175 
(i) REQUEST.—An eligible product de-
veloper may submit to the Secretary a 
written request for the eligible product de-
veloper to be authorized to obtain suffi-
cient quantities of an individual covered 
product subject to a REMS with ETASU. 
(ii) AUTHORIZATION.—Not later than 
120 days after the date on which a request 
under clause (i) is received, the Secretary 
shall, by written notice, authorize the eligi-
ble product developer to obtain sufficient 
quantities of an individual covered product 
subject to a REMS with ETASU for pur-
poses of— 
(I) development and testing that 
does not involve human clinical trials, 
if the eligible product developer has 
agreed to comply with any conditions 
the Secretary determines necessary; or 
(II) development and testing that 
involves human clinical trials, if the 
eligible product developer has— 
(aa)(AA) submitted proto-
cols, 
informed 
consent 
docu-
ments, and informational mate-
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176 
rials for testing that include pro-
tections that provide safety pro-
tections comparable to those pro-
vided by the REMS for the cov-
ered product; or 
(BB) otherwise satisfied the 
Secretary that such protections 
will be provided; and 
(bb) met any other require-
ments the Secretary may estab-
lish. 
(iii) NOTICE.—A covered product au-
thorization issued under this subparagraph 
shall state that the provision of the covered 
product by the license holder under the 
terms of the authorization will not be a 
violation of the REMS for the covered 
product. 
(3) AFFIRMATIVE DEFENSE.—In a civil action 
brought under paragraph (1), it shall be an affirma-
tive defense, on which the defendant has the burden 
of persuasion by a preponderance of the evidence— 
(A) that, on the date on which the eligible 
product developer requested to purchase suffi-
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177 
cient quantities of the covered product from the 
license holder— 
(i) neither the license holder nor any 
of its agents, wholesalers, or distributors 
was engaged in the manufacturing or com-
mercial marketing of the covered product; 
and 
(ii) neither the license holder nor any 
of its agents, wholesalers, or distributors 
otherwise had access to inventory of the 
covered product to supply to the eligible 
product developer on commercially reason-
able, market-based terms; 
(B) that— 
(i) the license holder sells the covered 
product through agents, distributors, or 
wholesalers; 
(ii) the license holder has placed no 
restrictions, explicit or implicit, on its 
agents, distributors, or wholesalers to sell 
covered products to eligible product devel-
opers; and 
(iii) the covered product can be pur-
chased by the eligible product developer in 
sufficient quantities on commercially rea-
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sonable, market-based terms from the 
agents, distributors, or wholesalers of the 
license holder; or 
(C) that the license holder made an offer 
to the individual specified pursuant to para-
graph (2)(A)(iii)(III), by a means of commu-
nication (electronic, written, or both) specified 
pursuant to such paragraph, to sell sufficient 
quantities of the covered product to the eligible 
product developer at commercially reasonable 
market-based terms— 
(i) for a covered product that is not 
subject to a REMS with ETASU, by the 
date that is 14 days after the date on 
which the license holder received the re-
quest for the covered product, and the eli-
gible product developer did not accept such 
offer by the date that is 7 days after the 
date on which the eligible product devel-
oper received such offer from the license 
holder; or 
(ii) for a covered product that is sub-
ject to a REMS with ETASU, by the date 
that is 20 days after the date on which the 
license holder received the request for the 
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covered product, and the eligible product 
developer did not accept such offer by the 
date that is 10 days after the date on 
which the eligible product developer re-
ceived such offer from the license holder. 
(4) REMEDIES.— 
(A) IN GENERAL.—If an eligible product 
developer prevails in a civil action brought 
under paragraph (1), the court shall— 
(i) order the license holder to provide 
to the eligible product developer without 
delay sufficient quantities of the covered 
product on commercially reasonable, mar-
ket-based terms; 
(ii) award to the eligible product de-
veloper reasonable attorney’s fees and costs 
of the civil action; and 
(iii) award to the eligible product de-
veloper a monetary amount sufficient to 
deter the license holder from failing to pro-
vide eligible product developers with suffi-
cient quantities of a covered product on 
commercially 
reasonable, 
market-based 
terms, if the court finds, by a preponder-
ance of the evidence— 
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(I) that the license holder delayed 
providing sufficient quantities of the 
covered product to the eligible product 
developer without a legitimate busi-
ness justification; or 
(II) that the license holder failed 
to comply with an order issued under 
clause (i). 
