JRC Responsibilities. The JRC shall provide general oversight on the Collaboration activities during the Research Term and serve to facilitate communications between the Parties, and shall have specific responsibilities for:
2.3.1 monitoring activities under each SOW;
2.3.2 forming any subcommittee as it or the Parties deem appropriate or necessary, deciding the scope of responsibilities of any subcommittee, supervising the subcommittees and resolving issues and disputes submitted by any subcommittee;
2.3.3 reviewing and recommending any amendments to any SOW (including the proposed research activities and budgets);
2.3.4 periodic review of the overall goals and strategy of the Collaboration;
2.3.5 providing strategic direction to Aarvik’s activities under the Collaboration to ensure the delivery of Compounds suitable for further preclinical development;
2.3.6 reviewing the relevant Data Package(s);
2.3.7 discussing the suitability of any Compounds for Development;
2.3.8 reviewing and implementing patenting and Intellectual Property Right protection strategies on Compounds and other Collaboration IP;
2.3.9 discussing any patentability or freedom-to-operate issue about the Compound(s);
2.3.10 facilitating access to and the exchange of information between the Parties related to the Collaboration activities, including monitoring and approving the exchange of relevant information and data between the Parties as required for the performance of any SOW;
2.3.11 discussing certain payments described in Section 6.2.2 and 6.2.3 below; and
2.3.12 such other responsibilities as may be assigned to the JRC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
JRC Responsibilities. During any of the Research Terms, the JRC will:
4.4.1. Review, discuss and provide advice as to the progress of research activities to identify and characterize Compounds;
4.4.2. Review, discuss and provide advice on the progress of Research Activities as against the applicable Research Plan and Research Budget for each Research Program;
4.4.3. Review and discuss Morphic’s estimates of the FTE Costs and Out-of-Pocket Costs anticipated to be incurred in the performance of the Morphic Research Activities for the subsequent two (2) Calendar Years, in accordance with Section 2.2.3 (Updates to Research Plans and Research Budgets);
4.4.4. Review, discuss and determine whether to approve (a) any updates to any Research Plan or Research Budget, in accordance with Section 2.2.3 (Updates to Research Plans and Research Budgets) and (b) any excess costs incurred by Morphic in the performance of the Morphic Research Activities, in accordance with Section 2.3.1 (Allocation of Costs);
4.4.5. Review, discuss and develop a Research Plan for each Replacement Target MoA, in accordance with Section 2.6.5 (Research Plans for Replacement Target MoAs);
4.4.6. Review, discuss and coordinate the delivery of the reports by Morphic regarding the Research Activities, in accordance with Section 2.8 (Research Reports);
4.4.7. Review and discuss the IND-Enabling Study Report for each Research Program delivered to the JRC by Xxxxxxx, in accordance with Section 3.3 (IND-Enabling Study Report);
4.4.8. Form such other committees as the JRC may deem appropriate, including (a) individual committees to oversee Research Activities under a particular Research Program and (b) the JFC, in accordance with Section 4.5 (Joint Finance Committee);
4.4.9. Attempt to resolve any disputes between the Parties related to the performance of the Research Activities on an informal basis (subject to Section 4.6 (JRC Decision-Making), Section 4.7 (Resolution of JRC Disputes) and Section 4.8 (Limitations on Decision Making)); and
4.4.10. Perform such other functions as expressly set forth in this Agreement or allocated to the JRC by the written agreement of the Parties.
JRC Responsibilities. During the Research Term, the JRC shall have the following specific responsibilities:
8.2.3.1. oversee the performance of the Research Plan and coordinate the activities of the Parties under the Research Plan;
8.2.3.2. report and monitor progress of Research Activities under the Research Plan and discuss any results thereunder;
8.2.3.3. review data generated in the course of the Research Service by Repare, including with respect to assay development and results of optimization and screening, and consider and advise on any technical issues that arise in the course of the Research Service;
8.2.3.4. review the progress of activities under the Research Plan and review and approve any amendments thereto, including any necessary amendments to the Research Plan budget as a result of any amendment to the Research Plan, any other amendment to the Research Plan budget, any amendment to Repare’s FTE requirements, and any amendment to the timelines or activities under the Research Plan;
8.2.3.5. overseeing the JRC’s Working Group and ensuring effective participation in each such Working Group’s operations by any of its members;
8.2.3.6. resolve disputes arising at the Working Group;
8.2.3.7. select a list of proposed Drug Candidates;
8.2.3.8. resolve any disagreement between the Parties relating to the Research Plan; and
8.2.3.9. perform such other activities as the Parties agree in writing shall be the responsibility of the JRC or that are otherwise assigned to the JRC under this Agreement.
JRC Responsibilities. The role of the JRC shall be to oversee the pre-clinical development of the Licensed Products. [ * ], and any material amendments to such strategies, plans and protocols; provided, however, Quark shall have the right to complete the Non-Ophthalmic Pre-clinical Studies. Quark shall update the JRC from time to time regarding the progress of its Non-Ophthalmic Pre-Clinical Studies, and shall provide the JRC with the data and other results of such studies as soon as practicable after such studies are completed. The JRC shall review the data and results of such studies with the goal of identifying Non-Ophthalmic Uses that are appropriate for further development and (if successful) commercialization as Licensed Products. The JRC shall decide whether to pursue further development, including clinical studies, of the Licensed Product for each Non-Ophthalmic Use. Upon final decision following review of all data for all Non-Ophthalmic Pre-clinical Studies, the JRC and its subcommittees shall terminate.
