of Alvotech’s Tranche A bonds and approximately 33.99% of Alvotech’s Tranche B bonds ($75,699,188 aggregate principal amount). Such affiliates’ equity stake, which was acquired after a conversion of a portion of the Alvotech debt securities, would be valued at approximately $1.5 million, assuming a value of $10.00 per share and the consummation of the Business Combination. The Tranche A bonds and Tranche B bonds will remain outstanding after the consummation of the Business Combination; |
• | the fact that the Sponsor (and OACB’s officers and directors who are members of the Sponsor) has invested an aggregate of $7,025,000 in OACB, comprised of the $25,000 purchase price of 6,250,000 OACB Class B Ordinary Shares and the $7,000,000 purchase price for 4,666,667 OACB Private Warrants. Assuming a trading price of $9.86 per OACB Class A Ordinary Share and $1.09 per OACB Public Warrant (based upon the respective closing prices of the OACB Class A Ordinary Shares and the OACB Public Warrants on the NYSE on January 31, 2022), the 6,250,000 Class B Ordinary Shares and 4,666,667 OACB Private Warrants would have an implied aggregate market value of approximately $66,711,667. Even if the trading price of the TopCo Ordinary Shares were as low as $1.12 per share, the aggregate market value of the OACB Class B Ordinary Shares alone (without taking into account the value of the OACB Private Warrants) would be approximately equal to the initial investment in OACB by the Initial Shareholders. As a result, the Initial Shareholders are likely to be able to make a substantial profit on their investment in OACB at a time when TopCo Ordinary Shares have lost significant value. On the other hand, if OACB liquidates without completing a business combination before September 21, 2022, the Initial Shareholders will likely lose their entire investment in OACB; |
• | the fact that the Sponsor and OACB’s officers and directors will benefit from the completion of a business combination and may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidate; and |
• | the fact that the Sponsor and its affiliates can earn a positive rate of return on their investment, even if Public Shareholders experience a negative rate of return in the post-business combination company. |
Amounts in thousands, except share amounts, per share amounts and percentages |
Assuming No Redemptions |
Assuming 25% of Maximum Redemptions |
Assuming 50% of Maximum Redemptions |
Assuming 75% of Maximum Redemptions |
Assuming Maximum Redemptions |
|||||||||||||||||||||||||||||||||||
Ownership in Shares |
% |
Ownership in Shares |
% |
Ownership in Shares |
% |
Ownership in Shares |
% |
Ownership in Shares |
% |
|||||||||||||||||||||||||||||||
Alvotech shareholders (1) |
180,600,000 | 79 | % | 180,600,000 | 80 | % | 180,600,000 | 81 | % | 180,600,000 | 83 | % | 180,600,000 | 84 | % | |||||||||||||||||||||||||
OACB shareholders (2) |
25,000,000 | 11 | % | 21,876,176 | 10 | % | 18,752,353 | 9 | % | 15,628,529 | 7 | % | 12,504,705 | 6 | % | |||||||||||||||||||||||||
Sponsor (3) |
5,000,000 | 2 | % | 5,000,000 | 2 | % | 5,000,000 | 2 | % | 5,000,000 | 2 | % | 5,000,000 | 2 | % | |||||||||||||||||||||||||
PIPE investors |
17,493,000 | 8 | % | 17,493,000 | 8 | % | 17,493,000 | 8 | % | 17,493,000 | 8 | % | 17,493,000 | 8 | % | |||||||||||||||||||||||||
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|
|
|||||||||||||||||||||||||||||||
Pro Forma Ordinary Shares Outstanding |
228,093,000 |
224,969,176 |
221,845,353 |
218,721,529 |
215,597,705 |
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(1) | Excludes 38,330,000 Seller Earn Out Shares that are subject to certain transfer, vesting and buyback restrictions. Holders of the Seller Earn Out are entitled to the voting and dividend rights generally granted to holders of TopCo Ordinary Shares. |
(2) | Excludes 6,250,000 of Public OACB Warrants which will be converted into warrants for new TopCo Ordinary Shares. |
(3) | Excludes 1,250,000 Sponsor Earn Out Shares that are subject to certain transfer, vesting and buyback restrictions. Holders of the Sponsor Earn Out Shares are entitled to the voting and dividend rights generally granted to holders of TopCo Ordinary Shares. Also excludes 4,666,667 of Private OACB Warrants which will be converted into warrants for new TopCo Ordinary Shares. |
(1) | For more information about the ownership interests of Alvotech Holdings S.A., prior to the Business Combination, please see the section entitled “ Security Ownership of Certain Beneficial Owners and Management of TopCo. |
(2) | The diagram above shows all subsidiaries of Alvotech Holdings S.A. |
(1) | The diagram above shows all subsidiaries of TopCo. |
(2) | The diagram above does not include Seller Earn Out Shares (as defined below) or Sponsor Earn Out Shares (as defined below). |
• | OACB has no operating or financial history and its results of operations and those of TopCo may differ significantly from the unaudited pro forma financial data included in this proxy statement. |
• | OACB may not be able to consummate an initial business combination within 24 months after the closing of its initial public offering, in which case OACB would cease all operations except for the purpose of winding up and OACB would redeem its Public Shares and liquidate. |
• | The ability of the Public Shareholders to exercise redemption rights with respect to a large number of OACB Class A Ordinary Shares could increase the probability that the Business Combination will be unsuccessful and that OACB’s shareholders will have to wait for liquidation in order to redeem their Public Shares. |
• | The process of taking a company public by means of a business combination with a special purpose acquisition company (“SPAC”) is different from taking a company public through an underwritten offering and may create risks for our unaffiliated investors. |
• | If a Public Shareholder fails to receive or timely act upon notice of OACB’s offer to redeem OACB Class A Ordinary Shares in connection with the Business Combination or fails to comply with the procedures for tendering its shares, such shares may not be redeemed. |
• | If a shareholder or a “group” of shareholders are deemed to hold in excess of 15% of OACB Class A Ordinary Shares, such shareholder or group will lose the ability to redeem all such shares in excess of 15% of OACB Class A Ordinary Shares. |
• | OACB’s shareholders cannot be sure of the market value of the TopCo Ordinary Shares to be issued upon completion of the Business Combination. |
• | The TopCo Ordinary Shares to be received by OACB’s shareholders as a result of the Business Combination will have different rights from OACB Class A Ordinary Shares. |
• | The Sponsor and OACB’s executive officers and directors have potential conflicts of interest in recommending that shareholders vote in favor of approval of the Business Combination Proposal and approval of the other proposals described in the Registration Statement of which this proxy statement/prospectus is a part. |
• | If OACB fails to consummate the PIPE Financing, it may not have enough funds to complete the Business Combination. |
• | Subsequent to the consummation of the Business Combination, TopCo may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on its financial condition, results of operations and share price, which could cause you to lose some or all of your investment. |
• | OACB’s shareholders will have a reduced ownership and voting interest after consummation of the Business Combination and will exercise less influence over management. |
• | OACB has identified a material weakness in its internal control over financial reporting. If OACB is unable to develop and maintain an effective system of internal control over financial reporting, it may not be able to accurately report its financial results in a timely manner, which may adversely affect investor confidence in OACB and materially and adversely affect its business and operating results. |
• | OACB may face litigation and other risks as a result of the material weakness in our internal control over financial reporting. |
• | Alvotech has a limited operating history in a highly regulated environment, has incurred significant losses since its inception, anticipates that it may continue to incur significant losses for the immediate future and may never be profitable. |
• | The regulatory approval processes of the FDA, European Commission and comparable national or regional authorities are lengthy and time consuming and Alvotech cannot give any assurance that marketing authorization applications for any of its product candidates will receive regulatory approval. |
• | Alvotech’s product candidates may cause unexpected side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if granted. |
• | Even if Alvotech obtains regulatory approval for a product candidate, its products will remain subject to continuous subsequent regulatory obligations and scrutiny. |
• | Alvotech relies on third parties to conduct its nonclinical and clinical studies, to manufacture aspects of clinical and commercial supplies of its product candidates, and to store critical components of its product candidates. If these third parties do not successfully carry out their contractual duties, or are not compliant with regulatory requirements, Alvotech may not be able to obtain regulatory approval for or commercialize its product candidates. |
• | Alvotech is subject to a multitude of risks related to manufacturing. Any adverse developments affecting the manufacturing operations of Alvotech’s biosimilar products could substantially increase its costs and limit supply for its products, or could affect the approval status of its products. |
• | Alvotech may not realize the benefits expected through the Joint Venture and the Joint Venture could have adverse effects on Alvotech’s business. |
• | Alvotech’s biosimilar product candidates, if approved, will face significant competition from the reference products, from other biosimilar products that reference the same reference products including those which may have regulatory exclusivities, and from other medicinal products approved for the same indication(s) as the reference products. Alvotech’s failure to effectively compete may prevent it from achieving significant market penetration and expansion. |
• | Alvotech currently has no marketing and sales organization. |
• | If Alvotech infringes or is alleged to infringe the intellectual property rights of third parties, its business could be harmed. Alvotech is in legal proceedings adverse to AbbVie relating to Alvotech’s biosimilar adalimumab product, the AVT02 product. |
• | Alvotech has identified material weaknesses in its internal control over financial reporting. If Alvotech is unable to remediate these material weaknesses, or if TopCo experiences additional material weaknesses in the future or otherwise is unable to develop and maintain an effective system of internal controls in the future, TopCo may not be able to produce timely and accurate financial statements or comply with applicable laws and regulations. |
• | TopCo has no operating or financial history and its results of operations may differ significantly from the unaudited pro forma financial data included in this proxy statement/prospectus. |
• | The market price and trading volume of TopCo Ordinary Shares and TopCo Warrants may be volatile and could decline significantly following the Business Combination. |
For the Nine Months ended September 30, 2021 (as restated) |
For the Period from August 5, 2020 (inception) to December 31, 2020 (as restated) |
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Statement of Operations Data: |
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General and administrative costs |
$ | 3,626,413 | $ | 270,964 | ||||
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Loss from operations |
(3,626,413 | ) | (270,964 | ) | ||||
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Other income (expense) |
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Net gain on investments held in Trust Account |
19,250 | 6,919 | ||||||
Change in fair value of derivative warrant liabilities |
11,549,160 | (8,574,000 | ) | |||||
Financing costs – derivative warrant liabilities |
— | (433,190 | ) | |||||
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Total other income (expense) |
11,568,410 | (9,000,271 | ) | |||||
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Net (loss) income |
7,941,997 | (9,271,235 | ) | |||||
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Basic and diluted weighted average shares outstanding of Class A ordinary shares |
25,000,000 | 17,176,871 | ||||||
Basic and diluted net income loss per ordinary share |
0.25 | (0.40 | ) | |||||
Basic and diluted weighted average shares outstanding of Class B ordinary shares |
6,250,000 | 6,058,673 | ||||||
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Basic and diluted net loss per ordinary share |
$ | 0.25 | $ | (0.40 | ) | |||
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As of September 30, 2021 (as restated) |
As of December 31, 2020 (as restated) |
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Condensed Balance Sheet Data (At Period End): |
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Total assets |
$ | 251,077,485 | $ | 251,534,022 | ||||
Total liabilities |
22,207,302 | 30,605,835 | ||||||
Class A ordinary shares subject to possible redemption |
250,000,000 | 250,000,000 | ||||||
Total shareholders’ deficit |
(21,129,817 | ) | (29,071,814 | ) |
For the Nine Months ended September 30, 2021 (as restated) |
For the Period from August 5, 2020 (inception) to December 31, 2020 (as restated) |
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Cash Flow Data: |
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Net cash used in operating activities |
$ | (299,004 | ) | $ | (315,876 | ) | ||
Net cash provided by (used in) investing activities |
25,000 | (250,000,000 | ) | |||||
Net cash (used in) provided by financing activities |
$ | (85,000 | ) | $ | 251,583,590 |
Six Months Ended June 30, |
Year Ended December 31, |
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2021 |
2020 |
2020 |
2019 |
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Revenue |
2,008 | 10,310 | 66,616 | 31,918 | ||||||||||||
Other income |
348 | 1,381 | 2,833 | 50,757 | ||||||||||||
Research and development expenses |
(90,403 | ) | (63,601 | ) | (148,072 | ) | (95,557 | ) | ||||||||
General and administrative expenses |
(86,360 | ) | (22,191 | ) | (58,914 | ) | (48,566 | ) | ||||||||
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Operating loss |
(174,407 | ) | (74,101 | ) | (137,537 | ) | (61,448 | ) | ||||||||
Share of net (loss) / profit of joint venture |
(837 | ) | 180 | (1,505 | ) | (192 | ) | |||||||||
Finance income |
4 | 8,372 | 5,608 | 6,932 | ||||||||||||
Finance costs |
(123,575 | ) | (49,048 | ) | (161,551 | ) | (158,467 | ) | ||||||||
Exchange rate differences |
(3,611 | ) | 12,443 | 3,215 | 3,790 | |||||||||||
Gain on extinguishment of financial liabilities |
2,561 | — | — | — | ||||||||||||
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Non-operating loss |
(125,458 | ) | (28,053 | ) | (154,233 | ) | (147,937 | ) | ||||||||
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Loss before taxes |
(299,865 | ) | (102,154 | ) | (291,770 | ) | (209,385 | ) | ||||||||
Income tax benefit / (expense) |
25,918 | 31 | 121,726 | (491 | ) | |||||||||||
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Loss for the period |
(273,947 | ) | (102,123 | ) | (170,044 | ) | (209,876 | ) | ||||||||
Other comprehensive income / (loss) |
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Exchange rate differences on translation of foreign operations |
243 | (265 | ) | 5,954 | (1,468 | ) | ||||||||||
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Total comprehensive loss |
(273,704 | ) | (102,388 | ) | (164,090 | ) | (211,344 | ) | ||||||||
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Loss per share |
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Basic and diluted loss per share |
(37.13 | ) | (14.72 | ) | (24.32 | ) | (30.77 | ) |
As of June 30, 2021 |
As of December 31, |
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2020 |
2019 |
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Total assets |
520,139 | 474,422 | 374,526 | |||||||||
Total equity |
(1,013,421 | ) | (867,243 | ) | (767,538 | ) | ||||||
Total liabilities |
1,533,560 | 1,341,665 | 1,142,064 |
Six Months Ended June 30, |
Year Ended December 31, |
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2021 |
2020 |
2020 |
2019 |
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Net cash used in operating activities |
(84,734 | ) | (50,988 | ) | (74,295 | ) | (88,548 | ) | ||||||||
Net cash used in investing activities |
(6,972 | ) | (9,511 | ) | (16,903 | ) | (12,876 | ) | ||||||||
Net cash generated from financing activities |
102,001 | 11,713 | 55,402 | 116,370 |
• | Assuming No Redemptions: |
• | Assuming Maximum Redemptions: |
Pro Forma Combined (Assuming No Redemptions) |
Pro Forma Combined (Assuming Maximum Redemptions) |
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(in $ thousands, except per share data) |
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Summary of Unaudited Pro Forma Condensed Combined Statement of Profit or Loss Data for the Six Months Ended June 30, 2021 |
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Revenue |
$ | 2,008 | $ | 2,008 | ||||
Pro forma net loss |
(176,646 | ) | (176,646 | ) | ||||
Pro forma net loss per share – basic and diluted |
$ | (0.66 | ) | $ | (0.69 | ) | ||
Summary of Unaudited Pro Forma Condensed Combined Statement of Profit or Loss Data for the Year Ended December 31, 2020 |
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Revenue |
$ | 66,616 | $ | 66,616 | ||||
Pro forma net loss |
(24,114 | ) | (25,739 | ) | ||||
Pro forma net loss per share – basic and diluted |
$ | (0.09 | ) | $ | (0.10 | ) | ||
Summary of Unaudited Pro Forma Condensed Combined Statement of Financial Position Data as of June 30, 2021 |
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Total assets |
$ | 1,039,704 | $ | 914,750 | ||||
Total liabilities |
976,347 | 976,347 | ||||||
Total equity |
63,357 | (61,597 | ) |
• | our ability to consummate the Business Combination; |
• | the benefits of the Business Combination; |
• | the Combined Company’s financial performance following the Business Combination; |
• | the ability to obtain or maintain the listing of the TopCo Ordinary Shares or TopCo Warrants on Nasdaq and Nasdaq First North, following the Business Combination; |
• | changes in Alvotech’s strategy, future operations, financial position, estimated revenues and losses, projected costs, prospects and plans; |
• | Alvotech’s strategic advantages and the impact those advantages will have on future financial and operational results; |
• | Alvotech’s and TopCo’s expansion plans and opportunities; |
• | Alvotech’s ability to grow its business in a cost-effective manner; |
• | the implementation, market acceptance and success of Alvotech’s business model; |
• | developments and projections relating to Alvotech’s competitors and industry, including the estimated growth of the industry; |
• | Alvotech’s approach and goals with respect to technology; |
• | Alvotech’s expectations regarding its ability to obtain and maintain intellectual property protection and not infringe on the rights of others; |
• | the impact of the COVID-19 pandemic on Alvotech’s business; |
• | changes in applicable laws or regulations; |
• | the outcome of any known and unknown litigation and regulatory proceedings, including AbbVie litigation; |
• | Alvotech’s ability to obtain and maintain regulatory approval for its product candidates of the FDA, European Commission and comparable national or regional authorities; |
• | Alvotech’s ability to comply with all applicable laws and regulations; |
• | Alvotech’s ability to successfully launch its products in certain markets after obtaining regulatory approval for such market; |
• | Alvotech’s estimates of expenses and profitability; |
• | Alvotech’s ability to identify and successfully develop new product candidates; |
• | Alvotech’s relationship with third party providers for clinical and non-clinical studies, supplies, and manufacturing of its products; |
• | Alvotech’s ability to manage its manufacturing risks; and |
• | Alvotech’s relationship with partners for the commercialization of its product candidates. |
• | the occurrence of any event, change or other circumstances that could delay the Business Combination or give rise to the termination of the Business Combination Agreement; |
• | the outcome of any legal proceedings that may be instituted against OACB, TopCo or Alvotech following announcement of the proposed Business Combination and transactions contemplated thereby; |
• | the outcome of the legal proceedings adverse to AbbVie relating to Alvotech’s biosimilar adalimumab product, AVT02; |
• | the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of OACB or to satisfy other conditions to the Closing in the Business Combination Agreement; |
• | the ability to obtain or maintain the listing of the TopCo Ordinary Shares on Nasdaq and Nasdaq First North following the Business Combination; |
• | the risk that the proposed Business Combination disrupts current plans and operations of Alvotech as a result of the announcement and consummation of the transactions described herein; |
• | our ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition and the ability of Alvotech to grow and manage growth profitably following the Business Combination; |
• | costs related to the Business Combination; |
• | changes in applicable laws or regulations; |
• | the effects of the COVID-19 pandemic on Alvotech’s business; |
• | the inherent uncertainty of projected financial information with respect to OACB, TopCo or Alvotech, and the possibility that the assumptions underlying such projections ultimately prove incorrect, as described further under “Certain Unaudited Alvotech Prospective Financial Information”; |
• | the effects of competition on Alvotech’s future business; |
• | Alvotech’s position in the market against current and future competitors; |
• | Alvotech’s expansion into new products, services, technologies or geographic regions; |
• | the ability to implement business plans, forecasts, and other expectations after the completion of the proposed transaction, and identify and realize additional opportunities; |
• | the risk of downturns and the possibility of rapid change in the highly competitive industry in which Alvotech operates; |
• | the risk that Alvotech and its current and future collaborators are unable to successfully develop, seek marketing approval for, and commercialize Alvotech’s products or services, or experience significant delays in doing so; |
• | the risk that the post-combination company may never achieve or sustain profitability; |
• | the risk that the post-combination company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; |
• | the risk that the post-combination company experiences difficulties in managing its growth and expanding operations; |
• | the risk that Alvotech has identified a material weakness in its internal control over financial reporting which, if not corrected, could affect the reliability of Alvotech’s financial statements; |
• | the risk that Alvotech is unable to secure or protect its intellectual property; |
• | the risk that estimated growth of the industry does not occur, or does not occur at the rates or timing Alvotech has assumed based on third-party estimates and its own internal analyses; |
• | the possibility that OACB or Alvotech may be adversely affected by other economic, business, and/or competitive factors; and |
• | other risks and uncertainties described in this proxy statement/prospectus, including those under the section entitled “ Risk Factors |
• | continues its analytical, nonclinical and clinical development of its product candidates; |
• | expands the scope of its current clinical studies for its product candidates; |
• | advances its programs into more expensive clinical studies; |
• | initiates additional analytical, nonclinical, clinical or other studies for its product candidates; |
• | changes or adds contract manufacturers, clinical research service providers, testing laboratories, device suppliers, legal service providers or other vendors or suppliers; |
• | establishes a sales and marketing infrastructure; |
• | seeks to identify, assess, acquire and/or develop other biosimilar product candidates or products that may be complementary to its products; |
• | makes upfront, milestone, royalty or other payments under any license agreements; |
• | seeks to create, maintain, protect, expand and enforce its intellectual property portfolio; |
• | engages legal counsel and technical experts to help evaluate and avoid infringing any valid and enforceable intellectual property rights of third parties; |
• | engages in litigation including patent litigation with reference product companies or others that may hold patents allegedly infringed by Alvotech; |
• | seeks to attract and retain skilled personnel; |
• | creates additional infrastructure to support its operations as a public company and its product development and planned future commercialization efforts; and |
• | experiences any delays or encounters issues with any of the above, including but not limited to failed studies, conflicting results, safety issues, delays due to the COVID-19 pandemic, litigation or regulatory challenges that may require longer follow-up of existing studies, additional major studies or additional supportive studies in order to obtain marketing approval. |
• | completing analytical, nonclinical and clinical development of its product candidates; |
• | developing and testing of its product formulations; |
• | obtaining and retaining regulatory and marketing approvals for product candidates for which Alvotech completes clinical studies; |
• | developing a sustainable and scalable manufacturing process for any approved product candidates that is compliant with regulatory manufacturing requirements and establishing and maintaining supply and |
manufacturing relationships with third parties that can conduct the process and provide adequate (in amount and quality) products to support clinical development and the market demand for its product candidates, if approved; |
• | launching and commercializing product candidates for which Alvotech obtains regulatory and marketing approval, either directly or with collaboration partners or distributors; |
• | obtaining adequate third-party payor coverage and reimbursements for its products; |
• | obtaining market acceptance of biosimilar pharmaceuticals and its product candidates as viable treatment options; |
• | addressing any competing technological and market developments; |
• | identifying, assessing and developing (or acquiring/in-licensing) new product candidates; |
• | negotiating favorable or commercially reasonable terms in any collaboration, licensing or other arrangements into which Alvotech may enter; |
• | maintaining, protecting and expanding its portfolio of intellectual property rights, including patents, trade secrets and know-how; |
• | attracting, hiring and retaining qualified personnel; and |
• | the result of potential litigation including patent litigation with reference product companies or others that may allegedly infringement by Alvotech. |
• | whether Alvotech can obtain sufficient capital to begin production and grow its business; |
• | Alvotech’s ability to manage its growth; |
• | the ability to obtain necessary regulatory approvals; |
• | the timing and costs of new and existing marketing and promotional efforts; |
• | competition, including from established and future competitors; |
• | estimates regarding industry and market growth; |
• | Alvotech’s ability to retain existing key management, to integrate recent hires and to attract, retain and motivate qualified personnel; |
• | the overall strength and stability of the economies in the markets in which it operates or intends to operate in the future; and |
• | regulatory, legislative and political changes. |
• | the scope, rate of progress, results and cost of its analytical studies, clinical studies, nonclinical testing and other related activities; |
• | the cost of manufacturing clinical supplies and establishing commercial supplies, of its product candidates and any products that Alvotech may develop; |
• | the number and characteristics of product candidates that Alvotech pursues; |
• | the cost, timing and outcomes of regulatory approvals; |
• | the cost and timing of establishing sales, marketing and distribution capabilities; |
• | the terms and timing of any collaborative, licensing and other arrangements that Alvotech may establish, including any milestone and royalty payments thereunder; and |
• | the cost, timing and outcomes of any litigation that Alvotech may file or that may be filed against Alvotech by third parties. |
• | the data collected from analytical, nonclinical, or clinical studies of its product candidates may not be sufficient to support an application for marketing approval as a biosimilar; |
• | the FDA or comparable national or regional regulatory authorities may disagree with the design or implementation, or sufficiency of its analytical, nonclinical, or clinical studies; |
• | the FDA or comparable regulatory authorities may disagree with its interpretation of data from analytical and bioanalytical studies, nonclinical studies or clinical studies; |
• | Alvotech may be unable to provide adequate scientific justification to the FDA or comparable regulatory authorities for extrapolation of a product candidate to each proposed indication; |
• | the FDA or comparable regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications, facilities or third-party manufacturers with which Alvotech contracts for clinical and commercial supplies; |
• | the approval may be blocked by regulatory exclusivity held by a competing manufacturer; and |
• | the approval requirements, policies, or regulations of the FDA or comparable regulatory authorities may significantly change in a manner rendering its clinical, nonclinical, analytical, or chemistry, manufacturing, and control data insufficient for approval. |
• | inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation of human clinical studies; |
• | delays in reaching a consensus with regulatory agencies on study design; |
• | delays in reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical study sites; |
• | delays in obtaining required Institutional Review Board, or IRB, approval or Ethics Committee positive opinion at each clinical study site; |
• | imposition of a clinical hold by regulatory agencies, after review of an investigational new drug, or IND, application or amendment or equivalent application or amendment, or an inspection of its clinical study operations or study sites or as a result of adverse events reported during a clinical trial; |
• | delays in administering studies as a result of adverse events or complaints; |
• | delays in recruiting suitable or sufficient numbers of patients to participate in its clinical studies sponsored by Alvotech or its partners; |
• | difficulty collaborating with patient groups and investigators; |
• | failure by its CROs, clinical study sites, other third parties or Alvotech to adhere to clinical study requirements; |
• | failure to perform in accordance with the FDA’s good clinical practices requirements or applicable regulatory guidelines in other countries; |
• | delays in having patients complete participation in a study or return for post-treatment follow-up, or patients dropping out of a study; |
• | occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits; |
• | difficulties justifying the scientific relevance of non-U.S. comparators for use in studies intended to support marketing approval by FDA; |
• | questions with regard to the scientific justification for extrapolation of findings across indications; |
• | changes in regulatory requirements or policies that require amending or submitting new clinical protocols; |
• | the cost of clinical studies of its product candidates being greater than Alvotech anticipates; |
• | clinical studies of its product candidates producing negative or inconclusive results, which may result in Alvotech deciding or regulators requiring Alvotech to conduct additional clinical studies or to abandon product development programs; |
• | delays in manufacturing, testing, releasing, validating or importing/exporting and/or distributing sufficient stable quantities of its product candidates and reference products for use in clinical studies or the inability to do any of the foregoing; |
• | staffing shortages and limitation on the movement of people as a result of the COVID-19 pandemic and related local, national or international governmental restrictions; and |
• | delays or interruptions to preclinical studies, clinical trials, Alvotech’s receipt of services from third-party service providers or Alvotech’s supply chain due to the COVID-19 pandemic or otherwise. |
• | regulatory authorities may suspend, withdraw or vary approvals of such product; |
• | regulatory authorities may require additional warnings on the label or otherwise require labeling to be updated or narrowed; |
• | Alvotech may be required to agree to a Risk Evaluation and Mitigation Strategy, or REMS, or a shared system REMS, which could include a medication guide for distribution to patients outlining the risks of side effects, a communication plan for healthcare providers and/or other elements to assure safe use; |
• | Alvotech could be sued and potentially held liable for harm caused to patients; and |
• | Alvotech’s reputation may suffer. |
• | issue warning or untitled letters; |
• | refer a case to the U.S. Department of Justice to impose civil or criminal penalties; |
• | begin proceedings to suspend or withdraw regulatory approval; |
• | issue an import alert; |
• | suspend Alvotech’s ongoing clinical studies or put Alvotech’s investigational new drug application (“IND”) on clinical hold; |
• | refuse to approve pending applications (including supplements to approved applications) submitted by Alvotech; |
• | ask Alvotech to initiate a product recall; or |
• | refer a case to the U.S. Department of Justice to seize and forfeit products or obtain an injunction imposing restrictions on its operations. |
• | its collaboration partners may incur financial, legal or other difficulties that force them to limit or reduce their participation in its joint projects; |
• | its collaboration partners may be pursuing alternative technologies or developing alternative products that are competitive to its technology and products, either on their own or in partnership with others; |
• | its collaboration partners may terminate their collaborations with Alvotech, which could make it difficult for Alvotech to attract new partners or adversely affect perception of Alvotech in the business and financial communities; and |
• | its collaboration partners may pursue higher priority programs or change the focus of their development programs, which could affect their commitment to Alvotech. |
• | raw material and/or consumable shortages from external suppliers; |
• | product loss due to contamination, equipment failure, or operator error; and |
• | equipment installation and qualification failures, equipment breakdowns, labor shortages, natural disasters, power failures and numerous other factors associated with the manufacturing facilities in which its products are produced. |
• | settling patent lawsuits with biosimilar companies, resulting in such patents remaining an obstacle for biosimilar approval by others; |
• | submitting Citizen Petitions to request the FDA Commissioner to take administrative action with respect to prospective and submitted biosimilar applications or to elaborate or amend the standard of review for such biosimilar applications; |
• | appealing denials of Citizen Petitions in U.S. federal district courts and seeking injunctive relief to reverse approval of biosimilar applications; |
• | restricting access to reference brand products for equivalence and biosimilarity testing that interferes with timely biosimilar development plans; |
• | attempting to influence potential market share by conducting medical education with physicians, payors, regulators and patients claiming that biosimilar products are too complex for biosimilar approval or are too dissimilar from reference products to be trusted as safe and effective alternatives; |
• | implementing payor market access tactics that benefit their brands at the expense of biosimilars; |
• | seeking state law restrictions on the substitution of biosimilar products at the pharmacy without the intervention of a physician or through other restrictive means such as excessive recordkeeping requirements or patient and physician notification; |
• | seeking federal or state regulatory restrictions, or equivalent foreign restrictions, on the use of the same non-proprietary name as the reference brand product for a biosimilar or interchangeable biologic; |
• | seeking changes to the U.S. Pharmacopeia, an industry recognized compilation of drug and biologic standards, or equivalent international or foreign standards; |
• | obtaining new patents covering existing products or processes which could extend patent exclusivity for a number of years or otherwise delay the launch of biosimilars; |
• | originator could compete with Alvotech by manufacturing or commercializing their own proprietary biosimilar product to the reference product they sponsor; and |
• | influencing legislatures so that they attach special patent extension amendments to unrelated federal legislation. |
• | the safety and efficacy of the product as demonstrated in clinical studies and through the demonstration of biosimilarity; |
• | any potential advantages over competing biosimilars and/or other treatments in the same therapeutic space(s); |
• | the prevalence and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling; |
• | the clinical indications for which approval is granted; |
• | the possibility that a competitor may achieve interchangeability in the U.S. and Alvotech may not; |
• | relative convenience and ease of administration; |
• | the extent to which its product may be more or less similar to the reference product than competing biosimilar product candidates; |
• | policies and practices governing the naming of biological product candidates; |
• | prevalence of the disease or condition for which the product is approved; |
• | the cost of treatment, particularly in relation to competing treatments; |
• | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
• | the strength of marketing and distribution support and timing of market introduction of competitive products; |
• | publicity concerning its products or competing products and treatments; |
• | the extent to which third-party payors provide adequate third-party coverage and reimbursement for its product candidates, if approved; |
• | patients’ willingness to pay out-of-pocket |
• | its ability to maintain compliance with regulatory requirements. |
• | Alvotech may not be successful in identifying potential product candidates that pass its strict screening criteria; |
• | Alvotech may not be able to overcome technological hurdles to development or a product candidate may not be capable of producing commercial quantities at an acceptable cost or at all; |
• | Alvotech may not be able to assemble sufficient resources to acquire or discover additional product candidates; |
• | Alvotech’s product candidates may not succeed in analytical, nonclinical, or clinical testing; |
• | Alvotech’s potential product candidates may fail to show biosimilarity to reference products; |
• | Alvotech may not be successful in overcoming intellectual property obstacles in a timely manner or at all; and |
• | competitors may develop alternatives that render Alvotech’s product candidates obsolete or less attractive or the market for a product candidate may change such that a product candidate may not justify further development. |
• | the federal Anti-Kickback Statute, which prohibits, among other things, , any individual or entity from knowingly and willfully soliciting, offering or paying remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce another individual or entity to : (a) refer an individual to a person for the furnishing (or arranging for the furnishing) of any item or service for which payment may be made under a federal health care program; (b) purchase or order any covered item or service; (c) arrange for the purchase or order of any covered item or service; or (d) recommend the purchase or order of any covered item or service; |
• | federal civil and criminal false claims laws and civil monetary penalties laws, including the FCA and the CMPL, which prohibit, among other things, individuals or entities from knowingly presenting or causing to be presented false, fictitious, or fraudulent claims for payment to the U.S. government; |
• | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of health information that allows identification of individual patients on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, as well as individuals and entities that provide services on behalf of a covered entity that involve individually identifiable health information, known as business associates, as well as their covered subcontractors; |
• | Federal and state transparency laws and regulations, such as the federal Physician Payments Sunshine Act. The federal Physician Payment Sunshine Act which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value made by such manufacturers to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), physicians and their immediate family members in such manufacturers. Beginning in 2022, applicable manufacturers also will be required to report such information regarding its payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year; and |
• | state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers, state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the national or federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; national or state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and national or state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
• | multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses; |
• | failure by Alvotech or its collaboration partners to obtain and maintain regulatory approvals for the use of its products in various countries; |
• | additional potentially relevant third-party patent rights; |
• | complexities and difficulties in obtaining protection and enforcing its intellectual property; |
• | difficulties in staffing and managing foreign operations by Alvotech or its collaboration partners; |
• | complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems by its collaboration partners; |
• | limits in its or its collaboration partners’ ability to penetrate international markets; |
• | financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for its products; |
• | foreign exchange risk, as Alvotech’s has significant asset and liabilities denominated in foreign currencies (mainly in EUR, GBP, ISK, and CHF), and a 10% fluctuation of the exchange rate of ISK against the USD can significantly impact Alvotech; |
• | natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; |
• | certain expenses including, among others, expenses for travel, translation and insurance; and |
• | regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act its books and records provisions or its anti-bribery provisions. |
• | a limited availability of market quotations for its securities; |
• | reduced liquidity for its securities; |
• | a determination that TopCo Ordinary Shares are a “penny stock” which will require brokers trading in the TopCo Ordinary Shares to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for its securities; |
• | a limited amount of news and analyst coverage; and |
• | a decreased ability to issue additional securities or obtain additional financing in the future. |
• | the realization of any of the risk factors presented in this proxy statement/prospectus; |
• | actual or anticipated differences in TopCo’s estimates, or in the estimates of analysts, for TopCo’s revenues, results of operations, liquidity or financial condition; |
• | additions and departures of key personnel; |
• | failure to comply with the requirements of Nasdaq; |
• | failure to comply with the Sarbanes-Oxley Act or other laws or regulations; |
• | future issuances, sales or resales, or anticipated issuances, sales or resales, of TopCo Ordinary Shares; |
• | publication of research reports about TopCo; |
• | the performance and market valuations of other similar companies; |
• | broad disruptions in the financial markets, including sudden disruptions in the credit markets; |
• | material and adverse impact of the COVID-19 pandemic on the markets and the broader global economy; |
• | speculation in the press or investment community; |
• | actual, potential or perceived control, accounting or reporting problems; and |
• | changes in accounting principles, policies and guidelines. |
• | the judgment of the U.S. court is final and enforceable ( exécutoire |
• | the U.S. court had full jurisdiction over the subject matter leading to the judgment (that is, its jurisdiction was in compliance both with Luxembourg private international law rules and with the applicable domestic U.S. federal or state jurisdictional rules); |
• | the U.S. court applied to the dispute the substantive law which is designated by the Luxembourg conflict of laws rules or, at least, such court’s order must not contravene the principles underlying those rules (based on recent case law and legal doctrine, it is not certain that this condition would still be required for an exequatur to be granted by a Luxembourg court); |
• | the judgment was granted following proceedings where the counterparty had the opportunity to appear and, if it appeared, to present a defense, and the decision of the foreign court must not have been obtained by fraud, but in compliance with the rights of the defendant; |
• | the U.S. court acted in accordance with its own procedural laws; |
• | the judgment of the U.S. court does not contradict an already issued judgment of a Luxembourg court, and |
• | the decisions and the considerations of the U.S. court must not be contrary to Luxembourg international public policy rules (as such term is interpreted under the laws of Luxembourg) or have been given in proceedings of a tax or criminal nature or rendered subsequent to an evasion of Luxembourg law ( fraude à la loi |
• | changes in financial estimates by analysts; |
• | announcements by it or its competitors of significant contracts, productions, acquisitions or capital commitments; |
• | fluctuations in its quarterly financial results or the quarterly financial results of companies perceived to be similar to it; |
• | general economic conditions; |
• | changes in market valuations of similar companies; |
• | terrorist acts; |
• | changes in its capital structure, such as future issuances of securities or the incurrence of additional debt; |
• | future sales of TopCo Ordinary Shares; |
• | regulatory developments in the U.S. or other countries; |
• | litigation involving TopCo, its subsidiaries or its general industry; and |
• | additions or departures of key personnel. |
• | the beneficial ownership of the Sponsor and certain of OACB’s directors of an aggregate of 6,250,000 OACB Class B Ordinary Shares, which shares would become worthless if OACB does not complete a business combination within the applicable time period, as the Initial Shareholders have waived any right to redemption with respect to these shares for no consideration in return. Such shares have an aggregate market value of approximately $ based on the closing price of OACB Class A Ordinary Shares of $ on NYSE on , 2022, the record date for the OACB General Meeting; |
• | OACB’s directors will not receive reimbursement for any out-of-pocket |
• | the potential continuation of certain OACB’s directors as directors of the post-Business Combination company; |
• | the continued indemnification of current directors and officers of OACB and the continuation of directors’ and officers’ liability insurance after the Business Combination; |
• | certain of OACB’s officers and directors are employed by Oaktree. Certain affiliates of Oaktree have an approximately 1% equity stake in Alvotech and hold approximately 47.48% ($82,953,251 aggregate principal amount) of Alvotech’s Tranche A bonds and approximately 33.99% of Alvotech’s Tranche B bonds ($75,699,188 aggregate principal amount). Such affiliates’ equity stake, which was acquired after a conversion of a portion of the Alvotech debt securities, would be valued at approximately $1.5 million, assuming a value of $10.00 per share and the consummation of the Business Combination. The Tranche A bonds and Tranche B bonds will remain outstanding after the consummation of the Business Combination; |
• | the fact that the Sponsor (and OACB’s officers and directors who are members of the Sponsor) has invested an aggregate of $7,025,000 in OACB, comprised of the $25,000 purchase price of 6,250,000 OACB Class B Ordinary Shares and the $7,000,000 purchase price for 4,666,667 OACB Private |
Warrants. Assuming a trading price of $9.86 per OACB Class A Ordinary Share and $1.09 per OACB Public Warrant (based upon the respective closing prices of the OACB Class A Ordinary Shares and the OACB Public Warrants on the NYSE on January 31, 2022), the 6,250,000 Class B Ordinary Shares and 4,666,667 OACB Private Warrants would have an implied aggregate market value of approximately $66,711,667. Even if the trading price of the TopCo Ordinary Shares were as low as $1.12 per share, the aggregate market value of the OACB Class B Ordinary Shares alone (without taking into account the value of the OACB Private Warrants) would be approximately equal to the initial investment in OACB by the Initial Shareholders. As a result, the Initial Shareholders are likely to be able to make a substantial profit on their investment in OACB at a time when TopCo Ordinary Shares have lost significant value. On the other hand, if OACB liquidates without completing a business combination before September 21, 2022, the Initial Shareholders will likely lose their entire investment in OACB; |
• | the fact that the Sponsor and OACB’s officers and directors will benefit from the completion of a business combination and may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidate; and |
• | the fact that the Sponsor and its affiliates can earn a positive rate of return on their investment, even if Public Shareholders experience a negative rate of return in the post-business combination company. |
• | costs and difficulties inherent in managing cross-border business operations; |
• | rules and regulations regarding currency redemption; |
• | complex corporate withholding taxes on individuals; |
• | laws governing the manner in which future business combinations may be effected; |
• | exchange listing and/or delisting requirements; |
• | tariffs and trade barriers; |
• | regulations related to customs and import/export matters; |
• | local or regional economic policies and market conditions; |
• | unexpected changes in regulatory requirements; |
• | longer payment cycles; |
• | tax issues, such as tax law changes and variations in tax laws in the various jurisdictions in which Alvotech does business; |
• | currency fluctuations and exchange controls; |
• | rates of inflation; |
• | challenges in collecting accounts receivable; |
• | cultural and language differences; |
• | employment regulations; |
• | underdeveloped or unpredictable legal or regulatory systems; |
• | corruption; |
• | protection of intellectual property; |
• | social unrest, crime, strikes, riots and civil disturbances; |
• | regime changes and political upheaval; |
• | terrorist attacks and wars; and |
• | deterioration of political relations with the United States. |
• | OACB will merge with and into TopCo, whereby (i) all of the outstanding OACB Ordinary Shares will be exchanged for TopCo Ordinary Shares on a one-for-one |
• | immediately after the effectiveness of the First Merger but prior to the Conversion, TopCo will redeem and cancel the initial shares held by the initial sole shareholder of TopCo pursuant to a share capital reduction of TopCo; |
• | immediately after the effectiveness of the First Merger and the Redemption, the legal form of TopCo shall be changed from a simplified joint stock company ( société par actions simplifiée société anonyme |
• | immediately following the effectiveness of the Conversion and following the PIPE Financing, Alvotech will merge with and into TopCo, whereby all outstanding Alvotech Ordinary Shares will be exchanged for TopCo Ordinary Shares, pursuant to a share capital increase of TopCo, with TopCo as the surviving company in the merger. |
• | The former owners of Alvotech will hold the largest portion of voting rights in TopCo; |
• | Alvotech has the right to appoint a majority of the directors in TopCo; |
• | Alvotech’s existing senior management team will comprise senior management of TopCo; |
• | The operations of Alvotech will represent the ongoing operations of TopCo; |
• | Alvotech is the larger of the combining entities based on fair value, assets, revenues and profits; and |
• | TopCo will assume Alvotech’s headquarters. |
• | Assuming no redemptions |
• | Assuming maximum redemptions per-share redemption price of $10.00, which is the maximum redemption amount after which the closing conditions of the Business Combination Agreement are still achieved. Such closing conditions require that TopCo will receive aggregate transaction proceeds, prior to the payment of transaction costs, of $300.0 million comprising (i) the funds held in the Trust Account after giving effect to the OACB shareholder redemption and (ii) aggregate proceeds from the PIPE Financing. |
Assuming No Redemptions |
Assuming Maximum Redemptions |
|||||||||||||||
Shareholders |
Ownership in Shares |
% |
Ownership in Shares |
% |
||||||||||||
Alvotech shareholders (1) |
218,930,000 | 82 | % | 218,930,000 | 86 | % | ||||||||||
OACB shareholders |
25,000,000 | 9 | % | 12,504,705 | 5 | % | ||||||||||
Sponsor (2) |
6,250,000 | 2 | % | 6,250,000 | 2 | % | ||||||||||
Subscribers |
17,493,000 | 7 | % | 17,493,000 | 7 | % | ||||||||||
|
|
|
|
|||||||||||||
Total |
267,673,000 | 255,177,705 |
(1) | Includes 38,330,000 of Seller Earn Out Shares. Refer to tickmark (J) in the transaction accounting adjustments section for additional details. |
(2) | Includes 1,250,000 of Sponsor Earn Out Shares. Refer to tickmark (K) in the transaction accounting adjustments section for additional details. |
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||||||||||||||||||||||||||||||
Alvotech (IFRS, Historical) |
OACB (US GAAP, Restated) |
IFRS conversion and presentation alignment (Note 2) |
Transaction Accounting Adjustments |
Pro Forma Combined |
Additional Transaction Accounting Adjustments |
Pro Forma Combined |
||||||||||||||||||||||||||||||
Non-current assets |
||||||||||||||||||||||||||||||||||||
Property, plant and equipment |
$ | 63,363 | $ | — | $ | — | $ | — | $ | 63,363 | $ | — | $ | 63,363 | ||||||||||||||||||||||
Right-of-use |
124,208 | — | — | — | 124,208 | — | 124,208 | |||||||||||||||||||||||||||||
Goodwill |
13,168 | — | — | — | 13,168 | — | 13,168 | |||||||||||||||||||||||||||||
Other intangible assets |
4,420 | — | — | — | 4,420 | — | 4,420 | |||||||||||||||||||||||||||||
Contract assets |
1,843 | — | — | — | 1,843 | — | 1,843 | |||||||||||||||||||||||||||||
Investment in joint venture |
56,394 | — | — | — | 56,394 | — | 56,394 | |||||||||||||||||||||||||||||
Other long-term assets |
714 | — | — | — | 714 | — | 714 | |||||||||||||||||||||||||||||
Restricted cash |
10,087 | — | — | — | 10,087 | — | 10,087 | |||||||||||||||||||||||||||||
Deferred tax assets |
147,936 | — | — | — | 147,936 | — | 147,936 | |||||||||||||||||||||||||||||
Investments held in Trust Account |
— | 250,023 | — | (250,023 | ) | A |
— | — | — | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Total non-current assets |
422,133 | 250,023 | — | (250,023 | ) | 422,133 | — | 422,133 | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Current assets |
||||||||||||||||||||||||||||||||||||
Inventories |
19,922 | — | — | — | 19,922 | — | 19,922 | |||||||||||||||||||||||||||||
Trade receivables |
5,732 | — | — | — | 5,732 | — | 5,732 | |||||||||||||||||||||||||||||
Contract assets |
12,390 | — | — | — | 12,390 | — | 12,390 | |||||||||||||||||||||||||||||
Other current assets |
16,826 | — | 205 | — | 17,031 | — | 17,031 | |||||||||||||||||||||||||||||
Receivables from related parties |
1,150 | — | — | — | 1,150 | — | 1,150 | |||||||||||||||||||||||||||||
Cash and cash equivalents |
41,986 | 954 | — | 250,023 | A |
561,346 | (124,954 | ) | L |
436,392 | ||||||||||||||||||||||||||
174,930 | B |
|||||||||||||||||||||||||||||||||||
(8,850 | ) | C |
||||||||||||||||||||||||||||||||||
(49,000 | ) | D |
||||||||||||||||||||||||||||||||||
151,303 | E |
|||||||||||||||||||||||||||||||||||
Prepaid expenses |
— | 205 | (205 | ) | — | — | — | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Total current assets |
98,006 | 1,159 | — | 518,406 | 617,571 | (124,954 | ) | 492,617 | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Total assets |
$ | 520,139 | $ | 251,182 | $ | — | $ | 268,383 | $ | 1,039,704 | $ | (124,954 | ) | $ | 914,750 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Commitments and contingencies |
||||||||||||||||||||||||||||||||||||
Class A ordinary shares subject to possible redemption |
— | 250,000 | (250,000 | ) | — | — | — | |||||||||||||||||||||||||||||
Equity |
— | — | — | |||||||||||||||||||||||||||||||||
Share capital |
79 | — | — | 175 | B |
2,231 | (125 | ) | L |
2,106 | ||||||||||||||||||||||||||
56 | E |
|||||||||||||||||||||||||||||||||||
250 | F |
|||||||||||||||||||||||||||||||||||
1,671 | G |
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||||||||||||||||||||||||||||||
Alvotech (IFRS, Historical) |
OACB (US GAAP, Restated) |
IFRS conversion and presentation alignment (Note 2) |
Transaction Accounting Adjustments |
Pro Forma Combined |
Additional Transaction Accounting Adjustments |
Pro Forma Combined |
||||||||||||||||||||||||||||||
Share premium |
294,260 | — | — | 174,755 | B |
1,226,127 | 1,625 | I |
1,102,923 | |||||||||||||||||||||||||||
(6,123 | ) | D |
(124,829 | ) | L |
|||||||||||||||||||||||||||||||
705,856 | E |
|||||||||||||||||||||||||||||||||||
249,751 | F |
|||||||||||||||||||||||||||||||||||
(1,671 | ) | G |
||||||||||||||||||||||||||||||||||
(38,729 | ) | H |
||||||||||||||||||||||||||||||||||
94,428 | I |
|||||||||||||||||||||||||||||||||||
(236,800 | ) | J |
||||||||||||||||||||||||||||||||||
(9,600 | ) | K |
||||||||||||||||||||||||||||||||||
Class A ordinary shares |
— | — | — | — | F |
— | — | — | ||||||||||||||||||||||||||||
Class B ordinary shares |
— | 1 | — | (1 | ) | F |
— | — | — | |||||||||||||||||||||||||||
Translation reserve |
5,217 | — | — | — | 5,217 | — | 5,217 | |||||||||||||||||||||||||||||
Additional paid-in capital |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||
Accumulated deficit |
(1,312,977 | ) | (22,229 | ) | — | (41,727 | ) | D |
(1,170,218 | ) | (1,625 | ) | I |
(1,171,843 | ) | |||||||||||||||||||||
262,414 | E |
|||||||||||||||||||||||||||||||||||
38,729 | H |
|||||||||||||||||||||||||||||||||||
(94,428 | ) | I |
||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Total equity |
(1,013,421 | ) | (22,228 | ) | — | 1,099,006 | 63,357 | (124,954 | ) | (61,597 | ) | |||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Non-current liabilities |
||||||||||||||||||||||||||||||||||||
Borrowings |
564,126 | — | — | (214,707 | ) | E |
349,419 | — | 349,419 | |||||||||||||||||||||||||||
Derivative financial liabilities |
602,316 | — | 13,427 | (602,316 | ) | E |
259,827 | — | 259,827 | |||||||||||||||||||||||||||
236,800 | J |
|||||||||||||||||||||||||||||||||||
9,600 | K |
|||||||||||||||||||||||||||||||||||
Other long-term liability to related party |
7,440 | — | — | — | 7,440 | — | 7,440 | |||||||||||||||||||||||||||||
Lease liabilities |
120,639 | — | — | — | 120,639 | — | 120,639 | |||||||||||||||||||||||||||||
Long-term incentive plan |
101,108 | — | — | — | 101,108 | — | 101,108 | |||||||||||||||||||||||||||||
Contract liabilities |
61,656 | — | — | — | 61,656 | — | 61,656 | |||||||||||||||||||||||||||||
Deferred tax liability |
162 | — | — | — | 162 | — | 162 | |||||||||||||||||||||||||||||
Deferred legal fees |
— | 100 | — | (100 | ) | C |
— | — | — | |||||||||||||||||||||||||||
Deferred underwriting commissions |
— | 8,750 | — | (8,750 | ) | C |
— | — | — | |||||||||||||||||||||||||||
Derivative warrant liabilities |
— | 13,427 | (13,427 | ) | — | — | — | — | ||||||||||||||||||||||||||||
Class A ordinary shares subject to redemption |
— | — | 250,000 | (250,000 | ) | F |
— | — | — | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Total non-current liabilities |
1,457,447 | 22,277 | 250,000 | (829,473 | ) | 900,251 | — | 900,251 | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Current liabilities |
— | — | — | — | ||||||||||||||||||||||||||||||||
Trade and other payables |
30,462 | 25 | — | 30,487 | — | 30,487 | ||||||||||||||||||||||||||||||
Lease liabilities |
5,435 | — | — | — | 5,435 | — | 5,435 | |||||||||||||||||||||||||||||
Current maturities of borrowings |
2,503 | — | — | — | 2,503 | — | 2,503 |
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||||||||||||||||||||||||||||||
Alvotech (IFRS, Historical) |
OACB (US GAAP, Restated) |
IFRS conversion and presentation alignment (Note 2) |
Transaction Accounting Adjustments |
Pro Forma Combined |
Additional Transaction Accounting Adjustments |
Pro Forma Combined |
||||||||||||||||||||||||||||||
Liabilities to related parties |
3,886 | — | 293 | — | 4,179 | — | 4,179 | |||||||||||||||||||||||||||||
Contract liabilities |
15,399 | — | — | — | 15,399 | — | 15,399 | |||||||||||||||||||||||||||||
Taxes payable |
294 | — | — | 294 | — | 294 | ||||||||||||||||||||||||||||||
Other current liabilities |
18,134 | 815 | (1,150 | ) | D |
17,799 | — | 17,799 | ||||||||||||||||||||||||||||
Accounts payable |
25 | (25 | ) | — | — | — | ||||||||||||||||||||||||||||||
Accrued expenses |
— | 815 | (815 | ) | — | — | — | — | ||||||||||||||||||||||||||||
Accrued expenses-related party |
— | 174 | (174 | ) | — | — | — | — | ||||||||||||||||||||||||||||
Advance from related party |
— | 119 | (119 | ) | — | — | — | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Total current liabilities |
76,113 | 1,133 | — | (1,150 | ) | 76,096 | — | 76,096 | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Total liabilities |
1,533,560 | 23,410 | 250,000 | (830,623 | ) | 976,347 | — | 976,347 | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Total equity and liabilities |
$ | 520,139 | $ | 251,182 | $ | — | $ | 268,383 | $ | 1,039,704 | $ | (124,954 | ) | $ | 914,750 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||||||||||||||||||||||||||
Alvotech (IFRS, Historical) |
OACB (US GAAP, Restated) |
IFRS conversion and presentation alignment (Note 2) |
Transaction Accounting Adjustments |
Pro Forma Combined |
Additional Transaction Accounting Adjustments |
Pro Forma Combined |
||||||||||||||||||||||||||
Revenue |
$ | 2,008 | $ | — | $ | — | $ | — | $ | 2,008 | $ | — | $ | 2,008 | ||||||||||||||||||
Other income |
348 | — | — | — | 348 | — | 348 | |||||||||||||||||||||||||
Research and development expenses |
(90,403 | ) | — | — | — | (90,403 | ) | — | (90,403 | ) | ||||||||||||||||||||||
General and administrative expenses |
(86,360 | ) | (1,119 | ) | — | 1,950 | M |
(85,529 | ) | — | (85,529 | ) | ||||||||||||||||||||
— | ||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Operating loss |
(174,407 | ) | (1,119 | ) | — | 1,950 | (173,576 | ) | — | (173,576 | ) | |||||||||||||||||||||
Share of net loss of joint venture |
(837 | ) | — | — | — | (837 | ) | — | (837 | ) | ||||||||||||||||||||||
Finance income |
4 | — | 7,963 | (16 | ) | N |
7,951 | — | 7,951 | |||||||||||||||||||||||
Finance costs |
(123,575 | ) | — | 88,523 | O |
(35,052 | ) | — | (35,052 | ) | ||||||||||||||||||||||
Exchange rate differences |
(3,611 | ) | — | — | — | (3,611 | ) | — | (3,611 | ) | ||||||||||||||||||||||
Gain on extinguishment of financial liabilities |
2,561 | — | — | — | 2,561 | — | 2,561 | |||||||||||||||||||||||||
Net gain on investments held in Trust Account |
— | 16 | (16 | ) | — | — | — | |||||||||||||||||||||||||
Change in fair value of derivative warrant liabilities |
— | 7,947 | (7,947 | ) | — | — | — | — | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Non-operating (loss) / profit |
(125,458 | ) | 7,963 | — | 88,507 | (28,988 | ) | — | (28,988 | ) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
(Loss) / profit before taxes |
(299,865 | ) | 6,844 | — | 90,457 | (202,564 | ) | — | (202,564 | ) | ||||||||||||||||||||||
Income tax benefit |
25,918 | — | — | — | 25,918 | — | 25,918 | |||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
(Loss) / profit for the period |
$ | (273,947 | ) | $ | 6,844 | $ | — | $ | 90,457 | $ | (176,646 | ) | $ | — | $ | (176,646 | ) | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||||||||||||||||||||||||||
Alvotech (IFRS, Historical) |
OACB (US GAAP, Restated) |
IFRS conversion and presentation alignment (Note 2) |
Transaction Accounting Adjustments |
Pro Forma Combined |
Additional Transaction Accounting Adjustments |
Pro Forma Combined |
||||||||||||||||||||||||||
Net loss per share - basic and diluted |
$ | (37.13 | ) | |||||||||||||||||||||||||||||
Basic and diluted net income per share, Class A Ordinary Shares |
$ | 0.22 | ||||||||||||||||||||||||||||||
Basic and diluted net income per share, Class B Ordinary Shares |
$ | 0.22 | ||||||||||||||||||||||||||||||
Pro forma weighted average ordinary shares outstanding - basic and diluted |
228,093,000 | 215,597,705 | ||||||||||||||||||||||||||||||
Pro forma net loss per share - basic and diluted |
$ | (0.66 | ) | $ | (0.69 | ) |
Year ended December 31, 2020 |
For the Period August 5, 2020 (inception) through December 31, 2020 |
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||||||||||||||||||||||||||||
Alvotech (IFRS, Historical) |
OACB (US GAAP, Restated) |
IFRS conversion and presentation alignment (Note 2) |
Transaction Accounting Adjustments |
Pro Forma Combined |
Additional Transaction Accounting Adjustments |
Pro Forma Combined |
||||||||||||||||||||||||||||||
Revenue |
$ | 66,616 | $ | — | $ | — | $ | — | $ | 66,616 | $ | — | $ | 66,616 | ||||||||||||||||||||||
Other income |
2,833 | — | — | — | 2,833 | — | 2,833 | |||||||||||||||||||||||||||||
Research and development expenses |
(148,072 | ) | — | — | — | (148,072 | ) | — | (148,072 | ) | ||||||||||||||||||||||||||
General and administrative expenses |
(58,914 | ) | (271 | ) | — | (43,677 | ) | M |
(197,290 | ) | (1,625 | ) | P |
(198,915 | ) | |||||||||||||||||||||
(94,428 | ) | P |
||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Operating loss |
(137,537 | ) | (271 | ) | — | (138,105 | ) | (275,913 | ) | (1,625 | ) | (277,538 | ) | |||||||||||||||||||||||
Share of net loss of joint venture |
(1,505 | ) | — | — | — | (1,505 | ) | — | (1,505 | ) | ||||||||||||||||||||||||||
Finance income |
5,608 | — | 7 | (7 | ) | N |
51,233 | — | 51,233 | |||||||||||||||||||||||||||
45,625 | O |
|||||||||||||||||||||||||||||||||||
Finance costs |
(161,551 | ) | — | (9,007 | ) | 98,523 | O |
(72,035 | ) | — | (72,035 | ) | ||||||||||||||||||||||||
Exchange rate differences |
3,215 | — | — | — | 3,215 | — | 3,215 | |||||||||||||||||||||||||||||
Gain on extinguishment of financial liabilities |
— | — | — | 149,165 | O |
149,165 | — | 149,165 | ||||||||||||||||||||||||||||
Unrealized gain on investments held in Trust Account |
— | 7 | (7 | ) | — | — | — | — | ||||||||||||||||||||||||||||
Change in fair value of derivative warrant liabilities |
— | (8,574 | ) | 8,574 | — | — | — | — | ||||||||||||||||||||||||||||
Financing costs – derivative warrant liabilities |
— | (433 | ) | 433 | — | — | — | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Non-operating (loss) / profit |
(154,233 | ) | (9,000 | ) | — | 293,306 | 130,073 | — | 130,073 | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2020 |
For the Period August 5, 2020 (inception) through December 31, 2020 |
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||||||||||||||||||||||||||||
Alvotech (IFRS, Historical) |
OACB (US GAAP, Restated) |
IFRS conversion and presentation alignment (Note 2) |
Transaction Accounting Adjustments |
Pro Forma Combined |
Additional Transaction Accounting Adjustments |
Pro Forma Combined |
||||||||||||||||||||||||||||||
(Loss) / profit before taxes |
$ | (291,770 | ) | $ | (9,271 | ) | $ | — | $ | 155,201 | $ | (145,840 | ) | $ | (1,625 | ) | $ | (147,465 | ) | |||||||||||||||||
Income tax benefit |
121,726 | — | — | — | 121,726 | — | 121,726 | |||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
(Loss) / profit for the year |
(170,044 | ) | (9,271 | ) | — | 155,201 | (24,114 | ) | (1,625 | ) | (25,739 | ) | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Net loss per share - basic and diluted |
$ | (24.32 | ) | |||||||||||||||||||||||||||||||||
Basic and diluted net loss per share, Class A Ordinary Shares |
$ | (0.40 | ) | |||||||||||||||||||||||||||||||||
Basic and diluted net loss per share, Class B Ordinary Shares |
$ | (0.40 | ) | |||||||||||||||||||||||||||||||||
Pro forma weighted average ordinary shares outstanding - basic and diluted |
228,093,000 | 215,597,705 | ||||||||||||||||||||||||||||||||||
Pro forma net loss per share - basic and diluted |
$ | (0.09 | ) | (0.10 | ) |
A. | Reflects the liquidation and reclassification of $250.0 million of funds held in the Trust Account to cash and cash equivalents that becomes available following the Business Combination. |
B. | Represents the proceeds of approximately $174.9 million from the issuance and sale of 17,493,000 shares of TopCo Ordinary Shares at $10.00 per share pursuant to the terms of the PIPE Financing. |
C. | Reflects the settlement of deferred underwriting commissions and deferred legal fees, both of which are OACB liabilities to be paid by TopCo upon the closing of the Business Combination. |
D. | Represents preliminary estimated transaction costs expected to be incurred by OACB and Alvotech of approximately $22.6 million and $27.2 million, respectively, for advisory, banking, printing, legal, and accounting fees incurred as part of the Business Combination. |
E. | Represents the issuance of Alvotech Class A Ordinary Shares to existing Alvotech investors as a result of Alvotech Shareholders entering into the BCA Framework Agreement with Alvotech, TopCo and Floki Holdings S.à r.l. The BCA Framework Agreement resulted in the following events: |
• | Alvotech recognizing finance income of $113.2 million resulting from the remeasurement of the derivative liabilities at the date of extinguishment; and |
• | Alvotech issuing $655.9 million in equity for the exchange of $240.5 million of outstanding principal and accrued payment-in-kind |
F. | Represents the exchange of 25,000,000 OACB Class A Ordinary Shares, all of which were subject to possible redemption, and 5,000,000 OACB Class B Ordinary Shares into 30,000,000 TopCo Ordinary Shares. |
G. | Represents the exchange of 13,386,098 Alvotech Class A Ordinary Shares, after giving effect to the events described in (E) above, and 95,701 Alvotech Class B Shares into 180,600,000 TopCo Ordinary Shares and 38,330,000 Seller Earn Out Shares (as defined below) as described in (J) below. |
H. | Represents the elimination of OACB’s historical accumulated deficit after recording the transaction costs to be incurred by OACB as described in (D) above. |
I. | Represents the preliminary estimated expense recognized, in accordance with IFRS 2, for the excess of the fair value of TopCo Ordinary Shares issued and the fair value of OACB’s identifiable net assets at the date of the Business Combination, resulting in a $94.4 million and $96.1 million increase to accumulated loss assuming no redemptions and maximum redemptions, respectively. The fair value of shares issued was estimated based on a market price of $9.87 per share (as of December 10, 2021). The fair value of shares issued includes the shares to be issued under the Sponsor Letter Agreement, which includes shares to be issued to the Initial Shareholders of OACB if future volume-weighted average price targets of TopCo Ordinary Shares are met in a specified time period. The value is preliminary and will change based on fluctuations in the share price of the OACB Ordinary Shares and OACB Warrants through the closing date. A one percent change in the market price per share would result in a change of $1.7 million in the estimated expense assuming no redemptions and maximum redemptions, respectively. |
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||||||||||
Shares |
(in 000s) |
Shares |
(in 000s) |
|||||||||||||
OACB Shareholders |
||||||||||||||||
Class A shareholders |
25,000,000 | 12,504,705 | ||||||||||||||
Class B shareholders |
5,000,000 | 5,000,000 | ||||||||||||||
Sponsor Earn Out Shares |
1,250,000 | 1,250,000 | ||||||||||||||
|
|
|
|
|||||||||||||
Total TopCo Shares to be issued to OACB shareholders |
31,250,000 |
18,754,705 |
||||||||||||||
Fair value of Shares issued to OACB as of December 10, 2021 |
$ | 296,100 | $ | 172,771 | ||||||||||||
Fair Value of Sponsor Earn Out Shares issued to OACB as of December 10, 2021 |
9,600 | 9,600 | ||||||||||||||
|
|
|
|
|||||||||||||
Estimated market value |
305,700 | 182,371 |
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||||||||||
Shares |
(in 000s) |
Shares |
(in 000s) |
|||||||||||||
Net assets of OACB as of June 30, 2021 |
227,772 | 227,772 | ||||||||||||||
Less: OACB transaction costs |
(16,500 | ) | (16,500 | ) | ||||||||||||
Less: Effect of maximum redemption of 12,495,295 OACB Class A Ordinary Shares |
— | (124,954 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Adjusted net assets of OACB as of June 30, 2021 |
211,272 |
86,318 |
||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Difference - being IFRS 2 charge for listing services |
$ |
94,428 |
$ |
96,053 |
J. | Represents 38,330,000 TopCo Ordinary Shares to be issued to the Alvotech Shareholders (the “Seller Earn Out Shares”) at the Second Merger Effective Time. One half of the Seller Earn Out Shares will vest if, at any time during the five years following the closing of the Business Combination, the TopCo Ordinary Share price is at or above a volume weighted average price (“VWAP”) of $15.00 per share for any ten trading days within any twenty trading day period, with the other half vesting at a VWAP of $20.00 per share for any ten trading days within any twenty trading day period. The Seller Earn Out Shares will be accounted for as liabilities in accordance with IAS 32 following consummation of the Business Combination and, accordingly, will be subject to ongoing mark-to-market |
K. | Represents 1,250,000 TopCo Ordinary Shares issued to the Sponsor (the “Sponsor Earn Out Shares”) at the First Merger Effective Time. One half of the Sponsor Earn Out Shares will vest if, at any time during the five years following the closing of the Business Combination, the TopCo Ordinary Share price is at or above a VWAP of $12.50 per share for any ten trading days within any twenty trading day period, with the other half vesting at a VWAP of $15.00 per share. The Sponsor Earn Out Shares will be accounted for as liabilities in accordance with IAS 32 following consummation of the Business Combination and, accordingly, will be subject to ongoing mark-to-market |
L. | Reflects the maximum redemption of 12,495,295 OACB Class A Ordinary Shares for aggregate redemption payments of $125.0 million at a redemption price of $10.00 per share based on the funds held in the Trust Account as of June 30, 2021 of $250.0 million. |
M. | To reflect the recognition of transaction costs, as described in (D) above, during the year ended December 31, 2020. These costs are a nonrecurring item. |
N. | To eliminate interest income earned on funds in the Trust Account which will be released upon closing of the Business Combination. |
O. | Reflects the following pro forma adjustments: |
• | Elimination of the $67.6 million and $60.8 million finance costs recognized during the six months ended June 30, 2021 and year ended December 31, 2020, respectively, for the change in fair value of derivative financial liabilities associated with Alvotech’s convertible shareholder loans that were extinguished, as described in (E) above. |
• | Elimination of the $20.9 million and $37.7 million of finance costs recognized during the six months ended June 30, 2021 and the year ended December 31, 2020, respectively, for interest expense associated with Alvotech’s convertible shareholder loans. |
• | Recognition of $45.6 million of finance income for the remeasurement of derivative liabilities at the date of extinguishment and the $149.2 million gain on extinguishment of financial liabilities as described in (E) above. |
P. | Represents $94.4 million and $96.1 million of expense recognized assuming no redemptions and maximum redemptions, respectively, in accordance with IFRS 2, for the difference between the fair value of TopCo Ordinary Shares issued and the fair value of OACB’s identifiable net assets, as described in (I) above. This cost is a nonrecurring item. |
For the six months ended June 30, 2021 |
||||||||
(in thousands, except share and per share data) |
||||||||
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||
Pro forma loss (1) |
$ | (150,526) | $ | (149,247) | ||||
Weighted average shares outstanding - basic and diluted |
228,093,000 | 215,597,705 | ||||||
Pro forma loss per share - basic and diluted |
$ | (0.66) | $ | (0.69) | ||||
Weighted average shares outstanding - basic and diluted |
||||||||
Alvotech shareholders |
180,600,000 | 180,600,000 | ||||||
OACB shareholders |
30,000,000 | 17,504,705 | ||||||
PIPE investors |
17,493,000 | 17,493,000 | ||||||
|
|
|
|
|||||
Total |
228,093,000 | 215,597,705 |
(1) |
Holders of the Seller Earn Out and Sponsor Earn Out Shares are entitled to the voting and dividend rights generally granted to holders of TopCo Ordinary Shares. As such, these shares are considered to be participating securities. Accordingly, the pro forma loss is adjusted for the loss attributable to these unvested shares, which are not included in the weighted average shares outstanding. |
For the year ended December 31, 2020 |
||||||||
(in thousands, except share and per share data) |
||||||||
Scenario 1 Assuming No Redemptions |
Scenario 2 Assuming Maximum Redemptions |
|||||||
Pro forma loss (1) |
$ | (20,548 | ) | $ | (21,747 | ) | ||
Weighted average shares outstanding - basic and diluted |
228,093,000 | 215,597,705 | ||||||
Pro forma loss per share - basic and diluted |
$ | (0.09 | ) | $ | (0.10 | ) | ||
Weighted average shares outstanding - basic and diluted |
||||||||
Alvotech shareholders |
180,600,000 | 180,600,000 | ||||||
OACB shareholders |
30,000,000 | 17,504,705 | ||||||
PIPE investors |
17,493,000 | 17,493,000 | ||||||
|
|
|
|
|||||
Total |
228,093,000 | 215,597,705 |
(1) |
Holders of the Seller Earn Out and Sponsor Earn Out Shares are entitled to the voting and dividend rights generally granted to holders of TopCo Ordinary Shares. As such, these shares are considered to be participating securities. Accordingly, the pro forma loss is adjusted for the loss attributable to these unvested shares, which are not included in the weighted average shares outstanding. |
Combined Pro Forma |
||||||||||||||||
Alvotech (Historical) |
OACB (Historical) |
Assuming No Redemptions |
Assuming Maximum Redemptions |
|||||||||||||
As of and for the period ended June 30, 2021 for Alvotech and OACB |
||||||||||||||||
Book value per share (1) |
$ | (128.47 | ) | $ | (0.71 | ) | $ | 0.28 | $ | (0.29 | ) | |||||
Cash dividends per share |
— | — | — | — | ||||||||||||
Weighted average shares: |
||||||||||||||||
Weighted average of outstanding Ordinary shares – basic and diluted (2) |
7,377,421 | 25,000,000 | 228,093,000 | 215,597,705 | ||||||||||||
Earnings (loss) per share: |
||||||||||||||||
Loss per outstanding shares, basic and diluted |
$ | (37.13 | ) | $ | 0.22 | $ | (0.66 | ) | $ | (0.69 | ) | |||||
Weighted average shares: |
||||||||||||||||
Weighted average of outstanding Ordinary shares – basic and diluted (3) |
— | 6,250,000 | — | — | ||||||||||||
Earnings per share: |
||||||||||||||||
Earnings per outstanding shares - basic and diluted |
— | $ | 0.22 | — | — |
(1) | Book value per share is calculated using the formula: Total shareholder’s equity divided by shares outstanding. |
(2) | Represents the basic and diluted weighted average shares outstanding of OACB Class A Ordinary Shares. The pro forma weighted average shares outstanding excludes the Seller Earn Out Shares and Sponsor Earn Out Shares, as such shares have not yet vested. |
(3) | Represents the basic and diluted weighted average shares outstanding of OACB Class B Ordinary Shares. |
Combined Pro Forma |
||||||||||||||||
Alvotech (Historical) |
OACB (Historical) |
Assuming No Redemptions |
Assuming Maximum Redemptions |
|||||||||||||
As of and for the year ended December 31, 2020 for Alvotech and OACB |
||||||||||||||||
Book value per share (1) |
$ | (119.47 | ) | $ | (0.93 | ) | ||||||||||
Cash dividends per share |
— | — | — | — | ||||||||||||
Weighted average shares: |
||||||||||||||||
Weighted average of outstanding Ordinary shares – basic and diluted (2) |
6,990,889 | 17,176,871 | 228,093,000 | 215,597,705 | ||||||||||||
Loss per share: |
||||||||||||||||
Loss per outstanding shares, basic and diluted |
$ | (24.32 | ) | $ | (0.40 | ) | $ | (0.09 | ) | $ | (0.10) | |||||
Weighted average shares: |
||||||||||||||||
Weighted average of outstanding Ordinary shares – basic and diluted (3) |
— | 6,058,673 | — | — | ||||||||||||
Loss per share: |
||||||||||||||||
Loss per outstanding shares – basic and diluted |
— | $ | (0.40 | ) | — | — |
(1) | Book value per share is calculated using the formula: Total shareholder’s equity divided by shares outstanding. |
(2) | Represents the basic and diluted weighted average shares outstanding of OACB Class A Ordinary Shares. The pro forma weighted average shares outstanding excludes the Seller Earn Out Shares and Sponsor Earn Out Shares, as such shares have not yet vested. |
(3) | Represents the basic and diluted weighted average shares outstanding of OACB Class B Ordinary Shares. |
• | The Business Combination Proposal—a proposal to approve the adoption of the Business Combination Agreement and the Business Combination. |
• | The First Merger Proposal—a proposal to approve the First Merger and authorize and approve the entry into the Plan of First Merger. |
• | The Shareholder Adjournment Proposal—a proposal to authorize the adjournment of the OACB General Meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies if, based on proxies received prior to the OACB General Meeting, there are not sufficient votes to approve the Business Combination Proposal or the First Merger Proposal, or Public Shareholders have elected to redeem an amount of Public Shares such that the minimum available cash condition to the obligation to closing of the Business Combination would not be satisfied. |
• | the beneficial ownership of the Sponsor and certain of OACB’s directors of an aggregate of OACB Class B Ordinary Shares, which shares would become worthless if OACB does not complete a business combination within the applicable time period, as the Initial Shareholders have waived any right to redemption with respect to these shares for no consideration in return. Such shares have an aggregate market value of approximately $ , based on the closing price of OACB Class A Ordinary Shares of $ on the New York Stock Exchange on , 2022 the record date for the OACB General Meeting; |
• | OACB’s directors will not receive reimbursement for any out-of-pocket |
• | the potential continuation of certain of OACB’s directors as directors of TopCo; |
• | the continued indemnification of current directors and officers of OACB and the continuation of directors’ and officers’ liability insurance after the Business Combination; |
• | certain of OACB’s officers and directors are employed by Oaktree. Certain affiliates of Oaktree have an approximately 1% equity stake in Alvotech and hold approximately 47.48% ($82,953,251 aggregate principal amount) of Alvotech’s Tranche A bonds and approximately 33.99% of Alvotech’s Tranche B bonds ($75,699,188 aggregate principal amount). Such affiliates’ equity stake, which was acquired after a conversion of a portion of the Alvotech debt securities, would be valued at approximately $1.5 million, assuming a value of $10.00 per share and the consummation of the Business Combination. The Tranche A bonds and Tranche B bonds will remain outstanding after the consummation of the Business Combination; |
• | the fact that the Sponsor (and OACB’s officers and directors who are members of the Sponsor) has invested an aggregate of $7,025,000 in OACB, comprised of the $25,000 purchase price of 6,250,000 OACB Class B Ordinary Shares and the $7,000,000 purchase price for 4,666,667 OACB Private Warrants. Assuming a trading price of $9.86 per OACB Class A Ordinary Share and $1.09 per OACB Public Warrant (based upon the respective closing prices of the OACB Class A Ordinary Shares and the OACB Public Warrants on the NYSE on January 31, 2022), the 6,250,000 Class B Ordinary Shares and 4,666,667 OACB Private Warrants would have an implied aggregate market value of approximately $66,711,667. Even if the trading price of the TopCo Ordinary Shares were as low as $1.12 per share, the aggregate market value of the OACB Class B Ordinary Shares alone (without taking into account the value of the OACB Private Warrants) would be approximately equal to the initial investment in OACB by the Initial Shareholders. As a result, the Initial Shareholders are likely to be able to make a substantial profit on their investment in OACB at a time when TopCo Ordinary Shares have lost significant value. On the other hand, if OACB liquidates without completing a business combination before September 21, 2022, the Initial Shareholders will likely lose their entire investment in OACB; |
• | the fact that the Sponsor and OACB’s officers and directors will benefit from the completion of a business combination and may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidate; and |
• | the fact that the Sponsor and its affiliates can earn a positive rate of return on their investment, even if Public Shareholders experience a negative rate of return in the post-business combination company. |
• | You can vote by completing, signing and returning the enclosed proxy card(s) in the postage-paid envelope provided. If you hold your shares or warrants in “street name” through a bank, broker or other nominee, you will need to follow the instructions provided to you by your bank, broker or other nominee to ensure that your shares are represented and voted at the applicable OACB General Meeting(s). If you vote by proxy card, your “proxy,” whose name is listed on the proxy card, will vote your shares as you instruct on the proxy card. If you sign and return the proxy card but do not give instructions on how to vote your shares, your Ordinary Shares will be voted as recommended by OACB’s board of directors. With respect to proposals for the OACB General Meeting, that means: “FOR” the Business Combination Proposal, “FOR” the First Merger Proposal, and “FOR” the Shareholder Adjournment Proposal. |
• | You can attend the OACB General Meeting and vote virtually or in person. However, if your OACB Ordinary Shares are held in the name of your broker, bank or other nominee, you must get a proxy from the broker, bank or other nominee. That is the only way we can be sure that the broker, bank or nominee has not already voted your OACB Ordinary Shares. |
• | Submit a request in writing that OACB redeem your Public Shares for cash to Continental, OACB’s transfer agent, at the following address: |
• | Deliver your Public Shares either physically or electronically through DTC to OACB’s transfer agent. Shareholders seeking to exercise their redemption rights and opting to deliver physical certificates should allot sufficient time to obtain physical certificates from the transfer agent. It is OACB’s understanding that shareholders should generally allot at least one week to obtain physical certificates from the transfer agent. However, OACB does not have any control over this process and it may take longer than one week. Shareholders who hold their shares in street name will have to coordinate with their bank, broker or other nominee to have the shares certificated or delivered electronically. If you do not submit a written request and deliver your Public Shares as described above, your shares will not be redeemed. |
• | review of Alvotech’s material contracts, intellectual property, financial, tax, legal, real estate, environmental, insurance and accounting due diligence; |
• | meetings and calls with the management team and advisors of Alvotech regarding operations, historical financials and performance, forecasts, strategic plans, and key metrics; |
• | consultations with Alvotech’s management and legal and financial advisors; |
• | tours of Alvotech’s facilities in Iceland; |
• | review of healthcare and FDA regulatory due diligence materials prepared by legal advisors; |
• | discussions with Alvotech’s suppliers and industry partners; |
• | review of Alvotech’s unaudited financial statements for the years ended December 31, 2020 and 2019; |
• | financial review and analysis of Alvotech and the Business Combination; |
• | financial projections prepared by Alvotech’s management team; |
• | study of analyst reports and market trends in the biologic and biosimilar industries; |
• | analysis on comparable target companies; and |
• | research on comparable transactions. |
• | Rapid Growth |
• | Fully-Integrated Platform in-house, and a global network of commercial partners and believes the nature of Alvotech’s platform will enable it to innovate and systematically develop and manufacture biosimilar medicines. |
• | Diversified Pipeline |
• | Partnerships |
• | Scalability in-house (such as R&D and manufacturing) to focus on speed, cost, and quality, Alvotech can be therapeutically agnostic as commercial partners are responsible for sales and marketing costs. This allows Alvotech to add multiple products to its pipeline without materially |
changing its cost structure. With the capacity to add one to two additional programs every 12 to 18 months, on both an organic and inorganic basis, Alvotech is positioned for sustained growth and managed risk. |
• | Experienced Management Team |
• | Financial Profile |
• | Strategic Plan |
○ |
Invest in and differentiate its platform. |
○ |
Evaluate the evolving biologic landscape for the right programs to pursue. |
○ |
Advance high-value product candidates towards launch. |
○ |
Pursue and execute on strategic partnerships across the globe. |
○ |
Attract and retain the highest quality talent to fulfill the Alvotech vision. Alvotech’s people are a critical element in shaping and executing its strategy. Alvotech’s founder, chairman and principal investor has built and led two successful global generics enterprises and has provided the vision and resources to grow Alvotech as a built-for-purpose, top-tier global pharmaceutical firms. |
○ |
Maintain and further develop Alvotech’s commitment to sustainability and corporate responsibility beyond its fundamental mission of expanding access to medicines while lowering costs for patients |
• | Terms of Transaction |
to complete the transactions contemplated therein and their ability to terminate the agreement. See “— The Business Combination Agreement Certain Agreements Related to the Business Combination |
• | Results of Review of Transaction non-disclosure agreements with approximately 73 potential business combination targets (other than Alvotech), and submitted non-binding indications of interest or letters of intent with respect to 8 potential business combination targets (other than Alvotech). Despite these efforts, the OACB board of directors was not aware of any transaction available to OACB that it believed was more favorable than the Business Combination with Alvotech. In addition, the OACB board of directors considered that the terms of the Business Combination had been negotiated on an arm’s-length basis in light of each party’s judgment about its ability to negotiate different or better terms or into alternative strategic transactions. Based on the negotiations, the OACB board of directors considered that it believed that the terms of the Business Combination Agreement and related agreements were the best terms to which OACB was reasonably likely to agree. See “—The Background to the Business Combination |
• | Continued Ownership by Alvotech Shareholders |
• | PIPE Financing |
• | Attractive Valuation earn-out provisions in the Business Combination Agreement designed to create an alignment with Alvotech’s shareholders following the Business Combination. |
• | Potential Inability to Complete the Business Combination |
conditions under the Business Combination Agreement in order for the Business Combination to be consummated. The OAC board of directors noted that the Business Combination Agreement includes a condition that, the aggregate cash proceeds from OACB’s trust account, together with the proceeds from the PIPE Financing, being no less than $300,000,000 (after deducting any amounts paid to OACB shareholders that exercise their redemption rights in connection with the Business Combination). As of , 2022, the record date of the OACB General Meeting, without giving effect to any future redemptions that may occur, the trust account has approximately $ million. Further, the OACB board of directors Board considered the risk that current public shareholders would exercise their redemption rights is mitigated because Alvotech will be acquired at an aggregate purchase price that the OACB board of directors evaluated and considers to be attractive to OACB’s shareholders. |
• | Alvotech Business Risks Risk Factors |
• | Post-Business Combination Corporate Governance The Business Combination Agreement |
• | Limitations of Review |
• | No Survival of Remedies for Breach of Representations, Warranties or Covenants of Alvotech |
• | Interests of OACB ’ s Directors and Executive Officers — Interests of OACB’s Directors and Officers in the Business Combination |
combination by OACB with any other target business(es) and (iii) certain of OACB’s officers and directors are employed by Oaktree. Certain of OACB’s officers and directors are employed by Oaktree. Certain of OACB’s officers and directors are employed by Oaktree. Certain of OACB’s officers and directors are employed by Oaktree. Certain affiliates of Oaktree have an approximately 1% equity stake in Alvotech and hold approximately 47.48% ($82,953,251 aggregate principal amount) of Alvotech’s Tranche A bonds and approximately 33.99% of Alvotech’s Tranche B bonds ($75,699,188 aggregate principal amount). Such affiliates’ equity stake, which was acquired after a conversion of a portion of the Alvotech debt securities, would be valued at approximately $1.5 million, assuming a value of $10.00 per share and the consummation of the Business Combination. The Tranche A bonds and Tranche B bonds will remain outstanding after the consummation of the Business Combination; |
• | the beneficial ownership of the Sponsor and certain of OACB’s directors of an aggregate of OACB Ordinary Shares, which shares would become worthless if OACB does not complete a business combination within the applicable time period, as the Sponsor, OACB officers and directors have waived any right to redemption with respect to these shares for no consideration in return. Such shares have an aggregate market value of approximately $ based on the closing price of OACB Ordinary Shares of $ on the New York Stock Exchange on , 2022, the record date for the OACB General Meeting; |
• | OACB’s directors will not receive reimbursement for any out-of-pocket |
• | the potential continuation of certain of OACB’s directors as directors of OACB; |
• | the continued indemnification of current directors and officers of OACB and the continuation of directors’ and officers’ liability insurance after the Business Combination; |
• | certain of OACB’s officers and directors are employed by Oaktree. Certain affiliates of Oaktree have an approximately 1% equity stake in Alvotech and hold approximately 47.48% ($82,953,251 aggregate principal amount) of Alvotech’s Tranche A bonds and approximately 33.99% of Alvotech’s Tranche B bonds ($75,699,188 aggregate principal amount). Such affiliates’ equity stake, which was acquired after a conversion of a portion of the Alvotech debt securities, would be valued at approximately $1.5 million, assuming a value of $10.00 per share and the consummation of the Business Combination. The Tranche A bonds and Tranche B bonds will remain outstanding after the consummation of the Business Combination; |
• | the fact that the Sponsor (and OACB’s officers and directors who are members of the Sponsor) has invested an aggregate of $7,025,000 in OACB, comprised of the $25,000 purchase price of 6,250,000 OACB Class B Ordinary Shares and the $7,000,000 purchase price for 4,666,667 OACB Private Warrants. Assuming a trading price of $9.86 per OACB Class A Ordinary Share and $1.09 per OACB Public Warrant (based upon the respective closing prices of the OACB Class A Ordinary Shares and the OACB Public Warrants on the NYSE on January 31, 2022), the 6,250,000 Class B Ordinary Shares and 4,666,667 OACB Private Warrants would have an implied aggregate market value of approximately $66,711,667. Even if the trading price of the TopCo Ordinary Shares were as low as $1.12 per share, the aggregate market value of the OACB Class B Ordinary Shares alone (without taking into account the value of the OACB Private Warrants) would be approximately equal to the initial investment in OACB by the Initial Shareholders. As a result, the Initial Shareholders are likely to be able to make a substantial profit on their investment in OACB at a time when TopCo Ordinary |
Shares have lost significant value. On the other hand, if OACB liquidates without completing a business combination before September 21, 2022, the Initial Shareholders will likely lose their entire investment in OACB; |
• | the fact that the Sponsor and OACB’s officers and directors will benefit from the completion of a business combination and may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidate; and |
• | the fact that the Sponsor and its affiliates can earn a positive rate of return on their investment, even if Public Shareholders experience a negative rate of return in the post-business combination company. |
Coherus (1) |
Biocon Biologics (Parent) (3) |
Alvotech |
Celltrion |
Samsung Biopsis (4) |
||||||||||||||||
TAM - Current Pipeline ($Billion) (1) |
21.7 | (2) |
46.4 | 82.2 | 61.9 | 68.7 | ||||||||||||||
Total Enterprise Value ($Billion) (5) |
$ | 1.5 | $ | 6.4 | $ | 2.3 | (6) |
$ | 25.7 | $ | 45.5 | |||||||||
EV / NTM EBITDA (5) |
N/M | (7) |
20.4x | N/A | 26.3x | 68.2x | ||||||||||||||
2021 - 2025 Revenue CAGR (5) |
28 | % | N/A | >90 | % | 19 | % | 13 | % | |||||||||||
2025E Gross Margin (5) |
90 | % | N/A | ~85 | % | N/A | 47 | % | ||||||||||||
2025E Adj. EBITDA Margin (5) |
19 | % | N/A | >60 | % | 47 | % | 55 | % | |||||||||||
Number of Employees |
310 | 13,500+ | ~645 | ~1,950 | 3,400+ | |||||||||||||||
Number of Manufacturing Sites |
0 | 3 | (8) |
2 | 3 | 3 | ||||||||||||||
Global Commercial Reach |
2 | 120+ | 60+ | 90+ | Undisclosed | (9) |
(1) | Figures based on peak WW biologic sales from 2021-2026 per Evaluate Pharma based on publicly disclosed product portfolios. See “ Business of Alvotech—Our Pipeline |
(2) | TAM based on peak U.S. biologic sales from 2021-2026 per Evaluate Pharma based on publicly disclosed product portfolios. |
(3) | TAM based on Biocon Biologics products and pipeline excluding recombinant human insulin; financial and operational metrics based on parent company Biocon. |
(4) | TAM based on Samsung Bioepis products and pipeline through its joint venture with Biogen; financial and operational metrics based on parent company Samsung Biologics. |
(5) | With the exception of Alvotech, projections and market data per CapIQ and Refinitiv as of November 16, 2021. See “ The Business Combination—Certain Unaudited Alvotech Prospective Financial Information |
(6) | Based on illustrative share price of $10.00, pro forma shares outstanding of 226 million and pro forma estimated net cash of $10 million as of November 15, 2021 (inclusive of $404 million of expected net proceeds from the transaction, assuming no redemptions). |
(7) | Coherus NTM EBITDA of ($44 million). |
(8) | Represents biosimilar sites. |
(9) | Samsung Bioepis has global commercial partnerships with Biogen and Merck; Merck’s global reach spans 140+ countries. |
(in $ millions, except per share data): |
FY 2021 |
FY 2025 |
||||
Total Alvotech Revenue |
$30 - $60 |
Greater than $800 | ||||
Adjusted EBITDA |
($150) – ($200) | Greater than 60% Margin |
• | Revenue from product sales are expected to be approximately 85% of revenue and were estimated considering the following factors: |
○ |
Market size for each target market. The target markets in question are established products that generate significant global revenue which is generally disclosed by the originator companies on a quarterly and annual basis. |
○ |
Price erosion for each target market. Assumptions on price erosion driven by competition through biosimilars (including Alvotech’s) are made. For the U.S. market, price erosions assumed in Alvotech’s forecasts were greater than historical market examples for biosimilars. |
○ |
Market share for each target market. The revenue forecasts assume that Alvotech is able to achieve market share in each product category. |
○ |
Alvotech share of economics. The economics that are outlined in Alvotech’s commercial agreements with partners are incorporated into the forecasts to reflect Alvotech’s share of any in-market sales. |
• | Revenue from milestone payments are expected to be approximately 15% of total revenue. These milestone payments, received from commercialization partners, are forecasted based on the expected achievement of the underlying triggering events, typically including signing of the commercialization contract, completion of key clinical requirements, product approval, and product launch. Certain agreements also contain performance-based milestones. Further, milestone revenue is subject to IFRS revenue recognition standards that are also incorporated into the forecasts. Projections assume that Alvotech does not intend to market any product on their own for any market. |
• | Cost of Goods Sold are estimated to be approximately 15% of total revenue and were estimated by applying known or estimated cost parameters to product volume forecasts based on market share estimates. These costs include direct material, direct and indirect labor, 3rd party costs (if applicable), and overhead costs. |
• | Operating costs are estimated to be between approximately 19% and 26% of total sales, and are comprised of: |
○ |