(B) MAXIMUM
MONETARY
AMOUNT.—A 
monetary amount awarded under subparagraph 
(A)(iii) shall not be greater than the revenue 
that the license holder earned on the covered 
product during the period— 
(i) beginning on— 
(I) for a covered product that is 
not subject to a REMS with ETASU, 
the date that is 31 days after the date 
on which the license holder received 
the request; or 
(II) for a covered product that is 
subject to a REMS with ETASU, the 
date that is 31 days after the later 
of— 
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181 
(aa) the date on which the 
license holder received the re-
quest; or 
(bb) the date on which the 
license holder received a copy of 
the covered product authorization 
issued by the Secretary in ac-
cordance with paragraph (2)(B); 
and 
(ii) ending on the date on which the 
eligible product developer received suffi-
cient quantities of the covered product. 
(C) AVOIDANCE
OF
DELAY.—The court 
may issue an order under subparagraph (A)(i) 
before conducting further proceedings that may 
be necessary to determine whether the eligible 
product developer is entitled to an award under 
clause (ii) or (iii) of subparagraph (A), or the 
amount of any such award. 
(c) LIMITATION OF LIABILITY.—A license holder for 
a covered product shall not be liable for any claim under 
Federal, State, or local law arising out of the failure of 
an eligible product developer to follow adequate safeguards 
to assure safe use of the covered product during develop-
ment or testing activities described in this section, includ-
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182 
ing transportation, handling, use, or disposal of the cov-
ered product by the eligible product developer. 
(d) NO VIOLATION OF REMS.—Section 505–1 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355– 
1) is amended by adding at the end the following new sub-
section: 
‘‘(l) PROVISION OF SAMPLES NOT A VIOLATION OF 
STRATEGY.—The provision of samples of a covered prod-
uct to an eligible product developer (as those terms are 
defined in section 301(a) of the Lower Costs, More Cures 
Act of 2019) shall not be considered a violation of the 
requirements of any risk evaluation and mitigation strat-
egy that may be in place under this section for such 
drug.’’. 
(e) RULE OF CONSTRUCTION.— 
(1) DEFINITION.—In this subsection, the term 
‘‘antitrust laws’’— 
(A) has the meaning given the term in 
subsection (a) of the first section of the Clayton 
Act (15 U.S.C. 12); and 
(B) includes section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) to the 
extent that such section applies to unfair meth-
ods of competition. 
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183 
(2) ANTITRUST LAWS.—Nothing in this section 
shall be construed to limit the operation of any pro-
vision of the antitrust laws. 
SEC. 302. REMS APPROVAL PROCESS FOR SUBSEQUENT 
FILERS. 
Section 505–1 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355–1), as amended by section 301, 
is further amended— 
(1) in subsection (g)(4)(B)— 
(A) in clause (i) by striking ‘‘or’’ after the 
semicolon; 
(B) in clause (ii) by striking the period at 
the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(iii) accommodate different, com-
parable aspects of the elements to assure 
safe use for a drug that is the subject of 
an application under section 505(j), and 
the applicable listed drug.’’; 
(2) in subsection (i)(1), by striking subpara-
graph (C) and inserting the following: 
‘‘(C)(i) Elements to assure safe use, if re-
quired under subsection (f) for the listed drug, 
which, subject to clause (ii), for a drug that is 
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the subject of an application under section 
505(j) may use— 
‘‘(I) a single, shared system with the 
listed drug under subsection (f); or 
‘‘(II) a different, comparable aspect of 
the elements to assure safe use under sub-
section (f). 
‘‘(ii) The Secretary may require a drug 
that is the subject of an application under sec-
tion 505(j) and the listed drug to use a single, 
shared system under subsection (f), if the Sec-
retary determines that no different, comparable 
aspect of the elements to assure safe use could 
satisfy the requirements of subsection (f).’’; 
(3) in subsection (i), by adding at the end the 
following: 
‘‘(3) SHARED
REMS.—If the Secretary ap-
proves, in accordance with paragraph (1)(C)(i)(II), a 
different, comparable aspect of the elements to as-
sure safe use under subsection (f) for a drug that 
is the subject of an abbreviated new drug application 
under section 505(j), the Secretary may require that 
such different comparable aspect of the elements to 
assure safe use can be used with respect to any 
other drug that is the subject of an application 
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185 
under section 505(j) or 505(b) that references the 
same listed drug.’’; and 
(4) by adding at the end the following: 
‘‘(m) SEPARATE REMS.—When used in this section, 
the terms ‘different, comparable aspect of the elements to 
assure safe use’ or ‘different, comparable approved risk 
evaluation and mitigation strategies’ means a risk evalua-
tion and mitigation strategy for a drug that is the subject 
of an application under section 505(j) that uses different 
methods or operational means than the strategy required 
under subsection (a) for the applicable listed drug, or 
other application under section 505(j) with the same such 
listed drug, but achieves the same level of safety as such 
strategy.’’. 
