Award/Contract — Moderna COVID-19 Vaccine, Contract No. W911QY20C0100
Summary
An Award/Contract on Standard Form 26, Contract No. W911QY20C0100, with the contractor shown as MODERNATX, INC. The form states a total amount of contract of $1,525,000,000.00, and its Section A describes a requirement of the Natick Division of Army Contracting Command - Aberdeen Proving Ground (ACC-APG) for SARS-CoV-2 mRNA-1273 Vaccine doses under Operation Warp Speed. Section B lists priced items, including item 0001AA for 15,000,000 doses at $12.25 each ($183,750,000.00) and an EUA or BLA incentive item 0003AA of $3.00 each ($45,000,000.00), earned only if an Emergency Use Authorization or Biologics License Application is obtained no later than 31 January 2021. The pages at the end list reports and plans such as a Risk Management Plan (RMP).
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Cite this document
“Award/Contract — Moderna COVID-19 Vaccine, Contract No. W911QY20C0100.”
Original at www.hhs.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/hhs-moderna-covid-19-vaccine-contract-w911qy20c0100-8ac4303b12/
, SHA-256 b662000f0af73beb123b329375b5af9d97f936c187913672a9b97588b1f11420.Full text
1. THIS CONTRACT' IS A RATED ORDER RATING
PAGE OF PAGES
AWARD/CONTRACT UNDER DPAS (15 CFR 700) 1 I 53
2. CONTRACT (Proc. Inst. !dent) NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
VV911QY20C0100 09 Aug 2020 0011534693
5. ISSUED BY CODE W91 1C/Y 6. ADMINISTERED BY (Ifother than Item 5) C0DEIS2206A
WOK ACC-APG NATICK DEFENSE CONTRACT MANAGEMENT AGENCY
CONTRACT NG DIVISION DCMA BOSTON
BLDG 1 GENERAL GREENE AVENUE 495 SUMMER STREET
NATICK MA 01760-5011 BOSTON MA 02210-2138
7. NAME AND ADDRESS OF CONTRACTOR (No., street city, county, state and z0 code) 8. DELIVERY
MODERNATX, INC. [ ] FOB ORIGIN [Xi OTHER (See belon)
9 DISCOUNT FOR PROMPTP AY MENT
200 TECHNOLOGY SO
CAMBRIDGE MA 02139-3578
10 SUBMIT INVOICES 1 III \I
(4 copies unless otheruise spec(lied)
TO THE ADDRESS Section G
CODE 6RF'85 FACILITY CODE SHOWN IN:
11. SHIP TO/MARK FOR CODE 12. PAYMENT WILL BE MADE BY CODE M00337
DEFENSE F NANCE AND ACCOUNT NG SERVICE
DFAS - COLUMBUS CENTER (H00337)
NORTH ENTITLEMENT OPERATIONS
P.O. BOX 182317
See Schedule COLUMBUS OH 432113-22(56
13. AUTHORITY FOR USING OT HER THAN FULL AND OPEN 14. ACCOUNTING AND APPROPRIATION DATA
COMPETITION: See Schedule
[ X 110 U.S.C. 2304(c)( 2 ) [ ] 41 U.S.C. 253(c)( )
15A. ITEM NO. 15B. SUPPLIES/ SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
SEE SCHEDULE
15G. TOTAL AMO UNTO F CONTRACT $1,525,000,000.00
16. TABLE OF CONTENTS
(X) I SEC. I DESCRIPTION I PAGE(S) (X) I SEC. I DESCRIPTION I PAGE(S)
PART I -111ESCHE)ULE PART II - CO NIRACT CLAUSES
X A SOLICITATION/ CONTRACT FORM 1 -2 X 1 I !CONTRACT CLAUSES 145 - 51
X B SUPPLIES OR SERVICES AND PRICES/ COSTS 3-18 PART III — LIST° F DOCUMENTS EXHIBITS AND OTHER ATTACH.
X C DESCRIPTION/ SPECS./ WORK STATEMENT 19 - 27 X I J ILIST OF ATTACHMENTS 52 - 53
X D PACKAGING AND MARKING 28 PART IV - REPRESENTAMONS AND INS'IRUCTIO NS
X E INSPECTION AND ACCEPTANCE 29 - 30 REPRESENTATIONS, CERTIFICATIONS AND
K
X F DELIVERIES OR PERFORMANCE 31 - 33 OTHER ST AT EMENT S OF OFFERORS
X G CONTRACT ADMINISTRATION DATA 34 - 38 L INSTRS, CONDS., AND NOTICES TO OFFERORS
X H SPECIAL CONTRACT REQUIREMENTS 39 - 44 M EVALUATION FACTORS FOR AWARD
CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE
17 [ I CONTRACTOR'S NEGOTIATED AGREEMENT Contractor is reouired to s go thic 18 [ ] SEALEMID AWARD (Contractor is not required to sign this document)
document and retuml cooks to issuing office) Contractor agrees to furnish and deliver all Your bid on Solicitation Number W911QY20R0043
items or perform all the services set forth or otherwise identified above and on any continuation
sheets for the consideration stated herein The rights and obligations of the parties to this
contract shall be subject to and governed by the following documents: (a) this award/contract, including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as
(b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications. to the terms listed above and on any continuation sheets This award consummates the contract which consists of the
as are attached or incorporated by reference herein following documents: (a) the Governments solicitation and your bid, and (b) this award/contract No further contractual
(Attachments are listed herein) document is necessary (Block 18 should be checled only when awarding a sealed-bid contract)
19A.NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER
/ BRANCH CHIEF
TEL: EMAIL:
19B.NAME OF CONTRACTOR 19C.DATE SIGNED 20 20C. DATE SIGNED
y..) ) ( 6 11-Aug-2020
BY BY '
(Signature of person authorized to sign) (Signature of Contracting Officer)
AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 26 (REV 5/2011)
Previous edition is NOT usable Prescribed by GSA — FAR (48 CFR) 53 214(a)
W911QY20C0100
Page 2 of 53
Section A - Solicitation/Contract Form
A.1 The U.S. Army Contracting Command - Aberdeen Proving Ground (ACC-APG), Natick Division has a
requirement for up to 500 million SARS-CoV-2 mRNA-1273 Vaccine doses (100m) in support of Joint Program
Executive Office - Chemical Biological Radiological Nuclear Defense (JPEO-CBRND), the Assistant Secretary for
Preparedness and Response (ASPR), and Biomedical Advanced Research and Development Authority (BARDA).
All doses of mRNA-1273 Vaccine referenced herein are 1001.tg doses. All doses will be delivered in a multi- dose
vial with a volume sufficient for 10 doses per vial.
W911QY20C0100
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Section B - Supplies or Services and Prices
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0001 $0.00
SARS-CoV-2 mRNA-1273 Vaccine
FFP
The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-
1273 Vaccine filled drug product (FDP), JAW Section C, Statement of Work
(SOW) and CDRLs (Exhibit A) on this contract.
PROJECT: Operation Warp Speed
NET AMT $0.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0001AA 15,000,000 Each $12.25 $183,750,000.00
15M Doses
FFP
FOB: Origin (Shipping Point)
PURCHASE REQUEST NUMBER: 0011534693
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $183,750,000.00
ACRN AA $183,750,000.00
CIN: GFEBS001153469300001
W911QY20C0100
Page 4 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0001AB 22,000,000 Each $12.25 $269,500,000.00
22M Doses
FFP
FOB: Origin (Shipping Point)
PURCHASE REQUEST NUMBER: 0011534693
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $269,500,000.00
ACRN AB $269,500,000.00
CIN: GFEBS001153469300002
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0001AC 30,000,000 Each $12.25 $367,500,000.00
30M Doses
FFP
FOB: Destination
PURCHASE REQUEST NUMBER: 0011534693
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $367,500,000.00
ACRN AA $367,500,000.00
CIN: GFEBS001153469300003
W911QY20C0100
Page 5 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0001AD 33,000,000 Each $12.25 $404,250,000.00
33M Doses
FFP
FOB: Destination
PURCHASE REQUEST NUMBER: 0011534693
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $404,250,000.00
ACRN AA $404,250,000.00
CIN: GFEBS001153469300004
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0002 1 Job $0.00 TBN
Vendor Managed Inventory
FFP
a. The contractor shall secure, manage and maintain storage for up to 100M doses
of mRNA-1273 vaccine and deliver to the designated government facility in
accordance with Section F.
b.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $0.00
W911QY20C0100
Page 6 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0003 $0.00
EUA or BLA Incentive
FFP
This is an incentive CLIN and will be earned only if an Emergency Use
Authorization (EUA) or Biologics License Application (BLA) is obtained no later
than 31 January 2021.
PROJECT: Operation Warp Speed
NET AMT $0.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0003AA 15,000,000 Each $3.00 $45,000,000.00
EUA or BLA Incentive
FFP
If earned, this incentive shall be paid at final acceptance of subCLIN 0001AA.
FOB: Destination
PSC CD: 6505
NET AMT $45,000,000.00
W911QY20C0100
Page 7 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0003AB 22,000,000 Each $3.00 $66,000,000.00
EUA or BLA Incentive
FFP
If earned, this incentive shall be paid at fmal acceptance of subCLIN 0001AB.
FOB: Destination
PSC CD: 6505
NET AMT $66,000,000.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0003AC 30,000,000 Each $3.00 $90,000,000.00
EUA or BLA Incentive
FFP
If earned, this incentive shall be paid at final acceptance of subCLIN 0001AC.
