SOUCITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMSOFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30
2 CONTRACT NO

3 AD/EFFECTIVE DATEVV9110Y20C0119

30-Sep-2020
a NAME

7 FOR SCUCITATIONINFORMATION CALL
9. ISSUED BY

4 ORDER NUMBER

10. THIS ACQUISITION IS

w9i loyCODE

VVBQK ACC-APG NATICK DIVISIONBLDG 1 GENERAL GREENE AVENUE
NATICK MA 01760.5011

FAX: 508-233-5700
11. DELIVERY FOR FOB DEST1NA•

6 SOUCITATICN LSSUE DATEb TELEPHONE NUMBER (No Cdfect Calls)

B OFFER DUE DATE/LOCAL TIMEUNRESTRICTED ORD SET ASIDE:E HUBZONE SMALL

1

BUSINESS

325412
SIZE STANDARD:

I 8(A)

1,250
13b. RATING

13a THIS CONTRACT IS ARATED ORDER UNDERDPAS (15 CFR 700)

TION UNLESS BLOCK IS
MARKED

14. METHOD OF SOLICITATIONSEE SCHEDULE

RFD
CODE J 90202% FOR:NAICS:EDWOSEI

12. DISCOUNT TERMS

15 DELIVER TO

54

5 SOUCITATICN NUMBER'SMALL BUSINESSSERVICE-DISABLED
I VETERAN-OWNEDSMALL BUSINESSTEL:PAGE 1 OF

EN-014NE0 SMALL BU
SS (OSS)
111 EUGIBLE UNDER THE AOMEN-01ANEDWALL BuSI NESS PROGRAM.

LI

1 REQUISITION NUMBER
C011556543

RFP

IFB

116. ADMINISTERED BY

CODE

JPEO.CBRND

SEE ITEM 98222 HOADLEY RD E510i
ABERDEEN PROVING GROUND MD 21010

17a.CONTRACTOR/
OFFEROR

C005 136%M(,2FACILITY 36vyK2
CODE

IlBa. PAYMENT WILL BE MADE BY

CODE

Ho0493!MANSE FINANCE AND ACCOUNTING SERVICEDFAS-INDY VP GFEBS
8899 E 56TH Slf-e=hi
INDIANAPOLIS IN 46249-3800

ASTRAZENECA PHARMACEUTICALS LP

1800 CONCORD PIKEWILMINGTON DE 19803-2902

1ELER-101€ NO.
17b. CHECK IF RBMRTANCE IS DIFFERENT AND FUTSUCH ADDRESS IN OFFER
19.
fTEM NO.

18b. SUBW IWOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCKBELOW IS CHECKEDX SEE ADDENDUM
21.
QUANTITY20.
SCHEDJLE OF SUPFLES/ SERVICES

22.
UNIT

24.
AMOUNT

23.
UNfT PRICESEE SCHEDULE
26. TOTAL AWARD AMOUNT (For Govt. Use Only)

25. ACCOUNTING AND APPROPRIATION DATA

See Schedule

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4 FAR 52212-3. 52212-5 ARE ATTACHEDADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED.

ADDENDA DARE DARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

fa

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANYADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

30a. Sx 29 AWARD OF CONTRACT: REF

NOT ATTACHED

M07442

OFFER DATED =maga. YOUR OFFER ON SOLICITATION(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARESET FORTH HEREIN, IS ACCEPTED AS TO ITEMS: SEE SCHEDULE., I J . UNITED STATES OF AMERICA• i -, OF OFFERORICONTRACTOR

EAREDARE(SIGNATURE OF CONTRACTING OFFICER)ku) ko)30b. NAME AND TITLE OF SIGNER

30c. DATE SIGNED

31b. HAW OF CONTRACTING OFFICER(TYPE OR PRINT)

31c. DATE SIGNED(TYPE OR PRINT)TELJ) ( 0 1
AUTHORED FOR LOCAL REFRCOUCTIONFREVIOUS EDRON IS NOT USABLE

q I s• 120143 EMAIL

30-Sep-202.0

STANDARD FORM 1449 (REV. 2/2012)
Ftescribed by GSA - FAR (48 CF1 53212

I

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMSOFFEROR TO COMPLETE BLOCKS 12, 17, 23,24, AND 30
2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

W9110Y2000119

30-Sep-2020

7. FOR SOLICITATIONINFORMATION CALL:

a NAME

9. ISSUED BY

CODE

1. REQUISITION NUMBER
0011555540

4. ORDER NUMBER

W911QY

10. THIS ACQUISITION IS

PAGE 1 OF

5. SOUCITATION NUMBER

6. SOUCITATION ISSUE DATE

b. TELEPHONE NUMBER (No Collect Calls)

8. OFFER DUE DATE/LOCAL TIMEX UNRESTRICTED OR

SET ASIDE:WOMEN -OWNED SMALL BUS NESS (WOSB)EUG BLE UNDER THE VVOMEN-OWNEDSMALL BUSINESS PROGRAMSMALL BUSINESSNAICS:HUBZONE SMALLII BUSINESSLEDSERVICE-DISABLED
VETERAN-OWNEDSMALL BUSINESSTEL:FAX: 508-233-5700

325412
SIZE STANDARD:

8(A)

1,250
13b. RATING

12. DISCOUNT TERMS
13a. THIS CONTRACT IS ARATED ORDER UNDERDPAS (15 CFR 700)

TION UNLESS BLOCK IS
MARKED

14. METHOD OF SOLICITATIONSEE SCHEDULE

IFB

RFQ

15. DELIVER TOCODE

W9OZCI2% FOR:j

W6QK ACC-APG NATICK DIVISIONBLDG 1 GENERAL GREENE AVENUE
NATICK MA 01760-5011

11. DELIVERY FOR FOB DESTINA-

54

16. ADMINISTERED BY

RFP
CODE

JPEO-CBRND

SEE ITEM 98222 HOADLEY RD E5101
ABERDEEN PROVING GROUND MD 21010

17a. CONTRACTOR/
OFFEROR

CODE 36wK2

FACILITY

36wK218a. PAYMENT WILL BE MADE BY

CODE

1400490CODE

DEFENSE FINANCE AND ACCOUNTING SERVICEDFAS- INDY VP GFEBS
8899 E 56TH STREETINDIANAPOLIS )N46249-3800

ASTRAZENECA PHARMACEUTICALS LP
1800 CONCORD PIKEWILMINGTON DE 19803-2902

Tam ONE NO
17b. CHECK IF RBVIRTANCE IS DIFFERENT AND FUTSUCH ADDRESS IN OFFER
19.
ITEM NO.

18b.SUBMIT INN/OICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCKBELOW IS CHECKEDX SEE ADDENDUM
21.
QUANTITY20.
SCHEDULE OF SUPPLIES/ SERVICES

22.
UNIT

23.
UNIT PRICE

24.
AMOUNT

SEE SCHEDULE
26. TOTAL AWARD AMOUNT (For Govt. Use Only)

25. ACCOUNTING AND APPROPRIATION DATA

See Schedule_

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

ADDENDAARE

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED.

ADDENDAARE

ARE NOT ATTACHED__
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN-

0COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANYADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

29. AWARD OF CONTRACT: REF.

30c. DATE SIGNEDAZD7442

OFFER DATED 09-Sep-2020. YOUR OFFER ON SOLICITATION(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARESET FORTH HEREIN, IS ACCEPTED AS TO ITEMS: SEE SCHEDULE

31a .UNITED STATES OF AMERICA

30a.SIGNATURE OF OFFEROR/CONTRACTOR

30b.NAVE AND TITLE OF SIGNER

x(SIGNATURE OF CONTRACTING OFFICER)

311). NAME OF CONTRACTING OFFICER(TYPE OR PRINT)

31c. DATE SIGNED(TYPE OR PRINT)
30-Sep-2020

AUTHORIZED FOR LOCAL REPRODUCTIONPREVIOUS EDMON IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)
Prescr bed by GSA - FAR (48 CFR) 53.212

PAGE 2 0F54

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS(CONTINUED)
19.
M3VINO.

20.
SCHEDULE OF SUPPLIES/ SERVICES21.
QUA NTTIN

22.
UNIT

23.

uNn- PRICE

24.
AMOUNT

SEE SCHEDULE

32a. QUANTITY IN COLUMN 21 HAS BEEN_
RECEIVED _ INSPECTEDACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
32b. SIGNATURE OF AUTHORIZED GOVERNMENT

32c. DATE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENTREPRESENTATIVE

REPRESENTATIVE

321. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER

34. VOUCHER NUMBER

35. AMOUNT VERIFIEDCORRECT FOR

36. PAYMENT

37. CHECK NUMBERCOMPLETE
PARTIALPARTIAL

FINAL

FINAL

38. S/R ACCOUNT NUMBER

39. S/R VOUCHER NUMBER

40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT 42a. RECEIVED BY (Print)
41c. DATE
41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER
42b. RECEIVED AT (Location)
42c. DATE RECD (YY/MM/00)

AUTHORIZED FOR LOCAL REPRODUCTIONPREVIOUS EDITION IS NOT USABLE

42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK
Prescr bed by GSA — FAR (48 CFR) 53.212

Section SF 1449 - CONTINUATION SHEETITEM NO
0001

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE
Each
100,000
SARS-CoV-2 Therapeutic AZD7442
FFP
The contractor shall provide SARS-CoV-2 therapeutic AZD7442

AMOUNTAll required work shall be IAW the SOW and Commercial Solution Proposal titled"AZD7442 JPEO CSO Technical Volume_revised 09Sep", dated September 9,
2020.
FOB: Destination
PSC CD: 6550

NET AMTITEM NO
000101

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

ACRN AA @FFP
PURCHASE REQUEST NUMBER: 0011555540

NET AMT

ACRN AA
CIN: GFEBS001155554000001$0.00

ITEM NO
0002

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICE

Technical Data Deliverables
FFP
The contractor shall deliver technical data IAW the contract datadeliverables listed within this contract. The contractor may consolidate reporting
where applicable across its contracts with ACC-APG Natick for SARS-CoV-2
Therapeutic AZD7442. Consolidated reporting must be submitted to all POC'slisted in each of the contracts.
FOB: Destination
PSC CD: 6550

NET AMT

STATEMENT OF WORKADDENDUM: The following pages hereby supplements FAR 52.212-4
1. Background:
In December 2019, a novel (new) coronavirus known as SARS-CoV-2 ("the virus") 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 Services (HHS) declared apublic health emergency on January 31, 2020, under section 319 of the Public Health Service Act (42U.S.C. 247d), in response to COVID-19. On March 1, 2020, the President of the United States, pursuant tosections 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.
Under the President's Operation Warp Speed Mission, HHS is leading a whole of nation effort with theprimary goal to execute on a well-defined portfolio of COVID-19 Medical Countermeasures (MCM)
candidates to maximize probability of having safe and effective diagnostics, therapeutics and vaccines as
fast as possible for mass distribution. As such, JPEO-CBRND has an Area of Interest (AoI) for therapeutics
manufacturing and fill-finish of advanced SARS-CoV-2 MCMs. Therapeutics manufacturing is expected tomeet the necessary US Food and Drug Administration (FDA) requirements for beginning a Phase 3 clinical
trial, and the product must be granted licensure or Emergency Use Authorization (EUA) by the FDA.
2. Objective:
The government seeks to acquire treatment courses of therapeutic MCMs against SARS-CoV-2 that areeither direct acting antivirals or host directed therapeutics, which indirectly inhibit the coronavirus
lifecycle. Manufacturing shall occur using Current Good Manufacturing Practices (cGMP) validated
manufacturing processes for bulk drug substance and fill and finished drug product. The specificobjective is the acquisition of a minimum of 100,000 treatment courses for a targeted US population by, to treat the US population indicated in the Offeror's target population. The intent is"Large Scale production capability in a short period of time with little to no advance notice under theconditions for which the MCM is required." Prior to purchase by the Government, the product mustreceive approval or clearance from the FDA for either an Emergency Use Authorization (EUA) under
Section 564 of the Federal Food, Drug & Cosmetic Act, or a biologics license application under theprovisions of §351(a) of the Public Health Service Act, to permit use and marketing of the product.

AMOUNT
NSP

3. Tasks:
Task 1: Establish a quality agreement between the US Government and Offeror on requirements for the
US Government to accept packaged drug product AZD7442 as a completed deliverable. Quality
agreement must be negotiated within theof award and prior to Government acceptance ofdrug product.
Task 2: Provide withinof award Product Development Source Material and Manufacturing Plan tofulfill the US Government order for AZD7442. The manufacturing plan should include all materials
required for drug substance/active pharmaceutical ingredient manufacturing and finished drug product, an
acquisition plan for acquiring necessary materials, all key subcontractors and manufacturing sites, and adetailed schedule for providing the final approved product AZD7442 to the US Government.
Task 3: Manufacture of the therapeutic product AZD7442 shall occur using an established manufacturing
process for bulk drug substance and fill and finished drug product, with a ramp-up capacity plan thatprovides enough doses of AZD7442 to meet the desired number of treatment courses.
Task 4— Storage

Task 5 — Distribution

Task 6— Program Management Activities:
The offeror must establish the capacity in compliance with FDA cGMP regulations, and Biosafety Level
standards if applicable. The offeror must be responsible for management of all activities, subcontractors,
etc. to meet the goals of the contract, including holding routine meetings with USG, and completion of
meeting minutes. On a monthly basis, the offeror(s) must provide a monthly report that includes capacity
availability and utilization, as well as any issues that affect the operational availability of the reserved
capacity.
4. AoI Deliverables:

CDRL#
01

Deliverable
Meetings

Deliverable Descriptionr

Reporting Procedures and Due Dates

The contractor shall complete an
initial teleconference after contract
01.1

01.2

01.3

Post Award
Teleconference

Kickoff Meeting

Every 2 weeks
Teleconference

01.4

Quarterly Meetings

CDRL#

Deliverable

award
1. Outline activities for the next 30 days
2. Discuss agenda items for the
post- award Kickoff Meeting (01.2)

The Contractor shall complete a
Kickoff meeting after contract award*Within one week of contract award*Contractor shall provide agenda and establish
a teleconference number at least 3 businessdays in advance of the teleconference unless
notified that JPEO-CBRND will supply one• COR edits/approves and instructs contractor to
distribute agenda prior to meeting by at least 2
business days
*Contractor provides meeting minutes to COR
within 3 business days after the meeting• COR reviews, comments and approves minutes
within 10 business days

*Within a month of contract award, pending
concurrence by the contracting officer*Contractor shall provide itinerary and agenda atleast 5 business days in advance of site visit or
virtual meeting• COR edits/approves and instructs contractorto
distribute agenda prior to meeting by at least 3
business days
*Contractor provides meeting minutes to COR
within 3 business days after the meeting• COR reviews, comments, and approves minutes
within 10 business days

The Contractor shall participate in
teleconferences every 2 weeks, with
JPEO-CBRND to discuss theperformance on the contract. Meeting
frequency can be increased as needed
during the course of the project'Contractor provides agenda to COR no laterthan
2 business days in advance of meeting• COR edits/approves and instructs contractor to
distribute agenda prior to meeting*Contractor distributes agenda and presentationmaterials at least 24 hours in advance.Contractor provides meeting minutes to COR
within 3 business days of the meeting• COR reviews, comments, and approves minutes
within 6 business days

At the discretion of the government
the Contractor shall hold recurring
teleconference or face-to-face
Project Review Meetings up to four
per year either in Washington D.0 or
at worksites of the Contractor or subcontractors. Face-to-face meetings shallalternate between Washington DC andContractor,
sub-contractor sites. The meetings will be*Contractor shall provide itinerary and agenda atleast 5 business days, and presentation materials
at least 3 business days in advance of sitevisit• COR edits/approves and instructs contractor to
distribute agenda prior to meeting by at least 3
business days
.Contractor provides meeting minutes to COR
within 3 business days after the meeting• COR reviews, comments, and approves minutes
within 10 business days

Deliverable Description

Reporting Procedures and Due Dates

used to discuss contract progress inrelation to the Program
Management
deliverables described below aswell as study designs, technical,
regulatory, and ethical aspects of the
program.

01.5

FDA Meetings

The Contractor shall forward the dates
and times of any meeting with the FDA to
JPEO-CBRND and make arrangements
for appropriate JPEO-CBRND staff toattend the FDA meetings. JPEO-CBRND
staff shall include up to a maximum of four
people (typically COR and up to 3 subject
matter experts)• Contractor shall notify JPEO-CBRND of
upcoming FDA meeting withinofscheduling Type A, B or C meetings OR withinof meeting occurrence for ad hoc
meetings.The Contractor shall forward initial Contractor and
FDA-issued draft minutes and final minutes of any
meeting with the FDA to JPEO-CBRND within'of receipt

Upon request of the Government, theContractor shall participate in a daily
check-in update with the project staff(via teleconference or email).

01.6

Daily check in withproject staff for
COVID-19 Contract

The updates will address key cost,schedule and technical updates. Daily
updates may be shared with senior
Government leaders during the COVID19 response and should be provided on a
non-confidential basis, unless the update
includes confidential information in whichcase Contractor shall provide the updatein both confidential and non-confidential
formats.

• No agenda will be required for the meeting• No meeting minutes are required.Contractor will provide bulleted email updates
following any call or in lieu of a call by 2PMforthat day

Daily check-ins may occur on weekdays,
excluding federal holidays. Upon requestof the Government. check-ins may also
occur on weekends and on federal
holidays, provided at least 24 hours'
notice.

02

Technical Reporting

02.1(Monthly)Monthly & Annual
Technical Progress
Reports/Annual
Meeting
02.2(Annual)The Monthly and Annual Technical
Progress reports shall address each of the
below items and be cross-referenced to
the Work Breakdown Structure (WBS).
Statement of Work (SOW), Integrated
Master Schedule (IMS), and Contract
Performance Report (CPR) — or as
applicable
1. An Executive Summary highlighting the
progress. issues and relevant
manufacturing, non-clinical, clinicaland.Monthly Reports shall be submitted on the 20:t1
day of the month covering the preceding month;
Annual Reports submitted on the 301h calendar
day of the month after each contract anniversary.
Monthly progress reports are not required for themonths when the Annual Report(s) are due, andMonthly/Annual
Report(s) are not due duffng a month when the
Final Report (final version, not draft) is due (seedeliverable 02.4). The COR and CO will review

CDRL#

Deliverable

Deliverable Description
regulatory activities. The Executive
Summary should highlight only criticalissues for that reporting period andresolution approach: limited to 2
pages
2. JPEO-CBRND Contractor Clinical
Trials Information Sheet — coveringongoing JPEO-CBRND -sponsoredclinical studies. This form shall provide
data on relevant activities during theperiod covered, by study site,
including: cumulative enrollment; newenrollments; screen failures: patients
dropped from study: AE and SAEs:
activation or inactivation of study sites;
investigator appointments or changes;
and status of IRB/IEC
review/approvallrenewal
3. Progress in meeting contract
milestones organized by WBS, overall
project assessment, problems
encountered and recommended
solutions. The reports shall detail theplanned and actual progress during
the period covered, explaining any
differences between the two and thecorrective steps
4. A three-month rolling forecast of the
key planned activities, referencing
the WBS/IMS
5. A tracking log of progress onregulatory submissions with the FDA
number, description of submission,date of submission, status ofsubmission and next steps
6. Estimated and Actual Expenses
a. This report shall also contain a narrative
or table detailing whether there is asignificant discrepancy (>10%) at thistime between the % of work completed
and the cumulative costs incurred todate. Monthly and actual expenses
should be broken down to theappropriate WBS level. This section of
the report should also containestimates for the Subcontractors'
expenses from the previous month if
the Subcontractor did not submit a billin the previous month. If thesubcontractor(s) was not working or
did not incur any costs in the previous
month, then a statement to this effectshould be included in this report for
those respective subcontractors If the
COR and CO are satisfied that thecontractor's reporting is sufficient toconvey this information, thissection may be waived.

