W911QY-21-R-0021 Solicitation.pdf

PDF 662 KB Posted

Attached to
Stability Testing Of rBV A/B And rF1V Critical Material Lots
Solicitation number
W911QY-21-R-0021
Issued by

About this file

Written by GovTribe AI ·

This document is a solicitation for stability testing services. The U.S. Army is seeking a contractor to conduct 3, 6, and 12 month stability testing of recombinant Botulinum A/B and recombinant Plague F1V vaccine materials, drug products, drug substances, and associated reference materials and reagents. Testing must comply with FDA cGMP and ICH guidelines. The period of performance is 60 months consisting of a 12-month base period and four 12-month option periods. The government will award a single firm fixed price contract and anticipates using commercial items to satisfy requirements. Offerors must be capable of successfully executing or managing the required stability testing. Data generated will be controlled unclassified information. The place of performance is to be determined. The solicitation number is W911QY-21-R-0021 and proposals are due by the date specified within the solicitation.

View the file

Other files

File Type Posted
Questions Answers W911QY-21-R-0021 11 May 2021.pdf PDF
W911QY-21-R-0021 Solicitation Amendment 0002 11 May 2021.pdf PDF
Questions Answers W911QY-21-R-0021 10 May 2021.pdf PDF
Attachment 0004 - W911QY-21-R-0021 Price.xlsx XLSX spreadsheet
Exhibits A001-A004.pdf PDF
Attachments 0001-0003 - W911QY-21-R-0021.pdf PDF

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file
Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

SEE ADDENDUM

(No Collect Calls)

W911QY21R0021 30-Apr-2021

b. TELEPHONE NUMBER

301-619-8148

8. OFFER DUE DATE/LOCAL TIME

04:30 PM 14 May 2021

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W911QY9. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

SCOTT HOFFMAN

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W6QK ACC-APG NATICK DIVISION

110 THOMAS JOHNSON DR SUITE #240

FREDERICK MD 21702

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE 16. ADMINISTERED BY

SEE SCHEDULE

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

X SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

541715

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF185

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W911QY21R0021

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

rF1V DP GMP 2 - Stability Testing

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP2 in accordance with table 1.2, storage Conditions: 4 degrees Celsius to occur at each time point provided by each priced subCLIN below.

NET AMT

0001AA 1 Each rF1V DP GMP 2 - Time Point 1

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP 2 in accordance with table 1.2, storage Conditions: 4 degrees Celsius.

FOB: Destination

PSC CD: AC13

0001AB 1 Each rF1V DP GMP 2 - Time Point 2

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP 2 in accordance with table 1.2, storage Conditions: 4 degrees Celsius.

0001AC 1 Each OPTION rF1V DP GMP 2 - Time Point 3

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP 2 in accordance with table 1.2, storage Conditions: 4 degrees Celsius.

0001AD 1 Each OPTION rF1V DP GMP 2 - Time Point 4

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP 2 in accordance with table 1.2, storage Conditions: 4 degrees Celsius.

0001AE 1 Each OPTION rF1V DP GMP 2 - Time Point 5

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP 2 in accordance with table 1.2, storage Conditions: 4 degrees Celsius.

0001AF 1 Each OPTION rF1V DP GMP 2 - Time Point 6

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP 2 in accordance with table 1.2, storage Conditions: 4 degrees Celsius.

0001AG 1 Each OPTION rF1V DP GMP 2 - Time Point 7

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP 2 in accordance with table 1.2, storage Conditions: 4 degrees Celsius.

rF1V DP GMP 1 - Stability Testing

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance provided at each priced subCLIN below.

0002AA 1 Each OPTION rF1V DP GMP 1 - Time Point 1

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with table 1.2, storage Conditions: 4 degrees Celsius.

0002AB 1 Each OPTION rF1V DP GMP 1 - Time Point 2

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0002AC 1 Each OPTION rF1V DP GMP 1 - Time Point 3

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0002AD 1 Each OPTION rF1V DP GMP 1 - Time Point 4

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0002AE 1 Each OPTION rF1V DP GMP 1 - Time Point 5

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0002AF 1 Each OPTION rF1V DP GMP 1 - Time Point 6

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0002AG 1 Each OPTION rF1V DP GMP 1 - Time Point 7

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

rF1V DP GMP 3 - Stability Testing

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP3 in accordance provided at each priced subCLIN below.

