genetically targeted drug

(A) is the subject of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for the treatment of a rare disease or condition (as such term is defined in section 360bb of this title) that is serious or life-threatening;

(B) may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product; and

(C) incorporates or utilizes a genetically targeted technology;