Pharmacovigilance Obligations. After the Closing, Seller shall promptly provide Purchaser an electronic copy of the CIOMS I form for all legacy data of Adverse Events with respect to any Seller Product that is within Seller’s (or its Affiliate’s, as appropriate) possession, for inclusion in Purchaser’s safety database for the Product. After the Closing, Purchaser shall have all responsibility for required reporting of Adverse Events with respect to Seller Products.
Pharmacovigilance Obligations. (a) As promptly as practicable after the date hereof, and in any event prior to the Closing Date, the parties hereto shall execute and deliver a pharmacovigilance agreement, in - 65 - form and substance as Buyer and Seller (acting in good faith) mutually agree (the “Pharmacovigilance Agreement”), setting forth the responsibilities of each party or their designees with respect to the pharmacovigilance matters relating to the Consumer Care Products and the Rx Products in all jurisdictions. The Pharmacovigilance Agreement shall establish procedures and timeframes for ensuring compliance with all applicable product vigilance requirements, including any shared reporting responsibilities) and shall include customary terms for an agreement of that type, and in any event including the following:
Pharmacovigilance Obligations. This Section 5.8 shall be effective from and after Closing Date.
Pharmacovigilance Obligations. After the Closing, subject to the Transition Services Agreement, the Seller Parties shall promptly provide Purchaser an electronic copy of the CIOMS I form for all legacy data of Adverse Events recorded prior to the Closing with respect to any Seller Product that is within the Seller Parties’ (or their Affiliate’s, as appropriate) possession, for inclusion in Purchaser’s safety database for the Seller Product. After the Closing, Purchaser shall have all responsibility for required reporting of Adverse Events with respect to Seller Products in the Territory.
Pharmacovigilance Obligations
