Prospective Grant of Exclusive License: Development of Anti-Angiogenesis Cancer Therapeutics Targeting Adrenomedullin or Proadrenomedullin N-Terminal 20 Peptide (PAMP), 44862-44864 [E9-20881]

Download as PDF 44862 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices license or passport. All visitors should be prepared to have their personal belongings inspected and to go through metal detection inspection. When driving to NIH, plan some extra time to get through the security checkpoints at the visitor entrances to campus. Be aware that visitor parking lots on the NIH campus can fill up quickly. The NIH campus is also accessible via the metro Red Line, Medical Center Station. The Natcher Conference Center is a 5-minute walk from the Medical Center Metro Station. Additional NIH campus visitor information is available at: https:// www.nih.gov/about/visitor/index.htm. Information about the IACC and a registration link for this meeting are available on the Web site: https:// www.iacc.hhs.gov. Dated: August 24, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–20872 Filed 8–28–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration cprice-sewell on DSK2BSOYB1PROD with NOTICES Request for Nominations to the SAMHSA National Advisory Council The Substance Abuse and Mental Health Services Administration (SAMHSA) is accepting nominations through October 7, 2009, to fill vacancies for its five advisory committees (the SAMHSA National Advisory Council, the Center for Substance abuse Prevention, Center for Substance Abuse Treatment and Center for Mental Health Services National Advisory Councils and the Advisory Committee for Women’s Services). Under section 502 of the Public Health Service Act, the National Advisory Councils (NAC) provide advice to the Secretary of the U.S. Department of Health and Human Services (HHS), SAMHSA Administrator, and/or Center Directors on a broad range of polices and services related to substance use and mental health. Legislation requires that each NAC be composed of 12 members: nine members must be leading representatives of the health disciplines (including public health, behavioral health, and social sciences) relevant to the mission of SAMHSA and its Centers and three members must be from the general public and include leaders in the fields of public policy, public VerDate Nov<24>2008 14:57 Aug 28, 2009 Jkt 217001 relations, law, health policy, economics, or management. Under section 501 of the Public Health Service Act, the Advisory Committee for Women’s Services (ACWS) is statutorily mandated to advise the SAMHSA Administrator and the Associate Administrator for Women’s Services on appropriate activities to be undertaken by SAMHSA and its Centers with respect to women’s substance abuse and mental health services. The SAMHSA Administrator will appoint the 10 members of this Committee. The members must be from among physicians, practitioners, treatment providers, and other health professionals, whose clinical practice, specialization, or professional expertise includes a significant focus on women’s substance abuse and mental health conditions. The current lists of members for the advisory committees are available on the SAMHSA Web site at https:// nac.samhsa.gov/index.aspx. Members are appointed for a term of up to four years. Individuals are nominated, selected, and appointed to a NAC or the ACWS to contribute to the advisory committee’s objectives based on their qualifications. The Federal Advisory Committee Act (FACA) and HHS policy require that committee membership be fairly balanced in terms of points of view represented and the committee’s functions to be performed. Consideration is given to a broad representation of geographic areas, gender, race/ethnicity, and disability. The advisory committees will meet not less than two times per year and on an as needed basis. Any interested person or organization may nominate qualified individuals for membership. Self-nominations are also welcome. Nominations must include a resume and short biography describing the educational and professional qualifications of the nominee and the nominee’s current occupation, position, address and daytime telephone number. Individuals may be recommended for membership on more than one advisory committee, but will be appointed to only one advisory body. Nominations can be sent by U.S. Mail or electronically to Ms. Toian Vaughn, Designated Federal Official, at the address below. Contact: Toian Vaughn, M.S.W., Designated Federal