Axumin Injections

Synopsis for Axumin Obtainment:

This is a Sole Source Synopsis published for informational purposes only. This proposed action is for the procurement of Axumin (fluciclovine F 18) injections for the patient population served by the Medical Treatment Facility (MTF) on Wright-Patterson Air Force Base (WPAFB). See Attachment 1, Statement of Work (SOW).

The Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b)(1), “Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.” The contracting officer has determined that only one source is reasonably available: PETNET Solutions, Inc.

This proposed procurement will be a Sole Source under North American Industry Classification System Code (NAICS) 325412: Pharmaceutical Preparation Manufacturing. Business size standard for NAICS 325412 is 1,250 employees. PSC/FSC code: 6515: Medical and Surgical Instruments, Equipment, and Supplies.

The proposed source is PETNET Solutions, Inc. located at 810 Innovation Dr., Knoxville, TN 37932-2562. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.  This notice of intent is not a request for competitive quotations. However, all responsible sources may submit a capability statement, proposal, quotation or exception to the intent to purchase on a sole source basis, which shall be considered by the Government.  Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

In order to comply with FAR 5.207(c)(15), the reason for lack of competition is as follows: The Government requires Axumin (fluciclovine F 18) injections for the patient population served by the Medical Treatment Facility (MTF) on Wright-Patterson Air Force Base (WPAFB). The Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in patients with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It greatly reduces the number of studies needed for prostate cancer diagnosis and can detect prostate cancer at an earlier stage. The sole distribution of the injection that meets these needs is through PETNET Solutions, Inc. The proposed sole source is the only known reliable source able to satisfy the Government’s requirements. Please see Attachment 1, Statement of Work (SOW) for more complete details.

Delivery Schedule:                   Vendor will deliver doses of Axumin to the Customer Locations FOB destination and will add any applicable delivery charges to the invoice. Delivery schedules will be determined at time of order.

Delivery Destination:               4881 Sugar Maple Drive

                                                            Bldg. 830. Area A

                                                            WPAFB OH 45433-5529

Delivery Type: FOB Destination (As defined in FAR 2.101 – Definitions, the seller or consignor is responsible for risk of loss.)

Inspection and Acceptance: Both inspection and acceptance will be by the Government at Destination.

Important Notice to Contractors:  All prospective awardees are required to register at the System for Award Management (SAM) and to maintain active registration during the life of the contract.  SAM can be accessed at https://www.sam.gov.  For a detailed description of the applicable SAM requirements and payment information, please review the clauses included in the attached solicitation.

Any information should be e-mailed to both kyle.wheat@us.af.mil, and jenah.hernek@us.af.mil. Only inquiries/information received through e-mail by this date will be considered.  Be advised all correspondence sent via e-mail shall contain a subject line that reads “Axumin Injections” Note that e-mail filters at Wright-Patterson AFB are designed to filter e-mails without subject lines or with suspicious subject lines or contents (i.e., .exe, or .zip files).  Therefore, if this subject line is not included, the e-mail may not get through the e-mail filters.  Also be advised that .zip or .exe files are not allowable attachments and may be deleted by the e-mail filters at Wright-Patterson Air Force Base.  If sending attachments with e-mail ensure only .PDF, .doc, or .xls documents are sent.  The e-mail filter may delete any other form of attachments.

Attachments:

1. Statement of Work (SOW), dated 4 February 2020
2. PETNET Sole Source Justification (SSJ)