; and (ii) the date on which the enforcement action has concluded. (3) Covered entity The term covered entity means any entity that is— (A) a drug manufacturer; and (B) (i) operating under Federal settlement, including a Federal consent decree; or (ii) the subject of an enforcement action in a court of the United States or by an agency. 303. Prohibition against excessive price (a) Prohibition Beginning on the effective date of the regulation required by subsection (b), the manufacturer of a prescription drug or medical device shall not charge an excessive price, as determined pursuant to such regulation, for such drug or device. (b) Formula The Board shall by regulation prescribe a formula for determining whether the average manufacturer price of such drug or device over an annual quarter is an excessive price. (c) Determination of excessive price If the Board determines, on its own initiative or in response to a petition submitted under subsection (d), that the manufacturer of a prescription drug or medical device charges an excessive price for such drug or device in violation of subsection (a)— (1) the Board shall give the manufacturer— (A) notice of such violation; and (B) subject to subsection (d), a period to correct such violation; and (2) if the manufacturer fails to correct the violation by the end of such period, the manufacturer shall be subject to section 304, section 1927(c)(2)(E) of the Social Security Act (as added by subsection (c) of section 304), and section 4192 of the Internal Revenue Code of 1986, as added by subsection (d) of section 304. (d) Petitions Any person may petition the Board to make a determination under subsection (c) regarding the pricing of a prescription drug or medical device. Not later than 90 days after the date of receipt of such a petition, the Board shall— (1) make a determination under subsection (c) regarding such pricing