definiens: means the Phase 3 global clinical studies for the DD - CKDIndication, known informally as the INNO2VATE studies, consisting of a conversion study and acorrection study, and known formally as the “ Phase 3, Randomized, Open - Label, Active - Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the MaintenanceTreatment of Anemia in Subjects with Dialysis - Dependent Chronic Kidney Disease ( INNO2VATE – Conversion ) ” ( AKB-6548 - CI-0017 ) and the “ Phase 3, Randomized, Open - Label, Active - Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction ofAnemia in Subjects with Incident Dialysis - Dependent Chronic Kidney Disease ( INNO2VATE – Correction ) ” ( AKB-6548 - CI-0016).5CONFIDENTIAL 1.48 means any court, agency, department, authority, or otherinstrumentality of any national, state, county, city, or other political subdivision