definiens: means, with respect to any Product, the Regulatory Approval requiredby Applicable Laws in any country or region in the Territory in order to sell such Product for use in the Field in such countryor region . in the United States shall mean final approval of an NDA or sNDApermitting marketing of the applicable Product in interstate commerce in the United States, in the European Union shall mean marketing authorization for the applicable Product, including pricereimbursement approval, pursuant to Council Directive 2001/83 / EC, as amended, or Council Regulation 2309/93 / EEC, asamended and in Japan shall mean final approval of an application submitted to theMinistry of Health, Labor and Welfare and the publication of a New Drug Approval Information Package permittingmarketing of the applicable Product, including price reimbursement approval, in Japan, as any of the foregoing may beamended from time to time