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

3. AWARD/EFFECTIVE DATEW911QY21C0012

09-Nov-2020

7. FOR SOLICITATIONINFORMATION CALL:

a. NAME

9. ISSUED BY

CODE

4. ORDER NUMBER

W911QY

10. THIS ACQUISITION IS

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

TEL:
FAX (b) (6)11. DELIVERY FOR FOB DESTINATION UNLESS BLOCK IS

1. REQUISITION NUMBER
0011560875-0001

PAGE 1 OF

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

b. TELEPHONE NUMBER (No Collect Calls)

8. OFFER DUE DATE/LOCAL TIMEX UNRESTRICTED OR

SMALL BUSINESSHUBZONE SMALL
BUSINESSEDWOSBSERVICE-DISABLED
VETERAN-OWNEDSMALL BUSINESS

8(A)541380SIZE STANDARD:(b) (4)13b. RATING

14. METHOD OF SOLICITATIONSEE SCHEDULE

RFQ
CODE

% FOR:NAICS:

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

Net 30 Days

MARKEDIFB

16. ADMINISTERED BY

RFP
CODE

SEE ITEM 9

SEE SCHEDULE
17a.CONTRACTOR/
OFFERORSET ASIDE:WOMEN-OWNED SMALL BUSINESS (WOSB)ELIGIBLE UNDER THE WOMEN-OWNEDSMALL BUSINESS PROGRAM

12. DISCOUNT TERMS

15. DELIVER TO

67

FACILITY
CODE

CODE 1CD10

1CD1018a. PAYMENT WILL BE MADE BY

CODE

HQ0490

DEFENSE FINANCE AND ACCOUNTNG SERVICEDFAS- NDY VP GFEBS
8899 E 56TH STREETINDIANAPOLIS IN 46249-3800

MICROBIOLOGICS, INC.
(b) (6)200 COOPER AVE N
SAINT CLOUD MN 56303-4452

TELEPHONE NO (b) (6)17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT
SUCH ADDRESS IN OFFER
19.
ITEM NO.

18b. SUBMIT NVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCKX SEE ADDENDUM
BELOW IS CHECKED

20.
SCHEDULE OF SUPPLIES/ SERVICES

21.
QUANTITY

22.
UNIT

23.
UNIT PRICE

24.
AMOUNT

SEE SCHEDULE
26. TOTAL AWARD AMOUNT (For Gov t. Use Only )25. ACCOUNTING AND APPROPRIATION DATA

See Schedule(b) (4)27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

ADDENDAARE

ARE NOT ATTACHED

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

ADDENDAARE

ARE NOT ATTACHED

X 28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

1COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANYADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

29. AWARD OF CONTRACT: REF.
OFFER DATED 08-Oct-2020. YOUR OFFER ON SOLICITATION(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARESET FORTH HEREIN, IS ACCEPTED AS TO ITEMS: SEE SCHEDULE

REF: Commercial Solutions Proposal

31a.UNITED STATES OF AMERICA

30a. SIGNATURE OF OFFEROR/CONTRACTOR(SIGNATURE OF CONTRACTING OFFICER)(b) (6)30b. NAME AND TITLE OF SIGNER(TYPE OR PRINT)

30c. DATE SIGNED

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

31c. DATE SIGNED(b) (6)

TEL: (b) (6)09-Nov-2020

EMAIL: (b) (6)

AUTHORIZED FOR LOCAL REPRODUCTIONPREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)
Prescribed by GSA – FAR (48 CFR) 53.212

PAGE 2 OF 67

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS(CONTINUED)
19.
ITEM NO.

20.
SCHEDULE OF SUPPLIES/ SERVICES

21.
QUANTITY

22.
UNIT

23.
UNIT PRICE

24.
AMOUNT

SEE SCHEDULE

32a. QUANTITY IN COLUMN 21 HAS BEEN
RECEIVEDINSPECTEDACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

32c. DATE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENTREPRESENTATIVE

REPRESENTATIVE

32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER

34. VOUCHER NUMBER

35. AMOUNT VERIFIEDCORRECT FOR

36. PAYMENT

37. CHECK NUMBERCOMPLETE
PARTIALPARTIAL

FINAL

FINAL

38. S/R ACCOUNT NUMBER

39. S/R VOUCHER NUMBER

40. PAID BY

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

AUTHORIZED FOR LOCAL REPRODUCTIONPREVIOUS EDITION IS NOT USABLE

42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK
Prescribed by GSA – FAR (48 CFR) 53.212

W911QY21C0012
Page 3 of 67
Section SF 1449 - CONTINUATION SHEETITEM NO
0001

ITEM NO
000101

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1Each$(b) (4)Technlology Transfer of Wild Type Assay
FFP
The contractor shall Technology Transfer (TT) the validated WT virus
neutralization (VN) assay and demonstrate method equivalence. All required work
shall be IAW the SOW and Commercial Solution Proposal titled "COMMERCIAL
SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001-A002", dated
November 9, 2020.
FOB: Destination
PSC CD: Q301

SUPPLIES/SERVICESQUANTITYUNIT

AMOUNT$(b) (4)NET AMT$(b) (4)UNIT PRICEAMOUNT(b) (4)

ACRN AA @ $(b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0001

NET AMT
ACRN AA
CIN: GFEBS001156087500001(b) (4)(b) (4)

W911QY21C0012
Page 4 of 67
ITEM NO
0002

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
Technology Transfer of Reporter VN Assay
FFP
The contractor shall Technology Transfer (TT) the qualified reporter VN assay andsubsequent validation. All required work shall be IAW the SOW and Commercial
Solution Proposal titled "COMMERCIAL SOLUTIONS PROPOSAL: CSO AOIW911QY-20-S-C001-A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301

NET AMTITEM NO
000201

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

ACRN AA @ (b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0001

NET AMT
ACRN AA
CIN: GFEBS001156087500002(b) (4)(b) (4)

W911QY21C0012
Page 5 of 67
ITEM NO
0003

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE
1,000
Each
(b) (4)
Initial Assay Sample Testing
FFP
The contractor shall test 500 samples using of the wild type validated assay and500 samples using of the validated reporter virus type assay. All required work
shall be IAW the SOW and Commercial Solution Proposal titled "COMMERCIAL
SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001-A002", dated
November 9, 2020.
FOB: Destination
PSC CD: Q301

NET AMTITEM NO
000301

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

ACRN AA @ (b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0001

NET AMT
ACRN AA
CIN: GFEBS001156087500003(b) (4)(b) (4)

W911QY21C0012
Page 6 of 67
ITEM NO
0004

ITEM NO
000401

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
Drug Master File (DMF) WT Assay
FFP
The contractor provide a Drug Master File (DMF) WT virus neutralization VN
assay. All required work shall be IAW the SOW and Commercial Solution
Proposal titled "COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY20-S-C001-A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301

SUPPLIES/SERVICESQUANTITYUNIT

AMOUNT(b) (4)

NET AMT(b) (4)

UNIT PRICEAMOUNT(b) (4)

ACRN AA @ (b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0001

NET AMT
ACRN AA
CIN: GFEBS001156087500004(b) (4)(b) (4)

W911QY21C0012
Page 7 of 67
ITEM NO
0005

ITEM NO
000501

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
Drug Master File (DMF) Reporter VN Assay
FFP
The contractor provide a Drug Master File (DMF) reporter VN assay. All required
work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301

SUPPLIES/SERVICESQUANTITYUNIT

AMOUNT(b) (4)

NET AMT(b) (4)

UNIT PRICEAMOUNT(b) (4)

ACRN AA @ (b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0001

NET AMT
ACRN AA
CIN: GFEBS001156087500005(b) (4)(b) (4)

W911QY21C0012
Page 8 of 67
ITEM NO
1001

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 1 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1002

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 2 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 9 of 67
ITEM NO
1003

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 3 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1004

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 4 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 10 of 67
ITEM NO
1005

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 5 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1006

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 6 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 11 of 67
ITEM NO
1007

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 7 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1008

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 8 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 12 of 67
ITEM NO
1009

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 9 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1010

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 10 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 13 of 67
ITEM NO
1011

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 11 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1012

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 12 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 14 of 67
ITEM NO
1013

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 13 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1014

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 14 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 15 of 67
ITEM NO
1015

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 15 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1016

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 16 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 16 of 67
ITEM NO
1017

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 17 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1018

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 18 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 17 of 67
ITEM NO
1019

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 19 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1020

SUPPLIES/SERVICESQUANTITY
1,000

UNIT
Each

UNIT PRICEOPTION

Testing of 1,000 Samples
FFP
Option 20 - Testing of 1,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 18 of 67
ITEM NO
1021

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 21 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1022

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 22 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 19 of 67
ITEM NO1023

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 23 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO1024

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 24 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 20 of 67
ITEM NO
1025

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 25 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO1026

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 26 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 21 of 67
ITEM NO
1027

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 27 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1028

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 28 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 22 of 67
ITEM NO1029

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 29 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO
1030

SUPPLIES/SERVICESQUANTITY
2,000

UNIT
Each

UNIT PRICEOPTION

Testing of 2,000 Samples
FFP
Option 30 - Testing of 2,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 23 of 67
ITEM NO
1031

SUPPLIES/SERVICESQUANTITY
5,000

UNIT
Each

UNIT PRICEOPTION

Testing of 5,000 Samples
FFP
Option 31 - Testing of 5,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO1032

SUPPLIES/SERVICESQUANTITY
5,000

UNIT
Each

UNIT PRICEOPTION

Testing of 5,000 Samples
FFP
Option 32 - Testing of 5,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 24 of 67
ITEM NO1033

SUPPLIES/SERVICESQUANTITY
5,000

UNIT
Each

UNIT PRICEOPTION

Testing of 5,000 Samples
FFP
Option 33 - Testing of 5,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTITEM NO1034

SUPPLIES/SERVICESQUANTITY
5,000

UNIT
Each

UNIT PRICEOPTION

Testing of 5,000 Samples
FFP
Option 34 - Testing of 5,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)(b) (4)

W911QY21C0012
Page 25 of 67
ITEM NO1035

SUPPLIES/SERVICESQUANTITY
5,000

UNIT
Each

UNIT PRICEOPTION

Testing of 5,000 Samples
FFP
Option 35 - Testing of 5,000 clinical trial samples using one of the validated assay.
All required work shall be IAW the SOW and Commercial Solution Proposal titled"COMMERCIAL SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001A002", dated November 9, 2020.
FOB: Destination
PSC CD: Q301(b) (4)

NET AMTAMOUNT(b) (4)(b) (4)ADDENDUM: The following pages hereby supplements FAR 52.212-4
SOW For COVID-19 Immune Assay Implementation and Serum Testing Services
Title of Project: Establishment of high throughput neutralization assay laboratory capability for COVID-19 andtesting of human serum samples
1.

Introduction
An outbreak of respiratory disease caused by a novel coronavirus was first detected in China in late 2019 and has now
spread worldwide, including the United States (US). The virus has been named Severe Acute Respiratory Disease
Coronavirus-2 (SARS-CoV-2) and causes Coronavirus Disease 2019 (COVID-19). On January 30, 2020, theInternational Health Regulations Emergency Committee of the World Health Organization (WHO), declared theoutbreak a “Public Health Emergency of International Concern” (PHEIC). On January 31, the US Department of
Health and Human Services Secretary (HHS), Alex M. Azar II, declared a Public Health Emergency for the US to aid
the nation’s healthcare community in responding to COVID-19. On March 11, WHO publicly declared COVID-19 asa pandemic. On March 13, the President of the United States declared the COVID-19 outbreak a national emergency.
The US Government (USG) has identified COVID-19 vaccine candidates (prototypes) that are progressing rapidly
through advanced research and development activities. A joint HHS and Department of Defense (DOD) leadershipteam named Operation Warp Speed (OWS) is charged with development of COVID-19 vaccines and other medical
countermeasures.
This procurement action is aimed at providing additional laboratory assay capacity sites for analysis of serum samples
collected from subjects enrolled in COVID-19 vaccine clinical trials. Serum samples are tested to ascertain the abilityof the vaccine to induce an immune response. Studies have shown that serum antibodies directed against viral spike(S) that block infection of target cells can be readily detected by Virus Neutralization (VN) assays. The USG has
supported development of two VN assays at two organizations herein designates as “assay developer laboratory(ADL)” and seeks to transfer this assay technology to a new facility per this solicitation.
The FDA published guidance Development and Licensure of Vaccines to Prevent COVID-19 (6/30/2020) for
manufacturers developing COVID-19 vaccines. The guidance document states: “There are currently no acceptedsurrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19 vaccine” (1). Use of new
vaccines will require an Emergency Use Authorization or a BLA approval based on direct evidence of vaccine safety
and efficacy in protecting humans from SARS-CoV-2 infection and/or clinical disease. The ultimate goal of thisproject is to provide serologic data to support establishment of a correlate of protection. The latter would facilitate

W911QY21C0012
Page 26 of 67
expanded use of approved COVID-19 vaccines and accelerated approvals of additional vaccines.
2.

