Prospective Grant of Exclusive License: Development of Anti-Angiogenesis Cancer Therapeutics Targeting Adrenomedullin or Proadrenomedullin N-Terminal 20 Peptide (PAMP), 44862-44864 [E9-20881]
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Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices
license or passport. All visitors should
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Dated: August 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–20872 Filed 8–28–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
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Request for Nominations to the
SAMHSA National Advisory Council
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) is accepting nominations
through October 7, 2009, to fill
vacancies for its five advisory
committees (the SAMHSA National
Advisory Council, the Center for
Substance abuse Prevention, Center for
Substance Abuse Treatment and Center
for Mental Health Services National
Advisory Councils and the Advisory
Committee for Women’s Services).
Under section 502 of the Public Health
Service Act, the National Advisory
Councils (NAC) provide advice to the
Secretary of the U.S. Department of
Health and Human Services (HHS),
SAMHSA Administrator, and/or Center
Directors on a broad range of polices
and services related to substance use
and mental health.
Legislation requires that each NAC be
composed of 12 members: nine
members must be leading
representatives of the health disciplines
(including public health, behavioral
health, and social sciences) relevant to
the mission of SAMHSA and its Centers
and three members must be from the
general public and include leaders in
the fields of public policy, public
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relations, law, health policy, economics,
or management.
Under section 501 of the Public
Health Service Act, the Advisory
Committee for Women’s Services
(ACWS) is statutorily mandated to
advise the SAMHSA Administrator and
the Associate Administrator for
Women’s Services on appropriate
activities to be undertaken by SAMHSA
and its Centers with respect to women’s
substance abuse and mental health
services. The SAMHSA Administrator
will appoint the 10 members of this
Committee. The members must be from
among physicians, practitioners,
treatment providers, and other health
professionals, whose clinical practice,
specialization, or professional expertise
includes a significant focus on women’s
substance abuse and mental health
conditions.
The current lists of members for the
advisory committees are available on
the SAMHSA Web site at https://
nac.samhsa.gov/index.aspx.
Members are appointed for a term of
up to four years. Individuals are
nominated, selected, and appointed to a
NAC or the ACWS to contribute to the
advisory committee’s objectives based
on their qualifications. The Federal
Advisory Committee Act (FACA) and
HHS policy require that committee
membership be fairly balanced in terms
of points of view represented and the
committee’s functions to be performed.
Consideration is given to a broad
representation of geographic areas,
gender, race/ethnicity, and disability.
The advisory committees will meet not
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as needed basis.
Any interested person or organization
may nominate qualified individuals for
membership. Self-nominations are also
welcome. Nominations must include a
resume and short biography describing
the educational and professional
qualifications of the nominee and the
nominee’s current occupation, position,
address and daytime telephone number.
Individuals may be recommended for
membership on more than one advisory
committee, but will be appointed to
only one advisory body. Nominations
can be sent by U.S. Mail or
electronically to Ms. Toian Vaughn,
Designated Federal Official, at the
address below.
Contact: Toian Vaughn, M.S.W.,
Designated Federal Official, SAMHSA
National Advisory Council and
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Officer, 1 Choke Cherry Road, Room 8–
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Telephone: (240) 276–2307; Fax: (240)
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276–2220 and E-mail:
toian.vaughn@samhsa.hhs.gov.
Toian Vaughn,
Committee Management Officer, Substance
Abuse and Mental Health Services
Administration.
[FR Doc. E9–20884 Filed 8–28–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of AntiAngiogenesis Cancer Therapeutics
Targeting Adrenomedullin or
Proadrenomedullin N-Terminal 20
Peptide (PAMP)
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, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in U.S. Patent Application
No. 60/002,514, filed on August 18,
1995, entitled ‘‘Functional Role of
Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human
Pathology and Physiology’’ (HHS
Reference No. E–206–1995/0–US–01);
U.S. Patent Application No. 60/002,936,
filed on August 30, 1995, entitled
‘‘Functional Role of Adrenomedullin
(AM) and the Gene-Related Product
(PAMP) in Human Pathology and
Physiology’’ (HHS Reference No. E–
206–1995/1–US–01); U.S. Patent
Application No. 60/013,172, filed on
March 12, 1996, entitled ‘‘Functional
Role of Adrenomedullin (AM) and the
Gene-Related Product (PAMP) in
Human Pathology and Physiology’’
(HHS Reference No. E–206–1995/2–US–
01); PCT Application No. PCT/US96/
13286, filed on August 16, 1996,
entitled ‘‘Functional Role of
Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human
Pathology and Physiology’’ (HHS
Reference No. E–206–1995/3–PCT–01);
Australian Patent No. 710662, issued on
October 5, 2000, entitled ‘‘Functional
Role of Adrenomedullin (AM) and the
Gene-Related Product (PAMP) in
Human Pathology and Physiology’’
(HHS Reference No. E–206–1995/3–AU–
02); Canadian Patent Application No.
