Elkurt – Ocean Biomedical, Malaria Vaccine, Exclusive License Agreement

Equitable Access | Affordable pricing
Equitable Access | Territory access commitments

Structural Questions

Affordable Pricing

How is an affordable price determined?
Should there be a difference between the pricing for public sector and private sector purchasers?
Should prices be tiered by country or region and over what time period?
Does the funder have the right to audit the developer’s calculation of ‘affordable price’?
What are the remedies if an ‘affordable price’ is not achieved?

Territory Access Commitments

How should ‘territory’ be defined under the agreement? Should the definition make a distinction between different types of purchaser (e.g. public sector vs. private sector)?
Should the developer be required to apply for regulatory approval in priority access markets?
Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
Should the developer be required to identify a third party that could fulfill supply requirements for the access territories in the event that the developer does not?

Summary of Approaches

Affordable Pricing

Should prices be tiered by country or region and over what time period?
- Elkurt must consider reasonable requests to reduce royalties when Ocean demonstrates licenses products will be available in certain countries at reduced costs.

Territory Access Commitments

Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
- The parties must cooperate to make essential medicines available in economically disadvantaged nations.

Annotations

This exclusive license agreement (“Agreement”) for the development and commercialization of a malaria vaccine is between Elkurt, Inc., a private corporation, and Ocean Biomedical, Inc. (“Ocean”), a publicly listed academic spin-out biopharmaceutical company. The Agreement grants licenses to patented technology and related know-how initially developed by Rhode Island Hospital (“RIH”) and Seattle Children’s Research Institute (“SCRI”). The Agreement is effective as of January 26, 2021 with certain amendments effective as of April 2021.

The Agreement is part of a set of related transactions which occurred in January 2021. That month, SCRI and RIH entered into an agreement which provided RIH with the authority to manage the relevant IP rights. Then RIH granted a license to Elkurt, which, in turn, entered into this Agreement with Ocean. The Territory for the license grant is worldwide and for the Field of Malaria, insect-borne, and other parasitic diseases.

RIH, SCRI and Elkurt retain some rights in the background IP that is the subject of the Agreement, including the right to license some background technology to humanitarian agencies. The U.S. government has rights to the background IP due to the funding that the Foundation for the National Institutes of Health (“FNIH“) provided to SCRI. The Agreement also grants a license in Ocean foreground IP to the NIH, which NIH may exercise if Ocean fails to timely make a malaria vaccine available in the developing world. The Agreement contemplates that Ocean will develop and/or commercialize the background IP via sublicensees, at least in part.

The Agreement requires Ocean to make commercially reasonable efforts to develop a malaria vaccine (or other products) in accordance with a Development and Commercialization plan, which is attached to the Agreement but redacted. Failure by Ocean to meet the deadlines and milestones in the plan can be considered a material breach and cause for immediate contract termination.

Provision Language

EXHIBIT E: Global Access for Essential Medicines

4. SUBLICENSING

4.1. The Parties will cooperate such that essential medicines which may be developed under this License can be made available in economically disadvantaged nations. Elkurt agrees to consider reasonable requests of LICENSEE for a commensurate reduction of royalty and sublicensing fees in circumstances where LICENSEE demonstrates to the satisfaction of Elkurt (and RIH, SCRI and FNIH as the case may be) that LICENSED PRODUCTS are or will be made available in such nations at reduced cost.

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Elkurt – Ocean Biomedical, Malaria Vaccine, Exclusive License Agreement

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Elkurt – Ocean Biomedical, Malaria Vaccine, Exclusive License Agreement

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