Official, SAMHSA National Advisory Council and SAMHSA Committee Management Officer, 1 Choke Cherry Road, Room 8– 1089, Rockville, Maryland 20857. Telephone: (240) 276–2307; Fax: (240) PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 276–2220 and E-mail: toian.vaughn@samhsa.hhs.gov. Toian Vaughn, Committee Management Officer, Substance Abuse and Mental Health Services Administration. [FR Doc. E9–20884 Filed 8–28–09; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Development of AntiAngiogenesis Cancer Therapeutics Targeting Adrenomedullin or Proadrenomedullin N-Terminal 20 Peptide (PAMP) AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: 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 (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/002,514, filed on August 18, 1995, entitled ‘‘Functional Role of Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/0–US–01); U.S. Patent Application No. 60/002,936, filed on August 30, 1995, entitled ‘‘Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E– 206–1995/1–US–01); U.S. Patent Application No. 60/013,172, filed on March 12, 1996, entitled ‘‘Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/2–US– 01); PCT Application No. PCT/US96/ 13286, filed on August 16, 1996, entitled ‘‘Functional Role of Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/3–PCT–01); Australian Patent No. 710662, issued on October 5, 2000, entitled ‘‘Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/3–AU– 02); Canadian Patent Application No. 2229741, filed on August 16, 1996, entitled ‘‘Functional Role of E:\FR\FM\31AUN1.SGM 31AUN1 cprice-sewell on DSK2BSOYB1PROD with NOTICES Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/3–CA–03); U.S. Patent No. 6,320,022, issued on November 20, 2001, entitled ‘‘Adrenomedullin Peptides’’ (HHS Reference No. E–206–1995/3–US–04); European Patent No. 0845036, issued on June 2, 1999, entitled ‘‘Functional Role of Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/3–EP–07), and validated in France, Germany, and the United Kingdom; Japanese Patent Application No. 509499/97, filed on August 16, 1996, entitled ‘‘Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/3–JP– 09); U.S. Patent No. 7,101,548, issued on September 5, 2006, entitled ‘‘Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/3–US– 10); U.S. Patent Application No. 11/ 517,599, filed on September 5, 2006, entitled ‘‘Functional Role of Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/3–US–11); Japanese Patent No. 4077861, issued on February 8, 2008, entitled ‘‘Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology’’ (HHS Reference No. E–206–1995/3–JP– 12); U.S. Patent Application No. 60/ 153,397, filed on September 10, 1999, entitled ‘‘Determination of AM–Binding Proteins and the Association of Adrenomedullin (AM) Therewith’’ (HHS Reference No. E–256–1999/0–US– 01); PCT Application No. PCT/US00/ 24722, filed on September 8, 2000, entitled ‘‘Determination of AM–Binding Proteins and the Association of Adrenomedullin (AM) Therewith’’ (HHS Reference No. E–256–1999/0– PCT–02); Australian Patent No. 774725, issued on May 25, 2004, entitled ‘‘Determination of AM–Binding Proteins and the Association of Adrenomedullin (AM) Therewith’’ (HHS Reference No. E–256–1999/0–AU–03); Canadian Patent Application No. 2383419, filed on September 8, 2000, entitled ‘‘Determination of AM–Binding Proteins and the Association of Adrenomedullin (AM) Therewith’’ (HHS Reference No. E–256–1999/0–CA–04); European Patent No. 1214600, issued on December 21, 2005, entitled ‘‘Determination of AM– Binding Proteins and the Association of VerDate Nov<24>2008 14:57 Aug 28, 2009 Jkt 217001 Adrenomedullin (AM) Therewith’’ (HHS Reference No. E–256–1999/0–EP– 05), and validated in France, Germany, the United Kingdom, Italy, Spain, and Portugal; U.S. Patent Application No. 10/070,853, filed on March 8, 2002, entitled ‘‘Determination of AM–Binding Proteins and the Association of Adrenomedullin (AM) Therewith’’ (HHS Reference No. E–256–1999/0–US– 06); U.S. Patent Application No. 11/ 530,411, filed on September 8, 2006, entitled ‘‘Determination of AM–Binding Proteins and the Association of Adrenomedullin (AM) Therewith’’ (HHS Reference No. E–256–1999/0–US– 13); U.S. Patent Application No. 12/ 236,418, filed on September 23, 2008, entitled ‘‘Determination of AM–Binding Proteins and the Association of Adrenomedullin (AM) Therewith’’ (HHS Reference No. E–256–1999/0–US– 14); U.S. Patent Application No. 60/ 425,018, filed on November 7, 2002, entitled ‘‘A