A02-3 - JA-20-05-0313 Redacted.pdf

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA). The customer is the U.S.

Army Medical Research Institute of Chemical Defense (USAMRICD).

2. Description of Action:

Nature: X New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number _______________________________ Blanket Purchase Agreement (BPA) Number _______________ Order/BPA# _______ against FSS Contract #_____ _________ Order #___________ against Multiple Award IDIQ Contract Name or #______________

Order #_______ against a single award IDC Contract

Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: X Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) X Other Funds:

Name of Manufacturer for Brand Name Equipment:

Molecular Devices (Cage Code: 0H297; DUNS: 125123125) 3860 North 1st Street San Jose, CA 95134

Brand Name Buy: X Yes No

3. Description of Services or Supplies: This procurement is for an Image Xpress Pico EC System with Cell Reporter Xpress automated Image Acquisition and Analysis software. The software license allows five concurrent logins as well as a maximum of ten computer cores for distributed image analysis. The system provides standard image analysis algorithms that include cell counting, cell scoring, and other analysis modules for a total of 17 analysis modules in all. Other features include a perpetual license for digital confocal 2-D on-the-fly deconvolution for use with the CellReporterXpress Software, and the ImageXpress Pico; an advance analysis bundle

Control No: JA 20-05-0313 for Granularity Analysis Algorithm, the Neurite Tracing Algorithm, and the Translocation Algorithm; and a CellReporterXpress license for multi-wavelength cell scoring. The procurement includes 1-year warranty covering parts & labor.

Delivery Date: 30 days after date of award

4. Authority:

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

Or

Or

X FAR 8.405-6(a)(1)(i)(B) and 8.405-6(b)(1)Brand Name

FAR 8.405-6(a)(1)(i)(A) Urgency FAR 8.405-6(a)(1)(i)(B) Only One Source is Capable FAR 8.405-6(a)(1)(i)(C) Logical Follow-on

FAR 16.505(b)(2)(i)(B) Only One Awardee is Capable FAR 16.505(a)(4) Brand Name FAR 16.505(b)(2)(i)(A) Urgency FAR 16.505(b)(2)(i)(C) Logical Follow-on FAR 16.505(b)(2)(i)(D) Minimum Guarantee

5. Reasons for Authority Cited:

a. Consideration is restricted to one manufacturer, Molecular Devices, but there are three licensed authorized resellers of Molecular Devices brand name equipment. ICD has current funding for fluoroacetate studies through the National Institute of Health (NIH) Inter-Agency Agreement (IAA). The scientific protocols for clinical trials involves the utilization of cellular screening models, such as 3D human liver spheroid models.

The Pico Image Express System fulfills the following mission essential directives of the subject program:

Multiple Imaging modes: ImageXpress Pico offers objectives ranging from 4x to 63x and can operate in colorimetric, brightfield fluorescence, or Digital Confocal 2D on-the-fly deconvolution imaging modes.

Plate-to-individual cell view: Data can be visualized at multiple levels from plate overview to individual cells. A wide variety of data visualization tools from the plate and cellular level empower users to learn as much as possible from their images and assays.

Regional Identification: Live Preview capabilities allows users to pan around the sample and adjust focus.

Preconfigured Analysis Protocols: over 25 preconfigured analysis protocols including simple cell counting and neurite tracing analysis cellular screening which are requirement of currently funded clinical trials. Analysis parameters can be optimized by selecting cells that match specific criteria of cellular studies in our research project.

Z-Stack Acquisition: Generate sharper images for more accurate segmentation using z-stack acquisition with the ability to acquire a series of images at different focal points to capture more detail than with a single slice for final projection.

Environmental Control: Multi-day, time lapse, and live cell assays can be run using the onboard environmental system with options for humidity, CO2, and O2 control.

Optimized to prevent z-drift, the software also provides real-time monitoring of environmental state, ensuring optimal assay conditions.

b. The brand name specified in this action is the only brand name that will meet the Government’s need. USAMRICD has a requirement to support the currently funded fluoroacetate NIH IAA. A main component of the project is our cellular screening models, including a 3D human liver spheroid model. For the spheroids, imaging is a crucial component of identifying toxic effects of metabolic poisons and any benefit of potential therapeutics. Without the ability to image in 3 dimensions in a high throughput manner ICD will not be able to properly assess therapeutics to toxic chemicals in any 3D cell culture system, which would result in potential failure of the IAA project.

Additionally, portions of two potential projects spanning from FY21-23 will require access to high throughput 3D imaging capabilities. The use of any other software would render the hardware configuration inoperable as the manufacturer, Palo Alto, is the only software manufacturer that produces licenses and premium support to manage the brand name hardware.

c. Lack of approval for this Limiting Competition Justification would result in purchase of an alternative system which would not satisfy current and projected future federal funded clinical trial research. The purchase of alternative systems with reduced capabilities would negatively affect ICD’s as the limited capabilities of other systems would not fulfill the identified mission essential characteristics of the cellular screening requirements for fluoroacetate studies financed by the National Institute of Health Inter-Agency Agreement.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, X apply and will be followed, or do not apply due to an exception at 5.202

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

Action is NOT a brand name restriction and is under $150K, no posting required

Action is a brand name restriction, under $25K, no posting required X This action is a brand name restriction, over $25K. The JA will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

FAR 6.305(f) FAR 8.405-6(b)(3)(iii)(A) FAR 8.405-6(b)(3)(iii)(B) FAR 8.405-6(b)(3)(iii)(C) FAR 16.505(a)(4)(iii(C)

7. Market Research: Market research determined that Molecular Devices is the sole manufacturer of ImageXpress Pico EC System with Cell Reporter Xpress automated image acquisition and analysis software. There are three licensed authorized resellers of Pico Image Express hardware and software systems: 1) Government Scientific; 2) VWR, and 3) Franklin Marshall. Two resellers are classified as large businesses and one reseller is classified as a small business. Since there are not two or more small businesses that can fulfill this brand name requirement, no set aside for small business will be made. The procurement will be unrestricted with NAICS code 339112 Surgical and Medical Instrument Manufacturing.

8. Other Facts:

a. Procurement history: not applicable. There have been prior purchases of other products from Molecular Devices by ICD. But this particular system, Pico Image Xpress hardware & software, has not been acquired previously.

b. Any other facts: All factual information available has been previously stated to support this Limiting Competition Justification.

9. Technical/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.

Typed Name:

Date:

Title:

Signature

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name:

Date:

Title:

Signatur