; (2) in the case of a manufacturing process, the holder of the patent with respect to such process; or (3) in the case of open source contributions, the persons or communities that openly shared knowledge, data, materials, and technology on a royalty-free and nondiscriminatory basis. (c) Criteria The Board shall, by regulation, establish criteria for the selection of recipients, and for determining the amount, of prize payments under this section. Such criteria shall include consideration of the following: (1) The number of patients who would benefit from the drug, biological product, or manufacturing process involved, including (in cases of global neglected diseases, global infectious diseases, and other global public health priorities) the number of non-United States patients. (2) The incremental therapeutic benefit of the drug, biological product, or manufacturing process involved as compared to existing drugs, biological products, and manufacturing processes available to treat the same disease or condition, except that the Board shall provide for cases where drugs, biological products, or manufacturing processes are developed at roughly the same time, so that the comparison is to products that were not recently developed. (3) The degree to which the drug, biological product, or manufacturing process involved addresses priority health care needs, including— (A) current and emerging global infectious diseases; (B) severe illnesses with small client populations (such as indications for which orphan designation has been granted under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ))