definiens: or means all applicable standards relating tomanufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finishedpharmaceutical products, including ( i ) the principles detailed in the U.S. Current Good Manufacturing Practices, 21C.F.R. Parts 210 as may be amended from time to time, ( ii ) Laws promulgated by any Governmental Authority havingjurisdiction over the manufacture of the Drug Product, and ( iii ) guidance documents promulgated by any GovernmentalAuthority having jurisdiction over the manufacture of the Drug Product, in ( including but not limited to advisoryopinions, compliance policy guides and guidelines ) which guidance documents are being implemented by PII or withinthe pharmaceutical manufacturing industry for such Drug Product and specifically identified by [COMPANY] to be applicableto this Agreement, subject to, with respect to clause ( iii ) only, any arrangements, additions or clarifications agreed tofrom time to time by the Parties in the Quality Agreement