Safety Data Exchange. Within twelve (12) months following the Effective Date, but at the latest before the start of a clinical trial by Santen, the Parties shall negotiate in good faith and enter into a safety data exchange agreement regarding Compounds and Products and Tracon Products, which shall set forth standard operating procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions/experiences sufficient to permit each Party to comply with its regulatory and other legal obligations within the applicable timeframes. Such safety data exchange agreement shall identify which Party shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and safety data relating to Compounds and Products and Tracon Products to the appropriate Regulatory Authorities in the Territory in accordance with all Applicable Law. Such agreement shall allow each Party to comply with all regulatory and legal requirements regarding the management of safety data by providing for the exchange of relevant information in the appropriate format within applicable timeframes. Unless otherwise mutually agreed by the Parties, Tracon shall maintain a global safety database for Compounds and Tracon Products, and Santen shall maintain one or more safety database(s) for Products covering the entire world.
Appears in 3 contracts
Sources: License Agreement (Tracon Pharmaceuticals, Inc.), License Agreement (Tracon Pharmaceuticals, Inc.), License Agreement (Tracon Pharmaceuticals Inc)