definiens: or means the then - current standards for themanufacture of fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finishedpharmaceutical products set forth ( i ) in 21 U.S.C. 351(a)(2)(B ), in U.S. FDA regulations at 21 C.F.R. Parts210 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 ) inInternational Conference on Harmonization ( ICH ) Guidelines relating to the manufacture of activepharmaceutical ingredients and finished pharmaceuticals as may be amended from time to time ; ( iii ) allother similar Applicable Laws relating to the manufacturing of active pharmaceutical ingredients andpromulgated by any other governmental authority having jurisdiction over the manufacture of drugcompounds in the countries in which the Product containing Compound will be used or sold ; and ( iv ) alladditional regulatory authority documents or regulations that replace, amend, modify, supplant orcomplement any of the foregoing