definiens: means the internal costs and out - of - pocket costs incurred as an expense in accordance withgenerally accepted accounting principles by or on behalf of a Party or its Affiliates in carrying out the Development of theProduct 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 drugs used in such clinical trials ), ( ii ) filing fees andother costs associated with any Regulatory Filings ; ( iii ) costs related to manufacturing development ; and ( iv ) all other coststhat are directly attributable and reasonably allocable to the Development activities for the Products . For purposes of thisdefinition : ( a ) out - of - pocket costs mean the actual expense incurred with respect to a Third Party for specific Developmentactivities relating to the Products ; and ( b ) internal costs means the applicable FTE Rate multiplied by the number of FTEhours expended in carrying out the Development activities in accordance with the Development Plan . For clarity, the costsassociated with attending or participating in meetings of the JPT are expressly excluded from this definition