; and (II) does not to relate to— (aa) allegations of fraud resulting, or potentially resulting, in a loss of taxpayer dollars; or (bb) allegations of conduct having an adverse impact, or a potentially adverse impact, on the health of the public. (D) Person The term person has the meaning given such term in section 201(e) of the Federal Food, Drug, and Cosmetic Act. (E) Product The term product means a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351, and subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act. (2) Supplemental payments to increase congressional investments in medical research (A) Supplemental payment assessment and collection Beginning with the first fiscal year that begins at least 60 days after the date of enactment of the Medical Innovation Act of 2017 , and each subsequent fiscal year, the Secretary shall, in accordance with this paragraph, assess and collect supplemental payments to increase congressional investments in medical research from each covered manufacturer described in subparagraph (B). (B) Criteria for assessing payments A covered manufacturer that meets both of the following criteria for a calendar year (referred to in this subparagraph and subparagraph (D) as the applicable calendar year ) shall be assessed a supplemental payment under subparagraph (A) for the fiscal year beginning in the proceeding calendar year: (i) A covered manufacturer that, during the 5-year period immediately preceding the date on which the payment is assessed, but not before the date of enactment of the Medical Innovation Act of 2017 , entered into a covered settlement agreement. (ii) A covered manufacturer that reported net income of at least $1,000,000,000 to the Securities and Exchange Commission on a form, including form 10–K or form 20–F, or that the Secretary otherwise determines to have had net income of at least $1,000,000,000— (I) during the applicable calendar year