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SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00007OBLIGATION AMOUNT: $3,300,000,000.00

a. The purpose of this modification (P00007) is to:‐ Revise Section A (Authority FAR 43.103(a)(3), Mutual Agreement of the Parties)‐ Exercise, revise delivery schedule for, and fund Option 3 and 4 CLINs 3001, 3001AA, 3001AB, 3001AC, 3001AD,
4001, 4001AA, 4001AB, 4001AC for a total of $3,300,000,00 (Authority FAR 52.217‐7)‐ Update Contracting Officer (Authority FAR 43.103(b))‐ Add Performance Based Payments for Options 3 and 4; and revise the table in Section G, accordingly (Authority
FAR 52.232‐16)‐ Add clause H.19 Product Variations (Authority FAR 43.103(a)(3), Mutual Agreement of the Parties)‐ Revise Attachment 0007, Performance Based Payment (PBP) Milestone Schedule, and Attachment 0008, PBP
Milestone Billing Plan (Authority FAR 52.243‐1).
b. This modification was requested by the program office to meet the Government’s mission requirements.
c. The total funded amount has increased by $3,300,000,000 from $4,845,591,662.60 to $8,145,591,662.60. The
total contract value amount remains unchanged.
All other terms and conditions remain unchanged. Please see below for details.

SECTION A - SOLICITATION/CONTRACT FORM

The total cost of this contract was increased by $3,300,000,000.00 from
$4,845,591,662.60 to $8,145,591,662.60.

The following have been modified:
A.1
The U.S. Army Contracting Command - Aberdeen Proving Ground (ACC-APG), Natick Division has arequirement for up to 500 million SARS-CoV-2 mRNA-1273 Vaccine doses (100 μg & 50 μg, based on variation

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supplied) in support of Joint Program Executive Office - Chemical Biological Radiological Nuclear Defense (JPEOCBRND), the Assistant Secretary for Preparedness and Response (ASPR), and Biomedical Advanced Research andDevelopment Authority (BARDA).
All doses of mRNA-1273 Vaccine to satisfy the delivery requirements of CLINs 0001, 1001, and 2001 are 100 μg
doses which will be delivered in a multi-dose vial containing either 6.3mL fill volume (1260mcg) (b) (4)or 8.0mL fill volume (1600mcg) (b) (4)(as described in Moderna’s
COVID-19 Vaccine Authorized Fact Sheet and label).
Specifications of doses of mRNA-1273 Vaccine to satisfy the delivery requirements of CLINs 3001 and 4001 aredescribed in Section H.19.
The delivery schedule for CLINs 3001 and 4001 may be concurrent with Moderna’s Biologics License Application
and FDA approval of the SARS-CoV-2 vaccine. Moderna agrees to continue to perform all regulatory efforts
required to ensure that product delivered while the SARS-CoV-2 vaccine was under Emergency Use Authorization
will remain available for use in the US.

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 3001
The CLIN extended description has changed from: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.
To:
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), Clause no. H-19, and CDRLs (Exhibit A) on this contract.
.
The option status has changed from Option to Option Exercised.

SUBCLIN 3001AA
The CLIN description has changed from 33.4M Doses to 25M Doses.
The pricing detail quantity has decreased by 8,400,000.00 from 33,400,000.00 to 25,000,000.00.
The option status has changed from Option to Option Exercised.
The total cost of this line item has decreased by $138,600,000.00 from $551,100,000.00 to$412,500,000.00.

SUBCLIN 3001AB
The CLIN description has changed from 33.4M Doses to 25M Doses.
The pricing detail quantity has decreased by 8,400,000.00 from 33,400,000.00 to 25,000,000.00.
The option status has changed from Option to Option Exercised.
The total cost of this line item has decreased by $138,600,000.00 from $551,100,000.00 to$412,500,000.00.

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SUBCLIN 3001AC
The CLIN description has changed from 33.2M Doses to 30M Doses.
The pricing detail quantity has decreased by 3,200,000.00 from 33,200,000.00 to 30,000,000.00.
The option status has changed from Option to Option Exercised.
The total cost of this line item has decreased by $52,800,000.00 from $547,800,000.00 to$495,000,000.00.

CLIN 4001
The CLIN extended description has changed from: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.
To:
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), Clause no. 19, and CDRLs (Exhibit A) on this contract.
.
The option status has changed from Option to Option Exercised.

