AWARD/CONTRACT
2. CONTRACT (Proc.. hist 'dent) NO.

1. THIS CONTRACT IS A RAT ED ORDER

PAGE OF PAGES
1 I
84
4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

28 Oct 2020

W1501(142191003
5. ISSUED BY

RATING!

UNDER DPAS (15 CFR 700)
3. EFFECTIVE DATECODE W1501(N0011567172

6. ADMINISTERED BY (Jothersbcgt item 5)

US ARMY CCNTRACTNG COMMAND
PHIS ROAD
PICAT NNY NJ 97806-5030

CODEI

See Item 5

7. NAME AND ADDRESS OF CONTRACTOR

8. DELIVERY[ ] FOB ORIGFN_., street city, coun(v; state and 49 code)04,

ASTRAZENECA FHARMACEUTICALS LP
1933 CONCORD P ICE
WILM NGTCN DE 19303-2902[ X ] OTHER(See bebw)

9 DISCOUNT FOR PROMPT PAYMENT

10 SUBMIT INVOICESCODE 36WK2
11. SHIP TO/MARK FOR

FACILITY CODE
CODE

ITEM

(4 copies unless ceiterttise spec fled)
TO THE ADDRESSSHOWN IN:

CODE H00237

12. PAYMENT WILL BE MADE BY,

DFAS COWMBUS CENTERDFAS COWMBUS/NORTH ENTITLEMENT
P.O BOX 182317
COLUMBUS OH 43218-2266

See Schedule

13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN
COMPETITION:[
110 U.S.C. 2304(c)() [] 41 U.S.C. 253(c)()

14. ACCOUNTING AND APPROPRIATION DATA

15A ITEM NO.

15C. QUANTITY

15B. SUPPLIES/ SERVICES

See Schedule
15D. UNIT

15E. UNIT PRICE

15F. AMOUNTSEE SCHEDULE

15G. TOTAL AMOUNT OF CONTRACT$1,208,933,813.79,
16. TABLE OF CONTENTS,—DESCRIPTIONI PAGE(S), (X) I SEC. I
DESCRIPTIONI PAGE(S),(X)IC.I
PART! - THE S C HEDL'IE
PART II - C 0 NTRIC T C LAUSESXA SOLICITATION/ CONTRACT FORM
1 -2
I I 'CONTRACT CLAUSES
1XB SUPPLIES OR SERVICES AND PRICES/ COSTS
3- 24 _PART DI — LIST OF DOCUMENTS, EXHIBITS AND OTHER ATLAC H.
,X
C DESCRIPTION/ SPECS./ WORK STATEMENT
25 - 36
X I J ILIST OF ATTACHMENT S
184
D PACKAGING AND MARKINGPARTIN - REPRESENTATIONS AND LNS IRUC110 NS
E INSPECTION AND ACCEPTANCEREPRESENTATIONS. CERTIFICATIONS ANDKF DELIVERIES OR PERFORMANCEOTHER STATEMENTS OF OFFERORS,XG CONTRACT ADMINISTRATION DATA
37
L INSTRS. CONDS, AND NOTICES TO OFFERORS,•X
H SPECIAL CONTRACT REQUIREMENTS
38 - 83
M EVALUATION FACT ORS FOR AWARDCONTRACTING OFFICER WELL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR IS (SEALED-BID PROCUREMENT) AS APPLICABLE

17 [XI CONTRACTOR: S NEGOTIATED AGREEMENT
Contractor is required to sign thisdocument and reurn1
copies to issuing office)Contractor agrees to furnish and deliver all
items or perform all the services set forth or otherwise identified above and on any cementation
sheets for the consideration stated herein The rights and obligation of the parties to thiscontract shall be subject to and governed by the following documents: (a) this awardkattract,(b) the solicitation, if any, and (e) such provisions, representations, certifications, and specification,
as are attached or incorporated by reference herein(Attachments are listed herein)

19A. NAME AND TITLE OF SIGNER (Type or print)

18 [y

1 SEALED-BID AWARD (Contractor is not reimiivel to sip this cleti-pummt 3
bid rii &thrum...Number

including the addition or changes made by you which additions or changes are set forth in full above, is hereby accepted as
to the terns listed above and on any continuation sheets This award consummates the contract which consists of thefollowing documents: (a) the Govermnenfs solicitation and your Ncl, and (b) this award/contract No falter contractual
document is necessary (Block 18 should be checled only when awarding a sealed-bid contract)

20A. NAME OF CONTRACTING OFFICER

rraTia/ CONTRACTING OFFICERTEL: NaT15=1

19B. NAME OF CONTRACTOR,

19C. DATE SIGNED 20B.

MN

8 1 i

(b) (6)EMAIL riaTi
8

: ti

C

:

,

20C. DATE SIGNED

28-Oct-2020
BY

BY(Stgoaarre ofperson authorted to sign)
AUTHORIZED FOR LOCAL REPRODUCTION
Previous edition is NOT usable(Signature of Contracting Officer)
STANDARD FORM 26 (REV 5/2011)
Prescnbed by GSA — FAR (48 CFR) 53214(a)Section A - Solicitation/Contract FormEXECUTIVE SUMMARY

1) This Undefinitized Project Agreement (UPA) is being issued by The Army Contracting
Command — New Jersey to AstraZeneca Pharmaceuticals LP (AstraZeneca), 1800 Concord Pike,
Wilmington, DE, 19803-2902.
2) Both parties agree that the general scope of this UPA requires AstraZeneca to Conduct Phase 3
clinical trials and demonstrate the ability to manufacture and distribute 100 Million (M) doses of
the ChAdOx1 nCoV-19 vaccine (now referred to as AZD1222) to the United States Government
to prevent the general population from developing symptoms of the COVID-19 infection.
3) This action has a total Firm Fixed Price value of $1,208,933,813.79. It is not anticipated that the
total value of this action will increase during the definitization process.
4) Funding is obligated in the total amount of $1,208,933,813.79, however performance is only
authorized up to (b) (4)of total UPA value prior to definitization.
5) The anticipated Period of Performance is 39 months from the effective date, ending 31-December
2023.
6) The Effective Date of this UPA is identified in Block 3 on Page 1 of this agreement.
7) The estimated preliminary delivery schedule, setting forth the quantities and timing of delivery ofeach shipment of AZD1222 initially projected by AstraZeneca as of the Effective Date of this
UPA, is set out in Section H Table 2: Payable Milestones. AstraZeneca shall provide a Dose
Tracking Tool that will include updated estimates, based on AstraZeneca's knowledge, of
antici • ated • uantities and timing. As soon as reasonably possible, and in any event not later than(b) (4)prior to each anticipated delivery, AstraZeneca shall use commerciallyreasonable efforts to provide a firm and final delivery schedule for each shipment setting forth thequantities of AZD1222 and the date for delivery of each shipment.
8) The Representations and Certifications made by AstraZeneca in the System for AwardManagement (SAM) are hereby incorporated into this contract by reference.
9) The terms and conditions set forth in this UPA are not expected to materially change prior todefinitization, however aspects may be negotiated prior to definitization.
10) This contract shall have a Health Resources Priotities and Allocation System (HRPAS) priority
rating of DO-HR. See Section H for additional information.

Section B - Supplies or Services and Prices

ITEM NO
0001

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 1
FFP
To be invoiced upon agreement award.
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AA
CIN: GFEB5001156717200001

ITEM NO
0002

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

Milestone 2
FFP
DS (b) (4)comp etion ..te o (b) (4)UNIT PRICEAMOUNT(b) (4)

Expected

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AA
CIN: GFEBS001156717200002(b) (4)ITEM NO

SUPPLIES/SERVICESQUANTITY

10003

Milestone 3
FFP
DP (b) (4)

UNIT
Lot

UNIT PRICEAMOUNT,(b) (4)Expected completion da e o (b) (4)

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AA
GFEBS001156717200003

ITEM NO
0004

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICE(b) (4)AMOUNT

Milestone 4
FFP(b) (4)of commercial scale DS (GMP or non-GMP). Expected completion date(b) (4)

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT

ACRN AA
CIN: GFEBS001156717200004(b) (4)ITEM NO
0005

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PR ICI.:(b) (4)AMOUNT

Milestone 5
FFP
1151RM Prelim DART study report. Expected completion date of (b) (4)
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AA
CIN: GFEBS001156717200005

ITEM NO
0006

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 6
FFP(b) (4)

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT

ACRN AA
CIN: GFEBS001156717200006(b) (4)ITEM NO
0007

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

AMOUNT

UNIT PRICE(b) (4)

Milestone 7
FFP(b) (4)

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEBS001156717200007

ITEM NO
0008

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 8FFP(b) (4)

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200008(b) (4)ITEM NO
0009

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 9FFP(b) (4)

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMTb (4)ACRN AB
CIN: GFEBS001156717200009

ITEM NO
0010

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 10
FFP
of commercial scale DS (GMP or non-GMP). Expected completion

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEB5001156717200010(b) (4)ITEM NO
0011

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOIJNT(b) (4)

Milestone 11
FFP
DP Validation Report. Expected completion date ot (b) (4)
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEBS001156717200011

ITEM NO
0012

SUPPLIES/SERVICESQUANTITY
1

LNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 12
FFP
DS Validation Report. Expected completion date of (b) (4)
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200012(b) (4)ITEM NO
0013

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 13
FFP(b) (4)

Expecte • comp awn .teo (b) (4)
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEBS001156717200013

ITEM NO
0014

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 14
FFP(b) (4)of commercial scale DS (GMP or non-GMP). Expected completiong te o (b) (4)

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200014(b) (4)ITEM NO
0015

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

\NIO1IN I

UNIT PRICE(b) (4)

Milestone 15
FFP
Deliver (b) (4)Doses FP to (b) See Article I.C.10 for Due Date.
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEB5001156717200015

ITEM NO
0016

SUPPLIES/SERVICES
Milestone 16
FFP
Deliver (b) ( 4)QUANTITY
1

Doses FP to (b)

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)See Article I.C.10 for Due Date.

FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200016(b) (4)ITEM NO
0017

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

Milestone 17a
FFP
Doses FP (b) (4)Deliver (b) (4)for Due Date.
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

UNIT PRICEAMOUNT(b) (4)See Article I.C.10

NET AMT(b) (4)

ACRN AB
CIN: GFEBS001156717200017

ITEM NO
0018

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

AMOUNT

UNIT PRICE(b) (4)

Milestone 17b
FFP
Pharmacovigilance. Concurrent with Milestone 17a.
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200018(b) (4)ITEM NO
0019

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

Milestone 18a
FFP
Doses FP (b) (4)Deliver (b) (4)for Due Date.
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

AMOUNT

UNIT PRICE
1(b) (4)See Article I.C.10

NET AMT(b) (4)

ACRN AB
CIN: GFEBS001156717200019

ITEM NO0020

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 18b
FFP
Pharmacovigilance. Concurrent with Milestone 18a.
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200020(b) (4)ITEM NO

SUPPLIES/SERVICES

0021

QUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 19
FFP
Pediatric Phase 3 Study. Details to be finalized prior to work beginning on
Pediatric Phase 3 Study. This Milestone represents a rough order of magnitude, andadditional Milestones will be added upon a future bilateral modification.
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEB5001156717200021

ITEM NO
0022

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICE(b) (4)AMOUNT

Milestone 20
FFP
BLA Submission. Expected completion date of (b) (4)
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT

ACRN AB
CIN: GFEBS001156717200022(b) (4)ITEM NO
0023

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 21
FFP
Phase 3 LSLV. Expected completion date 01 (b) (4)
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEB5001156717200023

ITEM NO
0024

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 22
FFP
Ph3 Final CSR. Expected completion date o (b) (4)
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200024(b) (4)ITEM NO
0025

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 23
FFP(b) (4) enrollment of (b) (4) (DOD Approval ofla patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
ON: GFEBS001156717200025

ITEM NO
0026

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 24
enrollment o (b)(DOD Approval ofOpatient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200026(b) (4)ITEM NO0027

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 25
FFP(b) (4) enrollment of (b)(DOD Approval 0 (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEB5001156717200027

ITEM NO
0028

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 26
FFP(b) (4) enrollment of (b)(DOD Approval of (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEB5001156717200028(b) (4)ITEM NO
0029

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT

1(b) (4)Milestone 27
FFP(b) (4) enrollment of (b)(DOD Approval 0 (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEB5001156717200029

ITEM NO0030

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 28
FFP(b) (4) enrollment of (b)(DOD Approval oiril patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEB5001156717200030(b) (4)ITEM NO0031

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT

1(b) (4)Milestone 29
FFP(b) (4) enrollment of (b)(DOD Approval 0 (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEBS001156717200031

ITEM NO0032

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 30
FFP(b) (4) enrollment of (b)(DOD Approval of (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200032(b) (4)ITEM NO0033

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 31
FFP(b) (4) enrollment of (b)(DOD Approval 0 (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEB5001156717200033

ITEM NO0034

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 32
FFP(b) (4) enrollment of (b)(DOD Approval 041 patient increment)
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEB5001156717200034(b) (4)ITEM NO
0035

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 33
FFP(b) (4) enrollment of (b)(DOD Approval 0 (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEB5001156717200035

ITEM NO
0036

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 34
FFP(b) (4) enrollment of (b)(DOD Approval of (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEB5001156717200036(b) (4)ITEM NO
0037

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 35
FFP(b) (4) enrollment of (b)(DOD Approval 0(b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEB5001156717200037

ITEM NO
0038

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

AMOUNT

UNIT PRICE(b) (4)

Milestone 36
FFP(b) (4) enrollment of (b)(DOD Approval of(b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200038(b) (4)ITEM NO0039

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

\NIOIIN I

UNIT PRICE(b) (4)

Milestone 37
FFP(b) (4) enrollment of (b)(DOD Approval 0 (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEB5001156717200039

ITEM NO
0040

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 38
FFP(b) (4) enrollment of (b)(DOD Approval of (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEB5001156717200040(b) (4)ITEM NO
0041

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 39
FFP(b) (4) enrollment of (b)(DOD Approval 0 (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEBS001156717200041

ITEM NO
0042

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 40
FFP(b) (4) enrollment of (b)(DOD Approval of (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEB5001156717200042(b) (4)ITEM NO
0043

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 41
FFP(b) (4) enrollment of (b)(DOD Approval 0 (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT(b) (4)

ACRN AB
CIN: GFEBS001156717200043

ITEM NO0044

SUPPLIES/SERVICESQUANTITY
1

UNIT
Lot

UNIT PRICEAMOUNT(b) (4)

Milestone 42
FFP(b) (4) enrollment o (b)(DOD Approval of (b) patient increment).
FOB: Destination
PURCHASE REQUEST NUMBER: 0011567172
PSC CD: AN13

NET AMT
ACRN AB
CIN: GFEBS001156717200044(b) (4)

Section C - Descriptions and Specifications
STATEMENT OF WORKSTATEMENT OF WORK
1.

