; and (ii) (I) with respect to a hard switch under paragraph (1)(A), the manufacturer took the action for reasons relating to the safety risk to patients of the listed drug or reference product; (II) with respect to an action described in paragraph (1)(A)(ii)(I)(aa), there is a supply disruption that— (aa) is outside of the control of the manufacturer; (bb) prevents the production or distribution of the applicable listed drug or reference product; and (cc) cannot be remedied by reasonable efforts; or (III) with respect to a soft switch under paragraph (1)(B), the manufacturer had legitimate pro-competitive reasons, apart from the financial effects of reduced competition, to take the action. (B) Rule of construction Nothing in subparagraph (A) may be construed to limit the information that the Commission may otherwise obtain in any proceeding or action instituted with respect to a violation of this section. (4) Response With respect to a justification offered by a manufacturer under paragraph (3), the Commission may— (A) rebut any evidence presented by a manufacturer during that justification; or (B) establish by a preponderance of the evidence that— (i) on balance, the pro-competitive benefits from the conduct described in subparagraph (A) or (B) of paragraph (1), as applicable, do not outweigh any anticompetitive effects of the conduct, even in consideration of the justification so offered; or (ii) (I) the conduct described in paragraph (1) is not reasonably necessary to address or achieve the justifications described in clause (ii) of paragraph (3)(A)