Safety Data Exchange Agreement definition

Safety Data Exchange Agreement has the meaning set forth in Section 6.6.3.

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

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).

Examples of Safety Data Exchange Agreement in a sentence

• Each Party will comply with its respective obligations under each Safety Data Exchange Agreement and cause its Affiliates, licensees, and Sublicensees to comply with such obligations.

• Each Safety Data Exchange Agreement will also detail each Party’s responsibilities with respect to recalls and withdrawals of the Licensed Products within Japan.

• To the extent that there is a conflict between the terms of this Agreement and the terms of any Safety Data Exchange Agreement, the terms of the applicable Safety Data Exchange Agreement will govern with respect to the subject matter set forth therein.

• In addition, the sale, transfer or assignment of all or substantially all of Acer’s rights in the Product under this Section 1.4.(a) shall require the concurrent assignment to such Third Party of the Exclusive License Agreement and the related Clinical Quality and Supply Agreements, the Commercial Supply Agreement and the Safety Data Exchange Agreement, if any.

More Definitions of Safety Data Exchange Agreement

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 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 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 has the meaning set forth in Section 4.2 (Safety and Adverse Event Reporting).

Safety Data Exchange Agreement or “SDEA” shall mean the agreement to be entered into between the Parties within ninety (90) days following the Effective Date in a form substantially similar to the form set forth in Appendix 3 hereof, which generally governs the Parties’ responsibilities related to the safety data and regulatory reporting requirements for the Products.