FINAL -- HSHQDC-10-R-00054 -- 14 AUG 2012.pdf

HSHQDC-12-R-00061

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 2

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

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J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ______________ calendar days (60 calendar days unless a different period is inserted

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

RSCB-12-0018608/14/2012

X

DHS/OPO/S&T/CHEMBIO

U.S. Dept. of Homeland Security Office of Procurement Operations S&T Acquisition Division 245 Murray Lane, SW, #0115 Washington DC 20528-0115

1600 ED 09/14/2012

Dena Nannetti 202 dena.nannetti@hq.dhs.gov

254-8654

PAGE(S)

Kristian Jovanovic

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 2

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

HSHQDC-12-R-00061

(A) (B) (C) (D) (E) (F)

Request for Proposals (RFP) for acquisition of Master Seed Virus (MSV) and Working Seed Virus (WSV) Lots for Foot-and-Mouth Disease (FMD) Molecular Vaccine Countermeasures.

** This RFP is a Total Small Business Set-Aside **

DO/DPAS Rating: NONE Delivery: 1095 Days After Award Delivery Location Code: DHS Department of Homeland Security 245 Murray Lane Bldg. 410 Washington DC 20528

FOB: Destination

0001 Provide support to the Foreign Animal Disease Program within the Department of Homeland Security, Science and Technology Directorate.

All work shall be accomplished in accordance with the attached Terms and Conditions and Statement of Work (SOW).

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

SECTION A – SF 33

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Pursuant to Homeland Security Presidential Directive-9 (HSPD-9), the Secretary of Homeland Security is responsible for coordinating the overall national effort to enhance the protection of the critical infrastructure and key resources of the United States. This includes the defense of agriculture and food.

Under HSPD, DHS is tasked with accelerating and enhancing the development of countermeasures – including vaccines – for Foreign Animal Diseases (FADs). HSPD-9 also recognized the need for a federal stockpile and mandated the creation of the National Veterinary Stockpile (NVS). This effort is to support a transition strategy to develop licensed or licensable, replication-deficient, human adenovirus vector Foot and Mouth Disease (FMD) vaccines for future procurement by USDA Animal and Plant Health Inspection Services (APHIS) Emergency Management and Diagnostics, including the APHIS NVS.

B.2. ADVANCE UNDERSTANDINGS

a. The Contractor shall obtain the Contracting Officer‘s approval, in writing, for any subcontract or consultant whose price exceeds 5% of the total value of the contract price during any year of contract performance.

b. In accordance with the license entitled Limitations on Use of Certain Government Furnished

Property appended to and made part of this Contract, the Department of Homeland Security, Science and Technology Directorate will provide the Contractor with access to the covered intellectual property and biological materials necessary to produce virus master seeds for government purposes, including but not limited to the right of the government to solicit competitively, to contract for and to transfer master cell seeds, master cell working seeds, and pre-master seed virus to third parties for use in the production of master seed virus (MSV) banks. MSV banks will be eventually used for FMD vaccine production and procurement by the USDA APHIS Emergency Mangement and Diagnostics, including the USDA APHIS NVS. The intellectual property SHALL NOT be used for any other purpose.

SECTION C – STATEMENT OF WORK

C.1. Background

The Department of Homeland Security (DHS) is committed to using cutting edge technologies and scientific talent in its quest to make America safer. DHS‘s Directorate of Science & Technology (S&T) is tasked with researching and organizing the scientific, engineering, and technological resources of the United States and leveraging these existing resources into technological tools to help protect the homeland. The DHS S&T Plum Island Animal Disease Center (PIADC) in Long Island, NY, is a unique research facility and critical national asset conducting research on diseases of livestock to protect America from terrorist threats directed against agriculture from the intentional introduction of diseases.

Under Homeland Security Presidential Directive-9 (HSPD-9), the Secretary of Homeland Security is responsible for coordinating the overall national effort to enhance the protection of the critical infrastructure and key resources of the United States, including the defense of agriculture and food.

HSPD-9 mandates efforts, coordinated through DHS, to ―create a new biological threat awareness capacity that will enhance detection and characterization of an attack.‖ (HSPD-9, paragraph 10). HSPD-9 also mandates that DHS accelerate and enhance the development of countermeasures (including vaccines) for Foreign Animal Diseases (FADs). HSPD-9 also recognized the need for a federal stockpile and mandated the creation of the National Veterinary Stockpile.

To fulfill these requirements, DHS S&T supports FAD vaccine R&D countermeasure programs at PIADC to strengthen the nation‘s ability to predict and respond to the incursion of a foreign animal disease (FAD). The goal of the vaccine countermeasure program is to transition licensable FAD vaccine candidates to industry partners who complete development studies for USDA Center for Veterinary Biologics (CVB) biological product licensure and subsequent product manufacturing.

