P03-JOFOC Under the SAT 02.13.2024 2.docx

Justification for Other than Full and Open Competition (Under the SAT) Open Market FAR 13.106-1

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

The Department of Health and Human Services.

National Institutes of Health Clinical Center Purchasing and Contracts Department 6701 Democracy Blvd Bethesda, MD 20892

POTS:

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

The National Institutes of Health, Office of Purchasing and Contracts on behalf of Department of Transfusion Medicine intends to award a firm-fixed price contract to Therakos for quantity five (5) cases of Cellex USA Kits needed for emergent Extracorporeal Photopheresis kits used for patient care.

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED TO MEET THE AGENCY’S NEEDS

Cellex USA Kits are needed for Extracorporeal Photopheresis (ECP) procedures for Clinical Center patients. These kits are only manufactured and sold by the Cellex equipment manufacturer Therakos. These kits are for very rare photopheresis procedures that are not done regularly. The request for these procedures is based on treatment plans that vary based on the condition of the patient(s) and are communicated to us by the primary care team as needed. We do not stock large quantities due to the high costs, short expiration date, and the unpredictability of the need. In addition, due to the astronomical costs, it would not be ideal to stock them and have them expire. Moreover, we recently had a recall of some kits which have significantly lowered our inventory. While waiting for replacement of the recalled kits by the manufacturer it is important to order more kits now since it takes a while for the orders to go through procurement.

Supplies Required:

Description:

THERAKOS® CELLEX® Photopheresis System Procedural Kits Quantity 5 Cases Price per case: $9,309 x 5 = $46,545.00

Shipped as one (1) case of three (3) individual procedural kits.

4. THE TOTAL ESTIMATE FOR THIS PROJECT: $46,545.00

5. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPENCOMPETITION. Check the applicable below.

_X_ FAR 13.106-1(b) (1): For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available (e.g. urgency, inclusive licensing agreements, brand name, or industrial mobilization).

___FAR 13.501 (a) (1) (ii) &2(i): For actions for commercial supplies or services greater than the SAT but not exceeding $6.5M, the citation is: Test Program for commercial Items, Section 4202 of the Clinger-Cohen Act of 1996.

6. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED

Proposed Contractor:

Therakos Inc.

675 James S Mcdonnell Blvd Hazelwood, Missouri T-(908) 238-6600

SAM UIE: KGLHB9TM34M5

The THERAKOS® CELLEX® Photopheresis SYSTEM Procedural kits must be used in conjunction with the Therakos CellEx System which is the platform currently in place for the patient extracorporeal photopheresis procedures. Therakos/Mallinckrodt is the sole-source manufacturer of this product.

7. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM ASMANY POTENTIAL SOURCES AS PRACTIABLE

8. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE.

9. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OFTHE REASON MARKET RESEARCH WAS NOT CONDUCTED

10. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPENCOMPETITION.

11. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THEACQUISITION.

12. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OROVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITIONFOR THE REQUIRED SUPPLIES OR SERVICES.

13. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

Name and Title

14. Contracting Officer Certification “I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

Malinda Dehner Contracting Officer