CSIC-MPP, COVID-19 Antibody Diagnostic, Patent & Material License Agreement

Protecting & sharing information | Confidentiality

Summary of Approaches

What is the scope of confidential information?
- Confidential Information is all information disclosed by one party to the other, including any technical, scientific or business information, know-how, data or materials of a confidential or proprietary nature.
What are the obligations of the parties to protect confidential information?
- Confidentiality obligations apply for 10 years after the contract term expires.
- The parties must not copy or disclose Confidential Information to a third party without express written permission.
- Confidential Information may be used for the purpose of executing the Agreement only.
Are there any exceptions to the confidentiality obligations?
- The parties may disclose Confidential Information in regulatory filings, in litigation, for legal compliance, or to employees, agents or contractors of a party on a need-to-know basis.
- Confidential Information obligations also do not apply when the information is (1) public knowledge; (2) independently developed; (3) known prior to disclosure; (4) originates with a third party; or (5) must be disclosed by law.
Are the parties permitted to make public announcements related to the project?
- The MPP may publish the Agreement and related sublicenses on the MPP website.

Annotations

This Patent and Material License Agreement is between the Spanish National Research Council (“CSIC“), a state agency of the Spanish government, and the Medicines Patent Pool (“MPP“), a United Nations-backed nongovernmental organization that pools licenses from intellectual property owners and sublicences technology for generic production and distribution in low-income and lower-middle-income countries (“LMICs“). MPP is the “implementing arm” of the World Health Organization’s COVID-19 Technology Access Pool (C-TAP), which facilitates equitable access to COVID-19 products. The Agreement concerns a COVID-19 antibody test (the “Test”) developed and owned by CSIC. The Agreement is effective as of November 2021.

Scientists in the CSIC National Center for Biotechnology developed the technology that is the subject of this Agreement. CSIC filed patent applications in the Spanish Patent & Trademark Office and European Patent Office.

The Agreement provides a non-exclusive license that permits the MPP to sublicense CSIC intellectual property and materials to generic manufacturers who will develop and commercialize ELISA kits and lateral flow tests for the detection of antibodies against COVID-19 (“Field”) primarily for use in LMICs.

The Agreement specifies only a few elements of future sublicenses, including a 15% royalty on sales to high-income countries, and royalty-free sales and an affordability term for LMICs. The MPP and CSIC must both approve other sublicense terms and the selection of sublicensees.

CSIC must transfer intellectual property and materials, including know-how and expression vectors for cells with DNA that encode the proteins needed for COVID-19 antibody testing. MPP or its sublicensees must pay CSIC’s manufacturing costs, and MPP pays travel and out-of-pocket expenses incurred by CSIC staff involved in technology transfer to MPP sublicensees. CSIC does not warrant that its technology is patentable, nor that its use is noninfringing.

Provision Language

Definitionsstrong>em>p>
“Confidential Informationstrong>” span>means any and all information, including but not limited to technical, scientific and business information, knowledge, know–how, data and materials of a confidential or proprietary nature owned or controlled by a Party (“Disclosing Partystrong>em>”) and disclosed to the other Party (“Receiving Partystrong>em>”) under this Agreement.span>p>
6. Confidentialityb>span>p>
6.1 Treatment of Confidential Information.b> Each of the Parties shall ensure that, during the Term of this Agreement and during ten (10) years thereafter, Confidential Information:span>p>
a) shall be used in a reserved manner.span>p>
b) shall not be copied or disclosed in whole or in part by or to Third Parties without having span>obtained the express written authorization from the Disclosing Party, except that such written authorization shall not be necessary in the following instances:span>p>
i. Regulatory filings; 
ii. Prosecuting or defending litigation; 
iii. Complying with applicable governmental laws and regulations; and 
iv. Disclosure in connection with this Agreement to its staff, consultants, actual or span>potential donors, advisors, officers and non–voting Board Members, subcontractors, or licensees on a “need–to–know” basis and using the same diligence as that used by the Receiving Party in protecting its own proprietary information;span>p>
c) shall not be used in whole or in part for any purpose other than the execution of this span>Agreement;span>p>
The Parties shall be liable to each other for breach of this obligation, whether by its employees, associates, Sublicensees or any other person to whom the Confidential Information was disclosed.span>p>
In the event that there is current legislation on the protection of personal data, the Parties declare their recognition and respect for it.span>p>
6.2 Exceptions in the Treatment of Confidential Information.b> Notwithstanding Sub–clause 5.1., no Party shall be liable for use or disclosure of Confidential Information that:span>p>
a) is published or becomes generally known to the public through no fault or omission of the span>Receiving Party; orspan>p>
b) is independently developed by or for the Receiving Party without reference to or reliance upon the Confidential Information and such development can be evidenced by written span>documentation upon request by the Disclosing Party; or span>p>
c) is rightfully known by the Receiving Party prior to the date of disclosure to the Receiving Party and such knowledge can be evidenced by written documentation upon request by the span>Disclosing Party; orspan>p>
d) The information received comes from a Third Party that does not require secrecy, orspan>p>
e) is required to be disclosed by law or by judicial or administrative request. In this case, the Receiving Party will immediately notify the Issuing Party of such request so that it can file the appropriate precautionary measures, and will not disclose more Confidential Information than that which is strictly required by the judicial or administrative order.span>p>
6.3 Publication of this Agreementb>. strong>The Parties agree that a copy of this Agreement as well as all sublicences may be publicly disclosed on MPP’s website. Such disclosure will not constitute a breach of either Party’s obligations under this clause 6.span>p>

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