Nuclear Pharmacy Facility, Nuclear Medicine Division (NMD), Department of Radiology and Imaging Sciences (RADIS), NIH Clinical Center

Subject: JUSTIFICATION AND APPROVAL (J&A) – JUSTIFICATION FOR

OTHER THAN FULL AND OPEN COMPETITION

To: Contracting Officer

NATIONAL INSTITUTES OF HEALTH (NIH), CLINICAL CENTER

(CC),

OFFICE OF PURCHASING AND CONTRACTS

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY:

Requiring Activity: National Institutes of Health, Clinical Center, Nuclear Pharmacy Facility, Nuclear Medicine Division, RADIS Address: NIH Clinical Center

10 Center Drive Building 10, Room 1C492 Bethesda, MD 20892

Contracting Officer’s Representative (COR) or Administrative Officer’s (AO) Contact Information:

CONTRACTING ACTIVITY:

National Institutes of Health (NIH) Clinical Center (CC)/Office of Purchasing and Contracts (OPC) Two Democracy Plaza 6707 Democracy Boulevard, Suite 106 Bethesda, Maryland 20892

National Institutes of Health

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING

APPROVED:

This is a continuation of IDIQ #36F79725D0093 awarded to Progenics Pharmaceuticals, Inc. (A wholly own subsidiary of Lantheus Holdings, Inc) as a sole source contract in accordance with Federal Acquisition Regulation (FAR) 6.302-1.

The Government intends to procure a commercially available United States Food and Drug Administration (US FDA) approved radiopharmaceutical, Piflufolastat F- 18 injection (PylarifyTM), for prostate cancer patient care by the Nuclear Medicine Division, Department of Radiology and Imaging Sciences at the NIH Clinical Center.

DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED, INCLUDING

THE DELIVERY SCHEDULE AND/OR THE PERIOD OF PERFORMANCE AND

DOLLAR VALUE OF THE ACQUISITON:

The contractor shall arrange to deliver patient-ready Piflufolastat F-18 injection (PylarifyTM) on demand to the NIH Nuclear Pharmacy Facility, Department of Radiology and Imaging Sciences of the Clinical Center for imaging of prostate cancer. This contract will be valid from October1, 2026 to September 30, 2027 with the Economic Price Adjustment Clause (for FSS Pricing adjustment on calendar year 2026) as outlined in FAR 52.216-2 (Economic Price Adjustment- Standing Supplies).

The Period of Performance (PoP) shall consist of a Period of twelve (12) months:

3. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN

FULL AND OPEN COMPETITION:

FAR 6.302-1 – Only one responsible source and no other supplies or services will satisfy agency requirements [41 USC 253(c) (1)]: The supplies or services required by the Agency are available from only on responsible source and no other supplies or services will satisfy agency requirements.

FAR 6.302-1(c) – Only one responsible source and no other supplies or services will satisfy agency requirements [41 USC 253(c) (1)]: Brand Name Justification. The use of such descriptions in the acquisition is essential to the Government’s requirement, thereby precluding consideration of a product manufactured by another company.

FAR 6.302-2 – Unusual and compelling Urgency [41 USC 253(c) (2)]: The agency's need for the supplies or services is of such an unusual and compelling urgency that the government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. (NOTE: These justifications may be made and approved after contract award when preparation and approval prior to award would unreasonably delay the acquisition. Lack of advanced planning is not justification for the use of this authority.)

FAR 6.302-3 – Industrial Mobilization; engineering, development, or research capability; or expert services [41 USC 253(c) (3)]: It is necessary to award the contract to a particular source or sources in order (i) to maintain a facility, producer, manufacturer, or other supplier available for furnishing supplies or services in case of a national emergency or to achieve industrial mobilization, or (ii) to establish or maintain an essential engineering, research, or development capability to be provided by an educational or other nonprofit institution or a federally funded research and development center or (iii) to acquire the services of an expert neutral person for any current or anticipated litigation or dispute.

