definiens: in the United Statesshall mean final approval of an NDA or sNDA permitting marketing of the applicable Product in interstate commerce in theUnited States ; ( b ) in the European Union shall mean marketing authorization for theapplicable Product granted either by a Regulatory Authority in any Major European Country or by the EMEA pursuant toCouncil Directive 2001/83 / EC, as amended, or Council Regulation 2309/93 / EEC, as amended, together with the first pricingapproval and government reimbursement approval for the applicable Product granted by a Regulatory Authority in any MajorEuropean Country or by the EMEA, as the case may be ; and ( c ) in Japan shall meanfinal approval of an application submitted to the Ministry of Health, Labor and Welfare and the publication of a New DrugApproval Information Package permitting marketing of the applicable Product in Japan, together with pricing approval andgovernment reimbursement approval, as any of the foregoing may be amended from time to time