Common use of Adverse Event Reports Clause in Contracts

Adverse Event Reports. In addition to the updates described in Section 3.2(a) hereof, Novartis shall provide ImmunoGen with all Adverse Event information and medical complaint information relating to Licensed Products as such information is compiled or prepared by Novartis in the ordinary course of business in connection with the Development or Commercialization of any Licensed Product, in accordance with the terms of a pharmacovigilance agreement to be negotiated in good faith by the Parties and, in any event, within the time frames consistent with reporting obligations under Applicable Laws. Novartis shall hold the global safety database for all Licensed Products. Novartis shall be responsible for reporting all Adverse Events to Regulatory Authorities worldwide. Novartis shall be responsible for the core safety information to be included in the Investigators’ Brochure and Core Data Sheet. To the extent that it may apply to a Licensed Product, ImmunoGen agrees to provide Novartis with Serious Adverse Event and product complaint information relating to any product containing an Ab-Cytotoxic Product that is compiled and prepared by ImmunoGen or any Third Party collaborator in the ordinary course of business in connection with the development, commercialization or sale of any such product, in accordance with the terms of the pharmacovigilance agreement; provided, however, that the foregoing shall not require ImmunoGen to violate any agreements with or confidentiality obligations owed to any Third Party.