Prospective Grant of Start-up Exclusive Evaluation Option License: A Novel HIV-1 Entry Inhibitor, 35964-35965 [2015-15334]
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Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
Dated: June 17, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–15309 Filed 6–22–15; 8:45 am]
National Cancer Institute; Notice of
Closed Meetings
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DEPARTMENT OF HEALTH AND
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National Institutes of Health
National Institute of Neurological
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the public
in accordance with the provisions set
forth in sections 552b(c)(4) and
552b(c)(6), Title 5 U.S.C., as amended.
The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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Name of Committee: National Institute of
Neurological Disorders and Stroke Special,
Emphasis Panel; Review of Blood Brain
Barrier Application.
Date: July 21, 2015.
Time: 9:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Natalia Strunnikova,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Division of Extramural
Research, NINDS/NIH/DHHS/Neuroscience
Center, 6001 Executive Boulevard, Suite
3208, MSC 9529, Bethesda, MD 20892, 301–
496–3755, strunnikovan@ninds.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: June 17, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–15306 Filed 6–22–15; 8:45 am]
BILLING CODE 4140–01–P
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National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; OmnibusSEP 15 Genetic Mouse Models, Molecular
Mechanisms of Therapy.
Date: July 14–15, 2015.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Rooms
2E030/1E030, Rockville, MD 20850,
(Telephone Conference Call).
Contact Person: Nicholas J. Kenney, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W246, Rockville, MD 20850,
240–276–6374 nicholas.kenney@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Advanced
Development of Technologies for Cancer
Research (R33).
Date: July 22, 2015.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
2W914, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Jeffrey E. DeClue, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W238, Bethesda, MD 20892–
9750, 240–276–6371, decluej@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Physical
Sciences Oncology Projects.
Date: July 28–29, 2015.
Time: 6:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue Bethesda, MD 20814.
PO 00000
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Contact Person: Gerald G. Lovinger, Ph.D.,
Scientific Review Officer, Research and
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W266, Rockville, MD 20850,
240–276–6385, lovingeg@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Innovative
Molecular Analysis Technologies for Cancer
Research (R21).
Date: August 4, 2015.
Time: 7:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Room Forest Glen, Bethesda, MD 20852.
Contact Person: Jeffrey E. DeClue, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W238, Bethesda, MD 20892–
9750, 240–276–6371, decluej@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: June 17, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–15310 Filed 6–22–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up
Exclusive Evaluation Option License:
A Novel HIV–1 Entry Inhibitor
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 a
start-up exclusive evaluation option
license agreement to practice the
inventions embodied in U.S. Provisional
Patent Application No. 61/791,885 (NIH
Ref. No. E–033–2013/0–US–01), filed
March 15, 2013; International PCT
Application No. PCT/US2014/024120
(NIH Ref. No. E–033–2013/1–PCT–01),
filed March 12, 2014; all entitled,
‘‘Stabilized Single Human CD4 Domains
and Fusion Proteins;’’ and all
SUMMARY:
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
continuing applications and foreign
counterparts to Absino Co., Ltd, a
company having a place of business in
Beijing, China.
The patent rights in these inventions
have (a) been assigned to the United
States of America, as represented by the
Secretary, Department of Health and
Human Services who has delegated
authority for the licensing of inventions
to the National Institutes of Health or (b)
been exclusively licensed to the
National Institutes of Health.
The prospective start-up exclusive
evaluation option license territory may
be China, the U.S., and Europe, and the
field of use may be limited to the
development of bispecific multivalent
human immunodeficiency virus type 1
(HIV–1) neutralizing fusion proteins as
HIV entry inhibitors for the treatment of
HIV infections.
Upon the expiration or termination of
the start-up exclusive evaluation option
license, Absino Co., Ltd will have the
exclusive right to execute an exclusive
commercialization license which will
supersede and replace the start-up
exclusive evaluation option license with
no greater field of use and territory than
granted in the start-up exclusive
evaluation option license.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July 8,
2015 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated start-up exclusive
evaluation option license should be
directed to: Sally Hu, Ph.D., M.B.A.,
Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–5606; Facsimile: (301) 402–
0220; Email: hus@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
subject technology is HIV–1 entry
inhibitors that can neutralize many
subtypes of HIV–1 isolates including
clade A–E and tropism R5 and X4 (using
either CCR5 or CXCR4 co-receptor for
entry). These entry inhibitors are fusion
proteins and have a potency about 10fold higher than that of the broadly
neutralizing antibody VRC01 that is in
Phase I clinical trial, or 50-fold higher
than that of the FDA approved HIV
entry inhibitor Fuzeon. Therefore, these
fusion proteins are promising drug
candidates for HIV/AIDS prevention
and treatment.
