80 FR 35964 - Prospective Grant of Start-up Exclusive Evaluation Option License: A Novel HIV-1 Entry Inhibitor
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 120 (June 23, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 120 (June 23, 2015)
| Page Range | 35964-35965 | |
| FR Document | 2015-15334 |
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)] [Notices] [Pages 35964-35965] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15334] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-up Exclusive Evaluation Option License: A Novel HIV-1 Entry Inhibitor 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 start-up exclusive evaluation option license agreement to practice the inventions embodied in U.S. Provisional Patent Application No. 61/791,885 (NIH Ref. No. E- 033-2013/0-US-01), filed March 15, 2013; International PCT Application No. PCT/US2014/024120 (NIH Ref. No. E-033-2013/1-PCT-01), filed March 12, 2014; all entitled, ``Stabilized Single Human CD4 Domains and Fusion Proteins;'' and all [[Page 35965]] continuing applications and foreign counterparts to Absino Co., Ltd, a company having a place of business in Beijing, China. The patent rights in these inventions have (a) been assigned to the United States of America, as represented by the Secretary, Department of Health and Human Services who has delegated authority for the licensing of inventions to the National Institutes of Health or (b) been exclusively licensed to the National Institutes of Health. The prospective start-up exclusive evaluation option license territory may be China, the U.S., and Europe, and the field of use may be limited to the development of bispecific multivalent human immunodeficiency virus type 1 (HIV-1) neutralizing fusion proteins as HIV entry inhibitors for the treatment of HIV infections. Upon the expiration or termination of the start-up exclusive evaluation option license, Absino Co., Ltd will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the start-up exclusive evaluation option license with no greater field of use and territory than granted in the start-up exclusive evaluation 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 July 8, 2015 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated start-up exclusive evaluation option license should be directed to: Sally Hu, Ph.D., M.B.A., 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- 5606; Facsimile: (301) 402-0220; Email: [email protected]. SUPPLEMENTARY INFORMATION: The subject technology is HIV-1 entry inhibitors that can neutralize many subtypes of HIV-1 isolates including clade A-E and tropism R5 and X4 (using either CCR5 or CXCR4 co-receptor for entry). These entry inhibitors are fusion proteins and have a potency about 10-fold higher than that of the broadly neutralizing antibody VRC01 that is in Phase I clinical trial, or 50- fold higher than that of the FDA approved HIV entry inhibitor Fuzeon. Therefore, these fusion proteins are promising drug candidates for HIV/ AIDS prevention and treatment. The prospective start-up exclusive evaluation 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 start-up exclusive evaluation option license may be granted unless within fifteen (15) 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 part 404. 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 start-up exclusive evaluation 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: June 16, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015-15334 Filed 6-22-15; 8:45 am] BILLING CODE 4140-01-P
![35964 Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
Dated: June 17, 2015. DEPARTMENT OF HEALTH AND Contact Person: Gerald G. Lovinger, Ph.D.,
Melanie J. Gray, HUMAN SERVICES Scientific Review Officer, Research and
Technology and Contract Review Branch,
Program Analyst, Office of Federal Advisory Division of Extramural Activities, National
Committee Policy. National Institutes of Health
Cancer Institute, NIH, 9609 Medical Center
[FR Doc. 2015–15309 Filed 6–22–15; 8:45 am]
National Cancer Institute; Notice of Drive, Room 7W266, Rockville, MD 20850,
BILLING CODE 4140–01–P 240–276–6385, lovingeg@mail.nih.gov.
Closed Meetings
Name of Committee: National Cancer
Pursuant to section 10(d) of the Institute Special Emphasis Panel; Innovative
DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as Molecular Analysis Technologies for Cancer
amended (5 U.S.C. App.), notice is Research (R21).
HUMAN SERVICES
hereby given of the following meetings. Date: August 4, 2015.
Time: 7:30 a.m. to 6:00 p.m.
National Institutes of Health The meetings will be closed to the
Agenda: To review and evaluate grant
public in accordance with the applications.
