definiens: means, on a Project - by - Project or Product - by - Product basis ( as applicable ), FTE Costs and Out - of - Pocket Costs incurred by either Party or its Affiliates in Developing such Project or Product in the Field and in the Territory, in accordance with this Agreement and consistent with the applicable Development Plan, including such FTE Costs and Out - of - Pocket Costs which are : ( a ) explicitly included in the budget included in the applicable Development Plan, subject to Section 4.1(c ) and Section 4.4, ( b ) Manufacturing Costs for such Product ( or the relevant Products in such Project ) used in Development, ( c ) Patent and Trademark Costs for Patent Rights Covering such Product ( or the relevant Products in such Project ) and ( d ) Medical Affairs Costs ; in each case determined from the books and records of the applicable Party and its Affiliates maintained in accordance with Accounting Standards