Prospective Grant of Exclusive License: Multivalent Vaccines for Rabies Virus and Ebola and Marburg (Filoviruses), 18039-18040 [2014-07023]
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18039
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices
TABLE 1—ESTIMATES FOR ANNUAL BURDEN HOURS
Type of data collection
instrument
Number of
respondents
Frequency of
response
Average time
per response
Annual hour
burden
Focus Groups ..................................................................................................
Pre/Post Test ...................................................................................................
Survey ..............................................................................................................
Interview ...........................................................................................................
Tracking/Feedback Form .................................................................................
500
2,500
2,500
500
1,500
1
1
1
1
1
1
15/60
15/60
1
30/60
500
625
625
500
750
Total ..........................................................................................................
7,500
........................
........................
3,000
Dated: March 21, 2014.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis, and Communications, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, National
Institutes of Health.
[FR Doc. 2014–07105 Filed 3–28–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of a Single
Domain Human Anti-Mesothelin
Monoclonal Antibody 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 start-up option license to
practice the inventions embodied in
U.S. Patent Application 61/706,396
entitled ‘‘Mesothelin Antibodies and
Methods for Eliciting Potent Antitumor
Activity’’ [HHS Ref. E–236–2012/0–US–
01], PCT Application PCT/US2013/
059883 entitled ‘‘Mesothelin Antibodies
and Methods for Eliciting Potent
Antitumor Activity’’ [HHS Ref. E–236–
2012/0–PCT–02], and all related
continuing and foreign patents/patent
applications for the technology family,
to H2Bio, Inc. The patent rights in these
inventions have been assigned to and/or
exclusively licensed to the Government
of the United States of America.
The prospective exclusive start-up
option licensed territory may be
worldwide, and the field of use may be
limited to:
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
The use of the monoclonal antibody SD1
(and glycoengineered variants thereof) as an
antibody therapy for the treatment of
mesothelioma, pancreatic cancer, ovarian
cancer and lung adenocarcinoma. The
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18:10 Mar 28, 2014
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Licensed Field of Use explicitly excludes the
use of the antibody in the form of an
immunoconjugate, including, but not limited
to, immunotoxins.
Upon the expiration or termination of
the exclusive start-up option license,
H2Bio, Inc. will have the exclusive right
to execute an exclusive
commercialization license which will
supersede and replace the exclusive
start-up option license with no greater
field of use and territory than granted in
the exclusive start-up 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 April
15, 2014 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: David A. Lambertson,
Ph.D., Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–4632; Facsimile: (301) 402–
0220; Email: lambertsond@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns a monoclonal
antibody and methods of using the
antibody for the treatment of
mesothelin-expressing cancers,
including mesothelioma, lung cancer,
ovarian cancer and pancreatic cancer.
The specific antibody covered by this
technology is designated SD1, which is
a single domain, fully human
monoclonal antibody against
mesothelin.
Mesothelin is a cell surface antigen
that is preferentially expressed on
certain types of cancer cells. The SD1
antibody can selectively bind to these
cancer cells and induce cell death while
leaving healthy, essential cells
unharmed. This can result in an
effective therapeutic strategy with fewer
side effects due to less non-specific
killing of cells.
The prospective exclusive start-up
option license will be royalty bearing
and will comply with the terms and
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
conditions of 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive
start-up option license may be granted
unless 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
within fifteen (15) days from the date of
this published notice.
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
start-up 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 27, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–07022 Filed 3–28–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Multivalent Vaccines for
Rabies Virus and Ebola and Marburg
(Filoviruses)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health (NIH),
Department of Health and Human
Services (HHS), is contemplating the
grant of a an exclusive license to
practice the following invention as
embodied in the following patent
applications: E–032–2011/0, Blaney et
al., ‘‘Multivalent Vaccines for Rabies
Virus and Filoviruses,’’ U.S. Patent
Application Number 61/439,046, filed
SUMMARY:
E:\FR\FM\31MRN1.SGM
31MRN1
18040
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices
on February 3, 2011, PCT Application
Number PCT/US2012/23575, filed on
February 2, 2012, U.S. Patent
Application Number 13/983,545, filed
on August 2, 2013, European Patent
Application Number 12702953.6, filed
on February 2, 2012, and Canadian
Patent Application Number 2826594,
filed on February 2, 2012, to Exxell BIO,
Inc., having a place of business in
Shoreview, Minnesota, United States of
America. The patent rights in these
inventions have been assigned to the
United States of America and Thomas
Jefferson University.
Only written comments and/or
application for a license which are
received by the NIH Office of
Technology Transfer on or before April
30, 2014 will be considered.
DATES:
Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Peter Soukas, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Email:
ps193c@nih.gov; Telephone: (301) 435–
4646; Facsimile: (301) 402–0220.
