Protocol and Statistical Analysis Plan. An initial Protocol and a draft statistical analysis plan for the Study have been agreed to by the Parties as of the Effective Date and are attached hereto as Appendix A. Through the JDC, FLX shall (a) provide any proposed revisions to the then current Protocol or statistical analysis plan to Merck for Merck’s review and comment, (b) consider in good faith any changes requested by Merck, and (c) incorporate any changes requested by Merck with respect to Merck Compound. FLX shall then submit the proposed revised Protocol or statistical analysis plan, as applicable, to the JDC for approval. To the extent the JDC cannot agree unanimously regarding the Protocol or statistical analysis plan for final approval: (i) [***] shall have final decision-making authority with respect to matters related to [***] (including with respect to [***]); (ii) [***] shall have final decision-making authority with respect to matters related to [***] (including with respect to [***]); and (iii) all other matters on which the JDC cannot agree shall be resolved in accordance with Section 3.11.3. Once the final Protocol or statistical analysis plan has been approved in accordance with this Section 4.1, Merck’s prior written consent shall be required for: (i) any [***] changes to such approved final Protocol or statistical analysis plan (other than [***] changes relating [***]); or (ii) any changes to such approved final Protocol or statistical analysis plan [***] relating to [***]. Any such proposed changes will be sent in writing to Merck’s Project Manager and Merck’s Alliance Manager. 4.1.1. Notwithstanding anything to the contrary contained herein, [***], in its sole discretion, shall have the sole right to determine [***] and shall have the final decision on all matters relating to [***] (including [***]) and any information regarding [***]. 4.1.2. Notwithstanding anything to the contrary contained herein, [***], in its sole discretion, shall have the sole right to determine [***] and shall have the final decision on all matters relating to [***] (including [***]), [***], and any information regarding [***].
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Sources: Clinical Trial Collaboration and Supply Agreement (RAPT Therapeutics, Inc.), Clinical Trial Collaboration and Supply Agreement (RAPT Therapeutics, Inc.)