Research and development costs: estimated to be between 15-20% of total sales. Research and development costs are forecasted at the program level and consider factors such as headcount, facilities, supplies, clinical requirements, and 3rd party CRO fees, among others. |
○ |
General and administrative costs: estimated to be between 4-6% of total sales. General and administrative costs are forecasted on a line-item basis and include functions such as Finance, IT, HR, Legal and other administrative functions that are instrumental to running the business. |
○ |
Sales & marketing costs: Alvotech relies on a network of commercial partners in order market its products. As such, there are no material sales and marketing costs forecasted. The forecast assumes that Alvotech will not market any product on their own for any market. |
• | The global markets for biologic and biosimilar medicines are forecasted to grow at a compound annual growth rate exceeding 10%, reaching approximately $555 billion and approximately $80 billion by 2026, respectively; |
• | Alvotech has seven products in its pipeline across multiple therapeutic areas, and its pipeline addresses reference products treating a diverse set of conditions across autoimmunity, ophthalmology, |
osteoporosis, and oncology, with total estimated current peak originator sales of more than $80 billion in the aggregate; |
• | Alvotech’s most advanced product AVT02, its biosimilar to Humira, was approved by the European Commission in November of 2021. In the United States, AVT02’s approval is currently in deferred status. The FDA has scheduled inspections of the AVT02 manufacturing sites, a required step in the AVT02 Biosimilar BLA approval process, in the first half of 2022. While the timing of the AVT02 approval is not determinable as of the date of this proxy statement/prospectus, we have assumed that AVT02 will ultimately receive final approval from the FDA; |
• | While Alvotech is currently involved in litigation arising out of the development of AVT02, we have assumed that such litigation will be unsuccessful in blocking Alvotech from launching AVT02 either in the United States or in any other target market worldwide. See “ — Alvotech is involved in various court proceedings with AbbVie regarding its AVT02 product; |
• | Alvotech expects to achieve $800 million in revenues by 2025, the majority of which is expected to be derived from programs that are either in clinical trials or have completed them. Alvotech has assumed that it will continue to receive ongoing payments from commercial partners that help offset R&D costs; |
• | Expected high single-digit revenue growth beyond 2025; |
• | Alvotech has formed strategic commercialization partnerships covering more than 50 countries with leading pharmaceutical companies. Alvotech’s commercial partners are responsible for product sales, and remit approximately 40% of their in-market sales to Alvotech. For an overview of Alvotech’s key partners, see “ Business of Alvotech—Commercial partnerships |
• | Alvotech applied a probability of success of 75% or higher to its clinical and pre-clinical programs. Unlike innovative pharmaceutical companies, Alvotech is establishing biosimilars against an existing approved drug, which results in a development process that is less uncertain relative to originator biologics development processes. Alvotech has experience with developing biosimilars with each of its host cell lines (CHO and SP2/0) and processes (Fed batch, perfusion), and believes it has the process science and analytical capabilities required to develop these manufacturing processes. Alvotech’s belief in its probability of success in delivering its pipeline is also driven by its management team that has developed over a dozen biosimilars in the past. Alvotech expects to launch five products by 2025 in more than 50 markets; and |
• | Milestone revenues are paid by Alvotech’s partners, typically earlier on in the development process of a product candidate, and are an important and ongoing part of Alvotech’s business model as they help subsidize research and development. Alvotech has collected over $155 million of milestones to date and has estimated the potential to receive up to $916 million in the future. |
Partner |
Milestone Payments prior to December 31, 2021 |
Future milestone payments |
||||||||||||||||||
Prior to FY 2019 |
FY 2019 |
FY 2020 |
FY 2021 |
|||||||||||||||||
Teva |
$ | 0 | $ | 0 | $ | 40,000,000 | $ | 35,000,000 | $ | 455,000,000 | ||||||||||
Stada (1) |
$ | 0 | $ | 0 | $ | 31,738,000 | $ | 1,066,000 | $ | 296,125,000 | ||||||||||
Jamp Pharma (2) |
$ | 0 | $ | 0 | $ | 15,000,000 | $ | 0 | $ | 41,699,000 | ||||||||||
Fuji Pharma |
$ | 0 | $ | 4,600,000 | $ | 3,000,000 | $ | 0 | $ | 32,400,000 | ||||||||||
Other partners |
$ | 0 | $ | 11,790,000 | $ | 10,624,000 | $ | 5,700,000 | $ | 91,286,000 | ||||||||||
TOTAL |
$ | 0 | $ | 16,390,000 | $ | 100,362,000 | $ | 41,766,000 | $ | 916,510,000 |
(1) |
Payable in Euro and converted at the December 31, 2020 exchange rate of EUR/USD 1.23015. |
(2) |
Milestone payments are payable in Canadian Dollars and converted at the December 31, 2020 exchange rate of CAD/USD 0.78381. |
• | on the First Merger Effective Time, OACB will merge with and into TopCo, whereby (i) all of the outstanding OACB Ordinary Shares will be exchanged for TopCo Ordinary Shares on a one-for-one |
• | immediately after the effectiveness of the First Merger but prior to the Conversion, TopCo will redeem and cancel the shares held by the initial sole shareholder of TopCo pursuant to a share capital reduction of TopCo; |
• | immediately after the effectiveness of the First Merger and the Redemption, the legal form of TopCo shall be changed from a simplified joint stock company ( société par actions simplifiée société anonyme |
• | immediately following the effectiveness of the Conversion and the PIPE Financing, Alvotech will merge with and into TopCo, whereby all outstanding Alvotech Ordinary Shares will be exchanged for TopCo Ordinary Shares, pursuant to a share capital increase of TopCo, with TopCo as the surviving company in the merger. |
• | each share of OACB Ordinary Shares issued and outstanding immediately prior to the First Merger Effective Time (other than the OACB Class A Ordinary Shares validly submitted for redemption pursuant to OACB’s Memorandum and Articles of Association and the OACB Ordinary Shares held immediately prior to the First Merger Effective Time by OACB as treasury shares) shall be automatically canceled and extinguished and exchanged for TopCo Ordinary Share pursuant to a share capital increase of TopCo. From and after the First Merger Effective Time, all outstanding OACB Ordinary Shares shall automatically cease to exist, and such Person that, immediately prior to the First Merger Effective Time, was registered as a holder of the OACB Ordinary Shares in the register of members of OACB shall thereafter cease to be a member of OACB and shall cease to have any rights with respect to such shares except as otherwise provided for herein or under applicable Law; |
• | by virtue of the First Merger and without any action on the part of any Party or any other Person, each OACB Ordinary Share held immediately prior to the First Merger Effective Time by OACB as treasury shares shall be canceled and surrendered (as applicable), and no consideration shall be paid with respect thereto. |
• | each issued and outstanding Alvotech Ordinary Share shall be automatically canceled and extinguished and exchanged for TopCo Ordinary Shares pursuant to a share capital increase of TopCo, in accordance with the Allocation Schedule. |
(1) | For more information about the ownership interests of our Initial Shareholders, including the Sponsor, prior to the Business Combination, please see the section entitled “ Security Ownership Of Certain Beneficial Owners and Management of TopCo. |
(1) | For more information about the ownership interests of Alvotech Holdings S.A., prior to the Business Combination, please see the section entitled “ Security Ownership of Certain Beneficial Owners and Management of TopCo. |
(2) | The diagram above shows all subsidiaries of Alvotech Holdings S.A. |
(1) | The diagram above shows all subsidiaries of TopCo. |
(2) | The diagram above does not include Seller Earn Out Shares or Sponsor Earn Out Shares. |
• | financial institutions; |
• | insurance companies; |
• | mutual funds; |
• | pension plans; |
• | S corporations; |
• | broker-dealers; |
• | traders in securities that elect mark-to-market treatment; |
• | regulated investment companies; |
• | real estate investment trusts; |
• | trusts and estates; |
• | tax-exempt organizations (including private foundations); |
• | investors that hold our Public Shares or public warrants or who will hold TopCo Ordinary Shares or TopCo Warrants as part of a “straddle,” “hedge,” “conversion,” “synthetic security,” “constructive ownership transaction,” “constructive sale” or other integrated transaction for U.S. federal income tax purposes; |
• | U.S. Holders that have a functional currency other than the U.S. dollar; |
• | U.S. expatriates or former long-term residents of the United States; |
• | investors subject to the U.S. “inversion” rules; |
• | U.S. Holders owning or considered as owning (directly, indirectly, constructively, or through attribution) 5% (measured by vote or value) or more of our Public Shares, or, following the Business Combination, TopCo Ordinary Shares; |
• | persons who purchase TopCo Ordinary Shares as part of the PIPE Financing; |
• | persons that acquired our Public Shares or OACB Public Warrants or will acquire TopCo Ordinary Shares or TopCo Warrants pursuant to an exercise of employee share options, in connection with employee share incentive plans or otherwise as compensation as compensation; |
• | controlled foreign corporations; |
• | passive foreign investment companies; and |
• | persons who are not U.S. Holders, all of whom may be subject to tax rules that differ materially from those summarized below. |
• | an individual who is a U.S. citizen or resident of the United States; |
• | a corporation (including an entity treated as a corporation for U.S. federal income tax purposes) created or organized in or under the laws of the United States, any state thereof or the District of Columbia; |
• | an estate the income of which is includible in gross income for U.S. federal income tax purposes regardless of its source; or |
• | a trust (A) if a court within the United States is able to exercise primary supervision over administration of the trust and one or more U.S. persons (within the meaning of the Code) have the authority to control all substantial decisions of the trust or (B) that has in effect a valid election under applicable U.S. Department of Treasury regulations (“Treasury Regulations”) to be treated as a U.S. person. |
• | the U.S. Holder’s gain or excess distribution will be allocated ratably over the U.S. Holder’s holding period for the TopCo Ordinary Shares; |
• | the amount allocated to the U.S. Holder’s taxable year in which the U.S. Holder recognized the gain or received the excess distribution, and to any period in the U.S. Holder’s holding period before the first day of TopCo’s first taxable year in which TopCo is a PFIC, will be taxed as ordinary income; |
• | the amount allocated to other taxable years (or portions thereof) of the U.S. Holder and included in its holding period will be taxed at the highest tax rate in effect for that year and applicable to the U.S. Holder; and |
• | an additional tax equal to the interest charge generally applicable to underpayments of tax will be imposed on the U.S. Holder with respect to the tax attributable to each such other taxable year of the U.S. Holder. |
• | From 2013 to 2017, Alvotech focused on building out capabilities in its platform, recruiting experienced scientific and technical staff, acquiring key technologies and knowhow, and investing in R&D for its AVT02 program and early-stage target selection to build out its portfolio. |
• | From 2018 to 2020, with its headquarters, laboratory and manufacturing facility fully operational, Alvotech shifted to commercial readiness and began focusing on broadening and accelerating its pipeline of product candidates; rounding out its global network of commercial partnerships to encompass nearly every major market; and completing the clinical and regulatory steps required to become a commercial stage biosimilars company. |
• | Since the beginning of 2021, Alvotech has been focused on deploying its platform, advancing its pipeline towards and onto the global marketplace. The company’s plan is to commercialize five products by the end of 2025 through our world-class network of partners and to scale up its manufacturing capabilities in China and Iceland. |
1. | IQVIA institute report, “Biosimilars in the United States 2020 – 2024” |
2. | Size based on illustrative antibody size |
3. | Per Evaluate Pharma |
• | The growth and success of reference products, FDA approvals for which have more than doubled from 23 between 2006 and 2010 to 60 between 2016 and 2020; |
• | The high cost and expense burden of these therapies on the healthcare system, with global spending on biologics estimated to increase at a CAGR of 11% between 2020 and 2026 to approximately $555 billion, and accounting for 40% of pharmaceutical spending in the U.S. in 2020, up from 30% in 2014; |
• | The large number of major early biologics that are losing U.S. patent exclusivity, over 35 products between 2018 and 2026, each with more than $1 billion each in annual sales. |
• | Platform Invest in and differentiate its platform. know-how enables Alvotech to have a full set of capabilities and control, from analysis of reference products and cell line development through fill-and-finish |
manufacturing and regulatory approvals. Further, it provides Alvotech the ability to innovate efficiencies in every step of the process and project those cost-savings throughout its portfolio. Alvotech is one of few companies with demonstrated manufacturing capabilities using both of the two most widely-used host cell lines — Chinese hamster ovary (“CHO”) and SP2/0 — as well as cell culture processes, fed batch and perfusion. These capabilities enable Alvotech to innovate and produce biosimilars that are not only high quality but that can also be manufactured more efficiently. Alvotech believes this represents a fundamental advantage when competing with both the sponsors of the reference products and other biosimilar companies. |
• | Portfolio: Evaluate the evolving biologic landscape for the right programs to pursue. |
• | Pipeline: Advance high-value product candidates towards launch. |
• | Commercial Partnerships Pursue and execute on strategic partnerships across the globe. |
• | People: Attract and retain the highest quality talent to fulfill the Alvotech vision |
Alvotech as a built-for-purpose, top-tier global pharmaceutical firms. Further, Alvotech has attracted highly talented and dedicated technical, laboratory and support staff talent from 38 countries around the world. As of November 30, 2021, 60% of its 718 employees and contractors hold advanced degrees and 86% are involved in R&D, quality and technical operations. |
• | ESG and corporate responsibility: Maintain and further develop Alvotech’s commitment to sustainability and corporate responsibility beyond its fundamental mission of expanding access to medicines while lowering costs for patients |
• | Global reach: best-in-class |
• | Local expertise: |
• | Portfolio scale: |
• | Product selection flexibility: in-house set of innovator products, nor is it confined to specific therapeutic areas. We do not need to make product selection decisions to fit a pre-existing commercial strategy or sales and marketing infrastructure, but rather we can take a flexible approach to product selection, evaluating candidates based on their clinical merits, partner preferences and commercial opportunity. We are able to access markets through an existing network or create a new network through our partnership model in various therapeutic areas and various geographies. |
• | Platform leveragability: |
• | Milestones: |
to $1,075 million, of which over $155 million has been thus far collected. Milestones offset the cost of development and create a shared risk alignment with our partners. We further view milestones as a consistent and repeating revenue opportunity, as we fully expect to continue to add product candidates to our pipeline, and subsequently out-license them in order to maximize the value of our dedicated biosimilar development and manufacturing infrastructure. |
• | Competitive situation |
• | Launch timing |
• | Portfolio fit |
• | Differentiation: |
• | Feasibility and cost: |
• | Partner insights: |
• | We have patent applications entitled “pharmaceutical formulations for adalimumab” that are pending in Europe, Canada, Australia, Japan, New Zealand, China, and the United States, all owned by Alvotech. Any patents issuing from these pending applications would be expected to expire no earlier than 2038. |
• | We also have patent applications entitled “Aqueous Formulations of TNF-alpha Antibodies in High Concentrations” that are pending in Australia, New Zealand, Japan, Israel, Europe, China, the United States and Canada, all owned by Alvotech. Any patents issuing from these pending applications would be expected to expire no earlier than 2040. |
• | analytical studies demonstrating that the proposed biosimilar product is highly similar to the approved product notwithstanding minor differences in clinically inactive components; |
• | animal studies (including the assessment of toxicity and immunogenicity); and |
• | a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product. |
• | the proposed biosimilar product and reference product utilize the same mechanism of action for the condition(s) of use prescribed, recommended or suggested in the proposed labeling, but only to the extent the mechanism(s) of action are known for the reference product; |
• | the condition or conditions of use prescribed, recommended or suggested in the labeling for the proposed biosimilar product have been previously approved for the reference product; |
• | the route of administration, the dosage form and the strength of the proposed biosimilar product are the same as those for the reference product; and |
• | the facility in which the biological product is manufactured, processed, packed or held meets standards designed to assure that the biological product continues to be safe, pure, and potent. |
• | the proposed product is biosimilar to the reference product; |
• | the proposed product is expected to produce the same clinical result as the reference product in any given patient; and |
• | for a product that is administered more than once to an individual, the risk to the patient in terms of safety or diminished efficacy of alternating or switching between the biosimilar and the reference product is no greater than the risk of using the reference product without such alternation or switch. |
• | require revisions to approved labeling to add new safety information; |
• | require post-market studies to assess new safety risks; |
• | issue fines, warning letters, or untitled letters; |
• | place post-approval clinical trials on hold; |
• | detain or refusal to permit the import or export of products; or |
• | seek injunctions, civil forfeiture, civil money penalties, or other civil relief; or |
• | seek criminal penalties or prosecution. |
Name |
Age |
Title | ||||
Executive Officers |
||||||
Robert Wessman |
52 | Executive Chairman of the Board of Directors | ||||
Mark Levick |
58 | Chief Executive Officer | ||||
Tanya Zharov |
55 | Deputy Chief Executive Officer | ||||
Joseph E. McClellan |
48 | Chief Scientific Officer | ||||
Sean Gaskell |
40 | Chief Technical Officer | ||||
Joel Morales |
44 | Chief Financial Officer | ||||
Reem Malki |
51 | Chief Quality Officer | ||||
Anil Okay |
34 | Chief Commercial Officer | ||||
Ming Li |
45 | Chief Strategy Officer | ||||
Directors |
||||||
Richard Davies |
60 | Director and Deputy Chairman | ||||
Tomas Ekman |
54 | Director | ||||
Faysal Kalmoua |
46 | Director | ||||
Ann Merchant |
56 | Director | ||||
Arni Hardarson |
55 | Director | ||||
Lisa Graver |
50 | Director | ||||
Linda McGoldrick |
66 | Director |
• | personnel expenses, including salaries, benefits and other compensation expenses; |
• | costs of funding the execution of studies performed both internally and externally; |
• | costs of purchasing laboratory supplies and non-capital equipment used in designing, developing and manufacturing preclinical study and clinical trial materials; |
• | expenses related to quality control and other advancement development; |
• | consultant fees; |
• | expenses related to regulatory activities, including filing fees paid to regulatory agencies; |
• | facility costs including rent, depreciation and maintenance expenses; |
• | fees for maintaining licenses under third party licensing agreements; |
• | expenses incurred in preparation for commercial launch, such as designing and developing commercial-scale manufacturing capabilities and processes, quality control processes, production asset valuation and other related activities; and |
• | costs related to amortization, depreciation and impairment losses related to software and property, plant and equipment used in research and development activities. |
• | the number of trials required for approval; |
• | the per patient trial costs; |
• | the number of patients who participate in the trials; |
• | the number of sites included in the trials; |
• | the countries in which the trials are conducted; |
• | the length of time required to enroll eligible patients; |
• | the dose that patients receive; |
• | the drop-out or discontinuation rates of patients; |
• | the potential additional safety monitoring or other studies requested by regulatory agencies; |
• | the duration of patient follow-up; |
• | any delays in key trial activities and patient enrollment or diversion of healthcare resources as a result of the COVID-19 pandemic; |
• | production shortages or other supply interruptions in clinical trial materials resulting from the COVID-19 pandemic; |
• | the timing and receipt of regulatory approvals; and |
• | the efficacy and safety profile of the product candidates. |
USD in thousands |
2021 | 2020 | ||||||
Revenue |
2,008 | 10,310 | ||||||
Other income |
348 | 1,381 | ||||||
Research and development expenses |
(90,403 | ) | (63,601 | ) | ||||
General and administrative expenses |
(86,360 | ) | (22,191 | ) | ||||
|
|
|
|
|||||
Operating loss |
(174,407 | ) | (74,101 | ) | ||||
|
|
|
|
|||||
Share of net (loss) / profit of joint venture |
(837 | ) | 180 | |||||
Finance income |
4 | 8,372 | ||||||
Finance costs |
(123,575 | ) | (49,048 | ) | ||||
Exchange rate differences |
(3,611 | ) | 12,443 | |||||
Gain on extinguishment of financial liabilities |
2,561 | — | ||||||
|
|
|
|
|||||
Non–Operating loss |
(125,458 | ) | (28,053 | ) | ||||
|
|
|
|
|||||
Loss before taxes |
(299,865 | ) | (102,154 | ) | ||||
Income tax benefit |
25,918 | 31 | ||||||
|
|
|
|
|||||
Loss for the period |
(273,947 | ) | (102,123 | ) | ||||
|
|
|
|
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
Revenue |
2,008 | 10,310 | (8,302 | ) | (80.5 | ) |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
Other income |
348 | 1,381 | (1,033 | ) | (74.8 | ) |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
AVT02 development program expenses |
8,139 | 22,661 | (14,522 | ) | (64.1 | ) | ||||||||||
AVT04 development program expenses |
13,959 | 2,251 | 11,708 | 520.1 | ||||||||||||
AVT06 development program expenses |
4,851 | 107 | 4,744 | nm | ||||||||||||
Salary and other employee expenses |
33,893 | 22,556 | 11,337 | 50.3 | ||||||||||||
Depreciation and amortization |
9,560 | 4,264 | 5,296 | 124.2 | ||||||||||||
Other research and development expenses (1) |
20,001 | 11,762 | 8,239 | 70.0 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total research and development expenses |
90,403 | 63,601 | 26,802 | 42.1 | ||||||||||||
|
|
|
|
|
|
|
|
(1) | Other research and development expenses include manufacturing costs, facility costs and other operating expenses recognized as research and development expenses during the period. |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
General and administrative expenses |
86,360 | 22,191 | 64,169 | 289.2 |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
Share of net (loss) / profit of joint venture |
(837 | ) | 180 | (1,017 | ) | (565.0 | ) |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
Finance income |
4 | 8,372 | (8,368 | ) | (100.0 | ) |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
Finance costs |
123,575 | 49,048 | 74,527 | 151.9 |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
Exchange rate differences |
(3,611 | ) | 12,443 | (16,054 | ) | (129.0 | ) |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
Gain on extinguishment of financial liabilities |
2,561 | — | 2,561 | 100.0 |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
Income tax benefit |
25,918 | 31 | 25,887 | nm |
USD in thousands |
2020 | 2019 | ||||||
Revenue |
66,616 | 31,918 | ||||||
Other income |
2,833 | 50,757 | ||||||
Research and development expenses |
(148,072 | ) | (95,557 | ) | ||||
General and administrative expenses |
(58,914 | ) | (48,566 | ) | ||||
|
|
|
|
|||||
Operating loss |
(137,537 | ) | (61,448 | ) | ||||
|
|
|
|
|||||
Share of net loss of joint venture |
(1,505 | ) | (192 | ) | ||||
Finance income |
5,608 | 6,932 | ||||||
Finance costs |
(161,551 | ) | (158,467 | ) | ||||
Exchange rate differences |
3,215 | 3,790 | ||||||
|
|
|
|
|||||
Non–Operating loss |
(154,233 | ) | (147,937 | ) | ||||
|
|
|
|
|||||
Loss before taxes |
(291,770 | ) | (209,385 | ) | ||||
Income tax benefit / (expense) |
121,726 | (491 | ) | |||||
|
|
|
|
|||||
Loss for the year |
(170,044 | ) | (209,876 | ) | ||||
|
|
|
|
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
Revenue |
66,616 | 31,918 | 34,698 | 108.7 |
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
Other income |
2,833 | 50,757 | (47,924 | ) | (94.4 | ) |
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
AVT02 development program expenses |
42,440 | 30,655 | 11,785 | 38.4 | % | |||||||||||
AVT04 development program expenses |
15,148 | 3,045 | 12,103 | 397.5 | % | |||||||||||
AVT06 development program expenses |
2,321 | 302 | 2,019 | 668.5 | % | |||||||||||
Salary and other employee expenses |
49,043 | 34,998 | 14,045 | 40.1 | % | |||||||||||
Depreciation and amortization |
16,358 | 7,800 | 8,558 | 110 | % | |||||||||||
Other research and development expenses (1) |
22,762 | 18,757 | 4,005 | 21.4 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total research and development expenses |
148,072 | 95,557 | 52,515 | 55.0 | % | |||||||||||
|
|
|
|
|
|
|
|
(1) |
Other research and development expenses include manufacturing costs, facility costs and other operating expenses recognized as research and development expenses during the period. In 2020, other research and development expenses includes the payment made to Lotus Pharmaceutical Co. Ltd., a related party, related to the acquisition of rights for the commercialization of Alvotech’s biosimilar Adalimumab product in certain territories in Asia. |
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
General and administrative expenses |
58,914 | 48,566 | 10,348 | 21.3 |
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
Share of net loss of joint venture |
1,505 | 192 | 1,313 | 683.9 |
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
Finance income |
5,608 | 6,932 | (1,324 | ) | (19.1 | ) |
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
Finance costs |
161,551 | 158,467 | 3,084 | 1.9 |
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
Exchange rate differences |
3,215 | 3,790 | (575) | (15.2 | ) |
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
Income tax benefit / (expense) |
121,726 | (491 | ) | 122,217 | nm |
• | Income tax (benefit) expense; |
• | Total net finance (income) costs; |
• | Depreciation and amortization of property, plant, and equipment, right-of-use |
• | Impairment of property, plant, and equipment and other intangible assets; |
• | Long-term incentive plan expense; |
• | Share of net loss (profit) of joint venture; |
• | Exchange rate differences; |
• | Gain on extinguishment of financial liabilities; |
• | Transaction costs incurred in connection with the Business Combination; |
• | Gain on contribution of intellectual property; and |
• | Acquisition of rights for Adalimumab from Lotus Pharmaceutical Co. Ltd. |
USD in thousands |
2021 | 2020 | ||||||
Loss for the period |
(273,947 | ) | (102,123 | ) | ||||
Income tax benefit |
(25,918 | ) | (31 | ) | ||||
Total net finance costs |
123,571 | 40,676 | ||||||
Depreciation and amortization |
8,928 | 7,935 | ||||||
Impairment of property, plant and equipment and other intangible assets |
6,059 | — | ||||||
Long-term incentive plan expense (1) |
61,201 | 5,411 | ||||||
Share of net loss (profit) of joint venture |
837 | (180 | ) | |||||
Exchange rate differences |
3,611 | (12,443 | ) | |||||
Gain on extinguishment of financial liabilities |
(2,561 | ) | — | |||||
Transaction costs (2) |
1,950 | — | ||||||
|
|
|
|
|||||
Adjusted EBITDA |
(96,269 | ) | (60,755 | ) | ||||
|
|
|
|
(1) | Represents expense related to the long-term incentive plans, reported within general and administrative expenses. |
(2) | Represents transaction costs incurred in connection with the Business Combination, reported within general and administrative expenses. |
USD in thousands |
2020 | 2019 | ||||||
Loss for the year |
(170,044 | ) | (209,876 | ) | ||||
Income tax (benefit) expense |
(121,726 | ) | 491 | |||||
Total net finance costs |
155,943 | 151,535 | ||||||
Depreciation and amortization |
16,419 | 14,607 | ||||||
Impairment of property, plant and equipment |
2,142 | — | ||||||
Long-term incentive plan expense (1) |
18,053 | 22,384 | ||||||
Share of net loss of joint venture |
1,505 | 192 | ||||||
Exchange rate differences |
(3,215 | ) | (3,790 | ) | ||||
Gain on contribution of intellectual property (2) |
— | (45,000 | ) | |||||
Acquisition of rights for Adalimumab from Lotus Pharmaceutical Co. Ltd. (3) |
9,300 | — | ||||||
|
|
|
|
|||||
Adjusted EBITDA |
(91,623 | ) | (69,457 | ) | ||||
|
|
|
|
(1) | Represents expense related to the long-term incentive plans, reported within general and administrative expenses. |
(2) | Represents the gain recognized for the contribution of intellectual property to the Joint Venture, reported within other income. |
(3) | Represent the expense related to the acquisition of rights for Adalimumab from Lotus Pharmaceutical Co. Ltd., reported within research and development expenses. |
• | the progress, results, and costs of preclinical studies for any programs that Alvotech may develop; |
• | the costs, timing, and outcome of regulatory review of program candidates; |
• | Alvotech’s ability to establish and maintain collaborations, licensing, and other agreements with commercial partners on favorable terms, if at all; |
• | the achievement of milestones or occurrence of other developments that trigger payments under the agreements that Alvotech has entered into or may enter into with third parties or related parties; |
• | the extent to which Alvotech is obligated to reimburse clinical trial costs under collaboration agreements, if any; |
• | the costs of preparing, filing and prosecuting patent applications and maintaining, defending and enforcing Alvotech’s intellectual property rights; |
• | the extent to which Alvotech acquires or invests in businesses, products, technologies, or other joint ventures; |
• | the costs of performing commercial-scale manufacturing in-house and, if needed, securing manufacturing arrangements for commercial production of its program candidates; and |
• | the costs of establishing or contracting for sales and marketing capabilities if Alvotech obtains regulatory approvals to market program candidates. |
Change |
||||||||||||||||
Six Months Ended June 30, |
2020 to 2021 |
|||||||||||||||
USD in thousands |
2021 |
2020 |
$ |
% |
||||||||||||
Cash used in operating activities |
(84,734 | ) | (50,988 | ) | (33,746 | ) | (66.2 | ) | ||||||||
Cash used in investing activities |
(6,972 | ) | (9,511 | ) | 2,539 | 26.7 | ||||||||||
Cash generated from financing activities |
102,001 | 11,713 | 90,288 | 770.8 |
Change |
||||||||||||||||
Year Ended December 31, |
2019 to 2020 |
|||||||||||||||
USD in thousands |
2020 |
2019 |
$ |
% |
||||||||||||
Cash used in operating activities |
(74,295 | ) | (88,548 | ) | 14,253 | 16.1 | ||||||||||
Cash used in investing activities |
(16,903 | ) | (12,876 | ) | (4,027 | ) | (31.3 | ) | ||||||||
Cash generated from financing activities |
55,402 | 116,370 | (60,968 | ) | (52.4 | ) |
• | implemented a compliance tool to provide workflow and electronic approval capabilities as well as to maintain control evidence; |
• | engaged outside consultants to assist in evaluating the internal controls and developing a remediation plan to address the control deficiencies; |
• | began to implement entity level and business process-level controls to mitigate the key risks identified; |
• | prepared to implement a new ERP system; and |
• | hired more accounting resources. |
• | indebtedness other than expressly agreed or acknowledged or the issuance of certain stocks by the borrower or any subsidiary is not permitted; |
• | the creation of lien and securities by the borrower or any of its subsidiaries is restricted; |
• | certain payments and redemptions by the borrower or any of its subsidiaries other than those expressly agreed are prohibited; and |
• | certain obligations and restrictions relating to real estate assets located at the head office in Iceland are applicable. |
• | indebtedness other than expressly agreed or acknowledged or the issuance of certain stocks by the borrower or any subsidiary is not permitted; |
• | the creation of lien and securities by the borrower or any of its subsidiaries is restricted; |
• | certain payments and redemptions by the borrower or any of its subsidiaries other than those expressly agreed are prohibited; and |
• | certain obligations and restrictions relating to real estate assets located at the head office in Iceland are applicable. |
• | indebtedness other than expressly agreed or acknowledged or the issuance of certain stocks by the borrower or any subsidiary is not permitted; |
• | the creation of lien and securities by the borrower or any of its subsidiaries is restricted; |
• | certain payments and redemptions by the borrower or any of its subsidiaries other than those expressly agreed are prohibited; and |
• | certain obligations and restrictions relating to real estate assets located at the head office in Iceland are applicable. |
• | indebtedness other than expressly agreed or acknowledged or the issuance of certain stocks by the borrower or any subsidiary is not permitted; |
• | the creation of lien and securities by the borrower or any of its subsidiaries is restricted; |
• | certain payments and redemptions by the borrower or any of its subsidiaries other than those expressly agreed are prohibited; and |
• | certain obligations and restrictions relating to real estate assets located at the head office in Iceland are applicable. |
• | indebtedness other than expressly agreed or acknowledged or the issuance of certain stocks by the borrower or any subsidiary is not permitted; |
• | the creation of lien and securities by the borrower or any of its subsidiaries is restricted; |
• | certain payments and redemptions by the borrower or any of its subsidiaries other than those expressly agreed are prohibited; and |
• | certain obligations and restrictions relating to real estate assets located at the head office in Iceland are applicable. |
• | indebtedness other than expressly agreed or acknowledged or the issuance of certain stocks by the borrower or any subsidiary is not permitted; |
• | the creation of lien and securities by the borrower or any of its subsidiaries is restricted; |
• | certain payments and redemptions by the borrower or any of its subsidiaries other than those expressly agreed are prohibited; and |
• | certain obligations and restrictions relating to real estate assets located at the head office in Iceland are applicable. |
i. | confirmation by Alvogen of its prior full exercise of its warrant right under the shareholders agreement relating to Alvotech dated October 21, 2020; |
ii. | on December 14, 2021, Aztiq subscribed for a number of newly issued Alvotech Class A Ordinary Shares for an aggregate subscription price of $50 million which has been set-off against (a) the principal amount of the Floki Loan in the amount of $25 million and (b) an amount of accrued and unpaid interest due by Alvotech to Aztiq in the amount of $25 million; |
iii. | on December 14, 2021, Alvogen subscribed for a number of newly issued Alvotech Class A Ordinary Shares (a) for an aggregate subscription price of $48.7 million which has been set-off against the corresponding amount, consisting of accrued interest due by Alvotech to Alvogen, and (b) for an aggregate subscription price of $46.5 million which has been paid through conversion of the outstanding principal amount of $46.5 million under the Amended Alvogen Convertible Loan Agreement, including the Alvogen Transfer Debt, in accordance with the terms of the related conversion agreement; |
iv. | on December 14, 2021, Aztiq exercised its right under the Aztiq Warrant Agreement by subscribing for Alvotech Class A Ordinary Shares, and set off the subscription price of such new Alvotech Class A |
Ordinary Shares against (a) the outstanding principal amount due by Alvotech to Aztiq under the Amended Aztiq Convertible Loan Agreement in the amount of $11.7 million, and (b) the outstanding principal amount due by Alvotech to Aztiq under the 2020 Convertible Loan in the amount of $9.4 million; |
v. | on December 14, 2021, the outstanding principal amount under the 2020 Convertible Loan was converted into Alvotech Class A Ordinary Shares in accordance with the terms of the related conversion agreement in respect of all other holders thereof (except Aztiq as referred to under item (iv) above); |
vi. | accrued and unpaid interest on the different loan agreements to which Alvotech was a borrower was used by the creditors thereof to pay for newly issued Class A Shares of the Company at the valuation at which the PIPE Investors invest into TopCo; |
vii. | a compensatory share issue was agreed for holders of convertible bonds issued by Alvotech who/which had converted convertible bonds issued by Alvotech in June 2021 at a higher valuation than the valuation at which the PIPE Investors invest into TopCo; and |
viii. | the terms and conditions applicable to the Seller Earn Out Shares were agreed, i.e. (a) the holders of the Seller Earn Out Shares are entitled to the same voting and dividend rights generally granted to holders of TopCo Ordinary Shares and (b) vesting conditions and buyback provisions were set out. |
• | For an indefinite period of time after the completion of our initial business combination, the prospects for our success may depend entirely on the future performance of a single business. Unlike other entities that have the resources to complete business combinations with multiple entities in one or several industries, it is probable that we will not have the resources to diversify our operations and mitigate the risks of being in a single line of business. By completing our initial business combination with only a single entity, our lack of diversification may: subject us to negative economic, competitive and regulatory developments, any or all of which may have a substantial adverse impact on the particular industry in which we operate after our initial business combination; and |
• | cause us to depend on the marketing and sale of a single product or limited number of products or services. |
Name |
Age |
Title | ||
Patrick McCaney | 40 | Chief Executive Officer and Director | ||
Alexander Taubman | 33 | President | ||
Zaid Pardesi | 38 | Chief Financial Officer and Head of M&A | ||
Mathew Pendo | 57 | Chief Operating Officer | ||
John Frank | 64 | Chairman and Director | ||
Paul Meister | 68 | Director | ||
Andrea Wong | 54 | Director | ||
Anthony Grillo | 66 | Director |
• | meeting with our independent registered public accounting firm regarding, among other issues, audits, and adequacy of our accounting and control systems; |
• | monitoring the independence of the independent registered public accounting firm; |
• | verifying the rotation of the lead (or coordinating) audit partner having primary responsibility for the audit and the audit partner responsible for reviewing the audit as required by law; |
• | inquiring and discussing with management our compliance with applicable laws and regulations; |
• | pre-approving all audit services and permitted non-audit services to be performed by our independent registered public accounting firm, including the fees and terms of the services to be performed; |
• | appointing or replacing the independent registered public accounting firm; |
• | determining the compensation and oversight of the work of the independent registered public accounting firm (including resolution of disagreements between management and the independent auditor regarding financial reporting) for the purpose of preparing or issuing an audit report or related work; |
• | establishing procedures for the receipt, retention and treatment of complaints received by us regarding accounting, internal accounting controls or reports which raise material issues regarding our financial statements or accounting policies; |
• | monitoring compliance on a quarterly basis with the terms of our IPO and, if any noncompliance is identified, immediately taking all action necessary to rectify such noncompliance or otherwise causing compliance with the terms of our IPO; and |
• | reviewing and approving all payments made to our existing shareholders, executive officers or directors and their respective affiliates. Any payments made to members of our audit committee will be reviewed and approved by our board of directors, with the interested director or directors abstaining from such review and approval. |
• | should have demonstrated notable or significant achievements in business, education or public service; |
• | should possess the requisite intelligence, education and experience to make a significant contribution to the board of directors and bring a range of skills, diverse perspectives and backgrounds to its deliberations; and |
• | should have the highest ethical standards, a strong sense of professionalism and intense dedication to serving the interests of the shareholders. |
• | reviewing and approving on an annual basis the corporate goals and objectives relevant to our Chief Executive Officer’s compensation, evaluating our Chief Executive Officer’s performance in light of such goals and objectives and determining and approving the remuneration (if any) of our Chief Executive Officer based on such evaluation; |
• | reviewing and approving the compensation of all of our other Section 16 executive officers; |
• | reviewing our executive compensation policies and plans; |
• | implementing and administering our incentive compensation equity-based remuneration plans; |
• | assisting management in complying with our proxy statement and annual report disclosure requirements; |
• | approving all special perquisites, special cash payments and other special compensation and benefit arrangements for our executive officers and employees; |
• | producing a report on executive compensation to be included in our annual proxy statement; and |
• | reviewing, evaluating and recommending changes, if appropriate, to the remuneration for directors. |
• | duty to act in good faith in what the director or officer believes to be in the best interests of the company as a whole; |
• | duty to exercise powers for the purposes for which those powers were conferred and not for a collateral purpose; |
• | directors should not improperly fetter the exercise of future discretion; |
• | duty not to put themselves in a position in which there is a conflict between their duty to the company and their personal interests; and |
• | duty to exercise independent judgment. |
Individual |
Entity |
Entity’s Business |
Affiliation | |||
Patrick McCaney |
Oaktree Capital Management, L.P. |
Asset Management |
Managing Director and Portfolio Manager | |||
Oaktree Acquisition Corp. III |
Special Purpose Acquisition Company |
Co-Chief Executive Officer and Director | ||||
Alexander Taubman |
Oaktree Capital Management, L.P. |
Asset Management |
Managing Director | |||
Oaktree Acquisition Corp. III |
Special Purpose Acquisition Company |
Co-Chief Executive Officer | ||||
Taubman Ventures Group LLC and certain affiliates |
Asset Management |
Advisor | ||||
Zaid Pardesi |
Oaktree Capital Management, L.P. |
Asset Management |
Managing Director | |||
Oaktree Acquisition Corp. III |
Special Purpose Acquisition Company |
President and Chief Financial Officer | ||||
John Frank |
Oaktree Capital Management, L.P. |
Asset Management |
Vice Chairman | |||
Oaktree Acquisition Corp. III |
Special Purpose Acquisition Company |
Chairman and Director | ||||
Oaktree Specialty Lending Corporation |
Asset Management |
Chairman and Director | ||||
Chevron Corporation |
Energy |
Director | ||||
Mathew Pendo |
Oaktree Capital Management, L.P. |
Asset Management |
Managing Director, Head of Corporate Development and Capital Markets | |||
Oaktree Acquisition Corp. III |
Special Purpose Acquisition Company |
Chief Operating Officer |
Individual |
Entity |
Entity’s Business |
Affiliation | |||
Oaktree Specialty Lending Corporation |
Asset Management |
President and Chief Operating Officer | ||||
Oaktree Strategic Income II |
Asset Management |
President and Chief Operating Officer | ||||
Anthony Grillo |
NarrativeWave |
Software Development |
Director | |||
Littelfuse |
Electronic Component Manufacturing |
Director | ||||
Paul Meister |
Liberty Lane Partners, LLC |
Private Equity |
Co-Founder | |||
Perspecta Trust |
Investment, Trust and Wealth Advisory Services |
Co-Founder | ||||
Quanterix Corporation |
Healthcare |
Director | ||||
University of Michigan’s Life Sciences Institute |
Life Sciences |
Co-Chair of External Advisory Board; Chair of the Provost’s Advisory Committee | ||||
Aptiv PLC |
Technology |
Director | ||||
Amneal Pharmaceuticals, Inc. |
Healthcare |
Chairman and Director | ||||
Andrea Wong |
Liberty Media Corporation |
Media |
Director | |||
Qurate Retail Group |
Media |
Director | ||||
Hudson Pacific Properties |
Real Estate |
Director | ||||
Roblox Corporation |
Technology |
Director |
• | Our executive officers and directors are not required to, and will not, commit their full time to our affairs, which may result in a conflict of interest in allocating their time between our operations and our search for a business combination and their other businesses. We do not intend to have any full-time employees prior to the completion of our initial business combination. Each of our executive officers is engaged in several other business endeavors for which he may be entitled to substantial compensation, and our executive officers are not obligated to contribute any specific number of hours per week to our affairs. |
• | The Sponsor subscribed for Founder Shares and purchased private placement warrants in a transaction that closed simultaneously with the closing of our IPO. |
• | The Sponsor and each member of our management team have entered into agreements with us, pursuant to which they have agreed to waive their redemption rights with respect to their Founder Shares and Public Shares in connection with (i) the completion of our initial business combination and (ii) a shareholder vote to approve an amendment to our Memorandum and Articles of Association that would affect the substance or timing of our obligation to redeem 100% of our Public Shares if we have not consummated an initial business combination within 24 months from the closing of our IPO. Additionally, the Sponsor has agreed |
to waive its rights to liquidating distributions from the Trust Account with respect to its Founder Shares if we fail to complete our initial business combination within the prescribed time frame. If we do not complete our initial business combination within the prescribed time frame, the private placement warrants will expire worthless. Except as described herein, the Sponsor and our directors and executive officers have agreed not to transfer, assign or sell any of their Founder Shares until the earliest of (A) one year after the completion of our initial business combination or (B) subsequent to our initial business combination, (x) if the closing price of our Class A ordinary shares equals or exceeds $12.00 per share (as adjusted for share splits, share capitalizations, reorganizations, recapitalizations and the like) for any 20 trading days within any 30-trading day period commencing at least 150 days after our initial business combination, or (y) the date on which we complete a liquidation, merger, share exchange or other similar transaction that results in all of our shareholders having the right to exchange their ordinary shares for cash, securities or other property. The private placement warrants will not be transferable until 30 days following the completion of our initial business combination. Because each of our executive officers and directors owns ordinary shares or warrants directly or indirectly, they may have a conflict of interest in determining whether a particular target business is an appropriate business with which to effectuate our initial business combination. |
• | Our officers and directors may have a conflict of interest with respect to evaluating a particular business combination if the retention or resignation of any such officers and directors is included by a target business as a condition to any agreement with respect to our initial business combination. |
• | may significantly dilute the equity interest of current shareholders, which dilution would increase if the anti-dilution provisions in the OACB Class B ordinary Shares resulted in the issuance of OACB Class A ordinary Shares on a greater than one-to-one |
• | may subordinate the rights of holders of OACB Class A ordinary Shares if preference shares are issued with rights senior to those afforded the OACB Class A ordinary Shares; |
• | could cause a change in control if a substantial number of the OACB Class A ordinary Shares are issued, which may affect, among other things, our ability to use our net operating loss carry forwards, if any, and could result in the resignation or removal of our present officers and directors; |
• | may have the effect of delaying or preventing a change of control of us by diluting the share ownership or voting rights of a person seeking to obtain control of us; and |
• | may adversely affect prevailing market prices for the OACB Class A ordinary Shares and/or OACB Public Warrants. Similarly, if we issue debt securities or otherwise incur significant debt, it could result in: |
• | default and foreclosure on our assets if our operating revenues after an initial business combination are insufficient to repay our debt obligations; |
• | acceleration of our obligations to repay the indebtedness even if we make all principal and interest payments when due if we breach certain covenants that require the maintenance of certain financial ratios or reserves without a waiver or renegotiation of that covenant; |
• | our immediate payment of all principal and accrued interest, if any, if the debt security is payable on demand; |
• | our inability to obtain necessary additional financing if the debt security contains covenants restricting our ability to obtain such financing while the debt security is outstanding; |
• | our inability to pay dividends on the OACB Class A ordinary Shares; |
• | using a substantial portion of our cash flow to pay principal and interest on our debt, which will reduce the funds available for dividends on the OACB Class A ordinary Shares if declared, expenses, capital expenditures, acquisitions and other general corporate purposes; |
• | limitations on our flexibility in planning for and reacting to changes in our business and in the industry in which we operate; |
• | increased vulnerability to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation; and |
• | limitations on our ability to borrow additional amounts for expenses, capital expenditures, acquisitions, debt service requirements, execution of our strategy and other purposes and other disadvantages compared to our competitors who have less debt. |
Name |
Age |
Title | ||
Executive Officers |
||||
Robert Wessman |
52 | Executive Chairman of the Board of Directors | ||
Mark Levick |
58 | Chief Executive Officer | ||
Tanya Zharov |
55 | Deputy Chief Executive Officer | ||
Joseph E. McClellan |
48 | Chief Scientific Officer | ||
Sean Gaskell |
40 | Chief Technical Officer | ||
Joel Morales |
44 | Chief Financial Officer | ||
Reem Malki |
51 | Chief Quality Officer | ||
Anil Okay |
34 | Chief Commercial Officer | ||
Ming Li |
45 | Chief Strategy Officer | ||
Directors |
||||
Richard Davies |
60 | Director and Deputy Chairman | ||
Tomas Ekman |
54 | Director | ||
Faysal Kalmoua |
46 | Director | ||
Ann Merchant |
56 | Director | ||
Arni Hardarson |
55 | Director | ||
Lisa Graver |
50 | Director | ||
Linda McGoldrick |
66 | Director |
• | TopCo will have three independent directors and independent director representation on our audit, compensation and nominating committees immediately following the consummation of the Business Combination, and TopCo’s independent directors will meet regularly in executive sessions without the presence of our corporate officers or non-independent directors; |
• | at least one of the independent directors will qualify as an “audit committee financial expert” as defined by the SEC; and |
• | TopCo will implement a range of other corporate governance practices, including implementing a robust director education program. |
• | appointing, compensating, retaining, evaluating, terminating and overseeing our independent registered public accounting firm; |
• | discussing with our independent registered public accounting firm their independence from management; |
• | reviewing, with our independent registered public accounting firm, the scope and results of their audit; |
• | approving all audit and permissible non-audit services to be performed by our independent registered public accounting firm; |
• | overseeing the financial reporting process and discussing with management and our independent registered public accounting firm the annual financial statements that we file with the SEC; |
• | overseeing our financial and accounting controls and compliance with legal and regulatory requirements; |
• | reviewing our policies on risk assessment and risk management; |
• | reviewing related person transactions; and |
• | establishing procedures for the confidential anonymous submission of concerns regarding questionable accounting, internal controls or auditing matters. |
• | reviewing and approving the corporate goals and objectives, evaluating the performance of and reviewing and approving, (either alone or, if directed by the board of directors, in conjunction with a majority of the independent members of the board of directors) the compensation of our Chief Executive Officer; |
• | overseeing an evaluation of the performance of and reviewing and setting or making recommendations to our board of directors regarding the compensation of our other executive officers; |
• | reviewing and approving or making recommendations to our board of directors regarding our incentive compensation and equity-based plans, policies and programs; |
• | reviewing and approving all employment agreement and severance arrangements for our executive officers; |
• | making recommendations to our shareholders regarding the compensation of our directors; and |
• | retaining and overseeing any compensation consultants. |
• | identifying individuals qualified to become members of our board of directors, consistent with criteria approved by our board of directors; |
• | overseeing succession planning for our Chief Executive Officer and other executive officers; |
• | periodically reviewing our board of directors’ leadership structure and recommending any proposed changes to our board of directors; |
• | overseeing an annual evaluation of the effectiveness of our board of directors and its committees; and |
• | developing and recommending to our board of directors a set of corporate governance guidelines. |
• | prior authorization by a simple majority vote at an ordinary general meeting of shareholders, which authorization sets forth: |
• | the terms and conditions of the proposed repurchase and in particular the maximum number of ordinary shares to be repurchased; |
• | the duration of the period for which the authorization is given, which may not exceed five years; and |
• | in the case of repurchase for consideration, the minimum and maximum consideration per share, provided that the prior authorization shall not apply in the case of ordinary shares acquired by either TopCo, or by a person acting in his or her own name on its behalf, for the distribution thereof to its staff or to the staff of a company with which it is in a control relationship; |
• | only fully paid-up ordinary shares may be repurchased; and |
• | the voting and dividend rights attached to the repurchased shares will be suspended as long as the repurchased ordinary shares are held by TopCo; and the acquisition offer must be made on the same terms and conditions to all the shareholders who are in the same position, except for acquisitions which were unanimously decided by a general meeting at which all the shareholders were present or represented. In addition, listed companies may repurchase their own shares on the stock exchange without an acquisition offer having to be made to TopCo’s shareholders. |
Cayman Islands |
Luxembourg | |||
SHAREHOLDER APPROVAL OF BUSINESS COMBINATIONS |
Under the Cayman Companies Act a merger or consolidation of a company with or into one or more other companies requires the approval of shareholders by a special resolution passed by at least two-thirds (or such greater majority as may be specified by the articles of association) of the votes cast at a quorate meeting on the resolution or by written resolution unanimously adopted by all shareholders entitled to vote on the matter.All mergers (other than certain parent/subsidiary mergers) require shareholder approval. Where a bidder has acquired 90% or more of the shares in a Cayman Islands company, it can compel the acquisition of the shares of the remaining shareholders and thereby become the sole shareholder. A Cayman Islands company may also be acquired through a “scheme of arrangement” sanctioned by a Cayman Islands |
Under Luxembourg law and the articles of association, the board of directors has the broadest powers to take any action necessary or useful to achieve the company’s purpose. The board of directors’ powers are limited only by law and TopCo’s articles of association. Any type of business combination that would require an amendment to the articles of association, such as a merger, de-merger, dissolution, or voluntary liquidation, requires an extraordinary resolution of a general meeting of shareholders. Transactions such as a sale, lease, or exchange of certain company assets require only the approval of the board of directors. Neither Luxembourg law nor TopCo’s articles of association contain any provision requiring the board of directors to obtain shareholder approval of a sale, lease, or exchange of substantial assets of TopCo. However, the sale of all or a substantial part of TopCo’s |
Cayman Islands |
Luxembourg | |||
court and approved by 50%+1 in number and 75% in value of shareholders in attendance and voting at a shareholders’ meeting. | assets could lead to its dissolution for absence of corporate object and consequently would require the board of directors to obtain shareholder approval in an extraordinary general meeting. | |||
SPECIAL VOTE REQUIRED FOR COMBINATIONS WITH INTERESTED SHAREHOLDERS |
Subject to the articles of association, there are no general restrictions or prohibitions under Cayman Islands law with a shareholder transacting or contracting with the company. Shareholders (in their capacity as such) do not owe fiduciary duties to the company or their fellow shareholders. | Under Luxembourg law, no restriction exists as to the transactions that a shareholder may engage in with TopCo. The transaction must, however, be in TopCo’s corporate interest, which for instance requires that the transactions are made on arm’s length terms. | ||
SHAREHOLDER RIGHTS PLAN |
Under Cayman Islands law, subject to the articles of association the company, directors may have the power to allot, issue, grant options over or otherwise dispose of shares authorised and unissued shares with or without preferred, deferred or other rights or restrictions, whether in regard to dividends or other distribution, voting, return of capital or otherwise and to such persons, at such times and on such other terms as they think proper. | Pursuant to Luxembourg law, the shareholders may create an authorized share capital which allows the board of directors to increase the issued share capital in one or several tranches with or without share premium, against payment in cash or in kind, by conversion of claims on TopCo or in any other manner for any reason whatsoever including (i) issue subscription and/or conversion rights in relation to new shares or instruments within the limits of the authorized capital under the terms and conditions of warrants (which may be separate or linked to shares, bonds, notes or similar instruments issued by TopCo), convertible bonds, notes or similar instruments; (ii) determine the place and date of the issue or successive issues, the issue price, the terms and conditions of the subscription of and paying up on the new shares and instruments and (iii) remove or limit the statutory preferential subscription right of the shareholders in case of issue against payment in cash or shares, warrants (which may be separate or attached to shares, bonds, notes or similar instruments), convertible |
Cayman Islands |
Luxembourg | |||
bonds, notes or similar instruments within the limits of such authorized share capital. The board of directors may be further authorized to, under certain conditions, limit, restrict, or waive preferential subscription rights of existing shareholders when issuing new shares within the authorized share capital. The rights attached to the new shares issued within the authorized share capital will be equal to those attached to existing shares and set forth in the articles of association. In addition, the board of directors may be further authorized to make an allotment of existing or newly issued shares without consideration to (a) employees of TopCo or certain categories amongst those; (b) employees of companies or economic interest grouping in which TopCo holds directly or indirectly at least 10% of the share capital or voting rights; (c) employees of companies or economic interest grouping which directly or indirectly hold at least 10% of the share capital or voting rights of TopCo, (d) employees of companies or economic interest grouping in which at least 50% of the share capital or voting rights is held directly or indirectly by a company which holds directly or indirectly at least 50% of the share capital of TopCo; (e) members of the corporate bodies of TopCo or of the companies or economic interest grouping listed in point (b) to (d) above or certain categories amongst those. The authorization to the board of directors to issue additional shares or other instruments as described above within the authorized share capital (and to limit, restrict, or waive, as the case may be, |
Cayman Islands |
Luxembourg | |||
preferential subscription rights) as well as the authorization to allot shares without consideration may be valid for a period of up to five years, starting from either the date of the minutes of the extraordinary general meeting resolving upon such authorization or starting from the date of the publication of the minutes of the extraordinary general meeting resolving upon such authorization in the Luxembourg official gazette (RESA). The authorization may be renewed, increased or reduced by a resolution of the extraordinary general meeting of shareholders, with the quorum and majority rules set for the amendment of the articles of association. TopCo’s articles of association authorize its board of directors to issue TopCo Ordinary Shares within the limits of the authorized share capital at such times and on such terms as the board of directors or its delegates may decide for a period ending five years after the date of the creation of the authorized share capital or its publication date unless such period is extended, amended or renewed. Accordingly, the board of directors is authorized to issue TopCo Ordinary Shares up to the limits of authorized share capital until such date. TopCo currently intends to seek renewals and/or extensions as required from time to time. | ||||
APPRAISAL RIGHTS |
Under Cayman Islands law, holders of record of ordinary shares who comply with the applicable requirements of Section 238 of the Cayman Companies Act may have the right, under certain circumstances, to dissent from a statutory merger and exercise appraisal. | Neither Luxembourg law nor TopCo’s articles of association provide for appraisal rights. |
Cayman Islands |
Luxembourg | |||
(“dissenter”) rights, including rights to seek payment of the fair value of their ordinary shares, which, if necessary, may ultimately be determined by the court. | ||||
SHAREHOLDER CONSENT TO ACTION WITHOUT MEETING |
Shareholder written resolutions are permitted under Cayman Islands law. | A shareholder meeting must always be called if the matter to be considered requires a shareholder resolution under Luxembourg law or TopCo’s articles of association. Pursuant to Luxembourg law, shareholders of a public limited liability company may not take actions by written consent. All shareholder actions must be approved at an actual meeting of shareholders held before a notary public or under private seal, depending on the nature of the matter. Shareholders may vote in person, by proxy or, if the articles of association provide for that possibility, by correspondence. The articles of association of TopCo provide for the possibility of vote by correspondence. | ||
MEETINGS OF SHAREHOLDERS |
The procedure for convening and holding shareholder meetings is set out in the articles of association. The articles of association will typically provide for the directors to convene a shareholder meeting whenever they think fit upon written notice to all shareholders entitled to receive notice and attend the meeting, or upon the requisition in writing of shareholders holding the prescribed share capital of the company carrying the right to vote at a meeting. On receiving the requisition, the directors are required to call and hold a shareholder meeting for the purposes set out in the requisition, subject to the terms set out in the articles of association. | Pursuant to Luxembourg law, at least one general meeting of shareholders must be held each year, within six months as from the close of the financial year. The purpose of such annual general meeting is to approve the annual accounts, allocate the results, proceed to statutory appointments and resolve on the discharge of the directors. Other general meetings of shareholders may be convened. Luxembourg law distinguishes between ordinary resolutions to be adopted and extraordinary resolutions to be adopted by the general meeting of shareholders. Extraordinary resolutions relate to proposed amendments to the articles of association and other |
Cayman Islands |
Luxembourg | |||
A Cayman Islands exempted company is not required by the Cayman Companies Act to convene an annual general meeting. A shareholder may attend and vote at the meeting personally or by proxy (or in the case of a corporation or other non-natural person by its duly authorized representative or proxy). |
limited matters. All other resolutions are ordinary resolutions. Pursuant to Luxemburg law, there is no requirement of a quorum for any ordinary resolutions to be considered at a general meeting and such ordinary resolutions shall be adopted by a simple majority of votes validly cast on such resolution. Abstentions are not considered “votes.” Extraordinary resolutions are required for any of the following matters, among others: (i) an increase or decrease of the authorized or issued share capital, (ii) a limitation or exclusion of preferential subscription rights, (iii) approval of a statutory merger or de-merger (scission Pursuant to Luxembourg law for any extraordinary resolutions to be considered at a general meeting, the quorum shall be at least one half (50%) of the issued share capital. If the said quorum is not present, a second meeting may be convened at which Luxembourg law does not prescribe a quorum. Any extraordinary resolution shall be adopted at a quorate general meeting (except as otherwise provided by mandatory law) by a two-thirds majority of the votes validly cast on such resolution by shareholders. Abstentions are not considered “votes.”The Luxembourg Company Law provides that if, as a result of losses, net assets fall below half of the share capital of the company, the board of directors shall convene an extraordinary general meeting of shareholders so that it is held within a period not |
Cayman Islands |
Luxembourg | |||
exceeding two months from the time at which the loss was or should have been ascertained by them and such meeting shall resolve on the possible dissolution of the company and possibly on other measures announced in the agenda. The board of directors shall, in such situation, draw up a special report which sets out the causes of that situation and justify its proposals eight days before the extraordinary general meeting. If it proposes to continue to conduct business, it shall set out in the report the measures it intends to take in order to remedy the financial situation of the company. The same rules apply if, as a result of losses, net assets fall below one-quarter of the share capital provided that in such case dissolution shall take place if approved by one-fourth of the votes casts at the extraordinary general meeting. | ||||
DISTRIBUTIONS AND DIVIDENDS; REPURCHASES AND REDEMPTIONS |
A Cayman Islands company is not permitted to declare or pay a dividend or distribution out of share premium, redeem or repurchase its own shares out of capital or share premium, or enter into a merger or consolidation unless the company is able to pay its debts as they fall due in the ordinary course of business (i.e. is able to satisfy a “cash flow” solvency test). There is no statutory requirement to evidence the solvency test in any form, although, if there is any doubt in respect of the company’s solvency, it would be prudent for the directors to seek auditor or other accounting verification. Similar rules apply in respect to redemptions. To the extent, however, that a Cayman Islands company is able to satisfy the | Under Luxembourg law, the amount and payment of dividends or other distributions is determined by a simple majority vote at a general shareholders’ meeting based on the recommendation of the board of directors, except in certain limited circumstances. Pursuant to TopCo’s articles of association, the board of directors has the power to pay interim dividends or make other distributions in accordance with applicable Luxembourg law. Distributions may be lawfully declared and paid if TopCo’s net profits and/or distributable reserves are sufficient under Luxembourg law. All TopCo Ordinary Shares rank pari passu with respect to the payment of dividends or other distributions unless the right to dividends or other distributions has been suspended in accordance |
Cayman Islands |
Luxembourg | |||
“cash flow” solvency test, subject to any contrary provisions in the articles of association, each of the above actions are permissible under Cayman Islands law. A Cayman Islands company may, if authorized by its articles of association, issue shares that are redeemable at the option of the company or the holder (redeemable shares) and purchase its own shares, whether redeemable or not. Although a share cannot be redeemed or repurchased if: • it is not fully paid up; • the result would be that there are no shares outstanding; or • the company has commenced liquidation. |
with TopCo’s articles of association or applicable law. Under Luxembourg law, at least 5% of TopCo’s net profits per year must be allocated to the creation of a legal reserve until such reserve has reached an amount equal to 10% of TopCo’s issued share capital. The allocation to the legal reserve becomes compulsory again when the legal reserve no longer represents 10% of TopCo’s issued share capital. The legal reserve is not available for distribution. Pursuant to Luxembourg law, TopCo (or any party acting on its behalf) may repurchase its own shares and hold them in treasury, provided that: • the shareholders at a general meeting have previously authorized the board of directors to acquire its ordinary shares. The general meeting shall determine the terms and conditions of the proposed acquisition and in particular the maximum number of shares to be acquired, the period for which the authorization is given (which may not exceed five years), and, in the case of acquisition for value, the maximum and minimum consideration; • the acquisitions, including shares previously acquired by TopCo and held by it and shares acquired by a person acting in his or her own name but on TopCo’s behalf, may not have the effect of |
Cayman Islands |
Luxembourg | |||
reducing the net assets below the amount of the issued share capital plus the reserves (which may not be distributed by law or under the articles of association); • the shares repurchased are fully paid-up; and• the acquisition offer must be made on the same terms and conditions to all the shareholders who are in the same position, except for acquisitions which were unanimously decided by a general meeting at which all the shareholders were present or represented. In addition, listed companies may repurchase their own shares on the stock exchange without an acquisition offer having to be made to TopCo’s shareholders. No prior authorization by shareholders is required (i) if the acquisition is made to prevent serious and imminent harm to TopCo, provided that the board of directors informs the next general meeting of the reasons for and the purpose of the acquisitions made, the number and nominal values or the accounting value of the shares acquired, the proportion of the subscribed capital which they represent, and the consideration paid for them, and (ii) in the case of shares acquired by either TopCo or by a person acting on its behalf with a view to redistributing the shares to its staff or staff of its controlled subsidiaries, provided |
Cayman Islands |
Luxembourg | |||
that the distribution of such shares is made within 12 months from their acquisition. | ||||
Luxembourg law provides for further situations in which the above conditions do not apply, including the acquisition of shares pursuant to a decision to reduce TopCo’s share capital or the acquisition of shares issued as redeemable shares. Such acquisitions may not have the effect of reducing net assets below the aggregate of subscribed capital and reserves (which may not be distributed by law) and are subject to specific provisions on reductions in share capital and redeemable shares under Luxembourg law. Any shares acquired in contravention of the above provisions must be resold within a period of one year after the acquisition or be cancelled at the expiration of the one-year period.As long as shares are held in treasury, the voting rights attached thereto are suspended. Further, to the extent the treasury shares are reflected as assets on TopCo’s balance sheet a non-distributable reserve of the same amount must be reflected as a liability. TopCo’s articles of association provide that TopCo Ordinary Shares may be repurchased in accordance with the law. | ||||
NUMBER OF DIRECTORS |
The Cayman Companies Act does not contain specific restrictions or requirements with respect to the composition of the board of directors of a Cayman Islands company. Similarly, the Cayman Companies Act does not stipulate a procedure for the appointment of directors, which instead would be prescribed in the articles of association of the company. Typically, the articles of | Pursuant to Luxembourg law, the TopCo Board must be composed of at least three directors. They are appointed by the general meeting of shareholders (by proposal of the board of directors, the shareholders, or a spontaneous candidacy) by a simple majority of the votes cast. Abstentions are not considered “votes.” Directors may be reelected, but the term of their office may not exceed six years. |
Cayman Islands |
Luxembourg | |||
association will also make provision for matters such as directors’ qualifications, terms of office and retirement, removal and rotation of directors, regulation of directors’ meetings, proceedings of the board and notice requirements, and the manner of determining questions that arise at board meetings. Sole directors and corporate directorships are permissible, subject to the articles of association. | TopCo’s articles of association will provide that the board of directors shall be composed of at least three directors. | |||
VACANCIES ON BOARD OF DIRECTORS |
The Cayman Companies Act does not contain specific restrictions or requirements with respect to the composition of the board of directors of a Cayman Islands company. Similarly, the Cayman Companies Act does not stipulate a procedure for the appointment of directors. Any provision dealing with the appointment of directors, is set out in the articles of association of the company. | TopCo’s articles of association provide that in case of a vacancy the remaining members of the board of directors may elect a director to fill the vacancy, on a temporary basis and for a period of time not exceeding the initial mandate of the replaced member of the board of directors, until the next general meeting of shareholders, which shall resolve on the permanent appointment in compliance with the applicable legal provisions and the articles of association. | ||
REMOVAL OF DIRECTORS; STAGGERED TERM OF DIRECTORS |
Any right to remove a director under Cayman Islands law is set out in the articles of association. Subject to any contrary provision in the articles of association, directors may be appointed for whatever term as may be commercially agreed between the company and the directors. | Under Luxembourg law, a director may be removed at any time by the general meeting of shareholders (by proposal of the board of directors, the shareholders, or a spontaneous request) by a simple majority of the votes cast, with or without cause. TopCo’s articles of association will provide that the duration of the mandate of the directors will not exceed three (3) years. | ||
COMMITTEES |
Cayman Islands law permits directors to establish and delegate their powers, authorities and discretions to committees consisting of one or more directors. Subject to any conditions imposed by the directors, the proceedings of a | TopCo’s articles of association will provide that the board of directors may set up committees and determine their composition, powers, and rules. |
Cayman Islands |
Luxembourg | |||
committee will be governed by the same provisions regulating the proceedings of directors, so far as they are capable of applying. | ||||
CUMULATIVE VOTING |
Not applicable | Not applicable. | ||
AMENDMENT OF GOVERNING DOCUMENTS |
Under Cayman Islands law, the directors have no power to make, amend or repeal the memorandum of association or articles of association of a Cayman Islands company. Instead any amendment or alteration to the memorandum of association or the articles of association requires approval from the shareholders by a special resolution passed by at least two-thirds (or such greater majority as may be specified by the articles of association) of the votes cast at a quorate meeting on the resolution or by written resolution unanimously adopted by all shareholders entitled to vote on the matter.Where a company’s share capital is divided into different classes of shares and the rights of the holders of a class or series of shares are affected by the alteration differently than those of the holders of other classes or series of shares, it is typical for the articles of association to specify that the alteration is also subject to approval by consent in writing or resolution passed by a certain number (typically a two-thirds (2/3) majority) of the holders of shares of each class or series so affected, whether or not they are otherwise entitled to vote.In addition, certain extraordinary corporate actions, such as winding |
Under Luxembourg law, amendments to TopCo’s articles of association require an extraordinary general meeting of shareholders held in front of a Luxembourg notary at which at least one half (50%) of the share capital is present or represented. The notice of the extraordinary general meeting shall set out the proposed amendments to the articles of association. If the aforementioned quorum is not reached, a second meeting may be convened by means of a notice published in the Luxembourg official electronic gazette (RESA) and in a Luxembourg newspaper 15 days before the meeting. The second meeting shall be validly constituted regardless of the proportion of the share capital present or represented. At both meetings, resolutions will be adopted if approved by at least two-thirds of the votes cast by shareholders (unless otherwise required by Luxembourg law or the articles of association). Where classes of shares exist and the resolution to be adopted by the general meeting of shareholders changes the respective rights attaching to such shares, the resolution will be adopted only if the conditions as to quorum and | ||
up the company (voluntarily or by court order), changing the company’s name, or the merger or consolidation of the company with or into one or more other companies, require the approval of shareholders by a special | majority set out above are fulfilled with respect to each class of shares. An increase of the commitments of the shareholders requires the |
Cayman Islands |
Luxembourg | |||
resolution passed by at least two-thirds (or such greater majority as may be specified by the articles of association) of the votes cast at a quorate meeting on the resolution or by written resolution unanimously adopted by all shareholders entitled to vote on the matter. Other extraordinary actions, such as altering the company’s authorized share capital, require the approval of shareholders by an ordinary resolution passed by a simple majority (or such greater majority as may be specified by the articles of association) of the votes cast at a quorate meeting on the resolution or by written resolution unanimously adopted by all the shareholders entitled to vote on the matter. Cayman Islands law also provides for shareholder schemes of arrangements requiring the consent of at least a majority in number of the shareholders representing not less than 75% in value of the shares of each class affected by the scheme voting at the scheme meeting, and the sanction by the Grand Court of the Cayman Islands. |
unanimous consent of the shareholders. TopCo’s articles of association provide that for any extraordinary resolutions to be considered at a general meeting, the quorum shall be at least one-half of TopCo’s issued share capital. If the said quorum is not present, a second meeting may be convened at which Luxembourg law does not prescribe a quorum. Any extraordinary resolution shall be adopted at a quorate general meeting (save as otherwise provided by mandatory law) by a two-thirds majority of the votes validly cast on such resolution by shareholders. Abstentions are not considered “votes.”In very limited circumstances, the board of directors may be authorized by the shareholders to amend the articles of association, albeit always within the limits set forth by the shareholders at a duly convened shareholders’ meeting. This is the case in the context of TopCo’s authorized share capital within which the board of directors is authorized to issue further TopCo Ordinary Shares. The board of directors is then authorized to appear in front of a Luxembourg notary to record the capital increase and to amend the share capital set forth in the articles of association. The above also applies in case of the transfer of TopCo’s registered office outside the current municipality. | |||
INDEMNIFICATION OF DIRECTORS AND OFFICERS |
Cayman Islands law does not prohibit or restrict a company from indemnifying its directors | Luxembourg law permits TopCo to keep directors indemnified against any expenses, judgments, | ||
and officers against personal liability for any loss they may incur arising out of the company’s business. A company’s articles of association may provide for the indemnification of a director or an | fines and amounts paid in connection with liability of a director towards TopCo or a third party for management errors i.e., for wrongful acts committed during the execution of the |
Cayman Islands |
Luxembourg | |||
officer for breach of duty other than breaches of fiduciary duty and, save in circumstances where there has been willful neglect, willful default, fraud or dishonesty in the carrying out of fiduciary duties. In addition to any indemnities contained in the articles of association, the company will commonly obtain directors’ and officers’ (D&O) insurance. |
mandate ( mandat | |||
LIMITED LIABILITY OF DIRECTORS |
Generally speaking, directors do not incur personal liability for the debts, obligations or liabilities of a company except for those specified by statute and which arise out of negligence, fraud or breach of fiduciary duty on the part of an individual director, or due to an action not within his authority and not ratified by the company. | Luxembourg law does not provide for an ex ante limitation of liability but it permits TopCo to keep directors indemnified as set out above. | ||
ADVANCE NOTIFICATION REQUIREMENTS FOR PROPOSALS OF SHAREHOLDERS |
While not specifically provided for in the Cayman Companies Act, provided such right is set out in the articles of association, a shareholder may request the directors of a Cayman Islands company to propose a resolution for consideration at a shareholders’ meeting. Unless the articles of association provide otherwise, the directors have the discretion to refuse any such request, but in doing so must be mindful of their fiduciary duties towards the company. The directors will also need to be mindful of any right set out in the articles of association permitting shareholders to requisition a shareholder meeting. | One or several shareholders holding at least 10% of the share capital may request the addition of one or several items on the agenda of a general meeting. Such request must be addressed to the registered office of TopCo by registered mail at least five days before the general meeting. If one or more shareholders representing at least 10% of the share capital request so in writing, with an indication of the agenda, the convening of a general meeting, the board of directors or the statutory auditor must convene a general meeting. The general meeting must be held within a period of one month from receipt of such request. |
Cayman Islands |
Luxembourg | |||
SHAREHOLDERS’ SUITS |
Shareholder derivative actions have been brought in the Cayman Islands courts, and the Cayman Islands courts have confirmed the availability of such actions under Cayman Islands law. The Grand Court of the Cayman Islands has an established procedure as part of its rules for the Court granting leave for such claims to be brought. The Grand Court has also granted declarations of a shareholder’s right to bring a derivative action in a foreign jurisdiction, where that determination is helpful to questions of the foreign court’s jurisdiction to hear the claim. In most cases, the company will be the proper plaintiff in any claim based on a breach of duty owed to the company (such as a breach by a director of their fiduciary duties) and the litigation has to be brought by the company itself. Normally the articles of association of the company will state that the right to commence litigation lies with the board of directors. As such, the shareholders will need to persuade the directors to bring an action on behalf of the company or, if the directors decline to take this action, the shareholders will want to consider whether they can replace the directors with a newly constituted board, who can then initiate the action against the former directors. Alternatively, if a shareholder can bring himself, herself or itself within one of the exceptions to the rule in Foss v Harbottle, a decision of the English court which has been accepted into Cayman Islands law, such individual shareholder may be able to bring a derivative action, whereby such individual shareholder may bring an action in his, her or its own name but on behalf of the |
Under Luxembourg law, the board of directors has sole authority to decide whether to initiate legal action to enforce a company’s rights (other than, in certain circumstances, an action against board members). Shareholders generally do not have the authority to initiate legal action on a company’s behalf unless the company fails abusively to exercise its legal rights. However, a company’s shareholders may vote at a general meeting to initiate legal action against directors on grounds that the directors have failed to perform their duties. Luxembourg law does not provide for class action lawsuits. However, it is possible for plaintiffs who have similar but separate claims against the same defendant(s) to bring an action on a “group” basis by way of a joint action. It is also possible to ask the court, under article 206 of the Luxembourg New Civil Procedure Code, to join claims which are closely related and to rule on them together. In addition, minority shareholders holding an aggregate of 10% of the voting rights and who voted against the discharge to a director at the annual general meeting of the company can initiate legal action against the director on behalf of the company. |
Cayman Islands |
Luxembourg | |||
company. The exceptions are when the act complained of: (a) is ultra vires (i.e. beyond the capacity of) the company or illegal; (b) constitutes a “fraud on the minority”, and the wrongdoers are themselves in control of the company, so that they will not cause the company to bring an action; (c) is an irregularity in the passing of a resolution which requires a special majority; or (d) infringes the personal rights of an individual shareholder. In addition, a shareholder may have a direct right of action against the company if he, she or it can show that a duty owed to him, her or it personally (rather than to the company) has been breached. For example, if a shareholder is prevented from exercising a contractual right embedded in the articles of association of the company, he, she or it would generally bring a personal action against the company for a declaration or an injunction. |
• | 1% of the then outstanding equity shares of the same class; or |
• | the average weekly trading volume of TopCo Ordinary Shares of the same class during the four calendar weeks preceding the date on which notice of the sale is filed with the SEC. |
• | the issuer of the securities that was formerly a shell company has ceased to be a shell company; |
• | the issuer of the securities is subject to the reporting requirements of Section 13 or 15(d) of the Exchange Act; |
• | the issuer of the securities has filed all Exchange Act reports and material required to be filed, as applicable, during the preceding 12 months (or such shorter period that the issuer was required to file such reports and materials); and |
• | at least one year has elapsed from the time that the issuer filed Form 20-F type information with the SEC, which is expected to be filed promptly after completion of the Business Combination, reflecting its status as an entity that is not a shell company. |
• | each person known by OACB to beneficially own more than 5% of the outstanding OACB Ordinary Shares; |
• | each of OACB’s current executive officers and directors; |
• | all of OACB’s current executive officers and directors as a group; |
• | each person expected by TopCo to be the beneficial owner of more than 5% of the outstanding TopCo Ordinary Shares after the consummation of the Business Combination; |
• | each person who is expected to become an executive officer or a director of TopCo upon consummation of the Business Combination; and |
• | all of TopCo’s executive officers and directors following consummation of the Business Combination as a group. |
After Business Combination |
||||||||||||||||||||||||
Prior to Business Combination |
Assuming No Redemptions |
Assuming Maximum Redemptions |
||||||||||||||||||||||
Name and Address of Beneficial Owners |
Number of Shares |
% |
Number of Shares |
% |
Number of Shares |
% |
||||||||||||||||||
OACB directors and officers Pre-Business Combination(1) |
||||||||||||||||||||||||
Patrick McCaney |
||||||||||||||||||||||||
Alex Taubman |
||||||||||||||||||||||||
Zaid Pardesi |
||||||||||||||||||||||||
John Frank |
||||||||||||||||||||||||
Matthew Pendo |
After Business Combination |
||||||||||||||||||||||||
Prior to Business Combination |
Assuming No Redemptions |
Assuming Maximum Redemptions |
||||||||||||||||||||||
Name and Address of Beneficial Owners |
Number of Shares |
% |
Number of Shares |
% |
Number of Shares |
% |
||||||||||||||||||
Andrea Wong |
||||||||||||||||||||||||
Anthony Grillo |
||||||||||||||||||||||||
Paul Meister |
||||||||||||||||||||||||
OACB directors and officers Pre-Business Combination as a group (eight persons) |
||||||||||||||||||||||||
OACB Five Percent Holders Pre-Business Combination |
||||||||||||||||||||||||
Oaktree Acquisition Holdings II, L.P.(2) |
% | % | % | |||||||||||||||||||||
Integrated Core Strategies (US) LLC(3) |
% | % | % | |||||||||||||||||||||
TopCo director and officers Post-Business Combination(4) |
||||||||||||||||||||||||
Robert Wessman |
||||||||||||||||||||||||
Richard Davies |
||||||||||||||||||||||||
Tomas Ekman |
||||||||||||||||||||||||
Faysal Kalmoua |
||||||||||||||||||||||||
Ann Merchant |
||||||||||||||||||||||||
Arni Hardarson |
||||||||||||||||||||||||
Lisa Graver |
||||||||||||||||||||||||
Linda McGoldrick |
||||||||||||||||||||||||
Mark Levick |
||||||||||||||||||||||||
Tanya Zharov |
||||||||||||||||||||||||
Joseph E. McClellan |
||||||||||||||||||||||||
Sean Gaskell |
||||||||||||||||||||||||
Joel Morales |
||||||||||||||||||||||||
Reem Malki |
||||||||||||||||||||||||
Anil Okay |
||||||||||||||||||||||||
Ming Li |
||||||||||||||||||||||||
TopCo directors and officers Post-Business Combination as a group ( persons) |
% | % | ||||||||||||||||||||||
TopCo Five Percent Holders Post-Business Combination |
||||||||||||||||||||||||
Alvogen Lux Holdings S.à r.l.(5) |
% | % | ||||||||||||||||||||||
Aztiq Pharma Partners S.à r.l.(6) |
% | % |
* | Less than 1% |
1. | Unless otherwise noted, the business address of the Sponsor and each of the directors and executive officers of OACB is 333 South Grand Avenue, 28th Floor, Los Angeles, CA 90071. |
2. | OACB Acquisition Holdings II, L.P. (“Sponsor”) is the record holder of the shares reported herein. The general partner of Sponsor is Oaktree Acquisition Holdings II GP Ltd. (“Holdings GP”). The director of Holdings GP is Oaktree Capital Management, L.P. (“Oaktree”). The director of Oaktree is Oaktree Capital Management GP, LLC (“Management GP”). The sole managing member of Management GP is Atlas OCM Holdings, LLC (“Atlas”). Oaktree Capital Group Holdings GP, LLC (“OCGH GP”) is the indirect owner of the class B units of Atlas. Brookfield Asset Management, Inc. (“BAM”) is the indirect owner of the class A units of Atlas. Partners Limited (“Partners”) is the sole owner of Class B Limited Voting Shares of BAM. Each of Sponsor, Holdings GP, Oaktree, Management GP, Atlas, BAM, and Partners, disclaims beneficial ownership of the OACB Class B Ordinary Shares reported herein except to the extent of their respective pecuniary interest therein. The principal business office of each of Sponsor, Holdings GP, Oaktree, Management GP, Atlas and OCGH GP is 333 South Grand Avenue, 28th Floor, Los Angeles, CA 90071. |
The Principal Business Office of each of BAM and Partners is C/O Oaktree Capital Management, L.P., 333 South Grand Avenue, 28th Floor, Los Angeles, CA 90071. |
3. | According to a Schedule 13G/A filed with the SEC on January 26, 2021, on behalf of Integrated Core Strategies (US) LLC (“Integrated Core Strategies”) and includes OACB Class A Ordinary Shares beneficially held by Integrated Core Strategies, Riverview Group LLC, a Delaware limited liability company (“Riverview Group”), ICS Opportunities, Ltd., an exempted company organized under the laws of the Cayman Islands (“ICS Opportunities”), Millennium International Management LP, a Delaware limited partnership (“Millennium International Management”), Millennium Management LLC, a Delaware limited liability company (“Millennium Management”), Millennium Group Management LLC, a Delaware limited liability company (“Millennium Group Management”), and Israel A. Englander, a United States citizen (“Mr. Englander”), based solely on the Schedule 13G/A filed jointly by Integrated Core Strategies, Riverview Group, ICS Opportunities, Millennium International Management, Millennium Management, Millennium Group Management, and Mr. Englander, with the SEC on January 25, 2021. Integrated Core Strategies, Riverview Group, and ICS Opportunities beneficially own an aggregate of 1,600,480 OACB Class A Ordinary Shares as a result of holding 1,321,634 OACB Class A Ordinary Shares and 278,846 of the OACB Units. Millennium International Management, the investment manager to ICS Opportunities, Millennium Management, the general partner of the managing member of Integrated Core Strategies and Riverview Group and the general partner of the 100% owner of ICS Opportunities, Millennium Group Management, the managing member of Millennium Management and the general partner of Millennium International Management, and Mr. Englander, the sole voting trustee of a trust which is the managing member of Millennium Group Management, may be deemed to beneficially own 1,600,480 OACB Class A Ordinary Shares. The foregoing should not be construed in and of itself as an admission by Millennium International Management, Millennium Management, Millennium Group Management or Mr. Englander as to beneficial ownership of the securities owned by Integrated Core Strategies, Riverview Group or ICS Opportunities, as the case may be. The business address of each of Integrated Core Strategies, Riverview Group, and Mr. Englander is c/o Millennium Management LLC, 666 Fifth Avenue, New York, New York 10103; the business address of ICS Opportunities is c/o Millennium International Management LP, 666 Fifth Avenue, New York, New York 10103; the business address of each of Millennium International Management, Millennium Management, and Millennium Group Management is 666 Fifth Avenue, New York, New York 10103. |
4. | Unless otherwise noted, the business address of each of the directors and executive officers of TopCo is 9, Rue de Bitbourg, L-1273 Luxembourg, Grand Duchy of Luxembourg. |
5. | Includes shares held by Alvogen Lux Holdings S.a.r.l. (“Alvogen”). Through intermediary holding entities, Alvogen is a wholly-owned subsidiary of Celtic Holdings SCA (“Celtic Holdings”). Investment and voting decisions at Celtic Holdings are made by a majority vote of its board of directors, and therefore no individual director of Celtic Holdings is the beneficial owner of the securities, except with respect to the shares in which such director holds a pecuniary interest. The address of Alvogen is 5, rue Heienhaff, L-1736 Senningerberg, Luxembourg, Grand-Duchy of Luxembourg and the address of Celtic Holdings is 20, avenue Monterey, L-2163 Luxembourg, Grand-Duchy of Luxembourg. Each of Carmen Andre, Christoffer Sjøqvist, Tomas Ekman, Park Jung Ryun, Robert Wessman and Arni Hardarson is a director of Celtic Holdings entitled to participate in investment and voting decisions and therefore may be deemed to share voting and dispositive power with respect to the shares held by Celtic Holdings. Carmen Andre, Christoffer Sjøqvist, Tomas Ekman, Park Jung Ryun, Robert Wessman and Arni Hardarson each disclaim any beneficial ownership of any such shares, except to the extent of his or her pecuniary interest therein. |
6. | Includes shares held by Aztiq Pharma Partners S.a.r.l. (“APP”). APP is a wholly-owned subsidiary of Aztiq Fund I SCSp (“Aztiq Fund”). Investment and voting decisions at Aztiq Fund are made by its general partner, Floki GP S.à r.l. (“Aztiq GP”). The address of APP is 5, rue Heienhaff, L-1736 Senningerberg, Grand-Duchy of Luxembourg and the address of Aztiq Fund and Aztiq GP is at 4 rue Robert Stumper, L-2557 Luxembourg, Grand-Duchy of Luxembourg. Each of Danny Major, Marc Levebvre, Robert Wessman, Johann Johannsson and Arni Hardarson is a member of the board of directors of Aztiq GP entitled to participate in investment and voting decisions and therefore may be deemed to share voting and dispositive power with respect to the shares held by Aztiq Fund. Danny Major, Marc Levebvre, Robert Wessman, Johann Johannsson and Arni Hardarson each disclaim any beneficial ownership of any such shares, except to the extent of his or her pecuniary interest therein. |
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Assets |
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Current assets: |
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Cash |
$ | |||
Prepaid expenses |
||||
Total current assets |
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Investments held in Trust Account |
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Total assets |
$ |
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Liabilities, Class A Ordinary Shares Subject to Possible Redemption and Shareholders’ Deficit |
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Current liabilities: |
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Accounts payable |
$ | |||
Accrued expenses |
||||
Accrued expenses—related party |
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Advance from related party |
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Total current liabilities |
||||
Deferred legal fees |
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Deferred underwriting commissions |
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Derivative warrant liabilities |
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Total liabilities |
||||
Commitments and Contingencies |
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Class A ordinary shares; |
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Shareholders’ Deficit: |
||||
Preference shares, $ |
||||
Class A ordinary shares, $ |
||||
Class B ordinary shares, $ |
||||
Additional paid-in capital |
||||
Accumulated deficit |
( |
) | ||
Total shareholders’ deficit |
( |
) | ||
Total Liabilities, Class A Ordinary Shares Subject to Possible Redemption and Shareholders’ Deficit |
