definiens: means the regulatory requirements for current good manufacturing practices required by the applicable Regulatory Authority with respect to the Manufacture of the Bulk Intermediate and Bulk Drug pursuant to this Agreement, including the United St ates ’ current Good Manufacturing Practices pursuant to the U.S. Federal Food, Drug, and Cosmetic Act, as a mended ( 21 U.S.C. Sec . 301 et seq ., ), and relevant regulations promulgated thereunder ( includ ing, without limitation, 21 C.F.R. Parts 11, 210 an d 211 ), the European Union ’s current Good Manufacturi ng Practices pursuant to EC Directive 2003/94 / EC of 8 October 2003, and the International Conference on Harmonisation Guidance for Industry Q7 Good Manufacturing Practice Guidance for Active Pharmace utical Ingredients ( ), and any comparable regulatory requirements designated by the Parties a s applicable in a Firm Order, as such regulatory requirements may be amended from time to time