0003AB 1 Each OPTION rF1V DP GMP 1 - Time Point 2

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0003AC 1 Each OPTION rF1V DP GMP 1 - Time Point 3

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0003AD 1 Each OPTION rF1V DP GMP 1 - Time Point 4

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0003AE 1 Each OPTION rF1V DP GMP 1 - Time Point 5

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0003AF 1 Each OPTION rF1V DP GMP 1 - Time Point 6

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0003AG 1 Each OPTION rF1V DP GMP 1 - Time Point 7

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

0003AH 1 Each OPTION rF1V DP GMP 1 - Time Point 8

FFP

Performance of Stability Testing on rF1V Drug Product (DP) GMP1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: 4 degrees Celsius.

rF1V DS 1 - Stability Testing

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with table 1.3, storage Conditions: -70 degrees Celsius to occur at each time point

0004AA 1 Each rF1V DS 1 - Time Point 1

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0004AB 1 Each OPTION rF1V DS 1 - Time Point 2

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0004AC 1 Each OPTION rF1V DS 1 - Time Point 3

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0004AD 1 Each OPTION rF1V DS 1 - Time Point 4

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0004AE 1 Each OPTION rF1V DS 1 - Time Point 5

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius rF1V DS 2 - Stability Testing

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 2 in accordance

0005AA 1 Each rF1V DS 2 - Time Point 1

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 2 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0005AB 1 Each OPTION rF1V DS 2 - Time Point 2

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 2 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0005AC 1 Each OPTION rF1V DS 2 - Time Point 3

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 2 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0005AD 1 Each OPTION rF1V DS 2 - Time Point 4

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 2 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0005AE 1 Each OPTION rF1V DS 2 - Time Point 5

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 2 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius rF1V DS 3 - Stability Testing

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 3 in accordance

0006AA 1 Each rF1V DS 3 - Time Point 1

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 3 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0006AB 1 Each OPTION rF1V DS 3 - Time Point 2

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 3 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0006AC 1 Each OPTION rF1V DS 3 - Time Point 3

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 2 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0006AD 1 Each OPTION rF1V DS 3 - Time Point 4

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 3 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0006AE 1 Each OPTION rF1V DS 3 - Time Point 5

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 3 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius rF1V DP Ph2b - Stability Testing

FFP

Performance of Stability Testing on rF1V DP Phase 2b in accordance with table 1.2, storage Conditions: 4 degrees Celsius to occur at each time point provided by each priced subCLIN below.

0007AA 1 Each rF1V DP Ph2b - Time Point 1

FFP

Performance of Stability Testing on rF1V DP Ph2b in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

Storage Conditions: 4 degrees Celsius

0007AB 1 Each OPTION rF1V DS 1 - Time Point 2

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0007AC 1 Each OPTION rF1V DS 1 - Time Point 3

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0007AD 1 Each OPTION rF1V DS 1 - Time Point 4

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0007AE 1 Each OPTION rF1V DS 1 - Time Point 5

FFP

Performance of Stability Testing on rF1V Drug Substance (DS) 1 in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius rF1V DP Ref. Std.-Stability Testing

FFP

Performance of Stability Testing on rF1V Drug Poduct Reference Standard Material in accordance with the terms and conditions of this Contract. The frequency and estimated time point(s) are delineated at section F. Required Storage Conditions for this material is 4 degrees Celsius. Contemplated to occur February

0008AA 1 Each OPTION rF1V DP Ref. Std.- Time Point 1

FFP

Performance of Stability Testing on rF1V Drug Product (DP) reference standard in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0008AB 1 Each OPTION rF1V DP Ref. Std.- Time Point 2

FFP

Performance of Stability Testing on rF1V Drug Product (DP) reference standard in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0008AC 1 Each OPTION rF1V DP Ref. Std.- Time Point 3

FFP

Performance of Stability Testing on rF1V Drug Product (DP) reference standard in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius

0008AD 1 Each OPTION rF1V DP Ref. Std.- Time Point 4

FFP

Performance of Stability Testing on rF1V Drug Product (DP) reference standard in accordance with the terms and conditions of this Contract and at the time point delineated at section F. Storage Conditions: -70 degrees Celsius rF1V DS Ref. Mtrl.-Stability Testing

FFP

Performance of Stability Testing on rF1V Drug Substance Reference Material in accordance with table 1.3, storage Conditions: -70 degrees Celsius to occur at each time point provided by each priced subCLIN below.

