80_FR_54746 80 FR 54571 - Prospective Grant of a Start-up Exclusive Option License: Therapeutic Uses for Cardio-Metabolic Indications, Including Hypertriglyceridemia, Hypercholesterolemia and Diabetes

80 FR 54571 - Prospective Grant of a Start-up Exclusive Option License: Therapeutic Uses for Cardio-Metabolic Indications, Including Hypertriglyceridemia, Hypercholesterolemia and Diabetes

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 175 (September 10, 2015)

Page Range54571-54572
FR Document2015-22771

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Option License to practice the invention embodied in Patent Applications USSN 61/045,213, filed April 15, 2008; PCT/US2009/ 040560, filed April 14, 2009; and US 12/937,974, filed October 14, 2010, issued as 8,936,787 on January 20, 2015; titled ``Peptides Promoting Lipid Efflux'' (NIH Ref. E-138-2008/0) to Corvidia Corporation, having a place of business in Boston, MA. The patent rights in this invention have been assigned to the United States of America.

Federal Register, Volume 80 Issue 175 (Thursday, September 10, 2015)
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54571-54572]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of a Start-up Exclusive Option License: 
Therapeutic Uses for Cardio-Metabolic Indications, Including 
Hypertriglyceridemia, Hypercholesterolemia and Diabetes

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 (NIH), Department of 
Health and Human Services, is contemplating the grant of a

[[Page 54572]]

Start-Up Exclusive Option License to practice the invention embodied in 
Patent Applications USSN 61/045,213, filed April 15, 2008; PCT/US2009/
040560, filed April 14, 2009; and US 12/937,974, filed October 14, 
2010, issued as 8,936,787 on January 20, 2015; titled ``Peptides 
Promoting Lipid Efflux'' (NIH Ref. E-138-2008/0) to Corvidia 
Corporation, having a place of business in Boston, MA. The patent 
rights in this invention have been assigned to the United States of 
America.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before 
September 25, 2015 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: Cristina Thalhammer-Reyero, Ph.D., M.B.A., 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email: 
[email protected]; Telephone: 301-435-4507; Facsimile: 301-402-
0220.

SUPPLEMENTARY INFORMATION: The invention relates to compositions and 
methods for using multi-domain amphipathic [alpha]-helical peptides or 
peptide analogs to treat or inhibit dyslipidemic disorders. More 
specifically, the peptides and peptide analogs with multiple 
amphipathic [alpha]-helical domains: (a) Promote lipid efflux from 
cells via an ABCAl-dependent pathway; and (b) activate lipoprotein 
lipase.
    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 part 
404. The prospective exclusive option license may be granted unless, 
within 15 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 part 404.
    The field of use may be limited to ``Therapeutic uses for cardio-
metabolic indications, including hypertriglyceridemia, 
hypercholesterolemia and diabetes''.
    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: September 3, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-22771 Filed 9-9-15; 8:45 am]
BILLING CODE 4140-01-P



                                                                           Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices                                                 54571

