[Federal Register Volume 80, Number 234 (Monday, December 7, 2015)]
[Notices]
[Pages 76026-76027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30752]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health (NIH)


Prospective Grant of Start-Up Exclusive Evaluation Option License 
Agreement: Development and Commercialization of Aza-Epoxy Guaiane 
Derivatives for Treatment of Renal Cancer

AGENCY: National Institutes of Health.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Cancer Institute (NCI), National Institutes 
of Health, Department of Health and Human Services, is contemplating 
the grant of a Start-Up Exclusive Evaluation Option License Agreement 
to ElexiMed LLC, a company having a place of business at 5003 Green 
Mountain Circle, Suite 4, Columbia, MD 21044, USA, to practice the 
inventions embodied in the following patent applications.
    Intellectual Property--PCT Patent Application No. PCT/US2015/
014601, entitled ``Aza-Englerin Analogues--Novel Natural Product-Based 
Nitrogen-Containing Anti-Cancer Agents'' filed February 5, 2015 (HHS 
Ref. No.: E-090-2014/2-PCT-01); US Provisional Patent

[[Page 76027]]

Application No. 62/018,381, entitled ``Aza-epoxy-guaiane derivatives 
and treatment of cancer'' filed June 27, 2014 (HHS Ref. No. E-090-2014/
1-US-01); and US Provisional Patent Application No. 61/936,285, 
entitled ``Aza-englerin analogues and use in cancer therapy'' filed 
February 5, 2014 (HHS Ref. No. E-090-2014/0-US-01).
    The patent rights in these inventions have been assigned to the 
Government of the United States of America and the University of 
Hawaii.
    The territory of the prospective Start-Up Exclusive Evaluation 
Option License Agreement may be worldwide, and the field of use may be 
limited to ``Development and commercialization of aza-epoxy guaiane 
derivatives for treatment of renal cancer.''
    Upon the expiration or termination of the Start-up Exclusive 
Evaluation Option License Agreement, ElexiMed LLC will have the 
exclusive right to execute a Start-Up Exclusive Patent License 
Agreement which will supersede and replace the Start-up Exclusive 
Evaluation Option License Agreement, with no greater field of use and 
territory than granted in the Start-up Exclusive Evaluation Option 
License Agreement.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center on or before 
December 22, 2015 will be considered.

ADDRESSES: Requests for copies of the patent application(s), inquiries, 
comments, and other materials relating to the contemplated Start-Up 
Exclusive Evaluation Option License Agreement should be directed to: 
Rose Freel, Ph.D., Licensing and Patenting Manager, Technology Transfer 
Center, National Cancer Institute, Riverside 5, Suite 400, 8490 
Progress Drive, Frederick, MD 21702; telephone: 301-624-1257; 
Facsimile: 301-631-3027; Email: [email protected]. A signed 
confidentiality nondisclosure agreement will be required to receive 
copies of any patent applications that have not been published or 
issued by the United States Patent and Trademark Office or the World 
Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: This technology describes aza-englerins, 
synthetic analogues of the natural product Englerin A which displays 
potent and selective anti-cancer properties in several cancer cell 
lines. The aza-englerins were developed as novel cancer therapeutics 
and show significant bioavailability after oral administration in mice.
    The prospective Start-Up Exclusive Evaluation Option License 
Agreement is being considered under the small business initiative 
launched on October 1, 2011 and will comply with the terms and 
conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective 
Start-Up Exclusive Evaluation Option License Agreement and a subsequent 
Start-Up Exclusive Patent License Agreement may be granted unless the 
NCI receives written evidence and argument, within fifteen (15) days 
from the date of this published notice, that establishes that the grant 
of the contemplated Start-Up Exclusive Evaluation Option License 
Agreement would not be consistent with the requirements of 35 U.S.C. 
209 and 37 CFR part 404.7.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Start-Up Exclusive Evaluation Option 
License Agreement. 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: December 2, 2015.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2015-30752 Filed 12-4-15; 8:45 am]
 BILLING CODE 4140-01-P