; or (ii) section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ); and (B) fulfill any regulatory requirements relating to approval of such an application. (b) Civil action for failure To provide sufficient quantities of a covered product (1) In general An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms. (2) Elements (A) In general To prevail in a civil action brought under paragraph (1), an eligible product developer shall prove, by a preponderance of the evidence— (i) that— (I) the covered product is not subject to a REMS with ETASU; or (II) if the covered product is subject to a REMS with ETASU— (aa) the eligible product developer has obtained a covered product authorization from the Secretary in accordance with subparagraph (B); and (bb) the eligible product developer has provided a copy of the covered product authorization to the license holder; (ii) that, as of the date on which the civil action is filed, the product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms; (iii) that the eligible product developer has submitted a written request to purchase sufficient quantities of the covered product to the license holder and such request— (I) was sent to a named corporate officer of the license holder; (II) was made by certified or registered mail with return receipt requested; (III) specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered product to the eligible product developer and a means for electronic and written communications with that individual