Responsibilities of the JRC Sample Clauses

Responsibilities of the JRC. The JRC shall have the responsibility and authority to: (a) approve each Research Plan and any revisions thereto; (b) review and oversee the execution of the Research Plans; (c) approve the Screening plan and any changes thereto; (d) select Screening Hits for Target Validation; (e) select Collaboration Targets in Part 2 in accordance with Section 4.1.6; (f) approve the Target Validation plan and any changes thereto; (g) approve validated Collaboration Targets to be allocated to the Pool in Part 2; (h) maintain a list of Collaboration Targets; (i) establish timelines for research decision points; (j) determine Compound Criteria; (k) determine whether criteria have been met (Compound Criteria, Lead Series Identified Criteria, CLS Criteria, CCS Criteria); (l) select all Backup Compounds; (m) maintain a list of all Collaboration Compounds, including Backup Compounds; (n) determine and maintain a list of all Collaboration Targets in order of advancement of status; (o) review the research efforts of the Parties; (p) identify appropriate resources necessary to conduct the Research Plans (including recommending whether Roche’s chemistry resources should be included in Lead Optimization, e.g. in order to increase the number of parallel activities on multiple series in a Research Plan or for multiple Research Plans or to address specific optimization questions in Lead Optimization); (q) determine when and where to perform any pre-formulation activities, salt screening, and polymorph screening in accordance with CLS Criteria and CCS Criteria; (r) align on the drug substance and drug product specifications for the batches used for the GLP Tox Studies; (s) align on the drug substance and drug product strategy, including stability program, and its execution for the drug product used for the GLP Tox Studies and Phase I Studies; (t) determine whether drug substance and/or drug product batches for Phase I Studies shall be made at a CRO acceptable to Roche or by Roche itself using its facilities; (u) oversee manufacture and release of drug substance and drug product batches to be used for Phase I Studies; (v) review the GLP Tox Study protocol e.g. with respect to study design, dose selection or GLP exposure measurements; (w) determine whether drug substance and/or drug product batches for GLP-Tox Studies shall be made at a CRO acceptable to Roche or by Roche itself using its facilities; (x) oversee manufacture and release of drug substance and drug product batches to be use...
AutoNDA by SimpleDocs
Responsibilities of the JRC. Subject to Section 2.2.4, the Joint Research Committee shall perform the following functions: (i) review and amend the Research Plan, as needed; (ii) review the allocation of resources and efforts for the Research Program; (iii) monitor the progress of the Research Program; Research Collaboration and License Agreement (Tau) 10 CONFIDENTIAL FINAL EXECUTION VERSION (iv) subject to Section 2.3, coordinate, and be the primary conduit for, the transfer of ACI Antibodies, Program Antibodies and related research materials, Know-How, and Confidential Information between the Parties; and (v) Perform such other functions referred to in the Research Plan, as appropriate to further the purposes of the Research Program, or as otherwise specified in this Agreement or agreed to by the Parties.
Responsibilities of the JRC. The JRC shall have the responsibility and authority to: (a) approve each Research Plan; (b) revise and approve any revisions to each Research Plan; (c) review and oversee the execution of each Research Plan; (d) establish timelines and criteria for decision points; (e) determine whether criteria have been met; (f) review the efforts of the Parties and allocate those resources for each Research Plan (including the budget); (g) identify appropriate resources necessary to conduct each Research Plan; (h) establish and set expectations and mandates for JOT; (i) create or disband JOT as deemed appropriate or adjust membership; (j) oversee the JOTs, if applicable; (k) monitor and implement the transfer of the lcagen Technology to Roche and the transfer of Roche Technology to lcagen; (l) discuss data, results and reports regardless of where generated during each Research Term and ensure that all such data, results and reports are available to both Parties during such Research Term; (m) monitor and implement the transfer of Compounds and Products to Roche; (n) monitor the budget spend and manage reimbursement for lcagen activities under each Research Plan; and (o) attempt to resolve any disputes on an informal basis. The JRC shall have no responsibility and authority other than that expressly set forth in this Section.
Responsibilities of the JRC. The Joint Research Committee shall be responsible for performing the following functions: (i) reviewing and amending the Research Plan; (ii) reviewing and approving the allocation of resources and efforts for the Research Collaboration; (iii) evaluating the progress of the Research Collaboration, as compared with the objectives set forth in this Agreement and the Research Plan; (iv) coordinating, as the primary conduit for, the transfer of information and materials between the Parties during the Research Term; (v) discussing the target candidate profile for each Target; (vi) maintaining and updating a list of programs for consideration as part of the Draft Pool; (vii) maintaining a list of high priority Targets in accordance with Section A of the Research Plan; (viii) determining which Targets will be included in the Draft Pool, together with their associated Compound Criteria; and (ix) performing such other functions referred to the JRC in the Research Plan as appropriate to further the purposes of the Research Collaboration or as otherwise specified in this Agreement or agreed to by the Parties.