An accidental or intentional introduction of a FAD into US livestock or poultry would have severe consequences for animal health, food security, and the U.S. trade export economy. An intentional introduction of an FAD would likely involve the simultaneous infection of susceptible animals in numerous locations, and depending on the specific FAD, the number of animals and premises infected in a large multifocal outbreak would quickly overwhelm the ability to stamp out infected and exposed animals. In such a scenario, it would be highly desirable to use prophylactic vaccination to reduce the rate and size of the outbreak and increase the speed of recovery. Adequate doses of vaccine available within 24 hours of FAD diagnosis will be required to bring the outbreak under control as quickly as possible. Currently, there are no CVB licensed FMD vaccines manufactured in the U.S.

This contract, which is one component of an overall U.S. foreign animal disease vaccine program, provides funding to a company to engage in the activities necessary to obtain USDA CVB approval of MSV for use in the production of FMD vaccines.

C.2. Objectives

The main objective of this contract is to provide optimized master seed virus (MSV) and master working seed virus (WSV) lots (e.g., MSV+1, MSV+5) for replication deficient, human adenovirus vectored FMD (AdFMD) vaccine candidates. The AdFMD MSV, MSV+1, and MSV+5 lots shall be produced using a USDA CVB prequalified master cell stock (MCS) or MCS derived working cell stock (WCS), and a qualified pre-master seed AdFMD vaccine virus reference strain as designated by, and coordinated and transferred through DHS S&T. MSV, MSV+1, and MSV+5 must conform to the regulatory requirements of the USDA CVB (9 CFR Parts 101-123), and/or the European Medicines Agency (EMEA)‘s Committee for Medicinal Products for Veterinary Use (CVMP)(European Pharmacopoeia Directives 81/852/EEC as amended by Directive 92/18/EEC), and/or the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicine Products (VICH).

Compliance with Current Good Manufacturing Practices (cGMP), GMP-like environment (respect of GMP), or concepts of quality design consistent with cGMP is required for the production of the AdFMD MSV, MSV+1, and MSV+5 seeds.

The specific objectives of this contract are to:

i. For each Foot and Mouth Disease Virus Vaccine, Serotype (TBD), Live Adenovirus Vector, produce a minimum of six hundred vials of MSV, a minimum of six hundred vials of MSV+1, and a minimum of one hundred vials of MSV+5.

ii. For each MSV produced, test according to 9 CFR or European Pharmacopoeia Directive equivalent :

a. General requirements (9 CFR 113.64, 113.100, 113.200 and 113.300).

b. Purity tests (9 CFR 113.47).

c. Extraneous agent tests (9 CFR 113.46, 113.47, 113.52, and 113.55).

d. Safety testing in rodents and livestock (9 CFR 113.33 and 113.41).

iii. For each MSV produced, submission of a Veterinary Biologics Production and Test Report

(APHIS Form 2008) and a supporting report complete with material and materials (VS Memorandum 800.109) for review to USDA CVB to include (minimum):

a. Seed origin and passage history.

b. Identity (to include expression of the FMDV antigen).

c. Purity.

d. Extraneous agent.

e. Safety testing.

f. Summary Information Format (VS Memorandum 800.50 and 800.205), and all MSV related test reports (purity, extraneous agent, safety tests)(VS Memorandum 800.109).

iv. Submission for review to USDA CVB of documents related to biological raw materials and ancillary reagents used in MSV production.

v. Submission of MSV samples for USDA CVB confirmatory testing.

vi. Acceptance by USDA CVB of each AdFMD MSV submitted.

vii. Storage of AdFMD MSV, MSV+1 and MSV+5 for up to three years under conditions that maintain

MSV stability.

viii. Provide all QA, QC, regulatory, and project management services related to AdFMD MSV testing, document submissions and all other MSV related regulatory communications with USDA CVB.

C.3. Broad Statement of Contract Activities

To meet the objectives stated above the, the contractor shall engage in:

(a) Mammalian cell culture production using approved master cell bank (MCB) or master seed derived working cell bank (WCB) to produce master seed virus (MSV) and master seed derived working seed virus (WSV) stocks (e.g. MSV+1, MSV+5).

(b) Testing and characterization of MSV including identity, purity and extraneous agent testing.

(c) Quality Control (QC) and Assurance (QA) programs associated with MSV production, testing, and storage.

(d) Submission of MSV samples to USDA CVB for testing and approval.

(e) Interactions with veterinary medicine regulatory agencies including preparation and submission of reports and documents to USDA CVB.

(f) Storage, handling, and shipment (if required) of MSV materials from contractor site to a final destination.

The Department of Homeland Security, Science and Technology Directorate will ensure that the Contractor has a Special Purpose License to access AdFMD pre-master seed virus and approved MCB or WCB that will allow Contractor exclusive use for the sole purpose of producing AdFMD vaccine MSV, MSV+1, and MSV+5 banks for future use in DHS S&T FMD vaccine development programs solely for the USDA APHIS Emergency Management and Diagnostic Section, including the USDA APHIS NVS.

