63-9003-17_--REDACTED_JA_for_Sole_Source_via_Part_13.pdf

DEPARTMENT OF THE NAVY

NAVAL RESEARCH LABORATORY

4555 OVERLOOK AVE SW

WASHINGTON, DC 20375-5320

Justification for Other than Full and Open Competition and Brand Name or Equal Under Simplified Procedures For Certain Commercial Items In Accordance With Federal Acquisition Regulation (FAR) 13.5

PURCHASE REQUEST NO. 63-9003-17

J&A NO: J&A13.501-ST03

Estimated Cost: $375,000

On the basis of the following, I, as the Contracting Officer, hereby approve the use of a brand name or equal proposed contractual action pursuant to the authority of :

☒ 41 U.S.C. 1901 ☐ 41 U.S.C. 1903

1. The U.S. Department of Navy; Naval Research Laboratory Contracting Division proposes to solicit on a brand name or equal basis, under simplified procedures, for certain commercial items included in FAR subpart 13.5.

2. The nature and/or description of the action being approved, i.e., sole source under procedures for certain commercial items in accordance with FAR 13.5.

Code 6395 has a new requirement for a label-free interaction analysis system based on the principle of surface plasmon resonance (SPR), for biomolecular binding measurements. The requirement is expected to be procured on a brand name or equal basis, under FAR 13.5, for a GE Healthcare, Biacore 8K System, inside delivery, and training. The resulting contract will be awarded on a firm-fixed price basis

3. A description of the supplies and/or services required, including the delivery schedule and/or the period of performance (inclusive of all option periods), and the estimated dollar value of the acquisition.

The surface plasmon resonance (SPR) system contains the specifications as listed in Table I, with a delivery time of 6-9 months ARO and an estimated cost of $375,000, including shipping and handling.

The salient physical, functional, and/or performance characteristics of the SPR system that an “equal” item must meet to be acceptable for award shall be as follows:

The SPR system must be multiplexed, allowing for the parallel injection of solutions over a single sensor chip, and provide both kinetic and affinity binding information over the specified range of association and dissociation kinetic rate constants. The system must include the option of introducing analyte in a single cycle (no regeneration of surface needed) or multi-cycle kinetics in which the surface is chemically regenerated. The system must have a temperature controlled sample storage area with temperature range from 4 C to 40 C and an independently controlled analysis temperature range which also ranges from 4 C to 40 C. This system is required for integration and support of the existing NRL core programs: “Nanoscale Radar: Uncovering How Cells Heal Wounds” (NRL Nanoscience Institute, 6.1), “Micromechanical Properties of the Cytoskeleton in Living Cells” (NRL, 6.1) and the externally funded program “Uncovering How Cellular Navigation Systems Enable Wound Healing” (OSD – LUCI Program).

63-9003-17 -- JA for Sole Source via Part 13 pg. 2

TABLE I.

Accommodate both 96- and 384-well plate Up to 2 mL of volume for injection

Temperature controlled sample storage area and an independently controlled analysis temperature range

4 C to 39 C (or higher)

Measuring association rate constants and minimum dissociation rate constants

Association rate constants: 5x108 M-1 s-1 or higher Dissociation rate constants min: 1x10-5 s-1 or lower

Measuring maximum dissociation rate constant

0.4 s-1 or higher

Dissociation rate constant max: 0.4 s-1 or higher

Baseline noise Typically less than 0.03 RU

Refractive index range 1.33 to 1.38 (or higher)

Injection needles 6 or more

Injection needle design two fluidic channels per needle

Two-solution cycle option two different solutions introduced per single cycle

Continuous unattended hours of operation >48 hours or longer

Bare gold sensor chips Available from vendor

Cycles Single cycle and multi-cycle option with regeneration

Sample Types Protein, DNA, RNA in buffers, plasma and serum

Injection volume and flow rates As low as 1 microliter with flow rates of 100 microliter/minute or higher

Software Must include experimental design and analysis modules

4. The statutory authority permitting sole source.

☒ 41 U.S.C. 1901 ☐ 41 U.S.C. 1903

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring use of the authority.

Based on the results of a Sources Sought, posted on GSA eBuy, and a Request for Information, posted on FedBizOpps, GE Healthcare’s Biacore 8K system is the only system shown to be capable of providing an SPR system that meets or exceeds all specifications outlined in Table I, above. Market research indicates other companies’ similar products, or products lacking the particular features outlined above, do not meet, or have not been shown to be able to be modified to meet, the agency’s needs.