$ |
|||
General and administrative expenses |
$ | |||
Loss from operations |
( |
) | ||
Other income (expense) |
||||
Unrealized gain on investments held in Trust Account |
||||
Change in fair value of derivative warrant liabilities |
( |
) | ||
Financing costs – derivative warrant liabilities |
( |
) | ||
Total other income (expense) |
( |
) | ||
Net loss |
$ | ( |
) | |
Basic and diluted weighted average shares outstanding of Class A ordinary shares |
||||
Basic and diluted net income loss per ordinary share |
$ | ( |
) | |
Basic and diluted weighted average shares outstanding of Class B ordinary shares |
||||
Basic and diluted net loss per ordinary share |
$ | ( |
) | |
Ordinary Shares |
Additional Paid-in Capital |
Accumulated Deficit |
Total Shareholders’ Deficit |
|||||||||||||||||||||||||
Class A |
Class B |
|||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||
Balance—August 5, 2020 (inception) |
$ | $ | $ | $ | $ | |||||||||||||||||||||||
Issuance of Class B ordinary shares to Sponsor |
— | — | — | |||||||||||||||||||||||||
Excess of cash receipts over the fair value of the private warrants sold to Sponsor |
— | — | — | — | — | |||||||||||||||||||||||
Forfeiture of Class B ordinary shares by Sponsor |
— | — | ( |
) | ( |
) | — | — | ||||||||||||||||||||
Accretion on Class A ordinary shares subject to possible redemption |
— | — | — | — | ( |
) | ( |
) | ( |
) | ||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance—December 31, 2020 |
$ |
$ |
$ |
$ |
( |
) |
$ |
( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Operating Activities: |
||||
Net loss |
$ | ( |
) | |
Adjustments to reconcile net loss to net cash used in operating activities: |
||||
Unrealized gain on investments held in Trust Account |
( |
) | ||
General and administrative expenses paid by related party under note payable |
||||
Change in fair value of derivative warrant liabilities |
||||
Financing costs – derivative warrant liabilities |
||||
Changes in operating assets and liabilities: |
||||
Prepaid expenses |
( |
) | ||
Accounts payable |
||||
Accrued expenses |
||||
Due to related party |
||||
Net cash used in operating activities |
( |
) | ||
Cash Flows from Investing Activities |
||||
Cash deposited in Trust Account |
( |
) | ||
Net cash used in investing activities |
( |
) | ||
Cash Flows from Financing Activities: |
||||
Proceeds received from initial public offering, gross |
||||
Proceeds received from private placement |
||||
Offering costs paid |
( |
) | ||
Net cash provided by financing activities |
||||
Net increase in cash |
||||
Cash - beginning of the period |
||||
Cash - end of the period |
$ |
|||
Supplemental disclosure of noncash activities: |
||||
Offering costs paid by Sponsor in exchange for issuance of Class B ordinary shares |
$ | |||
Offering costs included in accrued expenses |
$ | |||
Offering costs included in note payable – related party |
$ | |||
Forfeiture of Class B ordinary shares from Sponsor |
$ | |||
Deferred legal fees |
$ | |||
Deferred underwriting commissions in connection with the initial public offering |
$ |
As of December 31, 2020 |
||||||||||||
As Previously Reported |
Restatement Adjustment |
As Restated |
||||||||||
Balance Sheet |
||||||||||||
Total assets |
$ | $ | $ | |||||||||
|
|
|
|
|
|
|||||||
Total liabilities |
||||||||||||
Class A ordinary shares, $ |
As of December 31, 2020 |
||||||||||||
As Previously Reported |
Restatement Adjustment |
As Restated |
||||||||||
Shareholders’ equity (deficit) |
||||||||||||
Preference shares- $ |
$ | $ | $ | |||||||||
Class A ordinary shares - $ |
( |
) | ||||||||||
Class B ordinary shares - $ |
||||||||||||
Additional paid-in-capital |
( |
) | ||||||||||
Accumulated deficit |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Total shareholders’ equity (deficit) |
( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|||||||
Total liabilities, Class A ordinary shares subject to possible redemption, and shareholders’ equity (deficit) |
$ | $ | $ | |||||||||
|
|
|
|
|
|
Earnings Per Share for Class A ordinary shares |
||||||||||||
As Reported |
Adjustment |
As Adjusted |
||||||||||
For the period from August 5, 2020 (inception) through December 31, 2020 |
||||||||||||
Net loss |
$ | ( |
) | $ | $ | ( |
) | |||||
Weighted average shares outstanding |
( |
) | ||||||||||
Basic and diluted earnings per share |
$ | $ | ( |
) | $ | ( |
) |
Earnings Per Share for Class B common stock |
||||||||||||
As Reported |
Adjustment |
As Adjusted |
||||||||||
For the period from August 5, 2020 (inception) through December 31, 2020 |
||||||||||||
Net loss |
$ | ( |
) | $ | $ | ( |
) | |||||
Weighted average shares outstanding |
||||||||||||
Basic and diluted earnings per share |
$ | ( |
) | $ | $ | ( |
) |
As Reported |
Adjustment |
As Restated |
||||||||||
Supplemental Disclosure of Noncash Financing Activities: |
||||||||||||
Initial value of Class A ordinary shares subject to possible redemption as revised |
$ | $ | ( |
) | $ | |||||||
Change in value of Class A ordinary shares subject to possible redemption |
$ | ( |
) | $ | $ |
As of September 21, 2020 |
As Revised |
Adjustment |
As Restated |
|||||||||
Total assets |
$ |
$ |
||||||||||
Total liabilities |
$ |
$ |
||||||||||
Class A common stock subject to possible redemption |
||||||||||||
Preferred stock |
||||||||||||
Class A common stock |
( |
) | ||||||||||
Class B common stock |
||||||||||||
Additional paid-in capital |
( |
) | ||||||||||
Accumulated deficit |
( |
) | ( |
) | ( |
) | ||||||
Total stockholders’ equity (deficit) |
$ |
$ |
( |
) |
$ |
( |
) | |||||
Total Liabilities, Class A Common Stock Subject to Possible Redemption and Stockholders’ Equity (Deficit) |
$ |
$ |
$ |
|||||||||
• | Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets; |
• | Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and |
• | Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
For the Period From August 5, 2020 (inception) Through December 31, 2020 |
||||||||
Class A |
Class B |
|||||||
Basic and diluted net loss per common share: |
||||||||
Numerator: |
||||||||
Allocation of net income |
$ | ( |
) | $ | ( |
) | ||
Denominator: |
||||||||
Basic and diluted weighted average common shares outstanding |
||||||||
Basic and diluted net income per common share |
$ | ( |
) | $ | ( |
) | ||
Gross Proceeds |
$ | |||
Less: |
— | |||
Offering costs allocated to Class A shares subject to possible redemption |
( |
) | ||
Proceeds allocated to Public Warrants at issuance |
( |
) | ||
Plus: |
||||
Accrection on Class A ordinary shares subject to possible redemption amount |
||||
Class A ordinary shares subject to possible redemption |
$ |
|||
• | in whole and not in part; |
• | at a price of $ |
• | upon a minimum of |
• | if, and only if, the closing price of the Class A ordinary shares equals or exceeds $ |
• | in whole and not in part; |
• | at $ |
• | if, and only if, the reported closing price of Class A ordinary shares equals or exceeds $ |
• | if the closing price of the Class A ordinary shares for any |
Description |
Quoted Prices in Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Other Unobservable Inputs (Level 3) |
|||||||||
Assets: |
||||||||||||
Investments held in Trust Account |
$ | $ | — | $ | — | |||||||
Liabilities: |
||||||||||||
Derivative warrant liabilities – Public Warrants |
$ | $ | — | $ | — | |||||||
Derivative warrant liabilities - Private Warrants |
$ | — | $ | — | $ |
As of September 21, 2020 |
As of September 30, 2020 |
As of December 31, 2020 |
||||||||||
Stock price |
$ | $ | $ | |||||||||
Volatility |
% | % | % | |||||||||
Expected life of the options to convert |
||||||||||||
Risk-free rate |
% | % | % | |||||||||
Dividend yield |
— | — | — |
Derivative warrant liabilities at August 5, 2020 (inception) |
$ | |||
Issuance of Public and Private Warrants |
||||
Change in fair value of derivative warrant liabilities |
||||
Transfer of Public Warrants to Level 1 |
( |
) | ||
Derivative warrant liabilities at December 31, 2020 |
$ | |||
As of September 30, 2020 |
||||||||||||
As Previously Reported |
Restatement Adjustment |
As Restated |
||||||||||
Unaudited Condensed Balance Sheet |
||||||||||||
Total assets |
$ | $ | $ | |||||||||
Total liabilities |
||||||||||||
Class A ordinary shares, $ |
||||||||||||
Shareholders’ equity |
||||||||||||
Preference shares - $ |
||||||||||||
Class A ordinary shares - $ |
( |
) | |
| ||||||||
Class B ordinary shares - $ |
||||||||||||
Additional paid-in-capital |
( |
) | |
| ||||||||
Accumulated deficit |
( |
) | ( |
) | ( |
) | ||||||
Total shareholders’ equity |
( |
) | ( |
) | ||||||||
Total liabilities and shareholders’ equity |
$ | $ | $ | |||||||||
Period From August 5, 2020 (Inception) Through September 30, 2020 |
||||||||||||
As Previously Reported |
Restatement Adjustment |
As Restated |
||||||||||
Unaudited Condensed Statement of Operations |
||||||||||||
Net loss |
$ | ( |
) | $ | $ | ( |
) | |||||
Basic and Diluted weighted-average Class A common shares outstanding |
( |
) | ||||||||||
Basic and Diluted net loss per Class A share |
$ | ( |
) | $ | ( |
) | ||||||
Basic and Diluted weighted-average Class B common shares outstanding |
||||||||||||
Basic and Diluted net loss per Class B share |
$ | ( |
) | $ | ( |
) | ||||||
Period From August 5, 2020 (Inception) Through September 30, 2020 |
||||||||||||
As Previously Reported |
Restatement Adjustment |
As Restated |
||||||||||
Unaudited Condensed Statement of Cash Flows |
||||||||||||
Initial value of Class A ordinary shares subject to possible redemption as revised |
$ | $ | ( |
) | $ | |||||||
Change in initial value of Class A ordinary shares subject to possible redemption as revised |
$ | ( |
) | $ | $ |
September 30, 2021 |
December 31, 2020 |
|||||||
(unaudited) |
||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash |
$ | $ | ||||||
Prepaid expenses |
||||||||
Total current assets |
||||||||
Investments held in Trust Account |
||||||||
Total assets |
$ |
$ |
||||||
Liabilities, Class A ordinary shares subject to possible redemption, and Shareholders’ Deficit |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued expenses |
||||||||
Accrued expenses—related party |
||||||||
Advance from related party |
||||||||
Total current liabilities |
||||||||
Deferred legal fees |
||||||||
Deferred underwriting commissions |
||||||||
Derivative warrant liabilities |
||||||||
Total liabilities |
||||||||
Commitments and Contingencies |
||||||||
Class A ordinary shares subject to possible redemption, $ |
||||||||
Shareholders’ Deficit: |
||||||||
Preference shares, $ |
||||||||
Class A ordinary shares subject to possible redemption, $ |
||||||||
Class B ordinary shares, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Total shareholders’ deficit |
( |
) | ( |
) | ||||
Total Liabilities, Class A ordinary shares subject to possible redemption, and Shareholders’ Deficit |
$ |
$ |
||||||
For The Three Months Ended September 30, 2021 |
For The Nine Months Ended September 30, 2021 |
For The Period From August 5, 2020 (Inception) Through September 30, 2020 |
||||||||||
General and administrative expenses |
$ | $ | $ | |||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ||||||
Other income |
||||||||||||
Change in fair value of derivative warrant liabilities |
( |
) | ||||||||||
Financing costs - derivative warrant liabilities |
— | — | ( |
) | ||||||||
Net gain on investments held in Trust Account |
||||||||||||
Total other income (loss) |
( |
) | ||||||||||
Net income (loss) |
$ | $ | $ | ( |
) | |||||||
Basic and diluted weighted average shares outstanding of Class A ordinary shares |
||||||||||||
Basic and diluted net income (loss) per share, Class A |
$ | $ | $ | ( |
) | |||||||
Basic and diluted weighted average shares outstanding of Class B ordinary shares |
||||||||||||
Basic and diluted net income (loss) per share, Class B |
$ | $ | $ | ( |
) | |||||||
Ordinary Shares |
Additional Paid-in Capital |
Accumulated Deficit |
Total Shareholders’ Deficit |
|||||||||||||||||||||||||
Class A |
Class B |
|||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||
Balance—December 31, 2020 |
— |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||
Net income |
— | — | — | — | — | |||||||||||||||||||||||
Balance—March 31, 2021 (unaudited), as restated |
— |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
Balance—June 30, 2021 (unaudited), as restated |
— |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||
Net income |
— | — | — | — | — | |||||||||||||||||||||||
Balance—September 30, 2021 (unaudited) |
— |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||
Ordinary Shares |
Additional Paid-in Capital |
Accumulated Deficit |
Total Shareholders’ Deficit |
|||||||||||||||||||||||||
Class A |
Class B |
|||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||
Balance—August 5, 2020 (inception) |
$ |
$ |
$ |
$ |
$ |
|||||||||||||||||||||||
Issuance of Class B ordinary shares to Sponsor |
— | — | — | |||||||||||||||||||||||||
Forfeiture of Class B ordinary shares from Sponsor |
— | — | ( |
) | ( |
) | — | — | ||||||||||||||||||||
Excess of cash receipts over the fair value of the private warrants sold to Sponsor |
— | — | — | — | — | |||||||||||||||||||||||
Accretion on Class A ordinary shares subject to possible redemption |
— | — | — | — | ( |
) | ( |
) | ( |
) | ||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
Balance—September 30, 2020 (unaudited) |
$ |
$ |
$ |
$ |
( |
) |
$ |
( |
) | |||||||||||||||||||
For The Nine Months Ended September 30, 2021 |
For The Period From August 5, 2020 (Inception) Through September 30, 2020 |
|||||||
Cash Flows from Operating Activities: |
||||||||
Net income (loss) |
$ | $ | ( |
) | ||||
Adjustments to reconcile net income (loss) to net cash used in operating activities: |
||||||||
Net gain on investments held in Trust Account |
( |
) | ( |
) | ||||
Change in fair value of derivative warrant liabilities |
( |
) | ||||||
Financing costs - derivative warrant liabilities |
— | |||||||
General and administrative expenses paid by related party under note payable |
— | |||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses |
( |
) | ||||||
Accounts payable |
||||||||
Accrued expenses |
— | |||||||
Accrued expenses - related party |
||||||||
Net cash used in operating activities |
( |
) | ||||||
Cash Flows from Investing Activities: |
||||||||
Cash withdrawn from Trust Account |
— | |||||||
Cash deposited in Trust Account |
( |
) | ||||||
Net cash provided by (used in) investing activities |
( |
) | ||||||
Cash Flows from Financing Activities: |
||||||||
Proceeds received from initial public offering, gross |
— | |||||||
Proceeds received from private placement |
— | |||||||
Offering costs paid |
( |
) | ( |
) | ||||
Net cash (used in) provided by financing activities |
( |
) | ||||||
Net change in cash |
( |
) | ||||||
Cash - beginning of the period |
— | |||||||
Cash - end of the period |
$ |
$ |
||||||
Supplemental disclosure of noncash investing and financing activities: |
||||||||
Offering costs paid by Sponsor in exchange for issuance of Class B ordinary shares |
$ | — | $ | |||||
Offering costs included in accounts payable |
$ | — | $ | |||||
Offering costs included in accrued expenses |
$ | — | $ | |||||
Offering costs included in note payable - related party |
$ | — | $ | |||||
Forfeiture of Class B ordinary shares from Sponsor |
$ | — | $ | |||||
Deferred legal fees |
$ | — | $ | |||||
Deferred underwriting commissions |
$ | — | $ |
As of March 31, 2021 (unaudited) |
As Reported |
Adjustment |
As Restated |
|||||||||
Total assets |
$ |
$ |
||||||||||
Total liabilities |
$ |
$ |
||||||||||
Class A ordinary shares subject to possible redemption |
$ | $ | ||||||||||
Preference shares |
||||||||||||
Class A ordinary shares |
( |
) | ||||||||||
Class B ordinary shares |
||||||||||||
Additional paid-in capital |
( |
) | ||||||||||
Accumulated deficit |
( |
) | ( |
) | ( |
) | ||||||
Total shareholders’ equity (deficit) |
$ |
$ |
( |
) |
$ |
( |
) | |||||
Total Liabilities, Class A Ordinary Shares Subject to Possible Redemption and Stockholders’ Equity (Deficit) |
$ |
$ |
$ |
|||||||||
Class A ordinary shares subject to redemption |
||||||||||||
Class A ordinary shares |
( |
) |
As Reported |
Adjustment |
As Restated |
||||||||||
Supplemental Disclosure of Noncash Financing Activities: |
||||||||||||
Change in value of Class A ordinary shares subject to possible redemption |
$ | $ | ( |
) | $ |
As of June 30, 2021 (unaudited) |
As Reported |
Adjustment |
As Restated |
|||||||||
Total assets |
$ |
$ |
||||||||||
|
|
|
|
|||||||||
Total liabilities |
$ |
$ |
||||||||||
|
|
|
|
|||||||||
Class A ordinary shares subject to possible redemption |
$ | $ | ||||||||||
Preference shares |
||||||||||||
Class A ordinary shares |
( |
) | ||||||||||
Class B ordinary shares |
||||||||||||
Additional paid-in capital |
( |
) | ||||||||||
Accumulated deficit |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Total shareholders’ equity (deficit) |
$ |
$ |
( |
) |
$ |
( |
) | |||||
|
|
|
|
|
|
|||||||
Total Liabilities, Class A Ordinary Shares Subject to Possible Redemption and Stockholders’ Equity (Deficit) |
$ |
$ |
$ |
|||||||||
|
|
|
|
|
|
|||||||
Class A ordinary shares subject to redemption |
||||||||||||
Class A ordinary shares |
( |
) |
As Reported |
Adjustment |
As Restated |
||||||||||
Supplemental Disclosure of Noncash Financing Activities: |
||||||||||||
Change in value of Class A ordinary shares subject to possible redemption |
$ | $ | ( |
) | $ |
Earnings Per Share for Class A ordinary shares |
||||||||||||
As Reported |
Adjustment |
As Adjusted |
||||||||||
Form 10-Q (March 31, 2021) - For the period three months ended March 31, 2021 (unaudited) |
||||||||||||
Net income |
$ | $ | $ | |||||||||
Weighted average shares outstanding |
||||||||||||
Basic and diluted earnings per share |
$ | $ | $ | |||||||||
Form 10-Q (June 30, 2021) - For the period three months ended June 30, 2021 (unaudited) |
||||||||||||
Net loss |
$ | ( |
) | $ | $ | ( |
) | |||||
Weighted average shares outstanding |
|
|
||||||||||
Basic and diluted loss per share |
$ | $ | ( |
) | $ | ( |
) | |||||
Form 10-Q (June 30, 2021) - For the period six months ended June 30, 2021 (unaudited) |
||||||||||||
Net income |
$ | $ | $ | |||||||||
Weighted average shares outstanding |
||||||||||||
Basic and diluted earnings per share |
$ | $ | $ | |||||||||
Earnings Per Share for Class B ordinary shares |
||||||||||||
As Reported |
Adjustment |
As Adjusted |
||||||||||
Form 10-Q (March 31, 2021) - For the period three months ended March 31, 2021 (unaudited) |
||||||||||||
Net income |
$ | $ | $ | |||||||||
Weighted average shares outstanding |
||||||||||||
Basic and diluted earnings per share |
$ | $ | ( |
) | $ | |||||||
Form 10-Q (June 30, 2021) - For the period three months ended June 30, 2021 (unaudited) |
||||||||||||
Net loss |
$ | ( |
) | $ | $ | ( |
) | |||||
Weighted average shares outstanding |
||||||||||||
Basic and diluted loss per share |
$ | ( |
) | $ | $ | ( |
) | |||||
Form 10-Q (June 30, 2021) - For the period six months ended June 30, 2021 (unaudited) |
||||||||||||
Net income |
$ | $ | $ | |||||||||
Weighted average shares outstanding |
||||||||||||
Basic and diluted earnings per share |
$ | $ | ( |
) | $ |
• | Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets; |
• | Level 2, defined as inputs other than quoted prices in active markets other than quoted prices included within Level 1 that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and |
• | Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
For the Three Months Ended September 30, 2021 |
For the Nine Months Ended September 30, 2021 |
|||||||||||||||
Class A |
Class B |
Class A |
Class B |
|||||||||||||
Basic and diluted net income per ordinary share: |
||||||||||||||||
Numerator: |
||||||||||||||||
Allocation of net income |
$ | $ | $ | $ | ||||||||||||
Denominator: |
||||||||||||||||
Basic and diluted weighted average ordinary shares outstanding |
||||||||||||||||
Basic and diluted net income per ordinary share |
$ | $ | $ | $ | ||||||||||||
For The Period From August 5, 2020 (Inception) Through September 30, 2020 |
||||||||
Class A |
Class B |
|||||||
Basic and diluted net loss per ordinary share: |
||||||||
Numerator: |
||||||||
Allocation of net loss |
$ | ( |
) | $ | ( |
) | ||
Denominator: |
||||||||
Basic and diluted weighted average ordinary shares outstanding |
||||||||
Basic and diluted net loss per ordinary share |
$ | ( |
) | $ | ( |
) | ||
Gross Proceeds |
$ | |||
Less: |
||||
Offering costs allocated to Class A shares subject to possible redemption |
( |
) | ||
Proceeds allocated to Public Warrants at issuance |
( |
) | ||
Plus: |
||||
Accretion on Class A ordinary shares subject to possible redemption amount |
||||
Class A ordinary shares subject to possible redemption |
$ |
|||
• | in whole and not in part; |
• | at a price of $ |
• | upon a minimum of |
• | if, and only if, the closing price of the Class A ordinary shares equals or exceeds $ |
• | in whole and not in part; |
• | at $ |
• | if, and only if, the reported closing price of Class A ordinary shares equals or exceeds $ |
• | if the closing price of the Class A ordinary shares for any |
September 30, 2021 Description |
Quoted Prices in Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Other Unobservable Inputs (Level 3) |
|||||||||
Assets: |
||||||||||||
Investments held in Trust Account |
$ | $ | — | $ | — | |||||||
Liabilities: |
||||||||||||
Derivative warrant liabilities-public warrants |
$ | $ | — | $ | — | |||||||
Derivative warrant liabilities-private warrants |
$ | — | $ | $ | — |
December 31, 2020 Description |
Quoted Prices in Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Other Unobservable Inputs (Level 3) |
|||||||||
Assets: |
||||||||||||
Investments held in Trust Account |
$ | $ | — | $ | — | |||||||
Liabilities: |
||||||||||||
Derivative warrant liabilities-public warrants |
$ | $ | — | $ | — | |||||||
Derivative warrant liabilities-private warrants |
$ | — | $ | — | $ |
As of December 31, 2020 |
||||
Stock price |
$ | |||
Volatility |
% | |||
Expected life of the options to convert |
||||
Risk-free rate |
% | |||
Dividend yield |
Derivative warrant liabilities at December 31, 2020 |
$ | |||
Change in fair value of derivative warrant liabilities |
( |
) | ||
Derivative warrant liabilities at March 31, 2021 |
||||
Transfer of private warrants to Level 2 |
( |
) | ||
Change in fair value of derivative warrant liabilities |
( |
) | ||
Derivative warrant liabilities at June 30, 2021 |
— | |||
Change in fair value of derivative warrant liabilities |
||||
Derivative warrant liabilities at September 30, 2021 |
$ | |||
F-51 | ||||
F-52 | ||||
F-53-F-54 | ||||
F-55 | ||||
F-56 | ||||
F-57-F-109 |
USD in thousands, except for per share amounts |
Notes | 2020 | 2019 | |||||||||
Revenue |
5 | 66,616 | 31,918 | |||||||||
Other income |
5 | 2,833 | 50,757 | |||||||||
Research and development expenses |
(148,072 | ) | (95,557 | ) | ||||||||
General and administrative expenses |
(58,914 | ) | (48,566 | ) | ||||||||
|
|
|
|
|||||||||
Operating loss |
(137,537 | ) | (61,448 | ) | ||||||||
Share of net loss of joint venture |
23 | (1,505 | ) | (192 | ) | |||||||
Finance income |
7 | 5,608 | 6,932 | |||||||||
Finance costs |
7 | (161,551 | ) | (158,467 | ) | |||||||
Exchange rate differences |
3,215 | 3,790 | ||||||||||
|
|
|
|
|||||||||
Non-operating loss |
(154,233 | ) | (147,937 | ) | ||||||||
|
|
|
|
|||||||||
Loss before taxes |
(291,770 | ) | (209,385 | ) | ||||||||
Income tax benefit / (expense) |
9 | 121,726 | (491 | ) | ||||||||
|
|
|
|
|||||||||
Loss for the year |
(170,044 | ) | (209,876 | ) | ||||||||
|
|
|
|
|||||||||
Other comprehensive income / (loss) |
||||||||||||
Item that will be reclassified to profit or loss in subsequent periods: |
||||||||||||
Exchange rate differences on translation of foreign operations |
5,954 | (1,468 | ) | |||||||||
|
|
|
|
|||||||||
Total comprehensive loss |
(164,090 | ) | (211,344 | ) | ||||||||
|
|
|
|
|||||||||
Loss per share |
||||||||||||
Basic and diluted loss for the year per share |
10 | (24.32 | ) | (30.77 | ) | |||||||
|
|
|
|
USD in thousands |
Notes |
31 December 2020 |
31 December 2019 |
|||||||||
Non-current assets |
||||||||||||
Property, plant and equipment |
11 | 65,446 | 67,660 | |||||||||
Right-of-use assets |
12 | 111,519 | 103,288 | |||||||||
Goodwill |
13 | 13,427 | 12,226 | |||||||||
Other intangible assets |
14 | 6,335 | 3,096 | |||||||||
Contract assets |
5 | 2,190 | 1,689 | |||||||||
Investment in joint venture |
23 | 56,679 | 54,020 | |||||||||
Other long-term assets |
714 | — | ||||||||||
Restricted cash |
15 | 10,087 | 10,086 | |||||||||
Deferred tax assets |
9 | 121,864 | — | |||||||||
|
|
|
|
|||||||||
Total non-current assets |
388,261 | 252,065 | ||||||||||
|
|
|
|
|||||||||
Current assets |
||||||||||||
Inventories |
9,646 | 6,391 | ||||||||||
Trade receivables |
583 | 22,353 | ||||||||||
Contract assets |
5 | 32,534 | 21,367 | |||||||||
Other current assets |
16 | 11,322 | 4,912 | |||||||||
Receivables from related parties |
21 | 387 | 35 | |||||||||
Cash and cash equivalents |
15 | 31,689 | 67,403 | |||||||||
|
|
|
|
|||||||||
Total current assets |
86,161 | 122,461 | ||||||||||
|
|
|
|
|||||||||
Total assets |
474,422 | 374,526 | ||||||||||
|
|
|
|
USD in thousands |
Notes |
31 December 2020 |
31 December 2019 |
|||||||||
Equity |
||||||||||||
Share capital |
17 | 73 | 69 | |||||||||
Share premium |
17 | 166,740 | 102,359 | |||||||||
Translation reserve |
4,974 | (980 | ) | |||||||||
Accumulated deficit |
(1,039,030 | ) | (868,986 | ) | ||||||||
|
|
|
|
|||||||||
Total equity |
(867,243 | ) | (767,538 | ) | ||||||||
|
|
|
|
|||||||||
Non-current liabilities |
||||||||||||
Borrowings |
18 | 565,396 | 473,287 | |||||||||
Derivative financial liabilities |
24 | 534,692 | 479,263 | |||||||||
Other long-term liability to related party |
2 | 7,440 | — | |||||||||
Lease liabilities |
12 | 103,474 | 97,287 | |||||||||
Long-term incentive plan |
19 | 40,593 | 22,293 | |||||||||
Contract liabilities |
5 | 38,874 | 15,471 | |||||||||
Deferred tax liability |
9 | 217 | 327 | |||||||||
|
|
|
|
|||||||||
Total non-current liabilities |
1,290,686 | 1,087,928 | ||||||||||
|
|
|
|
|||||||||
Current liabilities |
||||||||||||
Trade and other payables |
11,959 | 11,732 | ||||||||||
Lease liabilities |
12 | 5,473 | 4,507 | |||||||||
Current maturities of borrowings |
18 | 2,503 | 2,319 | |||||||||
Liabilities to related parties |
21 | 367 | 10,780 | |||||||||
Contract liabilities |
5 | 14,192 | 13,576 | |||||||||
Taxes payable |
69 | 261 | ||||||||||
Other current liabilities |
22 | 16,416 | 10,961 | |||||||||
|
|
|
|
|||||||||
Total current liabilities |
50,979 | 54,136 | ||||||||||
|
|
|
|
|||||||||
Total liabilities |
1,341,665 | 1,142,064 | ||||||||||
|
|
|
|
|||||||||
Total equity and liabilities |
474,422 | 374,526 | ||||||||||
|
|
|
|
USD in thousands |
Notes | 2020 | 2019 | |||||||||
Cash flows from operating activities |
||||||||||||
Loss for the year |
(170,044 | ) | (209,876 | ) | ||||||||
Adjustments for non-cash items: |
||||||||||||
Gain on contribution of intellectual property |
5 | — | (45,000 | ) | ||||||||
Long-term incentive plan expense |
6 | 18,053 | 22,384 | |||||||||
Depreciation and amortization |
8 | 16,419 | 14,607 | |||||||||
Impairment of property, plant and equipment |
11 | 2,142 | — | |||||||||
Share of net loss of joint venture |
23 | 1,505 | 192 | |||||||||
Finance income |
7 | (5,608 | ) | (6,932 | ) | |||||||
Finance costs |
7 | 161,551 | 158,467 | |||||||||
Exchange rate difference |
(3,215 | ) | (3,790 | ) | ||||||||
Income tax benefit / (expense) |
9 | (121,726 | ) | 491 | ||||||||
|
|
|
|
|||||||||
Operating cash flow before movement in working capital |
(100,923 | ) | (69,457 | ) | ||||||||
Increase in inventories |
(3,255 | ) | (4,163 | ) | ||||||||
Decrease / (increase) in trade receivables |
21,771 | (21,947 | ) | |||||||||
Increase in liabilities to related parties |
1,674 | — | ||||||||||
Increase in contract assets |
(11,667 | ) | (23,057 | ) | ||||||||
Increase in other assets |
(7,383 | ) | (2,188 | ) | ||||||||
Increase in trade and other payables |
227 | 1,968 | ||||||||||
Increase in contract liabilities |
24,019 | 29,046 | ||||||||||
Increase in other liabilities |
7,134 | 6,506 | ||||||||||
|
|
|
|
|||||||||
Cash used in operations |
(68,403 | ) | (83,292 | ) | ||||||||
Interest received |
212 | 1,657 | ||||||||||
Interest paid |
(5,664 | ) | (6,488 | ) | ||||||||
Income tax paid |
(440 | ) | (425 | ) | ||||||||
|
|
|
|
|||||||||
Net cash used in operating activities |
(74,295 | ) | (88,548 | ) | ||||||||
|
|
|
|
|||||||||
Cash flows from investing activities |
||||||||||||
Acquisition of property, plant and equipment |
11 | (7,485 | ) | (7,203 | ) | |||||||
Disposal of property, plant and equipment |
11 | 79 | 176 | |||||||||
Acquisition of intangible assets |
14 | (4,497 | ) | (849 | ) | |||||||
Investment in joint venture |
23 | (5,000 | ) | (5,000 | ) | |||||||
|
|
|
|
|||||||||
Net cash used in investing activities |
(16,903 | ) | (12,876 | ) | ||||||||
|
|
|
|
|||||||||
Cash flows from financing activities |
||||||||||||
Repayments of borrowings |
18 | (2,896 | ) | (24,306 | ) | |||||||
Repayments of principal portion of lease liabilities |
12 | (6,087 | ) | (3,841 | ) | |||||||
Net proceeds from new borrowings |
18 | 30,000 | 113,825 | |||||||||
Net proceeds on issue of equity shares |
21 | 34,385 | 30,692 | |||||||||
|
|
|
|
|||||||||
Net cash generated from financing activities |
55,402 | 116,370 | ||||||||||
|
|
|
|
|||||||||
(Decrease) / increase in cash and cash equivalents |
(35,796 | ) | 14,946 | |||||||||
Cash and cash equivalents at the beginning of the year |
15 | 67,403 | 52,251 | |||||||||
Effect of movements in exchange rates on cash held |
82 | 206 | ||||||||||
|
|
|
|
|||||||||
Cash and cash equivalents at the end of the year |
15 | 31,689 | 67,403 | |||||||||
|
|
|
|
Share capital |
Share premium |
Translation reserve |
Accumulated deficit |
Total equity |
||||||||||||||||
USD in thousands |
||||||||||||||||||||
At 1 January 2019 |
67 | 70,124 | 488 | (659,110 | ) | (588,431 | ) | |||||||||||||
Loss for the year |
— | — | — | (209,876 | ) | (209,876 | ) | |||||||||||||
Foreign currency translation differences |
— | — | (1,468 | ) | — | (1,468 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Other comprehensive loss |
— | — | (1,468 | ) | (209,876 | ) | (211,344 | ) | ||||||||||||
Increase in share capital |
2 | 32,235 | — | — | 32,237 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At 31 December 2019 |
69 | 102,359 | (980 | ) | (868,986 | ) | (767,538 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Loss for the year |
— | — | — | (170,044 | ) | (170,044 | ) | |||||||||||||
Foreign currency translation differences |
— | — | 5,954 | — | 5,954 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Other comprehensive income / (loss) |
— | — | 5,954 | (170,044 | ) | (164,090 | ) | |||||||||||||
Increase in share capital |
4 | 64,381 | — | — | 64,385 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At 31 December 2020 |
73 | 166,740 | 4,974 | (1,039,030 | ) | (867,243 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|
|
1. | General information |
Entity name | Principal activity |
Issued and paid capital |
Place of establishment |
Proportion of ownership and voting power held by Alvotech |
||||||||||||||
31.12.2020 | 31.12.2019 | |||||||||||||||||
Alvotech hf |
Biopharm. | 3,284,148 | Iceland | 100.00 | % | 100.00 | % | |||||||||||
Alvotech GmbH |
Biopharm. | 31,182 | Germany | 100.00 | % | 100.00 | % | |||||||||||
Alvotech Swiss AG |
Biopharm. | 153,930 | Switzerland | 100.00 | % | 100.00 | % | |||||||||||
Alvotech Hannover GmbH |
Biopharm. | 29,983 | Germany | 100.00 | % | 100.00 | % | |||||||||||
Alvotech Malta Ltd |
Group Serv. | 80,450 | Malta | 100.00 | % | 100.00 | % | |||||||||||
Alvotech USA Inc |
Biopharm. | 10 | USA | 100.00 | % | 100.00 | % | |||||||||||
Alvotech UK Ltd |
Group Serv. | 135 | UK | 100.00 | % | 0.00 | % | |||||||||||
Changchun Alvotech Bioph. Co. Ltd* |
Biopharm. | 110,000,021 | China | 50.00 | % | 50.00 | % |
* | Changchun Alvotech Biopharmaceutical Co., Ltd. is an unconsolidated joint venture (see Note 23). |
2. | Summary of significant accounting policies |
• | has power over the investee; |
• | is exposed, or has rights, to variable returns from its involvement with the investee; and |
• | has the ability to use its power to affect its returns. |
• | the size of the Company’s holding of voting rights relative to the size and dispersion of holdings of the other vote holders; |
• | potential voting rights held by the Company, other vote holders or other parties; |
• | rights arising from other contractual arrangements; and |
• | any additional facts and circumstances that indicate that the Company has, or does not have, the current ability to direct the relevant activities at the time that decisions need to be made, including voting patterns at previous shareholders’ meetings. |
• | Level 1: quoted prices in active markets for identical assets and liabilities; |
• | Level 2: inputs other than quoted prices that are observable for the asset or liability, either directly (e.g., prices) or indirectly (e.g., derived from prices); and |
• | Level 3: inputs for the asset or liability that are unobservable. |
Software |
3-5 years |
|||
Customer relationships |
7 years |
• | The initial recognition of an asset or a liability in a transaction that is not a business combination and that affects neither the taxable profit nor accounting profit; |
• | The initial recognition of residual goodwill (for deferred tax liabilities only); or |
• | Investments in subsidiaries, branches, associates and joint ventures, where the Group is able to control the timing of the reversal of the temporary difference and it is not probable that it will reverse in the foreseeable future. |
Facility equipment |
5-12 years | |
Computer equipment |
3 years | |
Leasehold improvements |
3-20 years | |
Furniture and fixtures |
5 years |
2.16 | Inventories |
2.17 | Financial assets |
2.18 | Financial liabilities |
2.19 | Litigation and other contingencies |
2.20 | Leases |
2.21 | Loss per share |
3. | New accounting standards |
4. | Segment reporting |
2020 | 2019 | |||||||
North America |
37,928 | 1,967 | ||||||
Europe |
19,710 | 21,420 | ||||||
Asia |
4,107 | 2,405 | ||||||
Other |
4,871 | 6,126 | ||||||
|
|
|
|
|||||
66,616 | 31,918 | |||||||
|
|
|
|
2020 | 2019 | |||||||
North America |
471 | — | ||||||
Europe |
207,355 | 196,634 | ||||||
Asia and Other |
1,892 | 1,411 | ||||||
|
|
|
|
|||||
209,718 | 198,045 | |||||||
|
|
|
|
2020 | 2019 | |||||||||||||||
Revenue | % Total | Revenue | % Total | |||||||||||||
Customer A |
36,270 | 54.4 | % | — | — | |||||||||||
Customer B |
18,572 | 27.9 | % | 18,198 | 57.0 | % | ||||||||||
Customer C |
* | * | 3,935 | 12.3 | % |
5. | Revenue and other income |
2020 | 2019 | |||||||
License revenue (point in time revenue recognition) |
24,067 | 18,009 | ||||||
Research and development and other service revenue (over time revenue recognition) |
42,549 | 13,909 | ||||||
|
|
|
|
|||||
66,616 | 31,918 | |||||||
|
|
|
|
Contract Assets |
Contract Liabilities |
|||||||
31 December 2018 |
— | — | ||||||
Contract asset additions |
26,599 | — | ||||||
Amounts transferred to trade receivables |
(3,543 | ) | — | |||||
Customer prepayments |
— | 34,366 | ||||||
Revenue recognized |
— | (5,319 | ) | |||||
|
|
|
|
|||||
31 December 2019 |
23,056 | 29,047 | ||||||
|
|
|
|
|||||
Contract asset additions |
43,795 | — | ||||||
Amounts transferred to trade receivables |
(32,127 | ) | — | |||||
Customer prepayments |
— | 44,418 | ||||||
Revenue recognized |
— | (20,399 | ) | |||||
|
|
|
|
|||||
31 December 2020 |
34,724 | 53,066 | ||||||
|
|
|
|
2020 | 2019 | |||||||
Gain on contribution of intellectual property to joint venture |
— | 45,000 | ||||||
Other |
2,833 | 5,757 | ||||||
|
|
|
|
|||||
2,833 | 50,757 | |||||||
|
|
|
|
6. | Salaries and other employee expenses |
2020 | 2019 | |||||||
Salary expense |
45,904 | 32,742 | ||||||
Defined contribution plan expense (1) |
5,234 | 3,980 | ||||||
Long-term incentive plan expense |
18,053 | 22,384 | ||||||
Other employee expense |
10,186 | 7,602 | ||||||
Temporary labor |
3,441 | 1,625 | ||||||
|
|
|
|
|||||
82,818 | 68,333 | |||||||
|
|
|
|
(1) | Defined contribution plan expense consists of costs incurred by the Group for employees of certain subsidiaries that are required by local laws to participate in pension schemes. These pension schemes are not sponsored or administered by the Group. Pursuant to the requirements of the schemes, the Group is required to contribute a certain percentage of its payroll costs to the pension schemes. Such contributions are charged to the consolidated statements of profit or loss and other comprehensive income or loss as they become payable in accordance with the rules of the pension schemes. |
2020 | 2019 | |||||||
Research and development expenses | 49,043 | 34,998 | ||||||
General and administrative expenses | 33,775 | 33,335 | ||||||
|
|
|
|
|||||
Total salary and other employee expenses |
82,818 | 68,333 | ||||||
|
|
|
|
7. | Finance income and finance cost |
2020 | 2019 | |||||||
Changes in the fair value of derivatives | 5,393 | 5,194 | ||||||
Interest income from cash and cash equivalents | 166 | 1,732 | ||||||
Other interest income | 49 | 6 | ||||||
|
|
|
|
|||||
5,608 | 6,932 | |||||||
|
|
|
|
2020 | 2019 | |||||||
Changes in the fair value of derivatives |
(60,823 | ) | (59,894 | ) | ||||
Interest on debt and borrowings |
(91,985 | ) | (90,214 | ) | ||||
Interest on lease liabilities |
(5,481 | ) | (5,541 | ) | ||||
Amortization of deferred debt issue costs |
(3,262 | ) | (2,818 | ) | ||||
|
|
|
|
|||||
(161,551 | ) | (158,467 | ) | |||||
|
|
|
|
8. | Depreciation and amortization |
2020 | 2019 | |||||||
Depreciation and impairment of property, plant and equipment (see note 11) |
10,363 | 7,390 | ||||||
Depreciation of right of use assets (see note 12) |
7,188 | 6,308 | ||||||
Amortization of intangibles assets (see note 14) |
1,010 | 909 | ||||||
|
|
|
|
|||||
18,561 | 14,607 | |||||||
|
|
|
|
2020 | 2019 | |||||||
Research and development expenses |
16,358 | 7,800 | ||||||
General and administrative expenses |
2,203 | 6,807 | ||||||
|
|
|
|
|||||
Total depreciation and amortization expense |
18,561 | 14,607 | ||||||
|
|
|
|
9. | Income tax |
2020 | 2019 | |||||||
Current tax |
||||||||
Direct taxes – current |
248 | 425 | ||||||
Direct taxes – prior year |
— | 105 | ||||||
Other employee expense |
— | — | ||||||
|
|
|
|
|||||
Total current tax |
248 | 530 | ||||||
|
|
|
|
|||||
Deferred tax |
||||||||
Current |
(121,974 | ) | (39 | ) | ||||
Prior year |
— | — | ||||||
|
|
|
|
|||||
Total deferred tax |
(121,974 | ) | (39 | ) | ||||
|
|
|
|
|||||
Total income tax benefit / (expense) |
(121,726 | ) | 491 | |||||
|
|
|
|
2020 | 2019 | |||||||
Tax rate |
24.9 | % | 24.9 | % | ||||
Effect of tax rate in foreign jurisdictions |
(4.9 | %) | (4.9 | %) | ||||
Recognition of tax losses |
27.9 | % | — | |||||
Valuation allowance |
(6.2 | %) | (20.2 | %) | ||||
|
|
|
|
|||||
Effective tax rate |
41.7 | % | (0.2 | %) | ||||
|
|
|
|
2020 | 2019 | |||||||
Balance at 1 January |
(327 | ) | (366 | ) | ||||
Deferred tax credited to profit or loss |
121,974 | 39 | ||||||
Deferred tax charged to other comprehensive income or loss |
— | — | ||||||
|
|
|
|
|||||
Balance at 31 December |
121,647 | (327 | ) | |||||
|
|
|
|
|||||
Deferred tax assets |
121,864 | — | ||||||
Deferred tax liabilities |
(217 | ) | (327 | ) | ||||
|
|
|
|
2020 | 2019 | |||||||
Deferred tax assets attributable to temporary differences in respect of tax losses |
121,864 | — | ||||||
Deferred tax liabilities attributable to other temporary differences |
(217 | ) | (327 | ) | ||||
|
|
|
|
|||||
Net deferred tax assets / (liabilities) |
121,647 | (327 | ) | |||||
|
|
|
|
2023-2025 |
40,010 | |||
2026-2028 |
234,775 | |||
Thereafter |
334,533 | |||
|
|
|||
609,318 | ||||
|
|
10. | Loss per share |
2020 | 2019 | |||||||
Earnings |
||||||||
Loss for the year |
(170,044 | ) | (209,876 | ) | ||||
Number of shares |
||||||||
Weighted average number of ordinary shares outstanding |
6,990,889 | 6,819,783 | ||||||
|
|
|
|
|||||
Basic and diluted loss per share |
(24.32 | ) | (30.77 | ) | ||||
|
|
|
|
11. | Property, plant and equipment |
Facility equipment |
Furniture, fixtures and leasehold improvements |
Computer equipment |
Total | |||||||||||||
Cost |
||||||||||||||||
Balance at 1 January 2020 |
63,081 | 26,407 | 1,444 | 90,932 | ||||||||||||
Additions |
6,334 | 1,119 | 32 | 7,485 | ||||||||||||
Disposals |
(197 | ) | — | — | (197 | ) | ||||||||||
Translation difference |
1,090 | 74 | 37 | 1,201 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance at 31 December 2020 |
70,308 | 27,600 | 1,513 | 99,421 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Depreciation |
||||||||||||||||
Balance at 1 January 2020 |
16,652 | 5,302 | 1,318 | 23,272 | ||||||||||||
Depreciation |
6,488 | 1,662 | 71 | 8,221 | ||||||||||||
Disposals |
(118 | ) | — | — | (118 | ) | ||||||||||
Impairment |
2,142 | — | — | 2,142 | ||||||||||||
Translation difference |
376 | 52 | 30 | 458 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance at 31 December 2020 |
25,540 | 7,016 | 1,419 | 33,975 | ||||||||||||
|
|
|
|
|
|
|
|
Facility equipment |
Furniture, fixtures and leasehold improvements |
Computer equipment |
Total | |||||||||||||
Net carrying amount |
||||||||||||||||
Balance at 31 December 2020 |
44,768 | 20,584 | 94 | 65,446 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Cost |
||||||||||||||||
Balance at 1 January 2019 |
57,324 | 25,767 | 1,368 | 84,459 | ||||||||||||
Additions |
6,420 | 681 | 102 | 7,203 | ||||||||||||
Disposals |
(422 | ) | (36 | ) | (17 | ) | (475 | ) | ||||||||
Translation difference |
(241 | ) | (5 | ) | (9 | ) | (255 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance at 31 December 2019 |
63,081 | 26,407 | 1,444 | 90,932 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Depreciation |
||||||||||||||||
Balance at 1 January 2019 |
11,411 | 3,691 | 1,186 | 16,288 | ||||||||||||
Depreciation |
5,582 | 1,652 | 156 | 7,390 | ||||||||||||
Disposals |
(247 | ) | (36 | ) | (16 | ) | (299 | ) | ||||||||
Translation difference |
(94 | ) | (5 | ) | (8 | ) | (107 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance at 31 December 2019 |
16,652 | 5,302 | 1,318 | 23,272 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net carrying amount |
||||||||||||||||
Balance at 31 December 2019 |
46,429 | 21,105 | 126 | 67,660 | ||||||||||||
|
|
|
|
|
|
|
|
12. | Leases |
2020 | 2019 | |||||||
Right-of-use |
||||||||
Balance at 1 January |
103,288 | 101,563 | ||||||
Adjustments for indexed leases |
2,983 | 2,430 | ||||||
New or renewed leases |
15,204 | 5,665 | ||||||
Terminated leases |
(2,206 | ) | — | |||||
Depreciation |
(7,188 | ) | (6,308 | ) | ||||
Translation difference |
(562 | ) | (62 | ) | ||||
|
|
|
|
|||||
Balance at 31 December |
111,519 | 103,288 | ||||||
|
|
|
|
2020 | 2019 | |||||||
Right-of-use |
||||||||
Facilities |
108,646 | 102,072 | ||||||
Fleet |
27 | 34 | ||||||
Equipment |
2,846 | 1,182 | ||||||
|
|
|
|
|||||
111,519 | 103,288 | |||||||
|
|
|
|
2020 | 2019 | |||||||
Lease liabilities |
||||||||
Balance at 1 January |
101,794 | 102,119 | ||||||
Adjustments for indexed leases |
2,983 | 2,430 | ||||||
New or renewed leases |
15,937 | 4,850 | ||||||
Installment payments |
(6,087 | ) | (3,841 | ) | ||||
Terminated leases |
(1,965 | ) | — | |||||
Foreign currency adjustment |
(3,248 | ) | (3,699 | ) | ||||
Translation difference |
(467 | ) | (65 | ) | ||||
|
|
|
|
|||||
Balance at 31 December |
108,947 | 101,794 | ||||||
|
|
|
|
|||||
Current liabilities |
(5,473 | ) | (4,507 | ) | ||||
Non-current liabilities |
103,474 | 97,287 | ||||||
|
|
|
|
2020 | 2019 | |||||||
Depreciation expense from right-of-use |
||||||||
Facilities |
(6,955 | ) | (6,142 | ) | ||||
Fleet |
(7 | ) | (6 | ) | ||||
Equipment |
(226 | ) | (160 | ) | ||||
|
|
|
|
|||||
Total depreciation expense from right-of-use |
(7,188 | ) | (6,308 | ) | ||||
|
|
|
|
|||||
Interest expense on lease liabilities |
(5,481 | ) | (5,541 | ) | ||||
Foreign currency difference on lease liability |
3,248 | 3,699 | ||||||
Loss on terminated leases |
(241 | ) | — | |||||
|
|
|
|
|||||
Total amount recognized in profit and loss |
(9,662 | ) | (8,150 | ) | ||||
|
|
|
|
2020 | 2019 | |||||||
Less than one year |
10,588 | 9,753 | ||||||
One to five years |
41,183 | 37,961 | ||||||
Thereafter |
112,371 | 112,129 | ||||||
|
|
|
|
|||||
164,142 | 159,843 | |||||||
|
|
|
|
13. | Goodwill |
2020 | 2019 | |||||||
Balance as of 1 January |
12,226 | 12,497 | ||||||
Translation difference |
1,201 | (271 | ) | |||||
|
|
|
|
|||||
Balance as of 31 December |
13,427 | 12,226 | ||||||
|
|
|
|
14. | Intangible assets |
Software | Customer relationships |
Total | ||||||||||
Cost |
||||||||||||
Balance at 1 January 2020 |
3,465 | 2,303 | 5,768 | |||||||||
Additions |
4,497 | — | 4,497 | |||||||||
Disposals |
(389 | ) | — | (389 | ) | |||||||
Translation difference |
30 | 225 | 255 | |||||||||
|
|
|
|
|
|
|||||||
Balance at 31 December 2020 |
7,603 | 2,528 | 10,131 | |||||||||
|
|
|
|
|
|
|||||||
Amortization |
||||||||||||
Balance at 1 January 2020 |
1,684 | 987 | 2,671 | |||||||||
Amortization |
649 | 361 | 1,010 | |||||||||
Disposals |
1 | — | 1 | |||||||||
Translation difference |
17 | 97 | 114 | |||||||||
|
|
|
|
|
|
|||||||
Balance at 31 December 2020 |
2,351 | 1,445 | 3,796 | |||||||||
|
|
|
|
|
|
|||||||
Net carrying amount |
||||||||||||
Balance at 31 December 2020 |
5,252 | 1,083 | 6,335 | |||||||||
|
|
|
|
|
|
|||||||
Software | Customer relationships |
Total | ||||||||||
Cost |
||||||||||||
Balance at 1 January 2019 |
2,636 | 2,354 | 4,990 | |||||||||
Additions |
849 | — | 849 | |||||||||
Disposals |
(20 | ) | — | (20 | ) | |||||||
Translation difference |
(1 | ) | (51 | ) | (52 | ) | ||||||
|
|
|
|
|
|
|||||||
Balance at 31 December 2019 |
3,464 | 2,303 | 5,767 | |||||||||
|
|
|
|
|
|
|||||||
Amortization |
||||||||||||
Balance at 1 January 2019 |
1,126 | 673 | 1,799 | |||||||||
Amortization |
580 | 329 | 909 | |||||||||
Disposals |
(20 | ) | — | (20 | ) | |||||||
Translation difference |
(2 | ) | (15 | ) | (17 | ) | ||||||
|
|
|
|
|
|
|||||||
Balance at 31 December 2019 |
1,684 | 987 | 2,671 | |||||||||
|
|
|
|
|
|
|||||||
Net carrying amount |
||||||||||||
Balance at 31 December 2019 |
1,780 | 1,316 | 3,096 | |||||||||
|
|
|
|
|
|
2020 | 2019 | |||||||
Research and development expenses |
357 | 319 | ||||||
General and administrative expenses |
653 | 590 | ||||||
|
|
|
|
|||||
1,010 | 909 | |||||||
|
|
|
|
15. | Cash and cash equivalents and restricted cash |
2020 | 2019 | |||||||
Cash and cash equivalents denominated in US dollars |
27,183 | 64,773 | ||||||
Cash and cash equivalents denominated in other currencies |
4,506 | 2,630 | ||||||
|
|
|
|
|||||
31,689 | 67,403 | |||||||
|
|
|
|
2020 | 2019 | |||||||
Balance at 1 January |
10,086 | 12,752 | ||||||
Restricted cash used for repayments of borrowings |
— | (2,747 | ) | |||||
Interest income |
1 | 81 | ||||||
|
|
|
|
|||||
Balance at 31 December |
10,087 | 10,086 | ||||||
|
|
|
|
16. | Other current assets |
2020 | 2019 | |||||||
Value-added tax |
3,858 | 2,108 | ||||||
Prepaid expenses |
5,922 | 1,246 | ||||||
Other short-term receivables |
1,542 | 1,558 | ||||||
|
|
|
|
|||||
11,322 | 4,912 | |||||||
|
|
|
|
17. | Share capital |
2020 | 2019 | |||||||||||||||
Shares | Share capital and share premium |
Shares | Share capital and share premium |
|||||||||||||
Class A ordinary shares |
7,163,438 | 164,384 | 6,841,361 | 99,999 | ||||||||||||
Class B ordinary shares |
95,701 | 2,429 | 95,701 | 2,429 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total share capital and share premium |
7,259,139 | 166,813 | 6,937,062 | 102,428 | ||||||||||||
|
|
|
|
|
|
|
|
Class A Shares |
Class B Shares |
Share capital |
Share premium |
Total | ||||||||||||||||
Balance at 1 January 2019 |
6,666,667 | 87,126 | 67 | 70,124 | 70,191 | |||||||||||||||
Share issue |
174,694 | 8,575 | 2 | 32,543 | 32,545 | |||||||||||||||
Transaction costs arising on share issue |
— | — | — | (308 | ) | (308 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance at 31 December 2019 |
6,841,361 | 95,701 | 69 | 102,359 | 102,428 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Share issue |
322,077 | — | 4 | 64,997 | 65,001 | |||||||||||||||
Transaction costs arising on share issue |
— | — | — | (616 | ) | (616 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance at 31 December 2020 |
7,163,438 | 95,701 | 73 | 166,740 | 166,813 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
18. | Borrowings |
2020 | 2019 | |||||||
Convertible shareholder loans, net of debt issue costs (see note 21) |
177,612 | 139,896 | ||||||
Convertible bonds, net of debt issue costs |
381,338 | 324,191 | ||||||
Other borrowings |
8,949 | 11,519 | ||||||
|
|
|
|
|||||
Total outstanding borrowings, net of debt issue costs |
567,899 | 475,606 | ||||||
Less: current portion of borrowings |
(2,503 | ) | (2,319 | ) | ||||
|
|
|
|
|||||
Total non-current borrowings |
565,396 | 473,287 | ||||||
|
|
|
|
2020 | 2019 | |||||||
Borrowings, net at 1 January |
475,606 | 295,849 | ||||||
Net proceeds from new borrowings |
30,000 | 113,825 | ||||||
Loans from related party converted to equity |
(30,000 | ) | — | |||||
Repayments of borrowings (1) |
(2,896 | ) | (27,053 | ) | ||||
Accrued interest |
91,985 | 90,214 | ||||||
Amortization of deferred debt issue costs |
3,262 | 2,818 | ||||||
Foreign currency exchange difference |
(58 | ) | (47 | ) | ||||
|
|
|
|
|||||
Borrowings, net at 31 December |
567,899 | 475,606 | ||||||
|
|
|
|
(1) | Includes $2.7 million of restricted cash used for repayments of borrowings during the year ended 31 December 2019. See Note 15 for additional information. |
2020 | 2019 | |||||||
Within one year |
2,503 | 2,319 | ||||||
Within two years |
115,788 | 2,472 | ||||||
Within three years |
396,651 | 32,983 | ||||||
Within four years |
64,166 | 452,009 | ||||||
Thereafter |
1,545 | 1,839 | ||||||
|
|
|
|
|||||
580,653 | 491,622 | |||||||
|
|
|
|
19. | Long-term incentive plans |
2020 | 2019 | |||||||
Risk-free interest rate |
0.1 | % | 1.6 | % | ||||
Volatility rate |
42.0 | % | 42.0 | % | ||||
Expected dividend yield |
— | — | ||||||
Expected life |
1.0 – 1.2 years | 1.4 – 2.5 years | ||||||
Share price at valuation |
$ | 1,465 | $ | 1,231 | ||||
Strike price |
$ | 904 – $1,296 | $ | 839 – $1,200 |
2020 | 2019 | |||||||
Balance at 1 January |
510 | 419 | ||||||
Additions |
10,322 | 91 | ||||||
Payments |
(331 | ) | — | |||||
|
|
|
|
|||||
Balance at 31 December |
10,501 | 510 | ||||||
|
|
|
|
20. | Litigation |
21. | Related parties |
Purchased service / interest |
Sold service |
Receivables | Payables/ loans |
|||||||||||||
Alvogen Lux Holdings S.à r.l. – Sister company (a) |
9,452 | 1,134 | — | 68,237 | ||||||||||||
Aztiq Pharma Partners S.à r.l. – Sister company (a) |
19,471 | — | — | 123,671 | ||||||||||||
Fasteignafélagið Sæmundur hf. – Sister company |
8,111 | — | — | 84,650 | ||||||||||||
Alvogen Iceland ehf. – Sister company |
2,268 | 1,310 | 38 | 21 | ||||||||||||
Alvogen ehf. – Sister company |
40 | — | — | 40 | ||||||||||||
Alvogen UK – Sister company |
1,153 | — | — | 132 | ||||||||||||
Lotus Pharmaceuticals Co. Ltd. – Sister company (b) |
3,060 | — | — | 7,440 | ||||||||||||
Alvogen Emerging Markets – Sister company |
68 | — | — | 11 | ||||||||||||
Alvogen Inc. – Sister company |
67 | — | — | 23 | ||||||||||||
Changchun Alvotech Biopharmac. Co. Ltd (c) |
— | — | 323 | — | ||||||||||||
Alvogen PB R&D LLC |
— | 7 | — | — | ||||||||||||
Alvogen Malta Operations Ltd – Sister company |
239 | — | — | — | ||||||||||||
Alvogen Malta Group Services – Sister company |
478 | — | — | 40 | ||||||||||||
Alvogen Malta Sh. Services – Sister company |
101 | — | — | — | ||||||||||||
Alvogen Malta LTD – Sister company |
— | 4 | — | — | ||||||||||||
Alvogen Malta (Outlicensing) Ltd – Sister company |
142 | 185 | 26 | 58 | ||||||||||||
Alvogen Spain SL – Sister Company |
132 | — | — | — | ||||||||||||
Norwich Clinical Services Ltd – Sister Company |
92 | — | — | 42 | ||||||||||||
Alvogen Pharma Pvt Ltd – Sister Company |
218 | — | — | — | ||||||||||||
HRJAF ehf – Sister company |
1,083 | — | — | 9,191 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
46,175 | 2,640 | 387 | 293,556 | |||||||||||||
|
|
|
|
|
|
|
|
(a) | The full amount of purchased service relates to interest expenses from long-term liabilities and the full amount of payables / loans are interest-bearing long-term liabilities (see Note 18). |
(b) | Payables to Lotus Pharmaceuticals Co. Ltd. consists of the long-term liability as further described in Note 2. This long-term liability is presented as “Other long-term liability to related party” on the consolidated statements of financial position. |
(c) | The amount receivable from Changchun Alvotech Biopharmac. Co. Ltd. relates to amounts due for reference drugs used in research and development studies and certain consulting fees incurred by the Group. This receivable is presented as a component of “Investment in joint venture” on the consolidated statements of financial position. |
Purchased service / interest |
Sold service |
Receivables | Payables/ loans |
|||||||||||||
Alvogen Lux Holdings S.à r.l. – Sister company (a) |
10,170 | — | — | 53,248 | ||||||||||||
Alvogen Aztiq AB – Sister company (a) |
804 | — | — | — | ||||||||||||
Aztiq Pharma Partners S.à r.l. – Sister company (a) |
11,390 | — | — | 127,325 | ||||||||||||
Fasteignafélagið Sæmundur hf. – Sister company |
6,901 | — | — | 81,841 | ||||||||||||
Alvogen Iceland ehf. – Sister company |
817 | 1,690 | 35 | — | ||||||||||||
Alvogen UK – Sister company |
1,060 | — | — | 174 | ||||||||||||
Norwich Pharmaceuticals Inc. Sister company |
— | — | — | 2,613 | ||||||||||||
Alvogen Inc. – Sister company |
455 | — | — | 2,119 | ||||||||||||
Changchun Alvotech Biopharmac. Co. Ltd |
— | — | — | 5,000 | ||||||||||||
Alvogen Malta Operations Ltd – Sister company |
849 | — | — | 550 | ||||||||||||
Alvogen Malta (Outlicensing) Ltd – Sister company |
— | 102 | — | 29 | ||||||||||||
Alvogen Spain SL – Sister Company |
78 | — | — | 1 | ||||||||||||
Norwich Clinical Services Ltd – Sister Company |
74 | — | — | 17 | ||||||||||||
Alvogen Pharma Pvt Ltd – Sister Company |
183 | — | — | 23 | ||||||||||||
HRJÁF ehf – Sister company |
243 | — | — | 3,416 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
33,024 | 1,792 | 35 | 276,356 | |||||||||||||
|
|
|
|
|
|
|
|
(a) | The full amount of purchased service relates to interest expenses from long-term liabilities and nearly the full amount of payables / loans are interest-bearing long-term liabilities (see Note 18). Payables/loans also includes $0.3 million of short term payables. |
2020 | 2019 | |||||||
Short-term employee benefits |
5,307 | 2,656 | ||||||
Other long-term benefits |
106 | — | ||||||
Termination benefits |
237 | — | ||||||
|
|
|
|
|||||
5,650 | 2,656 | |||||||
|
|
|
|
22. | Other current liabilities |
2020 | 2019 | |||||||
Unpaid salary and salary related expenses |
8,721 | 4,759 | ||||||
Accrued vacation leave |
3,682 | 2,325 | ||||||
Accrued expenses |
4,013 | 3,877 | ||||||
|
|
|
|
|||||
16,416 | 10,961 | |||||||
|
|
|
|
23. | Interests in joint ventures |
Name of entity |
Place of business |
Ownership interest |
Carrying Amount | |||||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||||||
Changchun Alvotech Biopharm. Co. Ltd. |
China | 50.0 | % | 50.0 | % | 56,679 | 54,020 |
2020 | 2019 | |||||||
Balance at 1 January |
54,020 | — | ||||||
Additions (1) |
— | 55,000 | ||||||
Share in losses |
(1,505 | ) | (192 | ) | ||||
Translation difference |
4,164 | (788 | ) | |||||
|
|
|
|
|||||
Balance at 31 December |
56,679 | 54,020 | ||||||
|
|
|
|
(1) | Additions represent the Group’s investment in JVCO, which is comprised of $10.0 million in cash and $45.0 million in intellectual property contributions. |
Summarized Statements of Financial Position (in thousands) |
2020 | 2019 | ||||||
Current assets |
||||||||
Cash and bank balances |
59,478 | 45,416 | ||||||
Receivable |
— | 55,000 | ||||||
Other current assets |
25,172 | 125 | ||||||
|
|
|
|
|||||
Total current assets |
84,650 | 100,541 | ||||||
|
|
|
|
|||||
Total non-current assets |
34,519 | 7,531 | ||||||
|
|
|
|
|||||
Current liabilities |
||||||||
Financial liabilities |
323 | — | ||||||
Other current liabilities |
5,785 | 308 | ||||||
|
|
|
|
|||||
Total current liabilities |
6,108 | 308 | ||||||
|
|
|
|
|||||
Net assets |
113,061 | 107,764 | ||||||
|
|
|
|
|||||
Reconciliation to carrying amounts (in thousands): |
2020 | 2019 | ||||||
Opening net assets at 1 January |
107,764 | — | ||||||
Profit / (loss) for the period |
(3,010 | ) | (384 | ) | ||||
Other comprehensive income |
— | — | ||||||
Cash contributions of owners |
— | 55,281 | ||||||
Receivable from owners |
— | 55,000 | ||||||
Dividends paid |
— | — | ||||||
Other, net |
8,307 | (2,133 | ) | |||||
|
|
|
|
|||||
Closing net assets at 31 December |
113,061 | 107,764 | ||||||
|
|
|
|
|||||
Group’s share in % |
50 | % | 50 | % | ||||
Group’s share in USD |
56,531 | 53,882 | ||||||
Other |
148 | 138 | ||||||
|
|
|
|
|||||
Carrying amount |
56,679 | 54,020 | ||||||
|
|
|
|
|||||
Summarized Statements of Profit or Loss &Other Comprehensive Income (in thousands) |
2020 | 2019* | ||||||
Revenue |
— | — | ||||||
Interest income |
2,518 | 761 | ||||||
Depreciation and Amortization |
26 | 9 | ||||||
Interest expense |
— | — | ||||||
Income tax expense |
— | — | ||||||
Other expenses |
4,844 | 1,314 | ||||||
Exchange rate differences |
658 | (179 | ) | |||||
|
|
|
|
|||||
Loss from continued operations |
(3,010 | ) | (383 | ) | ||||
|
|
|
|
|||||
Loss from discontinued operations |
— | — | ||||||
Loss for the period |
(3,010 | ) | (383 | ) | ||||
|
|
|
|
|||||
Other comprehensive income |
— | — | ||||||
Total comprehensive loss |
(3,010 | ) | (383 | ) | ||||
Dividends received from joint venture entity |
— | — |
24. | Financial instruments |
2020 | 2019 | |||||||
Cash and cash equivalents |
31,689 | 67,403 | ||||||
Restricted cash |
10,087 | 10,086 | ||||||
Trade receivables |
583 | 22,353 | ||||||
Other current assets |
11,322 | 4,912 | ||||||
Receivables from related parties |
387 | 35 | ||||||
|
|
|
|
|||||
54,068 | 104,789 | |||||||
|
|
|
|
2020 | 2019 | |||||||
Borrowings (measured at amortized cost) |
567,899 | 475,606 | ||||||
Derivative financial liabilities (measured at FVTPL) |
534,692 | 479,263 | ||||||
Other long-term liability to related party (measured at FVTPL) |
7,440 | — | ||||||
Long-term incentive plan (measured at FVTPL) |
40,593 | 22,293 | ||||||
Trade and other payables (measured at amortized cost) |
11,959 | 11,732 | ||||||
Lease liabilities (measured at amortized cost) |
108,947 | 101,794 | ||||||
Liabilities to related parties (measured at amortized cost) |
367 | 10,780 | ||||||
Other current liabilities |
16,416 | 10,961 | ||||||
|
|
|
|
|||||
1,288,313 | 1,112,429 | |||||||
|
|
|
|
At 31 December 2020 | ||||||||
Carrying Amount | Fair Value | |||||||
Convertible bonds |
391,244 | 399,388 | ||||||
Convertible shareholder loans |
171,574 | 210,026 | ||||||
|
|
|
|
|||||
562,818 | 609,414 | |||||||
|
|
|
|
|||||
At 31 December 2019 | ||||||||
Carrying Amount | Fair Value | |||||||
Convertible bonds |
337,652 | 341,423 | ||||||
Convertible shareholder loans |
135,682 | 169,457 | ||||||
|
|
|
|
|||||
473,334 | 510,880 | |||||||
|
|
|
|
2020 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Convertible shareholder loans |
||||||||||||||||
Conversion rights and warrant rights |
— | — | 220,695 | 220,695 | ||||||||||||
Funding rights |
— | — | 176,888 | 176,888 | ||||||||||||
Excess warrant rights |
— | — | 137,109 | 137,109 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
— | — | 534,692 | 534,692 | |||||||||||||
|
|
|
|
|
|
|
|
2019 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Convertible bonds |
||||||||||||||||
Conversion rights |
— | — | 5,393 | 5,393 | ||||||||||||
Convertible shareholder loans |
||||||||||||||||
Conversion rights and warrant rights |
— | — | 169,644 | 169,644 | ||||||||||||
Funding rights |
— | — | 199,843 | 199,843 | ||||||||||||
Excess warrant rights |
— | — | 104,383 | 104,383 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
— | — | 479,263 | 479,263 | |||||||||||||
|
|
|
|
|
|
|
|
2020 | 2019 | |||||||
Stock price at valuation |
$201.82 | $177.45 | ||||||
Conversion ratio |
0.387 | 0.387 | ||||||
Volatility rate |
42.5% | 42.5% | ||||||
Risk-free interest rate |
0.1% | 1.6% | ||||||
Expected dividend yield |
0.0% | 0.0% | ||||||
Risk-adjusted yield |
11.8% | 15.2% | ||||||
Expected life |
0.95 years | 0.95-1.95 years |
2020 | 2019 | |||||||
Stock price at valuation |
$201.82 | $177.45 | ||||||
Conversion ratio |
1.399 | 1.321 | ||||||
Volatility rate |
42.5% | 42.5% | ||||||
Risk-free interest rate |
0.1% | 1.6% | ||||||
Expected dividend yield |
0.0% | 0.0% | ||||||
Risky yield |
14.2% | 18.5% | ||||||
Expected life |
1-2 years |
1-3 years |
2020 | 2019 | |||||||
Stock price at valuation |
$201.82 | $177.45 | ||||||
Strike price |
$71.47 | $75.68 | ||||||
Volatility rate |
42.5% | 42.5% | ||||||
Risk-free interest rate |
0.1% | 1.6% | ||||||
Expected dividend yield |
0.0% | 0.0% | ||||||
Expected life |
1-2 years |
1-3 years |
2020 | 2019 | |||||||
Variable-rate financial liabilities +100 |
(90 | ) | (113 | ) | ||||
Variable-rate financial liabilities -100 |
90 | 113 |
Closing rate | Average rate | |||||||||||||||||||
2020 | 2019 | 2020 | 2019 | Change | ||||||||||||||||
EUR |
1.230 | 1.122 | 1.141 | 1.119 | 9.7% | |||||||||||||||
GBP |
1.361 | 1.316 | 1.283 | 1.276 | 3.4% | |||||||||||||||
ISK |
0.008 | 0.008 | 0.007 | 0.008 | (4.6%) | |||||||||||||||
CHF |
1.133 | 1.033 | 1.066 | 1.007 | 9.6% |
Assets | Liabilities | Net assets | ||||||||||
EUR |
11,864 | 11,792 | 72 | |||||||||
GBP |
26 | 437 | (411 | ) | ||||||||
ISK |
633 | 114,442 | (113,809 | ) | ||||||||
CHF |
231 | 4,498 | (4,267 | ) |
Assets | Liabilities | Net assets | ||||||||||
EUR |
28,389 | 20,290 | 8,099 | |||||||||
GBP |
54 | 363 | (309 | ) | ||||||||
ISK |
2,422 | 104,054 | (101,632 | ) | ||||||||
CHF |
297 | 2,312 | (2,015 | ) |
EUR | GBP | ISK | CHF | |||||||||||||
Year ended 31 December 2020 |
||||||||||||||||
-10% weakening |
(7 | ) | (41 | ) | (11,381 | ) | (427 | ) | ||||||||
+10% strengthening |
7 | 41 | 11,381 | 427 | ||||||||||||
Year ended 31 December 2019 |
||||||||||||||||
-10% weakening |
(810 | ) | (31 | ) | (10,163 | ) | (201 | ) | ||||||||
+10% strengthening |
810 | 31 | 10,163 | 201 |
2020 | 2019 | |||||||
Cash and cash equivalents |
31,689 | 67,403 | ||||||
Restricted cash and certificate deposits |
10,087 | 10,086 | ||||||
Other assets |
47,730 | 50,357 | ||||||
|
|
|
|
|||||
89,506 | 127,846 | |||||||
|
|
|
|
Within one year |
One to two years |
Thereafter | Total | |||||||||||||
Financial assets |
||||||||||||||||
Non-interest bearing |
582 | — | — | 582 | ||||||||||||
Variable-interest bearing |
31,689 | — | 10,087 | 41,776 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total financial assets |
32,271 | — | 10,087 | 42,358 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Financial liabilities |
||||||||||||||||
Non-interest bearing |
28,742 | — | 48,033 | 76,775 | ||||||||||||
Fixed-interest bearing – Borrowings |
— | 205,464 | 683,559 | 889,023 | ||||||||||||
Derivative liabilities |
— | 534,692 | — | 534,692 | ||||||||||||
Variable-interest bearing – Borrowings |
2,867 | 2,865 | 3,943 | 9,675 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
31,609 | 743,021 | 735,535 | 1,510,165 | |||||||||||||
|
|
|
|
|
|
|
|
Within one year |
One to two years |
Thereafter | Total | |||||||||||||
Financial assets |
||||||||||||||||
Non-interest bearing |
22,353 | — | — | 22,353 | ||||||||||||
Variable-interest bearing |
67,403 | — | 10,086 | 77,489 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total financial assets |
89,756 | — | 10,086 | 99,842 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Financial liabilities |
||||||||||||||||
Non-interest bearing |
33,473 | — | 22,293 | 55,766 | ||||||||||||
Fixed-interest bearing – Borrowings |
— | — | 900,129 | 900,129 | ||||||||||||
Derivative liabilities |
— | — | 479,263 | 479,263 | ||||||||||||
Variable-interest bearing – Borrowings |
2,876 | 2,868 | 6,893 | 12,637 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total financial liabilities |
36,349 | 2,868 | 1,408,578 | 1,447,795 | ||||||||||||
|
|
|
|
|
|
|
|
25. | Supplemental cash flow information |
2020 | 2019 | |||||||
Non-cash investing and financing activities |
||||||||
Right-of-use |
15,204 | 5,665 | ||||||
Equity issued through exercising of convertible shareholder loans |
30,000 | — |
26. | Subsequent events |
• | 1,522,103 shares from the exercise of warrant and funding rights in exchange for $101.3 million of cash; |
• | 1,137,248 shares from the exercise of warrant rights in exchange for the settlement of $73.7 million of accrued payment-in-kind |
• | 2,306,555 shares resulting from the conversion of $166.8 million of outstanding principal and accrued payment-in-kind |
F-111 | ||||
F-112-F-113 | ||||
F-114 | ||||
F-115 | ||||
F-116-F-134 |
USD in thousands, except for per share amounts |
Notes | Six months ended 30 June 2021 |
Six months ended 30 June 2020 |
|||||||||
Revenue |
5 | 2,008 | 10,310 | |||||||||
Other income |
18 | 348 | 1,381 | |||||||||
Research and development expenses |
(90,403 | ) | (63,601 | ) | ||||||||
General and administrative expenses |
(86,360 | ) | (22,191 | ) | ||||||||
|
|
|
|
|||||||||
Operating loss |
(174,407 | ) | (74,101 | ) | ||||||||
Share of net (loss) / profit of joint venture |
19 | (837 | ) | 180 | ||||||||
Finance income |
6 | 4 | 8,372 | |||||||||
Finance costs |
6 | (123,575 | ) | (49,048 | ) | |||||||
Exchange rate differences |
(3,611 | ) | 12,443 | |||||||||
Gain on extinguishment of financial liabilities |
15 | 2,561 | — | |||||||||
|
|
|
|
|||||||||
Non-operating loss |
(125,458 | ) | (28,053 | ) | ||||||||
|
|
|
|
|||||||||
Loss before taxes |
(299,865 | ) | (102,154 | ) | ||||||||
Income tax benefit |
7 | 25,918 | 31 | |||||||||
|
|
|
|
|||||||||
Loss for the period |
(273,947 | ) | (102,123 | ) | ||||||||
|
|
|
|
|||||||||
Other comprehensive income / (loss) |
||||||||||||
Item that will be reclassified to profit or loss in subsequent periods: |
||||||||||||
Exchange rate differences on translation of foreign operations |
243 | (265 | ) | |||||||||
|
|
|
|
|||||||||
Total comprehensive loss |
(273,704 | ) | (102,388 | ) | ||||||||
|
|
|
|
|||||||||
Loss per share |
||||||||||||
Basic and diluted loss for the period per share |
8 | (37.13 | ) | (14.72 | ) | |||||||
|
|
|
|
USD in thousands |
Notes | 30 June 2021 |
31 December 2020 |
|||||||||
Non-current assets |
||||||||||||
Property, plant and equipment |
9 | 63,363 | 65,446 | |||||||||
Right-of-use assets |
10 | 124,208 | 111,519 | |||||||||
Goodwill |
13,168 | 13,427 | ||||||||||
Other intangible assets |
11 | 4,420 | 6,335 | |||||||||
Contract assets |
5 | 1,843 | 2,190 | |||||||||
Investment in joint venture |
19 | 56,394 | 56,679 | |||||||||
Other long-term assets |
714 | 714 | ||||||||||
Restricted cash |
10,087 | 10,087 | ||||||||||
Deferred tax assets |
7 | 147,936 | 121,864 | |||||||||
|
|
|
|
|||||||||
Total non-current assets |
422,133 | 388,261 | ||||||||||
|
|
|
|
|||||||||
Current assets |
||||||||||||
Inventories |
19,922 | 9,646 | ||||||||||
Trade receivables |
5,732 | 583 | ||||||||||
Contract assets |
5 | 12,390 | 32,534 | |||||||||
Other current assets |
13 | 16,826 | 11,322 | |||||||||
Receivables from related parties |
18 | 1,150 | 387 | |||||||||
Cash and cash equivalents |
12 | 41,986 | 31,689 | |||||||||
|
|
|
|
|||||||||
Total current assets |
98,006 | 86,161 | ||||||||||
|
|
|
|
|||||||||
Total assets |
520,139 | 474,422 | ||||||||||
|
|
|
|
USD in thousands |
Notes | 30 June 2021 |
31 December 2020 |
|||||||||
Equity |
||||||||||||
Share capital |
14 | 79 | 73 | |||||||||
Share premium |
14 | 294,260 | 166,740 | |||||||||
Translation reserve |
5,217 | 4,974 | ||||||||||
Accumulated deficit |
(1,312,977 | ) | (1,039,030 | ) | ||||||||
|
|
|
|
|||||||||
Total equity |
(1,013,421 | ) | (867,243 | ) | ||||||||
|
|
|
|
|||||||||
Non-current liabilities |
||||||||||||
Borrowings |
15 | 564,126 | 565,396 | |||||||||
Derivative financial liabilities |
20 | 602,316 | 534,692 | |||||||||
Other long-term liability to related party |
18 | 7,440 | 7,440 | |||||||||
Lease liabilities |
10 | 120,639 | 103,474 | |||||||||
Long-term incentive plan |
16 | 101,108 | 40,593 | |||||||||
Contract liabilities |
5 | 61,656 | 38,874 | |||||||||
Deferred tax liability |
162 | 217 | ||||||||||
|
|
|
|
|||||||||
Total non-current liabilities |
1,457,447 | 1,290,686 | ||||||||||
|
|
|
|
|||||||||
Current liabilities |
||||||||||||
Trade and other payables |
30,462 | 11,959 | ||||||||||
Lease liabilities |
10 | 5,435 | 5,473 | |||||||||
Current maturities of borrowings |
15 | 2,503 | 2,503 | |||||||||
Liabilities to related parties |
18 | 3,886 | 367 | |||||||||
Contract liabilities |
5 | 15,399 | 14,192 | |||||||||
Taxes payable |
294 | 69 | ||||||||||
Other current liabilities |
18,134 | 16,416 | ||||||||||
|
|
|
|
|||||||||
Total current liabilities |
76,113 | 50,979 | ||||||||||
Total liabilities |
1,533,560 | 1,341,665 | ||||||||||
|
|
|
|
|||||||||
Total equity and liabilities |
520,139 | 474,422 | ||||||||||
|
|
|
|
USD in thousands |
Notes | Six months ended 30 June 2021 |
Six months ended 30 June 2020 |
|||||||||
Cash flows from operating activities |
||||||||||||
Loss for the period |
(273,947 | ) | (102,123 | ) | ||||||||
Adjustments for non-cash items: |
||||||||||||
Long-term incentive plan |
16 | 61,201 | 5,411 | |||||||||
Depreciation and amortization |
8,928 | 7,935 | ||||||||||
Impairment of property, plant and equipment |
9 | 2,066 | — | |||||||||
Impairment of other intangible assets |
11 | 3,993 | — | |||||||||
Share of net loss / (profit) of joint venture |
19 | 837 | (180 | ) | ||||||||
Finance income |
6 | (4 | ) | (8,372 | ) | |||||||
Finance costs |
6 | 123,575 | 49,048 | |||||||||
Gain on extinguishment of financial liabilities |
15 | (2,561 | ) | — | ||||||||
Exchange rate difference |
3,611 | (12,443 | ) | |||||||||
Income tax benefit |
7 | (25,918 | ) | (31 | ) | |||||||
|
|
|
|
|||||||||
Operating cash flow before movement in working capital |
(98,219 | ) | (60,755 | ) | ||||||||
(Increase) / decrease in inventories |
(10,276 | ) | 359 | |||||||||
Increase in trade receivables |
(5,149 | ) | (1,953 | ) | ||||||||
Increase in net liabilities with related parties |
2,756 | 2,209 | ||||||||||
Decrease in contract assets |
20,491 | 5,674 | ||||||||||
(Increase) / decrease in other assets |
(5,504 | ) | 264 | |||||||||
Increase in trade and other payables |
7,712 | 2,600 | ||||||||||
Increase in contract liabilities |
23,989 | 1,604 | ||||||||||
Increase in other liabilities |
1,032 | 2,052 | ||||||||||
|
|
|
|
|||||||||
Cash used in operations |
(63,168 | ) | (47,946 | ) | ||||||||
Interest received |
4 | 167 | ||||||||||
Interest paid |
(21,570 | ) | (3,209 | ) | ||||||||
|
|
|
|
|||||||||
Net cash used in operating activities |
(84,734 | ) | (50,988 | ) | ||||||||
|
|
|
|
|||||||||
Cash flows from investing activities |
||||||||||||
Acquisition of property, plant and equipment |
(6,606 | ) | (4,208 | ) | ||||||||
Acquisition of intangible assets |
(366 | ) | (303 | ) | ||||||||
Investment in joint venture |
— | (5,000 | ) | |||||||||
|
|
|
|
|||||||||
Net cash used in investing activities |
(6,972 | ) | (9,511 | ) | ||||||||
Cash flows from financing activities |
||||||||||||
Repayments of borrowings |
(36,115 | ) | (1,098 | ) | ||||||||
Repayments of principal portion of lease liabilities |
(3,016 | ) | (2,189 | ) | ||||||||
Net proceeds from new borrowings. |
114,282 | 15,000 | ||||||||||
Net proceeds on issue of equity shares |
26,850 | — | ||||||||||
|
|
|
|
|||||||||
Net cash generated from financing activities |
102,001 | 11,713 | ||||||||||
Increase / (decrease) in cash and cash equivalents |
10,295 | (48,786 | ) | |||||||||
Cash and cash equivalents at the beginning of the period |
31,689 | 67,403 | ||||||||||
Effect of movements in exchange rates on cash held |
2 | 201 | ||||||||||
|
|
|
|
|||||||||
Cash and cash equivalents at the end of the period |
12 | 41,986 | 18,818 | |||||||||
|
|
|
|
USD in thousands |
Share capital | Share premium |
Translation reserve |
Accumulated deficit |
Total equity |
|||||||||||||||
At 1 January 2020 |
69 | 102,359 | (980 | ) | (868,986 | ) | (767,538 | ) | ||||||||||||
Loss for the period |
— | — | — | (102,123 | ) | (102,123 | ) | |||||||||||||
Foreign currency translation differences |
— | — | (265 | ) | — | (265 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Other comprehensive income / (loss) |
— | — | (265 | ) | (102,123 | ) | (102,388 | ) | ||||||||||||
Increase in share capital |
— | — | — | — | — | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At 30 June 2020 |
69 | 102,359 | (1,245 | ) | (971,109 | ) | (869,926 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At 1 January 2021 |
73 | 166,740 | 4,974 | (1,039,030 | ) | (867,243 | ) | |||||||||||||
Loss for the period |
— | — | — | (273,947 | ) | (273,947 | ) | |||||||||||||
Foreign currency translation differences |
— | — | 243 | — | 243 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Other comprehensive income / (loss) |
— | — | 243 | (273,947 | ) | (273,704 | ) | |||||||||||||
Increase in share capital |
6 | 127,520 | — | — | 127,526 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At 30 June 2021 |
79 | 294,260 | 5,217 | (1,312,977 | ) | (1,013,421 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|
|
1. | General information |
2. | Basis of preparation |
3. | Significant changes in the current reporting period |
• | On 15 March 2021, the Group issued 173,427 Class A ordinary shares for $35.0 million in gross proceeds, completing the second and final round of a private placement offering. The first round of the private placement offering was completed in October 2020. |
• | Beginning in March of 2021, the Group became party to four litigations in the United States arising out of the development of its adalimumab biosimilar, and the filing of the corresponding biologics license application with the U.S. Food and Drug Administration. The counterparty in all matters involve AbbVie Inc. or certain of its subsidiaries. Refer to Note 17 for further information related to these matters. |
• | On 24 June 2021, the Group substantially amended the terms and conditions of its convertible bonds. In connection with the amendment, the Group converted a portion of the convertible bonds into Class A ordinary shares and redeemed a portion of the convertible bonds for cash. The remaining unconverted and unredeemed bonds reflected the amended terms and conditions, and the Group also issued new bonds reflective of such amendments. Refer to Note 15 for further details. |
• | The Group entered into additional lease agreements during the six months ended 30 June 2021, contributing to a net increase of $12.3 million and $17.2 million in right-of-use |
• | The Group recognized $61.2 million in expense related to its long-term incentive plans. Refer to Note 16 for further details. |
4. | New accounting standards |
5. | Revenue |
30 June | ||||||||
2021 | 2020 | |||||||
License revenue (point in time revenue recognition) |
930 | 8,975 | ||||||
Research and development and other service revenue (overtime revenue recognition) |
1,078 | 1,335 | ||||||
|
|
|
|
|||||
2,008 | 10,310 | |||||||
|
|
|
|
Contract Assets |
Contract Liabilities |
|||||||
1 January 2021 |
34,724 | 53,066 | ||||||
Contract asset additions |
— | — | ||||||
Amounts transferred to trade receivables |
(20,491 | ) | — | |||||
Customer prepayments |
— | 24,919 | ||||||
Revenue recognized |
— | (930 | ) | |||||
|
|
|
|
|||||
30 June 2021 |
14,233 | 77,055 | ||||||
|
|
|
|
6. | Finance income and finance cost |
30 June | ||||||||
2021 | 2020 | |||||||
Changes in the fair value of derivatives |
— | 8,205 | ||||||
Interest income from cash and cash equivalents |
— | 164 | ||||||
Other interest income |
4 | 3 | ||||||
|
|
|
|
|||||
4 | 8,372 | |||||||
|
|
|
|
30 June | ||||||||
2021 | 2020 | |||||||
Changes in the fair value of derivatives |
(67,624 | ) | (90 | ) | ||||
Interest on debt and borrowings |
(51,321 | ) | (44,684 | ) | ||||
Interest on lease liabilities |
(3,066 | ) | (2,643 | ) | ||||
Amortization of deferred debt issue costs |
(1,564 | ) | (1,631 | ) | ||||
|
|
|
|
|||||
(123,575 | ) | (49,048 | ) | |||||
|
|
|
|
7. | Income tax |
8. | Loss per share |
30 June | ||||||||
2021 | 2020 | |||||||
Earnings |
||||||||
Loss for the period |
(273,947 | ) | (102,123 | ) | ||||
Number of shares |
||||||||
Weighted average number of ordinary shares outstanding |
7,377,421 | 6,937,062 | ||||||
|
|
|
|
|||||
Basic and diluted loss per share |
(37.13 | ) | (14.72 | ) | ||||
|
|
|
|
9. | Property, plant and equipment |
10. | Leases |
2021 | ||||
Right-of-use |
||||
Balance at 1 January |
111,519 | |||
Adjustments for indexed leases |
2,645 | |||
New or renewed leases |
14,503 | |||
Depreciation |
(4,307 | ) | ||
Translation difference |
(152 | ) | ||
|
|
|||
Balance at 30 June |
124,208 | |||
|
|
2021 | ||||
Lease liabilities |
||||
Balance at 1 January |
108,947 | |||
Adjustments for indexed leases |
2,645 | |||
New or renewed leases |
14,503 | |||
Installment payments |
(3,016 | ) | ||
Foreign currency adjustment |
3,248 | |||
Translation difference |
(253 | ) | ||
|
|
|||
Balance at 30 June |
126,074 | |||
|
|
|||
Current liabilities |
(5,435 | ) | ||
Non-current liabilities |
120,639 | |||
|
|
30 June | ||||||||
2021 | 2020 | |||||||
Total depreciation expense from right-of-use |
(3,880 | ) | (3,397 | ) | ||||
Interest expense on lease liabilities |
(3,066 | ) | (2,643 | ) | ||||
Foreign currency difference on lease liability |
(3,248 | ) | 11,769 | |||||
|
|
|
|
|||||
Total amount recognized in profit and loss |
(10,194 | ) | 5,729 | |||||
|
|
|
|
2021 | ||||
Less than one year |
12,962 | |||
One to five years |
50,087 | |||
Thereafter |
113,677 | |||
|
|
|||
176,726 | ||||
|
|
11. | Other intangible assets |
12. | Cash and cash equivalents |
30 June 2021 |
31 December 2020 |
|||||||
Cash and cash equivalents denominated in US dollars |
40,346 | 27,183 | ||||||
Cash and cash equivalents denominated in other currencies |
1,640 | 4,506 | ||||||
|
|
|
|
|||||
41,986 | 31,689 | |||||||
|
|
|
|
13. | Other current assets |
30 June 2021 |
31 December 2020 |
|||||||
Value-added tax |
4,899 | 3,858 | ||||||
Prepaid expenses |
11,765 | 5,922 | ||||||
Other short-term receivables |
162 | 1,542 | ||||||
|
|
|
|
|||||
16,826 | 11,322 | |||||||
|
|
|
|
14. | Share capital |
Class A Shares |
Class B Shares |
Share capital |
Share premium | Total | ||||||||||||||||
Balance at 1 January 2021 |
7,163,438 | 95,701 | 73 | 166,740 | 166,813 | |||||||||||||||
Share issue |
629,114 | — | 6 | 127,969 | 127,975 | |||||||||||||||
Transaction costs on share issue |
— | — | — | (449 | ) | (449 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance at 30 June 2021 |
7,792,552 | 95,701 | 79 | 294,260 | 294,339 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
15. | Borrowings |
30 June 2021 |
31 December 2020 |
|||||||
Convertible shareholder loans, net of debt issue costs (see note 20) |
198,500 | 177,612 | ||||||
Convertible bonds, net of debt issue costs |
— | 381,338 | ||||||
Bonds |
359,907 | — | ||||||
Other borrowings |
8,222 | 8,949 | ||||||
|
|
|
|
|||||
Total outstanding borrowings, net of debt issue costs |
566,629 | 567,899 | ||||||
Less: current portion of borrowings |
(2,503 | ) | (2,503 | ) | ||||
|
|
|
|
|||||
Total non-current borrowings |
564,126 | 565,396 | ||||||
|
|
|
|
• | Transaction costs and fees incurred as part of the extinguishment; |
• | The acceleration of previously deferred debt issue costs incurred in connection with the issuance of the pre-transaction bonds; |
• | The acceleration of previously unamortized accretion of the pre-transaction bonds; and |
• | As part of the transaction, management elected, as its accounting policy, to recognize the difference between the carrying amount of the pre-transaction converted bonds and the related derivative financial liability and the fair value of the shares issued upon conversion in the |
unaudited condensed consolidated statement of profit or loss and other comprehensive income or loss. |
2021 | ||||
Borrowings, net at 1 January |
567,899 | |||
Bonds converted to equity |
(105,501 | ) | ||
Redemption of borrowings |
(36,115 | ) | ||
Paid payment-in-kind |
(19,200 | ) | ||
Net proceeds from new borrowings |
114,282 | |||
Accrued interest |
44,980 | |||
Amortization of deferred debt issue costs |
12,578 | |||
Premium on redeemed and unredeemed bonds |
15,471 | |||
Change in fair value at initial recognition of bonds |
(27,793 | ) | ||
|
|
|||
Foreign currency exchange difference |
28 | |||
|
|
|||
Borrowings, net at 30 June |
566,629 | |||
|
|
30 June 2021 | ||||
Within one year |
2,503 | |||
Within two years |
166,413 | |||
Within three years |
397,295 | |||
Within four years |
99 | |||
Thereafter |
495 | |||
|
|
|||
566,805 | ||||
|
|
16. | Long-term incentive plans |
30 June 2021 | ||||
Risk-free interest rate |
0.1 | % | ||
Volatility rate |
42.0 | % | ||
Expected dividend yield |
— | |||
Expected life |
1.0 – 2.0 years | |||
Share price at valuation |
$ | 2,700 | ||
Strike price |
$ | 1,045 – $1,437 |
30 June 2021 | ||||
Balance at 1 January |
10,501 | |||
Additions |
5,273 | |||
Payments |
(686 | ) | ||
|
|
|||
Balance at 30 June |
15,088 | |||
|
|
17. | Litigation |
18. | Related parties |
Purchased service / interest |
Sold service (d) | Receivables | Payables/ loans |
|||||||||||||
Alvogen Lux Holdings S.à r.l. – Sister company (a) |
5,275 | — | — | 73,512 | ||||||||||||
Alvogen Aztiq AB – Sister company (a) |
123 | — | — | 2,623 | ||||||||||||
Aztiq Pharma Partners S.à r.l. – Sister company (a) |
8,463 | — | — | 114,635 | ||||||||||||
Fasteignafélagið Sæmundur hf. – Sister company |
3,859 | — | — | 89,776 | ||||||||||||
Alvogen Iceland ehf. – Sister company |
346 | 1,045 | 172 | 459 | ||||||||||||
Alvogen ehf. – Sister company |
— | — | — | — | ||||||||||||
Alvogen UK – Sister company |
267 | — | — | 345 | ||||||||||||
Lotus Pharmaceuticals Co. Ltd. – Sister company (b) |
— | — | — | 7,440 | ||||||||||||
Alvogen Emerging Markets – Sister company |
134 | — | — | 62 | ||||||||||||
Alvogen Inc. – Sister company |
— | — | 395 | 75 | ||||||||||||
Changchun Alvotech Biopharmac. Co. Ltd (c) |
— | — | 323 | — | ||||||||||||
Alvogen Pharma India Ltd. – Sister company |
122 | — | 73 | |||||||||||||
Alvogen Malta Sh. Services – Sister company |
512 | — | 180 | 476 | ||||||||||||
Alvogen Malta (Outlicensing) Ltd – Sister company |
453 | — | 80 | 453 | ||||||||||||
Alvogen Spain SL – Sister Company |
148 | — | — | 23 | ||||||||||||
Norwich Clinical Services Ltd – Sister Company |
— | — | — | 49 | ||||||||||||
Lambhagavegur 7 ehf - Sister company |
110 | 10,634 | ||||||||||||||
Fasteignafélagið Eyjólfur ehf - Sister company |
— | 265 | ||||||||||||||
HRJAF ehf – Sister company |
684 | — | — | 9,541 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
20,496 | 1,045 | 1,150 | 310,441 | |||||||||||||
|
|
|
|
|
|
|
|
30 June 2020 | 31 December 2020 | |||||||||||||||
Purchased service / interest |
Sold service | Receivables | Payables/ loans |
|||||||||||||
Alvogen Lux Holdings S.à r.l. – Sister company (a) |
4,019 | — | — | 68,237 | ||||||||||||
Aztiq Pharma Partners S.à r.l. – Sister company (a) |
9,656 | — | — | 123,671 | ||||||||||||
Fasteignafélagið Sæmundur hf. – Sister company |
3,224 | — | — | 84,650 | ||||||||||||
Alvogen Iceland ehf. – Sister company |
1,402 | 371 | 38 | 21 | ||||||||||||
Alvogen ehf. – Sister company |
— | — | — | 40 | ||||||||||||
Alvogen UK – Sister company |
389 | — | — | 132 | ||||||||||||
Lotus Pharmaceuticals Co. Ltd. – Sister company (b) |
— | — | — | 7,440 | ||||||||||||
Alvogen Emerging Markets – Sister company |
— | — | — | 11 | ||||||||||||
Alvogen Inc. – Sister company |
— | — | — | 23 | ||||||||||||
Changchun Alvotech Biopharmac. Co. Ltd |
— | — | 323 | — | ||||||||||||
Alvogen Pharma India Ltd. – Sister company |
116 | — | ||||||||||||||
Alvogen Malta Operations Ltd – Sister company |
155 | — | — | — | ||||||||||||
Alvogen Malta (Outlicensing) Ltd – Sister company |
— | — | 26 | 58 | ||||||||||||
Alvogen Malta Group Services – Sister company |
412 | 40 | ||||||||||||||
Alvogen Spain SL – Sister Company |
70 | — | — | — | ||||||||||||
Norwich Clinical Services Ltd – Sister Company |
— | — | — | 42 | ||||||||||||
HRJAF ehf – Sister company |
480 | — | — | 9,191 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
19,923 | 371 | 387 | 293,556 | |||||||||||||
|
|
|
|
|
|
|
|
30 June | ||||||||
2021 | 2020 | |||||||
Short-term employee benefits |
3,163 | 2,506 | ||||||
Other long-term benefits |
63 | 0 | ||||||
Termination benefits |
204 | 0 | ||||||
|
|
|
|
|||||
3,430 | 2,506 | |||||||
|
|
|
|
19. | Interests in joint ventures |
30 June 2021 |
30 June 2020 |
|||||||
Balance at 1 January |
56,679 | 54,020 | ||||||
Share in (losses) / profits |
(837 | ) | 180 | |||||
Translation difference |
552 | (340 | ) | |||||
|
|
|
|
|||||
Balance at 30 June |
56,394 | 53,860 | ||||||
|
|
|
|
20. | Financial instruments |
30 June 2021 |
31 December 2020 |
|||||||
Cash and cash equivalents |
41,986 | 31,689 | ||||||
Restricted cash |
10,087 | 10,087 | ||||||
Trade receivables |
5,732 | 583 | ||||||
Other current assets |
16,826 | 11,322 | ||||||
Receivables from related parties |
1,150 | 387 | ||||||
|
|
|
|
|||||
75,781 | 54,068 | |||||||
|
|
|
|
30 June 2021 |
31 December 2020 |
|||||||
Borrowings (measured at amortized cost) |
566,629 | 567,899 | ||||||
Derivative financial liabilities (measured at FVTPL) |
602,316 | 534,692 | ||||||
Other long-term liability to related party (measured at FVTPL) |
7,440 | 7,440 | ||||||
Long-term incentive plan (measured at FVTPL) |
101,108 | 40,593 | ||||||
Trade and other payables (measured at amortized cost) |
30,462 | 11,959 | ||||||
Lease liabilities (measured at amortized cost) |
126,074 | 108,947 | ||||||
Liabilities to related parties (measured at amortized cost) |
3,886 | 367 | ||||||
Other current liabilities |
18,134 | 16,416 | ||||||
|
|
|
|
|||||
1,456,049 | 1,288,313 | |||||||
|
|
|
|
30 June 2021 | ||||||||
Carrying Amount |
Fair Value |
|||||||
Bonds |
358,993 | 358,840 | ||||||
Convertible shareholder loans |
192,046 | 227,943 | ||||||
|
|
|
|
|||||
551,039 | 586,783 | |||||||
|
|
|
|
31 December 2020 | ||||||||
Carrying Amount |
Fair Value |
|||||||
Convertible bonds |
391,244 | 399,388 | ||||||
Convertible shareholder loans |
171,574 | 210,026 | ||||||
|
|
|
|
|||||
562,818 | 609,414 | |||||||
|
|
|
|
30 June 2021 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Conversion rights and warrant rights |
— | — | 245,118 | 245,118 | ||||||||||||
Funding rights |
— | — | 202,212 | 202,212 | ||||||||||||
Excess warrant rights |
— | — | 154,986 | 154,986 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
— | — | 602,316 | 602,316 | |||||||||||||
|
|
|
|
|
|
|
|
31 December 2020 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Conversion rights and warrant rights |
— | — | 220,695 | 220,695 | ||||||||||||
Funding rights |
— | — | 176,888 | 176,888 | ||||||||||||
Excess warrant rights |
— | — | 137,109 | 137,109 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
— | — | 534,692 | 534,692 | |||||||||||||
|
|
|
|
|
|
|
|
30 June 2021 | ||||
Stock price at valuation |
$ | 204.03 | ||
Conversion ratio |
1.503 | |||
Volatility rate |
40.0 | % | ||
Risk-free interest rate |
0.1-0.2 |
% | ||
Expected dividend yield |
0.0 | % | ||
Risk-adjusted yield |
12.2 | % | ||
Expected life |
0.5 – 1.5 years |
30 June 2021 | ||||
Stock price at valuation |
$ | 204.03 | ||
Strike price |
$ | 66.55 | ||
Volatility rate |
40.0 | % | ||
Risk-free interest rate |
0.1-0.2 |
% | ||
Expected dividend yield |
0.0 | % | ||
Expected life |
0.5 – 1.5 years |
21. | Supplemental cash flow information |
2021 | 2020 | |||||||
Non-cash investing and financing activities |
||||||||
Right-of-use |
13,672 | 3,448 | ||||||
Equity issued through exercise of convertible bonds |
92,975 | — | ||||||
Bonds converted to equity |
105,501 | — | ||||||
Change in fair value at initial recognition of bonds |
27,516 | — |
22. | Subsequent events |
• | 1,522,103 shares from the exercise of warrant and funding rights in exchange for $101.3 million of cash; |
• | 1,137,248 shares from the exercise of warrant rights in exchange for the settlement of $73.7 million of accrued payment-in-kind |
• | 2,306,555 shares resulting from the conversion of $166.8 million of outstanding principal and accrued payment-in-kind |
ARTICLE 1 CERTAIN DEFINITIONS |
A-3 | |||||
Section 1.1 |
Definitions | A-3 | ||||
Section 1.2 |
Certain Defined Terms | A-14 | ||||
ARTICLE 2 MERGERS |
A-16 | |||||
Section 2.1 |
Closing Transactions | A-16 | ||||
Section 2.2 |
Allocation Schedule | A-19 | ||||
Section 2.3 |
Closing | A-19 | ||||
Section 2.4 |
Withholding | A-19 | ||||
Section 2.5 |
Parent Warrants | A-20 | ||||
Section 2.6 |
Earn Out | A-20 | ||||
ARTICLE 3 REPRESENTATIONS AND WARRANTIES RELATING TO THE COMPANY |
A-21 | |||||
Section 3.1 |
Organization and Qualification | A-21 | ||||
Section 3.2 |
Capitalization of the Group Companies | A-22 | ||||
Section 3.3 |
Authority | A-22 | ||||
Section 3.4 |
Financial Statements; Undisclosed Liabilities | A-23 | ||||
Section 3.5 |
Consents and Requisite Governmental Approvals; No Violations | A-24 | ||||
Section 3.6 |
Permits | A-24 | ||||
Section 3.7 |
Material Contracts | A-24 | ||||
Section 3.8 |
Absence of Changes | A-26 | ||||
Section 3.9 |
Litigation | A-26 | ||||
Section 3.10 |
Compliance with Applicable Law | A-27 | ||||
Section 3.11 |
Employee Plans | A-27 | ||||
Section 3.12 |
Environmental Matters | A-28 | ||||
Section 3.13 |
Intellectual Property | A-28 | ||||
Section 3.14 |
Labor Matters | A-30 | ||||
Section 3.15 |
Insurance | A-31 | ||||
Section 3.16 |
Tax Matters | A-32 | ||||
Section 3.17 |
Brokers | A-33 | ||||
Section 3.18 |
Real and Personal Property | A-33 | ||||
Section 3.19 |
Transactions with Affiliates | A-33 | ||||
Section 3.20 |
Data Privacy and Security | A-34 | ||||
Section 3.21 |
Compliance with International Trade & Anti-Corruption Laws | A-34 | ||||
Section 3.22 |
Information Supplied | A-35 | ||||
Section 3.23 |
Regulatory Compliance | A-35 | ||||
Section 3.24 |
Material Suppliers and Partners | A-36 | ||||
Section 3.25 |
Investigation; No Other Representations | A-37 | ||||
Section 3.26 |
EXCLUSIVITY OF REPRESENTATIONS AND WARRANTIES | A-37 | ||||
ARTICLE 4 REPRESENTATIONS AND WARRANTIES RELATING TO TOPCO |
A-38 | |||||
Section 4.1 |
Corporate Organization | A-38 | ||||
Section 4.2 |
Authority | A-38 | ||||
Section 4.3 |
Capitalization of TopCo | A-38 | ||||
Section 4.4 |
Consents and Requisite Governmental Approvals; No Violations | A-39 | ||||
Section 4.5 |
Business Activities | A-39 | ||||
Section 4.6 |
Investment Company Act | A-39 | ||||
Section 4.7 |
Tax Matters | A-39 | ||||
Section 4.8 |
Investigation; No Other Representations | A-39 | ||||
Section 4.9 |
EXCLUSIVITY OF REPRESENTATIONS AND WARRANTIES | A-40 |
ARTICLE 5 REPRESENTATIONS AND WARRANTIES RELATING TO PARENT |
A-40 | |||||
Section 5.1 |
Organization and Qualification | A-40 | ||||
Section 5.2 |
Authority | A-41 | ||||
Section 5.3 |
Consents and Requisite Government Approvals; No Violations | A-41 | ||||
Section 5.4 |
Brokers | A-41 | ||||
Section 5.5 |
Information Supplied | A-41 | ||||
Section 5.6 |
Capitalization of Parent | A-42 | ||||
Section 5.7 |
SEC Filings | A-42 | ||||
Section 5.8 |
Trust Account | A-42 | ||||
Section 5.9 |
Transactions with Affiliates | A-43 | ||||
Section 5.10 |
Litigation | A-43 | ||||
Section 5.11 |
Compliance with Applicable Law | A-43 | ||||
Section 5.12 |
Internal Controls; Listing; Financial Statements | A-44 | ||||
Section 5.13 |
No Undisclosed Liabilities | A-44 | ||||
Section 5.14 |
Tax Matters | A-45 | ||||
Section 5.15 |
Investigation; No Other Representations | A-46 | ||||
Section 5.16 |
EXCLUSIVITY OF REPRESENTATIONS AND WARRANTIES | A-46 | ||||
ARTICLE 6 COVENANTS |
A-47 | |||||
Section 6.1 |
Conduct of Business of the Company | A-47 | ||||
Section 6.2 |
Efforts to Consummate | A-49 | ||||
Section 6.3 |
Confidentiality and Access to Information | A-51 | ||||
Section 6.4 |
Public Announcements | A-51 | ||||
Section 6.5 |
Tax Matters | A-52 | ||||
Section 6.6 |
Exclusive Dealing | A-53 | ||||
Section 6.7 |
Preparation of Registration Statement / Proxy Statement | A-54 | ||||
Section 6.8 |
Parent Shareholder Approval | A-55 | ||||
Section 6.9 |
Conduct of Business of Parent | A-56 | ||||
Section 6.10 |
TopCo Incentive Equity Plan | A-57 | ||||
Section 6.11 |
Nasdaq and Nasdaq First North Listings | A-57 | ||||
Section 6.12 |
Trust Account | A-57 | ||||
Section 6.13 |
PCAOB Financials | A-58 | ||||
Section 6.14 |
Indemnification; Directors’ and Officers’ Insurance | A-58 | ||||
Section 6.15 |
Post-Closing Directors and Officers | A-59 | ||||
Section 6.16 |
Conduct of Business of TopCo | A-59 | ||||
Section 6.17 |
Termination and Amendment of Agreements | A-60 | ||||
Section 6.18 |
Employee Benefit Plan Matters | A-60 | ||||
Section 6.19 |
Audit | A-61 | ||||
Section 6.20 |
Employment Agreements | A-61 | ||||
ARTICLE 7 CONDITIONS TO CONSUMMATION OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT |
A-62 | |||||
Section 7.1 |
Conditions to the Obligations of the Parties | A-62 | ||||
Section 7.2 |
Other Conditions to the Obligations of Parent | A-62 | ||||
Section 7.3 |
Other Conditions to the Obligations of the Company | A-63 | ||||
Section 7.4 |
Frustration of Closing Conditions | A-64 | ||||
ARTICLE 8 TERMINATION |
A-64 | |||||
Section 8.1 |
Termination | A-64 | ||||
Section 8.2 |
Effect of Termination | A-65 | ||||
ARTICLE 9 MISCELLANEOUS |
A-65 | |||||
Section 9.1 |
Non-Survival |
A-65 | ||||
Section 9.2 |
Entire Agreement; Assignment | A-65 |
Section 9.3 |
Amendment | A-65 | ||||
Section 9.4 |
Notices | A-66 | ||||
Section 9.5 |
Governing Law | A-67 | ||||
Section 9.6 |
Fees and Expenses | A-67 | ||||
Section 9.7 |
Construction; Interpretation | A-67 | ||||
Section 9.8 |
Exhibits and Schedules | A-67 | ||||
Section 9.9 |
Parties in Interest | A-68 | ||||
Section 9.10 |
Severability | A-68 | ||||
Section 9.11 |
Counterparts; Electronic Signatures | A-68 | ||||
Section 9.12 |
Knowledge of Company; Knowledge of Parent | A-68 | ||||
Section 9.13 |
No Recourse | A-68 | ||||
Section 9.14 |
Extension; Waiver | A-68 | ||||
Section 9.15 |
Waiver of Jury Trial | A-69 | ||||
Section 9.16 |
Arbitration | A-69 | ||||
Section 9.17 |
Remedies | A-69 | ||||
Section 9.18 |
Trust Account Waiver | A-70 |
Exhibit A |
Form of Investor Rights Agreement | |
Exhibit B |
Form of Election on Internal Revenue Service Form 8832 | |
Exhibit C |
Plan of Merger | |
Exhibit D |
Agreed TopCo Governing Documents | |
Exhibit E |
Form of Warrant Assumption Agreement | |
Exhibit F |
Related Party Transactions Amendments | |
Exhibit G |
Cayman Plan of Merger |
Term |
Section | |
401(k) Plan |
Section 6.18 | |
Acquisition Proposal |
Section 6.6(a) | |
Additional Parent SEC Reports |
Section 5.7 | |
Additional PIPE Financing |
Section 6.2(d) | |
Agreed TopCo Governing Documents |
Section 2.1(d) | |
Agreement |
Introduction | |
Allocation Schedule |
Section 2.2 | |
Business Combination Proposal |
Section 6.8 | |
Buyback |
Section 2.6(b) | |
Cayman Islands Act |
Section 2.1(b)(ii) | |
Cayman Merger Documents |
Section 2.1(b)(i) | |
Cayman Plan of Merger |
Section 2.1(b)(i) | |
CBA |
Section 3.7(a)(xii) | |
Change in Recommendation |
Section 6.8 | |
Closing |
Section 2.3 | |
Closing Date |
Section 2.3 | |
Closing Filing |
Section 6.4(b) | |
Closing Press Release |
Section 6.4(b) |
Term |
Section | |
Company |
Introduction | |
Company Designee |
Section 6.15(c) | |
Conversion |
Recitals | |
Converted Warrant |
Section 2.5 | |
Copyrights |
Section 1.1 | |
Creator |
Section 3.13(d) | |
D&O Persons |
Section 6.14(a) | |
Election |
Recitals | |
Exchange |
Section 2.1(f)(vi) | |
Financial Statements |
Section 3.4(a) | |
First Merger |
Recitals | |
First Merger Consideration |
Section 2.1(b)(vi) | |
First Merger Documents |
Section 2.1(b)(i) | |
First Merger Effective Time |
Section 2.1(b)(i) | |
First Merger Shareholder Resolution |
Section 2.1(b)(ii) | |
First Surviving Company |
Section 2.1(b)(ii) | |
Framework Agreement |
Recitals | |
IFRS |
Section 3.4(a) | |
Incentive Plan |
Section 6.18(f) | |
Intended U.S. Tax Treatment |
Recitals | |
Investor Rights Agreement |
Recitals | |
Investors |
Recitals | |
IPO |
Section 9.18 | |
IRA Company Shareholders |
Recitals | |
Latest Balance Sheet |
Section 3.4(a) | |
Leased Real Property |
Section 3.18(b) | |
Luxembourg Company Law |
Section 2.1(b)(ii) | |
Luxembourg Merger Documents |
Section 2.1(b)(i) | |
Marks |
Section 1.1 | |
Material Contracts |
Section 3.7(a) | |
Material Partner |
Section 3.24(b) | |
Material Permits |
Section 3.6 | |
Material Supplier |
Section 3.24(a) | |
Merger Proposal |
Section 6.8 | |
Parent |
Introduction | |
Parent Acquisition Proposal |
Section 6.6(b) | |
Parent Board |
Section 6.8 | |
Parent Board Recommendation |
Section 6.8 | |
Parent Designee |
Section 6.15(b) | |
Parent Related Parties |
Section 5.9 | |
Parent Related Party Transactions |
Section 5.9 | |
Parent SEC Reports |
Section 5.7 | |
Parent Shareholders Meeting |
Section 6.8 | |
Parties |
Introduction | |
Patents |
Section 1.1 | |
PIPE Financing |
Recitals | |
PIPE Financing Amount |
Recitals | |
Plan of Merger |
Section 2.1(b)(i) | |
Post-Signing Company Financial Statements |
Section 6.13(a) | |
Privacy and Data Security Policies |
Section 3.20(a) | |
Prospectus |
Section 9.18 |
Term |
Section | |
Public Shareholders |
Section 9.18 | |
RCS |
Introduction | |
Redemption |
Recitals | |
Related Parties |
Section 3.19 | |
Related Party Transactions |
Section 3.19 | |
Related Proceeding |
Section 9.16 | |
Second Merger |
Recitals | |
Second Merger Documents |
Section 2.1(f)(i) | |
Second Merger Effective Time |
Section 2.1(f)(i) | |
Second Merger Surviving Company |
Section 2.1(f)(ii) | |
Signing Filing |
Section 6.4(b) | |
Signing Press Release |
Section 6.4(b) | |
Sponsor |
Recitals | |
Sponsor Letter Agreement |
Recitals | |
Sponsor Shares |
Recitals | |
Sponsor Warrants |
Recitals | |
Staff |
Section 5.12(d) | |
Statement |
Section 5.12(d) | |
Subscription Agreements |
Recitals | |
Termination Date |
Section 8.1(e) | |
TopCo |
Introduction | |
TopCo Board |
Section 6.15(a) | |
TopCo Incentive Equity Plan |
Section 6.10 | |
Transaction Proposals |
Section 6.8 | |
Transition Services Agreement |
Section 6.18(d) | |
Trust Account |
Section 9.18 | |
Trust Account Released Claims |
Section 9.18 | |
Trust Agreement |
Section 5.8 | |
Trustee |
Section 5.8 | |
Warrant Assumption Agreement |
Section 2.5 |
Attention: | Patrick McCaney |
Alexander Taubman |
Zaid Pardesi |
E-mail: |
pmccaney@oaktreecapital.com |
ataubman@oaktreecapital.com |
zpardesi@oaktreecapital.com |
Attention: | Matthew S. Arenson, P.C. |
Peter Seligson |
Michele Cumpston |
E-mail: |
matthew.arenson@kirkland.com |
peter.seligson@kirkland.com |
michele.cumpston@kirkland.com |
Attention: | Robert Wessman |
Danny Major |
E-mail: |
robert.wessman@alvogen.com |
danny.major@alvotech.com |
Attention: | Michal Berkner |
E-mail: |
mberkner@cooley.com |
ALVOTECH LUX HOLDINGS S.A.S. | ||
By: | /s/ Tanya Zharov | |
Name: Tanya Zharov | ||
Title: Chairman and Director | ||
ALVOTECH HOLDINGS S.A., | ||
By: | /s/ Robert Wessman | |
Name: Robert Wessman | ||
Title: Chairman of the Board of Directors | ||
OAKTREE ACQUISITION CORP. II | ||
By: | /s/ Zaid Pardesi | |
Name: Zaid Pardesi | ||
Title: Chief Financial Officer and Head of M&A |
Attn: | Robert Wessman |
Danny Major |
Email: | robert.wessman@alvogen.com |
danny.major@alvotech.com |
ALVOTECH LUX HOLDINGS S.A.S. : | ||
By: |
| |
Name: | ||
Title: |
INVESTORS: |
|
NEW HOLDER: |
ACCEPTED AND AGREED: | |||||
ALVOTECH LUX HOLDINGS S.A.S. | ||||||
Print Name: | |
|||||
By: | |
By: | |
1) |
Alvotech Lux Holdings S.A.S., société par actions simplifiée L-1273 Luxembourg, Grand Duchy of Luxembourg, registered with the Luxembourg Trade and Companies Register under number B258884 (the “Absorbing Company |
2) |
Oaktree Acquisition Corp. II KY1-9008, Cayman Islands, registered with Cayman Islands Registrar of Companies under registration number 364940 (the “Absorbed Company Merging Companies |
1. |
The companies involved in the Cross-Border Merger |
1.1 | Presentation of the Absorbing Company |
1.2 | Presentation of the Absorbed Company |
2. |
The Absorbing Company pursuant to the Cross-Border Merger |
3. |
Background and effects of the Cross-Border Merger |
3.1 | Background |
3.2 | Legal effects |
3.3 | Effective Time |
3.4 | Date as of which the operations of the Absorbed Company shall be treated from an accounting point of view as being carried out on behalf of the Absorbing Company |
4. |
Accounting aspects of the merger, share exchange ratio and independent expert |
4.1 | Financial statements used for the Cross-Border Merger |
(i) | the interim financial statements as at [***] Absorbing Company FS |
(ii) | the [annual [audited] accounts as at [***] / interim financial statements as at [***]] Absorbed Company FS |
4.2 | Valuation of the transferred assets and liabilities |
1 |
To be determined at execution. |
4.3 | Exchange ratio |
4.4 | Independent expert |
5. |
Delivery of shares |
6. |
Special rights for the shareholders and for the holders of other securities |
2 |
Ratio and nominal value to be confirmed by Alvotech. |
7. |
Special advantages to the Merger Experts and/or any members of the management, supervisory or controlling bodies of the Merging Companies |
8. |
Repercussions of the Cross-Border Merger on employment |
9. |
Information regarding the Cross-Border Merger |
a) | the Draft Terms of Merger; |
b) | [the annual accounts and the management reports for the last three (3) financial years of each of the Absorbed Company, if applicable |
c) |
[interim accounts of each of the Merging Companies dated [***]] 3 |
d) | the reports from the chairman ( président [relevant corporate body] 1021-5 of the Luxembourg Law; and |
e) | the reports from one or several independent experts in accordance with Article 1021-6 of the Luxembourg Law. |
10. |
Creditor rights |
10.1 | Creditors rights under Luxembourg law |
3 |
To be determined at execution. |
11.2 | Right of opposition of creditors under Cayman Islands law |
12 | Miscellaneous |
A. |
NAME - PURPOSE - DURATION - REGISTERED OFFICE |
Article |
1 Name - Legal form |
Article |
2 Purpose |
2.1 | The purpose of the Company is the holding of participations in any form whatsoever in Luxembourg and foreign companies and in any other form of investment, the acquisition by purchase, subscription or in any other manner as well as the transfer by sale, exchange or otherwise of securities of any kind and the administration, management, control and development of its portfolio. |
2.2 | The Company may grant loans to, as well as guarantees or security for the benefit of third parties to secure its obligations and obligations of other companies in which it holds a direct or indirect participation or right of any kind or which form part of the same group of companies as the Company, or otherwise assist such companies. |
2.3 | The Company may raise funds through borrowing in any form or by issuing any kind of notes, securities or debt instruments, bonds and debentures and generally issue securities of any type. |
2.4 | The Company may carry out any commercial, industrial, financial, real estate or intellectual property activities which it considers useful for the accomplishment of these purposes. |
Article |
3 Duration |
3.1 | The Company is incorporated for an unlimited period of time. |
3.2 | It may be dissolved at any time by a resolution of the general meeting of shareholders adopted in the manner required for an amendment of these articles of association. |
