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 1 of 4

NOTE: If a Justification was approved for the preceding acquisition, a copy of the approved Justification for the predecessor action must be included in the staff package for approval of the instant Justification. This applies to Justification staff packages that are submitted for review and approval at a level above the contracting officer. The predecessor Justification will be used as a reference document by the approving official.

Is this a new or amended J&A Document? New Amended ( Prior to Award Only! )

Is this a Bridge Action as defined in the AF Bridge Action Reduction Plan? Yes No

Funding level for this acquisition: >SAT and < $700K > $700K and < $13.5M

Contracting Activity: AFLCMC/PZIBA

Purchase Request / Local ID Number: N/A BPA

Program / Project (and PE, if applicable): PETNET Solutions, Inc. Blanket Purchase Agreement (BPA)

Program Type (PEO or Other Contracting): Other Contracting, Operational Base Support

Authority: AFFARS 5313.501 - 10 U.S.C. 2302b, Implementation of Simplified Acquisition Procedures (41 U.S.C. 1901)

AFFARS 5313.501 - 10 U.S.C. 2304a, Special Emergency Procurement Authority (41 U.S.C. 1903)

Estimated Contract Cost (including options): $1,200,000.00 Justification Type: Class Individual

COORDINATION (AFFARS 5306.304(a))

Date 26 Mar 2020

Project Lead / Program Mgr / Requiring Activity Megan Schaab, MSgt

Signature

Date

26 Mar 2020

Contracting Officer Kyle R. Wheat, TSgt

AFLCMC/PZIBA, 937-522-4632

Signature

Date

31 Mar 2020

Local Legal Reviewer Thomas J. Menza 88th ABW/JA, 937-904-2191

Signature

Date

15 Apr 2020

Chief of the Contracting Office (COCO) Donna Learned

AFLCMC/PZI, 937-255-1172

Signature

APPROVAL (AFFARS 5306.304(a) )

Date

16 Apr 2020

Competition Advocate David D. Hall

AFLCMC/PK, 937-255-3741

Signature

SCHAAB.MEGAN.LOUISE.1291816050 Digitally signed by SCHAAB.MEGAN.LOUISE.1291816050 Date: 2020.03.26 12:20:46 -04'00'

WHEAT.KYLE.RAYMON

D.1394844132

Digitally signed by

WHEAT.KYLE.RAYMOND.1394844132

Date: 2020.03.26 13:22:26 -04'00'

MENZA.THOMAS.J.1079

195126

Digitally signed by

MENZA.THOMAS.J.1079195126

Date: 2020.03.31 12:00:15 -04'00'

LEARNED.DONNA.M.12

30569092

Digitally signed by

LEARNED.DONNA.M.1230569092

Date: 2020.04.15 17:20:19 -04'00'

HALL.DAVID.D.1230210

Digitally signed by

HALL.DAVID.D.1230210949

Date: 2020.04.16 11:48:02 -04'00'

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

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 four (4) injections per month will be needed. Four (4) injections per month for five (5) years would result in 240 injections total. Each injection of Axumin costs approximately $4,406 based on the most current PETNET price list. 240 injections at $4,406 per injection results in a price of $1,057,440 over the span of the five (5) year BPA.

In addition to the Axumin injections, there will be a charge of $112 per delivery (delivered from Cincinnati) or $186 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:

Four (4) deliveries at $112 per delivery per month for five (5) years results in a total delivery charge of $26,880.

Individual calls placed against the BPA will be appropriated with stock funds. The ceiling amount of $1,200,000 ($1,057,440 + $26,880 + contingency orders/delivery/increased future prices) 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

18 Jun 2019 FOR OFFICIAL USE ONLY Page 3 of 4 method in treating and identifying patients with prostate cancer.

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Siemens' PETNET Solutions is the only manufacturer and distributor of Axumin in the United States. There are no other companies that would be able to fulfill the Wright-Patterson AFB Medical Center's need for Axumin, therefore no competitive solicitation will be utilized. PETNET allows other companies to distribute on occasion to select clients based on company-established criteria. Due to the unpredictability of PETNET's sub-distribution methods, PETNET is deemed the only reliable source to fulfill a 5-year BPA supply of Axumin.

A sources sought was initiated on 4 February 2020 - 10 February 2020 to investigate if there are any other distributors that could provide Axumin to the Air Force. During this time frame, the Government received two responses: TrillaMed LLC. and PETNET Solutions Inc.

TrillaMed LLC. cited experience in federal government opportunities by providing Axumin to the Veterans Health Administration (VHA). TrillaMed is a Service Disabled Veteran Owned Small Business (SDVOSB) and obtains Axumin through PETNET Solutions, Inc.

Since PETNET Solutions is the sole manufacturer and distributor of Axumin (with the exception of distribution capabilities granted by PETNET to TrillaMed), a sole source BPA to PETNET is in the best interest of the Government.

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The price will be determined fair and reasonable based on reviewing commercial and governmental purchases with similar quantities and using analysis techniques described in 15.403-3 (c) Commercial Items as necessary.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

IAW FAR Part 10, Market Research was conducted. Internet searches and a sources sought (see item VI, above), revealed no other manufacturers for this requirement. Siemens' PETNET Solutions is the only source of Axumin in the United States. There are no other companies that would be able to fulfill the Wright- Patterson AFB Medical Center's need for Axumin. Internet searches and the input of those with experience with Axumin procurement support the information of only one source.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

N/A

X. List of any sources that expressed, in writing, an interest in the acquisition.

See item VI, above.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

The MDG and 88 SGC will continue to perform market research in order to determine when and if other companies can

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

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.