; (5) the term REMS means a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ); (6) the term REMS with ETASU means a REMS that contains elements to assure safe use under section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ); (7) the term Secretary means the Secretary of Health and Human Services; (8) the term single, shared system of elements to assure safe use means a single, shared system of elements to assure safe use under section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ); and (9) the term sufficient quantities means an amount of a covered product that allows the eligible product developer to— (A) conduct testing to support an application— (i) for approval under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ); or (ii) for licensing under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ); and (B) fulfill any regulatory requirements relating to such an application for approval or licensing. (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)