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.
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 .
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.
During the Early Clinical Development Term, SGI will reimburse Unum for of all Development Costs for all Development Candidates actually incurred for the Territory pursuant to the Early Clinical Development Plan, in accordance with Section 11.5, subject to the following sentence. Notwithstanding the amounts allocated to Development activities in the Shared Territory in the applicable Early Clinical Development Plan budget, for any calendar year, Unum will only be permitted to recover Development Costs with respect to Development activities that have been INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED
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
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