Exhibit 10.30
[***] 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.
EXECUTION VERSION
This LICENSE AGREEMENT (this “Agreement”) is entered into as of January 13th, 2020 (the “Effective Date”) by and between Innovent Biologics (Suzhou) Co., Ltd., a PRC corporation (“Innovent”) and Coherus BioSciences, Inc., a Delaware corporation (“Coherus”). Innovent and Coherus are each referred to herein by name or as a “Party” or, collectively, as the “Parties.”
RECITALS
WHEREAS, Innovent owns or controls intellectual property rights related to the development, manufacture and commercialization of certain biosimilar products, including biosimilar products designated as IBI-301 and IBI-305, respectively;
WHEREAS, Coherus is a company focused on the development, manufacture and commercialization of biosimilar products; and
WHEREAS, Coherus wishes to obtain an exclusive license from Innovent, and Innovent wishes to grant an exclusive license to Coherus, the intellectual property rights related to certain of Innovent’s biosimilar products subject to and in accordance with the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
1.1 | “aBLA” means an abbreviated Biologics License Application filed with the FDA in the United States, as defined in Section 351(k) of the Public Health Services Act (42 U.S.C. 262(k)). |
1.4 | “Additional Active” means an active pharmaceutical or active biological ingredient that is not a Licensed Antibody. |
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1.9 | “Anti-Corruption Laws” means any and all Applicable Law that relates to anti-corruption or anti-bribery, including the U.S. Foreign Corrupt Practices Act. |
1.16 | “Bevacizumab Field” means the treatment, prevention or amelioration of any human diseases and conditions as included in the label of the Bevacizumab Reference Product. |
1.19 | “Bevacizumab Reference Product” means the biologic drug products containing drug substance Bevacizumab and sold under the trademark Avastin®. |
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1.20 | “Bevacizumab Reference Price” means the weighted average price as determined by (a) [***] and (b) [***]. |
1.23 | “BPCIA” means the Biologics Price Competition and Innovation Act of 2009, as amended from time to time. |
1.25 | “Business Day” means any day other than: (a) a Saturday or Sunday or (b) any day on which commercial banks in [***] are authorized or required by Applicable Law to remain closed. |
1.28 | “Clinical Trial” means any human clinical trial of a pharmaceutical or biological product and includes Phase 1 Clinical Trial and Phase 3 Clinical Trial. |
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Innovent Combination Product in the Innovent Territory; or (b) for the Development of the Licensed Antibody portion of the Innovent Combination Products in the Territory. |
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1.53 | “Existing Regulatory Materials” means Bevacizumab Existing Regulatory Materials and Rituximab Existing Regulatory Materials, as applicable. |
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1.57 | “FTE” means the equivalent of the work of one (1) person full time for one (1) Calendar Year (consisting of at least a total of [***] ([***]) hours per Calendar Year). |
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1.89 | “Knowledge” means, with respect to a Party, the actual knowledge of those persons of such Party listed on Exhibit A. |
1.90 | “Licensed Antibody” means Bevacizumab Antibody and, subject to Section 2.3(c), Rituximab Antibody. |
1.92 | “Licensed Products” shall mean Bevacizumab Licensed Product and, subject to Section 2.3(c), Rituximab Licensed Product. |
1.99 | “Manufacturing Technology Transfer Triggering Payment” has the meaning set forth in Section 7.3(a). |
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| (b) | retroactive price reductions, allowances, or credits actually granted upon rejections or returns of Licensed Product, including for recalls or damaged good and billing errors; |
| (g) | other similar and customary deductions which are in accordance with applicable Accounting Standards; and |
| (h) | amounts invoiced for sales of Licensed Product that are written off as uncollectible after reasonable collection efforts. |
Each of the foregoing deductions shall be determined as actually incurred from the books and records of Coherus, its Affiliates or sublicensees maintained in accordance with the Accounting Standards, consistently applied. Even if there is overlap between any of deductions set forth in Section 1.104(a) through Section 1.104(h) above, each individual item shall only be deducted once in the overall Net Sales calculation.
