definiens: means, with respect to a particular Licensed Product that has received RegulatoryApproval for a particular indication in a particular Region and is being marketed and sold by 3D Medicines or any of itsAffiliates or Sublicensees in the applicable 5 Region, a biologic product that ( a ) is sold in such Region by a Third Party that is not a sublicensee of 3D Medicines or itsAﬃliate, and where such Third Party did not purchase or acquire such product in a chain of distribution that included any of3D Medicines or its Aﬃliates or sublicensees, and ( b ) has received Regulatory Approval ( with all references in the deﬁnitionRegulatory Approval to to be deemed references to such biologic product ) in such Region for the sameindication as the applicable Licensed Product as a or similar designation of interchangeability bythe applicable Regulatory Authority in such Region pursuant to an expedited or abbreviated approval process, where suchLicensed Product is the reference product in such Region