SUBCLIN 4001AA
The CLIN description has changed from 33.4M Doses to 10M Doses.
The pricing detail quantity has decreased by 23,400,000.00 from 33,400,000.00 to 10,000,000.00.
The option status has changed from Option to Option Exercised.
The total cost of this line item has decreased by $386,100,000.00 from $551,100,000.00 to$165,000,000.00.

SUBCLIN 4001AB
The CLIN description has changed from 33.4M Doses to 28M Doses.
The pricing detail quantity has decreased by 5,400,000.00 from 33,400,000.00 to 28,000,000.00.
The option status has changed from Option to Option Exercised.
The total cost of this line item has decreased by $89,100,000.00 from $551,100,000.00 to$462,000,000.00.

SUBCLIN 4001AC
The CLIN description has changed from 33.2M Doses to 28M Doses.
The pricing detail quantity has decreased by 5,200,000.00 from 33,200,000.00 to 28,000,000.00.
The option status has changed from Option to Option Exercised.
The total cost of this line item has decreased by $85,800,000.00 from $547,800,000.00 to$462,000,000.00.
SUBCLIN 3001AD is added as follows:W911QY20C0100
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ITEM NO
3001AD

SUPPLIES/SERVICESQUANTITY
20,000,000

UNIT
Each

UNIT PRICE$16.50EXERCISEDOPTION

20M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than (b) (4)b. The government shall provide (b) (4) notification to exercise the option.
FOB: Destination
PURCHASE REQUEST NUMBER: 0011661905
PROJECT: Operation Warp Speed
PSC CD: 6505

AMOUNT$330,000,000.00.

NET AMT$330,000,000.00

ACRN AM
CIN: GFEBS001166190500004$330,000,000.00

SUBCLIN 4001AD is added as follows:
ITEM NO
4001AD

SUPPLIES/SERVICESQUANTITY
34,000,000

UNIT
Each

UNIT PRICE$16.50EXERCISEDOPTION

34M Doses
FFP
a. If executed, the option shall be awarded upon EUA or no later than (b) (4)b. The government shall provide (b) (4) notification to exercise the option.
FOB: Destination
PURCHASE REQUEST NUMBER: 0011661905
PROJECT: Operation Warp Speed
PSC CD: 6505

AMOUNT$561,000,000.00.

NET AMT
ACRN AM
CIN: GFEBS001166190500008

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:
STATEMENT OF WORKLARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE$561,000,000.00$561,000,000.00

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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 thathas 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 (42U.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, inparallel, 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 dosesc. 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.1.3 Consistent with the Updated EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination
Providers) dated 01 April 2021, up to 15 doses may be extracted from Moderna’s newly authorized multidose vials
with 8.0mL fill volume (1600mcg). The Government and Moderna agree that 15 doses per vial are only attainable
using premium low dead volume (LDV) syringes, which are in short supply globally. Utilizing initial ancillaryequipment, vaccine administration personnel can reliably extract 13 doses from these vials; however, theGovernment has identified needle/syringe combinations that can be used to extract 14 doses.
C.1.3.1 Given the two parties’ shared interest in reducing vaccine waste and accelerating the availability ofModerna’s SARS-CoV-2 vaccine doses, the Government and Moderna intend that the Moderna vaccines doses beadministered with needles and syringes compatible with extraction of 14 doses when possible. Toward this end, theGovernment shall maintain a list of syringe and/or needle combinations which will allow extraction of 14 doses per
8.0mL vial, which list shall be updated jointly by the Government and Moderna as any additional syringe and/or
needle combinations compatible with extraction of 14 doses/vial are identified. Furthermore, the Government will,to the extent that appropriate needles and syringes are available, assemble and ship kits containing sufficientquantities of syringes and needles compatible with extraction of 14 doses per vial (Kit Moderna 140) with
Moderna’s SARS-CoV-2 vaccine. The Government expects that these kits will be available beginning 01 May 2021
for a significant portion of Moderna’s remaining deliveries. If, however, appropriate syringes and needles are notavailable, the Government will revert to shipping the Kit Moderna 130 with Moderna’s SARS-CoV-2 vaccine.
C.2

APPLICABLE DOCUMENTS.

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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/textidx?SID=a95cab20f443897a400bb7e44a27cf4c&mc=true&tpl=/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 Moderna US, 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,qualified personnel, material, equipment and facilities (not otherwise provided by the USG under the terms of thiscontract) 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 productremains 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 theassigned 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, 2013), 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 eventthat a designated delivery site cannot receive product and the contractor provides storage beyond 20 days of productrelease, the contract will be subject to modification for acceptance purposes.

