Common use of Pharmacovigilance Agreement Clause in Contracts

Pharmacovigilance Agreement. Without limitation of Section 5.4, the Parties shall meet, as soon as practical following the Effective Date, but in no event later than four (4) weeks after the Effective Date of this Agreement, to commence good faith negotiations to establish a detailed pharmacovigilance agreement relating to the Product, which shall set forth standard operating procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions/adverse events sufficient to permit each Party to comply with its regulatory and other legal obligations within applicable timeframes.