Prototype Delivery Contract (100M Doses; (b) (4))
1.1. Manufacturing Demonstration (DOD :: Ii A WBS1&2)
1.1.1. Technology transfer, process development and process characterization to enable large scale
manufacturing and distribution
1.1.1.1. Drug Substance
1.1.1.1.1. Process TT
1.1.1.1.2. Analytical Method Transfer and Validation
1.1.1.1.3. Stability
1.1.1.1.4. DS Shipping Studies
1.1.1.1.5. Comparability
1.1.1.2. Drug Product1.1.1.2.1. Process TT
1.1.1.2.2. Analytical Method Transfer and Validation
1.1.1.2.3. Stability
1.1.1.2.4. DP Shipping Studies
1.1.1.2.5. Comparability
1.2. Demonstration DS Manufacture (DOD WBS2; BARDA WBS 2)
1.2.1. Manufacture & Release
1.2.2. Storage/Shipping
1.3. Demonstration DP Manufacture (DOD WBS3; BARDA WBS 3)
1.3.1. Manufacture & Release
1.3.2. Shipping
1.4. Demonstration DP Pack/Label (DOD WBS4)
1.4.1. Pack/Label
1.4.2. Storage/Shipping
1.5. Nonclinical Toxicology Demonstration (DOD WBS5
1.5.1. Dose-ranging developmental toxicology i(b) (4)1.5.2. GLP Prenatal / Postnatal Developmental Toxicity Study (b)(4)
1.6. Phase 3 Clinical Study (Adult) (DOD WBS6)
1.7. Phase 2/3 Clinical Study (Pediatric) (DOD WBS7)
1.8. HA Authorization/Approval (DOD WBS8)
1.8.1. EUA
1.8.2. BLA
1.8.3. PV
1.9. Project Management (DOD WBS9)

1. Prototype Delivery Contract (100M Doses- (b) (4)1.1. Manufacturing Demonstration (DOD Contract 1 WBS
1.1.1. Technology transfer, process development and process characterization to enable large scale
manufacturing and distribution
1.1.1.1. Drug Substance (DS)1.1.1.1.1. Process TT
The DS process will be developed from the (b) (4)used to support Ph3 in US, and scaled to (b) (4)on•

Establishment o (b) (4)manufacture

and associated downstream process.
Activities will focus primarily
to support the Drug Substance•Evaluation and optimization of the upstream and downstream processes to ensure robust
manufacturing operations and fit to plant•

Evaluation of process changes that may enhance process performance or enable morestreamlined manufacturing operations•

Process characterization

The rocess will be (b) (4)with the rocess develo ment activities. (b)(4)

A pre-va i. ation an x a 1 ation strategy. ase on an assessment o contro an
consistency t irou critical review, and experience gained through the tech transfer process will be
developed and discussed with the FDA.
AstraZeneca shall (b) (4)to perform tech transfers.

If there are problems with the facility, equipment or capacity (b) (4)the USG will
active' encraoe to ensure timel and effective resolution o t ose issues (b) (4)(b) (4)All information related to raw materials, manufacture. testing and release activitie .(b) (4)(b) (4)

Other supporting work will be conducted as necessary/appropriate in support of licensure to possibly
include the following.

1.1.1.1.2. DS Analytical Method Transfer and Validation
AstraZeneca (b) (4)Reports. All in ormation wi .e e ivere

to develo Analytical Method Transfer Protocols and(b) (4)
AstraZeneca.

Proposed assays for test and release of DS. DS comparability. and DS stability are specified in Table
1.1.1.1.2-A. Table 1.1.1.1.2-B and Table 1.1.1.1.2-C. respectively. After sufficient experience andcompletion of validation testing may be reduced or altered based on experience gained during the techtransfer. validation and manufacturing processes. AstraZeneca and the Government recognize thatdifferent analytical methods may need to be developed and validated to support regulatory approval.

Table 1.1.1.I.2-A: Ding Substance Release Tests Planned, As Necessary
DS
In-Process

Method Description(b) (4)

DS Release

I
I
I
I
I
I
I

I
I
I
I
I
I
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I
I
I
I
I

I
I
I
I
I

Critical Quality Attribute EvaluatedMethodTest Purpose(b) (4)

Table 1.1.1,1,2-C: Drit.e: Substance Stability Assays Planned, As Necessaiy
Method Description

DS Stability(
ti

1.1.1.1.3. DS Stability

AstraZeneca (b) (4)to conduct DS sta ii

to develo a DS Stabili
test inStud Plan Table 1.1.1.1.3 and(b) (4)Table 1.1.1.1.3: Drug Substance Stability Test Schedule

MethodTemperature

Time-points in Mouths
TO*1075105107511115171A14151617151911111111121151U(b) (4)

W15Q1{N2191003
Page 29 of 84

1.1.1.1.4. DS Shipping Studies
AstraZeneca shall contract with established service providers to conduct protocol driven DS
shipping studies, use existing studies or provide other documented evidence to demonstrate that theDS can be transferred from the DS manufacturing site to the Drug Product (DP) manufacturing siteusing a qualified shipping solution. Drug Substance shipping studies will incorporate the following
aspects of shipping: (Note: A grouping strategy may be applied to utilize studies for more than one
location.)

1.1.1.1.5. DS Comparability
Analytical comparability of the DS will be • erformed usin• lot release tests as well as additional
characterization methodolo 3 (b)(4)1.1.1.2. Drug Product (DP)1.1.1.2.1. Technolo A Transfer
1.1.1.2.1.1.(b) (4)The DP process will be develo ed from the (b) (4)scaled to (b) (4)used to support Ph3 in US, and eventually
Activities will focus primarily on:(b) (4)

The DP process will be (b) (4)concurrent with the process development
activities. A pre-validation an va ia lion strategy. possibly based on an assessment of control andconsistency through critical analytical review, will be developed and discussed with the FDA toalign expectations. AstraZeneca shall contract with a third party for DP test and release and to
manage all documentation and reporting activities for testin and release of Dru• Product. Release
testing to ensure safe and efficacious material may include b) (4)1.1.1.2.1.2. (b) (4)W15QKN2191003
Page 30 of 84(b) (4)

The DP rocess will be develo d from thescale used to su ort Ph3 in US. and scaled to a (b) (4)Process w
implemented (b) (4)to meet the expecte pr. iction VO ume om t e site. Activities
will focus priman y on tie o owing:

A pre-validation and validation strategy, possibly based on an assessment of control and consistency
through critical analytical review, will be developed and discussed with the FDA to alignexpectations. AstraZeneca shall contract with a third party for DP test and release and to manage all
documentation and reporting activities for testinI and release of Drug Product. Release testing toensure safe and efficacious material may include b) (4)1.1.1.2.1.3. Support for licensure
This proposal includes scope and costs to support the following list of additional studies:

Additional data may be required for EUA, BLA approval or as post-marketing commitments during
the period of performance of the Other Transactional Agreement. AstraZeneca shall conduct
additional studies that would support licensure. If additional work is determined to be necessary by
AstraZeneca or required by the USG and regulatory authorities, it may be necessary to modify thescope and assess the fmancial impact, with changes implemented subject to approval by both parties.
1.1.1.2.2. DP Analytical Method Transfer and Validation
AstraZeneca shall contract to develop Analytical Method Transfer Protocols and Reports. All
information related to manufacture, testing and release activities will be delivered to AstraZeneca.
Assays proposed for test and release of DP, DP comparability, and DP stability are specified inTable 1.1.1.2.2-A, Table 1.1.1.2.2-B and Table 1.1.1.2.2-C, respectively.

Table 1.1.1.2.2-A Drug Product Release Tests Planned, As Necesscny

Method Description(b) (4)DP
ReleaseI
I
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W15QKN2191003

Page 31 of 84(b) (4)

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Table 1.I.1.2.2-B Drug Product Comparability Tests Planned, As Necessaiy
Method(b) (4)

Table I.1.1.2.2-C Drug Product Stability Tests Planned, As Necessmy

Method Description

DP Stability1

1.1.1.2.3. DP Stability
AstraZeneca shall contract to develo a DP Stability Study Plan and to conduct stability testing ofDP produce ,(b)(4). Drug Product container-closure system(s) will beassessed for sta ity concurrent. Sta
indicatin anal ;cal tests will be '-rformed assummarized in Table 1.1.1.2.2-c. (b) (4)1.1.1.2.4. DP Shipping Studies

W15QKN2191003
Page 32 of 84
hi accordance with federal regulations. AstraZeneca shall contract with an established service
provider to conduct a protocol driven DP shipping study, use existing studies, or provide otherdocumented evidence to establish the critical and qualified shipping parameters that will be used byexternal distribution teams in order to ensure successful DP transfer from the manufacturing site tothe (b) (4)distribution centers. Drug Product shipping studies will incorporate thefollowing aspects of shipping: (Note: A grouping strategy, worst-case parameter testing or existingstudies may be applied to utilize studies for more than one location.)(b) (4)(b) (4)(b) (4)1.1.1.2.5. DP Comparability

Analytical comparability of the DP will be erformed usui lot release tests as well as additional
characterization methodolo . . (b)(4)1.2. Demonstration DS Manufacture (DOD Contract 1 WBS2; BARDA WBS 2)
1.2.1. Manufacture & Release

AstraZeneca shall contract with and oversee the large-scale manufacture(b) (4)and execute DS quality agreements as is necessary for shipment to(b) (4) or DP manufacture.

AstraZeneca shall oversee review, approval and release of Drug Substance at (b) (4)to ensure that the
product meets quality and regulatory corn liance requirements. Specifically. AstraZeneca will ensuresatisfactory completion of the following by (b) (4)A.
B.

Batch Production Records for Drug Substance
Certificates of Analysis

of DS are budgeted. The US Govenunent will directly pay for (b) (4)Furthermore, AstraZeneca will pay ect y to (b) (4)itse a ance of costs for (b) (4)will be reimbursed to AstraZeneca
t unug i t le prototype contract nu estones.

W15QKN2191003
Page 33 of 84
AstraZeneca and the US Government note that (b) (4)In tie event t at t e DS pro uce excee st e requirements o t s contract, it s a a e use to pro uce up to 200M additional doses under UndefmitizedContract Action (UCA) W15QKN-20-C-0067.
1.2.2. Storage/Shipping

AZ will control all material within our quality system and material will not be final released until all testinghas been completed and CoA have been issued.
hi addition, AstraZeneca shall provide supply chain plaiming, management and logistics to manage
appropriate supply and inventories across all sites to fulfill the 100MM doses to the USG in the agreed
timeframes, and supplier management and oversight o (b) (4)1.3. Demonstration DP Manufacture (DOD Contract 1 VVBS3; BARDA WBS 3)
1.3.1. Manufacture & Release

AstraZeneca shall secure raw materials, manufacture and release 100,000,000 doses of DP filled into
ensuring that the product meets quali and regulatory comp iar.ce
requirements. Test and release will be conducted at subrecipient facilities (b) (4)AstraZeneca will ensuresatisfactory completion of the following:
A.
B.

Manufacturing Batch Production Records for Final Drug Product
Certificates of Analysis

1.4. Demonstration DP Pack/Label (DOD Contract 1 WBS4)
1.4.1. Pack/Label
AstraZeneca shall conduct at (b) (4)taroeted invent° of 100MM oses w

ack and label of final fill finished DP. A
e re ar -(b) (4)

1.4.2. Storage/Shipping

Pallets of finished DP will be stored at 2-8°C according to the terms and conditions specified in Article 16of the OTA.
1.5. Nonclinical Toxicology (DOD Contract 1 VVBS5
1.5.1. Dose-ranging developmental toxicology (b) (4)(b) (4)

W15Q1(N2191003
Page 34 of 84(b) (4)

1.5.2. GLP Prenatal / Postnatal Developmental Toxicity Study (b) (4)(b) (4)1.6. Phase 3 Clinical Study (Adult) (DOD Contract 1 WBS6)
1.6.1. Generally
AstraZeneca shall conduct a pivotal Phase 3 vaccine efficacy study in 30,000 adults in the US, Peru. andChile > 18 years of age who are healthy or who have stable chronic diseases, and who are at increased risk
for SARS-CoV-2 infection and COVID-19 disease. The study will be designed to provide robust efficacy,
safety (assumes a 2 year safety follow-up), tolerability, and immunogenicity data. AstraZeneca will completea study protocol and have it reviewed by Regulatory Authorities, perform set-up activities, commence study
and complete recruitment, analyze the study results and finalize a clinical study report with the goal to submit
the data to FDA to seek approval for use of the vaccine in the broader population. The study will include(b) (4)as summarized in the table below. In addition a DSMB will be managed by the NM.
Costs or mvestigator payments at (b) (4 )costs and the DSMB associated with this study will
be borne by the US Government.

1.6.2. Government Enrollment Notifications and Options
AstraZeneca shall notify the Government when it reasonably expects to enroll
sites, and thereafter for each incremental enrollment o(b) (4)

When AstraZeneca notifies the Government that it reasonably expects to enroll
at (b) (4)sites, the parties shall discuss whether there are any scientific or c mica reasonsad tiona enrollees would not provide beneficial clinical data (e.g., trial demographics would beinappropriately skewed). If there are such scientific or clinical reasons, as determined by the Government
exercising its reasonable and scientific expertise, (i) the Government would not be required to pay the costs
associated with the enrollment of such patients, and (ii) AstraZeneca would be permitted to enroll such
additional patients at (b (4)sites at its own cost and expense. If there are no such reasons, theGovernment would pay e costs of such enrollees as provided in the milestones. For clarity, theGovernment's decision cannot be based solely on costs; there must be a reasonable and justifiable scientificor clinical reason that warrants the Government's non-payment in respect of such additional enrollees.