Reporting Procedures and Due Dates
the monthly reports with the Contractor andprovide feedback• Contractor shall provide FINAL versions of reports
within 10 business days after receiving JPEOCBRND comments/edits

02.3 (Draft)

02.4 (Final)

Draft and Final
Technical Progress
ReportA draft and Final Technical Progress
Report containing a summation of thework performed and the results obtained
over the entire contract. This report shallbe in
sufficient detail to fully describe the• The Draft Technical Progress Report shall be
submitted
before the end of the
PoP and the Final Technical Progress Report onor before the completion date of the PoPCDRL#

Deliverable

Deliverable Description

progress achieved under all milestones.
Report should contain a timeline oforiginally planned and baselined activities
and milestones overlaid with actual
progress attained during the contract.
Descriptions and rationale for activities andmilestones that were not completed asplanned should be provided. The draft
report shall be duly marked as 'Draft'

Reporting Procedures and Due Dates• COR will provide feedback on draft report within
15 calendar days of receipt. which theContractor
shall consider incorporating into the Final Report

The Final Technical Progress Report
incorporating feedback received from
JPEO-CBRND and containing asummation of the work performed and theresults obtained for the entire contract
PoP. The final report shall document theresults of the entire contract. The final
report shall be duly marked as 'Final'. A
cover letter with the report will contain asummary (not to exceed 200 words) of
salient results achieved during theperformance of the contract

At JPEO-CBRND's request, Contractor
shall provide Manufacturing Reports to
JPEO-CBRND for review and comment
prior to submission to FDA
02.5

02.6

FDA Manufacturing
Reports

Product Development
Source Material and
Manufacturing
Reports andProjections

The COR and CO reserve the right torequest within the PoP a non-proprietary
Manufacturing Report for distribution within
the USGThe Contractor shall submit a detailed
spreadsheet regarding critical projectmaterials that are sourced from a location
other than the United States, sources, andmanufacturing sites, including but notlimited to: physical locations of sources of
raw and processed material by type ofmaterial; location and nature of work
performed at manufacturing sites; andlocation and nature of non-clinical andclinical study sites.

The Contractor will provide manufacturing
reports and manufacturing dose tracking
projections/actuals utilizing the "COVID-19
Dose Tracking Templates" or similar, on
any contract/agreement that is
manufacturing product, including productfor clinical trial use.

• Contractor will submit Manufacturing Reports at
leastprior to FDA submission.The Government will provide written commentsto
the manufacturing report within
after the submission• If corrective action is recommended, Contractor
must address all concerns raised by JPEOCBRND in writing• Contractor shall consider revising reports toaddress JPEO-CBRND's concerns and/or
recommendations prior to FDA submission• Contractor will submit Product Development
Source Material ReportoWithin month of contract awardoWithin 30 days of substantive changes are
made to sources and/or materialsoOr on the 6'1' month contract anniversary.
• Contractor will update the Dose Tracking
Template weekly during manufacturing
campaigns and dairy during response operations(where a Public Health Emergency has been
declared) and COVID-19 response. with the firstdeliverable submission within 15 days ofaward/modification. Updates to be provided
weekly in advance of commercial-scale
manufacturing and daily once material for use in
response operations begins manufacture.

CDRL#

Deliverable

Deliverable Description

Reporting Procedures and Due Dates• The Government will provide written comments to

the Product Development Source Material and
Manufacturing Report within 15 business days
after the submission'If corrective action is recommended, Contractor
must address all concerns raised by JPEOCBRND in writing*Product Development and Source Material report
to be submitted via spreadsheet; Dose Tracking
can be completed via spreadsheet or otherformat(e.g. XML or JSON) as agreed to by USG andcompany.

02.7

2.8

Contractor Locations

The contractor shall submit detailed data
regarding locations where work will be
performed under this contract, including
addresses, points of contact, and work
performed per location, to include subcontractors.

Pandemic
Management Plan

A pandemic facility and/or operational
management plan including change
procedures from normal to pandemic
operations Contractor will prepare an
operational plan to continue operations in
the event of a declared pandemic
emergency.

Final Data

02.9

Submission Package

Contractor must submit a data package
consisting of all raw data produced under
this contract. Data may be used by JPEOCBRND for analysis, evaluation, sharedwith other agencies, or shared outside of
the government consistent with FAR
52.22714. This submission package must be

tractor will submit Work Locations Report:• Withiof contract award.Withinafter a substantive
location or capabilities change*Withinof a substantive change if
the work performed supports medical
countermeasure development that addresses athreat that has been declared a Public Health
Emergency by the HHS Secretary or a Public
Health Emergency of International Concern(PHEIC) by the WHOContractor will submit Pandemic Management
Plan:•
Draft withinof award•
Final withinof award

tractor will submit at least
prior to contract
end date. Partial data-sets may also be requested
for delivery prior to submission of the Final Data
Submission Package.

delivered in a non-proprietary format.

If clinical trial data is included, that data
must be provided consistent withapplicable privacy laws to protect
personally identifiable information (PII).

02.10

Supplemental
Technical

Upon request and also as part ofdeliverables the Contractor shall provide

tractor shall provide the Technical Documents uponrequest from the CO or COR

CDRL#

Deliverable

Documents, Raw
Data. Tabulation Data(e.g.. CDISCcompliant SDTM SAS
XPT datasets), or
Data Analysis (e.g.,
CDISC-compliant
ADaM SAS XPT
datasets)

Deliverable Description

raw data. Tabulation Data (e.g.. CDISCcompliant SDTM SAS XPT datasets), or
Data Analysis (e.g., CDISC-compliant
ADaM SAS XPT datasets), or data reportto JPEO-CBRND.

Distribution Concept of Operations. JPEOCBRND, CDC, and MCM Manufacturers
play an important role in the distribution oftherapeutics to the American people undera nationwide response. JPEO-CBRND will
work with the manufacturer to monitor what
is in the manufacturing pipeline using theenclosed dose tracking templates (seeabove). JPEO-CBRND will relay final drug
product information as it is being released
to the CDC for allocation and ordering bystate public health departments.

02.11

Supply Chain andDistribution Tracking

Reporting Procedures and Due Dates

Provide the following information in order tocoordinate the movement and delivery of vaccine
product

CDRL#

Deliverable

Deliverable Description

Reporting Procedures and Due Dates(b) (4)

02.12

02.13

02.14

Manufacturing
Development Plan

Quality Management
Plan

Quality Agreement

This plan shall describe("describe the
manufacturing process for the drug/biologic
product to ensure conformity with
§501(a)(2)(B) of the Food, Drug, andCosmetics Act (FD&C Act, Title 21 UnitedStates Code (USC) §351 (a)(2)(B)),
regarding good manufacturing practices(GMP)), but is not limited to planned orcompleted drug substance studies: list of
excipients and information to support thesafety of excipients that, when appropriate,shall be cross-referenced; drug productand formulation development summaryfrom initial concept through final design;
physicochemical and biological properties;
manufacturing process development andvalidation program documents; container
closure system documents [description,
choice, rationale]; microbiological attributes
documents and plans; compatibility
documents (e.g., precipitation); assay
development and validation, stability plan:
and any associated risks.")

Plan may include, but is not limited to thequality policy and objectives, management
review, competencies and training, process
document control, feedback, evaluation,corrective action and preventive action,
process improvement, measurement, anddata analysis processes. The framework isnormally divided into infrastructure, senior
management responsibility, resource
management, lifecycle management, andquality management system evaluation•

Plan will be delivered electronicallyof contract award to the CO and COR•

Plan will be delivered electronicallyof contract award to the CO and COR•

Agreement will be signed by the USG and the
manufacturerof contract
award
Agreement will be delivered electronically toAgreement will determine the conditions ofacceptance by the USG of the purchased•

CDRL#

Deliverable

Deliverable Description

Reporting Procedures and Due Dates

product. No product will be accepted by the
USG until a quality agreement is in place.

the CO and COR

Audits

03

03.1

03.2

03.3

JPEO-CBRND
Audit

FDA Audits

OA Audits

Contractor shall accommodate periodic or
ad hoc site visits by JPEO-CBRND. If
JPEO-CBRND, the Contractor, or otherparties identifies any issues during anaudit. the Contractor shall capture theissues, identify potential solutions, andprovide a report to JPEO-CBRND• If issues are identified during the audit, Contractor
shall submit a report to JPEO-CBRND detailingthe finding and corrective action(s)of the audit.COR and CO will review the report and provide a
response to the Contractor• Once corrective action is completed, theContractor will provide a final report to JPEOCBRND

In the event of an FDA inspection that
occurs in relation to this contract and forthe product, or for any other FDA
inspection that has the reasonable
potential to impact the performance of thiscontract, the Contractor shall provide the
USG with an exact copy (non-redacted) of
the FDA Form 483 and the Establishment
Inspection Report (EIR). The Contractor
shall provide the COR and CO with copiesof the plan for addressing areas of nonconformance to FDA regulations for GLP.
GMP. or GCP guidelines as identified in
the audit report. status updates during theplans execution and a copy of all final
responses to the FDA. The Contractor
shall also provide redacted copies of any
FDA audits received from subcontractorsthat occur as a result of this contract or forthis product. The Contractor shall makearrangements for JPEO-CBRND
representative(s) to be present during thefinal debrief by the regulatory inspector• Contractor shall notify CO and CORof a scheduled FDA audit orlIMof an ad hoc site visit/audit if the FDA
does not provide advanced notice• Contractor shall provide copies of any FDA audit
report received from subcontractors that occuras
a result of this contract or for this productof receiving correspondence fromthe FDA or third party• Withinof audit report,
Contractor shall provide CO with a plan foraddressing areas of nonconformance. if anyare
identified

JPEO-CBRND reserves the right toparticipate in QA audits performed by thecontractor. Upon completion of theaudit/site visit the Contractor shall provide
a report capturing the findings, results andnext steps in proceeding with thesubcontractor. If action is requested of thesubcontractor, detailed concems foraddressing areas of non- conformance to
FDA regulations for GLP, GMP. or GOP
guidelines, as identified in the audit report.
must be provided to JPEO-CBRND. The
Contractor shall provide responses fromthe subcontractors to address theseconcerns and plans for corrective action• Contractor shall notify CO and COR a minimum ofin advance of upcoming.
audits/site visits of subcontractors• Contractor shall notify the COR and COof report completion.
• COR and CO will review the report and provide a
response to the Contractor with

CDRL#

03.4

03.5

03.6

Deliverable

Risk Management
Plan (RMP)

Integrated Master
Schedule (IMS)

Deviation Notificationand Mitigation
Strategy

Deliverable Description

The Contractor shall provide an RMP 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 will capture how the corrective
action will reduce impacts on cost,schedule and performance

The contractor shall provide an IMS that
illustrates project tasks, dependencies.
durations throughout the period of
performance, and milestones (GO/NOGO). The IMS must map to the WBS, andprovide baseline, and actual or forecast
dates for completion of tasks

Process for changing IMS activities
associated with cost and schedule asbaselined. Contractor shall notify JPEOCBRND of significant proposed changes
the IMS defined asReporting Procedures and Due Dates• A Draft is due
within contract
award; updates to the RMP are due concurrent
with Monthly Technical Progress Reports. The
contractor may choose to notify the govemment
up to two times every three months if there are nochanges from the prior submission, and not
submit an update.JPEO-CBRND will provide Contractor witha list of concerns in response plansubmitted'Contractor must address, in writing, all concerns
raised by JPEO-CBRND withinofContractors receipt of JPEO-CBRND's concerns'The IMS is to be submitted in both PDF andMicrosoft Project Form to the COR'The first Draft of the IMS is due
within contract award'The Government will request revisions, at which point the schedulebaseline for the period of performance will beset'Thereafter an updated IMS is due concurrent with
Monthly Technical Progress Reports'During a declared Public Health Emergency, the
IMS is to be delivered
contract
award, updates are due
and any
significant change)must be reported immediately to the COR and/or
designee.

'Due at least
prior to theContractor anticipating the need to implementchanges

Contractor shall provide a high level
management strategy for risk mitigation,
Contractor shall communicate to JPEOCBRND and document all criticalprogrammatic concems, issues, orprobable risks that have or are likely tosignificantly impact project schedule and/or
cost and/or performance.
03.7

Incident Report
but should be confirmed In

consultation with the COR. Incidents that
present liability to the project even withoutcost/schedule impact, such as breach of
GCP during a clinical study, must also bereported'Due withinof activity or incident orwithin
for a security activity or incident'Email or telephone with written follow-up to COR
and CO'Additional updates due to COR and COof additional developments'Contractor shall submit withinaCorrective Action Plan (if deemed necessary byeither party) to address any potential issues'If corrective action is deemed necessary,
Contractor must address in writing, itsconsideration of concerns raised by JPEOCBRND withinof receiving suchconcerns

CDRL#
09

Deliverable

Deliverable Description

Reporting Procedures and Due Dates

Advanced R&D
Products
1
Upon request, Contractor shall provide COTechnical Documents

and COR with deliverables from thefollowing contract funded activities: quality
agreements between contractors and subcontractors, process Development
Reports, Assay Qualification Plan/Report,
Assay Validation Plan/Report, Assay
Technology Transfer Report, Batch
Records, SOPs, Master Production
Records, Certificate of Analysis, ClinicalStudies Data or Reports. The CO and COR
reserve the right to request within the PoP
a non-proprietary technical document for
distribution within the Government

09.2

Animal Model or
Other Technology
Transfer Package

Contractor shall provide Animal Model or
Other Technology Transfer Package
containing relevant methodology and data
sufficient to enable other practitioners in
the field to successfully replicate
experimental conditions developed andtested with JPEO-CBRND support

09.3

Raw Data, Tabulation
Data (e.g., CDISCcompliant SDTM SAS
XPT datasets), or
Data Analysis (e.g.,
CDISC-compliant
ADaM SAS XPT
datasets)

09.1

09.4

Publications

Contractor shall provide raw data,
Tabulation Data (e.g., CDISC-compliant
SDTM SAS XPT datasets), or Data
Analysis (e.g., CDISC-compliant ADaM
SAS XPT datasets). to JPEO-CBRND
upon request

Any manuscript or scientific meeting
abstract containing data generated under
this contract must be submitted to JPEOCBRND for review prior to submission.
Acknowledgment of JPEO-CBRND
funding must be included as noted incontract articles
H.9 and H.24

*Contractor shall provide technical document
withinof CO or COR request.
Contractor can request additional time on an asneeded basis• If corrective action is recommended, theContractor must address, in writing.conc,ems
raised by JPEO-CBRND in writing• Contractor shall provide a draft packageof COR or CO request.Contractor shall revise the package to address
JPEO-CBRND's concerns. recommendations
and/or requests for additional detail*Contractor shall provide raw data, Tabulation
Data (e.g., CDISC-compliant SDTM SAS XPT
datasets), or Data Analysis (e.g., CDISCcompliant ADaM SAS XPT datasets) to CO and
COR withinof request• Contractor must submit all manuscript orscientific meeting abstract to PO and CO prior to
submission/presentation byformanuscripts andfor abstracts
or posters• Contractor must address in writing all concerns
raised by JPEO-CBRND in writing• Final submissions shall be submitted toJPEOCBRND
M . of its submission

10

Regulatory
Documents

10.1

10.2

FDA Correspondence

FDA Submissions

The Contractor shall memorialize any
correspondence between Contractor and
FDA and submit to JPEO-CBRND• Contractor shall provide copies of any FDA
correspondence withinofcorrespondence

The Contractor shall provide JPEOCBRND the opportunity to review andcomment upon all draft submissions
before submission to the FDA. Contractor
shall provide JPEO-CBRND with anelectronic copy of the final FDA• Contractor shall submit draft FDA submissions to
JPEO-CBRND at least
prior to
FDA submission.JPEO-CBRND will provide feedback to Contractor
withinof receipt

W911QY20C0119
Page 17 of 54
CDRL#

Deliverable

Deliverable Description
submission. All documents shall be duly
marked as either "Draft" or "Final"

11

Press Releases

Contractor agrees to accurately andfactually represent the work conductedunder this contract in all press releases

Reporting Procedures and Due Dates• The Contractor must address, in writing, itsconsideration of all concerns raised by JPEOCBRND prior to FDA submission• Final FDA submissions shall be submitted to
JPEO-CBRND• Contractor shall ensure that the CO has received
and approved an advanced copy of any press
release to this contract not less thanprior to the issuance of the press release• If corrective action is required, the Contractor
agrees to accurately and factually represent thework conducted under this contract in all press
releases• Any final press releases shall be submitted to
JPEO-CBRND no later thanprior to its release

2. petailed Description of Select Contract Deliverables
A. Monthly and Annual Progress Reports
In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit thefollowing reports in the manner stated below and in accordance with this Article F of this contract, and in the Statementof Work. attached to this contract as Attaclunent 1 (SECTION J-List of Attachments).
L

Monthly Progress Report

This report shall include a description of the activities during the reporting period, and the activities planned for theensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional partof the initial month. Thereafter, the reporting period shall consist of each calendar month.
The Contractor shall submit a Monthly Progress Report according to the dates set forth in the summary table ("Summaryof Contract Deliverables") under this article. The progress report shall conform to the requirements set forth in the
DELIVERIES Article in SECTION F of this contract.
The format should include:
•
•
•
•
•

•

A cover page that includes the contract number and title; the type of report and period that it covers; the Contractor's
name, address, telephone number, fax number, and e-mail address; and the date of submission;
SECTION I — EXECUTIVE SUMMARYSECTION II — PROGRESSSECTION II Part A: OVERALL PROGRESS - A description of overall progress.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A description of all meetings,
conference calls, etc. that have taken place during the reporting period. Include progress on administration andmanagement issues (e.g., evaluating, and managing subcontractor performance. and personnel changes).
SECTION II Part C: TECHNICAL PROGRESS - For each activity related to Gantt chart. document the results ofwork completed and cost incurred during the period covered in relation to proposed progress. effort and budget. The
report shall be in sufficient detail to explain comprehensively the results achieved. The description shall include
pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary
conclusions resulting from analysis and scientific evaluation of data accumulated to date under the contract. The
report shall include a description of problems encountered and proposed corrective action; differences between

W911QY20C0119
Page 18 of 54••

planned and actual progress, why the differences have occurred and what corrective actions are planned; preliminary
conclusions resulting from analysis and scientific evaluation of data accumulated to date under the project.
SECTION II Part D: PROPOSED WORK - A summary of work proposed related to Gantt chart for the next reporting
period and preprints/reprints of papers and abstracts.
SECTION III: Estimated and Actual Expenses.

a. This section of the report shall contain a narrative or table detailing whether there is a significant discrepancy (>10%)at this time between the % of work completed and the cumulative costs incurred to date. Monthly and actual expenses
should be broken down to the appropriate WBS level.
b. This section of the report should also contain estimates for the Subcontractors' expenses from the previous month if
the Subcontractor did not submit a bill in the previous month. If the subcontractor(s) was not working or did not incur
any costs in the previous month, then a statement to this effect should be included in this report for those respective
subcontractors.
A Monthly Progress Report will not be required in the same month that the Annual Progress Report is submitted.
ii. Annual Progress Report
This report shall include a summation of the results of the entire contract work for the period covered. Monthly Progress
Reports shall not be submitted in the same month when an Annual Progress Report is due. Furthermore, an Annual
Progress Report will not be required for the period when the Final Report is due.
The first Annual Progress Report shall be submitted in accordance with the date set forth in the table ("Summary ofContract Deliverables") under ARTICLE F.2. of this contract. The progress report shall conform to the requirements set
forth in the DELIVERIES Article in SECTION F of this contract.
Each Annual Progress Report shall include:
•
•
•
•
•

•

•
•

A Cover page that includes the contract number and title; the type of report and period that it covers; the Contractor's
name, address, telephone number, fax number, and email address; and the date of submission;
SECTION I: EXECUTIVE SUMMARY - A brief overview of the work completed, and the major accomplishments
achieved during the reporting period.
SECTION II: PROGRESSSECTION II Part A: OVERALL PROGRESS - A description of overall progress.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A high level summary of criticalmeetings, etc. that have taken place during the reporting period. Include progress on administration and management
to critical factors of the project (e.g. regulatory compliance audits and key personnel changes).
SECTION II Part C: TECHNICAL PROGRESS - A detailed description of the work performed structured to follow
the activities and decision gates outlined at the Integrated Baseline Review and as described in the Integrated Master
Plan. The Report should include a description of any problems (technical or financial) that occurred or were identified
during the reporting period, and how these problems were resolved.
SECTION II Part D: PROPOSED WORK - A summary of work proposed for the next year period to include an
updated Gantt Chart.
SECTION III: Estimated and Actual Expenses.

