Prospective Grant of an Exclusive Patent License: Development and Commercialization of Metarrestin and Its Analogs for the Treatment of Metastatic Cancers, 18324-18326 [2023-06318]

Download as PDF 18324 Federal Register / Vol. 88, No. 59 / Tuesday, March 28, 2023 / Notices (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: March 22, 2023. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–06406 Filed 3–27–23; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental and Craniofacial Research; Notice of Closed Meeting lotter on DSK11XQN23PROD with NOTICES1 Pursuant to section 10(d) 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: National Institute of Dental and Craniofacial Research Special Emphasis Panel; HEAL Initiative: Oral Complications Arising from Pharmacotherapies to Treat OUD. Date: April 27, 2023. Time: 12:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Dental and Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Aiwu Cheng, Ph.D., MD, Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, National Institute of Dental and Craniofacial Research, 6701 Democracy Blvd., Bethesda, MD 20892, 301–594–4859, Aiwu.cheng@ nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: March 23, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–06405 Filed 3–27–23; 8:45 am] BILLING CODE 4140–01–P 16:59 Mar 27, 2023 National Institutes of Health Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on April 24, 2023. The topic for this meeting will be ‘‘Type 1 Diabetes (T1D): Evolving Concepts in the Pathophysiology, Screening and Prevention’’. The meeting is open to the public. DATES: The meeting will be held on April 24, 2023 from 12:00 p.m. to 4:00 p.m. EST. ADDRESSES: The meeting will be held via the Zoom online video conferencing platform. For details, and to register, please contact dmicc@mail.nih.gov. FOR FURTHER INFORMATION CONTACT: For further information concerning this meeting, including a draft agenda, which will be posted when available, see the DMICC website, www.diabetescommittee.gov, or contact Dr. William Cefalu, Executive Secretary of the Diabetes Mellitus Interagency Coordinating Committee, National Institute of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Boulevard, Democracy 2, Room 6037, Bethesda, MD 20892, telephone: 301– 435–1011; email: dmicc@mail.nih.gov. SUPPLEMENTARY INFORMATION: In accordance with 42 U.S.C. 285c–3, the DMICC, chaired by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) comprising members of the Department of Health and Human Services and other federal agencies that support diabetes-related activities, facilitates cooperation, communication, and collaboration on diabetes among government entities. DMICC meetings, held several times a year, provide an opportunity for Committee members to learn about and discuss current and future diabetes programs in DMICC member organizations and to identify opportunities for collaboration. The April 24, 2023 DMICC meeting will focus on ‘‘Type 1 Diabetes (T1D): Evolving Concepts in the Pathophysiology, Screening and Prevention.’’ Any member of the public interested in presenting oral comments to the Committee should notify the contact person listed on this notice at least 5 days in advance of the meeting. SUMMARY: BILLING CODE 4140–01–P VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 259001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Interested individuals and representatives or organizations should submit a letter of intent, a brief description of the organization represented, and a written copy of their oral presentation in advance of the meeting. Only one representative of an organization will be allowed to present; oral comments and presentations will be limited to a maximum of 5 minutes. Printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the Committee by forwarding their statement to the contact person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Because of time constraints for the meeting, oral comments will be allowed on a first-come, first-serve basis. Members of the public who would like to receive email notification about future DMICC