Article |
4 Registered office |
4.1 | The registered office of the Company is established in the City of Luxembourg, Grand Duchy of Luxembourg. |
4.2 | The board of directors may transfer the registered office of the Company within the same municipality or to any other municipality in the Grand Duchy of Luxembourg and, if necessary, subsequently amend these articles of association to reflect such change of registered office. |
4.3 | Branches or other offices may be established either in the Grand Duchy of Luxembourg or abroad by a resolution of the board of directors. |
4.4 | In the event that the board of directors determines that extraordinary political, economic or social circumstances or natural disasters have occurred or are imminent that would interfere with the normal activities of the Company at its registered office, the registered office may be temporarily transferred abroad until the complete cessation of these extraordinary circumstances; such temporary measures shall not affect the nationality of the Company which, notwithstanding the temporary transfer of its registered office, shall remain a Luxembourg company. |
1 |
NTD: Form after Second Merger. |
2 |
NTD: name to be confirmed. |
B. |
SHARE CAPITAL – SHARES |
Article |
5 Share capital |
5.1 | The Company’s share capital is set at [***] United States dollars (USD [***]), represented by [***] ([***]) ordinary shares (the “ Shares |
5.2 | The Company’s share capital may be increased or reduced by a resolution of the general meeting of shareholders adopted in the manner required for an amendment of these articles of association or as set out in Article 6 hereof. |
5.3 | Any new Shares to be paid for in cash shall be offered by preference to the existing shareholder(s). In case of a plurality of shareholders, such Shares shall be offered to the shareholders holding the same class of shares in proportion to the number of Shares of that class held by them in the Company’s share capital. The board of directors shall determine the time period during which such preferential subscription right may be exercised, which may not be less than fourteen (14) days from the date of publication of the offer on the Recueil électronique des sociétés et associations . |
5.4 | The general meeting of shareholders may limit or cancel the preferential subscription right of the existing shareholders subject to quorum and majority required for an amendment of these articles of association. Notwithstanding the above, the board of directors may limit or cancel the preferential subscription right of the existing shareholders in accordance with Article 6 hereof. |
5.5 | If after the end of the subscription period not all of the preferential subscription rights offered to the existing shareholders have been subscribed by the latter, third parties may be allowed to participate in the share capital increase, except if the board of directors decides that the preferential subscription rights shall be offered to the existing shareholders who have already exercised their rights during the subscription period, in proportion to the portion that their Shares represent in the share capital; the modalities for the subscription to be determined by the board of directors. The board of directors may also decide in such case that the share capital shall only be increased by the amount of subscriptions received by the existing shareholders of the Company. |
5.6 | The Company may repurchase its own Shares subject to the provisions of the Law, and in conformity with all other applicable laws and regulations, including any rules and regulations of a foreign stock exchange or securities settlement system on which the Company’s shares are traded. |
Article |
6 Authorised capital |
6.1 | The authorised capital, excluding the share capital, is set at sixty million United States dollars (USD 60,000,000), consisting of Share Rights |
similar instruments, and (iv) confirm by way of a notarial deed within the legal deadline each and any share capital increase effectuated within the limits of the authorised capital and to amend Article 5.1 and Article 6.1 accordingly. The Shares to be issued upon exercise of any Share Rights may be issued beyond the initial authorized capital period of five (5) years as long as the Share Rights were issued within the relevant initial authorized capital period of five (5) years. |
6.2 | During a period of up to five (5) years from the date of the resolutions of the general meeting of the shareholders granting such authorisation to the board of directors or its subsequent renewal(s) and subject to the provisions of the Law, the board of directors is hereby authorised and empowered to (i) repurchase Shares, each having a nominal value of one cent (USD 0.01), in one or more occasions, (ii) determine the moment and place of repurchase of the Shares, (iii) proceed with the cancellation of the Shares so repurchased and the subsequent share capital reduction, (iv) allocate the amount of the share capital reductions to the shareholders of the Company, provided that in case such repurchase is made for value, the consideration payable for such shares shall be determined by the board of directors and shall not be lower than the nominal value of the repurchased Shares, and (v) record by way of a notarial deed each and any share capital reduction effectuated within the limits of this Article 6.2 and to amend Article 5.1 accordingly. |
6.3 | The above authorisations may be renewed through a resolution of the general meeting of the shareholders adopted in the manner required for an amendment of these articles of association and subject to the provisions of the Law, each time for a period not exceeding five (5) years. |
Article |
7 Shares – Transfer of Shares |
7.1 | The Company may have one or several shareholders. |
7.2 | Death, suspension of civil rights, dissolution, bankruptcy or insolvency or any other similar event regarding any of the shareholders shall not cause the dissolution of the Company. |
7.3 | The shares of the Company are in registered |
7.4 | The Company will recognise only one (1) holder per share. In case a share is owned by several persons, they shall appoint a single representative who shall represent them in respect of the Company. The Company has the right to suspend the exercise of all rights attached to that share, except for relevant information rights, until such representative has been appointed. |
7.5 | Subject to any contractual agreement to which the Shares or the shareholders may be subject to and the present articles of association, the shares are freely transferable in accordance with the provisions of the Law. |
7.6 | A register of shares shall be kept by the Company at its registered office, where it shall be available for inspection by any shareholder. This register shall contain all the information required by the Law. Ownership of ordinary shares will be established by registration in said register, or in the event separate registrars have been appointed pursuant to article 7.7, in such separate register(s). Without prejudice to the conditions for transfer by book entries provided for in article 7.9 of these articles of association, a transfer of Shares shall be carried out by means of a declaration of transfer entered in the relevant register, dated and signed by the transferor and the transferee or by their duly authorised representatives or by the Company upon notification of the transfer or acceptance of the transfer by the Company. The Company may accept and enter in the relevant register a transfer on the basis of correspondence or other documents recording the agreement between the transferor and the transferee. |
7.7 | The Company may appoint registrars in different jurisdictions who may each maintain a separate register for the Shares entered therein. Shareholders may elect to be entered into one of these registers and to transfer their Shares to another register so maintained. The board of directors may however impose transfer restrictions for Shares in compliance with applicable trading restrictions. A transfer to the register kept at the Company’s registered office may always be requested. |
7.8 | Subject to the provisions of article 7.9 and article 7.10, the Company may consider the person in whose name the Shares are registered in the register of shareholders as the full owner of such Shares. In the event that a holder of Shares does not provide an address in writing to which all notices or announcements from the Company may be sent, the Company may permit a notice to this effect to be entered into the register of shareholders and such holder’s address will be deemed to be at the registered office of the Company or such other address as may be so entered by the Company from time to time, until a different address shall be provided to the Company by such holder in writing. The holder may, at any time, change his address as entered in the register of shareholders by means of written notification to the Company. |
7.9 | The Shares may be held by a holder (the “ Holder |
7.10 | All communications and notices to be given to a registered shareholder shall be deemed validly made if made to the latest address communicated by the shareholder to the Company in accordance with article 7.8 or, if no address has been communicated by the shareholder, the registered office of the Company or such other address as may be so entered by the Company in the register from time to time according to article 7.9. |
7.11 | Where Shares are recorded in the register of shareholders in the name of or on behalf of a securities settlement system or the operator of such system and recorded as book-entry interests in the accounts of a professional depositary or any sub-depositary (any depositary and any sub-depositary being referred to hereinafter as a “Depositary |
7.12 | In connection with a general meeting of shareholders, the board of directors may decide that no entry shall be made in the register of shareholders and no notice of a transfer shall be recognised for voting purposes by the Company and any Depositary or registrar(s) during the period starting on the Record Date (as hereinafter defined) and ending on the closing of such general meeting, subject to compliance with the applicable rules of any foreign stock exchange, if the Shares of the Company are listed on a foreign stock exchange. |
C. |
GENERAL MEETINGS OF SHAREHOLDERS |
Article |
8 Powers of the general meeting of shareholders |
8.1 | The shareholders exercise their collective rights in the general meeting of shareholders. Any regularly constituted general meeting of shareholders of the Company shall represent the entire body of shareholders of the Company. The general meeting of shareholders is vested with the powers expressly reserved to it by the Law and by these articles of association. |
8.2 | If the Company has only one shareholder, any reference made herein to the “general meeting of shareholders” shall be construed as a reference to the “sole shareholder”, depending on the context and as applicable and powers conferred upon the general meeting of shareholders shall be exercised by the sole shareholder. |
Article |
9 Convening of general meetings of shareholders |
9.1 | The general meeting of shareholders of the Company may at any time be convened by the board of directors, to be held at such place and on such date as specified in the notice of such meeting. The board of directors shall convene the annual general meeting of shareholders within a period of six (6) months after the end of the Company’s financial year. Other general meetings of shareholders may be held at such place and time as may be specified in the respective notices of meeting. |
9.2 | The general meeting of shareholders must be convened by the board of directors upon the written request of one or several shareholders representing at least ten per cent (10%) of the Company’s share capital. |
9.3 | The convening notice for every general meeting of shareholders shall contain the date, time, place and agenda of the meeting and may be made through announcements filed with the Luxembourg Trade and Companies Register and published at least thirty (30) days before the meeting, on the Recueil é lectronique des soci é t é s et associations lettre missive |
9.4 | If the Shares of the Company are listed on a foreign stock exchange, all shareholders of the Company are entitled to be admitted to any general meeting of shareholders provided, however, that the board of directors may determine a date and time preceding the general meeting of shareholders as the record date for admission to such meeting, which may not be less than eight (8) calendar days prior to (and excluding) the date of the general meeting (the “ Record Date |
9.5 | Shareholders holding individually or collectively at least ten (10) per cent of the issued share capital of the Company, may request the addition of one or several new items on the agenda of the general meeting. This right shall be exercised upon request of the shareholders in writing submitted to the Company by registered letter at the address of the registered office of the Company. The requests shall include the details requested in the convening notice. The requests from the shareholders shall be received by the Company no later than eight (8) calendar days before the general meeting. |
9.6 | With respect to Shares which are not listed on a stock exchange, any Shareholder who holds one or more of such non-listed Share(s) of the Company, who is registered in the share register of the Company relating to such non-listed Shares on the Record Date, shall be admitted to the relevant general meeting. |
Article |
10 Conduct of general meetings of shareholders |
10.1 | The annual general meeting of shareholders shall be held within six (6) months of the end of the financial year in the Grand Duchy of Luxembourg at the registered office of the Company or at such other place in the Grand Duchy of Luxembourg as may be specified in the convening notice of such meeting. Other meetings of shareholders may be held at such place and time as may be specified in the respective convening notices. Holders of bonds are not entitled to attend meetings of shareholders. |
10.2 | A board of the meeting ( bureau |
directors. The board of the meeting shall ensure that the meeting is held in accordance with applicable rules and, in particular, in compliance with the rules in relation to convening, majority requirements, vote tallying and representation of shareholders. |
10.3 | An attendance list must be kept at all general meetings of shareholders. |
10.4 | A shareholder may act at any general meeting of shareholders by appointing another person as his proxy in writing or by facsimile, electronic mail or any other similar means of communication. One person may represent several or even all shareholders. |
10.5 | Shareholders taking part in a meeting by conference call, through video conference or by any other means of communication allowing for their identification, allowing all persons taking part in the meeting to hear one another on a continuous basis and allowing for an effective participation of all such persons in the meeting, are deemed to be present for the computation of the quorums and votes, subject to such means of communication being made available at the place of the meeting. |
10.6 | The board of directors may in its sole discretion authorize each shareholder to vote at a general meeting through a signed voting form sent by post, electronic mail, facsimile or any other means of communication authorised by the board of directors to the Company’s registered office or to the address specified in the convening notice. Subject to such authorization by the board of directors, the shareholders may only use voting forms provided by the Company which contain at least the place, date and time of the meeting, the agenda of the meeting, the proposals submitted to the shareholders, as well as for each proposal three (3) boxes allowing the shareholder to vote in favour thereof, against, or abstain from voting by ticking the appropriate box. The Company will only take into account voting forms received prior to the general meeting of shareholders to which they relate. For the avoidance of doubt, shareholders may not vote by voting forms where the board of directors has not authorized such voting method for a given general meeting. |
10.7 | Voting forms which, for a proposed resolution, do not show (i) a vote in favour of the proposed resolution, (ii) a vote against the proposed resolution or (iii) an abstention from voting on the proposed resolution, are void with respect to such resolution. If a shareholder votes by means of a voting form, the voting form shall be deposited at the registered office of the Company or with an agent of the Company duly authorised to receive such voting forms. The Company shall only take into account voting forms received no later than two (2) |
10.8 | If a shareholder votes by means of proxy, the proxy shall be deposited at the registered office of the Company or with an agent of the Company duly authorised to receive such proxies. The Company shall only take into account proxies received no later than two (2) business days prior to the date of the general meeting to which they relate. |
10.9 | A holder of Shares held through the operator of a securities settlement system or with a Depositary wishing to attend a general meeting must provide the Company with a certificate issued by such operator or Depositary certifying the number of Shares recorded in the relevant account on the Record Date and showing that such Shares are blocked until the closing of the general meeting to which it relates. Such certificate must be provided to the Company no later than two (2) business days prior to the date of such general meeting. If such holder of Shares votes by means of a proxy, article 10.8 of these articles of association shall apply. |
10.10 | The board of directors may determine further conditions that must be fulfilled by the shareholders for them to take part in any general meeting of shareholders and shorten or prolong periods for receipt of proxies and voting forms in the convening notice. |
10.11 | In connection with each general meeting, the board of directors is authorized to provide such rules of deliberations and such conditions for allowing shareholders to take part in the meeting as the board of directors deems appropriate. |
10.12 | Except to the extent inconsistent with the rules and conditions as adopted by the board of directors, the person presiding over the general meeting shall have the power and authority to prescribe such additional rules and conditions and to do all such acts as, in the judgment of such person, are appropriate for the proper conduct of the meeting. Such rules and conditions, whether adopted by the board of directors or prescribed by the person presiding over the meeting, may include, in each case to the extent permitted by applicable law: |
• | determining the order of business for the meeting subject to compliance with the agenda for the meeting; |
• | rules and procedures for maintaining order at the meeting and the safety of those present; |
• | limitations on attendance at or participation in the meeting to shareholders of record, their duly authorized and constituted attorneys or such other persons as the person presiding over the meeting shall determine; |
• | restrictions on entry to the meeting after the time fixed for the commencement thereof; and |
• | limitations on the time allotted to questions or comments by participants. |
Article |
11 Quorum, majority and vote |
11.1 | Each share entitles to one vote in general meetings of shareholders. |
11.2 | Subject to the rules of the applicable stock exchange, if any, on which a Share is listed, the board of directors may suspend the voting rights of any shareholder in breach of his/her/its obligations under any relevant contractual arrangement entered into by such shareholder. |
11.3 | Subject to the rules of the applicable stock exchange, if any, on which a Share is listed, in case the voting rights of one of several shareholders are suspended or the exercise of the voting rights has been waived by one or several shareholders in accordance with Article 11.2, such shareholders may attend any general meeting of the Company but the shares they hold are not taken into account for the determination of the conditions of quorum and majority to be complied with at the general meetings of the Company. |
11.4 | Except as otherwise required by the Law or these articles of association, resolutions at a general meeting of shareholders duly convened shall not require any quorum and shall be adopted at a simple majority of the votes validly cast regardless of the portion of capital represented. Abstentions and nil votes shall not be taken into account. |
Article |
12 Amendments of the articles of association |
12.1 | Except as otherwise provided herein or by the Law, these articles of association may be amended by a majority of at least two thirds of the votes validly cast at a general meeting at which a quorum of more than half of the Company’s share capital is present or represented. If no quorum is reached in a meeting, a second meeting may be convened in accordance with the provisions of Article 9.3, which may deliberate regardless of the quorum and at which resolutions are adopted at a majority of at least two thirds of the votes validly cast. Abstentions and nil votes shall not be taken into account. |
12.2 | Subject to the rules of the applicable stock exchange, if any, on which a Share is listed, in case voting rights of one of several shareholders are suspended or the exercise of the voting rights has been waived by one or several shareholders in accordance with Article 11.2, the provisions of Article 11.3 of these Articles of Association apply mutatis mutandis |
Article |
14 Adjournment of general meeting of shareholders |
Article |
15 Minutes of general meetings of shareholders |
15.1 | The board of any general meeting of shareholders shall draw up minutes of the meeting which shall be signed by the members of the board of the meeting as well as by any shareholder upon its request. |
15.2 | Any copy and excerpt of such original minutes to be produced in judicial proceedings or to be delivered to any third party, shall be certified as a true copy of the original by the notary having had custody of the original deed in case the meeting has been recorded in a notarial deed, or shall be signed by the chairman of the board of directors, if any, or by any two (2) of its members. |
Article |
16 Rules applicable in case of listing on a EU Regulated Market |
16.1 | In case the shares of the Company are admitted to trading on a regulated market within the meaning of Directive 2014/65/EU within the territory of the European Economic Area (the “EU Regulated Market”), the provisions of these articles of association shall apply with the following amendments and supplements: |
16.2 | Article 9.3 shall be replaced as follows: The convening notice for any general meeting of shareholders must contain (a) the agenda of the meeting, (b) the place, date and time of the meeting, (c) the description of the procedures that Shareholders must comply with in order to be able to participate and cast their votes in the general meeting, (d) statement of the Record Date and the manner in which shareholders have to register and a statement that only those who are shareholders on that date shall have the right to participate and vote in the general meeting, (e) indication of the postal and electronic addresses where and how the full unbridged text of the documents to be submitted to the general meeting and the draft resolutions may be obtained and (f) indication of the address of the internet site on which this information is available. Such notice shall take the form of announcements published (i) at least thirty (30) days before the meeting, in the Recueil Electronique des Sociétés et Associations non-discriminatory basis in such media as may reasonably be relied upon for the effective dissemination of information throughout the European Economic Area. A notice period of at least seventeen (17) days applies, in case of a second or subsequent convocation of a general meeting convened for lack of quorum required for the meeting convened by the first convocation, provided that this Article 9.3 has been complied with for the first convocation and no new item has been put on the agenda. In case the Shares are listed on a foreign stock exchange, the notices shall in addition be published in such other manner as may be required by laws, rules or regulations applicable to such stock exchange from time to time. If all of the shareholders are present or represented at a general meeting of shareholders and have waived any convening requirements, the meeting may be held without prior notice or publication. |
16.2.1 | Article 9.4 shall be replaced as follows: Any shareholder who holds one or more Shares of the Company at 00:00 (midnight Luxembourg time) on the date falling fourteen (14) days prior to (and excluding) the date of the general meeting (the “ Record Date sub-depository designated by such depository, a holder of Shares wishing to attend a general meeting of shareholders should receive from such operator or depository or sub-depository a certificate certifying the number of Shares recorded in the relevant account on the Record Date. The certificate should be submitted to the |
Company at its registered address no later than three (3) business days prior to the date of the general meeting. In the event that the Shareholder votes through proxies, the proxy has to be deposited at the registered office of the Company at the same time or with any agent of the Company, duly authorised to receive such proxies. The board of directors may set a shorter period for the submission of the certificate or the proxy. |
16.3 | Article 9.5 shall be replaced as follows: One or several Shareholders, representing at least five percent (5%) of the Company’s issued share capital, may (i) request to put one or several items to the agenda of any general meeting of shareholders, provided that such item is accompanied by a justification or a draft resolution to be adopted in the general meeting, or (ii) table draft resolutions for items included or to be included on the agenda of the general meeting. Such requests must be sent to the Company’s registered office in writing by registered letter or electronic means at least twenty-two (22) days prior to the date of the general meeting and include the postal or electronic address of the sender. In case such request entails a modification of the agenda of the relevant meeting, the Company will make available a revised agenda at least fifteen (15) days prior to the date of the general meeting. |
16.4 | Within fifteen (15) days following the general meeting of Shareholders, the Company shall publish on its website the voting results. |
D. |
MANAGEMENT |
Article |
17 Composition and powers of the board of directors, board rules |
17.1 | The Company shall be managed by a board of directors composed of at least three (3) directors (but in all cases an odd number), which shall be appointed pursuant to these articles of association and any nomination agreement to which the Company is a party as may be further determined in the board rules adopted by the board of directors. The directors shall be appointed by the general meeting of shareholders which shall determine their number, fix their remuneration, and their term of office, which may not exceed three (3) years. Directors may be reappointed for successive terms. |
17.2 | The board of directors is vested with the broadest powers to act in the name of the Company and to take any action necessary or useful to fulfill the Company’s corporate purpose, with the exception of the powers reserved by the Law or by these Articles of Association to the general meeting of shareholders. |
17.3 | The board of directors shall determine its own rules of procedure and may create one or several committees. The composition and the powers of such committee(s), the terms of the appointment, removal, remuneration and duration of the mandate of its/their members, as well as its/their rules of procedure are determined by the board of directors. The board of directors shall be in charge of the supervision of the activities of the committee(s). For the avoidance of doubt, such committees shall not constitute management committee in the sense of Article 441-11 of the Law. |
17.4 | The board of directors may, unanimously, pass resolutions by circular means when expressing its approval in writing, by facsimile, electronic mail or any other similar means of communication. Each director may express his consent separately, the entirety of the consents evidencing the adoption of the resolutions. The date of such resolutions shall be the date of the last signature. |
Article |
18 Daily management |
Article |
19 Appointment, removal and term of office of directors |
19.1 | The directors shall be appointed by the general meeting of shareholders which shall determine their remuneration and term of office. |
19.2 | Each director is appointed by the general meeting of shareholders at a simple majority of the votes validly cast. |
19.3 | Any director may be removed from office at any time with or without cause by the general meeting of shareholders at a simple majority of the votes validly cast. |
19.4 | If a legal entity is appointed as director of the Company, such legal entity must designate a physical person as permanent representative who shall perform this role in the name and on behalf of the legal entity. The relevant legal entity may only remove its permanent representative if it appoints a successor at the same time. An individual may only be a permanent representative of one (1) director of the Company and may not be himself a director of the Company at the same time. |
Article |
20 Vacancy in the office of a director |
20.1 | In the event of a vacancy in the office of a director because of death, legal incapacity, bankruptcy, resignation or otherwise, this vacancy may be filled on a temporary basis and for a period of time not exceeding the initial mandate of the replaced director by the remaining directors until the next meeting of shareholders which shall resolve on the permanent appointment in compliance with the applicable legal provisions. |
20.2 | In case the vacancy occurs in the office of the Company’s sole director, such vacancy must be filled without undue delay by the general meeting of shareholders. |
Article |
21 Conflict of interests |
21.1 | Save as otherwise provided by the Law, any director who has, directly or indirectly, a financial interest conflicting with the interest of the Company in connection with a transaction falling within the competence of the board of directors, must inform the board of directors of such conflict of interest and must have his declaration recorded in the minutes of the board meeting. The relevant director may not take part in the discussions relating to such transaction nor vote on such transaction. Any such conflict of interest must be reported to the next general meeting of shareholders prior to such meeting taking any resolution on any other item. |
21.2 | Where the Company comprises a single director, transactions made between the Company and the director having an interest conflicting with that of the Company are only mentioned in the resolution of the sole director. |
21.3 | Where, by reason of a conflicting interest, the number of directors required in order to validly deliberate is not met, the board of directors may decide to submit the decision on this specific item to the general meeting of shareholders. |
21.4 | The conflict of interest rules shall not apply where the decision of the board of directors or the sole director relates to day-to-day |
21.5 | The daily manager(s) of the Company, if any, are subject to articles 21.1 to 21.4 of these articles of association provided that if only one (1) daily manager has been appointed and is in a situation of conflicting interests, the relevant decision shall be adopted by the board of directors. |
Article |
22 Dealing with third parties |
22.1 | The Company shall be bound towards third parties in all circumstances by the joint signature of any two (2) directors or by the joint signature or the sole signature of any person(s) to whom such signatory power may have been delegated by the board of directors within the limits of such delegation. |
22.2 | Within the limits of the daily management, the Company shall be bound towards third parties by the signature of any person(s) to whom such power may have been delegated, acting individually or jointly in accordance within the limits of such delegation. |
Article |
23 Indemnification |
23.1 | The members of the board of directors, officers, employees and agents of the Company are not held personally liable for the indebtedness or other obligations of the Company. As agents of the Company, they are responsible for the performance of their duties. Subject to the exceptions and limitations listed in article 23.2 and mandatory provisions of law, every person who is, or has been, a member of the board of directors, officer ( mandataire mandataire Covered Persons ”), shall be indemnified by the Company to the fullest extent permitted by law against liability and against all expenses reasonably incurred or paid by them in connection with any claim, action, suit or proceeding which they become involved as a party or otherwise by virtue of his or her being or having been a Covered Person and against amounts paid or incurred by him or her in the settlement thereof. If applicable law is amended after approval of this Article 23 to authorize corporate action further eliminating or limiting the personal liability of Covered Persons, then the liability of a Covered Person to the Company shall be eliminated or limited to the fullest extent permitted by applicable law as so amended. The words “claim”, “action”, “suit” or “proceeding” shall apply to all claims, actions, suits or proceedings (civil, criminal or otherwise including appeals) actual or threatened and the words “liability” and “expenses” shall include without limitation attorneys’ fees, costs, judgments, amounts paid in settlement and other liabilities. |
23.2 | Expenses (including attorneys’ fees) incurred by a Covered Person in defending any claim (save for fraud, negligence or willful misconduct’s claims) shall be paid by the Company in advance of the final disposition of such claim upon receipt of an undertaking by or on behalf of such Covered Person to repay such amount if it shall ultimately be determined that such person is not entitled to be indemnified by the Company as authorized in this Article 23. Such expenses (including attorneys’ fees) incurred by former Covered Persons may be so paid upon such terms and conditions, if any, as the Company deems appropriate. |
23.3 | The indemnification and advancement of expenses provided by, or granted pursuant to, this Article 23 shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under this present articles of association, agreement, vote of shareholders or disinterested directors or otherwise, both as to action in such person’s official capacity and as to action in another capacity while holding such office, it being the policy of the Company that indemnification of the persons specified in this Article 23 shall be made to the fullest extent permitted by law. |
23.4 | Any repeal or modification of this Article 23 by the shareholders of the Company shall only be prospective and shall not affect the rights to indemnification and to the advancement of expenses of a Covered Person or protections or increase the liability of any Covered Person under this Article 23 in effect at the time of the alleged occurrence of any act or omission to act giving rise to liability or indemnification. |
23.5 | No indemnification shall be provided to any Covered Person (i) against any liability by reason of willful misfeasance, bad faith, gross negligence or reckless disregard of the duties involved in the conduct of his or her office (ii) with respect to any matter as to which he or she shall have been finally adjudicated to |
have acted in bad faith and not in the interest of the Company or (iii) in the event of a settlement, unless the settlement has been approved by a court of competent jurisdiction or by the board of directors. The termination of any claim, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the person did not act in good faith and in a manner which such person reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any claim, had reasonable cause to believe that such person’s conduct was unlawful. |
23.6 | The right of indemnification herein provided shall be severable, shall not affect any other rights to which any Covered Person may now or hereafter be entitled, shall continue as to a person who has ceased to be such Covered Person and shall inure to the benefit of the heirs, executors and administrators of such a person. Nothing contained herein shall affect or limit any rights to indemnification to which corporate personnel, including Covered Persons, may be entitled by contract or otherwise under law. The Company shall specifically be entitled to provide contractual indemnification to and may purchase and maintain insurance for any corporate personnel, including Covered Persons, as the Company may decide upon from time to time. |
23.7 | Notwithstanding any rights to indemnification, advancement of expenses and/or insurance that may be provided by any persons who is a pension fund, private investment fund or institutional lender or any wholly owned subsidiary of the foregoing, including for the avoidance of doubt, Oaktree Capital Management, L.P. and each of its managed funds and each affiliate of the foregoing (other than the Company and its subsidiaries) (collectively, the “ Other Indemnitors ”), to a Covered Person, with respect to the rights to indemnification, advancement of expenses and/or insurance set forth herein, the Company: (i) shall be the indemnitor of first resort (i.e., its obligations to Covered Persons are primary and any obligation of the Other Indemnitors to advance expenses or to provide indemnification for the same expenses or liabilities incurred by Covered Persons are secondary); and (ii) shall be required to advance the full amount of expenses incurred by Covered Persons and shall be liable for the full amount of all liabilities, without regard to any rights Covered Persons may have against any of the Other Indemnitors. No advancement or payment by the Other Indemnitors on behalf of Covered Persons with respect to any claim for which Covered Persons have sought indemnification from the Company shall affect the immediately preceding sentence, and the Other Indemnitors shall have a right of contribution and/or be subrogated to the extent of such advancement or payment to all of the rights of recovery of Covered Persons against the Company. Notwithstanding anything to the contrary herein, the obligations of the Company under this Article 23 shall only apply to Covered Persons in their capacity as Covered Persons. |
E. |
AUDIT AND SUPERVISION |
Article |
24 Auditor(s) |
24.1 | The transactions of the Company shall be supervised by one or several statutory auditors ( commissaires |
24.2 | The general meeting of shareholders of the Company shall appoint one or more independent auditors ( réviseurs d’entreprises agréés) |
24.3 | An independent auditor may only be removed by the general meeting of shareholders for cause or with his approval. |
F. |
FINANCIAL YEAR – ANNUAL ACCOUNTS – ALLOCATION OF PROFITS – INTERIM DIVIDENDS |
Article |
25 Financial year |
Article |
26 Annual accounts and allocation of profits |
26.1 | At the end of each financial year, the accounts are closed and the board of directors draws up an inventory of the Company’s assets and liabilities, the balance sheet and the profit and loss accounts in accordance with the law. |
26.2 | Of the annual net profits of the Company, five per cent (5%) at least shall be allocated to the legal reserve. This allocation shall cease to be mandatory as soon and as long as the aggregate amount of such reserve amounts to ten per cent (10%) of the share capital of the Company. |
26.3 | Sums contributed to a reserve of the Company may also be allocated to the legal reserve. |
26.4 | In case of a share capital reduction, the Company’s legal reserve may be reduced in proportion so that it does not exceed ten per cent (10%) of the share capital. |
26.5 | Upon recommendation of the board of directors, the general meeting of shareholders shall determine how the remainder of the Company’s profits shall be used in accordance with the Law and these articles of association. |
26.6 | Distributions shall be made to the shareholders in proportion to the number of Shares they hold in the Company. |
Article |
27 Interim dividends—Share premium and assimilated premiums |
27.1 | The board of directors may proceed with the payment of interim dividends subject to the provisions of the Law. |
27.2 | Any share premium, assimilated premium or other distributable reserve may be freely distributed to the shareholders subject to the provisions of the Law and these articles of association. |
G. |
LIQUIDATION |
Article |
28 Liquidation |
28.1 | In the event of dissolution of the Company in accordance with Article 3.2 of these Articles of Association, the liquidation shall be carried out by one or several liquidators who are appointed by the general meeting of shareholders deciding on such dissolution and which shall determine their powers and their compensation. Unless otherwise provided, the liquidators shall have the most extensive powers for the realisation of the assets and payment of the liabilities of the Company. |
28.2 | The surplus resulting from the realisation of the assets and the payment of the liabilities shall be distributed among the shareholders in proportion to the number of Shares of the Company held by them. |
H. |
FINAL CLAUSE—GOVERNING LAW |
Article |
29 Governing law |
OAKTREE ACQUISITION CORP. II | ||
By: | | |
Name: | ||
Title: | ||
ALVOTECH LUX HOLDINGS S.A.S. | ||
By: | | |
Name: | ||
Title: | ||
CONTINENTAL STOCK TRANSFER & TRUST COMPANY | ||
By: | | |
Name: | ||
Title: |
Topic |
Term | |
Services |
Alvogen (or its affiliates) will provide the services to Alvotech or its designees that (a) are currently provided by Alvogen (or its affiliates) to Alvotech or its designee, and (b) are set forth on the appendixes to the existing Service Agreement between Alvotech and Alvogen, dated January 1, 2021 (collectively, the “ Alvogen-Provided Services ”).Adalvo (or its affiliates) will provide the services to Alvotech or its designees that (a) are currently provided by Adalvo (or its affiliates) to Alvotech or its designee, and (b) are set forth on the appendixes to the existing Service Agreement between Alvotech and Alvogen, dated March 4, 2021 (collectively, the “Adalvo- Provided Services ”).Alvotech (or its affiliates) or its designee will provide the services to Alvogen and or Adalvo set forth in the appendix to the existing Service Agreements (“ Alvotech-Provided Services ”). | |
Service Schedule |
As soon as reasonably practicable following the date hereof, Alvogen, Adalvo and Alvotech shall finalize the schedules to the applicable Service Agreement to the reasonable satisfaction of Alvotech. The Parties acknowledge and agree that the final schedules to the Services Agreement shall reflect the following key principles: (a) the schedules shall include detailed descriptions of the Alvogen-Provided Services, the Adalvo-Provided Services and Alvotech-Provided Services; (b) the schedules shall list the Alvogen-Provided Services, the Adalvo-Provided Services and and Alvotech-Provided Services fees at a line item level to allow the Parties greater flexibility to terminate components of the services and reduce total fees payable; and (c) the schedules shall document any service levels applicable to the Alvogen-Provided Services, the Adalvo-Provided Services and and Alvotech-Provided Services. | |
Subcontracting |
Alvotech shall have the right to hire third-party subcontractors to provide the Alvotech-Provided Services hereunder (a) without Alvogen’s consent, (i) to the extent Alvotech is currently using such third-party subcontractors as of the date hereof, or (ii) to the extent Alvotech will use the third-party subcontractor to provide the applicable service to its own business and to Alvogen, (b) with Alvogen’s consent, not to be unreasonably withheld, for any third party contractor that provides Alvotech-Provided Services to Alvogen only. Alvogen shall have the right to hire third-party subcontractors to provide the Alvogen-Provided Services hereunder (a) without Alvotech’s consent, (i) to the extent Alvogen is currently using such third-party subcontractors as of the date hereof, or (ii) to the extent Alvogen will use the third-party subcontractor to provide the applicable service to its own business and to Alvogen, (b) with Alvotech’s consent, not to be unreasonably withheld, for any third party contractor that provides Alvogen-Provided Services to Alvotech only. Adalvo shall have the right to hire third-party subcontractors to provide the Adalvo-Provided Services hereunder (a) without Alvotech’s consent, (i) to the extent Adalvo is currently using such third-party subcontractors as of the date hereof, or (ii) to the extent |
Topic |
Term | |
Adalvo will use the third-party subcontractor to provide the applicable service to its own business and to Adalvo, (b) with Alvotech’s consent, not to be unreasonably withheld, for any third party contractor that provides Adlavo-Provided Services to Alvotech only. | ||
Pricing |
The price for the Alvogen-Provided Services will be equal to Alvogen’s direct costs plus a 5% mark-up for providing the Alvogen-Provided Services to Alvotech; provided that third party pass-through costs shall not include a mark-up. Alvogen shall provide its cost methodology for each Alvogen-Provided Service, including adequate supporting documentation to verify the price for the applicable Alvogen-Provided Service.The price for the Adalvo-Provided Services will be equal to Adalvo’s direct costs plus a 5% mark-up for providing the Adalvo-Provided Services to Alvotech; provided that third party pass-through costs shall not include a mark-up. Adalvo shall provide its cost methodology for each Adalvo-Provided Service, including adequate supporting documentation to verify the price for the applicable Adalvo-Provided Service.The price for the Alvotech-Provided Services will be equal to Alvotech’s direct costs plus a 5% mark-up for providing the Alvotech-Provided Services to Alvogen and or Adalvo; provided that third party costs shall not include a mark-up. Alvotech shall provide its cost methodology for each Alvotech-Provided Service, including adequate supporting documentation to verify the price for the applicable Alvotech-Provided Service.VAT will be added to the price for the Alvogen-Provided Services, Adalvo-Provided Services or Alvotech-Provided Services, as applicable. | |
Invoicing |
Alvogen will invoice Alvotech on a monthly basis in arrears for the Alvogen-Provided Services. Alvotech shall pay the invoiced amount within 45 days from receipt of the invoice. Adalvo will invoice Alvotech on a monthly basis in arrears for the Adalvo-Provided Services. Alvotech shall pay the invoiced amount within 45 days from receipt of the invoice. Alvotech will invoice Alvogen on a monthly basis for the Alvotech-Provided Services. Alvogen shall pay the invoiced amount within 45 days from receipt of the invoice. | |
Records; Audit Rights |
During the term of the Service Agreement, the Parties will keep and maintain, in accordance with past practice and applicable local law requirement, complete and accurate records, books of account, reports and other data necessary for the administration of the Service Agreement, including records of all direct operating costs related to the services for no less than a period of one year. Each Party will have the right, at its cost and expense, to audit and inspect, through an independent third party auditor subject to reasonable obligations of confidentiality and during normal business hours at a location to mutually agreeable to both parties, the books and records pertaining to the foregoing during the term and for one (1) year following the expiration or termination of the Service Agreement. | |
Term; Termination |
Term: Perpetual. Minimum term without termination right (only termination for cause as set out below) of the parties: [24] months after signing of the Service Agreement (“ Minimum Term ”).After Minimum Term, Alvotech may terminate any Alvogen-Provided Service on 30 days’ notice. After Minimum Term, Alvogen may terminate any Alvotech-Provided Service on 30 days’ notice. |
Topic |
Term | |
After Minimum Term, Adalvo may terminate any Adalvo-Provided Service on 9 months’ notice and Alvotech may terminate any Adalvo-Provided Services on 30 days’ notice. Notwithstanding the foregoing, either Party may terminate the Services Agreement upon (i) the liquidation, insolvency or bankruptcy of the other party, (ii) the other party ceasing or threatening to cease to carry on its business, or (iii) material breach by the other party of the definitive Service Agreement following written notice of such breach and a thirty day cure period. | ||
Confidentiality; Intellectual Property |
The existing terms regarding confidentiality and allocation of proprietary information and inventions shall continue to apply to the Service Agreement. | |
Indemnification and Liability |
Each Party will indemnify the other Party for all losses relating to any breach of the Services Agreement and the gross negligence, willful misconduct, or fraud of such Party. | |
Assignment |
Neither party will have the right to assign or transfer (including in connection with a change of control) the definitive agreement without the other party’s consent. | |
Non-Solicit |
During the term of each respective Service Agreement and for a period of 12 months following the termination of a Service Agreement, the Parties to each such Service Agreement shall be bound by customary non-solicitation provisions with respect to employees engaged in the provision of the applicable services, subject to customary carve outs. | |
Governing Law |
[Luxembourg], with international arbitration as a dispute resolution venue. |
CLAUSE |
PAGE |
|||||
1. |
DEFINITIONS AND INTERPRETATION | A-132 | ||||
2. |
PLAN OF MERGER | A-132 | ||||
3. |
TERMINATION | A-133 | ||||
4. |
COUNTERPARTS | A-134 | ||||
5. |
GOVERNING LAW | A-134 |
(1) | Alvotech Lux Holdings S.A.S., société par actions simplifiée L-1273 Luxembourg, Grand Duchy of Luxembourg and registered with the Luxembourg Trade and Company Register (Registre de Commerce et des Sociétés, Luxembourg Surviving Company |
(2) | Oaktree Acquisition Corp. II KY1-9008, Cayman Islands (the “Merging Company Companies |
(A) | The chairman ( président Merger Business Combination Agreement Draft Terms of Merger Companies Law 1021-1 et seq. of Chapter 2 on Mergers of the Luxembourg law of 10 August 1915 on commercial companies, as amended (the “Luxembourg Law |
(B) | The shareholders of the Merging Company have approved and adopted this Plan of Merger and the Draft Terms of Merger on the terms and subject to the conditions set forth herein and otherwise in accordance with the Companies Law and Luxembourg Law. All necessary approvals have been obtained from the chairman ( président |
(C) | Each of the Surviving Company and the Merging Company wishes to enter into this Plan of Merger and the Draft Terms of Merger pursuant to the provisions of Part XVI of the Companies Law and the provisions of articles 1021-1 et seq. of the Luxembourg Law. |
1. |
DEFINITIONS AND INTERPRETATION |
1.1 | Terms not otherwise defined in this Plan of Merger and the Draft Terms of Merger shall have the meanings given to them in the Business Combination Agreement, a copy of which is annexed at Annexure 1 hereto. |
1.2 | The Annexures |
2. |
PLAN OF MERGER |
2.1 | Company Details |
(a) | The constituent companies (as defined in the Companies Law) to this Plan of Merger are the Surviving Company and the Merging Company. |
(b) | The surviving company (as defined in the Companies Law) is the Surviving Company. |
(c) | The registered office of the: |
(i) | Surviving Company is 9, rue de Bitbourg, L-1273 Luxembourg, Grand Duchy of Luxembourg; and |
(ii) | Merging Company is c/o Walkers Corporate Limited, 190 Elgin Avenue, George Town, Grand Cayman KY1-9008, Cayman Islands. |
(d) | Immediately prior to the Effective Date, the issued share capital of the Surviving Company is forty thousand US dollars (USD 40,000) divided into four million (4,000,000) initial shares with a nominal value of one cent (USD 0.01) |
(e) | Immediately prior to the Effective Date, the authorised share capital of the Merging Company is US$33,100 divided into 300,000,000 Class A ordinary shares with a nominal or par value of US$0.0001, 30,000,000 Class B ordinary shares with a nominal or par value of US$0.0001, and 1,000,000 preference shares with a nominal or par value of US$0.0001. |
2.2 | Effective Date |
2.3 | Terms and Conditions; Share Rights |
(a) | The terms and conditions of the Merger, including the manner and basis of converting shares/interests in each constituent entity into interests in the Surviving Company, are set out in (i) the Business Combination Agreement in the form annexed at Annexure 1 hereto and (ii) the Draft Terms of Merger. |
(b) | The rights and restrictions attaching to the shares in the Surviving Company are set out in the articles of association of the Surviving Company. |
(c) | From the Effective Date, the articles of association of the Surviving Company shall be substantially in the form of those set out in Exhibit [D] to the the Business Combination Agreement in the form annexed at Annexure 1 hereto. |
2.4 | Directors’ Interests in the Merger |
(a) | The name and address of the chairman ( président |
(i) | Helga Tatjana Zharov, professionally residing at Sæmundargata 15-19, 101 Reykjavík, Iceland |
(b) | No director or chairman (as applicable) of either of the Companies will be paid any amounts or receive any benefits consequent upon the Merger. |
2.5 | Secured Creditors |
(a) | The Surviving Company has granted no fixed or floating security interests that are outstanding as at the date of this Plan of Merger. To be confirmed by Alvotech |
(b) | The Merging Company has granted no fixed or floating security interests that are outstanding as at the date of this Plan of Merger. |
3. |
TERMINATION |
3.1 | At any time prior to the Effective Date, this Plan of Merger may be terminated by the chairman of the Surviving Company and the board of directors of the Merging Company, acting jointly. |
4. |
COUNTERPARTS |
4.1 | This Plan of Merger may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument. Any party may enter into this Plan of Merger by executing any such counterpart. |
5. |
GOVERNING LAW |
5.1 | This Plan of Merger and the rights and obligations of the parties shall be governed by and construed in accordance with the laws of the Cayman Islands. |
SIGNED OAKTREE ACQUISITION CORP. II |
) | |||
) | | |||
) | Duly Authorised Signatory | |||
) | ||||
) | Name: | |||
) | ||||
) | Title: |
SIGNED ALVOTECH LUX HOLDINGS S.A.S. |
) | | ||||
) | Duly Authorised Signatory | |||||
) | ||||||
) | Name: | Helga Tatjana Zharov | ||||
) | ||||||
) | Title: | Chairman ( président |
1. | The name of the company is Oaktree Acquisition Corp. II (the “ Company |
2. | The registered office of the Company will be situated at the offices of Walkers Corporate Limited, Cayman Corporate Centre, 27 Hospital Road, George Town, Grand Cayman KY1-9008, Cayman Islands or at such other location as the Directors may from time to time determine. |
3. | The objects for which the Company is established are unrestricted and the Company shall have full power and authority to carry out any object not prohibited by any law as provided by Section 7(4) of the Companies Law (as amended) of the Cayman Islands (the “ Companies Law |
4. | The Company shall have and be capable of exercising all the functions of a natural person of full capacity irrespective of any question of corporate benefit as provided by Section 27(2) of the Companies Law. |
5. | The Company will not trade in the Cayman Islands with any person, firm or corporation except in furtherance of the business of the Company carried on outside the Cayman Islands; provided that nothing in this section shall be construed as to prevent the Company effecting and concluding contracts in the Cayman Islands, and exercising in the Cayman Islands all of its powers necessary for the carrying on of its business outside the Cayman Islands. |
6. | The liability of the shareholders of the Company is limited to the amount, if any, unpaid on the shares respectively held by them. |
7. | The authorised share capital of the Company is US$33,100 300,000,000 US$0.0001 30,000,000 US$0.0001 1,000,000 US$0.0001 sub-divide or consolidate the said shares or any of them and to issue all or any part of its capital whether original, redeemed, increased or reduced with or without any preference, priority, special privilege or other rights or subject to any postponement of rights or to any conditions or restrictions whatsoever and so that unless the conditions of issue shall otherwise expressly provide every issue of shares whether stated to be ordinary, preference or otherwise shall be subject to the powers on the part of the Company hereinbefore provided. |
8. | The Company may exercise the power contained in Section 206 of the Companies Law to deregister in the Cayman Islands and be registered by way of continuation in some other jurisdiction. |
CLAUSE |
PAGE |
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TABLE A |
B-5 | |||
INTERPRETATION |
B-5 | |||
PRELIMINARY |
B-8 | |||
SHARES |
B-8 | |||
FOUNDER SHARES CONVERSION AND ANTI-DILUTION RIGHTS |
B-9 | |||
MODIFICATION OF RIGHTS |
B-10 | |||
CERTIFICATES |
B-11 | |||
FRACTIONAL SHARES |
B-11 | |||
LIEN |
B-11 | |||
CALLS ON SHARES |
B-12 | |||
FORFEITURE OF SHARES |
B-12 | |||
TRANSFER OF SHARES |
B-13 | |||
TRANSMISSION OF SHARES |
B-13 | |||
ALTERATION OF SHARE CAPITAL |
B-14 | |||
REDEMPTION, PURCHASE AND SURRENDER OF SHARES |
B-14 | |||
TREASURY SHARES |
B-15 | |||
GENERAL MEETINGS |
B-15 | |||
NOTICE OF GENERAL MEETINGS |
B-16 | |||
PROCEEDINGS AT GENERAL MEETINGS |
B-16 | |||
VOTES OF SHAREHOLDERS |
B-17 | |||
CORPORATIONS ACTING BY REPRESENTATIVES AT MEETINGS |
B-18 | |||
CLEARING HOUSES |
B-18 | |||
DIRECTORS |
B-18 | |||
ALTERNATE DIRECTOR |
B-19 | |||
POWERS AND DUTIES OF DIRECTORS |
B-19 | |||
BORROWING POWERS OF DIRECTORS |
B-21 | |||
THE SEAL |
B-21 | |||
DISQUALIFICATION OF DIRECTORS |
B-21 | |||
PROCEEDINGS OF DIRECTORS |
B-22 | |||
DIVIDENDS |
B-23 | |||
ACCOUNTS, AUDIT AND ANNUAL RETURN AND DECLARATION |
B-24 | |||
CAPITALISATION OF RESERVES |
B-25 | |||
SHARE PREMIUM ACCOUNT |
B-25 | |||
NOTICES |
B-25 | |||
INDEMNITY |
B-26 | |||
NON-RECOGNITION OF TRUSTS |
B-27 | |||
BUSINESS COMBINATION REQUIREMENTS |
B-28 | |||
BUSINESS OPPORTUNITIES |
B-30 | |||
WINDING UP |
B-31 | |||
AMENDMENT OF ARTICLES OF ASSOCIATION |
B-31 | |||
CLOSING OF REGISTER OR FIXING RECORD DATE |
B-31 | |||
REGISTRATION BY WAY OF CONTINUATION |
B-32 | |||
MERGERS AND CONSOLIDATION |
B-32 | |||
DISCLOSURE |
B-32 |
1. | In these Articles the following defined terms will have the meanings ascribed to them, if not inconsistent with the subject or context: |
(a) | passed by a simple majority of such Shareholders as, being entitled to do so, vote in person or, where proxies are allowed, by proxy at a general meeting of the Company and where a poll is taken regard shall be had in computing a majority to the number of votes to which each Shareholder is entitled; or |
(b) | approved in writing by all of the Shareholders entitled to vote at a general meeting of the Company in one or more instruments each signed by one or more of the Shareholders and the effective date of the resolution so adopted shall be the date on which the instrument, or the last of such instruments, if more than one, is executed. |
(a) | passed by a majority of not less than two-thirds (or, (i) with respect to amending Article 167(b), prior to the consummation of a Business Combination, 100% of the votes cast at a meeting of the Shareholders and (ii) with respect to amending Articles 97 and 115(d), prior to the consummation of a Business Combination, a majority of not less than 90% of the votes cast at a meeting of the Shareholders) of such Shareholders as, being entitled to do so, vote in person or, where proxies are allowed, by proxy at a general meeting of the Company of which notice specifying the intention to propose the resolution as a special resolution has been duly given and where a poll is taken regard shall be had in computing a majority to the number of votes to which each Shareholder is entitled; or |
(b) | approved in writing by all of the Shareholders entitled to vote at a general meeting of the Company in one or more instruments each signed by one or more of the Shareholders and the effective date of the special resolution so adopted shall be the date on which the instrument or the last of such instruments, if more than one, is executed. |
2. | In these Articles, save where the context requires otherwise: |
(a) | words importing the singular number shall include the plural number and vice versa; |
(b) | words importing the masculine gender only shall include the feminine gender and any Person as the context may require; |
(c) | the word “may” shall be construed as permissive and the word “shall” shall be construed as imperative; |
(d) | reference to a dollar or dollars or USD (or $) and to a cent or cents is reference to dollars and cents of the United States of America; |
(e) | reference to a statutory enactment shall include reference to any amendment or reenactment thereof for the time being in force; |
(f) | reference to any determination by the Directors shall be construed as a determination by the Directors in their sole and absolute discretion and shall be applicable either generally or in any particular case; and |
(g) | reference to “in writing” shall be construed as written or represented by any means reproducible in writing, including any form of print, lithograph, email, facsimile, photograph or telex or represented by any other substitute or format for storage or transmission for writing or partly one and partly another. |
3. | Subject to the preceding Articles, any words defined in the Companies Law shall, if not inconsistent with the subject or context, bear the same meaning in these Articles. |
4. | The business of the Company may be commenced at any time after incorporation. |
5. | The Office shall be at such address in the Cayman Islands as the Directors may from time to time determine. The Company may in addition establish and maintain such other offices and places of business and agencies in such places as the Directors may from time to time determine. |
6. | The expenses incurred in the formation of the Company and in connection with the offer for subscription and issue of Shares shall be paid by the Company. Such expenses may be amortised over such period as the Directors may determine and the amount so paid shall be charged against income and/or capital in the accounts of the Company as the Directors shall determine. |
7. | The Directors shall keep, or cause to be kept, the Register at such place or (subject to compliance with the Companies Law and these Articles) places as the Directors may from time to time determine. In the absence of any such determination, the Register shall be kept at the Office. The Directors may keep, or cause to be kept, one or more Branch Registers as well as the Principal Register in accordance with the Companies Law, provided always that a duplicate of such Branch Register(s) shall be maintained with the Principal Register in accordance with the Companies Law and the rules or requirements of any Designated Stock Exchange. |
8. | Subject to these Articles, and, where applicable, the rules of the Designated Stock Exchange and/or any competent regulatory authority, all Shares for the time being unissued shall be under the control of the Directors who may: |
(a) | issue, allot and dispose of the same to such Persons, in such manner, on such terms and having such rights and being subject to such restrictions as they may from time to time determine; and |
(b) | grant options with respect to such Shares and issue warrants or similar instruments with respect thereto; |
9. | The Company may issue units of securities in the Company, which may be comprised of whole or fractional Shares, rights, options, warrants or convertible securities or securities of similar nature conferring the right upon the holders thereof to subscribe for, purchase or receive any class of Shares or other securities in the Company, upon such terms as the Directors may from time to time determine. The securities comprising any such units which are issued pursuant to the IPO can only be traded separately from one another on the 52nd day following the date of the prospectus relating to the IPO unless the Underwriters determine that an earlier date is acceptable, subject to the Company having filed a current report on Form 8-K with the SEC and a press release announcing when such separate trading will begin. Prior to such date, the units can be traded, but the securities comprising such units cannot be traded separately from one another. |
10. | The Directors, or the Shareholders by Ordinary Resolution, may authorise the division of Shares into any number of Classes and sub-classes and Series and sub-series and the different Classes and sub-classes and Series and sub-series shall be authorised, established and designated (or re-designated as the case may be) and the variations in the relative rights (including, without limitation, voting, dividend and redemption rights), restrictions, preferences, privileges and payment obligations as between the different Classes and Series (if any) may be fixed and determined by the Directors or the Shareholders by Ordinary Resolution. |
11. | The Company may insofar as may be permitted by law, pay a commission to any Person in consideration of his subscribing or agreeing to subscribe whether absolutely or conditionally for any Shares. Such commissions may be satisfied by the payment of cash or the lodgement of fully or partly paid-up Shares or partly in one way and partly in the other. The Company may also pay such brokerage as may be lawful on any issue of Shares. |
12. | The Directors may refuse to accept any application for Shares, and may accept any application in whole or in part, for any reason or for no reason. |
13. | Except as otherwise specified in these Articles or required by law, the holders of the Class A Shares and the Class B Shares shall vote as a single class. |
14. | At the time of the consummation of the Company’s initial Business Combination, the issued and outstanding Class B Ordinary Shares shall automatically be converted into such number of Class A Shares as is equal to 20% of the sum of: |
(a) | the total number of Class A Ordinary Shares issued in the IPO (including pursuant to the Over-Allotment Option), plus |
(b) | the total number of Class A Ordinary Shares issued or deemed issued, or issuable upon the conversion or exercise of any equity-linked securities issued or deemed issued, by the Company in connection with or in relation to the consummation of the initial Business Combination, excluding (x) any Class A Ordinary Shares or equity-linked securities exercisable for or convertible into Class A Ordinary Shares issued, or to be issued, to any seller in the initial Business Combination and (y) any private placement warrants issued to the Sponsor, its affiliates or any member of our management team upon conversion of working capital loans. |
15. | Notwithstanding anything to the contrary contained herein in no event shall the Class B Ordinary Shares convert into Class A Shares at a ratio that is less than one-for-one. |
16. | References in Articles 14 to Article 18 to “ converted conversion exchange |
17. | Each Class B Share shall convert into its pro rata number of Class A Shares as set forth in this Article 17. The pro rata share for each holder of Class B Shares will be determined as follows: Each Class B Ordinary Share shall convert into such number of Class A Shares as is equal to the product of 1 multiplied by a fraction, the numerator of which shall be the total number of Class A Shares into which all of the issued and outstanding Class B Shares shall be converted pursuant to this Article 17 and the denominator of which shall be the total number of issued and outstanding Class B Shares at the time of conversion. |
18. | The Directors may effect such conversion in the manner contemplated by Article 16 or in any other manner available under applicable law, including redeeming or repurchasing the relevant Class B Shares and applying the proceeds thereof towards payment for the new Class A Shares. For purposes of the repurchase or redemption, the Directors may, subject to the Company being able to pay its debts in the ordinary course of business, make payments out of amounts standing to the credit of the Company’s share premium account or out of its capital. |
19. | Whenever the capital of the Company is divided into different Classes (and as otherwise determined by the Directors) the rights attached to any such Class may, subject to any rights or restrictions for the time being attached to any Class only be materially adversely varied or abrogated with the consent in writing of the holders of not less than two-thirds of the issued Shares of the relevant Class, or with the sanction of a resolution passed at a separate meeting of the holders of the Shares of such Class by a majority of two-thirds of the votes cast at such a meeting. To every such separate meeting all the provisions of these Articles relating to general meetings of the Company or to the proceedings thereat shall, mutatis mutandis one-third in nominal or par value amount of the issued Shares of the relevant Class (but so that if at any adjourned meeting of such holders a quorum as above defined is not present, those Shareholders who are present shall form a quorum) and that, subject to any rights or restrictions for the time being attached to the Shares of that Class, every Shareholder of the Class shall on a poll have one vote for each Share of the Class held by him. For the purposes of this Article the Directors may treat all the Classes or any two or more Classes as forming one Class if they consider that all such Classes would be affected in the same way by the proposals under consideration, |
20. | The rights conferred upon the holders of the Shares of any Class issued with preferred or other rights shall not, subject to any rights or restrictions for the time being attached to the Shares of that Class, be deemed to be materially adversely varied or abrogated by, inter alia |
21. | If so determined by the Directors, any Person whose name is entered as a member in the Register may receive a certificate in the form determined by the Directors. All certificates shall specify the Share or Shares held by that person and the amount paid up thereon, provided that in respect of a Share or Shares held jointly by several persons the Company shall not be bound to issue more than one certificate, and delivery of a certificate for a Share to one of several joint holders shall be sufficient delivery to all. All certificates for Shares shall be delivered personally or sent through the post addressed to the member entitled thereto at the Member’s registered address as appearing in the Register. |
22. | Every share certificate of the Company shall bear legends required under the applicable laws, including the Exchange Act. |
23. | Any two or more certificates representing Shares of any one Class held by any Member may at the Member’s request be cancelled and a single new certificate for such Shares issued in lieu on payment (if the Directors shall so require) of $1.00 or such smaller sum as the Directors shall determine. |
24. | If a share certificate shall be damaged or defaced or alleged to have been lost, stolen or destroyed, a new certificate representing the same Shares may be issued to the relevant Member upon request subject to delivery up of the old certificate or (if alleged to have been lost, stolen or destroyed) compliance with such conditions as to evidence and indemnity and the payment of out-of-pocket |
25. | In the event that Shares are held jointly by several persons, any request may be made by any one of the joint holders and if so made shall be binding on all of the joint holders. |
26. | The Directors may issue fractions of a Share and, if so issued, a fraction of a Share shall be subject to and carry the corresponding fraction of liabilities (whether with respect to nominal or par value, premium, contributions, calls or otherwise), limitations, preferences, privileges, qualifications, restrictions, rights (including, without prejudice to the generality of the foregoing, voting and participation rights) and other attributes of a whole Share. If more than one fraction of a Share of the same Class is issued to or acquired by the same Shareholder such fractions shall be accumulated. |
27. | The Company has a first and paramount lien on every Share (whether or not fully paid) for all amounts (whether presently payable or not) payable at a fixed time or called in respect of that Share. The Company also has a first and paramount lien on every Share (whether or not fully paid) registered in the name of a Person indebted or under liability to the Company (whether he is the sole registered holder of a Share or one of two or more joint holders) for all amounts owing by him or his estate to the Company (whether or not presently payable). The Directors may at any time declare a Share to be wholly or in part exempt from the provisions of this Article. The Company’s lien on a Share extends to any amount payable in respect of it. |
28. | The Company may sell, in such manner as the Directors may determine, any Share on which the Company has a lien, but no sale shall be made unless an amount in respect of which the lien exists is presently payable nor until the expiration of fourteen days after a notice in writing, demanding payment of such part of the amount in respect of which the lien exists as is presently payable, has been given to the registered holder for the time being of the Share, or the Persons entitled thereto by reason of his death or bankruptcy. |
29. | For giving effect to any such sale the Directors may authorise some Person to transfer the Shares sold to the purchaser thereof. The purchaser shall be registered as the holder of the Shares comprised in any such |
transfer and he shall not be bound to see to the application of the purchase money, nor shall his title to the Shares be affected by any irregularity or invalidity in the proceedings in reference to the sale. |
30. | The proceeds of the sale after deduction of expenses, fees and commission incurred by the Company shall be received by the Company and applied in payment of such part of the amount in respect of which the lien exists as is presently payable, and the residue shall (subject to a like lien for sums not presently payable as existed upon the Shares prior to the sale) be paid to the Person entitled to the Shares immediately prior to the sale. |
31. | Subject to the terms of the allotment and issue of any Shares, the Directors may from time to time make calls upon the Shareholders in respect of any moneys unpaid on their Shares, and each Shareholder shall (subject to receiving at least fourteen days’ notice specifying the time or times of payment) pay to the Company at the time or times so specified the amount called on such Shares. |
32. | The joint holders of a Share shall be jointly and severally liable to pay calls in respect thereof. |
33. | If a sum called in respect of a Share is not paid before or on the day appointed for payment thereof, the Person from whom the sum is due shall pay interest upon the sum at the rate of eight percent per annum from the day appointed for the payment thereof to the time of the actual payment, but the Directors shall be at liberty to waive payment of that interest wholly or in part. |
34. | The provisions of these Articles as to the liability of joint holders and as to payment of interest shall apply in the case of non-payment of any sum which, by the terms of issue of a Share, becomes payable at a fixed time, whether on account of the amount of the Share, or by way of premium, as if the same had become payable by virtue of a call duly made and notified. |
35. | The Directors may make arrangements on the issue of partly paid Shares for a difference between the Shareholders, or the particular Shares, in the amount of calls to be paid and in the times of payment. |
36. | The Directors may, if they think fit, receive from any Shareholder willing to advance the same all or any part of the moneys uncalled and unpaid upon any partly paid Shares held by him, and upon all or any of the moneys so advanced may (until the same would, but for such advance, become presently payable) pay interest at such rate (not exceeding without the sanction of an Ordinary Resolution, eight percent per annum) as may be agreed upon between the Shareholder paying the sum in advance and the Directors. |
37. | If a Shareholder fails to pay any call or instalment of a call in respect of any Shares on the day appointed for payment, the Directors may, at any time thereafter during such time as any part of such call or instalment remains unpaid, serve a notice on him requiring payment of so much of the call or instalment as is unpaid, together with any interest which may have accrued. |
38. | The notice shall name a further day (not earlier than the expiration of fourteen days from the date of the notice) on or before which the payment required by the notice is to be made, and shall state that in the event of non-payment at or before the time appointed the Shares in respect of which the call was made will be liable to be forfeited. |
39. | If the requirements of any such notice as aforesaid are not complied with, any Share in respect of which the notice has been given may at any time thereafter, before the payment required by notice has been made, be forfeited by a resolution of the Directors to that effect. |
40. | A forfeited Share may be sold or otherwise disposed of on such terms and in such manner as the Directors think fit, and at any time before a sale or disposition the forfeiture may be cancelled on such terms as the Directors think fit. |
41. | A Person whose Shares have been forfeited shall cease to be a Shareholder in respect of the forfeited Shares, but shall, notwithstanding, remain liable to pay to the Company all moneys which at the date of forfeiture were payable by him to the Company in respect of the Shares forfeited, but his liability shall cease if and when the Company receives payment in full of the amount unpaid on the Shares forfeited. |
42. | A statutory declaration in writing that the declarant is a Director, and that a Share has been duly forfeited on a date stated in the declaration, shall be conclusive evidence of the facts in the declaration as against all Persons claiming to be entitled to the Share. |
43. | The Company may receive the consideration, if any, given for a Share on any sale or disposition thereof pursuant to the provisions of these Articles as to forfeiture and may execute a transfer of the Share in favour of the Person to whom the Share is sold or disposed of and that Person shall be registered as the holder of the Share, and shall not be bound to see to the application of the purchase money, if any, nor shall his title to the Shares be affected by any irregularity or invalidity in the proceedings in reference to the disposition or sale. |
44. | The provisions of these Articles as to forfeiture shall apply in the case of non-payment of any sum which by the terms of issue of a Share becomes due and payable, whether on account of the amount of the Share, or by way of premium, as if the same had been payable by virtue of a call duly made and notified. |
45. | Subject to these Articles and the rules or regulations of the Designated Stock Exchange or any relevant rules of the SEC or securities laws (including, but not limited to the Exchange Act), a Shareholder may transfer all or any of his or her Shares. |
46. | The instrument of transfer of any Share shall be in (i) any usual or common form; (ii) such form as is prescribed by the Designated Stock Exchange; or (iii) in any other form as the Directors may determine and shall be executed by or on behalf of the transferor and if in respect of a nil or partly paid up Share, or if so required by the Directors, shall also be executed on behalf of the transferee and shall be accompanied by the certificate (if any) of the Shares to which it relates and such other evidence as the Directors may reasonably require to show the right of the transferor to make the transfer. The transferor shall be deemed to remain a Shareholder until the name of the transferee is entered in the Register in respect of the relevant Shares. |
47. | Subject to the terms of issue thereof and the rules or regulations of the Designated Stock Exchange or any relevant rules of the SEC or securities laws (including, but not limited to the Exchange Act), the Directors may determine to decline to register any transfer of Shares without assigning any reason therefor. |
48. | The registration of transfers may be suspended at such times and for such periods as the Directors may from time to time determine. |
49. | All instruments of transfer that are registered shall be retained by the Company, but any instrument of transfer that the Directors decline to register shall (except in any case of fraud) be returned to the Person depositing the same. |
50. | The legal personal representative of a deceased sole holder of a Share shall be the only Person recognised by the Company as having any title to the Share. In the case of a Share registered in the name of two or more holders, the survivors or survivor, or the legal personal representatives of the deceased holder of the Share, shall be the only Person recognised by the Company as having any title to the Share. |
51. | Any Person becoming entitled to a Share in consequence of the death or bankruptcy of a Shareholder shall upon such evidence being produced as may from time to time be required by the Directors, have the right |
either to be registered as a Shareholder in respect of the Share or, instead of being registered himself, to make such transfer of the Share as the deceased or bankrupt Person could have made; but the Directors shall, in either case, have the same right to decline or suspend registration as they would have had in the case of a transfer of the Share by the deceased or bankrupt Person before the death or bankruptcy. |
52. | A Person becoming entitled to a Share by reason of the death or bankruptcy of a Shareholder shall be entitled to the same dividends and other advantages to which he would be entitled if he were the registered Shareholder, except that he shall not, before being registered as a Shareholder in respect of the Share, be entitled in respect of it to exercise any right conferred by membership in relation to meetings of the Company. |
53. | The Company may from time to time by Ordinary Resolution increase the share capital by such sum, to be divided into Shares of such Classes and amount, as the resolution shall prescribe. |
54. | The Company may by Ordinary Resolution: |
(a) | consolidate and divide all or any of its share capital into Shares of a larger amount than its existing Shares; |
(b) | convert all or any of its paid up Shares into stock and reconvert that stock into paid up Shares of any denomination; |
(c) | subdivide its existing Shares, or any of them into Shares of a smaller amount provided that in the subdivision the proportion between the amount paid and the amount, if any, unpaid on each reduced Share shall be the same as it was in case of the Share from which the reduced Share is derived; and |
(d) | cancel any Shares that, at the date of the passing of the resolution, have not been taken or agreed to be taken by any Person and diminish the amount of its share capital by the amount of the Shares so cancelled. |
55. | The Company may by Special Resolution reduce its share capital and any capital redemption reserve in any manner authorised by law. |
56. | Subject to the Companies Law and the rules of the Designated Stock Exchange, the Company may: |
(a) | issue Shares on terms that they are to be redeemed or are liable to be redeemed at the option of the Company or the Shareholder on such terms and in such manner as the Directors may determine; |
(b) | purchase its own Shares (including any redeemable Shares) on such terms and in such manner as the Directors may determine and agree with the Shareholder; |
(c) | make a payment in respect of the redemption or purchase of its own Shares in any manner authorised by the Companies Law, including out of its capital; and |
(d) | accept the surrender for no consideration of any paid up Share (including any redeemable Share) on such terms and in such manner as the Directors may determine. |
57. | With respect to redeeming or repurchasing the Shares: |
(a) | Members who hold Public Shares are entitled to request the redemption of such Shares in the circumstances described in Article 165; |
(b) | Shares held by the Founders shall be surrendered by the Founders on a pro rata basis for no consideration to the extent that the Over-Allotment Option is not exercised in full so that the Founders will own 20% of the Company’s issued Shares after the IPO (exclusive of any securities purchased in a private placement simultaneously with the IPO); and |
(c) | Public Shares shall be repurchased by way of tender offer in the circumstances set out in Article 161(b). |
58. | Any Share in respect of which notice of redemption has been given shall not be entitled to participate in the profits of the Company in respect of the period after the date specified as the date of redemption in the notice of redemption. |
59. | The redemption, purchase or surrender of any Share shall not be deemed to give rise to the redemption, purchase or surrender of any other Share. |
60. | The Directors may when making payments in respect of redemption or purchase of Shares, if authorised by the terms of issue of the Shares being redeemed or purchased or with the agreement of the holder of such Shares, make such payment either in cash or in specie including, without limitation, interests in a special purpose vehicle holding assets of the Company or holding entitlement to the proceeds of assets held by the Company or in a liquidating structure. |
61. | Shares that the Company purchases, redeems or acquires (by way of surrender or otherwise) may, at the option of the Company, be cancelled immediately or held as Treasury Shares in accordance with the Companies Law. In the event that the Directors do not specify that the relevant Shares are to be held as Treasury Shares, such Shares shall be cancelled. |
62. | No dividend may be declared or paid, and no other distribution (whether in cash or otherwise) of the Company’s assets (including any distribution of assets to members on a winding up) may be declared or paid in respect of a Treasury Share. |
63. | The Company shall be entered in the Register as the holder of the Treasury Shares provided that: |
(a) | the Company shall not be treated as a member for any purpose and shall not exercise any right in respect of the Treasury Shares, and any purported exercise of such a right shall be void; |
(b) | a Treasury Share shall not be voted, directly or indirectly, at any meeting of the Company and shall not be counted in determining the total number of issued shares at any given time, whether for the purposes of these Articles or the Companies Law, save that an allotment of Shares as fully paid bonus shares in respect of a Treasury Share is permitted and Shares allotted as fully paid bonus shares in respect of a treasury share shall be treated as Treasury Shares. |
64. | Treasury Shares may be disposed of by the Company on such terms and conditions as determined by the Directors. |
65. | The Directors may, whenever they think fit, convene a general meeting of the Company and, for the avoidance of doubt, Members shall not have the ability to call general meetings except as provided in Article 68. Members seeking to bring business before an annual general meeting or to nominate candidates for appointment as Directors at the annual general meeting must deliver notice to the principal executive officer of the Company not less than 90 days and not more than 120 days prior to the one-year anniversary of the preceding year’s annual general meeting or, if the Company did not hold an annual general meeting |
during the previous year, or if the date of the current annual general meeting has been changed by more than 30 days from the date of the previous year’s annual general meeting, then such deadline as may be set by the Directors. |
66. | For so long as the Company’s Shares are traded on a Designated Stock Exchange, the Company shall in each year hold a general meeting as its annual general meeting at such time and place as may be determined by the Directors in accordance with the rules of the Designated Stock Exchange, unless such Designated Stock Exchange does not require the holding of an annual general meeting. |
67. | The Directors may cancel or postpone any duly convened general meeting at any time prior to such meeting, for any reason or for no reason at any time prior to the time for holding such meeting or, if the meeting is adjourned, the time for holding such adjourned meeting. The Directors shall give Shareholders notice in writing of any cancellation or postponement. A postponement may be for a stated period of any length or indefinitely as the Directors may determine. |
68. | If at any time there are no Directors, any two Shareholders (or if there is only one Shareholder then that Shareholder) entitled to vote at general meetings of the Company may convene a general meeting in the same manner as nearly as possible as that in which general meetings may be convened by the Directors. |
69. | At least ten days’ notice in writing counting from the date service is deemed to take place as provided in these Articles specifying the place, the day and the hour of the meeting and the general nature of the business, shall be given in the manner hereinafter provided or in such other manner (if any) as may be prescribed by the Company by Ordinary Resolution to such Persons as are, under these Articles, entitled to receive such notices from the Company, but with the consent of all the Shareholders entitled to receive notice of some particular meeting and attend and vote thereat, that meeting may be convened by such shorter notice or without notice and in such manner as those Shareholders may think fit. |
70. | The accidental omission to give notice of a meeting to or the non-receipt of a notice of a meeting by any Shareholder shall not invalidate the proceedings at any meeting. |
71. | All business carried out at a general meeting shall be deemed special with the exception of sanctioning a dividend, the consideration of the accounts, balance sheets, any report of the Directors or of the Company’s auditors, and the fixing of the remuneration of the Company’s auditors. No special business shall be transacted at any general meeting without the consent of all Shareholders entitled to receive notice of that meeting unless notice of such special business has been given in the notice convening that meeting. |
72. | No business shall be transacted at any general meeting unless a quorum of Shareholders is present at the time when the meeting proceeds to business. Save as otherwise provided by these Articles, one or more Shareholders holding at least a majority of the paid up voting share capital of the Company present in person or by proxy and entitled to vote at that meeting shall form a quorum. |
73. | If within half an hour from the time appointed for the meeting a quorum is not present, the meeting, if convened upon the requisition of Shareholders, shall be dissolved. In any other case it shall stand adjourned to the same day in the next week, at the same time and place, and if at the adjourned meeting a quorum is not present within half an hour from the time appointed for the meeting the Shareholder or Shareholders present and entitled to vote shall form a quorum. |
74. | If the Directors wish to make this facility available for a specific general meeting or all general meetings of the Company, participation in any general meeting of the Company may be by means of a telephone or |
similar communication equipment by way of which all Persons participating in such meeting can communicate with each other and such participation shall be deemed to constitute presence in person at the meeting. |
75. | The chairman, if any, of the Directors shall preside as chairman at every general meeting of the Company. |
76. | If there is no such chairman, or if at any general meeting he is not present within fifteen minutes after the time appointed for holding the meeting or is unwilling to act as chairman, any Director or Person nominated by the Directors shall preside as chairman, failing which the Shareholders present in person or by proxy shall choose any Person present to be chairman of that meeting. |
77. | The chairman may adjourn a meeting from time to time and from place to place either: |
(a) | with the consent of any general meeting at which a quorum is present (and shall if so directed by the meeting); or |
(b) | without the consent of such meeting if, in his sole opinion, he considers it necessary to do so to: |
(i) | secure the orderly conduct or proceedings of the meeting; or |
(ii) | give all persons present in person or by proxy and having the right to speak and / or vote at such meeting, the ability to do so, but no business shall be transacted at any adjourned meeting other than the business left unfinished at the meeting from which the adjournment took place. When a meeting, or adjourned meeting, is adjourned for fourteen days or more, notice of the adjourned meeting shall be given in the manner provided for the original meeting. Save as aforesaid, it shall not be necessary to give any notice of an adjournment or of the business to be transacted at an adjourned meeting. |
78. | A resolution put to the vote of the meeting shall be decided on a poll. |
79. | A poll shall be taken in such manner as the chairman directs, and the result of the poll shall be deemed to be the resolution of the meeting at which the poll was demanded. |
80. | In the case of an equality of votes the chairman of the meeting shall be entitled to a second or casting vote. |
81. | A poll demanded on the election of a chairman of the meeting or on a question of adjournment shall be taken forthwith. A poll demanded on any other question shall be taken at such time as the chairman of the meeting directs. |
82. | Subject to any rights and restrictions for the time being attached to any Share, every Shareholder present in person and every Person representing a Shareholder by proxy shall, at a general meeting of the Company, shall have one vote for each Share of which he or the Person represented by proxy is the holder. |
83. | In the case of joint holders the vote of the senior who tenders a vote whether in person or by proxy shall be accepted to the exclusion of the votes of the other joint holders and for this purpose seniority shall be determined by the order in which the names stand in the Register. |
84. | A Shareholder of unsound mind, or in respect of whom an order has been made by any court having jurisdiction in lunacy, may vote in respect of Shares carrying the right to vote held by him, by his committee, or other Person in the nature of a committee appointed by that court, and any such committee or other Person, may vote in respect of such Shares by proxy. |
85. | No Shareholder shall be entitled to vote at any general meeting of the Company unless all calls, if any, or other sums presently payable by him in respect of Shares carrying the right to vote held by him have been paid. |
86. | On a poll votes may be given either personally or by proxy. |
87. | The instrument appointing a proxy shall be in writing under the hand of the appointor or of his attorney duly authorised in writing or, if the appointor is a corporation, either under Seal or under the hand of an Officer or attorney duly authorised. A proxy need not be a Shareholder. |
88. | An instrument appointing a proxy may be in any usual or common form or such other form as the Directors may approve. |
89. | The instrument appointing a proxy shall be deposited at the Office or at such other place as is specified for that purpose in the notice convening the meeting no later than the time for holding the meeting or, if the meeting is adjourned, the time for holding such adjourned meeting. |
90. | The instrument appointing a proxy shall be deemed to confer authority to demand or join in demanding a poll. |
91. | A resolution in writing signed by all the Shareholders for the time being entitled to receive notice of and to attend and vote at general meetings of the Company (or being corporations by their duly authorised representatives) shall be as valid and effective as if the same had been passed at a general meeting of the Company duly convened and held. |
92. | Any corporation which is a Shareholder or a Director may by resolution of its directors or other governing body authorise such Person as it thinks fit to act as its representative at any meeting of the Company or of any meeting of holders of a Class or of the Directors or of a committee of Directors, and the Person so authorised shall be entitled to exercise the same powers on behalf of the corporation which he represents as that corporation could exercise if it were an individual Shareholder or Director. |
93. | If a clearing house (or its nominee) is a Member of the Company it may, by resolution of its directors or other governing body or by power of attorney, authorise such person or persons as it thinks fit to act as its representative or representatives at any general meeting of the Company or at any general meeting of any class of Members of the Company provided that, if more than one person is so authorised, the authorisation shall specify the number and class of Shares in respect of which each such person is so authorised. A person so authorised pursuant to this Article shall be entitled to exercise the same powers on behalf of the clearing house (or its nominee) which he represents as that clearing house (or its nominee) could exercise if it were an individual Member holding the number and Class of Shares specified in such authorisation. |
94. | The Company may by Ordinary Resolution from time to time fix the maximum and minimum number of Directors to be appointed but unless such numbers are fixed as aforesaid the minimum number of Directors shall be one and the maximum number of Directors shall be unlimited. |
95. | There shall be no shareholding qualification for Directors. |
96. | For so long as the Company’s Shares are traded on a Designated Stock Exchange, the Directors shall be divided into three (3) classes designated as Class I, Class II and Class III, respectively. Directors shall be assigned to each class in accordance with a resolution or resolutions adopted by the board of Directors. At the first annual general meeting of Members after the IPO, the term of office of the Class I Directors shall expire and Class I Directors shall be elected for a full term of three (3) years. At the second annual general meeting of Members after the IPO, the term of office of the Class II Directors shall expire and Class II |
Directors shall be elected for a full term of three (3) years. At the third annual general meeting of Members after the IPO, the term of office of the Class III Directors shall expire and Class III Directors shall be elected for a full term of three (3) years. At each succeeding annual general meeting of Members, Directors shall be elected for a full term of three (3) years to succeed the Directors of the class whose terms expire at such annual general meeting. Notwithstanding the foregoing provisions of this Article, each Director shall hold office until the expiration of his term, until his successor shall have been duly elected and qualified or until his earlier death, resignation or removal. No decrease in the number of Directors constituting the board of Directors shall shorten the term of any incumbent Director. |
97. | Prior to the closing of an initial Business Combination, the Company may by Ordinary Resolution of the holders of the Class B Shares (only) appoint any person to be a Director. For the avoidance of doubt (i) prior to the closing of an initial Business Combination, holders of Class A Shares shall have no right to vote on the appointment or removal of any Director and (ii) following the closing of an initial Business Combination, the Company may by Ordinary Resolution (of all Shareholders entitled to vote) appoint or remove any Director in accordance with these Articles. |
98. | For so long as the Company’s Shares are traded on a Designated Stock Exchange, any and all vacancies in the board of Directors, however occurring, including, without limitation, by reason of an increase in the size of the board of Directors, or the death, resignation, disqualification or removal of a Director, may be filled by the affirmative vote of a majority of the remaining Directors then in office, even if less than a quorum of the board of Directors. Any Director appointed in accordance with the preceding sentence shall hold office for the remainder of the full term of the class of Directors in which the new directorship was created or the vacancy occurred and until such Director’s successor shall have been duly elected and qualified or until his or her earlier resignation, death or removal. When the number of Directors is increased or decreased, the board of Directors shall, subject to Article 96 above, determine the class or classes to which the increased or decreased number of Directors shall be apportioned; provided, however, that no decrease in the number of Directors shall shorten the term of any incumbent Director. In the event of a vacancy in the board of Directors, the remaining Directors, except as otherwise provided by law, shall exercise the powers of the full board of Directors until the vacancy is filled. |
99. | Any Director may in writing appoint another Person to be his alternate and, save to the extent provided otherwise in the form of appointment, such alternate shall have authority to sign written resolutions on behalf of the appointing Director, but shall not be authorised to sign such written resolutions where they have been signed by the appointing Director, and to act in such Director’s place at any meeting of the Directors. Every such alternate shall be entitled to attend and vote at meetings of the Directors as the alternate of the Director appointing him and where he is a Director to have a separate vote in addition to his own vote. A Director may at any time in writing revoke the appointment of an alternate appointed by him. Such alternate shall not be an Officer solely as a result of his appointment as an alternate other than in respect of such times as the alternate acts as a Director. The remuneration of such alternate shall be payable out of the remuneration of the Director appointing him and the proportion thereof shall be agreed between them. |