C.4. Detailed Milestones

The Contractor, as an independent organization and not as an agent of the Government, shall furnish or procure all necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation and travel, not otherwise provided by the Government under the terms of this contract, as needed to complete at a minimum, the following milestones and perform the following tasks while following USDA CVB regulations and guidelines and/or EMEA regulations and guidelines for cGMP.

Milestones 3, 8, 13, 18, 23, 28 and any other that require delivery of materials to United States Department of Agriculture (USDA) should also require confirmation of delivery to USDA by contractor to the DHS Contracting Officer and Contracting Officer‘s Representative (COR) of delivery to USDA.

Base Year

1. Milestone 1- Within 4 months of contract award, the Contractor shall produce 700 vials of MSV and 500 vials of MVS +1 Foot and Mouth Disease Virus Vaccine, Serotype #1, Live Adenovirus Vector.

Specifically, the Contractor shall:

1.1. Task 1. Expand research grade premaster seed preparations by culture on prequalified master cell seed (MCS) line and prepare 700 vials of MSV.

1.2. Task 2. Conduct identity, purity, extraneous agent, and safety testing on MSV.

1.3. Task 3. Expand MSV on MCS line and prepare 700 vials of MSV+1.

1.4. Task 4. Document biological raw material and ancillary reagents used in MSV and MSV+1 production.

1.5. Task 5. Vial and properly store the MSV and MSV +1 for future manufacture.

2. Milestone 2 - Within 5 months of contract award, the Contractor shall produce 100 vials of MSV+5 Foot and Mouth Disease Virus Vaccine, Serotype #1, Live Adenovirus Vector.

2.1. Task 1. Expand MSV+1 on MCS line and prepare 100 vials of MSV+5.

2.2. Task 2. Document biological raw material and ancillary reagents used in MSV+5 production.

2.3. Task 3. Vial and properly store the MSV+5 for future shipment to DHS S&T and/or other DHS

S&T designated third parties.

3. Milestone 3 -Within 6 months of contract award, the Contractor shall submit for review to USDA CVB an internal QA reviewed and completed Foot and Mouth Disease Virus Vaccine, Serotype #1, Live Adenovirus Vector, Veterinary Biologics Production and Test Report (VS Memorandum 800.109)(APHIS Form 2008) and an internal QA reviewed supporting report complete with material and materials, results, and conclusions for each test:

Specifically, the Contractor shall:

3.1. Task 1. Submit seed origin and passage history.

3.2. Task 2. Submit identity to include test results to confirm expression of FMDV antigen.

3.3. Task 3. Submit specific MSV test reports (at a minimum) to include purity, extraneous agent and safety.

3.4. Task 4. Submit master sequence (MSQ) characterization of the FMDV synthetic genes used in MVS production.

3.5. Task 5. Submit a Preliminary Summary Information Format for a Category III veterinary biologic.

3.6. Task 6. Submit documents related to biological raw materials and ancillary reagents used in

MSV production.

4. Milestone 4 – Within 8 months of contract award the Contractor shall submit Foot and Mouth Disease Virus Vaccine, Serotype #1, Live Adenovirus Vector, MSV samples to USDA CVB for confirmatory testing.

4.1. Task 1. Obtain CVB acceptance of the MSV test report.

4.2. Task 2. Obtain CVB acceptance to submit MSV samples for confirmatory testing.

4.3. Task 3. Submit MSV samples (number will be specified by CVB) to CVB for MSV confirmatory testing.

5. Milestone 5 – Within 10 months of contract award obtain approval for MSV approval for Foot and Mouth Disease Virus, Serotype #1, Live Adenovirus Vector.

6. Milestone 6 - Within 5 months of contract award, the Contractor shall produce 700 vials of MSV and 500 vials of MVS +1 Foot and Mouth Disease Virus Vaccine, Serotype #2, Live Adenovirus Vector.

6.1. Task 1. Expand research grade premaster seed preparations by culture on prequalified master cell seed (MCS) line and prepare 700 vials of MSV.

6.2. Task 2. Conduct identity, purity, extraneous agent, and safety testing on MSV.

6.3. Task 3. Expand MSV on MCS line and prepare 500 vials of MSV+1.

6.4. Task 4. Document biological raw material and ancillary reagents used in MSV and MSV+1 production.

6.5. Task 5. Vial and properly store the MSV and MSV +1 for future manufacture.

7. Milestone 7 - Within 6 months of contract award, the Contractor shall produce 100 vials of MSV+5 Foot and Mouth Disease Virus Vaccine, Serotype #2, Live Adenovirus Vector.