                                                  DEPARTMENT OF HEALTH AND                                  Name of Committee: Immunology                         Contact Person: Jonathan Arias, Ph.D.,
                                                  HUMAN SERVICES                                          Integrated Review Group; Hypersensitivity,            Scientific Review Officer, Center for
                                                                                                          Autoimmune, and Immune-mediated                       Scientific Review, National Institutes of
                                                  National Institutes of Health                           Diseases Study Section.                               Health, 6701 Rockledge Drive, Room 5170,
                                                                                                            Date: October 8–9, 2015.                            MSC 7840, Bethesda, MD 20892, 301–435–
                                                  Center for Scientific Review; Notice of                   Time: 8:00 a.m. to 5:00 p.m.                        2406, ariasj@csr.nih.gov.
                                                                                                            Agenda: To review and evaluate grant                  Name of Committee: Infectious Diseases
                                                  Closed Meetings                                         applications.                                         and Microbiology Integrated Review Group;
                                                    Pursuant to section 10(d) of the                        Place: Renaissance Washington DC,                   Clinical Research and Field Studies of
                                                  Federal Advisory Committee Act, as                      Dupont Circle, 1143 New Hampshire Avenue              Infectious Diseases Study Section.
                                                                                                          NW., Washington, DC 20037.                              Date: October 15–16, 2015.
                                                  amended (5 U.S.C. App.), notice is                        Contact Person: Bahiru Gametchu, DVM,
                                                  hereby given of the following meetings.                                                                         Time: 8:30 a.m. to 6:00 p.m.
                                                                                                          Ph.D., Scientific Review Officer, Center for            Agenda: To review and evaluate grant
                                                    The meetings will be closed to the                    Scientific Review, National Institutes of             applications.
                                                  public in accordance with the                           Health, 6701 Rockledge Drive, Room 4204,                Place: Doubletree Hotel Bethesda,
                                                  provisions set forth in sections                        MSC 7812, Bethesda, MD 20892, 301–408–                (Formerly Holiday Inn Select), 8120
                                                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              9329, gametchb@csr.nih.gov.                           Wisconsin Avenue, Bethesda, MD 20814.
                                                  as amended. The grant applications and                    Name of Committee: Biobehavioral and                  Contact Person: Soheyla Saadi, Ph.D.,
                                                  the discussions could disclose                          Behavioral Processes Integrated Review                Scientific Review Officer, Center for
                                                  confidential trade secrets or commercial                Group; Biobehavioral Mechanisms of                    Scientific Review, National Institutes of
                                                  property such as patentable material,                   Emotion, Stress and Health Study Section.             Health, 6701 Rockledge Drive, Room 3211,
                                                                                                            Date: October 13–14, 2015.                          MSC 7808, Bethesda, MD 20892, 301–435–
                                                  and personal information concerning
                                                                                                            Time: 8:00 a.m. to 5:00 p.m.                        0903, saadisoh@csr.nih.gov.
                                                  individuals associated with the grant
                                                                                                            Agenda: To review and evaluate grant                  Name of Committee: Center for Scientific
                                                  applications, the disclosure of which                   applications.                                         Review Special Emphasis Panel; PAR Panel:
                                                  would constitute a clearly unwarranted                    Place: Ritz-Carlton, Tysons Corner, 1700            Improvement of Animal Models for Stem
                                                  invasion of personal privacy.                           Tysons Boulevard, McLean, VA 22102.                   Cell-Based Regenerative Medicine.
                                                    Name of Committee: Musculoskeletal, Oral                Contact Person: Maribeth Champoux,                    Date: October 16, 2015.
                                                  and Skin Sciences Integrated Review Group;              Ph.D., Scientific Review Officer, Center for            Time: 8:00 a.m. to 5:00 p.m.
                                                  Skeletal Biology Development and Disease                Scientific Review, National Institutes of               Agenda: To review and evaluate grant
                                                  Study Section.                                          Health, 6701 Rockledge Drive, Room 3170,              applications.
                                                    Date: September 29–30, 2015.                          MSC 7848, Bethesda, MD 20892, (301) 594–                Place: Renaissance Harborplace Hotel, 202
                                                    Time: 8:00 a.m. to 6:30 p.m.                          3163, champoum@csr.nih.gov.                           East Pratt Street, Baltimore, MD 21202.
                                                    Agenda: To review and evaluate grant                    Name of Committee: Center for Scientific              Contact Person: Jonathan Arias, Ph.D.,
                                                  applications.                                           Review Special Emphasis Panel; Member                 Scientific Review Officer, Center for
                                                    Place: Mayflower Park Hotel, 405 Olive                Conflict: Neurobiology of Visual Perception           Scientific Review, National Institutes of
                                                  Way, Seattle, WA 98101.                                 and Decision Making.                                  Health, 6701 Rockledge Drive, Room 5170,
                                                    Contact Person: Aruna K Behera, Ph.D.,                  Date: October 13–14, 2015.                          MSC 7840, Bethesda, MD 20892, 301–435–