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Notwithstanding the foregoing, sales of a Licensed Product by and among Coherus, its Affiliates, and its (sub)licensees shall be deemed a sale for the purposes of Net Sales only in the event such of Coherus, its Affiliate, or (sub)licensee that is the purchaser is the ultimate end user of such Licensed Product.
Any Licensed Products used for promotional or advertising purposes, used for Clinical Trials, preclinical trials or other research purposes, free samples, named patient use, compassionate use, patient assistance, charitable use or distributed at no charge to patients unable to purchase the same shall not be included in Net Sales. Donations, dispositions or transfers for charitable reasons, which dispositions or transfers are at or below cost, shall also not be included in Net Sales.
With respect to Combination Products, the following shall apply:
In the event a Licensed Product is sold as a Combination Product, Net Sales of the Combination Product will be calculated by multiplying the total Net Sales of the Combination Product by the fraction A/(A+B), where A is the average per unit Net Sales in the applicable country in the Territory of the Licensed Product sold separately (without any Additional Active) in the same formulation and dosage in a comparable Indication, and B is the sum of the average per unit Net Sales in the applicable country in the Territory of all Additional Actives (in the same formulation and dosage in a comparable Indication as in the Combination Product) in the Combination Product, as applicable, in each case sold separately during the applicable Calendar Quarter. If A or B cannot be determined because average selling prices for the Licensed Product or the Additional Active(s) are not available separately in a particular country, then the Parties shall discuss an appropriate allocation of Net Sales to the Licensed Product and to the Additional Active(s), and thereafter Coherus will determine the allocation of Net Sales for the relevant transactions in good faith based on an equitable method of determining the same that takes into account, in the Territory, variations in potency, the relative contribution of each therapeutically active ingredient, and relative value to the end user of each therapeutically active ingredient.
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reissues, re-examinations and extensions, including any supplementary protection certificates of any of the foregoing. |
1.121 | “PRC” means the People’s Republic of China, which for purposes of this Agreement excludes Hong Kong, Macau and Taiwan. |
1.124 | “Prior CDA” means that certain mutual confidentiality agreement, by and between Innovent and Coherus dated April 22, 2019. |
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1.127 | “Reference Price” means the Bevacizumab Reference Price or the Rituximab Reference Price, as applicable. |
1.128 | “Regulatory Approval” means all approvals, licenses, and authorizations of the applicable Regulatory Authority necessary for the marketing and sale of a pharmaceutical or biological product for a particular Indication in a country or region (including separate Pricing Approvals, as necessary), and including the approvals by the applicable Regulatory Authority of any expansion or modification of the label for such Indication. |
1.133 | “Rituximab Existing Regulatory Materials Transfer Date” means the date on which all of the Rituximab Existing Regulatory Materials that the Parties through the JSC in accordance with Section 3.1(c)(ii) determine need to be translated into the English language under Section 5.2(a)(ii)(A) are provided by or on behalf of Innovent to Coherus. |
1.134 | “Rituximab Field” means the treatment, prevention or amelioration of any human diseases and conditions as included in the label of the Rituximab Reference Product. |
1.136 | “Rituximab Reference Product” means the biologic drug products containing drug substance Rituximab and sold under the trademark Rituxan®. |
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1.137 | “Rituximab Reference Price” means the weighted average price as determined by (a) [***] and (b) [***]. |
1.142 | “Senior Executive” means: (a) with respect to Innovent, [***]; and (b) with respect to Coherus, [***]. |
1.144 | “Sintilimab Product” means all products containing the Sintilimab Antibody. |
1.147 | “Territory” means the United States and Canada, including each of their respective territories and possessions. |
1.148 | “Third Party” means any Person other than Innovent or Coherus that is not an Affiliate of Innovent or of Coherus. |
1.149 | “Third Party Claim” means any and all suits, claims, actions, proceedings, or demands brought by a Third Party. |
1.154 | “Transition Assistance” has the meaning set forth in Section 13.8(d). |
1.155 | “United States” or “U.S.” means the United States of America and all of its territories and possessions. |
. As of the Effective Date and subject to the terms and conditions of this Agreement, Innovent hereby grants to Coherus a royalty-bearing, exclusive, non-transferable (except as provided in Section 14.4) and sublicenseable (subject to Section 2.5) license, under the
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Innovent IP to Develop, Manufacture (subject to Section 7.3), and Commercialize, the Bevacizumab Licensed Product in the Bevacizumab Field in the Territory.