The prospective start-up exclusive
evaluation option license will be royalty
VerDate Sep<11>2014
18:39 Jun 22, 2015
Jkt 235001
bearing 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 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.
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 start-up 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: June 16, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–15334 Filed 6–22–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Library of
Medicine Special Emphasis Panel; Conflicts
R01/R21/R13.
Date: July 30, 2015.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine, 6705
Rockledge Drive, Suite 301, Bethesda, MD
20817, (Telephone Conference Call).
Contact Person: Zoe E. Huang, MD.,
Scientific Review Officer, Extramural
Programs, National Library of Medicine, NIH,
6705 Rockledge Drive, Suite 301, Bethesda,
PO 00000
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MD 20892–7968, 301–594–4937, huangz@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: June 17, 2015.
Michelle Trout,
Program Analyst, Office of the Federal
Advisory Committee Policy.
[FR Doc. 2015–15299 Filed 6–22–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Endocrinology, Metabolism,
Nutrition and Reproductive Sciences.
Date: July 14, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, dianne.hardy@nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group;
NeuroAIDS and other End-Organ Diseases
Study Section.
Date: July 23, 2015.
Time: 8:00 a.m. to 6:00 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: Eduardo A Montalvo,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108,
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]]>Agencies
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 35964-35965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15334]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up Exclusive Evaluation Option
License: A Novel HIV-1 Entry Inhibitor
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 a start-up exclusive
evaluation option license agreement to practice the inventions embodied
in U.S. Provisional Patent Application No. 61/791,885 (NIH Ref. No. E-
033-2013/0-US-01), filed March 15, 2013; International PCT Application
No. PCT/US2014/024120 (NIH Ref. No. E-033-2013/1-PCT-01), filed March
12, 2014; all entitled, ``Stabilized Single Human CD4 Domains and
Fusion Proteins;'' and all
[[Page 35965]]
continuing applications and foreign counterparts to Absino Co., Ltd, a
company having a place of business in Beijing, China.
The patent rights in these inventions have (a) been assigned to the
United States of America, as represented by the Secretary, Department
of Health and Human Services who has delegated authority for the
licensing of inventions to the National Institutes of Health or (b)
been exclusively licensed to the National Institutes of Health.
The prospective start-up exclusive evaluation option license
territory may be China, the U.S., and Europe, and the field of use may
be limited to the development of bispecific multivalent human
immunodeficiency virus type 1 (HIV-1) neutralizing fusion proteins as
HIV entry inhibitors for the treatment of HIV infections.
Upon the expiration or termination of the start-up exclusive
evaluation option license, Absino Co., Ltd will have the exclusive
right to execute an exclusive commercialization license which will
supersede and replace the start-up exclusive evaluation option license
with no greater field of use and territory than granted in the start-up
exclusive evaluation option license.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before July
8, 2015 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated start-up
exclusive evaluation option license should be directed to: Sally Hu,
Ph.D., M.B.A., 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-
5606; Facsimile: (301) 402-0220; Email: hus@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The subject technology is HIV-1 entry
inhibitors that can neutralize many subtypes of HIV-1 isolates
including clade A-E and tropism R5 and X4 (using either CCR5 or CXCR4
co-receptor for entry). These entry inhibitors are fusion proteins and
have a potency about 10-fold higher than that of the broadly
neutralizing antibody VRC01 that is in Phase I clinical trial, or 50-
fold higher than that of the FDA approved HIV entry inhibitor Fuzeon.
Therefore, these fusion proteins are promising drug candidates for HIV/
AIDS prevention and treatment.
The prospective start-up exclusive evaluation option license will
be royalty bearing 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 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.
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 start-up 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: June 16, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-15334 Filed 6-22-15; 8:45 am]
BILLING CODE 4140-01-P
