80 FR 76026 - Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Development and Commercialization of Aza-Epoxy Guaiane Derivatives for Treatment of Renal Cancer
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health (NIH) Federal Register Volume 80, Issue 234 (December 7, 2015)
National Institutes of Health (NIH)
Federal Register Volume 80, Issue 234 (December 7, 2015)
| Page Range | 76026-76027 | |
| FR Document | 2015-30752 |
[Federal Register Volume 80, Number 234 (Monday, December 7, 2015)] [Notices] [Pages 76026-76027] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30752] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health (NIH) Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Development and Commercialization of Aza-Epoxy Guaiane Derivatives for Treatment of Renal Cancer AGENCY: National Institutes of Health. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to ElexiMed LLC, a company having a place of business at 5003 Green Mountain Circle, Suite 4, Columbia, MD 21044, USA, to practice the inventions embodied in the following patent applications. Intellectual Property--PCT Patent Application No. PCT/US2015/ 014601, entitled ``Aza-Englerin Analogues--Novel Natural Product-Based Nitrogen-Containing Anti-Cancer Agents'' filed February 5, 2015 (HHS Ref. No.: E-090-2014/2-PCT-01); US Provisional Patent [[Page 76027]] Application No. 62/018,381, entitled ``Aza-epoxy-guaiane derivatives and treatment of cancer'' filed June 27, 2014 (HHS Ref. No. E-090-2014/ 1-US-01); and US Provisional Patent Application No. 61/936,285, entitled ``Aza-englerin analogues and use in cancer therapy'' filed February 5, 2014 (HHS Ref. No. E-090-2014/0-US-01). The patent rights in these inventions have been assigned to the Government of the United States of America and the University of Hawaii. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Development and commercialization of aza-epoxy guaiane derivatives for treatment of renal cancer.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, ElexiMed LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement. DATES: Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before December 22, 2015 will be considered. ADDRESSES: Requests for copies of the patent application(s), inquiries, comments, and other materials relating to the contemplated Start-Up Exclusive Evaluation Option License Agreement should be directed to: Rose Freel, Ph.D., Licensing and Patenting Manager, Technology Transfer Center, National Cancer Institute, Riverside 5, Suite 400, 8490 Progress Drive, Frederick, MD 21702; telephone: 301-624-1257; Facsimile: 301-631-3027; Email: [email protected]. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published or issued by the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: This technology describes aza-englerins, synthetic analogues of the natural product Englerin A which displays potent and selective anti-cancer properties in several cancer cell lines. The aza-englerins were developed as novel cancer therapeutics and show significant bioavailability after oral administration in mice. The prospective Start-Up Exclusive Evaluation Option License Agreement is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective Start-Up Exclusive Evaluation Option License Agreement and a subsequent Start-Up Exclusive Patent License Agreement may be granted unless the NCI receives written evidence and argument, within fifteen (15) days from the date of this published notice, that establishes that the grant of the contemplated Start-Up Exclusive Evaluation Option License Agreement would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Start-Up Exclusive Evaluation Option License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: December 2, 2015. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2015-30752 Filed 12-4-15; 8:45 am] BILLING CODE 4140-01-P
![76026 Federal Register / Vol. 80, No. 234 / Monday, December 7, 2015 / Notices
Dated: November 20, 2015. 93.393, Cancer Cause and Prevention Room 7W608, Bethesda, MD 20892–9750,
Melanie Ross, Research; 93.394, Cancer Detection and 240–276–6458, lopacw@mail.nih.gov.
Diagnosis Research; 93.395, Cancer Name of Committee: National Cancer
CDR, USPHS, Designated Federal Officer,
Treatment Research; 93.396, Cancer Biology Institute Special Emphasis Panel; Innovative
Advisory Group on Prevention, Health
Research; 93.397, Cancer Centers Support; Research in Cancer Nanotechnology (IRCN).
Promotion, and Integrative and Public Health,
93.398, Cancer Research Manpower; 93.399, Date: February 25, 2016.
Office of the Surgeon General.
Cancer Control, National Institutes of Health, Time: 8:00 a.m. to 5:00 p.m.
[FR Doc. 2015–30749 Filed 12–4–15; 8:45 am] HHS) Agenda: To review and evaluate grant
BILLING CODE 4163–18–P
Dated: November 30, 2015. applications.
Place: Bethesda North Marriott Hotel and
Melanie J. Gray, Conference Center, 5701 Marinelli Road,
DEPARTMENT OF HEALTH AND Program Analyst, Office of Federal Advisory Bethesda, MD 20852.