Scope
The program goals are twofold: 1. Technology transfer of two VN assays to a Biosafety Level 3 (BSL3) laboratory
other than the ADL in compliance with GLP (Contract Base period). The first transfer will include transfer of a highthroughput validated neutralization assay and subsequent method equivalence demonstration meeting FDA
requirements for Phase 3 sample testing; the second will include technology transfer of a qualified live virus reporter
assay for subsequent validation meeting FDA requirements for Phase 3 sample testing. 2. Test serum samples fromhuman subjects enrolled in clinical trials of COVID-19 vaccines using the new validated assay in compliance with
GLP.

3.

Regulatory compliance
The offeror is expected to comply with GLP Standards (2).
The neutralization assays must be conducted with live SARS-CoV-2 virus; therefore, laboratory testing must be
conducted in a BSL-3 environment (3). The offeror’s facility must demonstrate appropriate permits for the operationof the laboratory facilities in compliance with BSL-3 as described in CDC Guidelines. The offeror should describe
the safety procedures and provide assurances regarding Facility Safety Plan, CDC guidelines, and the appropriate
SOPs and institutional biosafety requirements for handing live SARS-COV-2.
Given that the test results for human sera collected as part of a clinical trial are part of a BLA submission to the FDA,
the organization must be prepared to provide the necessary supporting quality systems documentation to the sponsor
company for inclusion in the regulatory filing or in the course of quality audits (4,5). These supporting quality
systems along with assay validation reports and other supporting documentation are required for GLP complianceand should be documented in the drug master file (DMF) or other negotiated means. The contractor is expected toparticipate in an External Quality Assurance scheme to assess continued ability to perform tests correctly.
A facility audit will be conducted.

4.

Statement of Objectives
The objective of this project is the establishment of a high throughput wild type and reporter SARS-CoV-2 virus
neutralization assays for COVID-19 for use in testing serum samples from human subjects enrolled in clinical trials
of COVID-19 vaccines in compliance with GLP.
Operation Warp Speed (OWS) has supported development of two VN assays at organizations herein designated as“assay developer laboratory (ADL)”. The ADL will develop the assays using two virus platforms - a live wild type
(WT) virus and a live reporter virus for transfer to the new facility. The WT virus is the clinical SARS-CoV-2
isolate WA1 strain isolated from the first US COVID-19 patient identified in Washington State and the reporter
virus has a bioluminescent luciferase gene inserted to generate a recombinant SARS-CoV-2 virus strain. The WT
virus assay will be transferred in a validated state; the reporter virus assay will be transferred in a qualified state.
After contract award, the offeror is expected to submit a protocol (in coordination with the ADL) to technology
transfer the previously validated WT VN assay to quantify SARS-CoV-2 neutralizing antibodies in human sera
using VERO E6 cells and subsequently perform method equivalence. The offeror will use a panel of COVID-19
convalescent and COVID-19 vaccine recipient samples to demonstrate method equivalence relative to theperformance characteristics at the ADL (4). The VN assay follows traditional protocols, with a serum sample that isserially diluted and then incubated with a known amount of virus (neutralization step). For the WT VN assay, a cellmonolayer is then inoculated with the sample/virus mix and incubated for approximately 24 hours prior to acetone
fixation and immunoenzymatic detection of SARS-COV-2 N protein expression (in situ N-ELISA). The VN assay
median endpoint titer is reported as the reciprocal of the highest dilution at which the input virus is neutralized ELISAOD units below an established threshold). The assay will be considered fully transferred only once the FDA has
reviewed and concurred with tech transfer acceptability through review of documentation submitted to a DMF orW911QY21C0012
Page 27 of 67
through other negotiated means.
Conversely, the reporter VN assay relies on a luminescence readout. This assay will be transferred in a qualifiedstate and the receiving lab will be required to validate the assay. Assay validation will be considered complete only
once the FDA has reviewed and concurred with validation report acceptability through review of documentation
submitted to a DMF or through other negotiated means.
Details of the protocol for both the assays will be provided by the ADL in the course of jointly preparing thetechnology transfer protocol package.

•

Base Period: Technology Transfer of validated and qualified OWS neutralization assays, subsequent method
equivalency demonstration and validation, and sample testing of 1000 clinical trial samples inclusive of a anequivalency convalescent serum panel•
Options 1-20: Sample testing of 1000 clinical trial specimens•
Options 21-30 : Sample testing of 2000 clinical trial specimens•
Options 31-35: Sample testing of 5000 clinical trial specimens
The proposal’s basic framework should include the following specific tasks:
Base Period (CLIN 0001-CLIN 005): Technology Transfer of one validated and one qualified OWS VN assay.
After contract award, the offeror will host an audit and should provide a project plan (in coordination with ADL)
that describes the approach to 1) technology transfer the validated WT virus assay and demonstrate method
equivalence with a panel of test serum samples provided by the USG and 2) technology transfer the qualified
reporter virus assay and subsequently validate the assay. Offerors are encouraged to describe their testing workflow
in detail to include the use of robotic systems in order to increase sample throughput. Assay validation and overall
readiness to test Phase 3 samples from the clinical trials includes FDA concurrence with the assay documentation
submitted to the DMF
CLIN0001: Technology transfer the validated WT VN assay.
oTechnology transfer package (documentation from ADL) will include the following:

(i)
(ii)

An assay specific SOP for WT VN assay
A validation protocol designed to evaluate precision, dilutional linearity, limit of detection, limit of quantification,
selectivity (matrix effects), and specificity as appropriate. The validation protocol shall include a statistical analysis
plan.
(iii) Serum equivalence panel (see 5. Critical reagents)(iv) A validation reporto

The offeror shall provide:i.

A proof-of-concept data report on assay performance conducted prior to assay validation or equivalence execution,
capturing, at a minimum, a demonstration of precision with two samples tested over three days.
Technology transfer assay protocol to demonstrate method equivalence (in coordination with the ADL)
Submission of the technology transfer protocol to the FDA DMFs
Execute the technology transfer assay protocol
A draft and final technology transfer report
Copies of FDA’s concurrence with WT VN assay equivalence testing indicating readiness to initiate Phase 3 clinical
trial sample testing

ii.
iii.
iv.
v.
vi.

CLIN0002: Technology transfer the qualified reporter VN assay and subsequent validationoTechnology transfer package (documentation from ADL) will include the following:W911QY21C0012
Page 28 of 67
(i)
(ii)

An assay specific SOP for live reporter VN assay
A qualification protocol designed to evaluate precision, dilutional linearity, limit of detection, limit of quantification,
selectivity (matrix effects), and specificity as appropriate. The qualification protocol shall include a statisticalanalysis plan.
(iii) Serum equivalence panel (see 5. Critical reagents)(iv) A qualification report.
o

The offeror shall provide:

(i)
(ii)
(iii)
(iv)

A draft and final validation protocol
A Validation Report
Submission of the validation report to the FDA DMF
Copies of FDA’s concurrence with validation report indicating readiness to initiate Phase 3 clinical trial sample
testing
CLIN0003: Testing of 1000 clinical trial specimens using the validated assays. (500 samples for WT and 500
samples for live virus reporter) The offeror shall provide:oooThe proposed sample testing turnaround time when operating at full capacity for extended periods
The offeror should provide a sample management plan that describes in substantial detail the procedures for serum
sample accessioning, handling, safety and integrity (including power failures and other risks), with auditable tracking
systems throughout the chain of custody.
The offeror should provide a data management plan describing the information technology infrastructure to receive
the serum samples data and demonstrate data integrity, accuracy and security thought the life cycle of the sample
and completion of the project.
CLIN0004: Drug Master File (DMF) WT Neutralization VN Assay
CLIN0005: Drug Master File (DMF) Reporter VN Assay
Contract Options (Options 1-35) : Testing of clinical trial samples using one of the validated
CLIN 1001-1020 Option 1-20: Testing of 1,000 clinical trial samples using one of the validated assay
CLIN 1021-1030 Option 21-30: Testing of 2,000 clinical trial samples using one of the validated assay
CLIN 1031-1035 Option 31-35: Testing of 5,000 clinical trial samples using one of the validated assay

5.

Critical reagentsThe USG will provide certain reagents (e.g. SARS-CoV-2 virus seed) and a panel of 18 human serum samples to assay
equivalence between different sites executing the same assay. This panel comprises 15 COVID-19 convalescentsamples (equally distributed among samples with low, medium and high antibody titers) with certified titers and 3
negative controls.

6.

Capacity
Minimum 1000 samples /week. The maximum capacity within the accepted proposal is expected to be 1,000
samples for the WT VN assay and 2000 for the reporter VN assay tested every seven days. Testing under options
that are exercised will be IAW the accepted proposals stated capacities.

7.

Period of Performance
The Base Period of Performance (POP): The proposed OWS VN assay capacity must be available for use in full nolater than February 15 2021(after FDA concurrence with the tech transfer and equivalence report). The total
proposed duration of this work is 12 months from award.

8.

Personnel and Place of performanceW911QY21C0012
Page 29 of 67
The proposal should describe the key personnel and provide CVs to document training and experience for the
project as well as the overall staffing plan for the proposed activities.
The facilities where the work will be conducted as well as supporting activities should be described in sufficient detailto support assessment of fitness for purpose.
9.