FOB: Destination
PSC CD: 6505
NET AMT $90,000,000.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0003AD 33,000,000 Each $3.00 $99,000,000.00
EUA or BLA Incentive
FFP
If earned, this incentive shall be paid at final acceptance of subCLIN 0001AD.
FOB: Destination
PSC CD: 6505
NET AMT $99,000,000.00
W911QY20C0100
Page 8 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0004 1 Job NSP
Technical Data
FFP
The contractor shall deliver technical Data IAW Contract Data Requirements List
(CDRL) IAW deliveries in Section C.4 and Section J, Exhibit A.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1001 $0.00
OPTION SARS-CoV-2 mRNA-1273 Vaccine
FFP
The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-
1273 Vaccine filled drug product (FDP), JAW Section C, Statement of Work
(SOW) and CDRLs (Exhibit A) on this contract.
PROJECT: Operation Warp Speed
NET AMT $0.00
W911QY20C0100
Page 9 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1001AA 33,200,000 Each $16.50 $547,800,000.00
OPTION 33.2M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $547,800,000.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1001AB 33,400,000 Each $16.50 $551,100,000.00
OPTION 33.4M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later tha
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $551,100,000.00
W911QY20C0100
Page 10 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1001AC 33,400,000 Each $16.50 $551,100,000.00
OPTION 33.4M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $551,100,000.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1002 1 Job $0.00 TBN
OPTION Vendor Managed Inventory
FFP
a. The contractor shall secure, manage and maintain storage for up to 100M doses
of mRNA-1273 vaccine and deliver to the designated government facility in
accordance with Section F.
b.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $0.00
W911QY20C0100
Page 11 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2001 $0.00
OPTION SARS-CoV-2 mRNA-1273 Vaccine
FFP
The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-
1273 Vaccine filled drug product (FDP), IAW Section C, Statement of Work
(SOW) and CDRLs (Exhibit A) on this contract.
PROJECT: Operation Warp Speed
NET AMT $0.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
200 1 AA 33,400,000 Each $16.50 $551,100,000.00
OPTION 33.4M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $551,100,000.00
W911QY20C0100
Page 12 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2001AB 33,400,000 Each $16.50 $551,100,000.00
OPTION 33.4M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b.The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $551,100,000.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2001AC 33,200,000 Each $16.50 $547,800,000.00
OPTION 33.2M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b.The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $547,800,000.00
W911QY20C0100
Page 13 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2002 1 Job $0.00 TBN
OPTION Vendor Managed Inventory
FFP
a. The contractor shall secure, manage and maintain storage for up to 100M doses
of mRNA-1273 vaccine and deliver to the designated government facility in
accordance with Section F.
b.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $0.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3001 $0.00
OPTION SARS-CoV-2 mRNA-1273 Vaccine
FFP
The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-
1273 Vaccine filled drug product (FDP), IAW Section C, Statement of Work
(SOW) and CDRLs (Exhibit A) on this contract.
PROJECT: Operation Warp Speed
NET AMT $0.00
W911QY20C0100
Page 14 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3001AA 33,400,000 Each $16.50 $551,100,000.00
OPTION 33.4M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $551,100,000.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3001AB 33,400,000 Each $16.50 $551,100,000.00
OPTION 33.4M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $551,100,000.00
W911QY20C0100
Page 15 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3001AC 33,200,000 Each $16.50 $547,800,000.00
OPTION 33.2M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $547,800,000.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3002 1 Job $0.00 TBN
OPTION Vendor Managed Inventory
FFP
The contractor shall secure, manage and maintain storage for up to 100M doses of
mRNA-1273 vaccine and deliver to the designated government facility in
accordance with Section F.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $0.00
W911QY20C0100
Page 16 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4001 $0.00
OPTION SARS-CoV-2 mRNA-1273 Vaccine
FFP
The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-
1273 Vaccine filled drug product (FDP), IAW Section C, Statement of Work
(SOW) and CDRLs (Exhibit A) on this contract.
PROJECT: Operation Warp Speed
NET AMT $0.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4001AA 33,400,000 Each $16.50 $551,100,000.00
OPTION 33.4M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $551,100,000.00
W911QY20C0100
Page 17 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4001AB 33,400,000 Each $16.50 $551,100,000.00
OPTION 33.4M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $551,100,000.00
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4001AC 33,200,000 Each $16.50 $547,800,000.00
OPTION 33.2M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than
b. The government shall provide notification to exercise the option.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $547,800,000.00
W911QY20C0100
Page 18 of 53
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4002 1 Job $0.00 TBN
OPTION Vendor Managed Inventory
FFP
The contractor shall secure, manage and maintain storage for up to 100M doses of
mRNA-1273 vaccine and deliver to the designated government facility in
accordance with Section F.
b.
FOB: Destination
PROJECT: Operation Warp Speed
PSC CD: 6505
NET AMT $0.00
W911QY20C0100
Page 19 of 53
Section C - Descriptions and Specifications
STATEMENT OF WORK
LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE
C.1 SCOPE. The Department of Defense and Health and Human Services (HHS) require large scale
manufacturing of vaccine doses in support of the national emergency response to the Coronavirus Disease 2019
(COVID-19) for the United States Government (USG) and the US population.
C.1.1 Background. In December 2019, a novel coronavirus now known as SARS-CoV-2 was first detected in
Wuhan, Hubei Province, People's Republic of China, causing outbreaks of the coronavirus disease COVID-19 that
has now spread globally. The Secretary of Health and Human Service declared a public health emergency on
January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19.
On March 1, 2020, the President of the United States, pursuant to sections 01 and 301 of the National Emergencies
Act (50 U.S.C. 1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42
U.S.C. 1320b-5), proclaimed that the COVID-19 outbreak in the United States constitutes a national emergency.
C.1.1.1 Under Operation Warp Speed (OWS), the Department of Defense and HHS are leading a whole of nation
effort to ensure development of promising vaccine, diagnostic and therapeutic candidates and ensure that these
medical countermeasures are available in the quantities required to reduce SARS-CoV-2 transmission, identify prior
and/or current infection, and improve patient care, thereby mitigating the impact of COVID-19 on the nation and its
people. The DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRD) is providing expertise and contracting support to HHS, in compliance with PL 115-92 Authorization
Letter for DoD Medical Priorities, through an Interagency Agreement, signed April 23, 2020. As OWS products
progress to clinical trials to evaluate the safety and efficacy of vaccines and therapeutics, it is critical that, in
parallel, the USG supports large scale manufacturing so that vaccine doses or therapeutic treatment courses are
immediately available for nationwide access as soon as a positive efficacy signal is obtained and the medical
countermeasures are authorized for widespread use.
C.1.2 Objective: The objective of this effort is to obtain the following:
a. Base Period: Large scale manufacturing of 100 million vaccine doses
b. Option Period 1: Large scale manufacturing of 100 million vaccine doses
c. Option Period 2: Large scale manufacturing of 100 million vaccine doses
d. Option Period 3: Large scale manufacturing of 100 million vaccine doses
e. Option Period 4: Large scale manufacturing of 100 million vaccine doses
The Base Period is 9 months, with overlapping options for a total of 20 months if all options are exercised.
C.2 APPLICABLE DOCUMENTS.
C.2.1 Federal Documents:
C.2.1.1 Title 21 Code of Federal Regulations (CFR), Food and Drugs: Part 210, Current Good Manufacturing
Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; and, Part 211, Current Good
Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General.
(https://www.ecfr.gov/cgi-bin/text-
idx?SID=a95cab20f443897a400bb7e44a27cf4c&mc=true&tp1=/ecfrbrowse/Title21/21cfrv4_02.tpl#0)
C.3 REQUIREMENTS. Independently, and not as an agent of the USG, in accordance with the Proposal
submitted by ModernaTX, Inc. in response to Solicitation Number W911QY20R0043, Titled, "Advanced
Procurement of mRNA-1273 Vaccine for Prevention of SARS-CoV-2 Coronavirus (COVID-19)"), dated July 10,
2020 (and any subsequent USG-approved revisions thereto), the contractor shall provide all necessary services,
W911QY20C0100
Page 20 of 53
qualified personnel, material, equipment and facilities (not otherwise provided by the USG under the terms of this
contract) to perform the specific tasks set forth below.
C.3.1 Contract Line Item Number (CLIN) 0001 - Base Period: Large Scale Manufacturing of 100 Million
Vaccine Doses.
C.3.1.1 The contractor shall complete all scope required for the production, release and delivery use of 100
million Final Drug Product (FDP) doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include, the following
tasks and other activities reasonably contemplated by such task:
C.3.1.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product
remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be
under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of
12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the
assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,
FDA Interactions and Inspections Documentation.
C.3.1.1.2 cGMP manufacturing of 100 million doses fully compliant with 21 CFR 210 and 211.
C.3.1.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations
and that labeling is updated as appropriate.
C.3.1.1.4 Coordinating with FDA to establish an approved commercial vial label, carton and packaging insert
(printed or electronic).
C.3.1.1.5 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of
PL 113-54 (Nov. 27, 22013), including product verification, serialization, traceability and detection and response
requirements, subject to any exceptions established by or the enforcement discretion of the FDA, including
"Exemption from Certain Product Tracing and Product Identification Requirements Under Section 582 of the FD&C
Act" (April 2020).
C.3.1.1.6 In coordination with the USG, the contractor shall conduct a demonstration of the vaccine shipping
process prior to the first delivery of FDP doses at a time mutually agreed to by the contractor and the USG.
Moderna shall provide specifications and details associated with the shipping process and containers (IAW CDRL
A005) to enable the USG to adequately plan and prepare for potential distribution of the vaccine.