JRC Responsibilities. The JRC shall be responsible for review and approval of all Product or related disease education materials, Promotional Materials and other communication to a Third Party, including pharmaco-economic data, that may be used in Promotion, medical to medical communication, patient education, press release or any other form of external communication intended for healthcare professionals, healthcare organized customers (such as IDNs and hospitals), and Payer organizations, patients or others who are reasonably likely to influence the prescription, use, reimbursement, or purchase of the Product. The JRC shall also ensure that all such materials are in compliance with Applicable Law and each Party’s Applicable Compliance/Review Policies. Any conflict between the Parties’ Applicable Compliance/Review Policies will be discussed by the JRC and the Compliance Managers to determine an appropriate resolution of such conflict.
JRC Responsibilities. In addition to its overall responsibility for monitoring the Research Programs, the JRC shall, in particular:
(a) work with the Project Co-Leaders to coordinate the activities of the Parties hereunder;
(b) review progress reports submitted by each JPT or Working Group with respect to its respective Research Program activities;
(c) review and approve Research Plans for a Research Program, reviewing and approving amendments to the Research Plans for its respective Research Program;
(d) discuss new Targets validated by Immunocore or added to the database of Targets that may be available for nomination as an Exclusive Target;
(e) review proposals for nomination of any Targets as a subsequent or additional Exclusive Target;
(f) work to resolve any disputes, controversy or claim related to the matters and authority of the JRC;
(g) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties;
(h) review and approve the allocation of resources and efforts for the Research Programs; Certain confidential information contained in this document, marked by [***], has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
(i) discuss the results of GNE’s research activities, if any, under the Research License; and
(j) discuss Immunocore’s progress in conducting any Clinical Trials with a Compound, where the Compound is not subject to any Third Party confidentiality restrictions.
JRC Responsibilities. In addition to its overall responsibility for monitoring and coordinating any agreed research program, the JRC shall, in particular:
(a) review and approve Research Plans and Research Budgets, and any amendments thereto;
(b) work with the Project Co-Leaders to implement and coordinate the activities of the Parties with respect to any agreed Research Plans;
(c) review and approve the allocation of resources and responsibilities for the agreed Research Programs;
(d) keep the JPT informed of the activities of (x) the JRC; and (y) the Parties under any Research Program;
(e) develop and approve a publication strategy for research, including research not linked to the Licensed Products, which strategy shall indicate any such publications that require prior approval of the JRC and a process for approval of such publications;
(f) work to resolve any disputes, controversy or claim related to the matters and authority of the JRC, including any issues presented to it by, and disputes within, any Working Group or the JPT; and
(g) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties. The JRC shall consider at its first meeting whether any additional matters should fall within its remit.
JRC Responsibilities. In addition to its overall responsibility for monitoring the activities of the Parties under any Research Plan, the JRC shall, in particular:
(a) work to resolve any disputes, controversy or claim between the Parties arising during the performance of any Research Plan and related to the matters under the authority of the JRC;
(b) review and approve the allocation of resources and efforts necessary to perform the Research Plans to the extent not agreed by the applicable JPT;
(c) review and approve any material amendments to any Research Plan proposed by the applicable JPT;
(d) upon Acceptance of a Selected Target and prior to finalizing the Research Plan for such Selected Target, review and approve the initial Lead Candidate Criteria for such Selected Target to be included in such Research Plan;
(e) prepare and approve, or review and approve to the extent initially prepared by the applicable JPT, modifications and/or additions to the Lead Candidate Criteria applicable to a given Selected Target and Research Plan;
(f) oversee the implementation of the Research Plans;
(g) ensure that each Party is informed regarding all material activities performed by the other Party under any Research Plan;
(h) maintain a list of all Research Plan Compounds identified under each Research Plan;
(i) review each Research Plan Compound for compliance with Lead Candidate Criteria and assess viability of any Research Plan Compound which does not meet or otherwise is not in compliance with the Lead Candidate Criteria in accordance with Clause 5.1 and discuss selection of Research Plan Compounds as Selected Candidates by Lilly; and CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. (j) perform such other functions as may be agreed to by the Parties (in each case subject to Clause 2.3) or as specified in this Agreement.
JRC Responsibilities. The JRC shall be responsible for planning, overseeing, reviewing and coordinating the work being done under the Research Program, including; (i) making decisions regarding the specific details of templates and Compounds for synthesis, including without limitation the Design Criteria for the Compounds; (ii) evaluating progress against timelines established by the JRC for the Research Program, including without limitation the design, quality assurance testing and delivery of Compounds; (iii) establishing and monitoring the schedule for delivery of Compounds; (iv) establishing, maintaining and updating on an ongoing basis a database record of the design of each of the Compounds and each Party's contribution to such design, as further described in Section 4.3.2; (v) recording and approving meeting minutes; and (vi) having the authority to accept or reject any Plates and/or Compound(s) synthesized that failed the Quality Control Criteria established by the Parties as set forth in Appendix B attached hereto, as may be amended in writing by the JRC from time to time.
JRC Responsibilities. The JRC will have that specific decision-making authority expressly enumerated in this Agreement and will provide oversight and a forum for discussing all matters arising in connection with this Agreement, including with respect to planning, reviewing and coordinating the various activities to be undertaken by the Parties pursuant to a Workflow Development Plan. In particular, the JRC will be responsible for:
3.2.1 rejecting or approving proposed Workflow Development Plans submitted to it by a Party or as amended by the JRC pursuant to Section 2.2.1 (
