Common use of Responsibility for the Product Clause in Contracts

Responsibility for the Product. From and after the Closing Date, and in no event later than the effective date of the transfer to Duramed of the applicable NDA, Duramed shall assume all regulatory responsibilities under applicable laws in connection with the Product and the Product NDA, including (a) responding to all medical inquiries, (b) responsibility for reporting any adverse drug events in connection with the Product, (c) responsibility for compliance with the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time, and (d) responsibility for any and all fee obligations for holders or owners of approved NDAs and Regulatory Approvals relating to the Product, including those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time. In connection therewith, Shire shall promptly after Closing deliver to Duramed all records, documentation and other information that Shire has prepared or has had prepared regarding the development, efficacy, safety and legal compliance of the Product, including all correspondence with Regulatory Authorities or other government/health agencies related to the Product. Shire acknowledges that pursuant to the terms of the Pharmacovigilance Agreement, Shire shall be responsible for compliance with certain of the foregoing obligations following the Closing. Without limiting Shire’s obligations under the Pharmacovigilance Agreement, Shire shall cooperate with Duramed following the Closing to provide reasonable assistance in connection with Duramed’s regulatory obligations related to the Product for a period of [*].