Responsibilities of the JRC. The JRC shall be responsible for performing the following functions: (i) review and approve each initial Research Plan and initial Optimization Plan; (ii) review and approve any proposed change to the Completion Criteria of a Research Plan or to the Optimization Completion Criteria of an Optimization Plan; (iii) monitor the efforts and resources (including FTEs) actually employed for each Research Program as compared to the applicable Research Plan; (iv) monitor the efforts and resources actually employed for each Optimization Program as compared to the applicable Optimization Plan; (v) evaluate the progress of each Research Program, as compared with the objectives set forth in this Agreement and the applicable Research Plan; (vi) evaluate the progress of each Optimization Program, as compared with the objectives set forth in this Agreement and the applicable Optimization Plan; (vii) oversee the JPT including disputes at the JPT; and (viii) perform such other functions referred to in a Research Plan or Optimization Plan or as agreed to in writing by the Parties.
Responsibilities of the JRC. The JRC shall have the responsibility and authority to: a) approve the Research Plan; b) review and revise the Research Plan; c) oversee the execution of the Research Plan; d) establish timelines and criteria for decision points; e) determine whether success- and other criteria have been met; f) evaluate [***] g) review the efforts of the Parties and allocate those resources for the Research Plan (including the budget); h) identify and agree on the appropriate resources (including FTE staffing requirements) necessary to conduct the Research Plan; i) establish a touch point site or similar tool to enable secured exchange of data generated under the Research Plan j) monitor and implement the transfer of the [***], both in terms of material available at Pieris and the corresponding amino acid and nucleic acid sequences, and any associated data generated under the Research Plan to Roche; k) monitor the number of FTE funding and adaptation of such number as necessary as set forth in Section 3.1.1; l) recommend action items to its respective decision making bodies; m) in a JRC meeting towards the end of the Research Term, list the materials and information to be provided by Pieris to Roche according to Section 10.3.1; n) attempt to resolve any disputes on an informal basis; o) determine the mechanism of project information exchange, including project team meetings. The JRC shall have no responsibility and authority other than that expressly set forth in this section or otherwise expressly provided in this Agreement.
Responsibilities of the JRC. The Joint Research Committee shall be responsible for performing the following functions: (a) review progress reported by the Joint Research Team with respect to activities under the approved Research Plan; (b) address and coordinate the resolution of issues that may arise relating to the Initial Knowledge Transfer and the Ongoing Knowledge Transfer in each case to the extent relating to the activities under the approved Research Plan; (c) review and approve amendments to the Research Plan as proposed by the Joint Research Team as well as any “Non-Clinical GDP Activities” set forth in the GDP; (d) together with the Joint Development Committee, review the annual Publication Plan developed by the Joint Research Team together with the Joint Development Team, and approve the portion of such plan addressed to research publications; (e) review and make recommendations to the JDC as to [***] (f) ensure that each Party keeps the JRC informed regarding all material activities performed by such Party under this Agreement that are within the purview of the JRC; and (g) perform such other functions as specified in this Agreement or as agreed to by the Parties in writing.
AutoNDA by SimpleDocs
Responsibilities of the JRC. (i) The JRC shall be responsible for overseeing and reviewing the progress and results of the Research Collaboration, including the creation and maintenance of the Data Room, and shall discuss and decide on any variations of or modifications or amendments to the Research Plan including decisions regarding any material change with respect to the Research Collaboration Term in accordance with Section 3.3.2. (ii) During the Research Collaboration Term, the JRC shall be responsible for the selection of Collaboration Compounds in preparation for the Start of Pre-Clinical Development. (iii) During the Research Collaboration Term, the JRC will review and approve the annual Research Plans proposed by the JPT and approve the budget therefor, including the use of external FTEs by Zealand Pharma, and any modifications thereto as recommended by the JPT.
Responsibilities of the JRC. The JRC shall be responsible for the Parties interacting cooperatively on conducting the Research Plan. At its meetings, the JRC shall: (i) jointly outline a strategy for conducting the Research Plan; (ii) evaluate each Party’s progress in carrying out its obligations to conduct the Research Plan, and the data generated by each Party in conducting the Research Plan; (iii) discuss and resolve any issues related to the transfer of Transferred Technology; and (iv) perform any other activities specifically described in this Agreement.
Responsibilities of the JRC. The JRC shall perform the following functions: (a) oversee and guide the overall strategic direction of each Research Program; (b) overseeing, reviewing and coordinating the conduct and progress of the Development of the applicable Program Molecule or Program Product, as described in each Research Plan and in accordance with each Research Budget; (c) periodically reviewing and updating each Research Plan, including each Research Budget and the allocation of responsibilities between the Parties, from time to time, and presenting such Research Plan and updates, as well as other amendments mutually agreed by the Parties; (d) overseeing the implementation of each Research Plan, and monitoring whether activities thereunder are performed in accordance with the timelines set forth therein and the terms set forth in Article 3; (e) facilitating communications between the Parties regarding the activities undertaken under each Research Program; (f) establishing, as appropriate, additional sub-committees or working groups responsible for managing specific aspects of each Research Program as contemplated herein; (g) overseeing and supervising the Subcommittees and resolve issues or Disputes elevated to it by any Subcommittee the JRC may establish; (h) for each Research Program, reviewing and approving Research Plan and Research Budget and all amendments to any of the foregoing; (i) reviewing and discussing Data arising from preclinical activities undertaken under each Research Plan; (j) managing the transfer of Know-How to give effect to each deliverable under each Research Program, including choosing the format and media for such transfer; (k) confirming the Research Plan and Research Budget for the Option Targets; (l) discussing any potential changes in Research Costs and the Research Budget; and (m) performing such other functions as are assigned to the JRC in this Agreement, or otherwise agreed by the Parties in writing.
Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!