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Prospective Grant of Exclusive License: Conjugate Vaccines To Prevent Diseases Caused by Nontypeable Haemophilus Influenzae and Moraxella Catarrhalis, Particularly Otitis Media

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National Institutes of Health, Public Health Service, DHHS.




This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Start Printed Page 71188404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license concerning the inventions embodied in: U.S. Patent Application Serial Number 08/842,409 (now USPN 6,207,157) entitled “Conjugate vaccine for Nontypeable H. influenzae”, its divisional application U. S. Patent Application Serial Number 09/789,017, and U.S. Patent Application Serial Number 60/071,483 (now U.S. Patent Application Serial Number 09/610,034 and PCT/US99/00590, National Staged in Australia, Brazil, Canada, China, Europe, Korea, Mexico, and Japan), entitled “Lipooligosaccharide-Based Vaccine for Prevention of Moraxella (Branhamella) catarrhalis Infections in Humans”, to Apovia, Inc., a company of San Diego, California. The United States of America is an assignee to the patent rights of these inventions.

The contemplated exclusive license may be limited to the development of vaccines for the prevention or treatment of diseases in humans caused by infection with nontypeable H. influenzae and M. catarrhalis.

This notice is a modification to two previous Federal Register Notices related to the technology published on March 5, 1999 (64 FR 10671) and on July 30, 1999 (64 FR 41452).


Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before January 28, 2003 will be considered.


Requests for a copy of the patents, inquiries or comments relating to the contemplated license should be directed to: Uri Reichman, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-4616, Facsimile: (301) 402-0220; E-mail:

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The inventions included in the prospective license describe conjugates of detoxified lipooligosaccharide (dLOS), isolated from the cellular membrane of either nontypeable H. Influenzae or M. catarrhalis and a carrier. These conjugates have been shown to raise bactericidal antibodies against the bacterial strain from which the dLOS was isolated and are also cross-reactive with different strains.

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 60 days from the date of this published Notice, NIH receives written evidence and argument that 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.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

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Dated: November 19, 2002.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.

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[FR Doc. 02-30230 Filed 11-27-02; 8:45 am]