New Target for Angiogenesis and Anti-Angiogenesis Therapy’’ (HHS Reference No. E–294–2002/0–US–01); PCT Application No. PCT/US03/35633, filed on November 7, 2003, entitled ‘‘A New Target for Angiogenesis and AntiAngiogenesis Therapy’’ (HHS Reference No. E–294–2002/0–PCT–02); U.S. Patent No. 7,462,593, issued on December 9, 2008, entitled ‘‘Compositions and Methods for Promoting Angiogenesis’’ (HHS Reference No. E–294–2002/0–US– 03); European Patent Application No. 03786608.4, filed on November 7, 2003, entitled ‘‘A New Target for Angiogenesis and Anti-Angiogenesis Therapy’’ (HHS Reference No. E–294–2002/0–EP–04); Australian Patent Application No. 2003295422, filed on April 18, 2005, entitled ‘‘A New Target for Angiogenesis and Anti-Angiogenesis Therapy’’ (HHS Reference No. E–294–2002/0–AU–05); Canadian Patent Application No. 2504953, filed on November 7, 2003, entitled ‘‘A New Target for Angiogenesis and Anti-Angiogenesis Therapy’’ (HHS Reference No. E–294–2002/0–CA–06); Japanese Patent Application No. 2004– 551922, filed on May 9, 2005, entitled ‘‘A New Target for Angiogenesis and Anti-Angiogenesis Therapy’’ (HHS Reference No. E–294–2002/0–JP–07); U.S. Patent Application No. 12/240,656, filed on September 29, 2008, entitled ‘‘Target for Anti-Angiogenesis Therapy’’ (HHS Reference No. E–294–2002/0–US– 08); U.S. Patent Application No. 60/ 500,650, filed on September 8, 2003, entitled ‘‘Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide’’ (HHS Reference No. E–246–2003/0–US–01); PCT Application No. PCT/US04/29293, filed on September 8, 2004, entitled PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 44863 ‘‘Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide’’ (HHS Reference No. E–246–2003/1–PCT–01); European Patent Application No. 04783513.7, filed on September 8, 2004, entitled ‘‘Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide’’ (HHS Reference No. E–246–2003/1–EP–03); Canadian Patent Application No. 2539467, filed on September 8, 2004, entitled ‘‘NonPeptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide’’ (HHS Reference No. E–246–2003/1–CA–04); Australian Patent Application No. 2004273057, filed on September 8, 2004, entitled ‘‘Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide’’ (HHS Reference No. E–246–2003/1–AU–05); and U.S. Patent Application No. 10/571,012, filed on March 8, 2006, entitled ‘‘Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide’’ (HHS Reference No. E–246–2003/1–US–06) to Arana Therapeutics (VIC) Pty. Ltd., having a place of business at Level 5, Building 4, 399 Royal Parade, Parkville, Victoria 3052, Australia, a wholly-owned subsidiary of Arana Therapeutics Limited, having a place of business at Level 2, 37 Epping Road, Macquarie Park, NSW 2113, Australia, a whollyowned subsidiary of Cephalon, Inc., having a place of business at 41 Moores Road, Frazer, PA 19355, USA. The patent rights in this invention have been assigned to the United States of America. The contemplated exclusive license territory may be worldwide, and the field of use may be limited to ‘‘use of peptide and affinity binding reagents (including but not limited to antibodies) that neutralize the action of PAMP or adrenomedullin to treat cancer’’. DATES: Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before October 30, 2009 will be considered. ADDRESSES: Requests for copies of the patents, inquiries, comments, and other materials relating to the contemplated license should be directed to: Tara L. Kirby, Ph.D., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: 301–435–4426; Facsimile: 301–402– 0220; E-mail: tarak@mail.nih.gov. SUPPLEMENTARY INFORMATION: These technologies relate to adrenomedullin and proadrenomedullin N-terminal 20 E:\FR\FM\31AUN1.SGM 31AUN1 44864 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices cprice-sewell on DSK2BSOYB1PROD with NOTICES peptide (PAMP), two potent angiogenic factors that are products of the same gene. Therapies that reduce (antagonize) the action of these factors have the potential to treat conditions where angiogenesis plays a pathological role, such as cancer and macular degeneration. Conversely, increasing (agonizing) the action of these factors may be useful for conditions where enhanced angiogenesis is desired, such as wound healing and cardiovascular disease. Adrenomedullin and PAMP have also been shown to play a role in other diseases, such as neurodegenerative disorders, diabetes, and allergic and inflammatory disease. More specifically, these technologies include peptides, antibodies and small molecules that agonize or antagonize the activity of adrenomedullin and PAMP. They also include methods for inhibiting or inducing angiogenesis, methods for inhibiting tumor growth, methods for treating cancer, and methods of treating a number of other conditions, such as wounds, neurological disease, allergic or inflammatory disease, diabetes, and cardiovascular disease. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, the NIH 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 404.7. Applications for a license in the prospective field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: August 24, 2009. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E9–20881 Filed 8–28–09; 8:45 am] BILLING CODE 4140–01–P VerDate Nov<24>2008 14:57 Aug 28, 2009 Jkt 217001 DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2009–0396] Collection of Information Under Review by Office of Management and Budget: OMB Control Number: 1625– 0008. Coast Guard, DHS. Thirty-day notice requesting comments. AGENCY: ACTION: SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this request for comments announces that the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) requesting an extension of its approval for the following collection of information: 1625–0008, Regattas and Marine Parades. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties. DATES: Please submit comments on or before September 30, 2009. ADDRESSES: You may submit comments identified by Coast Guard docket number [USCG–2009–0396] to the Docket Management Facility (DMF) at the U.S. Department of Transportation (DOT) or to OIRA. To avoid duplication, please submit your comments by only one of the following means: (1) Electronic submission: (a) To Coast Guard docket at https:// www.regulation.gov. (b) To OIRA by email via: oira_submission@omb.eop.gov. (2) Mail or Hand delivery: (a) DMF (M–30), DOT, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590– 0001. Hand deliver between the hours of 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202–366–9329. (b) To OIRA, 725 17th Street, NW., Washington, DC 20503, attention Desk Officer for the Coast Guard. (3) Fax: (a) To DMF, 202–493–2251. (b) To OIRA at 202–395–6566. To ensure your comments are received in time, mark the fax, attention Desk Officer for the Coast Guard. The DMF maintains the public docket for this Notice. Comments and material received from the public, as well as documents mentioned in this Notice as being available in the docket, will PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 become part of the docket and will be available for inspection or copying at room W12–140 on the West Building Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find the docket on the Internet at https://www.regulations.gov. A copy of the ICR is available through the docket on the Internet at https:// www.regulations.gov. Additionally, copies are available from: Commandant (CG–611), ATTN Paperwork Reduction Act Manager, U.S. Coast Guard, 2100 2nd St., SW., Stop 7101, Washington, DC 20593–7101. FOR FURTHER INFORMATION CONTACT: Mr. Arthur Requina, Office of Information Management, telephone 202–475–3523 or fax 202–475–3929, for questions on these documents. Contact Ms. Renee V. Wright, Program Manager, Docket Operations, 202–366–9826, for questions on the docket. SUPPLEMENTARY INFORMATION: The Coast Guard invites comments on whether this ICR should be granted based on it being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the collections; (2) the accuracy of the estimated burden of the collections; (3) ways to enhance the quality, utility, and clarity of information subject to the collections; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG 2009–0396]. For your comments to OIRA to be considered, it is best if they are received on or before the September 30, 2009. Public participation and request for comments: We encourage you to respond to this request by submitting comments and related materials. We will post all comments received, without change, to https:// www.regulations.gov. They will include any personal information you provide. We have an agreement with DOT to use their DMF. Please see the ‘‘Privacy Act’’ paragraph below. Submitting comments: If you submit a comment, please include the docket number [USCG–2009–0396], indicate the specific section of the document to which each comment applies, providing a reason for each comment. We recommend you include your name, E:\FR\FM\31AUN1.SGM 31AUN1

