; and (ii) (I) if the interest of justice so requires; or (II) for good cause shown, which— (aa) shall be established if the subsection (k) applicant fails to provide information required section 351(k)(2)(A) of the Public Health Service Act ( 42 U.S.C. 262(k)(2)(A) ) that would enable the reference product sponsor to form a reasonable belief with respect to whether a claim of infringement under this section could reasonably be asserted; and (bb) may be established— (AA) if there is a material change to the biological product (or process with respect to the biological product) of the subsection (k) applicant that is the subject of the application; (BB) if, with respect to a patent on the supplemental list described in section 351(l)(7)(A) of Public Health Service Act ( 42 U.S.C. 262(l)(7)(A) ), the patent would have issued before the date specified in such section 351(l)(7)(A) but for the failure of the Office to issue the patent or a delay in the issuance of the patent, as described in paragraph (1) of section 154(b) and subject to the limitations under paragraph (2) of such section 154(b); or (CC) for another reason that shows good cause, as determined appropriate by the court. (D) In determining whether good cause has been shown for the purposes of subparagraph (C)(ii)(II), a court may consider whether the reference product sponsor has provided a reasonable description of the identity and relevance of any information beyond the subsection (k) application that the court believes is necessary to enable the court to form a belief with respect to whether a claim of infringement under this section could reasonably be asserted. (E) The limitation imposed under subparagraph (A)— (i) shall apply only if the subsection (k) applicant completes all actions required under paragraphs (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l) of the Public Health Service Act ( 42 U.S.C. 262(l) )