Common use of Adverse Event and Complaint Reporting Procedures Clause in Contracts

Adverse Event and Complaint Reporting Procedures. (a) Each Party will maintain a record of any and all complaints it or its Affiliates or Sublicensees receives with respect to Licensed Product in connection with Development or Commercialization of Licensed Product during the License Term. Each Party will notify the other Party in reasonable detail of any complaint received by it or its Affiliates or Sublicensees with respect to Licensed Product within sufficient time to allow the other Party and its Affiliates or Sublicensees to comply with any and all regulatory and other requirements imposed upon them in any jurisdiction in which Licensed Product is tested in clinical studies, including Post-Approval Studies, or being marketed or sold. (b) AVEO will maintain a global safety database for Licensed Product. The cost of implementing and maintaining the global safety database shall be included as Development Costs, and shared equally by the Parties. Biogen Idec will have access to all data in the global safety database, subject to reasonable procedures to be mutually agreed upon by the Parties and set forth in the Drug Safety Information Exchange Agreement, as defined below. Biogen Idec will provide AVEO with all adverse event information and safety data relating to Licensed Product in its control through access to the global safety database. Biogen Idec will ensure that each of its Affiliates and Sublicensees will report to Biogen Idec or directly to AVEO the details around any adverse events and serious adverse events relating to Licensed Product in its control within the time periods for such reporting as specified in the Drug Safety Information Exchange Agreement. The holder of the relevant IND shall be responsible for submitting adverse event reports with respect to Licensed Product in the Field to applicable Regulatory Authorities; provided that, upon Regulatory Approval, Biogen Idec shall be responsible for submitting all required adverse event reports with respect to Licensed Product to the applicable Regulatory Authorities in the Licensed Territory. Biogen Idec’s costs associated with submitting adverse event reports in the Licensed Territory shall be borne by Biogen Idec. Upon Regulatory Approval, AVEO shall be responsible for submitting all other required adverse event reports with respect to the Licensed Product to the applicable Regulatory Authorities in the AVEO Territory. AVEO’s costs associated with submitting adverse event reports in the Licensed Territory as the IND holder during Development, to the extent applicable, shall be treated as a Development Costs to be borne by the Parties as specified in Section 5.4. AVEO’s costs associated with submitting adverse event reports with respect to the Licensed Product to the applicable Regulatory Authorities in the AVEO Territory shall be borne by AVEO. (c) At such time as is deemed appropriate by the JDC, the Parties will develop and agree in writing on a Drug Safety Information Exchange Agreement that will include safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, and any product quality and product complaints involving adverse experiences, related to the Licensed Product, sufficient to enable each Party to comply with its legal and regulatory obligations and consistent with the terms of this Agreement.