definiens: means the ongoing extension study of CDZ173 sponsored by [COMPANY] or its Affiliate entitled, “ An Open - label, Non - randomized Extension Study to Evaluate the Long Term Safety, Tolerability, Efficacy and Pharmacokinetics of CDZ1 73 in Patients With 4 APDS / PASLI ( Activated Phosphoinositide 3 - kinase Del ta Syndrome / p110 -activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodefici ency ) ” designated by ClinicalTrials.gov Identifier : NCT02859727 and sometimes referred to b y [COMPANY] as means the clinical trial protocol for the Extension Study as of the Effecti ve Date, as may be amended from time to time by mutual agreement of the Parties in accordance with Section 5.2(b ) or to the extent required by Applica ble Law or any relevant Regulatory Authority