[Federal Register Volume 79, Number 50 (Friday, March 14, 2014)]
[Notices]
[Page 14519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Evaluation License Agreement: 
Pre-Clinical Evaluation and Commercial Development of Anti-Tyrosine 
Kinase-Like Orphan Receptor 1 Antibody-Drug Conjugates for the 
Treatment of Human Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive license 
to practice the inventions embodied in U.S. Patent Application 61/
172,099 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0-
US-01], PCT Application No. PCT/US2010/032208 entitled ``Anti-human 
ROR1 Antibodies'' [HHS Ref. E-097-2009/0-PCT-02], U.S. Patent 
Application 61/418,550 entitled, ``Chimeric Rabbit/Human ROR1 
Antibodies'' [HHS Ref. No. E-039-2011/0-US-01], and PCT Application No. 
PCT/US2011/062670 entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'', 
and all related continuing and foreign patents/patent applications for 
the technology family, to Ardeagen Corporation. The patent rights in 
these inventions have been assigned to the Government of the United 
States of America.
    The prospective start-up exclusive evaluation option license 
territory may be worldwide and the field of use may be limited to pre-
clinical evaluation and commercial development of an antibody-drug 
conjugate comprising an anti-tyrosine protein kinase transmembrane 
receptor (ROR1) antibody for the treatment of human ROR1 expressing 
cancers, wherein the antibody moiety comprises the anti-ROR1 antibodies 
designated as 2A2, 2D11, R11, R12, or R31. For avoidance of doubt, this 
Agreement explicitly excludes the development of an immunotoxin 
comprising 2A2 and Pseudomonas exotoxin A targeted immunotoxins for the 
treatment of human ROR1 expressing cancers. Upon expiration or 
termination of the start-up exclusive evaluation option license, 
Ardeagen Corporation will have the right to execute a start-up 
exclusive patent commercialization license which will supersede and 
replace the start-up exclusive evaluation option license with no 
broader territory than granted in the start-up exclusive evaluation 
option license and the field of use will be commensurate with the 
commercial development plan at the time of conversion.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
March 31, 2014 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Jennifer Wong, M.S., 
Senior Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4633; Facsimile: (301) 
402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: Tyrosine kinase-like orphan receptor 1 
(ROR1) is a signature cell surface antigen for B-cell malignancies, 
most notably, B-cell chronic lymphocytic leukemia (B-CLL) and mantle 
cell lymphoma (MCL) cells, two incurable diseases. The investigators 
have developed a portfolio of chimeric anti-ROR1 monoclonal antibodies 
that selectively target ROR1 malignant B-cells but not normal B-cells. 
These antibodies may be linked to chemical drugs or biological toxins 
thus providing targeted cytotoxic delivery to malignant B-cells while 
sparing normal cells. Moreover, as these antibodies selectively target 
ROR1, they can also be used to diagnose B-cell malignancies.
    The prospective start-up exclusive evaluation option license 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. The prospective start-up exclusive 
evaluation option license, and a subsequent start-up exclusive patent 
commercialization license, may be granted unless within fifteen (15) 
days from the date of this published notice, 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 part 404.
    Any additional, properly filed, and 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 12, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-05678 Filed 3-13-14; 8:45 am]
BILLING CODE 4140-01-P