. As of the Effective Date and subject to the terms and conditions of this Agreement, Innovent hereby grants to Coherus a fully-paid, non-exclusive, non-transferable (except as provided in Section 14.4) and non-sublicenseable license, under the Innovent IP solely for Coherus, its Affiliates or designees to hold meetings with the FDA to discuss filing an IND, aBLA and other Regulatory Materials in the Territory using the Rituximab Existing Regulatory Materials transferred by Innovent to Coherus in accordance with Section 5.2(a)(ii)(A) (“Rituximab Non-Exclusive License”). The term of the Rituximab Non-Exclusive License shall terminate automatically on the earlier of (a) the Option Effective Date and (b) expiration of the Option Period, unless otherwise mutually agreed by the Parties.
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2.5 | Sublicense. |
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Combination Product in the Territory; provided that (i) prior to initiating the Development of any Innovent Combination Product in the Territory, Innovent shall provide Coherus with a written notice [***] to conduct such Development with a [***] plan for such Development; (ii) the Parties shall discuss the Development of such Innovent Combination Product in the Territory through the JSC; and (iii) the Parties shall coordinate the Development of such Innovent Combination Product in the Territory by or on behalf of Innovent through the JSC; [***]. Innovent shall not [***]. Notwithstanding the foregoing, Innovent may [***]. For clarity, Innovent may [***]. Subject to Coherus’s right to exclusively Commercialize the Licensed Products in the Territory, the Parties agree that in the event Innovent wishes to Commercialize an Innovent Combination Product in the Territory, the Parties shall [***]. |
2.8 | Right of First Negotiation. For a period of [***] days from the Effective Date, the Parties shall negotiate on [***] with respect to the terms and conditions under which Coherus may obtain a license under Patents and Know-How Controlled by Innovent with respect to the [***] for the [***]. |
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| (c) | Responsibilities of the JSC. The JSC’s responsibilities shall include, among others, the following: |
| (i) | promptly after the Effective Date, agree upon the scope and facilitate the transfer of all Bevacizumab Existing Regulatory Materials by Innovent to Coherus in accordance with Section 5.2(a)(i); |
| (ii) | promptly after the Effective Date, agree upon the scope and facilitate the transfer of all Rituximab Existing Regulatory Materials by Innovent to Coherus in accordance with Section 5.2(a)(ii); |
| (vi) | discuss and comment on each Party’s clinical summaries, synopsis, and protocols with respect to the Development of Licensed Products and Innovent Combination Products in the Territory; and |
. The JSC shall hold meetings at such times and places as shall be determined by a majority of the entire membership of the committee, but in no event, shall such meetings be held less frequently than once every [***] ([***]) months. Meetings of the JSC shall be held via internet, telephonically or by videoconference; provided that at least [***] ([***]) meetings per year shall be held in person. Meetings of the JSC shall be effective if at least [***] ([***]) members of the JSC, representing each Party, are in attendance or participating in the meeting. Each Party shall be responsible for the expenses incurred in connection with its employees, consultants and its members of the JSC attending or otherwise participating in JSC meetings.
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communications, and raising cross-Party or cross-functional disputes in a timely manner. Each Party may replace its Alliance Manager by written notice to the other Party. |
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| Notwithstanding anything to the contrary herein, in no event shall any Rituximab Existing Regulatory Material be deemed assigned or exclusively licensed by Innovent to Coherus prior to the Option Effective Date. |
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| (b) | Coherus shall provide Innovent with copies of all material Regulatory Materials relating to a Licensed Product received from any Regulatory Authority in the Territory [***] upon receipt. |
| (c) | Coherus shall reasonably inform and provide reasonable details to Innovent of any material communications with a Regulatory Authority relating to the Licensed Product through the JSC. |
6. | Commercialization |
. Subject to the terms and conditions of this Agreement, Coherus shall have the sole right (and shall solely control, at its discretion), itself or with or through its Affiliates, sublicensees, or other Third Parties, to Commercialize the Licensed Products in the Field in the Territory. All such Commercialization shall be at Coherus’s sole cost and expense.