W15QICN2191003
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When enrollment of 30.000 trial subjects is completed, the Parties shall assess how man
atients
AstraZeneca enrolled at (b) (4 )atsites, whether AstraZeneca enrolled fewer (ID) (4)(b) (4)
sites and, if so, e extent to which actual enrollment was (b) (4)"Patient So a(b) (4)1.7. Phase 2/3 Clinical Study (Pediatric) (DOD Contract 1 WBS7)
healthy pediatric subjects
AstraZeneca shall conduct a Phase 2/3 vaccine clinical study in an estimated b
aged 2 to <17 years. The study will be designed to provide robust safety, immunogenicity data. AstraZeneca
will complete a study protocol and have it reviewed by Regulatory Authorities, perform set-up activities,
commence study and complete recruitment, analyze the study results and finalize a clinical study report withthe goal to submit the data to FDA to seek approval for use of the vaccine in the pediatric population.
Additional safety studies or risk mitigation efforts may be advisable or required by the FDA in which casethey will be proposed as part of the scope and budget for this option if needed.
AstraZeneca must receive written authorization from the Agreements Officer prior to performance on thisSOW Section. The technical requirements of this section and associated payment milestones are based on thefacts and circumstances that are/were known at the time of base agreement award. It is anticipated that theserequirements may need to be revised prior to actual performance. Prior to any Contractor performance
pursuant to this section of the Statement of Work, technical requirements and milestone payments shall bemutually negotiated.
1.8. HA Authorization/Approval (DOD Contract 1 WBS8)
1.8.1. IND
AstraZeneca shall prepare and submit a pre-IND meeting request and briefing document with a request forexpedited feedback on Phase 3 enabling questions. FDA has indicated that written feedback will be provided
and that there will be an opportunity for a teleconference, if needed, to clarify the written feedback.
AstraZeneca will take the Agency's feedback into account in the development and submission of an IND to
support the FDA's review of the information and data to support the Phase 3 study initiation.
1.8.2. EUA
AstraZeneca shall support the submission of an Emergency Use Authorization request for the vaccine.
Working with the USG, AstraZeneca will seek FDA agreement on the appropriate information and data,
including the use of interim Phase 3 clinical data, needed for the preparation and submission of the EUA
request.
1.8.3. BLA
AstraZeneca shall prepare and submit a Biologics License Application (BLA). The content of the BLA will
be informed by consultations with the FDA on key regulatory questions as required to inform risk to approvaland possible mitigations to address risks.
1.8.4. Pharmacovigilance
AstraZeneca will perform pharmacovigilance activities according to US and Rest of World (ROW) clinicalstudy and post authorisation regulatory requirements as of 15 September 2020. In the event of new regulatory
requirements being implemented, the pharmacovigilance strategy and budget would be assessed forW15QKN2191003
Page 36 of 84
adequacy. This will include the collection, evaluation and re ortinL of safe
a licable territories in the rest of the world. (b) (4)data from both the US and1.9. Project Management (DOD Contract 1 WBS9)The Recipient shall provide qualified project management staff to manage the delivery of the scope definedin this proposal, and the project office. The project office will maintain the integrated project schedule andmanage deliverables as outlined in Article 17 of this Agreement.

W15QKN2191003
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Section G - Contract Administration Data

ACCOUNTING AND APPROPRIATION DATA
AA: 0212021202220400000665654255
COST CODE: A5XAHAMOUNT: !(b) (4)S.0074658.5.27.1

6100.9000021001

AB: 0212021202220400000665654255
COST CODE: A5XAHAMOUNT: '(b) (4)S.0074658.5.27

6100.9000021001

ACRN

CL1N/SLIN

CIN

AA

0001
0002
0003
0004
0005
0006
0007
0008
0009
0010
0011
0012
0013
0014
0015
0016
0017
0018
0019
0020
0021
0022
0023
0024
0025
0026
0027
0028
0029
0030
0031
0032
0033
0034
0035
0036
0037
0038
0039
0040
0041
0042
0043
0044

GFEB5001156717200001
GFEBS001156717200002
GFEB5001156717200003
GFEB5001156717200004
GFEBS001156717200005
GFEB5001156717200006
GFEB5001156717200007
GFEB5001156717200008
GFEB5001156717200009
GFEBS001156717200010
GFEB5001156717200011
GFEB5001156717200012
GFEBS001156717200013
GFEB5001156717200014
GFEB5001156717200015
GFEBS001156717200016
GFEB5001156717200017
GFEB5001156717200018
GFEB5001156717200019
GFEB5001156717200020
GFEBS001156717200021
GFEB5001156717200022
GFEB5001156717200023
GFEBS001156717200024
GFEB5001156717200025
GFEB5001156717200026
GFEBS001156717200027
0FEB5001156717200028
GFEB5001156717200029
GFEB5001156717200030
GFEBS001156717200031
GFEB5001156717200032
GFEB5001156717200033
GFEBS001156717200034
GFEBS001156717200035
GFEB5001156717200036
GFEB5001156717200037
GFEBS001156717200038
0FEB5001156717200039
GFEB5001156717200040
GFEB5001156717200041
GFEBS001156717200042
GFEB5001156717200043
GFEB5001156717200044

AB

AMOUNT(b) (4)

W15QKN2191003
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Section H - Special Contract Requirements
TERMS AND CONDITIONSTABLE OF CONTENTS
ARTICLE 1: BACKGROUND, DEFINITIONS AND SCOPE OF THE AGREEMENTARTICLE 2: TERM AND TERMINATIONARTICLE 3: PROJECT MANAGEMENT AND MODIFICATIONSARTICLE 4: MANAGEMENT OF THE PROJECTARTICLE 5: "PREP ACT" COVERAGE
ARTICLE 6: OBLIGATION AND PAYMENTARTICLE 7: DISPUTESARTICLE 8: CONFIDENTIAL INFORMATIONARTICLE 9: INTELLECTUAL PROPERTY RIGHTSARTICLE 10: DATA RIGHTSARTICLE 11: REGULATORY RIGHTSARTICLE 12: REGULATORY COMPLIANCE
ARTICLE 13: FOREIGN ACCESS TO DATAARTICLE 14: SCIENTIFIC PUBLICATIONS AND PRESS RELEASESARTICLE 15: ENSURING SUFFICIENT SUPPLY OF THE PRODUCTARTICLE 16: INSPECTION AND ACCEPTANCE
ARTICLE 17: REPORTING REQUIREMENTS
ARTICLE 18: INVOICING AND PAYMENT INSTRUCTIONSARTICLE 19: PROHIBITION ON THE USE OF CERTAIN TELECOMMUNICATIONS AND VIDEOSURVEILLANCE SERVICES OR EQUIPMENT
ARTICLE 20: HEALTH RESOURCES PRIORITIES AND ALLOCATIONS SYSTEMS (HRPAS) PRIORITY
RATINGW15QKN2191003
Page 39 of 84

ARTICLE 1: BACKGROUND, DEFINITIONS AND SCOPE OF THE AGREEMENT
A. Background
AstraZeneca Pharmaceuticals LP is committed to the clinical evaluation of the efficacy, safety and immunogenicityof the ChAdOxl nCoV-19 vaccine (now referred to as AZD1222) against SARS-CoV-2, for the prevention of COVID19 in adults, and for the evaluation of safety and immunogenicity in pediatric populations.
Vaccines are one of the most important public health interventions and provide the most broadly effective andeconomic approach to prevent wide-spread infectious disease; vaccination is responsible for the global elimination ofsmallpox, and near elimination of polio. SARS-CoV-2, the virus that causes COVID-19, infects cells using a spike(S) surface glycoprotein which is a perfect target for a protective vaccine that elicits neutralizing antibodies, but its
novelty is also a challenge. We are still learning the pathophysiology of the virus and developing a safe and effective
vaccine takes time. Many groups are rapidly advancing vaccines for SARS-CoV-2, utilizing a wide range of platforms
and approaches (Chen et al., 2020). Virally-vectored vaccines provide a number of advantages (Ewer et al., 2016).
These include induction of a strong T-cell response (particularly CD8 1-cells) as well as a strong humoral (antibody)
response, intrinsic adjuvanticity, and the potential for a plug and play approach that can leverage significant safety
and production/manufacturing information once developed for the vector to accelerate subsequent development withdifferent encoded antigens.
The AZD1222 vaccine developed at, and licensed from, the Jenner Institute at Oxford University, England, consistsof the replication-deficient simian adenovirus vector ChAdOxl (Dicks etal., 2012), modified to express the structural
surface glycoprotein (spike protein) antigen of SARS CoV-2. AZD1222 encodes the full-length, codon-optimized
coding sequence for the spike protein, derived from genome sequence deposited at GenBank (accession# MN908947).
The vaccine also incorporates a tissue plasminogen activator (tPA) signal sequence to drive cell-surface expression,
which has been shown to be beneficial in enhancing immunogenicity of another ChAdOxl vectored CoV vaccine;
ChAdOxl MERS (Alharbi et a/.,2017).
Chimpanzee adenovirus vaccine vectors have been safely administered to thousands of people, expressing a wide
range of infectious disease target antigens. Prior to a current Phase 1/2 in the UK, ChAdOx1 vectored vaccines
covering disease targets such as Zika, influenza and malaria have been given to over 320 volunteers with no safetyconcerns and had been shown to be highly immunogenic at single dose administration (c.f., Antrobus et al., 2014,
Wilkie etal., 2020). Of relevance, a single dose of a ChAdOx1 vectored vaccine expressing full-length spike proteinfrom another beta-coronavirus (MERS-CoV) has been shown to induce neutralizing antibodies in a recent humanclinical trial (Folegatti et al., 2020).
In preclinical studies, administration of AZD1222 induced a robust immune response resulting in production ofneutralizing antibodies in mice and a reduction in SARS-CoV-2 viral load in the bronchoalveolar lavage fluid of nonhuman primates after viral challenge. Following on to these encouraging results, a Phase 1/2 study in approximately
1000 healthy adults 18-55 years old was initiated (using GMP material generated at Oxford) and has recently
completed enrollment in the UK. A Phase 2/3 study to determine the efficacy, safety and immunogenicity of thevaccine in adults -?- 18 years old was initiated on May 30. A Phase 3 study to determine the efficacy, safety andimmunogenicity in adults 18-55 years of age was initiated in Brazil on June 23 and in the US on September 1, withplans for additional Phase 3 trials in other parts of the world.

B.

Definitions

Agreement Invention: Any invention conceived or first actually reduced to practice in the performance of thePrototype Project under this Agreement.
Agreements Officer or AO: Warranted contracting officer authorized to sign the final OTA for the Government.

W15QKN2191003
Page 40 of 84
Agreement's Officer's Representative or AOR: The individual designated by the Government to monitor alltechnical aspects and assist in agreement administration of the Prototype Project. The AOR shall only assist inagreement administration of the Prototype Project to the extent delegated such administration authority in writing in
the AOR delegation letter by the responsible Agreements Officer.
Background Invention: Background Invention means any Invention, or improvement to any Invention, other than an
Agreement Invention, that was conceived, designed, developed, produced, and/or reduced to practice prior toperformance of this Agreement, or outside the scope of work performed under this Agreement.
Cause: An event or issue that has been discovered that the Government believes may impact successful performanceof the OTA.
Data: Recorded information first created in performance of the Prototype Project, regardless of form or method ofrecording, which includes but is not limited to, technical data and software, but does not include Agreement Inventions,production/manufacturing Know-How, trade secrets, clinical data, or financial, administrative, cost, pricing or
management information.
Date of Completion: The date on which all work is completed or the date on which the period of performance ends.
Definitization: The Agreement on, or determination of, terms, specifications, and price, which converts theundefinitized Agreement to a definitive Agreement.
Deliverable(s): Any documentation (e.g. report, Executive Summary, Letter) given to the Government by
AstraZeneca as described in the second column of Table 1 in Article I, Section C.7 under the heading "Deliverable."
Effective Date: The date of execution of this Agreement by the Parties.
Field: The development of the ChAdOx SARS-CoV-2 prophylactic vaccine for the prevention of SARSCoV-2.
Government: The United States of America, as represented by The Department of Defense and the Department of
Health and Human Services.
Government Purpose Rights: The rights to (i) use, modify, reproduce, release, perform, display, or disclose Datasolely within the Government, (ii) release or disclose Data outside the Government, and (iii) authorize persons towhom release or disclosure has been made to use, modify, reproduce, release, perform, display, or disclose that Data;in each case (i)-(iii) solely as required for Government purposes. Government purposes do not include the rights touse, modify, reproduce, release, perform, display, or disclose Data for commercial or competitive purposes or toauthorize others to do so. Even where disclosure is made for Government purposes, such disclosure will be governedby a contractual terminology or a non-disclosure agreement restricting further dissemination of the information andotherwise ensuring compliance with the government's rights and obligations in the disclosed data.
Invention: Any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of theUnited States Code.
Know-How: Information, practical knowledge, techniques, and skill development by Recipient in the performanceof the Prototype Project and which is necessary for the Practical Application of an Agreement Invention within the
Field.
Limited Rights: The rights to use, modify, reproduce, perform, display, or disclose Data or other information, in
whole or in part, within the Government solely for research purposes for the Field. The Government will ensure that
disclosed information is safeguarded in accordance with the restrictions of this Agreement. The Government may not,without the prior written permission of Recipient, (i) release or disclose Data or other information outside theGovernment, (ii) use Data or other information for competitive procurement or manufacture, (iii) release or disclose

W15QKN2191003
Page 41 of 84
Data or other information for commercial purposes, or (iv) authorize Data or other information to be used by anotherparty.
Party: Each of the Government and AstraZeneca Pharmaceuticals, LP (collectively, "Parties").
Practical Application: With respect to an Agreement Invention, to manufacture, in the case of a composition of
product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in eachcase, under such conditions so as to establish that the Agreement Invention is capable of being utilized.
Program: Prototype efforts being conducted by the Parties pursuant to this Agreement.
Prototype Project: Has the meaning given in Article 1.C.
Project Coordination Team or PCT: Agreements Officer, Agreements Officer's Representative, Subject Matter
Experts and Team Leader(s) acting in support of Operation Warp Speed and responsible for periodic and ad-hoc
reporting to Operation Warp Speed Leadership.
Property: Any tangible personal property other than property actually consumed during the execution of work under
this Agreement.
Recipient: AstraZeneca Pharmaceuticals LP (AstraZeneca or AZ).
Under this Agreement: When used, for example but without limitation, in the definitions of Data, Know-How,
Property, and Agreement Inventions, means activities conducted pursuant to this Agreement that are Government
funded.
C.

