definiens: or means current good manufact uring practices and regulations applicable to the Manufacture of Product that are promulgated by any Regulatory Authority, including as promulgated under and in accordance with ( i ) the U.S. Federal Food, Drug and Cosmetic Act, Title 21 of the U.S. Code of Federal Regulations, Parts 210, 211, 600, 601 and 610, ( ii ) relevant EU legislation, including European Directive 2003/94 / EC or national implementations of that Directive, ( iii ) relevant guidelines, including the EU Guidelines for Good Manufacturing Practi ces for Medicinal Products ( Eudralex Vol . 4 and Annexes thereto ), ( iv ) International Conference on Harmonisation Good Manufacturing Practice Guide for Active Pharmaceuticals Ingredients and ( v ) and any analogous set of regulations, guidelines or standards as defined, from time to time, by any relevant Regulatory Authority having jurisdiction over the development, manufacture or commercialization of the Product, as applicable, in each case as in effect as of the date such manufacturing for the Product are or were conducted