Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: A3 Adenosine Receptor (A3AR) Agonists as an Orally-Administered Analgesic for Treatment of Chronic Neuropathic Pain, 73091-73092 [2014-28749]

Download as PDF Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting 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 Institute of Neurological Disorders and Stroke Special Emphasis Panel; Parkinson’s Disease Biomarker Program. Date: December 17, 2014. Time: 2:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Shanta Rajaram, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–435– 6033, rajarams@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: December 3, 2014. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–28753 Filed 12–8–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health rljohnson on DSK3VPTVN1PROD with NOTICES Center for Scientific Review; Notice of Closed Meetings 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 VerDate Sep<11>2014 14:48 Dec 08, 2014 Jkt 235001 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: Center for Scientific Review Special Emphasis Panel, PAR Panel: Cancer Health Disparities/Diversity in Basic Cancer Research. Date: December 8–9, 2014. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Rolf Jakobi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7806, Bethesda, MD 20892, 301–495– 1718, jakobir@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: AIDS and AIDS Related Research. Date: December 9, 2014. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Robert Freund, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, 301–435– 1050, freundr@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, PAR Panel: Multidisciplinary Studies of HIV and Viral Hepatitis Co-Infection. Date: December 10, 2014. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Shiv A. Prasad, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD 20892, 301–443– 5779, prasads@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Fellowships: AIDS and AIDS Related Applications. Date: December 11, 2014. Time: 10:00 a.m. to 6:00 p.m. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 73091 Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Mary Clare Walker, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 20892, (301) 435– 1165, walkermc@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: December 3, 2014. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–28751 Filed 12–8–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: A3 Adenosine Receptor (A3AR) Agonists as an OrallyAdministered Analgesic for Treatment of Chronic Neuropathic Pain 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 a Start-Up Exclusive Evaluation Option License Agreement to BioIntervene, Inc., a company having a place of business in Saint Louis, Missouri to practice the inventions embodied in the following patent applications and patents: 1. U.S. Patent 8,735,407, issued May 27, 2014, titled ‘‘Purine Derivatives As A3 Adenosine Receptor-Selective Agonists’’ [HHS Ref. No. E–140–2008/0– US–06]; 2. European Patent Application 09728154.7, filed March 24, 2009, titled ‘‘Purine Derivatives As A3 Adenosine Receptor-Selective Agonists’’ [HHS Ref. No. E–140–2008/0–EP–05]; 3. Canadian Patent Application 2720037, filed March 24, 2009, titled ‘‘Purine Derivatives As A3 Adenosine Receptor-Selective Agonists’’ [HHS Ref. No. E–140–2008/0–CA–04]; SUMMARY: E:\FR\FM\09DEN1.SGM 09DEN1 rljohnson on DSK3VPTVN1PROD with NOTICES 73092 Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 4. Australian Patent 2009231978, issued February 20, 2014, titled ‘‘Purine Derivatives As A3 Adenosine ReceptorSelective Agonists’’ [HHS Ref. No. E– 140–2008/0–AU–03]; 5. U.S. Patent Application 13/371,081, filed February 10, 2012, titled ‘‘A3 Adenosine Receptor Agonists And Antagonists’’ [HHS Ref. No. E–140– 2008/1–US–01]; 6. U.S. Provisional Application 61/ 909,742, filed November 27, 2013, titled ‘‘A3 Adenosine Receptor Agonists’’ [HHS Ref. No. E–742–2013/0–US–01]; and 7. U.S. Provisional Application 62/ 033,723, filed August 6, 2014, titled ‘‘A3 Adenosine Receptor Agonists’’ [HHS Ref. No. E–210–2014/0–US–01]. The patent rights in these inventions either have been assigned to the Government of the United States of America, or have been granted exclusive rights to the Government of the United States of America. The territory of the prospective Start-up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to: ‘‘The use of an A3 Adenosine Receptor (A3AR) agonist as an orally-administered analgesic, either as monotherapy or as an add-on analgesic, for treatment of chronic neuropathic pain conditions’’. Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, BioIntervene 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 Startup Exclusive Evaluation Option License Agreement. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before December 24, 2014 will be considered. ADDRESSES: Requests for copies of the patents, patent applications, inquiries, comments, and other materials relating to the contemplated Start-Up Exclusive Evaluation Option License Agreement should be directed to: Betty B. Tong, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 594–6565; Facsimile: (301) 402– 0220; Email: tongb@mail.nih.gov. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published or issued by VerDate Sep<11>2014 14:48 Dec 08, 2014 Jkt 235001 the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: The subject inventions describe selective A3 Adenosine Receptor (A3AR) agonists, and their in vivo activity reducing or preventing development of chronic neuropathic pain in an animal model. The A3AR subtype was linked with helping protect the heart from ischemia, controlling inflammation, and regulating cell proliferation. The compounds claimed are consistently highly selective and have smaller molecular weight, thus can offer greater oral bioavailability. Hence, the subject inventions may provide a new treatment for chronic neuropathic pain. The prospective Start-up Exclusive Evaluation Option License Agreement and a subsequent Start-up Exclusive Patent License Agreement may be granted unless the NIH 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. 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 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: December 3, 2014. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2014–28749 Filed 12–8–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615–0030] Agency Information Collection Activities: Application for Waiver of the Foreign Residence Requirement of Section 212(e) of the Immigration and Nationality Act, Form I–612; Revision of a Currently Approved ACTION: PO 00000 30-Day Notice. Frm 00067 Fmt 4703 Sfmt 4703 The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on September 10, 2014, at 79 FR 53720, allowing for a 60-day public comment period. USCIS did receive 1 comment in connection with the 60-day notice. DATES: The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until January 8, 2015. This process is conducted in accordance with 5 CFR 1320.10. ADDRESSES: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at oira_submission@ omb.eop.gov. Comments may also be submitted via fax at (202) 395–5806. All submissions received must include the agency name and the OMB Control Number 1615–0030. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of https://www.regulations.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Comments: Note: The address listed in this notice should only be used to submit comments concerning this information collection. Please do not submit requests for individual case status inquiries to this address. If you are seeking information about the status of your individual case, please check ‘‘My Case Status’’ online at: https:// egov.uscis.gov/cris/Dashboard.do, or call the USCIS National Customer Service Center at 1–800–375–5283. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, E:\FR\FM\09DEN1.SGM 09DEN1

