United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-06-08 article Notices D09002ee1c7f618ac D09002ee1c7f6193b United States Department of Health and Human Services originator org United States Government Agency or Subagency United States National Institutes of Health originator org United States Government Agency or Subagency This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: Intellectual Property: U.S. Provisional Patent Application 61/477,020 entitled "Human Monoclonal Antibody Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-PCT-02], Chinese Patent Application 201280029201.3 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-EP-04], and validated in France, Germany and the United Kingdom, United States Patent 9,206,257 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-US-05], United States Patent Application 14/837,903 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-EP-07], United States Patent Application 15/090,873 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130- 2011/0-US-12], Chinese Patent Application 201610290837.3 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-CN-13], European Patent Application 16166924.7 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-EP-14], and all continuing U.S. and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: "The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) The complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers." 81 FR 36933 https://www.govinfo.gov/app/details/FR-2016-06-08/2016-13530 2016-13530 fr08jn16-80 4140-01-P https://www.govinfo.gov/app/details/FR-2016-06-08/2016-13530 https://www.govinfo.gov/content/pkg/FR-2016-06-08/html/2016-13530.htm https://www.govinfo.gov/content/pkg/FR-2016-06-08/pdf/2016-13530.pdf 2 p. 36933 36934 81 FR 36933 Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the Treatment of Human Cancers; Federal Register Vol. 81, Issue NOTICE 2016-13530 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 2016-06-23 4140-01-P 2016-13530 Notice.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: Intellectual Property: U.S. Provisional Patent Application 61/477,020 entitled "Human Monoclonal Antibody Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-PCT-02], Chinese Patent Application 201280029201.3 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-EP-04], and validated in France, Germany and the United Kingdom, United States Patent 9,206,257 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-US-05], United States Patent Application 14/837,903 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-EP-07], United States Patent Application 15/090,873 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130- 2011/0-US-12], Chinese Patent Application 201610290837.3 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-CN-13], European Patent Application 16166924.7 entitled "Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof" [HHS Ref. E-130-2011/0-EP-14], and all continuing U.S. and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: "The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) The complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers."

Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before June 23, 2016 will be considered. Exclusive Licenses; Proposed Approvals: Development of Anti-GPC3 Chimeric Antigen Receptor based on HN3 for the Treatment of Human Cancers , david.lambertson@nih.gov Vol. 81, no. 110 Office of the Federal Register, National Archives and Records Administration 2016-06-08 continuing daily deposited born digital 343 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-06-08 P0b002ee18fcd9c4d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr08jn16 https://www.govinfo.gov/app/details/FR-2016-06-08 https://www.govinfo.gov/content/pkg/FR-2016-06-08/pdf/FR-2016-06-08.pdf https://www.govinfo.gov/content/pkg/FR-2016-06-08/xml/FR-2016-06-08.xml fdlp 36787 37120 DGPO 2016-06-08 2024-06-01 FR-2016-06-08 machine generated eng FR FR-2016-06-08 81 110