Prospective Grant of an Exclusive Patent License: Manufacture, Distribution, Sale and Use of T-Cell-Based Immunotherapies for Solid Tumors, 54629-54630 [2023-17256]

Download as PDF Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices Place: Porter Neuroscience Research Center, Building 35A, Room 620/630, 35 Convent Drive, Bethesda, MD 20892. Open: September 15, 2023, 10:00 a.m. to 11:50 a.m. Agenda: Staff reports on divisional, programmatical, and special activities. Place: Porter Neuroscience Research Center, Building 35A, Room 620/630, 35 Convent Drive, Bethesda, MD 20892. Contact Person: Rebecca Wagenaar-Miller, Ph.D., Director, Division of Extramural Activities, NIDCD/NIH, 6001 Executive Boulevard, Bethesda, MD 20892, (301) 496– 8693, rebecca.wagenaar-miller@nih.gov. Any interested person may file written comments with the committee by forwarding the 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. In the interest of security, NIH has procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus federal facility will be asked to show one form of identification (for example, a governmentissued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: https:// www.nidcd.nih.gov/about/advisory-council, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) Dated: August 8, 2023. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–17252 Filed 8–10–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 National Institute of Nursing Research; Notice of Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Nursing Research. This will be a hybrid meeting held inperson and virtually and will be open to the public as indicated below. Individuals who plan to attend inperson or view the virtual meeting and need special assistance or other reasonable accommodations, should VerDate Sep<11>2014 16:59 Aug 10, 2023 Jkt 259001 notify the Contact Person listed below in advance of the meeting. The meeting can be accessed from the NIH Videocast at the following link: https://videocast. nih.gov/watch=51158. 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 Council for Nursing Research. Date: September 12, 2023. Open: 9:00 a.m. to 10:30 a.m. Agenda: Call to Order and Opening Remarks, NINR Director’s Report, NCATS Updates, Priorities, and Opportunities for Collaboration. Place: National Institutes of Health, Building 31, C-Wing, Sixth Floor, Rooms A&B, 31 Center Drive, Bethesda, MD 20892 (Hybrid Meeting). Open: 10:45 a.m. to 12:30 p.m. Agenda: Community Partnerships to Advance Science for Society (ComPASS) Initiative, Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (AIM– AHEAD) Program. Place: National Institutes of Health, Building 31, C-Wing, Sixth Floor, Rooms A&B, 31 Center Drive, Bethesda, MD 20892 (Hybrid Meeting). Open: 1:00 p.m. to 3:00 p.m. Agenda: CSR Initiatives Related to Strengthening Review Panel Diversity, Addressing Bias, and Evaluating Panel Quality, Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative, Concepts, Council Open Discussion, Adjournment. Place: National Institutes of Health, Building 31, C-Wing, Sixth Floor, Rooms A&B, 31 Center Drive, Bethesda, MD 20892 (Hybrid Meeting). Closed: 3:00 p.m. to 3:20 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, C-Wing, Sixth Floor, 31 Center Drive, Bethesda, MD 20892. Contact Person: Elizabeth Tarlov, Ph.D., RN, Director, Division of Extramural Science Programs (DESP), National Institute of Nursing Research, Bethesda, MD 20892, (301) 594–1580, elizabeth.tarlov@nih.gov. Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of an organization may submit a letter of intent, a brief description of the organization represented and a short description of the oral presentation. Only one representative of an organization may be PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 54629 allowed to present oral comments and presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding the 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. In the interest of security, NIH has procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus federal facility will be asked to show one form of identification (for example, a governmentissued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: https:// www.ninr.nih.gov/aboutninr/nacnr, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.361, Nursing Research, National Institutes of Health, HHS) Dated: August 8, 2023. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–17253 Filed 8–10–23; 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: Manufacture, Distribution, Sale and Use of T-CellBased Immunotherapies for Solid Tumors AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Cancer Institute, both institutes of the National Institutes of Health, Department of Health and Human Services, 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 EnZeta Immunotherapies, Inc. of the State of Delaware. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center SUMMARY: E:\FR\FM\11AUN1.SGM 11AUN1 54630 Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices on or before August 28, 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: Richard T. Girards, Jr., Esq., MBA, Senior Technology Transfer Manager, National Institutes of Health, NCI Technology Transfer Center by email (richard.girards@nih.gov) or phone (240–276–6825). SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 Intellectual Property E–010–2021: Enhanced Antigen Reactivity of Immune Cells Expressing a Mutant Non-Signaling CD3 Zeta Chain 1. United States Provisional Patent Application No. 63/113,428, filed 13 November 2020 (HHS Reference No. E– 010–2021–0–US–01); 2. International Patent Application No. PCT/US2021/059109, filed 12 November 2021 (HHS Reference No. E– 010–2021–0–PCT–02); 3. United States Patent Application No. 18/036,112, filed 09 May 2023 (HHS Reference No. E–010–2021–0–US–02); 4. European Patent Application No. 21824143.8, filed 30 March 2023 (HHS Reference No. E–010–2021–0–EP–01); and 5. any and all other U.S. and ex-U.S. patents and patent applications claiming priority to any one of the foregoing, now or in the future. The patent and patent application 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 fields of use may be limited to the following: manufacture, distribution, sale and use of T-cell-based immunotherapies for solid tumors. These technologies disclose, e.g., cells expressing a modified CD3 subunit chain comprising at least one ITAM deletion. The inventive cells and populations thereof can be formulated into a composition, such as a pharmaceutical composition. Such cells and compositions thereof can be utilized to treat a wide variety of conditions, including but not limited to the indications within the scope of the contemplated exclusive license. This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 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 Cancer Institute receives written VerDate Sep<11>2014 16:59 Aug 10, 2023 Jkt 259001 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. 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. Dated: August 8, 2023. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2023–17256 Filed 8–10–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Secretary; Notice of Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Interagency Autism Coordinating Committee. The meeting will be open to the public to attend in person or virtually. In person attendance is limited to space available. Advanced registration is recommended. Virtual viewing will be accessible via NIH Videocast (https:// videocast.nih.gov/). Individuals who plan to attend in person or virtually and need special assistance or other reasonable accommodations should submit a request to the Contact Person listed on this notice at least seven (7) days prior to the meeting. Name of Committee: Interagency Autism Coordinating Committee (IACC). Date: October 11, 2023. Time: 10:00 a.m. to 5:00 p.m. Agenda: To discuss business, updates, and issues related to autism research and services activities. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, First Floor Conference Room, Rockville, MD 20852. Cost: The meeting is free and open to the public. Registration: A registration web link will be posted on the IACC website (www.iacc.hhs.gov) prior to the meeting. Preregistration is recommended. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Deadlines: Public Comment Due Date: Wednesday, September 20, 2023, by 5:00 p.m. ET. Public Comment Guidelines: For public comment instructions, see below. Contact Person: Ms. Rebecca Martin, Office of National Autism Coordination, National Institute of Mental Health, NIH, Phone: 301– 435–0886, Email: IACCPublicInquiries@ mail.nih.gov. Public Comments: The IACC welcomes written and oral public comments from members of the autism community and asks the community to review and adhere to its Public Comment Guidelines. In the 2021– 2023 IACC Strategic Plan, the IACC lists the ‘‘Spirit of Collaboration’’ as one of its core values, stating that, ‘‘We will treat others with respect, listen with open minds to the diverse lived experiences of people on the autism spectrum and their families, consider multiple solutions, and foster discussions where participants can comfortably share different opinions.’’ In keeping with this core value, the IACC and the NIMH Office of National Autism Coordination (ONAC) ask that members of the public who provide public comments or participate in meetings of the IACC also adhere to this core value. A limited number of slots are available for individuals to provide a ∼3-minute summary or excerpt of their written comment to the Committee during the meeting. For those interested in that opportunity, please indicate ‘‘Interested in providing oral comment’’ in your written submission, along with your name, address, email, phone number, and professional/organizational affiliation so that ONAC staff can contact you if a slot is available for you to provide a summary or excerpt of your comment during the meeting. For any given meeting, priority for comment slots will be given to individuals and organizations that have not previously provided comments in the current calendar year. This will help ensure that as many individuals and organizations as possible have an opportunity to share comments. Commenters going over their allotted 3minute slot may be asked to conclude immediately in order to allow other comments and the rest of the meeting to proceed on schedule. Public comment submissions received by 5:00 p.m. ET on Wednesday, September 20, 2023, will be provided to the Committee prior to the meeting for their consideration. Any written comments received after 5:00 p.m. ET, Wednesday, September 20, 2023, may be provided to the Committee either before or after the meeting, depending on the volume of comments received and the time required to process them in accordance with privacy regulations and other applicable Federal policies. The Committee is not able to respond individually to comments. All public comments become part of the public record. Attachments of copyrighted publications are not permitted, but web links or citations for any copyrighted works cited may be provided. For public comment guidelines, see: https://iacc.hhs.gov/ meetings/public-comments/guidelines/. Technical issues: If you experience any technical problems with the webcast, please email IACCPublicInquiries@mail.nih.gov. E:\FR\FM\11AUN1.SGM 11AUN1

