伊穆特普有限公司

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喬治街 264 號 32 樓

悉尼

新南威爾士州 2000

澳大利亞

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MSD 擁有對 MSD compound （如下定義）的知識產權，並正研發 MSD compound 用於治療特定的腫瘤類型。

合作方正在研發合作方 compound （如下定義）用於治療特定的腫瘤類型。

合作方希望贊助合作方臨床試驗 （如下定義），在該試驗中，合作方 compound 和 MSD compound 會以組合形式（如下定義）給予劑量。

根據本協議（如下定義）的條款，MSD 和合作方希望如本文所述進行合作，包括提供 MSD compound 和合作方 compound 用於 MSD compound 研究（如下定義）。

定義。

“「附屬公司」應當按照本協議簽署當日生效的《交易所法規》120億2條所賦予的含義進行解釋。「一方」指的是任何現在或將來直接或間接擁有或控制該方的公司、法人或其他實體，或者目前或將來由該方擁有或控制，或與該方共同擁有或控制的公司、法人或其他實體，只要該控制存在，即屬於該方。在本定義中，「控制」這個詞的含義是：(i) 對於法律實體，直接或間接擁有該法人發行股份中五成(50%)以上的投票權證券；或者(ii) 通過擁有投票權證券、合約權利、投票權、公司治理或其他方式，直接或間接擁有指導法人管理或政策的權力。

“協議」即本協議(包括所有附錄、附件和附表)，根據雙方不時修訂的本協議，按照該協議的規定。 第 16 (完整協議; 修正; 放棄)。

“聯盟經理”指根據雙方指定的聯盟經理（聯合開發委員會；經理）而選定的人。第 2.3 （聯合開發委員會; 經理）

“適用法律”指與本協議項下的特定活動相關的所有聯邦、州、地方、國家和區域型法規、法律、規則、條例和指示，包括從時間到時間可能有效的執行臨床試驗、醫療治療以及處理和保護個人和醫療數據的相關法律，包括：(i) 任何監管機構制定的法規; (ii) 製造業和醫療的良好製造規範及良好臨床實踐指南; (iii) 數據保護法; (iv) 禁止將美國產品和技術運送到某些受限制的國家、實體和個人的出口管制和經濟制裁法規; (v) 反賄賂和反腐敗法規關於與政府官員、公務員和代表互動的規定; (vi) 管理醫療提供者支付的法律和法規; (vii) 任何證交所的上市或其他規則或法規; 以及 (viii) 衛生、安全和環保保護法規。

Arising IP”應具有本協議中該術語的含義。 第 3.10.3.

“業務日” 指的是除星期六、星期日或商業銀行所在國家（或若在美國，在州內）法律允許或要求休市的日子外的任何其他日子。

“cGMP指的是製造產品時適用的當前良好製造規範和法規，這些規範和法規由相關的政府或監管機構制定，包括但不限於美國食品藥品監督管理局和歐洲藥品管理局。” 指的是EMA、FDA 和其他適用的監管機構正式發布並解釋的良好製造慣例，適用於Compound 的製造。

“控制權更換” 意味著：(a) 對於與 [***] 相關的所有或基本上所有資產或業務的出售；或 (b) 一宗涉及 [***] 的合併、重組或合併，其中合併、重組或合併之前的投票證券在上述合併、重組或合併之後立即不再代表生存實體的綜合表決權中至少占50%；或 (c) 任何第三方（或共同行動的第三方群體）直接或間接成為 [***] 總表決權的50% 或以上的有利所有者。

“臨床供應品質協議“ 意味著由協力廠商和默沙東母公司 MSD 的附屬公司 Merck Sharp & Dohme Corp. 簽署的臨床品質協議，日期為 [***]，可能會被雙方不時修改，並如進一步描述在 第 2.4 （臨床供應品質協議）。

“臨床數據“ 意味著協力廠商臨床數據、聯合臨床數據和 MSD 臨床數據。

“臨床安全數據“ 意味著所有來自協作廠商臨床試驗中不包含 MSD 化合物或涉及協作廠商化合物的其他臨床試驗部分的安全性和耐受性數據，包括所有包含有關不良事件、SAE和來自任何適用監管機構所要求的其他信息的安全報告，包括實驗室和影像數據的摘要表。

“CMC” 意味著“化學製造與管制作為藥品行業中的術語。

“合作夥伴在信息表的“合作夥伴實體名稱”行中指定的實體。

“合作夥伴地址在信息表的“合作夥伴地址”行中為合作夥伴設置的地址。

“合作者 背景專利” 指由合作者或其聯屬公司控制，並聲稱或涵蓋組合的專利，並非共同專利。

“合作者 Class A普通股compound” 意指 [***]。

“合作者臨床數據” 表示由任何一方或代表任何一方或根據任何一方指示或由雙方共同或根據雙方指示，在合作方藥品試驗期間生成的所有數據（包括原始數據）和結果，如果有合作方藥品試驗分支論，则該合作方藥品試驗數據不包括樣本測試結果、聯合臨床數據或MSD臨床數據。

“合作方 臨床試驗” 表示信息表中“合作方臨床試驗”條款中所規定的臨床試驗，如進一步描述在 第 2.1 （合作方臨床試驗）。

“合作方藥品” 表示信息表中“合作方藥品”條款中所規定的化合物， [***]。

“合作方的化合物部位（部分）”代表任何合作方臨床試驗中，患者預期會單獨或與一個或多個治療藥品同時或依序接受合作方的化合物，但不與MSD的化合物合併使用。

“合作方升級聯絡人”代表資訊表中“合作方JDC升級人員標題”行所列之人。

“合作方創作”代表[***]。

“Combination”代表使用或使用合作方的化合物和MSD[***]的方法。

“組合臂“”指的是合作夥伴臨床試驗中患者預期接受合作夥伴複方和MSD [***] 的一部分。

“化合物”代表協作化合物和MSD化合物。複合物”代表協作化合物或MSD化合物。

“機密信息”代表任何信息（包括個人數據）， Know-How表示演算法、數據、資訊、發明、知識、方法（包括使用、管理或劑量的方法）、慣例、結果、軟體、技巧、科技、專有技術和商業機密，包括分析和質量控制數據、分析方法（包括適用的參考標準）、化驗、生產記錄、化學結構和配方、物質組成、製造過程和數據、藥理學、毒理學和臨床測試數據和結果、製程、報告、研究數據、研究工具、序列、標準操作程式和技術，在每一個情況下，不論是否可專。 或者其他所有者提供給接受方的具有機密性義務的盤方或代表盤方與本協議有關的信息或材料，但有以下證據表明：（i）接收方在盤方披露時已經知道，而不是根據保密義務；（ii）該信息當時對公眾普遍可用或者屬於公共領域；（iii）該信息在披露後對公眾普遍可用或者屬於公共領域，並且不是由接收方違反本協議的行為；（iv）由無義務向盤方保密的第三方披露給接收方；或者（v）由接收方在不使用盤方機密信息的情況下隨後開發。MSD臨床數據被視為MSD的機密信息（MSD是“披露方”，協作方是“接收方”）[***]被視為協作方的機密信息（協作方是“披露方”，MSD是“接收方”）[***]。

“控制”或“控制” 表示針對特定資訊或知識產權的相關方或其聯屬公司擁有或持有對該等資訊或知識產權的許可權，並且有能力根據此 [***] 提供權利、許可證或轉授權。

“Controlling Party” 應具有其在【其他】中所規定的含義第 10.5.5.

“費用分擔國家“”在此具有所述詞彙的含義 第 10.3 （起訴）。

“CTA“”指提交或呈交給監管機構的用於獲得批准進行人類臨床研究的該產品之申請或提交（包括前述任何補充資料）的新藥申請、臨床試驗授權申請、探試藥品檔案或類似申請或提交，符合該監管機構的要求。

“數據保護法 “”指一方在與本協議有關時受適用的數據保護或隱私法律約束。

“數據保護條款 展品C 此處。

“數據分享計劃意指附呈的時間表 一級管制藥品.

“辯護黨” 指根據以下規定控制訴訟辯護的一方 第 14.2.3 節 （程序）。

“交貨” 指相對於給定數量的 (i) MSD 化合物，[***] 和 (ii) 合作者化合物，[***]。”交付” 應具有相關意義。

“發展黨” 應具有中賦予該術語的含義 部分 3.10.3.

“披露方” 指披露機密信息的一方（或其關聯公司） 下文所述的該當事方。

“生效日期” 指在 「生效日期」 行中規定的日期 信息表。

“艾瑪” 指歐洲藥品管理局和任何繼任機構。

1.40.  

「反海外腐敗法」 指美國《反海外腐敗法》。

“食品藥品管理局” 指美國食品藥品監督管理局。

“GCP” 指EMA、FDA和國際正式發佈的良好臨床實踐 人用藥品註冊技術要求協調會議，該會議可能不時生效，適用於化合物的測試。

“政府官員” 指：(i) 政府的任何官員或僱員或任何 政府部門、機構或工具；(ii) 以官方身份代表或代表政府或政府任何部門、機構或機構行事的任何人；(iii) 公司的任何高級人員或僱員；或 全部或部分歸政府所有的企業；(iv) 世界銀行或聯合國等國際公共組織的任何官員或僱員；(v) 某個政黨的任何官員或僱員或在某個政黨中行事的任何個人 代表一個政黨的官方身份；或 (vi) 任何政治職位候選人；在上述每種情況下 (i) 至 (vi) 中，當該政府官員以官方身份或以官方身份行事時 決策職責，負責進行監管檢查、政府授權或執照，或者有能力作出可能影響任何一方業務的決定。

“Information Sheet” means the table entitled Information Sheet set forth just before the preamble to this Agreement.

“Inventions” means all inventions and discoveries, whether or not patentable, that are made, conceived, or first actually reduced to practice by or on behalf of a Party, or by or on behalf of the Parties together: [***].

“Joint Clinical Data” means [***].

“Joint Development Committee” or “JDC” means the committee to be established by the Parties pursuant to Section 2.3 (Joint Development Committee; Managers).

“Joint Patent” means a Patent with respect to any Joint Invention.

“Joint Invention” means [***].

“Know-How” means any proprietary invention, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other data and information, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain.

“Liability” means any loss, damage, reasonable costs and expenses (including reasonable attorneys’ fees and expenses) incurred in connection with any claim, proceeding, or investigation by a Third Party arising [***].

“Manufacture,” “Manufactured,” or “Manufacturing” means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply.

“Manufacturer’s Release” or “Release” has the meaning ascribed to release of the MSD Compound in the Clinical Supply Quality Agreement.

“Manufacturing Site” means the facilities where a Compound is Manufactured by or on behalf of a Party.

“MSD” has the meaning set forth in the preamble to this Agreement.

“MSD Background Patents” means any Patent Controlled by MSD or its Affiliate that claims or covers the Combination and is not a Joint Patent.[***].

“MSD Clinical Data” means all data (including raw data) and results generated by or on behalf of either Party or at either Party’s direction, or by or on behalf of the Parties together or at their direction, in the course of the MSD Compound Arm(s), [***].

“MSD Compound” means pembrolizumab, a humanized anti-human PD-1 monoclonal antibody, [***].

“MSD Compound Arm(s)” means any portion of the Collaborator Clinical Trial where patients are intended to receive the MSD Compound either alone or in combination with one or more treatments but not in Combination with the Collaborator Compound.

“MSD Compound Study” means the arms of the Collaborator Clinical Trial where patients are intended to receive the MSD Compound either alone or in combination with one or more treatments (including the Collaborator Compound), as further described in Section 2.1 (The Collaborator Clinical Trial).

“MSD Compound Study Completion” means: (i) the date when the last patient enrolled in the MSD Compound Study has completed their last study-related assessment for evaluation excluding survival follow-up; or (ii) an alternative date as agreed to by the JDC in writing.

“MSD Inventions” means [***].

“NDA” means a New Drug Application, Biologics License Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the United States Federal Food, Drug and Cosmetic Act, or similar application or submission for a marketing authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in a country or group of countries.

“Non-Conformance” means, with respect to a given unit of Compound: (i) an event that deviates from an approved cGMP requirement with respect to the applicable Compound, such as a procedure, Specification, or operating parameter, or that requires an investigation to assess impact to the quality of the applicable Compound; or (ii) that such Compound failed to meet the applicable representations and warranties set forth in Article 8 (Supply and Use of Compounds) or Section 13.2 (Compounds). “Non-Conforming” shall have a correlative meaning.

“Non-Cost Sharing Countries” shall have the meaning given to such term in Section 10.3 (Prosecution).

“Non-Pursuing Party” shall have the meaning given to such term in Section 10.3 (Prosecution).

“Parties” and “Party” have the meanings set forth in the preamble to this Agreement.

“Patent” means (i) a patent application, (ii) any additions, priority applications, divisions, continuations, and continuations-in-part of the patent application, and (iii) all patents issuing on any of the foregoing patent applications, together with all invention certificates, substitutions, reissues, reexaminations, registrations, supplementary protection certificates, confirmations, renewals, and extensions of any of (i), (ii), or (iii), in any and all jurisdictions worldwide.

“PD-1 Antagonist” means any [***].

“Person” means any entity, including any individual, sole proprietorship, partnership, corporation, business trust, joint stock company, trust, unincorporated organization, association, limited liability company, institution, public benefit corporation, joint venture, or governmental entity.

“Pharmacovigilance Agreement” means that Pharmacovigilance Agreement executed by and between Collaborator and Merck Sharp & Dohme Corp., an Affiliate of MSD, dated [***], as may be amended by the parties thereto from time to time, and as further described in Section 2.6.

“Project Manager” means the Project Managers to be designated by the Parties pursuant to Section 2.3 (Joint Development Committee; Managers).

“Protocol” means the written documentation that describes the Collaborator Clinical Trial and sets forth specific activities to be performed as part of the conduct of the Collaborator Clinical Trial.

“Pursuing Party” shall have the meaning given to such term in Section 10.3 (Prosecution).

“Receiving Party” means a Party (or its Affiliate or representative) receiving Confidential Information of the other Party hereunder.

“Regulatory Approvals” means, with respect to a Compound, any and all permissions (other than the Manufacturing approvals) required to be obtained from any Regulatory Authority or other competent authority for the development, registration, importation and distribution of such Compound in any jurisdiction for use in the MSD Compound Study.

“Regulatory Authorities” means the FDA, national regulatory authorities, the EMA, any successor agency to the FDA or EMA and any agency or authority performing some or all of the functions of the FDA or EMA in any jurisdiction.

“Regulatory Documentation” means all submissions to Regulatory Authorities in connection with the development of a Compound, including all CTAs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse-event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including any documents that include Clinical Data).

“Regulatory Terms” means Exhibit D hereto.

“Related Agreements” means the Pharmacovigilance Agreement and the Clinical Supply Quality Agreement.

“Related Entities” means, with respect to each of Collaborator and MSD, such Party’s Affiliates and its and their directors, officers, employees and others acting on its or their behalf, including their respective Subcontractors.

“Restricted Rights” shall have the meaning given to such term in Section 10.3 (Prosecution)

“Right of Reference” means the “right of reference” defined in Title 21 of the U.S. Code of Federal Regulations, Part 314.3(b) or any non-U.S. equivalent including, with regard to a Party, allowing the applicable Regulatory Authority in a country to have access to relevant information and data (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Documentation filed with such Regulatory Authority with respect to a Party’s Compound.

“SAE” means a serious adverse event.

“Samples” means biological specimens collected from subjects participating in the MSD Compound Study, including any urine, blood and tissue samples.

“Sample Testing” means the analyses to be performed by each Party using the applicable Samples, as described in the Sample Testing Schedule.

