LSJ - Pylarify - S.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C250-26-AP-2583

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAR 538.7104-3

Acquisition Plan Action ID: 36C250-26-AP-2583

(1) Contracting Activity: Department of Veterans Affairs, NCO10, Cincinnati VAMC, Cincinnati, OH, submitted 2237 # 539-26-2-519-0017 for PROGENICS PHARMACEUTICALS INC.

(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 expiration 03/31/2030.

Name of Proposed Contractor: PROGENICS PHARMACEUTICALS INC Street Address: 331 TREBLE COVE RD City, State, Zip: BILLERICA, MA 01862 Phone: 977- 436-7344

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 560,872.00.

The Nuclear Medicine Department of the Cincinnati VA Medical Center is requesting a delivery order for the current and foreseen requirement for this radiopharmaceutical to support streamlining future orders. The requirement is for approximately 155 doses of Piflufolastat F-18 (PYLARIFY). The Progenics Pharmaceuticals Inc National Acquisition Center (NAC) contract (36F79725D0093) ends 03/31/2030.

Period of Performance: 05/01/2026-04/30/2027 Deliveries will occur on an as-needed basis.

(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.

GSAR 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf https://www.acquisition.gov/fss-ordering-procedures

VHAPG Part 808.405-6 Limiting Sources Page 2 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C250-26-AP-2583

GSAR 538.7104-3(b)(1)(ii): 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;

Progenics Pharmaceuticals is the sole manufacture of these items which are necessary to continue testing offered by the microbiology department. Accordingly, Progenics Pharmaceuticals is the only firm capable of providing the items described above.

GSAR 538.7104-3(b)(1)(iii): 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.

GSAR 538.7104-4: 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 GSAR 538.7102-2(b)(4) to aid the contracting officer in making this best value determination:

This order represents best value to the government since the National Acquisition Center (NAC) has already negotiated the best price for the government. The radiopharmaceutical market fluctuates constantly, and it is in the best interest of the government to contract with the manufacturer, Progenics Pharmaceuticals, Inc. with the agreed upon cost of the proprietary and highly specialized medication.

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

SBA SBS was searched using NAICS Code 325412 resulting in zero vendors found. The product is not on the Non-Manufacturer Rule Class Waiver list. Item is found on NAC Contract Number 36F79719D0170. Item can be procured by only one vendor, PROGENICS PHARMACEUTICALS INC. (OEM), as they are the only supplier of this pharmaceutical. Neither the VA Rule of Two nor SBA Rule of Two can be satisfied.

https://www.acquisition.gov/fss-ordering-procedures

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(7) Any Other Facts Supporting the Justification: FDA approved sole source vendor.

(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:

For forthcoming procurements related to radioactive diagnostic agents for prostate cancer screening, market research will be conducted annually to identify comparable and competitive products in the commercial marketplace.

(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.

DATE SIGNATURE

Joseph Cogswell Contract Specialist

NCO 10

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(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.

SIGNATURE DATE

Todd Cress Contracting Officer NCO 10 Contracting

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900K):

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

SIGNATURE DATE

Christopher Gundy Branch Chief NCO 10 Contracting https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx