Entasis – DNDi/GARDP, Gonorrhoea Medication, Collaboration Agreement

Protecting & sharing information | Information sharing

Summary of Approaches

What financial and project progress information must be shared between the parties?
- The parties must establish a “data room” where all documents relating to the collaboration must be filed. Entasis is responsible for maintaining the data room.
- Entasis must share documents relating to background IP in its possession at time of the effective date, which includes anything relating to API that is useful and necessary to the parties’ collaboration.
- Both parties must share background technology, developed at any time, that is included in the parties’ development plan.
- Both parties must share foreground IP documents and regulatory dossiers.
- The parties must update each other about the status and results of planned studies.
- If one party wishes to conduct a Clinical Trial in the Territory of the other Party, then they must provide the other Party with a copy of the proposed trial protocol for review, comment and consent.
- The parties must keep written laboratory notebooks and other records and reports of the progress of the Development Plan.
What is the required timeline for sharing information?
- Information must be shared 30 days from the relevant date. E.g., Entasis background IP must be shared within 30 days of the effective date, other background IP must be shared within 30 days of its inclusion in the development plan, and foreground IP documents must be shared within 30 days of their creation.

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.

“Contract Service Provider” or “CSP” shall mean any Third Party service provider contracted by either Party to perform certain aspects 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.

“Entasis Background Technology” shall mean any Background Technology of Entasis relating to the API that is necessary or useful for the performance of the Collaboration Programme; provided, however, that if any Third Party becomes an Affiliate of Entasis after the Effective Date, Entasis Background Technology shall exclude any IP controlled by such Third Party before such Third Party became Entasis’s Affiliate.

“Phase III MC Trial” shall mean an international phase III multi–centre Clinical Trial to be conducted consistent with the Development Plan with the objective of demonstrating the safety and efficacy of the Drug Product in people infected with Neisseiria gonorrhoeae.

“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.

4. Development of the Drug Product

QT (TQT) Study

4.6 Entasis shall:

4.6.1 regularly update DNDi of status of the QT (TQT) Study and in particular shall notify DNDi promptly of any serious adverse events and any communications with or inspections by the Drug Regulatory Authority; and

4.6.2 promptly provide to DNDi once finalized and validated by Entasis with NIAD the results of the TQ (TQT) Study including without limitation clinical study reports.

Phase III MC Trial

[…]

4.8 DNDi shall use commercially reasonable endeavours to perform and fund the Phase III MC Trial including:

4.8.4 regularly update Entasis through the JSC about the regulatory status of clinical trial applications and the status of the Phase III MC Trial; and

4.8.5 promptly provide to Entasis once finalized and validated by DNDi the results of the Phase III MC Trial including without limitation clinical study reports.

[…]

Further Development Responsibilities

4.15 If a Party desires to conduct a Clinical Trial in the Territory of the other Party, then such Party shall (i) provide the other Party with a copy of the proposed protocol of such Clinical Trial for review and comment by the other Party, which such comments shall be considered by the first Party in good faith, and (ii) obtain the consent of the other Party, such consent not to be unreasonably withheld.

4.16 Each Party shall keep or cause to be kept written laboratory notebooks and other records and reports of the progress of the Development Plan and its activities in sufficient detail and in good scientific manner. Such notebooks and other records must properly reflect all work done in relation to the Development Plan and the results achieved.

7. Information exchange

7.11 Within thirty (30) days of the Effective Date, the Parties shall establish an electronic data room in which of all documents that relate to the Collaboration Programme must be filed (the “Data Room”).

7.12 Within thirty (30) days of the Effective Date, Entasis shall provide to DNDi all of the Entasis Background Technology in its possession on the Effective Date. Each Party shall deposit any relevant documents relating to its Background Technology that is not in its possession on the Effective Date in the Data Room within thirty (30) days of such Background Technology being included in the Development Plan.

7.13 During the Term of this Agreement, each Party shall promptly communicate and make available to the other Party in a prompt manner and as it becomes available all of its Collaboration Technology and Regulatory Dossiers shall deposit all relevant documents in the Data Room as soon as reasonably practicable and in any event within thirty (30) days of creation of any relevant document.

7.14 Entasis shall be responsible for maintaining the Data Room for a period of one (1) year following expiry or termination of this Agreement and shall permit nominated representatives of DNDi or any DNDi CSP or Sublicensee to have access to the data room during that period.

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