| (a) | use Commercially Reasonable Efforts to Commercialize each Licensed Product promptly following First Commercial Sale of such Licensed Product in the Field in the Territory; |
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| (A) | [***]. |
| (B) | [***]. |
| (c) | Pursuant to the Manufacturing Technology Transfer Agreement, (i) Innovent shall transfer from Innovent or its Affiliates to Coherus, its Affiliates or the Approved CMO (in writing |
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| (d) | Coherus shall pay Innovent a one-time [***] Dollars ($[***]) upon the completion of the applicable Manufacturing Technology Transfer as mutually agreed upon by the Parties in accordance with each Manufacturing Technology Transfer Agreement (“Manufacturing Technology Transfer Completion Payments”). For clarity, the maximum Manufacturing Technology Transfer Completion Payments payable by Coherus to Innovent under this Agreement shall be [***] Dollars ($[***]) |
| (f) | Upon completion of a Manufacturing Technology Transfer for a Licensed Product, Coherus shall be free to transfer technology for each Licensed Product that it wishes to Manufacture to its Affiliates or one or more Third Party CMOs. Innovent shall have the rights to request Coherus to conduct audits of such CMOs and Innovent shall have the right to be present for any such audit and require Coherus to remediate any deficiency uncovered by such audit. |
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| Bevacizumab Product Milestone Event | Bevacizumab Product Milestone Payment Amount |
B1. | [***] | [***] Dollars ($[***]) |
B2. | [***] | [***] Dollars ($[***]) |
B3. | [***] | [***] Dollars ($[***]) |
B4. | [***] | [***] Dollars ($[***]) |
| Rituximab Product Milestone Event | Rituximab Product Milestone Payment Amount |
R1. | [***] | [***] Dollars ($[***]) |
R2. | [***] | [***] Dollars ($[***]) |
R3. | [***] | [***] Dollars ($[***]) |
R4. | [***] | [***] Dollars ($[***]) |
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.
The applicable royalty rate set forth in the table above shall apply only to that portion of the annual Net Sales of a given Licensed Product in the United States during a given Calendar Year that falls within the indicated range.
| (ii) | On a Licensed Product-by-Licensed Product in Canada, a [***] ([***]%) royalty on the annual Net Sales of a Licensed Product in a Calendar Year Canada. |
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| its Affiliates or sublicensees to such Third Party that are attributable to such right or license or the exercise thereof during such Calendar Quarter, subject to Section 8.4(c). |
. After the First Commercial Sale of any Licensed Products in the Field in the Territory, (i) within [***] ([***]) days after the end of each Calendar Quarter, Coherus shall deliver to Innovent a written report setting forth in reasonable detail, on a Licensed Product-by-Licensed Product basis, the calculation of (A) the aggregate Net Sales achieved for such Licensed Product in the Territory in such Calendar Quarter and (B) the calculation of the royalties owing by Coherus to Innovent pursuant to this Section 8.4 for such Calendar Quarter; and (ii) all amounts of royalties shall be due and payable within [***] ([***]) days after the end of the corresponding Calendar Quarter.
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| responsible for and pay any such Transfer Taxes imposed on it with respect to the Agreement Payments due to the Payee hereunder. |
| (iii) | Tax Cooperation. The Parties shall cooperate with respect to all documentation required by any taxing authority or reasonably requested by either Party to secure a reduction in the rate of applicable withholding taxes. |
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| (b) | The determination of inventorship under this Agreement, including the inventorship of Inventions, shall be determined in accordance with the U.S. patent laws and the rules and regulations of the U.S. Patent and Trademark Office. |
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| Patent Infringement, including by executing reasonably appropriate documents, cooperating in discovery, and joining as a party to the action if required. [***] may join [***] as a party plaintiff if [***] is an indispensable party to such proceeding and [***] agrees to be joined as a party. Additionally, [***] shall have the right to be represented in any such action by counsel of its own choice at [***] sole cost and expense. |
| (iii) | If Coherus elects not to exercise its rights under Section 9.3(b)(ii) within [***] ([***]) days of first becoming aware of a Joint Patent Infringement, then Innovent |
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.
