§ 45C. Clinical testing expenses for certain drugs for rare diseases or conditions
(a)
General rule
For purposes of section
38, the credit determined under this section for the taxable year is an amount equal to 50 percent of the qualified clinical testing expenses for the taxable year.
(b)
Qualified clinical testing expenses
For purposes of this section—
(1)
Qualified clinical testing expenses
(A)
In general
Except as otherwise provided in this paragraph, the term “qualified clinical testing expenses” means the amounts which are paid or incurred by the taxpayer during the taxable year which would be described in subsection (b) of section
41 if such subsection were applied with the modifications set forth in subparagraph (B).
(B)
Modifications
For purposes of subparagraph (A), subsection (b) of section
41 shall be applied—
(C)
Exclusion for amounts funded by grants, etc.
The term “qualified clinical testing expenses” shall not include any amount to the extent such amount is funded by any grant, contract, or otherwise by another person (or any governmental entity).
(D)
Special rule
For purposes of this paragraph, section
41 shall be deemed to remain in effect for periods after June 30, 1995, and before July 1, 1996, and periods after December 31, 2011.
(2)
Clinical testing
(A)
In general
The term “clinical testing” means any human clinical testing—
(i)
which is carried out under an exemption for a drug being tested for a rare disease or condition under section 505(i) of the Federal Food, Drug, and Cosmetic Act (or regulations issued under such section),
(ii)
which occurs—
(II)
before the date on which an application with respect to such drug is approved under section 505(b) of such Act or, if the drug is a biological product, before the date on which a license for such drug is issued under section 351 of the Public Health Service Act; [1] and
(iii)
which is conducted by or on behalf of the taxpayer to whom the designation under such section
526 applies.
(B)
Testing must be related to use for rare disease or condition
Human clinical testing shall be taken into account under subparagraph (A) only to the extent such testing is related to the use of a drug for the rare disease or condition for which it was designated under section 526 of the Federal Food, Drug, and Cosmetic Act.
(c)
Coordination with credit for increasing research expenditures
(1)
In general
Except as provided in paragraph (2), any qualified clinical testing expenses for a taxable year to which an election under this section applies shall not be taken into account for purposes of determining the credit allowable under section
41 for such taxable year.
(d)
Definition and special rules
(1)
Rare disease or condition
For purposes of this section, the term “rare disease or condition” means any disease or condition which—
(B)
affects more than 200,000 persons in the United States but for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug.
Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date such drug is designated under section 526 of the Federal Food, Drug, and Cosmetic Act.
(2)
Special limitations on foreign testing
(A)
In general
No credit shall be allowed under this section with respect to any clinical testing conducted outside the United States unless—
(B)
Special limitation for corporations to which section
936 applies
No credit shall be allowed under this section with respect to any clinical testing conducted by a corporation to which an election under section
936 applies.
[1] So in original. The semicolon probably should be a comma.