“Sample Testing Results” means the data and results arising from the Sample Testing.

“Sample Testing Schedule” means the schedule attached hereto as Schedule II.

“Sensitive Information” means [***] Confidential Information relating to MSD Inventions, the MSD Compound or the Combination.

“Specifications” means the requirements to which a Compound must conform. The Specifications for a Compound will be set forth in the certificate of analysis accompanying each batch of Compound supplied for use in the MSD Compound Study.

“Subcontractors” means any and all Third Parties to whom a Party delegates any of its obligations hereunder.

“Sunshine Act” shall mean the Physician Payments Sunshine Act as amended from time to time.

“Term” means the term of this Agreement, as set forth in Section 6.1 (Term).

“Third Party” means any Person or entity other than Collaborator, MSD or their respective Affiliates.

“Third-Party Infringement” means any [***].

“Toxicity and Safety Data” means all clinical adverse-event information or patient-related safety data [***].

“Transparency Report” means a transparency report in connection with reporting payments and other transfers of value made to health-care professionals, including investigators, steering-committee members, data-monitoring committee members, and consultants in connection with the MSD Compound Study in accordance with reporting requirements under Applicable Law, including the Sunshine Act and state gift laws, and the European Federation of Pharmaceutical Industries and Associations Disclosure Code, and a Party’s applicable policies.

“VAT” means a value-added or similar tax.

“Vial” means a single vial of MSD Compound, [***].

“Violation” means that a Party or any of its officers or directors or any other personnel (or other permitted agents of a Party performing activities hereunder) has been: (i) convicted of any of the felonies identified among the Exclusion Lists or (ii) identified or listed as having an active exclusion on any Exclusion List; or (iii) listed by any US Federal agency as being suspended, proposed for debarment, debarred, excluded or otherwise ineligible to participate in Federal procurement or non-procurement programs, including under any Exclusion List.

PERFORMANCE OF THE AGREEMENT. RELATED AGREEMENTS.

The Collaborator Clinical Trial. Collaborator is conducting or intends to conduct the Collaborator Clinical Trial, which Collaborator Clinical Trial has or is intended to have a Combination Arm(s). In addition, the Collaborator Clinical Trial may (or may not) have a Collaborator Compound Arm(s), an MSD Compound Arm(s), or both. The term “Collaborator Clinical Trial” as used in this Agreement refers to the Collaborator Clinical Trial as a whole, including the Combination Arm(s), and any Collaborator Compound Arm(s) or MSD Compound Arm(s) that form or are intended to form a part of the Collaborator Clinical Trial. The term “MSD Compound Study” refers to the Combination Arm(s) and any MSD Compound Arm(s) that form or are intended to form a part of the Collaborator Clinical Trial. Collaborator Clinical Trial, Collaborator Compound Arm(s), Combination Arm(s), MSD Compound Arm(s) and MSD Compound Study all refer to such arms as are intended to be conducted in accordance with the Protocol, including the Protocol as may be amended in accordance with Article 4 (PROTOCOL AND INFORMED CONSENT; CERTAIN COVENANTS).

Generally. Each Party shall: (i) contribute such resources as are necessary to conduct the activities contemplated by this Agreement; and (ii) act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party.

Joint Development Committee; Managers; Escalation.

The Parties shall form the Joint Development Committee made up of an equal number of representatives of MSD and Collaborator, which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement (except for activities under, and pursuant to, Article 10 (INTELLECTUAL PROPERTY)). Representatives of MSD and Collaborator on the JDC shall be entitled to one collective vote on behalf of each of MSD and Collaborator, respectively, on all matters upon which the JDC have the right to decide under this Agreement. Each Party shall designate a Project Manager who shall be responsible for implementing and coordinating activities and facilitating the exchange of information between the Parties with respect to the MSD Compound Study and shall be entitled to attend meetings of the JDC. JDC members will be agreed by both Parties.

Unless otherwise agreed by the JDC, the JDC shall meet a minimum of [***] times per year (with the Parties agreeing to the timing of the first meeting within [***] days following the Effective Date), to provide an update on the progress of the MSD Compound Study. The JDC may meet in person or by means of teleconference, internet conference, videoconference or similar means. Prior to any such meeting, Collaborator’s Project Manager shall provide a written update to MSD’s Project Manager and Alliance Manager containing information about the overall progress of the MSD Compound Study, recruitment status, interim analysis (if available), final analysis and other information relevant to the conduct of the MSD Compound Study (and data relating to the Collaborator Clinical Trial reasonably requested by MSD and relevant to the MSD Compound Study).

In addition to a Project Manager, each Party shall designate an Alliance Manager who shall serve as the primary point of contact for any issues arising under this Agreement and shall endeavor to ensure clear and responsive communication and the effective exchange of information between the Parties. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree.

In the event that (i) an issue arises and the Alliance Managers do not, after good faith efforts, reach agreement on such issue, (ii) there is a decision to be made by the JDC on which the members of the JDC do not agree, or (iii) the Parties cannot agree on a matter in respect of the Protocol, the issue shall be elevated to [***]. In the event such escalation does not result in resolution or consensus: (x) MSD shall have final decision-making authority with respect to issues related to MSD Compound (including, but not limited to PD-1 Antagonists and any biomarkers related to MSD Compound); and (y) Collaborator shall have final decision-making authority with respect to issues related to Collaborator Compound.

Clinical Supply Quality Agreement. Within [***] days after the Effective Date of this Agreement, but in any event before any supply of MSD Compound hereunder, the Parties (or their respective Affiliates) shall enter into an amendment to the Clinical Supply Quality Agreement that shall address and govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in the Study. In the event of any inconsistency between the terms of this Agreement and the Clinical Quality Agreement, the terms of this Agreement shall control. The amended Clinical Supply Quality Agreement shall, among other things: (i) detail classification of any Non-Conforming MSD Compound; (ii) include criteria for Manufacturer’s Release and related certificates and documentation; (iii) include criteria and timeframes for acceptance of MSD Compound; (iv) include procedures for the resolution of disputes regarding any Non-Conforming MSD Compound; (v) detail procedures and rights with respect to audit and inspection rights for Manufacturing sites; and (vi) include provisions governing the recall of Compounds. Quality matters and the Manufacture of the MSD Compound shall be governed by the terms of the Clinical Supply Quality Agreement in addition to the relevant quality provisions of this Agreement.

Data Protection. The Parties will comply with the Data Protection Terms set forth on Exhibit C.

Pharmacovigilance Agreement. The Parties shall amend the Pharmacovigilance Agreement prior to MSD Delivering MSD Compound to Collaborator hereunder. The amended Pharmacovigilance Agreement will: (i) include safety data exchange procedures; (ii) facilitate appropriate safety reviews; (iii) govern the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, pregnancy reports, and any other safety information arising from or related to the use of the MSD Compound and Collaborator Compound in the MSD Compound Study; and (iv) enable the Parties and their Affiliates to fulfill local and international regulatory reporting obligations to Regulatory Authorities, all of the foregoing in accordance with Applicable Law. For the avoidance of doubt, the obligations to provide safety data under the Pharmacovigilance Agreement will be independent of any obligations to provide safety data pursuant to this Agreement.

Delegation of Obligations. Each Party shall have the right to delegate any portion of its obligations hereunder only: (i) to such Party’s Affiliates; (ii) to Third Parties for purposes of performing MSD Compound Study activities or conducting Sample Testing for such Party; provided that such Third Parties shall be reputable and possess necessary skills and experience in relevant disciplines to undertake such activities in accordance with industry standards; (iii) [***]; or (iv) upon the other Party’s prior consent. Notwithstanding any

Relationship. [***]. Nothing in this Agreement shall: (i) prohibit either Party from performing other clinical studies with its own Compound, either individually or in combination with any other compound or product, in any therapeutic area; [***].

CONDUCT OF THE MSD COMPOUND STUDY.

Sponsor. Collaborator shall act as the sponsor of the Collaborator Clinical Trial under its own CTA for the Collaborator Compound with a Right of Reference to the CTA of the MSD Compound as described in Section 3.5 (Regulatory Matters); provided, however, that in no event shall Collaborator file an additional CTA for the MSD Compound Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests such an additional CTA for the MSD Compound Study, the Parties shall meet and agree on an approach to address such requirement.

Clinical Safety Data Review. If the Information Sheet indicates that this Agreement contains a safety gate (i.e. “Yes” is selected for the Safety Gate (Yes/No) row), then this Section 3.2 (Clinical Safety Data Review) shall apply to this Agreement. If “No” is selected, for such Safety Gate row, then this Section 3.2 (Clinical Safety Data Review) shall be deemed omitted from this Agreement and shall not apply. [***]

Performance. Collaborator shall ensure that the MSD Compound Study and all related activities are performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP.

Debarred Personnel; Exclusions Lists. Collaborator certifies that it has not and shall not use in any capacity the services of any person, including any subcontractor or individual, that has been excluded, debarred, suspended, proposed for suspension or debarment, in Violation or otherwise ineligible for government programs including Title 21 U.S.C. Section 335a or any foreign equivalent thereof. Collaborator has, as of the Effective Date screened itself, and its Affiliates’ officers and directors against the Exclusions Lists and has informed MSD whether it or any of its employees, officers or directors is or has been in Violation. Collaborator shall notify MSD in writing immediately if any suspension, proposed debarment, debarment or Violation occurs or comes to its attention with respect to any Person performing activities related to the MSD Compound Study or otherwise related to activities under this Agreement.

Regulatory Matters. The Parties shall comply with the Regulatory Terms as set forth in Exhibit D.

Investigator’s Brochure for MSD Compound. MSD shall provide Collaborator with (i) the current investigator’s brochure for the MSD Compound promptly following the Effective Date and before the initiation of the MSD Compound Study and (ii) any material updates or changes to the investigator’s brochure for the MSD Compound within [***] calendar days of internal approval during the Term for use by Collaborator as needed for regulatory and safety purposes. All versions of MSD’s investigator’s brochure for the MSD Compound provided by MSD to Collaborator shall be MSD Confidential Information.

Documentation. Collaborator shall maintain reports and all related documentation in good scientific manner and in compliance with Applicable Law. Collaborator shall provide to MSD all Collaborator Clinical Trial information and documentation reasonably requested by MSD to enable MSD to: (i) comply with any of its legal, regulatory or contractual obligations, or any request by any Regulatory Authority related to the MSD Compound; and (ii) determine whether the MSD Compound Study has been performed in accordance with this Agreement.

Copies. Collaborator shall provide to MSD copies of all Joint Clinical Data and any MSD Clinical Data in electronic form or other mutually agreeable alternate form and on the timelines specified in the Data Sharing Schedule or mutually agreed; provided, however, that a complete copy of the Joint Clinical Data and any MSD Clinical Data shall be provided to MSD no later than [***] days following MSD Compound Study Completion or any sooner termination of this Agreement. Collaborator shall ensure that: (i) all patient authorizations and consents required under Applicable Law in connection with the Collaborator Clinical Trial permit such sharing of Joint Clinical Data and any MSD Clinical Data with MSD; and (ii) it complies with Applicable Law in transferring personal data hereunder.

Sample Testing. Each Party shall provide Samples to the other Party as specified in the Protocol and as agreed to by the Joint Development Committee. Each Party shall use the Samples only for Sample Testing in accordance with the Sample Testing Schedule and the Protocol. Each Party shall provide the other Party such specified Sample Testing Results for the Sample Testing conducted by it or on its behalf, in electronic form or other form as agreed, on the timelines specified in the Sample Testing Schedule or as otherwise agreed. [***].

Ownership and Use of Clinical Data.

[***]. Collaborator shall maintain the Joint Clinical Data and any MSD Clinical Data in its internal database; provided, however, that at all times during the Term and for [***] days thereafter, Collaborator shall grant MSD access to all Joint Clinical Data and any MSD Clinical Data. [***].

[***].

Before publication or presentation of a summary of the Joint Clinical Data, neither Party may disclose the Joint Clinical Data publicly or to a Third Party without the consent of the other Party. Notwithstanding the foregoing, either Party may use and disclose such unpublished Joint Clinical Data: [***]. Ownership of any inventions resulting from the use of unpublished Joint Clinical Data that are not Inventions (the “Arising IP”) shall be owned by [***].

Notwithstanding anything to the contrary in this Section 3.10 (Ownership and Use of Clinical Data), Collaborator may: [***].

Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data may be used to obtain label changes for the Compounds. In such event, the Parties will collaborate in accordance with the Regulatory Terms set forth in Exhibit D.

Certain Memoranda and Reports. Promptly following MSD Compound Study Completion, Collaborator shall provide to MSD an electronic draft of the top-line results memorandum and an electronic draft of the final report of the results of the MSD Compound Study. MSD shall have [***] days after receipt of such results memorandum and [***] days after receipt of such final report to provide comments thereon. Collaborator shall consider any comments provided by MSD on either document and shall not include any statements in either document relating to the MSD Compound or the MSD Clinical Data that have not been approved by MSD. Collaborator shall deliver to MSD a final version of each such document promptly following finalization thereof.

Licensing.

Nothing in this Agreement shall prohibit or restrict a Party from licensing, assigning or transferring to an Affiliate or Third Party such Party’s Compound or any Inventions or Confidential Information owned solely by such Party.

[***].

Additional Coordination

To the extent a Party desires, based on the results of the MSD Compound Study, to seek Regulatory Approval of its Compound for use in the Combination, the Parties [***].

Each Party [***]. This Section 3.14 shall survive expiration, but not termination, of this Agreement.

PROTOCOL AND INFORMED CONSENT; CERTAIN COVENANTS.

Protocol. A synopsis of the Protocol, and any agreed draft statistical analysis plan for the MSD Compound Study or Collaborator Clinical Trial, are attached hereto as Exhibit A. Collaborator shall: (i) provide a draft of the Protocol (and any subsequent revisions thereof) to MSD for MSD’s review and comment; (ii) consider any changes to the draft of the Protocol requested by MSD; (iii) incorporate any changes requested by MSD with respect to MSD Compound; and (iv) submit the draft Protocol to MSD for final approval. The country or countries in which the MSD Compound Study will be performed will be reviewed and agreed upon by the JDC before MSD Compound Study initiation and any changes thereto will be subject to review and approval of the JDC. To the extent the Parties cannot agree regarding the contents of the Protocol for final approval: (x) [***] shall have final decision-making authority with respect to [***]; (y) [***] shall have final decision-making authority with respect to matters in the Protocol related [***]; and (z) all other matters in respect of the Protocol on which the Parties cannot agree shall be resolved in accordance with Section 2.3 (Joint Development Committee; Managers; Escalation). Notwithstanding anything to the contrary contained herein, each Party, in its sole discretion, shall have the sole right to determine the dose and dosing regimen for its Compound and shall have the final decision on all matters relating to its Compound and any information regarding its Compound included in the Protocol.

Informed Consent. Collaborator shall prepare the patient informed-consent form for the MSD Compound Study (which shall include provisions regarding MSD Compound safety, data sharing and the use of Samples in Sample Testing) in consultation and with approval of MSD (it being understood and agreed that the portions of the informed-consent form relating to the MSD Compound will be provided to Collaborator by MSD and adopted without modification by Collaborator).

Changes to Protocol or Informed Consent. Any proposed changes to: (i) the approved final Protocol (other than changes that are solely related to Collaborator Compound); or (ii) the informed consent form relating to the MSD Compound, including Sample Testing of the MSD Compound, shall be made only with MSD’s prior written consent. Any proposed changes (including those which do not require MSD’s consent) will be sent to MSD’s Project Manager and MSD’s Alliance Manager. For those changes requiring MSD’s consent, MSD will provide such consent, or a written explanation for why such consent is being withheld, within [***] Business Days after MSD receives a copy of the requested changes. If Protocol revisions made in accordance with this Section 4.3 would necessitate corresponding revisions to the definitions of Collaborator Clinical Trial, Combination Arm(s) or MSD Compound Study, such definitions shall be deemed to be revised consistent with such Protocol revisions.

