EXHIBIT 10.1
[***] Certain information in this exhibit has been omitted because it is permitted to be omitted by applicable regulatory guidance.
Execution Version
Confidential
February 9, 2022
SHANGHAI JUNSHI BIOSCIENCES CO., LTD.
Level 13, Building 2, Nos. 36 and 58, Hai Qu Road,
Shanghai, China 201203
Attention: CEO
CC: Board Secretary, Securities Department
Re: Extension of Right of Reference Under License Agreement between Coherus and Junshi.
Ladies and Gentlemen:
Reference is hereby made to that certain Exclusive License and Commercialization Agreement, dated February 1, 2021, between Coherus Biosciences, Inc. (“Coherus”) and Shanghai Junshi Biosciences Co., Ltd. (“Junshi”), as the same may be amended from time to time (the “License and Commercialization Agreement”). All capitalized terms used but not defined herein will have the meaning set forth in the License and Commercialization Agreement. [***].
[***] Coherus and Junshi execute this letter agreement (this “Letter Agreement”), memorializing their agreement to the following:
(a) | Grant of Right of Reference. Upon Junshi’s extension thereof to a Junshi Territory Licensee, Junshi will notify Coherus in writing and such Junshi Territory Licensee, its Affiliates, and the direct sublicensees of such Junshi Territory Licensee of the Licensed Technology (each, a “Junshi Territory Right of Reference Entity (JTRRE)”) will have, and Coherus grants to such JTRREs, a right of reference for use only in the Junshi Territory to all Regulatory Approvals and Regulatory Materials pertaining to the Licensed Products in the Field Controlled and submitted by or on behalf of Coherus or its Affiliates. |
(b) | Timing of Extension. Junshi may only extend its rights granted in Section 5.5 (Right of Reference) of the License and Commercialization Agreement with respect to Regulatory |
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Materials Controlled by Coherus with respect to a Licensed Product upon and after submission for Regulatory Approval of the subject Licensed Product. |
(c) | Limitations on Use. Each JTRRE may use such right of reference to such Regulatory Approvals and Regulatory Materials Controlled by Coherus or any of its Affiliates solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approval and any Pricing and Reimbursement Approvals of the Licensed Products in the Junshi Territory. Further, each JTRRE (A) may only rely on those portions of any such Regulatory Approvals or Regulatory Materials Controlled by Coherus or any of its Affiliates to the extent related to the Licensed Products that contain a Licensed Antibody and (B) may not rely on or have any right of reference with respect to those portions of any such Regulatory Approval or Regulatory Material to the extent relating to any product Controlled by Coherus or any of its Affiliates that is not a Licensed Product or to the active ingredient of any Combination Product or Combination Regimen that is not a Licensed Antibody. |
(d) | Costs. As between the Parties, [***] will [***] bear the costs and expenses of [***] as provided in [***] the License and Commercialization Agreement. |
(e) | Further Actions. Coherus will take such actions as may be reasonably requested by Junshi or its Affiliate to give effect to the intent of the extension of the right of reference made hereby and to give Junshi, its Affiliates and the JTRREs the benefit of Coherus’ and its Affiliates’ Regulatory Approvals and Regulatory Materials in the Junshi Territory as provided herein [***]. |
2. | Data Sharing and Reports. In consideration for the extension of the grant of the right of reference to each Junshi Territory Licensee pursuant to the terms of Section 1 (Grant of Right of Reference) above, Junshi will cause each Junshi Territory Licensee to agree in writing to comply with, and provide to Junshi for providing to Coherus the same data, reports, and information required to be provided by Junshi to Coherus under [***] the License and Commercialization Agreement. Accordingly, if Junshi desires to extend such right of reference to a Junshi Territory Licensee, then it must do so on the following conditions: |
(a) | Data Use and Exchange. The terms of an agreement between Junshi or its Affiliate and the Junshi Territory Licensee (“Junshi Territory Licensee Agreement”) must require the Junshi Territory Licensee to provide Junshi with copies of all data and results and all supporting documentation (e.g., protocols, Investigator’s Brochures, case report forms, analysis plans) that are generated by or on behalf of JTRREs in the Development of any Licensed Product For the Coherus Territory [***], except to the extent any such disclosure would be prohibited by any applicable law; provided, however, that in the case of a Combination Regimen in which any of the Other Component(s) is/are Controlled by a JTRRE (including when any such Other Component(s) is/are still in Development or the subject of one or more Regulatory Approval(s), a “Proprietary Combination Regimen”), each JTRRE is only required to disclose such data and results about the Licensed Product portion of the Proprietary Combination Regimen. The terms of the Junshi Territory Licensee Agreement must also permit Junshi to provide a copy of such data, results, and documentation to Coherus, except to the extent any such disclosure would be prohibited by any applicable law. Subject to Section 3 (Development Cost Sharing), Coherus will have the right to use and reference such data and results provided by Junshi for the purpose of obtaining, supporting, and maintaining Regulatory Approvals, as applicable, of the Licensed Products (but not any other part of a Proprietary Combination Regimen, if applicable) in the Coherus Territory [***]. The Junshi Territory Licensee Agreement must |
