Prospective Grant of Exclusive License: Pre-Clinical Evaluation and Commercial Development of Human Therapeutics for Liver Cancer and Ovarian Cancer Within the Scope of the Licensed Patent Rights, 9248-9249 [2014-03410]

Download as PDF 9248 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices the Board meeting. The Subcommittee meeting will now start at 06:30 p.m. on February 26, 2014, and end at 08:00 p.m., and the Board meeting will now start at 8:30 a.m. on February 27, 2014. The meeting is partially closed to the public. Dated: February 11, 2014. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–03407 Filed 2–14–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings tkelley on DSK3SPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Training and Career Development Application Review. Date: April 16, 2014. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W110, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Robert Bird, Ph.D., Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W110, Bethesda, MD 20892– 8328, 240–276–6344 birdr@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCORP Minority Community Sites Review. Date: April 22–23, 2014. Time: 5:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Marriott Courtyard Gaithersburg, Washingtonian Center, 204 Boardwalk Place, Gaithersburg, MD 20878. Contact Person: Michael B. Small, Ph.D., Chief, Program and Review Extramural Staff Training Office, Division of Extramural Activities, National Cancer Institute, NIH, VerDate Mar<15>2010 20:58 Feb 14, 2014 Jkt 232001 9609 Medical Center Drive, Room 7W412, Bethesda, MD 20892–9750, 240–276–6438 smallm@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCORP Research Base. Date: April 29–30, 2014. Time: 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 2W910/912, Rockville, MD 20850. Contact Person: Shamala K. Srinivas, Ph.D., Scientific Review Officer, Office of Referral, Review, and Program Coordination, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W530, Bethesda, MD 20892– 9750, 240–276–6442, shamala@mail.nih.gov. Information is also available on the Institute’s Center’s home page: https:// deainfo.nci.nih.gov/advisory/sep/sep.htm, where a roster and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS). Dated: February 12, 2014. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–03397 Filed 2–14–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, March 20, 2014, 07:00 p.m. to March 21, 2014, 04:00 p.m., Courtyard Marriott Washingtonian Center, 204 Boardwalk Place, Gaithersburg, MD 20878 which was published in the Federal Register on February 07, 2014, 79FR7466. The meeting notice is amended to change the location and time to 9609 Medical Center Drive, Room 5E30, Rockville, MD 20850, March 20, 2014, 10:00 a.m. to March 21, 2014, 3:30 p.m. Additionally the meeting is being held as a teleconference. The meeting is closed to the public. PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 Dated: February 12, 2014. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–03399 Filed 2–14–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Pre-Clinical Evaluation and Commercial Development of Human Therapeutics for Liver Cancer and Ovarian Cancer Within the Scope of the Licensed Patent Rights AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions covered under the scope of the following patents and patent applications: • United States Patent No. 8,207,142 issued Jun 26, 2012 entitled ‘‘Inhibitor of DNA Methylation’’ (HHS Ref. No. E– 081–2001/2–US–06); • EP Patent No. 1418949 issued June 19, 2013, entitled ‘‘Inhibitor of DNA Methylation’’ (HHS Ref. No. E–081– 2001/2–EP–02) and validated in Great Britain, Germany and France; • Australia Patent No. 2002322805 issued February 21, 2008 entitled ‘‘Inhibitor of DNA Methylation’’ (HHS Ref. No. E–081–2001/2–AU–03); • Australia Patent No. 2008200601 issued November 25, 2010 entitled ‘‘Inhibitor of DNA Methylation’’ (HHS Ref. No. E–081–2001/2–AU–07); • Canada Patent No. 2,454,147 issued May 21, 2013 entitled ‘‘Inhibitor of DNA Methylation’’ (HHS Ref. No. E–081– 2001/2–CA–04); • Japan Patent Application No. 2003– 517229 filed July 30, 2002 entitled ‘‘Inhibitor of DNA Methylation’’ (HHS Ref. No. E–081–2001/2–JP–05); and • Japan Patent No. 5416660 issued November 22, 2013 entitled ‘‘Inhibitor of DNA Methylation’’ (HHS Ref. No. E– 081–2001/2–JP–08) to Metheor Therapeutics, Corporation (‘‘METHEOR’’) a U.S. based company located in Shoreline, WA, USA. The patent rights in this invention have been assigned to the government of the United States of America. The prospective exclusive evaluation option license territory may be SUMMARY: E:\FR\FM\18FEN1.SGM 18FEN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices worldwide and the field of use may be limited to the pre-clinical evaluation and commercial development of human therapeutics for liver cancer and ovarian cancer within the scope of the Licensed Patent Rights. Upon expiration or termination of the exclusive evaluation option license, METHEOR will have the right to execute a start-up exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no broader field of use and territory than granted in the 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 March 5, 2014 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be directed to: Sabarni K. Chatterjee, Ph.D., M.B.A. Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5587; Facsimile: (301) 402–0220; Email: chatterjeesa@mail.nih.gov. SUPPLEMENTARY INFORMATION: The present inventions relate to a potent inhibitor of DNA methylation (Zebularine) that can specifically reactivate silenced tumor suppressor genes. This agent can be used to inhibit methylation and thereby combat certain cancers that have been linked to hypermethylation. This agent has also been shown in initial animal testing to be active orally and is more stable than some other agents in this same area of therapy and is a suitable candidate for further pre-clinical and clinical development as an anti-cancer agent to be used as monotherapy and/or as an adjunct to existing anti-cancer therapeutics. METHEOR has indicated its interest in developing Zebularine as novel epigenetic modifiers and drugs for oncologic indications. Pre-clinical research and clinical development will primarily focus on determining the safety and efficacy of the lead compound for liver and ovarian cancers. The prospective exclusive evaluation option license 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. The prospective exclusive evaluation option license, and a subsequent exclusive patent commercialization license, may VerDate Mar<15>2010 20:58 Feb 14, 2014 Jkt 232001 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. Any additional, properly filed, and complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated 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: February 12, 2014. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2014–03410 Filed 2–14–14; 8:45 am] BILLING CODE 4140–01–P ADVISORY COUNCIL ON HISTORIC PRESERVATION Notice of Advisory Council on Historic Preservation Quarterly Business Meeting Advisory Council on Historic Preservation. ACTION: Notice of Advisory Council on Historic Preservation Quarterly Business Meeting. AGENCY: Notice is hereby given that the Advisory Council on Historic Preservation (ACHP) will hold its next quarterly meeting on Friday, March 7, 2014. The meeting will be held in Room SR325 at the Russell Senate Office Building at Constitution and Delaware Avenues NE., Washington, DC, starting at 8:30 a.m. DATES: The quarterly meeting will take place on Friday, March 7, 2014, starting at 8:30 a.m. EST. ADDRESSES: The quarterly meeting will be held in Room SR325 at the Russell Senate Office Building at Constitution and Delaware Ave. NE., Washington, DC. FOR FURTHER INFORMATION CONTACT: Cindy Bienvenue, 202–606–8521, cbienvenue@achp.gov. SUPPLEMENTARY INFORMATION: The Advisory Council on Historic Preservation (ACHP) is an independent federal agency that promotes the preservation, enhancement, and sustainable use of our nation’s diverse historic resources, and advises the SUMMARY: PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 9249 President and the Congress on national historic preservation policy. The goal of the National Historic Preservation Act (NHPA), which established the ACHP in 1966, is to have federal agencies act as responsible stewards of our nation’s resources when their actions affect historic properties. The ACHP is the only entity with the legal responsibility to encourage federal agencies to factor historic preservation into federal project requirements. For more information on the ACHP, please visit our Web site at www.achp.gov. The agenda for the upcoming quarterly meeting of the ACHP is the following: Call to Order—8:30 a.m. I. Chairman’s Welcome II. Swearing In Ceremony III. Chairman’s Award IV. Chairman’s Report V. Historic Preservation Policy and Programs A. Building a More Inclusive Preservation Program: Proposed Executive Order B. Working With Indian Tribes: Proposed ACHP Policy for Tribal Historic Preservation Officers C. Preserve America Program D. 50th Anniversary of the National Historic Preservation Act E. Rightsizing Task Force Report and Implementation Plan F. Climate Change and Cultural Resources G. ACHP Legislative Agenda 1. Amendments to the National Historic Preservation Act 2. Recent Legislation Related to Historic Preservation 3. Advocacy Week VI. Section 106 Issues A. Report to Congress on Historic Post Offices Disposals B. 2015 Section 3 Report to the President C. Northern Plains Tribal Summit D. Federal Communications Commission Program Alternative for Positive Train Control VII. ACHP Management Issues A. ACHP FY 2014 and 2015 Budget B. Alumni Foundation Report C. ACHP Office Relocation Update VIII. New Business IX. Adjourn The meetings of the ACHP are open to the public. If you need special accommodations due to a disability, please contact Cindy Bienvenue, 202– 606–8521 or cbienvenue@achp.gov, at least seven (7) days prior to the meeting. Authority: 16 U.S.C. 470j. E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9248-9249]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03410]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Pre-Clinical Evaluation 
and Commercial Development of Human Therapeutics for Liver Cancer and 
Ovarian Cancer Within the Scope of the Licensed Patent Rights

