36C24721Q0302.docx

Contract Opportunity Special Notice

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* = Required Field Contract Opportunity Special Notice Q301

INTENT TO SOLE SOURCE

Amyvid for Pet Scans Base and Options Contract To PETNET SOLUTIONS, INC. DBA

PETNET PHARMACEUTICALS

29403-5799 36C24721Q0302 N 325412 Department of Veterans Affairs Ralph H. Johnson VA Medical Center 109 Bee Street Charleston SC 29403-5799 Thomas Nicholls | Contract Specialst Thomas.Nicholls@va.gov The Department of Veterans Affairs, Network Contracting Office 07 (NCO 07), hereby provides notice of its intent to award a sole source, firm fixed price base and options contract for Amyvid for Pet Scans Base and Options to PetNet Solutions, Inc. DBA PetNet Pharmaceuticals, 801 Innovation Dr., Knoxville, Tn 37932. The contract is expected to be awarded under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 13.106-1(b) – Soliciting from a Single Source. A Justification for Single Source Awards for Other Than Full and Open Competition has been prepared. The anticipated award date is June 30, 2021.

The contractor shall provide personnel for orders of FDG and Amyvid™ to be placed by RSO certified Nuclear Medicine personnel during standard hours of care Monday through Friday between the hours of 0700 (7:00 AM EST) and 1700 (5:00 PM EST). Orders will be placed almost exclusively on the business day prior to the scheduled delivery date.

The contractor shall calibrate all radiopharmaceutical doses to ensure proper activity ranges ± 10% of the specified ordered dose per specific requirements provided by RHJVAMC personnel based on guidelines outlined in 10 CFR Part 35. The FDG dose activities shall be calibrated for either 7 mCi or 12 mCi ± 10% of activity, or as specified by RHJVAMC. The calibrated Amyvid™ dose activities shall be calibrated for 10 mCi ± 10% of activity, or as specified by RHJVAMC.

The Contractor shall notify the RHJVAMC’s PET/CT Department immediately should the inability arise to provide FDG and Amyvid™ doses by the required date and time. Notification shall be made within two (2) hours of the Contractor becoming aware of the inability to provide the required doses.

These services and supplies will be performed/delivered to the Ralph H. Johnson VA Medical Center, Radiology Nuclear Medicine Department, 109 Bee Street, Charleston, SC 29401 NAICS code: 325412 - Pharmaceutical Preparation Manufacturing (SBA Size Standard 1,250 Employees) PSC: 6515 Medical and Surgical Instruments, Equipment, and Supplies

THIS NOTICE OF INTENT IS NOT A SOLICITATION OR REQUEST FOR COMPETITIVE QUOTES. However, interested parties may identify their interest and capability to respond to this requirement within seven calendar days after publication of this notice.

A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement. The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses will be considered. All responses from responsible sources will be fully considered. As a result of analyzing responses to this notice of intent, the Government shall determine if a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) to be eligible for award and must submit a current authorized distributor letter from the manufacturer.

All Service-Disabled Veteran Owned and Veteran Owned Small Businesses must submit a self-certifying statement that their company meets all criteria established IAW 13 CFR 121.406(b)(1)(i) through (b)(1)(iii) thus demonstrating compliance with the Non-Manufacturer Rule.

Interested parties are encouraged to furnish information by email only with “RESPONSE TO INTENT TO SOLE SOURCE 36C24721Q0302” in the subject line. All documents submitted will not be returned. All interested parties shall submit clear and convincing documentation demonstrating their capabilities to satisfy the requirements listed above to Thomas Nicholls, Contract Specialist, by email at Thomas.Nicholls@va.gov NO LATER THAN February 05, 2021 @ 15:00 PM EST. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities and experience that will demonstrate the ability to support these requirements.