V797D70039 36C25221F0121_1.docx

Contract Opportunity Justification and Approval Notice

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* = Required Field Contract Opportunity Justification and Approval Notice

IXIARO 6MCG JAPANESE ENCEPHALITIS VIRUS VACCINE (PF) INJ

53214-1476 36C25221F0121 N 325412 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 V797D70039 $370,500.00 01-28-2021

VALNEVA USA, INC.

910 CLOPPER RD STE 160S

GAITHERSBURG

MD

20878

LIMITED SOURCES JUSTIFICATION

ORDER >SAT FAR PART 8.405-6

Acquisition Plan Action ID: 36C252-21-AP-0742

(1) Contracting Activity: Department of Veterans Affairs, VISN 12, Capt. James A. Lovell FHCC, 3001 Green Bay Rd, North Chicago, IL 60064-3048, Associate Director Fleet Medicine (FLEET), PR # 556-21-2-7421-0003.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). This is a new requirement procurement to purchase the Japanese Encephalitis vaccine for military personnel.

Order against: FSS Contract Number: V797-70039

City, State, Zip:

Gaithersburg, MD 20878

(3) Description of Supplies or Services: The estimated value of the proposed action is $370,500. FHCC is requesting multiple quantities of the Japanese Encephalitis vaccine for military personnel. Inactivated Vero cell culture-derived Japanese encephalitis (JE) vaccine (manufactured as IXIARO) is the only JE vaccine licensed and available in the United States. The sole manufacturer is Valneva Austria GmbH. Procurement will proceed with sole source award to Valneva via its NAC.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020 Page of specialized; Ixiaro is the only licensed Japanese Encephalitis vaccine available in the United States, and it is solely manufactured by Valneva.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: Products on a VA NAC contract are already determined to be fair and reasonable. According to FPDS, the VA has purchased this vaccine before for the same and/or similar price.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted: Market Research confirms that Valneva is the sole manufacturer and distributor of Ixiaro.

(7) Any Other Facts Supporting the Justification: The CDC also confirms that Valnera is the sole source of Ixiaro for the United States.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: Not Applicable.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Teresa Beers-Wesolowski, CONTRACTING OFFICER GLAC/NCO/PCO 12

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K):

I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

David Picchi NCO/PCO 12 Branch Chief image1.png image2.png