. Upon Coherus’s request, Innovent shall obtain patent term restoration (including under the Drug Price Competition and Patent Term Restoration Act), supplemental protection certificates or their equivalents, and patent term extensions (collectively, “Patent Extensions”) with respect to the Innovent Patents. If Innovent does not take any action required by this Section 9.5 within [***] ([***]) days of Coherus’s request or if Innovent requests in writing for Coherus to take the actions necessary in connection with the applicable Patent Extension, then in each case Coherus shall be authorized and entitled to proceed with applications for such Patent
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Extension in the name of Innovent, as deemed appropriate by Coherus, and Innovent shall provide any reasonably necessary information and assistance to Coherus.
10.2 | Exceptions. Section 10.1 shall not apply with respect to any portion of the Confidential Information of the Disclosing Party to the extent that such Confidential Information: |
Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
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| (a) | Disclosure. Notwithstanding Section 10.1, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party in the following instances: |
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. Except as otherwise expressly set forth herein neither Party (or any of its respective Affiliates) shall use the name, trademark, trade name, or logo of the other Party or any of its Affiliates, or its or their respective employees, in any publicity, promotion, news release, or other public disclosure relating to this Agreement or its subject matter, without first obtaining the prior written consent of the other Party; provided, that such consent shall not be required to the extent use thereof may be required by Applicable Law, including the rules of any securities exchange or market on which a Party’s or its Affiliate’s securities are listed or traded. Each Party shall be authorized to use the name, trademark, trade name, or logo of the other Party in the manner that such other Party has previously approved, without the need to seek further consent or approval thereof from the other Party. Notwithstanding the foregoing, each Party shall be authorized to use the name and logo of the other Party on their websites or facilities to identify and demonstrate the collaboration relationship between the Parties in connection with this Agreement, without the need to seek further consent or approval thereof from the other Party.
. Each Party hereby represents and warrants to the other Party, as of the Effective Date that:
| (b) | such Party has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; |
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| transactions contemplated by this Agreement, or for the performance by it of its obligations under this Agreement; and |
. Innovent hereby represents and warrants to Coherus that as of the Effective Date:
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. Coherus hereby represents and warrants to Innovent that as of the Effective Date:
| (a) | Mutual Covenants. |
| (i) | Each Party hereby covenants to the other Party that such Party and its Affiliates shall perform its activities pursuant to this Agreement in compliance (and shall |
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| ensure compliance by any of its sublicensees and subcontractors) with all Applicable Law, including, to the extent applicable, GCP, GLP, GMP and Anti-Corruption Laws. |
. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED (AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY PROVIDED IN THIS AGREEMENT), INCLUDING WITH RESPECT TO ANY PATENTS OR KNOW-HOW, INCLUDING WARRANTIES OF VALIDITY OR ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, PERFORMANCE, AND NON-INFRINGEMENT OF ANY THIRD PARTY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHT. NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY DEVELOP, MANUFACTURE, OR COMMERCIALIZE ANY LICENSED PRODUCT OR, IF COMMERCIALIZED, THAT ANY PARTICULAR SALES LEVEL OF SUCH LICENSED PRODUCT WILL BE ACHIEVED.
. Coherus shall indemnify, defend, and hold harmless Innovent, its Affiliates, and its and their respective directors, officers, employees, agents, successors, and assigns (collectively, the “Innovent Indemnitees”) from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:
| (a) | subject to Section 9.4(e), the Development, Manufacture, or Commercialization of the Licensed Products in the Field in the Territory by Coherus, its Affiliates, or its sublicensees; |
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| (c) | any material breach by Coherus of any of its representations, warranties, covenants, agreements, or obligations under this Agreement; |
provided, however, that, in each case of Section 12.1(a), Section 12.1(b) or Section 12.1(c), such indemnity shall not apply to the extent Innovent has an indemnification obligation pursuant to Section 12.2(a), Section 12.2(b), Section 12.2(c) or Section 12.2(d) for such Damages.
