Common use of Adverse Drug Experience Reporting Clause in Contracts

Adverse Drug Experience Reporting. The Parties agree to use commercially reasonable efforts to reach agreement on Adverse Event Reporting Procedures which will be set forth in Exhibit D attached hereto (as the same may be amended from time to time by notice in writing from Purchaser to Supplier, the “Adverse Event Reporting Procedures”) at least three (3) months prior to Launch but shall reach such agreement no later than one (1) month prior to Launch. Supplier shall fully, accurately and promptly provide Purchaser with all data known to it at any time during the term of this Agreement or thereafter, which data indicate that any Licensed Product is or may be unsafe, lacks utility, or otherwise does not meet specifications in accordance with the Adverse Event Reporting Procedures, including, without limitation, any data or information received from Third Party partners or purchasers of Supplier that the Licensed Adjuvant is or may be unsafe, lacks utility, or otherwise does not meet specifications in accordance with the Adverse Event Reporting Procedures. Purchaser shall solely determine whether such information is required to be reported to FDA and any other Regulatory Authority.

Adverse Drug Experience Reporting. The Parties agree to use commercially reasonable efforts to reach agreement on Adverse Event Reporting Procedures which will be set forth in Exhibit D attached hereto (as the same may be amended from time to time by notice in writing from Purchaser to Supplier, the “Adverse Event Reporting Procedures”) at least three (3) months prior to Launch but shall reach such agreement no later than one (1) month prior to Launch. Supplier shall fully, accurately and promptly provide Purchaser with all data known to it at any time during the term of this Agreement or thereafter, which data indicate that any Licensed Product is or may be unsafe, lacks utility, or otherwise does not meet specifications in accordance with the Adverse Event Reporting Procedures, including, without limitation, any data or information received from Third Party partners or purchasers of Supplier that the Licensed Adjuvant is or may be unsafe, lacks utility, or otherwise does not meet specifications in accordance with the Adverse Event Reporting Procedures. Purchaser shall solely determine whether such information is required to be reported to FDA and any other Regulatory Authority. 3.9 Recalls.