definiens: means the internal cost s and out - of- pocket costs incurred as an expense by or on behalf of a Party or its Affiliates in carrying out the Development of the Product without limitation, ( i ) the costs of formulation and analyt ical development, ( ii ) costs related to manufacturing development including technology tran sfer cost ; ( iii ) filing fees and other costs associated with a ny Regulatory Filings ; and ( iv ) all other costs tha t are directly or indirectly attributable and reasonably allocable to the Develo pment activities for the Products including out of pocket cost and internal costs . For purposes of this definition : ( a ) out - of- pocket costs mean the actual expense incurred with respect to a Third Party for specific Development activities relating to the Products ; and ( b ) internal costs me ans the applicable FTE rates multiplied by the number of FTE hours expended in carrying out the Development activities in accordance with the development plan