Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY [*], HAS BEEN OMITTED BECAUSE Agenus INC., HAS DETERMINED such INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO AGENUS INC., IF PUBLICLY DISCLOSED.
LICENSE AND COLLABORATION AGREEMENT
This LICENSE AND COLLABORATION AGREEMENT (this “Agreement”) is made as of June 20, 2020 (the “Effective Date”) by and between Agenus Inc., a Delaware corporation with offices at 3 Forbes Road, Lexington, Massachusetts 02421, USA (“Agenus”), and Betta Pharmaceuticals Co., Ltd., having an address at No. 355 Xingzhong Road, Yuhang Economic and Technological Development Area, Hangzhou, China (“Betta”). Agenus and Betta may each be referred to herein individually as a “Party” or, collectively, as the “Parties”.
WHEREAS, Agenus owns or controls certain intellectual property rights with respect to its proprietary molecules known as Balstilimab and Zalifrelimab (each as defined below);
WHEREAS, Betta is a pharmaceutical company focused on the development and commercialization of innovative drug candidates and desires to obtain from Agenus certain license rights to develop and commercialize Balstilimab and Zalifrelimab into commercial products in the Field and in the Territory (each as defined below); and
WHEREAS, simultaneously with entering into this Agreement, Agenus, Betta and an Affiliate of Betta are entering into a stock purchase agreement, pursuant to which Agenus will issue, and such Affiliate of Betta will purchase, shares of capital stock of Agenus on the terms and conditions set forth therein.
NOW, THEREFORE, in consideration of the premises and of the mutual covenants set forth herein, the Parties, intending to be legally bound, hereby agree as follows:
Capitalized terms used but not otherwise defined in the body of this Agreement will have the meanings set forth in this ARTICLE 1.
1.1 | “Accounting Standards” means, as applicable (a) U.S. generally accepted accounting principles, consistently applied, (b) the PRC generally accepted accounting principles, consistently applied, or (c) International Financial Reporting Standards as issued by the International Accounting Standards Board, consistently applied. |
1.3 | “Agenus Manufacturing Technology” means the Manufacturing Materials and the Manufacturing Process for each Licensed Antibody. |
1.7 | “Antibody” means one (1) or more molecules, or one (1) or more genes encoding such molecule(s), which comprises or consists [*]. |
1.10 | “Balstilimab” means the Antibody targeting PD-1 identified by Chemical Abstract Service Registry Number 2148321-77-9 and internally referenced by Agenus as “AGEN2034.” |
1.11 | “Betta IP” means (a) Betta Improvements and Betta Improvement Patent Rights and (b) Know-How and Patent Rights [*] related to the Licensed Antibody or Licensed Products [*] for the exercise of the Retained Rights. |
1.12 | “Betta Other Component” means any Other Component that is Controlled by Betta or any of its Affiliates as of the Effective Date or during the Term. |
1.15 | “Bi-specific Licensed Products” means any Licensed Product that contains two (2) or more antigen-recognition sequences where [*] one is a Licensed Antibody [*]. |
1.16 | “BLA Submission Summaries” means the Regulatory Submission section containing manufacturing, nonclinical, and clinical summaries, equivalent to Module 2 of the U.S. FDA BLA Regulatory Submission. |
1.17 | “Business Day” means a day other than a Saturday or Sunday or a federal holiday in New York, New York, USA, or a public holiday in Hong Kong, or a national holiday in the People’s Republic of China. |
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1.25 | “Cover”, “Covering” or “Covered” with respect [*], the Development, Manufacture, and/or Commercialization of [*]. |
1.26 | “Data Privacy Laws” means the U.S. Health Insurance Portability and Accountability Act of 1996 Privacy and Security Rules, 45 C.F.R. Parts 160-164, and the Health Information Technology for |
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1.29 | “Exploit” or “Exploitation” means to Develop, Manufacture, have Manufactured, Commercialize, or otherwise use, offer for sale, sell, import, or otherwise exploit a product or process. |
1.33 | “FTE” means the equivalent of the work of a full-time individual for a twelve (12) month period. |
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1.39 | “Government Official” means any Person employed by or acting on behalf of a Governmental Body, government-controlled entity or public international organization. |
1.43 | “IND” means an investigational new drug application filed with the NMPA, or the equivalent in other jurisdictions in the Territory, for the authorization to commence Clinical Trials. |
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1.47 | “Licensed Know-How” means, subject to Section 14.3(b)(ii), all Know-How that (a) are Controlled by Agenus or any of its Affiliates, as of the Effective Date or during the Term; and (b) [*] Develop, Manufacture or Commercialize any Licensed Antibody or Licensed Product in the Field in the Territory. |
1.54 | “Net Sales” means, [*]. |
1.55 | “NMPA” mean the National Medical Product Administrations of the PRC, or its successor entity(ies) or authority thereto having substantially the same function. |
1.56 | “OFAC” means the Office of Foreign Assets Control of the U.S. Department of Treasury. |
1.57 | “Other Component” means, with respect to [*]. |
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extension or restoration mechanisms, including patent term extensions and supplementary protection certificates. |
1.59 | “Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity. |
1.60 | “PRC” means the People’s Republic of China, which for purposes of this Agreement only, excludes Hong Kong, Macau and Taiwan. |
1.64 | “Regulatory Approval” means, with respect to a Licensed Product in a country or region, all approvals that are necessary for the commercial sale of such Licensed Product for use in the Field in such country or region, excluding any pricing and reimbursement approvals, except to the extent required by Applicable Law to sell the Licensed Product in such country or region. |
1.67 | “Regulatory Submissions” means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and in each case any and all supporting documents (including documents arising in the course of Clinical Trials), and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Antibody and/or a Licensed Product. |
1.68 | “Representatives” means a Party, its Affiliates, and their respective sublicensees, employees, officers, contractors, consultants or agents. |
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1.69 | “Results” means all data (including all raw data), results, final clinical study reports and documentation [*]. |
1.73 | “Territory” means the PRC, Hong Kong, Macau and Taiwan, each of which will be considered a region under this Agreement. |
1.77 | “Value” means cash or cash equivalents invoiced or received, or in the event that in-kind, equity interests or other non-cash consideration is promised or received, the fair market value thereof. |
1.78 | “Zalifrelimab” means the Antibody targeting CTLA-4 identified by Chemical Abstract Service Registry Number 2148321-69-9 and internally referenced by Agenus as “AGEN1884.” |
1.79 | Additional Definitions. The following table identifies the location of definitions set forth in various sections of this Agreement: |
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Section | |
Abandoned Commercialization | 4.10 |
Abandoned Development | 4.10 |
Annual Net Sales | |
[*] | [*] |
Agenus | Preamble |
Agenus Indemnitees | 13.1 |
Agenus Improvements | 8.1(a) |
Agenus Improvement Patent Rights | 8.1(a) |
Agenus Product Mark | 6.2(b)(i) |
Agreement | Preamble |
Betta | Preamble |
[*] | [*] |
Betta Indemnitees | 13.2 |
Betta Improvements | 8.1(b) |
Betta Improvements Patent Rights | 8.1(b) |
Betta Product Mark | 6.2(b)(i) |
Chinese Trademarks | 6.2(b)(i) |
CMO | 1.34 |
Commercial Milestone | |
Commercial Milestones Notice | |
Cure Period | |
Disclosing Party | 9.1(a) |
Effective Date | Preamble |
Executive Officers | 3.3(a) |
Force Majeure Event | 14.6 |
General Distributor | 6.3(b) |
Global Branding Strategy | 6.2(a) |
Initial Payment | 7.1 |
Insolvency Event | |
Joint Improvements | 8.1(a) |
8.1(a) | |
JSC | 3.1(a) |
Liabilities | 13.1 |
License | 2.1 |
Licensed Patent Right Challenge | 8.6 |
[*] | [*] |
[*] | [*] |
Manager | 3.1(b) |
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5.2(e) | |
Manufacturing Technology Transfer Completion | 5.2(b) |
Milestone Payment | |
[*] | [*] |
New Trademark | 6.2(b)(i) |
Other Product | 1.20 |
Party(ies) | Preamble |
Permissible Deviation | 6.2(a) |
Price Difference | 6.3(b)(ii) |
Prior Agreements | 14.4 |
Product Invention | 8.1(a) |
Product Invention Patent Rights | 8.1(a) |
Product Marks | 6.2(b)(i) |
Product Trademarks | 6.2(b)(i) |
Promotional Materials | 6.2(c) |
Public Official | 11.6(b)(vi) |
Recipient | 9.1(a) |
Records | 5.2(d) |
Remaining Inventory | 10.3(c) |
Retained Rights | 2.3 |
Right of Reference | 4.7(g) |
Royalty Payment Statement | 7.5(b) |
Royalty Term | 7.4(a) |
SDEA | 4.6 |
SEC | 9.2(b) |
[*] | [*] |
[*] | [*] |
Specifications | 5.2(c) |
Sublicensee | 2.5(a) |
Sublicensee Breach | 2.5(c) |
Sublicensee Obligation | 2.5(c) |
Supply Agreement | 5.1 |
Tech Transfer Agreement | 5.2(b) |
Tech Transfer Fee | 7.2 |
Tech Transfer Notice | 5.2(b) |
Tech Transfer Plan | 5.2(b) |
Territory Development Plan | 4.1 |
Term | 10.1 |
Termination Date | 10.3(b) |
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6.1 | |
Territory Development Plan | 4.1 |
Territory Manufacturing Process | 5.2 (c) |
Territory Specifications | 5.2 (c) |
[*] | [*] |
Third Party Manufacturer | 5.2(b) |
Transaction Agreements | 11.7 |
Upstream License Agreement | 2.6 |
Upstream Licensor | 2.6 |
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| (d) | Copy of Sublicense Agreement. Betta will deliver to Agenus a true, complete and correct copy of each sublicense agreement (i) with respect to Betta Sublicensee, in the form entered |
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2.8 | Non-Compete. |
| (a) | By Betta. During the Term, except for the Licensed Antibodies and Licensed Products as expressly contemplated under this Agreement, Betta will not, and Betta will cause Betta Parties to not, [*]. |
| (b) | By Agenus. During the Term, except as required to perform the obligations provided in this Agreement and performance of this Agreement, Agenus will not, and Agenus will cause its Affiliates to not, [*]. |
ARTICLE 3. | GOVERNANCE |
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| (d) | Subcommittees. The JSC may establish and disband subcommittees as deemed necessary by the JSC in order to coordinate and expedite the Development, Manufacture or Commercialization of the Licensed Antibodies and the Licensed Products in the Field in the Territory. The Parties will have the right to appoint equal numbers of representatives to each subcommittee. No subcommittee established by the JSC will have the authority to bind the Parties hereunder and any such subcommittee will report to, and any decisions will be made by, the JSC. |
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| (i) | Subject to Section 3.3(a)(ii) below, Betta will have the final decision-making authority over [*]; and |
| (ii) | Agenus will have the final decision-making authority over the matter if [*]. |
| (b) | Exceptions. Notwithstanding the foregoing, neither Party may exercise its right to finally resolve a dispute: (i) in a manner that expands such Party’s rights or excuses such Party from any of its obligations under this Agreement; or (ii) in a manner that would require the other Party to perform any act that it [*]believes to be inconsistent with any Applicable Law or any approval, order, policy or guidelines of a Regulatory Authority in its Territory. |
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such tasks are known or can reasonably be ascertained. Betta will Develop each Licensed Antibody and Licensed Product in the Field and in the Territory in accordance with the applicable Territory Development Plan. Betta will be solely responsible for all costs and expenses in connection with the Development of Licensed Antibodies and Licensed Products in the Field and in the Territory. |
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| forms, investigator reports, raw data and any analyses thereof. To the extent permitted by Applicable Laws (including the requirements of applicable Regulatory Authorities), Betta will [*] ensure that any agreement any Betta Party enters into with any Person regarding the Licensed Product will include data sharing obligations for such Persons consistent with this Section 4.5(a). [*]. |
| (c) | All data and information disclosed by one Party to the other under this Agreement shall be deemed Confidential Information of the disclosing Party. |