ADDRESSES:
No
vaccine candidates against Ebola virus
(EBOV) or Marburg virus (MARV) are
nearing licensure, and the need to
develop a safe and efficacious vaccine
against filoviruses continues. Whereas
several preclinical and clinical vaccine
candidates against EBOV or MARV exist
(please see below for further
elaboration), their further development
is a major challenge based on safety
concerns, pre-existing vector immunity,
issues such as manufacturing, dosage,
and marketability, and funding for
development. The inventors have
developed a new platform based on live
or chemically inactivated (killed) rabies
virus (RABV) virions containing EBOV
glycoprotein (GP) in their envelope. In
preclinical trials, immunization with
such recombinant RABV virions
provided excellent protection in mice
against lethal challenge with the mouse
adapted EBOV and RABV. More
specifically, the inventors have
developed a trivalent filovirus vaccine
based on killed rabies virus virions for
use in humans to confer protection from
all medically relevant filoviruses and
RABV. Two additional vectors
containing EBOV Sudan GP or MARV
GP are planned to be constructed in
addition to the previously developed
EBOV Zaire GP containing vaccine. Live
attenuated vaccines have been
developed for use in at risk nonhuman
primate populations in Africa and
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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18:10 Mar 28, 2014
Jkt 232001
inactivated vaccines have been
developed for use in humans.
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. The prospective
exclusive license may be granted unless,
within thirty (30) 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.
The fields of use may be limited to (1)
inactivated vaccines against rabies virus
and filoviruses for use in humans and
(2) live attenuated vaccines against
rabies virus and filoviruses for use in
non-human animals.
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: March 26, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–07023 Filed 3–28–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; 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
contract proposals 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
and contract proposals, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Emphasis Panel; NIH Loan Repayment
Program (Clinical and Pediatric Researchers).
Date: April 24, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Environmental
Health Sciences, Keystone Building, 530
Davis Drive, Room 3094, Morrisville, NC
27560; (Virtual Meeting).
Contact Person: RoseAnne M. McGee,
Associate Scientific Review Administrator,
Scientific Review Branch, Division of
Extramural Research and Training, Nat.
Institute of Environmental Health Sciences,
P.O. Box 12233, MD EC–30, Research
Triangle Park, NC 27709, (919) 541–0752,
mcgee1@niehs.nih.gov.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; Career Grant Applications
Review in Environmental Health Sciences.
Date: April 24, 2014.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, Keystone Building, 530
Davis Drive, Room 3118, Morrisville, NC
27560, (Telephone Conference Call).
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research and Training, Nat. Institute of
Environmental Health Sciences, P.O. Box
12233, MD EC–30/Room 3171, Research
Triangle Park, NC 27709, (919) 541–0670,
worth@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: March 25, 2014.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–07021 Filed 3–28–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Center for Advancing Translational
Sciences.
E:\FR\FM\31MRN1.SGM
31MRN1
]]>Agencies
[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18039-18040]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07023]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Multivalent Vaccines for
Rabies Virus and Ebola and Marburg (Filoviruses)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
404, that the National Institutes of Health (NIH), Department of Health
and Human Services (HHS), is contemplating the grant of a an exclusive
license to practice the following invention as embodied in the
following patent applications: E-032-2011/0, Blaney et al.,
``Multivalent Vaccines for Rabies Virus and Filoviruses,'' U.S. Patent
Application Number 61/439,046, filed
[[Page 18040]]
on February 3, 2011, PCT Application Number PCT/US2012/23575, filed on
February 2, 2012, U.S. Patent Application Number 13/983,545, filed on
August 2, 2013, European Patent Application Number 12702953.6, filed on
February 2, 2012, and Canadian Patent Application Number 2826594, filed
on February 2, 2012, to Exxell BIO, Inc., having a place of business in
Shoreview, Minnesota, United States of America. The patent rights in
these inventions have been assigned to the United States of America and
Thomas Jefferson University.
DATES: Only written comments and/or application for a license which are
received by the NIH Office of Technology Transfer on or before April
30, 2014 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: Peter Soukas, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804; Email: ps193c@nih.gov; Telephone: (301) 435-
4646; Facsimile: (301) 402-0220.
SUPPLEMENTARY INFORMATION: No vaccine candidates against Ebola virus
(EBOV) or Marburg virus (MARV) are nearing licensure, and the need to
develop a safe and efficacious vaccine against filoviruses continues.
Whereas several preclinical and clinical vaccine candidates against
EBOV or MARV exist (please see below for further elaboration), their
further development is a major challenge based on safety concerns, pre-
existing vector immunity, issues such as manufacturing, dosage, and
marketability, and funding for development. The inventors have
developed a new platform based on live or chemically inactivated
(killed) rabies virus (RABV) virions containing EBOV glycoprotein (GP)
in their envelope. In preclinical trials, immunization with such
recombinant RABV virions provided excellent protection in mice against
lethal challenge with the mouse adapted EBOV and RABV. More
specifically, the inventors have developed a trivalent filovirus
vaccine based on killed rabies virus virions for use in humans to
confer protection from all medically relevant filoviruses and RABV. Two
additional vectors containing EBOV Sudan GP or MARV GP are planned to
be constructed in addition to the previously developed EBOV Zaire GP
containing vaccine. Live attenuated vaccines have been developed for
use in at risk nonhuman primate populations in Africa and inactivated
vaccines have been developed for use in humans.
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.
The prospective exclusive license may be granted unless, within thirty
(30) 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.
The fields of use may be limited to (1) inactivated vaccines
against rabies virus and filoviruses for use in humans and (2) live
attenuated vaccines against rabies virus and filoviruses for use in
non-human animals.
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: March 26, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-07023 Filed 3-28-14; 8:45 am]
BILLING CODE 4140-01-P
