definiens: means all applicable standards relating to manufa cturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk pro ducts or finished pharmaceutical products, includin g ( i ) the principles detailed in the U.S. Current Good Manufa cturing Practices, 21 C.F.R. Parts 210 and 211 and The Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice fo r Medicinal Products as each may be amended from time to time, ( ii ) the principles detailed in the ICH Q 7A guidelines, ( iii ) if [COMPANY] notifies New River that [COMPANY] intends to Commercialize a Collaboration Prod uct in a country, Laws promulgated by any Governmental Autho rity in such country having jurisdiction over the Manufacture of Compound or Collaboration Product, o r ( iv ) if [COMPANY] notifies - 2 - New River that [COMPANY] intends to Commercialize a Col laboration Product in a country, guidance documents promulgated by any Governmental Authority in such c ountry having jurisdiction over the Manufacture of Compound or Collaboration Product ( including but no t limited to advisory opinions, compliance policy g uides and guidelines ), which guidance documents are being implemented within the pharmaceutical manufacturin g industry