a. This section of the report shall contain a narrative or table detailing whether there were discrepancies between
estimated and actual expenses over the past year. Actual expenses should be broken down to the appropriate WBS level.
This section of the report should also contain estimates for outstanding costs for the previous year which may have been
incurred, but not yet billed.
Contractor also should include the following in the Annual Progress Report:
1. Copies of manuscripts (published and unpublished), abstracts, and any protocols or methods developed specificallyunder the contract during the reporting period; andW911QY20C0119
Page 19 of 54

2. A summary of any Subject Inventions per the requirements under FAR Clause 52.227-11.
Draft Final Report and Final Report
These reports are to include a summation of the work performed and results obtained for the entire contract period of
performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final
Report and Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract.
An Annual Progress Report will not be required for the period when the Final Report is due. The Draft Final Report andthe Final Report shall be submitted in accordance with the dates set forth in the table ("Summary of Contract
Deliverables") under ARTICLE F.2. of this contract.
The report shall conform to the following format:
1. Cover page to include the contract number, contract title, performance period covered, Contractor's name andaddress, telephone number, fax number, email address and submission date.
2. SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract effort including asummary of the major accomplishments relative to the specific activities set forth in theStatement of Work.
3. SECTION II: RESULTS - A detailed description of the work performed related to WBS and Gantt chart, the results
obtained, and the impact of the results on the scientific and/or public health community including a listing of all
manuscripts (published and in preparation) and abstracts presented during the entire period of performance and asummary of all inventions.
Draft Final Report: The Contractor is required to submit the Draft Final Report to the Contracting Officer's
Representative and Contracting Officer. The Contracting Officer's Representative and Contracting Officer will review theDraft Final Report and provide the Contractor with comments in accordance with the dates set forth in ARTICLE F.2. ofthis contract.
Final Report: The Contractor will deliver the final version of the Final Report on or before the completion date of thecontract. The final version shall include or address the COR's and CO's written comments on the draft report. Final
Report shall be submitted on or before the completion date of the contract.
iv. Summary of Salient Results
The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of salient results achieved
during the performance of the contract.
v. Audit Reports
Withinof an audit related to conformance to FDA regulations and guidance, including
adherence to GLP, GMP, GCP guidelines, the Contractor shall provide copies of the audit report (so long as received
from the FDA) and a plan for addressing areas of nonconformance to FDA regulations and guidelines for GLP, GMP, or
GCP guidelines as identified in the final audit report.
vi. Other Technical Reports
1. Supplemental Technical Documents
Upon request, Contractor shall provide CO and COR with the following contract funded documents as specified below
but not limited to: Process Development Reports; Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay
Technology Transfer Report, Batch Records, Contractor/Subcontractor Standard Operating Procedures (SOP's), Master
Production Records, Certificate of Analysis, Clinical Studies Data or Reports. The CO and COR reserve the right torequest within the Period of Performance a non-proprietary technical document for distribution within the USG.
Contractor shall provide technical document withinof CO or COR request. Contractor can request
additional time on an as needed basis. If edits are recommended, the Contractor must address, in writing, concerns raisedby JPEO-CBRND.

W911QY20C0119
Page 20 of 54

B. Deliverables Arising from FDA Correspondencei.

FDA Meetings

The Contractor shall forward the dates and times of any meeting with the FDA to JPEO-CBRND and make arrangements
forappropriate JPEO-CBRND staff to attend the FDA meetings. JPEO-CBRND staff shall include up to a maximum of four
people.
••Contractor shall notify JPEO-CBRND of upcoming FDA meeting withinof scheduling Type A, B or C
meetings OR withinof meeting occurrence for ad hoc meetings.
The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with
the FDA to JPEO-CBRND withinof receipt. All documents shall be duly marked as either "Draft" or"Final."ii. FDA Submissions
The Contractor shall provide JPEO-CBRND all documents submitted to the FDA. Contractor shall provide JPEOCBRND with anelectronic copy of the final FDA submission. All documents shall be duly
marked as either "Draft" or "Final."•••

When draft documents are submitted for JPEO-CBRND review, JPEO-CBRND will provide feedback to Contractor
withinof receipt.
When JPEO-CBRND reviews draft documents, the Contractor shall revise their documents to address JPEOCBRND's written concerns and/or recommendations prior to FDA submission.
Final FDA submissions shall be submitted to JPEO-CBRND concurrently or no later thanof theirsubmission to FDA.

iii. FDA Audits
In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA
inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the
USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR)
after the Contractors receipt of those documents. The Contractor shall provide the COR and CO withcopies of the plan for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as
identified in the audit report, status updates during the plans execution and a copy of all final responses to the FDA. The
Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of
this contract or for this product. The Contractor shall make arrangements for JPEO-CBRND representative(s) to bepresent during the final debrief by the regulatory inspector.
•••

Contractor shall notify CO and COR withinof a scheduled FDA audit or withinof an ad
hoc site visit/audit if the FDA does not provide advanced notice.
Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of thiscontract or for this product withinof receiving correspondence from the FDA, Subcontractor, or third
party.
Withinof audit report, Contractor shall provide CO with a plan for addressing areas ofnonconformance, if any are identified.

iv. Manufacturing Campaign Reports
Contractor shall provide Manufacturing Campaign Reports to JPEO-CBRND for review and comment prior to
submission to
FDA.

W911QY20C0119
Page 21 of 54

The COR and CO reserve the right to request within the Period of Performance (PoP) a non- proprietary Manufacturing
Campaign Report for distribution within the USG.
••••

Contractor will submit Manufacturing Campaign Reports at least
prior to FDA submission.
If corrective action is recommended, Contractor must address, in writing, all concerns raised by JPEO-CBRND.
Contractor shall revise the reports to address JPEO-CBRND's concerns and/or recommendations prior to FDA
submission.
Final FDA submission shall be submitted to JPEO-CBRND concurrently or no later thanaftersubmission to the FDA.

v. Other FDA Correspondence
The Contractor shall memorialize any correspondence between Contractor and FDA and submit to JPEO-CBRND. All
documents shall be duly marked as either "Draft" or "Final." Contractor shall provide written summary of any FDA
correspondence withinof correspondence.
i. Risk Management Plan
The Contractor shall provide a Risk Management Plan 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 willcapture how the corrective action will reduce impacts on cost, schedule and performance.
••••

Due within (b) (of contract award
Contractor provides updated Risk Management Plan in Monthly Progress Report
JPEO-CBRND shall provide Contractor with a written list of concerns in response plan submitted
Contractor must address, in writing, all concerns raised by JPEO-CBRND withinof Contractor'sreceipt of JPEO-CBRND's concerns.

DELIVERY INFORMATION
CLIN

DELIVERY DATE

0001

QUANTITYSHIP TO ADDRESSDODAAC /CAGE

100,000

JPEO-CBRND

W9OZQ28222 HOADLEY RD E5101
ABERDEEN PROVING GROUND MD 21010
FOB: Destination
000101 N/A

N/A

N/A

N/A

0002

N/A

N/A

N/A

N/A

ADDITIONAL SHIPPING INFOSECTION F DELIVERIES OR PERFORMANCE

W911QY20C0119
Page 22 of 54
F.1. The distribution plan is currently TBD.

F.2.Supply Chain Resiliency Plan: The contractor shall develop and submit withinof contract
award, a comprehensive Supply Chain Resiliency Program that provides identification and reporting of criticalcomponents associated with the secure supply of drug substance, drug product, and work-in-process through tofinished goods.
a) A critical component is defined as any material that is essential to the product or the manufacturing process
associated with that product. Included in the definition are consumables and disposables associated with
manufacturing. NOT included in the definition are facility and capital equipment.
Consideration of critical components includes the evaluation and potential impact of raw materials, excipients,
active ingredients, substances, pieces, parts, software, firmware, labeling, assembly, testing, analytical andenvironmental componentry, reagents, or utility materials which are used in the manufacturing of a drug, cell banks,
seed stocks, devices and key processing components and equipment. A clear example of a critical component is one
where a sole supplier is utilized.
The contractor shall identify key equipment suppliers, their locations, local resources, and the associated control
processes at the time of award. This document shall address planning and scheduling for active pharmaceuticalingredients, upstream, downstream, component assembly, finished drug product and delivery events as necessary forthe delivery of product.
a) Communication for these requirements shall be updated as part of an annual review, or as necessary, as part ofregular contractual communications.
b) For upstream and downstream processing, both single-use and re-usable in-place processing equipment, andmanufacturing disposables also shall be addressed. For finished goods, the inspection, labeling, packaging, andassociated machinery shall be addressed taking into account capacity capabilities.
c) The focus on the aspects of resiliency shall be on critical components and aspects of complying with the contractual
delivery schedule. Delivery methods shall be addressed, inclusive of items that are foreign-sourced, both high andlow volume, which would significantly affect throughput and adherence to the contractually agreed deliveries.
The contractor shall articulate in the plan, the methodology for inventory control, production planning, schedulingprocesses and ordering mechanisms, as part of those agreed deliveries.
a) Production rates and lead times shall be understood and communicated to the Contracting Officer or the Contracting
Officer's Representative as necessary.
b) Production throughput critical constraints should be well understood by activity and by design, and communicatedto contractual personnel. As necessary, communication should focus on identification, exploitation, elevation, andsecondary constraints of throughput, as appropriate.
Reports for critical items should include the following information:
a)
b)
c)
d)
e)
0

Critical Material
Vendor
Supplier, Manufacturing / Distribution Location
Supplier Lead Time
Shelf Life
Transportation / Shipping restrictions
The CO and COR reserve the right to request un-redacted copies of technical documents, during the period of
performance, for distribution within the Government. Documents shall be provided within
after COissues the request. The Contractor may arrange for additional time if deemed necessary, and agreed to by the CO.

W911QY20C0119
Page 23 of 54
F.3. Manufacturing Data Requirements: The Contractor shall submit withinof contract award
detailed data regarding project materials, sources, and manufacturing sites, including but not limited to: physicallocations of sources of raw and processed material by type of material; location and nature of work performed at
manufacturing, processing, and fill/finish sites; and location and nature of non-clinical and clinical studies sites. The
Government may provide a table in tabular format for Contractor to be used to submit such data which would
include but not be limited to the following:
•
•
•
•
•
•
•
•
•
•

Storage/inventory of ancillary materials (vials, needles, syringes, etc.)
Shipment of ancillary materials (vials, needles, syringes, etc.)
Disposal of ancillary materials (vials, needles, syringes, etc.)
Seed development or other starting material manufacturing
Bulk drug substance and/or adjuvant production
Fill, finish, and release of product or adjuvant
Storage/inventory of starting materials, bulk substance, or filled/final product or adjuvant
Stability information of bulk substance and/or finished product
Shipment of bulk substance of final productDisposal of bulk substance or final productF.4. Product Development Source Material and Manufacturing Reports and Projections: The Contractor shallsubmit a detailed spreadsheet regarding critical project materials that are sourced from a location other than the
United States, sources, and manufacturing sites, including but not limited to: physical locations of sources of raw
and processed material by type of material; location and nature of work performed at manufacturing sites; andlocation and nature of non-clinical and clinical study sites.
The Contractor will provide manufacturing reports and manufacturing dose tracking projections/actuals utilizing the"COVID-19 Dose Tracking Templates", on any contract/agreement that is manufacturing product:

•
o
o
o
•
•
•

Contractor will submit Product Development Source Material Report
Within month of contract award
Within 30 days of substantive changes are made to sources and/or materials
and on the eh month contract anniversary.
Contractor will update the Dose Tracking Template weekly, during manufacturing campaigns and COVID response,with the first deliverable submission within 15 days of award/modification
The Government will provide written comments to the Product Development Source Material and Manufacturing
Report within 15 business days after the submission
If corrective action is recommended, Contractor must address all concerns raised by the Government in writing
F.5. Contractor Locations: The contractor shall submit detailed data regarding locations where work will be
performed under this contract, including addresses, points of contact, and work performed per location, to include
sub-contractors.
Contractor will submit Work Locations Report:•••

Within 5 business days of contract award
Within 30 business days after a substantive location or capabilities change
Within 2 business days of a substantive change if the work performed supports medical countermeasuredevelopment that addresses a threat that has been declared a Public Health Emergency by the HHS Secretary or a
Public Health Emergency of International Concern (PHEIC) by the WHO•
F.6. Access and General Protection/Security Policy and Procedures: This standard language text is applicable to
ALL employees working on critical information related to Operation Warp Speed (OWS), and to those with an areaof performance within a Government controlled installation, facility or area. Employees shall comply withapplicable installation, facility and area commander installation/facility access and local security policies andW911QY20C0119
Page 24 of 54
procedures (provided by government representative). The performer also shall provide all information required forbackground checks necessary to access critical information related to OWS, and to meet Government installation
access requirements to be accomplished by installation Director of Emergency Services or Security Office. The
workforce must comply with all personnel identity verification requirements as directed by the Government and/or
local policy. In addition to the changes otherwise authorized by the changes clause of this agreement, should the
security status of OWS change the Government may require changes in performer security matters or processes. In
addition to the industry standards for employment background checks, The Contractor must be willing to have key
individuals, in exceptionally sensitive positions, identified for additional vetting by the United States Government.
F.7. Operational Security (OPSEC): The performer shall develop an OPSEC Standard Operating Procedure(SOP)/Plan within ninety (90)-calendar-days of project award to be reviewed and approved by the responsible
Government OPSEC officer. This plan will be submitted to the COR for coordination of approvals. This SOP/Planwill include identifying the critical information related to this contract, why it needs to be protected, where it islocated, who is responsible for it, and how to protect it.
F.8. Security Plan: The contractor shall develop a comprehensive security program that provides overall protectionof personnel, information, data, and facilities associated with fulfilling the Government requirement. This plan shallestablish security practices and procedures that demonstrate how the contractor will meet and adhere to the security
requirements outlined below prior to the commencement of product manufacturing, and shall be delivered to theGovernment within 30 calendar days of award. The contractor shall also ensure all subcontractors, consultants,
researchers, etc. performing work on behalf of this effort, comply with all Government security requirements andprime contractor security plans.
a) The Government 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 Draft Security Plan comments. and, submit
a Final Security Plan to the U.S. Government within (10) calendar days after receipt of the comments.
b) The Security Plan shall include a timeline for compliance of all the required security measures outlined by theGovernment.
c) Upon completion of initiating all security measures, the Contractor shall supply to the Contracting Officer a letter
certifying compliance to the elements outlined in the Final Security Plan.
At a minimum, the Final Security Plan shall address the following items:
Security Requirements:

1.
Facility Security Plan
Description: As part of the partner facility's overall security program, the contractor shall submit a written security
Ian with their proposal to the Government for review and approval by Government security subject
matter experts. The performance of work under the contract will be in accordance with the approved security plan.
The security plan will include the following processes and procedures at a minimum:organization chart and responsibilities
ecurity Administration
written security risk assessment for sitethreat levels with identification matrix (High, Medium, or Low)enhanced security procedures during elevated threatsliaison procedures with law enforcement
annual employee security education and training program
policies and proceduresersonnel Security
candidate recruitment process
background investigations process
employment suitability policy
employee access determination
rules of behavior/ conduct
termination procedures
non-disclosure agreements

W911QY20C0119
Page 25 of 54' hysical Security Policies and internal/external access control
I • cedures
protective services
identification/badging
employee and visitor access controls
parking areas and access control
perimeter fencing/barriers
product shipping, receiving and transport security procedures
facility security lighting
restricted areas
signageintrusion detection systems
alarm monitoring/response
closed circuit television
product storage security
other control measures as identified
I i ormation Security
identification and marking of sensitive information
access control
storage of information
document control procedures
retention/ destruction requirements
I nformation
intrusion detection and prevention systems
echnology/Cyber Security threat identification
1" olicies and Procedures
employee training (initial and annual)encryption systems
identification of sensitive information/media
password policy (max days 90)
lock screen time out policy (minimum time 20 minutes)
removable media policy
laptop policy
removal of IT assets for domestic/foreign travel
access control and determination
VPN procedures
WiFi and Bluetooth disabled when not in use
system document control
system backup
system disaster recovery
incident response
system audit procedures
property accountability
P.
Site Security Master Plan
I. escription: The partner facility shall provide a site schematic for security systems which includes: main access• oints; security cameras; electronic access points; IT Server Room: Product Storage Freezer/Room; and bioontainment laboratories.
c.

Site Threat / Vulnerability / Risk Assessment

II escription: The partner facility shall provide a written risk assessment for the facility addressing: criminal threat,i cluding crime data; foreign/domestic terrorist threat; industrial espionage; insider threats; natural disasters; andotential loss of critical infrastructure (power/water/natural gas, etc.) This assessment shall include
ecent data obtained from local law enforcement agencies. The assessment should be updated annually.
I.
Physical Security
It escription:iW911QY20C0119
Page 26 of 54
Closed Circuit Television(CCTV) Monitoring

Layered (internallextemal) CCTV coverage with time-lapse video
recording for buildings and areas where critical assets are processed or stored.

a)

CCTV coverage must include entry and exits to critical facilities, perimeters, andareas within the facility deemed critical to the execution of the contract.
Video recordings must be maintained for a minimum of 30 days.
CCTV surveillance system must be on emergency power backup.
CCTV coverage must include entry and exits to critical facilities, perimeters, andareas within the facility deemed critical to the execution of the contract.
Video recordings must be maintained for a minimum of 30 days.
CCTV surveillance system must be on emergency power backup.

Facility Lighting

Shipping and Receiving

Access Control

Employee/Visitor
Identification

Lighting must cover facility perimeter, parking areas, critical infrastructure, andentrances and exits to buildings.
Lighting must have emergency power backup.
Lighting must be sufficient for the effective operation of the CCTV surveillancesystem during hours of darkness.
Must have CCTV coverage and an electronic access control system.
Must have procedures in place to control access and movement of drivers picking up
or delivering shipments.
Must identify drivers picking up Government products by government issued photo
identification.
Must have an electronic intrusion detection system with centralized monitoring.
Responses to alarms must be immediate and documented in writing.
Employ an electronic system (i.e., card key) to control access to areas where assets
critical to the contract are located (facilities, laboratories, clean rooms, production
facilities, warehouses, server rooms, records storage, etc.).
The electronic access control should signal an alarm notification of unauthorized
attempts to access restricted areas.
Must have a system that provides a historical log of all key access transactions andkept on record for a minimum of12 months.
Must have procedures in place to track issuance of access cards to employees and theability to deactivate cards when they are lost or an employee leaves the company.
Response to electronic access control alarms must be immediate and documented inwriting and kept on record for a minimum of 12 months.
Should have written procedures to prevent employee piggybacking accessto critical infrastructure (generators, air handlers, fuel storage, etc.) should becontrolled and limited to those with a legitimate need for access.
Must have a written manual key accountability and inventory process.
Physical access controls should present a layered approach to critical assets within thefacility.

Should issue company photo identification to all employees.
Photo identification should be displayed above the waist anytime the employee is oncompany property.
Visitors should be sponsored by an employee and must present government issued
photo identification to enter the property.
Visitors should be logged in and out of the facility and should be escorted by an
employee while on the premises at all times.

W911QY20C0119
Page 27 of 54• ecurity Fencing
1. . tective Security Forces1'

tective Security Forces
erations,

0 I

Requirements for security fencing will be determined by the criticality of the
program, review of the security plan, threat assessment, and onsite security
assessment.
Requirements for security officers will be determined by the criticality of the
program, review of the security plan, threat assessment, and onsite security
assessment.
Must have in-service training program.
Must have Use of Force Continuum.
Must have communication systems available (i.e.. landline on post. cell phones,
handheld radio, and desktop computer).
Must have Standing Post Orders.

