a prescription drug plan or under an MA–PD plan offered by such sponsor or organization, respectively. (2) Price limitation In the case of a life-sustaining prescription drug that is negotiated by the Secretary pursuant to paragraph (1), the total payment described in such paragraph may not exceed 110 percent of the average price charged for such drug in the 5 reference countries described in section 2(b)(1)(B) of such Act (in this section referred to as the international reference price ). (3) Enforcement (A) In general In the case of a manufacturer of a life-sustaining prescription drug for which the Secretary has made a determination described in paragraph (1) that fails to enter into a negotiation and agree on a total payment with respect to such drugs as described in such paragraph within 9 months of such determination— (i) if such drug has an international reference price, the Secretary shall assess a civil monetary penalty equal to 2 times the difference between the total revenue for such drug from all sales in the United States made beginning after the date that is 9 months after such determination and the total revenue for such drug from all such sales made after such date that would have been received if the manufacturer charged the international reference price for such drug