Governance; Collaboration Program Management. 4.1. Within fifteen (15) Business Days of the Effective Date, the Parties will assign representatives to form a joint steering committee (the “JSC”). The JSC shall be responsible for overseeing the conduct of all Collaboration Programs, and approving the detailed requirements and deliverables for any Collaboration Program as developed by the JPT and/or JMC. The JSC shall have oversight and decision-making responsibilities for activities performed for each Collaboration Program and shall resolve disputes arising at the JPT and JMC. The JPT and JMC (where applicable) shall keep the JSC informed of the progress and activities under each Collaboration Program. The JSC shall be comprised of four (4) representatives (or such other number of representatives as the Parties may agree) from each of GSK and Adaptimmune. Each Party may replace any or all of its representatives on the JSC at any time upon written notice to the other Party in accordance with Section 16.1 or by e-mail to the other Party’s Alliance Manager. Each representative of a Party shall have sufficient seniority and appropriate expertise in biotechnology and pharmaceutical drug discovery and development to participate on the JSC. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party to attend meetings of the JSC as non-voting participants, subject to the confidentiality obligations of Article 10, as may be required by the agenda for such meetings. The Alliance Managers shall also participate as non-voting members in JSC meetings. 4.2. In addition to the responsibilities set forth in Section 4.1, the JSC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 4.5: 4.2.1. review and approve a Development Plan for each Collaboration Program in accordance with the timelines set forth in Article 5; 4.2.2. review and approve any changes required to the Development Plan for any Collaboration Program in accordance with Section 4.7; 4.2.3. review and monitor progress of each Collaboration Program with input from the JPT; 4.2.4. confirm whether the Lead Candidate Criteria have been achieved by a Therapy; 4.2.5. review and approve changes to the Lead Candidate Criteria for each Collaboration Program; 4.2.6. confirm whether the Clinical Development Candidate Criteria have been met by a Therapy; 4.2.7. review and approve changes to the Clinical Development Candidate Criteria for each Collaboration Program; 4.2.8. review and discuss data arising from the Xxxxx 0 Xxxxxx, Xxxxx 0 Trials or combination of Phase 1 Trials and Phase 2 Trials conducted under the Initial Target Program and determine whether they shall continue based on interim data; 4.2.9. review and monitor progress of the Initial Target Program with input from the JPT and JMC; 4.2.10. generally serve as a forum for exchange of information and to facilitate discussions regarding the conduct of the Collaboration Programs hereunder; 4.2.11. resolve disputes referred from the JPT or JMC; 4.2.12. develop a plan for technology transfer in accordance with Section 6.11 and review and determine the requirement for any additional documentation under Section 6.11 below; 4.2.13. review and approve the regulatory strategy for the Therapy directed to the Initial Target during the Initial Program Option Period; 4.2.14. review and determine the amount of initial training and technical assistance required from Adaptimmune to GSK under Section 6.11 together with the time for provision of such initial training and technical assistance; 4.2.15. addressing the issues assigned to the JSC as set forth in Section 11.9.2; and 4.2.16. such other responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed by the Parties from time to time. 4.3. Save as provided under Section 4.7, the JSC shall meet quarterly or more or less frequently as agreed by the Parties and chairing of the meetings shall be alternated between each Party’s designated representative, unless otherwise agreed. The meetings shall be held at the premises of the Party chairing the meeting unless otherwise agreed. The Parties may also agree to hold such meeting by telephone or video conference or webinar although at least one (1) meeting in any Year shall be in person to the extent possible. The first meeting shall be chaired by Adaptimmune and shall be held within thirty (30) days of the Effective Date. The Alliance Manager for the Party chairing each meeting shall be responsible for arranging the date of the meeting and shall circulate an agenda for the meeting at least ten (10) Business Days prior to the agreed date for the meeting. The other Party shall be entitled to comment on and add items to the agenda and re-circulate the agenda at least five (5) Business Days ahead of the agreed date of the meeting. The Parties shall each be responsible for their own costs and expenses incurred in participating and attending JSC meetings. Copies of data and proposals to be discussed shall be circulated by each Party at least forty eight (48) hours prior to each JSC meeting where reasonably possible.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Adaptimmune Therapeutics PLC), Collaboration and License Agreement (Adaptimmune LTD)
Governance; Collaboration Program Management. 4.1. 4.1 Within fifteen (15) Business Days [***] of the Effective Date, the Parties will assign representatives to form establish a joint steering committee (the “JSC”). The JSC shall be responsible for overseeing the conduct of all Collaboration Programs, and approving the detailed requirements and deliverables for any Collaboration Program as developed by the JPT and/or JMCJPT. The JSC shall have oversight and decision-making responsibilities for activities performed for each Collaboration Program and shall resolve disputes arising at the JPT and JMCJPT. The JPT and JMC (where applicable) shall keep the JSC informed of the progress and activities under each Collaboration Program. The JSC shall be comprised of four (4) [***] representatives (or such other number of representatives as the Parties may agree) from each of GSK and AdaptimmuneImmunocore. Each Party may replace any or all of its representatives on the JSC at any time upon written notice to the other Party in accordance with Section 16.1 or by e-mail to the other Party’s Alliance Manager. Each representative of a Party shall have sufficient seniority and appropriate expertise in biotechnology and pharmaceutical drug discovery and development to participate on the JSC. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party to attend meetings of the JSC as non-voting participants, subject to the confidentiality obligations of Article 10, as may be required by the agenda for such meetings. The Alliance Managers shall also participate as non-voting members in JSC meetings.
