Joint Monitoring and Advisory Group. Promptly following the Effective Date, the Parties will establish a joint monitoring and advisory group (“JMAG”) that shall meet regularly as specified in the applicable Team Charter to monitor progress of and advance the Project. The JMAG shall coordinate the efforts of CEPI and the Partners, with respect to the following activities for each Work Package (in addition to the responsibilities set out in the applicable Team Charter): 2.4.1 facilitate communications between the Parties; 2.4.2 monitor the performance and technical content of each Work Package against the milestones and their dates, and critically assess the results on an on-going basis to identify and address any weaknesses or delays in any Work Package; 2.4.3 approve the achievement of milestones (but the JMAG shall not have the right to approve final Project completion or confirm completion of Stage Gates, which shall be subject to the provisions of Clause 2.6); 2.4.4 provide a forum for discussion as to whether the activities currently agreed to are sufficient to satisfy CEPI’s mission; 2.4.5 have the authority to approve extensions to Work Package timelines up to ten (10) percent of the originally planned timeframe as set out in the relevant Work Package, provided that each such extension is at no cost to CEPI and does not impact the overall completion date of the Project; 2.4.6 have the authority to approve transfer of funds between cost categories within a Budget, to the extent that any such changes are cost neutral; 2.4.7 review and approve proposed changes and updates to the iPDP including, but not limited to, the Project Continuity Plan; 2.4.8 review and discuss pre-clinical and clinical trial protocols, including CMC development study protocols, and any substantial changes; 2.4.9 review and approve the regulatory strategy for the use of the Project Vaccine and receive regular updates on regulatory filings and submissions; 2.4.10 review the contractual and operational status and capabilities of Trusted Collaborator(s); 2.4.11 review and discuss publications; 2.4.12 discuss each Partner’s willingness to share any Project Results with any other CEPI awardees, such sharing of Project Results not to occur without the agreement of the Parties, unless otherwise agreed in a Work Package; 2.4.13 review and update the Equitable Access Plan (until the Equitable Access Group is established in accordance with Clause 14.3 in which case this will become a function of the Equitable Access Group); 2.4.14 discuss plans, as appropriate, for the development and manufacturing of the Project Vaccine and their scale-up and scale-out; 2.4.15 approve the Technical Reports and Project Results made available by a Partner pursuant to Clause 2.5; 2.4.16 review any reports and updates provided by any site visit groups; 2.4.17 keep CEPI updated on any progress with regard to the SPV, including plans for it to be established, funded, its proposed remit, any funding sources it may benefit from, the associated business case and any other relevant details; 2.4.18 provide a forum for coordinating the Parties’ responses to issues with respect to the Project Vaccine, to the extent relating to CEPI’s use, including unexpected disruptions to the supply of the Project Vaccine, recalls, safety issues or withdrawals of the Project Vaccine; 2.4.19 receive written notification of all Project Results; 2.4.20 discuss (i) any further cooperation of the Parties as further set forth in Clause 4.1 and Clause 4.3, and (ii) any collaboration in the event of an Outbreak as further set forth in Clause 4.2; and 2.4.21 discuss plans, as appropriate, for the development of manufacturing for the Project Vaccine, and its scale-up and scale-out. The JMAG shall disband on completion of the Project.
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Sources: Funding Agreement
Joint Monitoring and Advisory Group. Promptly following the Effective Date, the Parties will establish a joint monitoring and advisory group (“JMAG”) that shall meet regularly as specified in the applicable Team Charter to monitor progress of and advance the Project. The JMAG shall coordinate the efforts of CEPI and the Partners, with respect to the following activities for each Work Package (in addition to the responsibilities set out in the applicable Team Charter):
2.4.1 facilitate communications between the Parties;
2.4.2 monitor the performance and technical content of each Work Package against the Sensitivity: Official Use milestones and their dates, and critically assess the results on an on-going basis to identify and address any weaknesses or delays in any Work Package;
2.4.3 approve the achievement of milestones (but the JMAG shall not have the right to approve final Project completion or confirm completion of Stage Gates, which shall be subject to the provisions of Clause 2.6);
2.4.4 provide a forum for discussion as to whether the activities currently agreed to are sufficient to satisfy CEPI’s mission;
2.4.5 have the authority to approve extensions to Work Package timelines up to ten (10) percent of the originally planned timeframe as set out in the relevant Work Package, provided that each such extension is at no cost to CEPI and does not impact the overall completion date of the Project;
2.4.6 have the authority to approve transfer of funds between cost categories within a Budget, to the extent that any such changes are cost neutral;
2.4.7 review and approve proposed changes and updates to the iPDP including, but not limited to, the Project Continuity Plan;
2.4.8 review and discuss pre-clinical and clinical trial protocols, including CMC development study protocols, and any substantial changes;
2.4.9 review and approve the regulatory strategy for the use of the Project Vaccine and receive regular updates on regulatory filings and submissions;
2.4.10 review the contractual and operational status and capabilities of Trusted Collaborator(s);
2.4.11 review and discuss publications;
2.4.12 discuss each Partner’s willingness to share any Project Results with any other CEPI awardees, such sharing of Project Results not to occur without the agreement of the Parties, unless otherwise agreed in a Work Package;
2.4.13 review and update the Equitable Access Plan (until the Equitable Access Group is established in accordance with Clause 14.3 in which case this will become a function of the Equitable Access Group);
2.4.14 discuss plans, as appropriate, for the development and manufacturing of the Project Vaccine and their scale-up and scale-out;
2.4.15 approve the Technical Reports and Project Results made available by a Partner pursuant to Clause 2.5;
2.4.16 review any reports and updates provided by any site visit groups;
2.4.17 keep CEPI updated on any progress with regard to the SPV, including plans for it to be established, funded, its proposed remit, any funding sources it may benefit from, the associated business case and any other relevant details;
2.4.18 provide a forum for coordinating the Parties’ responses to issues with respect to the Project Vaccine, to the extent relating to CEPI’s use, including unexpected disruptions to the supply of the Project Vaccine, recalls, safety issues or withdrawals of the Project Vaccine;; Sensitivity: Official Use
2.4.19 receive written notification of all Project Results;
2.4.20 discuss (i) any further cooperation of the Parties as further set forth in Clause 4.1 and Clause 4.3, and (ii) any collaboration in the event of an Outbreak as further set forth in Clause 4.2; and
2.4.21 discuss plans, as appropriate, for the development of manufacturing for the Project Vaccine, and its scale-up and scale-out. The JMAG shall disband on completion of the Project.
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