Common use of Protocol and Related Documents Clause in Contracts

Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “Phase 1b/2 Study of VX15/2503 in combination with avelumab in patients with advanced non-small cell lung cancer”, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. Vaccinex and Merck shall agree on the contents of the Protocol; any changes to the Protocol that would require the approval of a Regulatory Authority or Institutional Review Board shall require prior written approval of all Parties. The contents of the Protocol and any proposed changes to the Protocol will be sent in writing to Merck’s Team Leader and Merck’s Manager. In the event that the Parties cannot agree in writing on the final Protocol, the matter shall be elevated in accordance with Section 3.8 for final resolution. In the event that the Managers cannot reach agreement on changes or amendments to the Protocol after elevating the matter in accordance with Section 3.8, Vaccinex shall have the final decision on any Protocol amendments solely related to the dosing of Vaccinex Compound, and Merck shall have the final decision on any Protocol amendments solely related to the dosing of Merck Compound. For clarity, Vaccinex may implement any change to the Protocol that would not require the approval of a Regulatory Authority or Institutional Review Board; provided, that Vaccinex gives prompt notice thereof to Merck. 4.2 Vaccinex shall prepare the patient informed consent forms for the Study (which shall include any required consent for the Sample Testing and sharing of patient data with Merck) in consultation with Merck (it being understood and agreed that the portion of the informed consent form relating to Merck Compound will be provided to Vaccinex by Merck). Any changes to such form that relate to the Sample Testing or Merck Compound or the sharing of data shall be subject to Merck’s review and prior written consent to be provided to Vaccinex in a timely manner. Any such proposed changes will be sent in writing to Merck’s Team Leader and Merck’s Manager. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany.

Protocol and Related Documents. 4.1 A summary of the An initial Protocol, entitled “Phase 1b/2 A ▇▇▇▇▇ ▇▇/▇, ▇▇▇▇-▇▇▇▇▇, Dose Escalation Study of VX15/2503 Entinostat in combination Combination with avelumab Pembrolizumab in patients Patients with advanced nonNon-small cell lung cancerCell Lung Cancer, with Expansion Cohorts in Patients with Non-small Cell Lung Cancer and Melanoma”, has been agreed to by the Parties as of the Effective Date, and a summary of which is attached as Appendix A. Vaccinex The Protocol, the statistical analysis plan, and Merck shall agree on the contents of the Protocol; any changes to the Protocol that would require amendments thereof will be finalized with the approval of a Regulatory Authority or Institutional Review Board shall require prior written approval of all Partiesthe JDC, subject to each Party’s decision-making rights as set forth below. The contents of If the Protocol and any proposed changes to the Protocol will be sent in writing to Merck’s Team Leader and Merck’s Manager. In the event that the Parties cannot agree in writing on the final Protocol, the matter shall be elevated in accordance with Section 3.8 for final resolution. In the event that the Managers JDC cannot reach agreement on changes or amendments to the Protocol after elevating the matter in accordance with Section 3.8, Vaccinex Syndax shall have the final decision on any Protocol amendments solely related such amendments. Notwithstanding the foregoing and anything to the dosing of Vaccinex Compoundcontrary contained herein: (a) ***, in its sole discretion, will determine *** for *** and Merck shall will have the final decision on any Protocol amendments solely related all matters relating to ***; and (b) ***, in its sole discretion, will determine *** for *** and will have the dosing of Merck Compound. For clarity, Vaccinex may implement any change final decision on all matters relating to the Protocol that would not require the approval of a Regulatory Authority or Institutional Review Board; provided, that Vaccinex gives prompt notice thereof to Merck***. 4.2 Vaccinex Syndax shall prepare the patient informed consent forms form for the Study (which shall include any required consent for the Sample Testing and sharing of patient data with MerckTesting) in consultation with Merck (it being understood and agreed that the portion of the informed consent form relating to the Merck Compound will be provided to Vaccinex Syndax by Merck). Any changes to such form that relate to the Sample Testing or the Merck Compound or the sharing of data shall be subject to Merck’s review and prior written consent to be provided to Vaccinex in a timely mannerconsent. Any such proposed changes will be sent in writing to Merck’s Team Leader Project Manager and Merck’s Alliance Manager. Note: Reference Merck will provide such consent, or a written explanation for why such consent is being withheld, within *** of receiving a copy of Syndax’s requested changes; provided that if Merck fails to “Merck” in this document refers provide such written explanation within such *** period, then Merck shall be deemed to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germanyhave consented to such change or changes.

