“Late Clinical Development Term” means, on a Development Candidate-by-Development Candidate basis, the period commencing on the expiration, without exercise, of the Opt-Out Right under Section 3.1 for such Development Candidate and ending upon the launch of the associated Product.

the first Development Milestone Fee is USD$[…​…] (“First Development Milestone Fee”);

During the Late Clinical Development Term, Unum will be responsible ​ and SGI will be responsible for ​ of all Development Costs for each Development Candidate and associated Product actually incurred for the Shared Territory pursuant to the Late Clinical Development Plan, subject to the following sentence. Notwithstanding the amounts allocated to Development activities in the Shared Territory in the applicable Late Clinical Development Plan budget, for any calendar year, each Party will only be permitted to recover Development Costs with respect to Development activities that have been allocated to such Party under the Late Clinical Development Plan and related budget in excess of the amount allocated therein # by up to ​ of the amount so allocated, or # with the unanimous approval of the JDC, which approval may be granted either in advance of such costs being incurred or retroactively. The Parties will reconcile the Development Costs they have actually incurred to reflect the foregoing allocation of Development Costs according to the procedures in Section 11.5 or Section 11.6, as applicable.

“Development” or “Develop” means engaging in preclinical and clinical drug development activities, including, but not limited to, discovery, test method development, stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, analytical method validation, manufacturing process validation, cleaning validation, post-approval changes, quality assurance/quality control, statistical analysis, report writing, preclinical studies, Clinical Trials, regulatory filing submission and approval and regulatory affairs.

“Development Services” means # those stages and aspects of the Services relating to Cell Line construction and Manufacturing Process development prior to scale up and manufacture of the Pilot Batch and # those stages and aspects of the Services relating to drug product formulation development and fill-finish development prior to drug product production. For clarity, Development Services excludes the manufacture of Pilot Batches and cGMP Batches.

Development Well means any well drilled for the production of Hydrocarbons pursuant to a Development Plan.

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 ​.

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.

“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)).