SEC. 303. RULE OF CONSTRUCTION. 
(a) IN GENERAL.—Nothing in this subtitle, the 
amendments made by this subtitle, or in section 505–1 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355–1), shall be construed as— 
(1) prohibiting a license holder from providing 
an eligible product developer access to a covered 
product in the absence of an authorization under 
this subtitle; or 
(2) in any way negating the applicability of a 
REMS with ETASU, as otherwise required under 
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such section 505–1, with respect to such covered 
product. 
(b) DEFINITIONS.—In this section, the terms ‘‘cov-
ered product’’, ‘‘eligible product developer’’, ‘‘license hold-
er’’, and ‘‘REMS with ETASU’’ have the meanings given 
such terms in section 301(a). 
Subtitle B—Pay-for-Delay 
SEC. 311. UNLAWFUL AGREEMENTS. 
(a) AGREEMENTS PROHIBITED.—Subject to sub-
sections (b) and (c), it shall be unlawful for an NDA or 
BLA holder and a subsequent filer (or for two subsequent 
filers) to enter into, or carry out, an agreement resolving 
or settling a covered patent infringement claim on a final 
or interim basis if under such agreement— 
(1) a subsequent filer directly or indirectly re-
ceives from such holder (or in the case of such an 
agreement between two subsequent filers, the other 
subsequent filer) anything of value, including a li-
cense; and 
(2) the subsequent filer agrees to limit or fore-
go research on, or development, manufacturing, 
marketing, or sales, for any period of time, of the 
covered product that is the subject of the application 
described in subparagraph (A) or (B) of subsection 
(g)(8). 
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(b) EXCLUSION.—It shall not be unlawful under sub-
section (a) if a party to an agreement described in such 
subsection demonstrates by clear and convincing evidence 
that the value described in subsection (a)(1) is compensa-
tion solely for other goods or services that the subsequent 
filer has promised to provide. 
(c) LIMITATION.—Nothing in this section shall pro-
hibit an agreement resolving or settling a covered patent 
infringement claim in which the consideration granted by 
the NDA or BLA holder to the subsequent filer (or from 
one subsequent filer to another) as part of the resolution 
or settlement includes only one or more of the following: 
(1) The right to market the covered product 
that is the subject of the application described in 
subparagraph (A) or (B) of subsection (g)(8) in the 
United States before the expiration of— 
(A) any patent that is the basis of the cov-
ered patent infringement claim; or 
(B) any patent right or other statutory ex-
clusivity that would prevent the marketing of 
such covered product. 
(2) A payment for reasonable litigation ex-
penses not to exceed $7,500,000 in the aggregate. 
(3) A covenant not to sue on any claim that 
such covered product infringes a patent. 
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188 
(d) ENFORCEMENT BY FEDERAL TRADE COMMIS-
SION.— 
(1) GENERAL APPLICATION.—The requirements 
of this section apply, according to their terms, to an 
NDA or BLA holder or subsequent filer that is— 
(A) a person, partnership, or corporation 
over which the Commission has authority pur-
suant to section 5(a)(2) of the Federal Trade 
Commission Act (15 U.S.C. 45(a)(2)); or 
(B) a person, partnership, or corporation 
over which the Commission would have author-
ity pursuant to such section but for the fact 
that such person, partnership, or corporation is 
not organized to carry on business for its own 
profit or that of its members. 
(2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES 
ENFORCEMENT AUTHORITY.— 
(A) IN GENERAL.—A violation of this sec-
tion shall be treated as an unfair or deceptive 
act or practice in violation of section 5(a)(1) of 
the Federal Trade Commission Act (15 U.S.C. 
45(a)(1)). 
(B) POWERS OF COMMISSION.—Except as 
provided in subparagraph (C) and paragraphs 
(1)(B) and (3)— 
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(i) the Commission shall enforce this 
section in the same manner, by the same 
means, and with the same jurisdiction, 
powers, and duties as though all applicable 
terms and provisions of the Federal Trade 
Commission Act (15 U.S.C. 41 et seq.) 
were incorporated into and made a part of 
this section; and 
(ii) any NDA or BLA holder or subse-
quent filer that violates this section shall 
be subject to the penalties and entitled to 
the privileges and immunities provided in 
the Federal Trade Commission Act. 
