The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) intends to negotiate with the J. Gladstone Institute of Virology and Immunology (Gladstone) for a multiple-year contract to establish a small-animal model to evaluate potential therapeutics for HIV-1 infection. This work is currently being performed by Gladstone under contract number N01-AI-05418, entitled “Tissue-Based Small Animal Model for HIV Drug Discovery”. The animal model being used is an immunodeficient mouse engrafted with human fetal thymus and liver (SCID-hu Thy/Liv) and infected with well-characterized isolates of HIV-1. Gladstone possesses a unique capability to evaluate potential HIV-1 therapeutics, alone and in combination, for efficacy and toxicity in vivo, in a validated animal model consisting of SCID mice engrafted with human fetal thymus and liver (SCID-hu Thy/Liv) tissue and infected with a diverse panel of well characterized primary isolates and molecular clones of HIV-1. Gladstone has a license from Stanford University, the holder of the patent rights for the SCID-hu Thy/Liv model, to use the model to evaluate therapeutic entities that may originate in the private sector. The statutory authority justifying this other than full and open competition is 41 U.S.C. 253(c)1) and FAR 6.302-1. See Numbered Note 22.

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