7.1. Task 1. Expand MSV+1 on MCS line and prepare 100 vials of MSV+5.

7.2. Task 2. Document biological raw material and ancillary reagents used in MSV+5 production.

7.3. Task 3. Vial and properly store the MSV+5 for future shipment to DHS S&T and/or other DHS

8. Milestone 8 -Within 7 months of contract award, the Contractor shall submit for review to USDA CVB an internal QA reviewed and completed Foot and Mouth Disease Virus Vaccine, Serotype #2, Live Adenovirus Vector, Veterinary Biologics Production and Test Report (VS Memorandum 800.109)(APHIS Form 2008) and an internal QA reviewed supporting report complete with material and materials, results, and conclusions for each test:

Specifically, the Contractor shall:

8.1. Task 1. Submit seed origin and passage history.

8.2. Task 2. Submit identity to include test results to confirm expression of FMDV antigen.

8.3. Task 3. Submit specific MSV test reports (at a minimum) to include purity, extraneous agent and safety.

8.4. Task 4. Submit master sequence (MSQ) characterization of the FMDV synthetic genes used in MVS production.

8.5. Task 5. Submit a Preliminary Summary Information Format for a Category III veterinary biologic.

8.6. Task 6. Submit documents related to biological raw materials and ancillary reagents used in

MSV production.

9. Milestone 9 – Within 9 months of contract award the Contractor shall submit Foot and Mouth Disease Virus Vaccine, Serotype #2, Live Adenovirus Vector, MSV samples to USDA CVB for

9.1. Task 1. Obtain CVB acceptance of the MSV test report.

9.2. Task 2. Obtain CVB acceptance to submit MSV samples for confirmatory testing.

9.3. Task 3. Submit MSV samples (number will be specified by CVB) to CVB for MSV confirmatory testing.

10. Milestone 10 – Within 11 months of contract award obtain approval for MSV approval for Foot and Mouth Disease Virus, Serotype #2, Live Adenovirus Vector.

11. Milestone 11- Within 6 months of contract award, the Contractor shall produce 700 vials of MSV and 500 vials of MVS +1 Foot and Mouth Disease Virus Vaccine, Serotype #3, Live Adenovirus

11.1. Task 1. Expand research grade premaster seed preparations by culture on prequalified master cell seed (MCS) line and prepare 700 vials of MSV.

11.2. Task 2. Conduct identity, purity, extraneous agent, and safety testing on MSV.

11.3. Task 3. Expand MSV on MCS line and prepare 500 vials of MSV+1.

11.4. Task 4. Document biological raw material and ancillary reagents used in MSV and MSV+1 production.

11.5. Task 5. Vial and properly store the MSV and MSV +1 for future manufacture.

12. Milestone 12 - Within 7 months of contract award, the Contractor shall produce 100 vials of MSV+5 Foot and Mouth Disease Virus Vaccine, Serotype #3, Live Adenovirus Vector.

12.1. Task 1. Expand MSV+1 on MCS line and prepare 100 vials of MSV+5.

12.2. Task 2. Document biological raw material and ancillary reagents used in MSV+5 production.

12.3. Task 3. Vial and properly store the MSV+5 for future shipment to DHS S&T and/or other DHS

13. Milestone 13 -Within 8 months of contract award, the Contractor shall submit for review to USDA CVB an internal QA reviewed and completed Foot and Mouth Disease Virus Vaccine, Serotype #3, Live Adenovirus Vector, Veterinary Biologics Production and Test Report (VS Memorandum 800.109)(APHIS Form 2008) and an internal QA reviewed supporting report complete with material and materials, results, and conclusions for each test:

Specifically, the Contractor shall:

13.1. Task 1. Submit seed origin and passage history.

13.2. Task 2. Submit identity to include test results to confirm expression of FMDV antigen.

13.3. Task 3. Submit specific MSV test reports (at a minimum) to include purity, extraneous agent and safety.

13.4. Task 4. Submit master sequence (MSQ) characterization of the FMDV synthetic genes used in MVS production.

13.5. Task 5. Submit a Preliminary Summary Information Format for a Category III veterinary biologic.

13.6. Task 6. Submit documents related to biological raw materials and ancillary reagents used in

MSV production.

14. Milestone 14 – Within 10 months of contract award the Contractor shall submit Foot and Mouth Disease Virus Vaccine, Serotype #3, Live Adenovirus Vector, MSV samples to USDA CVB for

14.1. Task 1. Obtain CVB acceptance of the MSV test report.

14.2. Task 2. Obtain CVB acceptance to submit MSV samples for confirmatory testing.

14.3. Task 3. Submit MSV samples (number will be specified by CVB) to CVB for MSV confirmatory testing.

15. Milestone 15 – Within 12 months of contract award obtain approval for MSV approval for Foot and Mouth Disease Virus, Serotype #3, Live Adenovirus Vector.

Option Year 1

1. Milestone 16- Within 4 months of contract award, the Contractor shall produce 700 vials of MSV and 500 vials of MVS +1 Foot and Mouth Disease Virus Vaccine, Serotype #4, Live Adenovirus

2. Milestone 17 - Within 5 months of contract award, the Contractor shall produce 100 vials of MSV+5 Foot and Mouth Disease Virus Vaccine, Serotype #4, Live Adenovirus Vector.

