On a Development Candidate-by-Development Candidate basis, within ​ days after the Development Candidate Selection Date, the Parties will prepare and recommend for approval to the JSC an Early Clinical Development Plan for each Development Candidate in the Territory, which Early Clinical Development Plan will be approved by the JSC.

“Development Plan” means a development plan (other than the Initial Development Plan and Budget) setting forth in reasonable detail specific Clinical Studies and other Development activities (other than the Initial Development Activities) to be performed with respect to the Licensed Compound or a Licensed Product, which plan shall set forth Clinical Studies and Development activities subsequent to those of the Initial Development Plan and Budget.

“Early Clinical Development Term” means, on a Development Candidate-by-Development Candidate basis, the period commencing on the Development Candidate Selection Date and ending upon the earlier of # the exercise of the Opt-Out Right under Section 3.1 or the expiration, without exercise, of the period therefor and # termination of Development of such Development Candidate.

“Development” or “Develop” - all preclinical development activities and all clinical drug development and regulatory activities regarding Compound or Product. Development shall include, without limitation, all preclinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, manufacturing clinical supplies, regulatory affairs, statistical analysis and report writing. When used as a verb, “Develop” shall mean to engage in Development.

Unless either Party (or both Parties) exercise(s) its Opt-Out Right, # SGI and Unum will collaborate on further Development activities of such Development Candidate and associated Product in accordance with this Agreement and the Late Clinical Development Plan for such Development Candidate and associated Product in the Shared Territory, and # SGI will be primarily responsible for further Development activities of such Development Candidate and associated Product in accordance with this Agreement and the Late Clinical Development Plan for such Development Candidate and associated Product in the Licensed Territory.

discuss, prepare and approve for submission to the JSC all Research Plans, Early Clinical Development Plans and Late Clinical Development Plans, and all annual and interim amendments to Research Plans, Early Clinical Development Plans and Late Clinical Development Plans for, respectively, Research Candidates and Development Candidates in the Territory;

“Segregate” means, with respect to an Alternative Product, to use diligent efforts to segregate the research, development, manufacture and commercialization activities relating to such Alternative Product from Research, Development, Manufacture and Commercialization with respect to any Research Candidates, Development Candidates or Products under this Agreement, including using diligent efforts to ensure that: # no personnel involved in performing the research, development, manufacture or commercialization of such Alternative Product have ​ relating to the Research, Development, Manufacture or Commercialization of any Research Candidates, Development Candidates or Products (provided that ​ may ​ regarding the Research, Development, Manufacture and Commercialization of any Research Candidates, Development Candidates or Products in connection with ​); and # no personnel involved in performing the Research, Development, Manufacture or Commercialization of any Research Candidates, Development Candidates or Products have access to ​ relating to the research, development, manufacture or commercialization of such Alternative Product (provided that ​ may ​ regarding the research, development, manufacture and commercialization of such Alternative Product in connection with ​).

During the Late Clinical Development Term for a Development Candidate, all Development of such Development Candidate and associated Product pursuant to this Agreement and activities to support and obtain Regulatory Approvals for such Development Candidate and associated Product in the Territory will be conducted pursuant to a development plan and budget (such plan, a “Late Clinical Development Plan” with respect to each Development Candidate) that describes # the proposed overall program of Development for the applicable Development Candidate, including all Clinical Trials, in the Territory, # the anticipated start dates and data availability dates of such Clinical Trials, # the proposed activities to support and obtain Regulatory Approvals for such Development Candidate and associated Product in the Territory, # the respective roles and responsibilities of each Party in connection with such activities, and # a detailed budget for all such activities in the Territory. In the event of any inconsistency between a Late Clinical Development Plan and this Agreement, the terms of this Agreement will prevail.

The terms under which SGI will supply Research and clinical supplies of SGI Antibodies to Unum for use as part of the Research Candidates and Development Candidates in the Territory under the Research Plan and Early Clinical Development Plan will be set forth in a supply agreement to be entered into between the Parties no later than ​ days after the Effective Date (the “SGI Antibodies Manufacturing Services Agreement”). Such SGI Antibodies Manufacturing Services Agreement will contain terms and conditions that are consistent with this Agreement.

the fifth Development Milestone Fee is USD$[…​…] (“Fifth Development Milestone Fee”).