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(1) The entity is- (A) an institution of higher education (as such term is defined in section 1001 of title 20) or a consortium of such institutions; or (B) an organization described in section 501(c)(3) of title 26 and exempt from tax under section 501(a) of such title.(2) The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences, which may include graduate training programs in areas relevant to priorities of the Critical Path Initiative.(3) The entity demonstrates they are ca...