definiens: means the regulatory requirements for current good manufacturing practices withrespect to the Manufacture of Bulk Intermediate and Bulk Drug pursuant to this Agreement, including theUnited States ' current Good Manufacturing Practices pursuant to the U.S. Federal Food, Drug, and CosmeticAct, as amended ( 21 U.S.C. Sec . 301 et seq ., ), and relevant regulations promulgated thereunder(including, without limitation, 21 C.F.R. Parts 11, 210 and 211 ), the European Union 's current GoodManufacturing Practices pursuant to EC Directive 2003/94 / EC of 8 October 2003, and the InternationalConference on Harmonisation Guidance for Industry Q7 Good Manufacturing Practice Guidance for ActivePharmaceutical Ingredients ( ), and any comparable regulatory requirements designated by theParties as applicable in a Firm Order, as such regulatory requirements may be amended from time to time