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;
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
During the Early Clinical Development Term Unum will keep the JDC fully informed regarding the progress and results of Development activities for Development Candidates in the Territory, including an annual review of results versus goals (as such goals are set forth in the Early Clinical Development Plan(s)).
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. No Borrower or Borrower Affiliate shall become a party to any Multiemployer Plan or Foreign Plan.
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