. Innovent shall indemnify and hold harmless Coherus, its Affiliates, and its and their respective directors, officers, employees, agents, successors, and assigns (collectively, the “Coherus Indemnitees”), from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:
| (b) | the Development by Innovent, its Affiliates, contractors or licensees of any Innovent Combination Product in the Territory, including product liability related to such Development; |
| (d) | any material breach by Innovent of any of its representations, warranties, covenants, agreements, or obligations under this Agreement; |
provided, however, that, in each case of, and Section 12.2(a), Section 12.2(b), Section 12.2(c) or Section 12.2(d), such indemnity shall not apply to the extent Coherus has an indemnification obligation pursuant to Section 12.1(a), Section 12.1(b) or Section 12.1(c) for such Damages.
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| own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the Indemnitor. |
. NEITHER INNOVENT NOR COHERUS, NOR ANY OF THEIR RESPECTIVE AFFILIATES, WILL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING LOST PROFITS OR LOST REVENUES), WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY, CONTRIBUTION, OR OTHERWISE, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 12.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT: (A) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 12.1 OR SECTION 12.2, AS APPLICABLE, IN CONNECTION WITH ANY THIRD PARTY CLAIMS; OR (B) DAMAGES AVAILABLE FOR A PARTY’S GROSS NEGLIGENCE, INTENTIONAL MISCONDUCT, OR FRAUD OR FOR BREACH OF ARTICLE 10.
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| may be extended in accordance with Section 13.2(a)), which shall commence as of the date of such determination. |
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| of or default under any such agreement with a Third Party and set off the costs thereof against amounts payable to such licensor under this Agreement. |
| (a) | On a Licensed Product-by-Licensed Product basis, Coherus may terminate this Agreement immediately upon receipt of [***]. |
| (b) | On a Licensed Product-by-Licensed Product basis, Coherus may terminate this Agreement immediately upon receipt of [***]. |
| (d) | Transition Assistance. Coherus shall reasonably cooperate with Innovent to assure a smooth transition of any Clinical Trials, Development, Manufacturing, or |
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| Commercialization activities related to the terminated or expired Licensed Product (“Transition Assistance”). |
| (i) | In the event of termination of this Agreement by Coherus in accordance with Section 13.5, Section 13.6, or Section 13.7 or by Innovent in accordance with Section 13.2, Section 13.3, or Section 13.4, Innovent may purchase the terminated or expired Licensed Product [***] plus [***] percent ([***]%) all of the inventory of the terminated or expired Licensed Product held by or on behalf of Coherus on the effective date of termination or expiration (including raw materials, intermediates, and finished, unfinished, or partially finished goods) in the applicable country in the Territory. Innovent shall notify Coherus within [***] ([***]) days after the effective date of termination or expiration whether Innovent wishes to purchase such inventory in accordance with this Section 13.8(f). In the event Innovent does not purchase such inventory, then Coherus shall be permitted to sell such inventory, provided that such sales occur within [***] ([***]) months after the effective date of termination or expiration and, provided further that Coherus shall remain obligated to pay royalties and report to Innovent with respect to Net Sales of such inventory in accordance with Article 8. |
| (ii) | In the event of expiration of this Agreement or termination of this Agreement by Coherus in accordance with Section 13.2 or Section 13.4, Coherus shall be permitted to sell all of the inventory of the terminated or expired Licensed Product held by or on behalf of Coherus on the effective date of termination or expiration (including raw materials, intermediates, and finished, unfinished, or partially finished goods), provided that such sales occur within [***] ([***]) months after the effective date of termination or expiration and, provided further that Coherus shall remain obligated to pay royalties and report to Innovent with respect to Net Sales of such inventory in accordance with Article 8. |
| (g) | Costs and Expenses. |
| (i) | [***] shall pay for the costs and expenses related to the transfer of all Regulatory Materials in accordance with Section 13.8(b) and Transition Assistance, in each case, in the event of termination of this Agreement by Coherus in accordance with Section 13.5, Section 13.6, or Section 13.7 or by Innovent in accordance with Section 13.2, Section 13.3, or Section 13.4. |
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. If one (1) or more of the terms or provisions of this Agreement is held by a court of competent jurisdiction to be void, invalid, or unenforceable in any situation in any jurisdiction, such holding shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the void, invalid, or unenforceable term or provision in any other situation or in any other jurisdiction, and the term or provision shall be considered severed from this Agreement solely for such situation and solely in such jurisdiction, unless the void, invalid, or unenforceable term or provision is of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the void, invalid, or unenforceable term or provision. If the final judgment of such court declares that any term or provision hereof is void, invalid, or unenforceable, the Parties agree to: (a) reduce the scope, duration, area, or applicability of the term or provision or to delete specific words or phrases to the minimum extent necessary to cause such term or provision as so reduced or amended to be enforceable; and (b) make a good-faith effort to replace any void, invalid, or unenforceable term or provision with a valid and enforceable term or provision such that the objectives contemplated by the Parties when entering this Agreement may be realized.
