; (F) patent applications that benefitted from such grants; (G) patent extensions; (H) exclusivity periods; and (I) waivers of fees; (6) the total expenditures of the manufacturer on research and development, itemized by basic and preclinical research and by clinical research, reported separately for each clinical trial, for the covered drug to demonstrate that the covered drug meets applicable statutory standards for approval under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), an exemption for investigational use under section 505(i) of the Federal Food, Drug, or Cosmetic Act ( 21 U.S.C. 355(i) ) or section 351 of the Public Health Service Act, or approval under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ), as applicable; (7) the total expenditures of the manufacturer on pursuing new or expanded indications or dosage changes for the covered drug under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); (8) the total expenditures of the manufacturer on carrying out postmarket requirements related to such drug, including under section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ); (9) the specific expenditures associated with marketing and advertising costs for the covered drug; (10) any anticipated royalty fees from licensing to other manufacturers; and (11) with respect to the manufacturer— (A) all stock-based performance metrics used by the manufacturer to determine executive compensation over the preceding 12 months