definiens: means the current good manufacturing practices for the manufacture of pharmaceutical products, including butnot limited to : ( a ) the United States Federal Food, Drug, and Cosmetic Act, as amended ( 21 U.S.C. § 321 et seq . ) and the regulatoryrequirements for current good manufacturing practices as promulgated by the FDA thereunder, including without limitation 21 C.F.R. § § 210,211, and Part 11 ( as applicable to electronic systems used in the manufacture of product ) ; and/or ( b ) the regulatory requirements for currentgood manufacturing practices as promulgated by the International Conference on Harmonization ( ICH ), Guidance for Industry Q7A GoodManufacturing Practice Guidance for Active Pharmaceutical Ingredients ; and/or the European Community Directive 2003/94 / EC of October 8,2003 ; and ( c ) the EC Guide to Good Manufacturing Practices for Medicinal Intermediate Products ; and ( d ) 2003/94 / EEC Directive ( assupplemented by Volume 4 of EudraLex published by the European Commission ), as amended, if and as implemented in the relevantconstituent country ; and ( e ) all additional applicable Regulatory Authority regulations that replace, amend, modify, supplant or complement anyof the foregoing ; and/or ( f ) any and all current Good Manufacturing Practices applicable to the manufacture, testing and/or any otherprocessing of pharmaceutical products in other countries and territories worldwide where the respective Finished Products are sold orotherwise marketed from time to time provided that [COMPANY] is informed about such other Good Manufacturing Practices by [COMPANY] inaccordance with Quality Assurance Agreement and [COMPANY] conﬁrms in writing that it will comply with such other Good ManufacturingPractices within a reasonable time so as not to delay release of the Finished Product by [COMPANY]