Merck – MPP, Molnupiravir License Agreement

Protecting & sharing information | Confidentiality

Summary of Approaches

MSD-MPP Agreement

What are the obligations of the parties to protect confidential information?
- Confidential Information must be used solely for the purpose of the Agreement and in a manner consistent with the rights granted.
Are the parties permitted to make public announcements related to the project?
- Each party must seek written approval from the other party prior to making press releases or publications.

MSD-MPP Agreement and Form of Sublicense

What are the obligations of the parties to protect confidential information?
- Each party will maintain the confidence of the other party’s confidential information during the term and for 10 years following the termination of this Agreement.
- Each party will destroy or return the other party’s confidential information within 30 days after the expiration/termination of this Agreement, except for retaining one copy for archival purposes.
Are there any exceptions to the confidentiality obligations?
- Confidential information does not include information that: (1) was known to the receiving party when disclosed; (2) becomes public knowledge; (3) is obtained from a third party not bound by confidentiality obligations; or (4) is independently developed by the receiving party.

Form of Sublicense

What are the obligations of the parties to protect confidential information? Are there any exceptions to the confidentiality obligations?
- The Confidential Information under the agreement will not be disclosed to any third party other than (i) to MSD for the purpose of compliance with the MSD-MPP Agreement; or (ii) to a government regulatory authority as required by law.
- MSD will have the right to disclose Confidential Information to other third parties, provided that it is disclosed under equally stringent confidentiality obligations.
Are the parties permitted to make public announcements related to the project?
- No press release about the agreement may be made without MPP’s prior consent, and MSD’s consent if applicable.

Annotations

This agreement between Merck Sharp & Dohme Corp (“MSD”) and the Medicines Patent Pool Foundation (“MPP”), effective from October 26, 2021, provides license grants related to molnupiravir, an investigational oral COVID-19 antiviral medicine (“MSD-MPP Agreement”). Under the terms of the agreement, MPP may grant royalty-bearing Sublicenses for the manufacture and sale of molnupiravir (defined with chemical structure and molecular formula in all forms as the “Substance”) and Product containing monulpiravir. The license grants are restricted to use for the treatment of COVID-19 caused by SARS-CoV-2 (“Field”) in a Territory of 105 lower- and middle-income countries (see Exhibit B, p.29, of the agreement for details). For South Africa, the Territory is restricted to sales through Public Sector channels only. A full list of the Patents applicable to the agreement is provided in Exhibit A (p. 26) of the agreement.

The Form of Sublicense Agreement is attached as Exhibit C to the MSD-MPP agreement. We have included terms from both agreements in our analysis in order to provide a complete overview of how key issues are addressed – the provision sections are sub-titled with either MSD-MPP Agreement or Form of Sublicense.

On January 20, 2022, MPP announced that it had signed sublicense agreements with 27 manufacturers located in 11 countries (Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam) in order to facilitate rapid access to Monulpiravir in LMICs. The resulting products produced by some of the licensees have now been added to the WHO’s list of prequalified medicines.

