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 D09002ee1c7f7ccf9 D09002ee1c7f7cd60 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 part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive evaluation option license agreement to practice the inventions embodied in U.S. Patent Application No. 61/172,099 entitled "Anti-human ROR1 Antibodies" filed April 23, 2009 [HHS Ref. E-097-2009/0-US-01], PCT Application No. PCT/US2010/032208 entitled "Anti-human ROR1 Antibodies" filed April 23, 2010 [HHS Ref. E-097-2009/0-PCT-02], European Patent Application No. 10715077.3 entitled, "Anti-human ROR1 Antibodies" filed October 24, 2011 [HHS Ref. No. E-097-2009/0-EP-03], U.S. Patent Application No. 13/265,582 entitled, "Anti-human ROR1 Antibodies" filed October 21, 2011 [HHS Ref. No. E-097-2009/0-US-04], Australian Patent Application No. 2010238723 entitled, "Anti-human ROR1 Antibodies" filed October 21, 2011 [HHS Ref. No. E-097-2009/0-AU- 04], Canadian Patent Application No. 2,759,733 entitled, "Anti-human ROR1 Antibodies" filed October 21, 2011 [HHS Ref. No. E-097-2009/0-CA- 05], US Provisional Application No. 61/418,550 entitled, "Chimeric rabbit/human ROR1 antibodies" filed December 1, 2010 [HHS Ref. E-039- 2011/0-US-01], PCT Application No. PCT/US2011/062670 entitled, "Chimeric rabbit/human ROR1 antibodies" filed November 30, 2011 [HHS Ref. E-039-2011/0-PCT-02]; Australian Patent Application No. 2011336650 entitled, "Chimeric rabbit/human ROR1 antibodies" filed November 30, 2011 [HHS Ref. E-039-2011/0-AU-03], Canadian Patent Application No. 2818992 entitled, "Chimeric rabbit/human ROR1 antibodies" filed November 30, 2011 [HHS Ref. E-039-2011/0-CA-04], European Patent Application No. 11791733.6 entitled, "Chimeric rabbit/human ROR1 antibodies" filed November 30, 2011 [HHS Ref. E-039-2011/0-EP-05] and U.S. Patent Application No. 13/990,977 entitled, "Chimeric rabbit/ human ROR1 antibodies" filed May 31, 2013 [HHS Ref. E-039-2011/0-US- 06] and all related continuing and foreign patents/patent applications for the technology family to NBE Therapeutics, Ltd. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive evaluation option license territory may be worldwide and the field of use may be limited to pre- clinical evaluation and commercial development of an antibody-drug conjugate comprising an anti-tyrosine protein kinase transmembrane receptor (ROR1) antibody for the treatment of human ROR1 expressing cancers utilizing enzymatic conjugation methods linking a small molecule to a full-length antibody, wherein the full-length antibody moiety comprises the anti-ROR1 antibodies or CDR3s within the scope of the Licensed Patent Rights. For avoidance of doubt, this Agreement explicitly excludes the following: (a) Antibody-drug conjugates utilizing non-enzymatic conjugation linking small molecules to said antibodies, (b) immunotoxins comprising anti-ROR1 antibodies and Pseudomonas exotoxins, and (c) non-full-length bispecific antibodies. Upon expiration or termination of the start-up exclusive evaluation option license, NBE Therapeutics, Ltd. will have the right to execute a start-up exclusive patent commercialization license which will supersede and replace the start-up exclusive evaluation option license with no broader territory than granted in the start-up exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion. 80 FR 15226 https://www.govinfo.gov/app/details/FR-2015-03-23/2015-06486 2015-06486 fr23mr15-68 4140-01-P https://www.govinfo.gov/app/details/FR-2015-03-23/2015-06486 https://www.govinfo.gov/content/pkg/FR-2015-03-23/html/2015-06486.htm https://www.govinfo.gov/content/pkg/FR-2015-03-23/pdf/2015-06486.pdf 2 p. 15226 15227 80 FR 15226 Prospective Grant of Start-up Exclusive Evaluation Option License Agreement: Pre-Clinical Evaluation and Commercial Development of Anti-Tyrosine Kinase-Like Orphan Receptor 1 Antibody-Drug Conjugates for the Treatment of Human Cancers; Federal Register Vol. 80, Issue NOTICE 2015-06486 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 4140-01-P 2015-06486 Notice.