Deliverables
The following deliverables would be provided by the offeror. The following proposed deliverable schedule is of
critical importance to the USG.
General Deliverablesa) PERIODIC TELECONFERENCES (Biweekly or as negotiated)
1) Draft bulleted agenda provided 48 hours prior to teleconference.
2) Meeting minutes provided 3 business days after teleconference.
b) COMMUNICATION MANAGEMENT PLAN
1) Outlines communications goals and strategies for the task order. Template will be provided.
c) MONTHLY REPORTS
1) Reports shall describe progress of meeting contract milestones- overall project assessment, problems encounteredand recommended solutions. The USG will receive information on the Tech transfer results/report, testing status,
number of samples processed, and number samples that are outstanding
2) Reports shall detail the planned progress and actual progress during the period covered, explaining occurrences ofany differences and corrective steps/actions planned if behind schedule. Deviation reporting should occur in real time.
3) Reports shall detail estimated invoice submissions/acceptance dates, and a narrative of the percentage of work
completed.
4) Reports shall include an updated Gantt.
d) DRAFT FINAL REPORT
1) A final report shall be provided for USG review and comment. The report shall summarize all work conductedduring the period of performance and provide all results (include specific items required in the report).
e) FINAL REPORT
1) The final report shall address USG comments regarding the draft report.
Technical deliverables
Del. #
1
2

3

Deliverable Description
Host a facility Audit
Procurement of critical reagentsand equipment; Proof-ofconcept data report, as
described under CLIN001
Assay technology transfer
protocol for WT virus (incoordination with ADL andBARDA)

Due Date
2 weeks from award
6 weeks after contract award

2 weeks from receipt of WT VN assay technology transfer package(documentation from ADL) as described under CLIN001

W911QY21C0012
Page 30 of 67
4

5
6

7
8

9

10
11

12

13
14

15

16

Validation protocol for reporter 2 weeks from receipt of reporter VN assay technology transfer
virus assay(in coordination with package (documentation from ADL) as described under CLIN002
ADL and BARDA)
Establishment of DMF(s)2 weeks from contract award
Submission of technology
5 weeks from receipt of technology transfer package (documentationtransfer protocol (WT assay)
from ADL)and validation protocol(Reporter assay) to DMF(s)Draft technology transfer
6 weeks from DMF submission of the technology transfer protocol
Report for WT virus assay
Final technology transfer
1 week from draft technology transfer report
Report for WT virus assay andsubmission to DMF
Copy of FDA concurrence on
Not applicable (dependent on FDA)WT virus assay readiness for
Phase 3 sample testing
Draft validation report for the
8 weeks from DMF submission of the validation protocol
reporter virus assay
Final validation report for the
1 week from draft validation reportreporter virus assay andsubmission to DMF
FDA concurrence on reporter
Not applicable (dependent on FDA)
virus assay readiness for Phase
3 sample testing
Testing batch of sera samples
3 weeks from sample receipt(1,000)
Testing batch of 1,000 sera
3 weeks from sample receipt
samples per option (Option 120)
Testing batch of 2,000 sera
4 weeks from sample receipt
samples per option (Option
21-30)
Testing batch of 5,000 sera
6 weeks from sample receipt
samples per option (Option 3135)

DELIVERY INFORMATION
CLIN

DELIVERY DATEQUANTITYSHIP TO ADDRESSDODAAC /CAGE

W911QY21C0012
Page 31 of 67
0001

POP 09-NOV-2020 TO
08-NOV-2021

N/A

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
000101 N/A

N/A

0002

N/A

POP 09-NOV-2020 TO
08-NOV-2021

N/A

N/A

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
000201 N/A

N/A

N/A

N/A

0003

N/A

BARDA

W56XNHPOP 09-NOV-2020 TO
08-NOV-2021(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
000301 N/A

N/A

0004

N/A

POP 09-NOV-2020 TO
08-NOV-2021

N/A

N/A

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
000401 N/A

N/A

0005

N/A

POP 09-NOV-2020 TO
08-NOV-2021

N/A

N/A

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
000501 N/A

N/A

N/A

N/A

W911QY21C0012
Page 32 of 67
1001

POP 09-NOV-2020 TO
08-NOV-2021

N/A

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
1002

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1003

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1004

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1005

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1006

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1007

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1008

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1009

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1010

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1011

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1012

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1013

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1014

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1015

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1016

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNHW911QY21C0012
Page 33 of 67
1017

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1018

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1019

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1020

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1021

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1022

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1023

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1024

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1025

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1026

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1027

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1028

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1029

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1030

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1031

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1032

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1033

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNH1034

POP 09-NOV-2020 TO
08-NOV-2021

N/A(SAME AS PREVIOUS LOCATION)
FOB: Destination

W56XNHW911QY21C0012
Page 36 of 67
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.
a)Communication for these requirements shall be updated as part of an annual review, or as necessary, as partof regular contractual communications.
b)
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 foreign-sourced, both
high and low volume, which would significantly affect throughput and adherence to the contractually agreed
deliveries.
The contractor shall articulate in the plan, the methodology for inventory control, , scheduling processes andordering mechanisms, as part of those agreed deliveries.
a)lead times shall be understood and communicated to the Contracting Officer or the Contracting Officer's
Representative as necessary.
b)
Production throughput critical constraints should be well understood by activity and by design, 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)
b)
c)
d)
e)
f)

Critical Material
Vendor
Supplier, Manufacturing / Distribution Location
Supplier Lead Time
Shelf Life
Transportation / Shipping restrictions

The CO and COR reserve the right to request un-redacted copies of technical documents, during the period of
performance, for distribution within the Government. Documents shall be provided within ten (10) days after CO
issues the request. The Contractor may arrange for additional time if deemed necessary, and agreed to by the CO.
F.3.
Product Development Source Material and Manufacturing 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.
F.4.
Contractor Locations: The contractor shall submit detailed data regarding locations where work will be
performed under this contract, including addresses, points of contact, and work performed per location, to include
sub-contractors.
Contractor will submit Work Locations Report:•
Within 5 business days of contract award•
Within 30 business days after a substantive location or capabilities change•
Within 2 business days of a substantive change if the work performed supports medical countermeasuredevelopment that addresses a threat that has been declared a Public Health Emergency by the HHS Secretary or a
Public Health Emergency of International Concern (PHEIC) by the WHO
F.5.
Access and General Protection/Security Policy and Procedures: This standard language text is
applicable to ALL employees working on critical information related to Operation Warp Speed (OWS), and to thosewith 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 policies andprocedures (provided by government representative). The performer also shall provide all information required forbackground checks necessary to access critical information related to OWS, and to meet Government installation

W911QY21C0012
Page 39 of 67
Closed Circuit Television(CCTV) Monitoringa)Layered (internal/external) CCTV coverage with time-lapse video
recording for buildings and areas where critical assets are processed or stored.
CCTV coverage must include entry and exits to critical facilities, perimeters, andareas within the facility deemed critical to the execution of the contract.
Video recordings must be maintained for a minimum of 30 days.
CCTV surveillance system must be on emergency power backup.
CCTV coverage must include entry and exits to critical facilities, perimeters, andareas within the facility deemed critical to the execution of the contract.
Video recordings must be maintained for a minimum of 30 days.
CCTV surveillance system must be on emergency power backup.

Facility Lighting

Shipping and Receiving

Access Control

Employee/Visitor
Identification

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

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

W911QY21C0012
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Identity Management

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

Access Control

Limit information system access to authorized users.
Identify information system users, processes acting on behalf of users, or devices andauthenticate identities before allowing access.
Limit physical access to information systems, equipment, and server rooms withelectronic access controls.
Limit access to/ verify access to use of external information systems.
Ensure that personnel are trained and are made aware of the security risks
associated with their activities and of the applicable laws, policies, standards,
regulations, or procedures related to information technology
systems.
Create, protect, and retain information system audit records to the extent needed toenable the monitoring, analysis, investigation, and reporting of unlawful,
unauthorized, or inappropriate system activity. Records must be kept for minimum
must be kept for 12 months.
Ensure the actions of individual information system users can be uniquely traced tothose users.
Update malicious code mechanisms when new releases are available.
Perform periodic scans of the information system and real time scans of files fromexternal sources as files are downloaded, opened, or executed.
Establish and enforce security configuration settings.
Implement sub networks for publically accessible system components that arephysically or logically separated from internal networks.

Training

Audit and Accountability

Configuration Management

Contingency Planning

Incident Response

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

W911QY21C0012
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1021
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Destination
Destination
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Destination

Government
Government
Government
Government
Government
Government
Government
Government
Government
Government
Government
Government
Government
Government
Government

Destination
Destination
Destination
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Destination
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Destination

Government
Government
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Government

CONTRACT ADMINISTRATION
Government Contract Administration:
In no event shall any understanding or agreement, contract modification, change order, or other matter in deviationfrom the terms of this contract between the Contractor and a person other than the Contracting Officer be effective orbinding upon the Government. All such actions must be formalized by a proper contractual document executed by theContracting Officer.
Contracting Officer:(b) (6)Bldg 1, General Greene Avenue Natick, MA 01760-5011
Procurement Specialist:(b) (6)Bldg 1, General Greene Avenue Natick, MA 01760-5011
Procurement Specialist:(b) (6)Bldg 1, General Greene Avenue Natick, MA 01760-5011
In no event shall any understanding or agreement, contract modification, change order, or other matter in deviationfrom the terms of this contract between the contractor and a person other than the Contracting Officer be effective orbinding upon the government. All such actions must be formalized by a proper contractual document executed by theContracting Officer.
Government Technical Points of Contact:
Contracting Officers Representative (COR):

W911QY21C0012
Page 45 of 67(b) (6)

Health Scientist
Influenza and Emerging Diseases Division
Biomedical Advanced Research and Development Authority (BARDA)/HHS/ASPR
200 C St SW,Washington, DC 20515
Email: (b) (6)
Office: (b) (6)Cell: (b) (6)Technical Point of Contact:(b) (6)

Biologist, Influenza and Emerging Diseases Division
Biomedical Advanced Research and Development Authority (BARDA)/HHS/ASPR
Email: (b) (6)
Office: (b) (6)Cell: (b) (6)Quality Assurance Point of Contact:(b) (6)

Title:Senior Regulatory Affairs Analyst
Email(b) (6)
Office:U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES |O’Neill Federal Office Building I Washington,
DC 20024
Phone: (b) (6)Contractor’s Contract Administration
Technical Point of Contact:(b) (6)

Senior Scientist
Email: (b) (6)
Office: (b) (6)Cell: (b) (6)Administrative Point of Contact:(b) (6)

Vice President (b) (6)Email: (b) (6)
Office: (b) (6)Cell: (b) (6)Contractor’s Past Performance Point of Contact (POC):
Annual contract past performance evaluations will be performed by the government. The offeror shall identify a Pointof Contact (POC) to participate in these on-line evaluations. This individual is required to register in the Contractor
Performance Assessment Reporting System (CPARS @ http://www.cpars.csd.disa.mil) and respond to thegovernment evaluations in a timely manner. The contractor POC responsible for this action is:(b) (6)

Vice President (b) (6)Email: (b) (6)
Office: (b) (6)W911QY21C0012
Page 46 of 67
Cell: (b) (6)Notifications of Revisions and Changes:
Notification of revision or changes to names or email addresses will be provided by official correspondence from the
PCO/ACO or office of the PCO/ACO in lieu of a contract modification. This does not apply to any such revisions orchanges in the event this contract includes a key personnel clause.

ACCOUNTING AND APPROPRIATION DATA
AA: 0212020202120400000664643255
COST CODE: A5XAHAMOUNT: (b) (4)S.0074658.5.11.1

6100.9000021001

ACRN

CLIN/SLINCINAMOUNTAA

000101000201000301000401000501

GFEBS001156087500001
GFEBS001156087500002
GFEBS001156087500003
GFEBS001156087500004
GFEBS001156087500005(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)TERMS AND CONDITIONSSPECIAL CONTRACT REQUIREMENTS
H.1.
Contractor’s Organization: The contractor's organization shall be established with authority to effectively
accomplish the objectives of the Statement of Work. This organization shall become effective upon award of thecontract and its integrity shall be maintained for the duration of the contract effort.
H.1.
Key Personnel: Any key personnel specified in this contract are considered to be essential to work
performance. At least thirty (30) calendar days prior to the contractor voluntarily diverting any of the specified
individuals to other programs or contracts the contractorshall notify the Contracting Officer and shall submit ajustification for the diversion or replacement and a request to replace the individual. The request must identify the
proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or
exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If theemployee of the contractoris terminated for cause or separates from the contractorvoluntarily with less than thirty (30)
calendar-day notice, the contractorshall provide the maximum notice practicable under the circumstances. The
contractorshall not divert, replace, or announce any such change to key personnel without the written consent of theContracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreementof the parties.
The following individuals are determined to be key personnel:•(b) (6)•(b) (6)•(b) (6)•(b) (6), Ph.D., Senior Scientist
Production Control and Operations Manager
Executive Director, Experimental Biology and Regulatory Affairs, General Manager for Microbiologics

