[Federal Register Volume 62, Number 51 (Monday, March 17, 1997)]
[Notices]
[Pages 12657-12658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Heart, Lung, and Blood Institute

SUMMARY: The National Institutes of Health is seeking Cooperative 
Research and Development Agreement (CRADA) partners for the future 
development and commercialization of Active Transglutaminase I.
    To speed the research and development of this compound, the 
National Institutes of Health is seeking a CRADA partner, in accordance 
with the Federal Technology Transfer Act of 1986, 15 U.S.C. 3710(a)(b), 
with capabilities to produce high grade quantities of the enzyme for 
further characterization and research in accordance with the 
regulations governing the transfer of Government-developed agents. Any 
proposals to produce and develop active Transglutaminase I will be 
considered.

ADDRESSES: CRADA proposals and questions about this opportunity should 
be addressed to: Ms. Sue Patow, Technology Transfer, NHLBI, Building 
31, Room 1B30, Bethesda, MD 20892 (301-402-5579) or E-mail proposals 
and questions to: <PatowS@nih. gov>.

SUPPLEMENTARY INFORMATION: A supply of active human transflutaminase I 
enzyme (TG1) for therapeutic research is required. For this purpose a 
suitable protein expression system should be available (mammalian, 
insect or microorganism) which will utilize DNA we provide that codes 
for TG1. production of 5 mg or more TG1 protein may be required for 
sufficient enzyme activity, but the exact quantity and frequency of 
supply will depend on the stability and activity of the product. 
Minimally purified TG1 enzyme will be accepted for initial tests, but 
more purified enzyme may subsequently be required. The exact form of 
the TG1 enzyme to be supplied will depend on

[[Page 12658]]

the capabilities of the expression system. Synthesis of `native' full-
size enzyme (92 kDa) will have highest priority. Alternatively, a 
truncated TG1 with high activity and stability may be tested (65 kDa). 
A standard transglutaminase activity assay will be used by the 
contractor to determine TG1 activity, and assess stability and optimal 
storage conditions.
    This CRADA aims include the rapid development of a supply of active 
human Transglutaminase I enzyme for further characterization and 
research, publication of research results and possible exploitation of 
commercial opportunities. The CRADA partner(s) will enjoy rights of 
first negotiation for licensing Government rights to any inventions 
arising under the agreement.
    The role of the NIAMS in this CRADA will be as follows:
    (1) Provide the Collaborator(s) with samples of the clone gene DNA;
    (2) Perform initial tests on Collaborator produced test enzyme for 
activity and function; and
    (3) Provide expertise in optimizing commercial development of this 
compound to produce the most useful product.
    The role of the Collaborator will be as follows:
    (1) Produce high quality Transglutaminase I in sufficient 
quantities for research studies;
    (2) Perform initial testing of Transglutaminase I for purity; and
    (3) Develop method(s) to produce large quantities of 
Transglutaminase I for commercial distribution.
    Selection criteria for choosing the CRADA partner(s) will include 
but not be limited to:
    (1) Ability to produce high quality Transglutaminase I in large 
quantities for research and evaluation;
    (2) The level of financial support the Collaborator will supply for 
the CRADA related Government activities;
    (3) A willingness to cooperate with the NIAMS in the publication of 
research results;
    (4) An agreement to be bound by DHHS rules involving human 
subjects, patent rights, and ethical treatment of animals; and
    (5) Agreement with provisions for equitable distribution of patent 
rights to any inventions developed under the CRADA(s).
    Generally, the rights of ownership are retained by the organization 
which is the employer of the inventor with, (1) an irrevocable, non-
exclusive, royalty-free license to the Government (when a company 
employee is sole inventor) or (2) an option to negotiate an exclusive 
or non-exclusive license to the company on terms that are appropriate 
(when the Government employee is the sole inventor).

    Dated: March 4, 1997.
Sheila E. Merritt,
Executive Officer, NHLBI.
[FR Doc. 97-6634 Filed 3-14-97; 8:45 am]
BILLING CODE 4140-01-M