definiens: means the then current good manufactur ing practices, standards, guidelines and regulation s promulgated and published by FDA, European Medicine s Agency and/or any other applicable Regulatory Authorities having jurisdiction over the Manufactur e of Moderna mRNA API ( or Drug Product ) or the Development or sale of any Product containing such Moderna mRNA API ( or Drug Product ), as applicable, relating to the testing, manufacturing, processing, packaging, holding or distribution of drug substan ces and finished drugs including any standards, guidelines and regulations as promulgated by, as applicable : ( i ) the FDA under and in accordance with the U.S. Federal Food, Drug and Cosmetic Act and Title 21, Parts 210 and 211 of the U.S. Code of Federal Regulations ; ( ii ) the EMA and the EU Commission under European Directive 2003/94 / EC ; and/or ( iii ) the ICH Harmonised Tripart ite Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients ( ICH Q7 ), as such standa rds, guidelines and regulations may be amended from time to time