W911QY21C0012
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H.1.1. Substitution of Key Personnel: The contractoragrees to assign to the contract those persons whose
resumes/CVs were submitted with the proposal who are necessary to fill the requirements of the contract. No
substitutions shall be made except in accordance with this guidance. All requests for substitution must provide a
detailed explanation of the circumstance necessitating the proposed substitution, a complete resume for the proposed
substitute and any other information requested by the contracting officer to approve or disapprove the proposed
substitution. All proposed substitutes must have qualifications that are equal to or higher than the qualifications of theperson to be replaced. The contracting officer or authorized representative
H.2.
Disclosure of Information: Performance under this contract may require the contractor to access non publicdata and information proprietary to a government agency, another government contractor or of such nature that its
dissemination or use other than as specified in the work statement would be adverse to the interests of the government
or others. Neither the Contractor, nor contractor personnel, shall divulge nor release data nor information developed
or obtained under performance of this contract, except authorized by government personnel or upon written approvalof the CO in accordance with OWS or other government policies and/or guidance. The contractor shall not use,
disclose, or reproduce proprietary data that bears a restrictive legend, other than as specified in this contract, or any
information at all regarding this agency.
The contractor shall comply with all government requirements for protection of non-public information. Unauthorized
disclosure of nonpublic information is prohibited by the government’s rules. Unauthorized disclosure may result intermination of the contract, replacement of a contractor employee, or other appropriate redress. Neither the contractor
nor the Contractor‘s employees shall disclose or cause to be disseminated, any information concerning the operationsof the activity, which could result in, or increase the likelihood of, the possibility of a breach of the activity‘s security
or interrupt the continuity of its operations.
No information related to data obtained under this contract shall be released or publicized without the prior writtenconsent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that nosuch consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any
government entity’ for submission to any securities exchange on which the Contractor’s (or its parent corporation’s)securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining
regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, orother business transactions.
H.3.
Publication and Publicity: The contractor shall not release any reports, manuscripts, press releases, orabstracts about the work being performed under this contract without written notice in advance to the government.
(a)Unless otherwise specified in this contract, the contractor may “NOT” publish the results of its work under
this contract. The contractor shall promptly send a copy of each submission to the COR for security review prior to
submission. The contractor shall also inform the COR when the abstract article or other publication is published, andfurnish a copy of it as finally published.
(b)
Unless authorized in writing by the CO, the contractor shall “NOT” display government logos including
Operating Division or Staff Division logos on any publications.
(c)
The contractor shall “NOT” reference the products(s) or services(s) awarded under this contract incommercial 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.
(d)
The contractor shall include this language, including this section (d) in all subcontracts where thesubcontractor may propose publishing the results of its work under the subcontract. The contractor shall acknowledge
the support of the government whenever publicizing the work under this contract in any media by including an
acknowledgement substantially as follows:"This project has been funded in whole or in part by the U.S. government under Contract No. ”W911QY-21-C- 0012”.
The US government is authorized to reproduce and distribute reprints for governmental purposes notwithstanding any

W911QY21C0012
Page 48 of 67
copyright notation thereon.
H.4.

Confidentiality of Information:a.
Confidential information, as used in this article, means information or data of a personal nature about anindividual, or proprietary information or data submitted by or pertaining to an institution or organization.
b.
The Contracting Officer and the contractor may, by mutual consent, identify elsewhere in this contract
specific information and/or categories of information which the government will furnish to the contractor or that thecontractor is expected to generate which is confidential. Similarly, the Contracting Officer and the contractor may, by
mutual consent, identify such confidential information from time to time during the performance of the contract.
Failure to agree will be settled pursuant to the "Disputes" clause.
c.
If it is established elsewhere in this contract that information to be utilized under this contract, or a portion
thereof, is subject to the Privacy Act, the contractor will follow the rules and procedures of disclosure set forth in the
Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records
determined to be subject to the Privacy Act.
d.
Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the priorwritten consent of the individual, institution, or organization.
e.
Whenever the contractor is uncertain with regard to the proper handling of material under the contract, or if
the material in question is subject to the Privacy Act or is confidential information subject to the provisions of thisarticle, the contractor shall obtain a written determination from the Contracting Officer prior to any release, disclosure,dissemination, or publication.
f.
Contracting Officer Determinations will reflect the result of internal coordination with appropriate program
and legal officials.
g.
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other
Federal, State or local laws.
All above requirements MUST be passed to all Sub-contractors.
H.5.
Organizational Conflicts of Interest: Performance under this contract may create an actual or potential
organizational conflict of interest such as are contemplated by FAR Part 9.505-General Rules. The contractor shallnot engage in any other contractual or other activities which could create an organizational conflict of interest (OCI).
This provision shall apply to the prime contractor and all sub-Contractors. This provision shall have effect throughout
the period of performance of this contract, any extensions thereto by change order or supplemental agreement, and fortwo (2) years thereafter. The government may pursue such remedies as may be permitted by law or this contract, upondetermination that an OCI has occurred.
The work performed under this contract may create a significant potential for certain conflicts of interest, as set forthin FAR Parts 9.505-1, 9.505-2, 9.505-3, and 9.505-4. It is the intention of the parties hereto to prevent both the potential
for bias in connection with the Contractor‘s performance of this contract, as well as the creation of any unfair
competitive advantage as a result of knowledge gained through access to any non-public data or third party proprietary
information.
The contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access orparticipation may result in any actual or potential OCI. Furthermore, the contractor shall promptly submit a plan to
the Contracting Officer to either avoid or mitigate any such OCI. The Contracting Officer will have sole discretion in
accepting the Contractor‘s mitigation plan. In the event the Contracting Officer unilaterally determines that any such
OCI cannot be satisfactorily avoided or mitigated, other remedies may be taken to prohibit the contractor fromparticipating in contract requirements related to OCI.

W911QY21C0012
Page 49 of 67
Whenever performance of this contract provides access to another Contractor‘s proprietary information, the contractor
shall enter into a written agreement with the other entities involved, as appropriate, in order to protect such proprietary
information from unauthorized use or disclosure for as long as it remains proprietary; and refrain from using suchproprietary information other than as agreed to, for example to provide assistance during technical evaluation of other
Contractors’ offers or products under this contract. An executed copy of all proprietary information agreements byindividual personnel or on a corporate basis shall be furnished to the CO within fifteen (15) calendar days of execution.
H.6.
Institutional Responsibility Regarding Investigator Conflicts of Interest: The Institution (includes any
Contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45 CFR Part 94,
Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that
Investigators (defined as the project director or principal Investigator and any other person, regardless of title orposition, who is responsible for the design, conduct, or reporting of research funded under government contracts, or
proposed for such funding, which may include, for example, collaborators or consultants) will not be biased by any
Investigator financial conflicts of interest. 45 CFR Part 94 is available at the following Web site:
https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=45:1.0.1.1.51
As required by 45 CFR Part 94, the Institution shall, at a minimum:a.
Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45
CFR Part 94, inform each Investigator of the policy, the Investigator's reporting responsibilities regarding disclosureof significant financial interests, and the applicable regulation, and make such policy available via a publicly accessible
Web site, or if none currently exist, available to any requestor within five business days of a request. A significant
financial interest means a financial interest consisting of one or more of the following interests of the Investigator (andthose of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's
institutional responsibilities:
1.
With regard to any publicly traded entity, a significant financial interest exists if the value of any
remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity
interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity
interests;
2.
With regard to any non-publicly traded entity, a significant financial interest exists if the value of any
remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds$5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest; or3.

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

Significant financial interests do not include the following:
1.
Income from seminars, lectures, or teaching, and service on advisory or review panels for government
agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an
Institution of higher learning; and2.
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator
does not directly control the investment decisions made in these vehicles.
b.
Require each Investigator to complete training regarding the Institution's financial conflicts of interest policy
prior to engaging in research related to any government funded contract and at least every four years. The Institution
must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or
subcontractors comply with the regulations.
c.
Designate an official(s) to solicit and review disclosures of significant financial interests from each
Investigator who is planning to participate in, or is participating in, the government funded research.
d.

Require that each Investigator who is planning to participate in the government funded research disclose toW911QY21C0012
Page 50 of 67
the Institution's designated official(s) the Investigator's significant financial interest (and those of the Investigator's
spouse and dependent children) no later than the date of submission of the Institution's proposal for government funded
research. Require that each Investigator who is participating in the government funded research to submit an updated
disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by
the Institution during the period of the award as well as within thirty days of discovering or acquiring a new significant
financial interest.
e.
Provide guidelines consistent with the regulations for the designated official(s) to determine whether an
Investigator's significant financial interest is related to government funded research and, if so related, whether thesignificant financial interest is a financial conflict of interest. An Investigator's significant financial interest is related
to government funded research when the Institution, thorough its designated official(s), reasonably determines thatthe significant financial interest: Could be affected by the government funded research; or is in an entity whose
financial interest could be affected by the research. A financial conflict of interest exists when the Institution, throughits designated official(s), reasonably determines that the significant financial interest could directly and significantly
affect the design, conduct, or reporting of the government funded research.
f.
Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts ofa subcontractor Investigator. Management of an identified financial conflict of interest requires development andimplementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part
94.5(a).
g.

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

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

W911QY21C0012
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H.7.
All special requirements list in Section H shall be included or added into any subcontract awarded by thecontractor. Additionally all required contract clauses must flow down to any and all subcontracts award by thecontractor.

CLAUSES INCORPORATED BY REFERENCE
52.204-7
52.204-13
52.204-21
52.204-24
52.204-25
52.212-3 Alt I
52.232-40
252.203-7000
252.204-7012
252.211-7003
52.227-11
252.227-7013
252.227-7015
252.227-7039
252.232-7003
252.232-7010
252.244-7000

System for Award Management
System for Award Management Maintenance
Basic Safeguarding of Covered Contractor Information
Systems
Representation Regarding Certain Telecommunications andVideo Surveillance Services or Equipment.
Prohibition on Contracting for Certain Telecommunications
and Video Surveillance Services or Equipment.
Offeror Representations and Certifications--Commercial
Items (AUG 2020) Alternate I
Providing Accelerated Payments to Small BusinessSubcontractors
Requirements Relating to Compensation of Former DoD
Officials
Safeguarding Covered Defense Information and Cyber
Incident Reporting
Item Unique Identification and Valuation
Patent Rights--Ownership By The Contractor
Rights in Technical Data--Noncommercial Items
Technical Data--Commercial Items
Patents--Reporting Of Subject Inventions
Electronic Submission of Payment Requests and Receiving
Reports
Levies on Contract Payments
Subcontracts for Commercial Items

OCT 2018
OCT 2018
JUN 2016
AUG 2020
AUG 2020
OCT 2014
DEC 2013
SEP 2011
DEC 2019
MAR 2016
MAY 2014
FEB 2014
FEB 2014
APR 1990
DEC 2018
DEC 2006
JUN 2013

CLAUSES INCORPORATED BY FULL TEXT
52.204-14 SERVICE CONTRACT REPORTING REQUIREMENTS (OCT 2016)(a) Definition. First-tier subcontract means a subcontract awarded directly by
the Contractor for the purpose of acquiring supplies or services (including construction) for performance of a prime
contract. It does not include the Contractor's supplier agreements with vendors, such as long-term arrangements formaterials or supplies that benefit multiple contracts and/or the costs of which are normally applied to a Contractor's
general and administrative expenses or indirect costs.
(b) The Contractor shall report, in accordance with paragraphs (c) and (d) of this clause, annually by October 31, forservices performed under this contract during the preceding Government fiscal year (October 1-September 30).
(c) The Contractor shall report the following information:(1) Contract number and, as applicable, order number.