Must wear distinct uniform identifying them as security officers.
Security Operations
IS escription:
I , omtation Sharing
Establish formal liaison with law enforcement.

..

Meet in person at a minimum annually. Document meeting notes and keep them onfile for a, minimum of 12 months. POC information for LE Officer that attended themeeting must be documented.
Implement procedures for receiving and disseminating threat information.
rainingecurity Management,.
ID

Conduct new employee security awareness training.
Conduct and maintain records of annual seam awareness trainin •Designate a knowledgeable security professional to manage the security of the
facility.
Ensure subcontractor compliance with all Government security requirements.

Personnel Security
escription:

I ecords Checks

I iring and Retention
tandards

Verification of social security number, date of birth, citizenship, education
credentials, five-year previous employment history, five-year previous residence
history, FDA disbarment, sex offender registry, credit check based upon position
within the company; motor vehicle records check as appropriate; and local/national
criminal history search.
Detailed policies and procedures concerning hiring and retention of employees,
employee conduct, and off boarding procedures.
Off Boarding procedures should be accomplished within 24 hour of
employee leaving the company. This includes termination of all network access.

.
Information Security
Is escription:
1. hysical Document Control Applicable documents shall be identified and marked as procurement sensitive.
proprietary, or with appropriate government markings.
Sensitive, proprietary, and government documents should be maintained in a
lockable filing cabinet/desk or other storage device and not be left unattended.
Access to sensitive information should be restricted to those with a need to know.

Documents must be destroyed using approved destruction measures (i.e,shredders/approved third party vendors / pulverizing / incinerating).
Information Technology & Cybersecurity
IS escription:ISmullein DestructionW911QY20C0119
Page 28 of 54
Identity Management

Physical devices and systems within the organization are inventoried and accounted
for annually.
Organizational cybersecurity policy is established and communicated.
Asset vulnerabilities are identified and documented.
Cyber threat intelligence is received from information sharing forums and sources.
Threats, vulnerabilities, likelihoods, and impacts are used to determine risk.
Identities and credentials are issued, managed, verified, revoked, and audited forauthorized devices, users and processes.
Users, devices, and other assets are authenticated (e.g., single-factor, multifactor)
commensurate with the risk of the transaction (e.g.,
individuals' security and privacy risks and other organizational risks)

Access Control

Limit information system access to authorized users.
Identify information system users, processes acting on behalf of users, or devices andauthenticate identities before allowing access.
Limit physical access to information systems, equipment, and server rooms withelectronic access controls.
Limit access to/ verify access to use of external information systems.
Ensure that personnel are trained and are made aware of the security risks associatedwith their activities and of the applicable laws, policies,
standards, regulations, or procedures related to information technology systems.

Training

Audit and Accountability

Configuration Management

Contingency Planning

Incident Response

Media and Information
Protection

Create, protect, and retain information system audit records to the extent needed toenable the monitoring, analysis, investigation, and reporting of unlawful,
unauthorized, or inappropriate system activity. Records must be kept for minimum
must be kept for 12 months.
Ensure the actions of individual information system users can be uniquely traced tothose users.
Update malicious code mechanisms when new releases are available.
Perform periodic scans of the information system and real time scans of files fromexternal sources as files are downloaded, opened, or executed.
Establish and enforce security configuration settings.
Implement sub networks for publically accessible system components that arephysically or logically separated from internal networks.

a)
Establish, implement, and maintain plans for emergency response,
backup operations, and post-disaster recovery for information systems to ensure theavailability of critical information resources at all times.
Establish an operational incident handling capability for information systems that
includes adequate preparation, detection, analysis,containment, and recovery of cybersecurity incidents. Exercise this capability
annually.
Protect information system media, both paper and digital.
Limit access to information on information systems media to authorized users.
Sanitize and destroy media no longer in use.
Control the use of removable media through technology or policy.

W911QY20C0119
Page 29 of 54
Physical and Environmental
Protection

Limit access to information systems. equipment. and the respective operating
environments to authorized individuals.
Intrusion detection and prevention system employed on IT networks.
Protect the physical and support infrastructure for all information systems.
Protect information systems against environmental hazards.
Escort visitors and monitor visitor activity.

Network Protection

Employ intrusion prevention and detection technology with immediate analysis
capabilities.
9.
Transportation Security
Description: Adequate security controls must be implemented to protect materials while in transit from theft.
destruction, manipulation, or damage.
Drivers
Drivers must be vetted in accordance with Government Personnel Security
Requirements.
Drivers must be trained on specific security and emergency procedures.
Drivers must be equipped with backup communications.
Driver identity must be 100 percent confirmed before the pick-up of any
Government product.
Drivers must never leave Government products unattended, and two drivers may berequired for longer transport routes or critical products during times of emergency.
Truck pickup and deliveries must be logged and kept on record for a minimum of 12months.
Transport Routes

Transport routes should be pre-planned and never deviated from except whenapproved or in the event of an emergency.
Transport routes should be continuously evaluated based upon new
threats, significant planned events, weather, and other situations that may delay or
disrupt transport.
Product Security
Government products must be secured with tamper resistant seals during transport,
and the transport trailer must be locked and sealed.
Tamper resistant seals must be verified as "secure" after the product is placed in thetransport vehicle.
Government products should be continually monitored by GPS technology while intransport. and any deviations from planned routes should be investigated anddocumented.
Contingency plans should be in place to keep the product secure during emergencies
such as accidents and transport vehicle breakdowns.
10. Security Reporting Requirements
Description: The partner facility shall notify the Government Security Team within 24 hours of any activity or
incident that is in violation of established security standards or indicates the loss or theft of goverrunent products.
The facts and circumstances associated with these incidents will be documented in writing for government review.

11. Security Audits
Description: The partner facility agrees to formal security audits conducted at the discretion of the government.
Security audits may include both prime and subcontractor.
I

INSPECTION AND ACCEPTANCE TERMS

W911QY20C0119
Page 30 of 54

Supplies/services will be inspected/accepted at:
CLIN
0001
0001010002

INSPECT AT
Destination
N/A
Destination

INSPECT BY
Government
N/A
Government

ACCEPT AT
Destination
N/A
Destination

ACCEPT BY
Government
N/A
Government

ACCOUNTlNG AND APPROPRIATION DATA
AA: 09720202021013000018170552520252
COST CODE: AHPDDAMOUNT:

S.0074658.1.1.15

ACRN

CLIN/SLIN

C1N

AA

000101

GFEBS001155554000001

6100.9000021001

AMOUNT

CONTRACT ADMINISTRATION
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.
Contracting Officer:(b) (6)Bldg 1, General Greene Avenue
Natick, MA 01760-5011
Procurement Specialist:

Bldg 1, General Greene Avenue
Natick, MA 01760-5011
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 orbinding upon the government. All such actions must be formalized by a proper contractual document executed by
the Contracting Officer.
G.2 Government Technical Points of Contact:
Program Manager:

W911QY20C0119
Page 31 of 54

G.3 Contractor's Contract Administration
Technical Point of Contact:

Administrative Point of Contact:

G.4 Contractor's Past Performance Point of Contact (POC):
Annual contract past performance evaluations will be performed by the government. The offeror shall identify aPoint of Contact (POC) to participate in these on-line evaluations. This individual is required to register in theContractor Performance Assessment Reporting System (CPARS @ http://www.cpars.csd.disa mil) and respond to
the government evaluations in a timely manner. The contractor POC responsible for this action is:

G.5 Notifications of Revisions and Changes:
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 orchanges in the event this contract includes a key personnel clause.

TERMS AND CONDITIONSSPECIAL CONTRACT REQUIREMENTS
H.1. The government hereby issues this contract action as an Undefinitized Contract Action (UCA) for the
manufacturing therapeutic AZD7442 in support of OWS. The UCA award is being executed as a result of the MCM
Commercial Solutions Opening (CSO) Solicitation W911QY-20-S-0001 Area of Interest (A0I) Number A003:
SARS-CoV-2 Medical Counter Measures (MCM) Therapeutics.
H.1.1. This contract shall be definitized NLT 180 days from the date of this award as required by the CONTRACT
DEFINITIZATION CLAUSE 252.217-7027. The government intends to obligate
upon award of the
UCA. The government has developed a definitization schedule that defines the milestone events required to definitize
the contract sooner than the required 180 days. The government reserves the right to utilize up to the full 180 day fordefinitization as required.

W911QY20C0119
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H.1.2. The Government expects that the definitized contract shall include additional terms that at a minimum will
include: a revised list of deliverables to more accurately reflect the final agreed-upon work to be performed;
apportionment of technical data rights for subject data generated under this contract; and ensuring sufficient supply of
the product to the Government.
H.2. 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 contractorvoluntarily diverting any of the specified
individuals to other programs or contracts the contractorshall notify the Contracting Officer and shall submit ajustification 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 theemployee of the contractoris terminated for cause or separates from the contractorvoluntarily with less than thirty(30) calendar-day notice, the contractorshall provide the maximum notice practicable under the circumstances. The
contractorshall not divert, replace, or announce any such change to key personnel without the written consent of theContracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect theagreement of the parties.
The following individuals are determined to be key personnel:
Technical point of contact:

Administrative point of contact:

H.3. Substitution of Key Personnel: The contractoragrees 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 guidance. All requests for substitution must provide a
detailed explanation of the circumstance necessitating the proposed obstitution, 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 theperson to be replaced. The contracting officer or authorized representative will evaluate such requests and promptly
notify the contractor of his approval or disapproval thereof.
The contractor further agrees to include the substance of this language in any subcontract, which may be awarded
under this contract.
H.4. Contractor's Organization: The contractor's organization shall be established with authority to effectively
accomplish the objectives of the Statement of Work. This organization shall become effective upon award of thecontract and its integrity shall be maintained for the duration of the contract effort.
H.5. Disclosure of Information: Performance under this contract may require the contractorto access non-publicdata and information proprietary to a government agency, another government contractoror 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 contractorpersonnel, shall divulge nor release data nor information developed or
obtained under performance of this contract, except authorized by government personnel or upon written approval ofW911QY20C0119
Page 33 of 54
the CO in accordance with OWS or other government policies and/or guidance. The contractorshall 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 contractorshall comply with all government requirements for protection of non-public information. Unauthorized
disclosure of nonpublic information is prohibited by the government's rules. Unauthorized disclosure may result intermination of the contract, replacement of a contractoremployee, or other appropriate redress. Neither thecontractornor the Contractor's employees shall disclose or cause to be disseminated, any information concerning theoperations of the activity, which could result in, or increase the likelihood of, the possibility of a breach of theactivity'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, orother business transactions.
H.6. Publication and Publicity: The contractor shall not release any reports, manuscripts, press releases, orabstracts 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 thiscontract. 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, andfurnish a copy of it as finally published.
(b) Unless authorized in writing by the CO, the contractor shall not display government logos 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 government approval or endorsementof the product(s) or service(s) provided.
(d) The contractor shall include this language, including this section (d) in all subcontracts where thesubcontractor may propose publishing the results of its work under the subcontract. The contractor shall acknowledge
the support of the government 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 by the U.S. government under Contract No. "W911QY-20-C0101". The US government is authorized to reproduce and distribute reprints for governmental purposes
notwithstanding any copyright notation thereon.
H.7. Confidentiality of Information:a.
Confidential information, as used in this article, means information or data of a personal nature about anindividual, or proprietary information or data submitted by or pertaining to an institution or organization.
b.
The Contracting Officer and the contractormay, by mutual consent, identify elsewhere in this contract specificinformation and/or categories of information which the government will furnish to the contractoror that thecontractoris expected to generate which is confidential. Similarly, the Contracting Officer and the contractormay, 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W911QY20C0119
Page 34 of 54
thereof, is subject to the Privacy Act, the contractorwill 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 priorwritten consent of the individual, institution, or organization.
e.
Whenever the contractoris 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 this article,
the contractorshall 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.
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in otherg.
Federal, State or local laws.
All above requirements MUST be passed to all Sub-contractors.
H.8. Organizational Conflicts of Interest: Performance under this contract may create an actual or potential
organizational conflict of interest such as are contemplated by FAR Part 9.505-General Rules. The contractorshall not
engage in any other contractual or other activities which could create an organizational conflict of interest (OCI).
This provision shall apply to the prime contractorand all sub-Contractors. This provision shall have effect throughout
the period of performance of this contract, any extensions thereto by change order or supplemental agreement, and fortwo (2) years thereafter. The government may pursue such remedies as may be permitted by law or this contract,
upon determination that an OCI has occurred.
The work performed under this contract may create a significant potential for certain conflicts of interest, as set forthin FAR Parts 9.505-1, 9.505-2, 9.505-3, and 9.505-4. It is the intention of the parties hereto to prevent both thepotential for bias in connection with the Contractor's performance of this contract, as well as the creation of any
unfair competitive advantage as a result of knowledge gained through access to any non-public data or third party
proprietary information.
The contractorshall notify the Contracting Officer immediately whenever it becomes aware that such access orparticipation may result in any actual or potential OCI. Furthermore, the contractorshall promptly submit a plan to theContracting Officer to either avoid or mitigate any such OCI. The Contracting Officer will have sole discretion in
accepting the Contractor's mitigation plan. In the event the Contracting Officer unilaterally determines that any such
OCI cannot be satisfactorily avoided or mitigated, other remedies may be taken to prohibit the contractorfrom
participating in contract requirements related to OCI.
Whenever performance of this contract provides access to another Contractor's proprietary information, thecontractorshall enter into a written agreement with the other entities involved, as appropriate, in order to protect suchproprietary information from unauthorized use or disclosure for as long as it remains proprietary; and refrain fromusing such proprietary information other than as agreed to, for example to provide assistance during technicalevaluation of other Contractors' offers or products under this contract. An executed copy of all proprietary
information agreements by individual personnel or on a corporate basis shall be furnished to the CO within fifteen(15) calendar days of execution.
H.9. Institutional Responsibility Regarding Investigator Conflicts of Interest: The Institution (includes any
Contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45 CFR Part 94,
Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that
Investigators (defined as the project director or principal Investigator and any other person, regardless of title orposition, who is responsible for the design, conduct, or reporting of research funded under government contracts, or
proposed for such funding, which may include, for example, collaborators or consultants) will not be biased by any

W911QY20C0119
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Investigator financial conflicts of interest. 45 CFR Part 94 is available at the following Web site:
http://www.ecfr.gov/cgibin/textidx?c=ecfr&SID=Oaf84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=
As required by 45 CFR Part 94, the Institution shall, at a minimum:a.
Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFRPart 94, inform each Investigator of the policy, the Investigator's reporting responsibilities regarding disclosure ofsignificant financial interests, and the applicable regulation, and make such policy available via a publicly accessible
Web site, or if none currently exist, available to any requestor within five business days of a request. A significant
financial interest means a financial interest consisting of one or more of the following interests of the Investigator(and those of the Investigator's spouse and dependent children) that reasonably appears to be related to theInvestigator's institutional responsibilities:
1.
With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration
received from the entity in the twelve months preceding the disclosure and the value of any equity interest in theentity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;
2.
With regard to any non-publicly traded entity, a significant financial interest exists if the value of any
remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds$5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest; or3.

Intellectual property rights and interests, upon receipt of income related to such rights and interest.

Significant financial interests do not include the following:
1.
Income from seminars, lectures, or teaching, and service on advisory or review panels for government
agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an
Institution of higher learning; and2.
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator
does not directly control the investment decisions made in these vehicles.
b.
Require each Investigator to complete training regarding the Institution's financial conflicts of interest policy
prior to engaging in research related to any government funded contract and at least every four years. The Institution
must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or
subcontractors comply with the regulations.
c.
Designate an official(s) to solicit and review disclosures of significant financial interests from each
Investigator who is planning to participate in, or is participating in, the government funded research.
d.
Require that each Investigator who is planning to participate in the government funded research disclose to theInstitution's designated official(s) the Investigator's significant financial interest (and those of the Investigator's
spouse and dependent children) no later than the date of submission of the Institution's proposal for government
funded research. Require that each Investigator who is participating in the government funded research to submit an
updated disclosure of significant financial interests at least annually, in accordance with the specific time period
prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring a
new significant financial interest.
e.
Provide guidelines consistent with the regulations for the designated official(s) to determine whether an
Investigator's significant financial interest is related to government funded research and, if so related, whether thesignificant financial interest is a financial conflict of interest. An Investigator's significant financial interest is related
to government funded research when the Institution, thorough its designated official(s), reasonably determines thatthe significant financial interest: Could be affected by the government funded research; or is in an entity whose
financial interest could be affected by the research. A financial conflict of interest exists when the Institution, throughW911QY20C0119
Page 36 of 54
its designated official(s), reasonably determines that the significant financial interest could directly and significantly
affect the design, conduct, or reporting of the government funded research.
f.
Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a
subcontractor Investigator. Management of an identified financial conflict of interest requires development andimplementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part
94.5(a).
g.

Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b).

h.
Maintain records relating to all Investigator disclosures of financial interests and the Institution's review of,and response to, such disclosures, and all actions under the Institution's policy or retrospective review, if applicable,
for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48 CFRPart 4, subpart 4.7, Contract Records Retention.
i.
Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative
actions to ensure Investigator compliance as appropriate.
j.
Complete the certification in Section K - Representations, Certifications, and Other Statements of Contractors
titled "Certification of Institutional Policy on Financial Conflicts of Interest".
k.
If the failure of an Institution to comply with an Institution's financial conflicts of interest policy or a financial
conflict of interest management plan appears to have biased the design, conduct, or reporting of the government
funded research, the Institution must promptly notify the Contracting Officer of the corrective action taken or to betaken. The Contracting Officer will consider the situation and, as necessary, take appropriate action or refer thematter to the Institution for further action, which may include directions to the Institution on how to maintainappropriate objectivity in the government funded research project.
1.
The Contracting Officer and/or government may inquire at any time before, during, or after award into any
Investigator disclosure of financial interests, and the Institution's review of, and response to, such disclosure,regardless of whether the disclosure resulted in the Institution's determination of a financial conflict of interests. The
Contracting Officer may require submission of the records or review them on site. On the basis of this review ofrecords or other information that may be available, the Contracting Officer may decide that a particular financial
conflict of interest will bias the objectivity of the government funded research to such an extent that further corrective
action is needed or that the Institution has not managed the financial conflict of interest in accordance with Part
94.6(b). The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.
m.
If the Contracting Officer determines that government funded clinical research, whose purpose is to evaluate
the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an
Investigator with a financial conflict of interest that was not managed or reported by the Institution, the Institution
shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of theresults of the research and to request an addendum to previously published presentations.
H.10.

Regulatory Rights and ComplianceContractor is the Sponsor of the Regulatory Application to FDA (as the terms "sponsor" and "applicant" are definedor used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20). Contractor has certain standing
before the FDA that entitles it to exclusive communications related to the Regulatory Application.
1.
The Parties agree that Contractor has invested significant time and resources in its platform and IP and is thebest company situated to manage production of the Technology. At the same time, the Parties acknowledge that theGovernment has made significant investments in the prototype. Accordingly, the Contractor and the Government
agree to the following:a.

The Contractor will provide to the Government all data including top-line summaries and key conclusions

W911QY20C0119
Page 37 of 54
from all studies supporting the regulatory filing and commercial approval to the extent that such data, summaries, andconclusions are funded by this Agreement. In addition, the Contractor will offer the Government the opportunity toreview and provide comments on a final draft of regulatory submissions which include data funded by thisAgreement. The Government will review any such submissions promptly upon receipt. The Contractor willreasonably consider any comments provided by the Government, and prior to submission will provide notification to
the Government of any additional edits or revisions. The Contractor will keep the Government apprised of planned
FDA meetings and post-meeting outcomes relating to activities funded by this Agreement.
b.
The Contractor shall provide the Government with all formal and informal communications and summaries
thereof to or from FDA, regarding the Technology within, and use best efforts to ensure that theGovernment representatives are invited to participate in any formal or informal Sponsor meetings with FDA.
Contractor shall (1) ensure that the Government representatives are consulted and are invited to participate in any
formal or informal Sponsor meetings with FDA related to the Technology; and (2) notify the FDA that theGovernment has the right to discuss with FDA any development efforts regarding the Technology.
2.
The manufacturing described in the Statement of Work will comply with Current Good Manufacturing
Practices (cGMP) regulations at 21 CFR 210 and 211. Production shall occur using cGMP validated manufacturing
process, fully compliant with 21 CFR 210 and 211, for bulk drug substance and fill and finished drug product, with a
ramp-up capacity that provides doses sufficient for the government to treat the US population.
3.
Production and distribution shall comply with applicable provisions of the Drug Supply Chain Security Act(DSCSA), Sections 581-585 of PL 113-54 (Nov 27, 2013), taking into account FDA's regular guidance for the
COVID-19 public health response.

