definiens: means, with respect to any particular compound, the sum of ( a ) all payments made by [COMPANY] or its Affiliates to Third Parties for process development, validation and related activities, manufacture, stability testing, supply or EXECUTION VERSION -21 - delivery of such compound, ( b ) Third Party royalties or other payments, to the extent attributable solely to the manufacture ( or the other activities described in clause ( a ) ) of such compound, and ( c ) any other customary and reasonable overhead costs actually incurred in, and reasonably allocable to, the manufacture or procurement of such compound, including : import and export duties ; applicable taxes assessed on the purchase of such material ; port fees and storage fees ; shipping and handling ; quality control ; and quality assurance . The methodology for calculating Pre - commercial Supply Costs shall be consistent with U.S. Generally Accepted Accounting Principles and [COMPANY] 's methodology for other compounds