first payment under the contract, and sufficient sup-
ply for susceptibility device manufacturers; 
‘‘(2) identify, track, and publicly report drug 
resistance data and trends using available data re-
lated to the antimicrobial drug; 
‘‘(3) develop and implement education and com-
munications strategies, including communications 
for individuals with limited English proficiency and 
individuals with disabilities, for health care profes-
sionals and patients about appropriate use of the 
antimicrobial drug; 
‘‘(4) submit an appropriate use assessment to 
the Secretary, Committee, Food and Drug Adminis-
tration, and Centers for Disease Control and Pre-
vention every 2 years regarding use of the anti-
microbial drug, including how the drug is being mar-
keted; 
‘‘(5) submit a plan for registering the drug in 
additional countries where an unmet medical need 
exists; 
‘‘(6) ensure a reliable drug supply chain, where 
any interruption to the supply chain will not last for 
more than 60 days in the United States; 
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‘‘(7) complete any postmarketing studies re-
quired by the Food and Drug Administration in a 
timely manner; 
‘‘(8) produce the drug at a reasonable volume 
determined with the Secretary to ensure patient ac-
cess to the drug; 
‘‘(9) price the drug at a price that is not lower 
than a comparable generic drug; 
‘‘(10) abide by the manufacturing and environ-
mental best practices in the supply chain to ensure 
that there is no discharge into, or contamination of, 
the environment by antimicrobial agents or products 
as a result of the manufacturing process; and 
‘‘(11) abide by other terms as the Secretary 
may require. 
‘‘(c) AMOUNT AND TERMS OF CONTRACTS.— 
‘‘(1) AMOUNTS.—A subscription contract under 
this section shall be for the sale to the Secretary of 
any quantity of the antimicrobial drug needed over 
the term of the contract under paragraph (2), at an 
agreed upon price, for a total projected amount de-
termined by the Secretary that is not less than 
$750,000,000 and not more than $3,000,000,000, 
adjusted for inflation, accounting for the favored 
characteristics of the drug, as determined by the 
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Secretary, in consultation with the Committee, under 
subsection (a)(2), and shall be allocated from the 
amount made available under section 399SS(a). Not 
later than 6 months after the subscription contract 
is granted under subsection (a), the Secretary shall 
provide payments for purchased drugs in install-
ments established by the Secretary in consultation 
with the sponsor of the antimicrobial drug and in ac-
cordance with subsection (d)(3). Funds received by 
the sponsor shall be used to support criteria quali-
fication under subsection (b), the completion of post-
marketing clinical studies, manufacturing, other pre-
clinical and clinical activities, or other activities 
agreed to by the Secretary and sponsor in the con-
tract. 
‘‘(2) TERMS.— 
‘‘(A) INITIAL TERM.—The initial term of a 
contract under this subsection shall be no less 
than 5 years or greater than the greater of 10 
years or the remaining period of time during 
which the sponsor has patent protections or a 
remaining exclusivity period with respect to the 
antimicrobial drug in the United States, as list-
ed in the publication of the Food and Drug Ad-
ministration entitled ‘Approved Drug Products 
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with Therapeutic Equivalence Evaluations’. 
Payments may be in equal annual installments 
with the option to redeem 50 percent of the last 
year’s reimbursement in year 1 of the contract 
in order to offset costs of establishing manufac-
turing capacity, or another subscription ar-
rangement to which the Secretary and sponsor 
agree. Subscription contracts shall remain in ef-
fect for such period even if the infection treated 
by such antimicrobial drug is later removed 
from the list of infections under section 
399OO(c)(1). 
‘‘(B) EXTENSION
OF
CONTRACTS.—The 
Secretary may extend a subscription contract 
with a sponsor under this subsection beyond the 
initial contract period. A single contract exten-
sion may be in effect not later than the date on 
which all periods of exclusivity granted by the 
Food and Drug Administration expire and shall 
be in an amount not to exceed $25,000,000 per 
year. All other terms of an extended contract 
shall be the same as the terms of the initial 
contract. The total amount of funding used on 
such contract extensions shall be no more than 
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$1,000,000,000, and shall be allocated from the 
amount made available under section 399SS. 
‘‘(C) MODIFICATION OF CONTRACTS.—The 
Secretary or sponsor, 1 year after the start of 
the contract period under this subsection and 
every 2 years thereafter, may request a modi-
fication of the amount of the contract based on 
information that adjusts favored characteristics 
in section 399OO(c)(2). 
‘‘(3) ADJUSTMENT.—In the case of an anti-
microbial drug that received a transitional subscrip-
tion contract under section 399OO(f), the amount of 
a subscription contract for such drug under this sec-
tion shall be reduced by the amount of the transi-
tional subscription contract under such section 
399OO(f) for such drug. 
‘‘(4) CONTRACTS
FOR
GENERIC
AND
BIO-
SIMILAR
VERSIONS.—Notwithstanding any other 
provision in this part, the Secretary may award a 
subscription contract under this section to a manu-
facturer of a generic or biosimilar version of an anti-
microbial drug for which a subscription contract has 
been awarded under this section. Such contracts 
shall be awarded in accordance with a procedure, in-
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