Redacted_W911QY-16-D-0009_Screening_Pouches_J A_Redacted.pdf

JUSTIFICATION AI\D APPROVAL

FOR OTHER THA¡{ FULL A¡{D OPEN COMPETITION

1. Agency/Contracting Activity: ACC-APG NCD Ft Detrick

2. Description of Action:

Nature: I New Requirement XX Follow-on Requirement

! Mod to Existing Purchase Order/Contract Number

Pricing: XX Firm-Fixed Price E Time & Materials ! Cost

Funds:

Procurement n Operations and Maintenance, Army (OMA) XX Other Funds: FY l6

Fiscal Year of Funds: 16

Name of Proposed Contractor(s)

Street Address:

City, State, Zip:

Phone: 801 -262-3 592 xl7 65

BioFire Defense LLC 79 W 4500 South, Suite 14

Salt Lake city, uT 84107-2663

3. Description of Services or Supplies:

The total estimated value of the proposed action is $ Total Maximum value

This action is for award of a single Firm-Fixed-Price Indefinite Delivery/ Indefinite Quantity (IDIQ) contract with BioFire Defense, Inc. as a follow on to the development and delivery Contract No.

W9l I QY-l I - C-003 l, for the manufacture and delivery of RAZOR EX Screening Pouches. The minimum quantities below are based upon the minimum lot size stipulated by the vendor. The variation between minimum and maximum lot sizes are based upon the historical usage fluctuations.

The award will contain a Base ordering period with three additional option ordering periods.

The proposed acquisition consists of the following:

Base ordering period (2016) CLIN 0001- RAZOR Reagent Pouch ea; Min Qty: 88, Max Qty = 352; Min CLIN Value :

Max CLIN Value:

Option Period I (2017) CLIN 0001- RAZOR Reagent Pouch ; Min Qty: 88, Max Qty :352; Min CLIN Value =

Max CLIN Value:

Option Period 2 (2018) CLIN 0001- RAZOR Reagent Pouch ea; Min Qty= 88, Max Qty =352; Min CLIN Value:

Max CLIN Value:

NCD-16-04

Option Period 3 (2019) CLIN000l- RAZORReagentPouch 0ea;MinQty"=88,MaxQty:3521,MinCLINValue:

Max CLIN Value=

Total Minimum Value: 8 Total Maximum Value=

4. Authority: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations, but other exceptions may apply per FAR 6.3.

Actions other than simplified acquisition procedures (select one):

XX FAR 6.302-l: Only one responsible source and no other supplies or services will satisfu agency requirements, l0 USC 2304(c)(l) n FAR 6.302-2: Unusual and compelling urgency, l0 USC n\a@)Q)

E fen 6302-5: Authorized or Required by Statute, l0 USC 230a(c)(5) n Other: insert appropriate authoritv here

5. Reasons for Authority Cited:

The RAZOR EX system is the only hand-portable, battery operated instrument currently frelded by Government agencies. The system utilizes a screening pouch consisting of assays for the identification and detection of biological threats. BioFire Diagnostics Inc. (BFDx) is the owner of the intellectual property (IP) and sole manufacturer of the RAXOR EX and the RAZOR Reagent screening pouches. These screening pouches contain freeze-dried real-time PCR assay reagents and are only compatible for use on the RAZOR EX instruments. BFDx has adapted CRP reagents into their commercial reagent screening pouches for Government of the shelf product for use solely by the Govemment for the detection/identification of biological agents. The material used in the assays contains classified materials regulated by CRP and not available for commercial developmenluse. No other firm possesses the technical capability or IP required to adapt CRP assays into the RAZOR Reagent screening pouches compatible with the RAZOR EX instrument system, and no other system is currently fielded by the Government. Development of a new system is ongoing under other programs, however delivery is not anticipated until FYl8.

This requirement is a follow-on contract for highly specialized equipment. It is cost prohibitive for the govemment to provide full and open competition, since the duplication of costs are estimated in excess of , resulting in several years in schedule delay. This IDIQ is only necessary until the next generation system is developed as a replacement. Previous purchase of the screening pouches was through contract W9l IQY-11-C-0031, under JA& N I l-01, approved on 08 OCT 2010. The initiation of the IDIQ is in the best interest of the govemment to extend the capability with a proven manufacturer in the timeliest and cost efficient way possible

6. Efforts to Obtain Competition: BFDx holds the IP and expertise on the technological processes to freeze-dry real-time PCR reagents into the proprietary RAZOR pouches; therefore, no competition can be expected. This action was previously synopsized on FedBizOpps on October 13, 2010 and will be synopsized prior to award in accordance with FAR 5.102(aX6). To date, no other sources have written to express an interest or capability, nor has any market research produced an alternative source.

7. Actions to Increase Competition: It is not anticipated this requirement will extend past FYl9. Current development of a replacement system is scheduled for completion in FY 18. No future acquisition is anticipated.

8. Market Research: The CRP Science Manager continually conducts market research as recent as

June 2015 using peer-reviewed scientific journals, PubMed queries and internet searches to identify potential real time PCR systems that are suitable for this need.' However, no company possesses the intellectual property and the documented validated and established processes/optimized procedures to perform this requirement. These RAZOR reagent pouches are only compatible on the RAZOR EX instrument and there are no commercially available biological detection assays and reagents utilizing government data signatures.

9. Procurement History:

Previous Purchase Order(s) or Contract(s): XX Yes flNo

If "Yes". for each purchase order or contract provide:

Purchase order or contract number: W9l lOY-l l-C-0031 Was action competed? lYes XX No If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

The RAZOR detection system was originally developed by Idaho Technologies Inc. (now BFDx) under contract with the Defense Threat Reduction Agency and U.S. Special Operations Command's Advanced Capability Technology Demonstration at a cost of Initial assessment for the RAZOR EX pouches containing CRP assays was conducted under contract W9l l3M-09-P-0040 awarded to ITI for resulting from a white paper submission received in response to BAA 07-01, with a follow-up Purchase Order, W9l1SR-l1-P-0001 for to analyze three (3) additional assays. In February 2011, Contract W9l lQY-l l- C-0031 was awarded as a sole source, J&A N-l l-01 under authority FAR 6.302-l(aX2XiiXA) (B), for a value of including options for RAZOR Reagent Pouch Production. In June 2012,ldaho Technologies lnc. partnered with another corporation forming BioFire Diagnostics, Inc.

10. Additional Information to support the justification. The RAZOR pouches are a component of the RAZOR EX system developed by BioFire Diagnostics, Inc. The government does not have any rights to the technical data package required to manufacture pouches.

11. Technical / Requirements Certification: I certify that the supporting data under my cognizance which is included in this abbreviated J&A is accurate and complete to the best of my knowledge and belief

Submitted By: type name Position Title

12. Fair and Reasonable Price Determination: As contracting officer, I hereby determine that the anticipated cost to the government for this contract action will be fair and reasonable. The technique used to determine fair and reasonable will be price analysis. As part of this basis, certified cost or pricing data will not be required because the dollar amount of this acquisition is below the thresho

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13. Contracting Officer's Approval: I hereby certify that this justification is accurate and complete to the best of my knowledge and belief. Based on the foregoing, I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described

9 Nov 2015

9 Nov 2015