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| Regulatory Approval for Betta’s benefit, (ii) will appoint Betta as its exclusive agent to handle all regulatory activities for the Licensed Product in the Field in the Territory, and (iii) will promptly transfer such Regulatory Approval to Betta or its designee when allowed by Applicable Laws; further provided that in the event and during any period that Agenus holds such Regulatory Approval for Betta’s benefit, (A) Agenus will not be obligated to perform any activities, bear any obligations, or bear any costs, in each case, in addition to the activities set forth in this Agreement due to Agenus or its Affiliate holding such Regulatory Approval; (B) Agenus will not assume any liability in connection with Agenus holding such Regulatory Approval; (C) should Agenus incur any costs or expenses related to holding or transferring any such Regulatory Approval, Betta will reimburse Agenus or its Affiliates for any and all costs and expenses incurred by Agenus in holding or transferring such Regulatory Approval; and (D) Betta will indemnify and hold Agenus Indemnitees from and against any and all Liabilities to the extent arising from Agenus holding such Regulatory Approval in the Field in the Territory as set forth in ARTICLE 13. |
| (c) | Agenus’ Responsibilities. Agenus will [*] cooperate with Betta in obtaining any Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for a Licensed Product in the Field and in the Territory including by providing reasonable access to clinical data, and other data, information, and documentation for Licensed Products in the Field that is included in the Licensed Know-How, including any Regulatory Approvals or Regulatory Submissions for the Licensed Products in the Field in the Territory and, as applicable, and subject to any Third Party obligations, outside the Territory. |
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| (ii) | Agenus will provide Betta with copies in the original language of sections relating to clinical results, efficacy, safety, dosage, and any other sections reasonably requested by Betta of (A) all Regulatory Submissions actually submitted (including in the original language thereof) in the United States; and (B) all Regulatory Approvals obtained or denied in the United States, in each case of (A) and (B), to the extent solely related to a Licensed Antibody in a monotherapy setting or in combination with the other Licensed Antibody, but excluding combinations of either or both Licensed Antibodies with any Other Component. |
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| 4.2, and to audit the study records of such Persons for data-sharing purposes as set forth in Section 4.5. Such audits will take place during normal business hours [*], unless significant non-compliance identified warrants further assessment or any Regulatory Authority reasonably requires additional time. Such audits will be conducted in a manner that minimizes interruption of Betta’s or the study site’s operations and will be at Agenus’ sole cost and expense. Persons auditing the facilities, books or records will be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement, and will abide by the safety protocols and standard operating procedures of the audited facility while on site. |
| (a) | The Parties agree that the Supply Agreement should be consistent with the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section |
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| 5.2(b), Agenus will [*] supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for use. |
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| permits and other approvals needed for such development and commercialization outside of the Territory where such supply is intended for use. [*]. |
5.3 | Quality Agreement. Prior to commencement of any Clinical Trial or Commercialization of a Licensed Product by the Betta Parties, Agenus and Betta will enter into a quality agreement setting forth the responsibilities of the Parties with respect to compliance with GMP in connection with Development, Manufacturing and Commercialization of Licensed Products in the Field and in the Territory and may include additional compliance requirements related to non-clinical and clinical operations. |
6.2 | Global Branding. |
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| (ii) | Betta will reasonably cooperate with Agenus to enable Agenus to ascertain that all uses of all of the Product Marks, as permitted hereunder, meet the quality standards set by Agenus in connection with its existing uses of each of such Product Mark, including by allowing Agenus and its representatives to make periodic inspection of Betta’s packaging, inserts, records, documents and other materials that contain any such Product Mark. |
6.3 | Sales and Distribution. |
| (a) | Betta Responsibilities. Betta will be responsible for booking sales and will warehouse and distribute Licensed Products in the Territory at its sole cost. Betta will be solely responsible for handling all returns of Licensed Products sold in the Territory, as well as all aspects of Licensed Product order processing, invoicing and collection, distribution, inventory and receivables of Licensed Products sold in the Territory. |
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| (iii) | Betta will, and Betta will cause all Betta Parties to, provide to Agenus all reasonable assistance, facilitation and support for the distribution of the Licensed Products in the applicable Provinces to comply with the Two-Invoice Policy. For the avoidance of doubt, in the case that Betta and the General Distributor directly make an agreement in accordance with this Section 6.3(b), such agreement will conform to the terms and conditions of this Agreement. |
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Development Milestone Event | Payment |
(i)[*] | [*] |
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If the Development milestone event described in clauses 7.3(a)(i) is not achieved, but the Development milestone event described in clause 7.3(a)(ii) is achieved, then such earlier skipped Milestone Payment will then be due and payable together with the Milestone Payment due for the achieved milestone event. [*] after the achievement of each Development milestone event, Betta will notify Agenus of such achievement. Agenus will invoice Betta for the Development Milestone Payment for each Development milestone event achieved following its receipt of such notice and Betta will make the Milestone Payment [*]following receipt of such invoice.
