Sirtex Limiting Competition Redacted.pdf

Control No: 23-RHCO-C-524

Version - February 2017

Memorandum for Record - Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: Medical Readiness Contracting Office- West William Beaumont Army Medical Center Fort Bliss, Texas

2. Description of Action: SIR-Spheres Y-90 resin microspheres required at William Beaumont Medical Center, Fort Bliss Texas

Nature: New Requirement Follow-on Requirement

Contract Vehicle: X Purchase Order Number 00 11988263

Blanket Purchase Agreement (BPA) Number

Order/BPA# against FSS Contract#

Order# against Multiple Award IDIQ Contract

Name or#

Order# against a single award IDC

Contract #

Modification# to existing PO/TO/DO/Call

Order #

Pricing/Contract Type: X Fixed Price Time & Materials/Labor Hours

Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) X Other Funds: DHP

FY: 2024

Name of Proposed Contractor(s) and Address:

Sirtex Medical Inc.

300 Unicorn Park Drive

Woburn, MA 01801

1-791-721-3800

Brand Name Buy: Yes No

3. Description of Services or Supplies: William Beaumont Army Medical Center request a follow-on contract for SIR-Spheres Y-90 resin microspheres, which are the only fully FDA PMA-approved Y-90 microspheres for colorectal cancer that has spread to the liver. SIR-Spheres Y-90 resin microspheres are approved to treat colon and rectal cancer which has spread to the liver. They are delivered thru a catheter placed in a patient groin or arm by a certified lnterventional Radiologist.

The spheres are delivered directly to the tumor site. Once in place the radiation dose delivered to the tumor will reduce it and increase the patient's chances of survival. The treatment will improve the quantity and quality of the patient's life.

Deliveries: 01 October 2023 to 30 September 2024

Total Value: $182,590.00

4. Authority:

x_ FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited:

a. Sirtex Medical is the only available vendor that matches the standard of care for the treatment of liver tumors by Y-90 radio pharmaceutical. The size of the microspheres matches the same size of the MAA particles used to map the location of the tumor in a patient liver. This will ensure accurate delivery and treatment of the tumor increasing the patient's quantity of life and quality of life.

b. Sirtex Medical is the only vendor that can deliver the radioactive doses to this area. Due to the remote location of Fort Bliss this is critical for patient care. Sirtex will provide a large enough radioactive dose so that the proper dose is delivered to the patient.

c. Without this treatment available patients with liver tumors would be required to go out to the network. The cost to the facility and the loss of the quality of care would drastically impact the patients care. With the advanced technology here at WBAMC patient receive care that goes above the standard. With

Nuclear Medicines advanced SPECT/CT scanners the providers are able to pinpoint where the treatment is going and ensure that no shunting of the treatment to the lungs.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, X apply and will be followed, or do not apply due to an exception at 5.202 .

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

Action is NOT a brand name restriction and is under $250K, no posting required

Action is a brand name restriction, under $25K, no posting required

Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

FAR 6.305(f)

FAR 8.405-6(b)(3)(iii)(A)

FAR 8.405-6(b)(3)(iii)(B)

FAR 8.405-6(b)(3)(iii)(C)

FAR 16.505(a)(4)(iii(C)

7. Market Research: Searches for Microspheres via the internet confirm that there are no other vendors that can provide this pharmaceutical and that Sirtex Medical, Inc. is the only manufacturer of these types of microspheres on the market. There is no indication that the government will obtain offers by soliciting, a sources sought notice was posted from 4-10 August 2023 and no responses were received, it is determined that this requirement will be sole source to Sirtex

Medical, Inc. as it provides the best value to the government and is the only provider capable of satisfying this requirement.

8. Other Facts: Sirtex Medical is the best match when planning the mapping of treatment for the patients. A "mapping" occurs prior to the patient by injecting

Tc99m MAA into the liver and assess where the particles can travel in the blood stream to ensure that no movement of particles into the lung tissue. Sirtex is the near match in the size and shape of particles to match the mapping. This will ensure that there is no shunting of the treatment into the lung disease and harm the patients lungs.

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Date:

Title:

Signature:

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon Historical Data.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name: Emerita Torres Date: 8/11/2023 Title: Contracting Officer

TORRES.EMERIT

Signature:

A.1017361771

Digitally signed by

TORRES.EMERITA.1017361771

Date: 2023.08.15 06:55:50 -05'00'