National Institute of Neurological provisions set forth in sections Place: Bethesda North Marriott Hotel &
Disorders and Stroke; Notice of Closed 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Conference Center, 5701 Marinelli Road,
Meetings as amended. The grant applications and Room Forest Glen, Bethesda, MD 20852.
the discussions could disclose Contact Person: Jeffrey E. DeClue, Ph.D.,
Pursuant to section 10(d) of the confidential trade secrets or commercial Scientific Review Officer, Research
Federal Advisory Committee Act, as property such as patentable material, Technology and Contract Review Branch,
Division of Extramural Activities, National
amended (5 U.S.C. App.), notice is and personal information concerning
Cancer Institute, NIH, 9609 Medical Center
hereby given of the following meeting. individuals associated with the grant Drive, Room 7W238, Bethesda, MD 20892–
The meeting will be closed to the public applications, the disclosure of which 9750, 240–276–6371, decluej@mail.nih.gov.
in accordance with the provisions set would constitute a clearly unwarranted
(Catalogue of Federal Domestic Assistance
forth in sections 552b(c)(4) and invasion of personal privacy.
Program Nos. 93.392, Cancer Construction;
552b(c)(6), Title 5 U.S.C., as amended. Name of Committee: National Cancer 93.393, Cancer Cause and Prevention
The grant applications and the Institute Special Emphasis Panel; Omnibus- Research; 93.394, Cancer Detection and
discussions could disclose confidential SEP 15 Genetic Mouse Models, Molecular Diagnosis Research; 93.395, Cancer
trade secrets or commercial property Mechanisms of Therapy. Treatment Research; 93.396, Cancer Biology
Date: July 14–15, 2015. Research; 93.397, Cancer Centers Support;
such as patentable material, and Time: 11:00 a.m. to 5:00 p.m. 93.398, Cancer Research Manpower; 93.399,
personal information concerning Agenda: To review and evaluate grant Cancer Control, National Institutes of Health,
individuals associated with the grant applications. HHS)
applications, the disclosure of which Place: National Cancer Institute Shady
Dated: June 17, 2015.
would constitute a clearly unwarranted Grove, 9609 Medical Center Drive, Rooms
2E030/1E030, Rockville, MD 20850, Melanie J. Gray,
invasion of personal privacy.
(Telephone Conference Call). Program Analyst, Office of Federal Advisory
Name of Committee: National Institute of Contact Person: Nicholas J. Kenney, Ph.D., Committee Policy.
Neurological Disorders and Stroke Special, Scientific Review Officer, Research [FR Doc. 2015–15310 Filed 6–22–15; 8:45 am]
Emphasis Panel; Review of Blood Brain Technology and Contract Review Branch, BILLING CODE 4140–01–P
Barrier Application. Division of Extramural Activities, National
Date: July 21, 2015. Cancer Institute, NIH, 9609 Medical Center
Time: 9:00 a.m. to 12:30 p.m. Drive, Room 7W246, Rockville, MD 20850,
240–276–6374 nicholas.kenney@nih.gov. DEPARTMENT OF HEALTH AND
Agenda: To review and evaluate grant HUMAN SERVICES
applications. Name of Committee: National Cancer
Place: National Institutes of Health, Institute Special Emphasis Panel; Advanced
National Institutes of Health
Development of Technologies for Cancer
Neuroscience Center, 6001 Executive
Research (R33).
Boulevard, Rockville, MD 20852 (Telephone Prospective Grant of Start-up
Date: July 22, 2015.
Conference Call). Time: 11:00 a.m. to 4:00 p.m. Exclusive Evaluation Option License:
Contact Person: Natalia Strunnikova, Agenda: To review and evaluate grant A Novel HIV–1 Entry Inhibitor
Ph.D., Scientific Review Officer, Scientific applications. AGENCY: National Institutes of Health,
Review Branch, Division of Extramural Place: National Cancer Institute Shady
HHS.
Research, NINDS/NIH/DHHS/Neuroscience Grove, 9609 Medical Center Drive, Room
Center, 6001 Executive Boulevard, Suite 2W914, Rockville, MD 20850, (Telephone ACTION: Notice.
3208, MSC 9529, Bethesda, MD 20892, 301– Conference Call).
