Common use of FDA Approval of Product Registration Clause in Contracts

FDA Approval of Product Registration. The following sentence shall be added to the end of Section 3.2 of the Original Agreement: “Reliant shall complete and file the “new owner” requirements as outlined in 21 CFR 314.72, a copy of which is attached hereto as Exhibit 3.2, within two (2) business days of notification that Xxxxxx has filed a transfer request for NDA 21-654 with the FDA (as contemplated by Section 3.7(c) of Amendment No. 1 to the Xxxxxx Agreement, dated as of November 11, 2004); provided, however, that nothing herein shall be deemed to create any liability or other obligation of Reliant or any of its Affiliates to Xxxxxx or any of its Affiliates under the Xxxxxx Agreement (as amended) or otherwise.” In addition, the Original Agreement shall be amended by adding thereto new Exhibit 3.2 in the form attached hereto as Exhibit A.