[Federal Register Volume 73, Number 31 (Thursday, February 14, 2008)]
[Notices]
[Pages 8702-8704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Cooperative Research and Development Agreement (CRADA) 
Opportunity With the National Heart Lung and Blood Institute and 
Licensing Opportunity for Development of Multi-Domain Amphipathic 
Helical Peptides for the Treatment of Cardiovascular Disease

AGENCY: National Institutes of Health, PHS, HHS.

ACTION: Notice.

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as 
amended, and in accordance with 35 U.S.C. 207 and 37 CFR Part 404, the 
National Institutes of Health (NIH) of the Public Health Service (PHS) 
of the Department of Health and Human Services (HHS) seeks a 
Cooperative Research and Development Agreement (CRADA) and/or 
license(s) with a pharmaceutical or biotechnology company to develop 
and commercialize amphipathic helical peptides potentially useful for 
the treatment and prevention of cardiovascular disease. The CRADA would 
have an expected duration of one (1) to five (5) years. The goals of 
the CRADA include the rapid publication of research results and timely 
commercialization of products, methods of treatment or prevention that 
may result from the research. The CRADA Collaborator will have an 
option to negotiate the terms of an exclusive or non-exclusive 
commercialization license to subject inventions arising under the CRADA 
defined by the CRADA Research Plan, subject to any pre-existing 
licenses already issued for other fields of use, and can apply for 
background licenses to the existing patent applications encompassed 
within HHS Reference Nos. E-114-2004/0-US-01 (United States Patent 
Application

[[Page 8703]]

Serial No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent 
Application Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent 
Application No. 2584048), E-114-2004/0-EP-05 (European Patent 
Application No. 05815961.7) and E-114-2004/0-JP-06 (Japanese Patent 
Application No. 2007-536912) titled: Multi-Domain Amphipathic Helical 
Peptides and Methods of Their Use.

DATES: Inquiries regarding CRADA proposals and scientific matters may 
be forwarded at any time. Confidential preliminary CRADA proposals, 
preferably two pages or less, must be submitted to the NHLBI on or 
before April 14, 2008. Guidelines for preparing final CRADA proposals 
will be communicated shortly thereafter to all respondents with whom 
initial confidential discussions will have established sufficient 
mutual interest.
    There is no deadline by which license applications must be received 
by the Office Technology Transfer however applicants are encouraged to 
respond on or before April 14, 2008. This notice replaces that 
published in the Federal Register on May 11, 2005 (70 FR 24832).

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Denise Crooks, Office of Technology Transfer and 
Development, NHLBI 6705 Rockledge Drive, MSC 7992, Bethesda, MD 20892 
(phone: 301-402-5579, Fax: 391-594-3080, E-mail: 
[email protected]).
    Scientific Inquiries should be directed to Dr. Alan T. Remaley, 
NHLBI, 10 Center Drive, Building 10, Room 2C-433, MSC 1508, Bethesda, 
MD 20892 (phone: 301-402-9796; fax: 301-402-1885; E-mail: 
[email protected]).
    Licensing inquiries and requests for license application should be 
directed to Ms. Fatima Sayyid, Technology Licensing Specialist, Office 
of Technology Transfer, NIH, 6011 Executive Blvd., Suite 325, 
Rockville, MD, 20852 (phone: 301-435-4521, Fax: 301-402-0220, E-mail: 
[email protected]).

SUPPLEMENTARY INFORMATION: 

Technology Available

    HHS scientists within the Lipoprotein Metabolism Section (LMS), 
NHLBI, have discovered a novel class of non-hemolytic amphipathic 
synthetic peptides that are specific for effluxing excess cellular 
cholesterol by the ABCA1 transporter. These agents have been shown to 
significantly inhibit the progression of atherosclerosis in a mouse 
model of cardiovascular disease. Details are noted in HHS Reference 
s E-114-2004/0-US-01 (United States Patent Application Serial 
No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent Application 
Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent Application 
No. 2584048), E-114-2004/0-EP-05 (European Patent Application No. 
05815961.7) and E-114-2004/0-JP-06 (Japanese Patent Application No. 
2007-536912) titled: Multi-Domain Amphipathic Helical Peptides and 
Methods of Their Use. They are available for review under an 
appropriate Confidential Disclosure Agreement.

Technology Sought

    Accordingly, HHS now seeks collaborative arrangements to provide 
more extensive biological and pharmacological evaluation of both 
current and any new amphipathic peptides that are being developed 
within the Lipoprotein Metabolism Section of NHLBI. The ultimate 
purpose of the collaboration would be to advance the most promising 
agents into clinical trials for the prevention and regression of 
cardiovascular disease. For collaboration with the private sector, a 
Cooperative Research and Development Agreement (CRADA) will be 
established to provide for equitable distribution of intellectual 
property rights developed under the collaboration. CRADA aims will 
include rapid publication of research results as well as full and 
timely exploitation of commercial opportunities.

NHLBI and Collaborator Responsibilities

    The role of LMS, NHLBI in this CRADA may include, but not be 
limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Perform in conjunction with Collaborator in vitro studies to 
identify novel peptides.
    3. Perform in conjunction with Collaborator animal studies on 
peptides with anti-atherosclerotic properties.
    4. Provide the Collaborator with sequences of any novel peptides 
for future pharmaceutical development.
    5. Planning and conducting research and clinical studies and 
interpreting research results.
    6. Publishing research results.
    The role of the CRADA Collaborator may include, but not be limited 
to:
    1. Providing significant intellectual, scientific, and technical 
expertise or experience to the research project.
    2. Planning scientific and clinical research studies and 
interpreting research results.
    3. Providing some financial support for CRADA-related research as 
outlined in the CRADA Research Plan.
    4. Publishing research results.
    Selection criteria for choosing the CRADA Collaborator may include, 
but not be limited to:
    1. The ability to collaborate with NHLBI on further research and 
development of this technology. This ability can be demonstrated 
through experience and expertise in this or related areas of technology 
indicating the ability to contribute intellectually to on-going 
research and development.
    2. Expertise and experience in the following areas: Peptide design 
and synthesis, performance of preclinical studies including animal 
model studies of atherosclerosis, animal toxicology studies, knowledge 
of GMP grade production and scale up and lipid reconstitution of 
synthetic peptides, and design, U.S. Food and Drug Administration 
regulatory filings, and performance of clinical trials. The 
demonstration of adequate resources to perform the research, 
development and commercialization of this technology (e.g. facilities, 
personnel, expertise and funds) and accomplish objectives according to 
an appropriate timetable to be outlined in the CRADA Collaborators 
proposal.
    3. The willingness to commit best efforts and demonstrated 
resources to the research, development and commercialization of this 
technology.
    4. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    5. The willingness to cooperate with the National Heart Lung and 
Blood Institute in the timely publication of research results.
    6. The willingness to accept the legal provisions and language of 
the CRADA with only minor modifications, if any. These provisions 
govern the equitable distribution of patent rights to CRADA inventions. 
Generally, the rights of ownership are retained by the organization 
that is the employer of the inventor, with (1) the grant of a license 
for research and other Government purposes to the Government when the 
CRADA Collaborator's employee is the sole inventor, or (2) the grant of 
an option to elect an exclusive or non-exclusive license to the CRADA 
Collaborator when the Government employee is the sole or joint 
inventor.


[[Page 8704]]


    Dated: February 7, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-2750 Filed 2-13-08; 8:45 am]
BILLING CODE 4140-01-P