                                                  Scientific Review Officer, Center for                     Time: 10:00 a.m. to 4:00 p.m.                       2406, ariasj@csr.nih.gov.
                                                  Scientific Review, National Institutes of                 Agenda: To review and evaluate grant                (Catalogue of Federal Domestic Assistance
                                                  Health, 6701 Rockledge Drive, Room 4211,                applications.                                         Program Nos. 93.306, Comparative Medicine;
                                                  MSC 7814, Bethesda, MD 20892, 301–435–                    Place: National Institutes of Health, 6701          93.333, Clinical Research, 93.306, 93.333,
                                                  6809, beheraak@csr.nih.gov.                             Rockledge Drive, Bethesda, MD 20892,                  93.337, 93.393–93.396, 93.837–93.844,
                                                    Name of Committee: Center for Scientific              (Virtual Meeting).                                    93.846–93.878, 93.892, 93.893, National
                                                  Review Special Emphasis Panel; Social                     Contact Person: Wei-Qin Zhao, Ph.D.,                Institutes of Health, HHS)
                                                  Sciences and Population Studies A:                      Scientific Review Officer, Center for
                                                                                                                                                                  Dated: September 3, 2015.
                                                  Additional Applications.                                Scientific Review, National Institutes of
                                                                                                          Health, 6701 Rockledge Drive, Room 5181,              Carolyn Baum,
                                                    Date: October 1, 2015.
                                                    Time: 10:00 a.m. to 4:00 p.m.                         MSC 7846, Bethesda, MD 20892–7846, 301–               Program Analyst, Office of Federal Advisory
                                                    Agenda: To review and evaluate grant                  435–1236, zhaow@csr.nih.gov.                          Committee Policy.
                                                  applications.                                             Name of Committee: Center for Scientific            [FR Doc. 2015–22767 Filed 9–9–15; 8:45 am]
                                                    Place: Residence Inn Bethesda, 7335                   Review Special Emphasis Panel;                        BILLING CODE 4140–01–P
                                                  Wisconsin Avenue, Bethesda, MD 20814.                   Neurobiology of Psychiatric Disorders.
                                                    Contact Person: Heidi B Friedman, Ph.D.,                Date: October 14, 2015.
                                                  Scientific Review Officer, Center for                     Time: 12:00 p.m. to 3:00 p.m.                       DEPARTMENT OF HEALTH AND
                                                  Scientific Review, National Institutes of                 Agenda: To review and evaluate grant
                                                                                                                                                                HUMAN SERVICES
                                                  Health, 6701 Rockledge Drive, Room 1012A,               applications.
                                                  MSC 7770, Bethesda, MD 20892, (301) 379–                  Place: National Institutes of Health, 6701
                                                                                                                                                                National Institutes of Health
                                                  5632, hfriedman@csr.nih.gov.                            Rockledge Drive, Bethesda, MD 20892,
                                                    Name of Committee: Surgical Sciences,                 (Telephone Conference Call).
                                                                                                                                                                Prospective Grant of a Start-up
                                                  Biomedical Imaging and Bioengineering                     Contact Person: Boris P Sokolov, Ph.D.,
                                                                                                          Scientific Review Officer, Center for                 Exclusive Option License: Therapeutic
                                                  Integrated Review Group; Biomedical
                                                                                                          Scientific Review, National Institutes of             Uses for Cardio-Metabolic Indications,
                                                  Imaging Technology A Study Section.
                                                    Date: October 5–6, 2015.                              Health, 6701 Rockledge Drive, Room 5217A,             Including Hypertriglyceridemia,
                                                    Time: 8:00 a.m. to 5:00 p.m.                          MSC 7846, Bethesda, MD 20892, 301–408–                Hypercholesterolemia and Diabetes
                                                    Agenda: To review and evaluate grant                  9115, bsokolov@csr.nih.gov.
                                                                                                                                                                AGENCY:    National Institutes of Health,
                                                  applications.                                             Name of Committee: Cell Biology
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                                                                                                                                                                HHS.
                                                    Place: Hilton Alexandria Mark Center,                 Integrated Review Group; Development—1
                                                  5000 Seminary Road, Alexandria, VA 22311.               Study Section.                                        ACTION:   Notice.
                                                    Contact Person: Ruth Grossman, DDS,                     Date: October 15–16, 2015.
                                                  Scientific Review Officer, Center for                     Time: 8:00 a.m. to 5:30 p.m.                        SUMMARY:   This is notice, in accordance
                                                  Scientific Review, National Institutes of                 Agenda: To review and evaluate grant                with 35 U.S.C. 209 and 37 CFR part 404,
                                                  Health, 6701 Rockledge Drive, Room 5215,                applications.                                         that the National Institutes of Health
                                                  Bethesda, MD 20892, (301) 435–2409,                       Place: Renaissance Harborplace Hotel, 202           (NIH), Department of Health and Human
                                                  grossmanrs@mail.nih.gov.                                East Pratt Street, Baltimore, MD 21202.               Services, is contemplating the grant of a


