; or (B) a modification to such price that is adopted by regulation after providing notice and the opportunity for the public to comment, if the Secretary determines such modification to be an appropriate and reasonable measure to protect United States residents from paying prices that are higher than prices in other countries with large economies and high incomes. (c) Additional requirements (1) In general In carrying out subsection (a), the Secretary may promulgate by regulation additional requirements to ensure that the price for the biomedical product or service described in subsection (a) be reasonable. (2) Requirements The additional requirements under paragraph (1) shall— (A) address the public interest in ensuring that publicly supported innovations for biomedical products and services have reasonable prices; and (B) take into account— (i) the importance of providing robust incentives to invest in biomedical research and development; and (ii) the challenges of administering agreements described in subsection (a), including in cases where third parties control relevant intellectual property, know-how, or other assets. (3) Possible mechanisms The additional requirements for reasonable pricing authorized by paragraph (1) may include— (A) mechanisms to— (i) lower prices or shorten exclusivity periods when revenues exceed targets; (ii) lower prices that exceed a standard of cost per health benefit achieved; or (iii) lower prices that constitute significant barriers to access or fiscal burdens on patients