Agencies

[Federal Register Volume 74, Number 167 (Monday, August 31, 2009)]
[Notices]
[Pages 44862-44864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of Anti-
Angiogenesis Cancer Therapeutics Targeting Adrenomedullin or 
Proadrenomedullin N-Terminal 20 Peptide (PAMP)

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

SUMMARY: 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 (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive patent license to practice the inventions embodied in U.S. 
Patent Application No. 60/002,514, filed on August 18, 1995, entitled 
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product 
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/0-US-01); U.S. Patent Application No. 60/002,936, filed on August 
30, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the 
Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS 
Reference No. E-206-1995/1-US-01); U.S. Patent Application No. 60/
013,172, filed on March 12, 1996, entitled ``Functional Role of 
Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human 
Pathology and Physiology'' (HHS Reference No. E-206-1995/2-US-01); PCT 
Application No. PCT/US96/13286, filed on August 16, 1996, entitled 
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product 
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/3-PCT-01); Australian Patent No. 710662, issued on October 5, 
2000, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-
Related Product (PAMP) in Human Pathology and Physiology'' (HHS 
Reference No. E-206-1995/3-AU-02); Canadian Patent Application No. 
2229741, filed on August 16, 1996, entitled ``Functional Role of

[[Page 44863]]

Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human 
Pathology and Physiology'' (HHS Reference No. E-206-1995/3-CA-03); U.S. 
Patent No. 6,320,022, issued on November 20, 2001, entitled 
``Adrenomedullin Peptides'' (HHS Reference No. E-206-1995/3-US-04); 
European Patent No. 0845036, issued on June 2, 1999, entitled 
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product 
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/3-EP-07), and validated in France, Germany, and the United 
Kingdom; Japanese Patent Application No. 509499/97, filed on August 16, 
1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-
Related Product (PAMP) in Human Pathology and Physiology'' (HHS 
Reference No. E-206-1995/3-JP-09); U.S. Patent No. 7,101,548, issued on 
September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM) 
and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' 
(HHS Reference No. E-206-1995/3-US-10); U.S. Patent Application No. 11/
517,599, filed on September 5, 2006, entitled ``Functional Role of 
Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human 
Pathology and Physiology'' (HHS Reference No. E-206-1995/3-US-11); 
Japanese Patent No. 4077861, issued on February 8, 2008, entitled 
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product 
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/3-JP-12); U.S. Patent Application No. 60/153,397, filed on 
September 10, 1999, entitled ``Determination of AM-Binding Proteins and 
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. 
E-256-1999/0-US-01); PCT Application No. PCT/US00/24722, filed on 
September 8, 2000, entitled ``Determination of AM-Binding Proteins and 
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. 
E-256-1999/0-PCT-02); Australian Patent No. 774725, issued on May 25, 
2004, entitled ``Determination of AM-Binding Proteins and the 
Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-
256-1999/0-AU-03); Canadian Patent Application No. 2383419, filed on 
September 8, 2000, entitled ``Determination of AM-Binding Proteins and 
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. 
E-256-1999/0-CA-04); European Patent No. 1214600, issued on December 
21, 2005, entitled ``Determination of AM-Binding Proteins and the 
Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-
256-1999/0-EP-05), and validated in France, Germany, the United 
Kingdom, Italy, Spain, and Portugal; U.S. Patent Application No. 10/
070,853, filed on March 8, 2002, entitled ``Determination of AM-Binding 
Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS 
Reference No. E-256091999/0-US-06); U.S. Patent Application No. 11/
530,411, filed on September 8, 2006, entitled ``Determination of AM-
Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' 
(HHS Reference No. E-256-1999/0-US-13); U.S. Patent Application No. 12/
236,418, filed on September 23, 2008, entitled ``Determination of AM-
Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' 
(HHS Reference No. E-256-1999/0-US-14); U.S. Patent Application No. 60/
425,018, filed on November 7, 2002, entitled ``A New Target for 
Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-
2002/0-US-01); PCT Application No. PCT/US03/35633, filed on November 7, 
2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis 
Therapy'' (HHS Reference No. E-294-2002/0-PCT-02); U.S. Patent No. 
7,462,593, issued on December 9, 2008, entitled ``Compositions and 
Methods for Promoting Angiogenesis'' (HHS Reference No. E-294-2002/0-
US-03); European Patent Application No. 03786608.4, filed on November 
7, 2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis 
Therapy'' (HHS Reference No. E-294-2002/0-EP-04); Australian Patent 
Application No. 2003295422, filed on April 18, 2005, entitled ``A New 
Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference 
No. E-294-2002/0-AU-05); Canadian Patent Application No. 2504953, filed 
on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti-
Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-CA-06); Japanese 
Patent Application No. 2004-551922, filed on May 9, 2005, entitled ``A 
New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS 
Reference No. E-294-2002/0-JP-07); U.S. Patent Application No. 12/
240,656, filed on September 29, 2008, entitled ``Target for Anti-
Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-US-08); U.S. 
Patent Application No. 60/500,650, filed on September 8, 2003, entitled 
``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And 
Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/0-US-01); PCT 
Application No. PCT/US04/29293, filed on September 8, 2004, entitled 
``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And 
Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-PCT-01); 
European Patent Application No. 04783513.7, filed on September 8, 2004, 
entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) 
And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-EP-03); 
Canadian Patent Application No. 2539467, filed on September 8, 2004, 
entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) 
And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-CA-04); 
Australian Patent Application No. 2004273057, filed on September 8, 
2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin 
(AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-
AU-05); and U.S. Patent Application No. 10/571,012, filed on March 8, 
2006, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin 
(AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-
US-06) to Arana Therapeutics (VIC) Pty. Ltd., having a place of 
business at Level 5, Building 4, 399 Royal Parade, Parkville, Victoria 
3052, Australia, a wholly-owned subsidiary of Arana Therapeutics 
Limited, having a place of business at Level 2, 37 Epping Road, 
Macquarie Park, NSW 2113, Australia, a wholly-owned subsidiary of 
Cephalon, Inc., having a place of business at 41 Moores Road, Frazer, 
PA 19355, USA. The patent rights in this invention have been assigned 
to the United States of America.
    The contemplated exclusive license territory may be worldwide, and 
the field of use may be limited to ``use of peptide and affinity 
binding reagents (including but not limited to antibodies) that 
neutralize the action of PAMP or adrenomedullin to treat cancer''.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before October 
30, 2009 will be considered.