Contact Person: Jeffrey E. DeClue, Ph.D.,
SUMMARY: This is notice, in accordance
496–3755, strunnikovan@ninds.nih.gov. with 35 U.S.C. 209 and 37 CFR part 404,
Scientific Review Officer, Research
(Catalogue of Federal Domestic Assistance Technology and Contract Review Branch, that the National Institutes of Health,
Program Nos. 93.853, Clinical Research Division of Extramural Activities, National Department of Health and Human
Related to Neurological Disorders; 93.854, Cancer Institute, NIH, 9609 Medical Center Services, is contemplating the grant of a
Biological Basis Research in the Drive, Room 7W238, Bethesda, MD 20892– start-up exclusive evaluation option
Neurosciences, National Institutes of Health, 9750, 240–276–6371, decluej@mail.nih.gov. license agreement to practice the
HHS) Name of Committee: National Cancer inventions embodied in U.S. Provisional
Institute Special Emphasis Panel; Physical
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: June 17, 2015. Patent Application No. 61/791,885 (NIH
Sciences Oncology Projects. Ref. No. E–033–2013/0–US–01), filed
Carolyn Baum, Date: July 28–29, 2015. March 15, 2013; International PCT
Program Analyst, Office of Federal Advisory Time: 6:00 p.m. to 6:00 p.m.
Committee Policy. Agenda: To review and evaluate grant
Application No. PCT/US2014/024120
applications. (NIH Ref. No. E–033–2013/1–PCT–01),
[FR Doc. 2015–15306 Filed 6–22–15; 8:45 am] filed March 12, 2014; all entitled,
Place: Doubletree Hotel Bethesda,
BILLING CODE 4140–01–P (Formerly Holiday Inn Select), 8120 ‘‘Stabilized Single Human CD4 Domains
Wisconsin Avenue Bethesda, MD 20814. and Fusion Proteins;’’ and all
VerDate Sep<11>2014 18:39 Jun 22, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\23JNN1.SGM 23JNN1](https://thefederalregister.org/doc/80_FR_36084/page/1.svg)
![Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices 35965
continuing applications and foreign bearing and will comply with the terms MD 20892–7968, 301–594–4937, huangz@
counterparts to Absino Co., Ltd, a and conditions of 35 U.S.C. 209 and 37 mail.nih.gov.
company having a place of business in CFR part 404. The prospective start-up (Catalogue of Federal Domestic Assistance
Beijing, China. exclusive evaluation option license may Program No. 93.879, Medical Library
The patent rights in these inventions be granted unless within fifteen (15) Assistance, National Institutes of Health,
have (a) been assigned to the United days from the date of this published HHS)
States of America, as represented by the notice, the NIH receives written Dated: June 17, 2015.
Secretary, Department of Health and evidence and argument that establishes Michelle Trout,
Human Services who has delegated that the grant of the license would not Program Analyst, Office of the Federal
authority for the licensing of inventions be consistent with the requirements of Advisory Committee Policy.
to the National Institutes of Health or (b) 35 U.S.C. 209 and 37 CFR part 404. [FR Doc. 2015–15299 Filed 6–22–15; 8:45 am]
been exclusively licensed to the Applications for a license in the field BILLING CODE 4140–01–P
National Institutes of Health. of use filed in response to this notice
The prospective start-up exclusive will be treated as objections to the grant
evaluation option license territory may of the contemplated start-up exclusive DEPARTMENT OF HEALTH AND
be China, the U.S., and Europe, and the evaluation option license. Comments HUMAN SERVICES
field of use may be limited to the and objections submitted to this notice
development of bispecific multivalent will not be made available for public National Institutes of Health
human immunodeficiency virus type 1 inspection and, to the extent permitted
(HIV–1) neutralizing fusion proteins as by law, will not be released under the Center for Scientific Review; Notice of
HIV entry inhibitors for the treatment of Freedom of Information Act, 5 U.S.C. Closed Meetings.
HIV infections. 552.