meetings should register for the listserv available on the DMICC website, www.diabetescommittee.gov. William T. Cefalu, Director, Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, and Metabolic Diseases, National Institutes of Health. [FR Doc. 2023–06358 Filed 3–27–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Development and Commercialization of Metarrestin and Its Analogs for the Treatment of Metastatic Cancers AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is 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 Oncala Bio Inc. (‘‘Oncala Bio’’), headquartered in Bend, OR. DATES: Only written comments and/or applications for a license which are received by the National Center for Advancing Translational Sciences’ SUMMARY: E:\FR\FM\28MRN1.SGM 28MRN1 Federal Register / Vol. 88, No. 59 / Tuesday, March 28, 2023 / Notices Office of Strategic Alliances on or before April 12, 2023 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Sury Vepa, Ph.D., J.D., Senior Licensing and Patenting Manager, Office of Strategic Alliances, Telephone: (301)–642–0460; Email: sury.vepa@nih.gov. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 Intellectual Property 1. U.S. Provisional Patent Application No. 61/576,780 filed on 12/16/2011 which is entitled ‘‘Compounds and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ (HHS Ref. No. E–276– 2011–0–US–01); 2. International Patent Application No. PCT/US2012/070155 filed on 12/17/ 2012 which is entitled ‘‘Compounds and Methods for The Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ (HHS Ref. No. E–276– 2011–0–PCT–02); 3. Australian Patent Application No. 2012353651 filed on 12/17/2012 which is entitled ‘‘Compounds and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ which was issued as Patent No. 2012353651 on 03/29/2018(HHS Ref. No. E–276–2011–0–AU–03); 4. Australian Patent Application No. 2017276258 filed on 12/17/2012 which is entitled ‘‘Compounds and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ which was issued as Patent No. 201727658 on 01/16/2020 (HHS Ref. No. E–276–2011–0–AU–10); 5. Canadian Patent Application No. 2859370 filed on 12/17/2012 which is entitled ‘‘Compounds and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ which was issued as Patent No. 2859370 on 01/ 26/2021(HHS Ref. No. E–276–2011–0– CA–04); 6. European Patent Application No. 12806846.7 filed on 12/17/2012 which is entitled ‘‘Compounds and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ which was issued as Patent No. 2791142 on 07/03/2019 and validated in Germany, Spain, France, Great Britain, Italy and Turkey (HHS Ref. No. E–276– 2011–0–EP–05); 7. U.S. Patent Application No. 14/ 364,759 filed on 06/12/2014 which is entitled ‘‘Compounds and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ which was issued as Patent No. 9,663,521 on VerDate Sep<11>2014 16:59 Mar 27, 2023 Jkt 259001 05/30/2017 (HHS Ref. No. E–276–2011– 0–US–07); 8. U.S. Patent Application No. 15/ 606,740 filed on 05/26/2017 which is entitled ‘‘Compounds and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ which was issued as Patent No. 10,301,314 on 05/28/2019 (HHS Ref. No. E–276–2011– 0–US–08); 9. Japanese Patent Application No. 547550/2014 filed on 06/13/2014 which is entitled ‘‘Compounds and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ which was issued as Patent No. 6463130 on 01/01/2019 (HHS Ref. No. E–276– 2011–0–JP–06); 10. Japanese Patent Application No. 102107/2017 filed on 05/23/2017 which is entitled ‘‘Compounds and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ which was issued as Patent No. 6726640 on 07/01/2020 (HHS Ref. No. E–276– 2011–0–JP–09); 11. U.S. Provisional Patent Application No. 62/671,964 filed on 05/ 15/2018 which is entitled ‘‘Formulations and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ (HHS Ref. No. E–114–2018–0–US–01); 12. International Patent Application No. PCT/US2019/32461 filed on 05/15/ 2019 which is entitled ‘‘Formulations and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ (HHS Ref. No. E–114– 2018–0–PCT–02); 13. Canadian Patent Application No. 3100211 filed on 11/12/2020 which is