Development Plan. An initial development plan is attached hereto as Exhibit A (such plan, as may be amended by time to time pursuant to this Agreement, the Development Plan). The Development Plan is a high-level summary of the Development activities Allergan anticipates being necessary to obtain Regulatory Approval for Licensed Products for the First Indication in the U.S. and [[Unknown Identifier]] Countries for which Allergan is using Commercially Reasonable Efforts to Develop and seek Regulatory Approval for a Licensed Product in the First Indication. For as long as Development activities under this Agreement are ongoing, on or before each anniversary of the Effective Date, Allergan shall prepare an amendment, as appropriate, to the then-current Development Plan to reflect material changes or additions to the Development of Licensed Products for the First Indication in the U.S. and [[Unknown Identifier]] Countries. Allergan shall submit all amendments to the Development Plan to UroGen and, upon such submission, the amended Development Plan will become effective and supersede the previous Development Plan.
Development Records. Allergan shall maintain, in good scientific manner, complete and accurate books and records pertaining to its Development activities hereunder, in sufficient detail to verify compliance with its obligations under this Agreement and which shall be appropriate for patent and regulatory purposes, in compliance with Applicable Law and properly reflect all work done and results achieved in the performance of its Development activities hereunder, which books and records shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such books and records shall be retained by Allergan for at least years after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law.
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.
Development Costs Relating to Initial Development Activities. [ ]
Development Process Generally. and intend that the ’s Work is to be treated as a “speculative” development by and that ’s approval right over the Base Building Schematics is generally limited to confirming conformance with the work described in [Schedule 1]. and intend that the process of the development of the Premises and construction of the Improvements will proceed in a collaborative, “open book” manner with the goal that the Premises will meet ’s requirements and will be undertaken in an efficient and cost-effective manner. shall use good faith efforts to carry out its obligations under this Work Letter with the standard of care to which landlords constructing projects similar to the Premises are held. shall respond to requests from timely and in good faith and not use its approval rights under this Work Letter for the purpose of delaying or frustrating the Premises being Ready for Occupancy. shall have full and current access to all material information related to the major elements of the development of the Premises and the right to participate in major decisions, all as more particularly described in, and subject to the terms and conditions of, this Work Letter. shall have the right at any time, either in the regularly scheduled Project Meetings or otherwise, to raise with in good faith any questions, concerns, suggestions or objections related to the development process, and shall consider all such questions, concerns, suggestions or objections in good faith, such that and shall work together in a reasonable,
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
Development Decision-Making. Except as otherwise expressly provided in this Agreement, all matters regarding the Early Clinical Development Program and the Late Clinical Development Program will be decided by unanimous agreement by the JDC.
Early Clinical Development. Subject to the terms and conditions of this Agreement, on a Development Candidate-by-Development Candidate basis, effective as of the date on which the Collaboration Antigen of such Development Candidate becomes a Collaboration Antigen under this Agreement, during the Early Clinical Development Term, SGI hereby grants to Unum an exclusive, sublicensable (solely as permitted in accordance with Section 10.4), royalty-free, fully-paid, worldwide license, under the SGI Background Technology and SGI Program IP, to clinically Develop such Development Candidate (and Manufacture same but only for such purpose and only as provided in this Agreement), all in accordance with the Early Clinical Development Plan, save that SGI will retain such rights as are necessary to perform any activities that the Parties may agree that SGI will perform under this Agreement.
Development and Planning Team. Within thirty (30) days following the Effective Date, the Parities will establish a development project team (the “Development Project Team”), which shall consist of an equal number of personnel from each Party who are appropriately skilled and knowledgeable in relation to the Development and Manufacturing of the Product. The Development Project Team shall serve as the coordinating body for the Development and Manufacturing Services to be provided under this Agreement and for the transfer of information between the Parties relating to the Services. The Development Project Team shall serve in an advisory capacity to the Parties to assist each Party in its planning of the overall development plan, allocation of resources, and planning and execution of Work Orders. However, the Development Project Team shall have no authority to bind either Party with respect to planning, allocation of resources, or execution of Work Orders, or any other matter.
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