definiens: or means current good manufacturing practices and regulationsapplicable to the Manufacture of Product that are promulgated by any Regulatory Authority, including as promulgated underand 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 nationalimplementations of that Directive, ( iii ) relevant guidelines, including the EU Guidelines for Good Manufacturing Practices forMedicinal Products ( Eudralex Vol . 4 and Annexes thereto ), ( iv ) International Conference on Harmonization GoodManufacturing 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 thedevelopment, manufacture or commercialization of the Product, as applicable, in each case as in eﬀect as of the date suchmanufacturing for the Product are or were conducted