Sole_Source_Redacted_14_Sep_2019.pdf

Control No: 19-06-0140

For Official Use Only

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

Teledyne Instruments, Inc.

PurIon Mass Spectrometer System

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702

2. Requiring Activity: The Requiring Activity is the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD), Building E2900, 8350 Ricketts Point Rd, APG-EA, MD 21010

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: X **Time & Materials:

* Cost:

Funds: RDT&E Operations and Maintenance, Army (OMA) Other Funds:

Fiscal Year of Funds: _FY 2019 and 2020

Estimated Total Dollar Value including Options:

4. Contractor Name:

Name of Proposed Contractor(s): Teledyne Instruments, Incorporated, dba Teledyne Isco Street Address: 4700 Superior Street City, State, Zip: Lincoln, NE 68504 Phone:

DUNS:

Cage Code:

5. Description of Supplies/Services: The Teledyne Instruments, Incorporated PurIon Mass Spectrometer (MS) System is required for the purification of organic molecules and peptides generated in USAMRICD’s synthetic chemistry laboratory to be investigated as medical countermeasures. The purchase of the Mass Spectrometer System is vital to the research and will allow USAMRICD to produce newly synthesized compounds that meet the 95% or greater purity standard required for biological activity testing, thus increasing the research throughput, speed the discovery and release of medical products, and knowledge solutions to chemical threats. Importantly, this instrument uses PeakTrak Integrated chromatography software as well as solvent pumps which can operate at a maximum pressure of 3500 psi. These features greatly simplify and facilitate the purification process while also ensuring that compounds are greater than 95% pure which is required for biological investigations. The electrospray ionization (ESI) is a requirement, as it is the optimal ion generation technique for small molecules. Additionally, the capability of scanning ion both positive and negative ion modes is critical for the Mass Spectrometer System. The Mass Spectrometer System features a novel solvent and waste level-sensing safety system which is essential for ensuring safety in the research environment. Lastly, the Mass Spectrometer System uses a unique Radio Frequency Identification (RFID) technology for automatic detection of flash columns and collection tube racks, which allows for increased research throughput by increasing the efficiency of the purification process. Finally, the Mass Spectrometer System must be able to connect with the existing Teledyne Isco CombiFlash EZ Prep System (PrepLC) and measure in real time, all materials running through the System.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: USAMRICD is required to increase research throughput, which includes the purification of synthesized compounds for testing as medical countermeasures. As a result of the increase, a Mass Spectrometer System is required for USAMRICD’s new laboratory space. An instrument that uses PeakTrak Integrated chromatography software and is equipped with solvent pumps that operate at a maximum pressure of 3500 psi for HPLC purification is required for optimal research progress and throughput. These features simplify the purification process and ensure compound purity. Furthermore, the Mass Spectrometer System is required in order to identify all compounds of the purification mixture as well as providing mass spectra of all products which is a requirement for all publications. The Teledyne Instruments PurIon Mass Spectrometer System is the gold standard of use in synthetic chemistry laboratories both in industry and academia. No other Mass Spectrometer System for a purification instrument will meet USAMRICD’s laboratory safety requirements that will efficiently produce compounds that meet the purity requirements necessary for USAMRICD’s Principal Investigations (PIs).

8. Efforts to obtain Competition: Market Research conducted identified two (2) Contractors with compatible products, ( ) and ( ) both designated as .

The instruments offered by these two (2) Contractors provide a Mass Spectrometer System used in combination with a PrepLC. As a result, USAMRICD contacted and by telephone in order to obtain additional information on the instruments as well as price quotations. A side- by-side comparison included in the Market Research document of the three (3) instruments from and revealed the instruments manufactured and do not meet all of the Mass Spectrometer System’s Minimal Essential Characteristics (MECs) required by USAMRICD to achieve optimal productivity, compound purity, safety and throughput for USAMRICD’s research program. Therefore the instruments provided by both and were determined not to be compatible with the existing Teledyne Instruments CombiFlash EZ Prep systems installed and currently used at USAMRICD.

a. Effective competition. No effective competition can be achieved as Teledyne

Instruments Incorporated is the only source available in the marketplace for the purchase of the PurIon Mass Spectrometer System.

b. Subcontracting competition. This requirement is a supply purchase and no subcontracting opportunities exist.

9. Actions to remove or overcome barriers Competition: There are no competition barriers as the required PurIon Mass Spectrometry System is only available from one

(1) source, the manufacturer, Teledyne Instruments Incorporated. Market research was conducted and documented that there are no resellers in the marketplace to purchase the required PurIon Mass Spectrometry System.

10. Market Survey: Market research was conducted by USAMRICD and USAMRAA.

As previously discussed, the results identified two (2) comparable instruments to the PurIon Mass Spectrometer System. In addition, the market research also resulted in identifying no resellers of the Teledyne instrument Incorporated PurIon Mass Spectrometry System.

11. Interested Sources: In accordance with Federal Acquisition Regulation (FAR) 5.201, Notice of Intent (NOI) W81XWH-19-Q-0196 was posted to Federal Business

Opportunities (FedBizOpps) on 7 June 2019 announcing the Government’s requirement for fifteen (15) days and closed on 22 June 2019. All interested sources purporting to have the ability to provide the required PurIon Mass Spectrometry System where required to submit Capability Statements. All Capability Statements would be evaluated to determine the relevancy and if the proposed product is comparable to the Teledyne Instruments Incorporated PurIon Mass Spectrometer System required by USAMRICD.

However, at the close of the NOI W81XWH-19-Q-0196 on 22 June 2019 10:00 AM EST, no responses or capability statements were submitted for consideration to the Contract Specialist.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: Not applicable.

Previously competed? Not applicable.

Previous authority for less than Full & Open Competition: Not applicable.

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Typed Name: Date:

Title: Signature:

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Typed Name: Date:

Title: Signature