Common use of Safety Data Exchange Clause in Contracts

Safety Data Exchange. Each Party shall be solely responsible, at its own expense, for complying with all applicable regulatory requirements with respect to Products in such Party’s Territory, including all safety reporting to Regulatory Authorities in such Party’s Territory. The Parties shall, promptly upon reasonable request by either Party, negotiate in good faith and enter into a pharmacovigilance/safety data exchange agreement for Products (the “PV Agreement”), which shall set forth standard operating procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions/experiences. The terms of the PV Agreement shall be no less stringent than those required by FDA and ICH guidelines and shall be sufficient to permit each Party to comply with its regulatory and legal requirements for the management and reporting of safety data regarding such Products by providing for the exchange of relevant information in appropriate format within applicable timeframes. Curis shall be responsible for maintaining, at its own expense, a global safety database for Products from each Licensed Program.