Safety Data Exchange Agreement definition

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

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

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

Examples of Safety Data Exchange Agreement in a sentence

Terex hereby agrees to pay all reasonable costs and expenses incurred by any Lender or any Issuing Bank in connection with any such filing or assignment, delegation and transfer.
The parties agree to develop and commit to a Safety Data Exchange Agreement (“SDEA”) that allows them to fulfill their respective regulatory and pharmacovigilence obligations relating to Adverse Drug Event and Adverse Drug Reaction reporting.
To avoid doubt, clause 10.1 to 10.3 do not limit any obligations under the Safety Data Exchange Agreement and Quality Agreement.
The Parties shall promptly update the Safety Data Exchange Agreement if required by changes in applicable Law.
Without limiting the foregoing, 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 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.

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

Safety Data Exchange Agreement means that certain pharmacovigilance agreement regarding the Compounds that shall be entered into by the Parties prior to the enrollment of the first patient in the Study.

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).