The court may, if a temporary restraining order 
or preliminary injunction is sought, require the 
filing of a bond or equivalent security in accord-
ance with the Federal Rules of Civil Procedure. 
‘‘(F) SAVINGS
PROVISION.—This para-
graph does not restrict any right that a person 
(or class of persons) may have under any stat-
ute or common law to seek enforcement of pro-
visions relating to Federal ownership of patents 
on candidate discoveries, or to seek any other 
relief (including relief against the Secretary). 
‘‘(e) APPLICATION FOR APPROVAL BY FOOD AND 
DRUG ADMINISTRATION.— 
‘‘(1) IN GENERAL.—Each application submitted 
to the Food and Drug Administration for the ap-
proval of a candidate discovery, or for authorization 
to engage in investigational uses of the discovery, 
shall be submitted by the Director of the Institute 
or by a private entity. In the case of a private entity, 
such application shall be submitted pursuant to— 
‘‘(A) a cooperative agreement or contract 
between the Director of the Institute and the 
private entity; and 
‘‘(B) a nonexclusive license granted by the 
Director to the private entity for the commer-
cial marketing of the discovery, notwithstanding 
any conflicting provision of chapter 18 of title 
35, United States Code. 
‘‘(2) INSTITUTE AS HOLDER OF APPROVED AP-
PLICATION.—In the case of an application referred 
to in paragraph (1) that is submitted by the Direc-
tor of the Institute and approved by the Food and 
Drug Administration, the Director, promptly after 
such approval, shall seek to provide to one or more 
appropriate private entities nonexclusive licenses for 
the commercial marketing of the candidate discovery 
involved, notwithstanding any conflicting provision 
of chapter 18 of title 35, United States Code. 
‘‘(f) FEDERAL LABORATORY SYSTEM.— 
‘‘(1) IN GENERAL.—The Director of the Insti-
tute shall carry out this section directly and through 
Federal laboratories established by the Director in 
accordance with paragraph (2). 
‘‘(2) CERTAIN REQUIREMENTS.—Subject to the 
extent of amounts made available in appropriations 
Acts, the Director shall establish 10 laboratories 
under paragraph (1). Each such laboratory shall be 
established within the National Institutes of Health, 
and shall be headed by an Associate Director, who 
shall be appointed by the Director of the Institute.
With respect to the location of the laboratories, the 
laboratories shall be equitably distributed among the 
various regions of the United States. 
‘‘(3) 
TEN-YEAR
PERFORMANCE
REVIEW.— 
Promptly after the expiration of the ten-year period 
beginning on the date on which a Federal laboratory 
under paragraph (2) becomes operational (as deter-
mined by the Director), and every ten years there-
after, the Director of the Institute shall provide for 
a comprehensive review of the performance of the 
laboratory. The Director may, for good cause found 
pursuant to such a review, terminate the laboratory. 
If the laboratory is terminated, the Director of the 
Institute shall transfer the duties of the laboratory, 
and the funds and other assets of the laboratory, to 
the remaining laboratories under paragraph (2), and 
shall transfer within the Institute the officers and 
employees of the laboratory, or otherwise provide for 
the disposition of such officers and employees in ac-
cordance with applicable law. 
‘‘(g) REWARDS FOR SIGNIFICANT ADVANCES.—The 
Director of the Institute shall establish a fund, consisting 
of amounts reserved under subsection (i)(2), from which 
the Director may provide cash awards to individuals or 
organizations that, in carrying out research and develop-
ment activities under subsection (c), make significant ad-
vances in knowledge regarding a disease, disorder, or other 
health condition, including new treatments or diagnostic 
techniques. 
‘‘(h) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘biological product’ has the 
meaning that applies under section 351. 
‘‘(2) The terms ‘drug’ and ‘device’ have the 
meanings given such terms under section 201 of the 
Federal Food, Drug, and Cosmetic Act. 
‘‘(i) FUNDING.— 
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
For the purpose of carrying out this section, there 
are authorized to be appropriated $19,930,000,000 
for fiscal year 2004, $20,400,000,000 for fiscal year 
2005, $20,910,000,000 for fiscal year 2006, 
$21,430,000,000 
for 
fiscal 
year 
2007, 
and 
$21,970,000,000 for fiscal year 2008. 
‘‘(2) REWARDS FOR SIGNIFICANT ADVANCES.— 
Of the amounts appropriated under paragraph (1) 
for a fiscal year, the Director of the Institute shall 
reserve $50,000,000 for the fund under subsection 
(g).’’. 
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