4.2. 4.2 In addition to the responsibilities set forth in Section 4.1, the JSC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 4.5:
4.2.1. 4.2.1 review and approve a Development Research Plan for each Collaboration Program in accordance with the timelines set forth in Article 5;
4.2.2. 4.2.2 review and approve any changes required to the Development Research Plan for any Collaboration Program in accordance with Section 4.7;
4.2.3. 4.2.3 review and monitor progress of each Collaboration Program with input from the JPT;
4.2.4. 4.2.4 confirm whether the Lead Candidate Criteria have been achieved by a TherapyCompound;
4.2.5. 4.2.5 review and approve changes to the Lead Candidate Criteria for each Collaboration Program;
4.2.6. 4.2.6 confirm whether the Clinical Development Candidate Candid ate Criteria have been met by a TherapyCompound;
4.2.7. 4.2.7 review and approve changes to the Clinical Development Candidate Criteria for each Collaboration Program;
4.2.8. 4.2.8 review and discuss data arising from the Xxxxx 0 Xxxxxx, Xxxxx 0 Trials or combination of Phase 1 Trials and Phase 2 I Trials conducted under the Initial Target Program and determine whether they shall continue based on interim dataPrograms;
4.2.9. review and monitor progress of the Initial Target Program with input from the JPT and JMC;
4.2.10. 4.2.9 generally serve as a forum for exchange of information and to facilitate discussions regarding the conduct of the Collaboration Programs hereunder;
4.2.11. 4.2.10 resolve disputes referred from the JPT or JMCJPT;
4.2.12. develop a plan for technology transfer in accordance with Section 6.11 and 4.2.11 review and determine the requirement for any additional documentation under Section 6.11 below;
4.2.13. review and approve the regulatory strategy for the Therapy directed to the Initial Target during the Initial Program Option Period;
4.2.14. 4.2.12 review and determine the amount of initial training and technical assistance required from Adaptimmune Immunocore to GSK under Section 6.11 together with the time for provision of such initial training and technical assistance;
4.2.15. addressing the issues assigned to the JSC as set forth in Section 11.9.2; and
4.2.16. 4.2.13 such other responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed by the Parties from time to time.
4.3. 4.3 Save as provided under Section 4.7, the JSC shall meet quarterly or more or less frequently as agreed by the Parties and chairing of the meetings shall be alternated between each Party’s designated representative, unless otherwise agreed. The meetings shall be held at the premises of the Party chairing the meeting unless otherwise agreed. The Parties may also agree to hold such meeting by telephone or video conference or webinar although at least one (1) meeting [***] in any Year shall be in person to the extent possible. The first meeting shall be chaired by Adaptimmune [***] and shall be held within thirty (30) days [***] of the Effective Date. The Alliance Manager for the Party chairing each meeting shall be responsible for arranging the date of the meeting and shall circulate an agenda for the meeting at least ten (10) Business Days prior to the agreed date for the meeting. The other Party shall be entitled [***] to comment on and add items to the agenda and re-circulate the agenda at least five (5) Business Days [***] ahead of the agreed date of the meeting. The Parties shall each be responsible for their own costs and expenses incurred in participating and attending JSC meetings. Copies of data and proposals to be discussed shall be circulated by each Party at least forty eight (48) hours [***] prior to each JSC meeting where reasonably possible.
