Master Alliance Provisions Guide (MAPGuide)

Funder Development Partnering Agreement

  • Business model | Governance

5. Project Management and Oversight

5.1 Project Lead and Project Manager. The Partner shall ensure that the Project Lead shall lead each Work Phase and shall assume the responsibilities of the Project Lead as set out in this Agreement. The Partner shall further ensure that the Project Lead has project management support to ensure that there is efficient co–ordination of each Work Phase on a day–to–day basis.

5.2. Project Lead replacement. If the Project Lead ceases to be involved with the Project, ceases to be employed by or provide services to the Partner, ceases to carry out research at premises controlled by the Partner, or is prevented from working on the Project through illness or injury for a period of over one (1) month, the Partner shall promptly notify FUNDER. In such a case, the Parties will seek to agree a suitable replacement Project Lead as soon as possible.

5.3. Joint Monitoring and Advisory Group. The Parties shall establish a JMAG to oversee all Work Phases as well as the Development, Manufacturing, Regulatory and Marketing Activities of any Product including:

5.3.1. monitoring the performance of each Work Phase and technical content of the Work Phase against the Milestones;

5.3.2. critically assessing the results of each Work Phase on an on–going basis and identifying and addressing any weaknesses or delays in any Work Phase;

5.3.3. subject to Clause 5.4, reviewing and approving the Development Plan, material changes and updates to the Development Plan (including any matters pertaining to any budget for Development) and progress against the Development Plan;

5.3.4. reviewing and approving the regulatory strategy for any Product in the Affected Territory, with any Approved Regulatory Authority and the Regulatory Filings with each;

5.3.5. reviewing and approving the Marketing Activities Plan and any material changes thereto (including any matters pertaining to budget);

5.3.6. receiving periodic updates on Outbreak System Activities, material Development activities, Outbreak Preparation Activities, Outbreak Response Activities and regulatory activities conducted or proposed to be conducted with respect to Product in the Affected Territory (including submission and prosecution of applications for Marketing Approval);

5.3.7 providing a forum for discussion as to whether Development and Marketing Activities are sufficient to satisfy FUNDER’s Mission and the Parties obligations to use Reasonable Efforts;

5.3.8. reviewing safety and compliance reports for the Product in the Affected Territory and providing a forum for co–ordinating the Parties’ responses to crises with respect to the Product, including unexpected disruptions to the supply of the Product, recalls, safety issues or withdrawals of Product;

5.3.9. reviewing and approving potential sublicenses; and

5.3.10. making such other decisions as may be delegated to the JMAG pursuant to this Agreement or by written agreement of the Parties.

5.4. No right to approve Milestones. The JMAG shall have no right to approve the achievement of Milestones (which right is reserved to FUNDER pursuant to Clause 3.8), to amend or vary the provisions of this Agreement, to alter the fundamental scope or objectives of the Project, or to change or enter into any Work Phase Statements which power is reserved to the Parties.

5.5. JMAG Composition. The JMAG shall be comprised of the following persons (“Members”):

5.5.1. the Project Lead, who shall be the chairperson of the JMAG;

5.5.2. an independent expert adviser with experience which is relevant to the Project; such Member to be agreed between the Parties. The costs and expenses of the independent expert adviser shall be met out of the FUNDER Funding; and

5.5.3. a FUNDER representative or nominee; FUNDER may, at its sole discretion, appoint or remove any FUNDER representative or nominee plus any accompanied expert(s) serving a FUNDER advisory capacity but who are not Members.

5.6. Quorum. The quorum for JMAG meetings shall be three (3) Members being the FUNDER Member, the Project Lead and the independent expert adviser. Decisions of the JMAG shall be made by unanimity of Members; where consensus cannot be reached, the matter shall be escalated in accordance with Clause 17.1.

5.7. Meeting Organisation. The Project Lead shall be responsible for organising JMAG meetings, including preparing meeting papers and ensuring that minutes of meetings are produced promptly after each meeting and circulated to Members in a timely manner. The Project Lead shall convene JMAG meetings at least once every three (3) months during each Work Phase, and after the end of the Project at least once every six (6) months (or less frequently with FUNDER’s consent). The Project Lead shall ensure that except in exceptional circumstances all Members are provided with at least ten (10) Business Days’ written notice of the JMAG meeting (accompanied by an agenda for the meeting, and a report on the progress of the Project, a spend report setting out use of the FUNDER Funding and details of the Partner’s Contribution used in the Project).

5.8. Attendance. Members may attend any JMAG meeting by telephone or other electronic means rather than in person, provided that all Members attending the meeting can hear and be heard for all parts of the meeting. Members attending a JMAG meeting by telephone or other electronic means shall have the same voting rights as a Member present in person.

5.9. Expert attendees. Each of the Parties may invite other members of their staff or consultants or other persons whose special skills or knowledge might advance the Project, the Development, Manufacturing, Regulatory and Marketing Activities of any Product or the FUNDER Mission to attend and address JMAG meetings as observers; such observers shall not be Members and shall not have a right to participate in JMAG decision–making process. With regards to notifications to JMAG of Project Inventions, JMAG shall solicit the advice of appropriate intellectual property counsel. The Project Lead shall ensure that any such observers sign confidentiality agreements in a form acceptable to both Parties.

17. Dispute Resolution, Governing Law and Jurisdiction

17.1 Escalation process. Any question, difference or dispute which may arise concerning the construction, meaning or effect of this Agreement, or concerning the rights or liabilities of the Parties hereunder, or any other matter arising out of or in connection with this Agreement shall first be submitted to the Chief Executive Officer of FUNDER and [Name, Title] of the Partner (the “Senior Officers”) for resolution (each of whom may call on others to advise them as they see fit). The Senior Officers shall discuss the matter arising in good faith and in a timely manner and endeavour to reach a mutually agreeable solution. If the Parties are unable to resolve such dispute through such negotiations within sixty (60) days of such dispute being escalated to the Senior Officers, then in respect of any dispute, controversy or claim other than those that concern:

17.1.1. the validity or infringement of Intellectual Property;

17.1.2. anti–trust, anti–monopoly or competition law or regulation; and

17.1.3. breach or threatened breach of Clauses 9, 10, 11 and 13,

the Parties irrevocably submit to arbitration in accordance with Clause 17.2. In respect of disputes relating to Clauses 17.1.1 to 17.1.3, (inclusive), the Parties irrevocably submit to the exclusive jurisdiction of the Courts of England and Wales.

17.2. Arbitration. Any disputes to be resolved by binding arbitration pursuant to Clause 17.1 (including any question regarding its existence, validity or termination or this Agreement), shall be referred to and finally resolved by arbitration under the LCIA Rules, which Rules are deemed to be incorporated by reference into this Clause. The number of arbitrators shall be one. The seat, or legal place, of arbitration shall be London, England. The language to be used in the arbitral proceedings shall be English.