definiens: means all applicable standards relating to manufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished pharmaceutical products, including ( i ) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and 211 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, ( ii ) the principles detailed in the ICH Q7 A guidelines, ( iii ) if [COMPANY] notifies New River that [COMPANY] intends to Commercialize a Collaboration Product in a country, Laws promulgated by any Governmental Authority in such country having jurisdiction over the Manufacture of Compound or Collaboration Product, or ( iv ) if [COMPANY] notifies -2 - CONFIDENTIAL TREATMENT New River that [COMPANY] intends to Commercialize a Collaboration Product in a country, guidance documents promulgated by any Governmental Authority in such country having jurisdiction over the Manufacture of Compound or Collaboration Product ( including but not limited to advisory opinions, compliance policy guides and guidelines ), which guidance documents are being implemented within the pharmaceutical manufacturing industry