W911QY21C0012
Page 52 of 67(2) The total dollar amount invoiced for services performed during the previous Government fiscal year under thecontract.
(3) The number of Contractor direct labor hours expended on the services performed during the previous
Government fiscal year.
(4) Data reported by subcontractors under paragraph (f) of this clause.
(d) The information required in paragraph (c) of this clause shall be submitted via the internet at www.sam.gov. (SeeSAM User Guide). If the Contractor fails to submit the report in a timely manner, the contracting officer will
exercise appropriate contractual remedies. In addition, the Contracting Officer will make the Contractor's failure tocomply with the reporting requirements a part of the Contractor's performance information under FAR subpart42.15.
(e) Agencies will review Contractor reported information for reasonableness and consistency with available contract
information. In the event the agency believes that revisions to the Contractor reported information are warranted, theagency will notify the Contractor no later than November 15. By November 30, the Contractor shall revise thereport, or document its rationale for the agency.
(f)(1) The Contractor shall require each first-tier subcontractor providing services under this contract, with
subcontract(s) each valued at or above the thresholds set forth in 4.1703(a)(2), to provide the following detailed
information to the Contractor in sufficient time to submit the report:(i) Subcontract number (including subcontractor name and unique entity identifier); and(ii) The number of first-tier subcontractor direct-labor hours expended on the services performed during the previous
Government fiscal year.
(2) The Contractor shall advise the subcontractor that the information will be made available to the public asrequired by section 743 of Division C of the Consolidated Appropriations Act, 2010.
(End of clause)

52.212-4

CONTRACT TERMS AND CONDITIONS-- COMMERCIAL ITEMS (OCT 2018)(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to therequirements of this contract. The Government reserves the right to inspect or test any supplies or services that havebeen tendered for acceptance. The Government may require repair or replacement of nonconforming supplies orreperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance
will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate
consideration for acceptance of nonconforming supplies or services. The Government must exercise its postacceptance rights (1) within a reasonable time after the defect was discovered or should have been discovered; and(2) before any substantial change occurs in the condition of the item, unless the change is due to the defect in theitem.
(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of
performance of this contract to a bank, trust company, or other financing institution, including any Federal lending
agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes
payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights toreceive payment under this contract.

W911QY21C0012
Page 53 of 67(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of theparties.
(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes'', as amended (41 U.S.C. 601-613).
Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or
action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR
52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently withperformance of this contract, pending final resolution of any dispute arising under the contract.
(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.
(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence
beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public
enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine
restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify theContracting Officer in writing as soon as it is reasonably possible after the commencement or any excusable delay,
setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch
and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.
(g) Invoice.
(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to theaddress designated in the contract to receive invoices. An invoice must include-(i) Name and address of the Contractor;(ii) Invoice date and number;(iii) Contract number, line item number and, if applicable, the order number;(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on
Government bill of lading;(vi) Terms of any discount for prompt payment offered;(vii) Name and address of official to whom payment is to be sent;(viii) Name, title, and phone number of person to notify in event of defective invoice; and(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if requiredelsewhere in this contract.
(x) Electronic funds transfer (EFT) banking information.
(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.
(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice,
the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation
provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for AwardManagement, or 52.232-34, Payment by Electronic
Funds Transfer--Other Than System for Award Management), or applicable agency procedures.
(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

W911QY21C0012
Page 54 of 67(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office ofManagement and Budget (OMB) prompt payment regulations at 5 CFR part 1315.
(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against
liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any
United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided theContractor is reasonably notified of such claims and proceedings.
(i) Payment.-(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to thedelivery destinations set forth in this contract.
(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C.
3903) and prompt payment regulations at 5 CFR part 1315.
(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate
EFT clause.
(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of theinvoice. For the purpose of computing the discount earned, payment shall be considered to have been made on thedate which appears on the payment check or the specified payment date if an electronic funds transfer payment ismade.
(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that theGovernment has otherwise overpaid on a contract financing or invoice payment, the Contractor shall-(i) Remit the overpayment amount to the payment office cited in the contract along with a description of theoverpayment including the-(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of
overpayment);(B) Affected contract number and delivery order number, if applicable;(C) Affected line item or subline item, if applicable; and(D) Contractor point of contact.
(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(6) Interest.
(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple
interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be theinterest rate established by the Secretary of the Treasury as provided in 41 U.S.C.
7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause,and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.
(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under thecontract.
(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if--W911QY21C0012
Page 55 of 67(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt
within 30 days;(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline
specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an
installment payment agreement; or(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer(see 32.607-2).
(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final
decision shall identify the same due date as the original demand for payment.
(v) Amounts shall be due at the earliest of the following dates:(A) The date fixed under this contract.
(B) The date of the first written demand for payment, including any demand for payment resulting from a default
termination.
(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due
date and ending on-(A) The date on which the designated office receives payment from the Contractor;(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has
been withheld as a credit against the contract debt; or(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to
the Contractor.
(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of theFederal Acquisition Regulation in effect on the date of this contract.
(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided
under this contract shall remain with the Contractor until, and shall pass to the Government upon:(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b.
destination.
(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.
(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or
any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all
work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject tothe terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of
the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to thesatisfaction of the Government using its standard record keeping system, have resulted from the termination. The
Contractor shall not be required to comply with the cost accounting standards or contract cost principles for thispurpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor
shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

W911QY21C0012
Page 56 of 67(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event ofany default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails toprovide the Government, upon request, with adequate assurances of future performance. In the event of termination
for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted,
and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it isdetermined that the Government improperly terminated this contract for default, such termination shall be deemed atermination for convenience.
(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to theGovernment upon acceptance, regardless of when or where the Government takes physical possession.
(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for
use for the particular purpose described in this contract.
(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to
the Government for consequential damages resulting from any defect or deficiencies in accepted items.
(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive
orders, rules and regulations applicable to its performance under this contract.
(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352
relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating
to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C.
chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118,
Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.
(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence inthe following order: (1) the schedule of supplies/services; (2) The Assignments, Disputes, Payments, Invoice, Other
Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphsof this clause; (3) the clause at 52.212-5; (4) addenda to this solicitation or contract, including any license
agreements for computer software; (5) solicitation provisions if this is a solicitation; (6) other paragraphs of thisclause; (7) the Standard Form 1449; (8) other documents, exhibits, and attachments; and (9) the specification.
(t) Reserved.
(u) Unauthorized Obligations.
(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract issubject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument oragreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity
for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C.
1341), the following shall govern:(i) Any such clause is unenforceable against the Government.
(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clauseby virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar
legal instrument or agreement is invoked through an ``I agree'' click box or other comparable mechanism (e.g.,``click-wrap'' or ``browse-wrap'' agreements), execution does not bind the Government or any
Government authorized end user to such clause.
(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.
(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized
by statute and specifically authorized under applicable agency regulations and procedures.

W911QY21C0012
Page 57 of 67(v) Incorporation by reference. The Contractor's representations and certifications, including those completed
electronically via the System for Award Management (SAM), are incorporated by reference into the contract.
(End of Clause)

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OREXECUTIVE ORDERS--COMMERCIAL ITEMS (AUG 2020)(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which areincorporated in this contract by reference, to implement provisions of law or Executive orders applicable toacquisitions of commercial items:(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.
113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided byKaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services orEquipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has
indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders
applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)
XX (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (Oct 1995)(41 U.S.C. 4704 and 10 U.S.C. 2402).
XX (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
____ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment
Act of 2009.)
XX (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L.
109-282) (31 U.S.C. 6101 note).
___ (5) [Reserved]
XX (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub.
L. 111-117, section 743 of Div. C).

W911QY21C0012
Page 58 of 67
XX (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended,or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
XX (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41
U.S.C. 2313).
____ (10) [Reserved]____ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).
(ii) Alternate I (MAR 2020) of 52.219-3.
____ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020)(if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).
____ (ii) Alternate I (MAR 2020) of 52.219-4.
____ (13) [Reserved]
XX (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).
____ (ii) Alternate I (MAR 2020) of 52.219-6.
____ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).
____ (ii) Alternate I (MAR 2020) of 52.219-7.
____ (16) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).
____ (17)(i) 52.219-9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).
____ (ii) Alternate I (NOV 2016) of 52.219-9.
____ (iii) Alternate II (NOV 2016) of 52.219-9.
____ (iv) Alternate III (JUN 2020) of 52.219-9.
____ (v) Alternate IV (JUN 2020) of 52.219-9.
____ (18) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).
____ (ii) Alternate I (MAR 2020) of 52.219-13.
____ (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C. 637(a)(14)).
____ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
____ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15
U.S.C. 657f).
____ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (MAY 2020) (15 U.S.C. 632(a)(2)).
____ (ii) Alternate I (MAR 2020) of 52.219-28.

W911QY21C0012
Page 59 of 67____ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged WomenOwned Small Business (EDWOSB) Concerns (MAR 2020) (15 U.S.C. 637(m)).
____ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns
Eligible Under the Women-Owned Small Business Program (MAR 2020) (15 U.S.C. 637(m)).
____ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).
____ (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)).
XX (27) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).
XX(28) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126).
XX (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
XX (30)(i) 52.222-26, Equal Opportunity (SEPT 2016) (E.O. 11246).
____ (ii) Alternate I (FEB 1999) of 52.222-26.
XX (31)(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
____ (ii) Alternate I (JUL 2014) of 52.222-35.
XX (32)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
____ (ii) Alternate I (JUL 2014) of 52.222-36.
XX (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
XX (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O.
13496).
XX (35)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).
____ (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
XX (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to theacquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in
22.1803.)____ (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (MAY2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf
items.)____ (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition ofcommercially available off-the-shelf items.)____ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN2016) (E.O. 13693).
____ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners(JUN 2016) (E.O. 13693).
____ (40) (i) 52.223-13, Acquisition of EPEAT® Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and13514).

W911QY21C0012
Page 60 of 67____ (ii) Alternate I (OCT 2015) of 52.223-13.
____ (41)(i) 52.223-14, Acquisition of EPEAT® Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).
____ (ii) Alternate I (JUN 2014) of 52.223-14.
____ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).
____ (43)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s
13423 and 13514).
____ (ii) Alternate I (JUN 2014) of 52.223-16.
XX (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O.
13513).
____ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).
____ (46) 52.223-21, Foams (JUN 2016) (E.O. 13693).
____ (47)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).
____ (ii) Alternate I (JAN 2017) of 52.224-3.
____ (48) 52.225-1, Buy American--Supplies (MAY 2014) (41 U.S.C. chapter 83).
____ (49) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014) (41 U.S.C. chapter
83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77,
108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
____ (ii) Alternate I (MAY 2014) of 52.225-3.
____ (iii) Alternate II (MAY 2014) of 52.225-3.
____ (iv) Alternate III (MAY 2014) of 52.225-3.
XX (50) 52.225-5, Trade Agreements (OCT 2019) 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
XX (51) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes
administered by the Office of Foreign Assets Control of the Department of the Treasury).
____ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016)(Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
____ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150____ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV 2007) (42 U.S.C.
5150).
____ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
XX (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C. 4505, 10 U.S.C.
2307(f)).

W911QY21C0012
Page 61 of 67____ (57) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
____ (58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (OCT 2018) (31
U.S.C. 3332).
____ (59) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (JUL2013) (31 U.S.C. 3332).
XX (60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).
____ (61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).
____ (62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).
____ (63)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C.
Appx. 1241(b) and 10 U.S.C. 2631).
____ (ii) Alternate I (APR 2003) of 52.247-64.
____ (iii) Alternate II (FEB 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that
the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions oflaw or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)
XX (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).
XX (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C.
chapter 67).
_____ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (Multiple
Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
_____ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (MAY2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).
_____ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for
Maintenance, Calibration, or Repair of Certain Equipment--Requirements (MAY 2014) (41 U.S.C. chapter 67).
_____ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services--Requirements (MAY 2014) (41 U.S.C. chapter 67).
XX(7) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015) (E.O. 13658).
XX (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
_____ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph(d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as
defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit andRecords--Negotiation.

W911QY21C0012
Page 62 of 67(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shallhave access to and right to examine any of the Contractor's directly pertinent records involving transactions related
to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and otherevidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any
shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If
this contract is completely or partially terminated, the records relating to the work terminated shall be madeavailable for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes
clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available
until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data,
regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that
the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, theContractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1)in a subcontract forcommercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by theclause—(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.
113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided byKaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services orEquipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts
that offer further subcontracting opportunities. If the subcontract (except subcontracts
to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract
award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).
(xiii) _____ (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

W911QY21C0012
Page 63 of 67_____ (B) Alternate I (March 2, 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for
Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services--Requirements (May 2014) (41 U.S.C. chapter 67)(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

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

52.217-8

OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in
the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the
Secretary of Labor. The option provision may be exercised more than once, but the total extension of performancehereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to theContractor within period of performance listed in the option CLINS.
(End of clause)

52.217-9

OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)(a) The Government may extend the term of this contract by written notice to the Contractor within any time during
the period of performance listed within the option CLINS; provided that the Government gives the Contractor aW911QY21C0012
Page 64 of 67
preliminary written notice of its intent to extend at least 2 days before the contract expires. The preliminary noticedoes not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed
twenty four months.
(End of clause)

52.246-15

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

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)(a) Definitions. As used in this clause—“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit,
activity, or organization.