100. | Subject to the Companies Law, these Articles and to any resolutions passed in a general meeting, the business of the Company shall be managed by the Directors, who may pay all expenses incurred in setting up and registering the Company and may exercise all powers of the Company. No resolution passed by the Company in general meeting shall invalidate any prior act of the Directors that would have been valid if that resolution had not been passed. |
101. | The Directors may from time to time appoint any Person, whether or not a Director to hold such office in the Company as the Directors may think necessary for the administration of the Company (including, for the avoidance of doubt and without limitation, any chairman (or co-chairman) of the board of Directors, vice chairman of the board of Directors, one or more chief executive officers, presidents, a chief financial officer, a secretary, a treasurer, vice-presidents, one or more assistant vice presidents, one or more assistant treasurers, one or more assistant secretaries or any other officers as may be determined by the Directors), for such term and at such remuneration (whether by way of salary or commission or participation in profits or partly in one way and partly in another), and with such powers and duties as the Directors may think fit. Any Person so appointed by the Directors may be removed by the Directors. The Directors may also appoint one or more of their number to the office of managing director upon like terms, but any such appointment shall ipso facto terminate if any managing director ceases from any cause to be a Director, or if the Company by Ordinary Resolution resolves that his tenure of office be terminated. |
102. | The Directors may appoint any Person to be a Secretary (and if need be an assistant Secretary or assistant Secretaries) who shall hold office for such term, at such remuneration and upon such conditions and with such powers as they think fit. Any Secretary or assistant Secretary so appointed by the Directors may be removed by the Directors or by the Company. |
103. | The Directors may delegate any of their powers to committees consisting of such member or members of their body as they think fit; any committee so formed shall in the exercise of the powers so delegated conform to any regulations that may be imposed on it by the Directors. |
104. | The Directors may from time to time and at any time by power of attorney (whether under Seal or under hand) or otherwise appoint any company, firm or Person or body of Persons, whether nominated directly or indirectly by the Directors, to be the attorney or attorneys or authorised signatory (any such person being an “ Attorney Authorised Signatory |
105. | The Directors may from time to time provide for the management of the affairs of the Company in such manner as they shall think fit and the provisions contained in the three next following Articles shall not limit the general powers conferred by this Article. |
106. | The Directors from time to time and at any time may establish any committees, local boards or agencies for managing any of the affairs of the Company and may appoint any Person to be a member of such committees or local boards and may appoint any managers or agents of the Company and may fix the remuneration of any such Person. |
107. | The Directors from time to time and at any time may delegate to any such committee, local board, manager or agent any of the powers, authorities and discretions for the time being vested in the Directors and may authorise the members for the time being of any such local board, or any of them to fill any vacancies therein and to act notwithstanding vacancies and any such appointment or delegation may be made on such terms and subject to such conditions as the Directors may think fit and the Directors may at any time remove any Person so appointed and may annul or vary any such delegation, but no Person dealing in good faith and without notice of any such annulment or variation shall be affected thereby. |
108. | Any such delegates as aforesaid may be authorised by the Directors to sub-delegate all or any of the powers, authorities, and discretion for the time being vested in them. |
109. | The Directors may agree with a Shareholder to waive or modify the terms applicable to such Shareholder’s subscription for Shares without obtaining the consent of any other Shareholder; provided that such waiver or modification does not amount to a variation or abrogation of the rights attaching to the Shares of such other Shareholders. |
110. | The Directors shall have the authority to present a winding up petition on behalf of the Company without the sanction of a resolution passed by the Company in general meeting. |
111. | The Directors may exercise all the powers of the Company to borrow money and to mortgage or charge its undertaking, property and uncalled capital or any part thereof, or to otherwise provide for a security interest to be taken in such undertaking, property or uncalled capital, and to issue debentures, debenture stock and other securities whenever money is borrowed or as security for any debt, liability or obligation of the Company or of any third party. |
112. | The Seal shall not be affixed to any instrument except by the authority of a resolution of the Directors provided always that such authority may be given prior to or after the affixing of the Seal and if given after may be in general form confirming a number of affixings of the Seal. The Seal shall be affixed in the presence of a Director or a Secretary (or an assistant Secretary) or in the presence of any one or more Persons as the Directors may appoint for the purpose and every Person as aforesaid shall sign every instrument to which the Seal is so affixed in their presence. |
113. | The Company may maintain a facsimile of the Seal in such countries or places as the Directors may appoint and such facsimile Seal shall not be affixed to any instrument except by the authority of a resolution of the Directors provided always that such authority may be given prior to or after the affixing of such facsimile Seal and if given after may be in general form confirming a number of affixings of such facsimile Seal. The facsimile Seal shall be affixed in the presence of such Person or Persons as the Directors shall for this purpose appoint and such Person or Persons as aforesaid shall sign every instrument to which the facsimile Seal is so affixed in their presence and such affixing of the facsimile Seal and signing as aforesaid shall have the same meaning and effect as if the Seal had been affixed in the presence of and the instrument signed by a Director or a Secretary (or an assistant Secretary) or in the presence of any one or more Persons as the Directors may appoint for the purpose. |
114. | Notwithstanding the foregoing, a Secretary or any assistant Secretary shall have the authority to affix the Seal, or the facsimile Seal, to any instrument for the purposes of attesting authenticity of the matter contained therein but which does not create any obligation binding on the Company. |
115. | The office of Director shall be vacated, if the Director: |
(a) | becomes bankrupt or makes any arrangement or composition with his creditors; |
(b) | dies or is found to be or becomes of unsound mind; |
(c) | resigns his office by notice in writing to the Company; |
(d) | prior to the closing of an initial Business Combination, is removed from office by Ordinary Resolution of the holders of the Class B Shares (only); |
(e) | following the closing of an initial Business Combination, is removed from office by Ordinary Resolution of all Shareholders entitled to vote; or |
(f) | is removed from office pursuant to any other provision of these Articles. |
116. | The Directors may meet together (either within or outside the Cayman Islands) for the dispatch of business, adjourn, and otherwise regulate their meetings and proceedings as they think fit. Questions arising at any meeting shall be decided by a majority of votes. In case of an equality of votes the chairman shall have a second or casting vote. A Director may, and a Secretary or assistant Secretary on the requisition of a Director shall, at any time summon a meeting of the Directors. |
117. | A Director may participate in any meeting of the Directors, or of any committee appointed by the Directors of which such Director is a member, by means of telephone or similar communication equipment by way of which all Persons participating in such meeting can communicate with each other and such participation shall be deemed to constitute presence in person at the meeting. |
118. | The quorum necessary for the transaction of the business of the Directors may be fixed by the Directors, and unless so fixed, if there be two or more Directors the quorum shall be two, and if there be one Director the quorum shall be one. A Director represented by an alternate Director at any meeting shall be deemed to be present for the purposes of determining whether or not a quorum is present. |
119. | A Director who is in any way, whether directly or indirectly, interested in a contract or proposed contract with the Company shall declare the nature of his interest at a meeting of the Directors. A general notice given to the Directors by any Director to the effect that he is to be regarded as interested in any contract or other arrangement which may thereafter be made with that company or firm shall be deemed a sufficient declaration of interest in regard to any contract so made. A Director may vote in respect of any contract or proposed contract or arrangement notwithstanding that he may be interested therein and if he does so his vote shall be counted and he may be counted in the quorum at any meeting of the Directors at which any such contract or proposed contract or arrangement shall come before the meeting for consideration. |
120. | A Director may hold any other office or place of profit under the Company (other than the office of auditor) in conjunction with his office of Director for such period and on such terms (as to remuneration and otherwise) as the Directors may determine and no Director or intending Director shall be disqualified by his office from contracting with the Company either with regard to his tenure of any such other office or place of profit or as vendor, purchaser or otherwise, nor shall any such contract or arrangement entered into by or on behalf of the Company in which any Director is in any way interested, be liable to be avoided, nor shall any Director so contracting or being so interested be liable to account to the Company for any profit realised by any such contract or arrangement by reason of such Director holding that office or of the fiduciary relation thereby established. A Director, notwithstanding his interest, may be counted in the quorum present at any meeting of the Directors whereat he or any other Director is appointed to hold any such office or place of profit under the Company or whereat the terms of any such appointment are arranged and he may vote on any such appointment or arrangement. |
121. | Any Director may act by himself or his firm in a professional capacity for the Company, and he or his firm shall be entitled to remuneration for professional services as if he were not a Director; provided that nothing herein contained shall authorise a Director or his firm to act as auditor to the Company. |
122. | The Directors shall cause minutes to be made in books or loose-leaf folders provided for the purpose of recording: |
(a) | all appointments of Officers made by the Directors; |
(b) | the names of the Directors present at each meeting of the Directors and of any committee of the Directors; and |
(c) | all resolutions and proceedings at all meetings of the Company, and of the Directors and of committees of Directors. |
123. | When the chairman of a meeting of the Directors signs the minutes of such meeting the same shall be deemed to have been duly held notwithstanding that all the Directors have not actually come together or that there may have been a technical defect in the proceedings. |
124. | A resolution in writing signed by all the Directors or all the members of a committee of Directors entitled to receive notice of a meeting of Directors or committee of Directors, as the case may be (an alternate Director, subject as provided otherwise in the terms of appointment of the alternate Director, being entitled to sign such a resolution on behalf of his appointer), shall be as valid and effectual as if it had been passed at a duly called and constituted meeting of Directors or committee of Directors, as the case may be. When signed a resolution may consist of several documents each signed by one or more of the Directors or his duly appointed alternate. |
125. | The continuing Directors may act notwithstanding any vacancy in their body but if and for so long as their number is reduced below the number fixed by or pursuant to these Articles as the necessary quorum of Directors, the continuing Directors may act for the purpose of increasing the number, or of summoning a general meeting of the Company, but for no other purpose. |
126. | The Directors may elect a chairman of their meetings and determine the period for which he is to hold office but if no such chairman is elected, or if at any meeting the chairman is not present within fifteen minutes after the time appointed for holding the meeting, the Directors present may choose one of their number to be chairman of the meeting. |
127. | Subject to any regulations imposed on it by the Directors, a committee appointed by the Directors may elect a chairman of its meetings. If no such chairman is elected, or if at any meeting the chairman is not present within fifteen minutes after the time appointed for holding the meeting, the committee members present may choose one of their number to be chairman of the meeting. |
128. | A committee appointed by the Directors may meet and adjourn as it thinks proper. Subject to any regulations imposed on it by the Directors, questions arising at any meeting shall be determined by a majority of votes of the committee members present and in case of an equality of votes the chairman shall have a second or casting vote. |
129. | All acts done by any meeting of the Directors or of a committee of Directors, or by any Person acting as a Director, shall notwithstanding that it be afterwards discovered that there was some defect in the appointment of any such Director or Person acting as aforesaid, or that they or any of them were disqualified, be as valid as if every such Person had been duly appointed and was qualified to be a Director. |
130. | Subject to any rights and restrictions for the time being attached to any Shares, or as otherwise provided for in the Companies Law and these Articles, the Directors may from time to time declare dividends (including interim dividends) and other distributions on Shares in issue and authorise payment of the same out of the funds of the Company lawfully available therefor. |
131. | Subject to any rights and restrictions for the time being attached to any Shares, the Company by Ordinary Resolution may declare dividends, but no dividend shall exceed the amount recommended by the Directors. |
132. | The Directors may determine, before recommending or declaring any dividend, to set aside out of the funds legally available for distribution such sums as they think proper as a reserve or reserves which shall be applicable for meeting contingencies, or for equalising dividends or for any other purpose to which those funds may be properly applied and pending such application may, at the determination of the Directors, either be employed in the business of the Company or be invested in such investments as the Directors may from time to time think fit. |
133. | Any dividend may be paid in any manner as the Directors may determine. If paid by cheque it will be sent through the post to the registered address of the Shareholder or Person entitled thereto, or in the case of joint holders, to any one of such joint holders at his registered address or to such Person and such address |
as the Shareholder or Person entitled, or such joint holders as the case may be, may direct. Every such cheque shall be made payable to the order of the Person to whom it is sent or to the order of such other Person as the Shareholder or Person entitled, or such joint holders as the case may be, may direct. |
134. | The Directors when paying dividends to the Shareholders in accordance with the foregoing provisions of these Articles may make such payment either in cash or in specie and may determine the extent to which amounts may be withheld therefrom (including, without limitation, any taxes, fees, expenses or other liabilities for which a Shareholder (or the Company, as a result of any action or inaction of the Shareholder) is liable). |
135. | Subject to any rights and restrictions for the time being attached to any Shares, all dividends shall be declared and paid according to the amounts paid up on the Shares, but if and for so long as nothing is paid up on any of the Shares dividends may be declared and paid according to the par value of the Shares. |
136. | If several Persons are registered as joint holders of any Share, any of them may give effectual receipts for any dividend or other moneys payable on or in respect of the Share. |
137. | No dividend shall bear interest against the Company. |
138. | The books of account relating to the Company’s affairs shall be kept in such manner as may be determined from time to time by the Directors. |
139. | The books of account shall be kept at the Office, or at such other place or places as the Directors think fit, and shall always be open to the inspection of the Directors. |
140. | The Directors may from time to time determine whether and to what extent and at what times and places and under what conditions or regulations the accounts and books of the Company or any of them shall be open to the inspection of Shareholders not being Directors, and no Shareholder (not being a Director) shall have any right of inspecting any account or book or document of the Company except as conferred by law or authorised by the Directors or by Ordinary Resolution. |
141. | The accounts relating to the Company’s affairs shall only be audited if the Directors so determine, in which case the financial year end and the accounting principles will be determined by the Directors. The financial year of the Company shall end on 31 December of each year or such other date as the Directors may determine. |
142. | Without prejudice to the freedom of the Directors to establish any other committee, if the Shares are listed or quoted on the Designated Stock Exchange, and if required by the Designated Stock Exchange, the Directors shall establish and maintain an audit committee (the “ Audit Committee |
143. | The Directors in each year shall prepare, or cause to be prepared, an annual return and declaration setting forth the particulars required by the Companies Law and deliver a copy thereof to the Registrar of Companies in the Cayman Islands. |
144. | Subject to the Companies Law and these Articles, the Directors may: |
(a) | resolve to capitalise an amount standing to the credit of reserves (including a Share Premium Account, capital redemption reserve and profit and loss account), whether or not available for distribution; |
(b) | appropriate the sum resolved to be capitalised to the Shareholders in proportion to the nominal amount of Shares (whether or not fully paid) held by them respectively and apply that sum on their behalf in or towards: |
(i) | paying up the amounts (if any) for the time being unpaid on Shares held by them respectively, or |
(ii) | paying up in full unissued Shares or debentures of a nominal amount equal to that sum, and allot the Shares or debentures, credited as fully paid, to the Shareholders (or as they may direct) in those proportions, or partly in one way and partly in the other, but the Share Premium Account, the capital redemption reserve and profits which are not available for distribution may, for the purposes of this Article, only be applied in paying up unissued Shares to be allotted to Shareholders credited as fully paid; |
(c) | make any arrangements they think fit to resolve a difficulty arising in the distribution of a capitalised reserve and in particular, without limitation, where Shares or debentures become distributable in fractions the Directors may deal with the fractions as they think fit; |
(d) | authorise a Person to enter (on behalf of all the Shareholders concerned) into an agreement with the Company providing for either: |
(i) | the allotment to the Shareholders respectively, credited as fully paid, of Shares or debentures to which they may be entitled on the capitalisation, or |
(ii) | the payment by the Company on behalf of the Shareholders (by the application of their respective proportions of the reserves resolved to be capitalised) of the amounts or part of the amounts remaining unpaid on their existing Shares, and any such agreement made under this authority being effective and binding on all those Shareholders; and |
(e) | generally do all acts and things required to give effect to any of the actions contemplated by this Article. |
145. | The Directors shall in accordance with the Companies Law establish a Share Premium Account and shall carry to the credit of such account from time to time a sum equal to the amount or value of the premium paid on the issue of any Share. |
146. | There shall be debited to any Share Premium Account on the redemption or purchase of a Share the difference between the nominal value of such Share and the redemption or purchase price provided always that at the determination of the Directors such sum may be paid out of the profits of the Company or, if permitted by the Companies Law, out of capital. |
147. |
148. | Any notice or document may be served by the Company or by the Person entitled to give notice to any Shareholder either personally, or by posting it airmail or air courier service in a prepaid letter addressed to |
such Shareholder at his address as appearing in the Register, or by electronic mail to any electronic mail address such Shareholder may have specified in writing for the purpose of such service of notices, or by facsimile should the Directors deem it appropriate. In the case of joint holders of a Share, all notices shall be given to that one of the joint holders whose name stands first in the Register in respect of the joint holding, and notice so given shall be sufficient notice to all the joint holders. |
149. | Any Shareholder present, either personally or by proxy, at any meeting of the Company shall for all purposes be deemed to have received due notice of such meeting and, where requisite, of the purposes for which such meeting was convened. |
150. | Any notice or other document, if served by: |
(a) | post, shall be deemed to have been served five clear days after the time when the letter containing the same is posted; |
(b) | facsimile, shall be deemed to have been served upon production by the transmitting facsimile machine of a report confirming transmission of the facsimile in full to the facsimile number of the recipient; |
(c) | recognised courier service, shall be deemed to have been served 48 hours after the time when the letter containing the same is delivered to the courier service; or |
(d) | electronic mail, shall be deemed to have been served immediately upon the time of the transmission by electronic mail. |
151. | Any notice or document delivered or sent in accordance with the terms of these Articles shall notwithstanding that such Shareholder be then dead or bankrupt, and whether or not the Company has notice of his death or bankruptcy, be deemed to have been duly served in respect of any Share registered in the name of such Shareholder as sole or joint holder, unless his name shall at the time of the service of the notice or document, have been removed from the Register as the holder of the Share, and such service shall for all purposes be deemed a sufficient service of such notice or document on all Persons interested (whether jointly with or as claiming through or under him) in the Share. |
152. | Notice of every general meeting of the Company shall be given to: |
(a) | all Shareholders holding Shares with the right to receive notice and who have supplied to the Company an address for the giving of notices to them; and |
(b) | every Person entitled to a Share in consequence of the death or bankruptcy of a Shareholder, who but for his death or bankruptcy would be entitled to receive notice of the meeting. |
153. | To the fullest extent permitted by law, every Director (including for the purposes of this Article any alternate Director appointed pursuant to the provisions of these Articles), Secretary, assistant Secretary, or other Officer (but not including the Company’s auditors) and the personal representatives of the same (each an “ Indemnified Person Proceeding |
discharge of his duties, powers, authorities or discretions, or in respect of any actions or activities undertaken by an Indemnified Person provided for and in accordance with the provisions set out above (inclusive), including without prejudice to the generality of the foregoing, any costs, expenses, losses or liabilities incurred by such Indemnified Person in defending or otherwise being involved in, (whether successfully or otherwise) any civil proceedings concerning the Company or its affairs in any court whether in the Cayman Islands or elsewhere. Each Member agrees to waive any claim or right of action he or she might have, whether individually or by or in the right of the Company, against any Director on account of any action taken by such Director, or the failure of such Director to take any action in the performance of his duties with or for the Company; provided that such waiver shall not extend to any matter in respect of any actual fraud willful default or willful neglect which may attach to such Director. |
154. | No Indemnified Person shall be liable: |
(a) | for the acts, receipts, neglects, defaults or omissions of any other Director or Officer or agent of the Company; or |
(b) | for any loss on account of defect of title to any property of the Company; or |
(c) | on account of the insufficiency of any security in or upon which any money of the Company shall be invested; or |
(d) | for any loss incurred through any bank, broker or other similar Person; or |
(e) | for any loss occasioned by any negligence, default, breach of duty, breach of trust, error of judgement or oversight on such Indemnified Person’s part; or |
(f) | for any loss, damage or misfortune whatsoever which may happen in or arise from the execution or discharge of the duties, powers, authorities, or discretions of such Indemnified Person’s office or in relation thereto; unless the same shall happen through such Indemnified Person’s own actual fraud, wilful default or wilful neglect as determined by a court of competent jurisdiction. |
155. | The Company will pay the expenses (including attorneys’ fees) incurred by a Indemnified Person in defending any Proceeding in advance of its final disposition, provided, however, that, to the extent required by applicable law, such payment of expenses in advance of the final disposition of the Proceeding shall be made only upon receipt of an undertaking by the Indemnified Person to repay all amounts advanced if it should be ultimately determined that the Indemnified Person is not entitled to be indemnified under these Articles or otherwise. |
156. | The Directors, on behalf of the Company, may purchase and maintain insurance for the benefit of any Director or officer of the Company against any liability which, by virtue of any rule of law, would otherwise attach to such person in respect of any negligence, default, breach of duty or breach of trust of which such person may be guilty in relation to the Company. |
157. | The rights to indemnification and advancement of expenses conferred on any indemnitee as set out above will not be exclusive of any other rights that any indemnitee may have or hereafter acquire. The rights to indemnification and advancement of expenses set out above will be contract rights and such rights will continue as to an Indemnified Person who has ceased to be a Director or officer and shall inure to the benefit of his or her heirs, executors and administrators. |
158. | Subject to the proviso hereto, no Person shall be recognised by the Company as holding any Share upon any trust and the Company shall not, unless required by law, be bound by or be compelled in any way to recognise (even when having notice thereof) any equitable, contingent, future or partial interest in any Share or (except only as otherwise provided by these Articles or as the Companies Law requires) any other right in respect of any Share except an absolute right to the entirety thereof in each Shareholder registered |
in the Register, provided that, notwithstanding the foregoing, the Company shall be entitled to recognise any such interests as shall be determined by the Directors. |
159. | Notwithstanding any other provision of the Articles, the Articles under this heading “Business Combination Requirements” shall apply during the period commencing upon the adoption of the Articles and terminating upon the first to occur of the consummation of any Business Combination and the distribution of the Trust Fund pursuant to Article 167. In the event of a conflict between the Articles under this heading “Business Combination Requirements” and any other Articles, the provisions of the Articles under this heading “Business Combination Requirements” shall prevail. |
160. | Article 167(b) may not be amended prior to the consummation of a Business Combination without a Special Resolution, the approval threshold for which is unanimity (100%) of all votes cast at a meeting of the Shareholders. |
161. | Prior to the consummation of any Business Combination, the Company shall either: |
(a) | submit such Business Combination to its Members for approval; or |
(b) | provide Members with the opportunity to have their Shares repurchased by means of a tender offer for a per-Share repurchase price payable in cash, equal to the aggregate amount then on deposit in the Trust Fund, calculated as of two business days prior to the consummation of a Business Combination, including interest earned on the Trust Fund and not previously released to the Company to fund Regulatory Withdrawals, subject to an annual limit of $250,000, for a maximum of 24 months and/or to pay income taxes, if any, (less up to $100,000 of interest to pay dissolution expenses), divided by the number of Public Shares then in issue, provided that the Company shall not repurchase Public Shares in an amount that would cause the Company’s net tangible assets to be less than US$5,000,001. |
162. | If the Company initiates any tender offer in accordance with Rule 13e-4 and Regulation 14E of the Exchange Act in connection with a Business Combination, it shall file tender offer documents with the SEC prior to completing a Business Combination which contain substantially the same financial and other information about such Business Combination and the redemption rights as is required under Regulation 14A of the Exchange Act. |
163. | If, alternatively, the Company holds a Member vote to approve a proposed Business Combination, the Company will conduct any compulsory redemption in conjunction with a proxy solicitation pursuant to Regulation 14A of the Exchange Act and not pursuant to the tender offer rules and file proxy materials with the SEC. |
164. | At a general meeting called for the purposes of approving a Business Combination pursuant to these Articles, in the event that a majority of the Shares voted are voted for the approval of a Business Combination, the Company shall be authorised to consummate a Business Combination. |
165. | Any Member holding Public Shares who is not a Founder, officer or Director may, contemporaneously with any vote on a Business Combination, elect to have their Public Shares redeemed for cash (the “ IPO Redemption |
agent electronically using The Depository Trust Company’s DWAC (Deposit/Withdrawal At Custodian) System, at the holder’s option, in each case up to two business days prior to the initially scheduled vote on the proposal to approve a Business Combination. If so demanded, the Company shall pay any such redeeming Member, regardless of whether he is voting for or against such proposed Business Combination, a per-Share redemption price payable in cash, equal to the aggregate amount then on deposit in the Trust Fund calculated as of two business days prior to the consummation of a Business Combination, including interest earned on the Trust Fund and not previously released to the Company to fund Regulatory Withdrawals, subject to an annual limit of $250,000, for a maximum of 24 months and/or to pay income taxes, if any, (less up to $100,000 of interest to pay dissolution expenses), divided by the number of Public Shares then in issue (such redemption price being referred to herein as the “Redemption Price |
166. | The Redemption Price shall be paid promptly following the consummation of the relevant Business Combination. If the proposed Business Combination is not approved or completed for any reason then such redemptions shall be cancelled and share certificates (if any) returned to the relevant Members as appropriate. |
167. | (a) In the event that either the Company does not consummate a Business Combination by twenty-four months after the closing of the IPO, or such later time as the Members of the Company may approve in accordance with the Articles or per-Share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Fund, including interest earned on the Trust Fund and not previously released to the Company to fund Regulatory Withdrawals, subject to an annual limit of $250,000, for a maximum of 24 months and/or to pay income taxes, if any, (less up to $100,000 of interest to pay dissolution expenses), divided by the number of Public Shares then in issue, which redemption will completely extinguish public Members’ rights as Members (including the right to receive further liquidation distributions, if any); and (iii) as promptly as reasonably possible following such redemption, subject to the approval of the Company’s remaining Members and the Directors, liquidate and dissolve, subject in the case of sub-articles (ii) and (iii), to its obligations under Cayman Islands law to provide for claims of creditors and in all cases subject to the other requirements of applicable law. |
168. | Except for the withdrawal of interest to pay income taxes and for Regulatory Withdrawals, if any, none of the funds held in the Trust Fund shall be released from the Trust Fund until the earlier of an IPO Redemption pursuant to Article 165, a repurchase of Shares by means of a tender offer pursuant to Article 161(b), a distribution of the Trust Fund pursuant to Article 167(a) or an amendment under Article 167(b). In no other circumstance shall a holder of Public Shares have any right or interest of any kind in the Trust Fund. |
169. | After the issue of Public Shares, and prior to the consummation of a Business Combination, the Directors shall not issue additional Shares or any other securities that would entitle the holders thereof to: (a) receive funds from the Trust Fund; or (b) vote on any Business Combination or any other proposal presented to the Shareholders prior to or in connection with the completion of a Business Combination. |
170. | The Company must complete one or more Business Combinations having an aggregate fair market value of at least 80% of the assets held in the Trust Fund (net of amounts previously disbursed to the Company’s management for regulatory compliance requirements and other costs related thereto and excluding the amount of deferred underwriting discounts held in the Trust Fund and taxes payable on the income earned on the Trust Fund) at the time of the Company’s signing a definitive agreement in connection with a Business Combination. An initial Business Combination must not be effectuated with another blank cheque company or a similar company with nominal operations. In the event the Company enters into a Business Combination with an entity that is affiliated with the Sponsor, officers or Directors, the Company, or a committee of independent directors (as defined pursuant to the rules and regulations of the Designated Stock Exchange), will obtain an opinion that our initial Business Combination is fair to the Company from a financial point of view from either an independent investment banking firm that is a member of the Financial Industry Regulatory Authority, Inc. (“ FINRA |
171. | Any payment made to members of the Audit Committee (if one exists) shall require the review and approval of the Directors, with any Director interested in such payment abstaining from such review and approval. |
172. | A Director may vote in respect of any Business Combination in which such Director has a conflict of interest with respect to the evaluation of such Business Combination. Such Director must disclose such interest or conflict to the other Directors. |
173. | The Audit Committee shall monitor compliance with the terms of the IPO and, if any non-compliance is identified, the Audit Committee shall be charged with the responsibility to take all action necessary to rectify such non-compliance or otherwise cause compliance with the terms of the IPO. |
174. | The Company may enter into a Business Combination with a target business that is affiliated with the Sponsor, the Directors or officers of the Company if such transaction were approved by a majority of the independent directors (as defined in Article 170) and the directors that did not have an interest in such transaction. In the event the Company enters into a Business Combination with an entity that is affiliated with the Sponsor, the Directors or officers, the Company, or a committee of independent directors (as defined in Article 170), will obtain an opinion that the Business Combination is fair to the Company from a financial point of view from either an independent investment banking firm that is a member of FINRA or an independent accounting firm. |
175. | In recognition and anticipation of the facts that: (a) directors, managers, officers, members, partners, managing members, employees and/or agents of one or more members of the Investor Group (each of the foregoing, an “ Investor Group Related Person |
176. | To the fullest extent permitted by applicable law, the Investor Group and the Investor Group Related Persons shall have no duty, except and to the extent expressly assumed by contract, to refrain from engaging directly or indirectly in the same or similar business activities or lines of business as the Company. |
177. | To the fullest extent permitted by applicable law, the Company renounces any interest or expectancy of the Company in, or in being offered an opportunity to participate in, any potential transaction or matter which |
may be a corporate opportunity for either the Investor Group or the Investor Group Related Persons, on the one hand, and the Company, on the other. |
178. | Except to the extent expressly assumed by contract, to the fullest extent permitted by applicable law, the Investor Group and the Investor Group Related Persons shall have no duty to communicate or offer any such corporate opportunity to the Company and shall not be liable to the Company or its Members for breach of any fiduciary duty as a Member, Director and/or officer of the Company solely by reason of the fact that such party pursues or acquires such corporate opportunity for itself, himself or herself, directs such corporate opportunity to another person, or does not communicate information regarding such corporate opportunity to the Company. |
179. | Except as provided elsewhere in these Articles, the Company hereby renounces any interest or expectancy of the Company in, or in being offered an opportunity to participate in, any potential transaction or matter which may be a corporate opportunity for both the Company and the Investor Group, about which a Director and/or officer of the Company who is also an Investor Group Related Person acquires knowledge and the Company shall, to the fullest extent permitted by applicable law, waive any interest in any such corporate opportunity offered to any Director or officer. |
180. | To the extent a court might hold that the conduct of any activity related to a corporate opportunity that is renounced in this Article to be a breach of duty to the Company or its Members, the Company and (if applicable) each Member hereby waives, to the fullest extent permitted by applicable law, any and all claims and causes of action that the Company may have for such activities described in Articles 175 to 178 above. To the fullest extent permitted by applicable law, the provisions of Articles 175 to 178 apply equally to activities conducted in the future and that have been conducted in the past. |
181. | If the Company shall be wound up the liquidator shall apply the assets of the Company in such manner and order as he thinks fit in satisfaction of creditors’ claims. |
182. | If the Company shall be wound up, the liquidator may, with the sanction of an Ordinary Resolution divide amongst the Shareholders in specie or kind the whole or any part of the assets of the Company (whether they shall consist of property of the same kind or not) and may, for such purpose set such value as he deems fair upon any property to be divided as aforesaid and may determine how such division shall be carried out as between the Shareholders or different Classes. The liquidator may, with the like sanction, vest the whole or any part of such assets in trustees upon such trusts for the benefit of the Shareholders as the liquidator, with the like sanction shall think fit, but so that no Shareholder shall be compelled to accept any assets whereon there is any liability. |
183. | Subject to the Companies Law and the rights attaching to the various Classes, the Company may at any time and from time to time by Special Resolution alter or amend these Articles in whole or in part. |
184. | For the purpose of determining those Shareholders that are entitled to receive notice of, attend or vote at any meeting of Shareholders or any adjournment thereof, or those Shareholders that are entitled to receive payment of any dividend, or in order to make a determination as to who is a Shareholder for any other purpose, the Directors may, by any means in accordance with the requirements of any Designated Stock Exchange, provide that the Register shall be closed for transfers for a stated period which shall not exceed |
in any case 40 days. If the Register shall be so closed for the purpose of determining those Shareholders that are entitled to receive notice of, attend or vote at a meeting of Shareholders the Register shall be so closed for at least ten days immediately preceding such meeting and the record date for such determination shall be the date of the closure of the Register. |
185. | In lieu of or apart from closing the Register, the Directors may fix in advance a date as the record date for any such determination of those Shareholders that are entitled to receive notice of, attend or vote at a meeting of the Shareholders and for the purpose of determining those Shareholders that are entitled to receive payment of any dividend the Directors may, at or within 90 days prior to the date of declaration of such dividend, fix a subsequent date as the record date for such determination. |
186. | If the Register is not so closed and no record date is fixed for the determination of those Shareholders entitled to receive notice of, attend or vote at a meeting of Shareholders or those Shareholders that are entitled to receive payment of a dividend, the date on which notice of the meeting is posted or the date on which the resolution of the Directors declaring such dividend is adopted, as the case may be, shall be the record date for such determination of Shareholders. When a determination of those Shareholders that are entitled to receive notice of, attend or vote at a meeting of Shareholders has been made as provided in this Article, such determination shall apply to any adjournment thereof. |
187. | The Company may by Special Resolution resolve to be registered by way of continuation in a jurisdiction outside the Cayman Islands or such other jurisdiction in which it is for the time being incorporated, registered or existing. In furtherance of a resolution adopted pursuant to this Article, the Directors may cause an application to be made to the Registrar of Companies to deregister the Company in the Cayman Islands or such other jurisdiction in which it is for the time being incorporated, registered or existing and may cause all such further steps as they consider appropriate to be taken to effect the transfer by way of continuation of the Company. |
188. | The Company may merge or consolidate in accordance with the Companies Law. |
189. | To the extent required by the Companies Law, the Company may by Special Resolution resolve to merge or consolidate the Company. |
190. | The Directors, or any authorised service providers (including the Officers, the Secretary and the registered office agent of the Company), shall be entitled to disclose to any regulatory or judicial authority, or to any stock exchange on which the Shares may from time to time be listed, any information regarding the affairs of the Company including, without limitation, information contained in the Register and books of the Company. |
A. |
NAME – PURPOSE – DURATION – REGISTERED OFFICE |
Article |
1 Name – Legal form |
Article |
2 Purpose |
2.1 | The purpose of the Company is the holding of participations in any form whatsoever in Luxembourg and foreign companies and in any other form of investment, the acquisition by purchase, subscription or in any other manner as well as the transfer by sale, exchange or otherwise of securities of any kind and the administration, management, control and development of its portfolio. |
2.2 | The Company may grant loans to, as well as guarantees or security for the benefit of third parties to secure its obligations and obligations of other companies in which it holds a direct or indirect participation or right of any kind or which form part of the same group of companies as the Company, or otherwise assist such companies. |
2.3 | The Company may raise funds through borrowing in any form or by issuing any kind of notes, securities or debt instruments, bonds and debentures and generally issue securities of any type. |
2.4 | The Company may carry out any commercial, industrial, financial, real estate or intellectual property activities which it considers useful for the accomplishment of these purposes. |
Article |
3 Duration |
3.1 | The Company is incorporated for an unlimited period of time. |
3.2 | It may be dissolved at any time by a resolution of the general meeting of shareholders adopted in the manner required for an amendment of these articles of association. |
Article |
4 Registered office |
4.1 | The registered office of the Company is established in the City of Luxembourg, Grand Duchy of Luxembourg. |
4.2 | The board of directors may transfer the registered office of the Company within the same municipality or to any other municipality in the Grand Duchy of Luxembourg and, if necessary, subsequently amend these articles of association to reflect such change of registered office. |
4.3 | Branches or other offices may be established either in the Grand Duchy of Luxembourg or abroad by a resolution of the board of directors. |
4.4 | In the event that the board of directors determines that extraordinary political, economic or social circumstances or natural disasters have occurred or are imminent that would interfere with the normal activities of the Company at its registered office, the registered office may be temporarily transferred abroad until the complete cessation of these extraordinary circumstances; such temporary measures shall not affect the nationality of the Company which, notwithstanding the temporary transfer of its registered office, shall remain a Luxembourg company. |
B. |
SHARE CAPITAL – SHARES |
Article |
5 Share capital |
5.1 | The Company’s share capital is set at United States dollars (USD ), represented by ( ) ordinary shares (the “ Shares |
5.2 | The Company’s share capital may be increased or reduced by a resolution of the general meeting of shareholders adopted in the manner required for an amendment of these articles of association or as set out in Article 6 hereof. |
5.3 | Any new Shares to be paid for in cash shall be offered by preference to the existing shareholder(s). In case of a plurality of shareholders, such Shares shall be offered to the shareholders holding the same class of shares in proportion to the number of Shares of that class held by them in the Company’s share capital. The board of directors shall determine the time period during which such preferential subscription right may be exercised, which may not be less than fourteen (14) days from the date of publication of the offer on the Recueil électronique des sociétés et associations . |
5.4 | The general meeting of shareholders may limit or cancel the preferential subscription right of the existing shareholders subject to quorum and majority required for an amendment of these articles of association. Notwithstanding the above, the board of directors may limit or cancel the preferential subscription right of the existing shareholders in accordance with Article 6 hereof. |
5.5 | If after the end of the subscription period not all of the preferential subscription rights offered to the existing shareholders have been subscribed by the latter, third parties may be allowed to participate in the share capital increase, except if the board of directors decides that the preferential subscription rights shall be offered to the existing shareholders who have already exercised their rights during the subscription period, in proportion to the portion that their Shares represent in the share capital; the modalities for the subscription to be determined by the board of directors. The board of directors may also decide in such case that the share capital shall only be increased by the amount of subscriptions received by the existing shareholders of the Company. |
5.6 | The Company may repurchase its own Shares subject to the provisions of the Law, and in conformity with all other applicable laws and regulations, including any rules and regulations of a foreign stock exchange or securities settlement system on which the Company’s shares are traded. |
Article |
6 Authorised capital |
6.1 | The authorised capital, excluding the share capital, is set at sixty million United States dollars (USD 60,000,000), consisting of Share Rights |
subscription right of the shareholders in case of issue against payment in cash of Shares, warrants (which may be separate or attached to Shares, bonds, notes or similar instruments), convertible bonds, notes or similar instruments, and (iv) confirm by way of a notarial deed within the legal deadline each and any share capital increase effectuated within the limits of the authorised capital and to amend Article 5.1 and Article 6.1 accordingly. The Shares to be issued upon exercise of any Share Rights may be issued beyond the initial authorized capital period of five (5) years as long as the Share Rights were issued within the relevant initial authorized capital period of five (5) years. |
6.2 | During a period of up to five (5) years from the date of the resolutions of the general meeting of the shareholders granting such authorisation to the board of directors or its subsequent renewal(s) and subject to the provisions of the Law, the board of directors is hereby authorised and empowered to (i) repurchase Shares, each having a nominal value of one cent (USD 0.01), in one or more occasions, (ii) determine the moment and place of repurchase of the Shares, (iii) proceed with the cancellation of the Shares so repurchased and the subsequent share capital reduction, (iv) allocate the amount of the share capital reductions to the shareholders of the Company, provided that in case such repurchase is made for value, the consideration payable for such shares shall be determined by the board of directors and shall not be lower than the nominal value of the repurchased Shares, and (v) record by way of a notarial deed each and any share capital reduction effectuated within the limits of this Article 6.2 and to amend Article 5.1 accordingly. |
6.3 | The above authorisations may be renewed through a resolution of the general meeting of the shareholders adopted in the manner required for an amendment of these articles of association and subject to the provisions of the Law, each time for a period not exceeding five (5) years. |
Article |
7 Shares – Transfer of Shares |
7.1 | The Company may have one or several shareholders. |
7.2 | Death, suspension of civil rights, dissolution, bankruptcy or insolvency or any other similar event regarding any of the shareholders shall not cause the dissolution of the Company. |
7.3 | The shares of the Company are in registered |
7.4 | The Company will recognise only one (1) holder per share. In case a share is owned by several persons, they shall appoint a single representative who shall represent them in respect of the Company. The Company has the right to suspend the exercise of all rights attached to that share, except for relevant information rights, until such representative has been appointed. |
7.5 | Subject to any contractual agreement to which the Shares or the shareholders may be subject to and the present articles of association, the shares are freely transferable in accordance with the provisions of the Law. |
7.6 | A register of shares shall be kept by the Company at its registered office, where it shall be available for inspection by any shareholder. This register shall contain all the information required by the Law. Ownership of ordinary shares will be established by registration in said register, or in the event separate registrars have been appointed pursuant to article 7.7, in such separate register(s). Without prejudice to the conditions for transfer by book entries provided for in article 7.9 of these articles of association, a transfer of Shares shall be carried out by means of a declaration of transfer entered in the relevant register, dated and signed by the transferor and the transferee or by their duly authorised representatives or by the Company upon notification of the transfer or acceptance of the transfer by the Company. The Company may accept and enter in the relevant register a transfer on the basis of correspondence or other documents recording the agreement between the transferor and the transferee. |
7.7 | The Company may appoint registrars in different jurisdictions who may each maintain a separate register for the Shares entered therein. Shareholders may elect to be entered into one of these registers and to transfer their Shares to another register so maintained. The board of directors may however impose transfer |
restrictions for Shares in compliance with applicable trading restrictions. A transfer to the register kept at the Company’s registered office may always be requested. |
7.8 | Subject to the provisions of article 7.9 and article 7.10, the Company may consider the person in whose name the Shares are registered in the register of shareholders as the full owner of such Shares. In the event that a holder of Shares does not provide an address in writing to which all notices or announcements from the Company may be sent, the Company may permit a notice to this effect to be entered into the register of shareholders and such holder’s address will be deemed to be at the registered office of the Company or such other address as may be so entered by the Company from time to time, until a different address shall be provided to the Company by such holder in writing. The holder may, at any time, change his address as entered in the register of shareholders by means of written notification to the Company. |
7.9 | The Shares may be held by a holder (the “ Holder |
7.10 | All communications and notices to be given to a registered shareholder shall be deemed validly made if made to the latest address communicated by the shareholder to the Company in accordance with article 7.8 or, if no address has been communicated by the shareholder, the registered office of the Company or such other address as may be so entered by the Company in the register from time to time according to article 7.9. |
7.11 | Where Shares are recorded in the register of shareholders in the name of or on behalf of a securities settlement system or the operator of such system and recorded as book-entry interests in the accounts of a professional depositary or any sub-depositary (any depositary and any sub-depositary being referred to hereinafter as a “Depositary |
7.12 | In connection with a general meeting of shareholders, the board of directors may decide that no entry shall be made in the register of shareholders and no notice of a transfer shall be recognised for voting purposes by the Company and any Depositary or registrar(s) during the period starting on the Record Date (as hereinafter defined) and ending on the closing of such general meeting, subject to compliance with the applicable rules of any foreign stock exchange, if the Shares of the Company are listed on a foreign stock exchange. |
C. |
GENERAL MEETINGS OF SHAREHOLDERS |
Article |
8 Powers of the general meeting of shareholders |
8.1 | The shareholders exercise their collective rights in the general meeting of shareholders. Any regularly constituted general meeting of shareholders of the Company shall represent the entire body of shareholders of the Company. The general meeting of shareholders is vested with the powers expressly reserved to it by the Law and by these articles of association. |
8.2 | If the Company has only one shareholder, any reference made herein to the “general meeting of shareholders” shall be construed as a reference to the “sole shareholder”, depending on the context and as applicable and powers conferred upon the general meeting of shareholders shall be exercised by the sole shareholder. |
Article |
9 Convening of general meetings of shareholders |
9.1 | The general meeting of shareholders of the Company may at any time be convened by the board of directors, to be held at such place and on such date as specified in the notice of such meeting. The board of directors shall convene the annual general meeting of shareholders within a period of six (6) months after the end of the Company’s financial year. Other general meetings of shareholders may be held at such place and time as may be specified in the respective notices of meeting. |
9.2 | The general meeting of shareholders must be convened by the board of directors upon the written request of one or several shareholders representing at least ten per cent (10%) of the Company’s share capital. |
9.3 | The convening notice for every general meeting of shareholders shall contain the date, time, place and agenda of the meeting and may be made through announcements filed with the Luxembourg Trade and Companies Register and published at least thirty (30) days before the meeting, on the Recueil é lectronique des soci é t é s et associations lettre missive |
9.4 | If the Shares of the Company are listed on a foreign stock exchange, all shareholders of the Company are entitled to be admitted to any general meeting of shareholders provided, however, that the board of directors may determine a date and time preceding the general meeting of shareholders as the record date for admission to such meeting, which may not be less than eight (8) calendar days prior to (and excluding) the date of the general meeting (the “ Record Date |
9.5 | Shareholders holding individually or collectively at least ten (10) per cent of the issued share capital of the Company, may request the addition of one or several new items on the agenda of the general meeting. This right shall be exercised upon request of the shareholders in writing submitted to the Company by registered letter at the address of the registered office of the Company. The requests shall include the details requested in the convening notice. The requests from the shareholders shall be received by the Company no later than eight (8) calendar days before the general meeting. |
9.6 | With respect to Shares which are not listed on a stock exchange, any Shareholder who holds one or more of such non-listed Share(s) of the Company, who is registered in the share register of the Company relating to such non-listed Shares on the Record Date, shall be admitted to the relevant general meeting. |
Article |
10 Conduct of general meetings of shareholders |
10.1 | The annual general meeting of shareholders shall be held within six (6) months of the end of the financial year in the Grand Duchy of Luxembourg at the registered office of the Company or at such other place in the Grand Duchy of Luxembourg as may be specified in the convening notice of such meeting. Other meetings of shareholders may be held at such place and time as may be specified in the respective convening notices. Holders of bonds are not entitled to attend meetings of shareholders. |
10.2 | A board of the meeting ( bureau |
directors. The board of the meeting shall ensure that the meeting is held in accordance with applicable rules and, in particular, in compliance with the rules in relation to convening, majority requirements, vote tallying and representation of shareholders. |
10.3 | An attendance list must be kept at all general meetings of shareholders. |
10.4 | A shareholder may act at any general meeting of shareholders by appointing another person as his proxy in writing or by facsimile, electronic mail or any other similar means of communication. One person may represent several or even all shareholders. |
10.5 | Shareholders taking part in a meeting by conference call, through video conference or by any other means of communication allowing for their identification, allowing all persons taking part in the meeting to hear one another on a continuous basis and allowing for an effective participation of all such persons in the meeting, are deemed to be present for the computation of the quorums and votes, subject to such means of communication being made available at the place of the meeting. |
10.6 | The board of directors may in its sole discretion authorize each shareholder to vote at a general meeting through a signed voting form sent by post, electronic mail, facsimile or any other means of communication authorised by the board of directors to the Company’s registered office or to the address specified in the convening notice. Subject to such authorization by the board of directors, the shareholders may only use voting forms provided by the Company which contain at least the place, date and time of the meeting, the agenda of the meeting, the proposals submitted to the shareholders, as well as for each proposal three (3) boxes allowing the shareholder to vote in favour thereof, against, or abstain from voting by ticking the appropriate box. The Company will only take into account voting forms received prior to the general meeting of shareholders to which they relate. For the avoidance of doubt, shareholders may not vote by voting forms where the board of directors has not authorized such voting method for a given general meeting. |
10.7 | Voting forms which, for a proposed resolution, do not show (i) a vote in favour of the proposed resolution, (ii) a vote against the proposed resolution or (iii) an abstention from voting on the proposed resolution, are void with respect to such resolution. If a shareholder votes by means of a voting form, the voting form shall be deposited at the registered office of the Company or with an agent of the Company duly authorised to receive such voting forms. The Company shall only take into account voting forms received no later than two (2) |
10.8 | If a shareholder votes by means of proxy, the proxy shall be deposited at the registered office of the Company or with an agent of the Company duly authorised to receive such proxies. The Company shall only take into account proxies received no later than two (2) business days prior to the date of the general meeting to which they relate. |
10.9 | A holder of Shares held through the operator of a securities settlement system or with a Depositary wishing to attend a general meeting must provide the Company with a certificate issued by such operator or Depositary certifying the number of Shares recorded in the relevant account on the Record Date and showing that such Shares are blocked until the closing of the general meeting to which it relates. Such certificate must be provided to the Company no later than two (2) business days prior to the date of such general meeting. If such holder of Shares votes by means of a proxy, article 10.8 of these articles of association shall apply. |
10.10 | The board of directors may determine further conditions that must be fulfilled by the shareholders for them to take part in any general meeting of shareholders and shorten or prolong periods for receipt of proxies and voting forms in the convening notice. |
10.11 | In connection with each general meeting, the board of directors is authorized to provide such rules of deliberations and such conditions for allowing shareholders to take part in the meeting as the board of directors deems appropriate. |
10.12 | Except to the extent inconsistent with the rules and conditions as adopted by the board of directors, the person presiding over the general meeting shall have the power and authority to prescribe such additional rules and conditions and to do all such acts as, in the judgment of such person, are appropriate for the proper conduct of the meeting. Such rules and conditions, whether adopted by the board of directors or prescribed by the person presiding over the meeting, may include, in each case to the extent permitted by applicable law: |
- | determining the order of business for the meeting subject to compliance with the agenda for the meeting; |
- | rules and procedures for maintaining order at the meeting and the safety of those present; |
- | limitations on attendance at or participation in the meeting to shareholders of record, their duly authorized and constituted attorneys or such other persons as the person presiding over the meeting shall determine; |
- | restrictions on entry to the meeting after the time fixed for the commencement thereof; and |
- | limitations on the time allotted to questions or comments by participants. |
Article |
11 Quorum, majority and vote |
11.1 | Each share entitles to one vote in general meetings of shareholders. |
11.2 | Subject to the rules of the applicable stock exchange, if any, on which a Share is listed, the board of directors may suspend the voting rights of any shareholder in breach of his/her/its obligations under any relevant contractual arrangement entered into by such shareholder. |
11.3 | Subject to the rules of the applicable stock exchange, if any, on which a Share is listed, in case the voting rights of one of several shareholders are suspended or the exercise of the voting rights has been waived by one or several shareholders in accordance with Article 11.2, such shareholders may attend any general meeting of the Company but the shares they hold are not taken into account for the determination of the conditions of quorum and majority to be complied with at the general meetings of the Company. |
11.4 | Except as otherwise required by the Law or these articles of association, resolutions at a general meeting of shareholders duly convened shall not require any quorum and shall be adopted at a simple majority of the votes validly cast regardless of the portion of capital represented. Abstentions and nil votes shall not be taken into account. |
Article |
12 Amendments of the articles of association |
12.1 | Except as otherwise provided herein or by the Law, these articles of association may be amended by a majority of at least two thirds of the votes validly cast at a general meeting at which a quorum of more than half of the Company’s share capital is present or represented. If no quorum is reached in a meeting, a second meeting may be convened in accordance with the provisions of Article 9.3, which may deliberate regardless of the quorum and at which resolutions are adopted at a majority of at least two thirds of the votes validly cast. Abstentions and nil votes shall not be taken into account. |
12.2 | Subject to the rules of the applicable stock exchange, if any, on which a Share is listed, in case voting rights of one of several shareholders are suspended or the exercise of the voting rights has been waived by one or several shareholders in accordance with Article 11.2, the provisions of Article 11.3 of these Articles of Association apply mutatis mutandis |
Article |
13 Change of nationality |
Article |
14 Adjournment of general meeting of shareholders |
Article |
15 Minutes of general meetings of shareholders |
15.1 | The board of any general meeting of shareholders shall draw up minutes of the meeting which shall be signed by the members of the board of the meeting as well as by any shareholder upon its request. |
15.2 | Any copy and excerpt of such original minutes to be produced in judicial proceedings or to be delivered to any third party, shall be certified as a true copy of the original by the notary having had custody of the original deed in case the meeting has been recorded in a notarial deed, or shall be signed by the chairman of the board of directors, if any, or by any two (2) of its members. |
Article |
16 Rules applicable in case of listing on a EU Regulated Market |
16.1 | In case the shares of the Company are admitted to trading on a regulated market within the meaning of Directive 2014/65/EU within the territory of the European Economic Area (the “EU Regulated Market”), the provisions of these articles of association shall apply with the following amendments and supplements: |
16.2 | Article 9.3 shall be replaced as follows: The convening notice for any general meeting of shareholders must contain (a) the agenda of the meeting, (b) the place, date and time of the meeting, (c) the description of the procedures that Shareholders must comply with in order to be able to participate and cast their votes in the general meeting, (d) statement of the Record Date and the manner in which shareholders have to register and a statement that only those who are shareholders on that date shall have the right to participate and vote in the general meeting, (e) indication of the postal and electronic addresses where and how the full unbridged text of the documents to be submitted to the general meeting and the draft resolutions may be obtained and (f) indication of the address of the internet site on which this information is available. Such notice shall take the form of announcements published (i) at least thirty (30) days before the meeting, in the Recueil Electronique des Sociétés et Associations non-discriminatory basis in such media as may reasonably be relied upon for the effective dissemination of information throughout the European Economic Area. A notice period of at least seventeen (17) days applies, in case of a second or subsequent convocation of a general meeting convened for lack of quorum required for the meeting convened by the first convocation, provided that this Article 9.3 has been complied with for the first convocation and no new item has been put on the agenda. In case the Shares are listed on a foreign stock exchange, the notices shall in addition be published in such other manner as may be required by laws, rules or regulations applicable to such stock exchange from time to time. If all of the shareholders are present or represented at a general meeting of shareholders and have waived any convening requirements, the meeting may be held without prior notice or publication. |
16.2.1 | Article 9.4 shall be replaced as follows: Any shareholder who holds one or more Shares of the Company at 00:00 (midnight Luxembourg time) on the date falling fourteen (14) days prior to (and excluding) the date of the general meeting (the “ Record Date sub-depository designated by such depository, a holder of Shares wishing to attend a general meeting of shareholders should receive from such operator or depository or sub-depository a certificate certifying the number of Shares recorded in the relevant account on the Record Date. The certificate should be submitted to the Company at its registered address no later than three (3) business days prior to the date of the general meeting. In the event that the Shareholder votes through proxies, the proxy has to be deposited at the registered office of the |
Company at the same time or with any agent of the Company, duly authorised to receive such proxies. The board of directors may set a shorter period for the submission of the certificate or the proxy. |
16.3 | Article 9.5 shall be replaced as follows: One or several Shareholders, representing at least five percent (5%) of the Company’s issued share capital, may (i) request to put one or several items to the agenda of any general meeting of shareholders, provided that such item is accompanied by a justification or a draft resolution to be adopted in the general meeting, or (ii) table draft resolutions for items included or to be included on the agenda of the general meeting. Such requests must be sent to the Company’s registered office in writing by registered letter or electronic means at least twenty-two (22) days prior to the date of the general meeting and include the postal or electronic address of the sender. In case such request entails a modification of the agenda of the relevant meeting, the Company will make available a revised agenda at least fifteen (15) days prior to the date of the general meeting. |
16.4 | Within fifteen (15) days following the general meeting of Shareholders, the Company shall publish on its website the voting results. |
D. |
MANAGEMENT |
Article |
17 Composition and powers of the board of directors, board rules |
17.1 | The Company shall be managed by a board of directors composed of at least three (3) directors (but in all cases an odd number), which shall be appointed pursuant to these articles of association and any nomination agreement to which the Company is a party as may be further determined in the board rules adopted by the board of directors. The directors shall be appointed by the general meeting of shareholders which shall determine their number, fix their remuneration, and their term of office, which may not exceed three (3) years. Directors may be reappointed for successive terms. |
17.2 | The board of directors is vested with the broadest powers to act in the name of the Company and to take any action necessary or useful to fulfill the Company’s corporate purpose, with the exception of the powers reserved by the Law or by these Articles of Association to the general meeting of shareholders. |
17.3 | The board of directors shall determine its own rules of procedure and may create one or several committees. The composition and the powers of such committee(s), the terms of the appointment, removal, remuneration and duration of the mandate of its/their members, as well as its/their rules of procedure are determined by the board of directors. The board of directors shall be in charge of the supervision of the activities of the committee(s). For the avoidance of doubt, such committees shall not constitute management committee in the sense of Article 441-11 of the Law. |
17.4 | The board of directors may, unanimously, pass resolutions by circular means when expressing its approval in writing, by facsimile, electronic mail or any other similar means of communication. Each director may express his consent separately, the entirety of the consents evidencing the adoption of the resolutions. The date of such resolutions shall be the date of the last signature. |
Article |
18 Daily management |
Article |
19 Appointment, removal and term of office of directors |
19.1 | The directors shall be appointed by the general meeting of shareholders which shall determine their remuneration and term of office. |
19.2 | Each director is appointed by the general meeting of shareholders at a simple majority of the votes validly cast. |
19.3 | Any director may be removed from office at any time with or without cause by the general meeting of shareholders at a simple majority of the votes validly cast. |
19.4 | If a legal entity is appointed as director of the Company, such legal entity must designate a physical person as permanent representative who shall perform this role in the name and on behalf of the legal entity. The relevant legal entity may only remove its permanent representative if it appoints a successor at the same time. An individual may only be a permanent representative of one (1) director of the Company and may not be himself a director of the Company at the same time. |
Article |
20 Vacancy in the office of a director |
20.1 | In the event of a vacancy in the office of a director because of death, legal incapacity, bankruptcy, resignation or otherwise, this vacancy may be filled on a temporary basis and for a period of time not exceeding the initial mandate of the replaced director by the remaining directors until the next meeting of shareholders which shall resolve on the permanent appointment in compliance with the applicable legal provisions. |
20.2 | In case the vacancy occurs in the office of the Company’s sole director, such vacancy must be filled without undue delay by the general meeting of shareholders. |
Article |
21 Conflict of interests |
21.1 | Save as otherwise provided by the Law, any director who has, directly or indirectly, a financial interest conflicting with the interest of the Company in connection with a transaction falling within the competence of the board of directors, must inform the board of directors of such conflict of interest and must have his declaration recorded in the minutes of the board meeting. The relevant director may not take part in the discussions relating to such transaction nor vote on such transaction. Any such conflict of interest must be reported to the next general meeting of shareholders prior to such meeting taking any resolution on any other item. |
21.2 | Where the Company comprises a single director, transactions made between the Company and the director having an interest conflicting with that of the Company are only mentioned in the resolution of the sole director. |
21.3 | Where, by reason of a conflicting interest, the number of directors required in order to validly deliberate is not met, the board of directors may decide to submit the decision on this specific item to the general meeting of shareholders. |
21.4 | The conflict of interest rules shall not apply where the decision of the board of directors or the sole director relates to day-to-day |
21.5 | The daily manager(s) of the Company, if any, are subject to articles 21.1 to 21.4 of these articles of association provided that if only one (1) daily manager has been appointed and is in a situation of conflicting interests, the relevant decision shall be adopted by the board of directors. |
Article |
22 Dealing with third parties |
22.1 | The Company shall be bound towards third parties in all circumstances by the joint signature of any two (2) directors or by the joint signature or the sole signature of any person(s) to whom such signatory power may have been delegated by the board of directors within the limits of such delegation. |
22.2 | Within the limits of the daily management, the Company shall be bound towards third parties by the signature of any person(s) to whom such power may have been delegated, acting individually or jointly in accordance within the limits of such delegation. |
Article |
23 Indemnification |
23.1 | The members of the board of directors, officers, employees and agents of the Company are not held personally liable for the indebtedness or other obligations of the Company. As agents of the Company, they are responsible for the performance of their duties. Subject to the exceptions and limitations listed in article 23.2 and mandatory provisions of law, every person who is, or has been, a member of the board of directors, officer ( mandataire mandataire Covered Persons ”), shall be indemnified by the Company to the fullest extent permitted by law against liability and against all expenses reasonably incurred or paid by them in connection with any claim, action, suit or proceeding which they become involved as a party or otherwise by virtue of his or her being or having been a Covered Person and against amounts paid or incurred by him or her in the settlement thereof. If applicable law is amended after approval of this Article 23 to authorize corporate action further eliminating or limiting the personal liability of Covered Persons, then the liability of a Covered Person to the Company shall be eliminated or limited to the fullest extent permitted by applicable law as so amended. The words “claim”, “action”, “suit” or “proceeding” shall apply to all claims, actions, suits or proceedings (civil, criminal or otherwise including appeals) actual or threatened and the words “liability” and “expenses” shall include without limitation attorneys’ fees, costs, judgments, amounts paid in settlement and other liabilities. |
23.2 | Expenses (including attorneys’ fees) incurred by a Covered Person in defending any claim (save for fraud, negligence or willful misconduct’s claims) shall be paid by the Company in advance of the final disposition of such claim upon receipt of an undertaking by or on behalf of such Covered Person to repay such amount if it shall ultimately be determined that such person is not entitled to be indemnified by the Company as authorized in this Article 23. Such expenses (including attorneys’ fees) incurred by former Covered Persons may be so paid upon such terms and conditions, if any, as the Company deems appropriate. |
23.3 | The indemnification and advancement of expenses provided by, or granted pursuant to, this Article 23 shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under this present articles of association, agreement, vote of shareholders or disinterested directors or otherwise, both as to action in such person’s official capacity and as to action in another capacity while holding such office, it being the policy of the Company that indemnification of the persons specified in this Article 23 shall be made to the fullest extent permitted by law. |
23.4 | Any repeal or modification of this Article 23 by the shareholders of the Company shall only be prospective and shall not affect the rights to indemnification and to the advancement of expenses of a Covered Person or protections or increase the liability of any Covered Person under this Article 23 in effect at the time of the alleged occurrence of any act or omission to act giving rise to liability or indemnification. |
23.5 | No indemnification shall be provided to any Covered Person (i) against any liability by reason of willful misfeasance, bad faith, gross negligence or reckless disregard of the duties involved in the conduct of his or her office (ii) with respect to any matter as to which he or she shall have been finally adjudicated to have acted in bad faith and not in the interest of the Company or (iii) in the event of a settlement, unless the settlement has been approved by a court of competent jurisdiction or by the board of directors. The termination of any claim, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the person did not act in good faith and in a manner which such person reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any claim, had reasonable cause to believe that such person’s conduct was unlawful. |
23.6 | The right of indemnification herein provided shall be severable, shall not affect any other rights to which any Covered Person may now or hereafter be entitled, shall continue as to a person who has ceased to be such Covered Person and shall inure to the benefit of the heirs, executors and administrators of such a |
person. Nothing contained herein shall affect or limit any rights to indemnification to which corporate personnel, including Covered Persons, may be entitled by contract or otherwise under law. The Company shall specifically be entitled to provide contractual indemnification to and may purchase and maintain insurance for any corporate personnel, including Covered Persons, as the Company may decide upon from time to time. |
23.7 | Notwithstanding any rights to indemnification, advancement of expenses and/or insurance that may be provided by any persons who is a pension fund, private investment fund or institutional lender or any wholly owned subsidiary of the foregoing, including for the avoidance of doubt, Oaktree Capital Management, L.P. and each of its managed funds and each affiliate of the foregoing (other than the Company and its subsidiaries) (collectively, the “ Other Indemnitors ”), to a Covered Person, with respect to the rights to indemnification, advancement of expenses and/or insurance set forth herein, the Company: (i) shall be the indemnitor of first resort (i.e., its obligations to Covered Persons are primary and any obligation of the Other Indemnitors to advance expenses or to provide indemnification for the same expenses or liabilities incurred by Covered Persons are secondary); and (ii) shall be required to advance the full amount of expenses incurred by Covered Persons and shall be liable for the full amount of all liabilities, without regard to any rights Covered Persons may have against any of the Other Indemnitors. No advancement or payment by the Other Indemnitors on behalf of Covered Persons with respect to any claim for which Covered Persons have sought indemnification from the Company shall affect the immediately preceding sentence, and the Other Indemnitors shall have a right of contribution and/or be subrogated to the extent of such advancement or payment to all of the rights of recovery of Covered Persons against the Company. Notwithstanding anything to the contrary herein, the obligations of the Company under this Article 23 shall only apply to Covered Persons in their capacity as Covered Persons. |
E. |
AUDIT AND SUPERVISION |
Article |
24 Auditor(s) |
24.1 | The transactions of the Company shall be supervised by one or several statutory auditors ( commissaires |
24.2 | The general meeting of shareholders of the Company shall appoint one or more independent auditors ( réviseurs d’entreprises agréés) |
24.3 | An independent auditor may only be removed by the general meeting of shareholders for cause or with his approval. |
F. |
FINANCIAL YEAR – ANNUAL ACCOUNTS – ALLOCATION OF PROFITS – INTERIM DIVIDENDS |
Article |
25 Financial year |
Article |
26 Annual accounts and allocation of profits |
26.1 | At the end of each financial year, the accounts are closed and the board of directors draws up an inventory of the Company’s assets and liabilities, the balance sheet and the profit and loss accounts in accordance with the law. |
26.2 | Of the annual net profits of the Company, five per cent (5%) at least shall be allocated to the legal reserve. This allocation shall cease to be mandatory as soon and as long as the aggregate amount of such reserve amounts to ten per cent (10%) of the share capital of the Company. |
26.3 | Sums contributed to a reserve of the Company may also be allocated to the legal reserve. |
26.4 | In case of a share capital reduction, the Company’s legal reserve may be reduced in proportion so that it does not exceed ten per cent (10%) of the share capital. |
26.5 | Upon recommendation of the board of directors, the general meeting of shareholders shall determine how the remainder of the Company’s profits shall be used in accordance with the Law and these articles of association. |
26.6 | Distributions shall be made to the shareholders in proportion to the number of Shares they hold in the Company. |
Article |
27 Interim dividends – Share premium and assimilated premiums |
27.1 | The board of directors may proceed with the payment of interim dividends subject to the provisions of the Law. |
27.2 | Any share premium, assimilated premium or other distributable reserve may be freely distributed to the shareholders subject to the provisions of the Law and these articles of association. |
G. |
LIQUIDATION |
Article |
28 Liquidation |
28.1 | In the event of dissolution of the Company in accordance with Article 3.2 of these Articles of Association, the liquidation shall be carried out by one or several liquidators who are appointed by the general meeting of shareholders deciding on such dissolution and which shall determine their powers and their compensation. Unless otherwise provided, the liquidators shall have the most extensive powers for the realisation of the assets and payment of the liabilities of the Company. |
28.2 | The surplus resulting from the realisation of the assets and the payment of the liabilities shall be distributed among the shareholders in proportion to the number of Shares of the Company held by them. |
H. |
FINAL CLAUSE – GOVERNING LAW |
Article |
29 Governing law |
1 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
2 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
3 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
4 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
5 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
6 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
7 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
8 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
9 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
10 |
Note to Draft : Bracketed language to be included in the agreement executed by Alvogen. |
11 |
Note to Draft : Bracketed language to be included in the agreement executed by Aztiq. |
12 |
Note to Draft : Bracketed language to be included in the agreements executed by Alvogen and Aztiq. |
13 |
Note to Draft : Bracketed language to be included in the agreement executed by Alvogen. |
14 |
Note to Draft : Bracketed language to be included in the agreement executed by Alvogen. |
15 |
Note to Draft : To be included in the agreement executed by Alvogen. |
16 |
Note to Draft : To be included in the agreement executed by Alvogen. |
17 |
Note to Draft : To be included only for entities, not an individual. |
18 |
Note to Draft : Bracketed language to be included in the agreement executed by Robert Wessman (personally). |
PARENT: | ||
OAKTREE ACQUISITION CORP. II | ||
By: | | |
Name: | ||
Title: |
TopCo: | ||
ALVOTECH LUX HOLDINGS S.A.S. | ||
By: | | |
Name: | ||
Title: |
Company : | ||
ALVOTECH HOLDINGS S.A., | ||
By: | | |
Name: | ||
Title: |
COMPANY SHAREHOLDER : | ||
[ NAME | ||
/// | ||
[ NAME | ||
By: | | |
Name: | ||
Title: | ||
[______________] | ||
[______________] | ||
[______________] | ||
Attention: [______________] | ||
Facsimile: [______________] | ||
Email: [______________] |
Company Shareholder |
Class, Number and Type of Equity Interests |
|||
[•] |
[ | •] |
Name of Investor: | State/Country of Formation or Domicile: | |||||
By: | |
|||||
Name: | |
|||||
Title: | |
|||||
Name in which Shares are to be registered (if different): | Date: ________, 2021 | |||||
Investor’s EIN: | ||||||
Business Address-Street: | Mailing Address-Street (if different): | |||||
City, State, Zip: | City, State, Zip: | |||||
Attn: | |
Attn: | | |||
Telephone No.: | Telephone No.: | |||||
Facsimile No.: | Facsimile No.: | |||||
Number of Shares subscribed for: | ||||||
Aggregate Subscription Amount: $ | Price Per Share: $10.00 |
OAKTREE ACQUISITION CORP. II | ||
By: | | |
Name: | ||
Title: | ||
ALVOTECH LUX HOLDINGS S.A.S. | ||
By: | | |
Name: | ||
Title: |
A. | QUALIFIED INSTITUTIONAL BUYER STATUS |
B. | INSTITUTIONAL ACCREDITED INVESTOR STATUS |
1. | ☐ We are an “accredited investor” (within the meaning of Rule 501(a) under the Securities Act or an entity in which all of the equity holders are accredited investors within the meaning of Rule 501(a) under the Securities Act), and have marked and initialed the appropriate box on the following page indicating the provision under which we qualify as an “accredited investor.” |
2. | ☐ We are not a natural person. |
Alvotech Holdings S.A. | ||
9, rue de Bitbourg | ||
L-1273 Luxembourg | ||
Grand Duchy of Luxembourg | ||
Attention: | Robert Wessman | |
Danny Major | ||
E-mail: |
robert.wessman@alvogen.com | |
danny.major@alvotech.com | ||
with a copy to: | ||
Cooley (UK) LLP | ||
22 Bishopsgate | ||
London EC2N 4BQ, UK | ||
Attention: | Michal Berkner | |
E-mail: |
mberkner@cooley.com |
Name of Investor: | State/Country of Formation or Domicile: | |||||||
By: | |
|||||||
Name: | |
|||||||
Title: | |
|||||||
Name in which Shares are to be registered (if different): | Date: ________, 2021 | |||||||
Investor’s EIN: | ||||||||
Business Address-Street: | Mailing Address-Street (if different): | |||||||
City, State, Zip: | City, State, Zip: | |||||||
Attn: | |
Attn: | | |||||
Telephone No.: | Telephone No.: | |||||||
Facsimile No.: | Facsimile No.: | |||||||
Number of Shares subscribed for: | ||||||||
Aggregate Subscription Amount: $ | Price Per Share: $10.00 |
OAKTREE ACQUISITION CORP. II | ||
By: | | |
Name: | ||
Title: | ||
ALVOTECH LUX HOLDINGS S.A.S. | ||
By: | | |
Name: | ||
Title: |
OAKTREE ACQUISITION HOLDINGS II, L.P. By: Oaktree Acquisition Holdings II GP, Ltd. By: Oaktree Capital Management, L.P., its sole director | ||
By: |
/s/ Brian Price | |
Name: Brian Price | ||
Title: Senior Vice President |
By: |
/s/ Maria Attar | |
Name: Maria Attar | ||
Title: Vice President |
OAKTREE ACQUISITION CORP. II | ||
By: |
/s/ Zaid Pardesi | |
Name: Zaid Pardesi | ||
Title: Chief Financial Officer and Head of M&A |
ALVOTECH LUX HOLDINGS S.A.S. | ||
By: |
/s/ Tanya Zharov | |
Name: Tanya Zharov | ||
Title: Chairman and Director |
21.1* | List of subsidiaries of TopCo. | |
23.1*** | Consent of WithumSmith+Brown, PC, independent registered accounting firm for OACB. | |
23.2*** | Consent of Deloitte ehf., independent registered accounting firm for Alvotech. | |
23.3** | Consent of Arendt & Medernach (included as part of Exhibit 5.1). | |
23.4** | Consent of Kirkland & Ellis (included as part of Exhibit 8.1). | |
24.1* | Power of Attorney (included on signature page to the initial filing of the Registration Statement). | |
99.1* | Consent of Robert Wessman to be named as a director. | |
99.2* | Consent of Richard Davies to be named as a director. | |
99.3* | Consent of Tomas Ekman to be named as a director. | |
99.4* | Consent of Faysal Kalmoua to be named as a director. | |
99.5* | Consent of Ann Merchant to be named as a director. | |
99.6* | Consent of Arni Hardarson to be named as a director. | |
99.7* | Consent of Lisa Graver to be named as a director. | |
99.8* | Consent of Linda McGoldrick to be named as a director. | |
99.9** | Consent of to be named as a director. | |
99.10** | Form of Proxy for OACB General Meeting. | |
99.11*** | Registrant’s waiver request and representation under Item 8.A.4. | |
101.INS*** | Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) | |
101.SCH*** | Inline XBRL Taxonomy Extension Schema Document | |
101.CAL*** | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF*** | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB*** | Inline XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE*** | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
104 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) | |
107*** | Filing Fee Table |
* | Previously filed. |
** | To be filed by amendment. |
*** | Filed herewith. |
† | Certain schedules and exhibits to this Exhibit have been omitted pursuant to Company S-K Item 601(b)(2). The Registrant agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request. |
†† | Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit. |
+ | Certain schedules and exhibits to this Exhibit have been omitted pursuant to Regulation S-K Item 601(a)(5). The Company agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request. |
Alvotech Lux Holdings S.A.S. | ||
By: | /s/ Helga Tatjana Zharov | |
Name: Helga Tatjana Zharov | ||
Title: Chairperson ( Président |
NAME |
POSITION |
DATE | ||
/s/ Helga Tatjana Zharov Helga Tatjana Zharov |
Chairperson ( président ( Principal Executive Officer, Principal Financial Officer, Principal Accounting Officer |
February 4, 2022 |
Alvotech USA Inc. | ||
By: | /s/ Philip Caramanica | |
Name: Philip Caramanica |
Exhibit 10.25
Dated 22 January 2018
Product Rights Agreement
between
Alvotech HF.
and
Alvogen Lux Holdings Sarl
White & Case LLP
5 Old Broad Street
London EC2N 1DW
TABLE OF CONTENTS
Page | ||||||
ARTICLE 1 DEFINITIONS |
1 | |||||
Section 1.1 |
Defined Terms | 1 | ||||
ARTICLE 2 PRODUCT DEVELOPMENT |
17 | |||||
Section 2.1 |
Development Efforts | 17 | ||||
Section 2.2 |
Occurrence of Technical Failure | 18 | ||||
Section 2.3 |
Effect of Technical Failure | 18 | ||||
Section 2.4 |
New Products | 19 | ||||
Section 2.5 |
Research Plan | 19 | ||||
Section 2.6 |
Subcontracting Research | 20 | ||||
Section 2.7 |
Research Reports and Records | 20 | ||||
Section 2.8 |
Exclusivity; Independent Product Development | 20 | ||||
Section 2.9 |
Medical Affairs | 22 | ||||
ARTICLE 3 OTHER TERRITORIES |
22 | |||||
Section 3.1 |
Alvogen Right of Last Look | 22 | ||||
Section 3.2 |
Alvogen Right of First Refusal | 23 | ||||
ARTICLE 4 PAYMENTS |
24 | |||||
Section 4.1 |
Payment Obligations | 24 | ||||
Section 4.2 |
Reports | 25 | ||||
ARTICLE 5 MANUFACTURE OF PRODUCTS; SALES AND MARKETING |
26 | |||||
Section 5.1 |
Manufacture and Purchase Requirements | 26 | ||||
Section 5.2 |
Manufacturing Standards; Changes to Product Specifications | 27 | ||||
Section 5.3 |
Quality Control | 27 | ||||
Section 5.4 |
Product Packaging and Labeling | 28 | ||||
Section 5.5 |
Product Documentation | 28 | ||||
Section 5.6 |
Manufacturing Costs | 29 | ||||
Section 5.7 |
Audit Rights | 30 | ||||
Section 5.8 |
Non-Medical Product Complaints | 30 | ||||
Section 5.9 |
Medical/Technical Inquiries | 31 | ||||
Section 5.10 |
Failed Batch | 31 | ||||
Section 5.11 |
Product Recalls | 31 | ||||
Section 5.12 |
Maintenance of Registrations and Reporting | 32 | ||||
Section 5.13 |
Regulatory Inspections | 32 | ||||
Section 5.14 |
Notice to Alvogen | 33 | ||||
Section 5.15 |
Product Pricing and Promotion; Agency Contacts | 33 | ||||
Section 5.16 |
Sales and Marketing; Right to remove a Product | 33 |
TABLE OF CONTENTS
(continued)
Page | ||||||
Section 5.17 |
Restrictions on Sales and Marketing | 34 | ||||
ARTICLE 6 INTELLECTUAL PROPERTY OWNERSHIP AND LICENSES |
35 | |||||
Section 6.1 |
Product Trademarks | 35 | ||||
Section 6.2 |
License to Alvogen Marks | 35 | ||||
Section 6.3 |
Conditions and Requirements of Trademark Licenses | 35 | ||||
Section 6.4 |
Alvotech Intellectual Property | 36 | ||||
Section 6.5 |
Intellectual Property Steering Committee | 37 | ||||
Section 6.6 |
Intellectual Property Proceedings | 38 | ||||
Section 6.7 |
Manufacturing Process | 40 | ||||
Section 6.8 |
Alvogen Credit | 40 | ||||
Section 6.9 |
Reimbursement Requirements | 40 | ||||
Section 6.10 |
Disputes Relating to Intellectual Property Claims Brought Against Third Parties By Alvotech or Alvogen | 41 | ||||
Section 6.11 |
Recovered Amounts | 42 | ||||
Section 6.12 |
Confidentiality of Actions | 42 | ||||
Section 6.13 |
Article XIII Not Applicable | 43 | ||||
ARTICLE 7 FORECASTS AND ORDERS |
43 | |||||
Section 7.1 |
Forecasts and Orders | 43 | ||||
Section 7.2 |
Forecast Discussions | 43 | ||||
Section 7.3 |
Purchase Orders | 43 | ||||
Section 7.4 |
Purchase Order Acceptance | 43 | ||||
Section 7.5 |
Purchase Order Changes and Cancellation | 44 | ||||
Section 7.6 |
Inability to Manufacture; Supply Allocation | 44 | ||||
Section 7.7 |
Delivery | 45 | ||||
Section 7.8 |
Inspection; Nonconforming Shipment | 46 | ||||
Section 7.9 |
Product Defects and Returns | 47 | ||||
Section 7.10 |
Shelf Life | 47 | ||||
Section 7.11 |
Labor Disputes | 47 | ||||
Section 7.12 |
Supply Chain Security | 47 | ||||
ARTICLE 8 PRODUCTION TRANSFER |
48 | |||||
Section 8.1 |
Manufacture Option | 48 | ||||
Section 8.2 |
Manufacture of Designated Product | 50 | ||||
Section 8.3 |
Audit Rights | 50 | ||||
ARTICLE 9 EXECUTIVE STEERING COMMITTEE |
51 | |||||
Section 9.1 |
Formation and Purpose | 51 | ||||
Section 9.2 |
Membership | 52 |
ii
TABLE OF CONTENTS
(continued)
Page | ||||||
Section 9.3 |
Meeting Requirements | 52 | ||||
Section 9.4 |
Decision-Making; Dispute Resolution | 52 | ||||
Section 9.5 |
Meeting Minutes | 53 | ||||
Section 9.6 |
Working Committees | 53 | ||||
Section 9.7 |
Expenses | 53 | ||||
Section 9.8 |
Information Rights; Access | 54 | ||||
Section 9.9 |
Agreement by Consent of the Parties | 54 | ||||
ARTICLE 10 CONFIDENTIALITY; TAXES |
55 | |||||
Section 10.1 |
Confidentiality | 55 | ||||
Section 10.2 |
Agents and Investors | 55 | ||||
Section 10.3 |
Restrictions on Sharing Information | 55 | ||||
Section 10.4 |
Taxes | 56 | ||||
ARTICLE 11 WARRANTIES AND COVENANTS |
57 | |||||
Section 11.1 |
Warranties of Alvotech | 57 | ||||
Section 11.2 |
Warranties of Alvogen | 59 | ||||
Section 11.3 |
Public Announcements | 60 | ||||
Section 11.4 |
Disposition of Product Rights Following Termination of Research Program Based on a Technical Failure | 60 | ||||
Section 11.5 |
Insurance | 60 | ||||
ARTICLE 12 TERM AND TERMINATION |
61 | |||||
Section 12.1 |
Term | 61 | ||||
Section 12.2 |
Termination | 61 | ||||
Section 12.3 |
Survival | 62 | ||||
ARTICLE 13 INDEMNIFICATION AND LIABILITY LIMITS |
62 | |||||
Section 13.1 |
Indemnification by Alvotech | 62 | ||||
Section 13.2 |
Indemnification by Alvogen | 62 | ||||
Section 13.3 |
Indemnification Procedure | 63 | ||||
Section 13.4 |
Limitations on Liability | 64 | ||||
Section 13.5 |
Unavailability of Indemnification | 64 | ||||
Section 13.6 |
Other Losses | 64 | ||||
ARTICLE 14 MISCELLANEOUS |
64 | |||||
Section 14.1 |
Force Majeure | 64 | ||||
Section 14.2 |
Notices | 65 | ||||
Section 14.3 |
Governing Law | 65 | ||||
Section 14.4 |
Internal Dispute Resolution | 66 | ||||
Section 14.5 |
Enforcement | 66 |
iii
TABLE OF CONTENTS
(continued)
Page | ||||||
Section 14.6 |
Relationship of the Parties | 66 | ||||
Section 14.7 |
Assignment | 66 | ||||
Section 14.8 |
Binding Effect | 66 | ||||
Section 14.9 |
Entire Agreement; Amendments | 66 | ||||
Section 14.10 |
Rules of Construction | 67 | ||||
Section 14.11 |
Waiver | 67 | ||||
Section 14.12 |
Counterparts | 67 | ||||
Section 14.13 |
Electronic Execution and Delivery | 67 | ||||
Section 14.14 |
License Protection | 67 | ||||
Section 14.15 |
Further Assurances | 67 | ||||
Section 14.16 |
Compliance with Applicable Laws | 67 | ||||
Section 14.17 |
Exhibits | 67 | ||||
Section 14.18 |
Headings | 68 | ||||
Section 14.19 |
Expenses | 68 | ||||
Section 14.20 |
No Third Party Beneficiaries | 68 | ||||
Section 14.21 |
Equitable Remedies | 68 |
iv
PRODUCT RIGHTS AGREEMENT
This PRODUCT RIGHTS AGREEMENT (this Agreement) is entered into as of 22 January 2018 (the Effective Date) by and among Alvotech hf., a public limited company incorporated under the laws of Iceland (Alvotech), and Alvogen Lux Holdings Sarl, a limited company established under the law of the Grand Duchy of Luxembourg (Alvogen).