CLAUSES INCORPORATED BY REFERENCE

52.204-7
52.204-13
52.204-21
52.204-24
52.212-3 Alt I
52.232-40
252.203-7000
252.203-7003
252.204-7012
252.211-7003
252.232-7003
252.232-7010
252.244-7000

System for Award Management
System for Award Management Maintenance
Basic Safeguarding of Covered Contractor Information
Systems
Representation Regarding Certain Telecommunications andVideo Surveillance Services or Equipment.
Offeror Representations and Certifications—Commercial
Items (AUG 2020) Alternate I
Providing Accelerated Payments to Small BusinessSubcontractors
Requirements Relating to Compensation of Former DoD
Officials
Agency Office of the Inspector General
Safeguarding Covered Defense Information and Cyber
Incident Reporting
Item Unique Identification and Valuation
Electronic Submission of Payment Requests and Receiving
Reports
Levies on Contract Payments
Subcontracts for Commercial Items

OCT 2018
OCT 2018
JUN 2016
AUG 2020
OCT 2014
DEC 2013
SEP 2011
AUG 2019
DEC 2019
MAR 2016
DEC 2018
DEC 2006
JUN 2013

CLAUSES INCORPORATED BY FULL TEXT

52.212-4

CONTRACT TERMS AND CONDITIONS-- COMMERCIAL ITEMS (OCT 2018)

W911QY20C0119
Page 38 of 54(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to therequirements of this contract. The Government reserves the right to inspect or test any supplies or services that havebeen tendered for acceptance. The Government may require repair or replacement of nonconforming supplies orreperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance
will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate
consideration for acceptance of nonconforming supplies or services. The Government must exercise its postacceptance rights (1) within a reasonable time after the defect was discovered or should have been discovered; and(2) before any substantial change occurs in the condition of the item, unless the change is due to the defect in theitem.
(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of
performance of this contract to a bank, trust company, or other financing institution, including any Federal lending
agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes
payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights toreceive payment under this contract.
(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of theparties.
(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes", as amended (41 U.S.C. 601-613).
Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or
action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR
52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently withperformance of this contract, pending final resolution of any dispute arising under the contract.
(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

U) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence
beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public
enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine
restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify theContracting Officer in writing as soon as it is reasonably possible after the commencement or any excusable delay,
setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch
and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.
(g) Invoice.
(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to theaddress designated in the contract to receive invoices. An invoice must include-(i) Name and address of the Contractor;(ii) Invoice date and number;(iii) Contract number, line item number and, if applicable, the order number;(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on
Government bill of lading;(vi) Terms of any discount for prompt payment offered;(vii) Name and address of official to whom payment is to be sent;(viii) Name, title, and phone number of person to notify in event of defective invoice; andW911QY20C0119
Page 39 of 54(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if requiredelsewhere in this contract.
(x) Electronic funds transfer (EFT) banking information.
(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.
(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice,
the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation
provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for AwardManagement, or 52.232-34, Payment by Electronic
Funds Transfer--Other Than System for Award Management), or applicable agency procedures.
(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.
(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office ofManagement and Budget (OMB) prompt payment regulations at 5 CFR part 1315.
(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against
liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any
United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided theContractor is reasonably notified of such claims and proceedings.
(i) Payment.-(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to thedelivery destinations set forth in this contract.
(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C.
3903) and prompt payment regulations at 5 CFR part 1315.
(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate
EFT clause.
(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of theinvoice. For the purpose of computing the discount earned, payment shall be considered to have been made on thedate which appears on the payment check or the specified payment date if an electronic funds transfer payment ismade.
(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that theGovernment has otherwise overpaid on a contract financing or invoice payment, the Contractor shall-(i) Remit the overpayment amount to the payment office cited in the contract along with a description of theoverpayment including the-(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of
overpayment);(B) Affected contract number and delivery order number, if applicable;(C) Affected line item or subline item, if applicable; and(D) Contractor point of contact.

W911QY20C0119
Page 40 of 54(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(6) Interest.
(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple
interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be theinterest rate established by the Secretary of the Treasury as provided in 41 U.S.C.
7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause,and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.
(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under thecontract.
(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if-(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt
within 30 days;(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline
specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an
installment payment agreement; or(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer(see 32.607-2).
(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final
decision shall identify the same due date as the original demand for payment.
(v) Amounts shall be due at the earliest of the following dates:(A) The date fixed under this contract.
(B) The date of the first written demand for payment, including any demand for payment resulting from a default
termination.
(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due
date and ending on-(A) The date on which the designated office receives payment from the Contractor;(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has
been withheld as a credit against the contract debt; or(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to
the Contractor.
(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of theFederal Acquisition Regulation in effect on the date of this contract.
(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided
under this contract shall remain with the Contractor until, and shall pass to the Government upon:(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; orW911QY20C0119
Page 41 of 54(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b.
destination.
(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.
(1) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or
any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all
work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject tothe terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of
the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to thesatisfaction of the Government using its standard record keeping system, have resulted from the termination. The
Contractor shall not be required to comply with the cost accounting standards or contract cost principles for thispurpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor
shall not be paid for any work performed or costs incurred which reasonably could have been avoided.
(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event ofany default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails toprovide the Government, upon request, with adequate assurances of future performance. In the event of termination
for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted,
and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it isdetermined that the Government improperly terminated this contract for default, such termination shall be deemed atermination for convenience.
(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to theGovernment upon acceptance, regardless of when or where the Government takes physical possession.
(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for
use for the particular purpose described in this contract.
(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to
the Government for consequential damages resulting from any defect or deficiencies in accepted items.
(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive
orders, rules and regulations applicable to its performance under this contract.
(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352
relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating
to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C.
chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118,
Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.
(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence inthe following order: (1) the schedule of supplies/services; (2) The Assignments, Disputes, Payments, Invoice, Other
Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphsof this clause; (3) the clause at 52.212-5; (4) addenda to this solicitation or contract, including any license
agreements for computer software; (5) solicitation provisions if this is a solicitation; (6) other paragraphs of thisclause; (7) the Standard Form 1449; (8) other documents, exhibits, and attachments; and (9) the specification.
(t) Reserved.
(u) Unauthorized Obligations.
(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract issubject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument oragreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity

W911QY20C0119
Page 42 of 54
for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C.
1341), the following shall govern:(i) Any such clause is unenforceable against the Government.
(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clauseby virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar
legal instrument or agreement is invoked through an "I agree" click box or other comparable mechanism (e.g.,"click-wrap" or "browse-wrap" agreements), execution does not bind the Government or any
Government authorized end user to such clause.
(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.
(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized
by statute and specifically authorized under applicable agency regulations and procedures.
(v) Incorporation by reference. The Contractor's representations and certifications, including those completed
electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OREXECUTIVE ORDERS--COMMERCIAL ITEMS (AUG 2020)(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which areincorporated in this contract by reference, to implement provisions of law or Executive orders applicable toacquisitions of commercial items:(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.
113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided byKaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services orEquipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has
indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders
applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)
XX (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (Oct 1995)(41 U.S.C. 4704 and 10 U.S.C. 2402).

W911QY20C0119
Page 43 of 54
XX (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment
Act of 2009.)
XX (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L.
109-282) (31 U.S.C. 6101 note).
(5) [Reserved](6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div.
C).
(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub.
L. 111-117, section 743 of Div. C).
(8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred,
Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
XX (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41
U.S.C. 2313).
(10) [Reserved](11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).
(ii) Alternate! (MAR 2020) of 52.219-3.
(12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020)(if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).
(ii) Alternate I (MAR 2020) of 52.219-4.
(13) [Reserved]
XX (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).
(ii) Alternate I (MAR 2020) of 52.219-6.
(15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).
(ii) Alternate I (MAR 2020) of 52.219-7.
(16) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).
(17)(i) 52.219-9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).
(ii) Alternate! (NOV 2016) of 52.219-9.
(iii) Alternate!! (NOV 2016) of 52.219-9.
(iv) Alternate III (JUN 2020) of 52.219-9.
(v) Alternate IV (JUN 2020) of 52.219-9.

W911QY20C0119
Page 44 of 54(18) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).
(ii) Alternate I (MAR 2020) of 52.219-13.
(19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C. 637(a)(14)).
(20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15
U.S.C. 6570.
(22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (MAY 2020) (15 U.S.C. 632(a)(2)).
(ii) Alternate I (MAR 2020) of 52.219-28.
(23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged WomenOwned Small Business (EDWOSB) Concerns (MAR 2020) (15 U.S.C. 637(m)).
(24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns
Eligible Under the Women-Owned Small Business Program (MAR 2020) (15 U.S.C. 637(m)).
(25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).
(26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)).
XX (27) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).
XX(28) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126).
XX (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
XX (30)(i) 52.222-26, Equal Opportunity (SEPT 2016) (E.O. 11246).
_(ii) Alternate I (FEB 1999) of 52.222-26.

XX (31)(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
_(ii) Alternate I (JUL 2014) of 52.222-35.

XX (32)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(ii) Alternate I (JUL 2014) of 52.222-36.
XX (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
XX (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O.
13496).
XX (35)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).
(ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
XX (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. 0. 12989). (Not applicable to theacquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in
22.1803.)

W911QY20C0119
Page 45 of 54(37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated Items (MAY2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf
items.)(ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition ofcommercially available off-the-shelf items.)(38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN2016) (E.O. 13693).
(39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners(JUN 2016) (E.O. 13693).
(40) (i) 52.223-13, Acquisition of EPEATO Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and13514).
(ii) Alternate I (OCT 2015) of 52.223-13.
(41)(i) 52.223-14, Acquisition of EPEATO Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).
(ii) Alternate! (JUN 2014) of 52.223-14.
(42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).
(43)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s
13423 and 13514).
(ii) Alternate I (JUN 2014) of 52.223-16.
XX (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O.
13513).
(45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).
(46) 52.223-21, Foams (JUN 2016) (E.O. 13693).
(47)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).
(ii) Alternate! (JAN 2017) of 52.224-3.
(48) 52.225-1, Buy American--Supplies (MAY 2014) (41 U.S.C. chapter 83).
(49) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014) (41 U.S.C. chapter
83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77,
108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
(ii) Alternate I (MAY 2014) of 52.225-3.
(iii) Alternate II (MAY 2014) of 52.225-3.
(iv) Alternate III (MAY 2014) of 52.225-3.
XX (50) 52.225-5, Trade Agreements (OCT 2019) 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

W911QY20C0119
Page 46 of 54
XX (51) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes
administered by the Office of Foreign Assets Control of the Department of the Treasury).
(52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016)(Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150
(54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV 2007) (42 U.S.C.
5150).
(55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
XX (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C. 4505, 10 U.S.C.
2307(f)).
(57) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
(58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (OCT 2018) (31
U.S.C. 3332).
(59) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (JUL2013) (31 U.S.C. 3332).
XX (60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).
(61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).
(62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).
(63)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C.
Appx. 1241(b) and 10 U.S.C. 2631).
(ii) Alternate I (APR 2003) of 52.247-64.
(iii) Alternate II (FEB 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that
the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions oflaw or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)
XX (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).
XX (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C.
chapter 67).
(3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (Multiple
Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
(4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (MAY2014) (29 U.S.0 206 and 41 U.S.C. chapter 67).
(5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for
Maintenance, Calibration, or Repair of Certain Equipment--Requirements (MAY 2014) (41 U.S.C. chapter 67).

W911QY20C0119
Page 47 of 54(6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services--Requirements (MAY 2014) (41 U.S.C. chapter 67).
XX(7) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015) (E.O. 13658).
XX (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph(d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as
defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit andRecords--Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shallhave access to and right to examine any of the Contractor's directly pertinent records involving transactions related
to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and otherevidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any
shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If
this contract is completely or partially terminated, the records relating to the work terminated shall be madeavailable for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes
clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available
until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data,
regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that
the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, theContractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1)in a subcontract forcommercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by theclause—(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.
113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided byKaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services orEquipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts
that offer further subcontracting opportunities. If the subcontract (except subcontracts
to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract
award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

W911QY20C0119
Page 48 of 54(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).
(xiii) XX (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).
(B) Alternate I (March 2,2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for
Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services--Requirements (May 2014) (41 U.S.C. chapter 67)(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. 0. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section
862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (JUN 2020) (42 U.S.C. 1792). Flow
down required in accordance with paragraph (e) of FAR clause 52.226-6.
(xxii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of
additional clauses necessary to satisfy its contractual obligations.
(End of clause)

52.216-23

EXECUTION AND COMMENCEMENT OF WORK (APR 1984)W911QY20C0119
Page 49 of 54

The Contractor shall indicate acceptance of this letter contract by signing three copies of the contract and returningthem to the Contracting Officer not later than
. Upon acceptance by both parties, the Contractor shall proceedwith performance of the work, including purchase of necessary materials.
(End of clause)

52.246-15

CERTIFICATE OF CONFORMANCE (APR 1984)(a) When authorized in writing by the cognizant Contract Administration Office (CAO), the Contractor shall shipwith a Certificate of Conformance any supplies for which the contract would otherwise require inspection at source.
In no case shall the Government's right to inspect supplies under the inspection provisions of this contract beprejudiced. Shipments of such supplies will not be made under this contract until use of the Certificate ofConformance has been authorized in writing by the CAO, or inspection and acceptance have occurred.
(b) The Contractor's signed certificate shall be attached to or included on the top copy of the inspection or receiving
report distributed to the payment office or attached to the CAO copy when contract administration (Block 10 of the
DD Form 250) is performed by the Defense Contract Administration Services. In addition, a copy of the signed
certificate shall also be attached to or entered on copies of the inspection or receiving report accompanying theshipment.
(c) The Government has the right to reject defective supplies or services within a reasonable time after delivery by
written notification to the Contractor. The Contractor shall in such event promptly replace, correct, or repair therejected supplies or services at the Contractor's expense.
(d) The certificate shall read as follows:"I certify that on[insert date], the[insert Contractor's name] furnished the supplies or services calledvia[Carrier] on[identify the bill of lading or shipping document] infor by Contract No.
accordance with all applicable requirements. I further certify that the supplies or services are of the quality specified
and conform in all respects with the contract requirements, including specifications, drawings, preservation,
packaging, packing, marking requirements, and physical item identification (part number), and are in the quantity
shown on this or on the attached acceptance document."
Date of Execution:
Signature:
Title:(End of clause)

52.246-16

RESPONSIBILITY FOR SUPPLIES (APR 1984)(a) Title to supplies furnished under this contract shall pass to the Government upon formal acceptance, regardlessof when or where the Government takes physical possession, unless the contract specifically provides for earlier
passage of title.
(b) Unless the contract specifically provides otherwise, risk of loss of or damage to supplies shall remain with theContractor until, and shall pass to the Government upon-(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; orW911QY20C0119
Page 50 of 54(2) Acceptance by the Government or delivery of the supplies to the Government at the destination specified in thecontract, whichever is later, if transportation is f.o.b. destination.
(c) Paragraph (b) of this section shall not apply to supplies that so fail to conform to contract requirements as to givea right of rejection. The risk of loss of or damage to such nonconforming supplies remains with the Contractor until
cure or acceptance. After cure or acceptance, paragraph (b) of this section shall apply.
(d) Under paragraph (b) of this section, the Contractor shall not be liable for loss of or damage to supplies caused by
the negligence of officers, agents, or employees of the Government acting within the scope of their employment.
(End of clause)

252.217-7027

CONTRACT DEFINITIZATION (DEC 2012)(a) A Undefinitized Contract Action (UCA) is contemplated. The Contractor agrees to begin promptly negotiatingwith the Contracting Officer the terms of a definitive contract that will include (1) all clauses required by the Federal
Acquisition Regulation (FAR) on the date of execution of the undefinitized contract action, (2) all clauses requiredby law on the date of execution of the definitive contract action, and (3) any other mutually agreeable clauses, terms,
and conditions. The Contractor agrees to submit firm fixed price proposal and certified cost or pricing data
supporting its proposal.
(b) The schedule for definitizing this contract is as follows (insert target date for definitization of the contract action
and dates for submission of proposal, beginning of negotiations, and, if appropriate, submission of the make-or-buy
and subcontracting plans and certified cost or pricing data).
Receipt of Qualifying Proposal:

9 September 2020

UCA Issued:

30 September 2020

Beginning of Negotiations:

30 November 2020

Complete Negotiations:

15 December 2020

Definitization of UCA:

19 February 2021(c) If agreement on a definitive contract action to supersede this undefinitized contract action is not reached by thetarget date in paragraph (b) of this clause, or within any extension of it granted by the Contracting Officer, theContracting Officer may, with the approval of the head of the contracting activity, determine a reasonable price or
fee in accordance with subpart 15.4 and part 31 of the FAR, subject to Contractor appeal as provided in the Disputes
clause. In any event, the Contractor shall proceed with completion of the contract, subject only to the Limitation ofGovernment Liability clause.
(1) After the Contracting Officer's determination of price or fee, the contract shall be governed by-(i) All clauses required by the FAR on the date of execution of this undefinitized contract action for either fixedprice or cost-reimbursement contracts, as determined by the Contracting Officer under this paragraph (c);(ii) All clauses required by law as of the date of the Contracting Officer's determination; and(iii) Any other clauses, terms, and conditions mutually agreed upon.
(2) To the extent consistent with paragraph (c)(1) of this clause, all clauses, terms, and conditions included in thisW911QY20C0119
Page 51 of 54
undefinitized contract action shall continue in effect, except those that by their nature apply only to an undefinitized
contract action.
(d) The definitive contract resulting from this undefinitized contract action will include a negotiated firm fixed pricein no event to exceed(End of clause)

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
WorlcFlow (WAWF).
"Local processing office (LPO)" is the office responsible for payment certification when payment certification isdone external to the entitlement system.
"Payment request" and "receiving report" are defined in the clause at 252.232-7003, Electronic Submission ofPayment 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) 252.2327003, Electronic Submission of Payment Requests and Receiving Reports.
(c) WAWF access. To access WAWF, the Contractor shall—(1) Have a designated electronic business point of contact in the System for Award Management at
https://www.sam.gov; and(2) Be registered to use WAWF at https://wawf.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 beaccessed 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):(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.
(ii) For fixed price line items—

W911QY20C0119
Page 52 of 54(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting
Officer.

Receiving Report (DD 250) Destination Inspection / Destination Acceptance Inspection and Acceptance at place ofdestination(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets therequirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by theContracting Officer.

Invoice as 2-in-1 (FP Services Only — No DD250 Required)(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 thecontract.
[Note: The Contractor may use a WAWF "combo" document type to create some combinations of invoice andreceiving report in one step.](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
Issue By DoDAAC
Admin DoDAAC**
Inspect By DoDAAC
Ship To Code
Ship From CodeMark For CodeNA

Service Approver (DoDAAC)

NA

Service Acceptor (DoDAAC)

NA

Accept at Other DoDAAC

NA

LPO DoDAAC

NA

DCAA Auditor DoDAAC

I NA

Other DoDAAC(s)NAW911QY20C0119
Page 53 of 54(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the typeof 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.

