Prospective Grant of Co-Exclusive Option License: The Development of a Single Domain Human Anti-Mesothelin Monoclonal Antibody for the Treatment of Human Cancers, 42025-42026 [2014-16853]
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Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices
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(Catalogue of Federal Domestic Assistance
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Dated: July 14, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–16857 Filed 7–17–14; 8:45 am]
Name of Committee: Center for Scientific
Review Special Emphasis Panel Aspects of
NeuroAIDS.
Date: August 8, 2014.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
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Contact Person: Mary Clare Walker, Ph.D.,
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(Catalogue of Federal Domestic Assistance
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93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 14, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–16855 Filed 7–17–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
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DEPARTMENT OF HEALTH AND
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National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
sroberts on DSK5SPTVN1PROD with NOTICES
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
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Name of Committee: Center for Scientific
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Conflict: AIDS and AIDS Related Research.
Date: August 6–7, 2014.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Robert Freund, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@csr.nih.gov.
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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 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 Member
Conflict: AIDS and AIDS Related Research.
Date: July 21, 2014.
Time: 4:00 p.m. to 6:00 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: Jose H. Guerrier, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1137, guerriej@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
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limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Member
Conflict: AIDS and AIDS Related Research.
Date: July 23, 2014.
Time: 10:00 a.m. to 12:30 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: Mark P. Rubert, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1775, rubertm@csr.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.
(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: July 14, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–16856 Filed 7–17–14; 8:45 am]
BILLING CODE 4140–01–P
Center for Scientific Review; Notice of
Closed Meetings
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42025
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Co-Exclusive
Option 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 a
co-exclusive (or exclusive, if the other
party declines to move forward with an
agreement) 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 MesoPharm Therapeutics, Inc. The
SUMMARY:
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42026
Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices
patent rights in these inventions have
been assigned to and/or exclusively
licensed to the Government of the
United States of America.
The prospective co-exclusive (or
exclusive) start-up option licensed
territory may be worldwide, and the
field of use may be limited to:
sroberts on DSK5SPTVN1PROD with NOTICES
The use of the monoclonal antibody SD1
(and glycoengineered variants thereof) as an
antibody therapy for the treatment of
mesothelioma, pancreatic cancer, breast
cancer, ovarian cancer and lung
adenocarcinoma. The 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 co-exclusive start-up option license,
MesoPharm Therapeutics, Inc. will have
the co-exclusive right to execute a coexclusive (or exclusive, if the other
party declines their option)
commercialization license which will
supersede and replace the co-exclusive
start-up option license with no greater
field of use and territory than granted in
the co-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
August 4, 2014 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated co-exclusive start-up
option 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.
VerDate Mar<15>2010
23:20 Jul 17, 2014
Jkt 232001
The prospective co-exclusive start-up
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 co-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 coexclusive 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: July 14, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–16853 Filed 7–17–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
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collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Multi-Site Evaluation
of the Safe Schools/Healthy Students
(SS/HS) State Program—NEW
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Center for Mental Health
Services (CMHS) will conduct the
multi-site evaluation of the Safe
Schools/Healthy Students (SS/HS) state
program. The data collected through the
multi-site evaluation addresses three
study components: (1) The planning,
collaboration, and partnership study; (2)
the implementation study; and (3) the
workforce study.
The SS/HS state program funded
grantees in seven states beginning in
September 2013. Data will be collected
from state/tribal administrators, Local
Education Authorities (LEAs)/Districts,
local program staff (e.g., school resource
officers, teachers and administrators,
and psychologists) and program
partners (e.g., parents, representatives
from the juvenile justice and mental
health providers).
Data collection activities will include
key informant interviews, and webbased surveys. The instruments to be
used for data collection are as follows:
Planning, Collaboration and Partnership
Study
• State Key Informant Interview
Protocol.
• District Key Informant Interview
Protocol.
• State Collaborator Survey.
• District Collaborator Survey.
• State Collaboration Indicator Data
Instrument.
• District Collaboration Indicator Data
Instrument.
Implementation Study
• State & District Key Informant
Interview Protocol.
• School-Level Survey.
Workforce Study
• No additional instruments will be
used for this study. Data will be
gathered from the Planning,
Collaboration and Partnership Study
and the Implementation Study.
A summary table of the number of
respondents and respondent burden has
also been included.
Data Collection Activities for MSE
Grantees
Data for all instruments will be
collected annually with the exception of
data for the state and District
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]]>Agencies
[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Notices]
[Pages 42025-42026]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16853]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Co-Exclusive Option 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.
-----------------------------------------------------------------------
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 co-exclusive (or
exclusive, if the other party declines to move forward with an
agreement) 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 MesoPharm
Therapeutics, Inc. The
[[Page 42026]]
patent rights in these inventions have been assigned to and/or
exclusively licensed to the Government of the United States of America.
The prospective co-exclusive (or exclusive) start-up option
licensed territory may be worldwide, and the field of use may be
limited to:
The use of the monoclonal antibody SD1 (and glycoengineered
variants thereof) as an antibody therapy for the treatment of
mesothelioma, pancreatic cancer, breast cancer, ovarian cancer and
lung adenocarcinoma. The 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 co-exclusive start-up
option license, MesoPharm Therapeutics, Inc. will have the co-exclusive
right to execute a co-exclusive (or exclusive, if the other party
declines their option) commercialization license which will supersede
and replace the co-exclusive start-up option license with no greater
field of use and territory than granted in the co-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
August 4, 2014 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated co-exclusive
start-up option 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 co-exclusive start-up 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 co-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 co-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: July 14, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-16853 Filed 7-17-14; 8:45 am]
BILLING CODE 4140-01-P
