[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Page 16692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Option Exclusive License: The 
Development of Liposomal Therapeutic Agents for the Treatment of Human 
Epithelial Cancers and Liposarcomas

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant to ZoneOne 
Pharma, Inc., of an exclusive evaluation option license to practice the 
inventions embodied in the following US Patent (and all foreign 
counterparts): Serial No. 6,890,917 entitled, ``Geldanamycin Derivative 
and Method of Treating Cancer Using Same'' [HHS Ref. E-050-2000/0-US-
15]. The patent rights in this invention have been assigned to the 
Government of the United States of America.
    The prospective exclusive evaluation option license territory may 
be worldwide, and the field of use may be limited to:

The pharmaceutical use in humans of 17-dimethylaminoethylamino-17-
demethoxygeldanamycin (``17-DMAG'') as a liposome-encapsulated drug, 
alone or in combination with other agents, for the treatment of the 
following types of cancer: ovary, pancreas, metastatic skin, head 
and neck, colon, kidney, non-small cell lung, or liposarcoma.

    Upon the expiration or termination of the exclusive evaluation 
option license, ZoneOne Pharma, Inc., will have the exclusive right to 
execute an exclusive commercialization license which will supersede and 
replace the exclusive evaluation option license with no greater field 
of use and territory than granted in the exclusive evaluation option 
license.

DATES: Only written comments or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before April 2, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Patrick McCue, Ph.D., 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-5560; Facsimile: (301) 
402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: This invention concerns 17-DMAG, the first 
water-soluble analog of 17-AAG, a less toxic and more stable analog of 
the antitumor antibiotic geldanamycin.
    The prospective exclusive evaluation license is being considered 
under the small business initiative launched on 1 October 2011, and 
will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 
404.7. The prospective exclusive evaluation license, and a subsequent 
exclusive commercialization license, may be granted unless the 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 within fifteen (15) days from the date of 
this published notice.
    Complete applications for a license in the field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive evaluation option license. Comments and 
objections submitted 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: March 8, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-06069 Filed 3-15-13; 8:45 am]
BILLING CODE 4140-01-P