definiens: means, with respect to a given [COMPANY] Product, the full - time equivalent costs(under a reasonable accounting mechanism to be agreed upon by the Parties ) and out - of - pocket costs that Oragenicsor any of its Affiliates or Product Sublicensees incurred in manufacturing such [COMPANY] Products, including costsand expenses incurred in connection with ( 1 ) the development or validation of any manufacturing process, formulations or delivery systems, or improvements 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 Partycosts and expenses incurred in connection with qualification 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 and labeling ; ( 7 ) shipping configurations and shipping studies ; and(8 ) overseeing the conduct of any of the foregoing . shall further include : ( a ) to the extent thatany such [COMPANY] Product is 5CONFIDENTIAL TREATMENT REQUESTED BY ORAGENICS, INC