3. Milestone 18 -Within 6 months of contract award, the Contractor shall submit for review to USDA CVB an internal QA reviewed and completed Foot and Mouth Disease Virus Vaccine, Serotype #4, Live Adenovirus Vector, Veterinary Biologics Production and Test Report (VS Memorandum 800.109)(APHIS Form 2008) and an internal QA reviewed supporting report complete with material and materials, results, and conclusions for each test:

4. Milestone 19 – Within 8 months of contract award the Contractor shall submit Foot and Mouth Disease Virus Vaccine, Serotype #4, Live Adenovirus Vector, MSV samples to USDA CVB for

5. Milestone 20 – Within 10 months of contract award obtain approval for MSV approval for Foot and Mouth Disease Virus, Serotype #4, Live Adenovirus Vector.

6. Milestone 21 - Within 5 months of contract award, the Contractor shall produce 700 vials of MSV and 500 vials of MVS +1 Foot and Mouth Disease Virus Vaccine, Serotype #5, Live Adenovirus

7. Milestone 22 - Within 6 months of contract award, the Contractor shall produce 100 vials of MSV+5 Foot and Mouth Disease Virus Vaccine, Serotype #5, Live Adenovirus Vector.

8. Milestone 23 -Within 7 months of contract award, the Contractor shall submit for review to USDA CVB an internal QA reviewed and completed Foot and Mouth Disease Virus Vaccine, Serotype #5, Live Adenovirus Vector, Veterinary Biologics Production and Test Report (VS Memorandum 800.109)(APHIS Form 2008) and an internal QA reviewed supporting report complete with material and materials, results, and conclusions for each test.

9. Milestone 24 – Within 9 months of contract award the Contractor shall submit Foot and Mouth Disease Virus Vaccine, Serotype #5, Live Adenovirus Vector, MSV samples to USDA CVB for

10. Milestone 25 – Within 11 months of contract award obtain approval for MSV approval for Foot and Mouth Disease Virus, Serotype #5, Live Adenovirus Vector.

11. Milestone 26- Within 6 months of contract award, the Contractor shall produce 700 vials of MSV and 500 vials of MVS +1 Foot and Mouth Disease Virus Vaccine, Serotype #6, Live Adenovirus Vector.

12. Milestone 27 - Within 7 months of contract award, the Contractor shall produce 100 vials of MSV+5 Foot and Mouth Disease Virus Vaccine, Serotype #6, Live Adenovirus Vector.

13. Milestone 28 -Within 8 months of contract award, the Contractor shall submit for review to USDA CVB an internal QA reviewed and completed Foot and Mouth Disease Virus Vaccine, Serotype #6, Live Adenovirus Vector, Veterinary Biologics Production and Test Report (VS Memorandum 800.109)(APHIS Form 2008) and an internal QA reviewed supporting report complete with material and materials, results, and conclusions for each test.

14. Milestone 29 – Within 10 months of contract award the Contractor shall submit Foot and Mouth Disease Virus Vaccine, Serotype #6, Live Adenovirus Vector, MSV samples to USDA CVB for confirmatory testing.

15. Milestone 30 – Within 12 months of contract award obtain approval for MSV approval for Foot and Mouth Disease Virus, Serotype #6, Live Adenovirus Vector.

Option Year 2

1. Milestone 31- Within 4 months of contract award, the Contractor shall produce 700 vials of MSV and 500 vials of MVS +1 Foot and Mouth Disease Virus Vaccine, Serotype #7, Live Adenovirus

2. Milestone 32 - Within 5 months of contract award, the Contractor shall produce 100 vials of MSV+5 Foot and Mouth Disease Virus Vaccine, Serotype #7, Live Adenovirus Vector.

3. Milestone 33 -Within 6 months of contract award, the Contractor shall submit for review to USDA CVB an internal QA reviewed and completed Foot and Mouth Disease Virus Vaccine, Serotype #7, Live Adenovirus Vector, Veterinary Biologics Production and Test Report (VS Memorandum

800.109)(APHIS Form 2008) and an internal QA reviewed supporting report complete with material and materials, results, and conclusions for each test:

4. Milestone 34 – Within 8 months of contract award the Contractor shall submit Foot and Mouth Disease Virus Vaccine, Serotype #7, Live Adenovirus Vector, MSV samples to USDA CVB for

5. Milestone 35 – Within 10 months of contract award obtain approval for MSV approval for Foot and Mouth Disease Virus, Serotype #7, Live Adenovirus Vector.

