definiens: means(a ) in the United States, final approval of an NDA or sNDA permitting marketing of the applicable Product in interstatecommerce in the United States ; ( b ) in the European Union, marketing authorization for the applicable Product granted eitherby a Regulatory Authority in any Major European Country or by the EMEA pursuant to Council Directive 2001/83 / EC, asamended, or Council Regulation 2309/93 / EEC, as amended, together with pricing approval and government reimbursementapproval at a level reasonably acceptable to [COMPANY] for the applicable Product granted by a Regulatory Authority in any MajorEuropean Country ; and ( c ) in Japan, final approval of an application submitted to the MHLW and the publication of a NewDrug Approval Information Package permitting marketing of the applicable Product in Japan, together with pricing approvaland government reimbursement approval at a level reasonably acceptable to [COMPANY], as any of the foregoing may be amendedfrom time to time