On July 17, 2025, KEI submitted comments regarding the prospective Exclusive, Inter-Institutional Agreement-Institution Lead for the development and commercialization of engineered commensals to generate antigen-specific T and B cells (90 FR 29028), which is set to be given to CZ Biohub SF.
CZ Biohub SF, or the Chan Zuckerberg Biohub San Francisco, is also heavily involved with many universities and is a collaboration between UC Berkeley, UC San Francisco, and Stanford University. This Inter-Institutional Agreement-Institution Lead is designed to consolidate the patent rights to CZB with the expressed purpose of the development and commercialization of developed products. KEI urges the NIH to ensure that the exclusive license and any sublicense include terms that ensure the product is available and affordable to the public.
KEI has asked for measures to be put in place to prevent price gouging, that the license should include a requirement that the licensee provide manufacturing know-how and regulatory marketing and/or data rights to the NIH or any entity designated by the NIH, in the event that the NIH determines that the price in the United States is excessive, and/or in order to expand access to treatments in developing countries that do not have sufficient or reasonably priced access.
KEI’s full comments are available here: KEI-Comments-NIH-License-CZ-Biohub-17July2025