6. Milestone 36 - Within 5 months of contract award, the Contractor shall produce 700 vials of MSV and 500 vials of MVS +1 Foot and Mouth Disease Virus Vaccine, Serotype #8, Live Adenovirus

7. Milestone 37 - Within 6 months of contract award, the Contractor shall produce 100 vials of MSV+5 Foot and Mouth Disease Virus Vaccine, Serotype #8, Live Adenovirus Vector.

8. Milestone 38 -Within 7 months of contract award, the Contractor shall submit for review to USDA CVB an internal QA reviewed and completed Foot and Mouth Disease Virus Vaccine, Serotype #8, Live Adenovirus Vector, Veterinary Biologics Production and Test Report (VS Memorandum 800.109)(APHIS Form 2008) and an internal QA reviewed supporting report complete with material and materials, results, and conclusions for each test:

9. Milestone 39 – Within 9 months of contract award the Contractor shall submit Foot and Mouth Disease Virus Vaccine, Serotype #8, Live Adenovirus Vector, MSV samples to USDA CVB for

10. Milestone 40 – Within 11 months of contract award obtain approval for MSV approval for Foot and Mouth Disease Virus, Serotype #8, Live Adenovirus Vector.

11. Milestone 41- Within 6 months of contract award, the Contractor shall produce 700 vials of MSV and 500 vials of MVS +1 Foot and Mouth Disease Virus Vaccine, Serotype #9, Live Adenovirus Vector.

12. Milestone 42 - Within 7 months of contract award, the Contractor shall produce 100 vials of MSV+5 Foot and Mouth Disease Virus Vaccine, Serotype #9, Live Adenovirus Vector.

13. Milestone 43 -Within 8 months of contract award, the Contractor shall submit for review to USDA CVB an internal QA reviewed and completed Foot and Mouth Disease Virus Vaccine, Serotype #9, Live Adenovirus Vector, Veterinary Biologics Production and Test Report (VS Memorandum 800.109)(APHIS Form 2008) and an internal QA reviewed supporting report complete with material and materials, results, and conclusions for each test:

14. Milestone 44 – Within 10 months of contract award the Contractor shall submit Foot and Mouth Disease Virus Vaccine, Serotype #10, Live Adenovirus Vector, MSV samples to USDA CVB for

15. Milestone 45 – Within 12 months of contract award obtain approval for MSV approval for Foot and Mouth Disease Virus, Serotype #9, Live Adenovirus Vector.

C.5. Security Plan

The work performed for vaccine development, manufacture, and storage will be performed in compliance with biosafety procedures as described in CDC‘s Biosafety in Microbiology and Biomedical Laboratories (current edition of the BMBL).

SECTION D - PACKAGING, MARKING AND SHIPPING

D.1. General

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. As appropriate, note on the face page of the report or plan and when feasible on the binding: (1) ―one volume only‖ or (2) ―volume 1 of x, volume 2 of x‖ etc.

The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

D.2. Method of Shipping

Unless otherwise specified by the Contracting Officer or the Contracting Officer‘s Representative (COR), delivery of all reports and other documents to be furnished to the government under this contract (including invoices), shall be made in PDF format and sent via email.

Deliveries other than reports and documents shall be delivered per the Contracting Officer‘s or the Contracting Officer‘s Representative (COR)‘s instructions.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this section, the DHS Contracting Officer‘s Representative, (COR) -- Dr. Bruce

Harper -- is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at DHS Plum Island Animal Disease Center (PIADC).

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

52.246-3 Inspection of Supplies—Cost Reimbursement (May 2001)

SECTION F - DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

a. The period of performance of this for the base period of this contract shall be 12 months from date of award.

b. The period of performance for the option periods of this contract shall be as follows, which is at the discretion of the Government and subject to availability of funds:

Period Dates Base Year 12 Months

Option Year 1 12 Months

Option Year 2 12 Months

c. The total period of performance for this contract, including the base period and all option periods shall not exceed three (3) years.

F.2. REPORTING REQUIREMENTS

All reports required under this contract shall be submitted to the COR and the Contracting Officer in electronic format. At his/her discretion, the COR may also direct the Contractor to submit hard copies of the reports to the COR. All reports shall be in Microsoft Word format.

a. Technical Reports

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with the DELIVERIES provisions in SECTION F of this contract:

(1) Quarterly Reports and Semi Annual Performance Review (SAPR) Meetings

The quarterly report is due the 15 th day after end of the Contractor reporting period. It will detail activities performed during the previous three months and provides a means to capture incremental progress on project goals, milestones, deliverables, lessons learned, and a financial summary. It shall also discuss any program risks and mitigation strategies that the Contractor will take to address the risks identified. The report shall be formatted in accordance with the report template provided by the Department of Homeland Security Contracting Officer‘s Representative (DHS COR).

A Semi Annual performance review is due every 180 days from the date of contract award.

Semi Annual performance review meetings shall be conducted in person or through teleconference with the DHS COR and other technical representatives. The venue, duration, and format will be determined in consultation with the DHS COR.

