allocate primary responsibility as between the Parties for tasks relating to the Research and Development of Research Candidates and Development Candidates where not already specified in the Research Plan, Early Clinical Development Plans or Late Clinical Development Plans therefor;
Opt-Out Party means, on a Development Candidate-by-Development Candidate and associated Product-by-Product basis, the Party that opts-out of further Development and Commercialization of such Development Candidate and associated Product pursuant to Section 3.1 or Section 3.2.
The Parties will share all Manufacturing Costs relating to ACTR T-cells incurred by Unum to support Development of Development Candidates in the Shared Territory in accordance with the Late Clinical Development Plan as Development Costs pursuant to Section 6.5(c).
The Parties will share all Manufacturing Costs relating to SGI Antibodies incurred by SGI to support Development of Development Candidates in the Shared Territory in accordance with the Late Clinical Development Plan as Development Costs pursuant to Section 6.5(c).
On a Development Candidate-by-Development Candidate basis, within days after the JSC meeting to consider the Phase 1 Clinical Data, the Parties will prepare and recommend for approval to the JSC an initial Late Clinical Development Plan for such Development Candidate in the Territory, which Late Clinical Development Plan will be approved by the JSC.
Selection of Products. For each Development Candidate, during the Late Clinical Development Term and following review of the data from activities under the applicable Early Clinical Development Plan and Late Clinical Development Plan, the JSC will decide whether such Development Candidate should be selected as a Product for Commercialization pursuant to a Joint Commercialization Plan in accordance with the terms and conditions of this Agreement. If, following the review of data from activities under the applicable Early Clinical Development Plan and Late Clinical Development Plan, the JSC does not agree whether such Development Candidate is appropriate for selection as a Product, then a Party may exercise its Opt-Out Right with respect to such Development Candidate and associated Product in accordance with Section 3.2.
All Development of any given Development Candidate during the Early Clinical Development Term will be conducted pursuant to a development plan and budget (such plan, an Early Clinical Development Plan with respect to each Development Candidate) that describes # the proposed overall program of Development for the applicable Development Candidate, including Phase 1 Clinical Trials in particular, at least one (1) Qualifying Phase 1 Clinical Trial, # the anticipated start dates and data availability dates of Phase 1 Clinical Trials, # 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 an initial Early Clinical Development Plan and this Agreement, the terms of this Agreement will prevail.
oversee and review Development responsibilities for each Development Candidate;
Development time development total time frame of 2 years.
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.
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