Entasis – DNDi/GARDP, Gonorrhoea Medication, Collaboration Agreement

Protecting & sharing information | Publication of results

Summary of Approaches

What information are the parties required or permitted to publish?
- The parties are encouraged to publish scientific data and the results of the collaboration program.
- If the parties choose to publish they must give the other party an opportunity to review and comment.
- The party proposing publication must remove confidential information on request and delay for a period of up to 90 days to permit the other party to seek patent protection.
What are the acceptable publication channels?
- Results can be shared through scientific journals, abstracts and conferences.

Annotations

This collaboration agreement (“Agreement”) for the development and commercialization of a gonorrhea drug is between Entasis Therapeutics Limited, a U.K.-registered subsidiary of an antibiotic resistance biotech firm, and Drugs for Neglected Diseases initiative (“DNDi”), a nonprofit drug research and development organization. DNDi acted through the Global Antibiotic Research and Development Partnership (“GARDP”), which was then an unincorporated DNDi partnership with the World Health Organization. The parties agreed to jointly develop gonorrhoea products using Zolliflodacin, an oral antibiotic developed with support from the National Institutes of Health (“NIH”). The Agreement is effective as of July 4, 2017. In 2019, GARDP, which had become an independent nonprofit foundation, replaced DNDi as a contractual party on the same terms as in the original Agreement.

When the Agreement was executed, Entasis had already filed an investigational new drug application with the FDA, and completed two phase 1 clinical trials and a phase 2 trial. The Agreement contemplates that the parties will conduct additional studies, beginning with a QT trial in the United States, which measures the drug’s impact on an aspect of the heart’s functioning, that Entasis will conduct (“QT Study”). When the QT study is complete, DNDi will sponsor an international, multicenter phase III study (“Phase III MC Trial”). The parties will collaborate on Phase III MC Trial design. DNDi must also conduct chemistry, manufacturing and control (“CMC”) activities as part of drug development. The regulatory strategy is based in part on Entasis obtaining authorization from the FDA and EMA first.

A Joint Steering Committee (“JSC”) manages the collaboration in accordance with a development plan, regulatory plan, and manufacturing and supply plan. The development and regulatory plans were attached to the Agreement but redacted. The manufacturing and supply plan was to be negotiated after the collaboration began.

Each party grants the other an exclusive license in its background technology and foreground technology, which the Agreement calls “collaboration technology”. Both parties must share manufacturing know-how. Entasis must share API know-how needed for some DNDi development activities. The Agreement does not contemplate jointly-owned foreground technology.

The Agreement includes provisions to prevent antibiotic resistance, including a prohibition on development for “future indications” without both parties’ consent. When negotiating a manufacturing and supply plan, the parties must minimize the number of manufacturing sublicencees in order to ensure continued efficacy and responsible use of the product.

Entasis’ territory includes specified high-income countries. DNDi will commercialize products for the rest of the world. The schedule that defines each party’s exact Territory is redacted, however territory information is available in this GARDP press release.

Provision Language

14. Scientific Publications

14.1 Notwithstanding Clause 13, and in accordance with DNDi’s mission statement on providing access to the public of its research, DNDi and Entasis will encourage publications in scientific journals, abstracts or conferences of the scientific data and/or results of the Collaboration Programme pursuant to this Clause 14.

14.2 Each Party shall submit to the other Party prior to publication any draft publication relating to the Collaboration Programme for review at least twenty–eight (28) days prior to the intended date of publication, and permit it to submit comments which the publishing Party shall reasonably take into account, or object to such publication on the grounds that it discloses patentable inventions or discloses confidential technology of a Party. Should Patent Rights be sought by a Party upon any data in the draft publication, publication can be delayed by a maximum period of ninety (90) days to allow for drafting of the Patent Rights application. Each Party will, on the reasonable request from the other Party, remove from any proposed manuscript or presentation any Confidential Information of the other Party provided that neither Party will be prevented from publishing Confidential Information of the other Party (and in particular clinical data) to the extent that publication of such Confidential Information is required for any Regulatory Dossier or in order to obtain a Marketing Authorisation.

14.3 Both Parties will ensure that all written communications, including those that originate from one of their respective partners, indicate that the Drug Product was jointly developed through collaboration between DNDi and Entasis.

Download Full Agreement

Master Alliance Provisions Guide (MAPGuide)

Entasis – DNDi/GARDP, Gonorrhoea Medication, Collaboration Agreement

Provision Language

Contact Us

Get In Touch

Browse

Contact Us

Get In Touch

Browse

Sign Up to Our Newsletter

Master Alliance Provisions Guide (MAPGuide)

Entasis – DNDi/GARDP, Gonorrhoea Medication, Collaboration Agreement

Provision Language

Get In Touch

Browse

Title

Sign Up to Our Newsletter

Agreement Type

Select Partner Type

Select Development Stage

Select Technology

Select Issue or Sub-issues