any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents that may be granted to us in the future will be commercially useful in protecting our commercial products and methods of manufacturing the same.
We are actively seeking U.S. and international patent protection for a variety of technologies, including the following: research tools and methods, methods for transferring genetic material into cells, AAV-based biological products, methods of designing novel AAV constructs, methods for treating diseases of interest and methods for manufacturing our products. We also intend to seek patent protection or rely upon trade secret rights to protect other technologies that may be used to discover and validate targets and that may be used to identify and develop novel biological products. We seek protection, in part, through confidentiality and proprietary information agreements. We are a party to various license agreements that give us rights to use specific technologies in our research and development, and future commercialization.
Licensed Technology and Intellectual Property
We have secured an exclusive license through Nationwide Children’s Hospital to a family of patent applications for AAV treatments for patients with MPS III A and B. The family includes three pending applications in the United States. Patent(s) that may grant from this family is/are expected to expire approximately in 2031 and 2032.
We licensed the exclusive rights to an international patent family from the Nebraska Medical Center and the Ohio State Innovation Foundation. The family is directed to AAV gene therapy for the treatment of CLN3 disease. The patent family includes pending applications in the United States, Canada, Europe, China, Japan, New Zealand, and Australia. Patent(s) that may grant from this family is/are expected to expire approximately in 2035.
To support our EB franchise we licensed a patent family from Stanford University. The patent family covers technology for the treatment of RDEB. Patent applications are pending in the United States, Canada, Europe, Israel, Japan, South Korea, China, New Zealand, Australia, Russia, Mexico, South Africa, and Brazil. Patent(s) that may grant from this portfolio is/are expected to expire approximately in 2037.
We licensed an international patent family of novel AAV vectors for use across diseases from the University of North Carolina at Chapel Hill. This portfolio has been filed nationally in multiple jurisdictions including the United States, Australia, Brazil, China, Hong Kong, Europe, Canada, Israel, India, Japan, South Korea, Mexico, New Zealand, Russia, and South Africa. Patent(s) that may grant from this patent family is/are generally expected to expire approximately in 2035.
Also from the University of North Carolina at Chapel Hill, we have rights to a patent portfolio to support our CLN1 gene therapy program. This agreement provides an exclusive field of use license for the treatment of CLN1 disease. Patent applications are pending in the United States, Canada, Europe, Israel, India, China, Japan, South Korea, Australia, New Zealand, Mexico, Brazil, Russia, and South Africa. Patent(s) that may grant from this portfolio are expected to expire approximately in 2037.
On November 5, 2018, we announced a license agreement with REGENXBIO Inc. Under the terms of the agreement, REGENXBIO has granted Abeona an exclusive worldwide license (subject to certain non-exclusive rights previously granted for MPS IIIA), with rights to sublicense, to REGENXBIO’s NAV AAV9 vector for the development and commercialization of gene therapies for the treatment of MPS IIIA, MPS IIIB, CLN1 Disease and CLN3 Disease. In return for these rights, REGENXBIO will receive a guaranteed $20 million upfront payment, $10 million of which was paid upon signing and $10 million of which will be paid within 12 months of the effective date. In addition, REGENXBIO will receive a total of $100 million in annual fees, payable upon the second through sixth anniversaries of the agreement, $20 million of which is guaranteed. REGENXBIO is also eligible to receive potential commercial milestone payments of up to $60 million. REGENXBIO will also receive low double-digit royalties on net sales of products incorporating the licensed intellectual property.
We continue to explore strategies to support patent grant extensions for all of our licensed portfolios.
U.S. Biologic Products Development Process
In the United States, the FDA regulates biologic products including gene therapy products under the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), and