[Federal Register Volume 60, Number 237 (Monday, December 11, 1995)] [Notices] [Page 63538] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-30003] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Prospective Grant of Exclusive License: Antibacterial Therapy With Bacteriophage Genotypically Modified to Delay Inactivation by the Host Defense System AGENCY: National Institutes of Health, Public Health Service, DHHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is notice in accordance with 15 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i) that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive world-wide license to practice the inventions embodied in U.S. Patent Application 08/222,956 and corresponding foreign patent applications entitled, ``Antibacterial Therapy with Bacteriophage Genotypically Modified to Delay Inactivation by the Host Defense System'' to Exponential Therapies, Inc., New York, New York 10001. The patent rights in these inventions have been assigned to the United States of America. 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 sixty (60) days from the date of this published notice, NIH receives written evidence and argument that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Alternatively, the subject technology may be licensed as a CRADA invention under 15 U.S.C. 3701 et seq. if it is determined to have been made in whole or in part under CRADA 94/0023. The patent application concerns bacteriophage therapy and discloses methods that enable bacteriophage to delay inactivation by any and all parts of the host defense system (HDS) against foreign objects that would tend to reduce the numbers of bacteriophage and/or the efficiency of those phage at killing the host bacteria present during an infection. The application discloses two method for producing genotypically modified bacteriophage: (1) Selection by serial passaging and (2) genetic engineering. The foregoing methods can be used to manufacture a variety of distinct therapeutics for antibiotic-resistant bacterial diseases. ADDRESSES: Requests for copies of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Girish C. Barua, Ph.D., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7735 ext. 263; facsimile: 301/402-0220. A signed Confidentiality Agreement will be required to receive copies of the patent applications. Applications for a license in the indicated exclusive field(s) of use filed in response to this notice will be treated as objections to the grant of the contemplated license. Only written comments and/or applications for a license which are received by NIH on or before February 9, 1996 will be considered. 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. Dated: December 1, 1995. Barbara M. McGarey, Deputy Director, Office of Technology Transfer. [FR Doc. 95-30003 Filed 12-8-95; 8:45 am] BILLING CODE 4140-01-M@