Upon the expiration or termination of Pursuant to section 10(d) of the
the start-up exclusive evaluation option Dated: June 16, 2015. Federal Advisory Committee Act, as
license, Absino Co., Ltd will have the Richard U. Rodriguez, amended (5 U.S.C. App.), notice is
exclusive right to execute an exclusive Acting Director, Office of Technology hereby given of the following meetings.
commercialization license which will Transfer, National Institutes of Health. The meetings will be closed to the
supersede and replace the start-up [FR Doc. 2015–15334 Filed 6–22–15; 8:45 am] public in accordance with the
exclusive evaluation option license with BILLING CODE 4140–01–P provisions set forth in sections
no greater field of use and territory than 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
granted in the start-up exclusive as amended. The grant applications and
evaluation option license. DEPARTMENT OF HEALTH AND the discussions could disclose
DATES: Only written comments and/or HUMAN SERVICES confidential trade secrets or commercial
applications for a license which are property such as patentable material,
National Institutes of Health and personal information concerning
received by the NIH Office of
Technology Transfer on or before July 8, National Library of Medicine; Notice of individuals associated with the grant
2015 will be considered. Closed Meeting applications, the disclosure of which
ADDRESSES: Requests for copies of the would constitute a clearly unwarranted
patent application, inquiries, comments, Pursuant to section 10(d) of the invasion of personal privacy.
and other materials relating to the Federal Advisory Committee Act, as Name of Committee: Center for Scientific
contemplated start-up exclusive amended (5 U.S.C. App), notice is Review Special Emphasis Panel;
evaluation option license should be hereby given of the following meeting. Fellowships: Endocrinology, Metabolism,
directed to: Sally Hu, Ph.D., M.B.A., The meeting will be closed to the Nutrition and Reproductive Sciences.
Senior Licensing and Patenting Date: July 14, 2015.
public in accordance with the Time: 8:00 a.m. to 5:00 p.m.
Manager, Office of Technology Transfer, provisions set forth in sections Agenda: To review and evaluate grant
National Institutes of Health, 6011 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications.
Executive Boulevard, Suite 325, as amended. The grant applications and Place: National Institutes of Health, 6701
Rockville, MD 20852–3804; Telephone: the discussions could disclose Rockledge Drive, Bethesda, MD 20892
(301) 435–5606; Facsimile: (301) 402– confidential trade secrets or commercial (Virtual Meeting).
0220; Email: hus@mail.nih.gov. property such as patentable materials, Contact Person: Dianne Hardy, Ph.D.,
SUPPLEMENTARY INFORMATION: The and personal information concerning Scientific Review Officer, Center for
individuals associated with the grant Scientific Review, National Institutes of
subject technology is HIV–1 entry
Health, 6701 Rockledge Drive, Room 6175,
inhibitors that can neutralize many applications, the disclosure of which MSC 7892, Bethesda, MD 20892, 301–435–
subtypes of HIV–1 isolates including would constitute a clearly unwarranted 1154, dianne.hardy@nih.gov.
clade A–E and tropism R5 and X4 (using invasion of personal privacy. Name of Committee: AIDS and Related
either CCR5 or CXCR4 co-receptor for Name of Committee: National Library of Research Integrated Review Group;
entry). These entry inhibitors are fusion Medicine Special Emphasis Panel; Conflicts NeuroAIDS and other End-Organ Diseases
proteins and have a potency about 10- R01/R21/R13. Study Section.
fold higher than that of the broadly Date: July 30, 2015. Date: July 23, 2015.
neutralizing antibody VRC01 that is in Time: 12:00 p.m. to 4:00 p.m. Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant Agenda: To review and evaluate grant
mstockstill on DSK4VPTVN1PROD with NOTICES
Phase I clinical trial, or 50-fold higher
than that of the FDA approved HIV applications. applications.
Place: National Library of Medicine, 6705 Place: Hyatt Regency Bethesda, One
entry inhibitor Fuzeon. Therefore, these
Rockledge Drive, Suite 301, Bethesda, MD Bethesda Metro Center, 7400 Wisconsin
fusion proteins are promising drug 20817, (Telephone Conference Call). Avenue, Bethesda, MD 20814.
candidates for HIV/AIDS prevention Contact Person: Zoe E. Huang, MD., Contact Person: Eduardo A Montalvo,
and treatment. Scientific Review Officer, Extramural Ph.D., Scientific Review Officer, Center for
The prospective start-up exclusive Programs, National Library of Medicine, NIH, Scientific Review, National Institutes of
evaluation option license will be royalty 6705 Rockledge Drive, Suite 301, Bethesda, Health, 6701 Rockledge Drive, Room 5108,
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Document Created: 2018-02-22 11:15:08
Document Modified: 2018-02-22 11:15:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before July 8, 2015 will be considered. | |
| FR Citation | 80 FR 35964 |
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