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                                                  54572                    Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices

                                                  Start-Up Exclusive Option License to                    under the Freedom of Information Act,                   Dated: September 4, 2015.
                                                  practice the invention embodied in                      5 U.S.C. 552.                                         Melanie J. Gray,
                                                  Patent Applications USSN 61/045,213,                      Dated: September 3, 2015.                           Program Analyst, Office of Federal Advisory
                                                  filed April 15, 2008; PCT/US2009/                       Richard U. Rodriguez,                                 Committee Policy.
                                                  040560, filed April 14, 2009; and US 12/                                                                      [FR Doc. 2015–22802 Filed 9–9–15; 8:45 am]
                                                                                                          Acting Director, Office of Technology
                                                  937,974, filed October 14, 2010, issued                 Transfer, National Institutes of Health.              BILLING CODE 4140–01–P
                                                  as 8,936,787 on January 20, 2015; titled
                                                                                                          [FR Doc. 2015–22771 Filed 9–9–15; 8:45 am]
                                                  ‘‘Peptides Promoting Lipid Efflux’’ (NIH
                                                                                                          BILLING CODE 4140–01–P
                                                  Ref. E–138–2008/0) to Corvidia                                                                                DEPARTMENT OF HEALTH AND
                                                  Corporation, having a place of business                                                                       HUMAN SERVICES
                                                  in Boston, MA. The patent rights in this                DEPARTMENT OF HEALTH AND
                                                  invention have been assigned to the                     HUMAN SERVICES                                        National Institutes of Health
                                                  United States of America.
                                                  DATES: Only written comments and/or                     National Institutes of Health                         National Institute of Mental Health;
                                                  application for a license that are                                                                            Notice of Closed Meeting
                                                  received by the NIH Office of                           National Institute on Aging; Notice of
                                                  Technology Transfer on or before                        Closed Meetings                                         Pursuant to section 10(d) of the
                                                  September 25, 2015 will be considered.                    Pursuant to section 10(d) of the                    Federal Advisory Committee Act, as
                                                  ADDRESSES: Requests for a copy of the                   Federal Advisory Committee Act, as                    amended (5 U.S.C. App.), notice is
                                                  patent application, inquiries, comments                 amended (5 U.S.C. App.), notice is                    hereby given of the following meeting.
                                                  and other materials relating to the                     hereby given of the following meetings.                 The meeting will be closed to the
                                                  contemplated license should be directed                   The meetings will be closed to the                  public in accordance with the
                                                  to: Cristina Thalhammer-Reyero, Ph.D.,                  public in accordance with the                         provisions set forth in sections
                                                  M.B.A., Office of Technology Transfer,                  provisions set forth in sections                      552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                  National Institutes of Health, 6011                     552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            as amended. The grant applications and
                                                  Executive Boulevard, Suite 325,                         as amended. The grant applications and                the discussions could disclose
                                                  Rockville, MD 20852–3804; Email:                        the discussions could disclose                        confidential trade secrets or commercial
                                                  ThalhamC@mail.nih.gov; Telephone:                       confidential trade secrets or commercial
                                                                                                                                                                property such as patentable material,
                                                  301–435–4507; Facsimile: 301–402–                       property such as patentable material,
                                                                                                                                                                and personal information concerning
                                                  0220.                                                   and personal information concerning
                                                                                                          individuals associated with the grant                 individuals associated with the grant
                                                  SUPPLEMENTARY INFORMATION:      The                     applications, the disclosure of which                 applications, the disclosure of which
                                                  invention relates to compositions and                   would constitute a clearly unwarranted                would constitute a clearly unwarranted
                                                  methods for using multi-domain                          invasion of personal privacy.                         invasion of personal privacy.
                                                  amphipathic a-helical peptides or                                                                               Name of Committee: National Institute of
                                                  peptide analogs to treat or inhibit                       Name of Committee: National Institute on
                                                                                                          Aging Special Emphasis Panel; Alzheimer’s             Mental Health Initial Review Group; Mental
