; and (B) the manufacturer of a covered outpatient drug that is subject to an agreement under this section (or its designee) to audit such records of the covered entity and of the contracted entity solely with respect to such drugs of the manufacturer. (13) Regulations (A) Not later than 180 days after the date of enactment of this paragraph, the Secretary shall promulgate final regulations through notice-and-comment rulemaking to implement the requirements of paragraph (11) and paragraph (12). Such regulations shall include model terms for the contractual agreement described in subparagraph (A) of paragraph (11). (B) Not later than 180 days after the date of enactment of this paragraph, the Secretary shall promulgate final regulations through notice-and-comment rulemaking to establish procedures, in the case in which the Secretary determines that a violation of the annual contract pharmacy independent on-site audit requirement in subparagraph (F) of paragraph (11), with respect to a contract pharmacy arrangement, was knowing and intentional— (i) for removing the contract pharmacy arrangement from a covered entity’s contract pharmacy network and disqualifying the entity from adding any additional contract pharmacies for a reasonable period, to be determined by the Secretary, of not less than two years