. Any notice required or permitted to be given by this Agreement shall be in writing and in English and shall be: (a) delivered by hand or by overnight courier with tracking capabilities; or (b) mailed postage prepaid by first class, registered, or certified mail, in each case, addressed as set forth below unless changed by notice so given:
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Coherus BioSciences, Inc.
333 Twin Dolphin Drive, Suite 600
Redwood City, CA, 94065, USA
Attention: [***]
With copies to (which shall not constitute notice):
Latham & Watkins LLP
140 Scott Drive
Menlo Park, CA 94025, USA
Attn: [***]
If to Innovent:
Innovent Biologics (Suzhou) Co., Ltd.
With copies to (which shall not constitute notice):
. A Party shall not be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to a cause beyond the reasonable control of such Party, including acts of God, fires, earthquakes, acts of war, terrorism, or civil unrest, or hurricane or other inclement weather; provided, that the affected Party: (a) promptly notifies the other Party; and (b) shall use its commercially reasonable efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance in accordance with the terms of this Agreement whenever such causes are removed. When such circumstances arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate in order to arrive at an equitable solution.
. Except as otherwise expressly provided in this Agreement, neither Party may assign any of its rights or delegate any of its obligations under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld. Subject to the other provisions of this Section 14.4, either Party may assign this Agreement, in its entirety, to (a) an Affiliate for so long as the Affiliate remains an Affiliate of such Party; (b) an acquirer (“Acquirer”) in a change of control or in connection with the sale of all or substantially all of either Party’s assets; or (c) an Acquirer in connection with the sale of all or substantially all of either Party’s assets to which this Agreement relates by first providing to the other Party a reasonable explanation of the capabilities and financial wherewithal of the prospective Acquirer and obtaining the prior written
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consent of the other Party, such consent not to be unreasonably withheld, delayed, or conditioned based on the consideration of the Licensed Products in the Field in the Territory; provided that in the event of any such transaction described in sub-section (a), (b) or (c) above, the Acquirer to which this Agreement is assigned expressly agrees in writing to assume and be bound by the obligations of the assigning Party under this Agreement. A copy of such writing shall be provided to the non‑assigning Party within thirty (30) days of the assignment. Subject to the foregoing and other applicable provisions of this Section 14.4, this Agreement will inure to the benefit of and bind the Parties’ successors and assigns. Any attempted assignment not in accordance with this Section 14.4 shall be void. In the event that a permitted assignment of this Agreement by a Party increases the tax liability of the other Party or any of its Affiliates over the amount of any Taxes that otherwise would have been payable in the absence of such assignment, the assigning Party shall reimburse the other Party for the amount of such increased Tax liability.
. The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release, or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by the Parties.
