definiens: shall mean, with respect to any Selected Compound or Product as to which [COMPANY] has exercised its co - funding option under Section 4.2, the expenses incurred by [COMPANY] or for its account that are attributable to the clinical development of such Selected Compound or Product in the United States from filing of an IND through the completion of Phase 2 Trial(s ) in accordance with the Development Plan and Budget for such Selected Compound or Product, calculated on a fully - burdened basis ( i.e., including Allocable Overhead specifically attributable thereto ) . Without limiting the generality of the foregoing, will include internal costs ( calculated on a full - time equivalent basis ) incurred by [COMPANY] and its Affiliates, and amounts paid by [COMPANY] to Third Parties, in connection with the conduct of Phase 1 Trials and Phase 2 Trials of such Selected Compound or Product, intended to support Product development in the United States ( including but not limited to supply of Selected Compound or Product for use in such trials, costs for formulation development . chemical process development . analytical and bioanalytical process development, meetings with regulatory agencies, and toxicology programs required by regulatory agencies after IND filing ), in each case to the extent such costs and amounts are incurred or paid in accordance with the then - current Development Plan and Budget therefor and that such costs and amounts are not attributable to any IND - enabling study unless . after IND filing, the FDA requires that such IND - enabling study be conducted . Co - Development Expense will exclude, without limitation, expenses incurred by [COMPANY] or for its account that are attributable to Phase 2/3 Trials and Phase 3 Trials of such Selected Compound or Product or any other development activity with respect to such Selected Compound or Product that is not expressly contemplated ~ the then - current Development Plan and Budget, expenses that are attributable to the development of any Selected Compound or Product with respect to which [COMPANY] has not exercised its co - funding option under Section 4.2, and expenses of clinical development activities not intended to support Product development in the United States . No cost or expense item included in Co - Development Expense shall include any internal profit margins or similar markups . Without limiting the generality of the foregoing, in order to ensure that subcontracting to Affiliates of [COMPANY] does not result in unnecessary increases in Co - Development Expense, the parties agree that Co - Development Expense for any activity subcontracted by [COMPANY] to its Affiliate shall be calculated in the same manner as if such activity were performed by [COMPANY] itself