definiens: means ( i ) Irofulven or 6 - hydroxymethylacylfulvene ( also known as HMAF or MGI-114 or IUPAC name, ( 6 ’ R)-6’-hydroxy-3’-(hydroxymethyl)-2’,4’,6’-trimethyls piro[cyclopropane-1,5’-inden]-7’(6 ’ H)-one or ( 5’R)-5’-hydroxy-1’-(hydroxymethyl)-2’,5 ’, 7’-trimethylspiro[cyclopropane-1,6’-indene]-4’-one ) ( CAS No . 158440 - 71 - 2 and/or CAS 187277 - 46 - 9 ) ( FDA U NII 6B799IH05A http://fdasis.nlm.nih.gov/srs/ProxyServlet?mergeDat a = true&objectHandle = DBMaint&APPLIC ATION_NAME = fdasrs&actionHandle = default&nextPage = jsp /srs / ResultScreen.jsp&TXTSUPE RLISTID=6B799IH05A ), an alkylating DNA damage repai r inhibitor, having molecular formula C 15 H18 O3, and/or ( ii ) any salt, free acid, free base, clathrate, sol vate, hydrate, hemihydrate, anhydride, ester, chela te, conformer, congener, crystal form, crystal habit, polymorph, a morphous solid, homolog, isomer, stereoisomer, enan tiomer, racemate, prodrug, isotopic or radiolabeled equival ent, metabolite, conjugate, complex or mixture of a ny of the foregoing with respect to Irofulven that has the sa me mechanism of action as Irofulven . For clarity, I rofulven includes the active pharmaceutical ingredient known as Irofulven, together with any salt, free acid, f ree base, clathrate, solvate, hydrate, hemihydrate, anhydride, ester, chelate, conformer, congener, crystal form, crystal habit, polymorph, amorphous solid, homolog, isomer, stereo isomer, enantiomer, racemate, prodrug, isotopic or radiolabeled equivalent, metabolite, conjugate, com plex or mixture thereof . For the purposes of this A greement, Irofulven does not include Irofulven Analogues