described in subsection (b)(2) for the first plan year in such negotiated price period. (3) Competitive licensing authority (A) In general Notwithstanding any exclusivity under clause (iii) or (iv) of section 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic Act, clause (iii) or (iv) of section 505(c)(3)(E) of such Act, section 351(k)(7)(A) of the Public Health Service Act, or section 527(a) of the Federal Food, Drug, and Cosmetic Act, or by an extension of such exclusivity under section 505A of such Act or section 505E of such Act, and any other provision of law that provides for market exclusivity (or extension of market exclusivity) with respect to a drug, in the case that the Secretary is unable to successfully negotiate an appropriate price for a covered part D drug for a negotiated price period, the Secretary shall authorize the use of any patent, clinical trial data, or other exclusivity granted by the Federal government with respect to such drug as the Secretary determines appropriate for purposes of manufacturing such drug for sale under a prescription drug plan or MA–PD plan. Any entity making use of a competitive license to use patent, clinical trial data, or other exclusivity under this section shall provide to the manufacturer holding such exclusivity reasonable compensation, as determined by the Secretary based on the following factors: (i) The risk-adjusted value of any Federal government subsidies and investments in research and development used to support the development of such drug. (ii) The risk-adjusted value of any investment made by such manufacturer in the research and development of such drug. (iii) The impact of the price, including license compensation payments, on meeting the medical need of all patients. (iv) The relationship between the price of such drug, including compensation payments, and the health benefits of such drug. (v) Other relevant factors determined appropriate by the Secretary to provide reasonable compensation. (B) Reasonable compensation The manufacturer