entitled ‘‘Formulations and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ (HHS Ref. No. E–114–2018–0–CA–03); 14. Australian Patent Application No. 2019271208 filed on 11/13/2020 which is entitled ‘‘Formulations and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ (HHS Ref. No. E–114–2018–0–AU–04); 15. Japanese Patent Application No. 2020–564095 filed on 11/13/2020 which is entitled ‘‘Formulations and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ (HHS Ref. No. E–114–2018–0–JP–06); 16. U.S. Patent Application No. 17/ 055,256 filed on 11/13/2020 which is entitled ‘‘Formulations and Methods for the Prevention and Treatment of Tumor Metastasis and Tumorigenesis’’ (HHS Ref. No. E–114–2018–0–US–07); and 17. European Patent Application No. 19728226.2 filed on 12/09/2020 which is entitled ‘‘Formulations and Methods for the Prevention and Treatment of PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 18325 Tumor Metastasis and Tumorigenesis’’ (HHS Ref. No. E–114–2018–0–EP–05). The patent rights in these inventions have been either assigned and/or exclusively licensed to the government of the United States of America, University of Kansas and Northwestern University. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the following: ‘‘Development, manufacture, use and commercialization of Metarrestin and its analogs disclosed and claimed in the prospective licensed patent rights, for the treatment of perinucleolar compartment (PNC) positive cancers or metastatic cancers.’’ E–276–2011 and E–104–2018 patent families are primarily directed to novel compositions, methods and formulations, which are selective against metastasis across different preclinical cancer histologies and without appreciable toxicity. Among others, the subject patent families disclose or claim the use of the small molecule metarrestin for the treatment of several types of metastatic cancers by disrupting a subcellular structure called the perinucleolar compartment (PNC) which is frequently found in metastatic tumors and cancer stem cells. 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 National Center for Advancing Translational Sciences 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 from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. E:\FR\FM\28MRN1.SGM 28MRN1 18326 Federal Register / Vol. 88, No. 59 / Tuesday, March 28, 2023 / Notices Dated: March 21, 2023. Joni L. Rutter, Director, Office of the Director, National Center for Advancing Translational Sciences. [FR Doc. 2023–06318 Filed 3–27–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2023–0063] Port Access Route Study: Approaches to Galveston Bay and Sabine Pass, Texas and Calcasieu Pass, Louisiana Coast Guard, DHS. Notice of study; correction and extension of comment period. AGENCY: ACTION: On March 1, 2023, the Coast Guard published a notice of a Port Access Route Study to evaluate the adequacy of existing vessel routing measures and determine whether additional vessel routing measures are necessary for port approaches to Galveston Bay and Sabine Pass, Texas, Calcasieu Pass, Louisiana, and international and domestic transit areas in the Eighth Coast Guard District area of responsibility. The Notice contained an incorrect telephone number for the agency contact listed. This document corrects that error and extends the public comment period to April 27, 2023. DATES: All comments and related material in response to the notice published at 88 FR 12966, on March 1, 2023, must be received on or before April 27, 2023. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight, Eastern Daylight Time, on the last day of the comment period. The correction in this document to the March 1, 2023 notice, FR Doc. 2023– 04207, is applicable March 28, 2023. ADDRESSES: You may submit comments identified by docket number USCG– 2023–0063 using the Federal eRulemaking Portal (https:// www.regulations.gov). See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section in the March 1, 2023 notice (88 FR 12966) for further instructions on submitting comments. FOR FURTHER INFORMATION CONTACT: If you have questions about this notice of study, call or email Ms. Brandi Canada, Eighth Coast Guard District (dpw), U.S. Coast Guard: telephone (504) 671–2330, lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 16:59 Mar 27, 2023 Jkt 259001 email SMB-D8NewOrleans-TXLAPARS@ uscg.mil. SUPPLEMENTARY INFORMATION: The comment period for the notice entitled ‘‘Port Access Route Study: Approaches to Galveston Bay and Sabine Pass, Texas and Calcasieu Pass, Louisiana,’’ that was published on March 1, 2023 (88 FR 12966) is extended to May 17, 2023. Correction In the Federal Register of March 1, 2023, in FR Doc. 2023–04207, on page 12967, in the second column, correct the FOR FURTHER INFORMATION CONTACT section to read: FOR FURTHER INFORMATION CONTACT: If you have questions about this notice of study, call or email Ms. Brandi Canada, Eighth Coast Guard District (dpw), U.S. Coast Guard: telephone 504–671–2330, email SMB-D8NewOrleans-TXLAPARS@ uscg.mil. Dated: March 23, 2023. Michael T. Cunningham, Chief, Office of Regulations and Administrative Law. [FR Doc. 2023–06372 Filed 3–27–23; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS–HQ–R–2023–N022 FXGO1664091HCC0–FF09D00000–190] Hunting and Wildlife Conservation Council Meeting Fish and Wildlife Service, Interior. ACTION: Notice of meeting. AGENCY: The U.S. Fish and Wildlife Service (Service) gives notice of a meeting of the Hunting and Wildlife Conservation Council (HWCC), in accordance with the Federal Advisory Committee Act. DATES: Meeting: The HWCC will meet on Monday, April 17, 2023, from 9 a.m. to 5 p.m. (Eastern Time). Registration: Registration to attend or participate in the meeting is required. The deadline for registration is Monday, April 10, 2023. Accessibility: The deadline for accessibility accommodation requests is Monday, April 10, 2023. Please see Accessibility Information below. ADDRESSES: The meeting will take place at the U.S. Department of the Interior, 1849 C Street NW, Washington, DC 20240. Virtual participation will also be available via teleconference and broadcast over the internet. To register SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 and receive the web address and telephone number for virtual participation, contact the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Douglas Hobbs, Designated Federal Officer, by email at doug_hobbs@ fws.gov, or by telephone at 703–358– 2336. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-ofcontact in the United States. The Hunting and Wildlife Conservation Council (HWCC) was established to further the provisions of the Fish and Wildlife Act of 1956 (16 U.S.C. 742a et seq.), the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701–1785), the National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd–ee), other statutes applicable to specific Department of the Interior bureaus, and Executive Order 13443 (August 16, 2007), ‘‘Facilitation of Hunting Heritage and Wildlife Conservation.’’ The HWCC’s purpose is to provide recommendations to the Federal Government, through the Secretary of the Interior and the Secretary of Agriculture, regarding policies and endeavors that (a) benefit wildlife resources; (b) encourage partnership among the public; sporting conservation organizations; and Federal, State, Tribal, and territorial governments; and (c) benefit fair-chase recreational hunting and safe recreational shooting sports. SUPPLEMENTARY INFORMATION: Meeting Agenda This meeting is open to the public. The meeting agenda will include briefings from Department of the Interior and Department of Agriculture agencies on their efforts to implement the Great American Outdoors Act, Inflation Reduction Act, and Bipartisan Infrastructure and Jobs Act; on the status of current operations of the National Wildlife Refuge System related to hunting and shooting sports; on landlocked Federal lands managed by the Bureau of Land Management; and on implementation of big game migration corridor conservation efforts. The HWCC will also hear reports from its subcommittees and provide time to hear public comment. The final agenda and other related meeting information will E:\FR\FM\28MRN1.SGM 28MRN1

