Exhibit 10.2
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
TERMINATION AGREEMENT
This TERMINATION AGREEMENT (this “Agreement”) is made and entered into effective as of February 24, 2021 (the “Effective Date”), by and between CANbridge BIOMED Limited, a corporation organized and existing under the laws of Hong Kong (“CANbridge”), and PUMA Biotechnology, Inc., a corporation organized and existing under the laws of Delaware, USA (“PUMA”), in the presence of Pierre Fabre Medicament SAS, a company duly organized and existing under the laws of France, having offices and principal place of business at 45 Place Abel Gance, 92100 Boulogne, France (“PFM”). CANbridge and PUMA are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
WHEREAS, CANbridgepharma Limited, a corporation organized and existing under the laws of Hong Kong, and PUMA entered into a Collaboration and License Agreement dated January 30, 2018 (the “License Agreement”);
WHEREAS, CANbridgepharma Limited assigned its interest under the License Agreement to CANbridge on or around July 23, 2018;
WHEREAS, the Parties mutually wish to terminate the License Agreement and any and all agreements and documents that relate to the License Agreement, including without limitation the Supply Agreement between the Parties dated as of August 22, 2019 (the “Supply Agreement”), the Quality and Technical Agreement between the Parties dated as of November 11, 2019 (the “Quality Agreement”), and the Safety Data Exchange Agreement between the Parties dated as of December 9, 2019 (the “Safety Data Agreement”), in each case, in each of their entirety as of the Effective Date, except as specifically set forth herein;
WHEREAS, in connection with termination of the License Agreement, Supply Agreement, Quality Agreement, Safety Data Agreement, and any and all other agreements and documents related thereto, CANbridge agrees to assign or transfer certain rights and assets to PUMA in connection therewith as set forth herein;
WHEREAS, PUMA and PFM entered into a license agreement dated March 29, 2019, as amended from time to time (“PFM License Agreement”);
WHEREAS, as of the Effective Date, PUMA and PFM are amending the PFM License Agreement to include the People’s Republic of China, including mainland China, Hong Kong, Macao and Taiwan, as part of the territory licensed to PFM under the PFM License Agreement;
WHEREAS, PFM is a third party beneficiary of certain rights provided under this Agreement, including the right to enforce certain obligations of CANbridge;
WHEREAS, as of the Effective Date, CANbridge and PFM are entering into the Ancillary Agreements to implement the transfer of certain items and rights previously held by CANbridge under the License Agreement and other agreements referenced above; and
WHEREAS, as of the Effective Date, PUMA and CANbridge are entering into a Settlement Agreement to settle certain disputes that have arisen between the parties related to the License Agreement.
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NOW THEREFORE, in consideration of the foregoing premises, the mutual promises and covenants of the Parties hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows.
1. | DEFINITIONS |
Capitalized terms not otherwise defined herein shall have the meanings ascribed to them under the License Agreement.
1.1 | “Affiliate” has the meaning set forth in the License Agreement, provided, however, that for purposes of Section 4.12(d), “Affiliate” shall not include [***]. |
1.2 | “Ancillary Agreements” means the Distribution Agreement and the Transition Services Agreement, and the quality agreement and the safety data exchange agreement contemplated therein. |
1.3 | “Designee” shall mean PFM or any of its Affiliates. |
1.4 | “Distribution Agreement” means the Distribution Agreement between CANbridge and a Designee dated as of the Effective Date. |
1.5 | “Personal Data” means any information that, pursuant to applicable Law (a) relates to an identified or identifiable natural person that is subject to access, collection, use, storage, processing, or disclosure restrictions, or (b) requires notification to a Person if such information is lost, misused, or wrongfully accessed. |
1.6 | “Transition Services Agreement” or “TSA” means the Transition Services Agreement between CANbridge and a Designee dated as of the Effective Date. |
2. | Termination; EFFECT OF TERMINATION; SURVIVAL. |
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| Marketing Authorization approved by the FDA: Article 1 (Definitions), the last sentence of Section 3.4.2 (Regulatory Communications), Section 3.4.5 (Regulatory Investigation or Inquiry) and Section 4.2.5 (Diversion), provided, however, in the event of conflict between any provisions of the License Agreement and this Agreement, the terms of this Agreement shall control solely with respect to provisions related to communications with Regulatory Authorities in the Territory, and for all other such conflicting provisions, the provisions of the License Agreement shall control, provided, further, the term “this Agreement” as used in the License Agreement shall include the License Agreement and this Agreement for the purposes of this Section 2.3(a). |