                                                  dyslipidemic disorders. More                                                                                  Health Services Research Committee.
                                                                                                          Disease Drug Development.
                                                  specifically, the peptides and peptide                    Date: October 8, 2015.                                Date: October 20, 2015.
                                                  analogs with multiple amphipathic a-                      Time: 1:00 a.m. to 4:30 p.m.                          Time: 8:30 a.m. to 12:00 p.m.
                                                  helical domains: (a) Promote lipid efflux                 Agenda: To review and evaluate grant                  Agenda: To review and evaluate grant
                                                  from cells via an ABCAl-dependent                       applications.                                         applications.
                                                  pathway; and (b) activate lipoprotein                     Place: National Institute on Aging,                   Place: St. Gregory Hotel, 2033 M Street
                                                  lipase.                                                 Gateway Building, Suite 2C212, 7201
                                                                                                                                                                NW., Washington, DC 20036.
                                                     The prospective exclusive license will               Wisconsin Avenue, Bethesda, MD 20892,
                                                                                                          (Telephone Conference Call).                            Contact Person: Aileen Schulte, Ph.D.,
                                                  be royalty bearing and will comply with                   Contact Person: Alexander Parsadanian,              Scientific Review Officer, Division of
                                                  the terms and conditions of 35 U.S.C.                   Ph.D., Scientific Review Officer National             Extramural Activities, National Institute of
                                                  209 and 37 CFR part 404. The                            Institute On Aging Gateway Building 2C/212,           Mental Health, NIH, Neuroscience Center,
                                                  prospective exclusive option license                    7201 Wisconsin Avenue, Bethesda, MD                   6001 Executive Blvd., Room 6136, MSC 9606,
                                                  may be granted unless, within 15 days                   20892, 301–496–9666, PARSADANIANA@                    Bethesda, MD 20852, 301–443–1225,
                                                  from the date of this published Notice,                 NIA.NIH.GOV.                                          aschulte@mail.nih.gov.
                                                  NIH receives written evidence and                         Name of Committee: National Institute on            (Catalogue of Federal Domestic Assistance
                                                  argument that establishes that the grant                Aging Special Emphasis Panel; Circadian
                                                                                                                                                                Program No. 93.242, Mental Health Research
                                                  of the license would not be consistent                  Oscillators and Aging.
                                                                                                            Date: October 21, 2015.                             Grants, National Institutes of Health, HHS)
                                                  with the requirements of 35 U.S.C. 209
                                                                                                            Time: 12:00 p.m. to 3:00 p.m.                         Dated: September 3, 2015.
                                                  and 37 CFR part 404.                                      Agenda: To review and evaluate grant
                                                     The field of use may be limited to                                                                         Carolyn A. Baum,
                                                                                                          applications.
                                                  ‘‘Therapeutic uses for cardio-metabolic                   Place: National Institute on Aging,                 Program Analyst, Office of Federal Advisory
                                                  indications, including                                  Gateway Building, Suite 2C212, 7201                   Committee Policy.
                                                  hypertriglyceridemia,                                   Wisconsin Avenue, Bethesda, MD 20892,                 [FR Doc. 2015–22766 Filed 9–9–15; 8:45 am]
                                                  hypercholesterolemia and diabetes’’.                    (Telephone Conference Call).                          BILLING CODE 4140–01–P
                                                                                                            Contact Person: Alexander Parsadanian,
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                     Properly filed competing applications
                                                                                                          Ph.D. Scientific Review Officer National
                                                  for a license filed in response to this                 Institute On Aging Gateway Building 2C/212,
                                                  notice will be treated as objections to                 7201 Wisconsin Avenue, Bethesda, MD
                                                  the contemplated license. Comments                      20892, 301–496–9666, PARSADANIANA@
                                                  and objections submitted in response to                 NIA.NIH.GOV.
                                                  this notice will not be made available                  (Catalogue of Federal Domestic Assistance
                                                  for public inspection, and, to the extent               Program Nos. 93.866, Aging Research,
                                                  permitted by law, will not be released                  National Institutes of Health, HHS)



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Document Created: 2015-12-15 10:03:49
Document Modified: 2015-12-15 10:03:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly written comments and/or application for a license that are received by the NIH Office of Technology Transfer on or before September 25, 2015 will be considered.
FR Citation80 FR 54571 

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