definiens: means, with respect to a particular Licensed Product thathas received Regulatory Approval in a regulatory jurisdiction in the Territory and is beingmarketed and sold by [COMPANY] or any of its Affiliates or Sublicensees in such jurisdiction, a pharmaceutical product that ( a ) is sold in such jurisdiction by a Third Party that is not anAffiliate, licensee or Sublicensee of [COMPANY], and did not purchase or acquire such productin a chain of distribution that included [COMPANY] or any of its Affiliates or Sublicensees, ( b)has received Regulatory Approval in such jurisdiction for at least one of the same Indicationsas such Licensed Product as a orsimilar designation of interchangeability by the applicable Regulatory Authority in suchjurisdiction pursuant to an expedited, abbreviated or bibliographic approval process inaccordance with the then - current rules and regulations in such jurisdiction, where suchapproval referred to or relied on ( A ) the approved NDA for such Licensed Product held byGenentech, its Affiliate or a Sublicensee in such- 11 - jurisdiction or ( B ) the data contained or incorporated by reference in such approved NDA forsuch Licensed Product in such jurisdiction