Definition and Calculation of Ultrio 2 Development Costs Sample Clauses

Definition and Calculation of Ultrio 2 Development Costs. “Ultrio 2 Development Cost” with respect to the Ultrio 2 Development Program means the fully-burdened cost of conducting the research and development (including clinical trials and domestic and international regulatory submissions) of the Ultrio 2 Assay Product, and shall include (i) the reasonable cost of all quantities of raw materials, intermediates and finished goods necessary for the manufacture of such quantities of the Ultrio 2 Assay Product utilized during the Ultrio 2 Development Program, and (ii) the reasonable cost of such quantities of the Ultrio 2 Assay Product that are manufactured for, but not utilized during, the Ultrio 2 Development Program, that are not sold nor retained for research and/or development or other internal purpose and are scrapped due to product expiration; provided, however that internal costs and costs payable to Third Parties for clinical trials shall not be included within “Ultrio 2 Development Costs” until such internal costs and costs payable to Third Parties exceed the Duplex/eSAS Clinical Trial Costs, as set forth in Sections F.1 and F.4 of the Short Form Agreement. “Ultrio 2 Development Costs” shall include any direct costs incurred in modification of the eSAS and Tigris instruments hardware and software as required for purposes of enabling the instruments to perform the Ultrio 2 Assay Product. In the event the modified TIGRIS instrument does not meet PRD requirements for MTBF, if both parties agree to proceed with the development program then the Supervisory Board will decide how to address the burden of instrument costs attributable to the Ultrio 2 modifications. Costs will be calculated in accordance with United States generally accepted accounting principles, consistently applied (“U.S. GAAP”), or as otherwise mutually agreed in writing between the parties.
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