; or (2) decline to make such a determination. (e) Continuing violation The Board shall not be required to give a manufacturer an opportunity to correct a violation, as described in subsection (c)(1)(B), before the manufacturer becomes subject to the provisions described in subsection (c)(2) for such violation, if— (1) the Board has already provided such an opportunity to correct to the manufacturer; and (2) the Board finds that the violation of subsection (a) is a continuation of an earlier violation with respect to which such an opportunity was provided. (f) Considerations The formula required by subsection (a) shall at a minimum take into consideration— (1) the average manufacturer price of the prescription drug or medical device over the respective annual quarter or quarters; (2) the average manufacturer price of other prescription drugs or medical devices in the same therapeutic class over the same quarter or quarters; (3) the average price at which the prescription drug or medical device and other prescription drugs and medical devices in the same therapeutic class have been sold by manufacturers in countries other than the United States; (4) the costs associated with producing and marketing the prescription drug or medical device, the value of the drug or device to patients where sufficient data is available to determine such value, the total Federal investment in the development of the drug or device, the size of the patient population receiving the drug or device, and other factors determinative as to the true cost of production