36C25019Q0498-001.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08 Page 1 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C250-19-AP-2915

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Louis Stokes Cleveland VA Medical

Center along with the Network Contracting Office (NCO) 10 is responsible for the proposed contracting action. Purchase Request #541-19-2-778-0179 is applicable.

2. Nature and/or Description of the Action Being Processed: The action being reviewed and approved is the purchase of Florbetapir F18 (Amyvid) doses and Fluciclovine F18 (Axumin) doses. This action will be awarded as a Firm Fixed Price, New Contract.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Florbetapir F18 (Amyvid) doses and Fluciclovine F18 (Axumin) doses in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements and 819.7007 Sole source awards to a verified service-disabled veteran-owned small business, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: In April 2012, the United States Food and Drug Administration approved florbetapir F18, branded as Amyvid. This injectable drug is a molecular imaging agent used in position emission tomography imaging to identify beta-amyloid neuritic plaque in patients being evaluated for Alzheimer’s disease. It is estimated that the Louis Stokes Cleveland VA Medical Center would purchase twelve Amyvid per year.

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 Louis Stokes Cleveland VA Medical Center would purchase sixty-five Axumin doses per year.

The estimated period of performance is June 18, 2019 – June 17, 2020.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127, as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

(X) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or ( ) 819.7008 Sole source awards to a verified veteran-owned small business

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

OFOC SOP Revision 08 Page 2 of 3

Revision 08 Date: 04/18/2018

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): PETNET Solutions Inc. and TrillaMed LLC, their exclusive SDVOSB Distributor, are the only sources of Florbetapir F18 (Amyvid) as they are the United States’ sole distributors and manufacturer for Blue Earth Diagnostics, Ltd., an England-based pharmaceutical company. Blue Earth Diagnostics, Ltd. licensed the product from GE Healthcare, Inc. who has patented the preparation methods for Amyvid through Patent #8,506,929 .

This also holds true for Fluciclovine F18 (Axumin) who has patented the preparation methods for Axumin through Patent #9,387,266.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The manufacturer of the requested Radiopharmaceuticals was contacted; PETNET Solutions Inc.

verified that TrillaMed LLC is their exclusive SDVOSB authorized distributor. VetBiz was queried using the NAICS 325412, Pharmaceutical Preparation Manufacturing and keywords Amyvid and Axumin, the search returned zero results. This non-competitive procurement is in the best interest of government due to there being no other sources that can meet this requirement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: While the price of the imaging agent is subject to higher profit margins due to the fact that it is a new and innovative drug just recently introduced to the marketplace, and it is standard practice in the pharmaceutical industry to recuperate the development costs through patent protection, the determination of fair and reasonableness has been made based on what the Government is currently spending on similar treatments outside the Louis Stokes Cleveland VAMC.

In addition, the final contract price for these Radiopharmaceuticals is identical to the prices on a previously awarded contract for this exact same requirement. Also, the contract prices are in line with the IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: The Contracting Officer’s Representative conducted a general market research using the internet search engines using the terms Florbetapir F18 and Fluciclovine F18. Each search result provided additional evidence that the tracing agent is only available through PETNET Solutions Inc. by way of the permission of Blue Earth Diagnostics, Ltd. The Contracting Officer queried VetBiz, the search returned zero results. GSA, NAC and Google were reviewed which also netted zero results. In addition, as mentioned above, the manufacturer of the requested Radiopharmaceuticals was contacted; PETNET Solutions Inc. verified that TrillaMed LLC is their exclusive SDVOSB authorized distributor.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

PETNET Solutions Inc. TrillaMed LLC.

810 Innovation Drive 30100 Telegraph Road, Suite 366 Knoxville, TN 37932 Bingham Farms, MI 48025

DUNS# 015223951 DUNS# 828126321

OFOC SOP Revision 08 Page 3 of 3

Revision 08 Date: 04/18/2018

11. 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: No actions are being taken to remove or overcome any barriers to competition. Patent laws and licensing agreements limit the influence of the VA on removing barriers to competition at this time.

Proceeding with this sole source to PETNET Solutions Inc.’s, exclusive distributor TrillaMed LLC, allows the Government to reduce costs by utilizing innovation and novel treatments as compared to traditional methods.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and 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.

Marie Dean Date Nuclear Medicine Coordinator Louis Stokes Cleveland VA Medical Center

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Christopher A. Callihan Contracting Officer

NCO 10

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Adam P. Weber Branch Chief Supply Team #1 (Ohio)

NCO 10

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx