Shionogi – GARDP, Cefiderocol License Agreement

Protecting & sharing information | Publication of Results

Summary of Approaches

What information are the parties required or permitted to publish?
- Shionogi, GARDP and GARDP sublicensees are permitted to publish, for scientific purposes, drug-development results which the party generated.
- Shionogi is entitled to review proposed publications when they relate to licensed products or any Shionogi proprietary or confidential information.
- Shionogi may remove confidential information and request reasonable delays for patent filings.
- Sublicense provisions: The requirements in the sublicense follow those in the head license.

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

8. INVENTIONS, PATENT MAINTENANCE, INFRINGEMENT span>b>span> span>b>p>
8.3 Development Activity License Results b>p>
(a) With respect to any inventions, know–how or results (whether or not patentable) developed or generated by or for GARDP and/or a Sublicensee in the performance of any Development activities conducted pursuant to this License Agreement or any Sublicense Agreement other than <a href=”#kt“>Developmenta> activities relating to <a href=”#kt“>Manufacturing a> (the results of which are governed by Section 8.2) (span>Development Resultsem>b>): span>p>
[…]span>p>
(iii) Each Party or as applicable the Sublicensee shall have the right to publish for scientific purposes Development Results developed or generated by or for such party (subject if applicable to the rights of one or more other parties that may also have participated in the development or generation thereof), subject to, with respect to any such Development Results that relate to the Licensed Product or any Shionogi proprietary or confidential information: (A) Shionogi’s prior review of any such proposed publication, (B) Shionogi’s right to remove Shionogi <a href=”https://ghiaa.org/provision_document/shionogi–gardp–cefiderocol–license–agreement–6/” target=”_blank” rel=”noopener“>Confidential Informationa>span> (but not the Development Results themselves) from any such proposed publication, and (C) any reasonable delay in publication requested by Shionogi for Shionogi to file any related patent applications. Shionogi shall have the right to oppose any such proposed publication for failure to comply with the foregoing requirements, or any objection based on reasonable concerns relating to the accuracy and/or quality of the data referenced therein, and the publication may not proceed until Shionogi’s opposition based on the above has been resolved as set forth herein. Any disagreement regarding proposed publications contemplated by this Section 8.3(a)(iii) shall be escalated for resolution to the Joint Steering Committee (span>JSCb>em>) formed pursuant to the Collaboration Agreement; a representative of the Sublicensee will be invited to the JSC meeting if the disagreement concerns a publication containing Development Results generated by the Sublicensee.span>p>
Schedule F: Provisions for Sublicense Agreementb>span>p>
6. Intellectual Propertystrong>p>
Development Activity Sublicense Results span>span>p>
(iii) Each Party shall have the right to publish for scientific purposes Development Results developed or generated by or for such Party (subject if applicable to the rights of one or more other parties that may also have participated in the development or generation thereof), subject to, with respect to any such Development Results that relate to the Licensed Product or any proprietary or confidential information of Licensor, (i) Licensor’s and Sublicensor’s prior review of any such proposed publication, (ii) Licensor’s right to remove its confidential information (but not of the Development Results themselves) from any such proposed publication, and (iii) Licensor’s right to request a reasonable delay in publication for Licensor to file any related patent applications. Licensor shall have the right to oppose any such proposed publication for failure to comply with the foregoing requirements, or for any objection based on reasonable concerns relating to the accuracy and/or quality of the data referenced therein, and the publication may not proceed until Licensor’s opposition based on the above has been resolved as set forth herein. Any disagreement regarding proposed publications contemplated by this Section shall be escalated for resolution to representatives of the Licensor, the Sublicensor and the Sublicensee.p>

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Shionogi – GARDP, Cefiderocol License Agreement

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Shionogi – GARDP, Cefiderocol License Agreement

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