FAR 6.302-4 – International agreement [41 USC 253(c) (4)]: Full and open competition need not be provided for when precluded by the terms of an international agreement or a treaty between the United States and a foreign government or international organization, or the written directions of a foreign government reimbursing the agency for the cost of the acquisition of the supplies or services for such government.

FAR 6.302-5 – Authorized or required by statute [41 USC 253(c) (5)]: A statute expressly authorizes or requires that the acquisition be made through another agency or from a specified source, or the agency's need is for a brand-name commercial item for authorized resale.

FAR 6.302-6 – National security [41 USC 253(c) (6)]: The disclosure of the agency's needs would compromise the national security unless the agency is permitted to limit the number of sources from which it solicits bids or proposals.

FAR 6.302-7 – Public Interest [41 USC 253(c) (7)]: The agency head determines that it is not in the public interest to use full and open competition in the particular acquisition concerned.

4. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE

OF THE AUTHORITY CITED:

This vendor developed this new drug, and is currently holding the exclusive patent right to this new radiopharmaceutical. It is the only FDA and US NRC vetted supplier of Piflufolastat F-18 injection (PylarifyTM), in the United States and the world.

5. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTIABLE:

Progenics Pharmaceuticals, Inc. (a wholly own subsidiary of Lantheus Holding, Inc.)

is the only FDA approved supplier of Piflufolastat F-18 injection (PylarifyTM), in the United States and the world. There is no other alternative supplier.

7. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS

OR STATEMENT OF THE REASON MARKET RESEARCH WAS NOT

CONDUCTED:

In accordance with FAR Part 10.002 (2) and (b) (1), methods used to conduct market research consisted of reviewing the results of recent market research undertaken to meet similar or identical requirements, querying the Government wide database of contracts and other procurement instruments intended for use by multiple agencies as well as other Government and commercial databases that provide information relevant to agency acquisitions. Methods also included reviewing catalogs and other generally available product literature published by manufacturers, distributors, and dealers. The methods were conducted in a manner that sought to determine the best acquisition strategy to acquire the items requested by the customer and meet the needs of the Government.

The following venues were queried during the Market Research Process:

1) Required Sources of Supplies and Services in accordance with FAR 8.002

a. GSA Advantage

b. GSA eLibary

c. Excess from Other Agencies

d. UNICOR (Federal Prison Industries)

e. Supplies which are on the Procurement List maintained by the

Committee for Purchase From People Who Are Blind or Severely Disabled

f. Wholesale Supply Sources

g. Mandatory Use of NAC Schedules

h. Other Sources (including educational and nonprofit institutions

No contractor was fond on the Priority Source list who meets the vendor criteria

2) Other Sources Queried during the Market Research Process:

a. System for Award Management (SAM)

A current records search using the System for Award Management (SAM) yielded a total of 134 contractors (excluding Other than Small Businesses) operating under NAICS 325412 and Q527 Nuclear Medicine).

b. Small Business Administration Dynamic Search A search using the SBA Quick Market search yielded 0 contractors operating under NAICS 325412 and Pylarify.

c. Vendor Information Pages

A search using the VIP yielded no Service Disabled Veteran Owned (SDVOSB) and Veteran Owned Small Business

(VOSB) contractors operating under the selected NAICS of 32514 and Pylarify.

After an extensive query and survey of the market was completed, only one capable source was discovered who can suffice the complex deliverables of this requirement. The company is as follows:

8. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND

OPEN COMPETITION:

There are currently no other supporting facts for the use of Other Than Full and Open Competition to be utilized at this time. All current and relevant information involved with the use of Other Than Full and Open Competition has been provided within this justification document.

9. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN

INTEREST IN THE ACQUISITION:

There were no other sources that expressed interest in writing or in any other capacity about this acquisition.

10. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO

REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE

ANY SUBSEQUENT ACQUISITION FOR THE REQUIRED SUPPLIES OR

SERVICES:

For future acquisitions, we will update our market research and investigate any potential new radiopharmaceuticals approved by the US FDA for similar clinical applications.