| (b) | the terms of the Supply Agreement, Quality Agreement and the Safety Data Agreement shall continue to survive with respect to (i) any and all Licensed Products supplied by PUMA to CANbridge or any of its Affiliates or designees prior to the Effective Date and (ii) any Licensed Products supplied by PUMA to CANbridge or any of its Affiliates of designees prior to the amendment of the supply agreement between PUMA and PFM (which amendment, for clarity, will contain provisions pursuant to which PUMA will agree to supply PFM, its Affiliates and/or its distributors, including CANbridge, and PFM will agree to receive and purchase, the Licensed Products from PUMA in accordance with the terms therein) (any such Licensed Products supplied by PUMA to CANbridge in accordance with this Section 2.3(b), “CANbridge Licensed Products”), provided, that (1) the term (A) “this Agreement” as used in the Supply Agreement shall include the Supply Agreement and this Agreement, (B) “QTA” as used in the Quality Agreement shall include the Quality Agreement and this Agreement, and (C) “the Agreement” as used in the Safety Data Agreement shall include the Safety Data Agreement and this Agreement, in each case, for the purposes of this Section 2.3(b); and (2) PUMA shall provide prompt written notice to CANbridge following effectiveness of any supply agreement entered into between PUMA and a Designee following the date hereof; |
| (c) | the following provisions of the License Agreement shall continue to survive so long as CANbridge or any of its Affiliates or contractors have title to any CANbridge Licensed Products: Section 4.2.2 (Commercialization Responsibilities), Section 4.2.5 (Diversion), Section 4.2.6 (No Violation), Section 6.1.2(b) (Sales Milestone Payments), Section 6.1.3 (Milestone Event Notice), Section 6.2 (Royalties), Section 6.3 (Royalty Payments and Reports), Section 6.5 (Financial Audits), Section 6.6 (Tax Matters), Section 6.7 (Currency of Payments), Section 6.8 (Blocked Currency), Section 6.9 (Late Payments), provided, the term “this Agreement” as used in the License Agreement shall include the License Agreement and this Agreement for the purposes of this Section 2.3(c); and |
| (d) | the following provisions of the License Agreement shall continue to survive the termination of the License Agreement: Sections 2.1.3, 3.3.1 (until the earlier of (a) [***] following the Effective Date, or (b) otherwise agreed under the Ancillary Agreements), 7.1, 7.2 (solely with respect to Joint Patent Rights), Article 8 (Confidentiality), Article 10 (Indemnification; Damages), Article 11 (Limitation of Liability), Article 13 (Dispute Resolution), and Article 14 (Miscellaneous); provided, however, in the event of conflict between any provisions of the License Agreement and this Agreement, the terms of this Agreement shall control, provided, further, the term “this Agreement” as used in the License Agreement shall include the License Agreement and this Agreement for the purposes of this Section 2.3(d); provided, further, [***]. |
| (e) | the following provisions of the Supply Agreement shall continue to survive the termination of the Supply Agreement: Article 1, Article 6, Article 8.3 and Article 10. |
| (f) | the following provisions of the Quality Agreement shall continue to survive the termination of the Quality Agreement: Article 22. |
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| (g) | the following provisions of the Safety and Data Agreement shall continue to survive the termination of the Safety and Data Agreement: Article 14. |
3. | PAYMENT |
3.1 | No later than [***] business days in France and in the US following the Effective Date, PUMA will pay CANbridge a termination fee of Twenty Million Dollars ($20,000,000). |
4. | POST-TERMINATION |
4.2 | Access. |
4.3 | Inventory and Stock; Promotional Materials. |
| (b) | Promotional Materials. Within [***] days from the Effective Date, CANbridge shall, or shall cause its Affiliates to (i) destroy any and all promotional materials related to the Licensed |
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| Products owned by CANbridge or any of its Affiliates, (ii) transfer such promotional materials to PUMA or a Designee or (iii) retain them for use in accordance with the Ancillary Agreements. |
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| as the Marketing Authorization holder of the Licensed Products in Taiwan and to take such actions in accordance with the provisions of this Agreement and the Ancillary Agreements. |
| (e) | Obligations. |
| (i) | PUMA and a Designee specified in writing by PUMA shall receive all advanced drafts of documents to be filed with a Governmental Authority pursuant to this Section 4.4 and shall be provided with reasonable amount of time to review and comment on the same prior to filing. CANbridge shall, and shall cause its Affiliate to, consider in good faith any reasonable comments timely provided by PUMA or such Designee. |
| (b) | If CANbridge or its Affiliates initiate, respond to, file, submit or otherwise communicate with a Governmental Authority in the Territory in connection with the Licensed Products, such |
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4.6 | Further Assurances. |
| (b) | CANbridge shall, and shall cause its Affiliates to perform certain activities related to quality and pharmacovigilance with respect to the Licensed Products in the Territory, as provided in the TSA. |
| (a) | a non-exclusive, fully paid-up, royalty-free, worldwide, transferable, perpetual and irrevocable license, with the right to sublicense, under any intellectual property rights Controlled by CANbridge claiming Inventions that are necessary or reasonably useful to make, use, sell, offer for sale, or import the Licensed Products as they exist as of the Effective Date (if any) (“Product Inventions and IP”) to make, use, sell, offer for sale, or import the Licensed Products; and |