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| No arbitrator (nor any arbitral tribunal) shall have the power to award punitive damages under this Agreement, and such award is expressly prohibited. Decisions of the arbitrator(s) shall be final and binding on the Parties. Judgment on the award so rendered may be entered in any court of competent jurisdiction. The costs of the arbitration shall be shared by the Parties during the course of such arbitration, as assessed by the International Chamber of Commerce, and shall be borne as determined by the arbitrator(s). |
. Innovent and Coherus are independent contractors under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute either Party as a partner, agent, or joint venturer of the other Party. Neither Innovent nor Coherus, respectively, shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of Innovent and Coherus, respectively, or to bind Innovent and Coherus, respectively, to any contract, agreement, or undertaking with any Third Party.
. Except as otherwise specified in this Agreement, each Party shall bear its own costs and expenses (including investment banking and legal fees and expenses) incurred in connection with this Agreement and the transactions contemplated hereby.
. There are no express or implied Third Party beneficiaries hereunder. The provisions of this Agreement are for the exclusive benefit of the Parties, and no other person or entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these provisions against any Party, except for the indemnification rights of the Innovent Indemnitees pursuant to Section 12.1 and Section 12.3 and the Coherus Indemnitees pursuant to Section 12.2 and Section 12.3.
. This Agreement, together with the attached Exhibits and Schedules, contains the entire agreement by the Parties with respect to the subject matter hereof and supersedes any prior express or implied agreements, understandings, and representations, either oral or written, which may have related to the subject matter hereof in any way, including the Prior CDA and any and all term sheets relating to the transactions contemplated by this Agreement and exchanged between the Parties prior to the Effective Date; provided, that this Agreement shall not supersede the terms and provisions of the Prior CDA applicable to any period prior to the Effective Date.
. This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together, and shall constitute one (1) and the same instrument. Any such counterpart, to the extent delivered by means of facsimile by .pdf, .tif, .gif, .jpeg, or similar attachment to electronic mail (any such delivery, an “Electronic Delivery”) shall be treated in all manner and respects as an
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original executed counterpart and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. No Party hereto shall raise the use of Electronic Delivery to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of Electronic Delivery as a defense to the formation of a contract, and each Party forever waives any such defense, except to the extent that such defense relates to lack of authenticity.
. Notwithstanding anything to the contrary herein, the Parties shall be entitled to seek equitable relief, including injunction and specific performance, as a remedy for any breach of this Agreement. Such remedies shall not be deemed to be the exclusive remedies for a breach of this Agreement but shall be in addition to all other remedies available at law or in equity. The Parties further agree not to raise as a defense or objection to the request or granting of such relief that any breach of this Agreement is or would be compensable by an award of money damages. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Applicable Law.
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| (ii) | Whenever the context may require, any pronoun shall include the corresponding masculine, feminine, and neuter forms. |
| (iv) | The words “including,” “includes,” “include,” “for example,” and “e.g.,” and words of similar import, shall be deemed to be followed by the words “without limitation.” |
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| (d) | Headings. Headings, captions, and the table of contents are for convenience only and shall not be used in the interpretation or construction of this Agreement. |
| (e) | Prior Drafts. No prior draft of this Agreement shall be used in the interpretation or construction of this Agreement. |
. Each Party shall execute, acknowledge, and deliver such further instruments, and do all such other ministerial, administrative, or similar acts, as may be reasonably necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement.
. Except as expressly set forth otherwise in this Agreement, each Party shall have the right to extend the rights and obligations granted in this Agreement to one or more of its Affiliates. All applicable terms and provisions of this Agreement, except this right to extend, shall apply to any such Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to the Party extending such rights and obligations. The Party extending the rights and obligations granted hereunder shall remain primarily liable for any acts or omissions of any of its Affiliates.
[Signature Page Follows]
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IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this License Agreement to be executed by their respective duly authorized officers as of the Effective Date.
COHERUS BIOSCIENCES, INC.
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By: /s/ Denny M. Lanfear | By: /s/ Michael Yu |
Name: Denny M. Lanfear | Name: Michael Yu |
Title: Chairman &Chief Executive | Title: CEO |
[Signature Page to License Agreement]
Omitted pursuant to Regulation S-K, Item 601(a)(5)