(C) JUDICIAL REVIEW.—In the case of a 
cease and desist order issued by the Commis-
sion under section 5 of the Federal Trade Com-
mission Act (15 U.S.C. 45) for violation of this 
section, a party to such order may obtain judi-
cial review of such order as provided in such 
section 5, except that— 
(i) such review may only be obtained 
in— 
(I) the United States Court of 
Appeals for the District of Columbia 
Circuit; 
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(II) the United States Court of 
Appeals for the circuit in which the 
ultimate parent entity, as defined in 
section 801.1(a)(3) of title 16, Code 
of Federal Regulations, or any suc-
cessor thereto, of the NDA or BLA 
holder (if any such holder is a party 
to such order) is incorporated as of 
the date that the application described 
in subparagraph (A) or (B) of sub-
section (g)(8) or an approved applica-
tion that is deemed to be a license for 
a biological product under section 
351(k) of the Public Health Service 
Act (42 U.S.C. 262(k)) pursuant to 
section 7002(e)(4) of the Biologics 
Price Competition and Innovation Act 
of 2009 (Public Law 111–148; 124 
Stat. 817) is submitted to the Com-
missioner of Food and Drugs; or 
(III) the United States Court of 
Appeals for the circuit in which the 
ultimate parent entity, as so defined, 
of any subsequent filer that is a party 
to such order is incorporated as of the 
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191 
date that the application described in 
subparagraph (A) or (B) of subsection 
(g)(8) is submitted to the Commis-
sioner of Food and Drugs; and 
(ii) the petition for review shall be 
filed in the court not later than 30 days 
after such order is served on the party 
seeking review. 
(3) ADDITIONAL ENFORCEMENT AUTHORITY.— 
(A) CIVIL
PENALTY.—The Commission 
may commence a civil action to recover a civil 
penalty in a district court of the United States 
against any NDA or BLA holder or subsequent 
filer that violates this section. 
(B) SPECIAL
RULE
FOR
RECOVERY
OF 
PENALTY
IF
CEASE
AND
DESIST
ORDER 
ISSUED.— 
(i) IN GENERAL.—If the Commission 
has issued a cease and desist order in a 
proceeding under section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) for 
violation of this section— 
(I) the Commission may com-
mence a civil action under subpara-
graph (A) to recover a civil penalty 
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against any party to such order at 
any time before the expiration of the 
1-year period beginning on the date 
on which such order becomes final 
under section 5(g) of such Act (15 
U.S.C. 45(g)); and 
(II) in such civil action, the find-
ings of the Commission as to the ma-
terial facts in such proceeding shall be 
conclusive, unless— 
(aa) the terms of such order 
expressly provide that the Com-
mission’s findings shall not be 
conclusive; or 
(bb) such order became final 
by reason of section 5(g)(1) of 
such Act (15 U.S.C. 45(g)(1)), in 
which case such findings shall be 
conclusive if supported by evi-
dence. 
(ii) RELATIONSHIP TO PENALTY FOR 
VIOLATION
OF
AN
ORDER.—The penalty 
provided in clause (i) for violation of this 
section is separate from and in addition to 
any penalty that may be incurred for viola-
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tion of an order of the Commission under 
section 5(l) of the Federal Trade Commis-
sion Act (15 U.S.C. 45(l)). 
(C) AMOUNT OF PENALTY.— 
(i) IN GENERAL.—The amount of a 
civil penalty imposed in a civil action under 
subparagraph (A) on a party to an agree-
ment described in subsection (a) shall be 
sufficient to deter violations of this section, 
but in no event greater than— 
(I) if such party is the NDA or 
BLA holder (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who gave the 
value described in subsection (a)(1)), 
the greater of— 
(aa) 3 times the value re-
ceived by such NDA or BLA 
holder (or by such subsequent 
filer) that is reasonably attrib-
utable to the violation of this sec-
tion; or 
(bb) 3 times the value given 
to the subsequent filer (or to the 
other subsequent filer) reason-
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194 
ably attributable to the violation 
of this section; and 
(II) if such party is the subse-
quent filer (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who received 
the value described in subsection 
(a)(1)), 3 times the value received by 
such subsequent filer that is reason-
ably attributable to the violation of 
this section. 
