definiens: means the reasonable out - of - pocket costs and internal costs incurred by CARDIOME ( orfor its account by an Affiliate or a Third Party ) after the Effective Date that are consistent with the Developmentactivities undertaken by CARDIOME pursuant to the applicable Global Development Plan ( and the budgetapproved by MERCK in connection therewith ) and are attributable to the Development of the Product . Forpurposes of this definition : .1 out - of - pocket costs means the actual amounts paid to a Third Party for specific external Developmentactivities applicable to the Product, including all filing fees required for and other costs associatedwith any Regulatory Filings and the actual amounts paid to any consultants engaged by CARDIOMEin accordance with the approved budget and Section 2.6.3 ; .2 internal costs means the applicable FTE Rate multiplied by the number of FTE hours utilized in therelevant period on activities directly relating to Development in accordance with the GlobalDevelopment Plan ; .3 out - of - pocket costs include reasonable travel expenses incurred in the performance of activitiesdirectly relating to Development in accordance with the Global Development Plan ; .4 the reasonable out - of - pocket and internal costs shall include the cost of Manufacturing orobtaining Vernakalant or Products or raw materials or intermediates therefor for use in theactivities in Section 1.1.50.1 or 1.1.50.2 ; .5Development Costs shall not, in any event, include costs associated with participation in the JSC or attendanceat a meeting of the PDT ; and .6CARDIOME ’s costs of the AVRO Trial are not Development Costs for the purposes of this Agreement