Common use of Notification and Approval of Changes Clause in Contracts

Notification and Approval of Changes. Purchaser shall have sole responsibility for obtaining any and all necessary regulatory approvals from the FDA for changes to the Specifications and the Marketing Authorizations for the Products other than the Azathioprine Product and for reporting any changes to such Specifications and the Marketing Authorizations to the FDA as appropriate; and AAI DS shall have such responsibility with respect to the Azathioprine Product. Upon request by Purchaser, AAI DS shall use commercially reasonable efforts to assist Purchaser in obtaining any such approvals; provided that Purchaser will pay AAI DS its standard fees and expenses therefor.