WHERAS, Alvotech has expertise in the development, distribution, marketing and commercialization of pharmaceutical products for human use;
WHEREAS, Alvotech and Alvogen desire to work together in connection with the development, distribution, marketing and commercialization, in the Alvogen Territories (as hereinafter defined), of the Products (as hereinafter defined), which Products are to compete against certain reference products, on the terms and subject to the conditions set forth in this Agreement; and
WHEREAS, Alvogen and Alvotech agree that Alvogen may, in certain circumstances, also acquire the rights to a Product Commercialization (as hereinafter defined) for Products or Candidate Products (as hereinafter defined) in Other Territories (as hereinafter defined).
NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Alvotech and Alvogen agree as follows:
ARTICLE 1
DEFINITIONS
Section 1.1 Defined Terms. The following words and phrases, when used herein with initial capital letters, shall have the meaning set forth or referenced below:
Act means, collectively, the United States Federal Food, Drug, and Cosmetic Act of 1938, including any amendments thereto (including any made by the BPCIA), and all regulations promulgated thereunder.
Action means any proceeding, action, claim (formal or informal, including by way of a letter), arbitration, administrative or regulatory action or other type of legal action, whether taken as a plaintiff or an initiating party (including through a request for declaratory judgment) or by way of counter-claim or defense.
Adalimumab Product means the product of Alvotech that is being developed as a Biosimilar to the reference product Adalimumab, as more specifically described in the applicable Product Data Sheet.
Adverse Determination means the issuance of (i) an injunction that restrains, enjoins or otherwise prohibits the development, making, use, sale, offer for sale, or import of, or Regulatory Approval of, a Product or (ii) an order, decree, ruling or settlement requiring the payment of material damages with respect to the manufacture, use, offer for sale or import of the Product, in either case based on allegations of infringements upon, or misappropriations of, any intellectual property rights of a Third Party.
Affected Territory means any Territory in which a Product has experienced a Technical Failure.
Affiliate means in respect of:
(a) Alvogen or any other member of the Alvogen Group, any other member of the Alvogen Group;
(b) Alvotech or any other member of the Alvotech Group, any other member of the Alvotech Group;
(c) the US Distributor or any other member of the US Distributor Group, any other member of the US Distributor Group,
and, for the avoidance of doubt, Alvotech and Alvogen shall not be Affiliates of each other for the purposes of this Agreement
Agents has the meaning set forth in Section 10.2.
Agreement has the meaning set forth in the first paragraph of this Product Rights Agreement.
Agreement IP has the meaning set forth in Section 6.4.
Alvogen has the meaning set forth in the first paragraph of this Agreement.
Alvogen Group means Celtic and any subsidiary undertaking of Celtic from time to time (and any other entity in which equity or debt securities are exchanged in consideration for equity and debt securities in Alvogen and/or any subsidiary undertaking of Alvogen).
Alvogen Marks means the corporate name Alvogen and trademarks, trade names, service marks, label marks and logos of Alvogen and its Affiliates, excluding the Product Marks.
Alvogens Knowledge means the actual knowledge, after reasonable inquiry, of Robert Wessman and Arni Hardarson.
Alvogen Territories means:
(a) for all Products (other than the Adalimumab Product) and the Bevacizumab Product, those jurisdictions set forth on Exhibit A; and
(b) for the Adalimumab Product and the Bevacizumab Product, those jurisdictions set forth on Exhibit A, excluding the Lotus Territories,
together, in each case, with any Other Territory in respect of which Alvogen acquires the rights to develop, license, distribute, market or commercialize a Product or a Candidate Product (as applicable) pursuant to Section 3.1 or Section 3.2, and Territory means any jurisdiction included in the Alvogen Territories.
Alvogen ROFR has the meaning set forth in Section 2.8(a).
Alvogen Lost Profits means, in the event of a Supply Failure for a Product in a particular Territory, (i) the Net Sales for such Product in such Territory that Alvogen would have expected to make but for the occurrence of such Supply Failure, assuming that Alvogen were to sell all of the units of the Products set forth in the Forecasts for the period of the Supply Failure and calculated on a basis consistent with the calculation of Net Sales for the twelve (12) month period immediately preceding such Supply Failure (or such shorter period during which Alvotech has been supplying such Product to Alvogen pursuant to the terms and conditions of this Agreement), less (ii) the royalty amount on such Net Sales that Alvogen would have been obligated to pay to Alvotech pursuant to this Agreement (not taking into account any credits or deductions to such royalties); provided, for the avoidance of doubt, that Alvogen Lost Profits shall not take into account lost market share or similar claims.
2
Alvotech has the meaning set forth in the first paragraph of this Agreement.
Alvotech Additional Funded Amounts has the meaning set forth in Section 2.3(c).
Alvotech Group means Alvotech and any subsidiary undertaking of Alvotech from time to time (and any other entity in which equity or debt securities are exchanged in consideration for equity and debt securities in Alvotech and/or any subsidiary undertaking of Alvotech).
Alvotech Intellectual Property means drugs, compounds, cell lines, formulae, inventions, innovations, ideas, discoveries, technology, trade secrets, know how, manufacturing and production processes and techniques, design specifications, schematics, research and development information, software, system flow charts, compiler information, user manuals and other documentation and confidential information, all as owned by Alvotech or an Affiliate of Alvotech and used in connection with the development or manufacture of the Products. For the avoidance of doubt, Alvotech Intellectual Property shall not include the Alvogen Marks or the Product Marks.
Alvotech Lost Profits means, in the event of a Recall with respect to a Product in a particular Territory, an amount equal to the percentage of Alvogens Net Sales with respect to the sale of such Product in such Territory that Alvogen would have been required to pay to Alvotech pursuant to Section 4.1 (not taking into account any credits or deductions to such amount) with respect to those units of such Product that Alvogen did not sell but would have been expected to sell but for the occurrence of such Recall, assuming that Alvogen were to sell all of the units of such Product set forth in the Forecasts for the period of time during which such Recall is in effect; provided, that in no event shall such amount exceed the percentage of Alvogens Net Sales with respect to such Product in such Territory that Alvogen would have been required to pay to Alvotech pursuant to Section 4.1 (not taking into account any credits or deductions to such royalties) for the twelve (12) month period beginning on the date of commencement of such Recall, assuming that Alvogen were to sell all of the units of such Product set forth in the Forecasts for such twelve (12) month period, less any amounts that Alvogen actually paid to Alvotech with respect to sales of such Product during such period.
Alvotech Purchase Option has the meaning set forth in Section 8.1(a).
Alvotech Quality Agreement has the meaning set forth in Section 8.1(d).
Alvotech Supply Agreement has the meaning set forth in Section 8.1(d).
Alvotech Supply Option has the meaning set forth in Section 8.1(a).
Alvotechs Knowledge means the actual knowledge, after reasonable inquiry, of Kevin Bain, Johann Johannsson and Rasmus Rojkjaer and, with respect to Section 6.7(a), each of such individuals successors and any other individual filling an otherwise equivalent role or having equivalent responsibilities.
Annual Operating Plan means, with respect to each Product for each Program Year, the Research Plan for such Product for such Program Year or, to the extent that such Program Year or any portion thereof occurs after the completion of the Research Plan for such Product, the plan for Alvotechs commercialization and supply of such Product.
Anticipated Monthly Product Requirements has the meaning set forth in Section 7.1.
Applicable Candidate Product has the meaning set forth in Section 2.8(b).
3
Applicable Law means each applicable federal, state, local or foreign constitution, treaty, law, statute, ordinance, rule, regulation, interpretation, directive, policy, order, writ, award, decree, injunction, judgment, stay or restraining order of any Governmental Authority or Regulatory Agency, the terms of any Regulatory Approval, and any other ruling or decision of, agreement with or by, or any other requirement of, any Governmental Authority, including the United States Foreign Corrupt Practices Act, 15 U.S.C. §§ 78dd-1, et. seq. and any other applicable U.S. or non-U.S. anti-corruption laws.
Average Sale Price means, with respect to a Party or the US Distributor (as the case may be) the weighted average sale price of a Product, Bundled Product or other product or service included in a Bundled Product, as applicable, sold by such Party or the US Distributor (as the case may be) and determined by dividing (i) the total gross sales, as invoiced, on sales of such Product, Bundled Product or other product or service during such period by such Party or the US Distributor (as the case may be) by (ii) the units of such Product, Bundled Product or other product or service sold during such period by such Party or the US Distributor (as the case may be). When determining the gross sales for a Product included in a Bundled Product, the methodology used to allocate a portion of the gross proceeds of the Bundled Product to such Product, as set forth in the definition of Net Sales or US Net Sales (as the case may be) shall be used to allocate gross sales proceeds to such Product.
Audit Period has the meaning set forth in Section 8.3(a).
Auditor has the meaning set forth in Section 5.6(b).
Bevacizumab Product means the biologic product consisting of a protein or peptide targeting one or more of the same indications as the reference product Bevacizumab and that does not differ in any clinically meaningful way from such reference product with respect to its amino acid sequence, analytical comparability, safety or efficacy, and that may in the future be developed by Alvotech or another member of the Alvotech Group.
Biobetter means, as compared to the reference product of a Product, a proprietary second- generation originator biologic product targeting the same treatment as such reference product, but that has superior safety or efficacy for such targeted treatment as compared to such reference product and which has been granted data exclusivity by the relevant Regulatory Agency.
Biosimilar means, as compared to the reference product of a Product, a biologic product consisting of a protein or peptide targeting one or more of the same indications as such reference product and that does not differ in any clinically meaningful way from such reference product with respect to its amino acid sequence, analytical comparability, safety or efficacy.
BPCIA means the United States Biologics Price Competition and Innovation Act of 2009, including any amendments thereto, and all regulations promulgated thereunder.
Buffer has the meaning set forth in clause (iii) of the definition of Technical Failure.
Bundled Product means, with respect to a Product, such Product together with any other product(s) and/or service(s) that are sold at a single unit price in a particular Territory whether packaged together or separately.
Business means the research, development, manufacture, licensing, commercialization and sale of the Products by Alvotech, Alvogen and their respective Affiliates and Subcontractors, either individually or jointly (including pursuant to the Research Program).
Business Activities means (i) the conduct of the Business, (ii) the development, manufacture, marketing, commercialization or sale of any Product, (iii) obtaining or maintaining Regulatory Approval for any Product in any Territory and/or (iv) any other action taken or to be taken by any Party or any of such Partys Affiliates under this Agreement.
4
Business Day means any day other than a Saturday, Sunday or a holiday on which national banking associations in the United Kingdom, Luxembourg or Reykjavik, Iceland are authorized by Applicable Law to be closed.
Candidate Product has the meaning set forth in Section 2.3(a).
CAPA has the meaning set forth in Section 5.10.
Celtic means Celtic Holdings S.C.A., a Luxembourg Société en commandite par actions incorporated in Luxembourg with the Luxembourg Trade and Companies Register under registration number B.197804, having its registered office at L-2163 Lux, 20, Avenue Monterey, Luxembourg.
cGMP means current and any future good manufacturing practices and quality system regulations set forth by the Regulatory Agency of a country in which the Products shall be sold, and if any of the Drug Substances and/or Products are manufactured outside of the Territories, shall include the current and any future good manufacturing practices and quality system regulations in the country(ies) in which the Drug Substance and/or Products are manufactured.
cGxP means current and any future good manufacturing, clinical, development or laboratory practices and quality system regulations, as applicable, set forth by any Regulatory Agency.
Competing Product has the meaning set forth in Section 2.8(b).
Components means all Drug Substances, raw materials, components/component parts, labeling, packaging (both primary and secondary), ancillary goods, shipping materials and other items used to manufacture and supply the Products hereunder in accordance with the applicable Specifications.
Confidential Information has the meaning set forth in Section 10.1.
Confidentiality Exceptions has the meaning set forth in Section 10.1.
Controlling Party means:
(i) in respect of any IP Action in relation to the Alvogen Marks or Product Marks, Alvogen; and
(ii) in respect of any IP Action in relation to the Alvotech Intellectual Property, Alvotech,
in each case, unless, pursuant to Section 6.6(a) or Section 6.6(b), Alvogen or Alvotech, as the case may be, has consented to the other Party controlling the relevant IP Action.
Cost of Goods Sold means, with respect to a Product, the Manufacturing Cost paid for such Product (determined in accordance with Section 5.6) plus twenty percent (20%) of such Manufacturing Cost.
Debarred Entity is a Person (other than an individual) that has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b), or by another Regulatory Agency pursuant to a comparable statue, from submitting or assisting in the submission of any abbreviated drug application, or any Affiliate of such Person.
Debarred Individual means an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b), or by another Regulatory Agency pursuant to a comparable statue, from providing services in any capacity to a Person that has an approved or pending drug product application.
Denosumab Product means the product of Alvotech that is being developed as a Biosimilar to the reference product Denosumab, as more specifically described in the applicable Product Data Sheet.
5
Designated Drug Substance Manufacturer has the meaning set forth in Section 8.1(a).
Designated Manufacturer has the meaning set forth in Section 8.1(a).
Designated Product has the meaning set forth in Section 8.1(a).
Designated Product Manufacturer has the meaning set forth in Section 8.1(a).
Designated Product Percentage has the meaning set forth in Section 8.2(b).
Determination Notice has the meaning set forth in Section 5.11(b).
Development Term means:
(i) with respect to each of the Initial Products, the period beginning on the date hereof;
(ii) with respect to any New Product, the date on which such New Product is selected by Alvotech and Alvogen in accordance with Section 2.4; and
(iii) with respect to any Replacement Product, the date on which such Replacement Product is selected by Alvotech and Alvogen in accordance with Section 2.3(a);
in each case continuing until Alvotech has received Regulatory Approval in each of the Alvogen Territories with respect to such Product.
Discretionary Changes has the meaning set forth in Section 5.2(b).
Dispute has the meaning set forth in Section 14.4.
Distributor means, for a given Product, a Third Party that a Person selects to market, promote, sell and/or distribute such Product on such Persons behalf.
Drug Substance has the meaning set forth in Section 8.1(a).
Drug Substance Quality Agreement has the meaning set forth in Section 8.1(e).
Drug Substance Supply Agreement has the meaning set forth in Section 8.1(e).
Effective Date has the meaning set forth in the first paragraph of this Agreement.
EMA means the European Medicines Agency.
Evaluator has the meaning set forth in Section 5.11(b).
Executive Steering Committee has the meaning set forth in Section 9.1.
Exercise Notice has the meaning set forth in Section 8.1(b).
Exercise Notice Delivery Date has the meaning set forth in Section 8.1(b).
Failure to Meet Clinical Endpoints means, with respect to any Product, one or more of the primary endpoints for Regulatory Approval of a Phase 3 Clinical Trial for such Product have not achieved statistical significance as determined by the alpha level, specific statistical test(s) and primary or secondary analysis populations defined in the applicable final protocol(s) and, if applicable, statistical analysis plan, as each may be amended from time to time upon the mutual agreement of Alvotech and Alvogen, through the use of any of the statistical analysis methods specified in the applicable protocol(s), as may be amended from time to time upon the mutual agreement of Alvotech and Alvogen, for analyzing such Products primary endpoints for Regulatory Approval.
6
FDA means the United States Food and Drug Administration.
First Commercial Sale means, for a given Product in a given Territory, the first commercial sale to a Third Party invoiced by Alvogen or any of its Affiliates with respect to such Product in such Territory after receiving Regulatory Approval for such Product in such Territory.
First US Commercial Sale means the first commercial sale invoiced by the US Distributor or its Affiliates after Alvotech has received Regulatory Approval for the Adalimumab Product in the United States.
Fixed Requirements Month has the meaning set forth in Section 7.1.
Forecasts has the meaning set forth in Section 7.1.
Future Product means any biologic product that is not part of the current portfolio of Alvotech or any Affiliate of Alvotech, but which Alvotech or any Affiliate of Alvotech formally decides to develop at a later stage.
GAAP means United States generally accepted accounting principles, consistently applied.
Golimumab Product means the product of Alvotech that is being developed as a Biosimilar to the reference product Golimumab, as more specifically described in the applicable Product Data Sheet.
Governmental Authority means any supranational, national, regional, state, provincial, local or other government, or other court of competent jurisdiction, legislature, governmental, administrative or regulatory agency, department, body, bureau, council or commission or any other supranational, national, regional, state, provincial, local or other governmental authority or instrumentality, in each case having jurisdiction in any country or other jurisdiction.
Impacted Product has the meaning set forth in Section 7.6(b).
Indemnification Notice has the meaning set forth in Section 13.3(a).
Indemnification Objection has the meaning set forth in Section 13.3(b).
Indemnified Party has the meaning set forth in Section 13.3(a).
Indemnifying Party has the meaning set forth in Section 13.3(a).
Indirect Costs means the costs and expenses appropriately allocated to the Research Program of a Product for supervisory services, occupancy, payroll, information systems, purchasing and accounting, and other overhead costs that are allocated to departments based on space occupied, headcount or activity-based methods.
Infringement Actions has the meaning set forth in Section 6.10(b).
Infringing Activity has the meaning set forth in Section 6.10(a).
Initial Forecast has the meaning set forth in Section 7.1.
Initial Products means the Adalimumab Product, the Denosumab Product, the Golimumab Product, and the Ustekinumab Product.
7
Intellectual Property means, with respect to any Person, all intellectual property, confidential information and proprietary information of such Person, including (i) patents and patent applications (including all reissuances, divisionals, continuations, continuations-in-part, revisions, extensions and reexaminations thereof), (ii) trademarks, service marks, trade dress, trade names, Internet domain names, assumed names and entity names, together with the goodwill of the Business associated with and symbolized by such trademarks, service marks, trade dress, trade names and entity names, in each case whether or not registered, (iii) published and unpublished works of authorship, whether copyrightable or not, including all statutory and common law copyrights associated therewith, and (iv) trade secrets.
Interchangeable means that the FDA has approved a product as an interchangeable product in accordance with its published guidelines.
Investor has the meaning set forth in Section 10.2.
IP Action means any Offensive Action or Third Party Action.
IP Assertion Notice has the meaning set forth in Section 6.10(a).
IP Chairman has the meaning set forth in Section 6.5(a).
IP Litigation Assistance has the meaning set forth in Section 6.6(c).
IP Litigation Costs means all costs and expenses incurred, paid (including through reimbursement to a Party) or payable by a Party resulting from, arising out of or relating to any IP Action, including all attorneys and other legal fees and expenses, costs and expenses of any opinions, advice or counseling, consultant or expert fees and expenses and court costs, but excluding any IP Settlement Costs.
IP Settlement Costs means all amounts paid or payable in settlement, satisfaction or judgment with respect to any IP Action, as applicable, including damages or other payments, including lump sum payments, periodic payments, on-going royalty payments and/or any other types of payment required to enable or resulting from the marketing, promotion, manufacture and/or sale of any of the Products.
IP Steering Committee has the meaning set forth in Section 6.5(a).
IP Strategy means a comprehensive strategy with respect to all Intellectual Property matters relating to the development, manufacture, marketing, commercialization and sale of the Products in each Territory, including with respect to the initiation of litigation, the earliest date on which each Product will be sold in each Territory and any changes to the development and manufacture of each Product, such as the institution of circumvention strategies or the proactive seeking of a license from a Third Party.
Joint Information has the meaning set forth in Section 10.1.
Labor Disruption has the meaning set forth in Section 7.11.
Lien means any liens, claims, charges, pledges, security interests or other encumbrances of any nature whatsoever.
Losses has the meaning set forth in Section 13.1(a).
Lotus Agreements means: (i) the Supply and Distribution Agreement in respect of the commercialization of the Adalimumab Product in South Korea, Taiwan and China by and between Alvotech and Lotus Pharmaceutical Co., Ltd. dated August 2, 2014; (ii) the Supply and Distribution Agreement in respect of the commercialization of the Adalimumab Product in other markets by and between Alvogen IPCO s.a.r.l. and Lotus Pharmaceutical Co., Ltd. dated August 1, 2014; (iii) the Supply and Distribution Agreement in respect of the commercialization of the Bevacizumab Product in South Korea, Taiwan and China by and between Alvotech and Lotus Pharmaceutical Co., Ltd. dated August 4, 2014; and (iv) the Supply and Distribution Agreement in respect of the commercialization of the Bevacizumab Product in other markets by and between Alvogen IPCO s.a.r.l. and Lotus Pharmaceutical Co., Ltd. dated August 3, 2014.
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Lotus Territories means China, South Korea, Taiwan, Hong Kong, Malaysia, Singapore, Thailand, Vietnam, Philippines, Indonesia and Myanmar.
Manufacture Option has the meaning set forth in Section 8.1(a).
Manufacture Plan has the meaning set forth in Section 8.1(c).
Manufacturing Cap has the meaning set forth in Section 8.1(a).
Manufacturing Cost means, with respect to a Product, the total cost to Alvotech to manufacture such Product, consisting solely of the following: (i) the actual cost incurred by Alvotech in acquiring Components supplied by Third Party suppliers (including any Designated Drug Substance Manufacturer) in connection with the manufacture and supply of such Product hereunder (giving effect to any volume discounts, rebates, credits or other factors that have the effect of reducing such cost to Alvotech); (ii) the direct labor cost incurred by Alvotech in manufacturing and supplying such Product hereunder; provided, that such cost is commercially reasonable and generally consistent with the direct labor costs incurred by other similarly situated biologic or pharmaceutical manufacturers located in the same geographic region in which such Product is manufactured; (iii) depreciation on equipment used by Alvotech in manufacturing and supplying such Product hereunder, (iv) utilities expense incurred by Alvotech in manufacturing and supplying such Product hereunder, (v) depreciation of the building(s) at the facility (or facilities) at which such Product is manufactured, (vi) amortization of rent expense for the building(s) at the facility (or facilities) at which such Product is manufactured and (vii) Indirect Costs and the other manufacturing overhead cost incurred by Alvotech in manufacturing and supplying such Product hereunder (including, for example, insurance and property taxes for the equipment and the building(s) at the facility (or facilities) at which such Product is manufactured); provided, that such costs shall be determined assuming full utilization of the facility (or facilities) at which such Product is manufactured (i.e., if such facility is being operated at less than full utilization, then the manufacturing overhead cost that would otherwise be applied to such Product shall be multiplied by the percentage of utilization of such facility). For the purposes of this definition, full utilization of a facility means seventy-five percent (75%) or more of the full manufacturing capacity of such facility.
Net Sales means, for a given Product or Bundled Product (as the case may be) and a specified period, the gross sales of such Product or Bundled Product invoiced by Alvogen or Alvotech, as applicable, or any of their respective Affiliates to non-Affiliates of Alvogen or Alvotech (including Distributors) during such period, less the following deductions to the extent charged as part of the invoiced price, or separately stated on the invoice or calculated as a function of the invoice price (without duplication, and to the extent not reimbursed by a Third Party):
(a) credits, allowances and returns for the account of Third Parties for spoiled, damaged, outdated, rejected, recalled or returned products;
(b) cash, quantity and trade discounts, rebates and wholesaler chargebacks to Third Parties;
(c) sales, use, value-added and other direct or indirect Taxes to the extent billed to and paid by Third Parties;
(d) transportation and insurance costs, customs duties, surcharges, other governmental charges and other handling expenses incurred in connection with the transportation, exportation or importation of products;
(e) management fees to group purchasing organizations and wholesaler fees; and
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(f) Medicaid and 340B and any other government rebate programs, including supplemental rebates.
For the avoidance of doubt, any such Product or Bundled Product that is provided for use as samples or in connection with a compassionate use program is not invoiced and therefore is not subject to the definition of Net Sales, is not a commercial sale for purposes of this Agreement and shall not be taken into account in determining Average Sale Price.
In the case of any sale or transfer of such Product or Bundled Product to a non-Affiliate other than in a transaction exclusively for cash, the Net Sales amount per unit shall be deemed to be the Average Sale Price.
With respect to a Bundled Product, the Net Sales of such Bundled Product shall first be calculated in accordance with the definition of Net Sales above, and then the Net Sales of such Product included in such Bundled Product shall be determined as follows:
(i) multiply the Net Sales of such Bundled Product by the fraction A/(A+B) where A is the Average Sale Price of such Product included in such Bundled Product when sold separately and B is the total of the Average Sale Prices of each of the other products(s) and/or services(s) included in such Bundled Product when sold separately;
(ii) if the Average Sale Price of the Product included in such Bundled Product can be determined, but the Average Sale Price of the other product(s) and/or services(s) included in such Bundled Product cannot be determined, then multiply the Net Sales of such Bundled Product by the fraction A/C where A is the Average Sale Price of such Product when sold separately and C is the Average Sale Price of such Bundled Product; or
(iii) if (x) the Average Sale Price of such Product included in such Bundled Product is not available for such period or (y) such Product included in such Bundled Product is not sold separately, then multiply the Net Sales of such Bundled Product by a percentage determined by the mutual agreement of Alvotech and Alvogen that represents the proportionate economic value of such Product included in such Bundled Product relative to the economic value contributed by the other product(s) and/or service(s) included in such Bundled Product. If Alvotech and Alvogen cannot reach agreement on the appropriate allocation, either Alvotech or Alvogen shall have the option to invoke the dispute resolution procedures set forth in Section 14.4 and Section 14.5 to finally determine the portion of the Net Sales of such Bundled Product allocable to such Product.
New Product has the meaning set forth in Section 2.4(a).
Notice Date has the meaning set forth in Section 5.4(b).
Obligated Purchases has the meaning set forth in Section 7.1.
Offensive Action has the meaning set forth in Section 6.6(a).
Other Agreements has the meaning set forth in Section 14.9.
Other Territories means:
(a) for all Products (other than the Adalimumab Product) and the Bevacizumab Product, all jurisdictions in the world that do not form part of the Alvogen Territories; and
(b) for the Adalimumab Product and the Bevacizumab Product, all jurisdictions in the world, including the Lotus Territories, that do not form part of the Alvogen Territories.
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Packaging Specifications means those packaging, labeling and branding specifications for the Products required for the manufacture of the Products that are to be purchased and supplied under this Agreement, which specifications shall be determined and may be amended from time to time in accordance with Section 5.4.
Parties means Alvotech and Alvogen.
Payment Period has the meaning set forth in Section 4.1(a).
Person means an individual, a partnership, a limited liability company, a corporation, an association, a joint stock company, a trust, a joint venture, an unincorporated organization, a Governmental Authority or other entity of any kind.
Phase 1 Clinical Trial means, with respect to a Product, a clinical trial of such Product utilizing a limited number of human beings to address comparative pharmacokinetics, pharmacodynamics and safety.
Phase 3 Clinical Trial means, with respect to a Product, one or a series of controlled pivotal studies of such Product by the administration of such Product to human beings where the principal purpose of such studies is to provide confirmatory/comparative safety, efficacy and immunogenicity data necessary to support the filing for Regulatory Approval for such Product.
PHS Act means, collectively, the United States Public Health Service Act, including any amendments thereto (including any made by the BPCIA), and all regulations promulgated thereunder.
Proceeding means any claim, action, suit, arbitration or proceeding by or before or otherwise involving, any Governmental Authority or arbitral body.
Product means an Initial Product, a New Product or a Replacement Product.
Product Commercialization has the meaning set forth in Section 3.1(a).
Product Complaint has the meaning set forth in Section 5.8.
Product Data Sheet means, with respect to a given Product, that certain document containing a target product profile, including all of the indications therefor, and designating for research, development and commercialization hereunder specified indications as set forth in the Minimum Data Needed to Support section of the target product profile for such Product (such specified indications to represent, in the case of each Product other than the Initial Products, at least eighty percent (80%) of the value of the worldwide sales of the reference product of the Product (determined according to the most current available data from IMS Health Incorporated or successor thereto at the time such Product becomes a Product hereunder) unless otherwise agreed to in writing by Alvotech and Alvogen).
Product Documentation means, with respect to a given Product, all marketing and promotional literature, packaging inserts (including patient information leaflets) and customer documentation applicable to such Product.
Product Marks has the meaning set forth in Section 6.1(a).
Product Specifications means those product and performance specifications for the Products, including Product formulae and materials required for the manufacture of the Products that are to be purchased and supplied under this Agreement, which specifications shall be determined and may be amended from time to time in accordance with Section 5.2.
Product Term means, with respect to a Product, the period beginning on the first date that Alvotech receives Regulatory Approval for such Product in any of the Alvogen Territories and continuing until the expiration of the Supply Term (unless earlier terminated pursuant to this Agreement).
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Program Related Costs means any direct costs and expenses and Indirect Costs incurred by Alvotech for the applicable Research Program, in each case to the extent recorded as such in accordance with Alvotechs internal accounting practices applied on a consistent basis, including the allocated costs for regulatory and research and development functions and services. Indirect Costs includable as Program Related Costs for any Product in any Quarterly Period shall not exceed twenty- five percent (25%) of the aggregate Program Related Costs for such Product in such Quarterly Period.
Program Year means a period of twelve (12) consecutive calendar months commencing on January 1 of each year.
Proposed Terms has the meaning set forth in Section 2.8(a).
Purchase Order has the meaning set forth in Section 7.3.
Quality Agreement has the meaning set forth in Section 5.3(a).
Quality Standards has the meaning set forth in Section 6.3(b).
Quarterly Period means a three (3) month period in each calendar year ending on March 31, June 30, September 30 or December 31 (as the case may be).
Recall has the meaning set forth in Section 5.11(a).
Records has the meaning set forth in Section 8.3(a).
Recovered Amounts has the meaning set forth in Section 6.11.
Registrations means all permits, licenses, approvals and authorizations granted by any Regulatory Agency with respect to the Products (including the manufacture, handling, use, storage, import, transport, distribution or sale thereof).
Regulatory Agency means any federal, state or local regulatory agency, department, bureau or other Governmental Authority in the United States, Canada, the European Union or any other jurisdiction, as applicable, including the FDA, the U.S. Pharmacopeial Convention, Health Canada and the EMA, in each case that is responsible for Registrations necessary for, or otherwise governs, the manufacture, handling, use, storage, import, transport, distribution or sale of the Products in a Territory.
Regulatory Approval means, with respect to any Product in a Territory, all necessary Registrations from the applicable Regulatory Agency in such Territory to manufacture, use, store, import, transport, market, promote, sell and place on the market such Product in such Territory.
Replacement Product has the meaning set forth in Section 2.3(a).
Replacement Product Option has the meaning set forth in Section 2.3(a).
Required Change has the meaning set forth in Section 5.2(a).
Research Program means all of Alvotechs, and its respective Affiliates and Subcontractors activities directed towards obtaining Regulatory Approval of the Products, including research, development, safety and efficacy studies, clinical trials (including Phase 1 Clinical Trials and Phase 3 Clinical Trials), process development, formulation work, regulatory, quality, data collection and analysis and project management (including required post-approval studies).
Research Plan has the meaning set forth in Section 2.5.
Rolling Forecast has the meaning set forth in Section 7.1.
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Sales and Marketing Costs has the meaning set forth in Section 5.16(a).
Sales Report has the meaning set forth in Section 4.1(a).
SEC has the meaning set forth in Section 11.3.
Shipment Authorization Date has the meaning set forth in Section 7.7.
Short-Term Forecast has the meaning set forth in Section 7.1.
Specifications means the Product Specifications and the Packaging Specifications.
Subcontractor has the meaning set forth in Section 2.6.
subsidiary undertaking has the meaning given to it in the Companies Act 2006.
Successful Completion of a Phase 1 Clinical Trial means, with respect to any Product, (i) the completion of a Phase 1 Clinical Trial for such Product, the results of which meet the primary bioequivalence endpoints for such Product and do not cause Alvotechs Chief Scientific Officer to determine in good faith that such Product presents risk of death, a life-threatening condition or other serious safety concerns to patients such that a Party cannot ethically continue to administer the applicable compound to patients in clinical trials or, following Regulatory Approval, to market, commercialize and sell such Product in any Territory, (ii) the completion of a chemistry and manufacturing controls bioanalytical biosimilarity assessment report demonstrating biosimilarity to the reference product for such Product, which report is reasonably acceptable to Alvogen, and (iii) Alvogens receipt of a staffing plan for Alvotechs manufacturing facility that is reasonably acceptable to Alvogen.
Successful Completion of a Phase 3 Clinical Trial means, with respect to any Product, (i) the completion of a Phase 3 Clinical Trial for such Product where there has been no Failure to Meet Clinical Endpoints and (ii) receipt of reasonable assurances from the relevant Regulatory Agency (which may be delivered in writing or orally, provided that, if delivered orally, representatives of each of Alvotech and Alvogen are present when such assurances are delivered) that no further clinical trials will be required to obtain Regulatory Approval with respect to (A) the pharmacokinetic comparability of the Phase 1 Clinical Trial with respect to such Product and (B) the commercial production of such Product.
Supply Failure has the meaning set forth in Section 7.6(a).
Supply Failure Damages Cap means, with respect to a Supply Failure for a Product in a particular Territory, (i) an amount equal to Alvogens actual Net Sales for such Product in such Territory for the twelve (12) month period immediately preceding such Supply Failure, less (ii) the royalty amount that Alvogen was obligated to pay to Alvotech on such Net Sales pursuant to Section 4.1 (not taking into account any credits or deductions to such royalties); provided, that if such Supply Failure occurs prior to the time that Alvogen has sold such Product for a period of at least twelve (12) months, then the amount referenced in clause (i) shall be determined by multiplying 365 by a fraction, the numerator of which is Alvogens aggregate actual Net Sales for such Product in such Territory during the period beginning on the commencement of the Supply Term for such Product and ending on the date of commencement of such Supply Failure, and the denominator of which is the total number of calendar days during such period.
Supply Term means, with respect to a Product, the period beginning on the date of the First Commercial Sale of such Product by Alvogen and continuing (unless earlier terminated pursuant to this Agreement) until the twenty (20) year anniversary of such date; provided, that each Supply Term (and any extension term thereof) shall automatically renew for an additional term of one (1) year unless Alvogen provides Alvotech with written notice of non-renewal at least twelve (12) months prior to the date on which such Supply Term (or extension term thereof) would otherwise automatically renew for an additional one (1) year term.
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Supply Year means, with respect to a Product, each calendar year during the applicable Supply Term, except that the first Supply Year with respect to such Product means the period beginning on the commencement of the Supply Term for such Product and ending on December 31 of the year in which such Supply Term commences.
Tax or Taxes means any and all taxes, duties, imposts, charges, withholdings, rates, levies and other governmental impositions and other taxes of any kind whatsoever and by whatever authority imposed, assessed or charged, together with all costs, charges, interest, penalties, fines and other additional statutory charges, incidental or related to the imposition thereof.
Taxing Authority means any governmental authority responsible for the imposition, assessment or collection of any Tax.
Technical Failure means, for a given Product:
(i) Patient Safety Issues or Failure to Meet Clinical Endpoints. (A) the applicable reference product of such Product is no longer being marketed, commercialized or sold in any Territory as a result of a patient safety or efficacy issue, (B) such Product has experienced a Failure to Meet Clinical Endpoints or (C) Alvotechs Chief Scientific Officer has determined in good faith that such Product presents risk of death, a life-threatening condition or other serious safety concerns to patients (including a patient safety issue resulting from the use of a Product that causes a clinical hold to be issued by the FDA, EMA or other Regulatory Agency on a clinical trial for such Product) and, with respect to either clause (A) or (C), in the good faith determination of such Chief Scientific Officer, a party cannot ethically continue to administer the applicable compound to patients in clinical trials or, following Regulatory Approval, to market, commercialize and sell such Product in any Territory;
(ii) Negative Regulatory Agency Response Letter. (A) Alvotechs receipt of a response letter from the EMA, or any Regulatory Agency in an Alvogen Territory, that is equivalent to a complete response letter from the FDA pursuant to 21 C.F.R. § 314.110 (or similar successor correspondence) regarding a Product such that, in the good faith determination of Alvotechs Chief Scientific Officer, Alvotechs receipt of Regulatory Approval with respect to such Product in an Alvogen Territory is not reasonably likely;
(iii) Anticipated Product Cost Overruns or Delays. Alvotechs good faith determination that the scope of the Research Program with respect to such Product as reflected in the Research Plan, has changed such that (A) the aggregate anticipated costs following the Effective Date for development of such Product exceed the aggregate budgeted amount set forth in the Research Plan for such Product by more than twenty percent (20%) of such budgeted amount (the applicable Buffer) or (B) such change in scope would reasonably be expected to delay the date of submission of a complete application to the applicable Regulatory Agency (or Regulatory Agencies) for Regulatory Approval of such Product with respect to one or more Territories by at least two (2) years beyond the target date for submission of such application thereto.
(iv) Actual Product Cost Overruns or Delays. (A) Alvotech has actually incurred aggregate costs following the Effective Date for development of such Product that exceed the aggregate budgeted amount set forth in the Research Plan for such Product by more than the applicable Buffer, (B) the date of submission of a complete application to the applicable Regulatory Agency (or Regulatory Agencies) for Regulatory Approval of such Product with respect to one or more Territories has actually been delayed by at least two (2) years beyond the target date for submission of such application thereto or (C) the Regulatory Approval of the Product has actually been delayed by at least three (3) years beyond the submission date to the applicable Regulatory Agency of an application for Regulatory Approval with respect to such Product.
(v) Technical Transfer Delays. in the event that, following the First Commercial Sale of a Product, it is necessary to obtain approval of the FDA or EMA for Alvotech to manufacture such Product at a new facility or for a Third Party to manufacture such Product (obtaining such approval and transferring the manufacturing of a Product to such Third Party being referred to as a technical
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transfer), (A) Alvogens good faith determination that the time for approval of the FDA or EMA for Alvotech to manufacture such Product at a new facility or for a Third Party to manufacture such Product after the necessity therefor arose would be longer than twenty four (24) months or (B) approval of the FDA or EMA for Alvotech to manufacture such Product at a new facility or for a Third Party to manufacture such Product has not been obtained by the date that is twenty-four (24) months after the necessity therefor arose; provided, that this clause (v) shall not become operative unless there is an actual or expected material interruption of supply to Alvogen of such Product;
(vi) Intellectual Property Matters. following consultation with, and receipt of a written legal opinion from, Alvogens external legal advisors, the good faith determination of Alvogens General Counsel that (A) an Adverse Determination has resulted from Alvogens launch of such Product in a Territory and, as may be applicable, either such Adverse Determination has become final and non-appealable or Alvogens General Counsel has determined in good faith that it is not likely that an appeal of such Adverse Determination will ultimately be successful or (B) an Adverse Determination is likely to result from Alvogens launch of such Product in a Alvogen Territory; or
(vii) Lack of Working Capital by Alvotech. Alvogens good faith determination, as of a given time, that Alvotech has less than eighty-five percent (85%) of the Working Capital necessary to meet Alvotechs estimated cash flow requirements (as set forth in the Annual Operating Plan) for the development/or and manufacture (as applicable at such time) of a particular Product for worldwide distribution for the one hundred eighty (180) day period immediately following such time.
No determination made by Alvogen or Alvotech, or a specified officer thereof (i.e., a Chief Scientific Officer or General Counsel, as applicable), for purposes of any of the foregoing clauses of this definition of Technical Failure shall be deemed to have been made in good faith unless such determination is certified by an authorized officer of the Party (who shall be the specified officer of Alvogen or Alvotech, if and as applicable) making such determination in a writing that is provided, together with reasonable documentation and/or other evidence supporting such determination, to each of the other Parties.
Technical Failure Notice has the meaning set forth in Section 2.2.
Third Party means any Person other than either of the Parties and their respective Affiliates.
Third Party Action has the meaning set forth in Section 6.6(b).
Third Party Claim has the meaning set forth in Section 13.3(a).
United States means the United States of America, including the District of Columbia, Puerto Rico and all other territories and possessions of the United States of America.
US Bundled Product means the Adalimumab Product together with any other product(s) and/or service(s) that are sold at a single unit price in the United States whether packaged together or separately.
US Distributor has the meaning set forth in Section 4.1(d).
US Distributor Group means the US Distributor and any subsidiary undertaking of the US Distributor from time to time.
US Net Sales means, for the Adalimumab Product or a US Bundled Product (as the case may be) and for a specified period, the gross sales of the Adalimumab Product or such US Bundled Product invoiced by the US Distributor, any of its Affiliates or any of its Distributors during such period, less the following deductions to the extent charged as part of the invoiced price, or separately stated on the invoice or calculated as a function of the invoice price (without duplication, and to the extent not reimbursed by a Third Party):
(a) credits, allowances and returns for the account of Third Parties for spoiled, damaged, outdated, rejected, recalled or returned products;
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(b) cash, quantity and trade discounts, rebates and wholesaler chargebacks to Third Parties;
(c) sales, use, value-added and other direct or indirect Taxes to the extent billed to and paid by Third Parties;
(d) transportation and insurance costs, customs duties, surcharges, other governmental charges and other handling expenses incurred in connection with the transportation, exportation or importation of products;
(e) management fees to group purchasing organizations and wholesaler fees; and
(f) Medicaid and 340B and any other government rebate programs, including supplemental rebates.
For the avoidance of doubt, any quantites of the Adalimumab Product or the US Bundled Product (as the case may be) that are provided for use as samples or in connection with a compassionate use program are not invoiced and therefore are not subject to the definition of US Net Sales, are not a commercial sale for purposes of this Agreement and shall not be taken into account in determining Average Sale Price.
In the case of any sale or transfer of the Adalimumab Product or a US Bundled Product to a non-Affiliate other than in a transaction exclusively for cash, the US Net Sales amount per unit shall be deemed to be the Average Sale Price.
With respect to a US Bundled Product, the US Net Sales of such US Bundled Product shall first be calculated in accordance with the definition of US Net Sales above, and then the US Net Sales of the Adalimumab Product included in such US Bundled Product shall be determined as follows:
(i) multiply the US Net Sales of such US Bundled Product by the fraction A/(A+B) where A is the Average Sale Price of the Adalimumab Product included in such US Bundled Product when sold separately and B is the total of the Average Sale Prices of each of the other products(s) and/or services(s) included in such US Bundled Product when sold separately;
(ii) if the Average Sale Price of the Adalimumab Product included in such US Bundled Product can be determined but the Average Sale Price of the other product(s) and/or services(s) included in such US Bundled Product cannot be determined, then multiply the US Net Sales of such US Bundled Product by the fraction A/C where A is the Average Sale Price of the Adalimumab Product when sold separately and C is the Average Sale Price of such US Bundled Product; or
(iii) if (x) the Average Sale Price of the Adalimumab Product included in such US Bundled Product is not available for such period or (y) the Adalimumab Product included in such US Bundled Product is not sold separately, then multiply the US Net Sales of such US Bundled Product by the percentage determined by the mutual agreement of Alvotech and the US Distributor (Alvotech taking into account any representations from Alvogen in this regard) that represents the proportionate economic value of the Adalimumab Product included in such US Bundled Product relative to the economic value contributed by the other product(s) and/or service(s) included in such US Bundled Product.
US Payment Period means the period commencing on the date on which the First US Commercial Sale occurs, and continuing so long as the US Distributor is commercially selling the Adalimumab Product in the United States.
US Sales Report has the meaning set forth in Section 4.1(d).
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Ustekinumab Product means the product of Alvotech that is being developed as a Biosimilar to the reference product Ustekinumab, as more specifically described in the applicable Product Data Sheet.
Variable Requirements Month has the meaning set forth in Section 7.1.
Working Capital means, as of a given time, an amount equal to (a) the sum of Alvotechs cash on hand, plus inventory, accounts receivable and the amounts of binding, undrawn funding commitments upon which Alvotech is entitled to draw at such time (subject only to customary conditions that are satisfied or satisfiable by Alvotech at such time), less (b) Alvotechs accounts payable as of such time.
Working Committee has the meaning set forth in Section 9.1.
ARTICLE 2
PRODUCT DEVELOPMENT
Section 2.1 Development Efforts.
(a) During the applicable Development Term with respect to each Product, Alvotech shall (i) use commercially reasonable efforts to develop such Product for the uses of such Product set forth in the Product Data Sheet for such Product in accordance with the Research Plan and (ii) use commercially reasonable efforts (taking into account the commercial potential of such Product in each Alvogen Territory) to obtain, in its own name (or the name of one of its Affiliates) and at its own cost, Regulatory Approvals for such Product in the Alvogen Territories. Alvotech shall use commercially reasonable efforts to conduct the Research Program in good scientific manner and using cGxP of the applicable Territory or other applicable jurisdiction where the Research Program is being conducted, to achieve the objectives of the Research Program efficiently and expeditiously, in compliance with all Applicable Laws. Alvotech shall complete all Phase 4 and post-marketing surveillance studies required to be completed by any Regulatory Agency with respect to a Product as a condition to Regulatory Approval of such Product. Notwithstanding anything in this Agreement to the contrary, Alvotech shall be responsible for taking any and all actions required to support all Product dossiers that may be necessary for any Registration or other Regulatory Approvals with respect to any Product, regardless of whether such actions are required to be taken prior to or following receipt of Regulatory Approval with respect to the applicable Product.
(b) Following Successful Completion of a Phase 3 Clinical Trial with respect to each Product, Alvotech shall use commercially reasonable efforts (taking into account the commercial potential of such Product in each Alvogen Territory) to obtain and maintain, solely in its own name (or the name of one of its Affiliates), and at its own cost, all Regulatory Approvals for such Product in the Alvogen Territories, which, for the avoidance of doubt, shall include the Regulatory Approval of the EMA (if applicable); provided, that Alvotech shall be responsible for obtaining and maintaining all Regulatory Approvals, if any, required to be obtained from each individual country that is included in such Partys Territories and is also covered by the Regulatory Approval of the EMA.
(c) Alvotech shall solely own all Regulatory Approvals that it obtains in accordance with this Section 2.1, and shall be fully responsible for all regulatory activities and requirements and for maintaining such Regulatory Approvals, in accordance with Section 5.12.
(d) Alvotech shall, to the extent permitted by the applicable Governmental Authority and Applicable Law, (i) promptly inform Alvogen of any material oral communication with, and provide copies of written communications with, any Governmental Authority regarding any applications for Regulatory Approval and (ii) exercise commercially reasonable efforts to notify Alvogen prior to participating in any formal meeting with any Governmental Authority in respect of any application for Regulatory Approval and the opportunity to attend and/or participate in such meeting.
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Section 2.2 Occurrence of Technical Failure. If Alvotech or Alvogen determines that conditions exist that would entitle such Party to determine that a Technical Failure has occurred with respect to any Product, then such Party shall provide such other Party with prompt written notice thereof (with a copy to the Executive Steering Committee), which notice shall include the details and evidence of such conditions (any such notice, a Technical Failure Notice), including (if applicable and provided that the Parties shall have entered into (and not terminated) a joint-defense and common interest agreement to protect the relevant attorney-client privilege) by providing to Alvotechs patent counsel a copy of the legal opinion obtained pursuant to clause (vi) of the definition of Technical Failure. Within thirty (30) days following receipt of the Technical Failure Notice, the Executive Steering Committee shall convene a meeting to review and discuss such conditions and the potential consequences thereof and shall, in accordance with Article IX, attempt to resolve any dispute with respect to whether such conditions would entitle Alvotech or Alvogen to determine that such Technical Failure has occurred. If the Executive Steering Committee is unable to resolve such dispute with respect to the occurrence of such Technical Failure within such thirty (30) day period, then such dispute shall be resolved in accordance with Section 14.4 and Section 14.5 of this Agreement; provided, that (i) if such dispute relates to a determination of whether a Technical Failure has occurred pursuant to a clause of the definition thereof that expressly entitles Alvogen (or a specified officer thereof) to make such determination, then Alvogen may make such determination in accordance with the standards for making such determination set forth in the applicable clause of the definition of Technical Failure following such thirty (30) day period and (ii) if such dispute relates to whether a Technical Failure has occurred pursuant to a clause of the definition thereof that expressly entitles Alvotech (or a specified officer thereof) to make such determination, then Alvotech may make such determination in accordance with the standards for making such determination set forth in the applicable clause of the definition of Technical Failure following such thirty (30) day period.
Section 2.3 Effect of Technical Failure.
(a) If any Technical Failure has occurred with respect to any Initial Product (including, for purposes of this Section 2.3(a), a Replacement Product with respect to such Initial Product) prior to Successful Completion of a Phase 1 Clinical Trial for such Product, then neither Alvotech nor Alvogen shall thereafter take any action with respect to the research, development, manufacture, marketing, licensing, commercialization or sale of such Product and, at Alvogens election, made by written notice by Alvogen to Alvotech within two (2) months following the determination of such Technical Failure, Alvogen may designate in writing a product consisting of any of the Future Products that has not previously been selected as a New Product or a Replacement Product (each such product, a Candidate Product) as a replacement for the affected Product (a Replacement Product) (the option described herein being referred to as the Replacement Product Option). Each product designated as a Replacement Product shall, upon selection, be considered a Product for all purposes hereunder (including Alvotechs development obligations under Section 2.1), and each Product as to which the Replacement Product Option has been exercised shall thereafter no longer be considered a Product hereunder.
(b) If any Technical Failure has occurred with respect to any Product in an Affected Territory following Successful Completion of a Phase 1 Clinical Trial for such Product in such Affected Territory, then (i) neither Alvotech nor Alvogen shall thereafter take any action with respect to the research, development, Regulatory Approval, manufacture, marketing, licensing, commercialization or sale of such Product in such Affected Territory and (ii) if such Technical Failure occurs following the commencement of the Product Term with respect to such Product, such Product Term shall terminate and the prohibition with respect to the commercial marketing and sale by Alvogen of a Competing Product set forth in Section 2.8(b) shall terminate with respect to such Product in the Affected Territory. For the avoidance of doubt, (X) the Parties acknowledge that a Technical Failure referred to in clause (i) or (vii) of the definition thereof shall constitute a Technical Failure in all Territories and, accordingly, in such case each Territory shall constitute an Affected Territory and (Y) if any Technical Failure has occurred pursuant to clause (ii)(A) of the definition thereof resulting from a decision by the EMA, then such Technical Failure shall constitute a Technical Failure in all Territories covered by the EMA and, accordingly, in such case each such Territory shall constitute an Affected Territory.
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(c) If, following the occurrence of a Technical Failure with respect to any Product, either Alvotech or Alvogen desires to resume the research, development and manufacture of such Product, or the marketing, licensing, commercialization or sale of such Product in any Affected Territory, such Party shall deliver written notice thereof to the Executive Steering Committee, which notice shall include reasonable detail as to such Partys plans and proposals with respect thereto. Following receipt of such notice, the Executive Steering Committee shall meet as soon as practicable thereafter to discuss and consider in good faith the plans and proposals of Alvotech or Alvogen, as applicable, with respect to resuming the research, development, manufacturing, marketing, licensing, commercialization and/or sale of such Product in such Territory (but none of the Executive Steering Committee, Alvotech or Alvogen shall have any obligation to agree upon any such plan or proposal). If, following the occurrence of a Technical Failure with respect to any Product, Alvotech desires to sell, license or otherwise dispose of all or any portion of the assets related to the research, development, manufacturing, marketing, licensing, commercialization and sale of such Product to a Third Party, then Alvotech shall provide notice thereof to Alvogen prior to such sale, license or other disposition, including a statement of all amounts paid by Alvotech or any Affiliate from and after the date of the occurrence of the Technical Failure in connection with the resumption of the research, development, manufacturing, marketing, commercialization and/or sale of such Product to a Third Party (such amounts incurred from time to time, the Alvotech Additional Funded Amounts). Following the completion of such sale, license or other disposition or, if such license includes ongoing payments by a Third Party to Alvotech, promptly following Alvotechs receipt of each such payment, Alvotech shall distribute the net proceeds from such sale, license or other disposition as follows: first, one hundred percent (100%) to Alvotech until Alvotech has received an amount equal to all Alvotech Additional Funded Amounts incurred by Alvotech or any Affiliate and, thereafter, forty percent (40%) to Alvogen and sixty percent (60%) to Alvotech.
(d) The termination of the Parties efforts to develop, obtain Regulatory Approval for, or launch, market, promote and sell any Product that suffers a Technical Failure shall have no effect on the Parties obligations with respect to the remaining Products under this Agreement or on the Parties obligations with respect to the affected Product in the Territories other than the Affected Territories.
Section 2.4 New Products.
(a) Alvotech and Alvogen may, from time-to-time but no later than five years following the Effective Date, by written agreement, select for development and commercialization hereunder any one (1) or more Candidate Products that has not previously become a Product hereunder (a Candidate Product so selected, as more specifically described in the applicable Research Plan, being referred to herein as a New Product). Except as expressly set forth herein, the New Product shall be considered a Product for all purposes hereunder (including Alvotechs development obligations under Section 2.1). If Alvotech and Alvogen elect to select a New Product, then such Parties may select as such New Product any Candidate Product except to the extent previously selected as a Replacement Product or a New Product. In connection with the designation of any Candidate Product or other product as a Product hereunder, Alvotech and Alvogen shall agree upon the Product Data Sheet therefor.
Section 2.5 Research Plan. Alvotech shall perform its obligations with respect to the Research Program with respect to each Product in each Program Year in accordance with a plan for such Product, broken out by Program Year (each such plan, a Research Plan). Each Research Plan shall contain (i) quarterly budgeted Program Related Costs for the Product covered by such Research Plan for each of the first three (3) Quarterly Periods of the Development Term for the Product covered by such Research Plan, (ii) annual budgeted Program Related Costs for the Product covered by such Research Plan for each Program Year during the Development Term and (iii) the target dates for the submission of an application for the Regulatory Approval of the Product covered by such Research Plan. Alvotech shall update each Research Plan at least forty-five (45) days prior to the start of each Program Year and shall, promptly following the selection of any Replacement Product or New Product, prepare a new Research Plan with respect to such Replacement Product or New Product, as applicable, which shall be consistent in form and substance with the Research Plan for the Adalimumab Product and shall include the development scope and projected costs for such Replacement Product or New Product, as applicable.
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Alvotech may also update each Research Plan on a quarterly basis. For the avoidance of doubt, the determination of whether a Technical Failure has occurred under clause (iii) or (iv) of the definition of Technical Failure shall be based upon the applicable budget for the Regulatory Approval reflected in the applicable initial Research Plan and shall not be affected by any modifications to such Research Plan following the date of the applicable initial Research Plan, unless such modifications have been communicated to Alvogen.
Section 2.6 Subcontracting Research. Alvotech may subcontract or outsource to Affiliates or Third Parties (each, a Subcontractor) any portion of its responsibilities under the Research Plan. Each Subcontractor shall enter into a customary confidentiality agreement and other agreements with Alvotech pursuant to which such Subcontractor shall be required to maintain the confidentiality of the Research Plan and the Research Program and comply with all Applicable Laws, including, if applicable, conducting the Research Program in good scientific manner and using cGxP, with respect to its work on the Research Program. Alvotech shall supervise and be responsible under this Agreement for the work of each such Subcontractor on the Research Program, and no subcontracting or outsourcing shall relieve Alvotech of any of its obligations hereunder.
Section 2.7 Research Reports and Records. Subject to Section 10.3, Alvotech shall, no later than ninety (90) days after the last day of each Program Year, provide Alvogen with a reasonably detailed report setting forth the status of the Research Program and a description and amounts of all Program Related Costs expended by Alvotech during such Program Year on a Product-by-Product basis. Such report shall also contain such other information related thereto as Alvogen may reasonably request from time to time. Alvotech shall, and shall cause each Subcontractor engaged by Alvotech pursuant to Section 2.6 to, maintain complete and accurate records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes and for purposes of demonstrating compliance with the terms hereof, that fully and properly reflect all work done, results achieved and Program Related Costs expended in performance of the Research Program. Alvotech shall retain all books and records related to the Research Program during the Development Term and for a period of five (5) years thereafter. During such period, upon the written request of Alvogen, the books and records of Alvotech and each Subcontractor engaged by Alvotech related to the Research Program, including those related to the expenditure of Program Related Costs, shall be subject to inspection and audit by and at the expense of Alvogen no more than one time in any Program Year. Such audit shall occur upon reasonable notice and during normal business hours by an independent auditor selected by Alvogen and reasonably acceptable to Alvotech. The auditing Party shall treat all information received or subject to review under this Section 2.7 as Confidential Information in accordance with the provisions of Article X. Alvogen shall cause its independent auditor to enter into a confidentiality agreement, in form and substance reasonably acceptable to Alvotech, to maintain such records and information of such other Party in confidence in accordance with Article X and not use such records or information except to the extent permitted by this Agreement, including any enforcement of the provisions hereof.
Section 2.8 Exclusivity; Independent Product Development.
(a) Except as expressly provided in, or contemplated by, this Agreement and the Other Agreements, during the Development Term or the Product Term with respect to any Product, Alvotech shall not, directly or indirectly, through an Affiliate or otherwise, take any material action, or enter into any agreement, arrangement or understanding, with respect to (i) the research, development or manufacture of such Product, (ii) obtaining any Regulatory Approval for such Product in any Territory or (iii) licensing, commercializing, marketing or selling such Product in any Territory or any Other Territory. In the event that Alvotech, or any other member of the Alvotech Group, proposes to enter into any agreement, arrangement or understanding with any Third Party with respect to the research, development, manufacture, licensing, commercialization, marketing or sale of any Candidate Product, (x) Alvotech shall, or shall procure that the relevant other member of the Alvotech Group shall, at least thirty (30) days prior to the date they would enter into such agreement, arrangement or understanding, provide written notice to Alvogen with the proposed terms of such agreement, arrangement or understanding (the Proposed Terms), and (y) for a period of thirty (30) days following receipt of such notice, Alvogen shall be entitled, by written notice to Alvotech, to exercise a right to enter into an agreement, arrangement
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or understanding, as applicable, with Alvotech comparable to the agreement, arrangement or understanding that Alvotech, or the relevant other member of the Alvotech Group, proposes to enter into with such Third Party and in lieu thereof (such right, the Alvogen ROFR). In the event Alvogen exercises the Alvogen ROFR, Alvogen and Alvotech shall negotiate in good faith the terms of the agreement, arrangement or understanding, which terms shall be substantially equivalent to the Proposed Terms or such other terms as shall be agreed upon by Alvogen and Alvotech. In the event Alvogen does not exercise the Alvogen ROFR, Alvotech, or the relevant other member of the Alvotech Group, shall be permitted to enter into the agreement, arrangement or understanding with the applicable Third Party on terms substantially equivalent to the Proposed Terms.
(b) Subject to the provisions of Section 2.3, Alvogen shall not, directly or indirectly, through an Affiliate or otherwise, in any Territory, commercially market, license or sell, including through a Distributor, any product (other than a Product) that is a Biosimilar or a Biobetter of the reference product of a Product (each, a Competing Product) during the Product Term for such Product. Neither Alvogen nor any of its Affiliates shall be limited or in any way prohibited by this Agreement from (i) taking any other action at any time with respect to a Competing Product, including actions related to (x) the research, development and manufacture of any Competing Product and (y) obtaining Regulatory Approval with respect to any Competing Product, (ii) commercially marketing, licensing or selling any Competing Product in any Territory prior to the commencement, or following the expiration or earlier termination, of the Product Term for such Product, (iii) commercially marketing, licensing or selling any Competing Product at any time outside of the Territories or (iv) taking any action whatsoever with respect to a product other than a Product or a Competing Product; provided, that, in each case, such actions by Alvogen or its relevant Affiliate do not materially interfere with Alvogens obligations pursuant to this Agreement. In the event that Alvogen or any of its Affiliates proposes to enter into any agreement, arrangement or understanding with any Third Party with respect to the research, development, manufacture, licensing, commercialization, marketing or sale of any product that is a Biosimilar to the reference product of any Candidate Product (the Applicable Candidate Product), (x) Alvogen shall, at least thirty (30) days prior to the date Alvogen or its relevant Affiliates would enter into such agreement, arrangement or understanding, provide written notice to Alvotech with the Proposed Terms and (y) for a period of thirty (30) days following receipt of such notice, Alvogen shall consider in good faith any proposal of Alvotech with respect to an alternative agreement, arrangement or understanding pursuant to which Alvogen and Alvotech could work together with respect to the research, development, manufacture, licensing, marketing, commercialization and/or sale of the Applicable Candidate Product or another product that is a Biosimilar to the reference product of the Applicable Candidate Product. If Alvogen or any of its Affiliates enters into any agreement, arrangement or understanding with any Third Party with respect to the research, development, manufacture, licensing, commercialization, marketing or sale of any product that is a Biosimilar of the reference product to the Applicable Candidate Product, then the Applicable Candidate Product shall thereafter no longer be a Candidate Product hereunder.
(c) Notwithstanding anything contained herein to the contrary, except as expressly authorized under this Agreement, Alvotech shall not, directly or indirectly, through an Affiliate or otherwise, at any time during the applicable Development Term or Product Term, take any material action involving or related to the research, development, manufacture, licensing, marketing, commercialization or sale of any product that is a Competing Product; provided, that, subject to Section 5.1, Alvotech or any of its Affiliates may (i) provide fill and finishing services to Third Parties with respect to products that are Competing Products with Alvogens prior written consent (which shall not be unreasonably withheld, delayed or conditioned) and (ii) enter into and consummate any transaction or series of related transactions involving the purchase, lease, license, exchange or other acquisition (including by merger, reorganization, consolidation or otherwise) by Alvotech or its relevant Affiliate of the assets and/or equity interest of any Person that is party to any fee-for-service arrangements with respect to one or more Competing Products and, following the consummation of such transaction or series of related transactions, such acquired Person may (A) provide fill and finishing services for Third Parties with respect to any Competing Product, consistent with the services provided by such acquired Person prior to its acquisition by Alvotech or its Affiliate, and (B) enter into and perform under fee-for-service arrangements with respect to any Competing Product, consistent with the services provided by
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such acquired Person prior to its acquisition by Alvotech or its Affiliate, in each case so long as such acquired Person does not receive any royalty or similar payment, share in any revenue or profit from or otherwise directly benefit in a similar manner from, in each case, the commercialization, licensing or sale of any Competing Product manufactured pursuant to such arrangement, and Alvotech or its Affiliate does not make available for use, in connection with the performance of such services, any Agreement IP. Notwithstanding the foregoing, (x) Alvotech may not, directly or indirectly, through an acquired Person or other Affiliate or otherwise, take any action that would otherwise be permitted by this Section 2.8(c) to the extent that the taking of such action would materially and adversely impact Alvotechs ability to perform or satisfy its obligations under this Agreement, including its ability to manufacture and supply the Products in quantities sufficient to meet Alvogens and Alvogens purchase requirements (including Alvogens purchase requirements as set forth in the Forecasts). For the avoidance of doubt, nothing in this Section 2.8(c) shall prohibit Alvotech, any of its Affiliates or any Person acquired by Alvotech from providing any services for Third Parties with respect to any products that are not Competing Products.
Section 2.9 Medical Affairs.
(a) Alvogen shall have full reasonable access to all clinical trial sites, records, documents, data and other information related to any clinical trial or study conducted by Alvotech hereunder, including protocols, statistical analysis plans, final CSRs and clinical trial enrollment, progress, results and data generated in scientific studies or memorialized in laboratory notebooks, and Alvogen is hereby granted an irrevocable, royalty-free, non-transferable license to use such data and information for purposes of the research, development, manufacture, marketing, commercialization or sale of any of the Products in accordance with this Agreement.
ARTICLE 3
OTHER TERRITORIES
Section 3.1 Alvogen Right of Last Look
(a) Alvotech shall not, and shall procure that all of its Affiliates shall not, enter into a binding agreement with a Third Party in respect of the development, licensing, distribution, marketing, commercialization or sale of any Product or any Candidate Product in any of the Other Territories (a Product Commercialization) without first following the process set out in the remaining provisions of this Section 3.1. For the avoidance of doubt, Alvotech having previously entered into the Lotus Agreements shall not constitute a breach of this Section 3.1.
(b) Alvotech shall ensure that the Alvogen appointees on the board of directors of Alvotech are regularly updated on the commencement of, and progress in, any discussions relating to any Product Commercialization with any Third Party and the development progress of all Products.
(c) Once Alvotech or any of its Affiliates has agreed the financial and other key commercial terms of a Product Commercialization with a Third Party on a non-binding basis (a Third Party Proposal), Alvotech shall promptly notify Alvogen of the terms of such Third Party Proposal.
(d) Alvogen may exercise an option to acquire the rights to the relevant Product Commercialization in respect of the particular Product by offering written terms to Alvotech (an Alovgen Counter-Proposal) that provide the same, or greater, aggregate financial value to Alvotech or its relevant Affiliate as the relevant Third Party Proposal (provided that the components of an Alvogen Counter-Proposal, including the term, need not be the same as the relevant Third Party Proposal).
(e) Provided that Alvotech has complied with its obligations in Section 3.1(b) above, Alvogen must exercise the right granted in Section 3.1(d):
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(i) if there is a meeting of the board of directors of Alvogen (the Alvogen Board) scheduled within 20 Business Days of Alvogens receipt of the notice from Alvotech of the relevant Third Party Proposal, within 2 Business Days of the meeting of the Alvogen Board; or
(ii) if there is no meeting of the Alvogen Board scheduled within 20 Business Days of Alvogens receipt of the notice from Alvotech of the relevant Third Party Proposal, within 15 Business Days of Alvogens receipt of the notice from Alvotech of the Third Party Proposal.
(f) In the event that Alvotech does not comply with its obligations in Section 3.1(b), Alvogen must provide to Alvotech an Alvogen Counter-Proposal within 30 Business Days of Alvogens receipt of the notice from Alvotech of such Third Party Proposal.
(g) In the event that Alvogen notifies Alvotech that it does not wish to make an Alvogen Counter-Proposal or Alvogen does not make an Alvogen Counter-Proposal within the time frames specified in Section 3.1(e) or Section 3.1(f) (as applicable), Alvotech or its relevant Affiliate may, in their sole discretion, accept the relevant Third Party Proposal.
(h) In the event that Alvogen makes an Alvogen Counter-Proposal which satisfies the requirements in Section 3.1(d) within the time-frames in Section 3.1(e)(i), Section 3.1(e)(ii) or Section 3.1(f) (as applicable), then Alvotech must accept such Alvogen Counter-Proposal and the Parties will cooperate in good faith and each acting reasonably to agree a written amendment to this Agreement that documents the terms governing the relevant Product Commercialization, which will include generally extending the provisions set out elsewhere in this Agreement, except this Article III, to the Product Commercialisation, subject to any amendments to such provisions which are mutually agreed in writing between the Parties.
(i) In the event that the Parties cannot agree whether the terms of an Alvogen Counter-Proposal provide the same, or greater, aggregate financial value to Alvotech or its relevant Affiliate as the relevant Third Party Proposal, that dispute shall be referred for resolution to an independent expert appointed by written agreement of the Parties or, in the absence of such agreement within 20 Business Days, by the President of the Institute of Chartered Accounts in England & Wales pursuant to the Presidents Appointments Scheme (the Expert). The Expert shall be instructed to reach its decision as soon as reasonably practicable and in any event within 30 Business Days of the referral to it of that dispute. The decision of the Expert will be final and binding on both Parties in the absence of manifest error. The Parties shall bear the costs of the Presidents Appointments Scheme (where applicable) and the Expert in equal shares.
Section 3.2 Alvogen Right of First Refusal
(a) Once a Product or a Candidate Product has completed a Phase 3
Clinical Trial, if:
(i) Alvogen proposes a Product Commercialization in respect of such Product or Candidate Product to Alvotech in any of the Other Territories (an Alvogen Proposal) that is on arms length terms and for an aggregate financial value that represents a fair market value for the applicable rights to that Product Commercialization for the proposed term; and
(ii) there is no agreement then in existence, or discussions ongoing, between Alvotech or any of its Affiliates and any Third Party in relation to an equivalent Product Commercialization,
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Alvotech must accept the Alvogen Proposal and the Parties will cooperate in good faith (each acting reasonably) to agree a written amendment to this Agreement that documents the terms governing the relevant Product Commercialization, which will include generally extending the provisions set out elsewhere in this Agreement, except this Article III, to the Product Commercialisation, subject to any amendments to such provisions which are mutually agreed in writing between the Parties.
(b) In the event that the Parties cannot agree whether an Alvogen Proposal is on arms length terms or represents fair market value, this dispute shall be referred forresolution to an Expert. The Expert shall be instructed to reach its decision as soon as reasonably practicable and in any event within 30 Business Days of referral to it of that dispute. The decision of the Expert will be final and binding on both Parties in the absence of manifest error. The Parties shall bear the costs of the Expert in equal shares.
ARTICLE 4
PAYMENTS
Section 4.1 Payment Obligations.
(a) Within forty-five (45) days following the end of each Quarterly Period occurring during the period commencing on the date on which the First Commercial Sale by Alvogen with respect to a Product in any of the Alvogen Territories occurs, and continuing so long as Alvogen is commercially selling such Product in any of the Alvogen Territories (the Payment Period), Alvogen shall deliver to Alvotech a written report (each, a Sales Report) setting forth in reasonable detail Alvogens calculation of its aggregate Net Sales of the Products in the Territories during the immediately preceding Quarterly Period.
(b) During the Payment Period, Alvogen shall be required to pay to Alvotech a royalty in an amount equal to fifty percent (50%) of Alvogens aggregate Net Sales on sales of the Products in the Alvogen Territories earned during each Quarterly Period during the Payment Period, in each case subject to the terms and conditions set forth in Section 2.3 and in Section 4.1(g)(i).
(c) If, during the Payment Period, Alvotech sells any Product to any Distributor or other Third Party in any Alvogen Territory (which the Parties acknowledge shall constitute a breach of this Agreement), then, without limiting Alvogens rights with respect to such breach, Alvotech shall (i) within forty-five (45) days following the end of each Quarterly Period in which Alvotech made any such sale during the Payment Period, deliver to Alvogen a Sales Report with respect to Alvotechs Net Sales of the Products in such Alvogen Territory during the immediately preceding Quarterly Period and (ii) be required to pay to Alvogen an amount equal to fifty percent (50%) of Alvotechs aggregate Net Sales to each Third Party of the Products in the Alvotech Territories earned during each Quarterly Period during the Payment Period, in each case subject to the terms and conditions set forth in Section 2.3 and in Section 4.1(g)(ii).
(d) If Alvotech enters into an agreement with a Third Party in respect of the development, manufacture, licensing, marketing, commercialization or sale of the Adalimumbab Product in the United States (following the procedure set out in Section 3.1) (such Third Party being a US Distributor), then Alvotech shall ensure that such agreement will contain an obligation on the US Distributor and Alvotech to share the total US Net Sales in percentages to be agreed.
(e) Within forty-five (45) days following the end of each Quarterly Period occurring during the US Payment Period, Alvotech shall deliver to Alvogen a written report (each, a US Sales Report) setting forth in reasonable detail the US Distributors calculation of its aggregate US Net Sales, and the total amount to be paid (by way of profit or revenue share, royalty payment or similar) by the US Distributor to Alvotech (the Alvotech Royalty Payment), during the immediately preceding Quarterly Period.
(f) During the US Payment Period, Alvotech shall pay to Alvogen a royalty in an amount equal to:
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(i) if the Adalimumab Product is not the first Biosimilar to be Interchangeable: (x) for a period of sixty (60) months from the start of the first US Payment Period, ten percent (10%) of the Alvotech Royalty Payment payable during each relevant Quarterly Period, and (y) for an additional twenty-four (24) months, seven and a half percent (7.5%) of the Alvotech Royalty Payment payable during each relevant Quarterly Period; or
(ii) if the Adalimumab Product is the first Biosimilar to be Interchangeable, for a period of sixty (60) months from the start of the first US Payment Period, seven and half percent (7.5%) of the Alvotech Royalty Payment payable during each relevant Quarterly Period.
(g) Within sixty (60) days following the end of each Quarterly Period:
(i) Alvogen shall pay to Alvotech all amounts payable pursuant to Section 4.1(b), with respect to such Quarterly Period, provided, that if, in lieu of making any such payment, or any portion thereof, Alvogen elects to apply any credit available to it, then Alvogen shall provide Alvotech with written notice of such election within such sixty (60) day period; and
(ii) Alvotech shall pay to Alvogen all amounts payable pursuant to Section 4.1(c) (if any) and Section 4.1(f), with respect to such Quarterly Period,
in each case, by wire transfer of immediately available funds to the account designated by such other Party.
Section 4.2 Reports.
(a) With respect to every Quarterly Period for which Alvogen is obligated to make any payments under Section 4.1, Alvogen shall furnish to Alvotech a written report for such Quarterly Period within forty-five (45) days after the end of such Quarterly Period showing in reasonably specific detail:
(i) the total gross sales in each country in each Alvogen Territory for each Product or Bundled Product sold by Alvogen and the detailed calculation of Net Sales in each such Territory for such Product or Bundled Product;
(ii) the dates of the First Commercial Sale of any Product (whether alone or as part of a Bundled Product) in any Territory (specifying the Territory) during such Quarterly Period; and
(iii) the exchange rates used in determining the payment amount in Dollars, if elected by Alvogen pursuant to Section 4.2(d).
(b) With respect to every Quarterly Period for which Alvotech is obligated to make any payments under Section 4.1(f), Alvotech shall furnish to Alvogen a written report for such Quarterly Period within forty-five (45) days after the end of such Quarterly Period showing in reasonably specific detail:
(i) the total gross sales in the United States for the Adalimumab Product or US Bundled Product sold by the US Distributor and the detailed calculation of US Net Sales in the United States for the Adalimumab Product or US Bundled Product;
(ii) the aggregate amount of royalties payable by the US Distributor to Alvotech in respect of all sales of the Adalimumab Product or US Bundled Product by the US Distributor in the United States;
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(iii) Alvotechs calculation of the total amount of the Alvotech Royalty Payment payable by Alvotech to Alvogen; and
(iv) the dates of the First US Commercial Sale of the Adalimumab Product (whether alone or as part of a US Bundled Product) in the United States during such Quarterly Period.
(c) With respect to sales of Products invoiced in Dollars, the gross sales and Net Sales or US Net Sales (including all adjustments and deductions permitted to be made hereunder in calculating the same) shall be expressed in Dollars and the applicable royalties (including the Alvotech Royalty Payment) shall be payable in Dollars.
(d) With respect to any sale of Products invoiced in a currency other than Dollars, the gross sales and Net Sales (including all adjustments and deductions permitted to be made hereunder in calculating the same) shall be at Alvogens option: (i) expressed in their Dollar equivalent, calculated using the foreign currency exchange rate for the applicable currency set forth in the Eastern Edition of the Wall Street Journal on the the day on which the relevant written report is furnished to Alvotech, and the applicable royalties shall be payable in Dollars; or (ii) expressed in the currency of the Territory in which such Product was sold, and the applicable royalties shall be payable in such currency.
ARTICLE 5
MANUFACTURE OF PRODUCTS; SALES AND MARKETING
Section 5.1 Manufacture and Purchase Requirements. Subject to the terms and conditions of this Agreement, during the applicable Product Term (i) Alvotech shall manufacture for, and sell and deliver to, Alvogen its total requirements for the applicable Product for sale, or resale by its Affiliates and Third Parties (including Distributors) in the Alvogen Territories and (ii) Alvogen shall purchase and take delivery of its total requirements of the applicable Product exclusively from Alvotech for Alvogens marketing, promotion, sale and use in the Alvogen Territories. For the avoidance of doubt, Alvotech shall be responsible for the procurement, manufacture, and qualification of the Components required for the manufacture of the Products and all costs thereof. Alvotech shall take all actions reasonably necessary to ensure that such manufacturing facility or facilities has sufficient capacity to manufacture the Products in quantities sufficient to meet Alvogens purchase requirements. In order to meet unanticipated demand, commencing with the thirteenth month following Alvogens delivery of an Initial Forecast for a Product, Alvotech shall maintain finished Product inventory in an amount equal to at least twenty-five percent (25%) of Alvogens forecasted requirement of such Product for the immediately following twelve (12) month period as set forth in the most recent Forecast provided by Alvogen in accordance with Section 7.1. If, at any time, Alvogen reasonably believes that Alvotech does not have sufficient capacity to manufacture the Products in quantities sufficient to meet Alvogens purchase requirements as set forth in the Forecasts, then Alvogen shall promptly provide Alvotech with written notice of such determination and, within ten (10) Business Days following Alvotechs receipt of such notice, the Executive Steering Committee shall promptly convene a meeting to identify potential actions that Alvotech may take in order to ensure that it will have sufficient capacity to manufacture the Products in quantities sufficient to meet Alvogens purchase requirements as set forth in the Forecasts. If, after a period of ten (10) Business Days, the members of the Executive Steering Committee are unable to reach a unanimous decision as to the actions that Alvotech should take in order to ensure that it will have sufficient capacity to manufacture the Products in quantities sufficient to meet Alvogens purchase requirements as set forth in the Forecasts, then such dispute shall be resolved in accordance with Section 9.4(b). As promptly as reasonably practical thereafter, Alvotech shall take such actions as it has been determined it should take to ensure that it will have such sufficient capacity.