(ii) FACTORS FOR CONSIDERATION.— 
In determining such amount, the court 
shall take into account— 
(I) the nature, circumstances, ex-
tent, and gravity of the violation; 
(II) with respect to the violator, 
the degree of culpability, any history 
of violations, the ability to pay, any 
effect on the ability to continue doing 
business, profits earned by the NDA 
or BLA holder (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who gave the 
value described in subsection (a)(1)), 
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compensation received by the subse-
quent filer (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who received 
the value described in subsection 
(a)(1)), and the amount of commerce 
affected; and 
(III) other matters that justice 
requires. 
(D) INJUNCTIONS AND OTHER EQUITABLE 
RELIEF.—In a civil action under subparagraph 
(A), the United States district courts are em-
powered to grant mandatory injunctions and 
such other and further equitable relief as they 
deem appropriate. 
(4) REMEDIES
IN
ADDITION.—Remedies pro-
vided in this subsection are in addition to, and not 
in lieu of, any other remedy provided by Federal 
law. 
(5) PRESERVATION OF AUTHORITY OF COMMIS-
SION.—Nothing in this section shall be construed to 
affect any authority of the Commission under any 
other provision of law. 
(e) FEDERAL TRADE COMMISSION RULEMAKING.— 
The Commission may, in its discretion, by rule promul-
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gated under section 553 of title 5, United States Code, 
exempt from this section certain agreements described in 
subsection (a) if the Commission finds such agreements 
to be in furtherance of market competition and for the 
benefit of consumers. 
(f) ANTITRUST LAWS.—Nothing in this section shall 
modify, impair, limit, or supersede the applicability of the 
antitrust laws as defined in subsection (a) of the first sec-
tion of the Clayton Act (15 U.S.C. 12(a)), and of section 
5 of the Federal Trade Commission Act (15 U.S.C. 45) 
to the extent that such section 5 applies to unfair methods 
of competition. Nothing in this section shall modify, im-
pair, limit, or supersede the right of a subsequent filer 
to assert claims or counterclaims against any person, 
under the antitrust laws or other laws relating to unfair 
competition. 
(g) DEFINITIONS.—In this section: 
(1) AGREEMENT
RESOLVING
OR
SETTLING
A 
COVERED
PATENT
INFRINGEMENT
CLAIM.—The 
term ‘‘agreement resolving or settling a covered pat-
ent infringement claim’’ means any agreement 
that— 
(A) resolves or settles a covered patent in-
fringement claim; or 
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197 
(B) is contingent upon, provides for a con-
tingent condition for, or is otherwise related to 
the resolution or settlement of a covered patent 
infringement claim. 
(2) COMMISSION.—The term ‘‘Commission’’ 
means the Federal Trade Commission. 
(3) COVERED PATENT INFRINGEMENT CLAIM.— 
The term ‘‘covered patent infringement claim’’ 
means an allegation made by the NDA or BLA hold-
er to a subsequent filer (or, in the case of an agree-
ment between two subsequent filers, by one subse-
quent filer to another), whether or not included in 
a complaint filed with a court of law, that— 
(A) the submission of the application de-
scribed in subparagraph (A) or (B) of para-
graph (9), or the manufacture, use, offering for 
sale, sale, or importation into the United States 
of a covered product that is the subject of such 
an application— 
(i) in the case of an agreement be-
tween an NDA or BLA holder and a sub-
sequent filer, infringes any patent owned 
by, or exclusively licensed to, the NDA or 
BLA holder of the covered product; or 
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198 
(ii) in the case of an agreement be-
tween two subsequent filers, infringes any 
patent owned by the subsequent filer; or 
(B) in the case of an agreement between 
an NDA or BLA holder and a subsequent filer, 
the covered product to be manufactured under 
such application uses a covered product as 
claimed in a published patent application. 
(4) COVERED
PRODUCT.—The term ‘‘covered 
product’’ means a drug (as defined in section 201(g) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(g))), including a biological product (as 
defined in section 351(i) of the Public Health Serv-
ice Act (42 U.S.C. 262(i))). 
(5) NDA OR BLA HOLDER.—The term ‘‘NDA 
or BLA holder’’ means— 
(A) the holder of— 
(i) an approved new drug application 
filed under section 505(b)(1) of the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(1)) for a covered product; 
or 
(ii) a biologics license application filed 
under section 351(a) of the Public Health 
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