C.3.1.1.7 Following release of product the contractor shall, promptly deliver product to the designated delivery site
via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. In the unforeseen event
that a designated delivery site cannot receive product and the contractor provides storage beyond 20 days of product
release, the contract will be subject to modification for acceptance purposes.
C.3.1.2 Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and
FDA representatives for required site visits and audits at facilities used to support this contract throughout the period
of performance of the contract.
C.3.1.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing
the finding and corrective action(s) in accordance with CDRL A001.
C.3.1.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and Contracting Officer's
Representative (COR) within of a scheduled FDA audit or within of an ad hoc site visit or
audit if the FDA does not provide advance notice. The contractor shall provide copies of any FDA Audit Report
received from subcontractors that occur as a result of this contract or for this product within of
receiving correspondence from the FDA or third party in accordance with CDRL A002. The Contractor shall
W911QY20C0100
Page 21 of 53
provide the Contracting Officer with a plan for addressing areas of nonconformance, if any are identified, within•
of submittal of the audit report in accordance with CDRL A002.
C.3.1.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the USG
has visibility and input on all FDA communications regarding the drugs and biologics for the following, but not
limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement
documentation in accordance with CDRL A002.
C.3.2 CLIN 1001 - Option Period 1: Large Scale Manufacturing of 100 Million Vaccine Doses.
C.3.2.1 The contractor shall complete all scope required for the production, release and delivery use of 100
million FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other
activities reasonably contemplated by such tasks:
C.3.2.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product
remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be
under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of
12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the
assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,
FDA Interactions and Inspections Documentation.
C.3.2.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement
discretion of the FDA.
C.3.2.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations
and that labeling is updated.
C.3.2.1.4 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of
PL 113-54 (Nov. 27, 22013), including product verification, serialization, traceability and detection and response
requirements subject to any exceptions established by or the enforcement discretion of the FDA.
C.3.2.1.5 Following release of the product the contractor shall deliver the product to the designated distribution site
via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural
disaster or other emergency affecting a designated delivery site restricts such site's ability to receive product, the
Contractor and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed
Inventory (VMI) at the contractor site.
C.3.2.2 Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and
FDA representatives for required site visits and audits at facilities used to support this contract throughout the period
of performance of the contract.
C.3.2.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the
finding and corrective action(s) in accordance with CDRL A001.
C.3.2.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within of a
scheduled FDA audit or within of an ad hoc site visit or audit if the FDA does not provide advance notice.
The contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of
this contract or for this product within of receiving correspondence from the FDA or third party in
accordance with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areas
of nonconformance, if any are identified, within of submittal of the audit report in accordance with
CDRL A002.
C.3.2.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the
USG has visibility and input on all FDA communications regarding the drugs and biologics for the following, but
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not limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement
documentation in accordance with CDRL A002.
C.3.3 CLIN 2001 - Option Period 2: Large Scale Manufacturing of 100 Million Vaccine Doses.
C.3.3.1 The contractor shall complete all scope required for the production, release and delivery use of 100 million
FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other activities
reasonably contemplated by such tasks:
C.3.3.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product
remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be
under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of
12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the
assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,
FDA Interactions and Inspections Documentation.
C.3.3.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement
discretion of the FDA.
C.3.3.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations
and that labeling is updated as appropriate.
C.3.3.1.4 Ensuring that the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-
585 of PL 113-54 (Nov. 27, 2013), including product verification, serialization, traceability and detection and
response requirements, subject to any exceptions established by or the enforcement discretion of the FDA.
C.3.3.1.5 Following release the contractor shall deliver product to the nearest designated distribution site via a
qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural disaster
or other emergency affecting a designated delivery site restricts such site's ability to receive product, the Contractor
and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed Inventory
(VMI) at the contractor site.
C.3.3.2 Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and
FDA representatives for required site visits and audits at facilities used to support this contract throughout the period
of performance of the contract.
C.3.3.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the
finding and corrective action(s) in accordance with CDRL A001.
C.3.3.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within of a
scheduled FDA audit or within of an ad hoc site visit or audit if the FDA does not provide advance notice.
The contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of
this contract or for this product within of receiving correspondence from the FDA or third party in
accordance with CDRL A002. The Contractor shall provide the Contracting Officer with a plan for addressing areas
of nonconformance, if any are identified, within of submittal of the audit report in accordance with
CDRL A002.
C.3.3.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the USG
has visibility and input on all FDA communications regarding the drugs and biologics for the following, but not
limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement
documentation in accordance with CDRL A002.
C.3.4 CLIN 3001 - Option Period 3: Large Scale Manufacturing of 100 Million Vaccine Doses.
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C.3.4.1 The contractor shall complete all scope required for the production, release and delivery use of 100 million
FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other activities
reasonably contemplated by such tasks:
C.3.4.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product
remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be
under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of
12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the
assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,
FDA Interactions and Inspections Documentation.
C.3.4.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement
discretion of the FDA.
C.3.4.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations
and that labeling is updated.
C.3.4.1.4 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of
PL 113-54 (Nov. 27, 22013), including product verification, serialization, traceability and detection and response
requirements subject to any exceptions established by or the enforcement discretion of the FDA.
C.3.4.1.5 Following release of the product the contractor shall deliver the product to the designated distribution site
via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural
disaster or other emergency affecting a designated delivery site restricts such site's ability to receive product, the
Contractor and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed
Inventory (VMI) at the contractor site.
C.3.4.2 Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and
FDA representatives for required site visits and audits at facilities used to support this contract throughout the period
of performance of the contract.
C.3.4.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the
finding and corrective action(s) in accordance with CDRL A001.
C.3.4.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within of a
scheduled FDA audit or within of an ad hoc site visit or audit if the FDA does not provide advance notice.
The contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of
this contract or for this product within of receiving correspondence from the FDA or third party in
accordance with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areas
of nonconformance, if any are identified, within of submittal of the audit report in accordance with
CDRL A002.
C.3.4.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the
USG has visibility and input on all FDA communications regarding mRNA-1273 for the following, but not limited
to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement documentation in
accordance with CDRL A002.
C.3.5 CLIN 4001 - Option Period 4: Large Scale Manufacturing of 100 Million Vaccine Doses.
C.3.5.1 The contractor shall complete all scope required for the production, release and delivery use of 100
million FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other
activities reasonably contemplated by such tasks:
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C.3.5.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product
remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be
under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of
12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the
assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,
FDA Interactions and Inspections Documentation.
C.3.5.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement
discretion of the FDA.
C.3.5.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations
and that labeling is updated.
C.3.5.1.4 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of
PL 113-54 (Nov. 27, 22013), including product verification, serialization, traceability and detection and response
requirements subject to any exceptions established by or the enforcement discretion of the FDA.
C.3.5.1.5 Following release of the product the contractor shall deliver the product to the designated distribution site
via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural
disaster or other emergency affecting a designated delivery site restricts such site's ability to receive product, the
Contractor and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed
Inventory (VMI) at the contractor site.
C.3.5.2 Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and
FDA representatives for required site visits and audits at facilities used to support this contract throughout the period
of performance of the contract.
C.3.5.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the
finding and corrective action(s) in accordance with CDRL A001.
C.3.5.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within of a
scheduled FDA audit or within of an ad hoc site visit or audit if the FDA does not provide advance notice.
The contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of
this contract or for this product within of receiving correspondence from the FDA or third party in
accordance with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areas
of nonconformance, if any are identified, within of submittal of the audit report in accordance with
CDRL A002.
C.3.5.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the
USG has visibility and input on all FDA communications regarding the drugs and biologics for the following, but
not limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement
documentation in accordance with CDRL A002.
C.4 CLIN 0002: Data Deliverables. The contractor shall provide the following in accordance with the
Contract Data Requirements List (CDRL), DD Forms 1423, provided at Appendix A.
C.4.1 Monthly Inventory Report (CDRL A003), detailing at a minimum, raw materials, Bulk mRNA, formulated
LNPs, and the fill, finish, and released product.
C.4.2 Quality Management Plan. The contractor shall provide a Quality Management Plan, in accordance with
CDRL A004, describing the quality policy and objectives, management review, competencies and training, process
document control, feedback, evaluation, corrective action and preventive action, process improvement,
measurement, and data analysis processes. The framework is normally divided into infrastructure, senior
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management responsibility, resource management, lifecycle management, and quality management system
evaluation.
C.4.3 Shipping Documentation (CDRL A005) for all Finished Drug Product (FDP) transferring from the
contractor's fill/finish facility to a USG facility. The contractor shall obtain concurrence on planned shipment
protocols prior to transport.
C.4.4 Expiring Items Report (CDRL A006) for all FDP in the USG's possession.
C.4.5 Key Personnel Listing (CDRL A007).
C.4.6 Monthly Technical Progress Report (CDRL A008), to include an Integrated Master Schedule, identifying
key activities and contract status.
C.4.7 Final Technical Report (CDRL A009), documenting the work performed and results obtained for the entire
contract period of performance.
C.4.8 Supply Chain Resiliency Plan (SCRP). The contractor shall provide, in accordance with CDRL A010 and
CDRL Attachment 0001, a comprehensive SCRP that provides for identification and reporting of critical
components associated with the secure supply of drug substance, drug product, and work-in-process through to
finished goods, and key equipment suppliers and their locations, including addresses, points of contact, and work
performed per location, to include subcontractors.
