definiens: means costs incurred by each Party that were reasonably necessary for, and that reasonably relat e to, the Development of a Product in accordance with this Agreement and the D evelopment Plan for that Product, including, without limitation, ( a ) all rea sonable and documented out - of - pocket costs and expenses incurred, ( b ) the costs of internal scientific, medical, technical or managerial personnel directly related to implementing the Development Plan for that Product, to be determined based on the applicable FTE Rate, with appropriate allocation in the case of an y such personnel devoting less than full time to such activities, unless anot her basis is otherwise agreed by the Parties in writing, ( c ) the Manufacturing Co sts of clinical supplies for such efforts, ( d ) direct costs and expenses incurre d in connection with manufacturing process development and validation, m anufacturing scale - up and improvements, stability testing and quality assuran ce / quality control development, and qualification and validation of Th ird Party contract manufacturers, and ( e ) any other costs explicitly i ncluded in the budgets included in the Development Plan for that Product