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.
Plan Amendments. The Board may from time to time modify, alter, amend or terminate the Plan. Any action permitted to be taken by the Board under the foregoing provision may be taken by the CHRO if such action:
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.
Amendments to the Development Plans. On an annual basis, or more often as the Parties deem appropriate, the JDC will prepare amendments to each then-current Early Clinical Development Plan or Late Clinical Development Plan for each Development Candidate for approval of the JSC. Each such amended Early Clinical Development Plan or Late Clinical Development Plan will specify the items described in Section 6.2(a)(i) or [Section 6.2(a)(iii)] as appropriate. Such amended Early Clinical Development Plan or Late Clinical Development Plan will cover the next calendar year (and additional periods as reasonably determined by the Parties). Such updated and amended Early Clinical Development Plan or Late Clinical Development Plan will reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to, respectively, the then-current Early Clinical Development Plan or Late Clinical Development Plan. In addition, the JDC may prepare amendments for approval by the JSC to the Early Clinical Development Plan or Late Clinical Development Plan, as appropriate, from time to time during the calendar year in order to reflect changes in such plans or budget for such calendar year, in each case, in accordance with the foregoing. Once approved by the JSC, the amended annual Early Clinical Development Plan or Late Clinical Development Plan will become effective for the applicable period on the date approved by the JSC (or such other date as the JSC will specify). Any JSC-approved amended Early Clinical Development Plan or Late Clinical Development Plan will supersede, respectively, the previous Early Clinical Development Plan or Late Clinical Development Plan for the Development Candidate for the applicable period.
Amendments; Plan Governs. This Grant Agreement may not be amended except in writing signed by the Company and the Grantee. Notwithstanding the foregoing, this Grant Agreement may be amended in writing signed only by the Company to: # correct any errors or ambiguities in this Grant Agreement; and/or # to make such changes that do not materially adversely affect the Grantee’s rights hereunder. This grant shall in no way affect the Grantee’s participation or benefits under any other plan or benefit program maintained or provided by the Company. This Agreement and the Plan constitutes the entire agreement between the parties hereto with respect to the subject matter hereof, and supersedes all prior agreements and understandings relating to the subject matter of this Agreement. In the event of a conflict between this Grant Agreement and the Plan, the Plan shall govern.
review, approve any proposed amendments to, and monitoring execution of the Development Plan;
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