4.4 The Alliance Manager from the Party that is not the chairing Party shall be responsible for preparing and circulating minutes, within [***] of each meeting of the JSC, setting forth, inter alia, an overview of the discussions at the meeting and a list of any actions and decisions approved by the JSC and a list of any issues to be resolved by the Executive Officers pursuant to Section 4.5. Such minutes shall be effective only after approved by both Parties in writing. With the sole exception of specific items of the meeting minutes to which the members cannot agree and that are escalated to the Executive Officers as provided in Section 4.5, definitive minutes of all JSC meetings shall be finalized no later than [***] after the meeting to which the minutes pertain. If, at any time during the preparation and finalization of the JSC minutes, the Parties do not agree on any issue with respect to the minutes, such issue shall be resolved by the escalation process set forth in Section 4.5. The decision resulting from the escalation process shall be recorded by the Alliance Manager in amended finalized minutes for such meeting.
4.5 Decisions of the JSC shall be made on a unanimous basis with each Party having one vote on the JSC. In the event of any inability to reach a decision at a JSC meeting, the [***] (the “Executive Officers”). Where resolution is still not possible within [***] of referral to the Executive Officers, GSK shall have the final decision-making authority save that GSK shall not be entitled to resolve any dispute in a way which would (a) require amendment of this Agreement; or (b) materially increase or change the scope of work, cost or expenses of Immunocore under any agreed Research Plan for any Collaboration Program or result in a material delay to the Collaboration Program; or (c) result in Immunocore losing any ownership interest in any Foreground; or (d) place patients at excessive risk or which might be reasonably considered to place patient health and safety at risk in a Clinical Trial conducted by Immunocore in accordance with a Research Plan. For the avoidance of doubt, a “material delay” shall mean an additional period of time added to any Program Phase of at [***] of the timelines set forth in the Research Plan. By way of example, if Project Phase 1 is scheduled to take [***] for Completion, then a material delay in that case shall be a suspension of work under Project Phase 1 for a period of [***]. Solely in the case where Immunocore reasonably believes GSK’s final decision will have one or more of the consequences set forth in (a) - (d) above, Immunocore may refer the matter to the dispute resolution process set forth in Article 15.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Immunocore LTD), Collaboration and License Agreement (Immunocore LTD)
Governance; Collaboration Program Management. 4.1. Within fifteen (15) Business Days of the Effective Date, the Parties will assign representatives to form a joint steering committee (the “JSC”). The JSC shall be responsible for overseeing the conduct of all Collaboration Programs, and approving the detailed requirements and deliverables for any Collaboration Program as developed by the JPT and/or JMC. The JSC shall have oversight and decision-making responsibilities for activities performed for each Collaboration Program and shall resolve disputes arising at the JPT and JMC. The JPT and JMC (where applicable) shall keep the JSC informed of the progress and activities under each Collaboration Program. The JSC shall be comprised of four (4) representatives (or such other number of representatives as the Parties may agree) from each of GSK and Adaptimmune. Each Party may replace any or all of its representatives on the JSC at any time upon written notice to the other Party in accordance with Section 16.1 or by e-mail to the other Party’s Alliance Manager. Each representative of a Party shall have sufficient seniority and appropriate expertise in biotechnology and pharmaceutical drug discovery and development to participate on the JSC. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party to attend meetings of the JSC as non-voting participants, subject to the confidentiality obligations of Article 10, as may be required by the agenda for such meetings. The Alliance Managers shall also participate as non-voting members in JSC meetings.
4.2. In addition to the responsibilities set forth in Section 4.1, the JSC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 4.5:
4.2.1. review and approve a Development Plan for each Collaboration Program in accordance with the timelines set forth in Article 5;
4.2.2. review and approve any changes required to the Development Plan for any Collaboration Program in accordance with Section 4.7;
4.2.3. review and monitor progress of each Collaboration Program with input from the JPT;
4.2.4. confirm whether the Lead Candidate Criteria have been achieved by a Therapy;
4.2.5. review and approve changes to the Lead Candidate Criteria for each Collaboration Program;
4.2.6. confirm whether the Clinical Development Candidate Criteria have been met by a Therapy;
4.2.7. review and approve changes to the Clinical Development Candidate Criteria for each Collaboration Program;
4.2.8. review and discuss data arising from the Xxxxx 0 Xxxxxx, Xxxxx 0 Trials or combination of Phase 1 Trials and Phase 2 Trials conducted under the Initial Target Program and determine whether they shall continue based on interim data;
4.2.9. review and monitor progress of the Initial Target Program with input from the JPT and JMC;
4.2.10. generally serve as a forum for exchange of information and to facilitate discussions regarding the conduct of the Collaboration Programs hereunder;
4.2.11. resolve disputes referred from the JPT or JMC;
4.2.12. develop a plan for technology transfer in accordance with Section 6.11 and review and determine the requirement for any additional documentation under Section 6.11 below;
4.2.13. review and approve the regulatory strategy for the Therapy directed to the Initial Target during the Initial Program Option Period;
4.2.14. review and determine the amount of initial training and technical assistance required from Adaptimmune to GSK under Section 6.11 together with the time for provision of such initial training and technical assistance;
4.2.15. addressing the issues assigned to the JSC as set forth in Section 11.9.2; and
4.2.16. such other responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed by the Parties from time to time.
