Common use of Responsibilities of the JRC Clause in Contracts

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 used in GLP-Tox Studies; (y) establish, set expectations and mandates for, oversee and disband JOTs; (z) recommend action items to each Party’s respective decision making bodies; and (aa) attempt to resolve any disputes on an informal basis. The JRC shall have all responsibility and authority regarding overseeing activities under the Research Plans, other than as expressly set forth in this Agreement. The JRC shall have no responsibility and authority other than that expressly set forth in this Section, unless mutually agreed by the Parties.

Responsibilities of the JRC. The JRC shall have the responsibility and authority authority, subject to the other provisions of this Agreement, including Sections 11.5 and 11.16, to: (a) approve each Research Plan and any revisions theretoits objectives; (b) update Roche on the C4T Pipeline and the targets in the C4T Pipeline on an ongoing basis, and at least [***] in advance of lead optimization; (c) approve any revisions to the Research Plans; (d) maintain an updated list of Targets and a tally of the number of Target exchanges; (e) review and oversee the execution of the Research Plans; (c) approve Plan and updates to the Screening plan and any changes thereto; (d) select Screening Hits Shared Development Cost Budget, including providing a rolling [***] estimate at each JRC meeting for Target Validation; (e) select Collaboration Targets in Part 2 in accordance with Section 4.1.6the [***] period following such JRC meeting; (f) approve monitor the Target Validation plan Shared Development Costs and any changes theretomanage reimbursement to C4T as set forth in Section 11.7; (g) approve validated Collaboration Targets to be allocated to the Pool in Part 2establish and set expectations and mandates for its JOT; (h) maintain a list of Collaboration Targetscreate or disband its JOT as deemed appropriate; (i) establish timelines for research decision pointsoversee its JOTs, if applicable; (j) determine Compound Criteriamaintain a list of Degronimids actually reduced to practice under the Research Plans; (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, screening and polymorph screening in accordance with CLS Criteria and CCS Criteria; (rl) verify whether Roche manufactures Degronimids for GLP Tox Studies (e.g. manufacturing process optimization, GLP Tox formulation, GLP analytics), as set forth in Section 7.1.; (m) align on the drug substance and drug product specifications for the batches used for the GLP Tox StudiesStudies as set forth in Section 4.1.6; (sn) 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; (vo) review the GLP Tox Study protocol protocol, e.g. with respect to study design, dose selection or GLP exposure measurementsmeasurements as set forth in Section 4.1.6; (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; (xp) oversee manufacture and release of drug substance and drug product batches to be used in GLP-GLP Tox Studies; (yq) establish, set expectations and mandates for, oversee and disband JOTsestablish timelines for research decision points; (zr) recommend action items determine whether success criteria have been met (LSI Achieved, CLS Criteria and CCS Criteria); (s) review the efforts of the Parties and allocate those resources for the Research Plan (including the budget); (t) monitor and implement the transfer of the C4T Technology to each Party’s respective decision making bodiesRoche as set forth in Section 7.3; (u) monitor and implement the transfer of the Degronimids and Product to Roche; and (aav) attempt to resolve any disputes on an informal basis. The JRC shall have all responsibility and authority regarding overseeing activities under the Research Plans, other than as expressly set forth in this Agreement. The JRC shall have no responsibility and authority other than that expressly set forth in this Section, unless mutually agreed by the PartiesSection 11.7.

Responsibilities of the JRC. The JRC shall have the responsibility and authority authority, subject to the other provisions of this Agreement, including Sections 6.6 and 6.8 below, to: (ai) recommend and approve each Target Evaluation Research Plan and each Joint Research Plan, and any revisions theretoor amendments to the Target Evaluation Research Plans and Joint Research Plans which are to be added to Appendix 3.1.3 and Appendix 1.57, respectively, within [***] of such approval by the JRC; (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; (iii) establish timelines and criteria for research decision points; (jiii) assess and determine Compound Criteriawhether a Collaboration Target has been successfully degraded during the Target Evaluation Phase; (kiv) assess and determine whether criteria Lead Series Criteria and Development Candidate Criteria (as each is set forth in the applicable Joint Research Plan) has been achieved, recommend to Calico whether to progress a Lead Series to the Lead Optimization Phase for a Collaboration Target (as defined in the applicable Joint Research Plan), and other deliverables or milestones under any Joint Research Plan have been met (Compound Criteria, met; modify and adopt alternative Lead Series Identified Criteria, CLS Criteria, CCS Criteria); (l) select all Backup Compounds; (m) maintain Criteria or Development Candidate Criteria on a list of all Collaboration Compounds, including Backup Compounds; (n) determine and maintain a list of all Target-by-Collaboration Targets in order of advancement of status; (o) review Target basis as agreed to by 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 StudiesJRC; (v) review the recommend Initiation of GLP Tox Study protocol e.g. with respect to study design, dose selection or GLP exposure measurementsfor a Collaboration Product for a Collaboration Target; (wvi) determine whether drug substance and/or drug product batches for GLP-Tox Studies shall be made at a CRO acceptable to Roche or oversee implementation of each Target Evaluation Research Plan and each Joint Research Plan by Roche itself using its facilitiesC4T and monitor the Parties’ activities under this Agreement; (xvii) oversee manufacture and release of drug substance and drug product batches approve Calico proposals regarding Collaboration Target substitution pursuant to be used in GLP-Tox Studiesthe Target Substitution Right; (yviii) establish, set expectations and mandates for, oversee and disband JOTsfor the Research Plan Representatives; (zix) recommend action items monitor and implement the transfer of the Protein Degraders, Protein Degrader Components and Collaboration Products to each Party’s respective decision making bodiesCalico; and (aax) attempt to resolve any disputes on an informal basis. The JRC shall have all responsibility and authority regarding overseeing activities under disputes; (xi) establish subcommittees as necessary to further the objectives of each Joint Research Plans, other than as expressly set forth in this Agreement. Plan; The JRC shall have no responsibility and authority other than that expressly set forth in this Section, unless mutually agreed by the PartiesSection 6.3.

