definiens: means, with respect to an MRT Product in a country or group of countries, all approvals, licenses, registrations and authorizatio ns of any Regulatory Authority and other Government al Entity with respect to such MRT Product that are necessary for the sale of such MRT Product in such country o r group of countries, including ( i ) the approval of any NDA or Biologics License Application by the FDA with r espect to the U.S. or ( ii ) the approval of any Marketing Auth orization Application by the EMA or national health authorit(ies ) with respect to the E.U., and, if req uired prior to sale of an MRT Product in such count ry or group of countries, Pricing and Reimbursement Approval . F or the avoidance of doubt, ATU, Law 648/96 and simi lar named patient programs do not constitute Regulatory Approval