0009AA 1 Each rF1V DS Ref. Mtrl. - Time Point 1

FFP

Performance of Stability Testing on rF1V DS Ref. Mtrl. in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

Storage Conditions: -70 degrees Celsius.

0009AB 1 Each OPTION rF1V DS Ref. Mtrl. - Time Point 2

FFP

Performance of Stability Testing on rF1V DS Ref. Mtrl. in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

Storage Conditions: -70 degrees Celsius.

0009AC 1 Each OPTION rF1V DS Ref. Mtrl. - Time Point 3

FFP

Performance of Stability Testing on rF1V DS Ref. Mtrl. in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

Storage Conditions: -70 degrees Celsius.

0009AD 1 Each OPTION rF1V DS Ref. Mtrl. - Time Point 4

FFP

Performance of Stability Testing on rF1V DS Ref. Mtrl. in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

Storage Conditions: -70 degrees Celsius.

0009AE 1 Each OPTION rF1V DS Ref. Mtrl. - Time Point 5

FFP

Performance of Stability Testing on rF1V DS Ref. Mtrl. in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

Storage Conditions: -70 degrees Celsius.

rF1V DS Ref. Std. Qual

FFP

Performance of rF1V DS Reference Standard Quality Testing using relative potency assay (RPA) in accordance with the terms and conditions of this Contract.

0010AA 1 Each rF1V DS Ref. Std. Qual

FFP

Performance of rF1V DS Reference Standard Quality Testing using relative potency assay (RPA) in accordance with the terms and conditions of this Contract.

Anti F1 IgY - Stability Testing

FFP

Performance of Stability Testing on Anti F1 IgY to occur at each time point

0011AA 1 Each Anti F1 IgY - Time Point 1

FFP

Performance of Stability Testing on Anti F1 IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0011AB 1 Each OPTION Anti F1 IgY - Time Point 2

FFP

Performance of Stability Testing on Anti F1 IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0011AC 1 Each OPTION Anti F1 IgY - Time Point 3

FFP

Performance of Stability Testing on Anti F1 IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0011AD 1 Each OPTION Anti F1 IgY - Time Point 4

FFP

Performance of Stability Testing on Anti F1 IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0011AE 1 Each OPTION Anti F1 IgY - Time Point 5

FFP

Performance of Stability Testing on Anti F1 IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

Anti F1V IgY - Stability Testing

FFP

Performance of Stability Testing on Anti F1V IgY to occur at each time point

0012AA 1 Each Anti F1V IgY - Time Point 1

FFP

Performance of Stability Testing on Anti F1V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0012AB 1 Each OPTION Anti F1V IgY - Time Point 2

FFP

Performance of Stability Testing on Anti F1V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0012AC 1 Each OPTION Anti F1V IgY - Time Point 3

FFP

Performance of Stability Testing on Anti F1V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0012AD 1 Each OPTION Anti F1V IgY - Time Point 4

FFP

Performance of Stability Testing on Anti F1V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0012AE 1 Each OPTION Anti F1V IgY - Time Point 5

FFP

Performance of Stability Testing on Anti F1V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

Anti V IgY - Stability Testing

FFP

Performance of Stability Testing on Anti V IgY to occur at each time point

0013AA 1 Each Anti V IgY - Time Point 1

FFP

Performance of Stability Testing on Anti V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0013AB 1 Each OPTION Anti V IgY - Time Point 2

FFP

Performance of Stability Testing on Anti V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0013AC 1 Each OPTION Anti V IgY - Time Point 3

FFP

Performance of Stability Testing on Anti V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0013AD 1 Each OPTION Anti V IgY - Time Point 4

FFP

Performance of Stability Testing on Anti V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0013AE 1 Each OPTION Anti V IgY - Time Point 5

FFP

Performance of Stability Testing on Anti V IgY in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

HRP-conj. 1° rabbit - Stability Testing

FFP

Performance of Stability Testing on Antibody HRP-conj. 1° rabbit to occur at each

0014AA 1 Each HRP-conj. 1° rabbit antib - Time Point 1

FFP

Performance of Stability Testing on Antibody HRP-conj. 1° rabbit in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0014AB 1 Each OPTION HRP-conj. 1° rabbit antib - Time Point 2

FFP

Performance of Stability Testing on Antibody HRP-conj. 1° rabbit in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0014AC 1 Each OPTION HRP-conj. 1° rabbit antib - Time Point 3

