definiens: means current good manufacturing practice as promulgated by the FDA under and in accordance with the FDC Act, Title 21, Parts 210, 211 and226 of the U.S. Code of Federal Regulations, and the guidelines and standards published by the FDA that relate to the testing, manufacturing, processing, packaging, holding or distribution of the Compound and all Licensed Products . To the extent consistent with U.S. law, also includesthe practices and standards described in the Guide to Good Manufacturing Practices for Medicinal Products as promulgated by the EuropeanCommission under European Directive 2003/94 / EC, similar standards, guidelines and regulations promulgated or otherwise required by applicableRegulatory Authorities in any other country or legal jurisdiction in the Territory and the ICH Harmonised Tripartite Good Manufacturing Practice Guide ForActive Pharmaceutical Ingredients ( ICH Q7 ), as each may be amended from time - to - time, or any successors thereto