Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines, 24320 [2018-11258]
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Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
Contact Person: Julia Berzhanskaya, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4234, MSC 9550, Bethesda,
MD 20892, 301–827–5840,
julia.berzhanskaya@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; SBIR
Phase II ‘‘Virtual Reality Tools for Treatment
of Substance Use Disorders’’ (5583).
Date: June 4, 2018.
Time: 10:00 a.m. to 11:30 a.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Julia Berzhanskaya, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4234, MSC 9550, Bethesda,
MD 20892, 301–827–5840,
julia.berzhanskaya@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: May 21, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–11216 Filed 5–24–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Production of Monovalent
Live Attenuated Zika Vaccines and
Multivalent Live Attenuated Flavivirus
Vaccines
National Institute of Allergy
and Infectious Diseases, National
Institutes of Health, Public Health
Service, DHHS.
ACTION: Notice.
amozie on DSK3GDR082PROD with NOTICES1
AGENCY:
SUMMARY: The National Institute of
Allergy and Infectious Diseases, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Commercialization
Patent License to practice the inventions
embodied in the Patents and Patent
Applications listed in the Summary
Information section of this notice to
Medigen Vaccines Biologics Corp.
VerDate Sep<11>2014
18:28 May 24, 2018
Jkt 241001
(Medigen), having a place of business in
Zhubei, Taiwan.
DATES: Only written comments and/or
application for a license which are
received by the NIAID Technology
Transfer and Intellectual Property Office
on or before June 25, 2018 will be
considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated Exclusive
Commercialization Patent License
should be directed to: Peter Soukas,
Technology Transfer and Patent
Specialist, Technology Transfer and
Intellectual Property Office, National
Institute of Allergy and Infectious
Diseases, National Institutes of Health,
5601 Fishers Lane, Suite 6D, Rockville,
MD 20852–9804; Email: ps193c@
nih.gov; Telephone: (301) 496–2644;
Facsimile: (240) 627–3117.
SUPPLEMENTARY INFORMATION:
Intellectual Property
U.S. Provisional Patent Application
Number 62/307,170, filed March 11,
2016 and entitled ‘‘Live Attenuated Zika
Virus Vaccines,’’ Whitehead et al., and
PCT Patent Application Number PCT/
US2017/0021989, filed March 11, 2017
and entitled ‘‘Live Attenuated Zika
Virus Vaccines,’’ Whitehead et al. [HHS
Reference E–118–2016/0]; and U.S. and
foreign patent applications claiming
priority to the aforementioned
applications.
The patent rights in these inventions
have been assigned to the government of
the United States of America.
The field of use may be limited to
monovalent live attenuated Zika
vaccines and multivalent live attenuated
flavivirus vaccines. The Licensed
Territory may be limited to Europe,
China, South Korea, Japan, India,
Australia and New Zealand.
Zika virus (ZIKV) is an emerging
infectious disease that was first
identified in 1947, and that has more
recently become a major public health
threat around the world. ZIKV has
recently been shown to cause
devastating neurological damage in
infants and serious complications in
adults in some cases, and may have
other effects that have not yet been
identified or definitively linked to the
virus. There are no treatments or
vaccines for this insidious virus.
Recommendations that women who live
in or travel to endemic areas avoid
pregnancy for long periods of time are
unrealistic, particularly in contexts
where access to reproductive services is
limited, and threaten to leave those
most likely to suffer the devastating
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
consequences of Zika without effective
protection. There is therefore urgent
need to develop biomedical
interventions in parallel with ongoing
public health efforts against ZIKV.
No vaccine exists today to prevent
ZIKV infections. The methods and
compositions of this invention provide
a means for prevention of ZIKV
infection by immunization with live
attenuated, immunogenic viral vaccines
against ZIKV and/or Dengue virus.
Many entities, governmental,
academic, and commercial, are actively
pursuing development of ZIKV vaccines
each using a different approach to
address this public health need. The
U.S. Government is coordinating its
vaccine development response to ZIKV
and has published this plan at https://
www.phe.gov/Preparedness/planning/
Pages/zika-white-paper.aspx.
Vaccine development approaches for
ZIKV include but are not limited to
inactivated virus (dead virus), live
attenuated virus (weakened virus),
recombinant viral vectors (weakened
virus with target genes added), and
subunit (portion of a virus) as well as
mRNA- and DNA-based (gene-targeted).