2229741, filed on August 16, 1996,
entitled ‘‘Functional Role of
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Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices
Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human
Pathology and Physiology’’ (HHS
Reference No. E–206–1995/3–CA–03);
U.S. Patent No. 6,320,022, issued on
November 20, 2001, entitled
‘‘Adrenomedullin Peptides’’ (HHS
Reference No. E–206–1995/3–US–04);
European Patent No. 0845036, issued on
June 2, 1999, entitled ‘‘Functional Role
of Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human
Pathology and Physiology’’ (HHS
Reference No. E–206–1995/3–EP–07),
and validated in France, Germany, and
the United Kingdom; Japanese Patent
Application No. 509499/97, filed on
August 16, 1996, entitled ‘‘Functional
Role of Adrenomedullin (AM) and the
Gene-Related Product (PAMP) in
Human Pathology and Physiology’’
(HHS Reference No. E–206–1995/3–JP–
09); U.S. Patent No. 7,101,548, issued on
September 5, 2006, entitled ‘‘Functional
Role of Adrenomedullin (AM) and the
Gene-Related Product (PAMP) in
Human Pathology and Physiology’’
(HHS Reference No. E–206–1995/3–US–
10); U.S. Patent Application No. 11/
517,599, filed on September 5, 2006,
entitled ‘‘Functional Role of
Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human
Pathology and Physiology’’ (HHS
Reference No. E–206–1995/3–US–11);
Japanese Patent No. 4077861, issued on
February 8, 2008, entitled ‘‘Functional
Role of Adrenomedullin (AM) and the
Gene-Related Product (PAMP) in
Human Pathology and Physiology’’
(HHS Reference No. E–206–1995/3–JP–
12); U.S. Patent Application No. 60/
153,397, filed on September 10, 1999,
entitled ‘‘Determination of AM–Binding
Proteins and the Association of
Adrenomedullin (AM) Therewith’’
(HHS Reference No. E–256–1999/0–US–
01); PCT Application No. PCT/US00/
24722, filed on September 8, 2000,
entitled ‘‘Determination of AM–Binding
Proteins and the Association of
Adrenomedullin (AM) Therewith’’
(HHS Reference No. E–256–1999/0–
PCT–02); Australian Patent No. 774725,
issued on May 25, 2004, entitled
‘‘Determination of AM–Binding Proteins
and the Association of Adrenomedullin
(AM) Therewith’’ (HHS Reference No.
E–256–1999/0–AU–03); Canadian
Patent Application No. 2383419, filed
on September 8, 2000, entitled
‘‘Determination of AM–Binding Proteins
and the Association of Adrenomedullin
(AM) Therewith’’ (HHS Reference No.
E–256–1999/0–CA–04); European Patent
No. 1214600, issued on December 21,
2005, entitled ‘‘Determination of AM–
Binding Proteins and the Association of
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Adrenomedullin (AM) Therewith’’
(HHS Reference No. E–256–1999/0–EP–
05), and validated in France, Germany,
the United Kingdom, Italy, Spain, and
Portugal; U.S. Patent Application No.
10/070,853, filed on March 8, 2002,
entitled ‘‘Determination of AM–Binding
Proteins and the Association of
Adrenomedullin (AM) Therewith’’
(HHS Reference No. E–256–1999/0–US–
06); U.S. Patent Application No. 11/
530,411, filed on September 8, 2006,
entitled ‘‘Determination of AM–Binding
Proteins and the Association of
Adrenomedullin (AM) Therewith’’
(HHS Reference No. E–256–1999/0–US–
13); U.S. Patent Application No. 12/
236,418, filed on September 23, 2008,
entitled ‘‘Determination of AM–Binding
Proteins and the Association of
Adrenomedullin (AM) Therewith’’
(HHS Reference No. E–256–1999/0–US–
14); U.S. Patent Application No. 60/
425,018, filed on November 7, 2002,
entitled ‘‘A New Target for Angiogenesis
and Anti-Angiogenesis Therapy’’ (HHS
Reference No. E–294–2002/0–US–01);
PCT Application No. PCT/US03/35633,
filed on November 7, 2003, entitled ‘‘A
New Target for Angiogenesis and AntiAngiogenesis Therapy’’ (HHS Reference
No. E–294–2002/0–PCT–02); U.S. Patent
No. 7,462,593, issued on December 9,
2008, entitled ‘‘Compositions and
Methods for Promoting Angiogenesis’’
(HHS Reference No. E–294–2002/0–US–
03); European Patent Application No.
