definiens: shall mean:(a)When a Party Manufactures directly, the sum of : ( i ) the cost ( as defined in each such Party'sAccounting Standards consistently applied ) to Manufacture a Shared Product ( or potential SharedProduct ), including items such as cost of materials, yield and waste levels, direct labor, etc . ; ( ii ) anyadditional applicable overhead, including items such as costs that relate to such Party ’s supervisory, occupancy, facility and equipment, etc ., as calculated according to and consistent with such Party’sinternal policies ; ( iii ) other such costs burdened to the product due to Manufacturing ( includinginventory write - offs and excess capacity charges to the extent not exceeding [ * * * ] ) ; and ( iv ) theactual costs associated with the technology transfer to a CMO to enable Manufacturing of thatproduct, including any upfront and milestone based payments and startup costs allocable to theShared Product that are associated therewith . All Cost of Manufacture shall be consistently applied tothe product for ongoing clinical trials