Common use of Appropriate Reporting of Adverse Events Clause in Contracts

Appropriate Reporting of Adverse Events. The parties agree that appropriate reporting of adverse events and other safety data relating to the Product is critical. Specific details regarding the management of information of adverse events, medical inquiries and Product complaints related to the use of the Product in the Territory and outside will be set out in a separate document, to be agreed to by the parties at least three (3) months before the first scheduled launch date in the Territory. The Pharmacovigilance and product labelling representatives of each party will work in good faith together to develop a document that identifies and/or provides: (a) which safety information will be exchanged; (b) when such information will be exchanged; (c) Endo will have regulatory reporting responsibilities; (d) Endo will manage the safety database for the Territory only; (e) Endo will be obligated to obtain follow-up information on incomplete safety reports for the Territory only; (f) that Endo will review the literature for safety report information for the Territory only; (g) that Endo will prepare required periodic safety updates for the Territory only; and (h) the identification of any other details required to appropriately manage safety information for the Product.

Appropriate Reporting of Adverse Events. The parties agree that appropriate reporting of adverse events and other safety data relating to the Product is critical. Specific details regarding the management of information of adverse events, medical inquiries and Product complaints related to the use of the Product in the Territory and outside will be set out in a separate document, to be agreed to by the parties at least three (3) months before the first scheduled launch date in the Territory. The Pharmacovigilance and product labelling representatives of each party will work in good faith together to develop a document that identifies and/or provides: (a) which safety information will be exchanged; (b) when such information will be exchanged; (c) Endo Paladin will have regulatory reporting responsibilities; (d) Endo Paladin will manage the safety database for the Territory only; (e) Endo Paladin will be obligated to obtain follow-up information on incomplete safety reports for the Territory only; (f) that Endo Paladin will review the literature for safety report information for the Territory only; (g) that Endo Paladin will prepare required periodic safety updates for the Territory only; and (h) the identification of any other details required to appropriately manage safety information for the Product.