Provision Language
16. General
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16.12. Resolution by senior executives: All disputes, controversies or claims between the Parties in connection with this Agreement, its construction, or the rights, duties or liabilities of either Party under this Agreement (a “Dispute”) must be resolved pursuant to the following resolution process in this clause 16.12 and the jurisdiction clause 16.13. The Parties to any dispute may alter or amend these procedures by agreement in writing.
16.12.1. To commence the resolution process, any Party may serve notice to the other Party identifying: (i) the nature of the Dispute; and (ii) the amount in Dispute.
16.12.2. Once notice is received, the parties must first attempt in good faith to resolve such Dispute by negotiation and consultation between themselves.
16.12.3. In the event that such Dispute is not resolved on an informal basis within 30 days after such notice is received, either Party may, by written notice to the other Party, refer the Dispute to the Executive Director in the case of the M PP and to the Pro Vice Chancellor for Innovation and Enterprise in the case of the University (together the “Designated Officers“) for attempted resolution by good faith negotiation.
16.12.4. If any Dispute is not resolved by the Designated Officers, then either Party may seek resolution by the English Courts, in accordance to clause 16.13.
16.13. Governing law: This Agreement is governed by, and is to be construed in accordance with, English law. Except as provided in clause 16.12 if any dispute is not resolved by the Designated Officers, then the English Courts will have exclusive jurisdiction to deal with any Dispute which has arisen or may arise out of, or in connection with, this Agreement.
Schedule 2 – The Responsibilities of the Parties
Steering Committee (SC)
Purpose: The Steering Committee shall be responsible for the following activities:
a) Selecting the ARV-SDNs for formulation development by the Development Partner;
b) Assigning priorities to the ARV-SDN formulations to be developed;
c) Overseeing and providing guidance during product development to be carried out by the Development Partner;
d) Ensuring that that technology transferred from the University is absorbed in a timely fashion by the Development Partner;
e) Ensuring that the Development Partner conducts product development, regulatory filing, and technology transfer to Commercialisation Partners in a timely fashion; and
f) Facilitating the engagement of third parties, including experts, as needed to assist activities identified above.
Composition: The Steering Committee shall consist of one representative from each of the following parties, as appointed annually:
a) the University and the MPP, prior to the Parties entering into a Sub-Licence Agreement with the Development Partner;
b) the University, MPP and the Development Partner, after the Parties enter have entered into a Sub-Licence Agreement with the Development Partner.
In the event a Steering Committee representative is unavailable, that representative can nominate someone from their own organisation (including consultants) to represent him/her in meetings.
Observers: In addition to the representatives, the Parties may elect two further observers for each meeting. The observers may be re-appointed or replaced for any subsequent meeting.
Meetings: Steering Committee is only quorate if all three representatives from the Parties are present. The presence of observers is not mandatory. Scientific or technical experts may be invited by the Steering Committee to the development team of the Development Partner on an ad hoc basis. Review meetings shall be held in the most cost effective manner:
a) Call(s) every month,
b) In-person or via video-conference at least on a quarterly basis,
c) In-person meeting at least once every six (6) months.
Cost: Steering Committee members and observers will not be compensated financially for their time spent on the Steering Committee. Travel costs shall be reimbursed from the project budget if the
project is funded by an external funder. If the project is funded by the Development Partner, all Steering Committee members and observers shall cover their own costs.
Specific activities of the Steering Committee:
1. Review the Development Partner’s draft development plan submitted as part of its expression of interest, and suggest improvements and amendments to the plan as needed for the purpose of:
i. Helping the Development Partner refine its development steps; and
ii. Helping the Development Partner specify its development timelines and milestones.
2. Work with the Development Partner’s development team, and help them finalise regulatory strategy/pathway; review and prioritise regulatory filings in the Territory with MPP’s assistance.
3. Work with the Development Partner’s development team, and help them finalise development and manufacturing strategy for the ARV-SON (meaning the ARV-SON powder prior to being formulated into appropriate dosage forms) and appropriate SON formulations, among other activities, which could be done in-house or out-sourced to third party as deemed acceptable by the Steering Committee.
4. (To be carried out by the Development Partner’s designated project manager and MPP’s designated business development manager): Schedule review meetings and ensure that the meetings take place as planned; run the review meetings, circulate meeting minutes, and follow up on the implementation of suggestions.
5. Through review meetings, monitor product development progress in reference to specified development plan; any change to the specified development plan requires the written approvals of the Steering Committee representatives from all three parties.
6. Oversee technology transfer from the University to the Development Partner and subsequently from the Development Partner to the Commercialisation Partners; helping the Development Partner and Commercialisation Partners troubleshoot issues whenever possible.
7. Review, finalise and approve the Development Partner’s budget proposal; monitor and ensure adherence to said budget;
8. Establish milestones for the product development, and
i. Approve disbursal requests
ii. Approve major capital expense required to be taken out of the project funding
iii. Approve major out-sourced vendors that have material bearing on the project time and costs.
9. Review, provide guidance on and approve staffing plan specific to the product development project.
10. Decide if audits are required and commission audits on product development activities as needed.
11. Help set up scientific or advisory panels as required and whenever applicable, recommend experts.
12. Reporting on product development (to be carried out with help from the project managers designated by the MPP and the Development Partner): review and approve status reports for MPP, University and Development Partner on key parameters of the projects such as: status of technology transfer, progress of product development, milestones met, projected dates of meeting future milestones, deviations from specified development plans with appropriate reasons, challenges and resolution or resolution plan, budget status, regulatory strategy/pathway and updates, regulatory filing status, audit reports, breach of agreements and resolution.
13. Conferences and meetings: decide on conference participation for presentation on the data relating to the project with the goal of improving visibility of the ARV-SDN formulations and help with uptake; review and approve publications, including conference abstracts, presentations and posters, and publications intended for submission to academic/clinical journals.
14. Communication: review and approve sections relating to product development in public communications concerning the project.