Responsibilities of the JRC. The JRC shall have the responsibility and authority to: (a) approve each Research Plan and any revisions theretothe Pre-Option *** Collaboration Plan; (b) revise and approve any revisions to the HB700 Collaboration Plan, Pre-Option *** Collaboration Plan and the *** Collaboration Plan; (c) review and oversee the execution of the Research Plans; (c) approve Pre-Option *** Collaboration Plan and the Screening plan and any changes theretoCollaboration Plan; (d) select Screening Hits for Target Validationreview the Data Packages pursuant to Section 3.4; (e) select Collaboration Targets in Part 2 in accordance with Section 4.1.6establish and revise timelines, Selection Criteria and Endpoints for the HB700 Program and the *** Program and approve the *** Cargo design; (f) approve determine whether the Target Validation plan Selection Criteria and any changes theretoEndpoints have been achieved and decide whether the activities shall move into the subsequent research or development phase of the Program; (g) approve validated Collaboration Targets to be allocated to determine if and when GMP Go-Decision for the Pool in Part 2*** Program shall occur; (h) maintain a list of Collaboration Targetsdetermine if and when to submit IND for the First Human Trial in the HB700 Program and the *** Program, approve its design and respective Endpoints; (i) establish timelines review the efforts of the Parties under each Program and approve and allocate those resources for research decision pointsthe Collaboration Plan (including the Collaboration Budget); (j) determine Compound Criteriaestablish and set expectations and mandates for JOTS; (k) determine whether criteria have been met (Compound Criteriacreate, Lead Series Identified Criteria, CLS Criteria, CCS Criteria)oversee and disband JOTs as deemed appropriate; (l) select all Backup Compounds[intentionally left blank]; (m) maintain a list establish and approve the Roche Go-Decision Technology Transfer Plan and monitor and implement the transfer of all Collaboration Compounds, including Backup Compoundsthe Roche Go-Decision Data and the Roche Continued Program Technology to Roche pursuant to the Roche Go-Decision Technology Transfer Plan and determine whether the Roche Go-Decision Technology Transfer is implemented successfully pursuant to the Roche Go-Decision Technology Transfer Plan; (n) determine monitor the Trial Costs and maintain a list of all Collaboration Targets preclinical costs and manage reimbursement to Hookipa as set forth in order of advancement of statusSection 9.3.3; (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 used in GLP-Tox Studies; (y) establish, set expectations and mandates for, oversee and disband JOTs; (z) recommend action items to each Party’s its respective decision making bodies; and (aap) attempt to resolve any disputes on an informal basis. The JRC shall have all responsibility and authority regarding overseeing activities under the Research Plans, other than as expressly set forth in this Agreement. The JRC shall have no responsibility and authority other than that expressly set forth in this Section, unless mutually agreed Section 5.3 or jointly assigned by the PartiesParties to the JRC in an amendment to this Agreement pursuant to Section 21.9 during the lifetime of the JRC pursuant to Section 5.12.