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C.3.1.2
Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA andFDA representatives for required site visits and audits at facilities used to support this contract throughout the periodof performance of the contract.
C.3.1.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailingthe 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 (b) (4)of a scheduled FDA audit or within (b) (4) of an ad hoc site visit oraudit 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 (b) (4)ofreceiving correspondence from the FDA or third party in accordance with CDRL A002. The Contractor shallprovide the Contracting Officer with a plan for addressing areas of nonconformance, if any are identified, withinof submittal of the audit report in accordance with CDRL A002.
(b) (4)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 notlimited 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 otheractivities 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 productremains 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 theassigned 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, 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.3.2.1.5 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, theContractor 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 andFDA representatives for required site visits and audits at facilities used to support this contract throughout the periodof performance of the contract.

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C.3.2.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing thefinding 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 (b) (4)of ascheduled FDA audit or within (b) (4) 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 (b) (4)of receiving correspondence from the FDA or third party inaccordance with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areasof nonconformance, if any are identified, within (b) (4)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
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 productremains 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 theassigned 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 581585 of PL 113-54 (Nov. 27, 2013), including product verification, serialization, traceability and detection andresponse 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 disasteror 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 andFDA representatives for required site visits and audits at facilities used to support this contract throughout the periodof 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 thefinding 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 (b) (4)of ascheduled FDA audit or within (b) (4) of an ad hoc site visit or audit if the FDA does not provide advance notice.

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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 (b) (4)of receiving correspondence from the FDA or third party inaccordance with CDRL A002. The Contractor shall provide the Contracting Officer with a plan for addressing areasof nonconformance, if any are identified, within (b) (4)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 notlimited 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.

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 productremains 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 theassigned 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, 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.3.4.1.5 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, theContractor 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 andFDA representatives for required site visits and audits at facilities used to support this contract throughout the periodof 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 thefinding 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 (b) (4)of ascheduled FDA audit or within (b) (4) 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 (b) (4)of receiving correspondence from the FDA or third party inaccordance with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areasof nonconformance, if any are identified, within (b) (4)of submittal of the audit report in accordance with
CDRL A002.

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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 inaccordance 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 otheractivities reasonably contemplated by such tasks:
C.3.5.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the productremains 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 theassigned 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, 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.3.5.1.5 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, theContractor 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 andFDA representatives for required site visits and audits at facilities used to support this contract throughout the periodof 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 thefinding 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 (b) (4)of ascheduled FDA audit or within (b) (4) 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 (b) (4)of receiving correspondence from the FDA or third party inaccordance with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areasof nonconformance, if any are identified, within (b) (4)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.

W911QY20C0100
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C.4
CLIN 0002: Data Deliverables. The contractor shall provide the following in accordance with theContract 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, formulated LNPs, and thefill, 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
management responsibility, resource management, lifecycle management, and quality management systemevaluation.
C.4.3 Shipping Documentation (CDRL A005) for all Finished Drug Product (FDP) transferring from thecontractor’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 criticalcomponents associated with the secure supply of drug substance, drug product, and work-in-process through tofinished 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 thatoutlines 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. The following RMP information shall be included in the Monthly Technical
Progress Report (CDRL A008).
Risk Register content:
a. Manuf/FF -risks or possible delays. If none N/Ab. Supply chain – same as abovec. Distribution challenges – same as above
d. Regulatory – same as above
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 accordancewith 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.

