; and (II) under common ownership and control with the manufacturer; or (ii) by contracting with an authorized third-party logistics provider (as defined in section 581 of the Federal Food Drug, and Cosmetic Act ( 21 U.S.C. 360eee )) located in the United States to store the drug in the United States. (G) A requirement that any covered pediatric cancer drug held in reserve supply be manufactured and held in accordance with— (i) good manufacturing practice requirements; (ii) the approved application for such drug under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); and (iii) applicable law. (H) A provision that allows the Secretary, or a third party designated by the Secretary, to audit the manufacturer and the eligible source facility for compliance with the terms of the agreement and applicable law— (i) on an annual basis; or (ii) more frequently, if the Secretary has a reasonable basis to believe that the manufacturer or eligible source facility is not complying with the terms of the agreement or applicable law. (I) A requirement that the manufacturer certify to the Secretary on an annual basis compliance with the terms of the agreement. (4) Optional terms for acquisition, construction, alteration, or renovation of establishment An agreement under this section between the Secretary and a manufacturer of a covered pediatric cancer drug may include a provision to allow the manufacturer to acquire, construct, alter, or renovate a non-federally owned establishment for the purpose of manufacturing covered pediatric cancer drugs— (A) as the Secretary determines necessary to ensure sufficient amounts of such drugs