ADDRESSES: Requests for copies of the patents, inquiries, comments, and 
other materials relating to the contemplated license should be directed 
to: Tara L. Kirby, Ph.D., Licensing and Patenting Manager, Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-
4426; Facsimile: 301-402-0220; E-mail: tarak@mail.nih.gov.

SUPPLEMENTARY INFORMATION: These technologies relate to adrenomedullin 
and proadrenomedullin N-terminal 20

[[Page 44864]]

peptide (PAMP), two potent angiogenic factors that are products of the 
same gene. Therapies that reduce (antagonize) the action of these 
factors have the potential to treat conditions where angiogenesis plays 
a pathological role, such as cancer and macular degeneration. 
Conversely, increasing (agonizing) the action of these factors may be 
useful for conditions where enhanced angiogenesis is desired, such as 
wound healing and cardiovascular disease. Adrenomedullin and PAMP have 
also been shown to play a role in other diseases, such as 
neurodegenerative disorders, diabetes, and allergic and inflammatory 
disease.
    More specifically, these technologies include peptides, antibodies 
and small molecules that agonize or antagonize the activity of 
adrenomedullin and PAMP. They also include methods for inhibiting or 
inducing angiogenesis, methods for inhibiting tumor growth, methods for 
treating cancer, and methods of treating a number of other conditions, 
such as wounds, neurological disease, allergic or inflammatory disease, 
diabetes, and cardiovascular disease.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within 60 days 
from the date of this published Notice, the NIH 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 404.7.
    Applications for a license in the prospective field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive license. Comments and objections submitted 
in response to this notice will not be made available for public 
inspection, and, to the extent permitted by law, will not be released 
under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: August 24, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-20881 Filed 8-28-09; 8:45 am]
BILLING CODE 4140-01-P
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