FFP

Performance of Stability Testing on Antibody HRP-conj. 1° rabbit in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0014AD 1 Each OPTION HRP-conj. 1° rabbit antib - Time Point 4

FFP

Performance of Stability Testing on Antibody HRP-conj. 1° rabbit in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0014AE 1 Each OPTION HRP-conj. 1° rabbit antib - Time Point 5

FFP

Performance of Stability Testing on Antibody HRP-conj. 1° rabbit in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

Rabbit Anti F1V - Stability Testing

FFP

Performance of Stability Testing on Rabbit Anti F1V to occur at each time point

0015AA 1 Each Rabbit Anti F1V - Time Point 1

FFP

Performance of Stability Testing on Rabbit Anti F1V in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0015AB 1 Each OPTION Rabbit Anti F1V - Time Point 2

FFP

Performance of Stability Testing on Rabbit Anti F1V in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0015AC 1 Each OPTION Rabbit Anti F1V - Time Point 3

FFP

Performance of Stability Testing on Rabbit Anti F1V in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0015AD 1 Each OPTION Rabbit Anti F1V - Time Point 4

FFP

Performance of Stability Testing on Rabbit Anti F1V in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0015AE 1 Each OPTION Rabbit Anti F1V - Time Point 5

FFP

Performance of Stability Testing on Rabbit Anti F1V in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

rBV DP GMP 1 - Stability Testing

FFP

Performance of Stability Testing on rBV Drug Product (DP) GMP1 in accordance with table 1.4, storage Conditions: 4 degrees Celsius to occur at each time point

0016AA 1 Each OPTION rBV DP GMP 1 - Time Point 1

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 1 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0016AB 1 Each OPTION rBV DP GMP 1 - Time Point 2

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 1 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0016AC 1 Each OPTION rBV DP GMP 1 - Time Point 3

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 1 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0016AD 1 Each OPTION rBV DP GMP 1 - Time Point 4

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 1 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0016AE 1 Each OPTION rBV DP GMP 1 - Time Point 5

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 1 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0016AF 1 Each OPTION rBV DP GMP 1 - Time Point 6

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 1 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0016AG 1 Each OPTION rBV DP GMP 1 - Time Point 7

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 1 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

rBV DP GMP 2 - Stability Testing

FFP

Performance of Stability Testing on rBV Drug Product (DP) GMP 2 in accordance

0017AA 1 Each rBV DP GMP 2 - Time Point 1

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 2 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0017AB 1 Each rBV DP GMP 2 - Time Point 2

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 2 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0017AC 1 Each OPTION rBV DP GMP 2 - Time Point 3

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 2 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0017AD 1 Each OPTION rBV DP GMP 2 - Time Point 4

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 2 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0017AE 1 Each OPTION rBV DP GMP 2 - Time Point 5

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 2 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0017AF 1 Each OPTION rBV DP GMP 2 - Time Point 6

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 2 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0017AG 1 Each OPTION rBV DP GMP 2 - Time Point 7

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 2 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

rBV DP GMP 3 - Stability Testing

FFP

Performance of Stability Testing on rBV Drug Product (DP) GMP 3 in accordance

0018AA 1 Each OPTION rBV DP GMP 3 - Time Point 1

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 3 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0018AB 1 Each OPTION rBV DP GMP 3 - Time Point 2

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 3 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0018AC 1 Each OPTION rBV DP GMP 3 - Time Point 3

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 3 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0018AD 1 Each OPTION rBV DP GMP 3 - Time Point 4

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 3 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0018AE 1 Each OPTION rBV DP GMP 3 - Time Point 5

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 3 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0018AF 1 Each OPTION rBV DP GMP 3 - Time Point 6

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 3 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

0018AG 1 Each OPTION rBV DP GMP 3 - Time Point 7

FFP

Performance of Stability Testing on rBV DP Drug Product (DP) GMP 3 in accordance with table 1.4, storage Conditions: 4 degrees Celsius.

rBV DP D1200138 - Stability Testing

FFP

Performance of Stability Testing on rBV DP D1200138 in accordance with table 1.4, storage Conditions: 4 degrees Celsius. to occur at each time point provided by each priced subCLIN below.

