; or (BB) otherwise satisfied the Secretary that such protections will be provided; and (bb) met any other requirements the Secretary may establish. (iii) Notice A covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the REMS for the covered product. (3) Affirmative defense In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence— (A) that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder— (i) neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and (ii) neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms; or (B) that— (i) the license holder sells the covered product through agents, distributors, or wholesalers; (ii) the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and (iii) the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder. (4) Remedies (A) In general If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall— (i) order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms