definiens: means the Out - of- Pocket Costs and FTE Costs ( or such other measure o f costs as may be specified in the Development Plan ) incurred by either Party or any of its Related Parties in Developing Collaboration Compounds and Licensed Pro ducts in conducting activi ties contemplated by the then- current Development Plan ( including any such costs incurred in connection with preparing and submitting any IND to applicable Regulatory Authori ties ), in accordance with this Agreement and determined from the books and records of such Party and its Affiliates maintained in acco rdance with GAAP ; provided that such activities and costs are c onsistent with the then- current Development Plan and budget contained therein . Development Costs exclude all Third Party License Payments and all payments due under Summit ’s existing grant agreements with t he Muscular Dystrophy Association, Inc. and the Duchenne Partner ’s Fund . Notwithstanding the forego ing, Development Costs will not include any costs incurred in connection with regulatory act ivities in support of obtaining any Regulatory Appr oval for any Collaboration Compound or Licensed Product, includi ng the cost of preparing and submitting any NDA with respect to a Collaboration Compound or License d Product or interacting with Regulatory A uthorities, which costs shall be borne by the Parties as set fo rth in Section 3.3