definiens: shall mean the comprehensive plan for ( i ) the Development of Antegren or, as applicable, any other Licensed Product, including, but not limited to activities designed to generate the preclinical, process development / manufacturing scale - up, clinical and regulatory information required for filing Drug Approval Applications in the Territory and ( ii ) the preparation and submission of Drug Approval Applications . An initial Development Plan is attached hereto as Exhibit C and incorporated herein, but may be modified pursuant to Section 4.2, and thereafter will be updated at least annually by the Joint 7 Project Team, as approved by the JSC, as specified in Section 4.2 . Subject to Section 4.7, the Development budget included as part of an Annual WorkplanlBudget for a particular calendar year shall, within the limitations provided for in Section 4.6 ( d ), constitute the maximum costs to be incurred thereunder during such calendar year for Development work, unless such budget is modified by the Joint Project Team, as approved by the JSC, in accordance with the terms of this Agreement