definiens: or means all applicable standards relating to manufacturing practicesfor intermediates, active pharmaceutical ingredients or finished pharmaceutical products, including without limitation ( i ) theprinciples detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and 211, The Rules GoverningMedicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products, and Q7AGood Manufacturing Practice Guidance For Active Pharmaceutical Ingredients ( ICH Q7A ), ( ii ) the principles promulgated byany applicable Governmental Body having jurisdiction over the manufacture of the API, in the form of laws, rules, orregulations, and ( iii ) the principles promulgated by any applicable Governmental Body having jurisdiction over themanufacture of the API, in the form of guidance documents ( including but not limited to advisory opinions, compliancepolicy guides and guidelines ), which guidance documents are being implemented within the pharmaceutical manufacturingindustry for such products ; in each case as in effect at the Effective Date and as amended, promulgated or accepted by anyapplicable Governmental Body from time to time during the Term