LSJ - Over Sat - CO.docx

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C250-22-AP-2484

(1) Contracting Activity: Department of Veterans Affairs, VISN 10, Ann Arbor Medical Center, Ann Arbor Michigan, Nuclear Medicine has requested Pylarify-Radio-Pharmaceutical. This procurement is being requested from the Contracting Activity: Department of Veterans Affairs, VISN 10, Network Contracting Office (NCO) 10, Kettering, Ohio.

2237 # 506-22-2-020-0171

(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: |X| FSS Contract Number: 36F79719D0170

DBA Progenics Pharmaceuticals

47th Floor Suite J

(3) Description of Supplies or Services: Supply the Diagnostic PET Radiopharmaceutical F-18 Pylarify for the imaging of Prostate specific membrane antigen in men.

The estimated value of the proposed action is $____________ It is used for the imaging of prostate specific membrane antigen (PSMA) in men. This is the only source for this F-18 PYLARIFY product.

(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. (CHECK THE APPLICABLE AUTHORITY BELOW AND COMPLETE)

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

|X| 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; the radioactive drug F-18 Piflufolastat {Pylarify) is manufactured and distributed by a sole vendor due to guidelines in FDA approval. All Nuclear Medicine imaging agents are unique and 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:

This is the only vendor FDA approved for manufacturing F-18 Piflufolastat Pylarify prostate imagining radioactive drug.

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

Lantheus / Progenic is the first and only FDA approved commercial manufacture of F-18 Piflufolastat Pylarify for prostate specific antigen detection of metastatic prostate cancer.

They have a FSS contract for pricing and Progenic Pharmaceutical, Inc. is marked as small business vendor on FSS contract. Nuclear Medicine is a highly specialized imaging department, and each radioactive drug is used to image a specific area of the body. New radioactive drugs due not come to market very often and many products are FDA approved or manufactured by one company due process requiring nuclear reactors and cyclotrons.

(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

(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

Ann Arbor VAMC

FACILITY

(10) Approvals in accordance with the :

The only FDA approved F-18 Piflufolastat imaging agent and all manufacturing rights belong to original vendor submission to FDA. Lantheus / Progenic is the first and only FDA approved commercial manufacture of F-18 Piflufolastat Pylarify for prostate specific antigen detection of metastatic prostate cancer. There is no generic form or multiple manufactures. An RFQ was posted to GSA e-buy, as an Intent to Sole Source to Progenic Pharmaceutical, Inc. No responses were received.

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