Transparency Reporting.

Responsibilities of the Parties. Collaborator is solely responsible for reporting payments and other transfers of value, (including supply of MSD Compound), made to health-care professionals, including investigators, steering-committee members, data-monitoring committee members, and consultants in connection with the MSD Compound Study in accordance with reporting requirements under Applicable Law, including the Sunshine Act and state gift laws, and the European Federation of Pharmaceutical Industries and Associations Disclosure Code, and Collaborator’s applicable policies. Promptly after the Effective Date, Collaborator will notify MSD of Collaborator’s point of contact for purposes of receiving information from MSD pursuant to this Section 4.4, along with such contact’s full name, email address, and telephone number. Collaborator may update such contact from time to time by notifying MSD pursuant to Article 21 (NOTICES). Where applicable, MSD will provide to such Collaborator contact all information regarding the value of the MSD Compound provided for use in the MSD Compound Study as required for such reporting. In the event that the value of the MSD Compound provided pursuant to this Section 4.4 materially changes, MSD shall notify Collaborator of such revised value and the effective date thereof.

Periods Collaborator is Not Required to Report. With respect to any annual reporting period in which Collaborator is not an entity that is required to make a Transparency Report under Applicable Law, Collaborator will: (i) notify MSD within [***] days after the commencement of such reporting period that Collaborator is not so required; and (ii) during such reporting period Collaborator will track and provide to MSD data regarding “indirect” payments or other transfers of value by Collaborator to health care professionals to the extent such payments or other transfers of value were required, instructed, directed or otherwise caused by MSD pursuant to this Agreement in the format requested by MSD and provided on a basis to be agreed upon by the Parties. Collaborator represents and warrants that any data provided by Collaborator to MSD pursuant to this Section 4.4 will be complete and accurate to the best of Collaborator’s knowledge.

Financial Disclosure. To the extent required by Applicable Law, Collaborator will be responsible for preparing and submitting the Financial Disclosure Module 1.3.4 components to the FDA for any Regulatory Documentation in connection with the Collaborator Clinical Trial. Collaborator shall promptly notify MSD of any reportable financial interest in MSD.

ADVERSE EVENT REPORTING.

Pharmacovigilance. Collaborator will be solely responsible for safety reporting for the Collaborator Clinical Trial and related activities, all in accordance with Applicable Law.

Transmission of SAEs. Collaborator will transmit to MSD all SAEs from the MSD Compound Study as set forth below. All cases will be transmitted on a CIOMS-1 form in English.

For fatal and life-threatening SAEs, Collaborator will transmit a processed case within [***] calendar days after receipt by Collaborator of notice of such SAEs.

For all other SAEs and newly diagnosed cancer, Collaborator will transmit a processed case within [***] calendar days after receipt by Collaborator of notice of such SAEs.

Cases of disease progression will be handled as outlined in the Protocol, and if the Protocol specifies that such cases are collected as SAEs, Collaborator will transmit such cases to MSD within the applicable timeframe set forth in Section 5.2.1 or Section 5.2.2.

For all other reportable information that includes: (i) overdose, exposure during pregnancy or lactation; and (ii) cases of potential drug-induced liver injury where the patient was exposed to the MSD Compound (if required to be collected or identified per the Protocol), Collaborator will transmit a processed case within [***] calendar days after receipt by Collaborator of such information.

TERM AND TERMINATION.

Term. The Term shall commence on the Effective Date and shall continue in full force and effect until [***].

MSD Termination for Unsafe Use. In the event MSD notifies Collaborator that it in good faith believes that the MSD Compound is being used unsafely in the MSD Compound Study and the grounds for such belief, and if either MSD believes such matter is not reasonably capable of remedy or if Collaborator fails to promptly remedy such issue to MSD’s reasonable satisfaction, MSD may terminate this Agreement and the supply of the MSD Compound by notice to Collaborator with immediate effect.

Termination for Breach. Either Party may terminate this Agreement by notice with immediate effect if the other Party commits a material breach of this Agreement and such material breach continues for [***] days after receipt of notice thereof from the non-breaching Party; provided that if such material breach is incapable of cure, then the notifying Party may terminate this Agreement by notice effective at the expiration of such [***]-day cure period. Either Party shall have the right to terminate this Agreement by notice to the other Party with immediate effect if such other Party fails to perform any of its obligations under Section 13.4 (Anti-Corruption) or breaches any representation or warranty contained

Termination for Patient Safety. If either Party determines in good faith that the MSD Compound Study or Collaborator Clinical Trial may unreasonably adversely affect patient safety, such Party shall promptly notify the other Party of such determination. The Party receiving such notice may propose modifications to the MSD Compound Study or Collaborator Clinical Trial to address the safety issue identified by the other Party and, if the notifying Party agrees, shall act to immediately implement such modifications; provided, however, that if the notifying Party, in its sole discretion, believes that there is imminent danger to patients, such Party need not wait for the proposed modifications and may instead terminate this Agreement immediately by notice to the other Party with immediate effect. Furthermore, the notifying Party may terminate this Agreement by notice to the other Party with immediate effect if, in its sole discretion, it believes that the modifications proposed by the other Party will not resolve the patient safety issue.

Termination for Regulatory Action; Other Reasons. Either Party may terminate this Agreement by notice to the other Party with immediate effect in the event that any Regulatory Authority takes any action, or raises any objection, that prevents the terminating Party from supplying its Compound for purposes of the MSD Compound Study. Additionally, either Party shall have the right to terminate this Agreement by notice with immediate effect to the other Party in the event that it determines in its sole discretion to withdraw any applicable Regulatory Approval for its Compound or to discontinue development of its Compound for medical, scientific or legal reasons. Subject to Section 6.11 (Wind-Down), it is understood that if a Party withdraws any applicable Regulatory Approval for its Compound in a subset of countries in which the MSD Compound Study will be performed, such Party’s right to terminate this Agreement shall be limited suspending its obligation to perform the MSD Compound Study in such countries.

Return of MSD Compound. If Collaborator remains in possession (including through any Affiliate or Subcontractor) of MSD Compound at the time this Agreement expires or is terminated, Collaborator shall promptly return or destroy all unused MSD Compound as instructed by MSD in its sole discretion. Collaborator shall provide certification of any requested destruction.

Survival. The provisions of Sections 3.4 (Debarred Personnel; Exclusions Lists) through 3.11 (Regulatory Submission)(inclusive), 6.7 (Survival) through 6.11 (Wind-Down)(inclusive), 8.5 (Provision of Compounds), 8.11 (Quality Control), 8.12 (VAT), 13.4.6, 14.2 (Indemnification), and 14.3 (LIMITATION OF LIABILITY), and Articles 1 (DEFINITIONS), 5 (ADVERSE EVENT REPORTING), 9 (CONFIDENTIALITY) through 12 (PUBLICATIONS; PRESS RELEASES)(inclusive), 16 (ENTIRE AGREEMENT; AMENDMENT; WAIVER), and 19 (INVALID PROVISION) through 24 (CONSTRUCTION)(inclusive) shall survive the expiration or termination of this Agreement.

No Prejudice. Termination of this Agreement shall be without prejudice to any claim or right of action of either Party for any breach of this Agreement. Except as set forth in Section 6.10 (Manufacturing Costs) and the foregoing sentence, the non-terminating Party shall have no claim against the terminating Party for compensation for any loss of whatever nature by virtue of the termination of this Agreement.

