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 [*].
Responsibility for the Product. Pursuant to the terms of the Pharmacovigilance Agreement, promptly after the Closing Date, and in no event later than the effective date of the transfer to Purchaser of the applicable Product Registrations, Purchaser shall assume all regulatory responsibilities permitted or required by applicable laws, in connection with the Product and the Product Registrations in the Territory, including (i) responding to all medical inquiries, (ii) responsibility for reporting any adverse drug events in connection with the Product, and (iii) responsibility for compliance with the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time. After the Closing Date, Purchaser shall assume all responsibility for any and all fee obligations for holders or owners of approved NDA's 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.
Responsibility for the Product. (a) Subject to the Supply Agreement, from and after the Closing Date, Buyer shall assume all regulatory responsibilities permitted by applicable Laws to be assumed by Buyer, reporting and otherwise, in connection with the Product, the Product Registrations, to the extent related to the period from and after the Closing Date, including responsibility for reporting any adverse drug experiences in connection with the Product in or with respect to the Territory, and responsibility for compliance with the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time.
Responsibility for the Product. From and after the Closing Date, Caraco shall have all post-Closing regulatory responsibilities under applicable laws and regulations, reporting and otherwise, in connection with the Products, except that Forest shall have the authority and responsibility with respect to regulatory matters and compliance with Applicable Law relating to Forest’s manufacture and supply obligations pursuant to Section 5.04(a) and the Supply Agreement referenced therein, including, securing necessary FDA approvals and site transfer approvals.
Responsibility for the Product. Subject to compliance by the Parties with the applicable provisions of the Transition Plan, from and after the Transition Date (or such earlier date as the NDA transfers to Orexo in accordance with Section 8.6(b) below), Orexo shall have all regulatory responsibilities under applicable Laws and regulations, reporting and otherwise, in connection with the Product in the Orexo Territory.
Responsibility for the Product. Subject to compliance by the parties with the applicable provisions of the Transition Services Agreement, from and after the Closing Date, JDS shall have all regulatory responsibilities under applicable laws and regulations, reporting and otherwise, in connection with the Product in the Territory.
Responsibility for the Product. (a) Promptly after the Closing Date Purchaser shall (i) obtain new NDC numbers for the Product, (ii) have its labeling for Product approved by the FDA, and (iii) use such new NDC numbers on all invoices, orders and other communications with customers and Regulatory Authorities. Seller shall report the termination date of its NDC numbers for the Product to the Centers for Medicare and Medicaid Services (“CMS”) in accordance with CMS guidelines, which termination date shall be the expiration date for the last lot of Product with its NDC numbers.
