definiens: g Approvu ( ' of a Product shall mean all upprovals . lieen ~ s, rel : iSlflltions or Iluthorizations of Regulatory Authorities in a country neccswy for the manufacture, use . ~1of1lge, impon, e ~ porl . distribution, pTOnlO(ion, llU1rtcting, oller for sale and sal~ of such Prodm : t in such coumry, For coomrics " here gO\'cmmenlal DJlIlfoval is required for prieinll andfor reimbursement for the Product to be reimbursed by natiooal health insurance { or it~ local equiVllcnt~ -Murkeling Approval ' · sh~1I IIOt be dttlTKd 10 occur until such pricing and/or reimbul'5Crnem approval is obcained, 1.76 Must R ~ ce ' shall ha'e the meuninll scI tarlh in Section 6.2, 1,78 ' of n ProdllCl shall mean a NelV Drug Application as defined in Title 21 of the U.S, Code of Federal Rellulations . Seclion 314.80, Cl seq .. and all llffiCndments and suppleme nts therClo, which is fikd w, lh lhe t·I)A, or the equivalent applicati on filed wilh ~lealih Canada in Canada . including all documents, data, POd other information concernin ; 511Ch ProdUCI thul filed ihat an : nccc5Sllry for " aining Marketing Approval for such Product