(2) Annual Report

An annual report is due every 400 days from the date of the contract award.

Monthly Technical Progress Reports:

On the fifteenth (15th) of each month the Contractor shall submit a report for the previous calendar month to the COR and the CO. The format and type of Technical Progress Report and Executive Summary will be provided by the COR. Technical Progress Reports will include baseline and updated project timelines, milestones and summaries of product manufacturing, testing, and clinical evaluation. A Technical Progress Report will not be required for the period when the Final Report is due. The Contractor shall submit one copy of the Technical Progress Report electronically via e-mail to the COR, CO and any others they designate. Such reports shall include the following specific information:

Title page- containing Technical Progress Report, the contract number and title, the period of performance or milestone being reported, the contractor's name, address, and other contact information, the author(s), and the date of submission.

Introduction/Background - An introduction covering the purpose and scope of the contract effort Progress - The report shall detail, document, and summarize the results of work performed, test results, and milestones achieved during the period covered. Also to be included is a summary of work planned for the next reporting period.

Issues - Issues resolved, new issues and outstanding issues are enumerated with options and recommendations for resolution. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and, if project activity is delinquent, then what corrective steps are planned. Revised timelines are provided Invoices – Summary of any invoices submitted during the reporting period

Action Items – Summary table of activities or tasks to be accomplished by a certain date and by whom.

Distribution List – A list of persons receiving the Technical Progress report Attachments – Results on the project are provided as attachments

Executive Summary

The executive summary shall accompany each Technical Progress Report, will be formatted in Microsoft Power Point presentations and include the following:

Title page containing Executive Title, the contract number and title, the period of performance or milestone being reported, the contractor's name and the date of submission. Project Progress presented as milestone events, test results, tasks, and other activities achieved during the reporting period as talking point bullets. Project Issues presented headings and each item as a talking point bullet.

Final Reports

By the expiration date of the contract, the Contractor shall submit a comprehensive Final Report that shall detail, document, and summarize the results of the entire contract work. The report shall explain comprehensively the results achieved. A draft Final Report will be submitted to the COR for review and revision, then the original, four copies, and an electronic file containing the Final Report with revisions shall be submitted to the COR for distribution to the CO and the Program.

b. Reports shall be sent to the following addresses as specified:

Deliver to:

No. of Copies

COR: Dr. Bruce Harper

One (1) Electronic Copy

One (1) Hard Copy – per request only

Contracting Officer: Kristian Jovanovic

One (1) Electronic Copy

F.3. DELIVERIES

a. Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in the Statement of Work in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the services, plans and reports required at the dates specified within SECTIONS C, F.2, and F.4 of this contract.

b. Deliveries required by the contractor shall be made F.O.B. destination to the address/addressee listed below:

DELIVERY POINT:

The physical delivery address is:

TBD – The COR will inform the Contractor where to deliver physical deliverables

All document based deliverables shall be sent via email to the appropriate email address(es).

c. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above Mondays through Fridays (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. EST only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

F.3. DELIVERABLES

Milestone Critical Path Deliverable Award Year

Delivery Following Contract Award

FMDV Vaccine, Serotype #1, Live Adenovirus Vector

700 vials of MSV 500 vials of MSV+1

BASE

YEAR

4 months

2 100 vials of MSV+5 5 months

3 Veterinary Biologics Production and Test Report Supporting report complete with material and methods, results and test conclusions

6 months

4 MSV samples submitted to CVB 8 months

5 MSV approval 10 months

FMDV Vaccine, Serotype #2, Live Adenovirus

Vector

5 months

7 100 vials of MSV+5 6 months

8 Veterinary Biologics Production and Test Report Supporting report complete with

7 months

9 MSV samples submitted to CVB 9 months

10 MSV approval 11 months

#3, Live Adenovirus

Vector

12 100 vials of MSV+5 7 months

13 Veterinary Biologics Production and Test Report Supporting report complete with

8 months

14 MSV samples submitted to CVB 10 months

15 MSV approval 12 months

#4, Live Adenovirus

Vector

OPTION

YEAR 1

4 months

17 100 vials of MSV+5 5 months

18 Veterinary Biologics Production and Test Report Supporting report complete with

19 MSV samples submitted to CVB 8 months

20 MSV approval 10 months

Year

Delivery Following Contract Award

#5, Live Adenovirus

Vector

5 months

22 100 vials of MSV+5 6 months

23 Veterinary Biologics Production and Test Report Supporting report complete with

24 MSV samples submitted to CVB 9 months

25 MSV approval 11 months

#6, Live Adenovirus

Vector

6 months

27 100 vials of MSV+5 7 months

28 Veterinary Biologics Production and Test Report Supporting report complete with material and methods, results and test conclusions

8 months

29 MSV samples submitted to CVB 10 months

30 MSV approval 12 months

#7, Live Adenovirus

Vector

YEAR 2

4 months

32 100 vials of MSV+5 5 months

33 Veterinary Biologics Production and Test Report Supporting report complete with material and methods, results and test conclusions