Confidential Information. Upon expiration or termination of this Agreement, each Party and its Affiliates shall promptly return to the Disclosing Party or destroy any Confidential Information of the Disclosing Party (other than Clinical Data, Sample Testing Results and Inventions) furnished to the Receiving Party; provided, however, that the Receiving Party may retain one copy of such Confidential Information in its confidential files, solely for purposes of exercising the Receiving Party’s rights hereunder, satisfying its obligations hereunder or complying with any legal proceeding or requirement with respect thereto, and provided further that the Receiving Party shall not be required to erase electronic files created in the ordinary course of business during automatic system back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information so long as such electronic files are: (i) maintained only on centralized storage servers (and not on personal computers or devices); (ii) not accessible by any of its personnel (other than its information technology specialists); and (iii) not otherwise accessed subsequently except with the written consent of the Disclosing Party or as required by law or legal process. Such retained copies of Confidential Information shall remain subject to the confidentiality and non-use obligations herein.

Manufacturing Costs. In the event of termination by MSD pursuant to Section 6.2 (MSD Termination for Unsafe Use) or 6.3 (Termination for Breach), [***]:

Wind-Down. In the event of termination by either Party pursuant to this Article 6, Collaborator shall perform wind-down activities in accordance with the Protocol.

COSTS.

SUPPLY AND USE OF COMPOUNDS.

Supply of the Compounds. Subject to the terms and conditions of this Agreement, each of Collaborator and MSD will use commercially reasonable efforts to supply, or cause to be supplied, its Compound in the quantities and on the timelines set forth in Exhibit B, for use in the MSD Compound Study. If a change to the Protocol in accordance with Article 4 (PROTOCOL AND INFORMED CONSENTS; CERTAIN COVENANTS) requires an increase of the quantity of MSD Compound to be provided of more than twenty percent (20%), the Parties shall amend Exhibit B to reflect such changes. Each Party shall also provide the other Party a contact person for the supply of its Compound under this Agreement. Notwithstanding the foregoing, or anything to the contrary herein, if a Party is: (i) not supplying its Compound in accordance with the terms of this Agreement, then the other Party shall have no obligation to supply its Compound; or (ii) allocating under Section 8.10 (Shortage; Allocation), then the other Party may allocate proportionally.

Manufacturing Delay. Each Party shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely affect supply of its Compound hereunder.

Compound Commitments. Each Party agrees, at its own cost, to Manufacture and supply its Compound in accordance with this Agreement and the Related Agreements. Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided that Collaborator shall be responsible for obtaining Regulatory Approvals for the MSD Compound Study as set forth in Section 3.5 (Regulatory Matters)).

Minimum Shelf Life Requirements. Each Party shall use commercially reasonable efforts to supply its Compound hereunder with an adequate remaining shelf life at the time of Delivery to meet the MSD Compound Study requirements.

Provision of Compounds.

MSD will Deliver the MSD Compound to the location specified by Collaborator. [***].

Collaborator is solely responsible for supplying (including all Manufacturing, acceptance and release testing) the Collaborator Compound for the Collaborator Clinical Trial and the subsequent handling, storage, transportation, warehousing and distribution of all such Collaborator Compound. Collaborator shall ensure that all such activities are conducted in compliance with Applicable Law and, with respect to the MSD Compound Study, the Clinical Supply Quality Agreement.

Labeling and Packaging; Use, Handling and Storage.

The Parties’ obligations with respect to the labeling and packaging of the MSD Compound are as set forth in the Clinical Supply Quality Agreement. MSD shall provide the MSD Compound to Collaborator in the form of [***].

Collaborator shall: (i) use the MSD Compound solely for purposes of performing the MSD Compound Study; and (ii) not use the MSD Compound in any manner that is inconsistent with this Agreement or for any commercial purpose. Collaborator shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the MSD Compound, and in particular shall not analyze the MSD Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Supply Quality Agreement.

Product Specifications. A certificate of analysis shall accompany each shipment of the MSD Compound to Collaborator.

Changes to Manufacturing. Each Party may make changes from time to time to its Compound or the Manufacturing Site, provided that such changes shall be in accordance with the Clinical Supply Quality Agreement.

Product Testing; Nonconformance.

After Manufacturer’s Release. After Manufacturer’s Release of the MSD Compound and concurrently with Delivery of the Compound to Collaborator, MSD shall provide Collaborator with the documentation described in the Clinical Supply Quality Agreement. Collaborator shall conduct the acceptance procedures under the Clinical Supply Quality Agreement within the time frames set forth therein. Collaborator shall be solely responsible for taking all steps necessary to determine that MSD Compound or Collaborator Compound, as applicable, is suitable for release before making such Compounds available for human use, and MSD shall assist Collaborator as Collaborator reasonably requests in making such determination for the MSD Compound. Collaborator shall be responsible for storage and maintenance of the MSD Compound until it is tested and released, which storage and maintenance shall be in compliance with: (i) the Specifications for the MSD Compound, (ii) the Clinical Supply Quality Agreement, (iii) Applicable Law, and (iv) any specific storage and maintenance requirements as may be provided by MSD from time to time. Collaborator shall be responsible for any failure of the MSD Compound to meet the Specifications to the extent caused after Delivery to Collaborator hereunder.

Non-Conformance.

In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.9.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party. Notification related to MSD Compound shall be in accordance with the Clinical Supply Quality Agreement. MSD shall investigate any Non-Conformance of the MSD Compound in accordance with the Clinical Supply Quality Agreement.

In the event that all or any portion of any proposed or actual shipment of the MSD Compound is agreed to be Non-Conforming at the time of Delivery to Collaborator then MSD shall replace any such Non-Conforming MSD Compound that has not been administered. The sole and exclusive remedies of Collaborator with respect to any MSD Compound that is found to be Non-Conforming at the time of Delivery shall be: [***]. In the event MSD Compound is lost or damaged by Collaborator after Delivery, MSD shall [***]; provided that [***].

Collaborator shall be responsible for, and MSD shall have no obligation or liability with respect to, any Collaborator Compound that is found to have a Non-Conformance. Collaborator shall replace any such Collaborator Compound that has not been administered. The sole and exclusive remedies of MSD with respect to any Collaborator Compound that is found to have a Non-Conformance at the time of Delivery shall be: [***].

Resolution of Discrepancies. Disagreements regarding any determination of Non-Conformance by Collaborator shall be resolved in accordance with the Clinical Supply Quality Agreement or, in situations where the Clinical Supply Quality Agreement does not apply, Section 20 (GOVERNING LAW; DISPUTE RESOLUTION).

Shortage; Allocation. If a Party believes in good faith that it will not be able to fulfill its supply obligations hereunder because its Compound is in short supply, such Party will provide prompt written notice to the other Party of such shortage, the shipments of Compound hereunder expected to be impacted and the quantity of its Compound that such Party reasonably determines it will be able to supply and the Parties will promptly discuss the situation (including allocation of Compound supplied hereunder within the MSD Compound Study). The Party experiencing the shortage shall have sole discretion, subject to Applicable Law, to determine how much Compound it will supply during the shortage, and such Party shall not be deemed to be in breach of this Agreement for failure to supply any quantities of its Compound as a result of such shortage. In case of one Party’s shortage of its Compound, the other Party shall be relieved of its obligations under this Agreement to the extent impacted by such shortage.

Quality Control. Each Party shall implement and perform operating procedures and controls for sampling, stability and other testing of its Compound, and for validation, documentation and release of its Compound and such other quality-assurance and quality-control procedures as are required by the Specifications, cGMPs and (with respect only to the MSD Compound) the Clinical Supply Quality Agreement.

VAT. Where MSD is treated as making a supply of goods in a particular jurisdiction for no consideration for VAT purposes, and Collaborator is treated as receiving such supply in the same jurisdiction, thus resulting in an amount of VAT being properly chargeable on such supply, Collaborator shall be obliged to pay to MSD the amount of VAT properly chargeable on such supply. Collaborator shall pay such VAT to MSD on receipt of a valid VAT invoice from MSD issued in accordance with the laws and regulations of the jurisdiction in which the VAT is properly chargeable. MSD will: (i) determine, in accordance with Applicable Law, the value of the supply that has been made and, as a result, the corresponding amount of VAT that is properly chargeable; and (ii) provide Collaborator any information or copies of documents in MSD’s Control as are reasonably necessary for VAT purposes to evidence that such supply will take, or has taken, place in the same jurisdiction.

