; and (ii) the average retail list price for the drug or biological product sold in Canada, France, Germany, Italy, Japan, and the United Kingdom, as calculated under subsection (c); and (B) 10. (2) Requirement The amount of a civil monetary penalty under paragraph (1) shall be calculated and charged for each unit of drug or biological product sold. (e) Data collection Each manufacturer of a drug or biological product shall submit to the Secretary on an annual basis— (1) the list price for the drug or biological product sold in the United States; and (2) the list price for the drug or biological product sold in each of Canada, France, Germany, Italy, Japan, and the United Kingdom. (f) Guidance and regulations The Secretary shall issue guidance and promulgate regulations to implement this section.