definiens: means, with respect to each of the Regional Targe t Pairs and the Optioned Target Pair, those costs and expenses dire ctly incurred in connection with the performance of any Development activities for the applicable Licen sed Antibodies or Licensed Products in accordance with the applicable Development Plans, including FT E Costs, fees charged by Third Party service providers, costs related to study drug, placebo, or comparator supply, and other Out - of - Pocket Costs reasonably incurred in connection with the performa nce of any Clinical Study with respect to such Licensed Antibodies or Licensed Products, costs rel ated to preparing and filing applications for Regulatory Approval or submissions to Regulatory Au thorities ( including associated filing fees, translation expenses and legal and other profession al service fees ), but excluding ( a ) overhead costs and capital expenditures, and ( b ) costs associated with Supplemental Studies ( other than for Supplemental Studies added to the RLP Development Plan for such Regional Target pursuant to Section 5.1.2.4 )