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Section 5.2 Manufacturing Standards; Changes to Product Specifications.
(a) The target Product Specifications with respect to each Product shall be included in the Research Plan for such Product. The Executive Steering Committee shall review and consider in good faith all changes to the target Product Specifications proposed by either Alvotech or Alvogen. No changes may be made to the target Product Specifications without the prior written approval of the Executive Steering Committee, except as a result of the procedures set forth in Section 9.4(b). Alvotech shall manufacture all Products in accordance with the applicable Product Specifications (as may be amended by the Executive Steering Committee or through the procedures set forth in Section 9.4(b)), all applicable cGMP and all Applicable Laws. Alvotech may not make any changes to the Product Specifications except (i) with the prior written approval of the Executive Steering Committee (subject to Section 5.2(b)) or (ii) as required by Applicable Law or other regulatory requirements, including cGMP (each such change described in clause (ii), a Required Change). Alvotech shall deliver notice to Alvogen of any Required Change to the Product Specifications promptly after Alvotech becomes aware of such change. Alvotech and Alvogen shall cooperate in promptly making any Required Changes and any changes to the Product Specifications that are required by medical or scientific concerns as to the toxicity, safety and/or efficacy of the Products. If a Required Change is made with respect to a Product, then each Party shall cover its own costs and expenses incurred by such Party related thereto, including all regulatory costs, transition costs, stocking costs and other expenses incurred by such Party related to such change, in such Partys performance of its obligations hereunder. If, following the date by which the Product Specifications are required to be changed pursuant to a Required Change, Alvogen is in possession of any Products manufactured in accordance with the Product Specifications in effect prior to the amendment thereof pursuant to such Required Change, and, as a result of such Required Change, Alvogen cannot sell such Products without violating an Applicable Law, then Alvotech shall credit Alvogens account in an amount equal to fifty percent (50%) of the aggregate purchase price paid by Alvogen to Alvotech for such Products.
(b) The Executive Steering Committee shall consider in good faith each proposed change to the Product Specifications that is not a Required Change, including changes to the existing Product and Product line extensions (collectively, Discretionary Changes). Any analytical method improvement shall be considered a Discretionary Change unless requested or required by a Regulatory Agency, in which case such improvement shall be considered a Required Change. If the Executive Steering Committee approves a Discretionary Change with respect to a Product, then each Party shall cover its own costs and expenses incurred by such Party related thereto, including all regulatory costs, transition costs, stocking costs and other expenses incurred by such Party related to such change, in such Partys performance of its obligations hereunder.
Section 5.3 Quality Control.
(a) Alvotech and Alvogen shall enter into a mutually agreeable quality agreement (the Quality Agreement) within six (6) months following the Effective Date, substantially consistent with Alvotechs standard form quality agreement provided to Alvogen prior to the Effective Date, which shall initially cover each of the Initial Products; provided that such Quality Agreement shall be amended from time to time to add any additional Product thereto and reflect any required changes from the addition of such Product.
(b) Alvotech shall apply its quality control procedures and in-plant quality control checks on the manufacture of all Products in the same manner as Alvotech applies such procedures and checks to products of similar nature manufactured for sale by Alvotech. In addition, Alvotech shall test and release the Products in accordance with the test methods described in the Quality Agreement, subject to the reasonable oversight of representatives of Alvogen, to ensure that the Products conform to the applicable Product Specifications and the Quality Agreement and shall make available to Alvogen the results of such tests. Alvotech and Alvogen may change the test methods from time to time by mutual agreement. All Products that Alvotech delivers to Alvogen pursuant to this Agreement shall, at the time of delivery, not be adulterated or misbranded within the meaning of all Applicable Laws in which the definitions of adulteration and misbranding are substantially the same as those contained in the Act or the PHS Act as such Applicable Laws are constituted and effective at the time of delivery. All Products that Alvotech delivers to Alvogen pursuant to this Agreement, shall, at the time of delivery, be free from defects in material and workmanship and shall be manufactured (i) in accordance and conformity with the applicable Product Specifications and (ii) in compliance with all Applicable Laws. All Products that Alvotech delivers to Alvogen pursuant to this Agreement shall be free from all Liens other than those that arise directly or as a result of actions taken by Alvogen.
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Section 5.4 Product Packaging and Labeling.
(a) With respect to the Products purchased by Alvogen from Alvotech for resale in the Alvogen Territories in accordance with the terms and conditions of this Agreement, (i) Alvogen shall control the content and type of all Packaging Specifications (and any changes or supplements thereto) for such Products, (ii) Alvotech shall label such Products in accordance with the applicable Packaging Specifications using content provided and approved by Alvogen (including all necessary photo-ready art (or its substantial equivalent)) bearing Alvogens corporate name, trade dress, NDC numbers and bar codes, and, if and only to the extent required by Applicable Law, Alvotechs corporate name, trade dress, NDC numbers and/or bar codes, along with the Alvogen Marks or Product Marks, and (iii) Alvotech shall be responsible, at its own expense, for ensuring that the content of all such Packaging Specifications for such Products is compliant with the applicable Registrations and all Applicable Laws in the Alvogen Territories. Alvogen shall consider in good faith all comments provided by Alvotech with respect to the content and type of all Packaging Specifications of Alvogen for such Products. To the extent that Alvotech is required to include Alvogens corporate name, trade dress, NDC numbers and/or bar codes on any packaging or labeling with respect to any Product, the presentation of Alvogens corporate name, trade dress, NDC numbers or bar codes on such packaging or labeling (and any changes thereto) shall be subject to Alvogens prior written consent (not to be unreasonably withheld, delayed or conditioned).
(b) Alvogen may, from time to time in its sole discretion, amend the Packaging Specifications applicable to the Products purchased by Alvogen from Alvotech for resale in the Alvogen Territories in accordance with the terms and conditions of this Agreement by delivering written notice of such amendments (including the required documentation specifying the content to be included in the amended labeling and packaging, including all necessary photo-ready art (or its substantial equivalent)) to Alvotech (the date that Alvotech receives such notice being referred to herein as the Notice Date). Promptly following the Notice Date, but in no event later than sixty (60) days thereafter, Alvotech shall (i) make such changes to the packaging, labeling and branding of the Products purchased by Alvogen from Alvotech for resale in the Alvogen Territories in accordance with the terms and conditions of this Agreement as are necessary to ensure that all such Products manufactured after such date conform to such Packaging Specifications as amended, and (ii) undertake the destruction of any packaging, labeling or branding material that has been rendered obsolete or unusable as a result of such amendment to the Packaging Specifications, all at Alvogens sole cost and expense.
(c) The Parties shall cooperate in promptly making any changes to the Packaging Specifications that are required by Applicable Law or other regulatory requirements (including cGMP).
Section 5.5 Product Documentation.
(a) With respect to the Products purchased by Alvogen from Alvotech for resale in the Alvogen Territories in accordance with the terms and conditions of this Agreement, (i) Alvotech shall control the content and type of, and shall be responsible for producing or procuring, at its own expense, all Product Documentation (and any changes or supplements thereto) for such Products, and (ii) Alvotech shall be responsible, at its own expense, for ensuring that the content of all such Product Documentation for such Products is compliant with the applicable Registrations and all Applicable Laws in the Territories. Alvotech shall consider in good faith all comments provided by Alvogen with respect to the content and type of all Product Documentation of Alvogen for such Products. To the extent that Alvotech is required to include Alvogens corporate name, trade dress, NDC numbers and/or bar codes on any Product Documentation with respect to any Product, the presentation of Alvogens corporate name, trade dress, NDC numbers or bar codes on such Product Documentation (and any changes thereto) shall be subject to the prior written consent (not to be unreasonably withheld, delayed or conditioned) of Alvogen.
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(b) The Parties shall cooperate in promptly making any changes to the Product Documentation that are required by Applicable Law or other regulatory requirements.
Section 5.6 Manufacturing Costs.
(a) Prior to the commencement of the Supply Term for any Product, the Executive Steering Committee shall agree on the Manufacturing Costs for the initial Supply Year, which shall be based upon Alvotechs good faith estimate for such initial Supply Year. On or prior to October 1 preceding the commencement of each Supply Year, Alvotech shall notify Alvogen and the Executive Steering Committee of the Manufacturing Cost for the following Supply Year, which shall be equal to the average actual manufacturing cost per unit of such Product through September 30 of the then-current Supply Year; provided, that if the first Supply Year with respect to a Product does not begin prior to July 1 of such first Supply Year, then the Manufacturing Costs for such Product for the Supply Year beginning on January 1 of the following calendar year shall be the same as the Manufacturing Costs for such Product for the first Supply Year of such Product, and such Manufacturing Costs shall be subject to increase or decrease on January 1 of the third Supply Year based upon notice given by Alvotech to Alvogen on or prior to October 1 of the second Supply Year. Any such adjustment to the Manufacturing Costs shall be effective with respect to Products requested by Alvogen for delivery after January 1 of the subsequent Supply Year but shall not be effective for Products requested by Alvogen for delivery before January 1 of the applicable subsequent Supply Year (even if Alvotech fails to deliver such Products prior to such January 1st). Alvotech may, following an unexpected and material increase in the actual manufacturing cost to Alvotech, but in no event more frequently than once per calendar quarter, request that the Executive Steering Committee approve a reasonable increase in the Manufacturing Costs, and, following its receipt of such request, the Executive Steering Committee shall review such request in good faith and either approve or deny such request within thirty (30) days following its receipt of such request. Except as set forth in this Section 5.6(a), Alvotech may not increase the Manufacturing Costs at any time during any Supply Year. Alvogen may, following an unexpected and material decrease in the actual manufacturing cost to Alvotech, but in no event more frequently than once per calendar quarter, request that the Executive Steering Committee approve a reasonable decrease in the Manufacturing Costs, and, following its receipt of such request, the Executive Steering Committee shall review such request in good faith and either approve or deny such request within thirty (30) days following its receipt of such request.
(b) Alvogen shall have the right, once every twelve (12) months and, additionally, at any time within thirty (30) days following receipt by the Executive Steering Committee of a request by Alvotech to increase the Manufacturing Costs, during normal business hours and at its own expense, to have an independent certified public accountant (an Auditor) selected by Alvogen and reasonably acceptable to Alvotech, audit all records maintained by Alvotech related to its calculation of the Manufacturing Costs. After having signed a reasonable confidentiality agreement prepared by Alvotech, the Auditor shall have the right to examine all records related to Alvotechs calculation of the Manufacturing Costs and to verify that the methodology for determining the Manufacturing Cost of similar Alvotech products manufactured at the manufacturing facility is substantially the same as the methodology for determining the Manufacturing Cost of the Products. Alvotech shall, at its expense, provide all reasonable cooperation to the Auditor with respect to any such audit. The Auditor shall provide its findings to Alvogen with a copy to Alvotech. In the event that Alvogen and Alvotech disagree on the validity of the direct labor and manufacturing overhead components of the Manufacturing Cost based on the Auditors report, Alvogen and Alvotech shall negotiate in good faith to attempt to resolve such disagreement.
(c) Alvotech shall provide to Alvogen no later than forty-five (45) days following the end of each Quarterly Period a written report for such Quarterly Period setting forth in reasonable detail the actual manufacturing costs applicable to the Products ordered by Alvogen during such Quarterly Period and the facility utilization rates for each facility in which Alvotech manufactures the Products.
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Section 5.7 Audit Rights.
(a) Upon ten (10) Business Days prior written notice to Alvotech, Alvogen shall have the right, once every twelve (12) months, to have representatives visit the manufacturing facilities at which Alvotech manufactures Products during normal business hours to review Alvotechs manufacturing operations relating to the Products and assess its compliance with cGMP, the Specifications and quality assurance standards and to discuss any related issues with Alvotechs manufacturing and management personnel. Alvotech shall provide Alvogen with copies of Alvotechs manufacturing records relating to the Products (including standard operating procedures, manufacturing and packaging records, deviations and associated investigations, out of specification result reports, product failure and/or rejection reports (or non-conforming material reports), equipment and facility qualification documentation, analytical method documents and associated reports, analytical test results and associated data, training records, in-coming raw materials testing documentation and vendor qualification reports, as well as other documents that may be supportive of the aforementioned documentation) for the purposes of assuring Product quality and compliance with agreed-upon manufacturing procedures.
(b) Upon two (2) Business Days prior written notice to Alvotech, Alvogen shall also have the right to conduct for cause audits to address product or safety concerns as discovered through Product failures related to Alvotechs manufacture of the Products. Product failures include issues related to stability out of specification, sterility and labeling or container integrity.
(c) Alvogen shall provide to Alvotech its written observations and conclusions from the audits it conducts from time to time pursuant to Section 5.7(a) or Section 5.7(b) within thirty (30) days after completion of its visit to an Alvotech manufacturing facility hereunder, and Alvotech shall, within thirty (30) days of its receipt thereof, provide to Alvogen a written response thereto. Alvotech and Alvogen will discuss such response and promptly agree on corrective action to be implemented as well as the appropriate apportionment of costs associated therewith. Alvogen shall have the right to review all relevant documentation in connection with such corrective actions.
(d) Alvotech shall permit each of the Regulatory Agencies to conduct any inspection related to the manufacture of the Products that such Regulatory Agency requires, and Alvotech shall reasonably cooperate with such Regulatory Agency in connection with any such inspection. Alvotech will provide Alvogen with notice of any such Regulatory Agency inspection as soon as practicable (but in no event less than twenty-four (24) hours prior to a pre-notified or scheduled inspection). Alvotech shall keep Alvogen reasonably informed of the status and progress of any such inspection and shall promptly furnish to Alvogen any report or correspondence issued by or provided to any Regulatory Agency in connection with such inspection, purged of any Alvotech trade secrets that are unrelated to Alvotechs activities under this Agreement and any information that is unrelated to the Products. Alvotech shall reasonably cooperate with Alvogen in good faith in connection with the preparation of any response or submission required to be provided to the applicable Regulatory Agency following completion of such inspection and consider in good faith Alvogens comments thereon; provided, that Alvotech shall control any such response or submission.
(e) Alvotech and Alvogen acknowledge that audits (including the results thereof) by Alvogen or its designees may involve the transfer of Confidential Information. For the avoidance of doubt, any such Confidential Information shall be subject to the terms of Article X.
Section 5.8 Non-Medical Product Complaints. Each Party shall notify each other Party promptly (but in any event no later than five (5) Business Days after receipt) of any Product complaints received from a Third Party (each, a Product Complaint) involving Alvotechs manufacture, filling or packaging of the Products; provided, however, that the failure of Alvogen to so notify Alvotech in a timely manner will not relieve Alvotech of any indemnification or other obligation that it may owe to Alvogen relating to any such Product Complaint unless and to the extent Alvotech is materially prejudiced by Alvogens failure to timely give such notice. Upon reasonable request by Alvogen, Alvotech shall conduct an internal investigation to determine the validity of such Product Complaint and Alvotech shall report the findings of such investigation to Alvogen promptly following the completion of such investigation, but in no event later than thirty (30) days after the date of Alvogens request. Alvotech shall pay all costs and expenses relating to such Product Complaint, including all costs and expenses relating to such internal
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investigation. In any event, (i) Alvogen shall be responsible for the management of (including the preparation of all responses with respect to) all Product Complaints related to sales of Products in the Alvogen Territories and, in connection therewith, Alvotech shall provide all reasonable assistance and materials requested by Alvogen in connection with its preparation of the response to such Product Complaint and reimburse Alvogen for all reasonable out of pocket costs and expenses incurred by Alvogen in connection with its preparation of such response Alvotech shall have the right to reasonably participate in the preparation of any response to a Product Complaint at its sole cost and expense. Notwithstanding the foregoing, if Alvotech reasonably determines in good faith that any Product Complaint resulted from Alvogens handling, storage, import, transport, distribution or sale of such Product, then Alvotech shall advise Alvogen of such determination; provided, that if Alvogen disagrees with such determination and provides Alvotech with written notice of such disagreement within two (2) months following the date on which Alvotech advises Alvogen of such determination, then such dispute shall be resolved in accordance with Section 14.4 and Section 14.5 and if it is ultimately determined that such Product Complaint did in fact result from Alvogens handling, storage, import, transport, distribution or sale of such Product, then Alvogen shall promptly reimburse Alvotech for all reasonable out-of-pocket costs and expenses incurred, paid or reimbursed by Alvotech, and shall be responsible for all out-of-pocket costs and expenses incurred by Alvogen, in connection with such Product Complaint, including the costs and expenses of any related internal investigations.
Section 5.9 Medical/Technical Inquiries. Each Party shall promptly (but in any event no later than thirty (30) Business Days after receipt) forward to the other Party all medical and technical inquires related to the Products; provided, however, the failure of a notifying Party to so notify each other Party in a timely manner will not relieve any other Party of any indemnification obligation that it may owe to the notifying Party relating to any such inquiry unless and to the extent that such other Party demonstrates that it is materially prejudiced by the notifying Partys failure to timely give such notice. Alvotech shall prepare all correspondence in response to inquiries with respect to Products sold in the Alvogen Territories. Alvogen shall review and approve, as soon as practicable but in no event later than thirty (30) days after receipt thereof, each response prepared by the notifying Party.
Section 5.10 Failed Batch. In accordance with the Quality Agreement, Alvotech shall reasonably investigate, and cooperate with Alvogen in investigating, any batch of the Product that fails to comply with applicable cGMP or fails to meet the applicable Specifications, Regulatory Agency requirements or Applicable Law. Alvotech shall keep Alvogen informed of the status of such investigation and, upon completion thereof, shall provide Alvogen with a final written report describing the cause of such failure and summarizing the results of such investigation. Alvogen and Alvotech shall mutually agree upon whether any corrective and preventative actions (CAPA) are indicated as a result of the investigation, and, if Alvogen and Alvotech conclude that CAPAs are required, Alvogen and Alvotech shall agree upon the schedule of completion thereof, and Alvotech shall take all such CAPAs in accordance with such schedule of completion.
Section 5.11 Product Recalls.
(a) Each Party shall promptly (but in no event later than two (2) Business Days) notify the other Party upon becoming aware of (i) any information concerning any Product that may adversely impact the quality, purity, safety or effectiveness of such Product or (ii) (A) the issuance by any Regulatory Agency or other Governmental Authority of a request, directive or order that one or more Products be recalled, (B) the ordering by a court of competent jurisdiction of such a recall or (C) the reasonable determination by Alvogen or Alvotech that a Product should be recalled (any such recall, a Recall). In the event of a Recall requested, directed or ordered by a Regulatory Agency or court of competent jurisdiction, the Parties shall jointly develop a strategy with respect to completing such Recall in accordance with the terms and conditions of such Recall. Alvogen shall be responsible for communication to its customers regarding any Recall and, subject to Section 5.11(b), for retrieving any Products that have been sold to its customers.
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(b) Except as set forth below, Alvotech shall bear all costs and expenses of, and shall be responsible for all corrective actions associated with, each Recall. Notwithstanding the foregoing, if Alvotech reasonably determines in good faith that any Recall resulted from Alvogens handling, use, storage, import, transport, distribution or sale of the applicable Product, then Alvotech shall provide Alvogen with written notice of such determination (the Determination Notice). Unless Alvogen provides Alvotech with written notice within two (2) months following its receipt of the Determination Notice that it agrees to bear all costs and expenses of such Recall, then Alvotech may request that the Executive Steering Committee appoint, and upon receipt of such request the Executive Steering Committee shall appoint, an independent Third Party with relevant expertise in medical product recalls (an Evaluator), to determine the relative degree of fault of each of Alvogen and Alvotech with regard to such Recall. If either Alvotech or Alvogen objects to the appointment of such Third Party by the Executive Steering Committee, each of Alvogen and Alvotech shall be entitled to nominate an Evaluator, and such Evaluators shall then choose a third Evaluator, which shall investigate and determine the relative percentages of fault of each of Alvogen and Alvotech with regard to the Recall, and each of Alvogen and Alvotech shall cooperate with such Evaluator in its investigation and determination. Upon the decision of the Evaluator, each of Alvotech and Alvogen shall then promptly pay its respective percentage of the aggregate costs and expenses for the Recall incurred by both such Parties, reimbursing the other such Party as necessary. If Alvotech is determined to be entirely at fault for the Recall, Alvotech shall promptly replace the quantity of Products that were recalled at no cost to Alvogen or reimburse or credit, as determined by Alvotech, Alvogen for any amounts previously paid to Alvotech by Alvogen for such recalled Product under Section 7.9. If Alvogen is determined to be entirely at fault for the Recall, then Alvogen shall reimburse Alvotech for (i) the Alvotech Lost Profits resulting from such Recall and (ii) all costs and expenses of such Recall, including corrective actions associated therewith. In addition, without limiting either Alvotechs or Alvogens obligation to indemnify the other under any provision of this Agreement, costs and expenses of a Recall shall include, with regard to either Alvotech or Alvogen, any and all actual out-of-pocket costs and/or liabilities reasonably incurred by such Party in connection therewith, including all expenses of notification and destruction and all out-of-pocket administrative expenses relating to any recall (e.g., out-of-pocket expenses relating to (i) the shipment, storage, testing and disposal of such recalled Product, (ii) preparation and maintenance of reports and records related to such Recall and (iii) notifications to any customer, distributor or user of such recalled Product). For purposes of this Agreement, the administrative expenses of a Recall shall include the reasonable expenses of notification and destruction or return of the recalled Product, and any actual out of pocket costs associated with the distribution of the replacement Product in exchange for the recalled Product.
Section 5.12 Maintenance of Registrations and Reporting. During the applicable Product Term, Alvotech shall, at its sole expense, obtain and maintain (a) all Registrations in the Alvogen Territories with respect to the applicable Products and (b) all permits, licenses and registrations granted by any Regulatory Agency with respect to the manufacture of the applicable Product by Alvotech. During the applicable Product Term, Alvotech shall prepare and file all reports (including Annual Product Quality Reviews and Annual Reports) related to matters regarding the manufacture of the Products with all applicable Regulatory Agencies in accordance with all Applicable Laws and shall make copies of such reports available to Alvogen, upon Alvogens written request. Alvotech shall also advise Alvogen of any occurrences or information arising out of Alvotechs manufacturing activities that have, or would reasonably be expected to have, adverse regulatory compliance and/or reporting consequences for the Products.
Section 5.13 Regulatory Inspections. Except as otherwise provided herein, Alvotech shall be responsible, at its sole expense, for handling and responding to all FDA and other Regulatory Agency inspections with respect to Alvotechs manufacture of the Products. Alvotech shall provide to Alvogen any information reasonably requested by Alvogen and all information requested by any Regulatory Agency concerning any governmental inspection related to the manufacture of the Products. Prior to responding to any notice or inquiry received by Alvotech from the FDA or any other Regulatory Agency with respect to the manufacture of the Products, Alvotech shall provide Alvogen with a copy of Alvotechs proposed response and a reasonable opportunity to review such proposed response prior to the date by which Alvotech must deliver such proposed response to the FDA or other Regulatory Agency in Alvogen Territories. Alvogen may provide comments with respect to such proposed response, which Alvotech shall consider in good faith. To the extent that Alvotech requires the reasonable assistance of Alvogen in order to fulfill its obligations pursuant to this Section 5.13, Alvogen agrees to reasonably cooperate with and assist Alvotech and Alvotech shall promptly reimburse Alvogen for Alvogens actual out-of-pocket expenses incurred in connection with such cooperation requested by Alvotech.
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Section 5.14 Notice to Alvogen.
(a) In the event that Alvotech is inspected by any Regulatory Agency as it relates to the Products, Alvotech shall notify Alvogen within twenty-hour (24) hours of (i) any such inspection with reasonable advance notice, (ii) any written material alleged violations or deficiencies relating to the manufacturing facility at which the Products are manufactured, packaged or stored and (iii) the corrective action to be taken, and shall promptly contest such alleged violations or deficiencies in good faith or take the required corrective action, each at Alvotechs sole expense.
(b) If Alvotech discovers that any batch of Product previously delivered to Alvogen by Alvotech fails to meet or otherwise comply with the applicable Specifications, Alvotech shall notify Alvogen within twenty-hour (24) hours of such failure and the nature thereof and comply with all provisions of this Agreement relating to defective Product. Alvotech shall consult with Alvogen in an effort to arrive at an acceptable procedure for taking appropriate action, pursuant to Section 7.8, in response to such failure.
Section 5.15 Product Pricing and Promotion; Agency Contacts. Alvogen shall be solely responsible for controlling, and Alvogen shall be entitled to control, exercising its discretion, the advertising, marketing, promotion, sales prices and pricing, promotional and marketing strategies and terms of sale for each Product in the Alvogen Territories. Alvotech shall be the contact for review and discussion of all Product Documentation for the Products with the applicable Governmental Authorities in each of the Alvogen Territories. The Parties acknowledge and agree that neither Party is currently manufacturing or selling any Product or a Competing Product and, but for the collaboration provided for herein, the Products might not be developed by any Party.
Section 5.16 Sales and Marketing; Right to remove a Product
(a) During the Product Term for each Product with respect to each Alvogen Territory in which Alvotech has received Regulatory Approval with respect to such Product, Alvogen shall, directly or indirectly through a subsidiary (including through a Distributor, as and to the extent permitted by Section 5.17(a)(ii)), use commercially reasonable efforts to market, promote, sell and distribute such Product in such Alvogen Territory. All such costs to market, promote, sell and distribute a Product in a Territory (Sales and Marketing Costs) shall be paid by Alvogen. For purposes of this Section 5.16, commercially reasonable efforts with respect to marketing, promoting, selling and distributing any Product means, at a minimum, efforts (including (a) sales representatives and/or medical science liaisons and (b) Product Documentation) comparable to (and no less than) those that Alvogen would use for any other product owned by Alvogen with similar potential commercial value and market potential to such Product.
(b) In the event that the sale price for a unit of any Product that is achievable by Alvogen in any particular Territory is less than an amount equal to one hundred and forty percent (140%) of the applicable Manufacturing Cost, Alvogen shall promptly notify Alvotech in writing (and provide reasonable documentation related thereto) and either Party may, following receipt of such notice and notwithstanding anything in this Agreement to the contrary, on written notice to the other Party remove such Product from the scope of this Agreement in relation to such Territory, in which case: (i) Alvotech shall not be required to supply such Product to Alvogen on an exclusive basis in such Territory, (ii) Alvotechs obligations to provide Alvogen with its total requirements for such Product in such Territory as set forth in Section 5.1 shall terminate, (iii) Alvogen may market, license, commercialize or sell any Competing Product in such Territory (whether such Competing Product was purchased from a Third Party, developed by Alvogen or otherwise) and (iv) the prohibition set forth in Section 5.17 with respect to the sale by Alvogen of any Product for or to any Third Party for sale in such Territory shall terminate.
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(c) In the event that the sale price potentially achievable for a unit of any Product by Alvogen in any Territory that has been subject to the procedure in Section 5.16(b) increases so that is greater than, or equal to, an amount equal to one hundred and forty percent (140%) of the applicable Manufacturing Cost, the Parties shall, each acting reasonably and in good faith, discuss whether, and on what terms, such Product may again be marketed, licensed, commercialized or sold by Alvogen in such Territory.
Section 5.17 Restrictions on Sales and Marketing.
(a) During the applicable Product Term, except as specifically authorized under this Agreement:
(i) Alvotech shall not (A) sell or market any Product except (1) to Alvogen in accordance with this Agreement for further sale or distribution in the Alvogen Territories, (2) to a Distributor, provided that such Distributor expressly agrees in writing not to sell such Product in the Alvogen Territories and to sell such Product only in a jurisdiction (or jurisdictions) outside the Alvogen Territories; provided, that Alvotech covenants and agrees to take all actions (including litigation) reasonably necessary to enforce such agreements with respect to each such Distributor, or (3) to any other Third Party, provided that no Product is delivered to such Third Party in any of the Alvogen Territories and Alvotech has a reasonable expectation that such Third Party will not sell such Product in the Alvogen Territories and will sell such Product only in a jurisdiction (or jurisdictions) outside the Alvogen Territories, or (B) otherwise directly or indirectly sell, market or commercialize any Product in any of the Alvogen Territories (it being acknowledged and agreed that any general marketing activities taken by or on behalf of Alvotech in a jurisdiction outside the Alvogen Territories that are not directed at the sale, marketing or commercialization of a Product in any Alvogen Territory and are not otherwise taken to circumvent the restrictions set forth in this Section 5.17(a)(i) (e.g., the broadcasting of a television advertisement on a station whose primary market is located outside the Alvogen Territories but whose signal can also be received in a Territory) shall not be deemed a breach of clause (B) of this Section 5.17(a)(i)); and
(ii) Alvogen shall not (A) sell any Product except (1) either directly or to a Distributor for resale on Alvogens behalf in accordance with this Agreement and subject to the obligations of Alvogen hereunder, provided that such Distributor expressly agrees in writing not to sell such Product outside the Alvogen Territories and to sell such Product only in a jurisdiction (or jurisdictions) within the Alvogen Territories; provided, further, that Alvogen covenants and agrees to take all actions (including litigation) reasonably necessary to enforce such agreements with respect to each such Distributor or (2) to any other Third Party, provided that no Product is delivered to such Third Party outside any of the Alvogen Territories and Alvogen has a reasonable expectation that such Third Party will not sell such Product outside the Alvogen Territories and will sell such Product only in a jurisdiction (or jurisdictions) inside the Alvogen Territories, or (B) otherwise directly or indirectly sell, market or commercialize any Product outside the Alvogen Territories (it being acknowledged and agreed that any general marketing activities taken by or on behalf of Alvogen in an Alvogen Territory that are not directed at the sale, marketing or commercialization of a Product outside any Alvogen Territory and are not otherwise taken to circumvent the restrictions set forth in this Section 5.17(a)(ii) (e.g., the broadcasting of a television advertisement on a station whose primary market is located in an Alvogen Territory but whose signal can also be received outside an Alvogen Territory) shall not be deemed a breach of clause (B) of this Section 5.17(a)(ii)).
(b) Notwithstanding the foregoing, nothing herein shall prevent or otherwise interfere with Alvogen (or any authorized Distributor or Third Party) from responding to or otherwise complying with a request of any customer to purchase Product outside of any of such Partys Territories, in accordance with the EUs passive sale rule or any successor Applicable Law then in existence during the Product Term.
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(c) Each Party shall be responsible and liable for the performance of each of its Distributors hereunder and for compliance of such Distributor with such Partys obligations hereunder with respect to the promotion, marketing, advertisement, sale and distribution of the Products. The Parties acknowledge and agree, for the avoidance of doubt, that a Partys sale of Product to a Distributor for resale thereby on such Partys behalf (or other use of a Distributor) shall not in any way relieve such Party of any of its obligations hereunder.
ARTICLE 6
INTELLECTUAL PROPERTY OWNERSHIP AND LICENSES
Section 6.1 Product Trademarks.
(a) The Parties agree that each Product shall be sold in the Alvogen Territories under the Alvogen Marks. As between the Parties, Alvogen shall own all right, title and interest in and to the Alvogen Marks in all Territories, and shall make all decisions with respect to clearing and registering the Alvogen Marks. Alvotech shall use commercially reasonable efforts to seek and obtain registration and other required approvals from the applicable Governmental Authorities and Regulatory Agencies in the Territories for all Alvogen Marks. If Alvotech reasonably determines that an Alvogen Mark cannot or is unlikely to be accepted for, or receives a bona fide challenge to, registration or other required approval from an applicable Governmental Authority or Regulatory Agency in a Territory, then Alvotech may abandon any application and/or choose to use (and attempt to so register) an alternative trade mark under which the Products shall be sold in such Territory (the Product Mark), subject to the approval of such Product Mark by Alvogen (which shall not be unreasonably withheld, delayed or conditioned). All out-of-pocket fees and costs relating to creating (including, at Alvotechs sole discretion, engaging a Third Party to generate a list of potential brands), clearing, filing of applications for, and the prosecution and maintenance of, the Product Marks (including all reasonable out-of-pocket fees and costs incurred by Alvotech pursuant to actions taken by Alvotech in accordance with the immediately following sentence) shall be paid by Alvogen (or, if applicable, reimbursed to Alvotech). As between the Parties, Alvogen shall make all decisions with respect to clearing and registering the Product Marks. Alvotech shall not, at any time, adopt, use or register with a Governmental Authority or Regulatory Agency any trademark or service mark that is comprised of (in part or in whole), derived from, similar to, a colorable imitation of, combined with or likely to be confused with, any Alvogen Mark or Product Mark, without the prior written consent of Alvogen. Alvotech may not use a variation of an Alvogen Mark or a Product Mark unless Alvogen pre-approves any such variation in writing. No Party may use any Product Mark, or any colorable imitation thereof, in the corporate or any entity name or as an assumed or fictitious name or trade name for such Party or any Affiliate thereof without the other Parties prior written consent.
Section 6.2 License to Alvogen Marks
Subject to the terms and conditions of this Agreement, Alvogen hereby grants to Alvotech a limited, revocable, non-exclusive, royalty free, non-transferable licence (without the right to sublicense) to use the Alvogen Marks and the Product Marks during the Product Terms solely for the purposes of packaging, labeling and branding the Products to be supplied to Alvogen in accordance with the Packaging Specifications. Alvotech acknowledges and agrees that Alvogen is the sole and exclusive owner of all right, title and interest in and to the Alvogen Marks and the Product Marks. All goodwill associated with the Alvogen Marks and the Product Marks shall inure to the benefit of Alvogen.
Section 6.3 Conditions and Requirements of Trademark Licenses. The following provisions shall be applicable with respect to the Alvogen Marks and the Product Marks.
(a) Alvotech agrees that, if directed in writing by Alvogen, each usage of the Alvogen Marks or the Product Marks licensed under this Agreement shall be followed by either the ®, the TM Trademark Notice symbol or by an alternative symbol and otherwise in accordance with any trademark usage guidelines provided in writing to Alvotech. In addition, Alvotech shall not remove any Trademark Notice symbol from any materials containing the same received from Alvogen or any of its Affiliates.
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(b) Alvotech agrees that it may only use the Alvogen Marks or the Product Marks in connection with, or to otherwise designate, the applicable Product as manufactured (or to be manufactured) pursuant to the terms of this Agreement, including Section 5.3 hereof, and only in the Alvogen Territories. Alvotech further acknowledges that the Products manufactured for, and delivered to Alvogen pursuant to the terms of this Agreement must be of sufficiently high quality in accordance with the quality standards set forth in Section 5.3 as to protect the goodwill of the business symbolized by the Alvogen Marks or the Product Marks. In order to preserve the value of the goodwill associated with the Alvogen Marks or the Product Marks, Alvotech agrees that (i) the quality controls and standards set forth in Section 5.3 (the Quality Standards) shall be strictly adhered to by Alvotech, and (ii) it shall conduct appropriate quality control activities to ensure the foregoing.
(c) So that Alvogen may assure itself of the maintenance of the Quality Standards and compliance with subsections (a) or (b) above, upon Alvogens written request from time to time, Alvotech shall provide Alvogen (and its representatives) with such records and information related to the Quality Standards as may be reasonably requested by Alvogen.
(d) Without the prior written consent of Alvogen, Alvotech shall not use the Alvogen Marks or the Product Marks (or a colorable imitation of an Alvogen Mark or a Product Mark) as part of an internet domain name or as part of an account name or user name in any social media (including Facebook, Google+, Twitter and LinkedIn).
(e) The license set forth in Section 6.2 as to each Alvogen Mark and Product Mark shall commence upon the commencement of the applicable Product Term and shall continue during the applicable Product Term unless terminated by Alvogen upon sixty (60) days prior written notice to Alvotech if Alvotech or any of its sub-licensees has committed a material breach of Section 6.2 or this Section 6.3 (with the specific nature of such breach being identified in such notice) and such breach is not cured within such sixty (60) day period or, if not curable, Alvotech and/or such applicable sub-licensee has not, within such sixty (60) day period, taken remedial steps (outlined in writing to Alvogen) which can be reasonably expected to prevent the recurrence of such breach in the future.
Section 6.4 Alvotech Intellectual Property. As between Alvotech and Alvogen, Alvotech shall own and retain ownership of all right, title and interest in and to the Alvotech Intellectual Property, whether pre-existing or developed by Alvotech in connection with this Agreement. At Alvotechs sole discretion, it may seek and obtain intellectual property registration and other intellectual property protection in its own name from applicable Governmental Authorities or Regulatory Agencies, including through the filing, prosecution and maintenance of patent application(s) with respect to the Alvotech Intellectual Property. In addition, Alvotech may, in its sole discretion elect to abandon any filing so made. Alvotech will keep Alvogen apprised as to the prosecution of any such applications. Without limiting or otherwise affecting the provisions of Section 2.8(b), Alvotech hereby grants to Alvogen a worldwide, irrevocable, royalty-free, non-transferable (except as part of a permitted assignment of this Agreement pursuant to Section 14.7) non-exclusive license (with the right to sublicense as provided herein) to use, manufacture, have manufactured, practice, sell and have sold, distribute and otherwise exploit, solely in connection with Alvogens business, any Alvotech Intellectual Property developed by Alvotech in performing its obligations under any Research Plan (the Agreement IP); provided, that such license shall terminate with respect to any Agreement IP relating only to a particular Product if, at any time, such Product is no longer considered a Product hereunder by reason of Alvogens exercise of the Replacement Product Option with respect to such Product. Alvotech will in good faith provide Alvogen with such materials and documentation reasonably necessary to allow Alvogen to understand and use the Agreement IP subject to the foregoing license. Alvogen shall be responsible for its sub- licensees compliance with the terms and conditions of this license to the Agreement IP as set forth in this Section 6.4. Without limiting the generality of the foregoing, all sublicenses of Alvogens rights under this Section 6.4 must be pursuant to a written agreement (a copy of each of which Alvogen shall provide to Alvotech) that is consistent with, and does not expand the terms of, this Section 6.4
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Section 6.5 Intellectual Property Steering Committee.
(a) The Parties may, on mutual agreement, establish an intellectual property steering committee (the IP Steering Committee). If established, the IP Steering Committee shall (i) review, comment on and, subject to Section 6.5(c), Section 6.5(d) and Section 6.5(e), agree upon the IP Strategy, and (ii) serve as a forum for discussion of matters relating to the IP Strategy, including each Partys ideas and tactics with respect to the IP Strategy. If the IP Steering Committee has not been established, the Parties shall agree, each acting reasonably and in good faith, and subject to Section 6.5(c), Section 6.5(d) and Section 6.5(e), the IP Strategy. Alvogen shall appoint one (1) representative of Alvogen to serve on the IP Steering Committee and Alvotech shall appoint one (1) representative of Alvotech to serve on the IP Steering Committee. Alvotech shall be permitted to appoint one of its representatives serving on the IP Steering Committee as chairman (the IP Chairman). The IP Chairman shall not have any more votes than any other member serving on the IP Steering Committee. Each individual appointed by a Party to serve on the IP Steering Committee shall be an individual of suitable authority and seniority who has significant experience or expertise in biopharmaceutical research, development, commercialization or marketing. A reasonable number of representatives of each Party (including counsel), who shall not be members of the IP Steering Committee, may attend meetings of the IP Steering Committee in the sole discretion of such Party.
(b) The IP Steering Committee, once established, shall meet from time to time at such times and locations, as selected by the IP Chairman or as the members of the IP Steering Committee shall mutually agree, following the Effective Date until the termination of this Agreement. The IP Steering Committee may meet by phone, videoconference or in-person based upon the mutual agreement of the members thereof. Meetings shall only be effective if the representatives of both Parties are present or participating in the meeting. The IP Steering Committee shall attempt to take all actions by reaching unanimity, and only actions undertaken and decisions reached unanimously shall be effective. Meetings of the IP Steering Committee shall be presided over by the IP Chairman. The IP Chairman may appoint any Person to act as secretary of a meeting.
(c) Provided that the IP Steering Committee has been established pursuant to Section 6.5(a), following the Effective Date and from time to time thereafter, either of the Parties may present to the IP Steering Committee the proposed IP Strategy and any proposed amendments thereto, and the non-proposing Party may propose changes to such proposed IP Strategy (or proposed amendments). If the members of the IP Steering Committee are unable to reach unanimity with respect to the IP Strategy or any amendment thereto after a period of ten (10) days following the initial presentation of the IP Strategy or any amendment thereto to the IP Steering Committee (or such other period of time as the IP Steering Committee unanimously agrees), then either Party may provide written notice thereof to the General Counsel of each Party. If the IP Steering Committee has not been established, following the Effective Date and from time to time thereafter, either of the Parties may present to the other the proposed IP Strategy and any proposed amendments thereto, and the non-proposing Party may propose changes to such proposed IP Strategy (or proposed amendments). If the Parties are unable to agree on the IP Strategy or any amendment thereto after a period of ten (10) days following the initial presentation of the IP Strategy or any amendment thereto to the non-proposing Party (or such other period of time as the Parties agree), then either Party may provide written notice thereof to the General Counsel of each Party.
(d) Promptly after a reference pursuant to Section 6.5(c), the General Counsels of each Party shall discuss the proposed IP Strategy or proposed amendment thereto in person or telephonically and use their good faith efforts to reach agreement with respect thereto within thirty (30) days following receipt of notice thereof from any Party. If the General Counsels are unable to reach agreement within such thirty (30) day period, then the General Counsel of Alvotech shall make the relevant determination in respect of matters relating to the Alvotech Intellectual Property and the General Counsel of Alvogen shall make the relevant determination in respect of matters relating to the Alvogen Marks or the Product Marks, in each case, in such officers reasonable discretion exercised in good faith, whereupon the IP Strategy, as amended, if at all, pursuant to the decision of the relevant General Counsel exercised in good faith, shall be the IP Strategy for purposes of this Agreement.
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(e) Notwithstanding Section 6.5(c) and Section 6.5(d), if:
(i) Alvotech determines in good faith that, as a result of an urgent matter, imminent threat or other matter requiring immediate attention in respect of the Alvotech Intellectual Property, an amendment or other modification to the IP Strategy is necessary, then Alvotech may make such amendment or other modification by written notice thereof to Alvogen, whereupon the IP Strategy as so amended or otherwise modified as specified in such written notice shall be the IP Strategy for purposes of this Agreement; or
(ii) Alvogen determines in good faith that, as a result of an urgent matter, imminent threat or other matter requiring immediate attention in respect of the Alvogen Marks or the Product Marks, an amendment or other modification to the IP Strategy is necessary, then Alvogen may make such amendment or other modification by written notice thereof to Alvotech, whereupon the IP Strategy as so amended or otherwise modified as specified in such written notice shall be the IP Strategy for purposes of this Agreement.
(f) If established, the relevant Party shall provide the IP Steering Committee with regular updates with respect to changes or developments that will affect the IP Strategy and contemplated changes to the IP Strategy and the IP Steering Committee shall provide the Executive Steering Committee with regular updates with respect to (i) all IP Actions and (ii) changes or developments that will affect the IP Strategy and contemplated changes to the IP Strategy.
(g) Each Party shall be responsible for the expenses of the participation of its representative(s) in the IP Steering Committee, including travel costs. To the extent practicable, each Party and the IP Steering Committee shall take such actions as shall be reasonably necessary to establish and preserve all applicable privileges, including the attorney-client privilege, with respect to matters considered by the IP Steering Committee and the information presented thereto.
Section 6.6 Intellectual Property Proceedings.
(a) In the event that the Controlling Party determines that it is necessary or desirable to commence any Action in any Territory relating to the Intellectual Property of any Third Party to enable or support the Business Activities, other than as covered by the terms of Section 6.10 (an Offensive Action), then the Controlling Party shall provide the other Party and, if applicable, the IP Steering Committee with notice of such determination along with the timeline for the commencement of such Action. No sooner than five (5) Business Days following delivery of such notice, the Controlling Party may (x) commence such Action on behalf of each of the Parties, using counsel of its own choosing, or (y) consent to the other Party commencing such Action on behalf of each of the Parties, using counsel of its own choosing. Without derogating from this Section 6.6(a), if required by Applicable Law or to the extent that the Controlling Party does not have standing to commence such Action in its own name, the other Party shall permit, and shall take all actions reasonably necessary to enable the Controlling Party to commence such Action in either or both of their respective names, including by being joined as necessary parties to such Action.
(b) In the event that any Third Party commences any Action relating to any Intellectual Property of such Third Party against any Party or any of such Partys Affiliates that will affect any of the Business Activities (a Third Party Action), the Party against whom such Action is commenced shall provide the other Party with prompt written notice thereof. Following the giving or receipt of such notice, as applicable, the Controlling Party shall determine the appropriate course of action, including either (x) assuming and controlling the defense of such Action with respect to each of the Parties, using counsel of its own choosing, or (y) consenting to the other Partys assumption and control of the defense of such Action with respect to each of the Parties, using counsel of its own choosing. To the
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extent that the other Partys assumption and control of the defense of any Third Party Action is expressly contemplated by the IP Strategy, then the Controlling Party shall be deemed to have consented to the Other Partys assumption and control of the defense of such Third Party Action. Except with the Controlling Partys prior written consent or as expressly contemplated by the IP Strategy, the other Party may not assume and control the defense of any Third Party Action; provided, that if the Controlling Party does not assume and control the defense of any Third Party Action commenced against the other Party, then the other Party may assume and control the defense of such Action solely with respect to itself, using counsel of its own choosing.
(c) The other Party shall provide all cooperation and assistance reasonably requested by the Controlling Party, including (i) notifying the Controlling Party of the existence of relevant facts applicable thereto and providing documents (including technical documentation and documentary evidence) related to the applicable Product and its development, any known prior art or as otherwise requested by the Controlling Party, (ii) allowing inspection, whether court-ordered or otherwise, of any facility owned, operated or controlled by Alvotech or its Affiliates, (i) providing witnesses who will assist in the preparation of evidence, provide written evidence, appear as witnesses in court and assist in other ways that the Controlling Party reasonably requests, (ii) identifying relevant experts to act as expert witnesses and (v) identifying and describing any Intellectual Property or know how that Alvotech has incorporated into a Product or into the processes to manufacture a Product (clauses (i) through (v) collectively, IP Litigation Assistance). The Controlling Party shall keep the other Party, such Partys counsel and, if applicable, the IP Steering Committee reasonably informed of the status and progress of any IP Actions (including providing such documentation and information as may be reasonably requested). The costs and expenses of keeping counsel retained by a Party (other than the Controlling Party) reasonably informed of the status and progress of any IP Actions shall be paid by such retaining Party. The Controlling Party shall consider in good faith all comments provided by the other Party and such other Partys counsel with respect to any IP Action and, to the extent permitted by Applicable Law, each other such Party and such other Partys counsel shall be permitted to attend (but not participate in) any proceeding with respect to any IP Action. Each Party shall be responsible for its own internal costs relating to IP Litigation Assistance (e.g., compensation of such Partys employees for time devoted to any IP Litigation Assistance) and such internal costs shall not be considered IP Litigation Costs of such Party, but any out-of-pocket costs (e.g., travel expenses) of any Party relating to IP Litigation Assistance shall be considered IP Litigation Costs of such Party, and the Controlling Party shall reimburse the other Party for any such IP Litigation Costs relating to IP Litigation Assistance.
(d) The Controlling Party may settle, compromise or consent to any judgment with respect to any IP Action without the prior written consent of the other Party on five (5) Business Days notice to the other Party (together with a complete copy of such proposed settlement, compromise, consent or judgment and such other documents as that other Party may reasonably request); provided, that if (i) prior to the expiration of such five (5) Business Day period, the other Party determines, and advises the Controlling Party of such determination in writing, that such settlement, compromise or consent to judgment would materially and adversely impact that other Party or any of its Affiliates, (ii) such settlement, compromise or consent to judgment would obtain any material non-monetary relief from the other Party or (iii) such settlement, compromise or consent to judgment does not release the other Party from all liability with respect to such IP Action other than the liability expressly contemplated by such settlement, compromise or consent to judgment, then the Controlling Party shall not settle, compromise or consent to any judgment with respect to such IP Action without the prior written consent of the other Party (not to be unreasonably withheld, delayed or conditioned). The Party that is not the Controlling Party may not settle, compromise or consent to any judgment with respect to any IP Action.
(e) Except as set forth in Section 6.6(c), Section 6.7 and Section 6.10, the Controlling Party shall pay all IP Litigation Costs incurred by the Controlling Party resulting from, arising out of or relating to any IP Action.
(f) If the settling, satisfaction or judgment with respect to any IP Action relating to any Alvogen Territory requires payment by Alvotech or Alvogen to any Third Party of any IP Settlement Costs, then the Controlling Party shall be responsible for paying directly, or reimbursing the other Party, as applicable, for such IP Settlement Costs.
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Section 6.7 Manufacturing Process.
(a) Alvotech warrants, covenants and agrees that the processes used by Alvotech to manufacture and produce the Products pursuant to this Agreement shall not, to Alvotechs Knowledge, infringe the intellectual property rights of any Third Party (other than the intellectual property rights of any Third Party of which Alvotech is not aware, and could not, with reasonable diligence, have been aware, a reasonably sufficient amount of time prior to the launch of the applicable Product as contemplated by the IP Strategy) in any of the Territories or in any jurisdiction in which any Product is manufactured; provided, that the foregoing warranty, covenant and agreement is not made with respect to any process used by Alvotech, the use of which is expressly contemplated by the IP Strategy (which, for clarity, shall be on a patent-by-patent basis).
Section 6.8 Alvogen Credit
(a) To the extent that Alvogen incurs or pays any IP Litigation Costs in connection with any IP Action relating to the Alvotech Intellectual Property in which it is the Controlling Party, Alvogen shall receive a credit against any and all amounts to be paid by Alvogen to Alvotech pursuant to Section 4.1(b) in an amount equal to one hundred percent (100%) of such IP Litigation Costs. To the extent that Alvogen applies any such credit against any amount paid or to be paid by Alvogen to Alvotech pursuant to Section 4.1(b) (the amount of such credit, the Applied Credit), the credit received by Alvogen with respect to the Product to which the action giving rise to the applicable IP Litigation Costs relates shall be increased by an amount equal to fifty percent (50%) of the Applied Credit. For the avoidance of doubt, Alvogen shall be deemed to have applied a credit to the extent that Alvogen reduces any amount otherwise payable by Alvogen to Alvotech by reducing such credit rather than making such payment in cash. Within ninety (90) days after the end of each calendar year in which Alvogen receives a credit pursuant to this Section 6.8(a) (the Credit Year), Alvotech shall reimburse Alovgen for any amounts for which it received a credit during the Credit Year, but which have not been applied pursuant to Section 4.1(b) prior to the date of such reimbursement (i.e., for the unapplied credit of Alvogen with respect to the Credit Year), and any unapplied credit of Alvogen with respect to the Credit Year shall be eliminated.
By way of example: Product A is involved in an IP Action in relation to the Alvotech Intellectual Property in which Alvogen is the Controlling Party and incurs $6,000,000 of IP Litigation Costs in 2020. As a result, Alvogen is entitled to a credit of $6,000,000 against amounts due from Alvogen to Alvotech pursuant to Section 4.1(b). If prior to March 31, 2021, Alvogen applies $2,000,000 of such credit against such amounts due from Alvogen to Alovtech, then the credit to which Alvogen is entitled pursuant to Section 6.8(a) with respect to 2020 shall be reduced to $4,000,000. Assuming Alvogen does not apply any more of such credit prior to March 31, 2021, then Alvotech shall reimburse Alvogen for $4,000,000 of IP Litigation Costs on March 31, 2021 and the credit to which Alvogen is entitled pursuant to Section 6.8(a) shall be reduced to zero (0).
Section 6.9 Reimbursement Requirements. To the extent that any Party would be required pursuant to this Article VI to reimburse any other Party (for any costs or expenses incurred by such other Party (or to otherwise pay any costs or expenses incurred by any other Party) with respect to any IP Action, such obligation shall be subject to submission by such other Party of reasonable documentation with respect thereto. To the extent that Alvogen would be entitled to receive a credit pursuant to this Article VI for any costs or expenses incurred by Alvogen with respect to any IP Action, such entitlement shall be subject to submission by Alovgen to Alvotech of reasonable documentation with respect thereto. To the extent that either Party would be entitled to be reimbursed for, or otherwise have paid, or Alvogen to receive a credit for, any costs or expenses incurred by that Party, such costs and expenses shall only be reimbursed, credited or paid to the extent reasonably incurred by that Party as determined in good faith by the other Party taking into account the commercial potential of the applicable Product in the applicable Territory. Unless otherwise provided in this Article VI, any payments in connection with indemnification or reimbursement required by this Article VI shall be made on a quarterly basis during the course of the IP Action.
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Section 6.10 Disputes Relating to Intellectual Property Claims Brought Against Third Parties By Alvotech or Alvogen.
(a) Each Party shall promptly give the other Party written notice (each, an IP Assertion Notice) of any actual or suspected infringements, misappropriations or other violations by a Third Party of the Alvogen Marks, the Product Marks or the Alvotech Intellectual Property (Infringing Activity) that come to such Partys or any of its Affiliates attention, as well as the identity of such Third Party and any evidence of such Infringing Activity within such Partys or any of its Affiliates custody or control that such Party or any of its Affiliates are reasonably able to provide.
(b) If the Infringing Activity involves the Alvogen Marks or the Product Marks, Alvogen shall have the first right, but not the obligation, at Alvogens sole cost and expense, to take any action in response to such Infringing Activity and/or to enter into or permit the settlement of any litigation or other enforcement action (collectively, Infringement Actions); provided, that Alvogen shall provide prompt written notice of any Infringement Action to Alvotech, permit Alvotech to review and comment on such Infringement Action and give reasonable consideration to any comments made by Alvotech in relation to such Infringement Action; provided, further, that Alvogen may not enter into any settlement or consent to any judgment with respect to such Infringement Action without Alvotechs prior written consent if the entry into such settlement or the consent to such judgment would diminish or otherwise adversely impact Alvotechs rights or reduce Alvogens obligations under this Agreement. If required by Applicable Law and to the extent Alvogen does not have standing, Alvotech shall permit, and shall take all actions reasonably necessary to enable, an Infringement Action to be brought in its name, including being joined as a necessary party, at Alvogens sole cost and expense. Alvogen shall reimburse Alvotech for all reasonable expenses incurred by Alvogen pursuant to its obligations under the preceding sentence.
(c) If Alvogen does not institute an Infringement Action against the Infringing Activity involving the Alvogen Marks or the Product Marks within three (3) months from the date of the IP Assertion Notice, Alvotech shall have the right, but not the obligation, at Alvotechs sole cost and expense, to bring the Infringement Action; provided, that Alvotech shall provide prompt written notice of any Infringement Action to Alvogen, permit Alvogen (subject to Alvogen signing a reasonable confidentiality agreement prepared by Alvotech) to review and comment on such Infringement Action and give reasonable consideration to any comments made by Alvogen in relation to such Infringement Action. If required by Applicable Law and to the extent Alvotech does not have standing, Alvogen shall permit, and shall take all actions reasonably necessary to enable, an Infringement Action to be brought in its name, including being joined as a necessary party, at Alvotechs sole cost and expense. Alvotech shall reimburse Alvogen for all reasonable expenses incurred by Alvogen pursuant to its obligations under the preceding sentence. Alvotech may not enter into any settlement or consent to any judgment with respect to such Infringement Action without the prior written consent of Alvogen (which consent will not be unreasonably withheld, delayed or conditioned).
(d) If the Infringing Activity involves the Alvotech Intellectual Property, Alvotech shall have the first right, but not the obligation, at Alvotechs sole cost and expense, to bring an Infringement Action; provided, that Alvotech shall provide prompt written notice of any Infringement Action to Alvogen, permit Alvogen (subject to Alvogen signing a reasonable confidentiality agreement prepared by Alvotech) to review and comment on such Infringement Action and give reasonable consideration to any comments made by Alvogen in relation to such Infringement Action. If required by Applicable Law and to the extent Alvotech does not have standing, Alvogen shall permit, and shall take all actions reasonably necessary to enable, an Infringement Action to be brought in its name, including being joined as a necessary party, at Alvotechs sole cost and expense. Alvotech shall reimburse Alvogen for all reasonable expenses incurred by Alvogen pursuant to its obligations under the preceding sentence. Alvotech may settle, compromise or consent to any judgment with respect to such Infringement Action without the prior written consent of Alvogen on five (5) Business Days notice to Alvogen; provided, that
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if, prior to the expiration of such five (5) Business Day period, Alvogen determines, and advises Alvotech of such determination in writing, that such settlement, compromise or consent to judgment would materially and adversely impact Alvogen or any of its Affiliates, or would diminish or otherwise adversely impact Alvogens rights or reduce Alvotechs obligations under this Agreement, then Alvotech shall not settle, compromise or consent to any judgment with respect to such Infringement Action without the prior written consent of Alvogen (which consent shall not be unreasonably withheld, delayed or conditioned).
(e) If Alvotech does not institute an Infringement Action against the Infringing Activity involving the Alvotech Intellectual Property within three (3) months from the date of the IP Assertion Notice, Alvogen shall have the right, but not the obligation, at Alvogens sole cost and expense, to bring the Infringement Action; provided, that Alvogen shall provide prompt written notice of any Infringement Action to Alvotech, permit Alvotech (subject to Alvotech signing a reasonable confidentiality agreement prepared by Alvogen) to review and comment on such Infringement Action and give reasonable consideration to any comments made by Alvotech in relation to such Infringement Action. If required by Applicable Law and to the extent Alvogen does not have standing, Alvotech shall permit an Infringement Action to be brought in its name, including being joined as a necessary party, at Alvogens sole cost and expense. Alvogen shall reimburse Alvotech for all reasonable expenses incurred by Alvotech pursuant to its obligations under the preceding sentence. Alvogen may not enter into any settlement or consent to any judgment with respect to such Infringement Action without the prior written consent of Alvotech (which consent will not be unreasonably withheld, delayed or conditioned).
(f) In any Infringement Action instituted by either Alvotech or Alvogen to enforce the Alvogen Marks, the Product Marks or the Alvotech Intellectual Property as provided herein, the other Party shall, at the reasonable request of the Party initiating such Infringement Action, cooperate and provide reasonable assistance to the Party prosecuting the Infringement Action. To the extent that the cooperation or assistance requested results in external costs being incurred by a Party, then the requesting Party shall be responsible for the payment of all reasonably incurred external expenses.
Section 6.11 Recovered Amounts. Any monetary damages, court-ordered third party costs, settlements, royalties or other recovery payable by any Third Party resulting from, arising out of or relating to any Infringement Action or any IP Action (Recovered Amounts) shall be distributed as follows:
(a) First, to reimburse the Party controlling the Infringement Action or IP Action for any IP Litigation Costs incurred by such Party in connection therewith, to the extent such Party has not been previously reimbursed therefor by application of any credit hereunder or otherwise;
(b) Second, to reimburse the Parties for any IP Litigation Costs incurred by the Parties in connection with any other IP Infringement Actions or IP Actions, to the extent not previously reimbursed by application of any credit hereunder or otherwise, on a pro rata basis among the Parties based upon the respective aggregate IP Litigation Costs incurred thereby and not previously reimbursed; and
(c) Thereafter, fifty percent (50%) to Alvotech and fifty percent (50%) to Alvogen.
The amount of any credits to which Alvogen is entitled pursuant to Section 6.8(a) shall be appropriately adjusted to reflect the application of any Recovered Amounts.
Section 6.12 Confidentiality of Actions. To the extent reasonably possible and permitted by Applicable Law and determined desirable by the IP Strategy, each of the Parties shall take all steps necessary to maintain as confidential, and to not publish or otherwise disclose, the existence and the substance of any IP Action or Infringement Action, and the existence and terms of any settlement or any judgment, award, decree or determination, or consent to any of the foregoing, relating to any Infringement Action.
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Section 6.13 Article XIII Not Applicable. Article XIII shall not apply to the extent its application would be inconsistent with this Article VI.
ARTICLE 7
FORECASTS AND ORDERS
Section 7.1 Forecasts and Orders. At least seven (7) months prior to the expected receipt of a Regulatory Approval with respect to a Product in a Territory, Alvogen shall provide to Alvotech a twenty-four (24) month forecast of its requirements for such Product (each such forecast, an Initial Forecast). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast of its anticipated requirements for each Product, and, beginning on the six (6) month anniversary of the Exercise Notice Delivery Date, the quantity of such Product, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the Rolling Forecast and, together with the Initial Forecast, the Forecasts). As used herein, the term Short-Term Forecast means the first seven (7) calendar months of the most recent Forecast, the term Fixed Requirements Month means the first, second or third calendar month set forth in a Short-Term Forecast, the term Variable Requirements Month means the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term Forecast, and the term Anticipated Monthly Product Requirements means, with respect to a given Product, the amounts set forth in the Short-Term Forecast with respect to such Product for a given calendar month. The Forecasts shall represent reasonable estimates for planning purposes only, which Alvogen shall be entitled to revise in future Forecasts, subject to the terms of this Section 7.1. Alvogen may adjust the Anticipated Monthly Product Requirements with respect to a given Product for each Variable Requirements Month set forth in each Short-Term Forecast to an amount not to exceed one hundred twenty-five percent (125%) or to be less than seventy-five percent (75%) of the Anticipated Monthly Product Requirements for such Product set forth in the Short-Term Forecast the first time that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to the terms of this Section 7.1, Alvogen shall purchase one hundred percent (100%) of the Anticipated Monthly Product Requirements for each Fixed Requirements Month set forth in each Short-Term Forecast less the amount, if any, of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer in accordance with Article VIII (the Obligated Purchases).
Section 7.2 Forecast Discussions. Within ten (10) Business Days following its receipt of each Forecast, Alvotech shall notify Alvogen if it reasonably expects that it will not be able to manufacture and deliver the amount of Products set forth on such Forecast during any month listed in such Forecast. If Alvotech provides such notice, then Alvotech and Alvogen shall work in good faith to reach a mutually acceptable alternative delivery forecast.
Section 7.3 Purchase Orders. Alvogen shall submit binding purchase orders for one or more Products (each, a Purchase Order) to Alvotech at least ninety (90) days prior to the requested delivery date for the Products ordered pursuant to such Purchase Order; provided that any Purchase Order may cover all or any portion of Alvogens Obligated Purchases for each month that is a Fixed Requirements Month at the time of submission of such Purchase Order, so long as Alvogen ultimately submits Purchase Orders that in the aggregate cover all of the Obligated Purchases for each Fixed Requirements Month. Each purchase of Products pursuant to a Purchase Order shall be governed exclusively by the terms contained herein and the Quality Agreement, and none of the provisions of such Purchase Order shall be applicable to such purchase except those specifying the identity of the Product being purchased, the quantity of the Products being ordered and the requested delivery dates for such Products. In the event of a conflict between the terms and conditions of this Agreement and any Purchase Order, the terms and conditions of this Agreement shall control.
Section 7.4 Purchase Order Acceptance. Alvotech shall be deemed to have accepted each Purchase Order five (5) Business Days after receipt thereof on the terms and subject to the conditions contained therein unless Alvotech issues a written notice of rejection during such five (5) Business Day period. Alvotech may reject a Purchase Order only as follows: (a) in whole, if such Purchase Order calls
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for the delivery of Products less than ninety (90) days from Alvotechs receipt of such Purchase Order or (b) if Alvogen orders quantities of Products for any calendar month in excess of twenty-five percent (25%) over those set forth in the Forecasts for such calendar month, in part, to the extent of such excess quantities; provided, however, Alvotech shall use commercially reasonable efforts to produce and deliver to Alvogen such excess quantities (subject to Section 7.5). Alvotech shall deliver Products against each Purchase Order that it has accepted pursuant to this Section 7.4 by the applicable delivery date(s) specified therein. The terms and conditions of any acknowledgment or other business form of Alvotech shall be of no force or effect other than to confirm or reject a Purchase Order in accordance with the foregoing terms.
Section 7.5 Purchase Order Changes and Cancellation.
(a) Changes. If Alvogen requests that changes be made to any of its Purchase Orders, Alvotech shall use commercially reasonable efforts to accommodate such changes within reasonable manufacturing capabilities and efficiencies. If Alvotech can reasonably accommodate such changes it will so notify Alvogen and the applicable Purchase Order shall be deemed amended to account for such requested changes. If Alvotech cannot reasonably accommodate such change, then Alvogen and Alvotech shall each nonetheless be bound to the original Purchase Orders.
(b) Cancellations. If Alvogen cancels any Purchase Order in its entirety, Alvotech shall be relieved of its manufacturing obligations relating to such Purchase Order but Alvogen will not be relieved of its payment obligation for (and Alvotech shall deliver to Alvogen) Product that Alvotech has started or completed manufacturing prior to the date of cancellation, unless Alvotech otherwise agrees in writing. Alvogen shall reimburse Alvotech for all actual out-of-pocket costs reasonably incurred by Alvotech and all losses reasonably related to unused production lines in connection with any cancelled Purchase Orders for which Alvogen has been relieved of its payment obligations as provided in this Section 7.5(b), in addition to the full amount of such Purchase Order that relates to Obligated Purchases.
Section 7.6 Inability to Manufacture; Supply Allocation.
(a) If Alvotech is unable to manufacture or supply one or more Products in the quantities or on the delivery dates specified in the applicable Purchase Order (including, for the avoidance of doubt, as a result of a Recall) other than (i) as a result of (A) a Recall for which Alvogen has been determined to be entirely at fault or (B) an event of force majeure (as defined in Section 14.1) or (ii) to the extent (and only to the extent) such Purchase Order would require Alvotech to deliver any quantity of Products in excess of the Obligated Purchases (each such inability to manufacture or supply, a Supply Failure), then it shall promptly notify Alvogen thereof and provide Alvogen with the underlying reason for such Supply Failure, the proposed remedial measures to be taken by Alvotech with respect to such Supply Failure and the date that such Supply Failure is expected to end, in each case, to the extent Alvotech has such information. Alvotechs delivery of the notification required by the immediately preceding sentence shall not relieve Alvotech of any of its obligations hereunder. Alvotech shall be solely responsible for undertaking commercially reasonable efforts to remediate each Supply Failure and to minimize any possible shortage of Product to Alvogen as a result of such Supply Failure. If Alvotech cannot undertake such measures promptly, then the Executive Steering Committee shall convene a meeting to discuss possible remedial action and to establish and implement a mutually agreed upon remediation plan.
(b) If a Supply Failure with respect to a Product (an Impacted Product) occurs and, as a result, Alvotech will not be able to manufacture and supply Alvogen with one hundred percent (100%) of the Obligated Purchases for each Fixed Requirements Month, then Alvogen, in its sole discretion and without limiting any other rights that Alvogen may have under this Agreement or under Applicable Law, may (i) agree to a revised delivery date, (ii) cancel some or all of its existing Purchase Orders for the Impacted Product without penalty, (iii) recover from Alvotech actual damages (including Alvogen Lost Profits) incurred by Alvogen as a result of such Supply Failure and/or (iv) purchase an amount of Competing Product with respect to the Impacted Product from a Third Party up to an amount reasonably sufficient to remedy the Supply Failure, and if Alvogen has previously exercised the
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Manufacture Option with respect to the Impacted Product, then the Designated Manufacturer may manufacture the Impacted Product without limitation following the commencement of such Supply Failure and continuing until such Supply Failure ends. If a Supply Failure occurs and Alvogen elects to purchase a replacement for the Impacted Product from a Third Party in accordance with this Section 7.6(b), then Alvotech shall provide Alvogen with all information and documentation in Alvotechs possession or control necessary for Alvogen to obtain and maintain a supply of such replacement product from a Third Party and reimburse Alvogen for all reasonable out-of-pocket costs and expenses actually incurred by Alvogen as a result thereof, along with an amount equal to the difference between (x) the price paid by Alvogen for such replacement product and (y) the price that Alvogen would have paid to Alvotech for the Impacted Product for the equivalent number of units of such replacement product. If Alvogen elects to recover actual damages in accordance with this Section 7.6(b), then Alvotech and Alvogen shall mutually determine in good faith the amount of such actual damages; provided, that if Alvotech and Alvogen are unable to mutually agree on the amount of such actual damages within thirty (30) Business Days following Alvotechs receipt of Alvogens claim for reimbursement of its actual damages, then Alvotech shall pay any undisputed amount to Alvogen and Alvotech and Alvogen shall resolve such dispute in accordance with Section 14.4 and Section 14.5. Notwithstanding the foregoing, in no event shall the aggregate amount payable by Alvotech to Alvogen pursuant to clause (iii) of the first sentence of this Section 7.6(b) and pursuant to the third sentence of this Section 7.6(b) with respect to any single Supply Failure (regardless of its length) as to any Product exceed the applicable Supply Failure Damages Cap; provided, that the maximum aggregate amount payable by Alvotech to Alvogen upon the occurrence of a Supply Failure with respect to any Product relating to Alvogens first purchase order with respect to such Product shall be an amount equal to the actual damages (including Alvogen Lost Profits) incurred by Alvogen during the twelve (12) month period immediately following the commencement of such Supply Failure, assuming that Alvogen were to sell all of the units of the Products set forth in the most recent Forecast provided to Alvotech prior to the commencement of such Supply Failure for such twelve (12) month period.
(c) If a Supply Failure occurs and, as a result of such Supply Failure, Alvotech is able to deliver some, but not all, of the quantity of the Impacted Product that Alvogen ordered pursuant to the applicable Purchase Order, then Alvotech shall allocate to Alvogen units of the Impacted Product such that Alvogen shall receive not less than the same percentage of units ordered pursuant to its Purchase Order that other Alvotech customers are receiving from Alvotech pursuant to their accepted purchase orders for the Impacted Product (but in no event shall Alvotech allocate to Alvogen a percentage of the total units being delivered that represents less than the percentage of the total units ordered by all customers (including Alvogen) that Alvogen received during the twelve (12) month period preceding such Supply Failure), until Alvotech has delivered to Alvogen one hundred percent (100%) of the number of units of such Impacted Product ordered by Alvogen pursuant to the applicable Purchase Order.
(d) If a Supply Failure occurs with respect to a Product and continues for more than twelve (12) months, then Alvogen shall be entitled to obtain approval of the FDA (and any other Regulatory Agency) for Alvogen or a Third Party to manufacture such Product to the extent that Alvogen or such Third Party has not already obtained such approval in connection with Alvogens exercise of the Manufacture Option in accordance with Article VIII, and, following receipt of such approval, manufacture any or all of its requirements for such Product itself, or purchase any or all of its requirements for such Product from such Third Party, as applicable, notwithstanding anything to the contrary contained herein. In connection therewith, Alvotech shall provide such assistance and grant a license to all rights in any intangible property, to Alvogen or such Third Party, as applicable, to the extent necessary for Alvogen or such Third Party to obtain such approval and to manufacture such Product and to the extent that Alvogen or such Third Party has not already received a license thereto in connection with Alvogens exercise of the Manufacture Option in accordance with Article VIII.
Section 7.7 Delivery. Alvotech shall deliver all Products to the location(s) specified by Alvogen, in accordance with the delivery schedule included in the applicable Purchase Order, at which point title to and risk of loss over the Products shall pass to Alvogen, including the control of ultimate destination and shipping. Alvotech shall not deliver any Product to Alvogen under this Agreement
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until (a) Alvotech has released such Product pursuant to the applicable Specifications and (b)Alvogen has authorized shipment of the Product by Alvotech after its review and approval in accordance with the provisions of Section 7.8(b) of the documentation and other materials that Alvotech is required to provide to Alvogen pursuant to Section 7.8(a) and Section 7.8(b) (such date, the Shipment Authorization Date); provided, however, that clause (a) of this sentence shall not relieve Alvotech of its obligation pursuant to Section 7.4 to deliver Product to Alvogen by the applicable delivery date set forth in the applicable Purchase Order. Alvogen will use commercially reasonable efforts to take delivery of all Products from Alvotech as soon as practicable following the Shipment Authorization Date, but in no event later than the delivery date specified in the applicable Purchase Order. Except as otherwise set forth in this Section 7.7, all freight, handling, insurance, duties, taxes and shipping expense relating to shipping the Products from Alvotechs manufacturing facility to the location(s) specified by Alvogen, in accordance with the delivery schedule included in the applicable Purchase Order, shall be borne by Alvotech.
Section 7.8 Inspection; Nonconforming Shipment.
(a) Certificate of Analysis and Certificate of Compliance. Upon completion of the manufacture of each batch of Product, Alvotech will provide Alvogen with a Certificate of Analysis and a Certificate of Compliance confirming that the batch was manufactured in conformity with the applicable Specifications, cGMP and all Applicable Laws.
(b) Inspection; Rejection. Alvogen shall have up to five (5) Business Days from the date of its receipt of the Certificate of Analysis and Certificate of Compliance that Alvotech is required to provide to Alvogen pursuant to Section 7.8(a) to inspect, and accept or reject, the corresponding batch as conforming or non-conforming with the applicable Product Specifications. If Alvogen reasonably believes, based upon its review of the Certificate of Analysis and Certificate of Compliance, that the applicable batch of Product does not conform with the applicable Product Specifications, Alvogen shall notify Alvotech during such five (5) Business Day period, and Alvotech will provide Alvogen with a copy of the master batch record and all other documents and records as required by the Quality Agreement and such samples of the batch and all other documents and records that Alvogen may reasonably request within two (2) Business Days of such request. Alvogen shall thereafter have an additional twenty-five (25) days to accept or reject the corresponding batch as conforming or non-conforming with the applicable Product Specifications. If Alvogen rejects the batch for failing to conform with the applicable Product Specifications, it shall promptly so notify Alvotech. If, as a result of further review and testing, Alvotech determines that the batch does conform to the applicable Product Specifications, Alvotech shall so notify Alvogen and Alvotech shall then submit samples of such batch to a mutually acceptable independent expert for testing.
(c) Testing. If such independent expert determines that the shipment conformed to the applicable Product Specifications, Alvogen shall bear all expenses of shipping to and testing by such independent expert of such shipment samples. If Alvotech or such independent expert confirms that such shipment did not meet the applicable Product Specifications, Alvotech shall replace, at no cost to Alvogen, that portion of the Product shipment that does not conform to the applicable Product Specifications, and shall bear all expenses of shipping and testing the shipment samples. Alvogen shall dispose of any nonconforming Product in its possession as directed by Alvotech, at Alvotechs expense.
(d) Deemed Acceptance. Alvogen shall be deemed to have accepted any Product that Alvogen does not reject for failing to conform to the applicable Specifications pursuant to this Section 7.8. The acceptance or deemed acceptance by Alvogen of any Product shall not affect any of Alvogens other rights under this Agreement, except that, upon Alvogens acceptance or deemed acceptance of any Product, Alvogen shall be deemed to have waived any claims relating to any defect with respect to such Product to the extent that such defect is disclosed in the applicable Certificate of Analysis and Certificate of Compliance in a reasonably conspicuous manner.
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Section 7.9 Product Defects and Returns. In the event that Alvogen receives any shipment of Products (or a portion thereof) that are not in compliance with the Packaging Specifications or are otherwise damaged or defective (other than as a result of a failure to conform to the applicable Product Specifications, in which case Alvogens rights with respect to such defective Product shall be as set forth in Section 7.8), Alvogen shall notify Alvotech within five (5) days following the day on which Alvogen received such Products, specifying the grounds for such rejection. Following delivery of such notice to Alvotech, Alvogen may return to Alvotech, at Alvotechs cost and expense, any such Products and Alvotech shall, at Alvogens option, either credit Alvogens account or provide non-defective replacement Products at no cost to Alvogen.
Section 7.10 Shelf Life. All Products shipped to Alvogen shall have an original approved Product shelf life of at least twenty-four (24) months, and all Products that have an original approved Product shelf life of twenty-four (24) months shall have, at the time of delivery to Alvogen, at least sixteen (16) months of remaining approved Product shelf life. All Products shipped to Alvogen that have an original approved Product shelf life of greater than twenty-four (24) months shall have, at the time of delivery to Alvogen, a remaining approved Product shelf life of at least seventy percent (70%) of the original approved Product shelf life.
Section 7.11 Labor Disputes. Alvotech shall promptly notify Alvogen of any anticipated labor dispute or labor shortage or any other labor performance interruption (a Labor Disruption) that Alvotech anticipates having a materially adverse impact on its ability to manufacture and supply any Product to Alvogen in accordance with the terms and conditions of this Agreement. Upon receipt of such notice, at Alvogens option at Alvotechs expense, Alvotech shall arrange for advance delivery or warehousing at locations acceptable to Alvogen of at least ninety (90) days worth of each Product affected by such Labor Disruption. Alvotech shall also provide Alvogen with its plan to satisfy its manufacture and supply obligations contained in this Agreement during such Labor Disruption as soon as practicable prior to the start of such Labor Disruption, and Alvotech shall keep Alvogen informed of the status of all negotiations related to the resolution of such Labor Disruption.
Section 7.12 Supply Chain Security. In connection with its manufacture and sale of the Products to Alvogen, Alvotech shall:
(a) implement procedures determined in Alvotechs sole discretion to screen all prospective employees (to the extent permitted by Applicable Law);
(b) require that all employees undergo security awareness training;
(c) ensure that all buildings used by Alvotech to manufacture or store any Product are constructed of materials that resist unlawful entry and protect against outside intrusion;
(d) take all steps necessary to put in place controls to protect against unauthorized access to buildings, containers, cargo storage areas, cargo, shipping documents and electronic systems;
(e) verify the physical integrity of all shipping containers used in connection with the shipment of any Product;
(f) strictly control all container seals and ensure that such seals meet or exceed the current PAS ISO 17712 standard for high security seals;
(g) utilize only international carriers and forwarders participating in the U.S. Customs-Trade Partnership Against Terrorism program or a comparable Authorized Economic Operator program (e.g., the European Union Taxation and Customs Union Directorate) to transport freight consigned to Alvogen; and
(h) provide Alvogen with proof that each supplier used by Alvotech is a certified participant in the U.S. Customs-Trade Partnership Against Terrorism program or a comparable Authorized Economic Operator program (e.g., the European Union Taxation and Customs Union Directorate).
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ARTICLE 8
PRODUCTION TRANSFER
Section 8.1 Manufacture Option.
(a) Subject to the terms and conditions of this Article VIII, Alvogen may, in its sole discretion, at any time after January 1, 2022, with respect to any Product (a Designated Product), (i) elect to engage a Third Party to manufacture, fill and package on its behalf, such Designated Product (the option described in this clause (i), the Manufacture Option, and the Third Party which is to manufacture, fill and package the Designated Product, the Designated Product Manufacturer) and, in connection therewith, the Designated Product Manufacturer may, in lieu of manufacturing any active drug substance (Drug Substance) required in connection with the manufacture of such Designated Product, require that Alvotech provide such Designated Product Manufacturer with such Drug Substance (the Alvotech Supply Option) or (ii) require that Alvotech purchase from a Third Party any Drug Substance required in connection with Alvotechs manufacture and supply of such Designated Product to Alvogen hereunder (the Alvotech Purchase Option, the Third Party which is to manufacture the Drug Substance, a Designated Drug Substance Manufacturer, and a Designated Product Manufacturer or a Designated Drug Substance Manufacturer, a Designated Manufacturer). Notwithstanding the foregoing, in no event shall the aggregate number of units with respect to any Designated Product manufactured by a Designated Product Manufacturer (or containing a Drug Substance manufactured by a Designated Drug Substance Manufacturer) represent more than twenty percent (20%) of the aggregate number of units of such Designated Product sold by Alvogen in any calendar year (the Manufacturing Cap). If Alvogen elects to exercise the Manufacture Option, Alvogen shall, to the extent commercially feasible, seek to transfer the manufacture, fill and package of units of the Designated Product to a Designated Product Manufacturer such that the units of the Designated Product manufactured, filled and packaged by the Designated Product Manufacturer and the units of the Designated Product manufactured, filled and packaged by Alvotech for Alvogen are sold by Alvogen at substantially the same average Net Sales price per unit. Alvogen may not engage a Third Party as a Designated Manufacturer without the prior written consent of Alvotech (which shall not be unreasonably be withheld, delayed or conditioned).
(b) If Alvogen elects to exercise the Manufacture Option or the Alvotech Purchase Option with respect to any Product, it shall deliver to Alvotech, at least six (6) months prior to the date on which Alvogen anticipates first taking any actions relating thereto (other than with respect to the preparation of the Manufacture Plan), written notice thereof (the Exercise Notice, and the date of delivery thereof, the Exercise Notice Delivery Date), which notice shall include, (i) if Alvogen exercises the Manufacture Option, (A) a statement as to whether Alvogen has elected to exercise the Alvotech Supply Option and details as to the Drug Substance to be supplied thereunder, (B) the identity of the Designated Product and the Designated Product Manufacturer, (C) the date on which Alvogen expects the Designated Product Manufacturer to commence manufacturing the Designated Product (including, if Alvogen elects to exercise the Alvotech Supply Option, the first date by which Alvogen expects that Alvotech shall be required to deliver to the Designated Product Manufacturer any Drug Substance with respect to the Designated Product Manufacturers manufacture of the Designated Product) and (D) the presentation(s) and quantities of the Designated Product that Alvogen expects the Designated Product Manufacturer to manufacture or (ii) if Alvogen exercises the Alvotech Purchase Option, (X) the identity of the Drug Substance that the Designated Drug Substance Manufacturer shall manufacture, (Y) the identity of the Designated Drug Substance Manufacturer and (Z) the date on which Alvogen expects the Designated Drug Substance Manufacturer to commence manufacturing the Drug Substance.
(c) If Alvogen exercises the Manufacture Option or the Alvotech Purchase Option, then promptly following the Exercise Notice Delivery Date, Alvotech and Alvogen shall negotiate in good faith with respect to the preparation of a plan (the Manufacture Plan) relating thereto. If Alvogen exercises the Manufacture Option, then the Manufacture Plan shall provide, among other things, that Alvotech shall, as soon as practicable following the six (6) month anniversary of the Exercise Notice Delivery Date, (i) deliver or license (on a royalty-free basis and pursuant to a mutually agreeable license agreement), as applicable, to Alvogen or the Designated Product Manufacturer all Intellectual Property,
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rights in intangible property, manufacturing records and data in the possession of Alvotech reasonably necessary for Alvogen or the Designated Product Manufacturer, as applicable, to (A) obtain all required Regulatory Approvals with respect to the manufacture of the Designated Product and (B) manufacture the Designated Product, (ii) make available any personnel of Alvotech reasonably necessary for the performance by Alvotech and Alvogen of their respective obligations set forth herein and in the Manufacture Plan and (iii) provide Drug Substance supply as required for the Designated Manufacturer to perform any necessary studies with respect to the Designated Product. In connection therewith, Alvotech and Alvogen shall form a joint technology transfer committee, consisting of an equal number of representatives of each of Alvotech and Alvogen (up to a maximum number of three (3) representatives each), which shall be responsible for implementing the Manufacture Plan. Alvogen shall pay all costs and expenses incurred by Alvogen in connection with the performance of its obligations under the Manufacture Plan, including all costs and expenses with respect to any applicable Regulatory Approvals required to be obtained by Alvogen or a Designated Product Manufacturer in connection with the manufacturing of the Designated Product, and Alvogen shall pay, or reimburse Alvotech for, all reasonable costs and expenses incurred by Alvotech in connection with the performance of its obligations under the Manufacture Plan.
(d) If, in connection with Alvogens exercise of the Manufacture Option, Alvogen exercises the Alvotech Supply Option, then Alvogen and Alvotech shall negotiate in good faith and enter into a customary supply agreement (the Alvotech Supply Agreement) and a customary quality agreement (the Alvotech Quality Agreement) with respect to the Drug Substance that Alvotech shall supply to Alvogen in connection with Alvogens exercise of the Alvotech Supply Option. Among other things, the Alvotech Supply Agreement shall provide that (x) Alvotech shall sell to Alvogen that quantity of Drug Substance with respect to a Designated Product as Alvogen may order from Alvotech, on and subject to the terms and conditions of the Alvotech Supply Agreement and the Alvotech Quality Agreement, (y) the aggregate purchase price to be paid to Alvotech by Alvogen for any Drug Substance purchased by Alvogen from Alvotech shall be equal to Alvotechs actual manufacturing cost with respect to such Drug Substance (including the allocable cost of Alvotech personnel, Indirect Costs and the other manufacturing overhead cost incurred by Alvotech in manufacturing and supplying such Drug Substance hereunder) and (z) Alvogen shall pay for all Drug Substance purchased by Alvogen from Alvotech pursuant to the Alvotech Supply Agreement within thirty (30) days following the later of the date of receipt of such Drug Substance by Alvogen and the date of receipt of the applicable invoice therefor by Alvogen.
(e) If Alvogen exercises the Alvotech Purchase Option with respect to any Designated Product, then Alvotech and the Designated Drug Substance Manufacturer shall negotiate in good faith and enter into a customary supply agreement (the Drug Substance Supply Agreement) and a customary quality agreement (the Drug Substance Quality Agreement) with respect to the Drug Substance that such Designated Drug Substance Manufacturer shall supply to Alvotech in connection with Alvogens exercise of the Alvotech Purchase Option. Among other things, the Drug Substance Supply Agreement shall provide that (i) Alvotech shall purchase from such Designated Drug Substance Manufacturer that quantity of Drug Substance with respect to the applicable Designated Product as may be agreed upon by Alvotech and Designated Drug Substance Manufacturer, on and subject to the terms and conditions of the Drug Substance Supply Agreement and the Drug Substance Quality Agreement, (ii) the aggregate purchase price to be paid by Alvotech for any Drug Substance purchased by Alvotech shall be equal to the actual price at which the Designated Drug Substance Manufacturer shall supply the Drug Substance, as agreed upon by Alvogen and such Designated Drug Substance Manufacturer, and (iii) Alvotech shall pay for all Drug Substance purchased by Alvotech from such Designated Drug Substance Manufacturer pursuant to the Drug Substance Supply Agreement within thirty (30) days following the later of the date of receipt of such Drug Substance by Alvotech and the date of receipt of the applicable invoice therefor by Alvotech. If Alvogen exercises the Alvotech Purchase Option, then, notwithstanding anything in Section 5.6 to the contrary, the Manufacturing Cost of any Product purchased by Alvogen from Alvotech that includes, as a Component thereof, any Drug Substance provided by Alvogen to Alvotech shall include Alvotechs actual cost of purchasing such Drug Substance from Alvogen.
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Section 8.2 Manufacture of Designated Product.
(a) If Alvogen exercises the Manufacture Option, then it shall ensure that the Designated Product Manufacturer manufactures such Designated Product in accordance with the applicable Product Specification (as may be amended by the Executive Steering Committee or through the procedures set forth in Section 9.4(b)), all applicable cGMP and all Applicable Laws. Neither Alvogen nor a Designated Product Manufacturer may make any changes to the applicable Product Specifications except (i) with the prior written approval of the Executive Steering Committee (subject to Section 5.2(b)) or (ii) with respect to changes thereto that are Required Changes. Alvogen shall package and label any Designated Product in accordance with the terms and conditions of Section 5.4. Promptly following Alvogens exercise of the Manufacture Option, Alvogen shall grant to the Designated Product Manufacturer a limited, revocable, non-exclusive, nontransferable, fully paid license (without the right to sublicense) to use the Alvogen Marks or the Product Marks (as applicable) during the Product Term solely for the purposes of (a) packaging, labeling and branding the Designated Products to the extent the Designated Products are required by Applicable Law to bear the Alvogen Marks, in each case in accordance with the Packaging Specifications.
(b) For each unit of Designated Product sold by Alvogen, Alvogen shall pay to Alvotech an amount equal to twenty percent (20%) of what the Manufacturing Cost would have been with respect to such unit of Designated Product if Alvotech had manufactured such unit of Designated Product (assuming that Alvogen did not exercise the Alvotech Purchase Option) (the Designated Product Percentage). Alvogen shall pay all such amounts to Alvotech within thirty (30) days following the delivery of such unit of Designated Product to the applicable customer.
(c) Upon the Exercise Notice Delivery Date with respect to any Designated Product, the restrictions imposed by Section 2.8(c) shall no longer prohibit Alvotechs performance of contract manufacturing for a Third Party of a Competing Product with respect to such Designated Product; provided, that (i) such contract manufacturing is performed pursuant to a customary fee-for-services arrangement and Alvotech does not receive any royalty or similar payment, share in any revenue or profit from or otherwise directly benefit from, in each case, the commercialization or sale of any Competing Product manufactured pursuant to such arrangement and (ii) Alvotechs performance of such contract manufacturing does not materially and adversely impact Alvotechs ability to perform or satisfy its obligations under this Agreement, including its ability to manufacture and supply the Products in quantities sufficient to meet Alvogens purchase requirements (including Alvogens purchase requirements as set forth in the Forecasts); provided, further, that in no event shall Alvotech be permitted to develop or manufacture any Drug Substance with respect to any Competing Product.
(d) For the avoidance of doubt, if Alvogen exercises the Manufacture Option with respect to any Designated Product, in no event shall Alvotech have any obligations with respect to (i) any product complaints received from a Third Party, (ii) any medical investigation, evaluation and reporting of adverse events or any medical or technical inquires resulting from, or otherwise directly related to the Designated Product Manufacturers manufacture, filing or packaging of such Designated Product, (iii) any batch of the Designated Product manufactured by the Designated Product Manufacturer that fails to comply with applicable cGMP or fails to meet the applicable Product Specifications, Regulatory Agency requirements or Applicable Law, (iv) the recall of any Designated Product manufactured by the Designated Product Manufacturer and (v) handling and responding to any FDA and other Regulatory Agency inspections with respect to the Designated Product Manufacturers manufacture of such Designated Product, except in any case as set forth in the Alvotech Supply Agreement or the Alvotech Quality Agreement pursuant to which Alvotech supplied the Designated Product Manufacturer with any Drug Substance for such Designated Product.