C.4.9 Risk Management Plan (RMP). The Contractor shall provide an RMP in accordance with CDRL A011 that
outlines the impacts of each risk in relation to the cost, schedule, and performance objectives. The plan shall include
risk mitigation strategies. Each risk mitigation strategy shall capture how the corrective action will reduce impacts
on cost, schedule and performance.
C.4.10 Manufacturing Reports and Dose Tracking. The Contractor shall provide, in accordance with CDRL A013,
manufacturing reports and manufacturing dose tracking projections and actuals utilizing the USG-provided
"COVID-19 Dose Tracking Template" (CDRL Attachment 0003).
C.4.11 Product Acceptance Report (for each lot of Drug Product). The contractor shall provide, in accordance
with CDRL A014, pictures of the drug product with lot number, drug product lot tree, list of associated deviations
(from drug substance and product), and a Certificate of Analysis.
C.4.12 Incident Report. The contractor shall communicate to BARDA and document all critical programmatic
concerns, issues, or probable risks that have or are likely to significantly impact project schedule and/or cost and/or
performance in accordance with CDRL A016. "Significant" is frequently defined as a 10% or greater cost or
schedule variance within a control account, but should be confirmed in consultation with the COR. Incidents that
present liability to the project even without cost/schedule impact, such as breach of GCP during a clinical study,
shall also be reported.
C.4.13 FDA Correspondence. The contractor shall provide any correspondence between Contractor and FDA
relevant to the scope of this contract and submit in accordance with CDRL A017.
C.4.14 Press Releases. The contractor shall accurately and factually represent the work conducted under this
contract in all press releases. The contractor shall provide an advance copy of any press release in accordance with
CDRL A018.
C.4.15 Manufacturing Development Plan. The contractor shall provide a Manufacturing Development Plan, in
accordance with CDRL A025, describing the manufacturing process for the drug/biologic product to ensure
conformity with §501(a)(2)(B) of the Food, Drug, and Cosmetics Act (FD&C Act, Title 21 United States Code
(USC) §351 (a)(2)(B)), regarding good manufacturing practices (GMP).
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C.5 Administration.
C.5.1 Post Award Teleconference. The contractor shall host a Post Award Teleconference within 7 calendar days
after contract award.
C.5.1.1 The contractor shall provide an Agenda, IAW CDRL A020, detailing the planned activities for the
subsequent 30 calendar days and shall discuss agenda items for the Post Award Kickoff Meeting.
C.5.1.2 The contractor shall provide Meeting Minutes IAW CDRL A021.
C.5.2 Post Award Kickoff Meeting. The contracting officer may request the contractor host a contract Kick-Off
Meeting within 30 calendar days after contract award via teleconference. The contracting officer shall establish the
date and time of the conference and prepare the agenda to include discussion on contract activities and schedule.
C.5.3 Bi-Weekly Teleconference. The contractor shall participate in bi-weekly teleconferences (or more frequent
meetings required by the USG if warranted based on contract activities) to discuss performance on the contract.
C.5.4 The contractor shall provide an Agenda, IAW CDRL A020; Meeting Minutes in accordance with CDRL
A021; and, Presentation Material in accordance with CDRL A022 for each of the aforementioned teleconferences or
meetings throughout the contract period of performance.
C.5.5 Daily "Check-In". The contractor shall participate in a daily "check-in" (via teleconference or email) to
address key cost, schedule and technical updates. Daily updates may be shared with senior USG leaders during the
COVID- 19 response and should be provided on a non-confidential basis, unless the update includes confidential
information in which case, the contractor shall provide the update in both confidential and non-confidential formats.
Daily check-ins may occur on weekdays, excluding federal holidays. Upon request of the USG, check-ins may also
occur on weekends and on federal holidays, provided at least 24 hours' notice.
C.6 Security.
C.6.1 Access and General Protection/Security Policy and Procedures. The contractor shall provide all information
required for background checks necessary to access critical information related to OWS, and to meet USG
installation access requirements to be accomplished by the installation Director of Emergency Services or Security
Office. The contractor employees shall comply with all personnel identity verification requirements as directed by
the USG and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract,
should the security status of OWS change the USG may require changes in the contractor's security matters or
processes. In addition to the industry standards for employment background checks, the contractor shall be willing
to have key individuals, in exceptionally sensitive positions, identified for additional vetting by the United States
USG.
C.6.2 Security Program and Plan. The contractor shall implement a comprehensive security program that provides
overall protection of personnel, information, data, and facilities associated with fulfilling the USG's requirement.
The contractor's security practices and procedures shall be detailed in a Security Plan, in accordance with CDRL
A019, and shall demonstrate how the contractor shall meet and adhere to the security requirements outlined in
CDRL Attachment 0002. This plan shall be delivered to the USG within 45 days of award, and the USG will review
in detail and submit comments within ten (10) business days to the Contracting Officer (CO) to be forwarded to the
Contractor. The Contractor shall review the Security Plan comments, and, submit a final Security Plan to the U.S.
USG within thirty (30) calendar days after receipt of the comments. The Security Plan shall include a timeline for
compliance of all the required security measures outlined in CDRL Attachment 0002.
C.6.3 Operational Security (OPSEC). The contractor shall develop and submit an OPSEC Standard Operating
Procedure (SOP)/Plan IAW CDRL A024. The contractor shall identify in the SOP/Plan critical information related
to this contract, why it needs to be protected, where it is located, who is responsible for it, and how to protect it.
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C.7 CLIN 0002 Vendor Managed Inventory (VMI). The Contractor shall provide the capability to store the
vaccine for up to 52 weeks, up to 100M doses of mRNA-1273 vaccine, in accordance with product labeling. The
contractor shall, in accordance with paragraph C.3.1.1.6, ensure the product storage of FDP doses for up to 12
months prior to delivery consistent with all FDA requirements to ensure that the product remains available for use in
target populations.
. The contractor shall store the product to insure product quality with
audible alarms and contacting. The contractor shall notify the USG within of detection of an incident with
the potential to impact product quality, and implement corrective actions to mitigate the incident. . BARDA/JPEO-
CBRND personnel may conduct Quality Audits of the storage facility, when deemed necessary. The contractor shall
notify the USG of Corrective/Preventive actions within of detection of an incident with potential to
impacts product quality. BARDA/JPEO-CBRND personnel may conduct Quality Audits of the storage facility,
when deemed necessary.
C.7.1 The USG will provide the contractor advance notice of the required delivery locations for the vaccine. The
contractor shall ship mRNA-1273 vaccines to designated locations in the United
States. The contractor shall be responsible for shipment of all vaccine product whether acceptance is conducted at
origin or destination.
C.7.2 The vaccine product shall be shipped and tracked by the distribution vendor's shipping tracking number, to
the USG-designated sites within the continental United States.
C.7.3
Implementation of a Vendor Managed Inventory Plan/SOP
(CDRL A012) shall be provided to the USG.
Notwithstanding either of the
foregoing sentences, the contractor shall not be liable for loss of or damage to supplies caused by the negligence of
officers, agents, or employees of the USG acting within the scope of their employment.
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Section D - Packaging and Marking
D.1 Vaccine markings and labeling will be in accordance with FDA and will be finalized through a contract
modification.
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Section E - Inspection and Acceptance
INSPECTION AND ACCEPTANCE TERMS
Supplies/services will be inspected/accepted at:
CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY
0001 N/A N/A N/A N/A
0001AA Origin Government Origin Government
0001AB Origin Government Origin Government
0001AC Destination Government Destination Government
0001AD Destination Government Destination Government
0002 Destination Government Destination Government
0003 N/A N/A N/A N/A
0003AA Destination Government Destination Government
0003AB Destination Government Destination Government
0003AC Destination Government Destination Government
0003AD Destination Government Destination Government
0004 Destination Government Destination Government
1001 N/A N/A N/A N/A
1001AA Destination Government Destination Government
1001AB Destination Government Destination Government
1001AC Destination Government Destination Government
1002 Destination Government Destination Government
2001 N/A N/A N/A N/A
2001AA Destination Government Destination Government
2001AB Destination Government Destination Government
2001AC Destination Government Destination Government
2002 Destination Government Destination Government
3001 N/A N/A N/A N/A
3001AA Destination Government Destination Government
3001AB Destination Government Destination Government
3001AC Destination Government Destination Government
3002 Destination Government Destination Government
4001 N/A N/A N/A N/A
4001AA Destination Government Destination Government
4001AB Destination Government Destination Government
4001AC Destination Government Destination Government
4002 Destination Government Destination Government
CLAUSES INCORPORATED BY REFERENCE
52.246-16 Responsibility For Supplies APR 1984
El. Inspection:
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Initial quality inspection of Filled Drug Product (FDP) shall occur when the Contractor performs release testing to
confirm that products complies with Contractor's release specifications and criteria. Contractor will submit in
WAWF to the Contracting Officer or the duly authorized representative of the Government with a Certificate of
Analysis for quality inspection of all deliverables. Initial Inspection under this contract will be performed at the
Contractor's facility, or the subcontractor facility, by the BARDA Contracting Officer Technical Representative
(COTR).
Final inspection of product shall occur when the Government inspects each shipment of product delivered to it
hereunder for visible damage and quantity withir of such delivery. In the event Contractor supplies
any product to the Government and it is established that such Product was damaged or does not include the
required quantities at the time of delivery, the Government shall promptly notify Contractor in writing within'
. Final inspection shall be conducted at the CDC location identified
as destination.
In the event the USG requires storage of the FDP to a Vendor Managed Inventory (VMI) location, final quantity
inspection shall be conducted by submission into WAWF of shipping or other documentation confirming quantity
to VMI location. Final physical inspection of the FDP shall be conducted upon receipt of product to USG location.