W911QY21C0012
Page 65 of 67“Document type” means the type of payment request or receiving report available for creation in Wide Area
WorkFlow (WAWF).
“Local processing office (LPO)” is the office responsible for payment certification when payment certification isdone external to the entitlement system.
“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission ofPayment Requests and Receiving Reports.
(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests
and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.2327003, Electronic Submission of Payment Requests and Receiving Reports.
(c) WAWF access. To access WAWF, the Contractor shall—(1) Have a designated electronic business point of contact in the System for Award Management at
https://www.sam.gov; and(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration
available at this web site.
(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training
Course and use the Practice Training Site before submitting payment requests through WAWF. Both can beaccessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.
(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data
Interchange, or File Transfer Protocol.
(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment
requests and receiving reports in WAWF for this contract or task or delivery order:(1) Document type. The Contractor shall submit payment requests using the following document type(s):(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.
(ii) For fixed price line items—(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting
Officer.
Receiving Report (DD 250) Destination Inspection / Destination Acceptance /Inspection and Acceptance at place ofdestination(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets therequirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by theContracting Officer.
Invoice as 2-in-1 (FP Services Only – No DD250 Required)(iii) For customary progress payments based on costs incurred, submit a progress payment request.
(iv) For performance based payments, submit a performance based payment request.
(v) For commercial item financing, submit a commercial item financing request.

W911QY21C0012
Page 66 of 67(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in thecontract.
[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice andreceiving report in one step.](3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in
applicable fields in WAWF when creating payment requests and receiving reports in the system.
Routing Data Table*
Field Name in WAWF

Data to be entered in WAWF

Pay Official DoDAAC(b) (4)

Issue By DoDAAC
Admin DoDAAC**
Inspect By DoDAAC
Ship To Code
Ship From CodeMark For Code
Service Approver (DoDAAC)
Service Acceptor (DoDAAC)
Accept at Other DoDAAC
LPO DoDAAC
DCAA Auditor DoDAAC
Other DoDAAC(s)(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert“See Schedule” or “Not applicable.”)(**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the
DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the typeof payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition
Regulation 52.216-7, Allowable Cost and Payment, as applicable.
(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.
(g) WAWF point of contact.
(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s
WAWF point of contact.
Name(b) (6)(b) (6)(b) (6)

Email

Phone

Job Title
JPEO WAWF Acceptor
COR/Acceptor
Contracting Officer

W911QY21C0012
Page 67 of 67
Contract Specialist
Contract Specialist(b) (6)(b) (6)(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.
(End of clause)

ATTACHMENTS & REFERENCES
Attachments:
Attachmnet 0001: Reference list

W911QY21C0012
P00001Page 2 of 31
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 1449 - CONTINUATION SHEETSOLICITATION/CONTRACT FORM

The total cost of this contract was increased by(b) (4)from (b) (4)(b) (4)
SUPPLIES OR SERVICES AND PRICES

CLIN 0003
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1001
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1002
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1003
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1004
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1005
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)toW911QY21C0012
P00001Page 3 of 31
CLIN 1006
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1007
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1008
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1009
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1010
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1011
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1012
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1013
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1014
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1015.

W911QY21C0012
P00001Page 4 of 31
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1016
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1017
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4) .
The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1018
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1019
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4) .
The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1020
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1021
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4) .
The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1022
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4) .
The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1023
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1024
The unit price amount has decreased by (b) (4) from (b) (4)to (b) (4) .

W911QY21C0012
P00001Page 5 of 31
The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1025
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1026
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4) .
The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1027
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1028
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1029
The unit price amount has decreased by (b) (4) from(b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1030
The unit price amount has decreased by(b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by $(b) (4)from (b) (4)to (b) (4)CLIN 1031
The unit price amount has decreased by (b) (4) from(b) (4)The total cost of this line item has decreased by (b) (4)to (b) (4)from (b) (4)to (b) (4)CLIN 1032
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1033
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4).

W911QY21C0012
P00001Page 6 of 31

CLIN 1034
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 1035
The unit price amount has decreased by (b) (4) from (b) (4) to (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 0006 is added as follows:
ITEM NO
0006

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
Technlology Transfer of Wild Type Assay
FFP
The contractor shall Technology Transfer (TT) the validated WT virus
neutralization (VN) assay and demonstrate method equivalence. All required work
shall be IAW the SOW and Commercial Solution Proposal titled "COMMERCIAL
SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001-A002", dated
November 9, 2020.
FOB: Destination
PSC CD: Q301

NET AMTAMOUNT(b) (4)(b) (4)SUBCLIN 000601 is added as follows:
ITEM NO
000601

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

ACRN AA @ (b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0002

NET AMT
ACRN AA
CIN: GFEBS001156087500006

CLIN 0007 is added as follows:(b) (4)(b) (4)

W911QY21C0012
P00001Page 7 of 31
ITEM NO
0007

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
Technlology Transfer of Wild Type Assay
FFP
The contractor shall Technology Transfer (TT) the validated WT virus
neutralization (VN) assay and demonstrate method equivalence. All required work
shall be IAW the SOW and Commercial Solution Proposal titled "COMMERCIAL
SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001-A002", dated
November 9, 2020.
FOB: Destination
PSC CD: Q301

NET AMTAMOUNT(b) (4)(b) (4)SUBCLIN 000701 is added as follows:
ITEM NO
000701

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

ACRN AA @ (b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0002

NET AMT
ACRN AA
CIN: GFEBS001156087500007

CLIN 0008 is added as follows:(b) (4)(b) (4)

W911QY21C0012
P00001Page 8 of 31
ITEM NO
0008

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
Technlology Transfer of Wild Type Assay
FFP
The contractor shall Technology Transfer (TT) the validated WT virus
neutralization (VN) assay and demonstrate method equivalence. All required work
shall be IAW the SOW and Commercial Solution Proposal titled "COMMERCIAL
SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001-A002", dated
November 9, 2020.
FOB: Destination
PSC CD: Q301

NET AMTAMOUNT(b) (4)(b) (4)SUBCLIN 000801 is added as follows:
ITEM NO
000801

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

ACRN AA @ (b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0002

NET AMT
ACRN AA
CIN: GFEBS001156087500008

CLIN 0009 is added as follows:(b) (4)(b) (4)

W911QY21C0012
P00001Page 9 of 31
ITEM NO
0009

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
Technlology Transfer of Wild Type Assay
FFP
The contractor shall Technology Transfer (TT) the validated WT virus
neutralization (VN) assay and demonstrate method equivalence. All required work
shall be IAW the SOW and Commercial Solution Proposal titled "COMMERCIAL
SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001-A002", dated
November 9, 2020.
FOB: Destination
PSC CD: Q301

NET AMTAMOUNT(b) (4)(b) (4)SUBCLIN 000901 is added as follows:
ITEM NO
000901

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

ACRN AA @ (b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0002

NET AMT
ACRN AA
CIN: GFEBS001156087500009

CLIN 0010 is added as follows:(b) (4)

W911QY21C0012
P00001Page 10 of 31
ITEM NO
0010

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
Technlology Transfer of Wild Type Assay
FFP
The contractor shall Technology Transfer (TT) the validated WT virus
neutralization (VN) assay and demonstrate method equivalence. All required work
shall be IAW the SOW and Commercial Solution Proposal titled "COMMERCIAL
SOLUTIONS PROPOSAL: CSO AOI W911QY-20-S-C001-A002", dated
November 9, 2020.
FOB: Destination
PSC CD: Q301

AMOUNT(b) (4)

NET AMT(b) (4)

UNIT PRICEAMOUNTSUBCLIN 001001 is added as follows:
ITEM NO
001001

SUPPLIES/SERVICESQUANTITY

UNIT(b) (4)

ACRN AA @ (b) (4)FFP
PURCHASE REQUEST NUMBER: 0011560875-0002

NET AMT
ACRN AA
CIN: GFEBS001156087500010(b) (4)

ACCOUNTING AND APPROPRIATION

Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by (b) (4)from(b) (4)to (b) (4).
SUBCLIN 000301:
AA: 0212020202120400000664643255
S.0074658.5.11.1
GFEBS001156087500003) was decreased by (b) (4)from (b) (4)SUBCLIN 000601:
Funding on SUBCLIN 000601 is initiated as follows:(b) (4)6100.9000021001 A5XAH (CIN
to (b) (4)W911QY21C0012
P00001Page 11 of 31
ACRN: AA
CIN: GFEBS001156087500006
Acctng Data: 0212020202120400000664643255

S.0074658.5.11.1

6100.9000021001

S.0074658.5.11.1

6100.9000021001

S.0074658.5.11.1

6100.9000021001

S.0074658.5.11.1

6100.9000021001

Increase:(b) (4)Total: (b) (4)Cost Code: A5XAHSUBCLIN 000701:
Funding on SUBCLIN 000701 is initiated as follows:
ACRN: AA
CIN: GFEBS001156087500007
Acctng Data: 0212020202120400000664643255
Increase: (b) (4)Total: (b) (4)Cost Code: A5XAHSUBCLIN 000801:
Funding on SUBCLIN 000801 is initiated as follows:
ACRN: AA
CIN: GFEBS001156087500008
Acctng Data: 0212020202120400000664643255
Increase: (b) (4)Total: (b) (4)Cost Code: A5XAHSUBCLIN 000901:
Funding on SUBCLIN 000901 is initiated as follows:
ACRN: AA
CIN: GFEBS001156087500009
Acctng Data: 0212020202120400000664643255
Increase: (b) (4)Total: (b) (4)W911QY21C0012
P00001Page 12 of 31
Cost Code: A5XAHSUBCLIN 001001:
Funding on SUBCLIN 001001 is initiated as follows:
ACRN: AA
CIN: GFEBS001156087500010
Acctng Data: 0212020202120400000664643255

S.0074658.5.11.1

6100.9000021001

Increase: (b) (4)Total: (b) (4)Cost Code: A5XAHDELIVERIES AND PERFORMANCE
The following Delivery Schedule for CLIN 0006 has been added:
DELIVERY DATEQUANTITY

POP 19-MAR-2021 TO
08-NOV-2021

N/A

SHIP TO ADDRESSDODAAC /
CAGE

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
The following Delivery Schedule for CLIN 0007 has been added:
DELIVERY DATEQUANTITY

POP 19-MAR-2021 TO
08-NOV-2021

N/A

SHIP TO ADDRESSDODAAC /
CAGE

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
The following Delivery Schedule for CLIN 0008 has been added:
DELIVERY DATEQUANTITYSHIP TO ADDRESSDODAAC /CAGE

W911QY21C0012
P00001Page 13 of 31
POP 19-MAR-2021 TO
08-NOV-2021

N/A

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
The following Delivery Schedule for CLIN 0009 has been added:
DELIVERY DATEQUANTITY

POP 19-MAR-2021 TO
08-NOV-2021

N/A

SHIP TO ADDRESSDODAAC /
CAGE

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
The following Delivery Schedule for CLIN 0010 has been added:
DELIVERY DATEQUANTITYSHIP TO ADDRESSDODAAC /CAGE

POP 19-MAR-2021 TO
08-NOV-2021

N/A

BARDA

W56XNH(b) (6)

BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTH
200 C STREET, SW
WASHINGTON DC 20024(b) (6)

FOB: Destination
INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for CLIN 0006:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 000601:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for CLIN 0007:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

W911QY21C0012
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The following Acceptance/Inspection Schedule was added for SUBCLIN 000701:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for CLIN 0008:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 000801:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for CLIN 0009:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 000901:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for CLIN 0010:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 001001:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following have been modified:

ADDENDUM: The following pages hereby supplements FAR 52.212-4
SOW For COVID-19 Immune Assay Implementation and Serum Testing Services
Title of Project: Establishment of high throughput neutralization assay laboratory capability for COVID-19 andtesting of human serum samples
1.

