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.
discuss, prepare and approve for submission to the JSC all Research Plans, Early Clinical Development Plans and Late Clinical Development Plans, and all annual and interim amendments to Research Plans, Early Clinical Development Plans and Late Clinical Development Plans for, respectively, Research Candidates and Development Candidates in the Territory;
Development and Commercialization Plans. Licensee shall perform, and shall ensure that its Affiliates, sublicensees, and Third Party contractors perform, the activities described in any Development Plan for the Licensed Product in a professional manner and in compliance with, to the extent applicable, Good Laboratory Practices, Good Clinical Practices and/or Good Manufacturing Practices and in compliance with all other applicable laws, rules, and regulations.
review and discuss reports from the JDC and JCC and provide guidance thereto, direct the activities of such Committees, and approve each Research Plan, Early Clinical Development Plan, Late Clinical Development Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto;
oversee the conduct of all Research Plans, Early Clinical Development Plans and Late Clinical Development Plans;
allocate primary responsibility as between the Parties for tasks relating to the Research and Development of Research Candidates and Development Candidates where not already specified in the Research Plan, Early Clinical Development Plans or Late Clinical Development Plans therefor;
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.
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.
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.
Plans. If it has not done so already, within ten (10) days after the Phase 1 Expansion Space Delivery Date, [[Organization B:Organization]] shall deliver to [[Organization A:Organization]] a space plan (the “[[Organization B:Organization]] Phase 1 Space Plan”) depicting [[Organization B:Organization]]’s desired improvements in the Phase 1 Expansion Space (the “Phase 1 [[Organization B:Organization]] Improvements”). Within ten (10) days after receipt of the [[Organization B:Organization]] Phase 1 Space Plan, [[Organization A:Organization]] will review and approve or disapprove the [[Organization B:Organization]] Phase 1 Space Plan in its reasonable discretion. If [[Organization A:Organization]] disapproves the [[Organization B:Organization]] Phase 1 Space Plan, it shall state with particularity the reasons for such disapproval. If disapproved, [[Organization B:Organization]] shall revise the [[Organization B:Organization]] Phase 1 Space Plan to address [[Organization A:Organization]]’s concerns and resubmit to [[Organization A:Organization]] for review and approval or disapproval. Upon approval of the [[Organization B:Organization]] Phase 1 Space Plan, [[Organization B:Organization]] shall cause working drawings (hereafter, “[[Organization B:Organization]] Phase 1 Working Drawings”) of the Phase 1 [[Organization B:Organization]] Improvements shown on the [[Organization B:Organization]] Phase 1 Space Plan to be prepared and delivered to [[Organization A:Organization]]. The [[Organization B:Organization]] Phase 1 Working Drawings shall consist of the plans and specifications in the form of working drawings or construction drawings identifying [[Organization B:Organization]]’s interior layout of the Phase 1 Expansion Space, including complete sets of architectural, structural, mechanical, electrical, and plumbing working drawings for all Phase 1 [[Organization B:Organization]] Improvements, in each case to the extent applicable. The [[Organization B:Organization]] Phase 1 Working Drawings shall include written instructions or specifications as may be necessary or required to secure a building permit from the City of Eden Prairie for said improvements to commence in due course. The [[Organization B:Organization]] Phase 1 Working Drawings shall be prepared by architects and engineers selected by [[Organization B:Organization]] and reasonably approved by
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