Common use of Adverse Experiences Clause in Contracts

Adverse Experiences. With respect to adverse drug experiences, as defined by 21 C.F.R. Section 314.80, and IND safety reports, as referenced in 21 C.F.R. Section 312.32, relating to PRODUCT, the Development Team shall establish operating procedures to report to the appropriate REGULATORY AUTHORITIES in the countries in which PRODUCT is being developed or commercialized, in accordance with the appropriate laws and regulations of the relevant countries and authorities. Such operating procedures shall include any measures necessary for each Party to fully comply with such laws and regulations as apply to such Party. The Parties will collaborate to agree to and implement, within ninety (90) days following the Effective Date, a separate agreement concerning Pharmacovigilance responsibilities and case exchange.