Prospective Grant of an Exclusive Patent License: Dimethyl Synaptamide for the Treatment of Autoimmune Disorders and Inflammatory Diseases, 66730-66731 [2024-18381]

Download as PDF 66730 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / Notices as time permits. Public participants wishing to offer written comments should send them to Sahira Rafiullah, using the contact information above, at least 3 business days prior to the meeting. Individuals who plan to attend either physically or virtually and need special assistance or other reasonable accommodation should notify Sahira Rafiullah through any of the methods listed above, at least 10 business days prior to the meeting. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2024–18370 Filed 8–15–24; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting lotter on DSK11XQN23PROD with NOTICES1 Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, 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: Eunice Kennedy Shriver National Institute of Child Health and Human Development Special Emphasis Panel; Medical Rehabilitation Research Resource (P50 Clinical Trial Optional). Date: November 4–5, 2024. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Child Health and Human Development, 6710B Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Helen Huang, Ph.D., Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Drive, Room 2137D, Bethesda, MD 20892, (301) 496–8558, helen.huang@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) VerDate Sep<11>2014 17:33 Aug 15, 2024 Jkt 262001 Dated: August 13, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2024–18409 Filed 8–15–24; 8:45 am] Prospective Grant of an Exclusive Patent License: Dimethyl Synaptamide for the Treatment of Autoimmune Disorders and Inflammatory Diseases BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health AGENCY: National Institutes of Health, HHS. National Institutes of Health ACTION: National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting SUMMARY: Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Interventional Agents Safety and Pharmacokinetic Services (IASPS). Date: September 10–13, 2024. Time: 12:00 p.m. to 7:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3E70A, Rockville, MD 20892 (Video Assisted Meeting). Contact Person: Soheyla Saadi, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3E70A, Rockville, MD 20892, (240) 669–5178, saadisoh@ niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: August 13, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–18410 Filed 8–15–24; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Notice. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Center for Advancing Translational Sciences (NCATS), both institutes of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Autala Bio Inc., A Civala Company (‘‘Autala’’), incorporated in Delaware. Only written comments and/or applications for a license that are received by the National Heart Lung and Blood Institute (NHLBI) Office of Technology Transfer And Development (OTTAD) on or before September 3, 2024 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Jillian Varonin, Ph.D., Technology Transfer Manager, NHLBI Office of Technology Transfer And Development, Telephone: (301) 496– 0505; Email: jillian.varonin@nih.gov. SUPPLEMENTARY INFORMATION: DATES: Intellectual Property 1. United States Provisional Patent Application No. 61/624,741, filed April 16, 2012, entitled ‘‘Derivatives Of Docosahexaenoylamide and Uses Thereof’’ [HHS Reference No. E–070– 2012–0–US–01]; 2. PCT Patent Application No. PCT/ US2013/032333, filed March 15, 2013, entitled ‘‘Derivatives Of Docosahexaenoylamide and Uses Thereof’’ [HHS Reference No. E–070– 2012–0–PCT–02]; 3. European Patent No. 2847178, filed March 15, 2013, entitled ‘‘Derivatives Of Docosahexaenoylamide and Uses Thereof’’ [HHS Reference No. E–070– 2012–0–EP–03]; 4. United States Patent No. 9,422,308, filed September 23, 2014, entitled ‘‘Derivatives Of Docosahexaenoylamide E:\FR\FM\16AUN1.SGM 16AUN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / Notices and Uses Thereof’’ [HHS Reference No. E–070–2012–0–US–04]; 5. Germany Patent No. 602013016154.2, filed October 30, 2014, entitled ‘‘Derivatives Of Docosahexaenoylamide and Uses Thereof’’ [HHS Reference No. E–070– 2012–0–DE–05]; 6. France Patent No. 2847178, filed October 30, 2014, entitled ‘‘Derivatives Of Docosahexaenoylamide and Uses Thereof’’ [HHS Reference No. E–070– 2012–0–FR–06]; 7. Great Britain Patent No. 2847178, filed October 30, 2014, entitled ‘‘Derivatives Of Docosahexaenoylamide and Uses Thereof’’ [HHS Reference No. E–070–2012–0–GB–07]. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the following: ‘‘Use of a G-protein-coupled receptor 110 (‘‘GPR110’’) agonist named dimethyl synaptamide (‘‘DMS’’) (also known as Compound NCGC00248435; (4Z,7Z,10Z,13Z,16Z,19Z)-N-(2-hydroxy2-methylpropyl) docosa-4,7,10,13,16,19hexaenamide; or ‘‘A8’’) to treat multiple sclerosis (‘‘MS’’), chronic inflammatory demyelinating polyradiculoneuropathy (‘‘CIDP’’), psoriasis, inflammatory bowel disease (‘‘IBD’’), Crohn’s disease, ulcerative colitis (‘‘UC’’), sclerosing cholangitis, ankylosing spondylitis, rheumatoid arthritis (‘‘RA’’), psoriatic arthritis, systemic lupus erythematosus (‘‘SLE’’), lupus nephritis, sarcoidosis, and Behcet’s disease.’’ This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the NHLBI Office of Technology Transfer And Development 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. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as VerDate Sep<11>2014 17:33 Aug 15, 2024 Jkt 262001 66731 required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Bruce D. Goldstein, Director, Office of Technology Transfer and Development, National Heart, Lung, and Blood Institute. Dated: August 13, 2024 Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–18381 Filed 8–15–24; 8:45 am] [FR Doc. 2024–18412 Filed 8–15–24; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Center for Scientific Review; Notice of Closed Meetings National Institute of Dental & Craniofacial Research; Notice of Partially Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, 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: Center for Scientific Review Special Emphasis Panel; Member Conflict: Respiratory Sciences. Date: September 9, 2024. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Michael L. Bloom, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7804, Bethesda, MD 20892, 301–451– 0132, bloomm2@mail.nih.gov. Name of Committee: Risk, Prevention and Health Behavior Integrated Review Group; Biobehavioral Medicine and Health Outcomes Study Section. Date: September 19–20, 2024. Time: 9:30 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Mark A. Vosvick, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, Bethesda, MD 20892, (301) 402–4128, mark.vosvick@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Dental and Craniofacial Research Council. The meeting will be held as a virtual meeting and is partially open to the public as indicated below. Individuals who plan to view the virtual meeting and need special assistance to view the meeting, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting website (https:// videocast.nih.gov/). Registration is not required to access the videocast. 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 Advisory Dental and Craniofacial Research Council. Date: September 11, 2024. Open: 10:00 a.m. to 3:15 p.m. Agenda: Report of the Director, NIDCR and concept clearances. Place: National Institute of Dental & Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting). Closed: 3:30 p.m. to 4:15 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Dental & Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting). E:\FR\FM\16AUN1.SGM 16AUN1

