; and (B) an application for such a waiver, at such time, in such manner, and containing such information as the Secretary may require; and (2) based upon the information in such application, the Secretary determines that— (A) the price increase is necessary to enable production of the drug, does not unduly restrict patient access to the drug, and does not negatively impact public health; and (B) such waiver or decrease constitutes a deviation from the reduction in market exclusivity that would otherwise apply under subsection (a) only to the extent necessary to achieve drug production objectives. (e) Period of market exclusivity For purposes of this section, the term period of market exclusivity means any period of market exclusivity granted with respect to a prescription drug under clause (ii), (iii), or (iv) of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) ), section 505(j)(5)(B)(iv) of such Act, clause (ii), (iii), or (iv) of section 505(j)(5)(F) of such Act, or paragraphs (6) or (7) of section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ).