definiens: means, with respect to a Licensed Product, ( a ) in the United States, approval by the FDA of anNDA, or similar application for marketing approval, and satisfaction of any related applicable FDA reg istration andnotification requirements ( if any ), and ( b ) in any country or region other than the United States, app roval by any Regulatory 13***Text Omitted and Filed Separately with the Secur ities and ExchangeCommission . Confidential Treatment Requested Under17 C.F.R. Sections 200.80(b)(4 ) and 240.24b-2 Authority having jurisdiction over such country or region of a single application or set of applicatio ns comparable to an NDAand satisfaction of any related applicable regulato ry and notification requirements, if any, together with any other approvalnecessary to make and sell pharmaceuticals commerci ally in such country or region . For purposes of cla rity, inthe United States means approval of an NDA permitti ng marketing of the applicable Licensed Product in interstate commercein the United States, in the European Union means marketing authorizati on for the applicable LicensedProduct pursuant to Council Directive 2001/83 / EC, a s amended, or Council Regulation 2309/93 / EEC, as am ended and in Japan means final approval of an application s ubmitted to the Ministry of Health, Labor and Welfa re ( ) and the publication of a New Drug Approval Inform ation Package permitting marketing of the applicabl e LicensedProduct in Japan, as any of the foregoing may be am ended from time to time