"Not applicable."(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.
(End of clause)

252.232-7007

LIMITATION OF GOVERNMENT'S OBLIGATION (APR 2014)(a) Contract line item(s) 0001 is/are incrementally funded. For this/these item(s), the sum ofof the total price is presently available for payment and allotted to this contract. An allotment schedule is set forth inparagraph (j) of this clause.
(b) For items(s) identified in paragraph (a) of this clause, the Contractor agrees to perform up to the point at which
the total amount payable by the Government, including reimbursement in the event of termination of those item(s)for the Government's convenience, approximates the total amount currently allotted to the contract. The Contractor
is not authorized to continue work on those item(s) beyond that point. The Government will not be obligated in any
event to reimburse the Contractor in excess of the amount allotted to the contract for those item(s) regardless ofanything to the contrary in the clause entitled "TERMINATION FOR THE CONVENIENCE OF THE
GOVERNMENT." As used in this clause, the total amount payable by the Government in the event of terminationof applicable contract line item(s) for convenience includes costs, profit and estimated termination settlement costs
for those item(s).
(c) Notwithstanding the dates specified in the allotment schedule in paragraph (j) of this clause, the Contractor will
notify the Contracting Officer in writing at least ninety days prior to the date when, in the Contractor's best
judgment, the work will reach the point at which the total amount payable by the Government, including any cost for
termination for convenience, will approximate 1))of the total amount then allotted to the contract for
performance of the applicable item(s). The notification will state (1) the estimated date when that point will bereached and (2) an estimate of additional funding, if any, needed to continue performance of applicable line items up
to the next scheduled date for allotment of funds identified in paragraph (j) of this clause, or to a mutually agreed
upon substitute date. The notification will also advise the Contracting Officer of the estimated amount of additional
funds that will be required for the timely performance of the item(s) funded pursuant to this clause, for subsequent
period as may be specified in the allotment schedule in paragraph (j) of this clause, or otherwise agreed to by theparties. If after such notification additional funds are not allotted by the date identified in the Contractor's
notification, or by an agreed substitute date, the Contracting Officer will terminate any item(s) for which additionalW911QY20C0119
Page 54 of 54
funds have not been allotted, pursuant to the clause of this contract entitled "TERMINATION FOR THE
CONVENIENCE OF THE GOVERNMENT".
(d) When additional funds are allotted for continued performance of the contract line item(s) identified in paragraph(a) of this clause, the parties will agree as to the period of contract performance which will be covered by the funds.
The provisions of paragraph (b) through (d) of this clause will apply in like manner to the additional allotted funds
and agreed substitute date, and the contract will be modified accordingly.
(e) If, solely by reason of failure of the Government to allot additional funds, by the dates indicated below, inamounts sufficient for timely performance of the contract line item(s) identified in paragraph (a) of this clause, theContractor incurs additional costs or is delayed in the performance of the work under this contract and if additional
funds are allotted, an equitable adjustment will be made in the price or prices (including appropriate target, billing,
and ceiling prices where applicable) of the item(s), or in the time of delivery, or both. Failure to agree to any such
equitable adjustment hereunder will be a dispute concerning a question of fact within the meaning of the clauseentitled "disputes."(f) The Government may at any time prior to termination allot additional funds for the performance of the contract
line item(s) identified in paragraph (a) of this clause.
(g) The termination provisions of this clause do not limit the rights of the Government under the clause entitled"DEFAULT." The provisions of this clause are limited to work and allotment of funds for the contract line item(s)set forth in paragraph (a) of this clause. This clause no longer applies once the contract if fully funded except withregard to the rights or obligations of the parties concerning equitable adjustments negotiated under paragraphs (d) or(e) of this clause.
(h) Nothing in this clause affects the right of the Government to this contract pursuant to the clause of this contract
entitled "TERMINATION FOR CONVENIENCE OF THE GOVERNMENT."(i) Nothing in this clause shall be construed as authorization of voluntary services whose acceptance is otherwise
prohibited under 31 U.S.C. 1342.
(j) The parties contemplate that the Government will allot funds to this contract in accordance with the following
schedule:
On execution of contract TBN
Upon Contract Definitization(End of clause)I CONTRACT ID CODE

PAGE OF PAGESAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
2 AMENDMENT/MODIFICATION NO

3 EFFECTIVE DATEPZ0001CODEI

36

5 PROJECTNO (Ifapplicable)

SEE SCHEDULE

08-Jan-2021

6 ISSUED BY

14 REQUISITION/PURCHASE REQ NO

7 ADMINISTERED BY (Ifother than item6)

W911QYWIKKACC-APG NATICK DRISIONBLDG 1GENERAL GREENE AVENUE
NATICK MA 01760-5011

CODE

See Item 6

9A. AMENDMENT OF SOLICITATION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)ASTRAZENECA PHARMACEUTICALS LP

11.1

9B. DATED (SEE ITEM 11)1800 CONCORD Ft KE
W LM NGTON DE 19803-2902

10A.MOD._ OF CONTRACT/ORDER NO.
W911QY20M119

v

"
CODE

10B.DATED (SEE ITEM 13)
X 30-Sep-2020'FACILITY CODE 36WK2
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

36WK2The above numbered solicitation is attended as set forth in Item 14 The hour and date specified far receipt of0fEr

is extended,

is not extended

Oar must acknowledge receipt ofthis anendment prior to the hour and date specified in the solicitation or as attended by one ofthe following methods:(a) By completing Items 8 and IS,and returning

copies ofthe runenchrent; (I,) By acknowledging receipt ofthis anendnent on each copy ofthe or submitted;or (c) By separate letter or telegram which includes a reference to the solicitation and anendment nunthers FAILURE OF YOUR ACKNOWLEDGMENTTO BE
RECEIVED ATTHE PLACE DESIGNATED FOR "ITIE RECEIPTOF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER Ifby virtue ofthis anendment you desire to change an offer already submitted, such change may be made by telegramor letter,
provided each telegramor letter makes rethrence to the solicitation and this amendn-ent, and is received prior to the opening hour :inEl date sped fled

12. ACCOUNTING AND APPROPRIATION DATA (If required)
See Schedule
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE
CONTRACT ORDER NO. IN ITEM 10A.
B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).
x C.THIS SUPPLEMENTAL ACiREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 52.216-25 Contract Definitization
D.OTHER (Specify type of modification and authority)
E. IMPORTANT: Contractor

is not,x

is required to sign this document and return1

copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number:Definitization See Summary of Changes

Except as provided herein, all terms and conditions ofthe document referenced in Item9A or 10A, as heretothre changed, retrains unchanged and in fill farce and effect

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONT RACT1NG OFFICER (Type or print 1
CONTRACT NC OFFICER
TEL

1

11

)

(

15C. DATE SIGNED

1

January 06, 2021-

16C. DATE SIGNED1

EXCEPTION TO SF 30
APPROVED BY OIRM 11-84

30- 1(15-04

08-Jan-2021
gnature of Contracting

leer
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

1 CONTRACTAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT.72- AMENDMENT/MODIFICATION NO

3 EFFECTIVE DATEPZ0001CODE

PAGE OF PAGES

1

4 REQUISITION/PURCHASE REQ NO

I

36

5 PROJECT NO (Ifapplicable)

SEE SCHEDULE

08-Jan-2021

6 ISSUED BY

CODE

7 ADMINISTERED BY (Ifother than item 6)

W911QY$A6C/K ACC-PPG NATICK DIVISIONEiDG 1 GENERAL GREENE AVENUENAITCK MA01760-5011

CODE

I

See Item 6

9A. AMENDMENT OF SOLICITATION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)ASTRAZENECA PHARMACEUTICALS LP

9B. DATED (SEE ITEM 11)

WE!
PIKE
WLM NGTON DE 19803-2902

I OA. MOD OF CONTRACT/ORDER NO.

X W9110Y2000119
CODE

10B. DATED (SEE ITEM 13)
X 30-Sep-2020'FACILITY CODE 36VVK2
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

36WK2The above nuntered solicitation is amended as set forth in Item 14 The hour and date specified fir receipt ofOffer

is extended,

is not extended

Oft mist acknowledge receipt ofthis aniendment prior to the hour and date specified in the solicitation or as amended by one ofthe bllouring methods:(a) By completing It
8 and 15, and returning
copies ofthe amendment; (b) By acknowledging receipt ofthis amendment on each copy ofthe or subnitted;or (c) By separate letter or telegramwhich includes a reference to the solicitation and amendment numbers FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FORME RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER Ifby virtue ofthis amendment you desire to change an offer already submitted, such change may be made by telegramor letter,
provided each telegramor letter makes rekrence to the solicitation and this amendment, and is received prior to the opening hour and date specified

12. ACCOUNTING AND APPROPRIATION DATA (If required)

See Schedule
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT S/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANCE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANCES SET FORTH IN ITEM 14 ARE MADE IN THE
CONTRACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANCES (such as changes in paying
office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).
x C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 52.216-25 Contract Definitization
D. OTHER (Specify type of modification and authority)
E. IMPORTANT: Contractor

is not,x

is required to sign this document and return1

copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number:Definitization See Sunynary of Changes

Except as provided herein, all terns and conditions ofthe document referenced in Item 9A or 10A, as hereto bre changed, remains unchanged and in full bite and effect

15k NAME AND TITLE OF SICiNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR

16B UNITED STATES OF AMERICA

16C. DATE SIGNED

BY

08-Jan-2021

15C. DATE SIGNED(Signature of person authorized to sign)
EXCEPTION TO SF 30
APPROVED BY OIRM 11-84(Signature of Contracting Officer)
30-105-04

STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W911QY20C0119
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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:
SUMMARY OF CHANGESACTION OBLIGATION AMOUNT:The purpose of this modification is to:1)Definitize the contract by amending the value and funding of CLIN 0001 and add CLIN 0003 according to thenegotiated prices.
2) Decrease the unit and total price of CLIN 0001.
3) Increase the funding on CLIN 0001.
4) Update the extended description in CLIN 0001.
5) Add CLIN 0003 Distribution and fully fund CLIN 0003.
6) Update the delivery date on CLIN 0001 to match the SOW required delivery of7) Update the SOW and Section F in order for this contract to align with the OTA.
8) Updated by substitution Sections F, G & H.
9) Remove clauses.

SECTION SF 1449 - CONTINUATION SHEETSOLICITATION/CONTRACT FORM

The total cost of this contract was decreased by

SUPPLIES OR SERVICES AND PRICES

CLIN 0001
A definitized action has occurred in this modification
The CLIN extended description has changed from:from

W911QY20C0119
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The contractor shall provide SARS-CoV-2 therapeutic AZD7442
All required work shall be IAW the SOW andCommercial Solution Proposal titled "A2D7442 JPEO CSO Technical Volume_revised 09Sep", dated September 9,
2020.

To:
The contractor shall provide SARS-CoV-2 therapeutic AZD7442
All required work shall be IAW the SOW andCommercial Solution Proposal titled "AZD7442 JPEO CSO Technical Volume_revised 09Sep", dated November
16, 2020.
The unit price amount has decreased byfrom
The total cost of this line item has decreased by

CLIN 0002
A definitized action has occurred in this modification
The pricing detail quantity• has been added.
The unit of issue Each has been added.
SUBCLIN 000102 is added as follows:
ITEM NO
000102

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

ACRN AA @FFP
PURCHASE REQUEST NUMBER: 0011555540-0001

NET AMT
ACRN AA
CIN: GFEBS001155554000002

CLIN 0003 is added as follows:$0.00

W911QY20C0119
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ITEM NO
0003

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE
1
Each
SARS-CoV-2 Therapeutic Distribution
FFP
The contractor shall provide distribution for SARS-CoV-2 therapeutic AZD7442

AMOUNT. All required work shall be IAW the SOW and Commercial
Solution Proposal titled "A2D7442 JPEO CSO Technical Volume_revised 09Sep",
dated November 16, 2020.
FOB: Destination
PSC CD: 6550

NET AMTSUBCLIN 000301 is added as follows:
ITEM NO
000301

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

ACRN AA @FFP
PURCHASE REQUEST NUMBER: 0011555540-0001

NET AMT$0.00

ACRN AA
CIN: GFEBS001155554000003

ACCOUNTING AND APPROPRIATION

Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by
from
SUBCLIN 000102:
Funding on SUBCLIN 000102 is initiated as follows:
ACRN: AA
CIN: GFEBS001155554000002
Acctng Data: 09720202021013000018170552520252

S.0074658.1.1.15

6100.9000021001

W911QY20C0119
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Increase:
Total:
Cost Code: AHPDDSUBCLIN 000301:
Funding on SUBCLIN 000301 is initiated as follows:
ACRN: AA
CIN: GFEBS001155554000003
Acctng Data: 09720202021013000018170552520252

S.0074658.1.1.15

6100.9000021001

Increase:
Total:
Cost Code: AHPDD
DELIVERIES AND PERFORMANCE
The following Delivery Schedule item for CLIN 0001 has been changed from:
DELIVERY DATEQUANTITYSHIP TO ADDRESSDODAAC /CAGE

100,000

JPEO-CBRND

W9OZQ28222 HOADLEY RD E5101
ABERDEEN PROVING GROUND MD 21010
FOB: DestinationTo:
DELIVERY DATEQUANTITYSHIP TO ADDRESSDODAAC /CAGE

100,000

JPEO-CBRND

W9()ZQ2

8222 HOADLEY RD E5101
ABERDEEN PROVING GROUND MD 21010
FOB: Destination

The following Delivery Schedule for CLIN 0003 has been added:
DELIVERY DATEQUANTITYSHIP TO ADDRESSDODAAC /CAGE

W911QY20C0119
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1

JPEO-CBRND

W9OZQ28222 HOADLEY RD E5101
ABERDEEN PROVING GROUND MD 2 1 0 1 0
FOB: Destination

INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for SUBCLIN 000102:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for CLIN 0003:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 000301:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following have been modified:
ADDITIONAL SHIPPING INFOSECTION F DELIVERIES OR PERFORMANCE
F.1.

The distribution plan is currently TBD.

The first
100,000 doses to be procured under this agreement
F.2.
Product Development Source Material and Manufacturing Reports and Projections: The
Contractor shall submit a detailed spreadsheet regarding critical project materials that are sourced from alocation other than the United States, sources, and manufacturing sites, including but not limited to: physicallocations of sources of raw and processed material by type of material; location and nature of work performed
at manufacturing sites; and location and nature of non-clinical and clinical study sites.
The Contractor will provide manufacturing reports and manufacturing dose tracking projections/actuals
utilizing the "COVID-19 Dose Tracking Templates", on any contract/agreement that is manufacturing product:• Contractor will submit Product Development Source Material ReportoWithin month of contract awardoWithin 30 days of substantive changes are made to sources and/or materialsoand on the 6th month contract anniversary.
• Contractor will update the Dose Tracking Template weekly, during manufacturing campaigns and COVID
response, with the first deliverable submission within 15 days of award/modification• The Government will provide written comments to the Product Development Source Material andW911QY20C0119
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Manufacturing Report within 15 business days after the submission• If corrective action is recommended, Contractor must address all concerns raised by the Government inwriting
F.3. Contractor Locations: The contractor shall submit detailed data regarding locations where work will
be performed under this contract, including addresses, points of contact, and work performed per location, to
include sub-contractors.
Contractor will submit Work Locations Report:• Within 5 business days of contract award• Within 30 business days after a substantive location or capabilities change• Within 2 business days of a substantive change if the work performed supports medical countermeasuredevelopment that addresses a threat that has been declared a Public Health Emergency by the HHS Secretaryor a Public Health Emergency of International Concern (PHEIC) by the WHO
F.4. Access and General Protection/Security Policy and Procedures: This standard language text is
applicable to ALL employees working on critical information related to Operation Warp Speed (OWS) withan area of performance within a Government controlled installation, facility or area. Employees shall comply
with applicable installation, facility and area commander installation/facility access and local security policies
and procedures (provided by government representative). The performer also shall provide all information
required for background checks necessary to access critical information related to OWS, and to meet
Government installation access requirements to be accomplished by installation Director of Emergency
Services or Security Office. The workforce must comply with all personnel identity verification requirements
as directed by the Government and/or local policy. In addition to the changes otherwise authorized by thechanges clause of this agreement, should the
security status of OWS change the Government may require changes in performer security matters or processes.
In addition to the industry standards for employment background checks, The Contractor must be willing tohave key individuals, in exceptionally sensitive positions, identified for additional vetting by the United States
Government.
CONTRACT ADMINISTRATION
G.1 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 aperson 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.
Contracting Officer:

Bldg 1, General Greene Avenue Natick, MA 01760-5011
Procurement Specialist:

Bldg 1, General Greene Avenue Natick, MA 01760-5011
G.2 Government Technical Points of Contact: Program Manager:

G.3 Contractor's Contract Administration
Technical Point of Contact:

W911QY20C0119
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Primary Investigator

Administrative Point of Contact:

G.4 Contractor's Past Performance Point of Contact (POC): Annual contract past performance evaluations will
be performed by the government. The offeror shall identify a Point of Contact (POC) to participate in these on-line
evaluations. This individual is required to register in the Contractor Performance Assessment Reporting System(CPARS @ http://www.cpars.csd.disa mil) and respond to the government evaluations in a timely manner. The
contractor POC responsible for this action is:

G.5 Notifications of Revisions and Changes: 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.
STATEMENT OF WORKADDENDUM: The following pages hereby supplements FAR 52.212-4
1. Background:
In December 2019, a novel (new) coronavirus known as SARS-CoV-2 ("the virus") was first detected in
Wuhan, Hubei Province, People's Republic of China, causing outbreaks of the coronavirus disease COVID19 that has now spread globally. The Secretary of Health and Human Services (HHS) declared a public healthemergency on January 31, 2020, under section 319 of the Public Health Service Act (42U.S.C. 247d), in response to COVID-19. On March 1, 2020, the President of the United States, pursuant tosections 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 outbreakin the United States constitutes a national emergency.
Under the President's Operation Warp Speed Mission, HHS is leading a whole of nation effort with the primary
goal to execute on a well-defined portfolio of COVID-19 Medical Countermeasures (MCM) candidates tomaximize probability of having safe and effective diagnostics, therapeutics and vaccines as fast as possible formass distribution. As such, BARDA has an Area of Interest (AoI) for therapeutics manufacturing and fill-finishof advanced SARS-CoV-2 MCMs. Therapeutics manufacturing is expected to meet the necessary US Foodand Drug Administration (FDA) requirements for beginning a Phase 3 clinical trial, and the product be granted
licensure by the FDA.
2. Objective:
The government seeks to acquire courses of therapeutic MCMs against SARS-CoV-2 that are either direct
acting antivirals or host directed therapeutics, which indirectly inhibit the coronavirus lifecycle. ManufacturingW911QY20C0119
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shall occur using Current Good Manufacturing Practices (cGMP) validated manufacturing processes for bulk
drug substance and fill and finished drug product. The specific objective is the acquisition of a niinimum of
100.000
dose courses for a targeted US population by. to treat the US population
indicated in the Offeror's target population. The intent is "Large Scale production capability in a short periodof time with little to no advance notice under the conditions for which the MCM is required."
Candidate MCM therapeutics shall have at minimum, capability of obtaining Emergency Use Authorization(EUA) and/or a reasonable chance of moving to Phase 3 clinical trials by
including all development
plans and efforts. manufacturing, all done in support of the goal of achieving FDA approval/licensure inOfferors must have started, or have completed, a Phase 1 clinical study no later than
3.

Tasks:
Task 1: Establish a quality agreement between the US Government and Offeror on requirements for the US
Government to accept packaged drug product as a completed deliverable. Quality agreement must be
negotiated within the firstof award and prior to Government acceptance of drug product.
Task 2: Provide withinof award Product Development Source Material and Manufacturing Plan tofulfill the US Goveriunent order. The manufacturing plan should include all materials required for drug
substance/active pharmaceutical ingredient manufacturing and finished drug product, an acquisition plan for
acquiring necessary materials, all key subcontractors and manufacturing sites, and a detailed schedule forproviding the final product to the US Government.
Task 3: Manufacture of the therapeutic product shall occur using an established manufacturing process for bulk
drug substance and fill and finished drug product. with a ramp-up capacity plan that provides enough doses tomeet the desired number of treatment courses.
Task 4— Storage

Task 5 — Distribution

Task 6 — Program Management Activities:
The offeror must establish the capacity in compliance with FDA cGMP regulations, and Biosafety Level
standards if applicable. The offeror must be responsible for management of all activities, subcontractors, etc.
to meet the goals of the contract, including holding routine meetings with USG, and completion of meeting
minutes. On a monthly basis, the offeror(s) must provide a monthly report that includes capacity availability
and utilization, as well as any issues that affect the operational availability of the reserved capacity.
4.

