definiens: means the standards relating to the then - current Good Manufacturing Practices for fine chemicals, API, intermediates, bulk products or finished pharmaceutical products set forth ( i ) in 21 U.S.C. 351(a)(2)(B ), in U.S. FDAregulations at 21 C.F.R. Parts 210 and 211 and in The Rules Governing Medicinal Products in the European Community, Volume IV, Good Manufacturing Practice for Medicinal Products, each as may be amended from time to time, ( ii ) in ICHGuidelines relating to the manufacture of API and finished pharmaceuticals as may be amended from time to time, or ( iii)applicable Laws promulgated by any Governmental Authority having jurisdiction over the manufacture of compounds orproducts or any components of either of the foregoing in the countries in which the Bulk Product or API, as applicable, willbe used or sold