0019AA 1 Each OPTION rBV DP D1200138 - Time Point 1

FFP

Performance of Stability Testing on rBV DP D1200138 in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0019AB 1 Each OPTION rBV DP D1200138 - Time Point 2

FFP

Performance of Stability Testing on rBV DP D1200138 in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0019AC 1 Each OPTION rBV DP D1200138 - Time Point 3

FFP

Performance of Stability Testing on rBV DP D1200138 in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0019AD 1 Each OPTION rBV DP D1200138 - Time Point 4

FFP

Performance of Stability Testing on rBV DP D1200138 in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

0019AE 1 Each OPTION rBV DP D1200138 - Time Point 5

FFP

Performance of Stability Testing on rBV DP D1200138 in accordance with the terms and conditions of this Contract and at the time point delineated at section F.

rBV A DS GMP 1 - Stability Testing

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP1 in accordance with table 1.5, storage Conditions: -70 degrees Celsius to occur at each

0020AA 1 Each rBV A DS GMP 1 - Time Point 1

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0020AB 1 Each rBV A DS GMP 1 - Time Point 2

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0020AC 1 Each OPTION rBV A DS GMP 1 - Time Point 3

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0020AD 1 Each OPTION rBV A DS GMP 1 - Time Point 4

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0020AE 1 Each OPTION rBV A DS GMP 1 - Time Point 5

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0020AF 1 Each OPTION rBV A DS GMP 1 - Time Point 6

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV A DS GMP 2 - Stability Testing

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP2 in

0021AA 1 Each rBV A DS GMP 2 - Time Point 1

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0021AB 1 Each OPTION rBV A DS GMP 2 - Time Point 2

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0021AC 1 Each OPTION rBV A DS GMP 2 - Time Point 3

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0021AD 1 Each OPTION rBV A DS GMP 2 - Time Point 4

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0021AE 1 Each OPTION rBV DS A GMP 2 - Time Point 5

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV B DS GMP 1 - Stability Testing

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 1 in

0022AA 1 Each rBV B DS GMP 1 - Time Point 1

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0022AB 1 Each OPTION rBV B DS GMP 1 - Time Point 2

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0022AC 1 Each OPTION rBV B DS GMP 1 - Time Point 3

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0022AD 1 Each OPTION rBV B DS GMP 1 - Time Point 4

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0022AE 1 Each OPTION rBV B DS GMP 1 - Time Point 5

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 1 in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV B DS GMP 2 - Stability Testing

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 2 in

0023AA 1 Each rBV B DS GMP 2 - Time Point 1

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0023AB 1 Each OPTION rBV B DS GMP 2 - Time Point 2

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0023AC 1 Each OPTION rBV B DS GMP 2 - Time Point 3

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0023AD 1 Each OPTION rBV B DS GMP 2 - Time Point 4

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0023AE 1 Each OPTION rBV B DS GMP 2 - Time Point 5

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 2 in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV A DS GMP 3 - Stability Testing

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 3 in

0024AA 1 Each OPTION rBV A DS GMP 3 - Time Point 1

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0024AB 1 Each OPTION rBV A DS GMP 3 - Time Point 2

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0024AC 1 Each OPTION rBV A DS GMP 3 - Time Point 3

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0024AD 1 Each OPTION rBV A DS GMP 3 - Time Point 4

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0024AE 1 Each OPTION rBV A DS GMP 3 - Time Point 5

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV A DS GMP 4 - Stability Testing

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 4 in

0025AA 1 Each OPTION rBV A DS GMP 4 - Time Point 1

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0025AB 1 Each OPTION rBV A DS GMP 4 - Time Point 2

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0025AC 1 Each OPTION rBV A DS GMP 4 - Time Point 3

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0025AD 1 Each OPTION rBV A DS GMP 4 - Time Point 4

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0025AE 1 Each OPTION rBV A DS GMP 4 - Time Point 5

FFP

Performance of Stability Testing on rBV A Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV B DS GMP 3 - Stability Testing

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 3 in

0026AA 1 Each OPTION rBV B DS GMP 3 - Time Point 1

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0026AB 1 Each OPTION rBV B DS GMP 3 - Time Point 2

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0026AC 1 Each OPTION rBV B DS GMP 3 - Time Point 3

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0026AD 1 Each OPTION rBV B DS GMP 3 - Time Point 4

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0026AE 1 Each OPTION rBV B DS GMP 3 - Time Point 5

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 3 in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV B DS GMP 4 - Stability Testing