Deliverables:
CDRL#

Deliverable

01

Meetings

Deliverable
Description

Reporting Proceduresand Due Dates

Data Rights

W911QY20C0119
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CDRLk;

Deliverable

Deliverable
Description

01.1

Post Award
Teleconference

The Contractor shallcomplete an initialteleconference after
agreement award
1.Outline activities forthe next 30 days
2. Discuss agenda items
for the post-award
Kickoff Meeting(01.2)

01.2

Kickoff
Meeting

The Contractor shallcomplete a Kickoff
meeting after
agreement award

Every 2 weeks
Teleconference

The Contractor shallparticipate in
teleconferences every
2 weeks, with
BARDA to discuss
the performance on
the Agreement.
Meeting frequency
can be increased asneeded during thecourse of the project

01.3

Reporting Proceduresand Due Dates*Within one week ofAgreement award*Contractor shall provide
agenda and establish ateleconference number at
least 3 business days inadvance of theteleconference unless
notified that BARDA will
supply one*PM edits/approves andinstructs Contractor to
distribute agenda prior tomeeting by at least 2
business days
*Contractor provides
meeting minutes to PM
within 3 business days
after the meeting• PM reviews, comments
and approves minutes
within 10 business days
*Within a month ofagreement award, pending
concurrence by theagreements officer
oContractor shall provide
itinerary and agenda atleast 5 business days inadvance of site visit or
virtual meeting• PM edits/approves andinstructs Contractor to
distribute agenda prior tomeeting by at least 3
business days
*Contractor provides
meeting minutes to PM
within 3 business days
after the meeting• PM reviews, comments.
and approves minutes
within 10 business days
*Contractor provides
agenda to PM no later
than 2 business days inadvance of meeting• PM edits/approves andinstmcts Contractor to
distribute agenda prior tomeeting*Contractor distributes
agenda and presentationmaterials at least 24 hours
in advance*Contractor provides
meeting minutes to PM

Data Rightsb) (4)

W911QY20C0119
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CDRL#

Deliverable

01.5

FDA Meeting
Minutes andotherconununications
with FDA

0202.3(Draft)02.4(Final)Deliverable
Description

As described in
Article 13

Reporting Proceduresand Due Dates
within 3 business days ofthe meeting• PM reviews, comments.
and approves minutes
within 6 business days
*Updates to include:
BARDA Contractor
Clinical Trials
Information Sheet.
forecast of activities
across each WBS number
as well as updates onplanned regulatory
submissions.
*Contractor shall notify
BARDA of upcoming
FDA meeting withinof scheduling Type
A. B or C meetings OR
withinofmeeting occurrence for ad
hoc meetings*The Contractor shallforward initial Contractor
and FDA-issued draft
minutes and final minutesof any meeting with the
FDA to BARDA within'of recei tTechnical
ReportingDraft and Final
Technical
Progress Report

A draft Final
Technical Progress
Report containing asummation of thework performed andthe results obtained
over the entire
Agreement. This
report shall be insufficient detail tofully describe theprogress achieved
under all milestones.
Report should containa timeline oforiginally planned andbaselined activities
and milestones
overlaid with actual
progress attained
during the Agreement.
Descriptions andrationale for activities
and milestones thatwere not completed asplanned should be
provided. The draft*The Draft Technical
Progess Report shall be
submitted
before the end of the
PoP and the Final
Technical Progress Reporton or before thecompletion date of the
PoP• PM will provide feedback
on draft report within 15
calendar days of receipt.
which the Contractor shallconsider incorporating
into the Final Report*The Final Technicalreport will include all
milestone reports
submitted throughout theperiod of performance andinclude an overarchingexecutive summary.

Data Rights

W911QY20C0119
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CDRLk;

02.6

Deliverable

Product
Development
Source Material
andManufacturing
Reports andProjections

Deliverable
Descri )tion
report shall be duly
marked as 'Draft'
The Final Technical
Progress Report
incorporating
feedback received
from BARDA andcontaining asummation of thework performed andthe results obtained
for the entire
agreement PoP. The
final report shalldocument the resultsof the entire
Agreement. The final
report shall be duly
marked as 'Final'. A
cover letter with thereport will contain asummary (not toexceed 200 words) of
salient results
achieved during theperformance of theAgreement
The Contractor shallsubmit a detailed
spreadsheet regarding
critical projectmaterials that aresourced from alocation other than the
United States,sources, andmanufacturing sites,
including but notlimited to: physicallocations of sources of
raw and processedmaterial by type ofmaterial: location andnature of work
performed at
manufacturing sites:
and location andnature of non-clinicaland clinical study
sites.
The Contractor will
providemanufacturing reports
and manufacturingdose tracking
projections/actuals
utilizing the "COVID-

Reportin,g Proceduresand Due Dates

Data Rights()
0• Contractor will submit
Product Development
Source Material Reporto Within month ofAgreement awardo Within 30 days of
substantive changes
e. aremade to sources and/or
materials
o Or on the 6th monthcontract anniversary.
• Contractor will update theDose Tracking Template
weekly during
manufacturing campaigns
and daily during response
operations (where a
Public Health Emergency
has been declared) and
COVID-19 response, withthe first deliverable
submission within 15 daysof award/modification.
Updates to be provided
weekly in advance ofcommercial-scale
manufacturing and daily
once material for use in
response operations

(
4.

)

W911QY20C0119
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CDRL#

02.7

2.8

Deliverable

Deliverable
Descri 'lion

Reporting Proceduresand Due Dates

19 Dose Tracking
Templates" or similar.
on anycontract agreementthat is manufacturing
product. including
product for clinical
trial use.

begins manufacture.
• The Government will
provide written comments
to the ProductDevelopment Source
Material and
Manufacturing Report
within 15 business days
after the submission• If corrective action isreconuuended. Contractor
must address all concerns
raised by BARDA in
writing• Product Development andSource Material report tobe submitted via
spreadsheet: Dose
Tracking can becompleted via spreadsheet
or other format (e.g. XML
or JSON) as agreed to by
USG and company.

Contractor
Locations

The Contractor shallsubmit detailed data
regarding locations
where work will be
performed under thiscontract, including
addresses, points ofcontact, and work
performed per
location, to include
sub-Contractors.

Contractor will submit
Work Locations Report:• Withinof
Agreement award• Withinafter a substantive
location or capabilities
change• Withinofa substantive change if thework perfomied supports
medical countermeasuredevelopment that
addresses a threat that has
been declared a Public
Health Emergency by the}MS Secretary or a Public
Health Emergency ofInternational Concern(PHEIC) by the WHO

Pandemic
Management
Plan

A pandemic facility
and/or operational
management plan
including change
procedures fromnormal to pandemic
operations Contractor
will prepare an
operational plan tocontinue operations in
the event of a declared
pandemic emergency.

Contractor will submit
Pandemic Management
Plan:
Draft withinof
award
Final within
of
award

•
•

Data Rights( 0) (4 )

W911QY20C0119
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CDRL

02.11

Deliverable

Supply Chain
and Distribution
Tracking

Deliverable
Description
Distribution Conceptof Operations.
BARDA. and MCM
Manufacturers play animportant role in the
distribution oftherapeutics to theAmerican people
under a nationwide
response. BARDA
will work with the
manufacturer tomonitor what is in the
manufacturing
pipeline using theenclosed dosetracking templates(see above).
Contractor will relay
final drug productinfonnation as it isbeing released to the
BARDA/ASPR for
allocation andordering by statepublic healthdepartments.

Reporting Proceduresand Due Dates

Provide the following
information in order tocoordinate the movementand deliv of AZD7442

I

Data Rights

W911QY20C0119
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CDRI.,,:

Deliverable

02.11aDistribution
Plan

02.12

Manufacturing
Development
Plan

Deliverable
Description

The plan shall comply
with applicableprovisions of the Drug
Supply Chain Security
Act (DSCSA),
Sections 581-585 of
PL 113-54 (Nov 27,2013), taking into
account FDA's
regular guidance for
the COVED-19 publichealth res ..nse.
This plan shalldescribe("describe the
manufacturing
process for the
drug/biologic productto ensure conformity
with §501(a)(2)(B) of
the Food, Drug, andCosmetics Act(FD&C Act, Title 21

Reporting Proceduresand Due Dates

Data Rights(b) (4)(o) (4)••Plan will be delivered
electronicallyof Agreement award
to the KO and PM

W911QY20C0119
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Reporting Proceduresand Due Dates •02.13

Quality
Management
Plan

United States Code(USC) §351
(aX2)(BD, regarding
good manufacturing
practices (GMP)), but
is not limited toplanned or completed
drug substancestudies; list of
excipients andinformation to support
the safety of
excipients that, whenappropriate, shall becross-referenced; drug
product andformulation
development
summary from initialconcept through final
design;physicochemical andbiological properties;
manufacturing
process development
and validation
program documents;
container closuresystem documents[description, choice,rationale];microbiologicalattributes documents
and plans;compatibility
documents (e.g.,precipitation); assay
development andvalidation, stability
plan; and any
associated risks.")
Plan may include, but
is not limited to thequality policy andobjectives,
management review,competencies andtraining, process
document control.
feedback, evaluation,corrective action andpreventive action,
process improvement,
measurement, anddata analysis
processes. The
framework isnormally divided into
infrastructure, senior•

Data Rights(b) (4)•

Plan will be delivered
electronicallyof Agreement award
to the KO and PM

W911QY20C0119
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CDRL#

02.14

Deliverable

Quality
Agreement

2.15

Releasedocumentation
for doses to bedelivered

2.16

Security Plan

03

Audits03.2

FDA
Inspections

Deliverable
Description
management
responsibility,
resource management.
lifecycle management.
and quality
management systemevaluation
Agreement will
determine theconditions ofacceptance by the
USG of the purchased
product. No productwill be accepted by
the USG until aquality agreement isin place.

Reporting Proceduresand Due Dates

( 1)

•

•

Agreement will be signedby the USG and the
manufacturerof Agreement award
Agreement will bedelivered electronically to
the KO and PM•

As described in
Article 5.B(11)In the event of an
FDA inspection that
occurs in relation tothis contract and forthe product. or for any
other FDA inspectionthat has thereasonable potential toimpact theperformance of thiscontract, theContractor shallprovide the USG withan exact copy (nonredacted) of the FDA
Fomi 483 and theEstablishment
Inspection Report(EIR). The Contractor
shall provide the PM
and KO with copies ofthe plan foraddressing areas ofnon-conformance to
FDA regulations for
GLP. GMP. or GCP
guidelines as
identified in the audit
report. status updates
during the plans
execution and a copyof all final responses
to the FDA. The
Contractor shall also

Data Rights•

Withiiof award/defuntization*Contractor shall notify
KO and PMof ascheduled FDA audit orwithinof an ad
hoc site visit/audit if the
FDA does not provide
advanced notice• Contractor shall provide
copies of any FDA audit
report received from
subContractors that occur
as a result of this contract
or for this product withinofreceiving correspondence
from the FDA or third
pasty• Withinof audit report. Contractor
shall provide KO with aplan for addressing areasof nonconformance, if any
are identified

)

( 4

)

W911QY20C0119
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CDRL#

03.3

Deliverable

QA Audits

,

03.4

Risk
Management
Plan (RMP)

Deliverable
Description
provide copies of any
FDA audits received
from subContractorsthat occur as a resultof this contract or forthis product. The
Contractor shall makearrangements for
BARDA
representative(s) to bepresent during thefinal debrief by theregulatory inspector

Reporting Proceduresand Due Dates

BARDA reserves theright to participate in
QA audits performedby the Contractor.
Upon completion of
the audit/site visit theContractor shallprovide a report
capturing the findings,
results and next steps
in proceeding with the
subContractor. If
action is requested of
the subContractor,
detailed concerns foraddressing areas ofnon-conformance to
FDA regulations for
GLP. GMP. or GCP
guidelines, as
identified in the audit
report. must be
provided to BARDA.
The Contractor shallprovide responses
from thesubContractors toaddress theseconcerns and plans forcorrective action*Contractor shall notify
KO and PM a minimumotinadvance of upcoming.
audits/site visits of
subContractors*Contractor shall notify the
PM and KOof report
completion.
*PM and KO will review
the report and provide a
response to the Contractor
with

The Contractor shallprovide an RMP thatoutlines the impactsof each risk in relation
to the cost, schedule.
and performance
objectives. The plan
shall include risk
mitigation strategics.
Each risk mitigation
strategy will capture
how the corrective
action will reduce
impacts on cost.

1*A Draft is due
within contract
award; updates to the
RMP are due concurrent
with Monthly Technical
Progress Reports. The
Contractor may choose to
notify the government up
to two times every threemonths if there are nochanges from the priorsubmission. and not
submit an update'BARDA will provide
Contractor with a list ofI

Data Rights

W911QY20C0119
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CDRL#

03.5

03.6

Deliverable

Integrated
MasterSchedule (IMS)

Deviation
Notification and
Mitigation
Strategy

Deliverable
Description
schedule andperformance

The Contractor shallprovide an IMS that
illustrates projecttasks. dependencies.
durations throughout
the period of
performance. andmilestones (GO/NOGO). The IMS must
map to the WBS. andprovide baseline, andactual or forecast
dates for completionof tasks

Process for changing
IMS activities
associated with costand schedule asbaselined. Contractor
shall notify BARDA
of significant
proposed changes the
IMS defined aswhich would
require a PoP
extension. Contractor
shall provide a highlevel management
strategy for risk
mitigation

Reporting Proceduresand Due Dates
concerns in response plansubmitted*Contractor must address.
in writing. all concerns
raised by BARDA withinofContractor's receipt ofBARDA's concerns*The IMS is to besubmitted in both PDF
and Microsoft Project
Form to the PM*The first Draft of the IMS
is duewithincontract award*The Government will
request revisions
at which
point the schedulebaseline for the period of
performance will be set*Thereafter an updated
IMS is due concurrent
with Monthly Technical
Progress Reports*During a declared Public
Health Emergency. the
IMS is to be deliveredof contract
award, updates are due
and anysi2nificant changemust be reported
immediately to the PM
and/or designee.
*Due at least
prior to theContractor anticipating
the need to implementchanges

Data Rights

W911QY20C0119
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CDRL#

03.7

Deliverable

Deliverable
Description
Contractor shallcommunicate to
BARDA anddocument all criticalprogrammaticconcerns, issues, orprobable risks thathave or are likely tosignificantly impact
project schedule
and/or cost and/or
performance.

Incident Report

but should be
confirmed inconsultation with the
PM. Incidents that
present liability to theproject even withoutcost/schedule impact.
such as breach of
GCP during a clinicalstudy. must also bereported09

09.1

Reporting Proceduresand Due Dates*Due withinofactivity or incident orwithinfor asecurity activity or
incident*Email or telephone withwritten follow-up to PM
and KO*Additional updates due toPM and KO withinof additional
developments*Contractor shall submit
withinaCorrective Action Plan (ifdeemed necessary byeither party) to address
any potential issues*If corrective action isdeemed necessary.
Contractor must addressin writing, itsconsideration of concerns
raised by BARDA withinofreceiving such concerns

Advanced
R&D ProductsTechnical
Documents

Upon request.
Contractor shallprovide KO and PM
with deliverables fromthe following contract
funded activities:
quality agreements
between Contractors
and sub-Contractors.
process Development
Reports. Assay
Qualification
Plan/Report. Assay
Validation
Plan/Report. Assay
Technology Transfer
Report. Batch
Records. SOPs.
Master Production
Records. Certificate
of Analysis. ClinicalStudies Data or
Reports. The KO andPM reserve the rightto request within the
PoP a non-proprietary
technical documentfor distribution within
the Govenunent*Contractor shall provide
technical document withinof KO orPM request. Contractor
can request additionaltime on an as needed basis*If corrective action isrecommended, theContractor must address.
in writing, concerns raisedby BARDA in writing

Data Rights(LI ) (4 )

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C'DRLk;09.2

Deliverable

Publications

Deliverable
Description
Any manuscript orscientific meeting
abstract describing
manufacturing ofproduct andcontaining data
generated under thiscontract must be
submitted to BARDA
for review prior to
submission.
Acknowledgment of
BARDA funding
must be included as
noted in contract
articles H.5 and H.6

Reporting Proceduresand Due Dates• Contractor must submit
all manuscript orscientific meeting abstract
to PO and KO prior to
submission/presentationbyformanuscripts andfor abstracts
or posters• Contractor must addressin writing all concerns
raised by JPEO in writing• Final submissions shall be
submitted to JPEO

Data Rights0) (4.)of its submission
10

10.1

10.3

10.4

11

Regulatory
Documents
FDA
Correspondence

EUA Filing

BLA FilingPress Releases

As described in
Article 13
The Contractor shallprovide a copy of any
request for EUA
submitted to the FDA
The Contractor shallprovide a copy of the
BLA submitted to the
FDA

Contractor agrees toaccurately andfactually represent thework conducted under
this contract in allpress releases• Contractor shall provide
copies of any FDA
correspondence widiirtofcorrespondence• Withinafter submission to the
FDA• Withinafter submission to the
FDA• Contractor shall ensurethat the KO has received
and approved an advanced
copy of any press releaseto this contract not less
than
prior
to the issuance of thepress release• If corrective action isrequired. the Contractor
agrees to accurately andfactually represent thework conducted under thiscontract in all press
releases• Any final press releases
shall be submitted to
BARDA no later thanprior toits release* The Government acknowledges that deliverables identified with an asterisk ("*") in the table above will require
AstraZeneca to deliver to the Government certain proprietary and confidential trade secret information related to
manufacturing, purification and formulation process for the monoclonal antibody drug product (AZD7422).

W911QY20C0119
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5. Detailed Description of Select Contract Deliverables
Supremacy Clause: In the event of any conflict or inconsistency between the narrative descriptions provided in thisSection and the Table above. the Table shall govern.
1.

Operational Security (OPSEC) Plan

The Awardee shall develop an OPSEC Standard Operating Procedure (SOP)/Plan within ninety (90)-calendar-days ofAgreement award to be reviewed and approved by the responsible Government OPSEC officer. This plan will be
submitted to the PM for coordination of approvals. This SOP/Plan will include identifying the critical information
related to this Agreement, why it needs to be protected, where it is located, who is responsible for it, and how to protectit.
2.

Security Plan

The Awardee shall develop a comprehensive security program that provides overall protection of personnel,
information, data, and facilities associated with fulfilling the Government requirement. This plan shall establish
security practices and procedures that demonstrate how the Awardee will meet and adhere to the security requirements
outlined below prior to the commencement of product manufacturing, and shall be delivered to the Government within
thirty (30) calendar days of award.

The Government will review in detail and submit comments within ten (10) business days to the Contracting Officer(KO) to be forwarded to the Awardee. The Awardee shall review the Draft Security Plan comments, and, submit a
Final Security Plan to the U.S. Government 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 by theGovernment.
Upon completion of initiating all security measures, the Awardee shall supply to the Agreements Officer a letter
certifying compliance to the elements outlined in the Final Security Plan.
At a minimum, the Final Security Plan shall address the following items:
Government Security Requirements:

1.

