definiens: means, with respect to each Licensed Product and each country or jurisdiction, the firstsale of such Licensed Product for use or consumption by the general public in such country or jurisdiction after:(a ) Regulatory Approval from the applicable Regulatory Authority has been obtained ; and ( b ) solely in the case of * * * * * * * * or * * * * * * * * is * * * * * * * *, ( i ) such * * * * * * * * or * * * * * * * * from the applicable Regulatory Authority has been obtained or(ii ) solely with respect to Section 5.2.1 ( and, for clarity, not for purposes of determining a Royalty Term or for any otherpurpose ), such * * * * * * * * or * * * * * * * * from the applicable Regulatory Authority has not been obtained but * * * * * * * * of suchLicensed Product as an * * * * * * * * in * * * * * * * *, as a * * * * * * * * in * * * * * * * * or as either an * * * * * * * * or a * * * * * * * * in * * * * * * * *, as applicable, are * * * * * * * * ; provided that a sale of a Licensed Product to a Party ’s Affiliate or Sublicensee shallnot constitute a First Commercial Sale ( unless the purchasing Affiliate or Sublicensee is the last Person in the distributionchain for such Licensed Product and is purchasing it for its own commercial use ) . For clarity, sales prior to satisfaction ofclause ( a ) and, if applicable, clause ( b)(i ) above, such as so - called and shall not be construed as a First Commercial Sale