definiens: means, with respect to Licensed Compounds, Licensed Products and Licensed ProductBiomarkers ( or placebo if required for the applicable clinical study pursuant to this Agreement ), the FTE Costs and Out - of - Pocket Costs of AVEO US or API or any of their respective Affiliates incurred in Manufacturing such LicensedCompounds, Licensed Products or Licensed Product Biomarkers, including costs and expenses incurred in connectionwith ( 1 ) the development or validation of any Manufacturing process, formulations or delivery systems, or improvementsto the foregoing ; ( 2 ) Manufacturing scale - up ; ( 3 ) in - process testing, stability testing and release testing ; ( 4 ) qualityassurance / quality control development ; ( 5 ) internal and Third Party costs and expenses incurred in connection withqualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections ; ( 6 ) packaging development and final packaging andlabeling ; ( 7 ) shipping configurations and shipping studies ; and ( 8) overseeing the conduct of any of the foregoing