W911QY20C0100
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C.4.12 Incident Report. The contractor shall communicate to BARDA and document all critical programmaticconcerns, 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 orschedule 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 thiscontract 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).
C.5 Administration.
C.5.1 Post Award Teleconference. The contractor shall host a Post Award Teleconference within 15 calendar days
after contract award.
C.5.1.1 The contractor shall provide an Agenda, IAW CDRL A020, detailing the planned activities for thesubsequent 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 thedate 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 frequentmeetings 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) toaddress 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W911QY20C0100
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AK: 0212021202220400000665654255
S.0074658.5.58
6100.9000021001 A5XAH (CIN
GFEBS001166190500001) was increased by $412,500,000.00 from $0.00 to $412,500,000.00
The contract ACRN AK has been added.
The CIN GFEBS001166190500001 has been added.
The Cost Code A5XAH has been added.
SUBCLIN 3001AB:
AK: 0212021202220400000665654255
S.0074658.5.58
6100.9000021001 A5XAH (CIN
GFEBS001166190500002) was increased by $412,500,000.00 from $0.00 to $412,500,000.00
The contract ACRN AK has been added.
The CIN GFEBS001166190500002 has been added.
The Cost Code A5XAH has been added.
SUBCLIN 3001AC:
AL: 0212021202220400000665654255
S.0074658.5.58.3
6100.9000021001 A5XAH (CIN
GFEBS001166190500003) was increased by $495,000,000.00 from $0.00 to $495,000,000.00
The contract ACRN AL has been added.
The CIN GFEBS001166190500003 has been added.
The Cost Code A5XAH has been added.
SUBCLIN 3001AD:
Funding on SUBCLIN 3001AD is initiated as follows:
ACRN: AM
CIN: GFEBS001166190500004
Acctng Data: 0212021202220400000665654255

S.0074658.5.58.1

6100.9000021001

Increase: $330,000,000.00
Total: $330,000,000.00
Cost Code: A5XAHSUBCLIN 4001AA:
AK: 0212021202220400000665654255
S.0074658.5.58
6100.9000021001 A5XAH (CIN
GFEBS001166190500005) was increased by $165,000,000.00 from $0.00 to $165,000,000.00
The contract ACRN AK has been added.
The CIN GFEBS001166190500005 has been added.
The Cost Code A5XAH has been added.
SUBCLIN 4001AB:
AN: 0212021202220400000665654255
S.0074658.5.58.2
6100.9000021001 A5XAH (CIN
GFEBS001166190500006) was increased by $462,000,000.00 from $0.00 to $462,000,000.00
The contract ACRN AN has been added.
The CIN GFEBS001166190500006 has been added.
The Cost Code A5XAH has been added.
SUBCLIN 4001AC:

W911QY20C0100
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Page 20 of 31
AN: 0212021202220400000665654255
S.0074658.5.58.2
6100.9000021001 A5XAH (CIN
GFEBS001166190500007) was increased by $462,000,000.00 from $0.00 to $462,000,000.00
The contract ACRN AN has been added.
The CIN GFEBS001166190500007 has been added.
The Cost Code A5XAH has been added.
SUBCLIN 4001AD:
Funding on SUBCLIN 4001AD is initiated as follows:
ACRN: AM
CIN: GFEBS001166190500008
Acctng Data: 0212021202220400000665654255

S.0074658.5.58.1

6100.9000021001

Increase: $561,000,000.00
Total: $561,000,000.00
Cost Code: A5XAH

The following have been modified:
G.1 GOVERNMENT CONTRACT ADMINISTRATION
In no event shall any understanding or agreement, contract modification, change order, or other matter in deviationfrom 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:(b) (6)

Joint COVID-19 Response Division
US Army Contracting Command
6472 Integrity Court (Building 4401)
Aberdeen Proving Ground, MD 21005-3013
Contract Specialist:(b) (6)

Joint COVID-19 Response Division
US Army Contracting Command
6472 Integrity Court (Building 4401)
Aberdeen Proving Ground, MD 21005-3013

G.2 GOVERNMENT TECHNICAL POINT OF CONTACT(b) (6)

Biologist/Project Officer
200 C Street, SW
Washington, DC 20201

G.3 CONTRACTOR’S CONTRACT ADMINISTRATION

W911QY20C0100
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Page 22 of 31
based Payment Milestone Billing Plan, identifies the contractor invoicing schedule for liquidation. The contractor
shall submit all invoices IAW Attachment 0008.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

The following have been modified:
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 orcontracts 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 thecontract (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, theContractor 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

(b) (6)

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 withthis 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 information 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 Government agency, another Government Contractor or of such nature that its dissemination or use other thanas specified in the work statement would be adverse to the interests of the Government or others. Neither theContractor, nor Contractor personnel, shall divulge nor release data nor information developed or obtained underperformance of this contract, except authorized by Government personnel or upon written approval of the CO which
the KO will provide in accordance with OWS or other Government policies and/or guidance. The Contractor shallW911QY20C0100
P00007
Page 23 of 31
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 Government’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 abreach of the activity‘s security or interrupt the continuity of its operations.
No information related to data obtained under this contract shall be released or publicized without the prior writtenconsent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that nosuch 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
H.3 except to the extent that a disclosure is otherwise prohibited by law.
H.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 acopy 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 supportof 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 inany 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 Informationa. 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 specificinformation and/or categories of information which the Government will furnish to the Contractor or that theContractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may,W911QY20C0100
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Page 31 of 31
Attachment 0005
Attachment 0006
Attachment 0007
Attachment 0008
Attachment 0009(b) (4)ModernaTx, Inc. Background Intellectual Property
Performance Base Payment Milestone Schedule
Performance Base Payment Milestone Billing PlanHRPAS Moderna Letter(End of Summary of Changes)

