definiens: means, in respect of any Program, the work conduc ted under the Development Plans for such Program and as set out i n Section 2.1 . If no Development Plan is applicable to a particular Prog ram, then Development shall include all research and development of the relevan t Product, including formulation, process development, Manufacturing for non - clinical and clinical use, non - clinical and clinical studies, regulatory plans and other elements of Regulatory Approvals conducted up to and including the End of Development for the Product ; ( 38 ) means, with respect to Development of any Product, the actual and reasonable FTE Costs and Out - of - Pocket C osts utilized or incurred by a Party after the Effective Date and up to the End of Development in fulfilling its obligations under a Development Plan in accordance with the corresponding budget and Development Timeline or as otherwise spe cified in this Agreement, - 7 - including Manufacturing Costs and patent costs . If no Development Plan is applicable to a particular Program, then the Develo pment Costs shall include the actual and reasonable FTE Costs and Out - of - Pocket C osts utilized or incurred by a Party after the Effective Date in Developing the Product that is the subject of the Program