definiens: means ( a ) a biologic therapeutic containing the same amino acid polymer as any Product;(b ) a biologic therapeutic containing an amino acid polymer that is highly similar, or similar enough to one contained ina reference Product, notwithstanding minor differences in clinically inactive components, to permit an applicant forRegulatory Approval for such biologic therapeutic to refer to and rely on clinical and other scientific Informationregarding the safety, purity, potency and/or efficacy of the reference Product in order to allow such biologictherapeutic to receive Regulatory Approval in any jurisdiction within the Territory through an abbreviated regulatorypathway ; or ( c ) a biologic therapeutic containing an amino acid polymer that is highly similar, or similar enough to onecontained in a reference Product, notwithstanding minor differences in clinically inactive components, to permit suchbiologic therapeutic to be marketed in any jurisdiction within the Territory as generic - equivalent, functionallyequivalent, biosimilar, biogeneric, interchangeable, or by using any other description referring to the reference Product(and / or such Product ’s clinical and other scientific Information ) for support for safety, purity, potency and/or efficacyclaims for such biologic therapeutic