definiens: or shall mean all applicable standards relating tomanufacturing practices for fine chemicals, intermediates, bulk products or finished pharmaceutical products . Forpurposes of this Agreement, cGMPs shall mean ( i ) the principles detailed in the U.S. Current Good ManufacturingPractices, 21 CFR Parts 210 and 211 and The Good Manufacturing Practice for Medicinal Products in the EuropeanCommunity, Volume IV, as each may be amended from time to time ; or ( ii ) promulgated by any GovernmentalAuthority having jurisdiction over theF-2manufacture of the Products, including those in the form of guidance documents ( including but not limited to advisoryopinions, compliance policy guides and guidelines ) that are being implemented within the pharmaceuticalmanufacturing industry for such Products, and subject to any arrangements, additions or clarifications agreed to fromtime to time by the Parties