definiens: means the occurrence of both of the following ( a ) Vorasidenib being granted approval for a New DrugApplication ( NDA ) from the FDA for the United States and with an approved label that specifically permits Vorasidenib ’s use as a single agentfor the adjuvant treatment of patients with Grade 2 glioma that have an IDH1 or IDH2 mutation ; and ( b ) if, and only if, the approval for a NewDrug Application ( NDA ) referred to in clause ( a ) requires the approval of a Vorasidenib Companion Diagnostic Test, then the VorasidenibCompanion Diagnostic Test being granted a Premarket Approval from the FDA for the United States ; provided that any accelerated approvalby the FDA of Vorasidenib or the Vorasidenib Companion Diagnostic Test shall not be deemed to satisfy clause ( a ) or ( b ), as applicable