Facility Security Plan

W911QY20C0119
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Description: As part of the partner facility's overall security program. the contractor shall submit a written security plan with
their proposal to the Government for review and approval by Government security subject matter experts. The performance ofwork under the contract will be in accordance with the approved security plan. The security plan will include the following
processes and procedures at a minianum:•organization chart and responsibilities
Security Administration•
written security risk assessment for site•threat levels with identification matrix (High. Medium, or Low)•enhanced security procedures during elevated threats•liaison procedures with law enforcement•
annual employee security education and training program•
policies and procedures
Personnel Security•
candidate recruitment process•
background investigations process•
employment suitability policy•
employee access determination•
rules of behavior/ conduct•
termination procedures•
non-disclosure agreements
Physical Security Policies andinternal/external access control•
Procedures•
protective services•
identification/badging•
employee and visitor access controls•
parking areas and access control•
perimeter fencing/barriers•
product shipping, receiving and transport security procedures•
facility security lighting•
restricted areas•
signage•intrusion detection systems•
alarm monitoring/response•
closed circuit television•
product storage security•
other control measures as identified
Information Security•
identification and marking of sensitive information•
access control•
storage of information•
document control procedures•
retention,' destruction requirements
Information Teclmology/Cyber•
intrusion detection and prevention systems
Security Policies and•threat identification
Procedures•
employee training (initial and annual)•encryption systems•
identification of sensitive information/media•
password policy (max days 90)•
lock screen time out policy (minimum time 20 minutes)•
removable media policy•
laptop policy•
removal of IT assets for domestic/foreign travel•
access control and deteimination•
VPN procedures•
WiFi and Bluetooth disabled when not in use•
system document control•
system backup•
system disaster recovery•
incident response•
system audit procedures•
property accountability

W911QY20C0119
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2. Site Security Master Plan
Description: The partner facility shall provide a site schematic for security systems which includes: main access points:
security cameras: electronic access points; IT Server Room: Product Storage Freezer/Room; and bio-containment laboratories.
3. Site Threat / Vulnerability / Risk Assessment
Description: The partner facility shall provide a written risk assessment for the facility addressing: criminal threat. including
crime data: foreign/domestic terrorist threat: industrial espionage: insider threats: natural disasters; and potential loss ofcritical infrastructure (power/water/natural gas. etc.) This assessment shall include recent data obtained from local law
enforcement agencies. The assessment should be updated annually.
4. Physical Security
Description:
Closed Circuit Television(CCTV) Monitoring

Facility Lighting

Shipping and Receiving

Access Control

Employee /Visitor
Identification

Security Fencinga)Layered (internal/external) CCTV coverage with time-lapse video recording forbuildings and areas where critical assets are processed or stored.
b) CCTV coverage must include entry and exits to critical facilities, perimeters, andareas within the facility deemed critical to the execution of the contract.
c) Video recordings must be maintained for a niinimum of 30 days.
d) CCTV surveillance system must be on emergency power backup.
e) CCTV coverage must include entry and exits to critical facilities. perimeters, andareas within the facility deemed critical to the execution of the contract.
I) Video recordings must be maintained for a minimum of 30 days.
g) CCTV surveillance system must be on emergency power backup.
a) Lighting must cover facility perimeter, parking areas. critical infrastructure, andentrances and exits to buildings.
b) Lighting must have emergency power backup.
c) Lighting must be sufficient for the effective operation of the CCTV surveillancesystem during hours of darkness.
a) Must have CCTV coverage and an electronic access control system.
b) Must have procedures in place to control access and movement of drivers picking
up or delivering shipments.
c) Must identify drivers picking up Government products by government issued
photo identification.
a) Must have an electronic intrusion detection system with centralized monitoring.
b) Responses to alarms must be immediate and documented in writing.
c) Employ an electronic system (i.e.. card key) to control access to areas whereassets critical to the contract are located (facilities, laboratories, clean rooms,
production facilities, warehouses, server rooms, records storage. etc.).
d) The electronic access control should signal an alarm notification of unauthorized
attempts to access restricted areas.
e) Must have a system that provides a historical log of all key access transactions
and kept on record for a minimum of12 months.
f) Must have procedures in place to track issuance of access cards to employees andthe ability to deactivate cards when they are lost or an employee leaves thecompany.
g) Response to electronic access control alarms must be inunediate and documented
in writing and kept on record for a minimum of 12 months.
h) Should have written procedures to prevent employee piggybacking accessi) to critical infrastructure (generators. air handlers. fuel storage. etc.) should becontrolled and limited to those with a legitimate need for access.
j) Must have a written manual key accountability and inventory process.
k) Physical access controls should present a layered approach to critical assets
within the facility.
a) Should issue company photo identification to all employees.
b) Photo identification should be displayed above the waist anytime the employee ison company property.
c) Visitors should be sponsored by an employee and must present government
issued photo identification to enter the property.
d) Visitors should be logged in and out of the facility and should be escorted by an
employee while on the premises at all times.
Requirements for security fencing will be determined by the criticality of the program.
review of the security plan, threat assessment, and onsite security assessment.

W911QY20C0119
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Protective Security Forces
Protective Security Forces
Operations

5. Security Operations
Description:
Information Sharing

Training
Security Management

Requirements for security officers will be determined by the criticality of the program,review of the security plan, threat assessment. and onsite security assessment.
a) Must have in-service training program.
b) Must have Use of Force Continuum.
c) Must have communication systems available (i.e.. landline on post, cell phones.
handheld radio. and desktop computer).
d) Must have Standing Post Orders.
e) Must wear distinct tulifonn identifying them as security officers.

a)
b)

c)
a)
b)
a)
b)

Establish formal liaison with law enforcement.
Meet in person at a minimum annually. Document meeting notes and keep themon file for a. minimum of 12 months. POC information for LE Officer that
attended the meeting must be documented.
Implement procedures for receiving and disseminating threat information.
Conduct new employee security awareness training.
Conduct and maintain records of annual security awareness training.
Designate a knowledgeable security professional to manage the security of the
facility.
Ensure subcontractor compliance with all Government security requirements.

6. Personnel Security
Description:
Records Checks

Hiring and Retention Standards

7. Information Security
Description:
Physical Document Control

Verification of social security number, date of birth. citizenship, education credentials, fiveyear previous employment history. five-year previous residence history. FDA disbarment.
sex offender registry. credit check based upon position within the company: motor vehicle
records check as appropriate: and local/national criminal history search.
a) Detailed policies and procedures concerning hiring and retention of employees.
employee conduct. and off boarding procedures.
b) Off Boarding procedures should be accomplished within 24 hour of employee
leaving the company. This includes termination of all network access.

a)Applicable documents shall be identified and marked as procurement sensitive.
proprietary. or with appropriate government markings.
b) Sensitive. proprietary. and government documents should be maintained in a
lockable filing cabinet/desk or other storage device and not be left unattended.
c) Access to sensitive information should be restricted to those with a need to know.
Document Destruction
Documents must be destroyed using approved destruction measures (i.e.
shredders/approved third party vendors / pulverizing / incinerating).
8. Information Technology & Cybersecurity
Description:
Identity Managementa) Physical devices and systems within the organization are inventoried andaccounted for annually.
b) Organizational cybersecurity policy is established and communicated.
c) Asset vulnerabilities are identified and documented.
d) Cyber threat intelligence is received from information sharing fonuns andsources.

e)f)g)

Access Control

a)
b)
c)
d)

Threats. vulnerabilities, likelihoods, and impacts are used to determine risk.
Identities and credentials are issued. managed. verified, revoked, and audited forauthorized devices, users and processes.
Users. devices, and other assets are authenticated (e.g.. single-factor. multifactor)
commensurate with the risk of the transaction (e.g.. individuals' security andprivacy risks and other organizational risks)
Limit information system access to authorized users.
Identify information system users, processes acting on behalf of users, or devices
and authenticate identities before allowing access.
Limit physical access to information systems. equipment, and server rooms withelectronic access controls.
Limit access to verify access to use of external information systems.

W911QY20C0119
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Traininga)Audit and Accountability

a)

b)
c)
d)
Configuration Managementa)b)Contingency Planninga)

Incident Response

Media and Information
Protection

Physical and Environmental
Protection

Ensure that personnel are trained and are made aware of the security risks
associated with their activities and of the applicable laws, policies, standards,
regulations. or procedures related to information technology systems.
Create, protect. and retain information system audit records to the extent needed
to enable the monitoring. analysis, investigation, and reporting of unlawful.
unauthorized, or inappropriate system activity. Records must be kept forminimum must be kept for 12 months.
Ensure the actions of individual information system users can be uniquely traced
to those users.
Update malicious code mechanisms when new releases are available.
Perform periodic scans of the information system and real time scans of files
from external sources as files are downloaded. opened. or executed.
Establish and enforce security configuration settings.
Implement sub networks for publically accessible system components that arephysically or logically separated from internal networks.

Establish. implement, and maintain plans for emergency response. backup
operations. and post-disaster recovery for information systems to ensure theavailability of critical information resources at all times.
a) Establish an operational incident handling capability for information systems that
includes adequate preparation, detection, analysis. containment, and recovery ofcybersecurity incidents. Exercise this capability annually.
a) Protect information system media, both paper and digital.
b) Limit access to information on information systems media to authorized users.
c) Sanitize and destroy media no longer in use.
d) Control the use of removable media through technology or policy.
a) Limit access to information systems. equipment. and the respective operating
environments to authorized individuals.
b) Intrusion detection and prevention system employed on IT networks.
c) Protect the physical and support infrastructure for all information systems.
d) Protect information systems against environmental hazards.
e) Escort visitors and monitor visitor activity.
Employ intrusion prevention and detection technology with immediate analysis capabilities.

Network Protection
9. Transportation Security
Description: Adequate security controls must be implemented to protect materials while in transit from theft, destruction.
manipulation, or damage.
Driversa) Drivers must be vetted in accordance with Government Personnel Security
Requirements.
b) Drivers must be trained on specific security and emergency procedures.
c) Drivers must be equipped with backup communications.
d) Driver identity must be 100 percent confirmed before the pick-up of any
Government product.
e) Drivers must never leave Government products unattended. and two drivers may
be required for longer transport routes or critical products during times of
emergency.
0 Truck pickup and deliveries must be logged and kept on record for a minimum of
12 months.
Transport Routesa) Transport routes should be pre-planned and never deviated from except whenapproved or in the event of an emergency.
b) Transport routes should be continuously evaluated based upon new threats.
sionficant planned events, weather, and other situations that may delay or disrupt
transport.
Product Securitya) Government products must be secured with tamper resistant seals duringtransport. and the transport trailer must be locked and sealed.
•
Tamper resistant seals must be verified as "secure" after the product isplaced in the transport vehicle.
b) Government products should be continually monitored by GPS technology whilein transport. and any deviations from planned routes should be investigated anddocumented.

W911QY20C0119
PZ0001Page 27 of 36c)Contingency plans should be in place to keep the product secure during
emergencies such as accidents and transport vehicle breakdowns.
10. Security Reporting Requirements
Description: The partner facility shall notify the Government Security Team within 24 hours of any activity or incident that isin violation of established security standards or indicates the loss or theft of government products. The facts and circumstances
associated with these incidents will be documented in writing for government review.
1
11. Security Audits
Description: The partner facility agrees to formal security audits conducted at the discretion of the government. Security
audits may include both prime and subcontractor.

TERMS AND CONDITIONSSPECIAL CONTRACT REQUIREMENTS
11.1.
The govenunent hereby issues this contract action as a defmitized contract action for the manufacturing
therapeutic AZD7442 in support of OWS. The award is being executed as a result of the MCM Commercial Solutions
Opening (CSO) Solicitation W911QY-20-S-0001 Area of Interest (AO') Number A003: SARS-CoV-2 Medical
Counter Measures (MCM) Therapeutics.

11.2.
Key Persoqnel: 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 ajustification 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 theemployee of the contractors 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 theContracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreementof the parties.
The following individuals are determined to be key personnel:
Technical point of contact:
Primary Investigator

Administrative point of contact:

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 guidance. 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 theperson 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.

W911QY20C0119
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The contractor further agrees to include the substance of this language in any subcontract, which may be awarded
under this contract.
H.4.
Contractor's Organization: The contractor's organization shall be established with authority to effectively
accomplish the objectives of the Statement of Work. This organization shall become effective upon award of thecontract and its integrity shall be maintained for the duration of the contract effort.
H.5.
Disclosure of Information: Performance under this contract may require the contractor to access non-publicdata and information proprietary to a government agency, another government 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 which specifically relates to AZD7442 (i.e., would not apply more broadly
to AstraZeneca's other antibody programs, such as its manufacturing platform), except authorized by government
personnel or upon written approval of the CO in accordance with OWS or other government 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 government requirements for protection of non-public information. Unauthorized
disclosure of nonpublic information is prohibited by the government's rules. Unauthorized disclosure may result intermination 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 operationsof 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.
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, orother business transactions.
H.6.
Publication and Publicity: The contractor shall not release any reports, manuscripts, press releases, orabstracts 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 thiscontract. The contractor shall promptly send a copy of each submission to the CUR for security review prior to
submission, and the Government's consent shall not be unreasonably withheld or delayed
The contractor shall also inform the CUR 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 government logos 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 government approval or endorsementof the product(s) or service(s) provided.
d.
The contractor shall include this language, including this section (d) in all subcontracts where thesubcontractor may propose publishing the results of its work under the subcontract. The contractor shall acknowledge
the support of the government 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 by the U.S. government under Contract No. "W911QY-20-C- 0119".

W911QY20C0119
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The US government is authorized to reproduce and distribute reprints for governmental purposes notwithstanding any
copyright notation thereon.
H.7.

Confidentiality of Information:a.
Confidential information, as used in this article, means information or data of a personal nature about anindividual, or proprietary information or data submitted by or pertaining to an institution or organization.
The Contracting Officer and the contractor may, by mutual consent, identify elsewhere in this contract specificb.
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 toagree 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 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
the material 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
and legal officials.
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in otherg.
Federal, State or local laws.
h.
Awardee shall include the requirements set forth in this Article in all Sub-awards entered into after the dateof effectiveness of this Agreement. Awardee acknowledges that confidential information will not be provided to subagreement holders unless or until Article H.7 flows down to the relevant sub-agreement, and such entity agrees to bein substantial compliance with this Article H.7.
H.8.

Subcontracts:a.
The Government acknowledges that, in order to combat the global pandemic and launch AZD7442 as quickly
as possible,b.
For clarity, as detailed within the Articles themselves, the following Articles require flow-down tosubagreements/contracts•

W911QY20C0119
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H.9 Taxes:

H.10 Title and Risk of Loss:

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OREXECUTIVE ORDERS--COMMERCIAL ITEMS (AUG 2020)(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which areincorporated in this contract by reference, to implement provisions of law or Executive orders applicable toacquisitions of commercial items:(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.
113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided byKaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services orEquipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has
indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders
applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)
XX (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (Oct 1995)(41 U.S.C. 4704 and 10 U.S.C. 2402).
XX (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment
Act of 2009.)

W911QY20C0119
PZ0001Page 31 of 36
XX (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L.
109-282) (31 U.S.C. 6101 note).
(5) [Reserved](6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div.
C).
(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub.
L. 111-117, section 743 of Div. C).
XX (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended,or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
xx (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41
U.S.C. 2313).
(10) [Reserved](11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).
(ii) Alternate I (MAR 2020) of 52.219-3.
(12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020)(if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).
(ii) Alternate I (MAR 2020) of 52.219-4.
____ (13) [Reserved](14)(i) 52.219-6, Notice of Total Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).
(ii) Alternate I (MAR 2020) of 52.219-6.
(15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).
(ii) Alternate I (MAR 2020) of 52.219-7.
(16) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).
(17)(i) 52.219-9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).
(ii) Alternate I (NOV 2016) of 52.219-9.
(iii) Alternate II (NOV 2016) of 52.219-9.
(iv) Alternate III (JUN 2020) of 52.219-9.
(v) Alternate IV (JUN 2020) of 52.219-9.
(18) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).
(ii) Alternate I (MAR 2020) of 52.219-13.
(19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C. 637(a)(14)).

W911QY20C0119
PZ0001Page 32 of 36(20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15
U.S.C. 6570.
(22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (MAY 2020) (15 U.S.C. 632(a)(2)).
(ii) Alternate I (MAR 2020) of 52.219-28.
(23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged WomenOwned Small Business (EDWOSB) Concerns (MAR 2020) (15 U.S.C. 637(m)).
(24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns
Eligible Under the Women-Owned Small Business Program (MAR 2020) (15 U.S.C. 637(m)).
(25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).
(26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)).
XX (27) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).
xx(28) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126).
XX (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
XX (30)(i) 52.222-26, Equal Opportunity (SEPT 2016) (E.O. 11246).
(ii) Alternate I (FEB 1999) of 52.222-26.
XX (31)(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ii) Alternate I (JUL 2014) of 52.222-35.
XX (32)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(ii) Alternate I (JUL 2014) of 52.222-36.
XX (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
XX (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O.
13496).
XX (35)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).
(ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(36) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. 0. 12989). (Not applicable to theacquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in
22.1803.)(37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated Items (MAY2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf
items.)(ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition ofcommercially available off-the-shelf items.)

W911QY20C0119
PZ0001Page 33 of 36(38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN2016) (E.O. 13693).
(39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners(JUN 2016) (E.O. 13693).
(40) (i) 52.223-13, Acquisition of EPEAT® Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and13514).
(ii) Alternate I (OCT 2015) of 52.223-13.
(41)(i) 52.223-14, Acquisition of EPEATO Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).
(ii) Alternate! (JUN 2014) of 52.223-14.
(42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).
(43)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s
13423 and 13514).
(ii) Alternate (JUN 2014) of 52.223-16.
XX (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O.
13513).
(45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).
(46) 52.223-21, Foams (JUN 2016) (E.O. 13693).
(47)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).
(ii) Alternate I (JAN 2017) of 52.224-3.
(48) 52.225-1, Buy American--Supplies (MAY 2014) (41 U.S.C. chapter 83).
(49) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014) (41 U.S.C. chapter
83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77,
108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
(ii) Alternate I (MAY 2014) of 52.225-3.
(iii) Alternate!! (MAY 2014) of 52.225-3.
(iv) Alternate III (MAY 2014) of 52.225-3.
(50) 52.225-5, Trade Agreements (OCT 2019) 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
XX (51) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes
administered by the Office of Foreign Assets Control of the Department of the Treasury).
(52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016)(Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150

W911QY20C0119
PZ0001Page 34 of 36(54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV 2007) (42 U.S.C.
5150).
(55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
XX (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C. 4505, 10 U.S.C.
2307(0).
(57) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(0).
(58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (OCT 2018) (31
U.S.C. 3332).
(59) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (JUL2013) (31 U.S.C. 3332).
(60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).
(61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).
(62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).
(63)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C.
Appx. 1241(b) and 10 U.S.C. 2631).
(ii) Alternate I (APR 2003) of 52.247-64.
(iii) Alternate II (FEB 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that
the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions oflaw or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)(1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).
(2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C.
chapter 67).
(3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (Multiple
Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
(4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (MAY2014) (29 U.S.0 206 and 41 U.S.C. chapter 67).
(5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for
Maintenance, Calibration, or Repair of Certain Equipment--Requirements (MAY 2014) (41 U.S.C. chapter 67).
(6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services--Requirements (MAY 2014) (41 U.S.C. chapter 67).
(7) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015) (E.O. 13658).
(8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).

W911QY20C0119
PZ0001Page 35 of 36(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph(d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as
defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit andRecords--Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shallhave access to and right to examine any of the Contractor's directly pertinent records involving transactions related
to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and otherevidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any
shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If
this contract is completely or partially terminated, the records relating to the work terminated shall be madeavailable for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes
clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available
until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data,
regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that
the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, theContractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1)in a subcontract forcommercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by theclause—(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.
113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided byKaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services orEquipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts
that offer further subcontracting opportunities. If the subcontract (except subcontracts
to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract
award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

W911QY20C0119
PZ0001Page 36 of 36(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
Flow down required in accordance with paragraph a) of FAR clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).
(xiii) XX (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).
(B) Alternate! (March 2,2015) of 52.222-50(22 U.S.C. chapter 78 and E.O. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for
Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services--Requirements (May 2014) (41 U.S.C. chapter 67)(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. 0. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

(xviii)52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section
862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (JUN 2020) (42 U.S.C. 1792). Flow
down required in accordance with paragraph (e) of FAR clause 52.226-6.
(xxii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of
additional clauses necessary to satisfy its contractual obligations.
(End of clause)

The following have been deleted:52.216-23
252.217-7027
252.232-7007

Execution And Commencement Of Work
Contract Definitization
Limitation Of Government's Obligation(End of Summary of Changes)

APR 1984
DEC 2012
APR 2014