definiens: shall mean the technical, medical and scientific licenses, registrations, authorizations and/or approvals of API, Intermediate Compound and / orClinical Product ( including without limitation IND, DMF, NDA or other prerequisitemanufacturing approvals or authorizations, and marketing authorization based upon suchapprovals or authorizations ) that are required by any national, supranational ( e.g., theEuropean Commission or the Council of thc European Union ), regional, state or localregulntory agency, department, bureau or othcr govemmental entity in the Territory, asamended or supplemented from time to time .. -2 . SUPPL Y OF INITIAL BATCH, INTERMEDIATE COMPOUND AND CLINICALPRODUCT2.1 ( a ) As of the Effective Date, ISIS has Manufactured approximately 430 grams of API(the ), which shall be subject to the terms of Ihis Agreement