Shionogi – GARDP, Cefiderocol License Agreement

Protecting & sharing information | Technology transfer

Summary of Approaches

What is included in the technology and/or materials to be transferred?
- At GARDP’s request, Shionogi must provide a single technical transfer of its manufacturing process to the first GARDP sublicensee ready to manufacture a licensed product. The transfer must include documentation that contains all manufacturing know-how reasonably necessary to effectuate the tech transfer and the reasonable assistance of Shionogi to enable its understanding and use.
What are the responsibilities of each party to in relation to the transfer of materials and/or technology?
- Shionogi must provide an electronic copy of the transfer documentation to GARDP, CHAI and the GARDP manufacturing licensee. Shionogi must provide reasonable assistance to the sublicensee.
- Technology transfers to additional sublicensees are the responsibility of GARDP, CHAI and/or the first manufacturing sublicensee.
- The entire technology transfer package, together with all related information and materials provided by Shionogi, are trade secrets.

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

4. TECHNICAL ASSISTANCE

[…]

4.2 Technical Transfer and Technical Transfer Package

(a) Shionogi shall be responsible at GARDP’s request for providing one technical transfer of its Manufacturing process to a Manufacturing Sublicensee in accordance with the Collaboration Agreement and the Market Access Plan (which technical transfer may, depending on the circumstances, involve a separate technical transfer of the Licensed Compound Manufacturing process to one entity and of the final Licensed Product Manufacturing process to another). This technical transfer shall include a transfer of a package of documentation to be prepared and provided by Shionogi for such Sublicensees’ use (the Technical Transfer Package) that contains all the Licensed ManufacturingKnow-How reasonably necessary for the effective technical transfer thereof, and a technical transfer process pursuant to which Shionogi or its contractors will provide reasonable assistance to enable the understanding and implementation of the Licensed Manufacturing Know-How. Shionogi will provide the Technical Transfer Package for the first Sublicensee set to Manufacture the Licensed Product in accordance with Shionogi’s Licensed Manufacturing Know-How pursuant to this License Agreement. Shionogi shall be responsible for providing one set of electronic copies of the Technical Transfer Package to the relevant Manufacturing Sublicensee; GARDP and/or CHAI shall also receive a set of electronic copies of the Technical Transfer Package. Any subsequent Sublicensee will be provided the Technical Transfer Package and all other assistance and support necessary to effect the transfer thereto by GARDP and/or CHAI and/or by the Manufacturing Sublicensee that received the initial technical transfer. The Technical Transfer Package and all information and materials provided by or on behalf of Shionogi in connection therewith are trade secrets of Shionogi.

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