[*] after the end of each calendar year, Betta will notify Agenus if any Commercial Milestones are achieved (“Commercial Milestones Notice”), provided that Betta will provide the unaudited Net Sales within [*] after the end of each calendar year. Agenus will invoice Betta for each Commercial Milestone Payment for each Commercial milestone achieved following its receipt of the Commercial Milestones Notice and Betta will make the Milestone Payment within [*] following receipt of such invoice. For clarity, Betta shall only be obligated to make payment once for the first time when a Commercial Milestone is achieved and Betta has no obligation to make further payment if such Commercial Milestone is achieved again.
7.4 | Running Royalties. Betta will pay to Agenus running royalties on Net Sales of all Licensed Products in the Territory at the applicable royalty rates, as set forth in the following table: |
Annual Aggregated Net Sales of all Licensed Products in the Territory | Royalty Rate |
(i)[*] | [*] |
(ii)[*] | [*] |
(iii)[*] | [*] |
(iv)[*] | [*] |
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| (i) | the expiration of the last-to-expire Licensed Patent in such region having a Valid Claim that Covers such Licensed Product; |
| (ii) | the expiration of all Regulatory Exclusivity Periods that apply to such Licensed Product in such region; or |
| (iii) | the tenth (10th) anniversary of the First Commercial Sale of such Licensed Product in the Territory. |
| (b) | Additional Provisions Regarding Royalties. Betta’s royalty obligations under this Section 7.4 will be subject to the following conditions: |
| (i) | only one royalty will be due and payable with respect to the same unit of Licensed Product; |
| (ii) | royalties when owed or paid hereunder will be non-refundable and non-creditable and not subject to set-off, except as expressly set forth herein; |
| (iv) | no royalties will accrue on the disposition of Licensed Products by the Betta Parties for use in clinical studies conducted by the Betta Parties; and |
| (v) | no royalty anti-stacking, offsets, or reductions of any kind will apply. Betta will be responsible for [*] ensure non-infringement of the Licensed Products under third party rights in the Territory in the Field. |
7.5 | Payment Terms. Unless otherwise stated below, this Section 7.5 will apply to all payments to be made by one Party to the other hereunder. |
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| all royalty payments due to Agenus pursuant to Section 7.4 (“Royalty Payment Statement”) for the relevant calendar quarter including: |
| (i) | the gross amount invoiced by the Betta Parties to any Third Party for the sale to such Third Party of Licensed Products; |
| (ii) | the calculation of Net Sales, including the applicable royalty rate and the type and amount of all deductions and offsets allocated with respect to such Net Sales; |
| (iii) | if applicable, the exchange rate, as defined in Section 7.5(a) used for calculating any royalties; and |
| (iv) | such other particulars as are reasonably necessary for an accurate accounting of the payments due pursuant to this Agreement. |
| (c) | Royalty Invoicing. |
| (i) | Agenus will invoice Betta for all royalties payable under this Agreement [*] following receipt of each Royalty Payment Statement for the applicable calendar quarter. |
| (ii) | With respect to any royalty payment by Betta to Agenus under Section 7.4, Betta will pay each invoice for such royalty payment [*] after delivery of such invoice to Betta by Agenus. |
| (d) | Overdue Payments. Any overdue payments to Agenus by Betta under this Agreement will accrue interest [*] (or the maximum legal interest rate allowed by Applicable Law, if less) from and after such date and Betta will be responsible for reasonable legal fees and expenses incurred by Agenus in connection with the collection thereof. |
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| deducted amounts such that, after deducting and withholding such amounts (including for taxes on the additional amounts payable), Agenus receives amounts equal to the amounts set forth hereunder before any withholdings and deductions; provided that, in the event that Agenus actually recovers any such withheld or deducted amounts paid by Betta to the applicable taxing authority, Agenus shall return, refund, reimburse, or credit any such recovered amounts to Betta. Betta will submit to Agenus appropriate proof of payment of the withheld or deducted taxes as well as the official receipts within a reasonable period of time. Each Party will, upon request, provide the other Party with reasonable assistance in order to assist such Party in seeking the benefit of any present or future tax exemptions and/or treaties against double taxation which may apply to any payments due Agenus under this Agreement. |
| (c) | For clarity, (i) all Product Inventions, Product Invention Patent Rights, Agenus Improvements, Agenus Improvement Patent Rights, Joint Improvements and Joint Improvement Patent Rights [*] for the Development, Manufacture or Commercialization of the Licensed Product in the Field in the Territory will be included in the Licensed IP and licensed to Betta under the License; and (ii) all Betta Improvements and Betta Improvement Patent Rights [*] will be included in the Betta IP and licensed to Agenus under the license granted by Betta to Agenus under Section 2.4. |