Scope of the Agreement
Prototype Project: The scope of this prototype project is the demonstration by AstraZeneca of the rapid,
large scale supply and logistics capability to manufacture and deliver to the Government 100M released andlabeled doses, in finished packaging, of the investigational AZD1222 vaccine (the "Prototype Project"). In
order to achieve regulatory authorization or licensure and ensure an informed decision as to use of the doses
produced under this Prototype Agreement, AstraZeneca will, in parallel, conduct preclinical and clinicalevaluation of the AZD1222 vaccine. Consistent with the Government's objectives under Operation Warp
Speed ("OWS"), AstraZeneca will exercise commercially reasonable efforts to employ its proprietary
manufacturing technology and processes, in a manner compliant with applicable laws and regulations,
including 21 CFR 210 and 211 and the Drug Supply Chain Security Act ("DSCSA") (to the extent required
for COVID-19 medical countermeasures, as defined by relevant U.S. Food and Drug Administration("FDA") guidance), to manufacture and deliver the AZD1222 vaccine. The successful provision of thesedoses shall establish the effectiveness of a technology capable of potentially providing immediate and longterm solutions to COVID-19 infections.
2. This effort further constitutes a prototype project because the project will be used to evaluate the technicalfeasibility during the ongoing COVID-19 pandemic and unprecedented threats to several components of thePrototype Project. In addition, this is a prototype project because AstraZeneca will demonstrate and proveout the at-scale, multi-lot proprietary manufacturing activities in order to assess the feasibility to support thenecessary quantity of safe and effective regimens required for vaccination of the U.S. population. A detailed
description of the specific activities supported by this Prototype Agreement is provided in the Statement ofWork, Appendix C (the "Statement of Work").
3. Associated Production: It is the intention of the Parties to simultaneously enter into a separate, but
associated, sole-source FAR-based contract for the continued production of 200 million doses of AZD1222.
Subject to applicable law and regulation, the Parties shall take all steps necessary to negotiate and enter intosuch a FAR-based contract in good faith with the intent of promptly signing such FAR-based contract assoon as possible after this Agreement.
4. Performance by Affiliates: The Government acknowledges and agrees that Recipient may perform its
obligations under this Agreement through one or more of its affiliates, provided that Recipient will beI.

W15QKN2191003
Page 42 of 84

5.

responsible for the full and timely performance as and when due under, and observance of, all the covenants,
terms, conditions and agreements set forth in this Agreement by its affiliates.
Reporting: The Government will have continuous involvement with AstraZeneca throughout the durationof the Period of Performance. The Government will also obtain access to research results and certain
technical data rights according to the Deliverables Table (Table 1). In addition, reporting from AstraZeneca
to the Government will include the following concerning AZD1222 (required components detailed in Article
17):•
Weekly Teleconferences•
Monthly and Annual Technical and Business Reports•
Draft and Final Technical and Business Reports•
FDA meetings, submissions, correspondence and audits•
Daily check-in, as reasonably requested by the AZD1222 PCT•
Critical programmatic concerns, issues or probable risks that are likely to impact projectschedule/cost/performance•
Technical documents relevant to the performance of activities within scope of this Prototype
Agreement•
Clinical and Operations dashboard•
Supply chain resiliency, including recipient locations•
Weekly Production Updates/Dose Tracker•
Draft and Final Non clinical and Clinical Study Protocols•
Interim and Final Non clinical and Clinical Study Reports•
Recipient audits of sub-agreement holders' facilities

6. Audits: Until such time as all doses have been delivered under this Agreement, and in no event after
expiration of the Period of Performance, audits under this Prototype Agreement may include Government
Quality Assurance audits — periodic, ad hoc or for cause — of AstraZeneca or sub-agreement holders' facilities
included in the AZD1222 su • .1 chain. The Government will provide notification of a periodic or ad hoc
audit at least (b) (4)prior to the intended audit date and both parties will work in goodfaith to accommodate the audit and determine scheduling. Audits performed for cause will not require
notification by the Government. In all audits, the Government will comply with the Person in Plant
requirements set forth in Article 1.C.7.
7. Person in Plant: The Government ma
to have a government representative in place at Recipient's
facility, with no fewer thanadvance notice of the desired date for that person to
be in place. The name, role, scope ane mutually agreed between the Parties in writing in
advance. The Government representative will adhere to the agreed scope and to the Recipient's policies,
procedures and instructions at all times. As determined by federal law, no Government representative shall
publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any
information coming to him in the course of employment or official duties, while stationed in a Recipient
plant.
If considered for cause, the Government may place representatives in place at Recipient's facility, with nofewer than (b) (4)advance notice of the desired date for the person(s) to be in place, subject
to applicable COVID protocols. The names, roles, scope, and duration will be provided to the Recipient inadvance. The Government representative will adhere to the Recipient's policies, procedures and instructions
regarding facility regulations at all times. As determined by federal law, no Government representative shall
publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any
information coming to him in the course of employment or official duties, while stationed in a Recipient
plant.
8. Deliverables: Deliverables under this Agreement are listed in Table 1.
9. Milestones: Payable milestones under this Agreement are listed in Table 2.
10. Delivery Schedule: AstraZeneca will use its best efforts to deliver 100M doses by (b) (4)Theforegoing delivery schedule is AstraZeneca's best projection of its manufacturing capability based on (i) thefacts and circumstances as they are known to AstraZeneca on the Effective Date and (ii) the planningassumptions shared with BARDA, including but not limited to the assumptions listed below:

W15Q1(1•12191003
Page 43 of 84

The Parties acknowledge that the clinical development schedule is subject to certain factors outside
AstraZeneca's control (e.g., actions taken by FDA) and that manufacturing scale-up is being progressed
simultaneously with establishment of the supply chain. AstraZeneca will keep the Government apprised ofclinical development and manufacturing progress as set forth in Article 17 of this Agreement, and to theextent any changes in circumstances necessitate a revision to the delivery schedule, will notify theGovernment as soon as reasonably practicable.
In addition, AstraZeneca shall notify the Government promptly upon manufacture and release of the firstDS batches and shall provide, in writing, AstraZeneca's latest estimate of drug substance and drug
pr ct yield for subsequent doses (the "Manufacturing Report"). Following the Government's receipt of the
Manufacturing Report, the Government and AstraZeneca shall discuss the report in good faith and adjust theforegoing delivery schedule as appropriate.

(b) (4)

W15Q1(N2191003
Page 44 of 84

Table 1: Deliverables#

Deliverable

Due Date(b) (4)

Format01

Provision of PL 115-92 Letter

02(b)
Production Updates /I , • racierTemplate to be provided
by AOR

03

A
Technical andusiness Reports, including Risk
Manes -ment Plan

AstraZeneca-determined
format, consistent with
Article 17

04

Draft and Final Nonchnical andClinical Study Protocols

AstraZeneca-determined
format, consistent with
Article 17

05

Interim and Final Nonclinical andClinical Study Reports

06

Draft and Final Technical Reports

07

EUA Filingas

BLA Filing

09

Manufacturing Development
Plan2

10

Quality Management Plan3

•

11
12
13
14
15
16
17
18

Shipping Specifications andDetails4
Delivery of 100M doses
AZD1222
Release documentation for doses
to be delivered
Security Plan
Supply Chain Resiliency Plan
Manufacturing Data
Requirements
Product Development Source
Material and Manufacturing
Reports
Reci 'lent Locations

nfa

Data Rights
1(b) (4)AstraZeneca-determined
format, consistent with
Article 17
AstraZeneca-determined
format, consistent with
Article 17
AstraZeneca-determined
formatAstraZeneca-determined
formatAstraZeneca-determined
formatAstraZeneca-determined
formatAstraZeneca-determined
formatn/AstraZeneca-determined
formatAstraZeneca-determined
format, consistent withOperation Warp Speed
OPSEC Requirements(Appendix B)'PL 115-92 Authorization Letter. All information provided under the authorization letter related to Public Law 11592 shall be delivered with the data rights listed in this Deliverable Table.
2 Manufacturing Development Plan. AstraZeneca will, in the level of detail and format that AstraZeneca solely elects(provided such format provides a reasonable and industry-standard level of detail), describe the manufacturing process forthe vaccine product to ensure conformity with §501(a)(2)(B) of the Food. Drug. and Cosmetics Act (FD&C Act. Title 21
United States Code ("U.S.C.") §351 (a)(2)(B)), regarding GMP. This lan shall describe as such information becomes
available to AstraZeneca, but is not limited to. (b) (4)W15Q1(/•12191003
Page 45 of 84
Quality Management Plan. AstraZeneca will, in the level of detail and format that AstraZeneca solely elects ()rovided
such format provides a reasonable and industry-standard level of detail rovide a e tall mana ement 'lan for clinicaland manufacturin efforts which ma include, but is not limited to. (b) (4)Shipping Specifications and Details. In coordination with the Government. Recipient will conduct a single
demonstration of the vaccine shipping process prior to the first delivery of doses at a time and in a manner mutually agreed
by the Parties. As set forth in the Deliverables Table above. Recipient agrees to share specifications and details associatedwith the shipping process and containers to enable the Govenunent to adequately plan and prepare for potential distributionof the vaccine. For clarity, this shipping demonstration will not include the shipping of actual released vaccine product.
4

W15QKN2191003
Page 46 of 84
Table 2: Payable Milestones
Milestone
NumberMilestone

1

Contract signature2

DS (b) (4)Estimated
Completion( )(DP (b) (4)4(b) (4)of commercial scale DS (GMP or
non-GMP)-

1151RM Prelim DART study report(b) (4)b) (4)

8b) (4)

9(b) (4)10(b) (4)of conunercial scale DS (GMP or
non-GMP)11

DP Validation Report

12

DS Validation Report13(b) (4)14(b) (4)of commercial scale DS (GMP or

15

Deliver (b) (4)Doses FP toll'

16

Deliver (b) (4)Doses FP to

17a

Delive (b) (4)Doses FP to (b) (4)(b) (4)17b

Pharmacovigilance18a(b) (4)See Article 1.C.10

18bPhannacovigilance

19
20
21

Pediatric Phase 3 Study (ROM)BLA Submission
Phase 3 LSLV

Concurrent withMilestone 18a( b) (4)22

Ph3 Final CSR

/3
24

)(

See Article 1.C.10
See Article 1.C.10
See Article 1.C.10
Concurrent withMilestone 17a

Doses FP to (b) (4)( (4 ) enrollment o (b)(b4 patient increment(b4 (4 ) enrollment o (b)(b, patient increment)(DOD Approval of(DOD Approval ofn/aBatch Record or
Certificate of Analysis
Certificate of Analysis
Batch Records (nonGMP) or Certificatesof Analysis (GMP)
Draft Report
Enrollment Tracker
Enrollment Tracker
Enrollment Tracker
Enrollment Tracker
Batch Records (nonGMP) or Certificatesof Analysis (GMP)
Validation Report

non-GMP)

Deliver

Determinant of
Successful
Completion

Validation ReportAO Approval per theterms of the SOW,
Section 1.8.4• hannacovi ilance
Batch Records (nonGMP) or Certificatesof Analysis (GMP)
AO Acceptance per
Arricle 16
AO Acceptance per
Article 16
AO Acceptance per
Article 16
AO Acceptance ofMilestone 17a
AO Acceptance per
Article 16
AO Acceptance ofMilestone 18a
TBD
BLA Filing
Enrollment Tracker
Final CSR (includes
safe follow-us
AO Approval
AO Approval

Budget(b) (4)••••

W15QKN2191003
Page 47 of 84(b) (4) enrollment o (b)(b) patient increment)(b) ' enrollment o (b)(b) patient increment)(b) 4 enrollment o (b)(b) patient increment)(b) (4 enrollment o (b)(b) patient increment)(b) (4 enrollment o (b(b) patient increment)(b) (4) enrollment o (b)(b) patient increment)(b) ( 4 ) enrollment o (b)(b) patient increment)(b) ( 4 ) enrollment o (b)(b) patient increment(b) (4) enrollment o (b)(b) patient increment)(b) (4) enrollment of (b)(b) patient increment)(b) (4) enrollment o (b)(b) patient increment)(b) (4 enrollment of (b)(b) patient increment)(b) (4 enrollment o (b)(b) patient increment)(b) ( 4 ) enrollment of (b)(b) patient increment)(b) ( 4 ) enrollment of (b)(b) patient increment)(b) ( 4 enrollment of (b)(b) patient increment)(b) ( 4 enrollment of (b)(b) patient increment)(b) ( 4 enrollment of (b)(b) patient increment
End of Contract

25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43

(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of(DOD Approval of

Total

AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approval
AO Approvalnla

n/a$1,208,933,813.79

ARTICLE 2: TERM AND TERMINATIONA.

Term of this Agreement

The period of performance for this Prototype Agreement is from the date of award through December 31, 2023 (the"Period of Performance").
Rights of TerminationB.
1. The Government will have unilateral right to terminate this agreement upon any one or more of the following
events:a.

W15Q1(N2191003
Page 48 of 84b.

The Recipient's Phase 3 clinical trial is terminated prior to completion for safety or efficacy reasons by
the Food and Drug Administration:c.

d.

AZ discontinues development due to emerging safety or efficacy data: or

2.

c. ( b I (4)With the exception o item 'e" a iove,
e Government exercises its n_ it to terminate iase• on an of these
events, the termination will be effective immediatel
on notification to the Reci • ient. (b) (4)5.

For in s ses of a termination wider item"e- above, (b) ( 4 )Milestone
NumberMilestone

1

Contract signature-,-

Budget(b) (4)DS (b) (4)(b) (4)DP (b) (4)(b) (4)510of conunercial scale DS (GMP or non-GMP)
1151RM Prelim DART study report(b) (4)of commercial scale DS (GMP or non-GMP

11

DP Validation Report

12
Total

DS Validation Report

6.

Recipient shall not be required to comply with the cost accounting standards or contract cost principles for thispurpose. The terms of Article 2 do not give the Government any right to audit the Recipient's records.

7.

From and after the effective date of any such termination. Recipient shall have no further obligation to deliver
any vaccine doses, and the Government shall have no further obligation to accept any such doses for delivery.

8.

The Government and the Recipient will negotiate in good faith a reasonable and timely adjustment of all
outstanding issues between the Parties as a result of termination. including disposition of animals and materials

W15QKN2191003
Page 49 of 84
acquired for research use. Failure of the Parties to agree to a reasonable adjustment will be resolved pursuant to
Article 7, Disputes. In the event of termination, the Parties shall negotiate in good faith a reasonable wind-downplan and neither Party shall have any continuing obligations to perform under the Program except as otherwise
specified herein. For clarity, the Recipient may choose to continue clinical trials following termination, in
accordance with patient safety, other ethical considerations and Applicable Law, which trials would be continued
at Recipient's cost and expense. To the extent the Recipient chooses not to continue any such trials, Recipient
will wind-down the trials to the extent permissible in accordance with patient safety, other ethical considerations,and Applicable Law, which trials would be wound-down at the Government's cost and expense.

C.

Stop Work Orders.

Except as required by applicable law or regulation, or judicial or administrative order, the Government shall not havethe authority to issue a stop work order to halt the work contemplated under this Statement of Work.
D.
Extension of Term
The Parties may extend by mutual written agreement the Period of Performance if funding availability and researchand development opportunities reasonably warrant.
ARTICLE 3: PROJECT MANAGEMENT AND MODIFICATIONSTechnical and project management of the manufacture and delivery of up to 100 million doses of AZD1222("Prototype") and associated scope within the Statement of Work shall be managed as detailed in this Article.
A.