Inspection of all reports and Contract Data Requirement List (CDRL) under this contract will be performed at
Destination by duly authorized representative of the Government.
E.2 Acceptance
a. Acceptance at origin shall occur at . Acceptance at destination shall occur
Regardless of where acceptance occurs, the contractor is responsible for
final delivery of Filled Drug Product (FDP) to a government designated CDC location.
b. Acceptance under this agreement will be performed by Army Contracting Command Aberdeen Proving Ground
(ACC-APG) Natick Contracting Division (NCD) Contracting Officer.
c. Acceptance of services under VMI SubCLINs ( List CLINS) shall occur upon satisfactory physical and quantity
inspection of FDP upon delivery at USG designated CDC location.
d. The parties acknowledge that acceptance may depend on the compliance with the Contractor's product
specifications. The KO and COR may prior to acceptance consult with FDA under its authority under Public Law
115-92 to determine whether the material to be delivered meets the Contractor's product specifications. To this
end, Contractor agrees to provide a letter to FDA authorizing the Government to engage in dialog with FDA about
the ultimate compliance of this product with the Contractor's product specifications prior to acceptance.
BARDA/COR will accept product according to the approved Product Acceptance Procedure.
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Section F - Deliveries or Performance
DELIVERY INFORMATION
CL1N DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC
CAGE
N/A N/A
N/A
FOB: Origin (Shipping Point)
N/A
FOB: Origin (Shipping Point)
N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
N/A N/A
N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
(b) (
202-260-6798
FOB: Destination
N/A N/A
N/A
FOB: Destination
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N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
N/A N/A
N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
N/A N/A
N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
N/A N/A
N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
N/A
FOB: Destination
CLAUSES INCORPORATED BY REFERENCE
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52.211-17 Delivery of Excess Quantities SEP 1989
52.242-15 Stop-Work Order AUG 1989
52.247-34 F.O.B. Destination NOV 1991
F.1 The contractor shall ship mRNA-1273 vaccines to designated locations in up to in the
United States. The contractor shall be responsible for secure shipment of all vaccine product whether acceptance is
conducted at origin or destination.
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Section G - Contract Administration Data
ACCOUNTING AND APPROPRIATION DATA
AA: 0212020202120400000664643255 S.0074658.5.6 6100.9000021001
COST CODE: A5XAH
AMOUNT: $955,500,000.00
AB: 0212020202120400000664643255 S.0074658.5.6.1 6100.9000021001
COST CODE: A5XAH
AMOUNT: $269,500,000.00
ACRN CLIN/SLIN CIN AMOUNT
AA 0001 AA GFEBS001153469300001 $183,750,000.00
0001AC GFEBS001153469300003 $367,500,000.00
0001AD GFEBS001153469300004 $404,250,000.00
AB 0001AB GFEBS001153469300002 $269,500,000.00
CLAUSES INCORPORATED BY REFERENCE
252.204-7006 Billing Instructions OCT 2005
252.232-7003 Electronic Submission of Payment Requests and Receiving DEC 2018
Reports
CLAUSES INCORPORATED BY FULL TEXT
252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)
(a) Definitions. As used in this clause—
"Department of Defense Activity Address Code (DoDAAC)" is a six position code that uniquely identifies a unit,
activity, or organization.
"Document type" means the type of payment request or receiving report available for creation in Wide Area
WorkFlow (WAWF).
"Local processing office (LPO)" is the office responsible for payment certification when payment certification is
done external to the entitlement system.
"Payment request" and "receiving report" are defined in the clause at 252.232-7003, Electronic Submission of
Payment Requests and Receiving Reports.
(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests
and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-
7003, Electronic Submission of Payment Requests and Receiving Reports.
(c) WAWF access. To access WAWF, the Contractor shall—
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(1) Have a designated electronic business point of contact in the System for Award Management at
littps://vvww.sam.gov: and
(2) Be registered to use WAWF at ht-tps://wavd.eb mil/ following the step-by-step procedures for self-registration
available at this web site.
(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training
Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be
accessed by selecting the "Web Based Training" link on the WAWF home page at https://wawf.eb.mil/.
(e) WAWF methods of document submission. Document submissions may be via web entry. Electronic Data
Interchange. or File Transfer Protocol.
(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment
requests and receiving reports in WAWF for this contract or task or delivery order:
(1) Document type. The Contractor shall submit payment requests using the following document type(s):
COMBO
(ii) For fixed price line items—
(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting
Officer.
Invoice and receiving report document type
(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1. which meets the
requirements for the invoice and receiving report. or the applicable invoice and receiving report, as specified by the
Contracting Officer.
N/A
(iii) For customary progress payments based on costs incurred, submit a progress payment request.
(iv) For performance based payments. submit a performance based payment request.
(v) For commercial item financing, submit a commercial item financing request.
(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the
contract.
(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in
applicable fields in WAWF when creating payment requests and receiving reports in the system.
Routing Data Table
Field Name in WAWF Data to be entered in WAWF
Pay Official DoDAAC HQ0337
Issue By DoDAAC W911QY
Admin DoDAAC** S2206A
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Inspect By DoDAAC 12206A / BARDA
Acceptor W911QY
Ship To I TDB
(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type
of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition
Regulation 52.216-7, Allowable Cost and Payment, as applicable.
(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.
(g) WAWF point of contact.
(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's
WAWF point of contact.
/ DCMA Boston-AFAW, Administrative Contracting Officer
(2) Contact the WAWF helpdesk at , if assistance is needed.
(End of clause)
FOR REFERANCE:
DFARS PGI 204.7108 Payment Instructions Table
https://www.acq.osd.mil/doao/dars/o5n/pgi htmkurrent/PGI204 71.htm#pavment instructions
G.I GOVERNMENT CONTRACT ADMINISTRATION
In no event shall any understanding or agreement, contract modification, change order, or other matter in deviation
from the terms of this contract between the Contractor and a person other than the Contracting Officer be effective
or binding upon the Government. All such actions must be formalized by a proper contractual document executed by
the Contracting Officer.
Procuring Contracting Officer:
Bldg. 1, General Greene Avenue
Natick, MA 01760-5011
Contract Specialist:
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Bldg. 1. General Greene Avenue
Natick. MA 01760-5011
G.2 GOVERNMENT TECHNICAL POINT OF CONTACT
Biologist/Project Officer
200 C Street. SW
Washington. DC 20201
G.3 CONTRACTOR'S CONTRACT ADMINISTRATION
ModernaTX. Inc.
200 Technology SQ.
Cambridge, MA 02139-3578
G.4 PLACES OF PERFORMANCE
ModernaTX. Inc.
200 Technology SQ.
Cambridge. MA 02139-3578
G.5 NOTIFICATION OF REVISIONS AND CHANGE
Notification of revision or changes to names or email addresses will be provided by official correspondence from the
PCO/ACO or office of the PCO/ACO in lieu of a contract modification. This does not apply to any such revisions or
changes in the event this contract includes a key personnel clause.
G.6 PERFORMANCE BASED PAYMENT
Performance-based payments (PBP) are authorized under this contract in accordance with FAR 52.232-32. The
contractor shall bill for the PBP upon achievement of the completion criteria identified in Attachment 0008.
Performance-based Payment Milestone Table. Upon achievement of the completion criteria, the contractor shall bill
for the PBP for the base and each option IAW the following schedule:
CLIN PERIOD AMOUNT
0001AA BASE $ 90,210,000
0001AA BASE $ 132,308,000
0001AA BASE $ 180,420,000
0001AA BASE $ 198,462,000
TOTAL $ 601,400,000
I
I
I
I
I
I
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Delivery Invoicing: PBPs are a type of contract financing and are recouped by the Government through deductions
of payments otherwise due to the contractor for the partial or complete delivery of contract items. The deductions
are made by applying a liquidation rate to the price of delivered contract items. Attachment 0009, Performance-
based Payment Milestone Billing Plan, identifies the contractor invoicing schedule for liquidation. The contractor
shall submit all invoices IAW Attachment 0009.
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Section H - Special Contract Requirements
H.1 Key Personnel
Any key personnel specified in this contract are considered to be essential to work performance. At least thirty (30)
calendar days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or
contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or
replacement and a request to replace the individual. The request must identify the proposed replacement and provide
an explanation of how the replacement's skills. experience, and credentials meet or exceed the requirements of the
contract (including, when applicable. Human Subjects Testing requirements). If the employee of the Contractor is
terminated for cause or separates from the Contractor voluntarily with less than thirty (30) calendar-day notice. the
Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert.
replace. or announce any such change to key personnel without the written consent of the Contracting Officer. The
contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. The
following individuals are determined to be key personnel:
Name Title
H.2 Substitution of Key Personnel
The Contractor agrees to assign to the contract those persons whose resumes/CVs were submitted with the proposal
who are necessary to fill the requirements of the contract. No substitutions shall be made except in accordance with
this clause.
All requests for substitution must provide a detailed explanation of the circumstance necessitating the proposed
substitution, a complete resume for the proposed substitute and any other infonnation requested by the contracting
officer to approve or disapprove the proposed substitution. All proposed substitutes must have qualifications that are
equal to or higher than the qualifications of the person to be replaced. The contracting officer or authorized
representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.
H.3 Disclosure of Information:
Performance under this contract may require the Contractor to access non-public data and information proprietary
to a Govenunent agency. another Govenunent Contractor or of such nature that its dissemination or use other than
as specified in the work statement would be adverse to the interests of the Government or others. Neither the
Contractor. nor Contractor personnel. shall divulge nor release data nor information developed or obtained under
performance of this contract. except authorized by Govenunent personnel or upon written approval of the CO which
the KO will provide in accordance with OWS or other Govenunent policies and/or guidance. The Contractor shall
not use. disclose, or reproduce proprietary data that bears a restrictive legend. other than as specified in this contract.
or any information at all regarding this agency.
