; and (F) in paragraph (11), as so redesignated— (i) in subparagraph (A), in the matter preceding clause (i), by inserting , at any time, after conduct testing ; and (ii) in subparagraph (B), by inserting , at any time, after fulfill ; (2) in subsection (b)(2)— (A) in subparagraph (A)(iii)— (i) in the matter preceding subclause (I), by striking a written request to purchase sufficient quantities of the covered product to the license holder, and such request— and inserting one or more written requests to purchase sufficient quantities of the covered product to the license holder for the relevant stage of development, and each such request— ; and (ii) in subclause (II), by inserting or by a designated delivery service before the semicolon at the end; and (B) in subparagraph (B), by amending clause (ii) to read as follows: (ii) Authorization The Secretary shall, by written notice, authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU for purposes of development and testing— (I) in the case of development and testing that does not involve human clinical trials, not later than 60 days after the date on which a request under clause (i) is received, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary; or (II) in the case of development and testing that involves human clinical trials, not later than 120 days after the date on which a request under clause (i) is received, if the eligible product developer has— (aa) (AA) submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered product; or (BB) otherwise satisfied the Secretary that such protections will be provided; and (bb) met any other requirements the Secretary may establish.