definiens: shall mean, with respect to each Lead Compound, approval in the AstellasTerritory by the Japanese Ministry of Health, Labour and Welfare, or in the FG Territory by U.S. or Europeanregulatory authorities, as the case may be, to market such Lead Compound for an indication within the Field . It isunderstood that pricing or reimbursement approval shall constitute a part of the Marketing Approval . In any event, Marketing Approval shall be deemed to have occurred with respect to a Lead Compound no later than the date of theFirst Commercial Sale of such Lead Compound in the FG Territory or the [COMPANY] Territory as the case may be, by orunder authority of FG or [COMPANY] respectively, or their Affiliate or Sublicensee, as the case may be, whether or notformal approval by the relevant health regulatory authority is required for the First Commercial Sale of such LeadCompound