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also require that if a JTRRE obtains the right to use or a right of reference to data Controlled by a Third Party with respect to a Combination Regimen, then the JTRRE must attempt to obtain sufficient rights from such Third Party to grant a further right to use or right of reference with respect to such Third Party data consistent with the foregoing rights to data and results generated by or on behalf of the JTRRE (i.e., the right of the JTRRE to extend such rights to Junshi and the right of Junshi to further extend such rights to Coherus). |
(c) | Development Reports. The Junshi Territory Licensee Agreement must require that at each joint development committee or similar meeting between Junshi or its Affiliate and any Junshi Territory Licensee at a time when Junshi Territory Licensee is performing, or having performed, Development activities for any Licensed Product (including any Combination Regimen) For the Coherus Territory, Junshi Territory Licensee must provide a report to Junshi summarizing the Development activities for the Licensed Products performed For the Coherus Territory during the period since the preceding meeting, the Development activities for the Licensed Products For the Coherus Territory in process, and the future Development activities for the Licensed Products For the Coherus Territory that any JTRREs or subcontractors expect to initiate, including a summary of the data, timelines, and results of such Development activities, in each case, except to the extent any such disclosure would be prohibited by any applicable law. The Junshi Territory Licensee Agreement must also permit Junshi to disclose the foregoing to Coherus, except to the extent any such disclosure would be prohibited by any applicable law. Such reports and any additional information provided by Junshi regarding such Development activities for the Licensed Products For the Coherus Territory, in each case, will be the Confidential Information of Junshi and subject to the terms of Article 12 (Confidentiality) of the License and Commercialization Agreement. |
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(e) | Enforcement. Junshi must enforce the foregoing provisions required to be included in the Junshi Territory Licensee Agreement against violations thereof by the Junshi Territory Licensee. |
3. | Development Cost Sharing. |
(a) | Junshi will include Development activities by each JTRRE for any Licensed Product (including any Combination Regimen) For the Coherus Territory and budget of the costs and expenses to be incurred in the performance such activities (“JTRRE Development Plan”) [***]. Coherus’ payments for the right to use and reference data and results granted under Section 2(a) (Data Use and Exchange) will be according to the amounts specified to be due under [***] the License and Commercialization Agreement, as applicable. |
(b) | Notwithstanding the foregoing, if Junshi is prevented by applicable law or Junshi’s contractual obligations to any Third Party from including the JTRRE Development Plan in the manner specified in section 3(a), then the Parties shall agree in writing the amounts of payments [***] will pay to [***] for the right, if desired by [***], to use and reference data and results granted under Section 2(a) (Data Use and Exchange) independent of the amounts specified to be due under [***] the License and Commercialization Agreement. |
4. | [***] |
5. | [***] Junshi will cause each JTRRE that is granted rights in [***] to agree to [***] that will restrict such JTRRE’s ability to [***]. |
6. | Miscellaneous. |
(a) | Governing Law. This Agreement will be governed by, and enforced and construed in accordance with, the laws of the State of New York, without regard to its conflicts of law provisions. |
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(c) | Confidentiality. The terms of this Letter Agreement are deemed “terms of this Agreement” and so “Confidential Information of both Parties” subject to Section 12.1 (Confidentiality; Exceptions) of the License and Commercialization Agreement mutatis mutandis as if such Section were set forth in this Letter Agreement; provided that each Party will be entitled to disclose the terms of this Letter Agreement to the extent permitted in Section 12.2 (Authorized Disclosure) of the License and Commercialization Agreement mutatis mutandis as if such Section were set forth in this Letter Agreement. |
(d) | Severability. If any one or more of the provisions of this Letter Agreement is held to be invalid or unenforceable by an arbitrator or by any court of competent jurisdiction from which no appeal can be or is taken, then the provision will be considered severed from this Letter Agreement and will not serve to invalidate any remaining provisions hereof. The Parties will make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering into this Letter Agreement may be realized. |
(e) | Independent Contractor. Each Party will act solely as an independent contractor, and nothing in this Letter Agreement will be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein will be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties. |
(f) | Further Actions. Each Party agrees to execute, acknowledge, and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Letter Agreement. |
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(i) | No Waiver. Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter will not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time. |
(j) | Counterparts. This Letter Agreement may be executed in one or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. |
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Please sign and return a copy of this Letter Agreement to us to acknowledge each party’s agreement on this matter. Thank you for all of your assistance.
Sincerely,
COHERUS BIOSCIENCES, INC.
/s/ Dennis M. Lanfear
Name:Dennis M. Lanfear
Title:Chairman & Chief Executive Officer
ACKNOWLEDGED AND AGREED:
SHANGHAI JUNSHI BIOSCIENCES CO., LTD.
/s/ Ning Li
Name:Ning Li
Title:CEO
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