Section # Development and Commercialization Plans 15
Development Candidates; Early Clinical Development Plan. SGI will pay to Unum one hundred percent (100%) of all Manufacturing Costs relating to ACTR T-cells incurred by Unum to support Development of Development Candidates in accordance with the Early Clinical Development Plan as Development Costs pursuant to Section 6.5(b).
The terms under which Unum will supply clinical supplies of ACTR T-cells to SGI for use as part of the Development Candidates in the Territory will be set forth in a supply agreement to be entered into between the Parties no later than days prior to the date of Initiation of a Clinical Trial of the first Development Candidate in the Territory (the ACTR T-cell Clinical Supply Agreement). Such ACTR T-cell Clinical Supply Agreement will contain customary terms and conditions, including quality, and otherwise be consistent with this Agreement.
During the preparation of the proposed Work Programs and Budgets and Development Plans contemplated in this clause 6, Operator shall consult with the Operating Committee or the appropriate subcommittees regarding the contents of such Work Programs and Budgets and Development Plans.
Review and comment on the Companys clinical development/testing plans.
'Marketing and Development Operations' means marketing and development information, including but not limited to, marketing and development plans, price and cost data, price and fee amounts, pricing and billing policies, quoting procedures, marketing techniques and methods of obtaining business, forecasts and forecast assumptions and volumes, and future plans and potential strategies of the Employer which have been or are being considered.
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.
Development Costs Relating to Initial Development Activities. [ ]
Development Milestone Payments. Licensee shall pay to Axsome the following development milestone payment (the “Development Milestone Payment”) upon the achievement of the following milestone for the Licensed Product (the “Development Milestone”), whether achieved by Licensee or an Affiliate or Sublicensee. Licensee shall promptly (but in no event later than seven (7) Business Days after) notify Axsome in writing of the achievement of the Development Milestone and Licensee shall pay Axsome in full the Development Milestone EAST\200870719.16
ERISA; Foreign Plans; Multiemployer Plans. Each Plan and each Foreign Plan complies with all applicable requirements of law and regulations and the provisions of the Plan documents except for a failure to comply which would not result in a material liability. No Benefit Plan has failed to satisfy the “minimum funding standard” (as defined in Section 412 of the Code or [Section 302] of ERISA), whether or not waived. Neither the Company nor any member of the Controlled Group has failed to make a required minimum contribution or, if applicable, a required installment, in either case, under Section 430(j) of the Code and of a material amount on or before the due date for such contribution or installment. Neither the Company nor any member of the Controlled Group has taken or failed to take any action which would constitute or result in a Termination Event which could reasonably be expected to subject the Company or a Controlled Group member to a material liability. Neither the Company nor any member of the Controlled Group has incurred any material liability to the PBGC which remains outstanding other than for the payment of premiums. For purposes of this [Section 6.9], “material” means any amount, noncompliance or other basis for liability which, individually or in the aggregate with each other basis for liability under this [Section 6.9], could reasonably be expected to subject the Company to liability having a Material Adverse Effect.
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