definiens: means, with respect to Adeona Products, the FTE costs ( under a reasonable accounting mechanism to be agreed upon by the Parties and out - of - pocket costs of a Party or any of its Affiliates incurred in manufacturing such Adeona Products, including costs and expenses incurred in connection with ( I ) the development or validation of any manufacturin g process, fonnulation s or delivery systems, or improvement s to the foregoing ; ( 2 ) manufacturing scale - up ; ( 3 ) in - process testing, stability testing and release testing ; ( 4 ) quality assurance / quality control development ; ( 5 ) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufactur ers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections ; ( 6 ) packagin g development and final packaging and labeling ; ( 7 ) shipping configuration s and shipping studies ; and ( 8) overseeing the conduct of any of the foregoing