Common use of Regulatory Transfer Clause in Contracts

Regulatory Transfer. At Closing, Seller will provide to Buyer copies of all portions of NDA 76-1021 and the SNDAs necessary to allow Buyer to comply with its obligations as the application holder. Seller further agrees to notify the FDA of the transfer of NDA 76-1021 in accordance with Section 505(j) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.72. Buyer agrees to notify the FDA of the transfers of NDA 76-1021 and SNDAs effective immediately upon the Closing and to submit as the new owner an application Form FDA 356h.