Project Governance. AstraZeneca is responsible for the overall management of the Prototype Project andrelated decisions. The Government and AstraZeneca are bound to each other by a duty of good faith inachieving the Prototype Project as defined in Article 1. As such, the Government will have continuous
involvement with AstraZeneca. AstraZeneca shall provide project results in accordance with the
Deliverables schedule identified in Table 1.

B.

Project Management. AstraZeneca and the Government will each designate an individual responsible forfacilitating the communications, reporting, and meetings between the Parties. For AstraZeneca the individual
will serve as PM, and for the Government the individual will be the AOR.

C.

Project Reviews. AstraZeneca and the Government will hold periodic project review meetings asdetermined by the AstraZeneca Pro'ect Mana er and AOR, however, these meetings shall not occur more
frequently than every (b) (4)D.

Reviews Resulting in Modifications. During the performance of this Prototype Agreement, as describedabove, it may be necessary to modify the scope of the Prototype Project or delivery timeframes. No
communications, whether oral or in writing, that purport to change this Agreement are valid unless and untila modification is issued by the AO. The Parties hereby agree that any mutually agreed upon written request
for modification shall be executed in an expedited timeframe.

E.

Bilateral Modifications. AstraZeneca or the Government may propose modifications to this Agreement. A
modification that materially changes the obligations of either the Government or AstraZeneca must be inwriting and signed by the AO and AstraZeneca's authorized official. AstraZeneca's requests formodifications shall detail the technical, chronological and financial impact of the proposed change on theStatement of Work or delivery timeframes.

F.

Unilateral Modifications. The AO may ONLY issue minor or administrative modifications, which do notchange the obligations of AstraZeneca in any adverse manner, such as changes to the paying office orappropriations data, incremental funding or changes to Government personnel identified in the Agreement.
Unilateral modifications will only be signed by the AO.

WI5QKN2191003
Page 50 of 84
G.

Agreement Administration
Government Points of Contact:
AO
NAME: (b) (6)Phi s Road. Picatinny Arsenal. NJ. 07806
MAILING ADDRESS:EMAIL: (b) (6)
PHONE: (b) (6)
AGENCY N
ION/SECTION: CCNJ-IC
NAME: (b) (6)
MAILING ADDRESS: Bid 10, Phipps Road, Picatinny Arsenal, NJ, 07806
EMAIL (b) (6)
PHONE: (b) (6)
AGENCY NAME/ION/SECTION: CCNJ-IC
AOR
NAME: b) {6)
MAILING ADDRESS: 200 C St SW, Washington DC 20024
EMAIL (b) (6)
PHONE: (b) ( 6)AGENCY N • I I IVISION/SECTION: HHS/ASPR/BARDA
AstraZeneca Points of Contact:
CLM
NAME:
MAILING ADDRESS:EMAIL:
PHONE
PM
NAME
MAILING ADDRESS:EMAIL:
PHONE

ARTICLE 4: MANAGEMENT OF THE PROJECTA.

Document Review

The Recipient shall provide the PCT sufficient opportunity to review study protocols, reports, daily enrollment anddemographic clinical data, and regulatory correspondence. PCT's comments on these documents will be viewed asadvisory in nature.
B.

Sub-agreement Holders

W15Q1(N2191003
Page 51 of 84(b) (4)2.
For clarity, as detailed within the Articles themselves, the following Articles require flow-down to subagreements/contracts ( b )(b) (4)ARTICLE 5: "PREP ACT" COVERAGE
In accordance with the Public Readiness and Emergency Preparedness Act ("PREP Act"), Pub. L. No. 109-148,
Division C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e), as well as the Secretaryof Health and Human Service's ("HHS") Declaration Under the Public Readiness and Emergency Preparedness Act
for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020, effective Feb. 4, 2020), andamended on April 15, 2020, 85 Fed. Reg. 21012, and on June 8, 2020, 85 Fed. Reg. 34740 (together, the "Prep Act
Declaration"):(i)This Agreement is being entered into for purposes of facilitating the manufacture, testing,development, distribution, administration, and use of "Covered Countermeasures" for responding to the COVID-19
public health emergency, in accordance with Section VI of the PREP Act Declaration;(ii)
AstraZeneca's performance of this Agreement falls within the scope of the "Recommended
Activities" for responding to the COVID-19 public health emergency in accordance with Section III of the PREP Act
Declaration; andAstraZeneca is a "Covered Person" per Section V of the PREP Act Declaration.
Therefore, in accordance with Sections IV and VII of the PREP Act Declaration, as well as the PREP Act (42 U.S.C.
§ 247d-6d), the Department of Defense contracting via assisted acquisition on behalf of the HHS, expressly
acknowledges and agrees that the HHS Declaration cited above, specifically its language providing immunity fromsuit and liability is applicable to this Agreement, as long as AstraZeneca's activities fall within the terms andconditions of the PREP Act and the PREP Act Declaration.
The Government may not use, or authorize the use of, any products or materials provided under this Agreement, unlesssuch use occurs in the United States (or a U.S. territory where U.S. law applies including, but not limited to, embassies,
military installations and NATO installations) and is protected from liability under a declaration issued under the
PREP Act, or a successor COVID-19 PREP Act Declaration of equal or greater scope. Any use where the applicationof the PREP Act is in question will be discussed with AstraZeneca prior to use and, if the Parties disagree on suchuse, the dispute will be resolved according to Article 7, "Disputes."

W15Q1{N2191003
Page 52 of 84

ARTICLE 6: OBLIGATION AND PAYMENT
A.

Obligation

1. Except as specified in Article V: Disputes, the Government's liability to make payments to the Recipient is limited
only to those funds obligated under this Agreement or by modification to the Agreement. The ACC-NJ Contracting
Activity may incrementally fund this Agreement. If modification becomes necessary in performance of thisAgreement, pursuant to Article 3 of this Agreement, the AO and the Recipient shall establish and execute a mutuallyagreed upon revised Schedule of Payable Milestones consistent with the current SOW.
B.

Payments(b) (4)

2. After accomplishment of each milestone, the Recipient will submit the corresponding invoice through aGovernment provided invoicing and payment system, as detailed in Article 18.

4. Payments will be made by the cognizant Defense Finance and Accounting Services office, as indicated below,
in accordance with the Prompt Payment Act. Article 18 details how to submit and process invoices.
5. Payments shall be made in the amounts set forth in the SOW, provided the AOR has verified the completionof the applicable milestones. The Government will pay AstraZeneca in US dollars.
6. (b) (4)W15QKN2191003
Page 53 of 84(b) (4)7. (b) (4)Comptroller Access Financial Records and Reports:C.

AstraZeneca shall maintain adequate records to account for Federal funds received under this Agreement and shallmaintain adequate records to account for funding provided under this Agreement. AstraZeneca relevant financial
records are subject to examination or audit by or on behalf of the Comptroller General, Contracting Activity AO, orother Govenunent Official for a period not to exceed three (3) years after expiration of the term of the Agreement.
The Comptroller General. AO or designee shall have direct access to sufficient records and information of any party
to this agreement or any entity that participates in the performance of this agreement to ensure full accountability for
all fimding under this Agreement. Such audit. examination or access shall be performed during business hours on
business days upon prior written notice and shall be subject to the security requirements of the audited party. Any
audit required during the course of the program may be conducted by the Comptroller General or other Govenunent
Official using Government auditors or. at the request of Recipient's external CPA accounting firm at the expense of
the Recipient.
1.

Lower Tier Agreements

The Perfornier shall include this Article, suitably modified to identify the Parties, in all subcontracts or lower tieragreements entered into solely in connection with this Agreement.

ARTICLE 7: DISPUTESA.

GeneralThe Parties shall conummicate with one another in good faith and in a timely, responsive, and cooperative manner
when raising issues under this Article.
B.

Dispute Resolution Procedures
1.

Any claim or dispute between the Government and AstraZeneca concerning questions of fact or law

arising from or in connection with this Agreement, and, whether or not involving an alleged breachof this Agreement, shall be raised and resolved under this Article.
2.

Whenever legal disputes or claims arise, the Parties shall attempt to resolve the issue(s) bydiscussion and come to mutual agreement on a resolution as soon as practicable. In no event shalla dispute. disagreement or misunderstanding that arose more than six (6) months prior to theW15QKN2191003
Page 54 of 84
notification made under sub-section B.3 of this Article constitute the basis for relief under this
Article unless one level above the AO, in the interests of justice, waives this requirement.

C.

3.

Failing resolution by mutual agreement, the aggrieved Party shall document the dispute,disagreement, or misunderstanding by notifying the other Party (through the AO or AstraZeneca's
POC, as the case may be) in writing of the relevant facts, identifying unresolved issues, andspecifying the clarification or remedy sought. Within five (5) working days after providing noticeto the other Party, the aggrieved Party may, in writing, request a joint decision by the ACC-NJ
Division Chief for Innovative Concepts and senior executive appointed by AstraZeneca. The otherParty shall submit a written response on the matter(s) in dispute within thirty (30) calendar days
after being notified that a decision has been requested. The Division Chief and the Recipient senior
executive shall conduct a review of the matter(s) in dispute and attempt to render a mutuallyagreeable decision in writing within thirty (30) calendar days of receipt of such written position.
Any such joint decision is final and binding.

4.

In the absence of a joint decision, upon written request to the ACC-NJ Associate Director madewithin thirty (30) calendar days of the expiration of the time for a decision under sub-section B.3
above, the dispute shall be further reviewed. The Associate Director may elect to conduct thisreview personally or through a designee or jointly with a senior executive appointed by AstraZeneca.
Following the review, the Associate Director or designee will resolve the issue(s) and notify theParties in writing. This decision may be appealed to any federal court of competent jurisdiction.

5.

Notwithstanding any other provisions of this Article, the Parties agree that AstraZeneca shall havethe right to pursue any contract dispute arising under this Agreement in any federal court ofcompetent jurisdiction, including the appropriate Court of Appeals, or the Supreme Court, at any
time without any administrative exhaustion requirements, and the timing requirements describedabove will not limit any claim in such tribunals.

Limitation of Damages

Claims for damages of any nature whatsoever pursued under this Agreement shall be limited to direct damages only
up to the aggregate amount of Government funding obligated as of the time the dispute arises, except with respect toviolations of Articles 5, 8, 9, or 10 of this Agreement.
ARTICLE 8: CONFIDENTIAL INFORMATION
A.
B.

C.

D.

"Confidential Information," as used in this Article, means information or data of a personal nature about
an individual, or proprietary information or data submitted by or pertaining to an institution or organization.
The Agreements Officer and the Recipient may, by mutual consent, identify elsewhere in this Agreement
specific information and/or categories of information which the Government will furnish to the Recipient orthat the Recipient is expected to generate which is confidential. Similarly, the Agreements Officer and theRecipient may, by mutual consent, identify such Confidential Information from time to time during the Periodof Performance. Failure to agree will be settled pursuant to the "Disputes" clause.
If it is established elsewhere in this Agreement that information to be utilized under this Agreement, or a
portion thereof, is subject to the Privacy Act, the Recipient 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.
The Receiving Party shall not directly or indirectly, divulge or reveal to any person or entity any Confidential
Information of another Party without the Disclosing Party's prior written consent, or use such Confidential
Information except as permitted under this Agreement. Confidential Information shall be subject to the sameprohibitions on disclosure as provided for under FAR Part 24.202. Further, any reproduction of Confidential
Information or portions thereof that is disseminated within the Government or AstraZeneca, shall be sharedstrictly on a need to know basis for the purposes of this Agreement and is subject to the restrictions of thisprovision. In addition to the above, Confidential Information is subject to the protections of the Trade Secrets
Act as well as any other remedies available under this Agreement or the law.

W15QICN2191003
Page 55 of 84
E.

Such obligation of confidentiality shall not apply to information which the Receiving Party can demonstrate
through competent evidence: (i) was at the time of disclosure in the public domain; (ii) has come into the
public domain after disclosure through no breach of this contract; (iii) was known to the Receiving Partyprior to disclosure thereof by the Disclosing Party; (iv) was lawfully disclosed to the Receiving Party by aThird Party which was not under an obligation of confidence to the Disclosing Party with respect thereto; or(v) was approved for public release by prior written permission of the Disclosing Party.
F.
Whenever the Recipient is uncertain with regard to the proper handling of material under the Agreement, or
if the material in question is subject to the Privacy Act or is Confidential Information subject to the provisionsof this Article, the Recipient shall obtain a written determination from the Agreements Officer prior to any
release, disclosure, dissemination, or publication.
G.
Agreements Officer Determinations will reflect the result of internal coordination with appropriate program
and legal officials.
H.
The provisions of paragraph (D) of this Article shall not apply to conflicting or overlapping provisions inother Federal, State or local laws.
The obligations of the Receiving Party under this Article shall continue for a period of seven (7) years fromconveyance of the Confidential Information
Subject to Article 4.B, all above requirements MUST be passed to all Sub-awards.

ARTICLE 9: INTELLECTUAL PROPERTY RIGHTSA.

(b) (4)B.

Background IF and Materials. Recipient and the Government each retain any intellectual property (IF)rights to their own materials, technical data (as defined in 22 C.F.R. § 120.10), technology, information,
documents, or Know-How—or potential rights, such as issued patents, patent applications, invention
disclosures, copyrighted works, or other written documentation—that exist prior to execution of thisAgreement or are developed outside the scope of this Agreement ("Background IF").

C.

(b) (4)D.

Government's Background IP. The Govenunent warrants that it has no Background IF and therefore lists"None" in Appendix A.

E.

Agreement Inventions. In the unlikely event that an invention is conceived or first actually reduced topractice in the performance of this Agreement ("Agreement Invention"), ownership of any Agreement
Invention, regardless of whether it is not patentable, or is patentable under U.S. patent law that is conceived
or first reduced to practice under this Agreement will follow inventorship in accordance with U.S. patent law.
Neither the Government nor Recipient anticipate the conception or reduction to practice of any Agreement
Invention. The Govenunent acknowledges that in the absence of any Agreement Invention, the Bayh-Dole
Act (35 U.S.C. §§ 200-212) does not apply to, nor govern, this Agreement. Since, in the absence of any
Agreement Invention, the Bayh-Dole Act, does not apply to this Agreement, as such, title to Agreement
Invention will accrue to the inventor or inventor-organintion. In the absence of any Agreement Invention,
the Government shall not have any rights to "march-in," as that term is defined in 35 U.S.C. § 203, andRecipient is not subject to the manufacturing requirements of 35 U.S.C. § 204.