Agencies

[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54629-54630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17256]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Manufacture, 
Distribution, Sale and Use of T-Cell-Based Immunotherapies for Solid 
Tumors

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The Eunice Kennedy Shriver National Institute of Child Health 
and Human Development and the National Cancer Institute, both 
institutes of the National Institutes of Health, Department of Health 
and Human Services, 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 EnZeta Immunotherapies, Inc. of the State of Delaware.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center

[[Page 54630]]

on or before August 28, 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: Richard T. Girards, Jr., Esq., MBA, Senior 
Technology Transfer Manager, National Institutes of Health, NCI 
Technology Transfer Center by email ([email protected]) or phone 
(240-276-6825).

SUPPLEMENTARY INFORMATION:

Intellectual Property

E-010-2021: Enhanced Antigen Reactivity of Immune Cells Expressing a 
Mutant Non-Signaling CD3 Zeta Chain

    1. United States Provisional Patent Application No. 63/113,428, 
filed 13 November 2020 (HHS Reference No. E-010-2021-0-US-01);
    2. International Patent Application No. PCT/US2021/059109, filed 12 
November 2021 (HHS Reference No. E-010-2021-0-PCT-02);
    3. United States Patent Application No. 18/036,112, filed 09 May 
2023 (HHS Reference No. E-010-2021-0-US-02);
    4. European Patent Application No. 21824143.8, filed 30 March 2023 
(HHS Reference No. E-010-2021-0-EP-01); and
    5. any and all other U.S. and ex-U.S. patents and patent 
applications claiming priority to any one of the foregoing, now or in 
the future.
    The patent and patent application 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 fields of use may be limited to the following: manufacture, 
distribution, sale and use of T-cell-based immunotherapies for solid 
tumors.
    These technologies disclose, e.g., cells expressing a modified CD3 
subunit chain comprising at least one ITAM deletion. The inventive 
cells and populations thereof can be formulated into a composition, 
such as a pharmaceutical composition. Such cells and compositions 
thereof can be utilized to treat a wide variety of conditions, 
including but not limited to the indications within the scope of the 
contemplated exclusive license.
    This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
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 Cancer 
Institute 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.
    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.

    Dated: August 8, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-17256 Filed 8-10-23; 8:45 am]
BILLING CODE 4140-01-P
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