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 intended foruse in humans and promulgated by any other governmental authority having jurisdiction over themanufacture of drug compounds in the countries in which the Product containing API will be used or soldas communicated to [COMPANY] in writing by [COMPANY] from time to time and as may be agreed to byPatheon, which agreement shall not be unreasonably withheld or delayed ; and ( iv ) all additional regulatoryauthority documents or regulations that replace, amend, modify, supplant or complement any of theforegoing