Co-Development Product Pharmacovigilance Sample Clauses

Co-Development Product Pharmacovigilance. At least sixty (60) days prior to the filing of an IND for any Co-Development Product, the Parties shall define and finalize the actions that the Parties shall employ with respect to the Co-Development Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Co-Development Product Pharmacovigilance Agreement”). The Lead Commercialization Party will be the global safety database holder for each Co-Development Product. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports and any other information concerning the safety of the Co-Development Products. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulations. Each Party hereby agrees to comply with its respective obligations under such Co-Development Product Pharmacovigilance Agreement and to cause its Affiliates and Sublicensees to comply with such obligations. The Party responsible for the global safety database will maintain the global safety database pursuant to its own policy and as necessary to comply with Applicable Laws governing adverse experiences in the Territory.