; (B) (i) that is reasonably likely to be required to respond to a public health emergency or to a chemical, biological, radiological, or nuclear threat; or (ii) the shortage of which would pose a significant threat to the United States health care system or at-risk populations; and (C) that has a vulnerable supply chain, such as a geographic concentration of manufacturing, poor quality or safety issues, complex manufacturing or chemistry, or few manufacturers. (5) Eligible entity The term eligible entity means a person that— (A) (i) is the holder of an approved application under subsection (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or subsection (k) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) for an eligible drug; (ii) maintains at least one domestic establishment registered under section 510(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(b) ) or one foreign establishment registered under section 510(i) of such Act that is located in a country that is a member of the Organisation for Economic Cooperation and Development that is capable of manufacturing the eligible drug; and (iii) has a strong record of good manufacturing practices of drugs; (B) (i) is a manufacturer of an active pharmaceutical ingredient for an eligible drug, in partnership with an entity that meets the requirements of subparagraph (A); (ii) maintains at least one domestic establishment registered under section 510(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(b) ) or one foreign establishment registered under section 510(i) of such Act that is located in a country that is a member of the Organisation for Economic Cooperation and Development that is capable of manufacturing the active pharmaceutical ingredient; and (iii) has a strong record of good manufacturing practices of active pharmaceutical ingredients