; and (4) meets price, quality, manufacturing concentration, manufacturing complexity, and other appropriate metrics as determined by the Secretary. 4. Distributions from essential pediatric cancer drug reserve supplies (a) In general If a covered pediatric cancer drug is in shortage (as defined in section 506C(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(h) )), or the Secretary has reason to believe that such a drug may be at risk of such a shortage, the Secretary may order a manufacturer with whom the Secretary has entered into an agreement under section 2 to distribute such drug from the reserve supply in accordance with such agreement in an effort to alleviate or prevent the shortage. (b) Payments for distribution (1) In general The Secretary shall require a recipient of a covered pediatric cancer drug distributed under subsection (a) to pay the Secretary for such drug. The amount of such payment shall not exceed the price for which the Secretary purchased such drug pursuant to an agreement under section 2. (2) Limitation The Secretary may use payments received pursuant to paragraph (1) only to replenish the reserve supply of the drugs distributed under subsection (a). (c) Inability To distribute or manage reserve supply (1) Inability to distribute If a manufacturer is not able or willing to distribute drugs in accordance with an order of the Secretary under subsection (a), the Secretary may take possession of and distribute such drugs. (2) Inability to manage reserve supply If a manufacturer can no longer hold or manage a reserve supply of covered pediatric cancer drugs in accordance with an agreement under section 2, the Secretary may take possession of the reserve supply. 5. Reports to Congress (a) In general For each year 1 or more drugs are held by a manufacturer in reserve supply pursuant to an agreement under section 2, the Secretary shall submit to Congress a report on the progress of the pilot program under such section. (b) Contents The reports referred to in subsection (a) shall