ROCHE_2018_07_06_09_46_53.doc

NMRC JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet Naval Medical Research and Development mission.

Nature and/or description of the action.

The need is for reagent components LightCycler Faststart UNG and 12.SmM dNTP blend. Both of these are manufactured by Roche Diagnostics. The Government intends on awarding a Finn Fixed Price contract. The proposed source is Roche Diagnostics, 9115 Hauge Road, Indianapolis, IN 46250.

Description of Supplies or Services:

The Molecular Department of the Biological Defense Research Directorate, Naval Medical Research Center produces reagents for biological defense applications. These reagents are employed by a variety of Navy, Department of Defense, and other US Government agencies for the detection and identification of biological warfare agents. The development process for the . production of these reagents included extensive testing of the reagent components to produce the best combination. Essential components, LightCycler Faststart UNG and 12.5mM dNTP blend, are required.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(l) and FAR 13.106-l{b)(l) soliciting from a single source.

Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited.

LightCycler Faststart UNG and 12.5mM dNTP blend produced by Roche are both essential components of reagents being produced by BDRD/NMRC for biological defense applications. These reagents are employed by a variety of Navy, Department of Defense, and other US Government agencies for the detection and identification of biological warfare agents. Additionally, these reagents are currently deployed globally for operational use. The development process included extensive testing of the components to produce the best combination. The LightCycler Faststart UNG and 12.5mM dNTP blend produced by Roche are two of these components. Switching to another vendor would invalidate all previous optimization and evaluation efforts. Reagents produced with these components from another vendor without extensive re-optimization and evaluation would result in reduced and scientifically questionable performance of the reagents. This is unacceptable to the agencies that employ the current reagents in ongoing operations.

Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

These specific reagent components must be produced by Roche Diagnostics. This purchase requirement will be posted to NECO and/or FedBizOpps in accordance with FAR 5.202.

Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the Roche Diagnostics commercial price list and will be determined fair and reasonable.

Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

See accompanying Market Research Memorandum.

Other facts supporting the use of other than full and open competition.

As above, the only acceptable vendor for the components is Roche Diagnostics. Previous purchases include the following:

N32398-l 5-P-0345 N32398-15-P-0360 N32398-16-P-0349 N32398-l 7.-P-0253 N32398-l 8-P-03 l 6

Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest.

Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

For the reasons set forth in Paragraph 5, NMRC has no plans at this time to compete future contacts for the reagent components covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements is feasible.

Point of Contact.

The points of contact at the Naval Medical Research Center, Silver Spring, MD, regarding the contents of the sole source justification is , Deborah M. Sharpe, who may be reached at (301) 319- 6471 or Edilberto Calma 301-319-6481.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

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Dustin Harrison LCDR, MSC, USN Molecular/BDRD/NMRC Phone Date

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Name Title Department/Command Phone Date

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer

Edilberto P. Calma Contracting Officer Phone Date file_4.png file_5.png file_6.png

Phone Date