Common use of Manufacturing Practices Clause in Contracts

Manufacturing Practices. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the manufacture of products by or on behalf of the Company and the Company’s subsidiaries, to the knowledge of the Company, has been and is being conducted in material compliance with all applicable Laws including the FDA’s current Good Manufacturing Practices. In addition, the Company and the Company’s subsidiaries have been and are in material compliance with all other applicable FDA requirements, including, but not limited to, registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207. For the purposes of this Agreement, “Good Manufacturing Practices” means current good manufacturing practices for drugs, including but not limited to the regulations for drugs and finished pharmaceutical products contained in 21 C.F.R. Part 210 and 211, respectively.