drugs that achieve improved clinical outcomes. Such a contract may authorize the contractor to use funds made available under the contract for completion of postmarketing clinical studies, manufacturing, and other preclinical and clinical efforts. (2) Requirements (A) In general The Secretary, through the office described in paragraph (4), may enter into a contract under paragraph (1)— (i) if the Secretary determines that the antimicrobial drug is intended to treat an infection for which there is an unmet clinical need, an anticipated clinical need, or drug resistance