Protocol and Related Documents. 4.1 An initial Protocol, entitled “A Xxxxx 0x/0, Xxxx-xxxxx, Dose Escalation Study of Entinostat in Combination with Pembrolizumab in Patients with Non-small Cell 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, a summary of which is attached as Appendix A. The Protocol, the statistical analysis plan, and any amendments thereof will be finalized with the approval of the JDC, subject to each Party’s decision-making rights as set forth below. If the JDC cannot reach agreement on amendments to the Protocol after elevating the matter in accordance with Section 3.8, Syndax shall have the final decision on such amendments. Notwithstanding the foregoing and anything to the contrary contained herein: (a) ***, in its sole discretion, will determine *** for *** and will have the final decision on all matters relating to ***; and (b) ***, in its sole discretion, will determine *** for *** and will have the final decision on all matters relating to ***.
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.
Protocol and Related Documents. 5.1 A summary of the initial Protocol, entitled “Phase 2 study targeting MET signaling with Darovasertib + Crizotinib in patients with advanced solid tumors”, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. Ideaya shall have the final decision regarding the contents of the Protocol; provided, however, that any material changes to the Protocol relating to the Study (other than relating solely to the Ideaya Compound), and any changes (whether or not material) relating to the Pfizer [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. Compound, shall require Pfizer’s prior written consent. Any such proposed changes will be sent in writing to Pfizer’s Project Manager and Pfizer’s Alliance Manager. 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.
Protocol and Related Documents. 4.1 A synopsis of each initial Protocol, entitled (i) for the Indication CRC “A Phase Ib/II dose seeking study of VXM01 in combination with the anti-PD-L1 antibody Avelumab in advanced solid malignancies with expansion cohort in colorectal cancer” and
Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “A phase Ib study of Oraxol in combination with Ramucirumab in patients with Gastric, Gastro-esophageal, or Esophageal Cancers” has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. The final Protocol must be accepted by both Parties. Athenex shall have the final decision regarding the contents of the Protocol; provided, however, that any material changes to the Protocol (other than relating solely to the Athenex Compound), and any changes (whether or not material) relating to the Lilly Compound, shall require Lilly’s prior written consent. Any such proposed changes will be sent in writing to Lilly’s Project Manager. Lilly will provide such consent, or a written explanation for why such consent is being withheld, within fifteen (15) Business Days of receiving a copy of Athenex’s requested changes; provided that if Lilly fails to provide such written explanation within such 15 Business Day period, then Lilly shall be deemed to have consented to such change or changes. Athenex will provide a copy of the final approved protocol and any subsequent protocol amendments. *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission.
Protocol and Related Documents. 4.1 A synopsis of the initial Protocol, entitled a combination of CMP-001 with avelumab and/or Pfizer compounds, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A (the “Protocol Summary”). Pfizer as sponsor shall finalize the contents of such Protocol consistent with the Synopsis. Any material deviations of such Protocol from the Synopsis that Pfizer as Study sponsor may determine are advisable shall require prior written approval of all Parties 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 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.
Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “A phase 1/2 study of IDE196 in patients with solid 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. Ideaya shall have the final decision regarding the contents of the Protocol; provided, however, that any material changes to the Protocol relating to the Study (other than relating solely to the Ideaya Compound), and any changes (whether or not material) relating to the Pfizer Compound, shall require Pfizer’s prior written consent Any such proposed changes will be sent in writing to Pfizer’s Project Manager and Pfizer’s Alliance Manager. 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.
Protocol and Related Documents. 4.1 A protocol and statistical analysis plan for the Study, has been agreed to by the Parties as of the Effective Date and is attached hereto as Appendix A (“Protocol”). The Protocol may be amended with the approval of the JDC, subject to each Party’s decision-making rights as set forth below.
Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “***” has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. The final Protocol must be accepted by both Parties. Athenex shall have the final decision regarding the contents of the Protocol; provided, however, that any material changes to the Protocol (other than relating solely to the Athenex Compound), and any changes (whether or not material) relating to the Lilly Compound, shall require Lilly’s prior written consent. Any such proposed changes will be sent in writing to Lilly’s Project Manager. Lilly will provide such consent, or a written explanation for why such consent is being withheld, within fifteen (15) Business Days of receiving a copy of Athenex’s requested changes; provided that if Lilly fails to provide such written explanation within such 15 Business Day period, then Lilly shall be deemed to have consented to such change or changes. Athenex will provide a copy of the final approved protocol and any subsequent protocol amendments. *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission.
Protocol and Related Documents. 11 Section 4.1. Protocol ........................................................................................................11 Section 4.2. Patient Informed Consent ..........................................................................12 Section 4.3. Sunshine Reporting .....................................................................................12 Article 5.