Agencies

[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Pages 18324-18326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06318]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Metarrestin and Its Analogs for the Treatment of 
Metastatic Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Center for Advancing Translational Sciences, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, is 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 Oncala Bio Inc. (``Oncala Bio''), headquartered in Bend, OR.

DATES: Only written comments and/or applications for a license which 
are received by the National Center for Advancing Translational 
Sciences'

[[Page 18325]]

Office of Strategic Alliances on or before April 12, 2023 will be 
considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Sury Vepa, Ph.D., J.D., Senior Licensing and 
Patenting Manager, Office of Strategic Alliances, Telephone: (301)-642-
0460; Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    1. U.S. Provisional Patent Application No. 61/576,780 filed on 12/
16/2011 which is entitled ``Compounds and Methods for the Prevention 
and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-
276-2011-0-US-01);
    2. International Patent Application No. PCT/US2012/070155 filed on 
12/17/2012 which is entitled ``Compounds and Methods for The Prevention 
and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-
276-2011-0-PCT-02);
    3. Australian Patent Application No. 2012353651 filed on 12/17/2012 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 2012353651 on 03/29/2018(HHS Ref. No. E-276-2011-0-AU-03);
    4. Australian Patent Application No. 2017276258 filed on 12/17/2012 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 201727658 on 01/16/2020 (HHS Ref. No. E-276-2011-0-AU-10);
    5. Canadian Patent Application No. 2859370 filed on 12/17/2012 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 2859370 on 01/26/2021(HHS Ref. No. E-276-2011-0-CA-04);
    6. European Patent Application No. 12806846.7 filed on 12/17/2012 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 2791142 on 07/03/2019 and validated in Germany, Spain, 
France, Great Britain, Italy and Turkey (HHS Ref. No. E-276-2011-0-EP-
05);
    7. U.S. Patent Application No. 14/364,759 filed on 06/12/2014 which 
is entitled ``Compounds and Methods for the Prevention and Treatment of 
Tumor Metastasis and Tumorigenesis'' which was issued as Patent No. 
9,663,521 on 05/30/2017 (HHS Ref. No. E-276-2011-0-US-07);
    8. U.S. Patent Application No. 15/606,740 filed on 05/26/2017 which 
is entitled ``Compounds and Methods for the Prevention and Treatment of 
Tumor Metastasis and Tumorigenesis'' which was issued as Patent No. 
10,301,314 on 05/28/2019 (HHS Ref. No. E-276-2011-0-US-08);
    9. Japanese Patent Application No. 547550/2014 filed on 06/13/2014 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 6463130 on 01/01/2019 (HHS Ref. No. E-276-2011-0-JP-06);
    10. Japanese Patent Application No. 102107/2017 filed on 05/23/2017 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 6726640 on 07/01/2020 (HHS Ref. No. E-276-2011-0-JP-09);
    11. U.S. Provisional Patent Application No. 62/671,964 filed on 05/
15/2018 which is entitled ``Formulations and Methods for the Prevention 
and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-
114-2018-0-US-01);
    12. International Patent Application No. PCT/US2019/32461 filed on 
05/15/2019 which is entitled ``Formulations and Methods for the 
Prevention and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS 
Ref. No. E-114-2018-0-PCT-02);
    13. Canadian Patent Application No. 3100211 filed on 11/12/2020 
which is entitled ``Formulations and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-114-
2018-0-CA-03);
    14. Australian Patent Application No. 2019271208 filed on 11/13/
2020 which is entitled ``Formulations and Methods for the Prevention 
and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-
114-2018-0-AU-04);
    15. Japanese Patent Application No. 2020-564095 filed on 11/13/2020 
which is entitled ``Formulations and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-114-
2018-0-JP-06);
    16. U.S. Patent Application No. 17/055,256 filed on 11/13/2020 
which is entitled ``Formulations and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-114-
2018-0-US-07); and
    17. European Patent Application No. 19728226.2 filed on 12/09/2020 
which is entitled ``Formulations and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-114-
2018-0-EP-05).
    The patent rights in these inventions have been either assigned 
and/or exclusively licensed to the government of the United States of 
America, University of Kansas and Northwestern University.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the following:
    ``Development, manufacture, use and commercialization of 
Metarrestin and its analogs disclosed and claimed in the prospective 
licensed patent rights, for the treatment of perinucleolar compartment 
(PNC) positive cancers or metastatic cancers.''
    E-276-2011 and E-104-2018 patent families are primarily directed to 
novel compositions, methods and formulations, which are selective 
against metastasis across different preclinical cancer histologies and 
without appreciable toxicity. Among others, the subject patent families 
disclose or claim the use of the small molecule metarrestin for the 
treatment of several types of metastatic cancers by disrupting a 
subcellular structure called the perinucleolar compartment (PNC) which 
is frequently found in metastatic tumors and cancer stem cells.
    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 National 
Center for Advancing Translational Sciences 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 from these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.


[[Page 18326]]


    Dated: March 21, 2023.
Joni L. Rutter,
Director, Office of the Director, National Center for Advancing 
Translational Sciences.
[FR Doc. 2023-06318 Filed 3-27-23; 8:45 am]
BILLING CODE 4140-01-P

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