These various strategies provide
multiple redundancies, expanded
choice, and ensure short and long term
maximal benefits to the public.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within thirty (30) days from the date of
this published notice, the National
Institute of Allergy and Infectious
Diseases 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.
Complete applications for a license in
the prospective field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Exclusive
Commercialization Patent License
Agreement. 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: May 14, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–11258 Filed 5–24–18; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Page 24320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11258]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Production of Monovalent
Live Attenuated Zika Vaccines and Multivalent Live Attenuated
Flavivirus Vaccines
AGENCY: National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases, an
institute of the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an Exclusive
Commercialization Patent License to practice the inventions embodied in
the Patents and Patent Applications listed in the Summary Information
section of this notice to Medigen Vaccines Biologics Corp. (Medigen),
having a place of business in Zhubei, Taiwan.
DATES: Only written comments and/or application for a license which are
received by the NIAID Technology Transfer and Intellectual Property
Office on or before June 25, 2018 will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated Exclusive
Commercialization Patent License should be directed to: Peter Soukas,
Technology Transfer and Patent Specialist, Technology Transfer and
Intellectual Property Office, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, 5601 Fishers Lane,
Suite 6D, Rockville, MD 20852-9804; Email: [email protected]; Telephone:
(301) 496-2644; Facsimile: (240) 627-3117.
SUPPLEMENTARY INFORMATION:
Intellectual Property
U.S. Provisional Patent Application Number 62/307,170, filed March
11, 2016 and entitled ``Live Attenuated Zika Virus Vaccines,''
Whitehead et al., and PCT Patent Application Number PCT/US2017/0021989,
filed March 11, 2017 and entitled ``Live Attenuated Zika Virus
Vaccines,'' Whitehead et al. [HHS Reference E-118-2016/0]; and U.S. and
foreign patent applications claiming priority to the aforementioned
applications.
The patent rights in these inventions have been assigned to the
government of the United States of America.
The field of use may be limited to monovalent live attenuated Zika
vaccines and multivalent live attenuated flavivirus vaccines. The
Licensed Territory may be limited to Europe, China, South Korea, Japan,
India, Australia and New Zealand.
Zika virus (ZIKV) is an emerging infectious disease that was first
identified in 1947, and that has more recently become a major public
health threat around the world. ZIKV has recently been shown to cause
devastating neurological damage in infants and serious complications in
adults in some cases, and may have other effects that have not yet been
identified or definitively linked to the virus. There are no treatments
or vaccines for this insidious virus. Recommendations that women who
live in or travel to endemic areas avoid pregnancy for long periods of
time are unrealistic, particularly in contexts where access to
reproductive services is limited, and threaten to leave those most
likely to suffer the devastating consequences of Zika without effective
protection. There is therefore urgent need to develop biomedical
interventions in parallel with ongoing public health efforts against
ZIKV.
No vaccine exists today to prevent ZIKV infections. The methods and
compositions of this invention provide a means for prevention of ZIKV
infection by immunization with live attenuated, immunogenic viral
vaccines against ZIKV and/or Dengue virus.
Many entities, governmental, academic, and commercial, are actively
pursuing development of ZIKV vaccines each using a different approach
to address this public health need. The U.S. Government is coordinating
its vaccine development response to ZIKV and has published this plan at
https://www.phe.gov/Preparedness/planning/Pages/zika-white-paper.aspx.
Vaccine development approaches for ZIKV include but are not limited
to inactivated virus (dead virus), live attenuated virus (weakened
virus), recombinant viral vectors (weakened virus with target genes
added), and subunit (portion of a virus) as well as mRNA- and DNA-based
(gene-targeted). These various strategies provide multiple
redundancies, expanded choice, and ensure short and long term maximal
benefits to the public.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and the prospective exclusive license may be granted unless within
thirty (30) days from the date of this published notice, the National
Institute of Allergy and Infectious Diseases 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.
Complete applications for a license in the prospective field of use
that are filed in response to this notice will be treated as objections
to the grant of the contemplated Exclusive Commercialization Patent
License Agreement. 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: May 14, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-11258 Filed 5-24-18; 8:45 am]
BILLING CODE 4140-01-P
