Within ten (10) Business Days following the end of each Agreement Quarter, the Licensee shall provide the Licensor with a quarterly written report on the status of development of, and any planned, as well as any filed and/or obtained, regulatory filing, and/or submissions for WHO prequalification and/or WHO Expert Review Panel review regarding the Licensed Product in relation to that Agreement Quarter. Such reporting shall be made in accordance with the Reporting Guidance issued by the Licensor and should cover (a) status of development of the Licensed Product, (b) regulatory filing plan for the Licensed Product, and (c) a list of countries for which such regulatory approvals or authorizations have been filed and/or obtained for the Licensed Product. The Parties agree to confer on a quarterly basis regarding such reports and also review development and filing status of the Licensed Product. […]

Source: Taken from a memorandum of understanding between Ferring (Licensor) and MPP (Licensee). The MOU includes a form of license agreement and sublicense agreement. Partner types: industry, multilateral; Product type: prevention and treatment of post-partum hemorrhage (heat-stable carbetocin); Development stage at signature: WHO PQ for prevention; clinical trials for treatment. Read in context.

The [Joint Product Committee] will:

(a) Oversee the planning and implementation of development activities, including post-Regulatory Approval activities;

(b) Review results of the development activities and discuss modifications to any planned development activities;

(c) Facilitate the exchange of regulatory documents and other regulatory information between the Parties;

(d) Review the Marketing Plan developed by LICENSEE and its implementation;

(e) Discuss the state of the markets for Licensed Product in the Territory and opportunities and issues concerning the Commercialization of Licensed Product, including consideration of marketing and promotional strategy, marketing research plans, labeling, Licensed Product positioning and Licensed Product profile issues;

(f) Monitor the sales efforts of Licensee in the Territory;

(g) Oversee and update the Outreach Plan; provided that any changes during the Exclusivity Term to Paragraph [x] of the Outreach Plan will not be subject to decision by the JPC and must be made, if at all, by amendment or modification of this Agreement.

(h) Have authority to establish one or more other committees that report to the JPC and assist the JPC in carrying out its responsibilities, which other committees will be subordinate to the JPC, will have such membership and responsibilities as the JPC will determine, and may be disbanded by the JPC at any time;

(i) Resolve, or attempt to resolve any disputes not resolved by any subordinate committee created by the JPC; and

(j) Perform such other functions as appropriate to further the purposes of this Agreement and as allocated to it jointly in writing by the Parties.

Source: taken from a license agreement between The Population Council (Licensor), and TherapeuticsMD, Inc. (Licensee). Partner types: non-profit research organization, industry; Product type: contraceptive (Nestorone); Development stage at signature: FDA regulatory review. Read in context.

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 [Licensee]’s assistance.

3. Work with the Development Partner’s development team, and help them finalise development and manufacturing strategy for the [product] (meaning the [product]powder prior to being formulated into appropriate dosage forms) and appropriate [product] 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 [Licensee]’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 [Licensor] 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 [Licensee] and the Development Partner): review and approve status reports for [Licensee], [Licensor] 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 [product] 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.

Source: taken from a license agreement between the University of Liverpool (Licensor) and MPP (Licensee). Under the agreement, MPP is expected to enter into sublicenses with Development Partners. Partner types: multilateral, academic institution; Product type: HIV therapeutic (nanomedicine); Development stage at signature: early clinical. Read in context.

The Parties agree to form a Development Committee to oversee the Development Plan and the Development activities performed by [Licensee] under this Agreement and the Project Agreements. The Parties acknowledge that development oversight is necessary solely for proper reporting by both [Licensor] and [Licensee] to [Funder] on the progress of the [Licensee] Product to be accessible to the public health market in the [Licensee] Territory, at an affordable price.

[…]

Development Committee. The Parties shall appoint a development committee of equal number of members designated by [Licensor] and [Licensee], respectively, no later than [***]after the Effective Date (“Development Committee”). The members from each Party collectively will have one (1) vote. The function of the Development Committee shall be to: (i) review and comment upon updates and changes to the [Licensee] Development Plan; (ii) advise on the Development of the [Licensee] Product generally; (iii) review the progress of the [Licensee] Development Plan and any related activities; (iv) appoint subcommittees (with equal participation by the Parties) and set forth the applicable procedures of operation for such subcommittees, and (v) otherwise oversee the [Licensee] Development Plan. The Development Committee shall hold meetings at least quarterly and at such other times as the Parties may agree or may be necessary. Meetings shall be held by teleconference or videoconference; provided, however, that there shall be at least [***] per calendar year, unless the Parties agree otherwise. Face-to-face meetings shall alternate between the principal business locations of the Parties or be held at such other location as may be mutually agreed upon by the Parties. Within [***] following the meeting of the Development Committee, [Licensee] will provide [Licensor] with the draft meeting minutes for review, including any decisions made by the Development Committee and any action items to be completed. Each Party shall bear its own costs and expenses incurred in connection with such meetings.

Source: taken from a license agreement between Valneva (Licensor) and Serum Institute of India (Licensee). The access commitments in this agreement are related to a funding agreement between Valneva and CEPI. Partner types: industry; Product type: chikungunya vaccine; Development stage at signature: phase 3 clinical trials. Read in context.