; or (bb) places the listed drug or reference product on the discontinued products list; or (II) the manufacturer of the listed drug or reference product announces discontinuance of, or intent to withdraw, the application for the reference product. (ii) The manufacturer of a previously approved drug or biological product markets or sells a follow-on product during the competition window. (B) Rebuttal (i) In general Subject to subparagraph (C), an action described in subparagraph (A) shall not be considered to be an unfair method of competition in or affecting commerce if— (I) with respect to an action described in subparagraph (A)(i), the manufacturer of the listed drug or reference product demonstrates to the Commission or a district court of the United States, as applicable, by a preponderance of the evidence in a proceeding initiated by the Commission under subsection (c)(1)(A), or in a suit brought under subparagraph (B) or (C) of subsection (c)(1), that the manufacturer removed such drug from the market for significant and documented safety reasons; or (II) with respect to an action described in subparagraph (A)(ii)— (aa) the manufacturer demonstrates to the Commission or a district court of the United States, as applicable, by a preponderance of the evidence in a proceeding initiated by the Commission under subsection (c)(1)(A), or in a suit brought under subparagraph (B) or (C) of subsection (c)(1), that— (AA) the follow-on product described in such subparagraph (A)(ii) (referred to in this subclause as the follow-on product ) provides a clinically meaningful and significant additional health benefit to the target population beyond that provided by the previously approved drug or biological product; (BB) the follow-on product was the available means that was least likely to reduce competition; and (CC) the manufacturer had substantive financial reasons, apart from the financial effects of reduced competition, to introduce the follow-on product to the market