Prospective Grant of Start-Up Option Exclusive License: The Development of Liposomal Therapeutic Agents for the Treatment of Human Epithelial Cancers and Liposarcomas, 16692 [2013-06069]

Download as PDF 16692 Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices • In vivo data available (animal) Inventors: Menghang Xia, Ruili Huang, Christopher P. Austin (all of NCATS). Intellectual Property: HHS Reference No. E–156–2012/0—US Application No. 61/692,560 filed 23 Aug 2012. Licensing Contact: Sabarni Chatterjee, Ph.D., MBA; 301–435–5587; chatterjeesa@mail.nih.gov. Collaborative Research Opportunity: The National Center for Advancing Translational Sciences, Division of PreClinical Innovation, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Combination Chemotherapeutics for the Treatment of Chordoma. For collaboration opportunities, please contact Lili M. Portilla, MPA at lilip@nih.gov. Dated: March 8, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–06070 Filed 3–15–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Option Exclusive License: The Development of Liposomal Therapeutic Agents for the Treatment of Human Epithelial Cancers and Liposarcomas National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to ZoneOne Pharma, Inc., of an exclusive evaluation option license to practice the inventions embodied in the following US Patent (and all foreign counterparts): Serial No. 6,890,917 entitled, ‘‘Geldanamycin Derivative and Method of Treating Cancer Using Same’’ [HHS Ref. E–050– 2000/0–US–15]. 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 worldwide, and the field of use may be limited to: pmangrum on DSK3VPTVN1PROD with NOTICES SUMMARY: The pharmaceutical use in humans of 17dimethylaminoethylamino-17- VerDate Mar<14>2013 15:16 Mar 15, 2013 Jkt 229001 demethoxygeldanamycin (‘‘17–DMAG’’) as a liposome-encapsulated drug, alone or in combination with other agents, for the treatment of the following types of cancer: ovary, pancreas, metastatic skin, head and neck, colon, kidney, non-small cell lung, or liposarcoma. Dated: March 8, 2013. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–06069 Filed 3–15–13; 8:45 am] BILLING CODE 4140–01–P Upon the expiration or termination of the exclusive evaluation option license, ZoneOne Pharma, Inc., will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the exclusive evaluation option license. Only written comments or applications for a license (or both) which are received by the NIH Office of Technology Transfer on or before April 2, 2013 will be considered. DATES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be directed to: Patrick McCue, Ph.D., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–5560; Facsimile: (301) 402–0220; Email: mccuepat@mail.nih.gov. ADDRESSES: This invention concerns 17–DMAG, the first water-soluble analog of 17–AAG, a less toxic and more stable analog of the antitumor antibiotic geldanamycin. The prospective exclusive evaluation license is being considered under the small business initiative launched on 1 October 2011, and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive evaluation license, and a subsequent exclusive commercialization license, may be granted unless the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7 within fifteen (15) days from the date of this published notice. 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. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS–2012–0059] Chemical Facility Anti-Terrorism Standards (CFATS) National Protection and Programs Directorate, DHS. ACTION: 30-day notice and request for comments; Extension of Information Collection Request: 1670–0014. AGENCY: The Department of Homeland Security (DHS), National Protection and Programs Directorate (NPPD), Office of Infrastructure Protection (IP), Infrastructure Security Compliance Division (ISCD) will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chapter 35). The Department previously published this ICR in the Federal Register on December 17, 2012, for a 60day public comment period.1 In this notice, NPPD is responding to one comment 2 and is soliciting public comments concerning the extension of Information Collection Request, Chemical Facility Anti-Terrorism Standards (CFATS) for an additional 30 days. DATES: Comments are encouraged and will be accepted until April 17, 2013. This process is conducted in accordance with 5 CFR 1320.10. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to OMB Desk Officer, Department of Homeland Security, National Protection and Programs Directorate. Comments must be SUMMARY: 1 See 77 FR 74677. The 60-day Federal Register notice for Information Collection 1670–0014, which solicited comments for 60 days, may be found at https://federalregister.gov/a/2012-30314. 2 The comment was submitted under docket # DHS–2012–0059 and provided comment not only on this information collection request (i.e., 1670– 0014), but also on ICR 1670–0007 and ICR 1670– 0015. The comment may be viewed at http:// www.regulations.gov/#!documentDetail;D=DHS2012-0059-0002. E:\FR\FM\18MRN1.SGM 18MRN1

Agencies

[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Page 16692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06069]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Option Exclusive License: The 
Development of Liposomal Therapeutic Agents for the Treatment of Human 
Epithelial Cancers and Liposarcomas

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant to ZoneOne 
Pharma, Inc., of an exclusive evaluation option license to practice the 
inventions embodied in the following US Patent (and all foreign 
counterparts): Serial No. 6,890,917 entitled, ``Geldanamycin Derivative 
and Method of Treating Cancer Using Same'' [HHS Ref. E-050-2000/0-US-
15]. 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 worldwide, and the field of use may be limited to:

The pharmaceutical use in humans of 17-dimethylaminoethylamino-17-
demethoxygeldanamycin (``17-DMAG'') as a liposome-encapsulated drug, 
alone or in combination with other agents, for the treatment of the 
following types of cancer: ovary, pancreas, metastatic skin, head 
and neck, colon, kidney, non-small cell lung, or liposarcoma.

    Upon the expiration or termination of the exclusive evaluation 
option license, ZoneOne Pharma, Inc., will have the exclusive right to 
execute an exclusive commercialization license which will supersede and 
replace the exclusive evaluation option license with no greater field 
of use and territory than granted in the exclusive evaluation option 
license.

DATES: Only written comments or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before April 2, 2013 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: Patrick McCue, Ph.D., 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-5560; Facsimile: (301) 
402-0220; Email: mccuepat@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This invention concerns 17-DMAG, the first 
water-soluble analog of 17-AAG, a less toxic and more stable analog of 
the antitumor antibiotic geldanamycin.
    The prospective exclusive evaluation license is being considered 
under the small business initiative launched on 1 October 2011, and 
will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 
404.7. The prospective exclusive evaluation license, and a subsequent 
exclusive commercialization license, may be granted unless the NIH 
receives written evidence and argument that establishes that the grant 
of the license would not be consistent with the requirements of 35 
U.S.C. 209 and 37 CFR 404.7 within fifteen (15) days from the date of 
this published notice.
    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: March 8, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-06069 Filed 3-15-13; 8:45 am]
BILLING CODE 4140-01-P