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

Examples of Pharmacovigilance Agreement in a sentence

• Not later than the [***] or such earlier date required by applicable Law, the Parties shall enter into a separate, written Pharmacovigilance Agreement containing specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to the Licensed Product.

• Chiesi will maintain its own safety database with regards to the data received during Clinical Trials sponsored by Chiesi and Chiesi will share with Gossamer such data, if any, in accordance with the Pharmacovigilance Agreement, which will allow both Parties to reasonably cooperate in order to comply with regulatory and pharmacovigilance obligations with respect to the Licensed Product.

• The Coherus-Apotex Pharmacovigilance Agreement will also provide for reimbursement by Apotex of Coherus’s internal and out-of-pocket costs and expenses associated with assisting Apotex with reporting adverse events within the Apotex Territory.

• The Pharmacovigilance Agreement shall define safety data exchange procedures concerning serious adverse events, including serious adverse drug reactions, with respect to any Licensed Products, sufficient to permit each Party and its Affiliates and Subcontractors or Sublicensees, as the case may be, to comply with applicable Law requirements pertaining to drug safety and pharmacovigilance.

• Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.

More Definitions of Pharmacovigilance Agreement

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

Pharmacovigilance Agreement shall have the meaning set out in Clause 9.2;

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.