definiens: shall mean costs incurred by the Parties after the Effective Date and specifically attributabl e to Developing the Compound or a Product, and may include without limitation : ( a ) ( b ) through ( d ) ; the out - of - pocket costs and expenses incurred to the extent not covered by ( b ) the costs ofintemal scientific, medical, technical or managerial personnel engaged in such efforts, which costs shall be detennined based on the applicable ITE Rate, unless another basis is otherwise agreed by the Parties in writing ; ( c ) the costs and expenses of clinical supplies for such efforts, including without limitation, ( i ) direct costs and expenses incurred to purchase andlor package comparator or combination drugs or devices, and ( ii ) direct costs and expenses of disposal of clinical samples ; and ( d ) the direct costs and expenses incurred in connection with manufacturing process developm ent and validation, manufacturing scale - up and improvements, stability testing and quality assurance / quality control development, and qualification and validation of Third Party contract manufacturers