MAPGuideⓇ
Equitable Access Toolkit

Incorporating Quality Assurance Considerations into Funding Agreements

Quality assurance requirements are an important consideration for ensuring that best practices and standards are not compromised in the pursuit of affordable and accelerated access, and that patients receive safe and effective products. Funding agreements can include quality assurance provisions requiring funded partners to adhere to quality standards relevant to the funded stage of product development. These obligations may include:

Compliance with national laws.

Compliance with one or more established best practice standards such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP, or cGMP), and Good Distribution Practice (GDP) (also collectively known as “GxP”).

Manufacturing finished products in compliance with the quality standards of the WHO Prequalification Programme (WHO PQ) or a WHO Listed Authority or Stringent Regulatory Authority (SRA), and/or an undertaking not to sell or supply a funded product until approval has been obtained from the required regulatory authority(ies).

Where applicable (for example, diagnostic products or medical devices), manufacturing products in accordance with relevant ISO standards.

Conduct of the funded project in compliance with applicable environmental and responsible manufacturing standards.

A requirement for the funded partner to establish and maintain appropriate quality assurance systems to ensure compliance with applicable standards.

A requirement for the funded partner to have its own written standards of good research practice and procedures for investigating allegations of scientific misconduct.

A requirement for the funded partner to promptly notify the funder of any quality issues identified.

Rights for the funder or its representative to inspect the funded partner’s records and facilities to verify compliance with quality standards, and the available remedies if the partner is found not to be in compliance.

Examples from the MAPGuide

Unless otherwise agreed by the Parties in writing, each Partner shall ensure that all components of the Project Vaccine are manufactured to GMP and any other applicable standards (including ISO9001).

Source: taken from a USD $34.8 million funding agreement between CEPI (Funder) and the University of Oxford and Barinthus Biotherapeutics (Developers). Partner types: non-profit funder, industry/academic institution; Product type: MERS vaccine; Development stage at signature: early stage development. Read in context.

 Awardee shall ensure that all activities performed under this agreement shall be performed in accordance with all applicable safety, legal, ethical and regulatory authority requirements or standards, including the [Funder] Third Party Code, any associated regulatory approval, clinical trials application and/or all applicable GxPs.

During the term, awardee will:

  • inform [Funder] of any significant quality-related issues, events or changes that are reasonably likely to adversely affect the supply of Products to Non-Traveler’s Market Countries;
  • within [***], notify [Funder] of the outcome of GxP regulatory inspections and any material adverse quality findings and any critical quality events (including serious breaches, deviations, audit findings, breaches of data integrity etc.) that are reasonably likely to adversely affect the supply of Products to Non-Traveler’s Market Countries; and
  • consider in good faith quality recommendations identified by [Funder] relating to the Project as may arise throughout the course of the Term in respect of the supply of Products to Non-Traveler’s Market Countries.

[…]

 Awardee shall, and shall use commercially reasonable endeavours to facilitate that the LMIC Manufacturers, permit [Funder], or its designee (subject to prior written consent by Awardee and/or the LMIC Manufacturer (as applicable) or such designee, not to be unreasonably conditioned, withheld or delayed), to conduct a detailed due diligence assessment of the relevant party’s quality systems on-site, provided such site visits shall be restricted to [***] visit per manufacturer each [***] during the Term. [Funder] shall cause its designee to enter into a reasonably acceptable confidentiality agreement with the relevant party obliging such designee to retain all such information in confidence pursuant to such confidentiality agreement. In the event that such assessment identifies any major or critical deficiencies in the relevant party’s quality system, Awardee shall, or shall obligate the LMIC Manufacturer to, take all actions reasonably necessary to correct such deficiencies.

Source: taken from a USD $41.3 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: licensed product. Read in context.

 XYZ shall ensure compliance at all times with the following;

  • Ensure an appropriate QMS covering in vitro diagnostic products, is in place and compliant with SRA and/or WHO Pre-qualification (“PQ”) requirements.

Source: taken from sample terms and conditions for FIND project investment agreements. Partner types: PDP, industry; Product type: diagnostics; Development stage at signature: project-dependent. Read in context.

 [Funder] expects the highest standards of integrity to be adhered to in the Projects it funds. For research grants, the Host Institution must have in place written standards of good research practice and written procedures for the investigation of allegations of scientific misconduct. Copies of these must be provided to [Funder] on request.

Source: taken from the standard grant terms and conditions for GOSH Charity (Funder). Partner types: philanthropic funder, academic institution, non-profit research institution; Product type: products for prevention, diagnosis, prognosis, or treatment of rare or complex paediatric diseases; Development stage at signature: early stage R&D. Read in context.

 The Company acknowledges the environmental, social and governance requirements of [Funder] set forth on Exhibit [x] and agrees to observe the referenced International Finance Corporation (“IFC”) performance standards.

Source: taken from a global health agreement between Adjuvant Global Health Technology Fund (Funder) and AN2 Therapeutics (Developer) signed in connection with a USD $7 million share purchase by Adjvant. Partner types: impact investor, industry; Product type: melioidosis and tuberculosis therapeutic (Epetraborole); Development stage at signature: preclinical. Read in context.

The Company is in compliance and will remain in compliance in all material respects with all applicable laws and regulations (including all laws and regulations related to clinical trials, human health and safety, the protection of the environment, research, development and manufacture of vaccines and drugs intended for human use) necessary to enable the Company to perform its obligations under the Investment Documents and in connection with each Project, and as of the Effective Date the Company is not aware of any action filed or commenced against the Company alleging any failure to comply. The Company is and will remain in compliance with all applicable cGMPs, Good Clinical Practices, Good Laboratory Practices and Good Industry Practices. The Company is not aware of facts that (with or without notice or lapse of time, or both) could reasonably be expected to result in the Company being in violation in any material respect of any law materially applicable to the Company’s performance of its obligations under the Investment Documents and in connection with each Project. The Company has in place and shall continue to maintain for the duration of its obligations under this Agreement and each Project, a compliance program reasonably designed to identify, prevent, and address any compliance issues.

Source: taken from a global access commitments agreement between the Gates Foundation (Funder) and CureVac (Developer) signed in relation to an investment in CureVac by the Foundation. Partner types: philanthropic funder, industry; Product type: vaccines and drugs for target diseases using mRNA platform technology; Development stage at signature: preclinical. Read in context.

The Recipient shall plan and implement the Project in a manner that promotes sustainable development and the protection of the environment.

Source: taken from the general grant terms and conditions for the Canada IDRC. Partner types: public funder, industry/academic institution; Product type: project-dependent; Development stage at signature: project-dependent.

Related Considerations
Pricing terms

Does the definition of affordable pricing consider achieving the lowest possible pricing while maintaining quality standards?

IP rights management

Are any requirements for licensing and technology transfer to alternative manufacturers  contingent on the identification of partners able to manufacture the product in accordance with quality standards?

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This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.