definiens: means : ( a ) an active pharmaceutical ingredient or drug substance comprisingGRN163, in unconjugated or any conjugated form ; or ( b ) a Bioequivalent of such pharmaceutical ingredient or drugsubstance described in clause ( a ) ( e.g., a homologous oligonucleotide having substantial identity to theoligonucleotide sequence of GRN163 having pharmaceutically or pharmacologically equivalent telomerase inhibitoryactivity, or any other biological activity that is ( at the relevant time ) recognized by the FDA or another RegulatoryAuthority as the predominant or primary mechanism of action in humans, such as may be reflected in associatedproduct labelling or package insert information at the relevant time ) as GRN163 in unconjugated or conjugated form ; or(c ) a salt, hydrate, solvate, polymorph, stereoisomer, prodrug, or metabolite of any of the foregoing pharmaceuticalingredients or drug substances described in clauses ( a ) or ( b )