Provision Language

MSD–MPP Agreementi>b>p>
7. Confidentiality And Publicationsb>span>p>
7.1 Confidential Information.b> All technology , <a href=”#kt“>Know-How a>span>, business information, quarterly reports, or any other confidential information disclosed by one Party (the “span>Disclosing Partyi>b>”) to the other Party (the “span>Receiving Partyi>b>”) hereunder (“span>Confidential Informationi>b>”) shall be used solely and exclusively by Receiving Party and in a manner consistent with the rights granted hereunder and the purposes of this Agreement as stated in the preamble and recitals hereto; maintained in confidence by the Receiving Party; and shall not be disclosed to any non–Party or used for any purpose except to exercise its rights and perform its obligations under this Agreement without the prior written consent of the Disclosing Party, except to the extent that the Receiving Party can demonstrate by competent written evidence that such information: (a) is known by the Receiving Party at the time of its receipt and, not through a prior disclosure by the Disclosing Party, as documented by the Receiving Party’s business records; (b) is in the public domain other than as a result of any breach of this Agreement by the Receiving Party; (c) is subsequently disclosed to the Receiving Party on a non–confidential basis by a third party who may lawfully do so; or (d) is independently discovered or developed by the Receiving Party without the use of Confidential Information provided by the Disclosing Party, as documented by the Receiving Party’s business records. For the avoidance of doubt, wherever MSD has a contractual obligation towards a Third Party to disclose information regarding the Product or Substance, MSD may disclose Confidential Information to that Third Party under obligations of confidentiality no less stringent than contained herein.span>p>
Within 30 days after any expiration or termination of this Agreement, Receiving Party shall destroy (and certify to the Disclosing Party such destruction) or return all Confidential Information provided by the Disclosing Party except as otherwise set forth in this Agreement. One copy of the Disclosing Party’s Confidential Information may be retained in the Receiving Party’s files solely for archival purposes as a means of determining any continuing or surviving obligations under this Agreement. The confidentiality obligations under this Agreement shall survive this Agreement for a period of 10 years.span>p>
7.2 Press Release.b> Each Party shall seek the other’s previous written approval of any initial press release or public announcement concerning the grant, scope or terms of this license prior to such press release or other publication being made. Following an initial announcement, neither Party shall be required to seek the other Party’s consent to additional related statements, provided such statements are accurate, factual, not misleading, and consistent with the confidentiality span>obligations required of either Party.span>p>
Form of Sublicense Agreementi>b>p>
11. Exchange Of Information, Confidentiality And Publicationsb>span>p>
11.3 b>Each Party hereto agrees to keep secret and confidential any and all business information, Know-How , quarterly reports, technology , or any other confidential information disclosed by one Party (“span>Confidential Informationi>b>”) to the other Party span>pursuant to this Agreement (including any discussions or correspondence relating to the preparation of this Agreement), and not to disclose such information to any Third Party other than to (i) MSD in order to comply with the MSD–MPP Agreement; and (ii) any Agency as may be required by applicable law or regulations. For the avoidance of doubt, MSD shall have the right to such Confidential Information and wherever MSD has a contractual obligation towards a Third Party to disclose information regarding the Product or Substance, MSD may disclose Confidential Information to span>that Third Party under obligations of confidentiality no less stringent than contained herein. The obligations imposed by this Section 11.3 shall not apply to any span>information: span>(a) which, at the time of disclosure, is in the public domain; or span>(b) which, after disclosure, becomes part of the public domain by publication or otherwise, through no fault of the receiving Party; or span>(c) which, at the time of disclosure, is already in the receiving Party’s possession from a source owing no obligation of confidentiality to the disclosing Party, and span>such possession can be properly demonstrated by the receiving Party; or span>(a) which is rightfully made available to the receiving party from sources independent of the disclosing Party; or span>(b) which is developed independently without the use or reference to the information received from the receiving Party and without making reference to Substance and/or Product.span>p>
11.4b> Licensee will keep MSD Know-How confidential subject to Section 11.3 above.span>p>
11.5b> Within 30 days after any expiration or termination of this Agreement, either Party shall destroy (and certify to the other Party such destruction) or return all Confidential Information provided by the other Party except as otherwise set forth in this span>Agreement. One copy of the other Party’s Confidential Information may be retained solely for archival purposes as a means of determining any continuing or surviving obligations under this Agreement.span>p>
11.6b> The obligations of confidentiality set forth in this Section 11 shall survive for a period of 10 years after the expiration, cancellation, or other termination of this Agreement.span>p>
11.7b> Subject always to MPP’s obligations under the MSD–MPP Agreement, MPP and Licensee agree that no public release or announcement concerning the Agreement shall be issued without the prior written consent of MPP and to the extent applicable, MSD, except if such release or announcement may be required by law (including without limitation information to any Agency), in which case the Licensee shall allow MSD span>reasonable time to comment on such release or announcement in advance of such issuance.span>p>

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Merck – MPP, Molnupiravir License Agreement

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Merck – MPP, Molnupiravir License Agreement

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