Neuren and ACADIA have agreed to an initial Development Plan with respect to the Development of the Compound for Rett syndrome in the Territory, including development tasks, timelines and a budget, an overview of which is set out in a schedule delivered by separate letter agreement of the parties.
= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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 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.
The terms under which SGI will supply clinical supplies of SGI Antibodies to Unum for use as part of the Development Candidates in the Territory under the Late Clinical Development Plan 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 SGI Antibodies Clinical Supply Agreement). Such SGI Antibodies Clinical Supply Agreement will contain terms and conditions that are consistent with this Agreement.
Initial Development Plan and Budget. Either Party, directly or through its representatives on the JDC, may propose amendments to the Initial Development Plan and Budget from time to time. Any and all such amendments shall be subject to approval by the JDC as set forth in Section 2.2.2, subject to the dispute resolution procedures set forth in Section 2.4.3.
Development Plan for Initial Indications. Prior to completion of the Initial Development Activities, the JDC shall jointly develop the Development Plan for further Development (other than Development covered by the Initial Development Plan and Budget), which will occur after [[Organization A:Organization]] proceeds with the In-Licensing, with respect to the Lead Compound for the Initial Indications. All Development activities, including any Clinical Studies, shall be designed and implemented so as to support the filing of Drug Approval Applications and the obtaining of Regulatory Approvals for the Licensed Product for the Initial Indications. Notwithstanding anything in Section 2.4 to the contrary, any disputes in the JDC regarding the details of the Development Plan will be finally determined by [[Organization A:Organization]] at its sole discretion; provided, that the inclusion of any Development activities to be performed by set forth in a Development Plan will require the prior written approval of .
Following the Commencement Date, Neuren and ACADIA shall discuss the Development Plan and coordinate and conduct all Development activities with respect to any Compound and any Product as set out in this clause 5, provided that ACADIA shall be responsible for the day-to-day operations and decision-making for all Development activities under the Development Plan or otherwise with respect to any Compound or any Product in the Territory.
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,
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