Common use of Regulatory Commitments Clause in Contracts

Regulatory Commitments. (a) From and after the Closing Date, Buyer shall assume control of, and responsibility for, all Assumed Liabilities arising from or related to any commitments or obligations to any Governmental Entities in connection with the MA and the Product and, except as otherwise set forth in Schedule 2.6, for all pharmacovigilance and medical information services for and in respect of the MA and the Product. (b) On the Closing Date, Buyer shall assume responsibility for all correspondence and communication with Third Parties, including all Governmental Entities, relating to the Product. Buyer shall also thereafter keep such records and make such reports relating to the Product as shall be reasonably necessary to document such communications in compliance with all applicable regulatory requirements. (c) Following the Closing Date, Buyer shall, as promptly as practicable, register with the FDA to obtain its own labeler code and list with the FDA its own NDC numbers with respect to the Product and to have in place as soon as reasonably practicable all resources such that manufacturing and sales can be accomplished under the NDC numbers of Buyer. Buyer shall be permitted to sell and distribute finished drug product included in Closing Inventory that has been labeled prior to Closing using Sellers’ NDC numbers until the earlier of (i) Buyer having its own labeler code with respect to the Product or (ii) twelve (12) months following the Closing. (d) Following the Closing Date, Buyer shall, as promptly as practicable, deliver or cause to be delivered to Sellers copies of all confirmations, acknowledgements and other correspondence from the FDA that the transfer of ownership of the MA to Buyer has been completed in full.