Introduction
An outbreak of respiratory disease caused by a novel coronavirus was first detected in China in late 2019 and has now
spread worldwide, including the United States (US). The virus has been named Severe Acute Respiratory Disease
Coronavirus-2 (SARS-CoV-2) and causes Coronavirus Disease 2019 (COVID-19). On January 30, 2020, theInternational Health Regulations Emergency Committee of the World Health Organization (WHO), declared theoutbreak a “Public Health Emergency of International Concern” (PHEIC). On January 31, the US Department of

W911QY21C0012
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Health and Human Services Secretary (HHS), Alex M. Azar II, declared a Public Health Emergency for the US to aid
the nation’s healthcare community in responding to COVID-19. On March 11, WHO publicly declared COVID-19 asa pandemic. On March 13, the President of the United States declared the COVID-19 outbreak a national emergency.
The US Government (USG) has identified COVID-19 vaccine candidates (prototypes) that are progressing rapidly
through advanced research and development activities. A joint HHS and Department of Defense (DOD) leadershipteam named Operation Warp Speed (OWS) is charged with development of COVID-19 vaccines and other medical
countermeasures.
This procurement action is aimed at providing additional laboratory assay capacity sites for analysis of serum samples
collected from subjects enrolled in COVID-19 vaccine clinical trials. Serum samples are tested to ascertain the abilityof the vaccine to induce an immune response. Studies have shown that serum antibodies directed against viral spike(S) that block infection of target cells can be readily detected by Virus Neutralization (VN) assays. The USG has
supported development of two VN assays at two organizations herein designates as “assay developer laboratory(ADL)” and seeks to transfer this assay technology to a new facility per this solicitation.
The FDA published guidance Development and Licensure of Vaccines to Prevent COVID-19 (6/30/2020) for
manufacturers developing COVID-19 vaccines. The guidance document states: “There are currently no acceptedsurrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19 vaccine” (1). Use of new
vaccines will require an Emergency Use Authorization or a BLA approval based on direct evidence of vaccine safety
and efficacy in protecting humans from SARS-CoV-2 infection and/or clinical disease. The ultimate goal of thisproject is to provide serologic data to support establishment of a correlate of protection. The latter would facilitate
expanded use of approved COVID-19 vaccines and accelerated approvals of additional vaccines.
2.

Scope
The program goals are twofold: 1. Technology transfer of two VN assays to a Biosafety Level 3 (BSL3) laboratory
other than the ADL in compliance with GCLP (Contract Base period). The first transfer will include transfer of a highthroughput validated neutralization assay and subsequent method equivalence demonstration meeting FDA
requirements for Phase 3 sample testing; the second will include technology transfer of a qualified live virus reporter
assay for subsequent validation meeting FDA requirements for Phase 3 sample testing. 2. Test serum samples fromhuman subjects enrolled in clinical trials of COVID-19 vaccines using the new validated assay in compliance with
GCLP.

3.

Regulatory compliance
The offeror is expected to comply with GCLP Standards (2).
The neutralization assays must be conducted with live SARS-CoV-2 virus; therefore, laboratory testing must be
conducted in a BSL-3 environment (3). The offeror’s facility must demonstrate appropriate permits for the operationof the laboratory facilities in compliance with BSL-3 as described in CDC Guidelines. The offeror should describe
the safety procedures and provide assurances regarding Facility Safety Plan, CDC guidelines, and the appropriate
SOPs and institutional biosafety requirements for handing live SARS-COV-2.
Given that the test results for human sera collected as part of a clinical trial are part of a BLA submission to the FDA,
the organization must be prepared to provide the necessary supporting quality systems documentation to the sponsor
company for inclusion in the regulatory filing or in the course of quality audits (4,5). These supporting quality
systems along with assay validation reports and other supporting documentation are required for GCLP complianceand should be documented in the drug master file (DMF) or other negotiated means. The contractor is expected toparticipate in an External Quality Assurance scheme to assess continued ability to perform tests correctly.
A facility audit will be conducted.

4.

Statement of Objectives
The objective of this project is the establishment of a high throughput wild type and reporter SARS-CoV-2 virus

W911QY21C0012
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neutralization assays for COVID-19 for use in testing serum samples from human subjects enrolled in clinical trials
of COVID-19 vaccines in compliance with GCLP.
Operation Warp Speed (OWS) has supported development of two VN assays at organizations herein designated as“assay developer laboratory (ADL)”. The ADL will develop the assays using two virus platforms - a live wild type
(WT) virus and a live reporter virus for transfer to the new facility. The WT virus is the clinical SARS-CoV-2
isolate WA1 strain isolated from the first US COVID-19 patient identified in Washington State and the reporter
virus has a bioluminescent luciferase gene inserted to generate a recombinant SARS-CoV-2 virus strain. The WT
virus assay will be transferred in a validated state; the reporter virus assay will be transferred in a qualified state.
After contract award, the offeror is expected to submit a protocol (in coordination with the ADL) to technology
transfer the previously validated WT VN assay to quantify SARS-CoV-2 neutralizing antibodies in human sera
using VERO E6 cells and subsequently perform method equivalence. The offeror will use a panel of COVID-19
convalescent and COVID-19 vaccine recipient samples to demonstrate method equivalence relative to theperformance characteristics at the ADL (4). The VN assay follows traditional protocols, with a serum sample that isserially diluted and then incubated with a known amount of virus (neutralization step). For the WT VN assay, a cellmonolayer is then inoculated with the sample/virus mix and incubated for approximately 24 hours prior to acetone
fixation and immunoenzymatic detection of SARS-COV-2 N protein expression (in situ N-ELISA). The VN assay
median endpoint titer is reported as the reciprocal of the highest dilution at which the input virus is neutralized ELISAOD units below an established threshold). The assay will be considered fully transferred only once the FDA has
reviewed and concurred with tech transfer acceptability through review of documentation submitted to a DMF or
through other negotiated means.
Conversely, the reporter VN assay relies on a luminescence readout. This assay will be transferred in a qualifiedstate and the receiving lab will be required to validate the assay. Assay validation will be considered complete only
once the FDA has reviewed and concurred with validation report acceptability through review of documentation
submitted to a DMF or through other negotiated means.
Details of the protocol for both the assays will be provided by the ADL in the course of jointly preparing thetechnology transfer protocol package.

•

Base Period: Technology Transfer of validated and qualified OWS neutralization assays, subsequent method
equivalency demonstration and validation, and sample testing of 1000 clinical trial samples inclusive of a anequivalency convalescent serum panel•
Options 1-20: Sample testing of 1000 clinical trial specimens•
Options 21-30 : Sample testing of 2000 clinical trial specimens•
Options 31-35: Sample testing of 5000 clinical trial specimens
The proposal’s basic framework should include the following specific tasks:
Base Period (CLIN 0001-CLIN 005): Technology Transfer of one validated and one qualified OWS VN assay.
After contract award, the offeror will host an audit and should provide a project plan (in coordination with ADL)
that describes the approach to 1) technology transfer the validated WT virus assay and demonstrate method
equivalence with a panel of test serum samples provided by the USG and 2) technology transfer the qualified
reporter virus assay and subsequently validate the assay. Offerors are encouraged to describe their testing workflow
in detail to include the use of robotic systems in order to increase sample throughput. Assay validation and overall
readiness to test Phase 3 samples from the clinical trials includes FDA concurrence with the assay documentation
submitted to the DMF
CLIN0001: Technology transfer the validated WT VN assay.
oTechnology transfer package (documentation from ADL) will include the following:

(i)
(ii)

An assay specific SOP for WT VN assay
A validation protocol designed to evaluate precision, dilutional linearity, limit of detection, limit of quantification,

W911QY21C0012
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selectivity (matrix effects), and specificity as appropriate. The validation protocol shall include a statistical analysis
plan.
(iii) Serum equivalence panel (see 5. Critical reagents)(iv) A validation reporto

The offeror shall provide:i.

A proof-of-concept data report on assay performance conducted prior to assay validation or equivalence execution,
capturing, at a minimum, a demonstration of precision with two samples tested over three days.
Technology transfer assay protocol to demonstrate method equivalence (in coordination with the ADL)
Submission of the technology transfer protocol to the FDA DMFs
Execute the technology transfer assay protocol
A draft and final technology transfer report
Copies of FDA’s concurrence with WT VN assay equivalence testing indicating readiness to initiate Phase 3 clinical
trial sample testing

ii.
iii.
iv.
v.
vi.

CLIN0002: Technology transfer the qualified reporter VN assay and subsequent validationoTechnology transfer package (documentation from ADL) will include the following:

(i)
(ii)

An assay specific SOP for live reporter VN assay
A qualification protocol designed to evaluate precision, dilutional linearity, limit of detection, limit of quantification,
selectivity (matrix effects), and specificity as appropriate. The qualification protocol shall include a statisticalanalysis plan.
(iii) Serum equivalence panel (see 5. Critical reagents)(iv) A qualification report.
o

The offeror shall provide:

(i)
(ii)
(iii)
(iv)

A draft and final validation protocol
A Validation Report
Submission of the validation report to the FDA DMF
Copies of FDA’s concurrence with validation report indicating readiness to initiate Phase 3 clinical trial sample
testing
CLIN0003: Testing of 1000 clinical trial specimens using the validated assays. (500 samples for WT and 500
samples for live virus reporter) The offeror shall provide:oooThe proposed sample testing turnaround time when operating at full capacity for extended periods
The offeror should provide a sample management plan that describes in substantial detail the procedures for serum
sample accessioning, handling, safety and integrity (including power failures and other risks), with auditable tracking
systems throughout the chain of custody.
The offeror should provide a data management plan describing the information technology infrastructure to receive
the serum samples data and demonstrate data integrity, accuracy and security thought the life cycle of the sample
and completion of the project.
CLIN0004: Drug Master File (DMF) WT Neutralization VN Assay
CLIN0005: Drug Master File (DMF) Reporter VN Assay
CLIN0006: Technology transfer the validated WT VN assay.
CLIN0007: Technology transfer the validated WT VN assay.
CLIN0008:: Technology transfer the validated WT VN assay.

W911QY21C0012
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CLIN0009: Technology transfer the validated WT VN assay.
CLIN0010: Technology transfer the validated WT VN assay.
Contract Options (Options 1-35) : Testing of clinical trial samples using one of the validated
CLIN 1001-1020 Option 1-20: Testing of 1,000 clinical trial samples using one of the validated assay
CLIN 1021-1030 Option 21-30: Testing of 2,000 clinical trial samples using one of the validated assay
CLIN 1031-1035 Option 31-35: Testing of 5,000 clinical trial samples using one of the validated assay
5.

Critical reagentsThe USG will provide certain reagents (e.g. SARS-CoV-2 virus seed) and a panel of 18 human serum samples to assay
equivalence between different sites executing the same assay. This panel comprises 15 COVID-19 convalescentsamples (equally distributed among samples with low, medium and high antibody titers) with certified titers and 3
negative controls.

6.

Capacity
Minimum 1000 samples /week. The maximum capacity within the accepted proposal is expected to be 1,000
samples for the WT VN assay and 2000 for the reporter VN assay tested every seven days. Testing under options
that are exercised will be IAW the accepted proposals stated capacities.

7.

Period of Performance
The Base Period of Performance (POP): The proposed OWS VN assay capacity must be available for use in full nolater than July 31 2021(after FDA concurrence with the tech transfer and equivalence report). The total proposed
duration of this work is 12 months from award.

8.