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 4 in

0027AA 1 Each OPTION rBV B DS GMP 4 - Time Point 1

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0027AB 1 Each OPTION rBV B DS GMP 4 - Time Point 2

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0027AC 1 Each OPTION rBV B DS GMP 4 - Time Point 3

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0027AD 1 Each OPTION rBV B DS GMP 4 - Time Point 4

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0027AE 1 Each OPTION rBV B DS GMP 4 - Time Point 5

FFP

Performance of Stability Testing on rBV B Drug Substance (DS) GMP 4 in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV A Ref.Mat Testing

FFP

Performance of Stability Testing on rBV A reference material in accordance with table 1.5, storage Conditions: -70 degrees Celsius to occur at each time point

0028AA 1 Each rBV A Ref.Mat. - Time Point 1

FFP

Performance of Stability Testing on rBV A reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0028AB 1 Each OPTION rBV A Ref.Mat. - Time Point 2

FFP

Performance of Stability Testing on rBV A reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0028AC 1 Each OPTION rBV A Ref.Mat. - Time Point 3

FFP

Performance of Stability Testing on rBV A reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0028AD 1 Each OPTION rBV A Ref.Mat. - Time Point 4

FFP

Performance of Stability Testing on rBV A reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0028AE 1 Each OPTION rBV A Ref.Mat. - Time Point 5

FFP

Performance of Stability Testing on rBV A reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV B Ref.Mat Testing

FFP

Performance of Stability Testing on rBV B reference material in accordance with table 1.5, storage Conditions: -70 degrees Celsius to occur at each time point

0029AA 1 Each rBV B Ref.Mat. - Time Point 1

FFP

Performance of Stability Testing on rBV B reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0029AB 1 Each OPTION rBV B Ref.Mat. - Time Point 2

FFP

Performance of Stability Testing on rBV B reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0029AC 1 Each OPTION rBV B Ref.Mat. - Time Point 3

FFP

Performance of Stability Testing on rBV B reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0029AD 1 Each OPTION rBV B Ref.Mat. - Time Point 4

FFP

Performance of Stability Testing on rBV B reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius

0029AE 1 Each OPTION rBV B Ref.Mat. - Time Point 5

FFP

Performance of Stability Testing on rBV B reference material in accordance with table 1.5, storage Conditions:-70 degrees Celsius rBV Anti-rBoNTA - Stability Testing

FFP

Performance of Stability Testing on rBV Anti-rBoNTA in accordance with

0030AA 1 Each rBV Anti-rBoNTA - Time Point 1

FFP

Performance of Stability Testing on rBV Anti-rBoNTA in accordance with

0030AB 1 Each OPTION rBV Anti-rBoNTA - Time Point 2

FFP

Performance of Stability Testing on rBV Anti-rBoNTA in accordance with

0030AC 1 Each OPTION rBV Anti-rBoNTA - Time Point 3

FFP

Performance of Stability Testing on rBV Anti-rBoNTA in accordance with

0030AD 1 Each OPTION rBV Anti-rBoNTA - Time Point 4

FFP

Performance of Stability Testing on rBV Anti-rBoNTA in accordance with

0030AE 1 Each OPTION rBV Anti-rBoNTA - Time Point 5

FFP

Performance of Stability Testing on rBV Anti-rBoNTA in accordance with rBV Anti-rBoNTB - Stability Testing

Performance of Stability Testing on rBV Anti-rBoNTB in accordance with

0031AA 1 Each rBV Anti-rBoNTB - Time Point 1

FFP

Performance of Stability Testing on rBV Anti-rBoNTB in accordance with

0031AB 1 Each OPTION rBV Anti-rBoNTB - Time Point 2

FFP

Performance of Stability Testing on rBV Anti-rBoNTB in accordance with

0031AC 1 Each OPTION rBV Anti-rBoNTB - Time Point 3

FFP

Performance of Stability Testing on rBV Anti-rBoNTB in accordance with

0031AD 1 Each OPTION rBV Anti-rBoNTB - Time Point 4

FFP

Performance of Stability Testing on rBV Anti-rBoNTB in accordance with

0031AE 1 Each OPTION rBV Anti-rBoNTB - Time Point 5

FFP

Performance of Stability Testing on rBV Anti-rBoNTB in accordance with rBV A Assay Ctrl - Testing

FFP

Performance of Stability Testing on rBV A Assay Ctrl in accordance with the terms and conditions

