Entasis – DNDi/GARDP, Gonorrhoea Medication, Collaboration Agreement

Protecting & sharing information | Confidentiality

Summary of Approaches

What is the scope of confidential information?
- Confidential information is nonpublic information that relates to the disclosing party’s background IP, commercialization plans or any information generated in connection with the Agreement, such as foreground IP.
What are the obligations of the parties to protect confidential information?
- The parties must keep confidential and not communicate confidential information.
- The parties may communicate confidential information only to employees and third parties with a need to know in order to perform the Agreement, provided they are bound by confidentiality and nonuse obligations no less stringent than those in the agreement.
- Nondisclosure obligations terminate at the end of the contract term or seven years after the information is disclosed.
Are there any exceptions to the confidentiality obligations?
- Confidentiality obligations do not apply to information that is (1) already in the party’s possession, lawfully; (2) in the public domain; (3) lawfully received from a third party not bound by an applicable confidentiality obligation; or (4) independently developed.
- Each party may disclose confidential information when required by law. The party also must notify the other party and cooperate with the other party’s efforts to limit the scope of disclosure and seek confidential treatment of the disclosed information.
Are the parties permitted to make public announcements related to the project?
- Prior written consent is required for all disclosures relating to the project, except for a few basic facts, such as that the parties will jointly develop a treatment for gonorrhoea using Zoliflodacin in their respective territories.
- Prior written consent is required for all press releases, even those containing these essential facts.
Can the parties use each other’s name and logo for general marketing materials?
- Each party must use its own name and logo in its respective territory absent the other party’s agreement.

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

Definitionsstrong>em>p>
“span>Confidential Informationb>” means any non–public information that is: (i) disclosed to the other Party (whether directly or indirectly) pursuant to or in the course of this Agreement howsoever disclosed that contains or relates to its <a href=”https://ghiaa.org/provision_document/entasis–dndi–gardp–gonorrhoea–medication–collaboration–agreement/” target=”_blank” rel=”noopener“>Background Technology a>span> or its plans to <a href=”#kt“>Commercialise a> the Drug Product; or (ii) is generated pursuant to this Agreement by a Party including, without limitation, the respective Collaboration Technology of each Partyspan>p>
 6. Product Manufacture and Supplyb>span>p>
6.1strong> Within six (6) months of the Effective Date or such longer period as may otherwise be agreed in writing (including by email), the Parties shall agree a detailed Manufacturing and Supply Plan for the supply of the Drug Product through the JSC. The Manufacturing and Supply Plan shall be based on the following principles: span>[…]span>p>
6.1.11 each Party (or its Sublicensee) shall use its own name and/or logo for Commercialisation in its Territory unless otherwise agreed.span>p>
13. Confidentiality and Restricted Useb>span>p>
13.1strong> Except as specifically set forth elsewhere in this Agreement, each Party shall use only for purposes of this Agreement, and, except as permitted in this Agreement, shall keep confidential and not communicate to any Third Party, all of the Confidential Information received or otherwise learned pursuant to this Agreement including without limitation Confidential Information exchanged prior to the Effective Date relating to the subject matter of this Agreement. span>p>
13.2strong> Each Party shall communicate the Confidential Information of the other Party only to its employees and Third Parties (including, but not limited to actual and potential funding partners, consultants, CSPs and Sublicensees) who need to know such Confidential Information in order to perform this Agreement and who have agreed to abide by confidentiality and restricted use obligations at least as stringent as those set forth herein (the “span>Permitted Recipientsb>em>”). Each Party shall be responsible to the other Party for any breach by its Permitted Recipients of such obligations. span>p>
13.3strong> The confidentiality and restricted use obligations set forth herein shall not apply to Confidential Information with respect to which the receiving Party can reasonably prove:span>p>
13.3.1 was already lawfully in such Party’s possession at the time of its disclosure hereunder, and not subject to any obligation of confidentiality or restricted use; span>p>
13.3.2 is in the public domain at the time of disclosure or becomes in the public domain after disclosure to the receiving Party through no action, fault or omission of the receiving Party;span>p>
13.3.3 is lawfully received by the receiving Party from a Third Party, provided that such Third Party is not subject to any obligation of confidentiality or restricted use with respect thereto; span>p>
13.3.4 is independently developed by the receiving Party without using any of the Confidential Information received hereunder;span>p>
13.3.5 that the receiving Party is required to disclose pursuant to applicable law, regulation or decision or order of any competent court, tribunal, governmental authorities or Drug Regulatory Authority, provided that the receiving Party has promptly disclosed such obligation to the disclosing Party and cooperates with the disclosing Party in efforts to (i) limit the extent of such disclosure to what is required to comply with the applicable law, regulatory, or decision, and (ii) obtain confidential treatment of the Confidential Information required to be disclosed. span>p>
13.4strong> The obligations of confidentiality and restricted use in this Clause 13 shall remain in force for the Term of this Agreement and for seven (7) years following disclosure of the relevant Confidential Information.span>p>
15. Publicityb>span>p>
15.1strong> Except as required by applicable law or the rules of any stock exchange, neither Party shall make any public disclosure concerning this Agreement or the subject matter hereof without the prior written consent of the other Party, which shall not be withheld unreasonably. span>p>
15.2strong> Notwithstanding Clause 15.1, either Party may disclose the information set forth on Schedule 7 (the “span>Disclosable Informationb>em>”) without the prior written consent of the other Party, provided that the disclosing Party gives the other Party a copy of or reference (e.g., link to internet site) to such disclosure at the time of disclosure. For the avoidance of doubt, any press release shall require the prior written consent of the non–disclosing Party, even if such press release is limited to the Disclosable Information.span>p>
Schedule 7: Disclosable Informationstrong>span>p>
The Agreement covers and relates to:p>
<ul>
<li>Treatment of gonorrhoea caused by Neisseria gonorrhoeae, Chlamydia trachomatis and/or Mycoplasma genitaliumli>
<li>With drug products containing zoliflodacinli>
<li>Commercialization by Entasis in certain high–income countries; and commercialization by DNDi in all other countries worldwideli>
<li>Joint drug development including formulation and clinical and non–clinical studies and subsequent registrationli>
<li>Each party’s commitment to ensure access to the Product.li>
ul>

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