definiens: means, with respect to a Shared Product in the United States, the following costs incurred by a Party onor after the first day of the month in which the Oncology Product Option with respect to such Shared Product is exercised inaccordance with Section 7.1(c ) of the Agreement, which costs are incurred directly in connection with the development ofsuch Shared Product in the Field in the United States in accordance with the Agreement and the Development Plan : ( a ) all Out - of - Pocket Expenses of either Party, its Affiliates or Infinity Related Parties payable to Third Parties ( excluding manufacturingcosts but including any filing or registration fees paid to a Regulatory Authority or other governmental authority in theUnited States ), which shall be without markup, ( b ) COGS for clinical supply of such Shared Product for development activitiesfor the United States, which shall be without markup, and ( c ) all direct and reasonable internal costs incurred by either Party, its Affiliates or Infinity Related Parties ( determined using the applicable FTE rate in the definition of FTE Costs ) ; provided, that for any development activities with respect to a Shared Product that are used or may be used in order to obtain 78Marketing Authorization both in the United States and outside the United States, costs for such development activities shallbe appropriately allocated by agreement of the JCC between costs allocable to the United States, which shall be included inDevelopment Costs, and costs not allocable to the United States, which shall not be included in Development Costs . Forclarification, Development Costs shall not include any costs incurred with respect to ( A ) any country - specific studies requiredby a Regulatory Authority solely in order to obtain Marketing Authorization in a country other than the United States, ( B ) anystudy that can not reasonably be used to obtain Marketing Authorization in the United States, or ( C ) registration feesspecifically required by or for Marketing Authorization in any country other than the United States