Responsibilities of the JRC. The JRC shall have oversee, review and coordinate the responsibility conduct and authority toprogress of the discovery and Research activities described in Article 4 and Section 5.3 with the objective of identifying and validating Targets, including by designating Targets as Identified Targets, and to identify Development Candidates for Non-Clinical GLP Studies pursuant to the Early Collaboration Program Plan. The JRC shall be responsible for: (ai) approve each overseeing and supervising the JST in its conduct of discovery and Research activities and its implementation of the Target Discovery Plan and any revisions theretoeach Early Collaboration Program Plan, and monitoring whether activities thereunder are performed in accordance with the timelines set forth therein, as described in Article 4 and Section 5.3; (bii) review reviewing and oversee evaluating any results or reports delivered by the execution JST with respect to the identification and validation of the Research PlansTargets, and determining whether any such Target qualifies as an Identified Target; (ciii) approve reviewing and evaluating any results or reports delivered by the Screening plan and any changes thereto; (d) select Screening Hits for Target Validation; (e) select Collaboration Targets in Part 2 in accordance JST with Section 4.1.6; (f) approve the Target Validation plan and any changes thereto; (g) approve validated Collaboration Targets to be allocated respect to the Pool in Part 2; (h) maintain a list Research of Identified Targets and Collaboration Targets; (iiv) 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 Criteriareviewing any supporting data and results of each Early Collaboration Program Plan delivered to the JRC pursuant to Section 5.3(c); (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 designating Compounds as Development Candidates for approval by the JSC and delivering data or results 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 Studiessupport thereto; (v) review for each Collaboration Program, discuss the GLP Tox Study protocol e.g. Early Collaboration Program Plan prepared by the Lead Party, and any proposed updates thereto; (vi) reviewing and approving any Research and Pre-Clinical Publication Strategy proposed by the Lead Party of a Collaboration Program, pursuant to Section 13.1; (vii) discussing any Additional Validation Activities requested by GSK for GSK Independent Programs (including the FTE requirements associated with such request), and prioritizing any requested Additional Validation Activities, including assessing scope, cost, timeline, and priority with respect to study design, dose selection or GLP exposure measurementsother activities being conducted under the Collaboration; (wviii) determine whether drug substance and/or drug product batches discussing 23andMe’s upcoming plans (if any) for GLP-Tox Studies shall be made at conducting Customer surveys with a CRO acceptable view to Roche or by Roche itself using its facilities; (x) oversee manufacture consider potential GSK requests for Supplementary CTR Services, and release of drug substance and drug product batches 23andMe’s ability to be used in GLP-Tox Studies; (y) establish, set expectations and mandates for, oversee and disband JOTs; (z) recommend action items to each Party’s respective decision making bodiesreasonably accommodate such requests under Section 5.7(d)(iii); and (aaix) attempt providing periodic updates to resolve any disputes on an informal basis. The JRC shall have all responsibility the JSC and authority regarding overseeing activities under otherwise supporting the Research PlansJSC’s decision-making, other than including with respect to Targets that are designated as expressly set forth in this Agreement. The JRC shall have no responsibility Identified Targets and authority other than Collaboration Targets, and Compounds that expressly set forth in this Section, unless mutually agreed by the Partiesare designated as Development Candidates.

Responsibilities of the JRC. The purposes of the JRC shall have be to review, direct, supervise and coordinate all operational and scientific aspects of the responsibility Research Program and authority to: all pre-clinical testing of Collaboration Compounds before commencement of Pre-Clinical Development. As part of its responsibilities, the JRC shall (a) approve each Research Plan promptly after the Commencement Date establish criteria of safety and efficacy that Collaboration Compounds will need to achieve before the JRC may recommend any revisions thereto; such Compound to BMS for consideration for advancement into Pre-Clinical Development as a Collaboration Lead Compound (it being *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. understood that the selection of whether a Collaboration Compounds will become a Collaboration Lead Compound resides in BMS); (b) review and oversee the execution of establish joint research teams to carry out the Research Plans; Program, (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 by Ligand 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 used in GLP-Tox Studies; (y) establish, set expectations and mandates for, oversee and disband JOTs; (z) recommend action items to each Party’s respective decision making bodies; and (aa) attempt to resolve any disputes on an informal basis. The JRC shall have all responsibility and authority regarding overseeing activities BMS under the Research PlansProgram and the pre-clinical testing of Collaboration Compounds before commencement of Pre-Clinical Development, (d) monitor the progress of the Research Program and evaluate the work performed and the results obtained in relation to the goals of the Research Program, (e) plan future activities under, and make any necessary or desirable modifications to, the Research Program and the Technical Operating Plan, (f) recommend Collaboration Compounds for further evaluation by the Parties under the Research Program and for Pre-Clinical Development and Development by BMS as a Collaboration Lead Compound , and (g) perform such other than as expressly set Research Program-related functions to which the Parties may agree in writing; provided, that any such writing that assigns new functions to JRC the terms of which conflict with the terms of this Agreement shall be null and void unless signed by a Senior Vice President (or higher level employee) of both Parties. Unless otherwise agreed by the JRC, the Party hosting each meeting of the JRC promptly shall prepare and deliver to the other Party within fifteen (15) business days after the date of such meeting, minutes of such meeting setting forth all decisions of the JRC relating to the Research Program in this Agreementform and content reasonably acceptable to the other Party. The JRC shall have no functions or responsibilities following the end of the Research Term, and, to the extent any functions or responsibilities are assigned to the JRC under this Agreement following the Research Term, such functions or responsibilities shall be performed by BMS. The JRC shall not have any jurisdiction or responsibility and authority other than that expressly set forth in this Sectionwith respect to resolving any dispute with respect to (i) patent validity or inventorship, unless mutually agreed by or (ii) the Partiesexistence of blocking Third Party intellectual property, or (iii) the filing, prosecution, maintenance or defense of any Research Program Intellectual Property.

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 used in GLP-Tox Studies;; ​ (y) establish, set expectations and mandates for, oversee and disband JOTs;; ​ (z) recommend action items to each Party’s respective decision making bodies; andand ​ (aa) attempt to resolve any disputes on an informal basis. ​ The JRC shall have all responsibility and authority regarding overseeing activities under the Research Plans, other than as expressly set forth in this Agreement. The JRC shall have no responsibility and authority other than that expressly set forth in this Section, unless mutually agreed by the Parties.. ​