definiens: ( ) means : ( a ) With respect to Bulk Hematide supplied to [COMPANY] by its Third Party contract manufacturer(s ), Manufacturing Costs shall mean the sum of ( i ) all amounts of all payments that [COMPANY] makes to such Third Party contract manufacturer(s ) for supply and delivery to Collaborator ( either directly, or first to [COMPANY] for subsequent delivery to Collaborator ) of such Bulk Hematide, plus all payments made to third party contractors for release and batch stability testing services for Bulk Hematide, and ( ii ) any Overhead Costs incurred in, and reasonably allocable to, the procurement of Bulk Hematide supplied to [COMPANY] and supplied to Collaborator . As used herein means direct and indirect logistics, quality control, quality assurance, support and management costs incurred in support of the Third Party contract manufacturer by [COMPANY] and shall be subject to the reasonable approval of Collaborator . Further, such methodology shall be consistent with U.S. Generally Accepted Accounting Principles and [COMPANY] 's methodology for other products and shall be consistent from year - to - year ~ and ( b ) With respect to Bulk Hematide manufactured by [COMPANY] and supplied to Collaborator, if any, Manufacturing Costs shall mean Direct Expenses, Indirect Expenses and Overhead Costs incurred in, and reasonably allocable to, the manufacture of such Bulk Hematide . As used herein : ( i ) are those material and labor and services expenses captured in time sheets, invoices, and the like which are specifically attributable to manufacture of the Bulk Hematide supplied to Collaborator, including costs of raw materials, 8 [ ] = CERTAIN CONf'lDENTIAL INFORMATION CONTAINED IN THIS DOCUI\!ENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED . manufacturing supplies, solvents, containers, container components, packaging, labels and other printed materials used in production . Direct labor expenses include salaries and fringe benefits for personnel directly involved in manufacturing Bulk Hematide in accordance with cGMP requirements such as production, quality control, quality assurance, microbiology, and other similar departments as needed who participate directly in the production of Bulk Hematide and components thereof . Direct services expenses include reasonable out of pocket payments to Third Parties for services related to the manufacture of Bulk Hematide or components thereof