Examples of Pharmacovigilance Agreement in a sentence
The Pharmacovigilance Agreement shall be executed before the initiation of the first Clinical Study conducted by either of the Parties for a CoDev Product that requires the other Party to report pharmacovigilance data generated by such Clinical Study to the Competent Authorities.
FibroGen and FibroGen (China) Medical Technology Development Co., Ltd., AstraZeneca and Astellas entered into a Tripartite Pharmacovigilance Agreement effective 13 November 2020 (the “PV Agreement”) to govern the responsibilities of each of the parties thereto in respect of pharmacovigilance activities for the Product globally, both in respect of clinical development and post-marketing PV activities.
When executed, the Pharmacovigilance Agreement shall remain a stand-alone document, independent from this Agreement to enable amendment thereto as required independently of this Agreement.
Notwithstanding Section 8.2 of the Collaboration Agreement, the Parties entered into a Pharmacovigilance Agreement dated May 30, 2023, whereby [***] agreed to [***] than had been contemplated in the Collaboration Agreement, subject to payment terms to be agreed in good faith by the Parties.
Other than as expressly set forth in the Pharmacovigilance Agreement, [***] is responsible for [***].