6 months

34 MSV samples submitted to CVB 8 months

35 MSV approval 10 months

#8, Live Adenovirus

Vector

5 months

37 100 vials of MSV+5 6 months

38 Veterinary Biologics Production and Test Report Supporting report complete with

39 MSV samples submitted to CVB 9 months

40 MSV approval 11 months

42 100 vials of MSV+5 7 months

Year

Delivery Following Contract Award

43 FMDV Vaccine, Serotype #9, Live Adenovirus

Vector

Veterinary Biologics Production and Test Report Supporting report complete with

8 months

44 MSV samples submitted to CVB 10 months

45 MSV approval 12 months

F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

http://www.acquisition.gov/comp/far/index.html.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

52.247-35, F.O.B. Destination Within Consignees Premises (April 1984).

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER

a. The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract.

b. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the Statement of Work; (2) modify or extend the period of performance; (3) change the delivery schedule;

(4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; (5) obligate or deobligate funds into the contract; or (6) otherwise change any terms and conditions of this contract.

c. No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

a. The following COR will represent the Government for the purpose of this contract:

Dr. Bruce Harper Director of Science Science & Technology Directorate Department of Homeland Security

b. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

G.3. KEY PERSONNEL AND FACILITIES

a. Pursuant to HSAR 2052.242-71 (Key Personnel and Facilities) incorporated in Section I of this contract, the following individual(s) is/are considered to be essential to the work being performed under this contract:

Name

Title

Per Contractor‘s Proposal Per Contractor‘s Proposal

b. Pursuant to HSAR 2052.242-71 (Key Personnel and Facilities) incorporated in Section I of this contract, the following facility/facilities is/are considered to be essential to the work being performed under this contract:

Facility Name

Location

Per Contractor‘s Proposal Per Contractor‘s Proposal

c. At least 30 days prior to diverting any of the specified individuals or facilities to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel or facilities without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

G.4 . INVOICE SUBMISSION

Pursuant to the provisions of the following FAR Clauses: 52.232-25 Prompt Payment; 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration; 52.232-34, Payment by Electronic Funds Transfer – Other Than Central Contractor Registration, in Section I of this contract, the Contractor shall submit vouchers or invoices for costs incurred and claimed for reimbursement in accordance with the following instructions.

In accordance with clause 52.232-33 or clause 52.232-34, all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH).

(a) The Contractor shall submit an original invoice via email to the following address:

SAT.Invoice.Consolidation@hq.dhs.gov

(b) Each invoice shall include the following:

(1) Contract Number

(2) Contractor Name

(3) Date of Invoice

(4) Invoice/voucher Number

(5) Amount

(6) Travel Costs

G.5. GOVERNMENT FURNISHED PROPERTY

DHS may furnish highly specialized laboratory equipment for vaccine manufacturing, vaccine downstream processing and vaccine serial analytical assays. Contractor shall identify and provide justification for any laboratory equipment that requires purchase in order to provide the supplies and services during the performance of this Contract.

G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1. SECURITY REQUIREMENTS

a. All work performed under this contract is controlled unclassified information (CUI)(formerly

FOUO) unless otherwise specified by DHS. This contract does not require access to information at the SECRET/National Security Information level.

H.2. ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS

Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by P.L.105-220 under Title IV (Rehabilitation Act Amendments of 1998) all Electronic and Information Technology (EIT) developed, procured, maintained and/or used under this contract shall be in compliance with the ―Electronic and Information Technology Accessibility Standards‖ set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the ―Access Board‖) in 36 CFR Part 1194.

The complete text of Section 508 Final Standards can be accessed at http://www.access-board.gov/ The standards applicable to this requirement are listed below:

mailto:SAT.Invoice.Consolidation@hq.dhs.gov http://www.access-board.gov/

§ 1194.41 Information, documentation, and support.

H.3. EPA ENERGY STAR REQUIREMENTS

Executive Order 13123, ―Greening the Government Through Efficient Energy Management‖ and FAR

23.203 require that when Federal Agencies acquire energy using products, they select, where life-cycle cost-effective, and available, ENERGY STAR® or other energy efficient products.

Unless the Contracting Officer determines otherwise, all energy-using products acquired under this contract must be either an ENERGY STAR® or other energy efficient product designated by the Department of Energy‘s Federal Energy Management Program (FEMP).

For more information about ENERGY STAR® see http://www.energystar.gov/ For more information about FEMP see http://www.eere.energy.gov/

H.4. ANTI - LOBBYING

a. Contract funds shall only be used for normal and recognized executive-legislative relationships.

Contract funds shall not be used, for publicity or propaganda purposes; or for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself.

b. Contract funds shall not be used to pay salary or expenses of the contractor or any agent acting for the contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

H.5. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or fund in whole or in part a meeting,…