W15QICN2191003
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In the event an Agreement Invention exists, the Parties represent and warrant that each inventor will assign
his or her rights in any such Agreement Inventions to his or her employing organization. If an Agreement
Invention is made either by a Recipient employee ("Sole Recipient Agreement Invention") or made by aGovernment employee ("Sole Government Agreement Invention") the entire rights to that sole Recipient
Agreement Invention or Sole Government Agreement Invention will be respectively assigned to the
Recipient or to the Government. If a Recipient employee and a Government employee jointly make an
Agreement invention ("Joint Agreement Invention"), it will be owned jointly by the Recipient and theGovernment. Ownership of inventions made in whole or in part with sub-Recipient or collaborator
employees, including employees of other components of the Government, will be determined solely pursuant
to an agreement between the Recipient and the applicable sub-Recipient or collaborator. Notwithstanding theforegoing, neither the Government nor Recipient anticipate the Government making a Sole Government
Agreement Invention, nor the Parties jointly making a Joint Agreement Invention, as Recipient employees
are solely responsible, as between the Parties, for performing the Prototype Project under this Agreement.
F.

Patent Applications. Each Party shall report any Agreement Inventions to the other Party within 60 days ofthe time the inventor discloses it in writing to its personnel responsible for patent matters. The Parties will
respectively have the option, in their discretion, to file a patent application claiming any Agreement Invention
made solely by their respective employees (but, for clarity, are not obligated to file patent applications
claiming any Agreement Invention, and will not forfeit title by electing to hold an Agreement Invention as atrade secret). The Parties will consult with each other regarding the options for filing a patent application
claiming a joint Agreement Invention. Within one (1) year of being notified of the discovery of an Agreement
Invention, each Party will provide notice of any filing of a patent application to the other Party. The Parties
will reasonably cooperate with each other in the preparation, filing, and prosecution of any patent application
claiming a Joint Agreement Invention. Any Party filing a patent application will bear expenses associatedwith filing and prosecuting the application, as well as maintaining any patents that issue from the application,
unless otherwise agreed by the Parties. Executive Order No. 9424 of 18 February 1944 requires all executive
Departments and agencies of the Government to forward through appropriate channels to the Commissioner
of Patents and Trademarks, for recording, all Government interests in patents or applications for patents.

G.

Patent Prosecution. Recipient agrees to take responsibility for the preparation, filing, prosecution, andmaintenance of any and all patents and patent applications listed as Recipient Background IP that are relevantto the work performed under this Agreement. Recipient shall keep the Government reasonably advised on
the status of Recipient Background IP by providing an annual report on the status of Recipient Background
IP. With respect to a Sole Recipient Agreement Invention or a Joint Agreement Invention, prior to acting on
a decision by Recipient to abandon or not file in any country a patent or patent application covering a Sole
Recipient Agreement Invention or a Joint Agreement Invention, Recipient shall so inform the Government
in a timely manner to allow Recipient to thoughtfully consider the Government's comments regarding sucha proposed decision.
(b) (4)(b) (4)

H.

Patent Enforcement. Recipient will have the first option to enforce any patent rights covering a Joint
Agreement Invention at Recipient's expense. If Recipient chooses not to exercise this option, the Government
may enforce patent rights covering a Joint Agreement Invention.

W15Q1(N2191003
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I.

Licenses.
Background IF. No Government funding was used to finance the Background 1P identified in Appendix A.
Therefore, Recipient does not grant to the Government any license to the Background IP identified inAppendix A.
Agreement Inventions. Any Sole Recipient Agreement Invention is subject to a nonexclusive,
nontransferable, irrevocable, paid-up license for the Government, to practice and have practiced theAgreement Invention on behalf of the Government. For any Sole Government Agreement Invention, upon
the Recipient's request, the Government agrees to enter into good faith negotiations with the Recipient
regarding the Recipient's receipt of a nonexclusive commercialization license covering the Government's
interest in any Sole Government Agreement Invention.

ARTICLE 10: DATA RIGHTS
A.

Background Data. "Background Data" shall mean all technical data, as defined in 22 C.F.R. § 120.10, thatexists prior to execution of this Agreement, or are developed outside the scope of this Agreement. Recipient's
Background Data includes, but is not limited to, the following technical data, to the extent such data exists
prior to execution of this Agreement or is developed outside the scope of this Agreement:

B.

Subject Data. All Data generated in connection with the performance of this Agreement, or that arises outof the use of any materials or enabling technology provided or used by the Recipient in the performance of
this Agreement, other Recipient materials or Recipient confidential information, whether conducted by theGovernment or the Recipient (collectively, the "Subject Data"), shall be owned by the Recipient. The Parties
anticipate that all Subject Data will fall within the deliverables set forth in the Deliverables Table. In theunlikely event that Subject Data is generated that would not be considered a deliverable as provided in the
Deliverables Table, all such Subject Data shall be subject to (b) (4)except as otherwise mutuallyagreed by the Parties. The Recipient agrees to retain and maintain in a c ear and readable manner, until seven(7) years after completion or termination of this Agreement, all Subject Data.

C.

Marking of Data. The Recipient will mark any Data delivered under this Agreement with the following
legend:"Use, duplication, or disclosure is subject to the restrictions as stated in Agreement No. W15QKN-20-9-1003
between the Government and the Recipient."
Any rights that the Recipient or the Government may have in Data delivered under this Agreement, whether
arising under this Agreement or otherwise, will not be affected by Recipient's failure to mark Data pursuant
to this Article.

W15Q1(1•12191003
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ARTICLE 11: REGULATORY RIGHTSThis Agreement involves research with an investigational biologic that is regulated by the U.S. Food and Drug
Administration (FDA) and requires FDA licensure before commercial authorization. It is expected that this contract
will result in the FDA authorization, licensure, and commercialization of the AZD1222. The Recipient is the Sponsorof the Regulatory Application (an investigational new drug application (IND), emergency use authorization (EUA),
biologics license application (BLA), or another regulatory filing submitted to FDA) that controls research under thiscontract. As the Sponsor of the Regulatory Application to FDA (as the terms "sponsor" and "applicant" are definedor used in at 21 CFR §§312.50, 600.3(0, the Recipient has certain standing before the FDA that entitles it to exclusive
communications related to the Regulatory Application.
The Parties agree that Recipient has invested significant time and resources in its platform and IP and is the bestcompany situated to manage production of AZD1222. At the same time, the Parties acknowledge that the Government
has made significant investments in the prototype project. Accordingly, the Recipient and the Government agree tothe following:
FDA Communications and Engagement. The Recipient will provide to the Government top-line
summaries and key conclusions from all studies supporting the FDA regulatory filing and commercial
approval to the extent that such data, summaries, and conclusions are funded by this Agreement. In addition,
the Recipient will offer the Government the opportunity to review and provide comments on a final draft ofregulatory submissions which include data funded by this Agreement. The Government will review any such
submissions promptly upon receipt. The Recipient will reasonably consider any comments provided by theGovernment, and prior to submission will provide notification to the Government of any additional edits orrevisions. The Recipient will keep the Government apprised of planned FDA meetings and post-meetingoutcomes relating to activities funded by this Agreement.

The Recipient shall provide the Government with all material communications and summaries thereof, bothformal and informal, to or from FDA, regarding AZD1222 within 48 hours, and make best efforts to ensurethat the Government representatives are invited to participate in any formal or informal Sponsor meetings
with FDA. Recipient shall (1) ensure that the Government representatives are consulted and are invited toparticipate in any formal or informal Sponsor meetings with FDA related to AZD1222:, and (2) notify the
FDA that the Government has the right to discuss with FDA any development efforts regarding AZD1222.
MCM-Related Counterterrorism Legislation. Public Law 115-92 allows the DoD to request, and FDA toprovide, assistance to expedite development of products to diagnose, treat, or prevent serious or lifethreatening diseases or conditions facing American military personnel. The Recipient recognizes that only
the DoD can utilize PL 115-92. As such, the Recipient will work proactively with the Government to leverage
this law to its maximum potential under this Agreement. The Recipient shall submit Public Law 115-92
Sponsor Authorization Letter that will be delivered to the designated OWS POC(s) within 30 days of award.
( b ) ( 4)ARTICLE 12: REGULATORY COMPLIANCE

W15QKN2191003
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A.

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 andfinished drug product, with a ramp-up capacity that provides doses sufficient for the government to treat the
US population.

B.

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.

C.

The clinical trial described in the Statement of Work will comply with ICH and FDA Good Clinical Practices(GCP) regulations at 21 CFR Part 11, 50, 54 and 56.

D.

All clinical sites and IRBs utilized in the clinical trial described in the Statement of Work are required toregister with the Office for Human Research Protections (OHRP) and receive Federal Wide Assurance(FWA) numbers in accordance with human subject protections regulations 45 C.F.R 46.103.

ARTICLE 13: FOREIGN ACCESS TO DATAA.

The Parties will comply with any applicable U.S. export control statutes or regulations in performing thisAgreement.

ARTICLE 14: SCIENTIFIC PUBLICATIONS AND PRESS RELEASESA.

Neither Recipient nor the Government shall make, or permit any person to make, any public announcement
concerning the existence, subject matter or terms of this Agreement, the transactions contemplated by it, or
the relationship between the Recipient and the Government hereunder, without the prior written consent of
the other, such consent not to be unreasonably withheld or delayed, except as required by law, any
governmental or regulatory authority (including, without limitation, any relevant securities exchange), any
court or other authority of competent jurisdiction.

B.

Notwithstanding the foregoing, Recipient and (its upstream licensor) retains the right, but not the obligation,
to prepare and submit scientific publications and release information to the public about its COVID-19
development program, without the Government's consent or involvement. The Recipient shall inform the
AOR when any abstract article or other publication is published, and furnish a copy of it as finally published.

C.

Unless authorized in writing by the AO, the Recipient shall not display Government logos including
Operating Division or Staff Division logos on any publications.

D.

The Recipient 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 orendorsement of the product(s) or service(s) provided.

E.

Subject to Article 4.B, the Recipient shall include this clause, including this section (d) in all subawards
where the sub-agreement holder may propose publishing the results of its work under the subaward. The
Recipient shall acknowledge the support of the Government whenever publicizing the work under thisAgreement in any written media by including an acknowledgement substantially as follows:"This project has been funded in whole or in part by the U.S. Government under Agreement No. W15QKN20-9-1003. The US Government is authorized to reproduce and distribute reprints for Governmental purposes
notwithstanding any copyright notation thereon."

ARTICLE 15: ENSURING SUFFICIENT SUPPLY OF THE PRODUCTW15Q1(1•12191003
Page 60 of 84
A.

In recognition of the Government's significant funding for the development and manufacturing of AZD1222
and the Government's need to provide sufficient quantities of a COVID-19 treatment to protect the UnitedStates population, the Government shall have the remedy described in this section to ensure sufficient supply
of AZD1222 to meet the needs of the public health or national security. This remedy is not available to theGovernment unless and until any of the following conditions is met, and is not available as a result of atermination under Article 2(B) of this Agreement:
i.

iv.

B.

Recipient gives notice, required to be submitted to the Government no later than 30 business days,
following any formal management decision to terminate the product development effort;
Within twenty-four (24) months after the effective date of this Agreement, Recipient, or another entity
acting on Recipient's behalf, fails to obtain either an Emergency Use Authorization under §564 of the
FD&C Act or a biologics license application under the provisions of §351(a) of the Public HealthService Act (PHSA) to permit use and marketing of AZD1222;
Recipient fails to commercially market AZD1222 within one (1) year after FDA approval, licensure
or clearance; orAstraZeneca gives written notice, required to be submitted to the Government no later than 15
business days, of any filing that anticipates Federal bankruptcy protection.

If one or more of the conditions listed in Section 15.A occur, AstraZeneca, upon the request of theGovernment, subject to the terms of the pre-existing agreement with Licensor, shall provide the following
items necessary for the Government to pursue FDA licensure/authorization and manufacturing of theTechnology with a third party for exclusive sale to the U.S. Govenunent:i.

a writing evidencing a non-exclusive, nontransferable, irrevocable (except for cause), royaltyfree paid-up license to practice or have practiced for or on behalf of the U.S. Government any
AstraZeneca Background lP and Background Data, as those terms are defined in Articles 9 and
10 of this Agreement, necessary to manufacture or have manufactured the Technology;
necessary FDA regulatory filings or authorizations owned or controlled by AstraZeneca related
to the Technology and any confirmatory instrument pertaining thereto; andany outstanding Deliverables contemplated or materials purchased under this Agreement.

C.

(b) (4)

D.

This Article will survive the acquisition or merger of the Recipient by or with a third party. This Article willsurvive the expiration of this agreement.

ARTICLE 16: INSPECTION AND ACCEPTANCE
A.

Delivery and Acceptance. Recipient shall notify the AO and AOR at least (b) (4)prior to initialdelivery of AZD1222. Exc tions are rmitted if a roved b the AO. U on not cation the AOR will
instruct the Reci ient (b) (4)W15QKN2191003
Page 61 of 84(b) (4)

Upon receipt of the rovided certificates and antimely requested
or re'ection. The Government

ection of product at the destination site(s) that was
the AOR will review and recommend acce tancee AO wi correspon mg y noti Recipient o acceptance or rejection.
However, e Government's acceptance of product will be deemed to have occurred if the Government does
not provide written notice of acceptance or rejection within (b) (4)of Recipient's
provision of all applicable certificates.
B.

Vendor-mana ed Invento . Product to be stored as VMI (b) (4)and ma be stored or a erio not on • er t Ian (b) (4)(b) (4)(b) (4)

Pro • uct ie

in VMI is su 1 ect to to owing requirements:b) (4)

Any deviations, out of specification ("00S") results, or other product issues, shall be reported to the USG
within (b) (4)of Recipient identification.
C.

(b) (4)

wi Inc u e

Product to be shipped to (b) (4)shall be shi 1 ed trackable b GPS. Reci lente o owing information on the pac mg ists provided with (10 ) (4)W15Q1{N2191003
Page 62 of 84i.

iv.

Transaction Information (Ti)Transaction History (TH)Transaction Statement (TS)Centers for Disease Control (CDC) Purchase Order (PO) Number

The Recipient will also transmit bulk shipment Advance Shipment Notices (ASNs) to CDC via Electronic
Data Interchange (EDI).
D.

Title and Ph sical Risk of Loss. ( b) ( 4)E.

Risk of Loss Due to Ex •(b) (4)ARTICLE 17: REPORTING REQUIREMENTS
During the period of performance, the Recipient will be responsible for periodic reporting as summarized in Article
1.C.5 "Reporting" and the Deliverables Table (Table 1). Required components and frequency of such reporting is asfollows:
A.