03786608.4, filed on November 7, 2003,
entitled ‘‘A New Target for Angiogenesis
and Anti-Angiogenesis Therapy’’ (HHS
Reference No. E–294–2002/0–EP–04);
Australian Patent Application No.
2003295422, filed on April 18, 2005,
entitled ‘‘A New Target for Angiogenesis
and Anti-Angiogenesis Therapy’’ (HHS
Reference No. E–294–2002/0–AU–05);
Canadian Patent Application No.
2504953, filed on November 7, 2003,
entitled ‘‘A New Target for Angiogenesis
and Anti-Angiogenesis Therapy’’ (HHS
Reference No. E–294–2002/0–CA–06);
Japanese Patent Application No. 2004–
551922, filed on May 9, 2005, entitled
‘‘A New Target for Angiogenesis and
Anti-Angiogenesis Therapy’’ (HHS
Reference No. E–294–2002/0–JP–07);
U.S. Patent Application No. 12/240,656,
filed on September 29, 2008, entitled
‘‘Target for Anti-Angiogenesis Therapy’’
(HHS Reference No. E–294–2002/0–US–
08); U.S. Patent Application No. 60/
500,650, filed on September 8, 2003,
entitled ‘‘Non-Peptide Agonists and
Antagonists of Adrenomedullin (AM)
And Gastrin Releasing Peptide’’ (HHS
Reference No. E–246–2003/0–US–01);
PCT Application No. PCT/US04/29293,
filed on September 8, 2004, entitled
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44863
‘‘Non-Peptide Agonists and Antagonists
of Adrenomedullin (AM) And Gastrin
Releasing Peptide’’ (HHS Reference No.
E–246–2003/1–PCT–01); European
Patent Application No. 04783513.7,
filed on September 8, 2004, entitled
‘‘Non-Peptide Agonists and Antagonists
of Adrenomedullin (AM) And Gastrin
Releasing Peptide’’ (HHS Reference No.
E–246–2003/1–EP–03); Canadian Patent
Application No. 2539467, filed on
September 8, 2004, entitled ‘‘NonPeptide Agonists and Antagonists of
Adrenomedullin (AM) And Gastrin
Releasing Peptide’’ (HHS Reference No.
E–246–2003/1–CA–04); Australian
Patent Application No. 2004273057,
filed on September 8, 2004, entitled
‘‘Non-Peptide Agonists and Antagonists
of Adrenomedullin (AM) And Gastrin
Releasing Peptide’’ (HHS Reference No.
E–246–2003/1–AU–05); and U.S. Patent
Application No. 10/571,012, filed on
March 8, 2006, entitled ‘‘Non-Peptide
Agonists and Antagonists of
Adrenomedullin (AM) And Gastrin
Releasing Peptide’’ (HHS Reference No.
E–246–2003/1–US–06) to Arana
Therapeutics (VIC) Pty. Ltd., having a
place of business at Level 5, Building 4,
399 Royal Parade, Parkville, Victoria
3052, Australia, a wholly-owned
subsidiary of Arana Therapeutics
Limited, having a place of business at
Level 2, 37 Epping Road, Macquarie
Park, NSW 2113, Australia, a whollyowned subsidiary of Cephalon, Inc.,
having a place of business at 41 Moores
Road, Frazer, PA 19355, USA. The
patent rights in this invention have been
assigned to the United States of
America.
The contemplated exclusive license
territory may be worldwide, and the
field of use may be limited to ‘‘use of
peptide and affinity binding reagents
(including but not limited to antibodies)
that neutralize the action of PAMP or
adrenomedullin to treat cancer’’.
DATES: Only written comments and/or
application for a license which are
received by the NIH Office of
Technology Transfer on or before
October 30, 2009 will be considered.
ADDRESSES: Requests for copies of the
patents, inquiries, comments, and other
materials relating to the contemplated
license should be directed to: Tara L.