Protocol and Related Documents. 4.1 A summary synopsis of the initial Protocol, entitled “Phase 1b/2 Study a combination of VX15/2503 in combination CMP-001 with avelumab in patients with advanced non-small cell lung cancer”and/or Pfizer compounds, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. Vaccinex and Merck A (the “Protocol Summary”). Pfizer as sponsor shall agree on finalize the contents of such Protocol consistent with the Protocol; any changes to Synopsis. Any material deviations of such Protocol from the Protocol Synopsis that would require the approval of a Regulatory Authority or Institutional Review Board Pfizer as Study sponsor may determine are advisable shall require prior written approval of all PartiesParties which approval shall not be unreasonably withheld or delayed. Pfizer shall send in writing its proposed final Protocol to the Alliance’s Alliance Manager for the Alliance’s review and comment and to Checkmate’s Alliance Manager for Checkmate’s review and comment. The contents Parties shall agree to a final Protocol within thirty (30) days from the date such proposed final Protocol is disclosed to the Alliance’s Alliance Manager and to Checkmate’s Alliance Manager, failing which the Protocol approval shall be elevated in accordance with Section 3.8 for final resolution. 4.2 After finalization of the Protocol and Protocol, any proposed changes amendments to the Protocol will be sent in writing to Merckthe Alliance’s Team Leader Alliance Manager and Merckto Checkmate’s ManagerAlliance Manager and require prior written approval of all Parties which shall not be unreasonably withheld or delayed. In the event that the Parties cannot agree in writing on amendments to the final Protocol, Protocol within fifteen (15) days from the date such proposed the matter shall be is elevated to the Alliance Managers in accordance with Section 3.8 for final resolution. . 4.3 In the event that the Alliance Managers cannot reach agreement on changes or amendments to the Protocol solely related to the dosing of the Alliance Compound, the Checkmate Compound or the Pfizer Compound after elevating the matter in accordance with Section 3.8, Vaccinex the Alliance, Checkmate or Pfizer, as the case may be, shall have the final decision on any such Protocol amendments solely related to the dosing of Vaccinex Compound, and Merck shall have the final decision on any Protocol amendments solely related to the dosing of Merck Compound. For clarity, Vaccinex may implement any change to the Protocol that would not require the approval of a Regulatory Authority or Institutional Review Board; provided, that Vaccinex gives prompt notice thereof to Merckamendments. 4.2 Vaccinex 4.4 Pfizer shall prepare the patient informed consent forms for the Study (which shall include any required consent for the Sample Testing and sharing of patient data with Merckthe Alliance and Checkmate) in consultation with Merck the Alliance and Checkmate (it being understood and agreed that the portion of the informed consent form relating to Merck the Alliance Compound will be provided to Vaccinex Pfizer by Merckthe Alliance and that the portion of the informed consent form relating to the Checkmate Compound will be provided to Pfizer by Checkmate). Any changes to such form that relate to the Sample Testing Testing, the Checkmate Compound or Merck the Alliance Compound or the sharing of data shall be subject respectively to MerckCheckmate’s and the Alliance’s review and prior written consent to be provided to Vaccinex in a timely mannerconsent. Any such proposed changes will be sent in writing to Merckthe Alliance’s Team Leader Project Manager and MerckCheckmate’s Alliance Manager. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany.

Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “Phase 1b/2 Study A phase 1/2 study of VX15/2503 in combination with avelumab IDE196 in patients with advanced non-small cell lung cancersolid tumors harboring GNAQ/11 mutations or PRKC fusions”, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. Vaccinex and Merck Ideaya shall agree on have the final decision regarding the contents of the Protocol; provided, however, that any material changes to the Protocol that would require relating to the approval of a Regulatory Authority Study (other than relating solely to the Ideaya Compound), and any changes (whether or Institutional Review Board not material) relating to the Pfizer Compound, shall require Pfizer’s prior written approval of all Parties. The contents of the Protocol and any consent Any such proposed changes to the Protocol will be sent in writing to MerckPfizer’s Team Leader Project Manager and MerckPfizer’s Alliance Manager. In the event Pfizer will provide such consent, or a written explanation for why such consent is being withheld, within [***] Business Days of receiving a copy of Ideaya’s requested changes; provided that the Parties cannot agree in writing on the final Protocolif Pfizer fails to provide such written explanation within such [***] Business Day period, the matter then Pfizer shall be elevated in accordance with Section 3.8 for final resolution. In the event that the Managers cannot reach agreement on changes deemed to have consented to such change or amendments to the Protocol after elevating the matter in accordance with Section 3.8, Vaccinex shall have the final decision on any Protocol amendments solely related to the dosing of Vaccinex Compound, and Merck shall have the final decision on any Protocol amendments solely related to the dosing of Merck Compound. For clarity, Vaccinex may implement any change to the Protocol that would not require the approval of a Regulatory Authority or Institutional Review Board; provided, that Vaccinex gives prompt notice thereof to Merckchanges. 4.2 Vaccinex Ideaya shall prepare the patient informed consent forms form for the Study (which shall include any required consent for the Sample Testing and sharing of patient data with MerckClinical Data sharing) in consultation with Merck Pfizer (it being understood and agreed that the portion of the informed consent form relating to Merck a Pfizer Compound will be provided to Vaccinex Ideaya by MerckPfizer). Any changes to such form that relate to the Sample Testing or Merck a Pfizer Compound or the sharing of data shall be subject to MerckPfizer’s review and prior written consent to be provided to Vaccinex in a timely mannerconsent. Any such proposed changes will be sent in writing to MerckPfizer’s Team Leader Project Manager and MerckPfizer’s Alliance Manager. Note: Reference Pfizer will provide such consent, or a written explanation for why such consent is being withheld, within [***] Business Days of receiving a copy of Ideaya’s requested changes; provided that if Pfizer fails to provide such written explanation within such [***] Business Day period, then Pfizer shall be deemed to have consented to such change or changes. 4.3 Within a reasonable time after the Effective Date, the Parties shall enter into an agreement related to the collection of financial disclosure information from “Merckclinical investigators” involved in the Study and the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents. Among other things, such agreement will provide (a) for Ideaya to track and collect from all “clinical investigators” involved in the Study either separate certification and/or disclosure forms for each of Ideaya and Pfizer or one (1) “combined” certification and/or disclosure form for both Ideaya and Pfizer and (b) that Ideaya 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 Study. For purposes of this Section 4.3, the term “clinical investigators” shall have the meaning set forth in Part 54.2(d) of Title 21 of the United States Code of Federal Regulations. 4.4 Pfizer may disclose in any lawful manner the terms of this Agreement, the support or funding that Pfizer is providing under this Agreement, and any other related information, to the extent necessary for Pfizer to meet its obligations under those laws, regulations and industry codes that require Pfizer to report payments or other transfers of [***] Certain information in this document refers has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the Group registrant if publicly disclosed. value to certain healthcare professionals and teaching hospitals (collectively, the “Transparency Laws”). Transparency Laws include, without limitation, section 6002 of Companies affiliated the U.S. Affordable Care Act and the EFPIA Code on Disclosure of Transfers of Value. Ideaya will provide Pfizer with Merck KGaAcomplete and accurate information about payments or other transfers of value reportable under Transparency Laws, Darmstadtand agrees to (and will cause its agents, Germany.employees and contractors to) cooperate with collection and disclosure of information necessary for Pfizer to meet its obligations under any Transparency Laws..