36C25019Q0131-000.docx

FedBizOpps Justification and Approval Notice

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* = Required Field FedBizOpps Justification and Approval Notice Rev. March 2010 Axumin Radiopharmaceutical for the Dayton VA Medical Center 43219-1834 36C25019Q0131 N 325412 Department of Veterans Affairs Columbus Chalmers P. Wylie Ambulatory Care Center 420 North James Road Columbus OH 43219-1834 Gina P. Crank

(614) 257-5267

FAR 6.302-1

36C25019P0320 87,920.00 all 12-01-2018

TRILLAMED, LLC

30100 TELEGRAPH RD

BINGHAM FARMS

MI

48025 www.va.gov The VA homepage gina.crank@va.gov Contracting Officer

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C250-19-AP-0517

1. Contracting Activity: Department of Veterans Affairs, VISN/NCO 10, Chalmers P. Wylie VA Ambulatory Care Center Columbus. Using purchase request # 552-19-1-778-0018.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: In late May 2016, the United States Food and Drug Administration approved fluciclovine F18, branded as Axumin. This injectable drug is a molecular imaging agent used in position emission tomography imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen following prior treatment. It is estimated that the Dayton VA Medical Center would purchase twenty Axumin doses for a period of 1 year.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: TrillaMed, the SDVOSB distributor for PETNET solutions, Inc. is the only source of fluciclovine F18 (Axumin) as they are the United States’ sole distributor. Axumin through Patent #9,387,266.

4. Description of market research conducted and results or statement why it was not conducted: The Contracting Officer conducted Market Research by VIP, GSA, NAC and the Internet. The Contracting Officer’s Representative conducted a general market research using the internet search engines using the term fluciclovine F18. Each search result provided additional evidence that the tracing agent is only available through TrillaMed/PETNET Solutions. For example, when searching “fluciclovine F18” in Google, of the top ten (10) results, four (4) were basic information about the radiopharmaceutical such as prescribing information and chemical make-up, three (3) were informational websites containing journal articles about imaging with fluciclovine F18 and two (2) discussed the FDA approval of the agent and one (1) was a news release from Blue Earth regarding the distribution of Axumin. This information confirms the information provided by the requesting service that this imaging agent is only available through TrillaMed/PETNET Solutions, Inc, due to a patent and licensing agreement.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

____________________________ 11/08/2018 Gina P. Crank Date Contracting Officer