Adverse Event Reporting; Safety Database Sample Clauses

Adverse Event Reporting; Safety Database. Each Party shall be responsible for reporting, at its expense, to appropriate authorities, in accordance with local requirements, all adverse events related to use of a Product in its respective Territory (or its respective designated country or region in the Co-Exclusive Territory); provided, that each Party shall consult with the other Party before making any such report. The non-reporting Party shall provide to the reporting Party, upon the reporting Party’s request, reasonable assistance in connection with the reporting of all of adverse events, responding to safety queries and assessing safety issues, in each case, to the extent related to a Product in the Territory. Adverse events related to the use of a Product in the Territory shall be recorded in a single, centralized database for such Product. Such database shall be held, owned and maintained by the Originating Party of such Product at the Originating Party’s expense, which shall be a Development Cost of the Originating Party hereunder. Direct access to the safety database for each Product will be granted to both Parties. Details of safety reporting activities relating to the Product in the Territory will be addressed in a pharmacovigilance agreement, which the Parties shall enter into within ************ following the first Regulatory Approval of such Product.