The Contractor shall comply with all applicable Government requirements for protection of non-public information.
Unauthorized disclosure of nonpublic information is prohibited by the Govenunent's rules. Unauthorized disclosure
may result in termination of the contract, replacement of a Contractor employee, or other appropriate redress.
Neither the Contractor nor the Contractor's employees shall disclose or cause to be disseminated. any information
concerning the operations of the activity, which could result in, or increase the likelihood of. the possibility of a
breach of the activity's security or interrupt the continuity of its operations.
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No information related to data obtained under this contract shall be released or publicized without the prior written
consent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no
such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any
government entity' for submission to any securities exchange on which the Contractor's (or its parent corporation's)
securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining
regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions,
or other business transactions. The exceptions identified in this paragraph apply to all disclosures under this Section
11.3 except to the extent that a disclosure is otherwise prohibited by law.
11.4 Publication and Publicity
The contractor shall not release any reports, manuscripts, press releases, or abstracts about the work being performed
under this contract without written notice in advance to the Government.
(a) Unless otherwise specified in this contract, the contractor may publish the results of its work under this contract.
The contractor shall promptly send a copy of each submission to the COR for security review prior to submission.
The contractor shall also inform the COR when the abstract article or other publication is published, and furnish a
copy of it as finally published.
(b) Unless authorized in writing by the CO, the contractor shall not display the DoD logo including Operating
Division or Staff Division logos on any publications.
(c) The contractor shall not reference the products(s) or services(s) awarded under this contract in commercial
advertising, as defined in FAR 31.205-1, in any manner which states or implies DoD approval or endorsement of the
product(s) or service(s) provided.
(d) The contractor shall include this clause, including this section (d) in all subcontracts where the subcontractor
may propose publishing the results of its work under the subcontract. The contractor shall acknowledge the support
of the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response,
Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in
any media by including an acknowledgement substantially as follows:
"This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for
Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract Number
W911QY-20-C-0100."
H.5 Confidentiality of Information
a. Confidential information, as used in this article, means non-public information or data of a personal nature
about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.
b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific
information and/or categories of information which the Government will furnish to the Contractor or that the
Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may,
by mutual consent, identify such confidential information from time to time during the performance of the contract.
Failure to agree will be settled pursuant to the "Disputes" clause.
c. If it is established elsewhere in this contract that information to be utilized under this contract, or a portion
thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in
the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of
records determined to be subject to the Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior
written consent of the individual, institution, or organization.
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e. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the
material in question is subject to the Privacy Act or is confidential information subject to the provisions of this
article, the Contractor shall obtain a written determination from the Contracting Officer prior to any release,
disclosure, dissemination, or publication.
f. Contracting Officer Determinations will reflect the result of internal coordination with appropriate program and
legal officials.
g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other
Federal, State or local laws.
ALL REQUIREMENTS OF THIS SECTION H.5 MUST BE PASSED TO ALL SUB-CONTRACTOR.
H.6 Regulatory Rights
This contract involves supply of a product that requires FDA pre-market approval or clearance before commercial
authorization. Contractor is seeking FDA authorization or clearance for the commercialization of mRNA-1273,
Moderna vaccine for SARS-CoV-2 Coronavirus (the "Technology"). The Contractor is the Sponsor of the
Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE),
emergency use authorization (EUA), new drug application (NDA), biologics license application (BLA), premarket
approval application (PMA), or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted
to FDA) for the technology. As the Sponsor of the Regulatory Application to FDA (as the terms "sponsor" and
"applicant" are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), the
Contractor has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory
Application.
Accordingly, the Contractor and the Government agree to the following:
a. DoD Medical Product Priority. PL 115-92 allows the DoD to request, and FDA to provide, assistance to expedite
development of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing
American military personnel. The contractor recognizes that only the DoD can utilize PL 115-92. As such, the
contractor will work proactively with the Government to leverage this law to its maximum potential under this
contract. The contractor shall submit Public Law 115-92 Sponsor Authorization Letter that will be delivered to the
designated OWS POC(s) within 30 days of award.
H.7 Performance Based Payment Liquidated under Termination
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Performance Based Payments (PBPs) have been authorized as a method of financing under this contract. In the
event the Moderna's mRNA-1273 COVID Vaccine is unsuccessful in its bid to obtain EUA or FDA approval, the
Government may issue a Termination for Convenience (T4C) in whole or in part, on this contract. Upon notice of a
T4C, the contractor shall submit a termination settlement proposal, IAW FAR 52.249-2, Termination for
Convenience of the Government (Fixed-Price).
11.8 Public Readiness and Emergency Preparedness (PREP) Act:
In accordance with the Public Readiness and Emergency Preparedness Act ("PREP Act"), Pub. L. No. 109-148,
Division C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e), as well as the
Secretary of HHS's Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020, effective Feb. 4, 2020), and amended on
April 15, 2020, 85 Fed. Reg. 21012 (together, the "Prep Act Declaration"):
(i) This Agreement is being entered into for purposes of facilitating the manufacture, testing, development,
distribution, administration, and use of "Covered Countermeasures" for responding to the COVID-19 public health
emergency, in accordance with Section VI of the PREP Act Declaration;
(ii) Contractor's performance of this Agreement falls within the scope of the "Recommended Activities" for
responding to the COVID-19 public health emergency, to the extent it is in accordance with Section III of the PREP
Act Declaration; and
(iii) Contractor is a "Covered Person" to the extent it is a person defined in Section V of the PREP Act
Declaration.
Therefore, in accordance with Sections IV and VII of the PREP Act Declaration as well as the PREP Act (42 U.S.C.
§ 247d-6d), the Department of Defense contracting via assisted acquisition on behalf of the expressly
acknowledges and agrees that the HHS Declaration cited above, specifically its language providing immunity from
suit and liability is applicable to this acquisition as long as Contractors activities fall within the terms and conditions
of the PREP Act and the PREP Act Declaration.
The Government may not use, or authorize the use of, any products or materials provided under this contract, unless
such use occurs in the United States (or a U.S. territory where U.S. law applies such as embassies, military and
NATO installations) and is protected from liability under a declaration issued under the PREP Act, or a successor
COVID-19 PREP Act Declaration of equal or greater scope. Any use where the application of the PREP Act is in
question will be discussed with Moderna prior to use and, if the parties disagree on such use, the dispute will be
resolved according to the "Disputes Clause" (52.233-1)
The items and technology covered by this Contract are being developed for both civil and military applications.
•
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•
H.10 Ensuring Sufficient Supply of the Product
1. In recognition of the Government's significant funding for the development and manufacturing of the
product in this contract and the Government's need to provide sufficient quantities of a COVID-19 vaccine to
protect the United States population, the Government shall have the remedy described in this section to ensure
sufficient supply of the product to meet the needs of the public health or national security. This remedy is not
available to the Government unless and until both of the following conditions ((a) and (b)) are met:
a. Moderna gives written notice, required to be submitted to the Government , of:
i. any formal management decision to terminate manufacturing of this product vaccine prior to delivery of any
doses to USG under this contract, including all exercised options, other than as a result of clinical failure, or serious
technical or safety reasons or;
ii. any formal management decision to discontinue sale of this product vaccine to the Government prior to delivery
of any doses to USG under this contract, including all exercised options, other than as a result of clinical failure, or
serious technical or safety reasons; or
iii. any filing that anticipates Federal bankruptcy protection; and
b. Moderna has submitted an Emergency Use Authorization application under §564 of the FD&C Act or a biologics
license application provisions of §351(a) of the Public Health Service Act (PHSA).
2. If both conditions listed in section I occur, Moderna, upon the request of the Government, shall provide the
following items necessary for the Government to pursue manufacturing of this product vaccine with a third party for
exclusive sale to the U.S. Government:
a. a writing evidencing a non-exclusive, nontransferable, irrevocable (except for cause), royalty-free paid-up license
to practice or have practiced for or on behalf of the U.S. Government any Moderna Background Patent, Copyright,
other Moderna Intellectual Property, Moderna Know-How, Moderna Technical Data rights necessary to
manufacture doses of the mRNA-1273 vaccine;
b. necessary FDA regulatory filings or authorizations owned or controlled by Moderna related to this product
vaccine and any confirmatory instrument pertaining thereto; and
c. any outstanding Deliverables contemplated or materials purchased under this contract.
3. This remedy will remain available until the end of the contract.
(4)
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H.12 Transportation to Final Destination
During the course of performance under this contract, the Government may require storage of the filled drug product
(FDP) before delivery to the final government location. In these circumstances, the Government will accept FDP at
the contractor facility (Origin). The contractor; however, shall continue to be responsible for secure delivery of the
vaccine to its final destination as identified on this contract.
H.13 Validation of IP/Data
The Parties acknowledge that background intellectual property and technical data assertions have been made and
evaluated by the parties. The parties agree that, should additional information relevant to these assertions become
available, the parties will reevaluate said assertions as necessary in the future.
H.14 Novation
Upon Moderna, US, Inc.'s registration in the System for Award Management, the Government will, at the
Contractor's request, complete a novation of this Contract to recognize Moderna US, Inc. as a counterparty instead
of Moderna TX, Inc. This novation will be completed through a modification executed by the Government that
identifies Moderna US, Inc. as the contracting party for all purposes as if it had originally executed the Contract.
