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, 14519 [2014-05678]
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Federal Register / Vol. 79, No. 50 / Friday, March 14, 2014 / Notices
A.12–1—ESTIMATES OF HOUR BURDEN—Continued
Type of
respondents
Number of
respondents
Clinical Evaluation ...........................................................................................
Survey Instrument ............................................................................................
Device Training ................................................................................................
Health Data Monitoring ....................................................................................
Device Return ..................................................................................................
Dated: March 3, 2014.
Robert S. Balaban,
Scientific Director, Dir, NHLBI, NIH.
Dated: March 3, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–05698 Filed 3–13–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Evaluation License Agreement: PreClinical Evaluation and Commercial
Development of Anti-Tyrosine KinaseLike Orphan Receptor 1 Antibody-Drug
Conjugates for the Treatment of
Human Cancers
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 ‘‘Antihuman 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
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:18 Mar 13, 2014
Jkt 232001
100
100
100
100
15
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 antiROR1 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.
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:
wongje@od.nih.gov.
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
DATES:
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Frequency of
response
Average
time per
response
1
1
2
2
1
Annual hour
burden
30/60
1
1
10
18/60
50
100
200
2,000
5
of chimeric anti-ROR1 monoclonal
antibodies that selectively target ROR1
malignant B-cells but not normal Bcells. 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
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 79, Number 50 (Friday, March 14, 2014)]
[Notices]
[Page 14519]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05678]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: wongje@od.nih.gov.
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