2
3
1
16
1

7 August 2020
6 August 2020
14 June 2021
14 June 2021
3 September 2020

W911QY20C0100
P00008Page 2 of 12
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00008OBLIGATION AMOUNT: $0.00
a. The purpose of this modification (P00008) is to:- Add H.20 Donation of Excess Product and Exhibit B (Authority FAR 43.103(a)(3), Mutual Agreement of theParties)b. This modification was requested by the program office to meet the Government’s mission requirements.
c. The total contract value and total funded amount remain unchanged.
All other terms and conditions remain unchanged. Please see below for details.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

The following have been modified:
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 orcontracts 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 thecontract (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, theContractor 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(b) (4)Title

W911QY20C0100
P00008Page 3 of 12
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 withthis 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 information 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 Government agency, another Government Contractor or of such nature that its dissemination or use other thanas specified in the work statement would be adverse to the interests of the Government or others. Neither theContractor, nor Contractor personnel, shall divulge nor release data nor information developed or obtained underperformance of this contract, except authorized by Government personnel or upon written approval of the CO which
the KO will provide in accordance with OWS or other Government policies and/or guidance. The Contractor shallnot 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 Government’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 abreach of the activity‘s security or interrupt the continuity of its operations.
No information related to data obtained under this contract shall be released or publicized without the prior writtenconsent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that nosuch 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
H.3 except to the extent that a disclosure is otherwise prohibited by law.
H.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 acopy 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.

W911QY20C0100
P00008Page 4 of 12
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 inany 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 Informationa. 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 specificinformation and/or categories of information which the Government will furnish to the Contractor or that theContractor 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 ofrecords 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 priorwritten consent of the individual, institution, or organization.
e. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if thematerial in question is subject to the Privacy Act or is confidential information subject to the provisions of thisarticle, 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 andlegal 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 theRegulatory 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), theContractor has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory
Application.

W911QY20C0100
P00008Page 12 of 12
f. Shipment of any donated doses under this Article does not constitute a violation of the Defense Production Act.

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

The following have been modified:Document Type
Exhibit A
Exhibit B
Attachment 0001
Attachment 0002
Attachment 0003
Attachment 0004
Attachment 0005
Attachment 0006
Attachment 0007
Attachment 0008
Attachment 0009

Description
CDRLs
Donation of Excess ProductSupply Chain Resiliency Plan for CDRL A010
Security Plan
Dose Tracking Template Draft Moderna
Data Rights(b) (4)ModernaTx, Inc. Background Intellectual Property
Performance Base Payment Milestone Schedule
Performance Base Payment Milestone Billing PlanHRPAS Moderna Letter(End of Summary of Changes)

Page #
15
1
3
7
Excel
3
2
3
1
16
1

Date
11 Feb 2021
16 June 2021
23 July 2020
23 July 2020
15 July 2020
7 August 2020
7 August 2020
6 August 2020
14 June 2021
14 June 2021
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       !# # #"(&(#&& "#& %'
# ( ' (!
& 4+   (- # (' (! #" - $$ ' (# !"!"(' # '# ((#"'"(63 /0=D3 <C;03@32 A=:717B/B7=< 7A /;3<232 /A A3B 4=@B6 7< B3;