| (d) | Each Party shall promptly notify the other Party of any Invention arising in connection with this Agreement, including Inventions made by Affiliates or sublicensees of the Party. |
8.2 | Ownership Disputes. The Parties will attempt [*] to resolve any disputes regarding ownership of Inventions, and all Patent Rights and any other intellectual property rights therein. In the event the Parties are unable to resolve such dispute through escalation to Executive Officers of the Party, such dispute will be resolved [*]. |
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| (d) | With respect to the Licensed IP in the Territory or any Betta Improvement Patent Right included within the license granted to Agenus under Section 2.4, the Party responsible for Prosecution will consult with and keep the other Party fully informed of material issues relating to the Prosecution of such Patent Rights, [*]. |
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8.5 | Cooperation. Each Party hereby agrees to provide to the other Party all reasonable assistance and cooperation reasonably necessary to enable such other Party to undertake Prosecution, enforcement and defense of Patent Rights as contemplated by this Agreement, including: (a) to cause its employees, and to use reasonable efforts to cause its licensees, sublicensees, independent contractors, agents and consultants, to be reasonably available to the other Party (or to the other Party’s authorized attorneys, agents or representatives); (b) to endeavor [*] to coordinate its efforts with the other Party to minimize or avoid interference with the Prosecution, enforcement and defense of the other Party’s Patent Rights that are subject to this Agreement; (c) to provide any necessary powers of attorney and executing any other required documents or instruments required to give effect to the terms of this Agreement; and (d) to cause its employees, and to use reasonable efforts to cause its licensees, sublicensees, independent contractors, agents and consultants, to provide any and all information required for the other Party to comply with its relevant duties of disclosure as required by Applicable Law in the United States or any other jurisdiction. |
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exercise its right to direct and control the defense of an Infringement Action, then Betta shall have such right; [*]. |
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| (d) | Notwithstanding the obligations in Section 9.1(a) and 9.1(c), the Recipient may disclose (and, in connection therewith, use) Confidential Information of the Disclosing Party, if such disclosure: |
| (ii) | consists entirely of Confidential Information previously approved by the Disclosing Party for public disclosure by the Recipient; or |
| (e) | Each Recipient will be responsible for any breach of the obligations of this Section 9.1 by any Person to whom such Recipient or its Affiliate disclosed the Disclosing Party’s Confidential Information. |
9.2 | Publicity; Attribution; Terms of this Agreement; Non-Use of Names. |
| (a) | Except as required by judicial order or Applicable Law, or as set forth below, neither Party may make any public announcement concerning this Agreement without the prior written consent of the other Party, which consent may not be unreasonably withheld or delayed. The Party preparing any such public announcement will provide the other Party with a draft thereof at least [*] prior to the date on which such Party would like to make the public announcement. Neither Party may use the name, trademark, trade name or logo of the other Party, its employees, or of [*], in any press release, advertising or promotional materials without the prior express written permission of the other Party or, as applicable, [*]. |
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| (d) | For purposes of clarity, either Party may issue a press release or public announcement or make such other disclosure if the content of such press release, public announcement or disclosure has previously been made public other than through a breach of this Agreement by the issuing Party or its Affiliates. |
9.3 | Publications. The Betta Parties will have the right to make disclosures pertaining to a Licensed Antibody and/or Licensed Product in recognized scientific publications or at scientific conferences in accordance with the following procedure: [*]. |
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| (B) | the Cure Period will be [*] in the event that a Party materially breaches any of its payment obligations to the other Party; provided, however, the failure to make the Initial Payment pursuant to Section 7.1 will be deemed an incurable material breach of a material provision of this Agreement and Agenus will have the right to terminate this Agreement in its entirety with immediate effect; |
provided that, in each case of (A) and (B) (other than with respect to the Initial Payment), the breaching Party may remedy such breach during such [*] Cure Period. If the breaching Party is Betta and the breach relates to Betta’s failure to enforce any material provisions of a Sublicensee, then following the Cure Period and operation of the applicable provisions of this Section 10.2(c), Agenus may terminate this Agreement in whole or in part, or at its option, solely with respect to such sublicense, and Betta will within [*] of such termination provide written confirmation to Agenus that such sublicense has been terminated.
