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 2013_register executive 2013-04-26 article Notices D09002ee1c7fb91db D09002ee1c7fb9259 United States Department of Health and Human Services originator org United States Government Agency or Subagency This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/026,816, entitled "O\2\-Aryl Substituted Diazeniumdiolates", filed September 27, 1996, now abandoned (HHS Ref. No. E-093-1996/0-US-01); U.S. Provisional Patent Application No. 60/045,917, entitled "O\2\-Aryl Substituted Diazeniumdiolates and Use Thereof", filed May 7, 1997, now abandoned (HHS Ref. No. E-093-1996/1-US-01); U.S. Provisional Patent Application No. 60/051,696, entitled "O\2\-Glycosylated 1-Substituted Diazen-l- IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1- YL] Diazen-1-IUM-l,2-Diolates", filed July 3, 1997, now abandoned (HHS Ref. No. E-093-1996/2-US-01); PCT Patent Application No. PCT/US1997/ 017267, entitled "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates", filed September 26, 1997, now abandoned (HHS Ref. No. E-093-1996/3-PCT-01); European Patent No. 0929538, entitled "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates", issued on November 24, 2004 [HHS Ref. No. E-093-1996/3-EP-02], which is validated in Great Britain [E-093-1996/3-GB-09], Germany [E-093-1996/3-DE-10], France [E- 093-1996/3-FR-11], Ireland [E-093-1996/3-IE-12], Italy [E-093-1996/3- IT-13], Switzerland [E-093-1996/3-CH-14] and Belgium [E-093-1996/3-BE- 15]; Australian Patent No. 733590, entitled "O\2\-Arylated or O\2\- Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\- Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates", issued on August 30, 2001 [HHS Ref. No. E-093-1996/3-AU- 03]; Canadian Patent No. 2266908, "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2- Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates," issued on July 20, 2010 [HHS Ref. No. E-093-1996/3-CA-04]; Japanese Patent No. 4285775, "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l- IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1- YL] Diazen-1-IUM-l,2-Diolates," issued on April 3, 1999 [HHS Ref. No. E-093-1996/3-JP-05]; U.S. Patent No. 6,610,660, entitled "O\2\- Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM- l,2-Diolates," issued on August 26, 2003 [HHS Ref. No. E-093-1996/3- US-06]; U.S. Patent No. 6,911,433, entitled "O\2\-Glycosylated 1- Substituted Diazen-l-IUM-1,2-Diolates," issued on June 28, 2005 [HHS Ref. No. E-093-1996/3-US-07]; European Patent Application No. 04009529.1, entitled "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates," filed on April 22, 2004 [E-093-1996/3-EP-08]; U.S. Patent No. 7,081,524, entitled "O\2\- Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates," issued on July 25, 2006 [HHS Ref. No. E-093-1996/3-US-16]; Japanese Patent No. 5015903, entitled "O\2\-Substituted 1-[(2- Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates and Compositions Thereof," issued on June 15, 2012 [HHS Ref. No. E-093-1996/3-JP-17]; Canadian Patent Application No. 2,705,474, entitled "O\2\-Glycosylated 1-Substituted Diazen-1-IUM-l,2-Diolates," filed on May 28, 2010 [E- 093-1996/3-CA-18]; and European Patent Application No. 10010885.1, entitled "O\2\-Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen- 1-IUM-l,2-Diolates," filed on September 24, 2012 [E-093-1996/3-EP-19], developed by Dr. Larry K. Keefer, Dr. Joseph E. Saavedra, et al. The prospective exclusive license territory may be "worldwide", and the field of use may be limited to: "use of O\2\-Arylated, O\2\- Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates, and O\2\- Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates for cancer treatment and prevention in humans." to JSK Therapeutics, Inc. ("JSKT"), a company incorporated under the laws of the State of Delaware having an office in at least Salt Lake City, Utah, U.S.A. The patent rights in these inventions have been assigned to the United States of America. 78 FR 24760 https://www.govinfo.gov/app/details/FR-2013-04-26/2013-09900 2013-09900 fr26ap13-68 4140-01-P https://www.govinfo.gov/app/details/FR-2013-04-26/2013-09900 https://www.govinfo.gov/content/pkg/FR-2013-04-26/html/2013-09900.htm https://www.govinfo.gov/content/pkg/FR-2013-04-26/pdf/2013-09900.pdf 2 p. 24760 24761 78 FR 24760 National Institutes of Health; Federal Register Vol. 78, Issue NOTICE 2013-09900 DEPARTMENT OF HEALTH AND HUMAN SERVICES 2013-05-13 4140-01-P 2013-09900 Notice.