(63 6=C@ /<2 2/B3 A>3174732 4=@ @3137>B =4#443@

7A 3FB3<232

7A <=B 3FB3<232#443@ ;CAB /19<=E:3253 @3137>B =4B67A /;3<2;3<B >@7=@ B= B63 6=C@ /<2 2/B3 A>3174732 7< B63 A=:717B/B7=< =@ /A /;3<232 0G =<3 =4B63 4=::=E7<5 ;3B6=2A
1=>73A =4B63 /;3<2;3<B 0 G /19<=E:3257<5 @3137>B =4B67A /;3<2;3<B =< 3/16 1=>G =4 B63 =443@ AC0;7BB32/ G 1=;>:3B7<5 B3;A  /<2  /<2 @3BC@<7<5=@ 1 G A3>/@/B3 :3BB3@ =@ B3:35@/;E6716 7<1:C23A / @343@3<13 B= B63 A=:717B/B7=< /<2 /;3<2;3<B <C;03@A  )& # -#)& "#+ !"( (# &* ( ( $  '"( #& ( &$( # #&' $&#& (# ( #)& " ( '$ !- &') ( "&(#" # -#)& #& 4 0G D7@BC3 =4 B67A /;3<2;3<B G=C 23A7@3 B= 16/<53 /< =443@ /:@3/2G AC0;7BB32 AC16 16/<53 ;/G 03 ;/23 0G B3:35@/;=@ :3BB3@
>@=D7232 3/16 B3:35@/;=@ :3BB3@ ;/93A @343@3<13 B= B63 A=:717B/B7=< /<2 B67A /;3<2;3<B /<2 7A @3137D32 >@7=@ B= B63 =>3<7<5 6=C@ /<2 2/B3 A>3174732

 #)"(" " $$&#$&(#" ( 4 @3?C7@32 (' (! $$ ' #" - (# !#(#"' # #"(&('#&&'( !#' ( #"(&(#&& "# ' '& " (!  (' " #&& ' '') $)&')"( (# '>3174G /CB6=@7BG ( "' '( #&( " (!
#"(&( #&& "# " (! 

& ! " ( ( #* ")!& #"(&(#&& ' !# (# & ( ( !"'(&(* "' AC16 /A 16/<53A 7< >/G7<5=44713 />>@=>@7/B7=< 2/B3 3B1 '( #&( " (!  $)&')"( (# ( )(#&(- # & &  (' ')$$ !"( &!"( ' "(& "(# $)&')"( (# )(#&(- #!** /1).  103-04(3-10 (+* #(& '>3174G BG>3 =4 ;=27471/B7=< /<2 /CB6=@7BG !$#&("( =<B@/1B=@

7A <=B&

7A @3?C7@32 B= A75< B67A 2=1C;3<B /<2 @3BC@<



1=>73A B= B63 7AAC7<5 =44713

 '&$(#" # !"!"(!#(#" #@5/<7H32 0G ) A31B7=< 63/27<5A 7<1:C27<5 A=:717B/B7=<1=<B@/1B AC0831B ;/BB3@
E63@3 43/A70:3
!=27471/B7=< =<B@=: "C;03@ (b) (6)!** /1).  103-04(3-10 (+*

F13>B /A >@=D7232 63@37< /:: B3@;A /<2 1=<27B7=<A =4B63 2=1C;3<B @343@3<132 7< B3; =@ /A 63@3B=4=@3 16/<532 @3;/7<A C<16/<532 /<2 7< 4C:: 4=@13 /<2 34431B

 "! " ((  # '"& (G>3 =@ >@7<B "! " ((  # #"(&(" #& (G>3 =@ >@7<B(b) (6)(b) (6)(b) (6)
 #"(&(#&#&#&(b) (6)

'75</BC@3 =4 >3@A=< /CB6=@7H32 B= A75<,$(#" (# '$$&#* - #&! " ( '" )"( '((' # !&June 16, 2021 (b) (6)

 

(b) (6)
 ( '"-XQH  '75</BC@3 =4 =<B@/1B7<5 #44713@'("& #&!
$@3A1@7032 0G '&   &  

&3D

 

W911QY20C0100
P00009Page 2 of 2
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00009OBLIGATION AMOUNT: $0.00

a. The purpose of this modification (P00009) is to:‐ Update Exhibit B as outlined in clause H.20 with donation information for donation to
Canada (Authority FAR 43.103(a)(3), Mutual Agreement of the Parties)b. This modification was requested by the program office to meet the Government’s mission
requirements.
c. The total contract value and total funded amount remains unchanged.