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| (i) | Either Party will have the right to terminate this Agreement in connection with a Force Majeure Event asserted by the other Party, in accordance with Section 14.6. |
| (iii) | [*]. |
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11.1 | Mutual Representations and Warranties. Each Party represents, warrants, and covenants to the other Party that as of the Effective Date: |
| (a) | It is duly organized, validly existing, and in good standing as a corporation or other entity as represented herein under the laws and regulations of its jurisdiction of incorporation, organization, or chartering; |
| (b) | it has the full right, power, and authority to enter into this Agreement and to perform its obligations hereunder; |
| (c) | the execution of this Agreement by its representative whose signature is set forth at the end hereof has been duly authorized by all necessary corporate action of the Party and shall not violate (i) such Party’s organizational documents; (ii) any agreement, instrument or contractual obligation to which such Party is a party or by which it is bound; (iii) any requirement of any Applicable Law; or (iv) any order, writ, judgment, injunction, decree, determination or award of any court or any Governmental Body presently in effect applicable to such Party; |
| (d) | when executed and delivered by such Party, this Agreement will constitute the legal, valid, and binding obligation of that Party, enforceable against that Party in accordance with its |
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| terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium or other laws relating to or affecting creditor’s rights generally and by general equitable principles; |
| (e) | as of the Effective Date, it is not currently bound by any agreement with any Third Party, or by any outstanding order, judgment, or decree of any court or administrative agency that restricts it from granting to such other Party the rights and licenses as set forth in this Agreement; and |
| (f) | such Party has valid and sufficient arrangements and agreements with its directors, officers and employees (which term shall include agents, consultants and subcontractors) such that ownership of intellectual property rights in and to any Inventions made by its directors, officers and employees vests in such Party. |
11.2 | Betta’s Representations and Warranties. Betta represents and warrants to Agenus that: |
| (b) | As of the Effective Date, to Betta’s knowledge there is no pending litigation against Betta or any of its Affiliates relating to, and neither Betta nor any of its Affiliates has received any written notice from any Third Party asserting, an allegation that the Development, Manufacturing or Commercialization activities of Betta or its Affiliates exceed the scope of any license granted by a Third Party pursuant to an agreement to which Betta or its Affiliates are currently bound. |
11.3 | Agenus’ Representations and Warranties. Agenus represents and warrants to Betta that as of the Effective Date: |
| (a) | Agenus Controls the Licensed IP, and Agenus has executed the Amendment to Inter-Company Agreements; |
| (b) | Agenus has the full rights, power and authority to grant the License granted herein, and is not prohibited from doing so by the terms of any agreement to which it is a party [*], and has the full right, power and authority to deliver the Licensed IP to Betta, and is not prohibited from doing so by the terms of any agreement to which it is a party, [*]; |
| (c) | The Upstream License Agreements include all agreements between Agenus or its Affiliates and a Third Party under which Agenus or its Affiliates have licensed or sublicensed the Licensed IP from a Third Party, and Agenus has provided Betta with a copy of each Upstream License Agreement, which copy has been redacted to remove any provisions or terms not necessary to determine Betta’s rights under the License. |
| (d) | [*]; |
| (e) | Agenus’ performance of its obligations under this Agreement does not or will not cause any breach of any Upstream License Agreements; |
| (f) | Agenus’ right, title and interest to all the Licensed IP are free of any lien or security interest; |
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| (h) | there are no written licenses or other agreements to which Agenus or any of its Affiliates is a party that relate in any material respect to any Licensed Antibody and/or Licensed Product in the Territory or any Licensed IP relating thereto, and Agenus has not granted any right or license to any Third Party relating to any of the intellectual property rights it Controls, which would conflict or interfere with any of the rights or licenses granted to Betta hereunder; |
| (i) | neither the execution and delivery of this Agreement nor the performance hereof by Agenus requires Agenus to obtain any permits, authorizations or consents from any Governmental Body or from any other person, firm or corporation, and such execution, delivery and performance will not result in the breach of or give rise to any right of termination, rescission, renegotiation or acceleration under, or trigger any other rights under, any agreement or contract to which Agenus is a party or to which it may be subject that relates to the Licensed IP or the Licensed Antibody and/or Licensed Product; and |
| (j) | there is no written action, suit, proceeding (other than routine patent office and regulatory matters), arbitration, or litigation of any nature, civil, criminal, regulatory or otherwise, in law or in equity, pending, or to its knowledge, threatened, against Agenus or any of its Affiliates, in each case in connection with the Licensed IP or the Licensed Antibodies and/or Licensed Products. |
| (b) | Betta will perform, and will cause Betta Parties to perform, their responsibilities and exercise their rights under this Agreement in compliance with this Agreement (including Section 11.6(b)) and all Applicable Laws, including all GCP, GLP, GDP, GMP, Anti-Corruption Laws and Data Privacy Laws; |
| (c) | Betta will not, and will not permit Betta Parties to, ship or otherwise make available Licensed Antibodies or Licensed Products outside of the Territory; |
| (d) | Betta will, and will cause Betta Parties to, maintain complete and accurate Records, and will ensure that no Records, including any Clinical Trial records or Manufacturing batch records, are tampered with or improperly modified; |
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| use by Agenus or its Affiliates or sublicensees of Clinical Trial data and records, and provide Agenus with copies of such record filings, licenses, approvals, and permits; |
| (f) | all employees and officers of Betta or Betta Parties working under this Agreement shall be under the obligation to assign all right, title and interest in and to their Inventions, whether or not patentable, if any, to Betta as the sole owner thereof, and under the obligation to maintain as confidential the Confidential Information of Betta; and |
| (ii) | The Betta Parties shall not enable, authorize or license any Third Party to take any action that would have the effect of allowing such Third Party to take any action relating to the Betta Existing IP that would be prohibited by this Section 11.4(g) if taken by a Betta Party. |
| (iii) | If any Betta Party asserts any claim or counterclaim or otherwise participates in any action, suit or proceeding that would be prohibited by this Section 11.4(g), then Betta shall, and shall use reasonable efforts to cause such Affiliate or other Betta Party to, (A) withdraw, file a dismissal with prejudice, or take all actions having similar effect, with respect to any such claim, counterclaim, action, suit or proceeding [*] of the earlier of (1) Agenus’s written request, or (2) Betta learning of such claim, counterclaim, action, suit or proceeding, and (B) if obtained, deliver a copy of such withdrawal or dismissal with prejudice, or reasonable documentary evidence of any similar action having similar effect, to Agenus within such [*] period. |
| (a) | Agenus will perform its responsibilities under this Agreement in compliance with this Agreement (including Section 11.6(b)) and all Applicable Laws, including all Anti-Corruption Laws; |
| (b) | all employees and officers of Agenus or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their Inventions, whether or not patentable, if any, to Agenus as the sole owner thereof, and under the obligation to maintain as confidential the Confidential Information of Agenus; |
