definiens: means, with respect to any Product, the Regulatory Approval requiredby Applicable Laws to sell such Product for use in the Field in a country or region in the Territory . shall include, without limitation, the approval of any Drug Approval Application . For purposes ofclarity, in the United States shall mean final approval of an NDA for the firstIndication or sNDA for an additional Indication permitting marketing of the applicable Product in interstate commerce in theUnited States, in the European Union shall mean marketing authorization for theapplicable Product pursuant to Council Directive 2001/83 / EC, as amended, or Council Regulation 2309/93 / EEC, as amendedand in Japan shall mean final approval of an application submitted to the Ministryof Health, Labor and Welfare and the publication of a New Drug Approval Information Package permitting marketing of theapplicable Product in Japan, as any of the foregoing may be supplemented or amended from time to time