CONFIDENTIALITY.

Confidential Information. Subject to Section 13.4.8 (Anti-Corruption), Collaborator and MSD agree to hold in confidence all Confidential Information of the other Party and use such Confidential Information only to fulfill its obligations or exercise its rights hereunder. Without limiting the foregoing, the Receiving Party may not, without the prior written permission of the Disclosing Party, disclose any Confidential Information of the Disclosing Party to any Third Party except to the extent such disclosure is: (i) required by Applicable Law; (ii) pursuant to the terms of this Agreement; or (iii) necessary for the conduct of the MSD Compound Study, and in each case ((i) through (iii)), provided that the Receiving Party shall provide reasonable advance notice to the Disclosing Party before making such disclosure. For the avoidance of doubt, Collaborator may, without MSD’s consent, disclose Confidential Information to clinical trial sites and clinical trial investigators performing the

Inventions. [***].

Personal Identifiable Data. All Confidential Information containing personal identifiable data shall be handled in accordance with all applicable data-protection and privacy laws, rules and regulations.

Publicity/Use of Names. Except as set forth in Section 12.3 (Press Releases), no Party shall use in any manner the name, trademark, trade name, logo or any other designation of the other Party, its Affiliates or their respective employee(s) in any publicity, promotion, news release or disclosure relating to this Agreement or its subject matter without the prior express written permission of such Person, except as may be required by Applicable Law. In the event of any such use required by Applicable Law, the Party using the name, trademark, trade name, or logo of the other Party, its Affiliates, or their respective employees shall provide such Party with reasonable prior written notice and the opportunity to provide comments on such use.

INTELLECTUAL PROPERTY.

Joint Ownership. [***].

Right to Exploit. [***].

Prosecution. [***].

Prohibition of Patenting. [***].

Patent Enforcement. [***].

Inventions Owned by Each Party. [***].

Mutual Freedom to Operate. Each Party hereby grants [***] (c) obtaining and promoting an initial or an updated label indication for the Combination in the same indication as the Combination Arm [***].

Termination. Any and all licenses granted under Section 10.7 (Mutual Freedom to Operate) shall terminate upon the expiration or earlier termination of this Agreement and shall not survive such expiration or termination; provided, however that the license granted in subsection (c) of Section 10.7 (Mutual Freedom to Operate) shall survive such expiration or termination except that if a Party terminates the Agreement pursuant to Section 6.3 (Termination for Breach), then only the grant to the terminating Party from the non-terminating Party shall survive.

Ownership of Other Inventions. [***].

REPRINTS; REFERENCES IN PUBLICATION.

PUBLICATIONS; PRESS RELEASES.

Clinical Trial Registry. Collaborator shall register the MSD Compound Study and Collaborator Clinical Trial with the clinical trials registry located at www.clinicaltrials.gov (or any non-U.S. equivalent clinical trial registry), shall list MSD as a collaborator with respect to the Collaborator Clinical Trial, and shall timely publish the results following completion of the MSD Compound Study, after taking appropriate action to secure any intellectual property rights arising from the MSD Compound Study. The results of the MSD Compound Study will be published in accordance with the Protocol.

Publication. Each Party shall use reasonable efforts to publish or present scientific papers with respect to the MSD Compound Study in accordance with accepted scientific practice. The Parties agree that, prior to submission of the results of the MSD Compound Study for publication or presentation or any other dissemination of such results (including oral dissemination), the publishing Party shall invite the other to comment on the content of the material to be published, presented, or otherwise disseminated according to the following procedure:

At least [***] days prior to submission for publication of any paper, letter or any other publication, or [***] days prior to submission for presentation of any abstract, poster, talk or any other presentation, the publishing Party shall provide to the other Party the full details of the proposed publication, presentation, or dissemination in an electronic version as an email attachment. Upon written request from the other Party, the publishing Party agrees not to submit data for publication/presentation/dissemination for an additional [***] days to allow for actions to be taken to preserve rights for patent protection.

The publishing Party shall reasonably consider any request by the other Party made within the periods set forth in Section 12.2.1 to modify the publication and the Parties shall work together to timely resolve any issue regarding the content for publication. Notwithstanding the foregoing, MSD Clinical Data shall be subject to final review and approval by MSD, not to be unreasonably withheld.

The publishing Party shall remove all Confidential Information of the other Party before finalizing the publication.

Press Releases Promptly following the Effective Date, Collaborator may issue the press release attached hereto as Exhibit E. Except as provided herein or as otherwise required by Applicable Law, neither Party shall make any public announcement concerning this Agreement or the MSD Compound Study without the prior written consent of the other Party. To the extent a Party desires to make such public announcement, including any such public announcement required by Applicable Law, such Party shall request permission of the other Party and provide the other Party with a draft thereof including drafts of all translations for review and comment at least [***] Business Days prior to the date on which such Party would like to make the public announcement (or, if it is not possible to provide a draft at least [***] Business Days in advance of a disclosure required by Applicable Law, such draft shall be provided as soon as reasonably practicable).

REPRESENTATIONS AND WARRANTIES; DISCLAIMERS.

Due Authorization. Each of Collaborator and MSD represents and warrants to the other that: (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms.

Compounds.

Collaborator Compound. Collaborator hereby represents and warrants to MSD that: (i) Collaborator has the full right, power and authority to grant all of the licenses granted to MSD under this Agreement; (ii) the Collaborator Compound is the proprietary compound of Collaborator; (iii) Collaborator solely owns or has exclusive rights to any Patents claiming the Collaborator Compound as a composition of matter and the unfettered ability on a worldwide basis to grant a license or sublicense to such Patents to promote an initial or an updated label indication for the Combination in the same indication as the Combination Arm during the longer of the Term and the life of such Patents; and (iv) at the time of Delivery of the Collaborator Compound, such Collaborator Compound shall have been Manufactured and supplied in compliance with its Specifications and all Applicable Law.

MSD Compound. MSD hereby represents and warrants to Collaborator that: (i) MSD has the full right, power and authority to grant all of the licenses granted to Collaborator under this Agreement; (ii) MSD Controls the MSD Compound; and (iii) at the time of Delivery of the MSD Compound, such MSD Compound shall have been Manufactured and supplied in compliance with its Specifications, the Clinical Supply Quality Agreement, and all Applicable Law.

Results. Neither Party undertakes that the MSD Compound Study shall lead to any particular result, nor is the success of the MSD Compound Study guaranteed. Neither Party shall be liable for any use that the other Party may make of the Joint Clinical Data nor for advice or information given in connection therewith.

Anti-Corruption.

The Parties acknowledge that the corporate policies or Codes of Conduct of Collaborator and MSD and their respective Affiliates require that each Party’s business be conducted within the letter and spirit of the law. Each Party agrees to conduct the business contemplated herein in a manner that is consistent with all Applicable Law, including the FCPA.

Each Party represents and warrants that it and its Related Entities have not, and covenants that it and its Related Entities will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any action in furtherance of, any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting it in obtaining or retaining business for it or the other Party, or in any way with the purpose or effect of public or commercial bribery.

Neither Party shall contact, or otherwise knowingly meet with, any Government Official for the purpose of discussing activities arising out of or in connection with this Agreement without the prior written approval of the other Party, except where such meeting is consistent with the purpose and terms of this Agreement and in compliance with Applicable Law.

Each Party represents and warrants that it: (i) is not excluded, debarred, suspended, proposed for suspension or debarment, in Violation or otherwise ineligible for government programs; (ii) has not employed or subcontracted with any Person for the performance of the MSD Compound Study who is excluded, debarred, suspended, proposed for suspension or debarment, or is in Violation or otherwise ineligible for government programs; and (iii) has conducted anti-corruption and bribery (e.g. FCPA) due-diligence review of all Third Parties it may hire to act on its behalf in connection with its performance under this Agreement.