0032AA 1 Each rBV A Assay Ctrl - Time Point 1

FFP

Performance of Stability Testing on rBV A Assay Ctrl in accordance with the terms and conditions

0032AB 1 Each OPTION rBV A Assay Ctrl - Time Point 2

FFP

Performance of Stability Testing on rBV A Assay Ctrl in accordance with the terms and conditions

0032AC 1 Each OPTION rBV A Assay Ctrl - Time Point 3

FFP

Performance of Stability Testing on rBV A Assay Ctrl in accordance with the terms and conditions

0032AD 1 Each OPTION rBV A Assay Ctrl - Time Point 4

FFP

Performance of Stability Testing on rBV A Assay Ctrl in accordance with the terms and conditions

0032AE 1 Each OPTION rBV A Assay Ctrl - Time Point 5

FFP

Performance of Stability Testing on rBV A Assay Ctrl in accordance with the terms and conditions rBV B Assay Ctrl - Testing

FFP

Performance of Stability Testing on rBV B Assay Ctrl in accordance with the terms and conditions

0033AA 1 Each rBV B Assay Ctrl - Time Point 1

FFP

Performance of Stability Testing on rBV B Assay Ctrl in accordance with the terms and conditions

0033AB 1 Each OPTION rBV B Assay Ctrl - Time Point 2

FFP

Performance of Stability Testing on rBV B Assay Ctrl in accordance with the terms and conditions

0033AC 1 Each OPTION rBV B Assay Ctrl - Time Point 3

FFP

Performance of Stability Testing on rBV B Assay Ctrl in accordance with the terms and conditions

0033AD 1 Each OPTION rBV B Assay Ctrl - Time Point 4

FFP

Performance of Stability Testing on rBV B Assay Ctrl in accordance with the terms and conditions

0033AE 1 Each OPTION rBV B Assay Ctrl - Time Point 5

FFP

Performance of Stability Testing on rBV B Assay Ctrl in accordance with the terms and conditions

(BoNT/A1) - Testing

FFP

Performance of Stability Testing on (BoNT/A1) in accordance with the terms and conditions

0034AA 1 Each OPTION (BoNT/A1) - Time Point 1

FFP

Performance of Stability Testing on (BoNT/A1) in accordance with the terms and conditions

0034AB 1 Each OPTION (BoNT/A1) - Time Point 2

FFP

Performance of Stability Testing on (BoNT/A1) in accordance with the terms and conditions

0034AC 1 Each OPTION (BoNT/A1) - Time Point 3

FFP

Performance of Stability Testing on (BoNT/A1) in accordance with the terms and conditions

0034AD 1 Each OPTION (BoNT/A1) - Time Point 4

FFP

Performance of Stability Testing on (BoNT/A1) in accordance with the terms and conditions

0034AE 1 Each OPTION (BoNT/A1) - Time Point 5

FFP

Performance of Stability Testing on (BoNT/A1) in accordance with the terms and conditions

(BoNT/B1) - Testing

FFP

Performance of Stability Testing on (BoNT/B1) in accordance with the terms and conditions

0035AA 1 Each OPTION (BoNT/B1) - Time Point 1

FFP

Performance of Stability Testing on (BoNT/B1) in accordance with the terms and conditions

0035AB 1 Each OPTION (BoNT/B1) - Time Point 2

FFP

Performance of Stability Testing on (BoNT/B1) in accordance with the terms and conditions

0035AC 1 Each OPTION (BoNT/B1) - Time Point 3

FFP

Performance of Stability Testing on (BoNT/B1) in accordance with the terms and conditions

0035AD 1 Each OPTION (BoNT/B1) - Time Point 4

FFP

Performance of Stability Testing on (BoNT/B1) in accordance with the terms and conditions

0035AE 1 Each OPTION (BoNT/B1) - Time Point 5

FFP

Performance of Stability Testing on (BoNT/B1) in accordance with the terms and conditions

CDRL A001 Biweekly Reporting

0036AA 16 Each CDRL A001 - Biweekly Report - Base

FFP

aThe Contractor shall provide biweekly reports that include meeting minutes for each biweekly meeting between the Government and Prime Contractor. Base year bi-weekly reporting anticipated as May 2021 - Dec 2021

0036AB 26 Each OPTION CDRL A001 - Biweekly Report - Optional 1

FFP

The Contractor shall provide biweekly reports that include meeting minutes for each biweekly meeting between the Government and Prime Contractor. Base year bi-weekly reporting anticipated as Jan 2022 - Dec 2022