Personnel and Place of performance
The proposal should describe the key personnel and provide CVs to document training and experience for the
project as well as the overall staffing plan for the proposed activities.
The facilities where the work will be conducted as well as supporting activities should be described in sufficient detailto support assessment of fitness for purpose.

9.

Deliverables
The following deliverables would be provided by the offeror. The following proposed deliverable schedule is of
critical importance to the USG.
General Deliverablesa) PERIODIC TELECONFERENCES (Biweekly or as negotiated)
1) Draft bulleted agenda provided 48 hours prior to teleconference.
2) Meeting minutes provided 3 business days after teleconference.
b) COMMUNICATION MANAGEMENT PLAN
1) Outlines communications goals and strategies for the task order. Template will be provided.
c) MONTHLY REPORTS
1) Reports shall describe progress of meeting contract milestones- overall project assessment, problems encountered

W911QY21C0012
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Copy of FDA
concurrence on WT
virus assay readinessfor Phase 3 sample
testing
Draft validation reportfor the reporter virus
assay
Final validation reportfor the reporter virus
assay and submission
to DMF
FDA concurrence onreporter virus assay
readiness for Phase 3
sample testing
Testing batch of sera
samples(1,000)
Testing batch of 1,000
sera samples per
option (Option 120)
Testing batch of 2,000
sera samples per
option (Option
21-30)
Testing batch of 5,000
sera
samples per option(Option 31-35)

Not applicable (dependent on FDA)

8 weeks from DMF submission of the validation protocol

1 week from draft validation report

Not applicable (dependent on FDA)

3 weeks from sample receipt

3 weeks from sample receipt

4 weeks from sample receipt

6 weeks from sample receipt

CONTRACT ADMINISTRATION
Government Contract Administration:
In no event shall any understanding or agreement, contract modification, change order, or other matter in deviationfrom the terms of this contract between the Contractor and a person other than the Contracting Officer be effective orbinding upon the Government. All such actions must be formalized by a proper contractual document executed by theContracting Officer.
Contracting Officer:(b) (6)

Email (b) (6)(b) (6)

Procurement Specialist:(b) (6)(b) (6)

Email: (b) (6)(b) (6)

W911QY21C0012
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In no event shall any understanding or agreement, contract modification, change order, or other matter in deviationfrom the terms of this contract between the contractor and a person other than the Contracting Officer be effective orbinding upon the government. All such actions must be formalized by a proper contractual document executed by theContracting Officer.
Government Technical Points of Contact:
Contracting Officers Representative (COR):(b) (6)

Health Scientist(b) (6)

Email: (b) (6)
Office: (b) (6)Cell: (b) (6)Technical Point of Contact:(b) (6)

Biologist, Influenza and Emerging Diseases Division(b) (6)

Email: (b) (6)
Office: (b) (6)Cell: (b) (6)Quality Assurance Point of Contact:(b) (6)

Title:Senior Regulatory Affairs Analyst
Email (b) (6)(b) (6)

Phone: (b) (6)Contractor’s Contract Administration
Technical Point of Contact:(b) (6)

Senior Scientist
Email: (b) (6)
Office: (b) (6)Cell: (b) (6)Administrative Point of Contact:(b) (6)

Vice President (b) (6)Email: (b) (6)
Office: (b) (6)Cell: (b) (6)Contractor’s Past Performance Point of Contact (POC):

W911QY21C0012
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Annual contract past performance evaluations will be performed by the government. The offeror shall identify a Pointof Contact (POC) to participate in these on-line evaluations. This individual is required to register in the Contractor
Performance Assessment Reporting System (CPARS @ http://www.cpars.csd.disa.mil) and respond to thegovernment evaluations in a timely manner. The contractor POC responsible for this action is:(b) (6)

Vice President (b) (6)Email (b) (6)
Office: (b) (6)Cell (b) (6)Notifications of Revisions and Changes:
Notification of revision or changes to names or email addresses will be provided by official correspondence from the
PCO/ACO or office of the PCO/ACO in lieu of a contract modification. This does not apply to any such revisions orchanges in the event this contract includes a key personnel clause.
DELIVERY OR PERFORMANCE
F.1.

Technical Deliverables

TECHNICAL DELIVERABLES

OWNER

PLANNEDSTARTPLANNEDFINISHAward of Contract(b) (4)

11/9/2020

11/09/2020

Establishment of DMF with FDA

11/17/2020

11/23/2020

Facility Audit

11/17/2020

12/18/2020

11/17/2020

12/27/2020

01/24/2021

06/01/2021

11/9/2020

Outstanding(b) (4)

11/17/2020

01/14/2021(b) (4)

Expand provided cells to generatemaster cell bank

11/14/2021

12/11/2020

Complete qualification of master cellbank

12/5/202003/03/2021

1/15/2021

01/17/2021

Complete qualification of virus
master bank

6/21/2021

07/06/2021

Hire additional staff as desired

11/17/2020

12/07/2020

Procurement of criticalreagents and equipment.
Begin installation.
Complete installations (IQOQPQetc.) & receive materials.
Receipt of tech transfer package

Receive virus stock, cells, andother reagents for the techtransfer

Expand provided virus stock tocomplete master virus bank

NOTES(b) (4)

W911QY21C0012
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Complete onboarding process

11/8/2020

12/07/2020

Complete assay specific training
for additional staff

03/1/2021

06/01/2021

Work with ADL tounderstand assay beingtransferred

11/17/2020

11/23/2020

Receipt of final of Umbrella protocol

TBD

TBD

Issue draft of tech transfer protocol

01/24/2021

03/15/2021

CLIN001-Perform proof of concept.
Materials provided by ADL/USG

03/08/2021

04/06/2021

Issue Proof of Concept data report to
ADL/USG

03/29/2021

04/06/2021

Complete and Issue Tech Transfer
Protocol for assay (Final)

11/24/2020

04/07/2021

Submission of tech transfer
protocol for WT assay to DMF

12/1/2020

04/07/2021

Execute Tech Transfer Protocol

04/11/2021

06/09/2021

Draft tech transfer report for WT
virus

04/07/2021

06/09/2021

Complete & Issue Final Tech
Transfer Report

05/14/2021

06/24/2021

05/14/2021

06/24/2021

Final tech transfer report for WT
virus submission to DMF(b) (4)(b) (4)(b) (4)(b) (4)F.2.
Supply Chain Resiliency Plan: The contractor shall develop and submit within 30 calendar days ofcontract award, a comprehensive Supply Chain Resiliency Program that provides identification and reporting of

critical components associated with the secure supply of. cells, virus, and assay positive and negative
controls. The USG will supply reagents associated with technology transfer but the organization is
expected to subsequently produce and procure their own critical reagents.
a)
A critical component is defined as any material that is essential to the assay t or the testing services
associated with this contract. Included in the definition are cell banks and virus seed stocks NOT included in thedefinition are facility and capital 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.
a)Communication for these requirements shall be updated as part of an annual review, or as necessary, as partof regular contractual communications.
b)
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 foreign-sourced, both
high and low volume, which would significantly affect throughput and adherence to the contractually agreed
deliveries.

W911QY21C0012
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The contractor shall articulate in the plan, the methodology for inventory control, , scheduling processes andordering mechanisms, as part of those agreed deliveries.
a)lead times shall be understood and communicated to the Contracting Officer or the Contracting Officer's
Representative as necessary.
b)
Production throughput critical constraints should be well understood by activity and by design, 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)
b)
c)
d)
e)
f)

Critical Material
Vendor
Supplier, Manufacturing / Distribution Location
Supplier Lead Time
Shelf Life
Transportation / Shipping restrictions

The CO and COR reserve the right to request un-redacted copies of technical documents, during the period of
performance, for distribution within the Government. Documents shall be provided within ten (10) days after CO
issues the request. The Contractor may arrange for additional time if deemed necessary, and agreed to by the CO.
F.3.
Product Development Source Material and Manufacturing 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.
F.4.
Contractor Locations: The contractor shall submit detailed data regarding locations where work will be
performed under this contract, including addresses, points of contact, and work performed per location, to include
sub-contractors.
Contractor will submit Work Locations Report:•
Within 5 business days of contract award•
Within 30 business days after a substantive location or capabilities change•
Within 2 business days of a substantive change if the work performed supports medical countermeasuredevelopment that addresses a threat that has been declared a Public Health Emergency by the HHS Secretary or a
Public Health Emergency of International Concern (PHEIC) by the WHO
F.5.
Access and General Protection/Security Policy and Procedures: This standard language text is
applicable to ALL employees working on critical information related to Operation Warp Speed (OWS), and to thosewith 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 policies andprocedures (provided by government representative). The performer also shall provide all information required forbackground checks necessary to access critical information related to OWS, and to meet Government installation
access requirements to be accomplished by installation Director of Emergency Services or Security Office. The
workforce must comply with all personnel identity verification requirements as directed by the Government and/or

local policy. In addition to the changes otherwise authorized by the changes clause of this agreement,
should the security status of OWS change the Government may require changes in performer security
matters or processes. In addition to the industry standards for employment background checks, The
Contractor must be willing to have key individuals, in exceptionally sensitive positions, identified for
additional vetting by the United States Government.
F.6.
Operational Security (OPSEC): The performer shall develop an OPSEC Standard Operating Procedure(SOP)/Plan within ninety (90)-calendar-days of project award to be reviewed and approved by the responsible
Government OPSEC officer. This plan will be submitted to the COR for coordination of approvals. This SOP/Planwill include identifying the critical information related to this contract, why it needs to be protected, where it isW911QY21C0012
P00001Page 27 of 31
CCTV coverage must include entry and exits to critical facilities, perimeters, andareas within the facility deemed critical to the execution of the contract.
Video recordings must be maintained for a minimum of 30 days.
CCTV surveillance system must be on emergency power backup.
CCTV coverage must include entry and exits to critical facilities, perimeters, andareas within the facility deemed critical to the execution of the contract.
Video recordings must be maintained for a minimum of 30 days.
CCTV surveillance system must be on emergency power backup.

Facility Lighting

Shipping and Receiving

Access Control

Employee/Visitor
Identification

Security Fencing

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

Should issue company photo identification to all employees.
Photo identification should be displayed above the waist anytime the employee is oncompany property.
Visitors should be sponsored by an employee and must present government issued
photo identification to enter the property.
Visitors should be logged in and out of the facility and should be escorted by an
employee while on the premises at all times.
Requirements for security fencing will be determined by the criticality of the
program, review of the security plan, threat assessment, and onsite security
assessment.

W911QY21C0012
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Cyber threat intelligence is received from information sharing forums and sources.
Threats, vulnerabilities, likelihoods, and impacts are used to determine risk.
Identities and credentials are issued, managed, verified, revoked, and audited forauthorized devices, users and processes.
Users, devices, and other assets are authenticated (e.g., single-factor,
multifactor) commensurate with the risk of the transaction (e.g., individuals’ security
and privacy risks and other organizational risks)

Access Control

Training

Audit and Accountability

Configuration Management

Contingency Planning

Incident Response

Media and Information
Protection

Limit information system access to authorized users.
Identify information system users, processes acting on behalf of users, or devices andauthenticate identities before allowing access.
Limit physical access to information systems, equipment, and server rooms withelectronic access controls.
Limit access to/ verify access to use of external information systems.
Ensure that personnel are trained and are made aware of the security risks
associated with their activities and of the applicable laws, policies, standards,
regulations, or procedures related to information technology
systems.
Create, protect, and retain information system audit records to the extent needed toenable the monitoring, analysis, investigation, and reporting of unlawful,
unauthorized, or inappropriate system activity. Records must be kept for minimum
must be kept for 12 months.
Ensure the actions of individual information system users can be uniquely traced tothose users.
Update malicious code mechanisms when new releases are available.
Perform periodic scans of the information system and real time scans of files fromexternal sources as files are downloaded, opened, or executed.
Establish and enforce security configuration settings.
Implement sub networks for publically accessible system components that arephysically or logically separated from internal networks.

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

Physical and Environmental
Protection

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

Network Protection

Employ intrusion prevention and detection technology with immediate analysis
capabilities.