“Development Milestone Fees” means the development milestone fees specified in Part 2 of the Fee Schedule.
Research, Development and Risk Management: Provide actuarial, marketing, research and development, and portfolio risk management support.
oversee the conduct of all Research Plans, Early Clinical Development Plans and Late Clinical Development Plans;
Development Plan means the development plan for the Compounds and Products attached hereto as [Exhibit A].
Development Well means any well drilled for the production of Hydrocarbons pursuant to a Development Plan.
All Manufacturing Costs relating to SGI Antibodies to support Research and Development of Research Candidates and Development Candidates in the Territory under the Research Plan and Early Clinical Development Plan will be borne solely by SGI.
On a Development Candidate-by-Development Candidate basis, if SGI does not provide an End of Phase 1 Opt-Out Notice within the time required therefor, for each such Development Candidate as set forth in Section .
Development Costs means all costs and expenses incurred by or on behalf of a Party or any of its Affiliates or subcontractors that are directly allocable to # the Development of Development Candidates and Products, and # activities to support and obtain Regulatory Approvals for such Development Candidates and Products, including: # such costs and expenses for Clinical Trials (including Required Phase 4 Clinical Trials) designed to support and obtain Regulatory Approvals for Development Candidates and Products, # such costs and expenses for compiling, filing and obtaining Regulatory Approvals of Development Candidates and Products, # such costs for clinical research organizations and other Third Parties in support of Development of Development Candidates and Products, # such costs for cell processing for the Development Candidates and Products, and # such costs for drug product or comparator drug for use in the activities described in clause (i); including, with respect to all such Development Costs, # internal FTE costs at the applicable FTE Rate; # recall expenses to be treated as Development Costs pursuant to Section 7.2; # Manufacturing Costs to be treated as Development Costs pursuant to Section 9.4; # Third Party Payments to the extent treated as Development Costs pursuant to Section 10.7, including, to the extent not already addressed in the Manufacturing Costs, any royalties or Third Party Payments attributable to Manufacture of ACTR T-cells or SGI Antibodies (as applicable) for Development; # prosecution and enforcement costs to be treated as Development Costs pursuant to [Section 12.2(c)(iii)(A)]; and # Shared Program Damages from Third Party Claims to be treated as Development Costs pursuant to Section 14.4; but in each case ((A) through (F)) excluding Joint Commercialization Costs and each of the following (except to the extent included in Manufacturing Costs): tax liabilities, capital expenditures incurred by either Party to obtain or maintain manufacturing capacity for Products, and overhead and other indirect cost allocations from either Party. For clarity, Development Costs exclude Research Costs and costs of Commercialization.
During the Late Clinical Development Term, each Party will keep the JDC fully informed regarding the progress and results of Development activities for Development Candidates and associated Products in the Territory (including any Supplemental Trials), including an annual review of results versus goals (as such goals are set forth in the Late Clinical Development Plan(s)).
On a Development Candidate-by-Development Candidate basis, during the period commencing and ending after the for such Development Candidate, either Party may provide written notice of its potential interest to opt-out of further Development and Commercialization of such Development Candidate and associated Product to the other Party (Notice of Potential Opt-Out). The Notice of Potential Opt-Out will clearly identify the applicable Development Candidate and associated Product that may be treated as a Reversion Product in accordance with Section 3.3, subject to the delivery of a Late Stage Opt-Out Notice in accordance with Section 3.2(c).
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