6505--valbenazine

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 03 Eff Date: 03/18/2021

Page 1 of 3

LIMITED SOURCES JUSTIFICATION

ORDER >SAT FAR PART 8.405-6

Acquisition Plan Action ID: 36C770-21-AP-0946

Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, Hines CMOP 2237 #765-21-4-800-0266

Description of Action: This is an individual brand-name justification to support the procurement of the following items:

NDC #/UPC

CMOP

Item #

DESCRIPTION

QTY

UNIT OF MEASURE

70370-1080-01

N0289

VALBENAZINE 80MG ORAL CAP

75

BT

70370-1040-01

V0286

VALBENAZINE 40MG ORAL

CAP

75

BT

The Hines, IL CMOP facility requires the above items to be procured with the support of the instant justification and approval for other than full and open competition. The proposed procurement action will be a firm fixed-price contract award for the supplies.

Order against: FSS Contract Number: 36F79718D0414 Name of Proposed Contractor: Neurocrine Biosciences, Inc. Street Address: 12780 El Camino Real

City, State, Zip: San Diego, CA 92130T2042

Phone: 858.617.7568

3) Description of Supplies or Services:

The estimated value of the proposed action is $677,821.50 The items above support Veterans Patient s prescriptions. This order is to be delivered in 3 days ARO.

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 specialized; Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. Brand Specific products are the same thing as dispense as written on a physician prescription. No National Drug Code (NDC) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify brand specific products in the VA PRINT NAME. This is not always inclusive where a particular NDC has been determined to be formulation specific by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code.

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.

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: No competition exists for these drugs, and the NAC CO has determined the price to be fair and reasonable.

Describe the Market Research Conducted This item is packaged by Neurocrine Biosciences, Inc. Neurocrine Biosciences, Inc. has this item on a NAC contract (36F79718D0414). Because they are the only vendor to sell this item, the Rule-of-Two was not met, therefore, this will be a sole-source procurement.

Any Other Facts Supporting the Justification: N/A

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: N/A

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. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

Carlos Araghi Digitally signed by

422091

Carlos Araghi 422091

Date: 2021.09.08

06:32:54 -05'00'

Carlos Araghi Date

Inventory Management Specialist Hines CMOP

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Larry M.

Digitally signed by Larry

M. Zaritz 184054

Zaritz 184054 Date: 2021.09.09 14:47:57

-05'00'

Larry Zaritz Date

Contracting Officer

One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

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

CHRISTY PENDLAY

Digitally signed by CHRISTY PENDLAY Date: 2021.09.09 16:04:19 -05'00'

Christy Pendlay Date

Supervisory Contract Officer Awarded contract 36F79718D0414 to NEUROCRINE BIOSCIENCES, INC. for 677821.50000000 on 2021-09-08.