Prospective Grant of Exclusive License: Human Monoclonal Antibodies, Their Fragments and Derivatives as Biotherapeutics for the Treatment of HIV Infections, 32110 [E6-8628]
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Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Notices
jlentini on PROD1PC65 with NOTICES
Name of Committee: Immunology
Integrated Review Group, Vaccines Against
Microbial Diseases.
Date: June 29–30, 2006.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Jian Wang, MD, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4198,
MSC 7812, Bethesda, MD 20892. (301) 435–
2778. wangjia@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Biophysical
and Biochemical Sciences Fellowship Panel.
Date: June 29–30, 2006.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Churchill Hotel, 1914 Connecticut
Avenue, NW., Washington, DC 20009.
Contact Person: James W. Mack, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892. (301) 435–1747. mackj2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict-Behavioral Pharmacology.
Date: June 29, 2006.
Time: 1 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call).
Contact Person: Maribeth Champoux, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3146,
MSC 7759, Bethesda, MD 20892. (301) 594–
3163. champoum@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Technology
Development.
Date: June 29–30, 2006.
Time: 6 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavillon, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Sally Ann Amero, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7849, Bethesda, MD 20892. (301) 435–
1159. ameros@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396. 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 25, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–5067 Filed 6–1–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Human Monoclonal
Antibodies, Their Fragments and
Derivatives as Biotherapeutics for the
Treatment of HIV Infections
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
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 (NIH), Department
of Health and Human Services (HHS), is
contemplating the grant of an exclusive
license to practice the inventions
embodied in: U.S. Provisional Patent
Application S/N 60/378,408, filed May
6, 2002 (E–144–2002/0–US–01), PCT
Application, PCT/US03/14292, filed
May 6, 2003, (E–144–2002/0–PCT–02),
converted into 03736557.4 (E–144–
2002/0–EP–04) filed in Europe on
December 3, 2004, and 2003237187 (E–
144–2002/0–AU–05) filed in Australia
on November 3, 2004, 10/513,725 (E–
144–2002/0–US–03) filed in USA on
November 5, 2004, as well as 2,484,930
(E–144–2002/0–CA–06) filed in Canada
on November 5, 2004, entitled ‘‘Novel
broadly cross-reactive HIV neutralizing
human monoclonal antibodies selected
from Fab phage display libraries using
a novel strategy based on alternative
antigen panning,’’ Inventors: Dimiter S.
Dimitrov (NCI) and Mei-Yun Zhang
(SAIC), to Profectus Biosciences, Inc.,
having a place of business in Baltimore,
Maryland. The patent rights in these
inventions have been assigned to the
United States of America.
DATES: Only written comments and/or
application for a license, which are
received by the NIH Office of
Technology Transfer on or before
August 1, 2006 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Sally Hu, Ph.D., M.B.A., Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
E-mail: hus@od.nih.gov; Telephone:
(301) 435–5606; Facsimile: (301) 402–
0220.
SUPPLEMENTARY INFORMATION: The
subject invention (E–144–2002/0)
identifies four antibodies, designed
4B1–4, 4B1–10, 4H4, and 5H22 (M12,
M14, M16, and M18). These four
antibodies were isolated from a human
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
Fab phage display library using
alternating antigen panning (AAP). All
four antibodies bind to recombinant HIV
envelope glycoproteins (Env) gp12089.6,
gp120JR–FL and gp120IIIB with high
affinity. Moreover, 4B1–10 binding to gp
120 or gp 140 is significantly enhanced
in the presence of the receptor CD4.
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 60 days from the date of this
published Notice, 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.
The field of use may be limited to the
development of human monoclonal
antibodies for use as a therapeutic or
preventative in HIV infection either
alone or in combination with other
compounds.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. 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: May 25, 2006.
David R. Sadowski,
Acting Director, Division of Technology
Development and Transfer, Office of
Technology Transfer, National Institutes of
Health.
[FR Doc. E6–8628 Filed 6–1–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
First-Generation Guidelines for NCISupported Biorepositories
AGENCY: National Institutes of Health
(NIH), National Cancer Institute (NCI),
HHS.
ACTION: Notice.
SUMMARY: The public comment period
for the First Generation Guidelines for
NCI-Supported Biorepositories (Federal
Register, Vol. 71, Number 82, Page
25814, April 28, 2006) will be extended
an additional 30 days beyond
publication of this notice.
DATES: Effective Date: July 3, 2006.
FOR FURTHER INFORMATION CONTACT:
Implementation assistance and inquiries
should be directed to senior staff of the
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[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Notices]
[Page 32110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8628]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Human Monoclonal
Antibodies, Their Fragments and Derivatives as Biotherapeutics for the
Treatment of HIV Infections
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 (NIH),
Department of Health and Human Services (HHS), is contemplating the
grant of an exclusive license to practice the inventions embodied in:
U.S. Provisional Patent Application S/N 60/378,408, filed May 6, 2002
(E-144-2002/0-US-01), PCT Application, PCT/US03/14292, filed May 6,
2003, (E-144-2002/0-PCT-02), converted into 03736557.4 (E-144-2002/0-
EP-04) filed in Europe on December 3, 2004, and 2003237187 (E-144-2002/
0-AU-05) filed in Australia on November 3, 2004, 10/513,725 (E-144-
2002/0-US-03) filed in USA on November 5, 2004, as well as 2,484,930
(E-144-2002/0-CA-06) filed in Canada on November 5, 2004, entitled
``Novel broadly cross-reactive HIV neutralizing human monoclonal
antibodies selected from Fab phage display libraries using a novel
strategy based on alternative antigen panning,'' Inventors: Dimiter S.
Dimitrov (NCI) and Mei-Yun Zhang (SAIC), to Profectus Biosciences,
Inc., having a place of business in Baltimore, Maryland. The patent
rights in these inventions have been assigned to the United States of
America.
DATES: Only written comments and/or application for a license, which
are received by the NIH Office of Technology Transfer on or before
August 1, 2006 will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Sally Hu, Ph.D., M.B.A., Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852-3804; E-mail: hus@od.nih.gov; Telephone:
(301) 435-5606; Facsimile: (301) 402-0220.
SUPPLEMENTARY INFORMATION: The subject invention (E-144-2002/0)
identifies four antibodies, designed 4B1-4, 4B1-10, 4H4, and 5H22 (M12,
M14, M16, and M18). These four antibodies were isolated from a human
Fab phage display library using alternating antigen panning (AAP). All
four antibodies bind to recombinant HIV envelope glycoproteins (Env)
gp12089.6, gp120JR-FL and gp120IIIB
with high affinity. Moreover, 4B1-10 binding to gp 120 or gp 140 is
significantly enhanced in the presence of the receptor CD4.
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 60 days
from the date of this published Notice, 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.
The field of use may be limited to the development of human
monoclonal antibodies for use as a therapeutic or preventative in HIV
infection either alone or in combination with other compounds.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. 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: May 25, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer,
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-8628 Filed 6-1-06; 8:45 am]
BILLING CODE 4140-01-P