(e) If Alvogen exercises the Manufacture Option or the Alvotech Purchase Option with respect to a Designated Product and a Supply Failure with respect to a Product occurs, including a Supply Failure resulting from Alvotechs failure to have sufficient Drug Substance to manufacture and supply such Product in quantities sufficient to meet Alvogens purchase requirements, then Alvogen shall use commercially reasonable efforts to mitigate such Supply Failure by increasing the production of the applicable Impacted Product or Drug Substance, as applicable; provided, that Alvogen shall have no liability as a result of its failure to mitigate such Supply Failure and Alvogen shall not in any
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way lose any rights or remedies with respect to any Supply Failure to the extent not so mitigated other than, in each case, in the event of Alvogens breach of its obligations pursuant to this Section 8.2(e). Further, if Alvotech is unable to manufacture and supply a Product in quantities sufficient to meet Alvogens purchase requirements with respect to such Product, then Alvotech and Alvogen shall discuss in good faith the possibility of a Designated Manufacturer manufacturing additional quantities of such Product for Alvogen at prices and other terms to be negotiated. If a Designated Manufacturer manufactures any quantity of any Product or Drug Substance pursuant to this Section 8.2(e), then Alvogen shall not be required to pay to Alvotech the Designated Product Percentage with respect to any Designated Products that Alvogen sells, and the aggregate purchase price to be paid to Alvotech by Alvogen for each Product shall be equal to that portion of the Manufacturing Cost applicable to such Product, in each case during the period in which such Designated Manufacturer is supplying Alvotech with such Product or Drug Substance pursuant to this Section 8.2(e). If a Supply Failure with respect to a Product occurs or a Designated Manufacturer enters into an agreement with Alvogen to supply any Product or Drug Substance to Alvogen, then the limits imposed by the second sentence of Section 8.1(a) shall be of no force or effect during the period of such Supply Failure or the period during which the Designated Manufacturer is supplying Alvogen with the Product or Drug Substance.
Section 8.3 Audit Rights.
(a) Not earlier than April 1 and not later than May 31 of each calendar year, Alvotech shall have the right, upon ten (10) Business Days prior written notice to Alvogen, to review all relevant books and records of Alvogen and to meet with personnel of Alvogen to determine whether Alvogen exceeded the Manufacturing Cap during the immediately preceding calendar year. In connection therewith, Alvogen shall provide Alvotech with copies of all books, records and other information related to the manufacturing of the Designated Product(s), and any other documents or records reasonably requested by Alvotech (the Records). Alvotech shall be entitled to review the Records for a period of sixty (60) days following its receipt of substantially all of the Records (the Audit Period). If, following its review of the Records, Alvotech determines that Alvogen exceeded the Manufacturing Cap during the immediately preceding calendar year, then it shall provide Alvogen and the Executive Steering Committee with written notice of such determination, along with details of, and evidence and reasonable documentation supporting, such determination, within sixty (60) days following expiration of the Audit Period. Within thirty (30) days following receipt of such notice, the Executive Steering Committee shall convene a meeting to review and discuss Alvotechs determination and attempt to resolve any dispute with respect to whether Alvogen exceeded the Manufacturing Cap during the applicable calendar year. If the Executive Steering Committee is unable to resolve such dispute within such thirty (30) day period, then such dispute shall be resolved in accordance with Section 14.4 and Section 14.5 of this Agreement.
(b) If it is ultimately determined in accordance with Section 8.3(a) that Alvogen exceeded the Manufacturing Cap during any calendar year, then Alvogen shall pay to Alvotech an amount equal to the Cost of Goods Sold with respect to the manufacture of the units of the Designated Product that Alvotech manufactured but was not paid therefor by Alvogen and would have been paid therefor by Alvogen if Alvogen had not exceeded the Manufacturing Cap. For the avoidance of doubt, to the extent that Alvogen exceeds the Manufacturing Cap, this Section 8.3(b) contains Alvotechs sole and exclusive remedy with respect thereto.
ARTICLE 9
EXECUTIVE STEERING COMMITTEE
Section 9.1 Formation and Purpose. In order to fulfill the objectives of this Agreement, Alvotech and Alvogen shall form, within thirty (30) days of the Effective Date, an executive steering committee (the Executive Steering Committee) whose initial members shall be decided by the Parties on formation. The Executive Steering Committee shall: (i) serve as a forum to resolve any disputes between Alvotech and Alvogen, (ii) make determinations, appointments or decisions as expressly provided in other provisions of this Agreement, and (iii) establish, on mutual agreement between the Parties, one or more working committees, which may include a product development and medical affairs working committee (with the members thereof rotating based on the lifecycle of the Product), a manufacturing working committee, a commercialization working committee and a safety working committee (each, a Working Committee).
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Section 9.2 Membership. The Executive Steering Committee shall consist of three (3) individuals appointed by Alvogen and three (3) individuals appointed by Alvotech. If either Alvotech or Alvogen seeks to appoint any individual to the Executive Steering Committee, then (i) such appointee shall be an individual of suitable authority and seniority who has significant experience or expertise in biopharmaceutical financing, research, development, commercialization or marketing, (ii) the appointing Party shall provide biographical information supporting such qualifications, and (iii) the non-appointing Party shall have the right to approve each such appointee, which approval shall not be unreasonably withheld, delayed or conditioned; provided, that in the event that any such appointee does not receive approval, the appointing Party may appoint another individual, subject in each case to the provisions of this Section 9.2. In addition, Alvotech and Alvogen agree that it may be beneficial for them to appoint up to two (2) individuals to serve as non-voting observers at meetings of the Executive Steering Committee. Substitutes, replacements or alternates may be appointed at any time, so long as the Party proposing such substitution, replacement or alternate gives the non-proposing Party reasonable prior notice thereof; provided, that in each case, the substitutes, replacements or alternates are appointed in accordance with this Section 9.2. Each member of the Executive Steering Committee shall be subject to customary confidentiality requirements, as in effect from time to time, at any time while such member is on the Executive Steering Committee, including being required to execute a customary non-disclosure agreement.
Section 9.3 Meeting Requirements. The Executive Steering Committee shall meet no less than once a year and more frequently if required in accordance with this Agreement or otherwise agreed by the Parties. The Executive Steering Committee may meet by phone, videoconference or in- person, at a mutually-acceptable location. Each meeting shall be held on a date to be agreed upon by Alvotech and Alvogen. Notwithstanding the foregoing, meetings may be called at any time if requested by one of Alvotech and Alvogen by prior written notice, including the corresponding agenda of the meeting, sent to Alvotech and Alvogen, as applicable, at least one (1) month in advance; provided, that if a meeting is required to be convened promptly pursuant to this Agreement, Alvotech and Alvogen shall exercise commercially reasonable efforts to convene such meeting as promptly as is practicable. Alvotech and Alvogen agree that reasonable flexibility is necessary, and therefore, three (3) different dates shall be proposed for each meeting, whenever possible. Meetings shall only be effective if at least one (1) representative designated by Alvogen and one (1) representative designated by Alvotech are present or participating in the meeting.
Section 9.4 Decision-Making; Dispute Resolution.
(a) The Executive Steering Committee shall have a single chairperson with customary duties; the chairperson shall alternate between Alvotech and Alvogen every twelve (12) months, and shall initially be designated by Alvogen. All decisions of the Executive Steering Committee shall be made by unanimous vote and the highest-ranking executive attending or participating in the meeting of each of Alvotech and Alvogen on the Executive Steering Committee shall have the right to vote on behalf of any members of the Executive Steering Committee from such Party not attending or participating in the meeting.
(b) If the members of the Executive Steering Committee are unable to reach a unanimous decision as to any matter (including any matter expressly required to be resolved by the Executive Steering Committee pursuant to this Agreement) after a period of ten (10) days, then, except in relation to disputes relating to commercialisation matters that will be dealt with in accordance with the remaining provisions of this Section, either Alvotech or Alvogen may provide written notice of such dispute to the Chief Executive Officer of the other Party. If such dispute relates to a commercialization matter, then the Chief Commercialization Officers (or their respective designees, who shall not be members of the Executive Steering Committee) of each of Alvotech and Alvogen shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If such dispute relates to any other matter, then the Chief
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Executive Officers (or their respective designees, who shall not be members of the Executive Steering Committee) of each of Alvotech and Alvogen shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Commercialization Officers or their designees within thirty (30) days after submission of such dispute to such officers, then (a) the Chief Executive Officer of Alvogen shall have authority to finally resolve, in such officers reasonable discretion exercised in good faith, any dispute related to the commercialization of the Products in the Alvogen Territories, (b) the Chairman of Alvotech shall have authority to finally resolve, in such officers reasonable discretion exercised in good faith, any dispute related to (i) platform technology related to manufacturing and development, (ii) manufacturing of the Products, including any increase or decrease in the Manufacturing Cost submitted for approval to the Executive Steering Committee in accordance with Section 5.6, (iii) chemistry, manufacturing and controls or (iv) intellectual property matters in any Territory (other than with respect to the Alvogen Marks or the Product Marks) and (c) the Chief Scientific Officer of Alvotech shall have authority to finally resolve, in such officers reasonable discretion exercised in good faith, any dispute related to regulatory affairs with respect to the Alvogen Territories. In the event Alvotech does not have a Chief Scientific Officer at the time of any such dispute, the reference to Chief Scientific Officer shall at such time mean Alvotechs senior executive officer exercising the authority customary for the office of Chief Scientific Officer. If any dispute subject to this Section 9.4(b) is not resolved in accordance with the procedures set out in this Section 9.4(b), then such dispute shall be resolved in accordance with Section 14.5. Notwithstanding the foregoing, if the dispute concerns the interpretation of this Agreement, the performance or alleged non-performance of a Partys obligations under this Agreement, or any other breach or alleged breach of this Agreement, such matters shall be resolved in accordance with Section 14.4 and Section 14.5 of this Agreement.
Section 9.5 Meeting Minutes. Definitive minutes of the Executive Steering Committee shall be finalized no later than thirty (30) days after the meeting to which the minutes pertain, as follows: (i) Alvotech shall be responsible for preparing and sending a draft of the minutes to Alvogen, and shall furnish such draft to Alvogen within ten (10) days of such meeting, (ii) Alvogen shall have ten (10) days after receiving the draft minutes to collect comments and to discuss any modifications thereon and (iii) within the following ten (10) days, the final version of the minutes shall be issued by Alvotech and shall be approved by Alvogen and Alvotech by signing and dating the minutes. The minutes shall include a list of any actions, decisions or determinations approved by the Executive Steering Committee and a list of any issues yet to be resolved. In addition, the minutes shall set forth the place and date where the next meeting shall be held.
Section 9.6 Working Committees. Each of Alvotech and Alvogen shall appoint a reasonable number of members to each Working Committee (once created), which members shall have appropriate technical expertise and experience consistent with the area of focus of each Working Committee. The members of the Working Committee on product development and medical affairs shall rotate from time to time based on the lifecycle of the Products. Each Working Committee shall serve as a forum for the exchange of ideas and information and for collaboration with respect to its area of focus, and shall fulfill such other responsibilities as shall be delegated to such Working Committee by the Executive Steering Committee. No Working Committee shall, however, make any final decisions or determinations with respect to any matter requiring agreement of the Parties under this Agreement or a determination by any Party hereunder. Each Working Committee shall meet regularly as the Executive Steering Committee or the members of such Working Committee determine to be appropriate, and each Working Committee shall report on a regular basis to the Executive Steering Committee.
Section 9.7 Expenses. Each of Alvotech and Alvogen shall be responsible for the expenses of the participation of its representatives in the Executive Steering Committee and any Working Committees, including travel costs.
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Section 9.8 Information Rights; Access.
(a) Except as prohibited by Applicable Law or any applicable Regulatory Agency, Alvotech and Alvogen shall each provide the Executive Steering Committee, any applicable Working Committee and the other Party with access to all records, documents and information related to the development, regulatory status and commercialization of the Products that such Party determines in good faith to be material and relevant, or is requested in good faith by the other Party, to provide access to the members of the Executive Steering Committee, any applicable Working Committee and the other Party with a reasonable understanding of the status and progress of the development, regulatory status and commercialization of the Products (without duplication if the information has otherwise been reported pursuant to other reporting disclosure obligations set forth herein), including the following items, in each case only as such Party has a responsibility for such items under this Agreement:
(i) records, documents, data (including raw preclinical and clinical data) and other information related to any scientific studies,
(ii) data generated in scientific studies or memorialized in laboratory notebooks;
(iii) protocols, statistical analysis plans, final CSRs;
(iv) clinical trial enrollment, progress and results;
(v) Product forecasts, competitive intelligence and market research;
(vi) intellectual property issues regarding the Products and status of any litigation or other claims or disputes with regard to the Products;
(vii) regulatory strategy, filings, activities, status, approvals (or other responses) and results for Governmental Authorities;
(viii) market access and reimbursement status issues;
(ix) commercialization plans and forecasts for the Products;
(x) availability of adequate supply of Products following commercialization; and
(xi) annual financial statements of Alvotech, audited by an independent accounting firm, and quarterly unaudited financial statements of Alvotech, which, in each case, shall include a balance sheet, statement of operations and statement of cash flows.
(b) Alvotech shall ensure that Alvogen shall have full reasonable access to all clinical sites, including the ability to make site visits, and the contract research organization (CRO) for each of the Products.
(c) All information received or subject to review under this Section 9.8 shall be considered Confidential Information, shall be subject to the provisions of Article X.
Section 9.9 Agreement by Consent of the Parties. Notwithstanding anything in this Agreement to the contrary, to the extent that this Agreement provides for a determination or other decision to be made by mutual or unanimous consent or mutual or unanimous agreement of the Parties and the Parties are unable to make such determination or other decision in accordance with the applicable terms of this Agreement, such determination or other decision shall be referred to the Executive Steering Committee for resolution, and shall be resolved, pursuant to Section 9.4.
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ARTICLE 10
CONFIDENTIALITY; TAXES
Section 10.1 Confidentiality. Each of Alvotech and Alvogen acknowledges that, in the course of discussions and negotiations and performing its obligations hereunder, (a) it has received or may receive information from the other Party and (b) the Parties may jointly create or develop information, data and processes that one or more of the Parties wish to protect from public disclosure (all information described in clauses (a) and (b), unless subject to the Confidentiality Exceptions, Confidential Information). Each Party shall retain in confidence all Confidential Information of the other Party and related to the Business and (except as expressly provided herein) shall not use Confidential Information of the other Party for any purpose other than the purposes indicated herein or disclose such Confidential Information to a Third Party other than its Agents without the written consent of the other Party. Confidential Information shall not include information that: (i) is or becomes public knowledge (through no fault of the receiving Party); (ii) is made lawfully available to the receiving Party by an independent Third Party that, to the knowledge of the receiving Party, is under no duty of confidentiality to the disclosing Party; (iii) is already in the receiving Partys possession at the time of receipt from the disclosing Party (and such prior possession can be reasonably demonstrated by competent evidence by the receiving Party) other than as a result of disclosure by an independent Third Party that, to the actual knowledge of the receiving Party, was under a duty of confidentiality to the disclosing Party; or (iv) is independently developed by the receiving Party and/or Affiliates without the use of Confidential Information (and such independent development can be reasonably demonstrated by competent evidence by the receiving Party) (collectively, the Confidentiality Exceptions). Notwithstanding the foregoing, a receiving Party may disclose Confidential Information to the extent required by Applicable Law; provided, however, that if legally permissible, the receiving Party shall give the disclosing Party advance written notice as promptly as is practicable to permit it to seek a protective order or other similar order, at the disclosing Partys sole cost, with respect to the disclosure of such Confidential Information, and, thereafter, the receiving Party shall disclose only the minimum Confidential Information that it is advised by counsel is required to be disclosed in order to comply. The Confidential Information described under clause (b) above (Joint Information) shall be considered Confidential Information of each of the Parties; provided, that, notwithstanding anything to the contrary in this Section 10.1 or Section 6.4, either of Alvotech or Alvogen may use Joint Information in connection with any aspect of its operations, not only in connection with this Agreement and the Business; provided, further, that the other confidentiality provisions of this Article X shall continue to apply to such Joint Information.
Section 10.2 Agents and Investors. Each of Alvotech and Alvogen shall limit disclosure of the other Partys Confidential Information to only those of their respective existing or prospective Affiliates, directors, managers, general partners, officers, employees and contractors (collectively Agents) who are concerned with the performance of this Agreement and have a legitimate need to know such Confidential Information in the performance of their duties and shall take reasonable measures to ensure that their respective Agents to whom Confidential Information is disclosed do not further disclose such Confidential Information to any Third Party, except as otherwise expressly permitted hereunder. Each Party may also disclose Confidential Information of the other Party to any stockholder, member, partner or investor (each, an Investor) of such first Party, but only if (i) such other Party has given prior written consent of such disclosure to such Investor (not to be unreasonably withheld, delayed or conditioned) and (ii) such Investor enters into a confidentiality agreement with such other Party, in form and substance reasonably acceptable to such other Party. Each Party shall be responsible for any breach of this Section 10.2 by its Agents or Investors and shall take all reasonably necessary measures to restrain its Agents and Investors from unauthorized disclosure or use of the Confidential Information.
Section 10.3 Restrictions on Sharing Information. Notwithstanding anything to the contrary, neither Party shall be obligated pursuant to this Agreement to provide, or grant access to, any information (a) that it reasonably and in good faith considers to be confidential information covered by an enforceable confidentiality agreement with a Third Party that restricts the disclosure of such information, (b) the disclosure of which would adversely affect the attorney-client privilege between such Party and its counsel or (c) the disclosure of which is not permitted pursuant to any Applicable Law or requirement of a Governmental Authority. Following the Effective Date and during the term of this Agreement, in connection with entering into any material agreement (or material amendment thereof) with any Third Party related to the Business, each Party agrees to use commercially reasonable efforts to negotiate with such Third Party to include provisions in such agreement (or such amendment) sufficient to allow the other Party to exercise its rights hereunder, including the right to receive relevant confidential information of such Third Party.
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Section 10.4 Taxes.
(a) Alvotech hereby warrants and agrees that it is treated, and shall be treated throughout the term of this Agreement, as a foreign person for all U.S. federal income tax purposes (including for purposes of the applicable provisions of the U.S. Internal Revenue Code of 1986, as amended, and the U.S. Treasury Regulations concerning information reporting, withholding tax and backup withholding tax (including as such term is used in Treasury Regulations §§ 1.6041- 4(a)(4) and 1.1441-4(a)(3)).
(b) Alvotech hereby warrants and agrees that it is a public limited company duly organized and existing under the laws of Iceland and is treated, and shall be treated throughout the term of this Agreement, as a foreign corporation for all U.S. federal income tax purposes.
(c) Alvotech shall deliver to Alvogen on or prior to the date of this Agreement, and promptly upon request by Alvogen, an accurate and complete originally signed IRS Form W-8BEN-E (or any successor or other applicable form prescribed by the Internal Revenue Service). In addition, Alvotech agrees that from time to time after the date hereof, when a lapse in time (or change in circumstances occurs or any other reason) renders the prior IRS W-8BEN-E form provided hereunder obsolete or inaccurate in any respect, Alvotech shall promptly deliver to Alvogen a new and accurate and complete originally signed IRS Form W-8BEN-E (or any successor or other applicable forms prescribed by the Internal Revenue Service.
(d) Alvotech acknowledges and agrees that it will not claim any credit for U.S. federal income tax purposes (including under Section 41 of the U.S. Internal Revenue Code of 1986, as amended) with respect to any amount paid or payable to Alvogen under this Agreement or any research and development expenses funded by such amounts.
(e) The Parties agree that for U.S. federal income tax purposes they will treat the transaction under this Agreement, unless otherwise required by Applicable Law, as a collaboration agreement that does not constitute a partnership or a joint venture, and agree to not take (or cause any Person to take), any position on any Tax return or in the course of any audit or examination inconsistent with such treatment, unless otherwise required by Applicable Law and except upon a final determination of the applicable Taxing Authority.
(f) Any and all payments by or on account of any obligation of either Party under this Agreement shall be made without deduction or withholding for any Taxes, except as required by Applicable Law. If any Applicable Law (as determined in the good faith discretion of the applicable withholding Party) requires the deduction or withholding of any Tax from any such payment by any Party, then the applicable Party shall be entitled to make such deduction or withholding and shall timely pay the full amount deducted or withheld to the relevant governmental authority in accordance with Applicable Law. As soon as practicable after any payment of Taxes by any Party to a Governmental Authority pursuant to this Section 10.4(f), such Party shall deliver to the other Party that was entitled to the payment subject to withholding, the original or a certified copy of a receipt issued by such governmental authority evidencing such payment, a copy of the return reporting such payment or other evidence of such payment reasonably satisfactory to the other Party. Upon the request of a Party, the Parties shall reasonably cooperate and shall use such reasonable efforts as necessary to reduce or eliminate the withholding of any Taxes from any payment by or on account of any obligation of one Party to the other Party. To the extent that such request is made by the Party entitled to the payment subject to withholding, such Party shall pay all reasonable costs and expenses incurred by the other Party in connection with any such cooperation and efforts.
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ARTICLE 11
WARRANTIES AND COVENANTS
Section 11.1 Warranties of Alvotech . Alvotech hereby warrants to Alvogen as of the Effective Date as follows:
(a) Organization and Good Standing. Alvotech is duly incorporated, validly existing and in good standing under the laws of Iceland with all requisite power and authority required to conduct its business as presently conducted.
(b) Authority. Alvotech has all requisite power and authority to execute and deliver this Agreement and to perform all of its obligations hereunder. The execution and delivery by Alvotech of this Agreement and the performance by Alvotech of its obligations hereunder have been duly authorized by all requisite limited company or similar action of Alvotech, and no other action on the part of Alvotech or its shareholders is necessary to authorize the execution, delivery or performance by Alvotech of this Agreement.
(c) Valid and Binding Agreement. This Agreement has been duly executed and delivered by Alvotech and constitutes the legal, valid and binding obligation of Alvotech, enforceable against Alvotech in accordance with its terms, except to the extent that the enforceability thereof may be limited by (i) applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or similar laws from time to time in effect affecting generally the enforcement of creditors rights and (ii) general principles of equity.
(d) Non-Contravention. The execution and delivery of this Agreement by Alvotech and the performance by Alvotech of its obligations hereunder does not and will not (i) violate any provision of the organizational documents of Alvotech, (ii) conflict with or violate any Applicable Law applicable to Alvotech or any of its assets or properties, (iii) require any permit, authorization, consent, approval, exemption or other action by, notice to or filing with any entity or Governmental Authority (other than as expressly contemplated hereby), (iv) violate, conflict with, result in a material breach of, or constitute (with or without notice or lapse of time or both) a material default under, or an event which would give rise to any right of notice, modification, acceleration, payment, cancellation or termination under, or in any manner release any party thereto from any obligation under, any permit or contract to which Alvotech is a party or by which any of its properties or assets are bound or (v) result in the creation or imposition of any Lien on any part of the properties or assets of Alvotech.
(e) No Commissions. Except for the payments required to be made to Alvogen pursuant to the terms of this Agreement, Alvotech is not under any obligation to pay any commission or similar fee in connection with the transactions contemplated by this Agreement.
(f) No Litigation. There is no Proceeding with respect to Alvotech pending or, to Alvotechs Knowledge, threatened in writing, and, to Alvotechs Knowledge, there is no investigation with respect to Alvotech pending before any Governmental Authority, in each case (i) that would reasonably be expected to prevent the consummation of the transactions contemplated by this Agreement, (ii) that would reasonably be expected to materially adversely affect the Research Program, the Products or the conduct of the Business or (iii) that would reasonably be expected to materially adversely affect reimbursement for a Product under any program funded by a Governmental Authority.
(g) Regulatory Matters; Compliance with Law. Alvotech and its Affiliates are, and have been at all times, in compliance in all respects with Applicable Laws that are or were applicable to the conduct of the Business or the ownership or use of any Product, except where any non-compliance with Applicable Law would not reasonably be expected to have, individually or in the aggregate, a material adverse effect on the Products, the conduct of the Business or Alvotechs ability to perform its obligations hereunder. No Governmental Authority has notified Alvotech or any of its Affiliates or Subcontractors that any activities related to the Business are in violation of any Applicable Law or the subject of any Proceeding or investigation, except where any violation of Applicable Law or any Proceeding or investigation would not reasonably be expected to have, individually or in the aggregate, a material adverse effect on the Products, the conduct of the Business or Alvotechs ability to perform its obligations hereunder.
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(h) No Competing Products. As of the Effective Date, neither Alvotech nor any of its Affiliates in any Alvogen Territory has an owned or in-licensed Competing Product of any Initial Product in any stage of development or commercialization, and neither Alvotech, nor any of its Affiliates has any present program and Alvotech has no approval from the Alvotech Product Review Committee to develop or acquire such a Competing Product of any Initial Product in any Territory.
(i) Intellectual Property.
(i) Except for the rights granted pursuant to Article VI, Alvotech exclusively owns all right, title and interest in and to the Alvotech Intellectual Property. None of the Alvotech Intellectual Property has been or is the subject of (A) any pending Proceeding with respect to inventorship challenges, interferences, reissues, reexaminations, inter parties review, post grant review, supplemental review, invalidation, opposition, cancellation or abandonment or any order, decree or other restriction of any Governmental Authority or other agreement restricting the use of such Alvotech Intellectual Property in connection with the Products, or (B) to Alvotechs Knowledge, any threatened Proceeding of the types described in clause (A).
(ii) Neither Alvotech nor any of Alvotechs Affiliates has received written notice from any Third Party claiming that the practice of the Alvotech Intellectual Property, conduct of the Business, or development, making, using, sale, offer for sale, or import of the Products infringes any patent claim of any Third Party or misappropriates or makes any unauthorized use of any patent or intellectual property rights of any Third Party.
(iii) To Alvotechs Knowledge, no Third Party is infringing, misappropriating or making any unauthorized use of any Alvotech Intellectual Property, and there is no Proceeding or investigation in contemplation of a Proceeding) by Alvotech pending or threatened against any Third Party relating to any Alvotech Intellectual Property.
(iv) None of the Alvotech Intellectual Property is subject to any outstanding decree, order, judgment or stipulation restricting in any manner the conduct of the Business or the development, making, use, sale, offer for sale or import of the Products.
(v) There are no contracts pursuant to which Alvotech in licenses or otherwise has rights under any patent or other Intellectual Property of any Third Party that is material to the Business or any Product or the Alvotech Intellectual Property. Alvotech has not out licensed or otherwise granted rights to any Third Party under any Alvotech Intellectual Property.
(j) Debarment. Neither Alvotech, nor any of its Affiliates, employees or agents has ever been, is currently, or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Debarred Individual. If, during the term of this Agreement, Alvotech or any of its Affiliates, employees or agents becomes or is the subject of any FDA investigation or debarment proceeding that could lead to Alvotech or such Affiliate, employee or agent, as applicable, becoming a Debarred Entity or Debarred Individual, Alvotech shall immediately notify Alvogen, and Alvogen shall have the right to immediately terminate this Agreement. This provision shall survive termination or expiration of this Agreement.
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Section 11.2 Warranties of Alvogen. Alvogen hereby warrants to Alvotech as of the Effective Date as follows:
(a) Organization and Good Standing. Alvogen is duly formed, validly existing and in good standing under the laws of the Grand Duchy of Luxembourg with all requisite power and authority required to conduct its business as presently conducted.
(b) Authority. Alvogen has all requisite corporate power and authority to execute and deliver this Agreement and to perform all of its obligations hereunder. The execution and delivery by Alvogen of this Agreement and the performance by Alvogen of its obligations hereunder have been duly authorized by all requisite corporate action of Alvogen and no other action on the part of Alvogen or its stockholders is necessary to authorize the execution, delivery or performance by Alvogen of this Agreement.
(c) Valid and Binding Agreement. This Agreement has been duly executed and delivered by Alvogen and constitutes the legal, valid and binding obligation of Alvogen enforceable against Alvogen in accordance with its terms, except to the extent that the enforceability thereof may be limited by (i) applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or similar laws from time to time in effect affecting generally the enforcement of creditors rights and (ii) general principles of equity.
(d) Non-Contravention. The execution and delivery of this Agreement by Alvogen and the performance by Alvogen of its obligations hereunder, including the grant of the license pursuant to Section 6.2, does not and will not (i) violate any provision of the organizational documents of Alvogen, (ii) conflict with or violate any Applicable Law applicable to Alvogen or its assets or properties, (iii) require any permit, authorization, consent, approval, exemption or other action by, notice to or filing with any entity or Governmental Authority (other than as expressly contemplated hereby), (iv) violate, conflict with, result in a material breach of, or constitute (with or without notice or lapse of time or both) a material default under, or an event which would give rise to any right of notice, modification, acceleration, payment, cancellation or termination under, or in any manner release any party thereto from any obligation under, any permit or contract to which Alvogen is a party or by which any of its properties or assets are bound or (v) result in the creation or imposition of any Lien on any part of the properties or assets of Alvogen.
(e) No Commissions. Except for any payments required to be made to Alvotech pursuant to the terms of this Agreement, Alvogen is not under any obligation to pay any commission or similar fee in connection with the transactions contemplated by this Agreement.
(f) No Litigation. There is no Proceeding with respect to Alvogen pending or, to Alvogens Knowledge, threatened in writing, and, to Alvogens Knowledge, there is no investigation with respect to Alvogen pending before any Governmental Authority, in each case (i) that would reasonably be expected to prevent the consummation of the transactions contemplated by this Agreement, (ii) that would reasonably be expected to materially adversely affect the Research Program, the Products or the conduct of the Business or (iii) that would reasonably be expected to materially adversely affect reimbursement for a Product under any program funded by a Governmental Authority.
(g) Regulatory Matters; Compliance with Law. Alvogen and its Affiliates are, and have been at all times, in compliance in all respects with Applicable Laws that are or were applicable to the conduct of the Business or the ownership or use of any Product, except where any non-compliance with Applicable Law would not reasonably be expected to have, individually or in the aggregate, a material adverse effect on the Products, the conduct of the Business or Alvogens ability to perform its obligations hereunder. No Governmental Authority has notified Alvogen or its Affiliates or Subcontractors that any activities related to the Business are in violation of any Applicable Law or the subject of any Proceeding or investigation, except where any violation of Applicable Law or any Proceeding or investigation would not reasonably be expected to have, individually or in the aggregate, a material adverse effect on the Products, the conduct of the Business or Alvogens ability to perform its obligations hereunder.
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(h) No Competing Products. As of the Effective Date, neither Alvogen nor any of its Affiliates in any Alvogen Territory has an owned or in-licensed Competing Product of any Initial Product in any stage of development or commercialization, and neither Alvogen nor any of its Affiliates has any present program and Alvogen has no approval from the Alvogen Product Review Committee to develop or acquire such a Competing Product of any Initial Product in any Alvogen Territory.
(i) Debarment. Alvogen warrants that neither it nor any of its Affiliates, employees or agents has ever been, is currently, or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Debarred Individual. If, during the term of this Agreement, Alvogen or any of its Affiliates, employees or agents becomes a Debarred Entity or Debarred Individual, Alvogen shall immediately notify Alvotech and Alvogen, and, if such occurrence materially and adversely affects Alvogens ability to perform its obligations hereunder, then Alvotech shall have the right to immediately terminate this Agreement. This provision shall survive termination or expiration of this Agreement.
Section 11.3 Public Announcements. Neither Party nor any of such Partys Affiliates shall make any public announcement regarding this Agreement or the terms and conditions thereof without the prior written consent of the other Party (not to be unreasonably withheld, delayed or conditioned), except to the extent such disclosure is required by Applicable Law; provided, however, that, without the prior written consent of Alvotech, Alvogen may (a) file with the Securities and Exchange Commission (the SEC) a Current Report on Form 8-K describing this Agreement and the transactions contemplated hereby, (b) file a copy of this Agreement with the SEC as an exhibit to such Current Report on Form 8-K or a subsequent periodic report and (c) upon notice to Alvotech, make such other public disclosures regarding this Agreement and the terms and conditions hereof as, on the advice of counsel for Alvogen, are required by applicable securities laws or regulations; provided, further, that the Parties shall consult with each other so as to minimize the necessary disclosure and shall seek confidential treatment of such portions of this Agreement or the terms and conditions thereof as agreed upon by the Parties and permitted under Applicable Laws.
Section 11.4 Disposition of Product Rights Following Termination of Research Program Based on a Technical Failure. Subject to Section 14.1, if either Alvotech or Alvogen terminates the Research Program with respect to a Product based upon a Technical Failure, then Alvotech and Alvogen shall meet as soon as reasonably practicable thereafter to discuss in good faith a mutually acceptable means of disposing of such Product.
Section 11.5 Insurance.
(a) Alvotech shall procure and maintain, at its own expense, the types of insurance specified below in United States Dollars with carriers rated A-VII or better with A. M. Best or similar rating agencies:
(i) during the Development Term and each Product Term, and for five (5) years thereafter if written on a claim made or occurrence reported form:
(A) workers compensation insurance in accordance with Applicable Law, which shall include a waiver of subrogation in favor of Alvogen;
(B) employers liability insurance with a limit of liability in an amount of not less than $500,000 and
(C) commercial crime or fidelity bond insurance in an amount of not less than $5,000,000 per occurrence and in the aggregate, including an endorsement for third party liability without the requirement of a conviction.
(ii) during the Development Term and each Product Term, and for five (5)years thereafter if written on a claim made or occurrence reported form:
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(A) commercial general liability insurance, including premises operations, products and completed operations, blanket contractual liability, personal injury and advertising injury including fire legal liability for bodily injury and property damage in an amount not less than $1,000,000 per occurrence and $2,000,000 in the aggregate;
(B) excess liability insurance, including products liability with a combined single limit in an amount of not less than $10,000,000 per occurrence and in the aggregate; and
(C) cargo legal liability insurance covering all risks of physical loss or damage to cargo handled by Alvotech, with a liability limit of not less than $500,000 per trailer.
(b) Alvogen and its Affiliates, directors, officers, employees and agents shall be an additional insured with respect to the commercial general liability, commercial automobile liability and excess liability policies described in Section 11.5(a). Prior to shipment of any Products, and annually thereafter, Alvotech shall furnish Alvogen with certificates of insurance evidencing the insurance coverages described in Section 11.5(a). The terms and conditions of each insurance policy obtained in accordance with this Section 11.5 shall require at least thirty (30) days written notice to Alvogen prior to any cancellation, non-renewal or material change of such policy (including all changes to the coverage provided by such policy). In the case of cancellation, non-renewal or material change in such coverage, Alvotech shall promptly provide Alvogen with a new certificate of insurance evidencing that Alvotech has obtained a new policy of insurance that meets the requirements of this Section 11.5. Alvotech agrees that its insurance shall act as primary and noncontributory from any other valid and collectible insurance maintained by Alvogen.
ARTICLE 12
TERM AND TERMINATION
Section 12.1 Term
(a) This Agreement shall commence on the Effective Date and, unless terminated earlier in accordance with its terms, shall expire in respect of each Product on the expiry of the relevant Supply Term.
Section 12.2 Termination.
(a) Notwithstanding anything contained herein to the contrary, Alvotech may terminate this Agreement in its entirety:
(i) upon sixty (60) days prior written notice to Alvogen if Alvogen has committed a material breach of this Agreement (with the specific nature of such breach, including the applicable provision of this Agreement that Alvogen has breached, being identified in such notice) if Alvogen fails to cure such breach (if curable) within such sixty (60) day period; or
(ii) immediately upon notice to Alvogen following, in the case of insolvency, the appointment of a receiver by a court of competent jurisdiction with respect to the material assets of Alvogen, the assignment for the benefit of creditors of the material assets of Alvogen, the entry of an Order for Relief under Title 11 of the United States Code against Alvogen or the appointment of a liquidator, administrator or similar officer in respect of Alvogen (or any analogous procedure in any jurisdiction).
(b) Notwithstanding anything contained herein to the contrary, Alvogen may terminate this Agreement in its entirety:
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(i) upon sixty (60) days prior written notice to Alvotech if Alvotech has committed a material breach of this Agreement (with the specific nature of such breach, including the applicable provision of this Agreement that Alvotech, as applicable, has breached, being identified in such notice) if Alvotech, as applicable, fails to cure such breach (if curable) within such sixty (60) day period; or
(ii) immediately upon notice to Alvotech following, in the case of insolvency, the appointment of a receiver by a court of competent jurisdiction with respect to the material assets of Alvotech, the assignment for the benefit of creditors of the material assets of Alvotech, the entry of an Order for Relief under Title 11 of the United States Code against Alvotech or the appointment of a liquidator, administrator or similar officer in respect of Alvogen (or any analogous procedure in any jurisdiction).
Section 12.3 Survival. Upon the termination of this Agreement or the expiration of the final Product Term, all covenants and agreements contained in this Agreement which, by their terms or context, are intended to survive will continue in full force and effect following the termination of this Agreement, including the provisions of Article I (Definitions), Section 5.12 (Maintenance of Registrations and Reporting), Article VI (Intellectual Property Ownership and Licenses), Article X (Confidentiality; Taxes; Nonsolicitation), Article XI (Warranties and Covenants), this Article XII (Termination), Article XIII (Indemnification) and Article XIV (Miscellaneous). Notwithstanding anything contained in this Agreement to the contrary, in no event shall the termination of this Agreement affect any Partys obligation to pay any amounts owed to the any other Party as of the time of such termination.
ARTICLE 13
INDEMNIFICATION AND LIABILITY LIMITS
Section 13.1 Indemnification by Alvotech.
(a) Alvotech shall indemnify, defend and hold harmless Alvogen, its Affiliates and its and their respective directors, officers, employees and agents from and against any and all losses, claims, actions, damages, liabilities, penalties, costs and expenses (including reasonable attorneys fees and court costs) (collectively, Losses), resulting from, arising out of or otherwise relating to (i) any breach by Alvotech of any of its obligations or warranties hereunder, (ii) the negligence, recklessness or willful misconduct by Alvotech or any of its Affiliates and Distributors or any of their respective officers, directors, employees, agents or representatives, (iii) any violation by Alvotech or any of its Affiliates and Distributors or any of their respective officers, directors, employees, agents or representatives of any Applicable Laws applicable to the performance of Alvotechs obligations under this Agreement, (iv) the development, manufacture, handling, use, storage, import, transport, promotion, marketing, advertising, distribution or sale of any Product by Alvotech or any of its employees, agents, Affiliates or Distributors in violation of this Agreement, (v) the manufacture, handling, use, storage, import, transport, distribution or sale of any Drug Substance by Alvotech or any of its employees, agents and Affiliates pursuant to Section 8.1, (vi) any sale of any Product outside the Territories, (vii) any clinical trial (including any Phase 1 Clinical Trial or Phase 3 Clinical Trial) conducted by Alvotech with respect to a Product solely resulting from Alvotechs failure to adhere to (A) the Research Plan or (B) any clinical protocol matters as determined under Article IX or (viii) any lack of safety or efficacy (including any allegations thereof) with respect to any of the Products solely resulting from Alvotechs failure to manufacture such Product in accordance with the applicable Product Specifications or otherwise resulting from Alvotechs manufacture of such Product.
Section 13.2 Indemnification by Alvogen. Alvogen shall indemnify, defend and hold harmless Alvotech, its Affiliates and its and their respective Affiliates directors, officers, employees and agents from and against any and all Losses resulting from (i) any breach by Alvogen of any of its obligations or warranties hereunder, (ii) the negligence, recklessness or willful misconduct by Alvogen or any of its Affiliates and Distributors or any of their respective officers, directors, employees, agents or representatives, (iii) any violation by Alvogen or any of its Affiliates and Distributors or any of their respective officers, directors, employees, agents or representatives of any Applicable Laws applicable to
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the performance of Alvogens obligations under this Agreement, (iv) the handling, use, storage, import, transport, promotion, marketing, advertising, distribution or sale of any Product by Alvogen or any of its employees, agents, Affiliates or Distributors in violation of this Agreement, or (v) the manufacture, handling, use, storage, import, transport, distribution or sale of any Designated Products or Drug Substance by Alvogen or any Designated Manufacturer, as applicable, or any of their respective employees, agents and Affiliates, pursuant to Section 8.1.
Section 13.3 Indemnification Procedure.
(a) The Party seeking indemnification under this Article XIII (the Indemnified Party) agrees to give prompt written notice (the Indemnification Notice) to the Party against whom indemnity is sought (the Indemnifying Party) of (i) the assertion of any claim, or the commencement of any proceeding in respect of which indemnity may be sought under this Article XIII (a Third Party Claim) or (ii) the existence of facts that it reasonably expects may give rise to a claim for indemnity under this Article XIII; provided, that the failure of an Indemnified Party to promptly notify the Indemnifying Party on a timely basis will not relieve the Indemnifying Party of any liability that it may have to the Indemnified Party unless and to the extent the Indemnifying Party demonstrates that it is materially prejudiced by the Indemnified Partys failure to give timely notice.
(b) If the Indemnifying Party does not object to any claim or claims made in the Indemnification Notice in a written objection (the Indemnification Objection) prior to the expiration of twenty (20) Business Days from the Indemnifying Partys receipt of the Indemnification Notice, the Indemnifying Party shall be deemed not to object to the information contained within the Indemnification Notice. If the Indemnifying Party delivers an Indemnification Objection within such twenty (20) Business Day period, the Indemnifying Party and the Indemnified Party shall attempt in good faith to resolve the dispute for twenty (20) Business Days after the Indemnifying Partys receipt of such Indemnification Objection. If no resolution is reached, the dispute shall be resolved in accordance with the provisions of Section 14.4 and Section 14.5.
(c) The Indemnifying Party, if it so elects, may assume and control the defense of a Third Party Claim at the Indemnifying Partys expense and shall consult with the Indemnified Party with respect thereto, including the employment of counsel reasonably satisfactory to the Indemnified Party; provided, however, that the Indemnifying Party shall not have the right to assume control of such defense if the claim that the Indemnifying Party seeks to assume control of (i) seeks material non-monetary relief or (ii) involves criminal or quasi-criminal allegations. If the Indemnifying Party is permitted to assume and control the defense of a Third Party Claim and elects to do so, the Indemnified Party shall have the right to employ counsel separate from counsel employed by the Indemnifying Party in any such action and to participate in the defense thereof, but the fees and expenses of such counsel employed by the Indemnified Party shall be at the expense of the Indemnified Party unless (x) the Indemnifying Party has specifically agreed in writing otherwise, (y) the Indemnified Party has been advised by outside counsel that a reasonable likelihood exists of a material conflict of interest between the Indemnifying Party and the Indemnified Party or (z) the Indemnifying Party has failed to assume the defense and employ counsel (in which case the fees and expenses of the Indemnified Partys counsel shall be paid by the Indemnifying Party if the Indemnifying Party otherwise has an obligation to indemnify the Indemnified Party for the related Third Party Claim). If the Indemnifying Party has assumed the defense of a Third Party Claim in accordance with the terms hereof, the Indemnifying Party may not enter into a settlement or consent to any judgment without the prior written consent of the Indemnified Party unless (A) such settlement or judgment involves monetary damages only, all of which will be paid, without limitation, by the Indemnifying Party, and no admission of fault or culpability on behalf of any Indemnified Party, and (B) a term of the settlement or judgment is that the Person or Persons asserting such claim unconditionally and irrevocably release all Indemnified Parties from all liability with respect to such claim; otherwise, the consent of the Indemnified Party shall be required in order to enter into any settlement of, or consent to the entry of a judgment with respect to, any claim (which consent shall not be unreasonably withhold, delayed or conditioned). If the Indemnifying Party does not assume and/or is not controlling the defense of a Third Party Claim for any reason, then the Indemnified Party may retain counsel of its own choosing, at the
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expense of the Indemnifying Party, and assume and control the defense of such Third Party Claim, and the Indemnifying Party shall have the right to employ counsel separate from counsel employed by the Indemnified Party in any such action and to participate in the defense thereof, but the fees and expenses of such counsel employed by the Indemnifying Party shall be at the expense of the Indemnifying Party. The Indemnified Party may not enter into a settlement or consent to any judgment of any Third Party Claim without the prior written consent of the Indemnifying Party (which shall not be unreasonably withheld, delayed or conditioned).
Section 13.4 Limitations on Liability. Except for Losses arising out of a failure of a Party to pay any amount owed hereunder, or arising as the result of the fraud, willful breach or fraudulent misrepresentation by a Party, or arising in respect of death or personal injury caused by that Partys negligence (or that of its Affiliates) and except for Losses actually paid or determined by a court of competent jurisdiction to be owing to a Third Party as a result of a Third Party Claim for which a Party may seek indemnification under Section 13.1 or Section 13.2 (including reasonable attorneys fees, court costs and other fees and expenses associated with the cost of defense thereof), neither Party, nor any of their respective Affiliates, directors, members, officers, employees, subcontractors or agents shall have, under any legal theory (including contract, tort (including negligence), breach of statutory duty or otherwise), any liability to the other Party for any consequential, indirect or punitive damages in connection with or arising out of this Agreement. For the avoidance of doubt, nothing contained in this Section 13.4 shall limit or in any way restrict any right of recovery of a Party to the extent expressly provided for elsewhere in this Agreement (including pursuant to Section 7.6).
Section 13.5 Unavailability of Indemnification. If the indemnification provided for in this Article XIII is held by a court of competent jurisdiction to be unavailable to an Indemnified Party with respect to any Loss, then the Indemnifying Party shall, in lieu of indemnifying such Indemnified Party hereunder, contribute to the amount paid or payable by such Indemnified Party as a result of such Loss in such proportion as is appropriate to reflect the relative fault of, and relative benefit enjoyed by, the Indemnifying Party, on the one hand, and the relative fault of, and relative benefit enjoyed by the Indemnified Party, on the other hand, in connection with the actions or omissions that resulted in such Loss as well as any other relevant equitable considerations.
Section 13.6 Other Losses. Notwithstanding anything in this Agreement to the contrary, if any Party incurs Losses relating to a lack of safety or efficacy with respect to a Product sold in a Territory (or allegation thereof) and such Losses do not result from, arise out of, or relate to an event, circumstance, action or failure to act covered by an indemnification obligation set forth in Section 13.1, then each of Alvotech and Alvogen shall be responsible (through the payment of, or the reimbursement of the Party incurring, the Losses) for a percentage of such Losses equal to the percentage of Net Sales that Alvotech or Alvogen, as applicable, receives or retains, as applicable, in accordance with Section 4.1 with respect to the Territory in which the sale of the Product giving rise to such Losses was made. The Party in whose Territory the sale of the Product giving rise to such Losses was made shall have the right to assume and control the defense of such claim; provided, that such Party may not settle, compromise or consent to any judgment with respect to such claim without the prior written consent of such other Party (which consent shall not be unreasonably withheld, delayed, or conditioned).
ARTICLE 14
MISCELLANEOUS
Section 14.1 Force Majeure.
(a) Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from the following causes beyond the reasonable control of the affected Party: fire, floods, earthquake, tsunami, ice, tornado, hurricane, windstorm, eruption, explosion, sabotage or vandalism, embargoes, war, acts of war (whether war be declared or not), invasion, domestic or foreign terrorist act, act of a public enemy, insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts,
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omissions or delays in acting by any Governmental Authority (each, an event of force majeure); provided, that such affected Party shall provide the other Party with prompt notice of the circumstances surrounding such a material failure or delay; provided, further, that the failure of an affected Party to promptly notify the other Party on a timely basis shall not prejudice the affected Party unless and to the extent the other Party demonstrates that it is materially prejudiced by the affected Partys failure to give such notice. For the avoidance of doubt, unless and until the Development Term or a Product Term is terminated in accordance with the terms of this Agreement, the occurrence of an event of force majeure shall not relieve any Party from making any payment, manufacturing and supplying any Product or otherwise fulfilling any obligation required hereunder, rather the period for performance of such obligation shall be tolled during the occurrence of such force majeure.
(b) If Alvotech becomes subject to an event of force majeure that interferes with production of Products at Alvotechs manufacturing facility, Alvotech and Alvogen shall mutually agree on implementation of an action plan to transfer production of Product to another Alvotech plant. Alvotech and Alvogen shall, after the execution of this Agreement and at the request of either Alvotech or Alvogen, meet to discuss and define such an action plan. Upon request, Alvotech shall provide Alvogen with a copy of its disaster recovery plan and its risk management and business continuity plans and, upon the occurrence of an event of force majeure to which Alvotech is subject, Alvotech shall take all applicable actions set forth in such plans if so requested by Alvogen.
Section 14.2 Notices. Any notice required or permitted to be given by any Party shall be in writing. All notices shall be to the Parties and addresses listed below, and shall be sufficiently given when received, if delivered personally or sent by overnight courier or, if noted below as being provided as a copy when pursuant to Article VI, by email.
If to Alvotech, to: | Alvotech hf. Saemundargata 15-19 101 Reykjavik Iceland Attention: Rasmus Rojkjaer | |||
With copies to: | White & Case LLP 5 Old Broad Street London, EC2N 1DW Attention: Ian Bagshaw | |||
And, if pursuant to Article VI, with copies to: | Andrea.Sweet@alvogen.com | |||
If to Alvogen, to: | 5 rue Heienhaff L-1736 Senningarberg Luxembourg Attention: Robert Wessman Arni Hardarson | |||
With copies to: | White & Case LLP 5 Old Broad Street London, EC2N 1DW Attention: Ian Bagshaw | |||
And, if pursuant to Article VI, with copies to: | Andrea.Sweet@alvogen.com |
Section 14.3 Governing Law. This Agreement shall be construed, governed, interpreted and applied in accordance with the laws of England and Wales, without giving effect to any conflicts of laws principles. The United Nations Convention on the International Sale of Goods is hereby expressly excluded.
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Section 14.4 Internal Dispute Resolution. In the event that a claim, dispute or difference arises out of or in connection with this Agreement, including any non contractual obligations arising in connection with this Agreement (a Dispute), that is not subject to the dispute resolution procedure in Section 9.4(b), prior to the initiation of proceedings as described in Section 14.5, the Dispute shall be submitted to the Chief Executive Officers of Alvogen and Alvotech, who shall use their good faith efforts to resolve the Dispute within fourteen (14) days after notice is provided pursuant to Section 14.2. If any such Dispute is not resolved by the Chief Executive Officers or their designees within fourteen (14) days after submission of such Dispute to such officers, then the Dispute shall be resolved in accordance with Section 14.5.
Section 14.5 Enforcement. If the Parties are unable to resolve any Dispute under Section 9.4(b) or Section 14.4, then the Parties irrevocably agree that the courts of England and Wales are to have exclusive jurisdiction to settle any such Dispute.
Section 14.6 Relationship of the Parties. The relationship of the Parties under this Agreement is that of independent contractors. Nothing contained in this Agreement nor shall the performance of any obligations under this Agreement create an association, partnership, joint venture or relationship of principal and agent, master and servant, or employer and employee between the Parties. Neither Party has any express or implied right or authority under this Agreement to assume or create any obligations or make any warranties on behalf of or in the name of the other Party or the other Partys Affiliates.
Section 14.7 Assignment. Neither Party may assign, transfer or sublicense any of its rights or obligations under this Agreement without the prior written consent of the other Party; provided, however, that either Party may assign this Agreement, in whole or in part, without such consent, to an Affiliate of such Party or to any Third Party successor by merger, acquisition or sale of all or substantially all of such Partys assets, upon written notice to the other Party of any such assignment and, in the case of an assignment to an Affiliate, such Party hereby guarantees the performance of any such Affiliate, and, in the case of a Third Party assignment, such Third Party shall assume the obligations and covenants, and shall make all of the warranties, of the assigning Party under this Agreement.
Section 14.8 Binding Effect. This Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective permitted successors and assigns; and by their signatures hereto, each Party intends to, and does hereby, become bound.
Section 14.9 Entire Agreement; Amendments. This Agreement, together with the Shareholders Agreement and the Quality Agreement (collectively, the Other Agreements) including the schedules and exhibits hereto and thereto, constitutes the whole agreement between the Parties relating to the subject matter of this Agreement and supersedes any prior written or oral arrangement, understanding or agreement between them relating to such subject matter. Each Party confirms that it has not entered into this Agreement on the basis of any representation, warranty, undertaking or other statement whatsoever, whether made negligently or innocently, by any person (whether a Party to this Agreement or not), other than as expressly set out in this Agreement. Each Party waives all rights and remedies which, but for this Section 14.9, might otherwise be available to it in respect of any such representation, warranty, collateral contract or other assurance. If there is any conflict, discrepancy, or inconsistency between the terms of the Quality Agreement, on the one hand, and this Agreement, on the other hand, in each case in regards to the subject matter thereof, the Quality Agreement, as applicable, shall control. The Parties, from time to time during the term of this Agreement, may modify any of the provisions hereof only by an instrument in writing duly executed by the Parties.
25.3 Severability. If any part or parts of this Agreement are held to be illegal, void or ineffective, the remaining portions of this Agreement shall remain in full force and effect. If any of the terms or provisions are in conflict with any Applicable Law, then such term(s) or provision(s) shall be deemed inoperative to the extent that they may conflict therewith, and shall be deemed to be modified or conformed with such Applicable Law. In the event of any ambiguity respecting any term or terms hereof, the Parties agree to construe and interpret such ambiguity in good faith in such a way as is appropriate to ensure its enforceability and viability. If any exclusive remedy provided hereunder is determined to be unenforceable, then the Party entitled to such remedy shall in lieu thereof be entitled to such other remedies as are available to such Party under this Agreement or in law or equity under Applicable Law, subject in any case to the limitations imposed by, and other terms of, this Agreement.
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Section 14.10 Rules of Construction. Interpretation of this Agreement shall be governed by the following rules of construction: (a) words in the singular shall be held to include the plural and vice versa, and words of one gender shall be held to include the other gender as the context requires; (b) references to the terms article, section, paragraph, exhibit and schedule are references to the articles, sections, paragraphs, exhibits and schedules to this Agreement unless otherwise specified; (c) references to $ and Dollars mean U.S. dollars; (d) the word including and words of similar import mean including without limitation, unless otherwise specified; (e) the word or shall not be exclusive; (f) provisions shall apply, when appropriate, to successive events and transactions; (g) a reference to any entity includes such entitys successors and permitted assigns; (h) this Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the Party drafting or causing any instrument to be drafted; and (i) each accounting term not otherwise defined in this Agreement has the meaning assigned to it in accordance with GAAP.
Section 14.11 Waiver.
No waiver of any right under this Agreement shall be effective unless in writing. Unless expressly stated otherwise, a waiver shall be effective only in the circumstances for which it is given. No delay or omission by either Party in exercising any right or remedy provided by law or under this Agreement shall constitute a waiver of such right or remedy. The single or partial exercise of a right or remedy under this Agreement shall not preclude any other nor restrict any further exercise of any such right or remedy. The rights and remedies provided in this Agreement are cumulative and do not exclude any rights or remedies provided by law except as otherwise expressly provided.
Section 14.12 Counterparts. This Agreement may be executed in multiple counterparts, and all such executed counterparts shall constitute the same agreement. It shall be necessary to account for only one such counterpart in proving the existence of terms of this Agreement.
Section 14.13 Electronic Execution and Delivery. A facsimile, PDF or other reproduction of this Agreement may be executed by one or more Parties, and an executed copy of this Agreement may be delivered by one or more Parties by facsimile, e-mail or other electronic transmission device pursuant to which the signature of or on behalf of such Party can be seen, and such execution and delivery shall be considered valid, binding and effective for all purposes. At the request of a Party, the other Party agrees to execute an original of this Agreement as well as any facsimile or reproduction thereof. The Parties hereby agree that neither Party shall raise the execution of facsimile, PDF or other reproduction of this Agreement, or the fact that any signature or document was transmitted or communicated by facsimile, e-mail or other electronic transmission device, as a defense to the formation of this Agreement.
Section 14.14 License Protection. The Parties acknowledge and agree that each of Alvotech and Alvogen shall be entitled to all of the rights and protections set forth in Section 365(n) of Title 11 of the United States Code with respect to all licenses contained herein.
Section 14.15 Further Assurances. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may reasonably be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
Section 14.16 Compliance with Applicable Laws. Each Party shall comply with all Applicable Laws governing its performance of the terms of this Agreement.
Section 14.17 Exhibits. All Exhibits referred to herein are hereby incorporated by reference.
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Section 14.18 Headings. The headings contained in this Agreement are used only as a matter of convenience, and in no way define, limit, construe or describe the scope or intent of any section of this Agreement.
Section 14.19 Expenses. Except as otherwise expressly set forth herein, each Party shall pay all costs and expenses incident to its negotiation and preparation of this Agreement and to its performance and compliance with all obligations contained herein on its part to be performed or complied with, including the fees, expenses and disbursements of its counsel and other advisors.
Section 14.20 No Third Party Beneficiaries. Except as contemplated by the terms of Article XIII, a Person who is not a Party to this Agreement has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce any of the terms of this Agreement. The rights of the Parties to terminate, rescind or agree any variation, waiver or settlement under this Agreement are not subject to the consent of any person that is not a Party to this Agreement.
Section 14.21 Equitable Remedies. Each Party acknowledges that a breach or threatened breach by such Party of any of its obligations under this Agreement would give rise to irreparable harm to the other Party for which monetary damages would not be an adequate remedy and hereby agrees that, in the event of such breach or a threatened breach by it of its obligations, the other Party shall, in addition to any and all other rights and remedies that may be available to it in respect of such breach, be entitled to seek equitable relief, including a temporary restraining order, an injunction or specific performance, subject in any case to Section 14.4 and Section 14.5.
IN WITNESS WHEREOF, the Parties hjave caused this Agreement to be executed as of the date first set forth above.
[Signature page follows]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first set forth above.
ALVOTECH HF. | ||
By: | /s/ Arni Hardarson | |
Name: Arni Hardarson | ||
Title: Authorised Signatory |
[Signature page to Product Rights Agreement - Alvotech hf.]
ALVOGEN LUX HOLDING SARL | ||
By: | /s/ Tomas Ekman | |
Name: Tomas Ekman | ||
Title: Class A Director |
[Signature page to Product Rights Agreement Alvogen Lux]
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Exhibit A
Alvogen Territories
Albania
Australi
Belarus
Bosnia
Bulgaria
China
Croatia
Cyprus
Czech Republic
Estonia
Hong Kong
Hungary
Iceland
Indonesia
Kazakhstan
Kosovo
Latvia
Lithuania
Macau
Macedonia
Malaysia
Malta
Moldova
Montenegro
Myanmar
New Zealand
Philippines
Poland
Romania
Russia
Serbia
Singapore
Slovak Republic
Slovenia
South Korea
Taiwan
Thailand
Ukraine
Vietnam
Exhibit 10.26
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. THE OMISSIONS HAVE BEEN INDICATED BY [***].
DATED 14 DECEMBER 2018
DEED OF AMENDMENT
between
Alvotech hf.
and
Alvogen Lux Holdings S.à r.l
relating to the Product Rights Agreement
CONTENTS
Clause | Page | |||||
1. |
Interpretation | 1 | ||||
2. |
Amendment | 2 | ||||
3. |
Entire Agreement | 8 | ||||
4. |
Counterparts | 8 | ||||
5. |
No rights of Third Parties | 8 | ||||
6. |
Governing Law and Jurisdiction | 8 |
THIS DEED OF AMENDMENT (Deed) is made on 14 December 2018
BETWEEN:
(1) | ALVOTECH hf., a public limited company incorporated under the laws of Iceland, having its registered offices at Sæmundargata 15-19, Reykjavík, Iceland, and registered under number 710113-0410 (Alvotech); and |
(2) | ALVOGEN LUX HOLDINGS S.à r.l., a private company with limited liability (société à responsabilité limitée) incorporated under the laws of the Grand Duchy of Luxembourg, having its registered office at 5, rue Heienhaff, L-1736 Senningerberg, Grand Duchy of Luxembourg and registered under number B-149.045 (Alvogen), |
(each a Party and together, the Parties).
WHEREAS:
(A) | On 22 January 2018, Alvotech and Alvogen entered into a Product Rights Agreement in relation to the development, distribution, marketing and commercialization of certain biosimilar products of Alvotech and its affiliates (the PRA). |
(B) | On or about the date of this Deed: |
(a) | Alvotech is to put in place a new convertible bond to refinance an existing bond and will use [***] of the proceeds from the new convertible bond to repay Alvogen a portion of the amount due to it under certain convertible loan agreements previously entered into between Alvogen and Alvotech; and |
(b) | Alvogen will release the existing guarantee of [***] which it provided to support the existing bond and will provide a new guarantee of [***] to support the new convertible bond (the New Guarantee). |
(C) | In consideration for Alvogen agreeing to provide the New Guarantee, the Parties have agreed to amend the PRA with effect from 22 January 2018 (the Effective Date) in accordance with the terms and conditions of this Deed. |
IT IS AGREED:
1. | Interpretation |
1.1 | In this Deed: |
(a) | unless a contrary intention appears, a reference to a clause or sub-clause is a reference to a clause or sub-clause of this Deed; |
(b) | any words following the terms including, include, in particular or any similar expression shall be construed as illustrative and shall not limit the sense of the words, phrase or term preceding those terms; |
(c) | the table of contents and headings are inserted for convenience only and do not affect the construction of this Deed; and |
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(d) | unless the context otherwise requires, words in the singular include the plural and vice versa and a reference to any gender includes all other genders. |
2. | Amendment |
2.1 | With effect from the Effective Date, the PRA is hereby amended as follows: |
(a) | the following new definitions are inserted into Section 1.1 (Defined Terms) of the PRA: |
Aflibercept Product means the product of Alvotech that is being developed as a Biosimilar to the reference product Aflibercept, as more specifically described in the applicable Product Data Sheet.
Alvotech Holdings means Alvotech Holdings S.A., a public limited liability company (société anonyme) incorporated and existing under the laws of the Grand Duchy of Luxembourg, having its registered office at 5, rue Heienhaff, L-1736 Senningerberg, Grand Duchy of Luxembourg, and registered with the Luxembourg Trade and Companies Register under number 229.193.
Eculizumab Product means the product of Alvotech that is being developed as a Biosimilar to the reference product Eculizumab, as more specifically described in the applicable Product Data Sheet.;
(b) | the definitions of Agreement in the first paragraph of page 1 of the PRA and Section 1.1 (Defined Terms) of the PRA are deleted in their entirety and the following definition is inserted into Section 1.1 (Defined Terms) of the PRA: |
Agreement means this product rights agreement, as amended, modified or varied from time to time in accordance with its terms.;
(c) | the definition of Alvotech Group is deleted in its entirety and replaced with the following: |
Alvotech Group means Alvotech Holdings and any subsidiary undertaking of Alvotech Holdings from time to time (and any other entity in which equity or debt securities are exchanged in consideration for equity and debt securities in Alvotech Holdings and/or any subsidiary undertaking of Alvotech Holdings).;
(d) | the definition of Alvotech Intellectual Property in Section 1.1 (Defined Terms) of the PRA is amended to add the following words at the end of the first sentence: |
, including any patents, patent applications or other intellectual property registrations obtained or filed by Alvotech or an Affiliate of Alvotech for any of the foregoing.;
(e) | in each of the definitions of Alvogen Territories and Other Territories in Section 1.1 (Defined Terms) of the PRA, the closing bracket immediately following the words the Adalimumab Product shall be moved to immediately follow the words the Bevacizumab Product.; |
(f) | a new definition of Key Territory shall be inserted in Section 1.1 (Defined Terms) of the PRA as follows: |
Key Territory means any Territory, the United States, any member state of the European Union and the United Kingdom following its withdrawal from the European Union.;
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(g) | the definitions of Failure to Meet Clinical Endpoints, Initial Products, Research Program and Technical Failure in Section 1.1 (Defined Terms) of the PRA are deleted in their entirety and replaced by the following: |
Failure to Meet Clinical Endpoints means, with respect to any Product, one or more of the primary endpoints for Regulatory Approval of a Phase 3 Clinical Trial for such Product have not achieved statistical significance as determined by the alpha level, specific statistical test(s) and primary or secondary analysis populations defined in the applicable final protocol(s) and, if applicable, statistical analysis plan, as (for the Alvogen Territories) each may be amended from time to time upon the mutual agreement of Alvotech and Alvogen, through the use of any of the statistical analysis methods specified in the applicable protocol(s), as (for each of the Alvogen Territories) may be amended from time to time upon the mutual agreement of Alvotech and Alvogen, for analysing such Products primary endpoints for Regulatory Approval.
Initial Products means the Adalimumab Product, the Aflibercept Product, the Denosumab Product, the Eculizumab Product, the Golimumab Product, and the Ustekinumab Product.
Research Program means all of Alvotechs, and its respective Affiliates and Subcontractors activities directed towards obtaining Regulatory Approval of the Products in any Alvogen Territory, including research, development, safety and efficacy studies, clinical trials (including Phase 1 Clinical Trials and Phase 3 Clinical Trials), process development, formulation work, regulatory, quality, data collection and analysis and project management (including required post-approval studies).
Technical Failure means, for a given Product:
(i) | Patient Safety Issues or Failure to Meet Clinical Endpoints. (A) the applicable reference product of such Product is no longer being marketed, commercialized or sold in any Key Territory as a result of a patient safety or efficacy issue, (B) such Product has experienced a Failure to Meet Clinical Endpoints or (C) Alvotechs Chief Scientific Officer has determined in good faith that such Product presents risk of death, a life-threatening condition or other serious safety concerns to patients (including a patient safety issue resulting from the use of a Product that causes a clinical hold to be issued by the FDA, EMA or other Regulatory Agency on a clinical trial for such Product) and, with respect to either clause (A) or (C), in the good faith determination of such Chief Scientific Officer, a party cannot ethically continue to administer the applicable compound to patients in clinical trials or, following Regulatory Approval, to market, commercialize and sell such Product in any Key Territory; |
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(ii) | Negative Regulatory Agency Response Letter. (A) Alvotechs receipt of a response letter from the EMA, the FDA or any Regulatory Agency in an Alvogen Territory, that is, or is equivalent to, a complete response letter from the FDA pursuant to 21 C.F.R. § 314.110 (or similar successor correspondence) regarding a Product such that, in the good faith determination of Alvotechs Chief Scientific Officer, Alvotechs receipt of Regulatory Approval with respect to such Product in a Key Territory is not reasonably likely; |
(iii) | Anticipated Product Cost Overruns or Delays. Alvotechs good faith determination that the scope of the Research Program with respect to such Product as reflected in the Research Plan, has changed such that (A) the aggregate anticipated costs following the Effective Date for development of such Product exceed the aggregate budgeted amount set forth in the Research Plan for such Product by more than twenty percent (20%) of such budgeted amount (the applicable Buffer) or (B) such change in scope would reasonably be expected to delay the date of submission of a complete application to the applicable Regulatory Agency (or Regulatory Agencies) for Regulatory Approval of such Product with respect to one or more Territories by at least two (2) years beyond the target date for submission of such application thereto. |
(iv) | Actual Product Cost Overruns or Delays. (A) Alvotech has actually incurred aggregate costs following the Effective Date for development of such Product that exceed the aggregate budgeted amount set forth in the Research Plan for such Product by more than the applicable Buffer, (B) the date of submission of a complete application to the applicable Regulatory Agency (or Regulatory Agencies) for Regulatory Approval of such Product with respect to one or more Territories has actually been delayed by at least two (2) years beyond the target date for submission of such application thereto or (C) the Regulatory Approval of the Product has actually been delayed by at least three (3) years beyond the submission date to the applicable Regulatory Agency of an application for Regulatory Approval with respect to such Product. |
(v) | Technical Transfer Delays. in the event that, following the First Commercial Sale of a Product, it is necessary to obtain approval of the FDA, EMA or any other Regulatory Agency for Alvotech to manufacture such Product at a new facility or for a Third Party to manufacture such Product (obtaining such approval and transferring the manufacturing of a Product to such Third Party being referred to as a technical transfer), (A) Alvogens good faith determination that the time for approval of the FDA, EMA or other Regulatory Agency for Alvotech to manufacture such Product at a new facility or for a Third Party to manufacture such Product after the necessity therefor arose would be longer than twenty four (24) months or (B) approval of the FDA, EMA or other Regulatory Agency for Alvotech to manufacture such Product at a new facility or for a Third Party to manufacture such Product has not been obtained by the date that is twenty-four (24) months after the necessity therefor arose; provided, that this clause (v) shall not become operative unless there is an actual or expected material interruption of supply to Alvogen of such Product; |
(vi) | Intellectual Property Matters. following consultation with, and receipt of a written legal opinion from, Alvogens external legal advisors, the good faith determination of Alvogens General Counsel that (A) an Adverse Determination has resulted from Alvogens launch of such Product in a |
4
Territory and, as may be applicable, either such Adverse Determination has become final and non-appealable or Alvogens General Counsel has determined in good faith that it is not likely that an appeal of such Adverse Determination will ultimately be successful or (B) an Adverse Determination is likely to result from Alvogens launch of such Product in an Alvogen Territory; or |
(vii) | Lack of Working Capital by Alvotech. Alvogens good faith determination, as of a given time, that Alvotech has less than eighty-five percent (85%) of the Working Capital necessary to meet Alvotechs estimated cash flow requirements (as set forth in the Annual Operating Plan) for the development and/or manufacture (as applicable at such time) of a particular Product for worldwide distribution for the one hundred eighty (180) day period immediately following such time. |
No determination made by Alvogen or Alvotech, or a specified officer thereof (i.e., a Chief Scientific Officer or General Counsel, as applicable), for purposes of any of the foregoing clauses of this definition of Technical Failure shall be deemed to have been made in good faith unless such determination is certified by an authorized officer of the Party (who shall be the specified officer of Alvogen or Alvotech, if and as applicable) making such determination in a writing that is provided, together with reasonable documentation and/or other evidence supporting such determination, to each of the other Parties.;
(h) | in each of the definitions of Regulatory Agency and Regulatory Approval in Section 1.1 (Defined Terms) of the PRA, all references to Territory are replaced by references to Key Territory; |
(i) | in the definition of Successful Completion of a Phase 1 Clinical Trial, the word Key is inserted immediately prior to the reference to Territory; |
(j) | Section 2.3(b) (Effect of Technical Failure) of the PRA is deleted in its entirety and replaced with the following: |
(b) If any Technical Failure has occurred with respect to any Product in an Affected Territory following Successful Completion of a Phase 1 Clinical Trial for such Product, then (i) neither Alvotech nor Alvogen shall thereafter take any action with respect to the research, development, Regulatory Approval, manufacture, marketing, licensing, commercialization or sale of such Product in such Affected Territory and (ii) if such Technical Failure occurs following the commencement of the Product Term with respect to such Product, such Product Term shall terminate and the prohibition with respect to the commercial marketing and sale by Alvogen of a Competing Product set forth in Section 2.8(b) shall terminate with respect to such Product in the Affected Territory, provided that (X) a Technical Failure referred to in clause (i), (ii)(A) (resulting from a decision by the FDA) or (vii) of the definition thereof shall constitute a Technical Failure in all Territories and, accordingly, in such case each Territory shall constitute an Affected Territory and in addition, Alvogen may exercise the Product Replacement Option for such Product; and (Y) if any Technical Failure has occurred pursuant to clause (ii)(A) of the definition thereof resulting from a decision by the EMA, then such Technical Failure shall constitute a Technical Failure in all Territories covered by the EMA and, accordingly, in such case each such Territory shall constitute an Affected Territory.;
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(k) | Section 2.8(a) (Exclusivity; Independent Product Development) of the PRA is deleted in its entirety and replaced with the following: |
(a) | Except as expressly provided in, or contemplated by, this Agreement and the Other Agreements, during the Development Term or the Product Term with respect to any Product, Alvotech shall not, directly or indirectly, through an Affiliate or otherwise, take any material action, or enter into any agreement, arrangement or understanding, with respect to (i) the research, development or manufacture of such Product, (ii) obtaining any Regulatory Approval for such Product in any Territory or (iii) licensing, commercializing, marketing or selling such Product in any Territory or any Other Territory, except in each case, that the entry into, or compliance with the terms of, the Lotus Agreements in the form they were in as at the Effective Date by Alvotech or its Affiliates shall not constitute a breach of these obligations. In the event that Alvotech, or any other member of the Alvotech Group, proposes to enter into any agreement, arrangement or understanding with any Third Party with respect to the research, development, manufacture, licensing, distribution, marketing, commercialization or sale of any Candidate Product in any Alvogen Territory, (x) Alvotech shall, or shall procure that the relevant other member of the Alvotech Group shall, at least thirty (30) days prior to the date they would enter into such agreement, arrangement or understanding, provide written notice to Alvogen with the proposed terms of such agreement, arrangement or understanding (the Proposed Terms), and (y) for a period of thirty (30) days following receipt of such notice, Alvogen shall be entitled, by written notice to Alvotech, to exercise a right to enter into an agreement, arrangement or understanding, as applicable, with Alvotech comparable to the agreement, arrangement or understanding that Alvotech, or the relevant other member of the Alvotech Group, proposes to enter into with such Third Party and in lieu thereof (such right, the Alvogen ROFR). In the event Alvogen exercises the Alvogen ROFR, Alvogen and Alvotech shall negotiate in good faith the terms of the agreement, arrangement or understanding, which terms shall be substantially equivalent to the Proposed Terms or such other terms as shall be agreed upon by Alvogen and Alvotech. In the event Alvogen does not exercise the Alvogen ROFR, Alvotech, or the relevant other member of the Alvotech Group, shall be permitted to enter into the agreement, arrangement or understanding with the applicable Third Party on terms substantially equivalent to the Proposed Terms.; |
(l) | Section 3.1(a) (Alvogen Right of Last Look) of the PRA is deleted in its entirety and replaced with the following: |
(a) | Alvotech shall not, and shall procure that all of its Affiliates shall not, enter into any agreement, arrangement or understanding with a Third Party in respect of the research, development, manufacture, licensing, distribution, marketing, commercialization or sale of any Product or any Candidate Product in any of the Other Territories (a Product Commercialization) without first following the process set out in the remaining provisions of this Section 3.1. For the avoidance of doubt, Alvotech having previously entered into the Lotus Agreements shall not constitute a breach of this Section 3.1.; |
6
(m) | in Section 3.2(a) (Alvogen Right of First Refusal) of the PRA: |
(i) | the words has completed a Phase 3 Clinical Trial, are deleted in their entirety and replaced with the following: |
has commenced a Phase 1 Clinical Trial,; and
(ii) | sub-section (ii) is deleted in its entirety and replaced with there is no agreement then in existence between Alvotech and or any of its Affiliates and any Third Party in relation to an equivalent Product Commercialization and neither Alvotech nor any of its Affiliates has agreed the financial and other key commercial terms of an equivalent Product Commercialization with a Third Party on a non-binding basis,; |
(n) | a new Section 4.3 is added after Section 4.2 (Reports) as follows: |
Section 4.3 Adalimumab Product Replacement. In the event that the First US Commercial Sale has not occurred by 31 December 2021, then Alvogen may elect to: (i) at any time prior to the occurrence of the First US Commercial Sale, select by written notice to Alvotech a different Product in relation to which the Alvotech Royalty Payment shall be payable, in which case all references to the Adalimumab Product in Section 4.1(d), Section 4.1(f) and Section 4.2(b) and in the definitions of US Payment Period, US Bundled Product, US Net Sales and First US Commercial Sale in Section 1.1 shall be deemed to be replaced with references to that Product so elected by Alvogen; or (ii) retain the Adalimumab Product as the Product in relation to which the Alvotech Royalty Payment shall be payable.;
(o) | in Section 5.2(b) the words in any Alvogen Territory shall be inserted after the words requested or required by a Regulatory Agency; |
(p) | in Section 6.1 (Product Trademarks), the sentence As between the Parties, Alvogen shall make all decisions with respect to clearing and registering the Product Marks. is deleted in its entirety and replaced by As between the Parties, Alvogen shall own all right, title and interest in and to the Product Marks and shall make all decisions with respect to clearing and registering the Product Marks.; |
(q) | in Section 6.4 (Alvotech Intellectual Property), the words any Alvotech Intellectual Property developed by Alvotech in performing its obligations under any Research Plan (the Agreement IP) are deleted in their entirety and replaced by the words the Alvotech Intellectual Property and the definition of Agreement IP is deleted in its entirety from Section 1.1 (Defined Terms) of the PRA. All references in the PRA to Agreement IP are replaced with Alvotech Intellectual Property.; |
(r) | a new Section 6.14 is added after Section 6.13 (Article XIII Not Applicable) as follows: |
7
Section 16.14 Disposition, sale or granting of rights in respect of Alvotech Intellectual Property. Alvotech or an Affiliate of Alvotech may dispose of, sell or grant a licence or other rights in respect of any Alvotech Intellectual Property to any Person; provided that, Alvotech shall, and shall procure that its relevant Affiliate shall, ensure that:
(a) | any disposition, sale or grant of a licence or other rights in respect of any Alvotech Intellectual Property shall be made subject to the terms of this Agreement; and |
(b) | any assignee, transferee or licensee of any Alvotech Intellectual Property agrees to be bound by the terms of this Agreement.; and |
(s) | in Section 14.9 (Entire Agreement; Amendments), the following shall be inserted at the end of the third sentence , except that nothing in this Section 14.9 shall operate to exclude or limit either Partys liability for fraudulent misrepresentation. |
2.2 | For the avoidance of doubt, the Parties agree and acknowledge that the warranties given by each of them in sections 11.1 and 11.2 of the PRA shall be deemed to be given on the Effective Date in respect of, and to apply to, each of the products added to the scope of the PRA by this Deed to reflect the fact that the definitions of Initial Products and Products (and all related definitions) include those products with effect from the Effective Date as a result of this Deed. |
2.3 | Save as expressly amended by Clause 2.1, the PRA shall remain in full force and effect in accordance with its terms. |
3. | Entire Agreement |
This Deed constitutes the whole agreement between the Parties relating to the subject matter of this Deed and supersedes any prior written or oral arrangement, understanding or agreement between them relating to such subject matter, other than the PRA.
4. | Counterparts |
This Deed may be entered into in any number of counterparts, all of which taken together shall constitute one and the same instrument. Any Party may enter into this Deed by executing any such counterpart.
5. | No rights of Third Parties |
A person who is not a Party to this Deed has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce any of the terms of this Deed.
6. | Governing Law and Jurisdiction |
6.1 | The Deed and any non-contractual obligations arising out of or in connection with it shall be governed by and construed in accordance with the laws of England and Wales. |
6.2 | Any claim, dispute or difference arising out of or in connection with this Deed, including in relation to any non-contractual obligations arising in connection with this Deed (a Dispute), shall be first submitted to the Chief Executive Officers of Alvogen and Alvotech, who shall use their good faith efforts to resolve the Dispute within fourteen (14) days of when it is submitted to them. If any such Dispute is not resolved by the Chief Executive Officers or their designees within such period, then the Parties irrevocably agree that the courts of England and Wales are to have exclusive jurisdiction to settle the Dispute. |
8
IN WITNESS whereof this Deed has been executed and delivered as a deed on the date which first appears above.
9
For and behalf of ALVOTECH hf.
/s/ Robert Wessman |
Name: Robert Wessman Title: Chairman |
_______, _____________________ |
For and behalf of ALVOGEN LUX HOLDINGS S.à r.l
/s/ Tomas Eckman |
Name: Tomas Eckman Title: Chairman |
_______, _____________________ |
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We hereby consent to the use in this Proxy Statement on Amendment No. 1 to Form F-4 of our report dated May 18, 2021, except for the effects of the restatement disclosed in Note 2, as to which the date is December 13, 2021, relating to the financial statements of Oaktree Acquisition Corp. II, which is contained in that Proxy Statement. We also consent to the reference to us under the caption Experts in the Prospectus.
/s/ WithumSmith+Brown, PC
New York, New York
February 4, 2022
Exhibit 23.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the use in this Registration Statement No. 333-261773 on Form F-4 of our report dated December 20, 2021, relating to the financial statements of Alvotech Holdings S.A.. We also consent to the reference to us under the heading Experts in such Registration Statement.
/s/ Pall Dadi Asgeirsson
Deloitte ehf.
Kópavogur, Iceland
February 4, 2022
Exhibit 99.11
February 4, 2022
Securities and Exchange Commission
Division of Corporation Finance
Office of the Chief Accountant
100 F Street NE
Washington, DC 20549
Re: | Alvotech Lux Holdings S.A.S. Registration Statement on Form F-4 (333-261773) | |
Application for Waiver of Requirements of Form 20-F, Item 8.A.4 |
Ladies and Gentlemen:
The undersigned, Alvotech Lux Holding S.A.S., a newly formed simplified joint stock company incorporated under the laws of the Grand Duchy of Luxembourg (TopCo), and Alvotech Holdings S.A., a public limited liability company incorporated under the laws of the Grand Duchy of Luxembourg (Alvotech), are submitting this letter in connection with TopCos filing of its registration statement on Form F-4 on December 20, 2021 (the Registration Statement) and TopCos filing on the date hereof of amendment No. 1 thereto (Amendment No. 1) in connection with the proposed business combination among Oaktree Acquisition Corp. II, a Cayman Islands exempted company, TopCo and Alvotech. We hereby respectfully request that the Securities and Exchange Commission (the Commission) waive the requirement of Item 8.A.4 of Form 20-F, which states that in the case of a companys initial public offering the Registration Statement on Form F-4 must contain audited financial statements of a date not older than 12 months from the date of the offering unless a waiver is obtained. See also Division of Corporation Finance, Financial Reporting Manual, Sections 1140.5 and 6220.3.
At the time of initial public filing on December 20, 2021, the Registration Statement satisfied Item 8.A.4 of Form 20-F, which is applicable to the Registration Statement pursuant to Item 14(h) of Form F-4, because it contained Alvotechs audited financial statements for the two years ended December 31, 2020 and 2019 prepared in accordance with International Financial Reporting Standards. However, because the Alvotechs audited financial statements for the year ended December 31, 2021 will not be available until approximately April 1, 2022, Amendment No. 1 contains only audited financial statements for the two years ended December 31, 2020 and 2019 and unaudited financial statements for the six months ended June 30, 2021 and 2020, in each case prepared in accordance with International Financial Reporting Standards.
TopCo and Alvotech are submitting this waiver request pursuant to Instruction 2 to Item 8.A.4 of Form 20-F, which provides that the Commission will waive the 12-month age of financial statements requirement if the company is able to represent that it is not required to comply with the 12-month requirement in any other jurisdiction outside the United States and that complying with the 12-month requirement is impracticable or involves undue hardship.
See also the Commissions November 1, 2004 release entitled International Reporting and Disclosure Issues in the Division of Corporation Finance (available on the Commissions website at http://www.sec.gov/divisions/corpfin/internatl/cfirdissues1104.htm) at Section III.B.c, in which the Commission notes:
the instruction indicates that the staff will waive the 12-month requirement where it is not applicable in the registrants other filing jurisdictions and is impracticable or involves undue hardship. As a result, we expect that the vast majority of IPOs will be subject only to the 15-month rule. The only times that we anticipate audited financial statements will be filed under the 12-month rule are when the registrant must comply with the rule in another jurisdiction, or when those audited financial statements are otherwise readily available.
In connection with this request, TopCo and Alvotech represent to the Commission that:
1. Alvotech is not currently a public reporting company in any other jurisdiction.
2. Alvotech is not required by any jurisdiction outside the United States to prepare, and has not prepared, financial statements audited under any generally accepted auditing standards for any interim period.
3. Compliance with Item 8.A.4 is impracticable and involves undue hardship for Alvotech.
4. Alvotech does not anticipate that its audited financial statements for the year ended December 31, 2021 will be available until April 1, 2022.
5. In no event will Alvotech seek effectiveness of the Registration Statement if its audited financial statements are older than 15 months at the time of the offering.
We will file this letter as an exhibit to the Registration Statement pursuant to Instruction 2 to Item 8.A.4 of Form 20-F.
Please do not hesitate to contact our Chief Financial Officer, Joel Morales, at Joel.Morales@alvotech.com if you have any questions regarding the foregoing or if we can provide any additional information.
Very truly yours, |
/s/ Helga Tatjana Zharov |
Helga Tatjana Zharov |
Chairperson |
Alvotech Lux Holding S.A.S. |
/s/ Mark Levick |
Mark Levick |
Chief Executive Officer |
Alvotech Holdings S.A. |
Exhibit 107
Calculation of Filing Fee Tables
Form F-4
(Form Type)
Alvotech Lux Holdings S.A.S.
(Exact Name of Registrant as Specified in its Charter)
Table 1: Newly Registered and Carry Forward Securities
Security Type |
Security Class Title | Fee Calculation or Carry Forward Rule |
Amount Registered(1) |
Proposed Maximum Offering Price Per Unit |
Maximum Aggregate Offering Price |
Fee Rate | Amount of Registration Fee |
|||||||||||||||||||||
Fees Previously Paid |
Equity | Alvotech Ordinary Shares(2)(5)(6) |
Other | 250,180,000 | $ | 9.90 | (6) | $ | 2,476,782,000.00 | 0.0000927 | $ | 229,597.69 | ||||||||||||||||
Equity | Warrants to purchase Alvotech Ordinary Shares(3)(5) |
Other | 10,916,667 | $ | 1.19 | (7) | $ | 12,990,833.73 | 0.0000927 | $ | 1,204.25 | |||||||||||||||||
Equity | Alvotech Ordinary Shares issuable on exercise of Warrants(4)(5)(8) |
Other | 10,916,667 | $ | 11.50 | (8) | $ | 125,541,670.50 | 0.0000927 | $ | 11,637.71 | |||||||||||||||||
Total Offering Amounts | $ | 2,615,314,504.23 | $ | 242,439.65 | ||||||||||||||||||||||||
Total Fees Previously Paid | $ | 242,439.65 | ||||||||||||||||||||||||||
Net Fee Due | $ | 0 |
(1) | All securities being registered will be issued by Alvotech Lux Holdings S.A.S., a simplified joint stock company (société par actions simplifiée) incorporated and existing under the laws of the Grand Duchy of Luxembourg, having its registered office at 9, Rue de Bitbourg, L-1273 Luxembourg, Grand Duchy of Luxembourg and registered with the Luxembourg Register of Commerce and Companies (R.C.S. Luxembourg) under number B258884 (TopCo). In connection with the Business Combination described in this registration statement and the enclosed proxy statement/prospectus (the Business Combination), among other things, (a) Oaktree Acquisition Corp. II, a Cayman Islands exempted company (OACB), will be merged with and into TopCo, whereby (i) all of the outstanding OACB Class A Ordinary Shares, par value $0.0001 per share (the OACB Class A Ordinary Shares or the Public Shares) and OACBs Class B Ordinary Shares, par value $0.0001 (the OACB Class B Ordinary Shares or the Founder Shares, and together with the OACB Class A Ordinary Shares or Public Shares, the OACB Ordinary Shares), will be exchanged for ordinary shares of TopCo (TopCo Ordinary Shares) and (ii) all of the outstanding warrants of OACB included in the units sold in OACBs IPO (the Public OACB Warrants), and all of the outstanding warrants of OACB purchased in a private placement in connection with OACBs IPO of units (the Private OACB Warrants and, together with the Public OACB Warrants, the OACB Warrants), in each case, entitling the holder thereof to purchase one share of the OACB Class A Ordinary Shares at an exercise price of $11.50 per share, will be converted into the right to receive TopCo Ordinary Shares on substantially the same terms as the OACB Warrants (the TopCo Warrants), and (b) Alvotech Holdings S.A., a public limited liability company (société anonyme) incorporated and existing under the laws of the Grand Duchy of Luxembourg, having its registered office at 9, Rue de Bitbourg, L-1273 Luxembourg, Grand Duchy of Luxembourg and registered with the Luxembourg Register of Commerce and Companies (R.C.S. Luxembourg) under number B229193 (Alvotech) will be merged with and into TopCo, whereby all outstanding class A ordinary shares and class B shares of Alvotech (collectively, the Alvotech Ordinary Shares) all with a nominal value of $0.01 per share, will be exchanged for TopCo Ordinary Shares. |
(2) | Includes (i) 218,930,000 TopCo Ordinary Shares to be received by the shareholders of Alvotech and (ii) 31,250,000 TopCo Ordinary Shares issuable in exchange |
for (a) outstanding OACB Class A Ordinary Shares included in outstanding units of OACB (OACB Units), each OACB Unit consisting of one share of OACB Class A Ordinary Shares and one-fourth of one Public OACB Warrant, issued pursuant to OACBs IPO and (b) the OACB Class B Ordinary Shares issued prior to OACBs IPO. Upon the consummation of the Business Combination, all OACB Units will be separated into their component securities, which will be exchanged for equivalent securities of TopCo as described in the proxy statement/prospectus included herein. |
(3) | OACB Warrants will automatically convert into TopCo Warrants upon consummation of the Business Combination as described in the proxy statement/prospectus included herein. |
(4) | Consists of TopCo Ordinary Shares issuable upon exercise of TopCo Warrants. Each TopCo Warrant will entitle the warrant holder to be issued one TopCo Ordinary Share at a price of $11.50 per share (subject to adjustment). |
(5) | Pursuant to Rule 416(a), an indeterminable number of additional securities are also being registered to prevent dilution resulting from stock splits, stock dividends or similar transactions. |
(6) | Estimated solely for the purpose of calculating the registration fee, based on the average of the high and low prices of the OACB Class A Ordinary Shares on the New York Stock Exchange (NYSE) on December 17, 2021 ($9.90 per share). This calculation is in accordance with Rules 457(c) and 457(f)(1) of the Securities Act. |
(7) | Estimated solely for the purpose of calculating the registration fee, based on the average of the high and low prices of the OACB Warrants on the NYSE on December 17, 2021 ($1.19 per warrant). This calculation is in accordance with Rules 457(c) and 457(f)(1) of the Securities Act. |
(8) | Represents the exercise price of the warrants. |