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4.10 | PUMA’s Representations and Warranties. PUMA represents and warrants to CANbridge as follows as of the Effective Date: |
| (a) | Entity Status. PUMA is a legal entity duly organized, validly existing and, where applicable, in good standing under the Laws of its jurisdiction of its organization or incorporation. |
| (b) | Authority. PUMA has the requisite corporate power and authority to enter into this Agreement, to perform its obligations hereunder and to consummate the transactions contemplated to be consummated by it hereby. The execution and delivery of this Agreement and the consummation of the transactions contemplated to be consummated by it hereby have been duly authorized by all necessary corporate actions of PUMA. This Agreement (assuming the due authorization, execution and delivery hereof by CANbridge) constitutes, the valid and legally binding obligation of PUMA, enforceable against PUMA in accordance with its terms, |
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| subject to (i) applicable bankruptcy, insolvency, reorganization, moratorium and similar laws affecting creditors’ rights and remedies generally and (ii) the remedy of specific performance and injunctive and other forms of equitable relief. |
| (c) | Non-Contravention. The execution, delivery and performance by PUMA of this Agreement and the consummation of the transactions contemplated hereby and the execution, delivery and performance by PUMA, do not and will not violate the articles of incorporation or bylaws or comparable organizational documents of PUMA, as applicable. |
| (d) | Litigation. Except for the matters described in this Agreement, to PUMA’s knowledge, there is no litigation, claim, investigation, or administrative action of any Governmental Authority, pending or threatened against PUMA or any of its Affiliates before any Governmental Authority in the Territory. |
4.11 | CANbridge’s Representations and Warranties. CANbridge represents and warrants to PUMA as follows as of the Effective Date: |
| (a) | Entity Status. CANbridge is a legal entity duly organized, validly existing and, where applicable, in good standing under the Laws of its jurisdiction of its organization or incorporation. |
| (i) | Neither CANbridge nor any of its Affiliates have granted any licenses or sublicenses to any Person under any Licensed Patents, Licensed Know-How and/or Licensed Trademarks. |
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| Agreement. All of the inventory, stock, marketing materials, Regulatory Filings, Marketing Authorizations and any other assets and rights that are owned or controlled by CANbridge and transferred or licensed to PUMA or a Designee specified by writing by PUMA pursuant to this Agreement are free and clear of all encumbrances and constitute all of CANbridge’s assets or rights related the Exploitation of the Licensed Products as they exist as of the Effective Date except as set forth in the Ancillary Agreements. |
| (ii) | Each Marketing Authorization, including each certificate or local agent status, issued or granted by the applicable Regulatory Authorities is in full force and effect. |
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| (iii) | CANbridge is the holder of all filings for Pricing and Reimbursement Approval in connection with the Licensed Products in the Territory as of the Effective Date. |
| (iv) | No litigation is pending or threatened regarding the revocation, cancellation, rescission, suspension, withdrawal, modification, or refusal to renew in the ordinary course any Marketing Authorization of the Licensed Products in the Territory, nor has any event occurred, to CANbridge’s knowledge, that would reasonably be expected to give rise to any right of notice, modification, acceleration, payment, cancellation, withdrawal, limitation, or termination of a Marketing Authorization issued by the Regulatory Authorities of mainland China, Hong Kong and Taiwan, respectively. |
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| (i) | CANbridge is the sole owner of, or otherwise has the exclusive right to own, or direct transfer of ownership of, the Product Trademarks. |
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| (vi) | To CANbridge’s knowledge, no Third Party is engaging in any activity that infringes or misappropriates the Product Trademarks in the Territory. |
| (viii) | As of the Effective Date, CANbridge or its Affiliates have not filed or registered any claims in any Patent Rights that cover or claim any Product Inventions and IP. |
| (ix) | As of the Effective Date, there are no fees, annuity fees or renewal fees that have accrued, or are otherwise payable in connection with the prosecution, registration or maintenance in connection with any CANbridge Product Patents. |
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| (i) | To the extent permitted by Laws, to protect PUMA’s and each Designee’s interest in the Exploitation of the Licensed Product in the Field and the Territory and in consideration of the benefits CANbridge will receive pursuant to the terms of this Agreement, CANbridge shall not, and shall cause its Affiliates to not, directly or indirectly through any Third Party (a) [***], or (b) [***]. |