HUMAN SERVICES Committee Policy. Contact Person: Nadeem Khan, Ph.D.,
[FR Doc. 2015–30719 Filed 12–4–15; 8:45 am] Scientific Review Officer, Research
National Institutes of Health BILLING CODE 4140–01–P
Technology and Contract Review Branch,
Division of Extramural Activities, National
National Institute on Alcohol Abuse Cancer Institute, NIH, 9609 Medical Center
and Alcoholism; Notice of Closed Drive, Room 7W260, Bethesda, MD 20892–
DEPARTMENT OF HEALTH AND 9750, 240–276–5856, nkhann3@nih.gov.
Meetings HUMAN SERVICES (Catalogue of Federal Domestic Assistance
Pursuant to section 10(d) of the Program Nos. 93.392, Cancer Construction;
National Institutes of Health 93.393, Cancer Cause and Prevention
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is Research; 93.394, Cancer Detection and
National Cancer Institute; Notice of Diagnosis Research; 93.395, Cancer
hereby given of the following meetings. Closed Meetings Treatment Research; 93.396, Cancer Biology
The meetings will be closed to the Research; 93.397, Cancer Centers Support;
public in accordance with the Pursuant to section 10(d) of the
93.398, Cancer Research Manpower; 93.399,
provisions set forth in sections Federal Advisory Committee Act, as Cancer Control, National Institutes of Health,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., amended (5 U.S.C. App.), notice is HHS)
as amended. The grant applications and hereby given of the following meetings.
The meetings will be closed to the Dated: November 30, 2015.
the discussions could disclose Melanie J. Gray,
confidential trade secrets or commercial public in accordance with the
provisions set forth in sections Program Analyst, Office of Federal Advisory
property such as patentable material, Committee Policy.
and personal information concerning 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and [FR Doc. 2015–30718 Filed 12–4–15; 8:45 am]
individuals associated with the grant
applications, the disclosure of which the discussions could disclose BILLING CODE 4140–01–P
would constitute a clearly unwarranted confidential trade secrets or commercial
invasion of personal privacy. property such as patentable material,
and personal information concerning DEPARTMENT OF HEALTH AND
Name of Committee: National Institute on individuals associated with the grant HUMAN SERVICES
Alcohol Abuse and Alcoholism Initial
Review Group; Neuroscience Review
applications, the disclosure of which
National Institutes of Health (NIH)
Subcommittee (AA–4). would constitute a clearly unwarranted
Date: March 2, 2016. invasion of personal privacy. Prospective Grant of Start-Up
Time: 8:00 a.m. to 5:00 p.m. Name of Committee: National Cancer Exclusive Evaluation Option License
Agenda: To review and evaluate grant Institute Special Emphasis Panel; NCI P01 Agreement: Development and
applications. Meeting II. Commercialization of Aza-Epoxy
Place: NIAAA, NIH, 5635 Fishers Lane, Date: February 2–3, 2016.
Terrace Level, Room 508, Rockville, MD
Guaiane Derivatives for Treatment of
Time: 8:00 a.m. to 5:00 p.m. Renal Cancer
20852. Agenda: To review and evaluate grant
Contact Person: Beata Buzas, Ph.D., applications. AGENCY: National Institutes of Health.
Scientific Review Officer, National Institute Place: Hilton Washington DC/Rockville,
on Alcohol Abuse and Alcoholism, National ACTION: Notice.
1750 Rockville Pike, Rockville, MD 20852.
Institutes of Health, 5635 Fishers Lane, Room Contact Person: Shakeel Ahmad, Ph.D., SUMMARY: This is notice, in accordance
2081, Rockville, MD 20852, 301–443–0800, Scientific Review Officer, Research Programs
bbuzas@mail.nih.gov.
