definiens: or shall mean current good manufacturing practices and regulations applicable to the Manufacture of Produc t that are promulgated by any Regulatory Authority, including as promulgated under and in accordance wi th ( i ) the U.S. Federal Food, Drug and Cosmetic Act, Title 21 of the U.S. Code of Federal Regulations, Parts 2 10, 211, 600, 601 and 610, ( ii ) relevant EU legisla tion, including European Directive 2003/94 / EC or national implementations of that Directive, ( iii ) relevant guidelines, including the EU Guidelines for Good Manufacturing Practices for Medicinal Products ( Eudralex Vol . 4 a nd 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 standar ds as defined, from time to time, by any relevant Regulat ory Authority having jurisdiction over the developm ent, manufacture or commercialization of the Product, as applicable, in each case as in effect as of the da te such manufacturing for the Product are or were conducted