| (ii) | Notwithstanding Section 4.12(d)(i), in the event that CANbridge is acquired by a Third Party and such Third Party [***], the further Exploitation of such [***] by such Third Party and its Affiliates after the consummation of the applicable acquisition transaction will not constitute a violation of this Section 4.12(d) so long as such Third Party and its Affiliates do not use or have access to any Confidential Information of PUMA or any of the Designees (whether relating to the clinical development or commercialization of any Licensed Products or otherwise). |
| (iii) | [***]. |
| (a) | In the event of a claim made by a [***] Indemnified Party (the “Indemnified Party”) for any claims arising under Section 5.1, the Indemnified Party shall give reasonably prompt written notice to [***] (the “Indemnifying Party”), which notice (an “Indemnification Notice”) shall: (i) state that the Indemnified Party has paid or properly accrued or reasonably anticipates that it will have to pay or accrue [***] Indemnified Parties Losses that are subject to indemnification pursuant to Section 5.1, (ii) specify in reasonable detail (to the extent known by the Indemnified Party) the individual items and amounts of such [***] Indemnified Parties Losses, the date each such item was paid or properly accrued, or the basis for such anticipated liability, and a description of the basis of such Indemnified Party’s claim for indemnification and (iii) to the extent practicable, include any other material details pertaining thereto, along with copies of the relevant documents evidencing such claim and the basis for indemnification |
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| sought (to the extent within its possession and disclosure is not proscribed by Law or contract and would not jeopardize any attorney-client privilege or other established legal privilege); provided, however, that no delay or failure on the part of the Indemnified Party in delivering an Indemnification Notice shall relieve the Indemnifying Party of its indemnification obligations under this Agreement except to the extent that the Indemnifying Party is actually and materially prejudiced by such delay or failure. |
| (b) | If an Indemnifying Party objects in writing to any claim or claims made in any Indemnification Notice, the Indemnifying Party and the Indemnified Party shall attempt in good faith for a period of [***] days following the Indemnified Party’s receipt of such objection notice to agree upon the respective rights of such parties with respect to each of such claims. If agreement on all of such disputed claims is not reached after such [***]-day period of good faith negotiation, either the Indemnifying Party or the Indemnified Party may initiate the dispute resolution proceedings provided in Article 13 of the License Agreement. |
5.3 | Liability Limitations Solely with Respect to [***] Indemnified Parties Losses. |
| (a) | Notwithstanding anything in this Agreement to the contrary, in no event shall [***] have liability under this Agreement to a [***] Indemnified Party for any [***] Indemnified Parties Losses or other damages, losses or liabilities that result from a breach of one or more [***], unless the aggregate amount of all such [***] Indemnified Parties Losses exceeds [***], in which event [***] shall be required to pay the amount of such [***] Indemnified Parties Losses from the first dollar, up to a maximum amount equal to [***]. |
| (b) | Notwithstanding anything in this Agreement to the contrary, [***]’s liability under this Agreement in connection with any [***] Indemnified Parties Losses or other damages, losses or liabilities incurred by a [***] Indemnified Party shall not exceed, in the aggregate, [***], except in the case of gross negligence, willful misconduct or fraud by [***] or its Affiliates. |
| (c) | Except as expressly permitted under this Agreement, neither Party shall have any right of setoff of any amounts due and payable, or any Liabilities arising, under this Agreement against any other amounts due and payable under this Agreement or any amounts due and payable, or any Liabilities arising, under any Ancillary Agreement. The payment obligations under each of this Agreement and the Ancillary Agreements remain independent obligations of each Party, irrespective of any amounts owed to any other Party under this Agreement or the respective Ancillary Agreements. |
| (d) | Notwithstanding anything to the contrary under this Agreement or any Ancillary Agreement, (i) [***] shall not be required to indemnify or otherwise provide recourse to [***] Indemnified Parties more than once for the same damages, losses or liabilities pursuant to this Agreement, any Ancillary Agreement or otherwise and (ii) no [***] Indemnified Party may obtain indemnity or other recourse for the same damages, losses or liabilities more than once under this Agreement or any Ancillary Agreement or otherwise. |
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6. | Non-exclusive Remedy. |
7. | CONFIDENTIALITY. |
7.2 | Permitted Disclosures. Each Party agrees that it and its Affiliates will provide or permit access to the other Party’s Confidential Information only to the receiving Party’s employees, consultants, advisors and sublicensees, and to the employees, consultants and advisors of the receiving Party’s Affiliates, in each case on a need to know basis who are subject to obligations of confidentiality and non-use with respect to such Confidential Information no less stringent than the obligations of confidentiality and non-use of the receiving Party pursuant to this Section 7.2 (Confidential Information); provided, however, that each Party will remain responsible for any failure by its Affiliates and sublicensees, and its and its Affiliates’ respective employees, consultants and advisors, to treat such Confidential Information as required under this Section 7.2 (Confidential Information) as if such Affiliates, employees, consultants, advisors and sublicensees were parties directly bound to the requirements of this Section 7.2 (Confidential Information). |
