Conduct of Study in Accordance with Protocol; Priority of Terms Sample Clauses

Conduct of Study in Accordance with Protocol; Priority of Terms. Subject to the initial and continuing approvals described in Section 1.2 below, Institution, through Principal Investigator, agrees to conduct a clinical study of paxalisib (GDC-0084) (“Study Drug”) in accordance with the study protocol entitled “A Phase 2 study of Paxalisib (GDC-0084) in recurrent or refractory Primary Central Nervous System Lymphoma (PCNSL).” attached to this Agreement as Exhibit A and herein incorporated by reference (“Study”). The Parties to this agree that the Study will be performed in strict accordance with the Study protocol entitled above, and any subsequent amendments thereto (the “Protocol”), applicable federal, state, and local laws, regulations and guidelines, and good clinical practices as required under FDA regulations (“GCPs”). In the event of any conflict between the Protocol and the provisions of the main body of this Agreement, the Protocol shall govern with respect to scientific, Study management and reporting and subject consent issues, and the provisions of the main body of this Agreement shall govern with respect to all other issues.
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Conduct of Study in Accordance with Protocol; Priority of Terms. Subject to the initial and continuing approvals described in Section 1.2 below, Institution, through Principal Investigator, agrees to conduct the Study in accordance with the Protocol, which is attached to this Agreement as Exhibit A and herein incorporated by reference. In the event of any conflict between the Protocol and the provisions of this Agreement, the Protocol shall govern with respect to scientific issues, and the provisions of this Agreement shall govern with respect to all other issues. The Study shall be conducted in accordance with all applicable federal, state and local laws relating to the conduct of clinical studies, including Food and Drug Administration (“FDA”) Good Clinical Practice (“GCP”), the Health Insurance Portability and Accountability Act of 1996 (together with any regulations promulgated thereunder, “HIPAA”), and the California Confidentiality of Medical Information Act (“CMIA”) (collectively “Applicable Laws”).

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