JA16002_Redacted_Redacted.pdf

Control Number JA16002

Justification and Approval for Other Than Full and Open Competition Justification

1. Contracting Activity:

The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity.

2. Description of Action:

The Walter Reed Army Institute of Research (WRAIR) Department of Discover, Experimental Therapeutics Branch (ET) in Silver Spring, MD is continuing research to develop a drug against malaria, drug-resistant bacteria, and leishmaniasis. WRAIR is seeking to purchase two Tecan Freedom EVO Liquid Handling platforms and one Tecan Infinite M1000 Plate Reader.

3. Description of Supplies/Services:

Tecan Infinite M1000 Plate Reader: WRAIR intends to use the plate reader in conjunction with its existing suite of Tecan analyzers. The assays for drug discovery and development for antiparasitic diseases require a multifunctional plate reader to meet the needs of drug development.

Tecan EVO200: WRAIR intends to use the EVO200 similar to its predecessor, EVO150, to continue its research performing six high-throughput in vitro assays for drug discovery against malaria, drug-resistant bacteria, and leishmaniasis.

The estimated dollar value is RDT&E 2 year funding will be utilized.

4. Authority Cited:

The statutory authority permitting other than full and open competition is U.S.C. 2304(c)(1), FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited:

Tecan Infinite M1000 Plate Reader

The assays for drug discovery and development for antiparasitic diseases require a multi-functional plate reader to meet WRAIR’s need for drug development. Without a plate reader that can accommodate all of WRAIR’s assay requirements for the reading of luminescence, fluorescence, and absorption, it will be unable to fulfill its drug discovery and development mission.

WRAIR has established and validated all of its in vitro assays on two similar (partial capability) Tecan plate readers, the GENois Plus and Infinite M200. The Infinite M1000 features will support both the GENois Plus and Infinite M200. The GENois Plus requires the use and purchase of separate filters for each required wavelength; the Infinite M1000 will allow users to dial in the wavelength needed for each assay. The Infinite M1000 will also support the need to read flurescnce and absoprtion as the Infinite M200 can only read luminescence. The Infinite M1000 is the only plate reader capable of satisfying the requirements of the existing instruments at WRAIR to accomplish its ongoing research.

An alternative type of reader would require the recreation and assay qualification of six high throughput assays for drug discovery which took 7 years to accomplish coupled with the requirement to retrain 8 FTEs on an alternative system.

Tecan EVO200

Tecan is the sole distributor of the Tecan Freedom EVO 200 Liquid Handling platform, and is the only model that can process all six in vitro assays.

WRAIR has conducted research over the past seven years and has established and validated all six in vitro assays on the Tecan Freedom EVO 150. The Tecan Freedom EVO 200 is the next generation platform and shares the same highly-specialized software (EVOware) as the Tecan Freedom EVO

150. Since both platforms utilize the same software, WRAIR can easily transfer all of its programs with little or no interruption. The only difference between the Tecan Freedom EVO 150, and the Fredom EVO 200 is that the 200 model has a much larger platform, which will greatly increase the throughput of every assay. In all other aspects, the two instruments are identically the same.

FDA Data Qualification

The FDA requires that WRAIR qualify the data generated by the assays for its intended use. Market research found using assays that were not qualified by the FDA required retooling, testing and submission with an estimated cost of . Additionally, re-qualification causing a great delay in the progress of the mission of finding a new drug for malaria, leishmaniasis and drug-resistant bacteria. Qualification of each assay is essential because WRAIR has a mission to find drugs that will eventually be submitted to the FDA for approval.

6. Efforts to Obtain Competition:

A request for information (RFI) was posted for both the Tecan Infinite M1000 and EVO200 for 6 and 8 days respectfully.

Infinite M1000: Only vendor that was capble of meeting this requirement was TECAN.

EVO2000: Results found that only one business, Konnis, a reseller of refurbished Tecan EVO200, as the only vendor capable of meeting the requirement. Konnis was determined to be unacceptable as WRAIR is attempting to procure a brand new instrument. The only vendor that was capble of meeting this requirement was TECAN.

7. Actions to Increase Competition:

Future acquisitions of both instruments will be competed to increase competition. Should an alternate vendor be able to provide FDA Qualified instruments with six high throughput assays this acquisition will be competed.

8. Market Research:

Market research was conducted through online reviews on capabilities of comparable models and by testing existing assays using instruments that WRAIR already possess from other companies, it was determined that TECAN as the only source that can provide the instrumentation necessary to support the mission of developing a drug against malaria, drug-resistant bacteria, and leishmaniasis.

9. Interested Sources:

To date, no other sources have written to express an interest. A Request for Information was synopsized on 30 August 2015 and closed on 8 September, 2015 for the Tecan M1000 and 28 August 2015 to 3 September 2015; the only vendor to respond was TECAN.

10. Other facts:

Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history. Reasonable efforts to retrieve the following items from the computer records, contract files, competition advocate office files or other sources are expected:

(1) Contract numbers and dates of the last several awards.

Not applicable.

(2) Competitive status of these actions. Was the requirement competitive?

(3) Authority previously used for less than full and open competition.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results:

(5) If any prior award was accomplished by full and open competition, a detailed explanation of the changed circumstances.

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive urgent buys:

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes:

c. Acquisition data availability.

d. Unusual and compelling urgency.

a. Subcontracting competition. In single source situations, address efforts to be taken by the

Government to assure that the prime contractor obtains as much competition as possible in its subcontracting:

11. Technical Certification:

I certify 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.

12. Requirements Certification:

I certify 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.

13. Fair and Reasonable Cost Determination:

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

It is anticipated that price analysis technique of comparing the proposed price with previous prices for same or similar services will be utilized.

14. Contracting Officer Certification.

I certify that this justification is accurate and complete to the best of my knowledge and belief.