0036AC 26 Each OPTION CDRL A001 - Biweekly Report - Optional 2

FFP

The Contractor shall provide biweekly reports that include meeting minutes for each biweekly meeting between the Government and Prime Contractor. Base year bi-weekly reporting anticipated as Jan 2023 - Dec 2023

0036AD 26 Each OPTION CDRL A001 - Biweekly Report - Optional 3

FFP

The Contractor shall provide biweekly reports that include meeting minutes for each biweekly meeting between the Government and Prime Contractor. Base year bi-weekly reporting anticipated as JAN 2024 - Dec 2024

0036AE 26 Each OPTION CDRL A001 - Biweekly Report - Optional 4

FFP

The Contractor shall provide biweekly reports that include meeting minutes for each biweekly meeting between the Government and Prime Contractor. Base year bi-weekly reporting anticipated as JAN 2025 - Dec 2025

CDRL A002 - Monthly Reporting

0037AA 8 Each CDRL A002 - Monthly Report (Base)

FFP

The Contractor shall provide monthly reports that include details of the Contractor's status, progress, and management reporting in accordance with CDRL A002. May 2021 - Dec 2021

0037AB 12 Each OPTION CDRL A002 - Monthly Report (Opt 1)

FFP

The Contractor shall provide monthly reports that include details of the Contractor's status, progress, and management reporting in accordance with CDRL A002. Jan 2022 - Dec 2022

0037AC 12 Each OPTION CDRL A002 - Monthly Report (Opt 2)

FFP

The Contractor shall provide monthly reports that include details of the Contractor's status, progress, and management reporting in accordance with CDRL A002. Jan 2023 - Dec 2023

0037AD 12 Each OPTION CDRL A002 - Monthly Report (Opt 3)

FFP

The Contractor shall provide monthly reports that include details of the Contractor's status, progress, and management reporting in accordance with CDRL A002. Jan 2024 - Dec 2024

0037AE 12 Each OPTION CDRL A002 - Monthly Report (Opt 4)

FFP

The Contractor shall provide monthly reports that include details of the Contractor's status, progress, and management reporting in accordance with CDRL A002. Jan 2025 - Dec 2025

CDRL A003 (SOPs)

FFP

The Contractor shall deliver Standard Operating Protocols (SOPs) to the Government for each test result within 30 days, after completion of that test. In accordance with Exhibit A003.

0038AA 35 Each CDRL A003 - SOP (Base)

FFP

The Contractor shall deliver Standard Operating Protocols (SOPs) to the Government for each test result within 30 days, after completion of that test.

0038AB 35 Each OPTION CDRL A003 - SOP (Opt 1)

FFP

The Contractor shall deliver Standard Operating Protocols (SOPs) to the Government for each test result within 30 days, after completion of that test.

0038AC 35 Each OPTION CDRL A003 - SOP (Opt 2)

FFP

The Contractor shall deliver Standard Operating Protocols (SOPs) to the Government for each test result within 30 days, after completion of that test.

0038AD 35 Each OPTION CDRL A003 - SOP (Opt 3)

FFP

The Contractor shall deliver Standard Operating Protocols (SOPs) to the Government for each test result within 30 days, after completion of that test.

0038AE 35 Each OPTION CDRL A003 - SOP (Opt 4)

FFP

The Contractor shall deliver Standard Operating Protocols (SOPs) to the Government for each test result within 30 days, after completion of that test.

0038AF 35 Each OPTION CDRL A003 - SOP (Opt 5)

FFP

The Contractor shall deliver Standard Operating Protocols (SOPs) to the Government for each test result within 30 days, after completion of that test.

CDRL A004 Quality Assurance Reporting

FFP

The Contractor shall submit testing results within 30 days of completion of testing for each testing time point in accordance with Exhibit A004. The results will be QA/QC prior to approval for payment.

0039AA 35 Each CDRL A004 - QA Reporting (Base)

FFP

The Contractor shall deliver Quality Assurance Reporting to the Government for each test result within 30 days, after completion of that test, in accordance with Exhibit A004.

0039AB 35 Each OPTION CDRL A004 - QA Reporting (Opt 1)

FFP

The Contractor shall deliver Quality Assurance Reporting to the Government for each test result within 30 days,…

This is the start of the file's text. The full file is on GovTribe.

File details come from the government source that posted it. Updated .