definiens: means, with respect to the Product, the Regulatory Approval required by Applicable Lawsto sell such Product for use for an Indication in the Field in a country or region in the Territory, excludingpricing approvals and government reimbursement approvals . For purposes of clarity, .1 in the United States shall mean final approval of an NDA or sNDA permitting marketing ofthe applicable Product in interstate commerce in the United States ; .2 in the European Union shall mean marketing authorization for the applicable Productgranted either by a Regulatory Authority in any Major European Country or by the EMEA pursuant to CouncilDirective 2001/83 / EC, as amended, or Council Regulation 2309/93 / EEC ; and .3 in Japan shall mean final approval of an application submitted to the Ministry of 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 amended from time to time