Weekly Teleconferences: The Recipient and the AZD1222 Project Coordination Team will participate in
teleconferences every week or at the request of the AOR to discuss the performance of the Agreement. The
Recipient will provide a proposed agenda by end of day prior to the meeting and will record, maintain andprovide draft-meeting minutes to the AOR for review and concurrence within two (2) business days of theteleconference. The AOR will provide feedback within 48 hours of receipt to enable finalization by the
Recipient. (For avoidance of doubt, financial information is not expected at these updates, which will betechnically focused. AOR reserves the right to include financial personnel in these project meetings, if
needed.) Final versions will be submitted to the BARDA eRoom.
On a quarterly basis, at the request of the AOR, the Weekly Teleconference may be expanded in scope toallow for a progress review of the preceding three months and planning for the next three months.

B.

Monthly and Annual Technical and Business Reports: The Recipient will submit Monthly Reports to the
AOR on the 215t of each month. The Monthly Reports shall provide a concise but comprehensive summaryof activities completed during the prior calendar month and the following: updated IMS with activities
broken down to WBS Level 4 and an updated Risk Management Plan. The AOR will provide clarification
requests or edits to the Recipient within 4 business days, and the Recipient will provide edits or justification
to AOR requests. Final versions will be uploaded to the BARDA eRoom.

W15QICN2191003
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At 12 month intervals based on award date, an Annual Technical and Business Report will replace theMonthly Technical and Business Report. The format of this report shall be consistent with the Monthly
Report and provide a concise but comprehensive summary of activities completed during the prior 12 month
period.
C.

Draft and Final Technical Pro ress Reports: The Recipient will submit a Draft Technical Progress Reportto the AOR no later than ( b) ( 4 ) prior to the end of the Period of Performance. The draft report will containa summation of the wor p ormed and results obtained for the entire Period of Performance. The AOR
will provide the Recipient with suggested edits and comments within ( b ) (4)of receipt. In
collaboration with the AOR, the Recipient will adjudicate the suggested e ts an comments and submit a
Final Technical Progress Report on or before the end of the Period of Performance.

D.

FDA meetings, submissions, correspondence and audits: The Recipient will notify the AOR of all FDA
meetings within) b) (4) of receiving a confirmed date and time. For all Type A, B or C FDA meetings, theRecipient will ii. e reasonable effort to ensure that members of the AZD1222 PCT are able to attend as
observers (maximum of four individuals). The Parties understand that meetings may be requested by the
Agency on an ad hoc basis and on a timeline that does not accommodate proper notification. In such
instances, the Recipient will make a reasonable effort to notify the AOR in advance of those meetings and,to the extent possible, ensure that members of the AZD1222 PCT are able to attend as observers (maximumof four individuals).
rior to
The Recipient will provide the AOR with draft submissions to the FDA at leas (b) (4)submission. The AOR will provide suggested edits and comments to the Recipient wi • • (b) (4)of receipt in order to inform the final submission. The Recipient will either include suggested edits within
the final draft, or provide *ustification for exclusion. The Recipient will make the final submission available
to the AOR within ( b ) (4) of submission to the Agency.

The Recipient will make all official meeting minutes and other correspondence from the Agency available
to the AOR within ( b ) (4) of receipt.
The Recipient will notify the AOR of all scheduled FDA audits within ( b) (4 ) of receiving a confirmed
date, time and location. Re ardin FDA site visits and audits that are not sc tiled in advance, the Recipient
will notify the AOR w. • I( b ) ( 4) of the site visit / audit. To the extent feasible, the Recipient will makereasonable effort to ensure at members of the AZD1222 PCT are able to attend daily debriefs as observers(maximum of four individuals).
E.

Daily check-in, as requested by the AZD1222 PCT: A program specific designee of the Recipient willhold a daily check-in with the AOR or AOR designee to discuss the performance of the Agreement. No
agenda, presentation, or official minutes need to be maintained for the regular meeting. The AOR may cancel
the daily check-in or substitute a technical or program specific meeting as a replacement. Daily check-ins are
expected only during business days.

F.

Confirmed, critical programmatic concerns, issues or probable risks that are likely to impact projectschedule/cost/performance: The Recipient will communicate and document all confirmed programmatic
risks to the AOR within ( b ) (4 ) of Recipient's awareness. Recipient shall communicate via email or
telephone. Following resolution, Recipient will • rovide all associated deviation reports and corrective andpreventative action plans to the AOR within (b) ( 4 ) of fmalization.
In addition, the Recipient will report to the government any activity or incident that is in violation of
established security standards or indicates the loss or theft of government products within (b) (4) ofRecipient's awareness of the activity or incident. Recipient will communicate via email, oral or written
communication.

G.

Technical documents relevant to the performance of activities within scope of this Prototype
Agreement: Upon request, the Recipient will make the following technical documents available to the AOR:

W15Q1(N2191003
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Process Development Reports. Assay Qualification Plan/Report. Assay Validation Plan/Report. Assay
Technology Transfer Report. Batch Records. SOPs, Master Production Records. Certificates of Analysis andManufacturing Campaign Reports.
H.

Clinical and Operations Dashboard: The Recipient shall provide raw clinical data, data analysis. and/or

data reports to the AZD1222 PCT. For a daily dashboard, the following will be provided on a daily basis or
as requested by the AOR:
1.

3.

I.

Recipient will provide data daily as requested in a Government-provided spreadsheet to support aclinical trial dashboard. Recipient and the Government will both work in good faith to ensure data isprovided to enable both teams to review the clinical trial(s);Recipient will provide read-only access to IRT and EDC data to two Government representatives:
Raw data, tabulation data (e.g., CDISC-compliant SDTM SAS XPT datasets). or data analysis(e.g., CDISC-compliant ADaM SAS XPT datasets) will be provided to the Government upon
database freeze(s) and database lock, and at any other times requested by the COL for the clinicalstudies supported under this Agreement.

Supply chain resiliency, including recipient locations: Within (b) (4)of award, theReci • ient will irovide the AOR with a su • '1 chain resilienc .1an. (b) (4 )J.

Dose Tracker: The Recipient will provide manufacturing reports and manufacturing dose tracking
projections/actuals utilizing the "COVID-19 Dose Tracking Templates.' or similar. Recipient will update theDose Trackin• Tern late weekl durin• manufacturin• campaigns and daily during response operations(b) (4)and COVED-19 response. with the first deliverable
SU mission wit 1r(b) (4)'cation. Ups ates to be provided weekly in advance of commercialscale manufacturing an
ily once material for use in response operations begins manufacture.

K.

Draft and Final Nonclinical and Clinical Stud Protocols: The Reci s ient will provide Draft Nonclinicaland Clinical Protocols to the AOR at least (b) (4)prior to planned submission to the
FDA. The AOR will facilitate review of the protoco
provi e t e Recipient with suggested edits andcomments within (b) (4)of receipt. In collaboration with the AOR. the Recipient will
adjudicate the suggeste e its an confluents prior to submission to the FDA.
L.

Interim and Final Nonclinical and Clinical Study Reports: The Rec. ient will provide final draft and final
Nonclinical and Clinical Study Reports to the AOR withinof those reports becoming

available to the Recipient. To the extent allowable by law and reInterim Study Reports and/or associated data to the AOR within
Recipient.
M.

Reci ient will also provideof availability to the

Recipient Audits of Sub-agreement Holders' Facilities: The Recipient will inform the AOR of upcoming,
ongoing, or recent audits/site visits conducted by Recipient of sub-agreement holders as part of the weekly
communications, including goals and agenda. The Government reserves the right to participate in the audits.
Upon completion of the audit/site visit the Recipient shall provide a report capturing the findings, results andnext steps in proceeding with the sub-agreement holder if action is requested by Recipient of the subagreement holder to address areas of non-confonnance to FDA regulations.

ARTICLE 18: INVOICING AND PAYMENT INSTRUCTIONSA.

Unless otherwise stated, the Recipient is required to utilize the Wide Area Work Flow (WAWF) system
when processing invoices and receiving reports under this Agreement. WAWF is a secure web-based systemfor electronic invoicing, receipt and acceptance. WAWF application enables electronic form submission of
invoices. Government inspection. and acceptance documents in order to support DoD's goal of moving to apaperless acquisition process. Authorized DoD users are notified of pending actions by e-mail and are

W15QKN2191003
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presented with a collection of documents required to process the contracting or financial action. It uses
Public Key Infrastructure (PKI) to electronically bind the digital signature to provide non-reputable proof
that the user electronically signed the document with the contents. Benefits include online access and full
spectrum view of document status, minimized re-keying and improving data accuracy, eliminating
unmatched disbursements and making all documentation required for payment easily accessible. The
Recipient shall:
1. Ensure an Electronic Business Point of Contact is designated within the System for Award Management
at http://www.sam.gov and2. Register to use WAWF-RA at the https://piee.eb.mil site. Step-by-step procedures to register areavailable at the https://piee.eb.mil. The Recipient is directed to use the "2-N-1" invoice format whenprocessing invoices.
3. Inspection/acceptance location. The Contractor shall select the following inspection/acceptancelocation(s) in WAWF, as specified by the contracting officer.
ORIGIN / ORIGIN
4. Document routing. The Recipient shall use the information in the Routing Data Table below only to fillin applicable fields in WAWF when creating payment requests and receiving reports in the system.
ROUTING DATA TABLE
Field Name in WAWF
Pay Official DoDAAC
Issue By DoDAAC
Admin DoDAAC
Inspect By DoDAAC (if applicable)
Ship To Code (if applicable)
Service Approver (DoDAAC)
Service Acceptor (DoDAAC)

Data to be entered in WAWF
HQ0338W15QKNW15QIC.N
W56XNHW56XNHW56XNHW56XNH

B. Payment request and supporting documentation. The Recipient shall ensure a payment
request includes appropriate line item and subline item descriptions of the work
performed as detailed in the SOW for specific milestones.
C. WAWF email notifications. The Recipient shall enter the email address identified below
in the "Send Additional Email Notifications" field of WAWF once a document is
submitted in the system.
Agreements Officer: (b) (6)mailto:Agreements Officer Representative:(b) (6)E. The Recipient may obtain clarification regarding invoicing in WAWF from thefollowing contracting activity's administrative WAWF point of contact. For technical
WAWF help, contact the WAWF help desk at 866-618-5988.
F. The following guidance is provided for invoicing processed under this Agreement through WAWF:
1. The AOR identified in Supplement 4, "Agreement Administration" shallcontinue to formally inspect and accept the deliverables/milestones. To the
maximum extent practicable, the AOR shall review the deliverable(s)milestone report(s) and either:i. provide a written notice of rejection to the Recipient which includes
feedback regarding deficiencies requiring correction or

W15QKN2191003
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ii. written notice of acceptance to the AO, and acceptance in the WAWF
system.
2. Acceptance within the WAWF system shall be performed by the AOR.
G. Note for DFAS: The Agreement shall be entered into the DFAS system by CLIN Milestone association (MS)/ACRN as delineated in Section B of the Award. The
Agreement is to be paid out by CLIN (MS)/ACRN. Payments shall be made using
the CLIN (MS)/ACRN association as delineated at Section B of this Award.
H. Recipient Information: As identified at Central Contractor Registration, i.e.,
Commercial and Government Entity (CAGE) Code, Dun & Bradstreet number(DUNS), and Tax Identification Number (TIN). Payments shall be made in theamounts set forth in the SOW, provided the AOR has verified the completion of themilestones.
ARTICLE 19: PROHIBITION ON THE USE OF CERTAIN TELECOMMUNICATIONS AND VIDEOSURVEILLANCE SERVICES OR EQUIPMENTa) Definitions. As used in this clause—

Backhaul means intermediate links between the core network, or backbone network, and the small
subnetworks at the edge of the network (e.g., connecting cell phones/towers to the core telephone
network). Backhaul can be wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).
Covered foreign country means The People's Republic of China.
Covered telecommunications equipment or services means—(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE
Corporation (or any subsidiary or affiliate of such entities);(2) For the purpose of public safety, security of Government facilities, physical security
surveillance of critical infrastructure, and other national security purposes, video surveillance
and telecommunications equipment produced by Hytera Communications Corporation,
Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any
subsidiary or affiliate of such entities);(3) Telecommunications or video surveillance services provided by such entities or using such
equipment; or(4) Telecommunications or video surveillance equipment or services produced or provided by anentity that the Secretary of Defense, in consultation with the Director of National Intelligenceor the Director of the Federal Bureau of Investigation, reasonably believes to be an entity
owned or controlled by, or otherwise connected to, the government of a covered foreigncountry.

Critical technology means—

W15QKN2191003
Page 67 of 84(1) Defense articles or defense services included on the United States Munitions List set forth in
the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Codeof Federal Regulations;(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of theExport Administration Regulations under subchapter C of chapter VII of title 15, Code ofFederal Regulations, and controlled(i) Pursuant to multilateral regimes, including for reasons relating to national security,
chemical and biological weapons proliferation, nuclear nonproliferation, or missile
technology; or(ii) For reasons relating to regional stability or surreptitious listening;(3) Specially designed and prepared nuclear equipment, parts and components, materials, software,and technology covered by part 810 of title 10, Code of Federal Regulations (relating toassistance to foreign atomic energy activities);(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal
Regulations (relating to export and import of nuclear equipment and material);(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of
title 9 of such Code, or part 73 of title 42 of such Code; or(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export
Control Reform Act of 2018 (50 U.S.C. 4817).

Interconnection arrangements means arrangements governing the physical connection of two or more
networks to allow the use of another's network to hand off traffic where it is ultimately delivered (e.g.,connection of a customer of telephone provider A to a customer of telephone company B) or sharing
data and other information resources.
Reasonable inquiry means an inquiry designed to uncover any information in the entity's possession
about the identity of the producer or provider of covered telecommunications equipment or services usedby the entity that excludes the need to include an internal or third-party audit.
Roaming means cellular communications services (e.g., voice, video, data) received from a visited
network when unable to connect to the facilities of the home network either because signal coverage is
too weak or because traffic is too high.
Substantial or essential component means any component necessary for the proper function or
performance of a piece of equipment, system, or service.
(b) Prohibition.
(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019
(Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or
obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service thatuses covered telecommunications equipment or services as a substantial or essential component of any
system, or as critical technology as part of any system. The Contractor is prohibited from providing to theW15QKN2191003
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Government any equipment, system, or service that uses covered telecommunications equipment or services
as a substantial or essential component of any system, or as critical technology as part of any system, unless
an exception at paragraph (c) of this clause applies or the covered telecommunication equipment or services
are covered by a waiver described in FAR 4.2104.
(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019
(Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into
a contract or agreement, or extending or renewing a contract or agreement, with an entity that uses any
equipment, system, or service that uses covered telecommunications equipment or services as a substantial
or essential component of any system, or as critical technology as part of any system, unless an exception atparagraph (c) of this clause applies or the covered telecommunication equipment or services are covered bya waiver described in FAR 4.2104. This prohibition applies to the use of covered telecommunications
equipment or services, regardless of whether that use is in performance of work under a Federal contract oragreement.
(c) Exceptions. This clause does not prohibit contractors from providing—(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection
arrangements; or(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any
user data or packets that such equipment transmits or otherwise handles.