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 an exclusive 
evaluation option license to practice the inventions covered under the 
scope of the following patents and patent applications:
     United States Patent No. 8,207,142 issued Jun 26, 2012 
entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-
US-06);
     EP Patent No. 1418949 issued June 19, 2013, entitled 
``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-EP-02) and 
validated in Great Britain, Germany and France;
     Australia Patent No. 2002322805 issued February 21, 2008 
entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-
AU-03);
     Australia Patent No. 2008200601 issued November 25, 2010 
entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-
AU-07);
     Canada Patent No. 2,454,147 issued May 21, 2013 entitled 
``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-CA-04);
     Japan Patent Application No. 2003-517229 filed July 30, 
2002 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-
2001/2-JP-05); and
     Japan Patent No. 5416660 issued November 22, 2013 entitled 
``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-JP-08)

to Metheor Therapeutics, Corporation (``METHEOR'') a U.S. based company 
located in Shoreline, WA, USA. The patent rights in this invention have 
been assigned to the government of the United States of America.
    The prospective exclusive evaluation option license territory may 
be

[[Page 9249]]

worldwide and the field of use may be limited to the pre-clinical 
evaluation and commercial development of human therapeutics for liver 
cancer and ovarian cancer within the scope of the Licensed Patent 
Rights. Upon expiration or termination of the exclusive evaluation 
option license, METHEOR will have the right to execute a start-up 
exclusive patent commercialization license which will supersede and 
replace the exclusive evaluation option license with no broader field 
of use and territory than granted in the 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 
March 5, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Sabarni K. Chatterjee, 
Ph.D., M.B.A. Licensing and Patenting Manager, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5587; 
Facsimile: (301) 402-0220; Email: chatterjeesa@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The present inventions relate to a potent 
inhibitor of DNA methylation (Zebularine) that can specifically 
reactivate silenced tumor suppressor genes. This agent can be used to 
inhibit methylation and thereby combat certain cancers that have been 
linked to hypermethylation. This agent has also been shown in initial 
animal testing to be active orally and is more stable than some other 
agents in this same area of therapy and is a suitable candidate for 
further pre-clinical and clinical development as an anti-cancer agent 
to be used as monotherapy and/or as an adjunct to existing anti-cancer 
therapeutics.
    METHEOR has indicated its interest in developing Zebularine as 
novel epigenetic modifiers and drugs for oncologic 
indications. Pre-clinical research and clinical development 
will primarily focus on determining the safety and efficacy of the lead 
compound for liver and ovarian cancers.
    The prospective exclusive evaluation option license 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. The prospective exclusive evaluation option license, 
and a subsequent exclusive patent commercialization 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.
    Any additional, properly filed, and complete applications for a 
license in the field of use filed in response to this notice will be 
treated as objections to the grant of the contemplated 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: February 12, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-03410 Filed 2-14-14; 8:45 am]
BILLING CODE 4140-01-P
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