Each Party represents and warrants that, except as disclosed to the other in writing prior to the Effective Date, such Party: (i) does not have any interest that directly or indirectly conflicts with its proper and ethical performance of this Agreement; (ii) shall maintain arm’s length relations with all Third Parties with which it deals for or on behalf of the other in performance of this Agreement; and (iii) has provided complete and accurate information and documentation to the other Party, the other Party’s Affiliates and its and their personnel in the course of any due diligence conducted by the other Party for this Agreement, including disclosure of any officers, employees, owners or Persons directly or indirectly retained by such Party in relation to the performance of this Agreement who are Government Officials or relatives of Government Officials. Each Party shall make all further disclosures to the other Party as are necessary to ensure the information provided remains complete and accurate throughout the Term. Subject to the foregoing, each Party agrees that prior to hiring or retaining any Government Official to assist in its performance of this Agreement it shall obtain the written consent of the other Party and complete a satisfactory anti-corruption and bribery (e.g., FCPA) due diligence review of such Government Official consistent with industry standards. Each Party further covenants that any future information and documentation submitted to the other Party as part of further due diligence or a certification shall be complete and accurate.

Each Party shall have the right during the Term, and for a period of [***] following termination of this Agreement, to conduct an investigation and audit of the other Party’s activities, books and records, to the extent they relate to that other Party’s performance under this Agreement, to verify compliance with the terms of this Section 13.4. Such other Party shall cooperate fully with such investigation or audit, the scope, method, nature and duration of which shall be at the sole reasonable discretion of the Party requesting such audit.

Each Party shall use commercially reasonable efforts to ensure that all transactions under the Agreement are properly and accurately recorded in all material respects on its books and records and that each document upon which entries in such books and records are based is complete and accurate in all material respects. Each Party further represents, warrants and covenants that all books, records, invoices and other documents relating to payments and expenses under this Agreement are and shall be complete and accurate and reflect in reasonable detail the character and amount of transactions and expenditures. Each Party shall maintain a system of internal accounting controls reasonably designed to ensure that no off-the-books or similar funds or accounts will be maintained or used in connection with this Agreement.

Each Party agrees that in the event that the other Party believes in good faith that there has been a possible violation of any provision of this Section 13.4, such other Party may make full disclosure of such belief and related information (including, if necessary, Confidential Information) needed to support such belief at any time and for any reason to any competent government bodies and agencies, and to anyone else such Party determines in good faith has a legitimate need to know.

Each Party shall comply with its own ethical business practices policy and any corporate integrity agreement (if applicable) to which it is subject. Each Party shall ensure that all of its employees involved in performing its obligations under this Agreement are made specifically aware of the compliance requirements under this Section 13.4. In addition, each Party shall ensure that all such employees participate in and complete mandatory compliance training to be conducted by each Party, including specific training on anti-bribery and corruption, prior to their performance of any obligations or activities under this Agreement. Each Party shall certify its continuing compliance with the requirements under this Section 13.4 on a periodic basis during the Term in such form as may be reasonably specified by the other Party.

Each Party shall have the right to terminate this Agreement immediately in accordance with Section 6.3 (Termination for Breach) in the event of any violation of this Section 13.4 by the other Party.

Sufficient Resources. Collaborator represents and warrants that it has sufficient resources to perform the activities for which it is responsible under this Agreement in accordance herewith.

DISCLAIMER. EXCEPT AS EXPRESSLY PROVIDED HEREIN, MSD MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE MSD COMPOUND, AND COLLABORATOR MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE COLLABORATOR COMPOUND, IN EACH CASE INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

INSURANCE; INDEMNIFICATION; LIMITATION OF LIABILITY.

Insurance. Each Party warrants that it maintains a policy or program of insurance or self-insurance at levels sufficient to support the indemnification obligations assumed herein. Upon request, a Party shall provide evidence of such insurance.

Indemnification.

Indemnification by Collaborator. [***].

Indemnification by MSD. {***].

Procedure. The obligations of MSD and Collaborator under this Section 14.2 (Indemnification) are conditioned upon the delivery of written notice to the indemnifying Party of any potential Liability within a reasonable time after the indemnified Party becomes aware of such potential Liability. The indemnifying Party will have the right to assume the defense of any suit or claim related to the Liability (using counsel reasonably satisfactory to the indemnified Party) if it has assumed responsibility for the suit or claim in writing; provided that the indemnified Party may assume the responsibility for such defense to the extent the indemnifying Party does not do so in a timely manner). The indemnified Party may participate in (but not control) the defense thereof at its sole cost and expense. The Defending Party shall keep the other Party advised of the status of such action, suit, proceeding or claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto. The Defending Party shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the other Party, which shall not be unreasonably withheld, conditioned or delayed. The Defending Party, but solely to the extent the Defending Party is also the indemnifying Party, shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the other Party from all liability with respect thereto or that imposes any liability or obligation on the other Party without the prior written consent of the other Party.

MSD Compound Study Subjects. Neither Party shall offer compensation on behalf of the other Party to any MSD Compound Study subject or bind the other Party to any indemnification obligations in favor of any MSD Compound Study subject.

LIMITATION OF LIABILITY. IN NO EVENT SHALL EITHER PARTY, ITS AFFILIATES AND ITS OR THEIR EMPLOYEES, DIRECTORS, SUBCONTRACTORS OR AGENTS BE LIABLE TO THE OTHER PARTY UNDER ANY THEORY FOR, NOR SHALL ANY INDEMNIFIED PARTY HAVE THE RIGHT TO RECOVER, ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR OTHER SIMILAR DAMAGES, ANY PUNITIVE DAMAGES, ANY LOST PROFIT, LOST SALE OR LOST OPPORTUNITY DAMAGES (WHETHER SUCH CLAIMED DAMAGES ARE DIRECT OR INDIRECT), ARISING DIRECTLY OR INDIRECTLY OUT OF OR RELATED TO THIS AGREEMENT, THE ACTIVITIES TO BE CONDUCTED BY THE PARTIES HEREUNDER OR THE COLLABORATOR CLINICAL TRIAL (INCLUDING THE MSD COMPOUND STUDY). SUCH LIMITATION SHALL NOT

FORCE MAJEURE.

ENTIRE AGREEMENT; AMENDMENT; WAIVER.

ASSIGNMENT AND AFFILIATES.

CHANGE OF CONTROL.

INVALID PROVISION.

GOVERNING LAW; DISPUTE RESOLUTION.

The Parties shall attempt to settle all disputes arising out of or in connection with this Agreement in an amicable manner. Any claim, dispute or controversy arising out of or relating to this Agreement, including the breach, termination or validity hereof or thereof, shall be governed by and construed in accordance with the substantive laws of [***], without giving effect to its choice of law principles.

Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed or maintained notwithstanding any ongoing discussions between the Parties.

NOTICES.

RELATIONSHIP OF THE PARTIES.

COUNTERPARTS AND DUE EXECUTION.

CONSTRUCTION.

By:

Name

Title

By:

Name

Title

Phase III collaboration will evaluate efti in combination with KEYTRUDA, MSD’s anti-PD-1 therapy, and standard chemotherapy in first-line non-small cell lung cancer (1L NSCLC)

TACTI-004 Phase III trial will enrol approximately 750 patients regardless of PD-L1 expression in order to address the entire 1L NSCLC market eligible for anti-PD-1 therapy

Under the collaboration, Immutep will conduct the registrational TACTI-004 Phase III trial and MSD will supply KEYTRUDA

Immutep retains commercial rights to efti

Efti in combination with KEYTRUDA with or without chemotherapy has generated compelling efficacy and favourable safety in 1L NSCLC, one of the most relevant cancer indications with a high unmet medical need, across all levels of PD-L1 expression (negative, low, and high)