Agencies

[Federal Register Volume 89, Number 159 (Friday, August 16, 2024)]
[Notices]
[Pages 66730-66731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18381]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Dimethyl 
Synaptamide for the Treatment of Autoimmune Disorders and Inflammatory 
Diseases

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
and the National Center for Advancing Translational Sciences (NCATS), 
both institutes of the National Institutes of Health (NIH), Department 
of Health and Human Services (HHS), are contemplating the grant of an 
Exclusive Patent License to practice the inventions embodied in the 
Patents and Patent Applications listed in the Supplementary Information 
section of this notice to Autala Bio Inc., A Civala Company 
(``Autala''), incorporated in Delaware.

DATES: Only written comments and/or applications for a license that are 
received by the National Heart Lung and Blood Institute (NHLBI) Office 
of Technology Transfer And Development (OTTAD) on or before September 
3, 2024 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Jillian Varonin, Ph.D., Technology Transfer 
Manager, NHLBI Office of Technology Transfer And Development, 
Telephone: (301) 496-0505; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    1. United States Provisional Patent Application No. 61/624,741, 
filed April 16, 2012, entitled ``Derivatives Of Docosahexaenoylamide 
and Uses Thereof'' [HHS Reference No. E-070-2012-0-US-01];
    2. PCT Patent Application No. PCT/US2013/032333, filed March 15, 
2013, entitled ``Derivatives Of Docosahexaenoylamide and Uses Thereof'' 
[HHS Reference No. E-070-2012-0-PCT-02];
    3. European Patent No. 2847178, filed March 15, 2013, entitled 
``Derivatives Of Docosahexaenoylamide and Uses Thereof'' [HHS Reference 
No. E-070-2012-0-EP-03];
    4. United States Patent No. 9,422,308, filed September 23, 2014, 
entitled ``Derivatives Of Docosahexaenoylamide

[[Page 66731]]

and Uses Thereof'' [HHS Reference No. E-070-2012-0-US-04];
    5. Germany Patent No. 602013016154.2, filed October 30, 2014, 
entitled ``Derivatives Of Docosahexaenoylamide and Uses Thereof'' [HHS 
Reference No. E-070-2012-0-DE-05];
    6. France Patent No. 2847178, filed October 30, 2014, entitled 
``Derivatives Of Docosahexaenoylamide and Uses Thereof'' [HHS Reference 
No. E-070-2012-0-FR-06];
    7. Great Britain Patent No. 2847178, filed October 30, 2014, 
entitled ``Derivatives Of Docosahexaenoylamide and Uses Thereof'' [HHS 
Reference No. E-070-2012-0-GB-07].
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the following:
    ``Use of a G-protein-coupled receptor 110 (``GPR110'') agonist 
named dimethyl synaptamide (``DMS'') (also known as Compound 
NCGC00248435; (4Z,7Z,10Z,13Z,16Z,19Z)-N-(2-hydroxy-2-methylpropyl) 
docosa-4,7,10,13,16,19-hexaenamide; or ``A8'') to treat multiple 
sclerosis (``MS''), chronic inflammatory demyelinating 
polyradiculoneuropathy (``CIDP''), psoriasis, inflammatory bowel 
disease (``IBD''), Crohn's disease, ulcerative colitis (``UC''), 
sclerosing cholangitis, ankylosing spondylitis, rheumatoid arthritis 
(``RA''), psoriatic arthritis, systemic lupus erythematosus (``SLE''), 
lupus nephritis, sarcoidosis, and Behcet's disease.''
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the NHLBI 
Office of Technology Transfer And Development 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

Bruce D. Goldstein,
Director, Office of Technology Transfer and Development, National 
Heart, Lung, and Blood Institute.
[FR Doc. 2024-18381 Filed 8-15-24; 8:45 am]
BILLING CODE 4140-01-P


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