Safety Data Exchange Agreement definition

Safety Data Exchange Agreement has the meaning set forth in Section 3.4.

Safety Data Exchange Agreement has the meaning set forth in Section 6.14(a).

Safety Data Exchange Agreement or “SDEA” has the meaning set forth in Section 4.4.

Examples of Safety Data Exchange Agreement in a sentence

• The Parties shall promptly update the Safety Data Exchange Agreement if required by changes in applicable Law.

• Each Party shall comply with its respective obligations under the Safety Data Exchange Agreement and shall cause its Affiliates and sublicensees to comply with such obligations.

• Within such time to ensure that all regulatory requirements are met, the Parties shall negotiate in good faith and enter into a Safety Data Exchange Agreement (“SDEA”), which will define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures to enable each Party (and their respective related Third Parties, if any) to comply with all of its legal and regulatory obligations related to such Regional Antibody Candidates or Regional Licensed Products.

• The Safety Data Exchange Agreement will set forth guidelines and procedures for the receipt, investigation, recording, review, communication, reporting and exchange between the Parties of Adverse Event reports and Other Safety Information, that, for purposes of information exchange between the Parties, will include Adverse Events and serious Adverse Events, and any other information concerning or impacting the safety of any Product or Licensed Agent.

• Without limiting the foregoing, upon Vertex’s request, the Parties will meet to establish a safety oversight working group comprised of members of both Parties, which, except as otherwise provided in the Safety Data Exchange Agreement, will discuss and establish processes and procedures for sharing information needed to support each Party’s regulatory responsibilities and to comply with applicable regulatory pharmacovigilance requirements.

More Definitions of Safety Data Exchange Agreement

Safety Data Exchange Agreement means that agreement between the Parties regarding receipt, investigation and reporting of product complaints, adverse events, product recalls, and any other information related to the safety of the Licensed Products as set forth in Section 10.03 (Adverse Drug Events).

Safety Data Exchange Agreement has the meaning set forth in Section 2.8.2.

Safety Data Exchange Agreement means that certain [***].

Safety Data Exchange Agreement means the safety data exchange agreement to be entered into by the Parties on the Signing Date, to be effective as of the Effective Date, in the form set out in Exhibit B.

Safety Data Exchange Agreement means a customary Safety Data Exchange Agreement, between Seller and an Affiliate of Buyer, with respect to the Product.

Safety Data Exchange Agreement or “SDEA” means the Safety Data and Exchange Agreement, by and between Emergent and Aptevo, of even date herewith, that defines the responsibilities of each Party with reference to each pharmacovigilance activity and specifies the processes involved for the exchange of safety information, including timelines and regulatory reporting responsibilities.

Safety Data Exchange Agreement means that certain pharmacovigilance agreement regarding the Compounds, on customary terms to be mutually agreed as negotiated in good faith and that shall be entered into by the Parties in conjunction herewith, within forty-five (45) days following the Effective Date and in any case prior to the enrollment of the first patient in the Study, as such agreement may be amended from time to time.