Pharmacovigilance Agreement definition

Pharmacovigilance Agreement has the meaning set forth in Section 4.3.

Pharmacovigilance Agreement has the meaning set forth in Section 5.1.

Pharmacovigilance Agreement has the meaning set forth in Section 6.3.1 (Pharmacovigilance Agreement).

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 [***].

More Definitions of Pharmacovigilance Agreement

Pharmacovigilance Agreement means the pharmacovigilance agreement to be executed by the Parties pursuant to Section 2.6 (Pharmacovigilance Agreement).

Pharmacovigilance Agreement shall have the meaning set forth in Section 7.2(b).

Pharmacovigilance Agreement means the agreement between the Seller and the Purchaser, to be entered into at Closing, in respect of pharmacovigilance and regulatory matters relating to the Products;

Pharmacovigilance Agreement means the agreement referred to as such in Section 6.7.

Pharmacovigilance Agreement means a pharmacovigilance agreement entered into by the Parties for a particular Study with respect to the exchange of safety information related to the Regeneron Product (alone or in the Combination) as set forth in Section 4.5.

Pharmacovigilance Agreement has the meaning set forth in Section 10.9.2.

Pharmacovigilance Agreement means an agreement entered into by the Parties to set forth the protocols and procedures for reporting adverse events and complying with reporting requirements set forth by Regulatory Authorities.