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| (b) | Notwithstanding anything to the contrary in this Agreement: |
| (ii) | The representations and warranties of PUMA will survive for [***] years following the Effective Date. |
| (iii) | The covenants and agreements contained in this Agreement that contemplate performance by either Party shall survive until the latest of (i) the expiration of the term of the undertaking set forth in this Agreement and (ii) [***] years following the Effective Date. |
10. | MISCELLANEOUS |
10.1 | Assignment; Successors. This Agreement and the rights and obligations of each Party under this Agreement will not be assignable, delegable, transferable, pledged or otherwise disposed of by either Party without the prior written consent of the other Party; provided, however, that PUMA may assign or transfer this Agreement together with all of its rights and obligations hereunder, without such consent, to an Affiliate or to a successor in interest in connection with the transfer or sale of all or substantially all of its business or assets to which this Agreement relates, or in the event of its merger or consolidation, reorganization or similar transaction, subject to the assignee agreeing in writing to be bound by the terms and conditions of this Agreement. Any assignment in violation of this Section 10.1 (Assignment) shall be null and void. Any permitted assignment of the rights and obligations of a Party under this Agreement will be binding on, and inure to the benefit of and be enforceable by and against, the successors and permitted assigns of the assigning Party. |
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notice pursuant to clause (a) or (b) above if the notice is of a default under this Agreement), upon completion of transmission, with transmission confirmed, to the addressee’s facsimile machine, as follows (or at such other addresses or facsimile numbers as may have been furnished in writing by a Party to the other as provided in this Section 10.3 (Notices)). This Section 10.3 (Notices) is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement. |
| If to PUMA: |
| PUMA Biotechnology, Inc. |
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| 10880 Wilshire Blvd., Suite 2150 |
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| Los Angeles, CA 90024 |
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| USA Attention: [***] |
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| With copies to: |
| Latham & Watkins |
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| 650 Town Center Drive |
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| 20th Floor Costa Mesa CA |
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| 92626-1925, USA |
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| Attention: Charles Ruck |
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| Fax: 1-714-755-8290 |
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| Latham & Watkins 140 Scott Drive |
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| Menlo Park, CA 94025-1008, USA |
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| Attention: Judith A. Hasko |
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| Fax: 1-650-463-2600 |
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| CANbridge Biomed Limited |
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| Sterling Centre No. 11 |
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| Cheung Yue Street, Kowloon |
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| Attention: Chief Executive Officer |
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| CANbridge Life Sciences Limited |
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| 303A Building E |
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| Wangjing Pioneer Park |
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| No. 2 LizeZhongEr Road |
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| Chaoyang District, Beijing, China |
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| Attention: Chief Executive Officer |
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| Ropes & Gray LLP |
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| 800 Boylston Street, Prudential Tower |
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| Boston, Massachusetts 02199-3600 |
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| Attention: David McIntosh, Esq. |
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| Fax: 617-235-0507 |
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IN WITNESS WHEREOF, each Party has caused this Agreement to be duly executed by its authorized representative under seal, in duplicate on the Effective Date.
PUMA Biotechnology, Inc. |
| CANbridge BIOMED Limited | ||
Signature : | /s/ Alan H. Auerbach |
| Signature : | /s/ Xue James Qun |
Name : | Alan H. Auerbach |
| Name : | Xue James Qun |
Title : | Chief Executive Officer |
| Title : | Director |
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In the presence of Pierre Fabre Médicament, SAS
Pierre Fabre Médicament, SAS | ||
Signature : | /s/ Jean-Luc Lowinski |
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Name : | Jean-Luc Lowinski |
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Title : | President |
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