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/026,816, entitled "O\2\-Aryl Substituted Diazeniumdiolates", filed September 27, 1996, now abandoned (HHS Ref. No. E-093-1996/0-US-01); U.S. Provisional Patent Application No. 60/045,917, entitled "O\2\-Aryl Substituted Diazeniumdiolates and Use Thereof", filed May 7, 1997, now abandoned (HHS Ref. No. E-093-1996/1-US-01); U.S. Provisional Patent Application No. 60/051,696, entitled "O\2\-Glycosylated 1-Substituted Diazen-l- IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1- YL] Diazen-1-IUM-l,2-Diolates", filed July 3, 1997, now abandoned (HHS Ref. No. E-093-1996/2-US-01); PCT Patent Application No. PCT/US1997/ 017267, entitled "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates", filed September 26, 1997, now abandoned (HHS Ref. No. E-093-1996/3-PCT-01); European Patent No. 0929538, entitled "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates", issued on November 24, 2004 [HHS Ref. No. E-093-1996/3-EP-02], which is validated in Great Britain [E-093-1996/3-GB-09], Germany [E-093-1996/3-DE-10], France [E- 093-1996/3-FR-11], Ireland [E-093-1996/3-IE-12], Italy [E-093-1996/3- IT-13], Switzerland [E-093-1996/3-CH-14] and Belgium [E-093-1996/3-BE- 15]; Australian Patent No. 733590, entitled "O\2\-Arylated or O\2\- Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\- Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates", issued on August 30, 2001 [HHS Ref. No. E-093-1996/3-AU- 03]; Canadian Patent No. 2266908, "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2- Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates," issued on July 20, 2010 [HHS Ref. No. E-093-1996/3-CA-04]; Japanese Patent No. 4285775, "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l- IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1- YL] Diazen-1-IUM-l,2-Diolates," issued on April 3, 1999 [HHS Ref. No. E-093-1996/3-JP-05]; U.S. Patent No. 6,610,660, entitled "O\2\- Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM- l,2-Diolates," issued on August 26, 2003 [HHS Ref. No. E-093-1996/3- US-06]; U.S. Patent No. 6,911,433, entitled "O\2\-Glycosylated 1- Substituted Diazen-l-IUM-1,2-Diolates," issued on June 28, 2005 [HHS Ref. No. E-093-1996/3-US-07]; European Patent Application No. 04009529.1, entitled "O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates," filed on April 22, 2004 [E-093-1996/3-EP-08]; U.S. Patent No. 7,081,524, entitled "O\2\- Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates," issued on July 25, 2006 [HHS Ref. No. E-093-1996/3-US-16]; Japanese Patent No. 5015903, entitled "O\2\-Substituted 1-[(2- Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates and Compositions Thereof," issued on June 15, 2012 [HHS Ref. No. E-093-1996/3-JP-17]; Canadian Patent Application No. 2,705,474, entitled "O\2\-Glycosylated 1-Substituted Diazen-1-IUM-l,2-Diolates," filed on May 28, 2010 [E- 093-1996/3-CA-18]; and European Patent Application No. 10010885.1, entitled "O\2\-Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen- 1-IUM-l,2-Diolates," filed on September 24, 2012 [E-093-1996/3-EP-19], developed by Dr. Larry K. Keefer, Dr. Joseph E. Saavedra, et al. The prospective exclusive license territory may be "worldwide", and the field of use may be limited to: "use of O\2\-Arylated, O\2\- Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates, and O\2\- Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates for cancer treatment and prevention in humans." to JSK Therapeutics, Inc. ("JSKT"), a company incorporated under the laws of the State of Delaware having an office in at least Salt Lake City, Utah, U.S.A. The patent rights in these inventions have been assigned to the United States of America.

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before May 13, 2013 will be considered. Grants of Start-Up Exclusive Licenses: Development of Diazeniumdiolate Derivatives for Cancer Treatment and Prevention in Humans , sydnorc@mail.nih.gov Vol. 78, no. 81 Office of the Federal Register, National Archives and Records Administration 2013-04-26 continuing daily deposited born digital 325 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-04-26 P0b002ee1848c4116 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr26ap13 https://www.govinfo.gov/app/details/FR-2013-04-26 https://www.govinfo.gov/content/pkg/FR-2013-04-26/pdf/FR-2013-04-26.pdf https://www.govinfo.gov/content/pkg/FR-2013-04-26/xml/FR-2013-04-26.xml fdlp 24665 24978 DGPO 2013-04-26 2024-06-03 FR-2013-04-26 machine generated eng FR FR-2013-04-26 78 81