P03 36C260-25-AP-2656 Signed.pdf

Request for Limited Sources Justification >SAT

VHAPG Part 808.405 6 Limiting Sources Page 1 of 3 Revision: 01 Effective Date: 09/01/2024

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405 6

Acquisition Plan Action ID: 36C260 25 AP 2656 JOFOC Tracking #: FY25 NCO 20 – 1333

(1) Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office Regional Procurement Office (RPO) West, Virtual Integrated Service Network (VISN) 20, located at 1601 E. Fourth Plain Blvd., Bldg. 17, Suite B428, Vancouver, WA 98661 in support of VISN 20 VA Puget Sound Healthcare System at 1660 South Columbian Way, Seattle, WA 98108. 2237:

663 25 3 062 0016, Period of Performance 06/01/2025 – 05/31/2026.

(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).

Order against: FSS Contract Number: 36F79725D0093

Name of Proposed Contractor: PROGENICS PHARMACEUTICALS INC

Street Address: 331 TREBLE COVE ROAD

City, State, Zip: NORTH BILLERICA, MA, 01862

Phone: 414 336 9169

(3) Description of Supplies or Services:

The estimated value of the proposed action is $415,002.80

This is an order for 115 BT’s of PYLARIFY Injections within FSS Contract 36F79725D0093 for $3,608.72 per BT. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent.

PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy.

(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:

VHAPG Part 808.405 6 Limiting Sources Page 2 of 3 Revision: 01 Effective Date: 09/01/2024

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.

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:

Price already determined Fair and Reasonable. This is off FSS Schedule with Progenics Pharmac euticals, Inc. Pricing established in VA NAC Pharmaceutical Catalog. NAC Pricing is uploaded in Briefcase. CS reviewed previous orders in FPDS. FSS 36F79725D0093 was awarded on 03/27/2025.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted:

A search on SBA Dynamic Small Business Search was conducted using NAICS code 325412. Th e search yielded 147 SD/VOSB organizations. However, only one company, Progenics Pharmaceuticals, Inc. manufactures the radiopharmaceutical PYLARIFY prescribed by the attending physician for Veterans at the Puget Sound VAMC. This pharmaceutical is only available to order through FSS Contract 36F79725D0093. A search on the NAC using the Trade name PYLARIFY only one contract, 36F79725D0093, was listed.

(7) Any Other Facts Supporting the Justification:

N/A

(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: N/A

VHAPG Part 808.405 6 Limiting Sources Page 3 of 3 Revision: 01 Effective Date: 09/01/2024

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

SIGNATURE DATE

(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 DATE

b. 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.

Jacob Jackson DATE Chief, Ancillary Patient Care

SAJAR CAMARA

Digitally signed by SAJAR

CAMARA

Date: 2025.05.12 09:27:38 -07'00'