Kirby, Ph.D., Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
301–435–4426; Facsimile: 301–402–
0220; E-mail: tarak@mail.nih.gov.
SUPPLEMENTARY INFORMATION: These
technologies relate to adrenomedullin
and proadrenomedullin N-terminal 20
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peptide (PAMP), two potent angiogenic
factors that are products of the same
gene. Therapies that reduce (antagonize)
the action of these factors have the
potential to treat conditions where
angiogenesis plays a pathological role,
such as cancer and macular
degeneration. Conversely, increasing
(agonizing) the action of these factors
may be useful for conditions where
enhanced angiogenesis is desired, such
as wound healing and cardiovascular
disease. Adrenomedullin and PAMP
have also been shown to play a role in
other diseases, such as
neurodegenerative disorders, diabetes,
and allergic and inflammatory disease.
More specifically, these technologies
include peptides, antibodies and small
molecules that agonize or antagonize the
activity of adrenomedullin and PAMP.
They also include methods for
inhibiting or inducing angiogenesis,
methods for inhibiting tumor growth,
methods for treating cancer, and
methods of treating a number of other
conditions, such as wounds,
neurological disease, allergic or
inflammatory disease, diabetes, and
cardiovascular disease.
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, 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 404.7.
Applications for a license in the
prospective field of use filed in response
to this notice will be treated as
objections to the grant of the
contemplated exclusive 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: August 24, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–20881 Filed 8–28–09; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2009–0396]
Collection of Information Under
Review by Office of Management and
Budget: OMB Control Number: 1625–
0008.
Coast Guard, DHS.
Thirty-day notice requesting
comments.
AGENCY:
ACTION:
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, this
request for comments announces that
the U.S. Coast Guard is forwarding an
Information Collection Request (ICR),
abstracted below, to the Office of
Information and Regulatory Affairs
(OIRA), Office of Management and
Budget (OMB) requesting an extension
of its approval for the following
collection of information: 1625–0008,
Regattas and Marine Parades. Our ICR
describes the information we seek to
collect from the public. Review and
comments by OIRA ensure we only
impose paperwork burdens
commensurate with our performance of
duties.
DATES: Please submit comments on or
before September 30, 2009.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2009–0396] to the
Docket Management Facility (DMF) at
the U.S. Department of Transportation
(DOT) or to OIRA. To avoid duplication,
please submit your comments by only
one of the following means:
(1) Electronic submission: (a) To Coast
Guard docket at https://
www.regulation.gov. (b) To OIRA by email via: oira_submission@omb.eop.gov.
(2) Mail or Hand delivery: (a) DMF
(M–30), DOT, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001. Hand deliver between the hours of
9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The
telephone number is 202–366–9329. (b)
To OIRA, 725 17th Street, NW.,
Washington, DC 20503, attention Desk
Officer for the Coast Guard.
(3) Fax: (a) To DMF, 202–493–2251.
(b) To OIRA at 202–395–6566. To
ensure your comments are received in
time, mark the fax, attention Desk
Officer for the Coast Guard.
The DMF maintains the public docket
for this Notice. Comments and material
received from the public, as well as
documents mentioned in this Notice as
being available in the docket, will
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become part of the docket and will be
available for inspection or copying at
room W12–140 on the West Building
Ground Floor, 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. You may also
find the docket on the Internet at
https://www.regulations.gov.
A copy of the ICR is available through
the docket on the Internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–611), ATTN Paperwork Reduction
Act Manager, U.S. Coast Guard, 2100
2nd St., SW., Stop 7101, Washington,
DC 20593–7101.
FOR FURTHER INFORMATION CONTACT: Mr.
Arthur Requina, Office of Information
Management, telephone 202–475–3523
or fax 202–475–3929, for questions on
these documents. Contact Ms. Renee V.
Wright, Program Manager, Docket
Operations, 202–366–9826, for
questions on the docket.
SUPPLEMENTARY INFORMATION: The Coast
Guard invites comments on whether
this ICR should be granted based on it
being necessary for the proper
performance of Departmental functions.
In particular, the Coast Guard would
appreciate comments addressing: (1)
The practical utility of the collections;
(2) the accuracy of the estimated burden
of the collections; (3) ways to enhance
the quality, utility, and clarity of
information subject to the collections;
and (4) ways to minimize the burden of
collections on respondents, including
the use of automated collection
techniques or other forms of information
technology.
