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 2015_register executive 2018-02-21 article Notices D09002ee1c7f78e88 D09002ee1c7f78f08 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 is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications: 1. U.S. Provisional Patent Application No. 61/237,889, filed August 26, 2009 entitled "Adoptive cell therapy with young T cells" (HHS Ref No. E-273-2009/0-US-01); 2. U.S. Patent No. 8,383,099 issued February 26, 2013 entitled "Adoptive cell therapy with young T cells" (HHS Ref No. E-273-2009/0- US-02); 3. U.S. Patent Application No. 13/742,541 filed January 16, 2013 entitled "Adoptive cell therapy with young T cells" (HHS Ref No. E- 273-2009/0-US-03); 4. U.S. Provisional Patent Application No. 61/466,200 filed March 22, 2011 entitled "Methods of growing tumor infiltrating lymphocytes in gas-permeable containers" (HHS Ref No. E-114-2011/0-US-01); 5. PCT Application No. PCT/US2012/029744 filed March 20, 2012 entitled "Methods of growing tumor infiltrating lymphocytes in gas- permeable containers" (HHS Ref No. E-114-2011/0-US-01); 6. U.S. Patent Application No. 13/424,646 filed May 20, 2012 entitled "Methods of growing tumor infiltrating lymphocytes in gas- permeable containers" (HHS Ref No. E-114-2011/0-US-01); 7. U.S. Provisional Patent Application No. 61/846,161 filed July 15, 2013 entitled "Methods of Preparing Anti-human Papillomavirus Antigen T Cells" (HHS Ref No. E-494-2013/0-US-01); 8. PCT Application No. PCT/US2014/046478 filed July 14, 2014 entitled "Methods of Preparing Anti-human Papillomavirus Antigen T Cells" (HHS Ref No. E-494-2013/0-PCT-02); The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights to develop, manufacture, distribute, sell and use unselected whole autologous tumor infiltrating lymphocyte (TIL) adoptive cell therapy products for the treatment of lung, breast, bladder, and HPV- positive cancers. Specifically excluded from this license are methods of generating or using selected subpopulations of TIL and the use of T cell receptors isolated from TIL. 80 FR 30080 https://www.govinfo.gov/app/details/FR-2015-05-26/2015-12539 2015-12539 fr26my15-92 4140-01-P https://www.govinfo.gov/app/details/FR-2015-05-26/2015-12539 https://www.govinfo.gov/content/pkg/FR-2015-05-26/html/2015-12539.htm https://www.govinfo.gov/content/pkg/FR-2015-05-26/pdf/2015-12539.pdf 2 p. 30080 30081 80 FR 30080 Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Lung, Breast, Bladder, and HPV-Positive Cancers; Federal Register Vol. 80, Issue NOTICE 2015-12539 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 2015-06-25 4140-01-P 2015-12539 Notice.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications: 1. U.S. Provisional Patent Application No. 61/237,889, filed August 26, 2009 entitled "Adoptive cell therapy with young T cells" (HHS Ref No. E-273-2009/0-US-01); 2. U.S. Patent No. 8,383,099 issued February 26, 2013 entitled "Adoptive cell therapy with young T cells" (HHS Ref No. E-273-2009/0- US-02); 3. U.S. Patent Application No. 13/742,541 filed January 16, 2013 entitled "Adoptive cell therapy with young T cells" (HHS Ref No. E- 273-2009/0-US-03); 4. U.S. Provisional Patent Application No. 61/466,200 filed March 22, 2011 entitled "Methods of growing tumor infiltrating lymphocytes in gas-permeable containers" (HHS Ref No. E-114-2011/0-US-01); 5. PCT Application No. PCT/US2012/029744 filed March 20, 2012 entitled "Methods of growing tumor infiltrating lymphocytes in gas- permeable containers" (HHS Ref No. E-114-2011/0-US-01); 6. U.S. Patent Application No. 13/424,646 filed May 20, 2012 entitled "Methods of growing tumor infiltrating lymphocytes in gas- permeable containers" (HHS Ref No. E-114-2011/0-US-01); 7. U.S. Provisional Patent Application No. 61/846,161 filed July 15, 2013 entitled "Methods of Preparing Anti-human Papillomavirus Antigen T Cells" (HHS Ref No. E-494-2013/0-US-01); 8. PCT Application No. PCT/US2014/046478 filed July 14, 2014 entitled "Methods of Preparing Anti-human Papillomavirus Antigen T Cells" (HHS Ref No. E-494-2013/0-PCT-02); The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights to develop, manufacture, distribute, sell and use unselected whole autologous tumor infiltrating lymphocyte (TIL) adoptive cell therapy products for the treatment of lung, breast, bladder, and HPV- positive cancers. Specifically excluded from this license are methods of generating or using selected subpopulations of TIL and the use of T cell receptors isolated from TIL.

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before June 25, 2015 will be considered. Exclusive Licenses: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Lung, Breast, Bladder, and HPV-Positive Cancers , hastingw@mail.nih.gov Vol. 80, no. 100 Office of the Federal Register, National Archives and Records Administration 2015-05-26 continuing daily deposited born digital 203 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-05-26 P0b002ee19884cc59 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr26my15 https://www.govinfo.gov/app/details/FR-2015-05-26 https://www.govinfo.gov/content/pkg/FR-2015-05-26/pdf/FR-2015-05-26.pdf https://www.govinfo.gov/content/pkg/FR-2015-05-26/xml/FR-2015-05-26.xml fdlp 29937 30128 DGPO 2018-02-21 2024-06-02 FR-2015-05-26 machine generated eng FR FR-2015-05-26 80 100