PETNET SSJ Signed_Redacted.pdf

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

FOR OFFICIAL USE ONLY

18 Jun 2019 FOR OFFICIAL USE ONLY Page 2 of 4

I. Contracting Activity.

Air Force Life Cycle Management Center Installation Contracting Division Operational Contracting Branch

AFLCMC/PZIBA

1940 Allbrook Drive, Room 109 WPAFB, Ohio 45433-5344

II. Nature and/or description of the action being processed.

This individual J&A authorizes the use of Other than Full and Open Competition procedures for a 5 year (no options) Firm-Fixed Price Blanket Purchase Agreement (BPA) to PETNET Solutions for Axumin (Flucicovine) F 18 injections.

III. Description of supplies/services required to meet agency needs.

The nuclear medicine department at Wright-Patterson Medical Center (WPAFB) requires PETNET Solutions supplies to perform imaging activities to detect recurring prostate cancer in patients. PETNET is the sole manufacturer and distributor of Axumin in the United States.

Axumin is a radioactive molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer and is the first FDA-approved F 18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer.

Under the contemplated BPA contract, PETNET will provide Axumin to the Customer Location (4881 Sugar Maple Dr., WPAFB, OH 45433) FOB destination with all specifications as identified in the Statement of Work (SOW).

Based on historical patient need, an estimated injections per month will be needed. injections per month for five (5) years would result in injections total. Each injection of Axumin costs approximately based on the most current PETNET price list. results in a price of over the span of the five (5) year BPA.

In addition to the Axumin injections, there will be a charge of per delivery (delivered from Cincinnati) or per delivery (delivered from Louisville) to the Medical Treatment Facility (MTF). As the majority of the injections will be fulfilled from the Cincinnati location, the calculation for the delivery charges for the five (5) year BPA are as follows:

Individual calls placed against the BPA will be appropriated with stock funds. The ceiling amount of is based off of the most recent PETNET price list, other commercial invoices, and the estimated number of scans required.

IV. Statutory authority permitting other than full and open competition.

10 U.S.C. 2302(b), Implementation of Simplified Acquisition Procedures (41 U.S.C 1901).

V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

Axumin is provided by Blue Earth Diagnostics Ltd. (“BED”) to the Siemens owned company, PETNET Solutions, for exclusive commercial manufacture and distribution. Siemens' PETNET Solutions is the only manufacturer/distributor of Axumin in the United States (see PETNET's Response to Wright Patterson AFB Sources Sought) which was confirmed through online market research. The use of Axumin allows the reduction of multiple tests in order to determine the presence and spread of prostate cancer in patients. It is the Wright-Patterson AFB Medical Center's most effective

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

FOR OFFICIAL USE ONLY

18 Jun 2019 FOR OFFICIAL USE ONLY Page 4 of 4 provide Axumin.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.