Comments to Coast Guard or OIRA
must contain the OMB Control Number
of the ICR. They must also contain the
docket number of this request, [USCG
2009–0396]. For your comments to
OIRA to be considered, it is best if they
are received on or before the September
30, 2009.
Public participation and request for
comments: We encourage you to
respond to this request by submitting
comments and related materials. We
will post all comments received,
without change, to https://
www.regulations.gov. They will include
any personal information you provide.
We have an agreement with DOT to use
their DMF. Please see the ‘‘Privacy Act’’
paragraph below.
Submitting comments: If you submit a
comment, please include the docket
number [USCG–2009–0396], indicate
the specific section of the document to
which each comment applies, providing
a reason for each comment. We
recommend you include your name,
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Agencies
[Federal Register Volume 74, Number 167 (Monday, August 31, 2009)]
[Notices]
[Pages 44862-44864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20881]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of Anti-
Angiogenesis Cancer Therapeutics Targeting Adrenomedullin or
Proadrenomedullin N-Terminal 20 Peptide (PAMP)
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, is contemplating the grant of
an exclusive patent license to practice the inventions embodied in U.S.
Patent Application No. 60/002,514, filed on August 18, 1995, entitled
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/0-US-01); U.S. Patent Application No. 60/002,936, filed on August
30, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the
Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS
Reference No. E-206-1995/1-US-01); U.S. Patent Application No. 60/
013,172, filed on March 12, 1996, entitled ``Functional Role of
Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human
Pathology and Physiology'' (HHS Reference No. E-206-1995/2-US-01); PCT
Application No. PCT/US96/13286, filed on August 16, 1996, entitled
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/3-PCT-01); Australian Patent No. 710662, issued on October 5,
2000, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-
Related Product (PAMP) in Human Pathology and Physiology'' (HHS
Reference No. E-206-1995/3-AU-02); Canadian Patent Application No.
2229741, filed on August 16, 1996, entitled ``Functional Role of
[[Page 44863]]
Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human
Pathology and Physiology'' (HHS Reference No. E-206-1995/3-CA-03); U.S.
Patent No. 6,320,022, issued on November 20, 2001, entitled
``Adrenomedullin Peptides'' (HHS Reference No. E-206-1995/3-US-04);
European Patent No. 0845036, issued on June 2, 1999, entitled
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/3-EP-07), and validated in France, Germany, and the United
Kingdom; Japanese Patent Application No. 509499/97, filed on August 16,
1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-
Related Product (PAMP) in Human Pathology and Physiology'' (HHS
Reference No. E-206-1995/3-JP-09); U.S. Patent No. 7,101,548, issued on
September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM)
and the Gene-Related Product (PAMP) in Human Pathology and Physiology''
(HHS Reference No. E-206-1995/3-US-10); U.S. Patent Application No. 11/
517,599, filed on September 5, 2006, entitled ``Functional Role of
Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human
Pathology and Physiology'' (HHS Reference No. E-206-1995/3-US-11);
Japanese Patent No. 4077861, issued on February 8, 2008, entitled
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/3-JP-12); U.S. Patent Application No. 60/153,397, filed on
September 10, 1999, entitled ``Determination of AM-Binding Proteins and
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No.
E-256-1999/0-US-01); PCT Application No. PCT/US00/24722, filed on
September 8, 2000, entitled ``Determination of AM-Binding Proteins and
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No.
E-256-1999/0-PCT-02); Australian Patent No. 774725, issued on May 25,
2004, entitled ``Determination of AM-Binding Proteins and the
Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-
256-1999/0-AU-03); Canadian Patent Application No. 2383419, filed on
September 8, 2000, entitled ``Determination of AM-Binding Proteins and
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No.
E-256-1999/0-CA-04); European Patent No. 1214600, issued on December
21, 2005, entitled ``Determination of AM-Binding Proteins and the
Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-
256-1999/0-EP-05), and validated in France, Germany, the United
Kingdom, Italy, Spain, and Portugal; U.S. Patent Application No. 10/
070,853, filed on March 8, 2002, entitled ``Determination of AM-Binding
Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS
Reference No. E-256091999/0-US-06); U.S. Patent Application No. 11/
530,411, filed on September 8, 2006, entitled ``Determination of AM-
Binding Proteins and the Association of Adrenomedullin (AM) Therewith''
(HHS Reference No. E-256-1999/0-US-13); U.S. Patent Application No. 12/
236,418, filed on September 23, 2008, entitled ``Determination of AM-
Binding Proteins and the Association of Adrenomedullin (AM) Therewith''
(HHS Reference No. E-256-1999/0-US-14); U.S. Patent Application No. 60/
425,018, filed on November 7, 2002, entitled ``A New Target for
Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-
2002/0-US-01); PCT Application No. PCT/US03/35633, filed on November 7,
2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis
Therapy'' (HHS Reference No. E-294-2002/0-PCT-02); U.S. Patent No.
