Common use of Adverse Experience Reporting Clause in Contracts

Adverse Experience Reporting. Arvinas agrees throughout the Term of this Agreement to notify Genentech of any information of which Arvinas becomes aware concerning any side effect, injury, toxicity or sensitivity reaction, or any unexpected incident, and the severity thereof, arising in connection with a product reasonably related to any Licensed PROTAC licensed to Genentech hereunder (hereinafter “Adverse Experience”), where such Adverse Experience is “Serious” (as defined hereinafter) and associated with the clinical uses, studies, investigations, tests and marketing of such product, whether or not determined to be attributable to such product. “Serious” as used in this Section refers to an Adverse Experience which results in death, is immediately life threatening, results in persistent and significant disability/incapacity or requires in-patient hospitalization, or prolongation of existing hospitalization, or is a congenital anomaly, cancer or an overdose. Other important medical events that may jeopardize the patient or may require intervention to prevent one of the outcomes previously listed should also be considered “Serious”. If such Adverse Experience is “Highly Serious” (that is, it results in death or is immediately life threatening), Arvinas will notify Genentech within [**]. For Adverse Experiences that are Serious, but not Highly Serious, Arvinas will notify Genentech within [**].

Appears in 4 contracts

Samples: Option, License, and Collaboration Agreement, Option, License, and Collaboration Agreement (Arvinas Holding Company, LLC), Option, License, and Collaboration Agreement (Arvinas Holding Company, LLC)

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