(d) Reporting requirement(1) In the event the Contractor identifies covered telecommunications equipment or services used as a
substantial or essential component of any system, or as critical technology as part of any system, duringcontract or agreement performance, or the Contractor is notified of such by a subcontractor at any tier or by
any other source, the Contractor shall report the information in paragraph (d)(2) of this clause to theAgreements Officer, unless elsewhere in this contract or agreement are established procedures for reporting theinformation; in the case of the Department of Defense, the Contractor shall report to the website
at https://dibnet.dod.mil.
(2) The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause(i) Within one business day from the date of such identification or notification: the contract number; theorder number(s), if applicable; supplier name; supplier unique entity identifier (if known); supplierCommercial and Government Entity (CAGE) code (if known); brand; model number (original
equipment manufacturer number, manufacturer part number, or wholesaler number); item description;
and any readily available information about mitigation actions undertaken or recommended.
(ii) Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: any
further available information about mitigation actions undertaken or recommended. In addition, theContractor shall describe the efforts it undertook to prevent use or submission of covered
telecommunications equipment or services, and any additional efforts that will be incorporated toprevent future use or submission of covered telecommunications equipment or services.
(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e) andexcluding paragraph (b)(2), in all subcontracts, sub-agreements and other contractual instruments, including
subcontracts for the acquisition of commercial items.

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ARTICLE 20: HEALTH RESOURCES PRIORITIES AND ALLOCATIONS SYSTEMS (HRPAS)
PRIORITY RATING
1) This contract shall have a I-IRPAS priority rating of (b) (4)2) This is a gm rated contract for the purpose of emergency preparedness and the Contractor shall follow all
the provisions of the HRPAS regulation (45 CFR Part 101). If the Contractor needs to utilize industrial
resources to fulfill this rated order for a health resource, it is authorized pursuant to 45 CFR Section 101.36(b)to place the same priority rating and program identification symbol for health resources on its orders forindustrial resources with its suppliers.
3) Each rated order executed by AstraZeneca must include the following:(a) The priority rating: HRPAS (b) (4)(b) A required delivery date or dates. The words immediately or as soon as possible do not constitute adelivery date;(c) The written signature on a manually placed order, or the digital signature or name on anelectronically placed order, of an individual authorized to sign rated orders for the person placing the order;and(d) A statement that reads in substance:(1) This is a rated order certified for national defense use, and you arc required to follow all
the provisions of the Health Resources Priorities and Allocations System regulation at 45 CFR part101.
(2) If the rated order is placed in support of emergency preparedness requirements andexpedited action is necessary and appropriate to meet these requirements, the following sentences
should be added following the statement set forth in paragraph (d)(1) of this section:
i. This rated order is placed for the purpose of emergency preparedness. It must be
accepted or rejected within two (2) days after receipt of the order if:
A. The order is issued in response to a hazard that has occurred; or
B. If the order is issued to prepare for an imminent hazard, as specified in
HRPAS Section 101.33(e).

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Appendix A
Background IF
Government Background II': None
AstraZenem Background IP:

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ihna:

WI5QICN2191003

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Appendix B
STANDARD OWS-SA LANGUAGE FOR DOD OT-BASED CONTRACTS

Supply Chain Resiliency Plan
The contractor shall develop and submit within (b) (4)of contract award, a comprehensive
Supply Chain Resiliency Program that provides identification and reporting of critical components associated withthe secure supply of drug substance, drug product, and work-in-process through to finished 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 defmition 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 and environmental
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. The Supply Chain Resiliency Plan shall address planning and scheduling for active
pharmaceutical ingredients, upstream, downstream, component assembly, finished drug product and delivery events
as necessary for the delivery of product.
a) Communication for these requirements shall be updated as part of an annual review, or as necessary, as partof regular 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,
and associated 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 thecontractual delivery schedule. Delivery methods shall be addressed, inclusive of items that are foreignsourced, both high and low volume, which would significantly affect throughput and adherence to thecontractually agreed deliveries.
The contractor shall articulate in the plan, the contractor's methodology for inventory control, production planning,scheduling processes 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 theContracting Officer's Representative as necessary.
b) Production throughput critical constraints should be well understood by activity and by design, andcommunicated to contractual personnel. As necessary, communication should focus on identification,
exploitation, elevation, and secondary constraints of throughput, as appropriate.
Reports for critical items should include the following information:a) Critical Materialb) Vendorc) Supplier, Manufacturing / Distribution Locationd) Supplier Lead Timee) Shelf Life
0 Transportation / Shipping restrictions
The CO and COR reserve the right to request un-redacted copies of technical documents provided in response to thissection, during the period of performance, for distribution within the Government. Documents shall be provided within(b) (4)after CO issues the request. The Contractor may arrange for additional time if deemed necessary, andagreed to by the CO.
Manufacturing Data Requirements

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The Contractor shall submit within (b) (4)of contract award detailed data regarding projectmaterials, sources, and manufacturing sites, Inc uding but not limited to: physical locations of sources of raw andprocessed material by type of material; location and nature of work performed at manufacturing, processing, andfill/finish sites; and location and nature of clinical studies sites (it being understood that such information already has
been provided). 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 product•Product Development Source Material and Manufacturine Reports and Projections
The Contractor shall submit 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 ofsources 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 studies sites (it being understood that such information
already has been provided).
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.
Reporting Procedures and Due Dates:•
Contractor will submit Product Development Source Material Reporto Within 1 month of contract awardo Within 30 days of substantive changes are made to sources and/or materialso Or on the 6t1i month contract anniversary.
•
Contractor will update the Dose Tracking Template weekly during manufacturing campaigns and daily
during response operations (where a Public Health Emergency has been declared) and COVID-19 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 inwriting•
Product Development and Source Material report to be 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 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 30 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
Access and General Protection/Security Policy and ProceduresThis standard language text is applicable to ALL employees working on critical information related to Operation Warp
Speed (OWS) with an 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

W15Q1(1•12191003
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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 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.
Operational Security (OPSEC1

The performer shall develop an OPSEC Standard Operating Procedure (SOP)/Plan within ninety (90)-calendar-daysof 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/Plan will include identifying the critical information
related to this contract, why it needs to be protected, where it is located, who is responsible for it, and how to protectit.
Security Plan

The contractor 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 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.
a) The Government will review in detail and submit comments within ten (10) business days to theContracting 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 thirty (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
the Government.
Upon completion of initiating all security measures, the Contractor shall supply to the Contracting Officer a letter(b) (4)

At a minimum. tie 1-ma 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 plan 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
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

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policies and procedures•
candidate recruitment process•
background investigations process•
employment suitability policy•
employee access determination•
rules of behavior/ conduct•
termination procedures•
non-disclosure agreements
Physical Security Policies•
internal/external access control
and Procedures•
protective services•
identification/badging•
employee and visitor access controls•
parking areas and access control•
perimeter fencing/barriers•
product shipping, receiving and transport sectuity 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•
intrusion detection and prevention systems
Technology/Cyber Security•
threat identification
Policies 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
2. Site Security Master Plan
Description: The partner facility shall provide a site schematic for security systems which includes: main accesspoints; security cameras; electronic access points; IT Server Room; Product Storage Freezer/Room; and biocontainment laboratories.
I
Personnel Security

W15Q1G•12191003
Pace "S of S4

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 of critical infrastructure (power/water/natural gas, etc.) This assessment shall include
recent data obtained from local law enforcement agencies. The assessment should be updated annually.
I
4. Physical Security
Description:
Closed Circuit Televisiona) Layered (internal/external) CCTV coverage with time-lapse video(CCTV) Monitoring
recording for buildings and areas where critical assets are processed orstored.
b) CCTV coverage must include entry and exits to critical facilities,
perimeters, and areas within the facility deemed critical to the executionof the contract.
c) Video recordings must be maintained for a minimum 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, and areas within the facility deemed critical to the executionof the contract.
f) Video recordings must be maintained for a minimum of 30 days.
g) CCTV surveillance system must be on emergency power backup.
Facility Lightinga) Lighting must cover facility perimeter, parking areas, criticalinfrastructure, and entrances and exits to buildings.
b) Lighting must have emergency power backup.
c) Lighting must be sufficient for the effective operation of the CCTV
surveillance system during hours of darkness.
Shipping and Receivinga) 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 govenunent
issued photo identification.
Access Controla) 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
where assets 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 ofunauthorized attempts to access restricted areas.
e) Must have a system that provides a historical log of all key accesstransactions and kept on record for a minimum of12 months.
f) Must have procedures in place to track issuance of access cards toemployees and the ability to deactivate cards when they are lost or an
employee leaves the company.
g) Response to electronic access control alarms must be immediate anddocumented in writing and kept on record for a minimum of 12 monthsh) Should have written procedures to prevent employee piggybacking
accessi) to critical infrastructure (generators, air handlers, fuel storage, etc.)
should be controlled and limited to those with a legitimate need foraccess.
j) Must have a written manual key accountability and inventory process.
k) Physical access controls should present a layered approach to criticalassets within the facility.

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EmployeeNisitor
Identificationa) Should issue company photo identification to all employees.
b) Photo identification should be displayed above the waist anytime theemployee is on 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.
Security Fencing
Requirements for security fencing will be determined by the criticality of the
program, review of the security plan, threat assessment, and onsite security
assessment.
Protective Security Forces
Requirements for security officers will be determined by the criticality of the
program, review of the security plan, threat assessment, and onsite security
assessment.
Protective Security Forcesa) Must have in-service training program.
Operationsb) 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 uniform identifying them as security officers.
i
5. Security Operations
Description:
Information Sharinga) Establish formal liaison with law enforcement.
b) Meet in person at a minimum annually. Document meeting notes andkeep them on file for a, minimum of 12 months. POC information for LE
Officer that attended the meeting must be documented.
c) Implement procedures for receiving and disseminating threat
information.
Traininga) Conduct new employee security awareness training.
b) Conduct and maintain records of annual security awareness training
Security Managementa) Designate a knowledgeable security professional to manage the secur ityof the facility.
b) Ensure subcontractor compliance with all Government security
requirements.
6. Personnel Security
Description:
Records Check,

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; andlocal/national criminal history search.
Hiring and Retentiona) Detailed policies and procedures concerning hiring and retention ofStandards
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.
7. Information Security
Description:
Physical Document Controla) Applicable documents shall be identified and marked as procurement
sensitive, proprietary, or with appropriate government markings.
b) Sensitive, proprietary, and government documents should be maintainedin a lockable filing cabinet/desk or other storage device and not be left
unattended.

W15Q1{1•12191003
Page 80 of 84c) Access to sensitive information should be restricted to those with a needto know.
Document Destruction
Documents must be destroyed using approved destruction measures (i.e,shredders/approved third party vendors / pulverizing / incinerating).
8. Information Technology & Cybersecmity
Description:

Identity Management

Access Control

Training

Audit and Accountability

Configuration 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 forums andsources.
e) Threats, vulnerabilities, likelihoods, and impacts are used to determine
risk.
f) Identities and credentials are issued, managed, verified, revoked, andaudited for authorized devices, users and processes.
g) 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)a) Limit information system access to authorized users.
b) Identify information system users, processes acting on behalf of users. ordevices and authenticate identities before allowing access.
c) Limit physical access to information systems, equipment, and serverrooms with electronic access controls.
d) Limit access to/ verify access to use of external information systems.
a) 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.
a) 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 for minimum must be kept for 12 months.
b) Ensure the actions of individual information system users can be
uniquely traced to those users.
c) Update malicious code mechanisms when new releases are available.
d) Perform periodic scans of the information system and real time scans offiles from external sources as files are downloaded, opened, or executed.
a) Establish and enforce security configuration settings.
b) Implement sub networks for publically accessible system componentsthat are physically or logically separated from internal networks.

Contingency Planninga)

Incident Responsea)Media and Information
Protection

a)
b)
c)

Establish, implement, and maintain plans for emergency response,
backup operations, and post-disaster recovery for information systems toensure the availability 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 thiscapability annuallyProtect information system media, both paper and digital.
Limit access to information on information systems media to authorizedusers.
Sanitize and destroy media no longer in use.

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a) Limit access to information systems, equipment, and the respective
operating environments to authorized individuals.
b) Intrusion detection and prevention system employed on IT network,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.
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.
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.
f) Truck pickup and deliveries must be logged and kept on record for aminimum of 12 months.
Transport Routesa) Transport routes should be pre-planned and never deviated from except
when approved or in the event of an emergency.
b) Transport routes should be continuously evaluated based upon new
threats, significant 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 is placed in the transport vehicle.
b) Government products should be continually monitored by GPS
technology while in transport, and any deviations from planned routes
should be investigated and documented.
c) 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 government products.
The facts and circumstances associated with these incidents will be documented in writing for government
review.
Physical and Environmental
Protection

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
Disclosure of Information

Performance under this contract may require the Contractor to access non-public data and information proprietary toa 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,

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nor Contractor personnel, shall divulge nor release data nor information obtained under performance of this contract,
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 in termination of the contract, replacement of a Contractor employee, or other appropriate redress. Neither
the Contractor nor the Contractor's employees shall disclose or cause to be disseminated, any information concerning
the operations of the activity, which could result in, or increase the likelihood of, the possibility of a breach of theactivity's security or interrupt the continuity of its operations.
No information related to data obtained from the Government under this contract shall be released or publicizedwithout the prior written consent of the COR, whose approval shall not be unreasonably withheld, conditioned, ordelayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similarorder; for submission to any Government entity for submission to any securities exchange on which the Contractor's(or its parent corporation's) securities may be listed for trading; or to third parties relating to securing, seeking,establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities,
or mergers, acquisitions, or other business transactions.
Financial Disclosure by Clinical Investigators.
The Contractor does and shall comply with the requirements of 21 CFR Part 54, Financial Disclosure by Clinical
Investigators.

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Appendix C
Statement of Work
(SEE SECTION C FOR STATEMENT OF WORK)W15QKN2191003
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Section J - List of Documents, Exhibits and Other Attachments
ATTACHMENTS

Attachment 01

PL 115-92 MODEL AUTHORIZATION FOR FDA TO SHARE NON-PUBLICINFORMATION WITH THE DEPARTMENT OF DEFENSE