definiens: means the internal costs and out - of - pocket costs incurred as an expense by or on behalf of a Partyor its Affiliates in carrying out the Development of the Product in accordance with the approved Development Plan, including, without limitation, ( i ) the costs of clinical trials ( including costs of procuring the Product(s ), placebos and comparator drugsused in such clinical trials ), ( ii ) filing fees and other costs associated with any Regulatory Filings ; ( iii ) costs related tomanufacturing development ; and ( iv ) all other costs that are directly attributable and reasonably allocable to the Developmentactivities for the Products . For purposes of this definition : ( a ) out - of - pocket costs mean the actual expense incurred withrespect to a Third Party for specific Development activities relating to the Products ; and ( b ) internal costs means the applicableFTE rate multiplied by the number of FTE hours expended in carrying out the Development activities in accordance with theDevelopment Plan . For clarity, the costs associated with attending or participating in meetings of the JSC are expresslyexcluded from this definition