P03 LSJ Pylarify_Redacted.pdf

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

Effective Date: 02/01/2022 Page 1 of 4

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 8, Orlando Commodities Contracting Office, Orlando VA Healthcare System, 13800 Veterans Way, Orlando, FL, 32827.

(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). The action is for a Federal Supply Schedule contract for radiopharmaceutical Pylarify Injection for the Orlando VA Healthcare System, Nuclear Medicine Department.

Order against: FSS Contract Number: 36F79719D0170

Name of Proposed Contractor: Progenics Pharmaceuticals, Inc.

Street Address: 331 Treble Cove Road City, State, Zip: N. Billerica, MA, 01862 Phone: 1-800-299-3431

Generic Name: PIFLUFOLASTAT F 18 Trade Name: PYLARIFY INJECTION National Drug Code: 71258-0022-01

(3) Description of Supplies or Services:

The estimated total contract value: .

Pylarify Injection is a nuclear medicine, which is a prostate-specific membrane antigen (PSMA) targeted for Positron Emission Tomography (PET) imaging of lymph nodes, bone, and soft tissue for the presence of prostate cancer in veteran patients. The requirement is a vendor to manufacture and distribute the nuclear medicine to the Orlando VA Healthcare System hospital.

(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.

Effective Date: 02/01/2022 Page 2 of 4

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;

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. Pylarify Injection is proprietary to Progenics Pharmaceutical which has the radiopharmaceutical elements of F 18 radioactive diagnostic agent to make up prostate-specific membrane antigen (PSMA) targeting PET images of lymph nodes, bone and soft tissues for any presence of prostate cancer.

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:

General Supply Schedule has already determined the prices under schedule contracts to be fair and reasonable. Therefore, ordering activities are not required to make separate determination of fair and reasonable pricing. IAW FAR 8.405-1.

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

Based on market research, a posting of a Sources Sought Notice 36C24823Q0068 to contracting opportunities on October 11, 2022, yielded responses from two small businesses (Telix Pharmaceutical and Jubilant DraxImage Radiopharmacies) and one Large business (Cardinal Health).

The three vendors offered an alternate brand, however this product is not an acceptable equal

, according to the Nuclear Medicine department. A Federal Supply Schedule contract 36F797D19D0170 is available with Progenics Pharmaceuticals, Inc (Small Business).

Progenics is the manufacturer of the nuclear medicine and can manufacture the required

Effective Date: 02/01/2022 Page 3 of 4

Progenics Pharmaceuticals as the medicine is proprietary to Progenics.

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:

Competition will be reconsidered on the next procurement requirement.

(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.

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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.

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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.

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HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

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