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Section I - Contract Clauses
CLAUSES INCORPORATED BY REFERENCE
52.202-1 Definitions JUN 2020
52.203-3 Gratuities APR 1984
52.203-5 Covenant Against Contingent Fees MAY 2014
52.203-6 Restrictions On Subcontractor Sales To The Government JUN 2020
52.203-7 Anti-Kickback Procedures JUN 2020
52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal orMAY 2014
Improper Activity
52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014
52.203-12 Limitation On Payments To Influence Certain Federal JUN 2020
Transactions
52.203-13 Contractor Code of Business Ethics and Conduct JUN 2020
52.203-17 Contractor Employee Whistleblower Rights and Requirement JUN 2020
To Inform Employees of Whistleblower Rights
52.204-1 Approval of Contract DEC 1989
52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber MAY 2011
Content Paper
52.204-10 Reporting Executive Compensation and First-Tier JUN 2020
Subcontract Awards
52.204-13 System for Award Management Maintenance OCT 2018
52.204-18 Commercial and Government Entity Code Maintenance JUL 2016
52.204-19 Incorporation by Reference of Representations and DEC 2014
Certifications.
52.204-23 Prohibition on Contracting for Hardware, Software, and JUL 2018
Services Developed or Provided by Kaspersky Lab and Other
Covered Entities.
52.204-25 Prohibition on Contracting for Certain Telecommunications AUG 2019
and Video Surveillance Services or Equipment.
52.209-6 Protecting the Government's Interest When Subcontracting JUN 2020
With Contractors Debarred, Suspended, or Proposed for
Debarment
52.209-10 Prohibition on Contracting With Inverted Domestic NOV 2015
Corporations
52.210-1 Market Research JUN 2020
52.215-2 Audit and Records--Negotiation JUN 2020
52.215-8 Order of Precedence--Uniform Contract Format OCT 1997
52.215-11 Price Reduction for Defective Certified Cost or Pricing Data-- JUN 2020
Modifications
52.215-13 Subcontractor Certified Cost or Pricing Data--Modifications JUN 2020
52.215-14 Integrity of Unit Prices JUN 2020
52.215-15 Pension Adjustments and Asset Reversions OCT 2010
52.215-18 Reversion or Adjustment of Plans for Postretirement Benefits JUL 2005
(PRB) Other than Pensions
52.215-19 Notification of Ownership Changes OCT 1997
52.215-21 Requirements for Certified Cost or Pricing Data and Data JUN 2020
Other Than Certified Cost or Pricing Data -- Modifications
52.217-4 Evaluation Of Options Exercised At The Time Of Contract JUN 1988
Award
52.217-7 Option For Increased Quantity-Separately Priced Line Item MAR 1989
52.217-8 Option To Extend Services NOV 1999
52.219-8 Utilization of Small Business Concerns OCT 2018
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52.219-28 Post-Award Small Business Program Rerepresentation MAY 2020
52.222-1 Notice To The Government Of Labor Disputes FEB 1997
52.222-3 Convict Labor JUN 2003
52.222-19 Child Labor -- Cooperation with Authorities and Remedies JAN 2020
52.222-21 Prohibition Of Segregated Facilities APR 2015
52.222-26 Equal Opportunity SEP 2016
52.222-35 Equal Opportunity for Veterans JUN 2020
52.222-36 Equal Opportunity for Workers with Disabilities JUN 2020
52.222-37 Employment Reports on Veterans JUN 2020
52.222-40 Notification of Employee Rights Under the National Labor DEC 2010
Relations Act
52.222-50 Combating Trafficking in Persons JAN 2019
52.222-54 Employment Eligibility Verification OCT 2015
52.223-6 Drug-Free Workplace MAY 2001
52.223-18 Encouraging Contractor Policies To Ban Text Messaging JUN 2020
While Driving
52.225-13 Restrictions on Certain Foreign Purchases JUN 2008
52.227-1 Authorization and Consent JUN 2020
52.227-1 Alt I Authorization And Consent (JUN 2020) - Alternate I APR 1984
52.227-2 Notice And Assistance Regarding Patent And Copyright JUN 2020
Infringement
52.227-11 Patent Rights--Ownership By The Contractor MAY 2014
52.232-9 Limitation On Withholding Of Payments APR 1984
52.232-17 Interest MAY 2014
52.232-23 Assignment Of Claims MAY 2014
52.232-25 Prompt Payment JAN 2017
52.232-33 Payment by Electronic Funds Transfer--System for Award OCT 2018
Management
52.232-39 Unenforceability of Unauthorized Obligations JUN 2013
52.232-40 Providing Accelerated Payments to Small Business DEC 2013
Subcontractors
52.233-1 Disputes MAY 2014
52.233-3 Protest After Award AUG 1996
52.233-4 Applicable Law for Breach of Contract Claim OCT 2004
52.242-13 Bankruptcy JUL 1995
52.243-1 Changes--Fixed Price AUG 1987
52.243-7 Notification Of Changes JAN 2017
52.244-5 Competition In Subcontracting DEC 1996
52.245-9 Use And Charges APR 2012
52.249-2 Termination For Convenience Of The Government (Fixed- APR 2012
Price)
52.249-8 Default (Fixed-Price Supply & Service) APR 1984
52.249-14 Excusable Delays APR 1984
252.203-7000 Requirements Relating to Compensation of Former DoD SEP 2011
Officials
252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013
252.203-7003 Agency Office of the Inspector General AUG 2019
252.211-7003 Item Unique Identification and Valuation MAR 2016
252.222-7006 Restrictions on the Use of Mandatory Arbitration Agreements DEC 2010
252.225-7048 Export-Controlled Items JUN 2013
252.227-7013 Rights in Technical Data--Noncommercial Items FEB 2014
252.227-7014 Rights in Noncommercial Computer Software and FEB 2014
Noncommercial Computer Software Documentation
252.227-7016 Rights in Bid or Proposal Information JAN 2011
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252.227-7017 Identification and Assertion of Use, Release, or Disclosure JAN 2011
Restrictions
252.227-7019 Validation of Asserted Restrictions--Computer Software SEP 2016
252.227-7028 Technical Data or Computer Software Previously Delivered JUN 1995
to the Government
252.227-7030 Technical Data--Withholding Of Payment MAR 2000
252.227-7037 Validation of Restrictive Markings on Technical Data SEP 2016
252.232-7007 Limitation Of Government's Obligation APR 2014
252.244-7000 Subcontracts for Commercial Items JUN 2013
CLAUSES INCORPORATED BY FULL TEXT
52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor within 5 days for;
provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30
days for Options 1 and 2, 60 days for Option 3 and 4 before the contract expires. The preliminary notice does not
commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 20
months.
(End of clause)
52.232-32 PERFORMANCE-BASED PAYMENTS (APR 2012)
(a) Amount of payments and limitations on payments. Subject to such other limitations and conditions as are
specified in this contract and this clause, the amount of payments and limitations on payments shall be specified in
the contract's description of the basis for payment.
(b) Contractor request for performance-based payment. The Contractor may submit requests for payment of
performance-based payments not more frequently than monthly, in a form and manner acceptable to the Contracting
Officer. Unless otherwise authorized by the Contracting Officer, all performance-based payments in any period for
which payment is being requested shall be included in a single request, appropriately itemized and totaled. The
Contractor's request shall contain the information and certification detailed in paragraphs (1) and (m) of this clause.
(c) Approval and payment of requests.
(1) The Contractor shall not be entitled to payment of a request for performance-based payment prior to successful
accomplishment of the event or performance criterion for which payment is requested. The Contracting Officer shall
determine whether the event or performance criterion for which payment is requested has been successfully
accomplished in accordance with the terms of the contract. The Contracting Officer may, at any time, require the
Contractor to substantiate the successful performance of any event or performance criterion which has been or is
represented as being payable.
(2) A payment under this performance-based payment clause is a contract financing payment under the Prompt
Payment clause of this contract and not subject to the interest penalty provisions of the Prompt Payment Act. The
designated payment office will pay approved requests on the 30th day after receipt of the request for performance-
based payment by the designated payment office. However, the designated payment office is not required to provide
W911QY20C0100
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payment if the Contracting Officer requires substantiation as provided in paragraph (c)(1) of this clause, or inquiries
into the status of an event or performance criterion, or into any of the conditions listed in paragraph (e) of this
clause, or into the Contractor certification. The payment period will not begin until the Contracting Officer approves
the request.
(3) The approval by the Contracting Officer of a request for performance-based payment does not constitute an
acceptance by the Government and does not excuse the Contractor from performance of obligations under this
contract.
(d) Liquidation of performance-based payments.
(1) Performance-based finance amounts paid prior to payment for delivery of an item shall be liquidated by
deducting a percentage or a designated dollar amount from the delivery payment. If the performance-based finance
payments are on a delivery item basis, the liquidation amount for each such line item shall be the percent of that
delivery item price that was previously paid under performance-based finance payments or the designated dollar
amount. If the performance-based finance payments are on a whole contract basis, liquidation shall be by either
predesignated liquidation amounts or a liquidation percentage.
(2) If at any time the amount of payments under this contract exceeds any limitation in this contract, the Contractor
shall repay to the Government the excess. Unless otherwise determined by the Contracting Officer, such excess shall
be credited as a reduction in the unliquidated performance-based payment balance(s), after adjustment of invoice
payments and balances for any retroactive price adjustments.