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| (ii) | Agenus and its Affiliates shall not enable, authorize or license any Third Party to take any action that would have the effect of allowing such Third Party to take any action relating to the [*] that would be prohibited by this Section 11.5(e) if taken by Agenus or its Affiliates. |
| (iii) | If Agenus or any Affiliate asserts any claim or counterclaim or otherwise participates in any action, suit or proceeding that would be prohibited by this Section 11.5(e), then Agenus shall, and shall use reasonable efforts to cause such Affiliate to, (A) withdraw, file a dismissal with prejudice, or take all actions having similar effect, with respect to any such claim, counterclaim, action, suit or proceeding [*] of the earlier of (1) Betta’s written request, or (2) Agenus learning of such claim, counterclaim, action, suit or proceeding, and (B) if obtained, deliver a copy of such withdrawal or dismissal with prejudice, or reasonable documentary evidence of any similar action having similar effect, to Betta [*] period. |
| (a) | No Debarment. Each Party hereby represents, warrants and covenants (on behalf of itself and its Affiliates) that it nor any of its Affiliates will not and has not employed or otherwise used in any capacity the services of any person debarred in performing any activities under or in connection with this Agreement under Section 335a of Title 21 of United States Code or by the FDA, or under any analogous laws under the Applicable Laws or by any Regulatory Authority in the Territory. Each Party will immediately notify the other Party in writing if any such debarment occurs or comes to its attention, and will, with respect to any person or entity so debarred, promptly remove such person or entity from performing any activities related to or in connection with the Territory Development Plans or this Agreement. |
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| (ii) | Each Party understands and agrees that it has complied and will continue to comply with all applicable Anti-Corruption Laws in connection with this Agreement in all material respects. |
| (iii) | To its best knowledge, each Party represents, warrants and covenants that no payments of money or anything of value have been or will be offered, promised, or paid, whether directly or indirectly, by any of its directors, officers, employees, Affiliates, or Third Party representatives to any Government Official in connection with this Agreement: (A) to influence any official act or decision of any Government Official; (B) to induce any Government Official to do or omit to do any act in violation of lawful duty; (C) to secure any improper business advantage; (D) to obtain or retain business for, or otherwise direct business to, any Party; or (E) otherwise in violation of Anti-Corruption Laws, in each case, in connection with this Agreement. |
| (iv) | To its best knowledge, each Party warrants, represents and covenants that, in connection with this Agreement, the Party, its Affiliates, directors, officers, employees, and Third Party representatives: (A) have not and will not request, accept, offer, promise, or give any bribe, kickback, or other corrupt payment to any person, including any representative of any commercial entity, in violation of any applicable Anti-Corruption Law; and (B) have not and will not request, offer, promise, or give any financial or other advantage to induce another person to perform a function or activity in order to obtain or retain an improper business advantage, in each case (A) and (B), in any way relating to this Agreement. |
| (vi) | Each Party represents and warrants that no formal or informal proceeding, investigation, or inquiries by or before any Governmental Body involving such |
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| Party or its Affiliates or, to the best knowledge of such Party, with respect to any Anti-Corruption Laws is pending or, to the knowledge of such Party, is threatened. |
| (vii) | Each Party covenants that it will promptly inform the other Party if such Party, or any of its directors, officers, employees, Affiliates, Third Party representatives, or sublicensees becomes subject to any investigation relating to any actual or potential violation of any applicable Anti-Corruption Law in connection with this Agreement, including any meeting, interview, inspection, or audit requested by any Governmental Body, upon such Party becoming aware of the foregoing. |
| (viii) | Each Party will, and will cause its Affiliates performing activities under this Agreement to, provide reasonable cooperation in connection with any good faith investigation conducted by the other Party into potential violations of applicable Anti-Corruption Laws in connection with this Agreement; provided that such Party will provide the other Party with a written notice at least [*] before the initiation of such investigation. |
| (x) | On an annual basis following the execution of this Agreement, or as reasonably requested [*] by Agenus, Betta agrees to submit a compliance certificate to Agenus which restates the representations, warranties and covenants that are set forth in this Section 11.6(b) and provides certification by Betta that it and its Affiliates performing activities under this Agreement has adhered, during the period covered by the compliance certificate, to such representations, warranties and covenants. |
| (xii) | Upon request by Agenus, Betta agrees to, and will cause any Affiliate performing activities under this Agreement to, participate in periodic anti-corruption training (including but not limited to Anti-Corruption Law training) conducted by Agenus or persons selected by Agenus. |
| (xiii) | Betta has received, understands and shall comply, and Betta will ensure that its Affiliates performing activities under this Agreement have received, understand |
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| (c) | Export Controls. Betta acknowledges that the Licensed IP is subject to the export control laws of the United States. Betta shall not, and will cause its Affiliates not to, export, report, or otherwise transfer the Licensed IP in violation of applicable export control laws. Neither Betta Parties nor any of their directors, officers, employees, or Affiliates is a Restricted Party. In relation to the activities contemplated by this Agreement, Betta Parties shall not (a) engage in any dealings or transactions, directly or indirectly, with or for the benefit of any Restricted Party; (b) violate applicable economic sanctions or export control laws; or (c) take, or refrain from taking, any action that foreseeably would cause Agenus to be in violation of applicable sanctions or export control laws. |
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NEGLIGENCE), STRICT LIABILITY, PRODUCT LIABILITY, OR OTHERWISE (INCLUDING THE ENTRY INTO, PERFORMANCE, OR BREACH OF THIS AGREEMENT), REGARDLESS OF WHETHER SUCH LOSS OR DAMAGE WAS FORESEEABLE OR THE PARTY AGAINST WHOM SUCH LIABILITY IS CLAIMED HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGE, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE. |
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| (a) | Neither Party may assign its rights and obligations under this Agreement without the prior written consent of the other Party, except that either Party may make such assignment, in whole or in party, without the prior written consent of the other Party to an Affiliate (so long as such Affiliate remains an Affiliate of such Party). The assigning Party will remain jointly and severally liable with such Affiliate with respect to all obligations so assigned. Any purported assignment in contravention of this Section 14.3 will, at the option of the non-assigning Party, be null and void and of no effect. No assignment will release either Party from responsibility for the performance of any accrued obligation of such Party hereunder. This Agreement will be binding upon and enforceable against the successor to or any permitted assignee from either of the Parties. |
| (b) | Each Party agrees that, notwithstanding any provisions of this Agreement to the contrary, including the definition of “Affiliate” in Section 1.2: |
| (i) | Agenus may assign this Agreement in whole or in part to a Third Party in connection with a Change in Control, subject to Section 14.3(b)(ii). |
Notices to Betta will be addressed to:
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Betta Pharmaceuticals Co. Ltd.