6. A description of efforts made to ensure offers/quotes are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized in FEDBIZOPPS (as required by FAR 5.2) and, if not, which exception under 5.202 applies.

The Contract Specialist posted a formal Request for Information, to FedBizOpps on 23 January 2017, via Sources Sought Notice N00173-17-RFI-TS03, in an effort to ensure offers/quotes would be solicited from as many potential sources as is practicable. The Sources Sought closed on 07 February 2017.

A combined synopsis solicitation will be posted on FBO for seven (7) days. Vendors will be given an opportunity to provide brand name or equal solutions that meet or exceed the salient physical, functional, http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/05.htm#P56_9651 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/05.htm#P67_10794

63-9003-17 -- JA for Sole Source via Part 13 pg. 3 and/or performance characteristics of the GE Healthcare Biocore 8K System, as outlined in Table 1 above, that an “equal” item must meet to be acceptable for award.

7. The anticipated dollar value of the proposed acquisition, including options if applicable, and a determination by the contracting officer that the anticipated cost to the government will be fair and reasonable.

The total anticipated dollar value of the proposed acquisition is expected to be $ , which includes the cost of the equipment, training and installation .

The Contracting Officer determines that the anticipated price will be fair and reasonable based on market research and a price list, if available.

8. A description of the market research conducted and the results or the reason market research was not conducted.

Market research was conducted for a In Situ Surface Plasmon Resonance (SPR) Bio-molecular Binding Kinetics Characterization System, via the following market research methods:

The end user sought information from biosensing retailers and manufacturers by contacting the

[several] vendors to discuss market capabilities and availability of products meeting NRL’s specifications and requirements. The summary of offerings is below:

63-9003-17 -- JA for Sole Source via Part 13 pg. 4

VENDOR CONTACT INFORMATION SUMMARY OF OFFERING

Reichert Technologies Life Sciences

Phone: 716-686-4522 Email: reichertspr.sales@ametek.com http://www.reichertspr.com/

Reichert’s instrument did not provide temperature controlled sample storage area and an independently controlled analysis temperature range of 4 C to 39 C (or higher). The Reichert system also did not incorporate two fluidic channels per needle.

Therefore Reichert was not able to meet the requirements.

BioNavis PH: 1-858-999-4233 Email: info@bionavis.com http://www.bionavis.com/en/material-science/products/220a-naali/

Bionavis’s instrument did not provide temperature controlled sample storage area and an independently controlled analysis temperature range of 4 C to 39 C (or higher). The BioNavis system also did not incorporate two fluidic channels per needle. The BioNavis system also did not meet the requirement for introducing two different solutions per single cycle.

Therefore BioNavis was not

Horiba Scientific

PH: 1 732 494 8660

info@jobinyvon.net http://www.horiba.com/us/en/scientific/products/surface-plasmon-resonance-imaging-spri/spri-platform/spr-imaging-systems/details/xelplex-multiplex-label-free-molecular-interaction-made-easy-76/

Horiba Scientific’s instrument did not provide temperature controlled sample storage area and an independently controlled analysis temperature range of 4 C to 39 C (or higher). Horiba Scientific’s instrument also did not meet the requirement of incorporating both single cycle and multi-cycle with regeneration options.

Therefore, Horiba Scientific was not able to meet the

Bioptix 303-545-5550 ext.103 info@bioptix.com http://www.bioptix.com/products/404pi/

Bioptix’s instrument did not provide temperature controlled sample storage area and an independently controlled analysis temperature range of 4 C to mailto:reichertspr.sales@ametek.com

63-9003-17 -- JA for Sole Source via Part 13 pg. 5

39 C (or higher). The Bioptix system also did not incorporate two fluidic channels per needle. The Bioptix system also did not meet the requirement for introducing two different solutions per single cycle.

Therefore Bioptix was not

GE

Healthcare Bio-Sciences Corp

PH: 202-660-2242

evan.behre@ge.com http://landing1.gehealthcare.com/Biacore8k.html

GE Healthcare provides a Surface Plasmon Resonance (SPR) System that meets the temperature, sensitivity and fluidic requirements for the application, namely the Biacore 8K system.

The Contract Specialist posted a Sources Sought on GSA Advantage, via RFQ ID RFQ1163663, on January 13, 2017. The Sources Sought closed on January 27, 2017. Only one vendor responded.

