2018-07844. Notice of Intent To Grant an Exclusive License

AGENCY:

Department of Veterans Affairs.

ACTION:

Notice of intent.

SUMMARY:

Notice is hereby given that the Department of Veterans Affairs (VA), Office of Research and Development, Technology Transfer Program, intends to grant to Meiogen Biotechnology Corporation, 20 Assembly Square Drive, Somerville, MA 02145, an exclusive license to U.S. patent application No. 62/571,900 (“Compositions and Methods of Interferon Alpha Binding Proteins”) VA Invention Disclosure number 2018-010 titled, “B18R (Normferon^TM-alpha).” The invention provides compositions comprising of interferon-alpha binding protein (B18R) and combined anti-retroviral therapy (cART) to treat HIV associated neurogenerative disorder (HAND). Ultimately, this invention provides a novel therapeutic option for subjects with HAND.

DATES:

Comments must be received by May 1, 2018.

ADDRESSES:

Written comments may be submitted through www.regulations.gov; by mail or hand-delivery to the Director, Regulations Management (02REG), Department of Veterans Affairs, 810 Vermont Avenue NW, Room 1068, Washington, DC 20420; or by fax to [phone] (this is not a toll-free number). Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Call [phone] for an appointment (this is not a toll-free number). In addition, during the comment period, comments may be viewed online through the Federal Docket Management System at www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Mr. Benjamin Henry, Technology Transfer Specialist, Office of Research and Development (10P9TT), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, [phone] (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

It is in the public interest to license this invention. Meiogen submitted a complete and sufficient application for a license. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 15 days from the date of this published Notice, the Department of Veterans Affairs Office of Research and Development, Technology Transfer Program receives written evidence and argument which establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Signing Authority: The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jacquelyn Hayes-Byrd, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on April 10, 2018, for publication.

Dated: April 10, 2018.

Jeffrey M. Martin,

Impact Analyst, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.