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

The following have been modified:Document Type
Exhibit A
Exhibit B
Attachment 0001
Attachment 0002
Attachment 0003
Attachment 0004
Attachment 0005
Attachment 0006
Attachment 0007
Attachment 0008
Attachment 0009

Description
CDRLs
Donation of Excess ProductSupply Chain Resiliency Plan for CDRL A010
Security Plan
Dose Tracking Template Draft Moderna
Data Rights(b) (4)ModernaTx, Inc. Background Intellectual Property
Performance Base Payment Milestone Schedule
Performance Base Payment Milestone Billing PlanHRPAS Moderna Letter(End of Summary of Changes)

Page #
15
1
3
7
Excel
3
2
3
1
16
1

Date
11 Feb 2021
16 June 2021
23 July 2020
23 July 2020
15 July 2020
7 August 2020
7 August 2020
6 August 2020
14 June 2021
14 June 2021
3 September 2020    

#"(&(  #

        

!"!"(!#(#" "#(* (3

51  

 '') -

#

& 

$ # $' $&#( "# 4 />>:71/0:3

&%)'(#"$)&' &% "#" "$ !"'(& - 4 =B63@ B6/< 7B3;

"

#

 

 "# "$! "#!#"#       % !""  &  #!#( $!# $  
! !% !$     !"!"( # '# ((#" "# "! " &'' # #"(&(#& "= 'B@33B =C<BG 'B/B3 /<2 .7> =23
! $" (b) (6)

 ( ' (!

 #( "!      !# # #"(&(#&& "#' &
( 
# ( ' (!
' 5-   (- # (' (! #" - $$ ' (# !"!"(' # '# ((#"'#

(63 /0=D3 <C;03@32 A=:717B/B7=< 7A /;3<232 /A A3B 4=@B6 7< B3;

(63 6=C@ /<2 2/B3 A>3174732 4=@ @3137>B =4#443@

7A 3FB3<232

7A <=B 3FB3<232#443@ ;CAB /19<=E:3253 @3137>B =4B67A /;3<2;3<B >@7=@ B= B63 6=C@ /<2 2/B3 A>3174732 7< B63 A=:717B/B7=< =@ /A /;3<232 0G =<3 =4B63 4=::=E7<5 ;3B6=2A
1=>73A =4B63 /;3<2;3<B 0 G /19<=E:3257<5 @3137>B =4B67A /;3<2;3<B =< 3/16 1=>G =4 B63 =443@ AC0;7BB32/ G 1=;>:3B7<5 B3;A  /<2  /<2 @3BC@<7<5=@ 1 G A3>/@/B3 :3BB3@ =@ B3:35@/;E6716 7<1:C23A / @343@3<13 B= B63 A=:717B/B7=< /<2 /;3<2;3<B <C;03@A  )& # -#)& "#+ !"( (# &* ( ( $  '"( #& ( &$( # #&' $&#& (# ( #)& " ( '$ !- &') ( "&(#" # -#)& #& 4 0G D7@BC3 =4 B67A /;3<2;3<B G=C 23A7@3 B= 16/<53 /< =443@ /:@3/2G AC0;7BB32 AC16 16/<53 ;/G 03 ;/23 0G B3:35@/;=@ :3BB3@
>@=D7232 3/16 B3:35@/;=@ :3BB3@ ;/93A @343@3<13 B= B63 A=:717B/B7=< /<2 B67A /;3<2;3<B /<2 7A @3137D32 >@7=@ B= B63 =>3<7<5 6=C@ /<2 2/B3 A>3174732

 #)"(" " $$&#$&(#" ( 4 @3?C7@32 (' (! $$ ' #" - (# !#(#"' # #"(&('#&&'( !#' ( #"(&(#&& "# ' '& " (!  (' " #&& ' '') $)&')"( (# '>3174G /CB6=@7BG ( "' '( #&( " (!
#"(&( #&& "# " (! 

& ! " ( ( #* ")!& #"(&(#&& ' !# (# & ( ( !"'(&(* "' AC16 /A 16/<53A 7< >/G7<5=44713 />>@=>@7/B7=< 2/B3 3B1 '( #&( " (!  $)&')"( (# ( )(#&(- # & '  (' ')$$ !"( &!"( ' "(& "(# $)&')"( (# )(#&(- #",, 02*/  214.15)4.21 )-, #(& '>3174G BG>3 =4 ;=27471/B7=< /<2 /CB6=@7BG !$#&("( =<B@/1B=@

7A <=B'

7A @3?C7@32 B= A75< B67A 2=1C;3<B /<2 @3BC@<



1=>73A B= B63 7AAC7<5 =44713

 '&$(#" # !"!"(!#(#" #@5/<7H32 0G ) A31B7=< 63/27<5A 7<1:C27<5 A=:717B/B7=<1=<B@/1B AC0831B ;/BB3@
E63@3 43/A70:3
!=27471/B7=< =<B@=: "C;03@ (b) (6)",, 02*/  214.15)4.21

