Entasis – DNDi/GARDP, Gonorrhoea Medication, Collaboration Agreement

Intellectual property | Ownership of IP

Summary of Approaches

Is the ownership of background IP impacted by this agreement?
- The Agreement does not affect ownership in the parties’ respective background IP.
What is the scope of background intellectual property? How will sideground IP be treated?
- Background Technology is defined as IP and other rights that were either: (i) controlled by a party as of the effective date; or (ii) conceived or reduced to practice by a party outside of the scope of the agreement during the agreement term (sideground IP).
Who will own new IP arising from the project?
- Each party owns the foreground IP that it develops. The Agreement does not appear to contemplate jointly owned results.

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

Definitions

“Background Technology” means the IP and other rights in the DNDi Background Technology or the Entasis Background Technology respectively that were either: (i) Controlled by the relevant Party as of the Effective Date; or (ii) conceived and reduced to practice, made or developed and Controlled by a Party during the Term outside the scope of the Collaboration Programme;

“Collaboration Technology” shall mean any IP and other rights in the API, the Drug Product and the Regulatory Dossier developed or conceived and reduced to practice in the performance of the Collaboration Programme.

“DNDi Background Technology” shall mean any Background Technology of DNDi that is necessary or useful for the performance of the Collaboration Programme

“DNDi Collaboration Technology” shall mean: (i) [*]; and; (ii) [*]; and (iii) all other Collaboration Technology that is developed or conceived by DNDi (or its employees, Sublicensees or agents, including CSPs) in the performance of the Collaboration Programme;

“Entasis Collaboration Technology” shall mean any Collaboration Technology that is developed or conceived by Entasis (or its employees, Sublicensees or agents, including CSPs) in the performance of the Collaboration Programme.

“Regulatory Dossier” means all regulatory documents and filings registered with a Drug Regulatory Authority for a Marketing Authorisation containing the administrative, safety, efficacy, quality, non–clinical and clinical data and CMC data for the Drug Product as it may change from time to time;

7. Intellectual Property

Ownership

7.1 All rights in, title to and interest in the DNDi Background Technology and the DNDi Collaboration Technology shall be owned by DNDi. DNDi shall promptly notify Entasis upon the creation of DNDi Background Technology and DNDi Collaboration Technology. Notwithstanding the foregoing or Clause 7.17, DNDi shall solely own all rights, title, and interest in and to all IP developed or conceived and reduced to practice in DNDi’s performance of [*] as DNDi Collaboration Technology; provided, that if DNDi does not file for Patent Rights on DNDi Collaboration Technology that would be reasonably patentable in the DNDi Territory or Entasis Territory within six (6) months of making such invention, or thereafter does not use commercially reasonable endeavors to prosecute and maintain such Patent Rights, then DNDi shall and hereby does assign to Entasis all of DNDi’s right, title, and interest in and to such IP. DNDi shall take, and shall cause its employees, agents, sublicensees, and contractors to take, all further acts reasonable required to effectuate the transfer of such IP. Any IP transferred to Entasis pursuant to this Clause 7.1 shall thereafter be considered as Entasis Collaboration Technology.

7.2 All rights in, title to and interest in the Entasis Background Technology and the Entasis Collaboration Technology shall be owned by Entasis. Entasis shall promptly notify DNDi upon the creation of Entasis Background Technology and Entasis Collaboration Technology.

7.3 The Parties agree that each Party shall retain ownership of all rights, title and interest in any part of the Regulatory Dossier which it (or any Party acting on its behalf) has authored provided that each Party shall be entitled to use the Regulatory Dossier for the purposes set out in Clauses 5.7 to 5.9 inclusive without the approval of the other Party.

7.4 Each Party shall procure that under the terms of any appointment of a CSP or Sublicensee that the CSP or Sublicensee does all such acts and things necessary to vest all right, title and interest in its Collaboration Technology in such Party.

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

Contact Us

Get In Touch

Browse

Contact Us

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