definiens: shall mean : ( i ) t he composition of PEG reagents ( including the REAGENT ) ; ( ii ) methods of using PEG reagents ( i ncluding the REAGENT ) by themselves or in combination with other PEG reagents or other substa nces ; ( iii ) methods of making, processing, analyzin g or characterizing PEG reagents ( including the REAGENT ) ; ( iv ) methods of attaching one or more PEG reagent s ( including the REAGENT ) to Page 4 of 48 or associating one or more PEG reagents ( including the REAGENT ) with or to any therapeutic agent ( incl uding the THERAPEUTIC AGENT ) ; ( v ) methods of directing or determining the point of attachment of one or more PEG reagents ( including the REAGENT ) to or associat ing one or more PEG reagents ( including the REAGENT ) with any therapeutic agent ( including the THERAPEUT IC AGENT ) ; ( vi ) the composition or formulation of a ny product ( other than the PRODUCT ) obtained by attach ing or associating one or more PEG reagents ( includ ing the REAGENT and including by PEGYLATION ) to or with any therapeutic agent ( excluding PEGYLATION of the THERAPEUTIC AGENT with the REAGENT ) ; and ( vi ) m ethods of making, formulating, combining, processing, using, analyzing or characterizing two ( 2 ) or more PEG reagents ( including the REAGENT ) in combination