definiens: means ( i ) any expenses accrued prior to or a fter the Effective Date, and which expenses are specifically attributable to the Development of Licensed Products, ( ii ) any costs ( whether internal or costs paid by a Party to a Third Party contract manufacturer ) incurred after the Effective Date for any o f the following with respect to bulk API or finished Licensed Product : manufacturing process development and validation, process improvements, associated analytical development and validation and the manufacture and testing of clinical and stability, confi rmation or consistency lots ( including registration stability, process development, qualification, process validation, QA, and test batches ), and ( iii ) any expenses incurred in connection with the preparation, submission and maintenance of any Regulatory - Documentation, and ( iv ) any royalty, milestone, or other payments payable to Third Parties on account of the Development of Licensed Products . Any costs for [COMPANY] ’s internal FTEs shall be calculated at a fixed rate to be agreed by the Parties in connec tion with the negotiation of the transition plan described in Section 10.4.2(a )