4.3. Save as provided under Section 4.7, the JSC shall meet quarterly or more or less frequently as agreed by the Parties and chairing of the meetings shall be alternated between each Party’s designated representative, unless otherwise agreed. The meetings shall be held at the premises of the Party chairing the meeting unless otherwise agreed. The Parties may also agree to hold such meeting by telephone or video conference or webinar although at least one (1) meeting in any Year shall be in person to the extent possible. The first meeting shall be chaired by Adaptimmune and shall be held within thirty (30) days of the Effective Date. The Alliance Manager for the Party chairing each meeting shall be responsible for arranging the date of the meeting and shall circulate an agenda for the meeting at least ten (10) Business Days prior to the agreed date for the meeting. The other Party shall be entitled to comment on and add items to the agenda and re-circulate the agenda at least five (5) Business Days ahead of the agreed date of the meeting. The Parties shall each be responsible for their own costs and expenses incurred in participating and attending JSC meetings. Copies of data and proposals to be discussed shall be circulated by each Party at least forty eight (48) hours prior to each JSC meeting where reasonably possible.
4.4. The Alliance Manager from the Party that is not the chairing Party shall be responsible for preparing and circulating minutes, within fifteen (15) Business Days of each meeting of the JSC, setting forth, inter alia, an overview of the discussions at the meeting and a list of any actions and decisions approved by the JSC and a list of any issues to be resolved by the Executive Officers pursuant to Section 4.5. Such minutes shall be effective only after approved by both Parties in writing. With the sole exception of specific items of the meeting minutes to which the members cannot agree and that are escalated to the Executive Officers as provided in Section 4.5, definitive minutes of all JSC meetings shall be finalized no later than twenty five (25) Business Days after the meeting to which the minutes pertain. If, at any time during the preparation and finalization of the JSC minutes, the Parties do not agree on any issue with respect to the minutes, such issue shall be resolved by the escalation process set forth in Section 4.5. The decision resulting from the escalation process shall be recorded by the Alliance Manager in amended finalized minutes for such meeting.
4.5. Decisions of the JSC shall be made on a unanimous basis with each Party having one vote on the JSC (irrespective of the number of attendees from each Party at any JSC meeting). In the event of any inability to reach a decision at a JSC meeting, the matter may be referred by either Party to in the case of Adaptimmune, the CEO of Adaptimmune and in the case of GSK, the President of Pharma R&D (or his designee) for resolution (the “Executive Officers”). Where resolution is still not possible within fifteen (15) Business Days of referral to the Executive Officers, GSK shall have the final decision-making authority save that GSK shall not be entitled to resolve any dispute in a way which would (a) require amendment of this Agreement; or (b) materially increase or change the scope of work, cost or expenses of Adaptimmune under any agreed Development Plan for any Collaboration Program or result in a *** to the Collaboration Program; or (c) result in Adaptimmune losing any ownership interest in any Collaboration Program IP; or (d) place patients at excessive risk or which might be reasonably considered to place patient health and safety at risk in any Clinical Trial conducted by Adaptimmune in accordance with a Development Plan; or (e) result in a change to the contributions of the Parties to the Development Plans including as to which Party contracts with any CMO or other subcontractor. For the avoidance of doubt, a *** . By way of example, if Project Phase 1 *** . Solely in the case where Adaptimmune reasonably believes GSK’s final decision will have one or more of the consequences set forth in (a) — (e) above, Adaptimmune may refer the matter to the dispute resolution process set forth in Article 15.
Appears in 1 contract
Samples: Collaboration and License Agreement (Adaptimmune Therapeutics PLC)
