Shionogi – GARDP, Cefiderocol License Agreement

Business model | Product supply

Summary of Approaches

What are the specific commitments made by the parties to supply and purchase the products?
- GARDP sublicensees must provide a sufficient or adequate supply to meet the needs of countries with their territory.
- Shionogi retains the right to conduct a compassionate use program in any country in the Territory. These programs may be transferred to GARDP or their sublicensees once a sublicense is able to manufacture a product that can be used for these purposes. However, Shionogi and GARDP may also agree on separate arrangements considering the need for sustainable supply and regulatory requirements in a particular country.
- Sublicense provisions: GARDP may agree not to seek another partner for the territory of a particular sublicensee, as long as that sublicensee is fulfiling its diligence commitments.
What actions must be taken by the supplier to ensure that it can fulfil the committed supply volume?
- Sublicensees’ precise obligations are set forth in their respective sublicense access plans.

Annotations

This License and Technology Transfer Agreement is between Shionogi, a public pharmaceutical company located in Japan, and the Global Antibiotic Research and Development Partnership (“GARDP”), a Swiss nonprofit antibiotic R&D organization. The Agreement governs a non-exclusive license of Shionogi technology relating to the antibiotic drug cefiderocol and technology transfer necessary for third party sublicensees to develop and commercialize the drug in a list of high-, middle-, and low-income countries (“Territory”). The Agreement is effective as of June 15, 2022.

The Agreement includes provisions for the sublicense agreements between GARDP and third parties in Schedule F. We have included these provisions under the relevant MAPGuide issues as part of our analysis of the agreement.

The Agreement is part of a broader collaboration between the Clinton Health Access Initiative (“CHAI”), Shionogi and GARDP, which is governed by a separate agreement (“Collaboration Agreement”). The Collaboration Agreement addresses operational aspects of the collaboration, including a “Market Access Plan”, which plans and tracks the specific activities required of Shionogi and GARDP. The collaboration aims to achieve both affordable and sustainable access to medication and good antimicrobial stewardship.

Shionogi’s primary role in the Agreement is to license cefiderocol technology, provide an initial technology transfer and grant access to data already submitted to regulatory authorities. GARDP’s role is to manage a network of sublicensees to develop and commercialize cefiderocol. However, Shionogi has significant control over sublicensing. Some notable examples include: the right to refuse proposed sublicensees and proposed sublicense access plans, which set forth sublicensee commercialization plans. Shionogi also has the right to veto proposed development activities, including clinical trials, regulatory filings and trademarks. GARDP and GARDP sublicensees are jointly and severally liable for sublicensees for certain breaches of the Agreement or relevant sublicense agreement.

While Shionogi must refer enquiries from potential sublicensees to GARDP for joint evaluation, Shionogi ultimately may decide to directly license the technology for commercialization in the same territory.

Provision Language

Definitionsstrong>em>p>
“Compassionate Useb>” means the use of Licensed Product outside of a clinical trial in a country where it has not been approved for commercialization and in accordance with applicable laws or regulations that allow such use to treat a patient with a serious or life–threatening disease or condition who has no comparable or satisfactory alternative treatment options. span>p>
2. LICENSE GRANTstrong>span>p>
2.3 Sublicenses b>p>
[…]p>
(q) Each Sublicensee that will <a href=”#kt“>Manufacturea> the Licensed Compound and Licensed Product for use and sale in the Territory will (i) do so in strict conformity with the applicable conditions specified in this License Agreement and their Sublicense Agreement, and (ii) use commercially reasonable efforts in accordance with the applicable <a href=”https://ghiaa.org/provision_document/shionogi–gardp–cefiderocol–license–agreement–4/” target=”_blank” rel=”noopener“>Sublicense Access Plana>span> to provide a sufficient supply thereof to meet the needs in the countries of the Territory. Without limiting the foregoing and to the extent applicable, each Sublicense Agreement with a Sublicensee that Manufactures Licensed Product shall require the Sublicensee to Manufacture the Licensed Product: (a) in a manner consistent with and in accordance with standards validated by a World Health Organization prequalification (span>WHO PQ b>) or by any applicable <a href=”#kt“>Stringent Regulatory Authoritya> (if the manufacturing site has already been approved by a Stringent Regulatory Authority) or, if neither WHO PQ or an SRA has assessed and confirmed compliance with such manufacturing standards, by a Third Party audit (including relative to GMP) to confirm adherence with WHO PQ and/or SRA standards, such third party to be agreed by both Parties; and (b) any applicable industry standards for responsible Manufacture of antibiotics.span>p>
[…]p>
2.13 Compassionate Usestrong>p>
The Parties agree that after the Effective Date of this License Agreement, Shionogi shall retain all rights to initiate and conduct a Compassionate Use or comparable early access program using Licensed Product Manufactured by Shionogi in all countries in the Territory. Once Licensed Product manufactured by a Sublicensee (including Licensed Product from the initial validation batch) can be used for such purposes under applicable laws and regulations, the conduct of Compassionate Use or comparable early access programs shall be transitioned to GARDP and/or applicable Sublicensee(s) for the Territory; provided that Shionogi may, in coordination with GARDP, choose to continue to conduct Compassionate Use or comparable early access programs for one or more countries in the Territory. Notwithstanding the foregoing, Shionogi and GARDP may agree on a case–by–case basis on an alternative approach for one or more countries in the Territory taking into account relevant criteria, such as the sustainable availability of sufficient quantities of Licensed Product for the applicable country(ies) (Manufactured by Shionogi), the agreement of Sublicensees to conduct such activities, and relevant regulatory considerations. span>p>
5. COMMERCIALIZATIONb>span>p>
[…]p>
(d) Each Sublicense Agreement will contain an obligation for the Sublicensee to use commercially reasonable efforts in accordance with the applicable Sublicense Access Plan to provide an adequate supply of the Licensed Product to meet the therapeutic needs in the countries of the Territory covered by their Sublicense.span>p>
Schedule F: Provisions for Sublicense Agreementb>span>p>
4. Sublicensor Commitment [OPTIONAL].strong> So long as Sublicensee is complying with its diligence obligations, Sublicensor hereby agrees not to seek another market access partner for the country(ies) covered by this Agreement. For the avoidance of doubt, nothing herein shall restrict Licensor or its agents’ development , manufacture, registration, or commercialization of the Licensed Product in the Territory. span>p>

Master Alliance Provisions Guide (MAPGuide)

Shionogi – GARDP, Cefiderocol License Agreement

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Shionogi – GARDP, Cefiderocol License Agreement

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