PV Agreement definition

PV Agreement shall have the meaning provided in Section 4.11.

PV Agreement means the pharmacovigilance agreement to be entered into by the Parties as provided in Section 3.15.

PV Agreement is defined in Section 2.7(a).

Examples of PV Agreement in a sentence

• The PV Agreement will govern all pharmacovigilance obligations arising as a result of entry into and implementation of this Agreement as more particularly set out therein.

• The parties further agree that the PV Agreement will be promptly amended as changes in legal and regulatory obligations require or as otherwise agreed by the Parties.

• Much collaboration has resulted in population-specific Disease Management Protocols (DMPs).

• On or prior to the Effective Date, the Parties shall enter (or shall procure that one of their respective duly authorised Affiliates enters) into the PV Agreement.

• Each Party separately and independently undertakes that, if one of its Affiliates enters into the PV Agreement, that Party shall comply with its Affiliate’s obligations under the PV Agreement as if it were a party thereto.

More Definitions of PV Agreement

PV Agreement means the First Amended and Restated Safety Agreement between Amgen Inc and GSK concerning the Collaboration Territory dated 15 July 2013.

PV Agreement is defined in Section 11.1.

PV Agreement means this Pharmacovigilance Agreement as amended under version control by the parties.

PV Agreement means the Lorcaserin Pharmacovigilance Agreement for the Exchange of Drug Safety Information, dated as of May 13, 2014, entered into by Eisai and Arena GmbH, as amended from time to time.

PV Agreement has the meaning set forth in Section 5.9(a).

PV Agreement means that certain Pharmacovigilance Agreement between Bristol Xxxxx Squibb Company and Lian Cardiovascular HK regarding Mavacamten (MYK-461) in the Territory, effective as of June 4, 2021, as may be amended from time to time.

PV Agreement means the pharmacovigilance agreement to be entered into by the Parties in accordance with Section 12.1. 1.63 “Quality Technical Agreement” means the quality technical agreement to be entered into by the Parties or its Affiliates pursuant to the Supply Agreement. 1.64 “Receiving Party” has the meaning given in Section 15.1. 1.65 “Recordati’s Group” means Recordati and its Affiliates. 1.66 “Regulatory Authority” means any Governmental Authority that is concerned with the safety, efficacy, reliability, manufacture, investigation, sale, or marketing of the Product, including, in the Territory, the MHLW and the PMDA. 1.67 “Regulatory Information” means all of the following, to the extent necessary or used as of the Effective Date by or on behalf of Aegerion or its Affiliates and is necessary, or reasonably useful (but only to the extent related to the Product in the Territory), to Manufacture, have Manufactured or Commercialize, have Commercialized the Product in the Territory (a) [***], (b) [***], and (c) [***]. 1.68 “Regulatory Notification” means any notification by or from a Regulatory Authority in relation to a Marketing Authorization. 1.69 “Regulatory Request” means any written request by an applicable Regulatory Authority or other Governmental Authority to amend, cancel, withdraw, or surrender any Marketing Authorization, or to take any step in relation thereto. 1.70 “Safety Related Information” means all adverse events, special situations (such as medication errors or medication management), other documentation such as source data and decisions related to individual case reports, minutes from safety meetings, signal detection 8 ACTIVE/99458941.1