Common use of Adverse Experience Reporting Clause in Contracts

Adverse Experience Reporting. (a) Prior to enrollment of Subjects in the Study, the Parties shall enter into a pharmacovigilance agreement setting forth the Parties’ responsibilities and obligations with respect to the procedures and timeframes for compliance with Applicable Law pertaining to safety reporting of the respective Molecules and the Combination (“PV Agreement”). (b) The Parties shall cooperate in determining how to respond to adverse experience reports under the Study. For adverse experience reports solely related to the Corvus Molecule, Corvus shall have final decision making authority. For adverse experience reports solely related to the Genentech Molecule, Genentech shall have final decision making authority. For adverse experience reports solely related to the Combination, [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. [***]. Notwithstanding the foregoing, Corvus may submit a response to Regulatory Authorities if required by a regulatory deadline. (c) Corvus shall be responsible for reporting adverse events from the Study to Regulatory Authorities in accordance with Applicable Law, including 21 CFR § 312.32.

Appears in 3 contracts

Samples: Phase I/Ib Combination Study Agreement (Corvus Pharmaceuticals, Inc.), Phase I/Ib Combination Study Agreement (Corvus Pharmaceuticals, Inc.), Phase I/Ib Combination Study Agreement (Corvus Pharmaceuticals, Inc.)

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Adverse Experience Reporting. (a) Prior to enrollment of Subjects in the Study, the Parties shall enter into a pharmacovigilance agreement setting forth the Parties’ responsibilities and obligations with respect to the procedures and timeframes for compliance with Applicable Law pertaining to safety reporting of the respective Molecules and the Combination (“PV Agreement”). (b) The Parties shall cooperate in determining how to respond to adverse experience reports under the Study. For adverse experience reports solely related to the Corvus Molecule, Corvus shall have final decision making authority. For adverse experience reports solely related to the Genentech Molecule, Genentech shall have final decision making authority. For adverse experience reports solely related to the Combination, [***] [***] Certain information in this document has been omitted excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect would likely cause competitive harm to the omitted portionsregistrant if publicly disclosed. [***]. Notwithstanding the foregoing, Corvus may submit a response to Regulatory Authorities if required by a regulatory deadline. (c) Corvus shall be responsible for reporting adverse events from the Study to Regulatory Authorities in accordance with Applicable Law, including 21 CFR § 312.32.

Appears in 1 contract

Samples: Phase I/Ib Combination Study Agreement (Corvus Pharmaceuticals, Inc.)

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