definiens: or means all applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products or finished pharmaceutical products . For purposes of this Agreement, cGMPs shall mean ( i ) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and The Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products as each may be amended from time to time or ( ii ) promulgated by any Governmental Authority having jurisdiction over the manufacture of the Products, in the form of Laws, ( iii ) promUlgated by any Governmental Authority having jurisdiction over the manufacture ofthe Products, in the form of guidance documents ( including but not limited to advisory opinions, compliance policy guides and guidelines ) which guidance documents are being implemented within the pharmaceutical manufacturing industry for such Products and - 3 -I·PRl1248889.l5 subject to any arrangements, additions or clarifications agreed to from time to time by the Parties in the Quality Agreement