definiens: means the FTE Costs ( charged in accordance with Section 5.2.2(c)(ii ) ( FTE Records and Calculation ) ) incurred, and the out -of - pocket costs recorded as an expense in accordance with GAAP, by or on behalf of a Party or any of its Affiliates after the Effective Date and during the Term that are incurred in accordance with the Joint Commercialization Plan and Budget and specifically identifiable and directly attributable to the following Manufacturing activities with respect to Joint Products in the U.S. for Commercialization purposes : 1.118.1 synthesis, making, production, proce ssing, purifying, formulating a Compound or Joint Product ; 1.118.2 filling, finishing, packaging and labelling ; 1.118.3 testing and releasing, shipping, handling storing and holding ; and 1.118.4 stability testing, quality assurance and quality control