definiens: means, with respect to a Licensed Product that ha s received Regulatory Approval in a Region, ( a ) a biologic therapeutic containing the same amino acid polymer as such Licensed Produc t, ( b ) a biologic therapeutic containing an amino acid polymer that is h ighly similar, or similar enough to one contained in a reference Licensed Product, notw ithstanding minor differences in clinically inactiv e components, to permit an applicant for Regulatory A pproval for such Schedule 1 -- i biologic therapeutic to r efer to and rely on clinical and other scientific i nformation regarding the safety, purity, potency and/or efficacy of the reference Li censed Product in order to allow such biologic therapeutic to receive Regulatory Approval in such Region through an abbre viated regulatory pathway, or ( c ) a biologic therapeutic containing an amino a cid polymer that is highly similar, or similar enou gh to one contained in a reference Licensed Product no twithstanding minor differences in clinically inact i ve components, to permit such biologic therapeutic to be marketed in such Region as generic- equivalent, functionally equivalent, biosimilar, biogeneric, bi obetter, interchangeable, or by using any other description referring to the reference Licensed Pro duct ( and/or such Licen sed Product ’s clinical and other scientific information ) for support for safety, pur ity, potency and/or efficacy claims for such biolog ic therapeutic