definiens: or shall mean all applicable standards relating to manufacturingpractices for fine chemicals, intermediates, bulk products or finished pharmaceutical products . For purposes of thisAgreement, cGMPs shall mean the principles ( i ) detailed in the U.S. Current Good Manufacturing Practices, 21 CFR Parts 210and The Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice forMedicinal Products as each may be amended from time to time or ( ii ) promulgated by any Governmental Authority havingjurisdiction over the manufacture of the Collaboration Product, in the form of Laws, ( iii ) promulgated by any GovernmentalAuthority having jurisdiction over the manufacture of the Collaboration Product, in the form of guidance documents(including but not limited to advisory opinions, compliance policy guides and guidelines ) which guidance documents arebeing implemented within the pharmaceutical7 manufacturing industry for such products and subject to any arrangements, additions or clarifications agreed to from time totime by the Parties in the Quality Agreement to be negotiated pursuant to Article 9