Limiting Sources Justification Over SAT_36C248-26-AP-14_REDACTED.pdf

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C248-26-AP-1449

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAR 538.7104-3

Acquisition Plan Action ID: 36C248-26-AP-1449

(1) Contracting Activity: Department of Veterans Affairs (VA), Network Contracting Office (NCO) 08, located at 8875 Hidden River Parkway, Tampa, FL 33637, in support of C.W. Bill Young Department of Veterans Affairs Medical Center at 10000 Bay Pines Blvd, Bay Pines, FL 33744.

2237: 516-26-2-121-0279

(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 Bay Pines VA Health Care System’s (BPVAHCS) Pharmacy Service has a requirement for Amtagvi (Lifileucel). A new delivery order will be placed off the following contract:

Order against: FSS Contract Number: 36F79724D0206

Name of Proposed Contractor: Iovance Biotherapeutics Manufacturing, LLC

Street Address: 300 Rouose Blvd.

City, State, Zip: Philadelphia, PA 19112

Phone: 614-553-5720

Generic Name: Lifileucel Inj, Susp Infusion Bag

Trade Name: Amtagvi Inj, Susp Infusion Bag

National Drug Code (NDC): 73776-0001-11

(3) Description of Supplies or Services:

The estimated value of the proposed action is $393,365.83.

Amtagvi (Lifileucel) is a U.S. Food and Drug Administration (FDA) approved tumor-infiltrating lymphocyte (TIL) therapy used for treating certain types of cancer, such as adult patients with unresectable or metastatic melanoma who have progressed following prior therapy. TIL therapy involves isolating lymphocytes that have infiltrated a tumor, expanding them outside the body, VHAPG Part 808.405-6 Limiting Sources Page 2 of 4

Acquisition ID#: 36C248-26-AP-1449 and then re-infusing them into the patient. The goal is to enhance the patient's immune response against cancer cells.

The period of performance is January 5, 2026 through April 4, 2026.

(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.

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; Amtagvi is the only FDA approved TIL therapy developed and manufactured exclusively by Iovance Biotherapeutics. There are no clinically equivalent or interchangeable products available on the market for this indication.

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 to aid the contracting officer in making this best value determination:

In accordance with GSAR 538.7102-2(d)(2), ordering activities are not required to make a fair and reasonable price determination for FSS products, services, or solutions at the order level or BPA level as FSS contract pricing has been determined fair and reasonable. However, the Federal Supply Schedule (FSS) includes specialized commercial pricing available for the Big Four government agencies: Department of Veterans Affairs (VA), the Department of Defense (DoD), VHAPG Part 808.405-6 Limiting Sources Page 3 of 4

Acquisition ID#: 36C248-26-AP-1449 the Public Health Service (including the Indian Health Service), and the Coast Guard which represents the best value.

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

Market research was conducted by reviewing historical contract information as well as queries on Federal Procurement Data System (FPDS), VA National Acquisition Center (NAC), GSA.gov, and System for Award Management (SAM), and the National Acquisition Center Catalog.

Small Business Administration (SBA) Dynamic Small Business Search (DSBS) was queried utilizing NAICS 325412 and 1 SDVOSB and 1 VOSB that could possibly fulfill this requirement.

Federal Procurement Data System (FPDS) was queried utilizing keywords “amtagvi” and “Lifileucel” with no results. Additionally, SAM.gov and GSA were also queried utilizing the same keywords generating zero results.

The VA National Acquisition Center (NAC) database was queried and resulted in only one contractor available on schedule 36F79724D0206, Iovance Biotherapeutics Manufacturing, LLC.

(7) Any Other Facts Supporting the Justification: None

(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: Market research will be conducted to identify emerging suppliers, alternative therapies, and new FDA-approved products that could meet the requirement in future acquisitions. Additionally, the VA will continue to track FDA approvals and clinical trial progress for competing therapies to determine when additional sources become available.

Furthermore, requirements will be thoroughly reviewed to potentially allow for broader competition if clinically equivalent alternatives become available.

01/02/2026