with 35 U.S.C. 209 and 37 CFR part 404,
Review Branch, Division of Extramural that the National Cancer Institute (NCI),
Name of Committee: National Institute on Activities, National Cancer Institute, 9609
Alcohol Abuse and Alcoholism Initial Medical Center Drive, Room 7W122,
National Institutes of Health,
Review Group; Biomedical Research Review Bethesda, MD 20892–9750, 240–276–6349, Department of Health and Human
Subcommittee (AA1). ahmads@mail.nih.gov. Services, is contemplating the grant of a
Date: March 8, 2016. Name of Committee: National Cancer Start-Up Exclusive Evaluation Option
Time: 8:00 a.m. to 5:00 p.m. Institute Special Emphasis Panel; NCI SPORE License Agreement to ElexiMed LLC, a
Agenda: To review and evaluate grant I Review. company having a place of business at
applications. Date: February 3–4, 2016. 5003 Green Mountain Circle, Suite 4,
Place: NIAAA, NIH, 5635 Fishers Lane, Time: 8:00 a.m. to 3:00 p.m. Columbia, MD 21044, USA, to practice
Terrace Level, Room 508, Rockville, MD Agenda: To review and evaluate grant the inventions embodied in the
20852. applications.
mstockstill on DSK4VPTVN1PROD with NOTICES
Contact Person: Philippe Marmillot, Ph.D.,
following patent applications.
Place: Bethesda North Marriott Hotel and Intellectual Property—PCT Patent
Scientific Review Officer, National Institute Conference Center, 5701 Marinelli Road,
on Alcohol Abuse and Alcoholism, National Application No. PCT/US2015/014601,
Bethesda, MD 20852.
Institutes of Health, 5635 Fishers Lane, Room Contact Person: Wlodek Lopaczynski, MD,
entitled ‘‘Aza-Englerin Analogues—
2017, Bethesda, MD 20892, 301–443–2861, Ph.D., Scientific Review Officer, Research Novel Natural Product-Based Nitrogen-
marmillotp@mail.nih.gov. Program Review Branch, Division of Containing Anti-Cancer Agents’’ filed
(Catalogue of Federal Domestic Assistance Extramural Activities, National Cancer February 5, 2015 (HHS Ref. No.: E–090–
Program Nos. 93.392, Cancer Construction; Institute, NIH, 9609 Medical Center Drive, 2014/2–PCT–01); US Provisional Patent
VerDate Sep<11>2014 18:36 Dec 04, 2015 Jkt 238001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\07DEN1.SGM 07DEN1](https://thefederalregister.org/doc/80_FR_76260/page/1.svg)
![Federal Register / Vol. 80, No. 234 / Monday, December 7, 2015 / Notices 76027
Application No. 62/018,381, entitled The prospective Start-Up Exclusive discussions could disclose confidential
‘‘Aza-epoxy-guaiane derivatives and Evaluation Option License Agreement is trade secrets or commercial property
treatment of cancer’’ filed June 27, 2014 being considered under the small such as patentable material, and
(HHS Ref. No. E–090–2014/1–US–01); business initiative launched on October personal information concerning
and US Provisional Patent Application 1, 2011 and will comply with the terms individuals associated with the grant
No. 61/936,285, entitled ‘‘Aza-englerin and conditions of 35 U.S.C. 209 and 37 applications and/or contract proposals,
analogues and use in cancer therapy’’ CFR part 404.7. The prospective Start- the disclosure of which would
filed February 5, 2014 (HHS Ref. No. E– Up Exclusive Evaluation Option License constitute a clearly unwarranted
090–2014/0–US–01). Agreement and a subsequent Start-Up invasion of personal privacy.
The patent rights in these inventions Exclusive Patent License Agreement Name of Committee: National Advisory
have been assigned to the Government may be granted unless the NCI receives Council for Biomedical Imaging and
of the United States of America and the written evidence and argument, within Bioengineering, NACBIB, January, 2016.
University of Hawaii. fifteen (15) days from the date of this Date: January 21, 2016.
The territory of the prospective Start- published notice, that establishes that Open: 8:30 a.m. to 12:00 p.m.
the grant of the contemplated Start-Up Agenda: Report from the Institute Director,
Up Exclusive Evaluation Option License
Exclusive Evaluation Option License other Institute Staff and Scientific
Agreement may be worldwide, and the Presentations.
field of use may be limited to Agreement would not be consistent with Place: The William F. Bolger Center,
‘‘Development and commercialization of the requirements of 35 U.S.C. 209 and Franklin Building, Classroom 1, 9600
aza-epoxy guaiane derivatives for 37 CFR part 404.7. Newbridge Drive, Potomac, MD 20854.
treatment of renal cancer.’’ Complete applications for a license in Closed: 1:00 p.m. to 3:30 p.m.