A formal Request for Information was posted to FedBizOpps on 23 January 2017, via Sources Sought Notice N00173-17-RFI-TS03. The FedBizOpps Sources Sought closed on 07 February 2017. Responses were received from three (3) vendors. A summary is provided below:

COMPANY: GE HEALTHCARE BIO-SCIENCES CORP. 100 RESULTS WAY, MARLBOROUGH MA 01752

A review of the vendor submission by GE Healthcare for “Request for Information NRL N00173-17-RFI-ST03 Surface Plasmon Resonance (SPR) Bio-molecular Binding Kinetics Characterization System,” was conducted.

Evaluation was focused on the technical data sheet for the Biacore 8K as this surface plasmon resonance system met the top line requirements for parallel injection of analyte and the specified range of associated and dissociation rate constants as provided by Government Scientific. A summary of the results for GE Healthcare compared to the technical requirements is shown in Table II. The GE Healthcare Biacore 8K meets or exceeds all the technical requirements required by NRL.

Table II.

PARAMETER TECHNICAL REQUIREMENT SUBMISSION COMPLIES WITH REQUIREMENT

(YES/NO)

Plate sizes 96- and 384-well compatible with 1500 uL or more volume

YES

Temperature control 4 C to 39 C, both sample storage area and analysis range (independent)

YES, Exceeds

Association rate and dissociation rate

Association rate of 5x108 M-1s-1 or higher and dissociation rate of 1x10-5 s-1 or lower

YES

Dissociation rate constant 0.4 s-1 or higher YES

RMS Noise Typically less than 0.03 RU YES, Exceeds

Refractive index range 1.33 to 1.38+ YES

Injection needles/channels 6 or more YES

63-9003-17 -- JA for Sole Source via Part 13 pg. 6

Fluidic channels/needle 2 fluidic channels per needle YES

Multiple solutions per cycle 2 solutions per cycle YES

Unattended operations 48 hours or more YES

Sensor chips for custom studies Bare gold sensor chips YES

Analyte cycles The option of introducing analyte in one cycle or in multiple cycles

YES

Range of sample types RNA, DNA, protein YES

Injection volume and flow rates 1uL and flow rates of up to 100 uL/min

YES

Software Aid in experiment design and analysis

YES

COMPANY: GOVERNMENT SCIENTIFIC – HEADQUARTERS: 12351 SUNRISE VALLEY DR. RESTON, VA 20191

A review of the vendor submission by Government Scientific for “Request for Information NRL N00173- 17-RFI-ST03 Surface Plasmon Resonance (SPR) Bio-molecular Binding Kinetics Characterization System,” was conducted. Evaluation was focused on the technical data sheet for the Biacore 8K as this surface plasmon resonance system met the top line requirements for parallel injection of analyte and the specified range of associated and dissociation rate constants as provided by Government Scientific. Below is a summary of the results for Government Scientific compared to the technical requirements is shown in Table III. The Government Scientific Biacore 8K (made by GE Healthceare) meets or exceeds all the technical requirements required by NRL.

Table III

(YES/NO)

Plate sizes 96- and 384-well compatible with 1500 uL or more volume

YES

Temperature control 4 C to 39 C, both sample storage area and analysis range (independent)

YES, Exceeds

Association rate and dissociation rate

Association rate of 5x108 M-1s-1 or higher and dissociation rate of 1x10-5 s-1 or lower

YES

Dissociation rate constant 0.4 s-1 or higher YES

RMS Noise Typically less than 0.03 RU YES, Exceeds

Refractive index range 1.33 to 1.38+ YES

Injection needles/channels 6 or more YES

Fluidic channels/needle 2 fluidic channels per needle YES

Multiple solutions per cycle 2 solutions per cycle YES

Unattended operations 48 hours or more YES

Sensor chips for custom studies Bare gold sensor chips YES

Analyte cycles The option of introducing analyte in one cycle or in multiple cycles

YES

Range of sample types RNA, DNA, protein YES

Injection volume and flow rates 1uL and flow rates of up to 100 uL/min

YES

Software Aid in experiment design and analysis

YES

63-9003-17 -- JA for Sole Source via Part 13 pg. 7

COMPANY: NANOSCALE LABS – HEADQUARTERS: 10725 SPRUCE STREET, FAIRFAX VA 22030

A review of the vendor submission by NanoscaleLABS for “Request for Information NRL N00173-17-RFI-ST03 Surface Plasmon Resonance (SPR) Bio-molecular Binding Kinetics Characterization System,” was conducted.

