SAFETY CRISIS MANAGEMENT Sample Clauses

SAFETY CRISIS MANAGEMENT. Promptly after the Effective Date of this Agreement, each Party shall identify, in writing, its representatives who will serve on the Parties' joint Drug Safety Committee. Each Party may replace any or all of its representatives to the joint Drug Safety Committee by providing written notice to the other Party. In the event of an unresolved dispute between the Parties over a safety issue involving the Product in the Field which rises to the level of a safety crisis that affects Product labeling or the conduct of a clinical trial, the Parties will notify both Parties' representatives on the joint Drug Safety Committee in order to organize a meeting. The Parties shall in addition exercise their best efforts to provide the joint Drug Safety Committee with all then-current information regarding the safety crisis issue prior to the meeting, if possible. The joint Drug Safety Committee shall agree on the appropriate measures to be taken to address the relevant safety issue, and which Party is most appropriate to implement such measures, which such Party or Parties shall fully implement such measures. The joint Drug Safety Committee shall operate by consensus. If the Drug Safety Committee is unable to reach a consensus decision with [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Related to SAFETY CRISIS MANAGEMENT

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