; (v) phase III of a clinical investigation of a new drug, as described in section 312.21(c) of title 21, Code of Federal Regulations, or any successor regulation; and (vi) post-market studies or clinical trials required under section 505(o) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o) ). (D) Limitations calculation The calculation of expenditure information disclosed under subparagraph (A) shall not include the following information, although such information may be disclosed separately: (i) Costs incurred in connection with licensing agreements or acquiring intellectual property. (ii) The cost of mergers or acquisitions. (iii) Any intangible costs, including estimates, adjustments, and assumptions related to the risk of failure, or the risk associated with seeking regulatory approval by the Food and Drug Administration or another agency. (iv) The estimated cost of capital. (3) Consultation in rulemaking In issuing rules under this subsection, the Commission— (A) shall consult with the Commissioner of Food and Drugs and the Director of the National Institutes of Health; and (B) may consult with the head of any other Federal agency or entity that the Commission determines is relevant. . 4. Severability If any provision of this Act, an amendment made by this Act, or the application of any such provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of the provisions of this Act, the amendments made by this Act, and the application of such provisions and amendments to any person or circumstance shall not be affected thereby.