Development Plan and Reporting Sample Clauses

Development Plan and Reporting. 5.1 Within [***] of the Effective Date, the OC will meet to discuss and agree on an initial version of the Development Plan and the Collaboration Budget, recognising that in so doing, the ultimate purpose is to design a plan that gives the Parties the best opportunity to achieve the Objectives. The Development Plan shall specify which of the Parties shall be the sponsor of each of the Collaboration Studies, and that Party’s responsibilities will include compliance with all obligations imposed on study sponsors under Applicable Law. The Collaboration Budget shall be broken down by agreed activities in applicable areas, including research, preclinical activities, Clinical Trials, pharmacovigilance or other activities. The Development Plan will include, among other things, (i) the initial indication(s) for which the CD39 Option Product is planned to be Developed, (ii) other indications for which the CD39 Option Product may be developed, (iii) the proposed overall program of Development for the CD39 Option Product for any indications elected by MedImmune, including without limitation all material nonclinical studies, toxicology, pharmacology studies, formulation, process development, CMC, clinical studies, and regulatory plans, (iv) critical activities anticipated to be undertaken, estimated timelines, decision points and relevant decision criteria, and (v) allocation of responsibilities between the Parties for the various activities to be undertaken under the Development Plan and estimated timelines; all based on what can reasonably be foreseen and planned at the time of preparation of the Development Plan. MedImmune shall review and submit an updated Development Plan and Collaboration Budget to the OC for approval at least