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive evaluation option license agreement to practice the inventions embodied in U.S. Patent Application No. 61/172,099 entitled "Anti-human ROR1 Antibodies" filed April 23, 2009 [HHS Ref. E-097-2009/0-US-01], PCT Application No. PCT/US2010/032208 entitled "Anti-human ROR1 Antibodies" filed April 23, 2010 [HHS Ref. E-097-2009/0-PCT-02], European Patent Application No. 10715077.3 entitled, "Anti-human ROR1 Antibodies" filed October 24, 2011 [HHS Ref. No. E-097-2009/0-EP-03], U.S. Patent Application No. 13/265,582 entitled, "Anti-human ROR1 Antibodies" filed October 21, 2011 [HHS Ref. No. E-097-2009/0-US-04], Australian Patent Application No. 2010238723 entitled, "Anti-human ROR1 Antibodies" filed October 21, 2011 [HHS Ref. No. E-097-2009/0-AU- 04], Canadian Patent Application No. 2,759,733 entitled, "Anti-human ROR1 Antibodies" filed October 21, 2011 [HHS Ref. No. E-097-2009/0-CA- 05], US Provisional Application No. 61/418,550 entitled, "Chimeric rabbit/human ROR1 antibodies" filed December 1, 2010 [HHS Ref. E-039- 2011/0-US-01], PCT Application No. PCT/US2011/062670 entitled, "Chimeric rabbit/human ROR1 antibodies" filed November 30, 2011 [HHS Ref. E-039-2011/0-PCT-02]; Australian Patent Application No. 2011336650 entitled, "Chimeric rabbit/human ROR1 antibodies" filed November 30, 2011 [HHS Ref. E-039-2011/0-AU-03], Canadian Patent Application No. 2818992 entitled, "Chimeric rabbit/human ROR1 antibodies" filed November 30, 2011 [HHS Ref. E-039-2011/0-CA-04], European Patent Application No. 11791733.6 entitled, "Chimeric rabbit/human ROR1 antibodies" filed November 30, 2011 [HHS Ref. E-039-2011/0-EP-05] and U.S. Patent Application No. 13/990,977 entitled, "Chimeric rabbit/ human ROR1 antibodies" filed May 31, 2013 [HHS Ref. E-039-2011/0-US- 06] and all related continuing and foreign patents/patent applications for the technology family to NBE Therapeutics, Ltd. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive evaluation option license territory may be worldwide and the field of use may be limited to pre- clinical evaluation and commercial development of an antibody-drug conjugate comprising an anti-tyrosine protein kinase transmembrane receptor (ROR1) antibody for the treatment of human ROR1 expressing cancers utilizing enzymatic conjugation methods linking a small molecule to a full-length antibody, wherein the full-length antibody moiety comprises the anti-ROR1 antibodies or CDR3s within the scope of the Licensed Patent Rights. For avoidance of doubt, this Agreement explicitly excludes the following: (a) Antibody-drug conjugates utilizing non-enzymatic conjugation linking small molecules to said antibodies, (b) immunotoxins comprising anti-ROR1 antibodies and Pseudomonas exotoxins, and (c) non-full-length bispecific antibodies. Upon expiration or termination of the start-up exclusive evaluation option license, NBE Therapeutics, Ltd. will have the right to execute a start-up exclusive patent commercialization license which will supersede and replace the start-up exclusive evaluation option license with no broader territory than granted in the start-up exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.

Exclusive Licenses: Pre-Clinical Evaluation and Commercial Development of Anti-Tyrosine Kinase-Like Orphan Receptor 1 Antibody-Drug Conjugates for the Treatment of Human Cancers , wongje@od.nih.gov Vol. 80, no. 55 Office of the Federal Register, National Archives and Records Administration 2015-03-23 continuing daily deposited born digital 366 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-03-23 P0b002ee198849fac 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23mr15 https://www.govinfo.gov/app/details/FR-2015-03-23 https://www.govinfo.gov/content/pkg/FR-2015-03-23/pdf/FR-2015-03-23.pdf https://www.govinfo.gov/content/pkg/FR-2015-03-23/xml/FR-2015-03-23.xml fdlp 15147 15474 DGPO 2018-02-21 2024-06-02 FR-2015-03-23 machine generated eng FR FR-2015-03-23 80 55