Agencies

[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Pages 73091-73092]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28749]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Evaluation Option License 
Agreement: A3 Adenosine Receptor (A3AR) Agonists as an Orally-
Administered Analgesic for Treatment of Chronic Neuropathic Pain

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 BioIntervene, Inc., a company 
having a place of business in Saint Louis, Missouri to practice the 
inventions embodied in the following patent applications and patents:
    1. U.S. Patent 8,735,407, issued May 27, 2014, titled ``Purine 
Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS Ref. No. 
E-140-2008/0-US-06];
    2. European Patent Application 09728154.7, filed March 24, 2009, 
titled ``Purine Derivatives As A3 Adenosine Receptor-Selective 
Agonists'' [HHS Ref. No. E-140-2008/0-EP-05];
    3. Canadian Patent Application 2720037, filed March 24, 2009, 
titled ``Purine Derivatives As A3 Adenosine Receptor-Selective 
Agonists'' [HHS Ref. No. E-140-2008/0-CA-04];

[[Page 73092]]

    4. Australian Patent 2009231978, issued February 20, 2014, titled 
``Purine Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS 
Ref. No. E-140-2008/0-AU-03];
    5. U.S. Patent Application 13/371,081, filed February 10, 2012, 
titled ``A3 Adenosine Receptor Agonists And Antagonists'' [HHS Ref. No. 
E-140-2008/1-US-01];
    6. U.S. Provisional Application 61/909,742, filed November 27, 
2013, titled ``A3 Adenosine Receptor Agonists'' [HHS Ref. No. E-742-
2013/0-US-01]; and
    7. U.S. Provisional Application 62/033,723, filed August 6, 2014, 
titled ``A3 Adenosine Receptor Agonists'' [HHS Ref. No. E-210-2014/0-
US-01].
    The patent rights in these inventions either have been assigned to 
the Government of the United States of America, or have been granted 
exclusive rights to the Government of the United States of America. The 
territory of the prospective Start-up Exclusive Evaluation Option 
License Agreement may be worldwide, and the field of use may be limited 
to: ``The use of an A3 Adenosine Receptor (A3AR) agonist as an orally-
administered analgesic, either as monotherapy or as an add-on 
analgesic, for treatment of chronic neuropathic pain conditions''.
    Upon the expiration or termination of the Start-up Exclusive 
Evaluation Option License Agreement, BioIntervene 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 NIH Office of Technology Transfer on or before 
December 24, 2014 will be considered.

ADDRESSES: Requests for copies of the patents, patent applications, 
inquiries, comments, and other materials relating to the contemplated 
Start-Up Exclusive Evaluation Option License Agreement should be 
directed to: Betty B. Tong, Ph.D., Senior Licensing and Patenting 
Manager, Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 594-6565; Facsimile: (301) 402-0220; Email: 
tongb@mail.nih.gov. 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: The subject inventions describe selective A3 
Adenosine Receptor (A3AR) agonists, and their in vivo activity reducing 
or preventing development of chronic neuropathic pain in an animal 
model. The A3AR subtype was linked with helping protect the heart from 
ischemia, controlling inflammation, and regulating cell proliferation. 
The compounds claimed are consistently highly selective and have 
smaller molecular weight, thus can offer greater oral bioavailability. 
Hence, the subject inventions may provide a new treatment for chronic 
neuropathic pain.
    The prospective Start-up Exclusive Evaluation Option License 
Agreement and a subsequent Start-up Exclusive Patent License Agreement 
may be granted unless the NIH 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.
    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 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: December 3, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2014-28749 Filed 12-8-14; 8:45 am]
BILLING CODE 4140-01-P
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