Evaluation was focused on the technical data sheet for the BI-4500 Series as this was the company’s only surface plasmon resonance system which met the top line requirements for parallel injection of analyte and the specified range of associated and dissociation rate constants as provided by NanoscaleLABS. A summary of the results for NanoscaleLABS compared to the technical requirements is shown in Table I. The NanoscaleLABS instrument does not meet the technical requirements required by NRL. All applications will require a total baseline noise of less than 0.03 RU in order to be used to measure NRL’s low molecular weight samples and accurately characterize their association and dissociation parameters. In addition, the NanoscaleLABS instrument has only 5 flow channels whereas NRL requires 6 or more. The additional channels enable the necessary high throughput screening NRL requires for the identification and characterization of large numbers of samples. There is no other way to evaluate the SPR system without the typical RMS noise level being less than 0.03 RU and 6 or more flow channels. Additional requirements that did not meet the technical requirements will be discussed in the footnotes of Table IV.

Table IV

(YES/NO)

Plate sizes 96- and 384-well compatible with 1500 uL or more volume

YES

Temperature control 4 C to 39 C, both sample storage area and analysis range (independent)

NO (a) Sample storage temperature area: 4 °C to 3 °C below ambient.

Independent SPR analysis temperature range from 6 °C to 50 °C.

Association rate and dissociation rate

Association rate of 5x108 M-1s-1 or higher and dissociation rate of 1x10-5 s-1 or lower

YES, exceeds

Dissociation rate constant 0.4 s-1 or higher YES

RMS Noise Typically less than 0.03 RU NO (b) Baseline noise is 0.06 RU

Refractive index range 1.33 to 1.38+ YES

Injection needles/channels 6 or more NO (c) Five flow channels available for experimental assay

Fluidic channels/needle 2 fluidic channels per needle NO (d) The autosampler has one needle that accesses two plate holders, each compatible with 384, 96, 48 and 12 plate formats.

Multiple solutions per cycle 2 solutions per cycle NO (e) Immobilization of the same analyte to sensing area with varying exposure times in a single injection.

Unattended operations 48 hours or more YES

Sensor chips for custom studies Bare gold sensor chips available YES

Analyte cycles The option of introducing analyte in one cycle or in multiple cycles

YES

Range of sample types RNA, DNA, protein YES

Injection volume and flow rates 1uL and flow rates of up to 100 uL/min

YES

Software Aid in experiment design and analysis

YES

(a) By not meeting our temperature range specifications both for analysis and sample storage, NRL will be unable to conduct numerous planned experiments on the temperature dependence of protein and nucleic acid analytes.

63-9003-17 -- JA for Sole Source via Part 13 pg. 8

(b) By not meeting the specification for typical RMS noise of 0.03 RU or lower this instrument will not allow NRL to measure low molecular weight samples and accurately characterize their association and dissociation parameters as needed.

(c) NRL requires 6 or more channels. The additional channels enable the high throughput screening NRL requires for the identification and characterization of large numbers of analytes and solutions.

(d) The specification is for two fluidic channels per needle which enables more reliable control and blank injection data to be taken on a given channel. The NanoscaleLABS technology does not meet this requirement.

(e) The NanoscaleLABS specification does not meet the requirement of having 2 solutions able to flow over the surface in a single cycle which is critical for our high-throughput buffer composition studies.

9. Any other facts supporting the use of sole source.

None

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

VENDOR NAME LOCATION POINT OF CONTACT CAPABILITY TYPE OF BUSINESS

GE Healthcare Bio-Sciences Corp

Marlborough, MA

Evan Behre

PH: 202-660-2242

evan.behre@ge.com

Company that makes the Biacore 8K SPR system which provides the capability to exceed or meet all technical requirements.

Large Business

Government Scientific Corp

Reston, VA Anette Cheltenham

PH (800) 248-8030

acheltenham@govsci.com

Reseller of commercial SPR systems including the Biacore 8K system.

Small Business

NanoscaleLabs Fairfax, VA Serge Kaddoura skaddoura@nanoscalelabs.com

The current list of SPR products DO NOT meet numerous technical requirements required in Part 3 above.

11. A statement of any actions the agency will take to remove or overcome any future barriers to competition before any subsequent acquisition for the supplies or services required.

This is a one-time purchase to acquire a single machine that is best suited to NRL’s research needs. As such, no actions are required to remove barriers to competition. This action is being competed on a brand-name or equal basis with a general description of those salient physical, functional, or performance characteristics of the brand name item that an “equal” item must meet to be acceptable for award.

Should the need for additional procurements of these specialized devices arise in the future, market research will be conducted to determine market availability and whether other companies’ similar products meet or can be modified to meet the agency’s needs.