Upon the expiration or termination of the prospective field of use that are filed Agenda: To review and evaluate grant
the Start-up Exclusive Evaluation in response to this notice will be treated applications and/or proposals.
as objections to the grant of the Place: The William F. Bolger Center,
Option License Agreement, ElexiMed Franklin Building, Classroom 1, 9600
LLC will have the exclusive right to contemplated Start-Up Exclusive
Evaluation Option License Agreement. Newbridge Drive, Potomac, MD 20854.
execute a Start-Up Exclusive Patent Contact Person: David George, Ph.D.,
License Agreement which will Comments and objections submitted to Acting Associate Director, Office of Research
supersede and replace the Start-up this notice will not be made available Administration, National Institute of
Exclusive Evaluation Option License for public inspection and, to the extent Biomedical Imaging and Bioengineering,
Agreement, with no greater field of use permitted by law, will not be released 6707 Democracy Boulevard, Room 920,
and territory than granted in the Start- under the Freedom of Information Act, Bethesda, MD 20892.
up Exclusive Evaluation Option License 5 U.S.C. 552. Any interested person may file written
Agreement. Dated: December 2, 2015. comments with the committee by forwarding
the statement to the Contact Person listed on
DATES: Only written comments and/or Richard U. Rodriguez, this notice. The statement should include the
applications for a license which are Associate Director, Technology Transfer name, address, telephone number and when
received by the NCI Technology Center, National Cancer Institute. applicable, the business or professional
Transfer Center on or before December [FR Doc. 2015–30752 Filed 12–4–15; 8:45 am] affiliation of the interested person.
22, 2015 will be considered. BILLING CODE 4140–01–P Information is also available on the
Institute’s/Center’s home page: http://www.
ADDRESSES: Requests for copies of the nibib1.nih.gov/about/NACBIB/NACBIB.htm,
patent application(s), inquiries, where an agenda and any additional
DEPARTMENT OF HEALTH AND
comments, and other materials relating information for the meeting will be posted
HUMAN SERVICES
to the contemplated Start-Up Exclusive when available.
Evaluation Option License Agreement National Institutes of Health Dated: December 2, 2015.
should be directed to: Rose Freel, Ph.D., Melanie J. Gray,
Licensing and Patenting Manager, National Institute of Biomedical Program Analyst, Office of Federal Advisory
Technology Transfer Center, National Imaging and Bioengineering; Notice of Committee Policy.
Cancer Institute, Riverside 5, Suite 400, Meeting [FR Doc. 2015–30750 Filed 12–4–15; 8:45 am]
8490 Progress Drive, Frederick, MD
21702; telephone: 301–624–1257; Pursuant to section 10(d) of the BILLING CODE 4140–01–P
Facsimile: 301–631–3027; Email: Federal Advisory Committee Act, as
rose.freel@nih.gov. A signed amended (5 U.S.C. App.), notice is
hereby given of a meeting of the DEPARTMENT OF HEALTH AND
confidentiality nondisclosure agreement HUMAN SERVICES
will be required to receive copies of any National Advisory Council for
patent applications that have not been Biomedical Imaging and Bioengineering.
The meeting will be open to the National Institutes of Health
published or issued by the United States
public as indicated below, with
Patent and Trademark Office or the National Institute on Aging; Notice of
attendance limited to space available.
World Intellectual Property Meeting
Individuals who plan to attend and
Organization.
need special assistance, such as sign Pursuant to section 10(d) of the
SUPPLEMENTARY INFORMATION: This language interpretation or other Federal Advisory Committee Act, as
technology describes aza-englerins, reasonable accommodations, should amended (5 U.S.C. App.), notice is
mstockstill on DSK4VPTVN1PROD with NOTICES
synthetic analogues of the natural notify the Contact Person listed below hereby given of a meeting of the
product Englerin A which displays in advance of the meeting. National Advisory Council on Aging.
potent and selective anti-cancer The meeting will be closed to the The meeting will be open to the
properties in several cancer cell lines. public in accordance with the public as indicated below, with
The aza-englerins were developed as provisions set forth in sections attendance limited to space available.
novel cancer therapeutics and show 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Individuals who plan to attend and
significant bioavailability after oral as amended. The grant applications need special assistance, such as sign
administration in mice. and/or contract proposals and the language interpretation or other
VerDate Sep<11>2014 18:36 Dec 04, 2015 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\07DEN1.SGM 07DEN1](https://thefederalregister.org/doc/80_FR_76260/page/2.svg)
Document Created: 2015-12-14 13:30:44
Document Modified: 2015-12-14 13:30:44
| 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 NCI Technology Transfer Center on or before December 22, 2015 will be considered. | |
| FR Citation | 80 FR 76026 |
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