No. 355 Xingzhong Rd. Yuhang District. Hangzhou.
PRC 311100
Attention: Chief Executive Officer
Telephone: [REDACTED]
with a copy to (which will not constitute notice):
PacGate Law Group
Suite 5501, 55th Floor, Fortune Financial Center, 5 East 3rd Ring Rd., Chaoyang District,
Beijing, 100020, China
Attention: Eric He
E-mail address: [REDACTED]
Notices to Agenus will be addressed to:
Agenus Inc.
3 Forbes Road
Lexington, Massachusetts 02421-7305, USA
Attention: Chief Executive Officer
Copy to: Legal Department
E-mail address: [REDACTED]
with a copy to (which will not constitute notice):
Ropes & Gray LLP
36F, Park Place 1601 Nanjing Road West
Shanghai 200040, China
Attention: Geoffrey Lin
E-mail address: [REDACTED]
provided, however, that if either Party will have designated a different address by notice to the other Party in accordance with this Section 14.5, then to the last address so designated.
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CoV-2 / COVID-19 pandemic will not constitute a Force Majeure Event with respect to Betta’s obligation to pay Agenus [*]. |
14.8 | Independent Contractors. It is understood and agreed that the relationship between the Parties is that of independent contractors and that nothing in this Agreement will be construed to create a joint venture or any relationship of employment, agency or partnership between the Parties to this Agreement. Neither Party is authorized to make any representations, commitments or statements of any kind on behalf of the other Party or to take any action that would bind the other Party. Furthermore, none of the transactions contemplated by this Agreement will be construed as a partnership for any tax purposes. |
14.9 | No Implied Waivers; Rights Cumulative. No failure on the part of a Party to exercise, and no delay by either Party in exercising, any right, power, remedy or privilege under this Agreement, or provided by statute or at law or in equity or otherwise, will impair, prejudice or constitute a waiver of any such right, power, remedy or privilege by such Party or be construed as a waiver of any breach of this Agreement or as an acquiescence therein by such Party, nor will any single or partial exercise of any such right, power, remedy or privilege by a Party preclude any other or further exercise thereof or the exercise of any other right, power, remedy or privilege. |
14.11 | Execution In Counterparts. This Agreement may be executed in any number of counterparts, each of which will be deemed an original, and all of which together will constitute one and the same instrument. Signatures provided by facsimile transmission or in Adobe™ Portable Document Format (.pdf) sent by electronic mail will be deemed to be original signatures. |
14.13 | Performance by Affiliates. Either Party may use one or more of its Affiliates to perform its obligations and duties hereunder and Affiliates of a Party are expressly granted certain rights herein; provided that each such Affiliate will be bound by the corresponding obligations of such Party and the Parties will remain liable hereunder for the prompt payment and performance of all their respective obligations hereunder. |
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14.14 | Exhibits. In the event of inconsistencies between this Agreement and any exhibit hereto, the terms of this Agreement will control. |
14.16 | Construction. In construing this Agreement, unless expressly specified otherwise: |
| (a) | headings and titles are for convenience only and do not affect the interpretation of this Agreement; |
| (b) | any list or examples following the word “including” will be interpreted without limitation to the generality of the preceding words; |
| (c) | the terms “hereof”, “hereto”, “hereby”, “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; |
| (d) | references to a Person are also to its successors, heirs and permitted assigns; |
| (e) | except if Business Days are specified, “day” refers to a calendar day; |
| (f) | if a period of time is specified and dates from a given day or Business Day, or the day or Business Day of an act or event, it is to be calculated exclusive of that day or Business Day; |
| (g) | references to a law include any amendment or modification to such law and any rules or regulations issued thereunder, whether such amendment or modification is made, or issuance of such rules or regulations occurs, before or, only with respect to events or developments occurring or actions taken or conditions existing after the date of such amendment, modification or issuance, after the Effective Date, but only to the extent such amendment or modification, to the extent it occurs after the date hereof, does not have a retroactive effect; |
| (h) | all references to “Dollars” or “$” herein will mean U.S. Dollars; |
| (i) | the word “will”, when used to indicate an obligation of a Person, will be construed to have the same meaning and effect as the word “shall” and |
| (j) | each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and provisions. |
[signature page follows]
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IN WITNESS WHEREOF the Parties, intending to be bound hereby, have caused their duly authorized representatives to execute this Agreement as of the Effective Date.
BETTA PHARMACEUTICALS CO. LTD.
/s/ Lieming Ding Name: Lieming Ding
AGENUS INC.
/s/ Garo H. Armen Name: Garo H. Armen Title: Chairman & CEO
|