7,462,593, issued on December 9, 2008, entitled ``Compositions and
Methods for Promoting Angiogenesis'' (HHS Reference No. E-294-2002/0-
US-03); European Patent Application No. 03786608.4, filed on November
7, 2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis
Therapy'' (HHS Reference No. E-294-2002/0-EP-04); Australian Patent
Application No. 2003295422, filed on April 18, 2005, entitled ``A New
Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference
No. E-294-2002/0-AU-05); Canadian Patent Application No. 2504953, filed
on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti-
Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-CA-06); Japanese
Patent Application No. 2004-551922, filed on May 9, 2005, entitled ``A
New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS
Reference No. E-294-2002/0-JP-07); U.S. Patent Application No. 12/
240,656, filed on September 29, 2008, entitled ``Target for Anti-
Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-US-08); U.S.
Patent Application No. 60/500,650, filed on September 8, 2003, entitled
``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And
Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/0-US-01); PCT
Application No. PCT/US04/29293, filed on September 8, 2004, entitled
``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And
Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-PCT-01);
European Patent Application No. 04783513.7, filed on September 8, 2004,
entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM)
And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-EP-03);
Canadian Patent Application No. 2539467, filed on September 8, 2004,
entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM)
And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-CA-04);
Australian Patent Application No. 2004273057, filed on September 8,
2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin
(AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-
AU-05); and U.S. Patent Application No. 10/571,012, filed on March 8,
2006, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin
(AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-
US-06) to Arana Therapeutics (VIC) Pty. Ltd., having a place of
business at Level 5, Building 4, 399 Royal Parade, Parkville, Victoria
3052, Australia, a wholly-owned subsidiary of Arana Therapeutics
Limited, having a place of business at Level 2, 37 Epping Road,
Macquarie Park, NSW 2113, Australia, a wholly-owned subsidiary of
Cephalon, Inc., having a place of business at 41 Moores Road, Frazer,
PA 19355, USA. The patent rights in this invention have been assigned
to the United States of America.
The contemplated exclusive license territory may be worldwide, and
the field of use may be limited to ``use of peptide and affinity
binding reagents (including but not limited to antibodies) that
neutralize the action of PAMP or adrenomedullin to treat cancer''.
DATES: Only written comments and/or application for a license which are
received by the NIH Office of Technology Transfer on or before October
30, 2009 will be considered.
ADDRESSES: Requests for copies of the patents, inquiries, comments, and
other materials relating to the contemplated license should be directed
to: Tara L. Kirby, Ph.D., Licensing and Patenting Manager, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-
4426; Facsimile: 301-402-0220; E-mail: tarak@mail.nih.gov.
SUPPLEMENTARY INFORMATION: These technologies relate to adrenomedullin
and proadrenomedullin N-terminal 20
[[Page 44864]]
peptide (PAMP), two potent angiogenic factors that are products of the
same gene. Therapies that reduce (antagonize) the action of these
factors have the potential to treat conditions where angiogenesis plays
a pathological role, such as cancer and macular degeneration.
Conversely, increasing (agonizing) the action of these factors may be
useful for conditions where enhanced angiogenesis is desired, such as
wound healing and cardiovascular disease. Adrenomedullin and PAMP have
also been shown to play a role in other diseases, such as
neurodegenerative disorders, diabetes, and allergic and inflammatory
disease.
More specifically, these technologies include peptides, antibodies
and small molecules that agonize or antagonize the activity of
adrenomedullin and PAMP. They also include methods for inhibiting or
inducing angiogenesis, methods for inhibiting tumor growth, methods for
treating cancer, and methods of treating a number of other conditions,
such as wounds, neurological disease, allergic or inflammatory disease,
diabetes, and cardiovascular disease.
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, 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 404.7.
Applications for a license in the prospective field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive 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: August 24, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-20881 Filed 8-28-09; 8:45 am]
BILLING CODE 4140-01-P