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Development Plans
Development Plans contract clause examples

and # FTE costs and out-of-pocket costs incurred by or on behalf of a Party or any of its Affiliates in accordance with this Agreement and directly allocable to Manufacturing activities relating to ACTR T-cells or SGI Antibodies (as applicable) for use in Development or Commercialization activities (excluding those activities covered under clause (a)), including CMC Activities specifically in support of Development or Commercialization of Development Candidates and Products. For clarity, Manufacturing Costs do not include the costs associated with general platform process improvements or scale-up activities with respect to ACTR T-cell technology, SGI Antibodies or SEA Technology that are outside of the activities approved for the Research Candidates, Development Candidates or Products in the applicable Research Plans, Early Clinical Development Plans, Late Clinical Development Plans or Joint Commercialization Plan or Supply Agreements.

For ACTR T-cells or SGI Antibodies (as applicable) manufactured by a Third Party, Manufacturing Costs described in [clause (a) above] will include: # the amount paid to such Third Party, to the extent treated as Manufacturing Costs pursuant to Section 10.7, including the supply price, any up-front payments, royalties, milestone payments or other payments, including payments relating to capital expenditures or the preparation or reservation of manufacturing capacity or equipment, and equipment cost depreciation, if such payments have been capitalized in accordance with GAAP, plus # the relevant manufacturing Party’s internal costs and out-of-pocket costs, incurred (including any prepayments) by the manufacturing Party, which costs are reasonably and directly allocable to Manufacturing ACTR T-cells or SGI Antibodies for use in Development or Commercialization activities and include the following types of costs: inventory write-offs, variances, manufacturing process improvements, storage, manufacturing scale-up, manufacturing site qualification, materials, quality assurance and quality control (including testing), supply chain management, capital equipment and similar activities comprising the manufacturing Party’s oversight of the manufacturing process, and any value-added tax or similar tax due on such amounts, plus # to the extent applicable, as reasonably determined by the Parties, # any royalties attributable to Manufacture of ACTR T-cells or SGI Antibodies (as applicable) due under the Unum Existing In-Licenses, SGI Existing In-License or any In-Licenses, plus # Third Party Payments to the extent to be included in Manufacturing Costs under Section 10.7.

For ACTR T-cells or SGI Antibodies (as applicable) Manufactured directly by a Party or its Affiliates, or for Manufacturing Costs incurred after Regulatory Approval of a Product, Manufacturing Costs will consist of # the quantity of ACTR T-cells or SGI Antibodies (as applicable) Manufactured times the Actual Unit Cost, plus # to the extent applicable, as reasonably determined by the Parties, # any royalties attributable to Manufacture of ACTR T-cells or SGI Antibodies (as applicable) due under the Unum Existing In-Licenses, SGI Existing In-License or any In-Licenses, plus # Third Party Payments to the extent to be included in Manufacturing Costs under Section 10.7. For the avoidance of doubt, the same element of cost may not be included more than once in computing Actual Unit Cost.

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