F13>B /A >@=D7232 63@37< /:: B3@;A /<2 1=<27B7=<A =4B63 2=1C;3<B @343@3<132 7< B3; =@ "! " ((  # '"& (G>3 =@ >@7<B "! " ((  # #"(&(" #& (G>3 =@ >@7<B(b) (6)# (b) (6)(b) (6)
 #"(&(#&#&#&(b) (6)

'75</BC@3 =4 >3@A=< /CB6=@7H32 B= A75<,$(#" (# '$$&#* - #&!  /A 63@3B=4=@3 16/<532 @3;/7<A C<16/<532 /<2 7< 4C:: 4=@13 /<2 34431B ( '" )"( '((' # !&(b) (6)

June 17,2021 - '75</BC@3 =4 =<B@/1B7<5 #44713@ 

(b) (6)
 ( '"-XQH  '("& #&!
$@3A1@7032 0G '&   &  

&3D

 

W911QY20C0100
P00010Page 2 of 2
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00010OBLIGATION AMOUNT: $0.00
a. The purpose of this modification (P00010) is to:‐ Update Exhibit B as outlined in clause H.20 with donation information for donation to Taiwan(Authority FAR 43.103(a)(3), Mutual Agreement of the Parties)b. This modification was requested by the program office to meet the Government’s mission requirements.
c. The total contract value and total funded amount remains unchanged.

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

The following have been modified:Document Type
Exhibit A
Exhibit B
Attachment 0001
Attachment 0002
Attachment 0003
Attachment 0004
Attachment 0005
Attachment 0006
Attachment 0007
Attachment 0008
Attachment 0009

Description
CDRLs
Donation of Excess ProductSupply Chain Resiliency Plan for CDRL A010
Security Plan
Dose Tracking Template Draft Moderna
Data Rights(b) (4)ModernaTx, Inc. Background Intellectual Property
Performance Base Payment Milestone Schedule
Performance Base Payment Milestone Billing PlanHRPAS Moderna Letter(End of Summary of Changes)

Page #
15
1
3
7
Excel
3
2
3
1
16
1

Date
11 Feb 2021
17 June 2021
23 July 2020
23 July 2020
15 July 2020
7 August 2020
7 August 2020
6 August 2020
14 June 2021
14 June 2021
3 September 2020

Attachment 0007
Performance Based Payment (PBP) Milestone Schedule
14 June 2021

CLIN

Milestone

0001
1001
2001
3001
4001

Capacity and
Raw Material
Severable
Reservation

Severable /Cumulative
Severable

Price$601,400,000(b) (4)(b) (4)(b) (4)(b) (4)

Milestone Completion
Verification Method

Moderna shall provide:
1) Written confirmation from the
CMO network that sufficient
capacity has been reserved; and, 2)
Written confirmation of reservationof sufficient raw materials alongwith a manufacturing schedule.

Attachment 0008
Performance Based Payment (PBP) Milestone Billing Plan
14 June 2021
Pages 16(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)Exhibit B - Donation of Excess ProductAs of 16 June 2021
Country

Mod NoBatch

Exp Date

COVID Vaccine TypeDS Source

Fill Finish Site

Dose Total

Exhibit B - Donation of Excess
Product As of 16 June 2021
Country

Mod NoBatch

CanadaP00009(b) (4)

Exp Date(b) (4)COVID Vaccine TypeDS Source

mRNA-1273(b) (4)(b) (4)Fill Finish Site

Dose Total(b) (4)1,000,020

Exhibit B - Donation of Excess ProductAs of 17 June 2021
Recipient

Mod NoBatch

CanadaP00009(b) (4)

TaiwanP00010(b) (4)

TaiwanP00010(b) (4)

TaiwanP00010(b) (4)

Exp Date(b) (4)(b) (4)(b) (4)(b) (4)COVID Vaccine TypeDS Source

Fill Finish Site

Dose Total

mRNA-1273(b) (4)(b) (4)1,000,020(b) (4)(b) (4)

960,680(b) (4)(b) (4)

955,780(b) (4)

333,620(b) (4)mRNA-1273(b) (4)mRNA-1273(b) (4)mRNA-1273(b) (4)(b) (4)