Justification for Other than Full and Open Competition-FAR Part 13 Acquisitions under SAT_Redacted.pdf

Justification for Other than Full and Open Competition – FAR Part 13 Acquisitions under the SAT

MEMORANDUM TO THE FILE

Subj: JUSTIFICATION FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION FOR A FAR PART 13 ACQUISITION UNDER THE SIMPLIFIED

ACQUISITION THRESHOLD

I. BACKGROUND:

1. FAR 13.106-1(b)(1)(i) states for purchases not exceeding the simplified acquisition threshold, 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 (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

2. As required by FAR 13.106-3(b)(i), this memorandum explains the absence of competition for this acquisition, as only one source will be solicited for this requirement (or for a portion of the requirement) and the requirement (or portion of the requirement to be sole-sourced) is not expected to exceed the simplified acquisition threshold.

II. DESCRIPTION OF ITEM OR SERVICE:

The requirement is for a 5000mCi Mo/Tc99m Nuclear Generator for patient care at the Nuclear Medicine Clinic, United States Naval Hospital Guam, to be shipped from the United States to the treatment facility. Lantheus is the sole source supplier for this specific requirement. The period of performance is from October 1, 2024, to December 30, 2024, on a fixed-price basis. The price per generator, including the delivery fee, is , with a total of 14 generators to be provided during the period of performance, resulting in a contract total of

The two manufacturers are Curium and Lantheus. Curium indicated that they do not use distributors - they sell directly to the end user. However, they do not currently have a Federal Supply Schedule or sell their Molybenbdenum-99 Generators to new customers in the North American market. Lantheus sells directly to the end user and uses a single, large business distributor - Ekert & Ziegler RadioPharma. Due to the limited supply of the low enriched uranium, there is no guarantee that the Ekert & Ziegler RadioPharma can obtain and deliver the generators from the manufacturer to meet the weekly schedule.

III. THE DETERMINATION FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION IS BASED ON THE FOLLOWING (select all that apply):

A. X ONLY ONE RESPONSIBLE SOURCE (select all that apply):

1. X RESTRICTIVE RIGHTS. The source has established proprietary rights, limited rights in data, patent rights, copyrights or secret processes in the item or service required.

2. ___ EXCLUSIVE LICENSING AGREEMENTS. The item or service is only available from the Original Equipment Manufacturer (OEM), or there is only one authorized distributor or technical representative for the OEM.

3. ___ OTHER REASONS.

B. ____ BRAND NAME

Justification for Other than Full and Open Competition – FAR Part 13 Acquisitions under the SAT

Item required must be a brand name, product, or feature of a product, particular to one manufacturer.

C. ___URGENT AND COMPELLING. The supplies or services are of such unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. Urgent requirements are supplies or services that will result in a work stoppage, or are mission critical and the routine processing time would result in injury to the Government. The determination that the procurement for the above item/service is an urgent and compelling requirement is based on the following:

1. Date on which the requirement was first identified:

2. Required delivery date/period of performance:

3. Explanation of why delivery/commencement of services by the date mentioned above is required:

V. CERTIFICATIONS:

A. Technical / Requirements Certification: I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

9/20/2024

[Gabriel Sampson] Date

[Insert Title: Nuclear Medicine Technologist

B. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

____________________ Pedro Reyes 9/20/2024

Signature Name (Printed) / Phone # Date