definiens: in the United States shall mean final approval of an NDA or sNDA permittingmarketing of the applicable Product in interstate commerce in the United States ; ( b ) in the EuropeanUnion shall mean marketing authorization for the applicable Product granted either by a Regulatory Authority in any Major European Country orby the EMEA pursuant to Council Directive 2001/83 / EC, as amended, or Council Regulation 2309/93 / EEC, as amended, together with the firstpricing approval and government reimbursement approval for the applicable Product granted by a Regulatory Authority in any Major EuropeanCountry or b y the EMEA, as the case may be ; and ( c ) in Japan shall mean final approval of anapplication submitted to the Ministry of Health, Labor and Welfare and the publication of a New Drug Approval Information Package permittingmarketing of the applicable Product in Japan, together with pricing approval and government reimbursement approval, as any of the foregoingmay be amended from time to time