(e) Reduction or suspension of performance-based payments. The Contracting Officer may reduce or suspend
performance-based payments, liquidate performance-based payments by deduction from any payment under the
contract, or take a combination of these actions after finding upon substantial evidence any of the following
conditions:
(1) The Contractor failed to comply with any material requirement of this contract (which includes paragraphs (h)
and (i) of this clause).
(2) Performance of this contract is endangered by the Contractor's --
(i) Failure to make progress; or
(ii) Unsatisfactory financial condition.
(3) The Contractor is delinquent in payment of any subcontractor or supplier under this contract in the ordinary
course of business.
(f) Title.
(1) Title to the property described in this paragraph (f) shall vest in the Government. Vestiture shall be immediately
upon the date of the first performance-based payment under this contract, for property acquired or produced before
that date. Otherwise, vestiture shall occur when the property is or should have been allocable or properly chargeable
to this contract
(2) "Property," as used in this clause, includes all of the following described items acquired or produced by the
Contractor that are or should be allocable or properly chargeable to this contract under sound and generally accepted
accounting principles and practices:
(i) Parts, materials, inventories, and work in process;
(ii) Special tooling and special test equipment to which the Government is to acquire title;
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(iii) Nondurable (i.e., noncapital) tools, jigs, dies, fixtures, molds, patterns, taps, gauges, test equipment and other
similar manufacturing aids, title to which would not be obtained as special tooling under subparagraph (f)(2)(ii) of
this clause; and
(iv) Drawings and technical data, to the extent the Contractor or subcontractors are required to deliver them to the
Government by other clauses of this contract.
(3) Although title to property is in the Government under this clause, other applicable clauses of this contract (e.g.,
the termination or clauses) shall determine the handling and disposition of the property.
(4) The Contractor may sell any scrap resulting from production under this contract, without requesting the
Contracting Officer's approval, provided that any significant reduction in the value of the property to which the
Government has title under this clause is reported in writing to the Contracting Officer.
(5) In order to acquire for its own use or dispose of property to which title is vested in the Government under this
clause, the Contractor shall obtain the Contracting Officer's advance approval of the action and the terms. If
approved, the basis for payment (the events or performance criteria) to which the property is related shall be deemed
to be not in compliance with the terms of the contract and not payable (if the property is part of or needed for
performance), and the Contractor shall refund the related performance-based payments in accordance with
paragraph (d) of this clause.
(6) When the Contractor completes all of the obligations under this contract, including liquidation of all
performance-based payments, title shall vest in the Contractor for all property (or the proceeds thereof) not --
(i) Delivered to, and accepted by, the Government under this contract; or
(ii) Incorporated in supplies delivered to, and accepted by, the Government under this contract and to which title is
vested in the Government under this clause.
(7) The terms of this contract concerning liability for Government-furnished property shall not apply to property to
which the Government acquired title solely under this clause.
(g) Risk of loss. Before delivery to and acceptance by the Government, the Contractor shall bear the risk of loss for
property, the title to which vests in the Government under this clause, except to the extent the Government expressly
assumes the risk. If any property is lost (see 45.101), the basis of payment (the events or performance criteria) to
which the property is related shall be deemed to be not in compliance with the terms of the contract and not payable
(if the property is part of or needed for performance), and the Contractor shall refund the related
performance-based payments in accordance with paragraph (d) of this clause.
(h) Records and controls. The Contractor shall maintain records and controls adequate for administration of this
clause. The Contractor shall have no entitlement to performance-based payments during any time the Contractor's
records or controls are determined by the Contracting Officer to be inadequate for administration of this clause.
(i) Reports and Government access. The Contractor shall promptly furnish reports, certificates, financial statements,
and other pertinent information requested by the Contracting Officer for the administration of this clause and to
determine that an event or other criterion prompting a financing payment has been successfully accomplished. The
Contractor shall give the Government reasonable opportunity to examine and verify the Contractor's records and to
examine and verify the Contractor's performance of this contract for administration of this clause.
(j) Special terms regarding default. If this contract is terminated under the Default clause,
(1) the Contractor shall, on demand, repay to the Government the amount of unliquidated performance-based
payments, and
(2) title shall vest in the Contractor, on full liquidation of all performance-based payments, for all property for which
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the Government elects not to require delivery under the Default clause of this contract. The Government shall be
liable for no payment except as provided by the Default clause.
(k) Reservation of rights.
(1) No payment or vesting of title under this clause shall --
(i) Excuse the Contractor from performance of obligations under this contract; or
(ii) Constitute a waiver of any of the rights or remedies of the parties under the contract.
(2) The Government's rights and remedies under this clause --
(i) Shall not be exclusive, but rather shall be in addition to any other rights and remedies provided by law or this
contract; and
(ii) Shall not be affected by delayed, partial, or omitted exercise of any right, remedy, power, or privilege, nor shall
such exercise or any single exercise preclude or impair any further exercise under this clause or the exercise of any
other right, power, or privilege of the Government.
(1) Content of Contractor's request for performance-based payment. The Contractor's request for performance-based
payment shall contain the following:
(1) The name and address of the Contractor;
(2) The date of the request for performance-based payment;
(3) The contract number and/or other identifier of the contract or order under which the request is made;
(4) Such information and documentation as is required by the contract's description of the basis for payment; and
(5) A certification by a Contractor official authorized to bind the Contractor, as specified in paragraph (m) of this
clause.
(m) Content of Contractor's certification. As required in paragraph (1)(5) of this clause, the Contractor shall make the
following certification in each request for performance-based payment:
I certify to the best of my knowledge and belief that --
(1) This request for performance-based payment is true and correct; this request (and attachments) has been prepared
from the books and records of the Contractor, in accordance with the contract and the instructions of the Contracting
Officer;
(2) (Except as reported in writing on ), all payments to subcontractors and suppliers under this contract
have been paid, or will be paid, currently, when due in the ordinary course of business;
(3) There are no encumbrances (except as reported in writing on ) against the property acquired or
produced for, and allocated or properly chargeable to, the contract which would affect or impair the Government's
title;
(4) There has been no materially adverse change in the financial condition of the Contractor since the submission by
the Contractor to the Government of the most recent written information dated ; and
(5) After the making of this requested performance-based payment, the amount of all payments for each deliverable
item for which performance-based payments have been requested will not exceed any limitation in the contract, and
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the amount of all payments under the contract will not exceed any limitation in the contract.
(End of Clause)
52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in
full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may
be accessed electronically at this/these address(es):
hftps://www.acquisition.gov/content/regulations
(End of clause)
52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)
(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an
authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.
(b) The use in this solicitation or contract of any Defense Federal Acquisition Regulation Supplement (48 CFR
Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the
regulation.
(End of clause)
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Section J - List of Documents, Exhibits and Other Attachments
Document Type Description Page # Date
Exhibit A CDRLs 14 18 July 2020
Attachment 0001 Supply Chain Resiliency Plan for CDRL A010 2 23 July 2020
Attachment 0002 Security Plan 6 23 July 2020
Attachment 0003 Dose Tracking Template Draft Moderna Excel 15 July 2020
Attachment 0004 Data Rights 1 7 August 2020
Attachment 0005 1 7 Au • 2020
Attachment 0006 ModemaTx, Inc. Background Intellectual Property I 6 August 2020
Attachment 0007 Performance Base Payment Milestone Schedule 1 7 August 2020
Attachment 0008 Performance Base Payment Milestone Billing Plan 15 7 August 2020
Exhibit A
Contract Data Requirements List (CDRL)
Data Item # Title of Data Item Subtitle Date
A001 Quality Audit Finding and Response BARDA Audit Findings Report 18-Jul-20
Record (QAFRR)
A002 Quality Audit Finding and Response FDA Audit Findings Report 1S-Jul-20
Record (QAFRR)
A003 Contractor Furnished Material (CFM) Monthly Inventory Report 18-Jul-20
Report
A004 Quality Program Plan Quality Program Plan 18-Jul-20
A005 Task Directive Documentation Shipping Documentation - Finished 18-Jul-20
Drag Products (FDP)
A006 Task Directive Documentation Expiring Item Report 18-Jul-20
A007 Contractor's Personnel Roster Key Personnel Listing 18-Jul-20
A008 Status Report Monthly Technical Progress Report 18-Jul-20
A009 Contract Summary Report Final Technical Report 18-Jul-20
A010 Supply Chain Risk Management Plan Supply Chain Resiliency Plan (SCRP) 18-Jul-20
A011 Contractor's Risk Management Plan Risk Management Plan (RMP) 18-Jul-20
A012 Research and Development of Vendor Managed Inventory Plan/SOP 18 Jul 20
Medical Products Regulated by the
U.S. Food and Drug Administration
A013 Internal Contractor Technical Data Manufacturing Reports and Dose 18-Jul-20
Tracking Projections/Actuals
A014 Certificate of Compliance (Analysis) Product Acceptance Report 18-Jul-20
A015 N/A - -
A016 Accident Incident Report Incident Report 18-Jul-20
A017 Internal Contractor Technical Data FDA Correspondence 18-Jul-20
Report
A018 Acquisition Support Documentation Press Releases 18-Jul-20
A019 Contractor's Standard Operating Security Plan 18-Jul-20
Procedures
A020 Conference Agenda Conference Agenda 18-Jul-20
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A021 Report, Record of Meeting/Minutes Meeting Minutes 18-Jul-20
A022 Presentation Material Presentation Material 18-Jul-20
A023 N/A - -
A024 Operations Security (OPSEC) Plan Operational Security (OPSEC) 18 Jul 20
SOP/Plan
A025 Research and Development of Manufacturing Development Plan 18 Jul 20
Medical Products Regulated by the
U.S. Food & Drug Administration
(FDA)
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