A02 - Limiting-Competition-under-SAT_ACC INTEGRA_.pdf

CUI

Control No: JA-23-08-1416

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014

2. Description of Action: This acquisition is for three (3) INTEGRA Biosciences Corporation (INTEGRA) WELLJET dispensers, proprietary pipettes, software, accessories, disposables, training, and a preventative maintenance plan for the dispensers.

Nature: ☒ New Requirement ☐ Follow-on Requirement

Contract Vehicle:

☒ Purchase Order Number: TBD ☐ Blanket Purchase Agreement (BPA) Number:

☐ Order/BPA #_ against FSS Contract #_ ☐ Order #_ against Multiple Award IDIQ Contract # ☐ Order #_ against a single award IDC Contract #_ ☐ Modification #_ to existing PO/TO/DO/Call Order #

Pricing/Contract Type:

☒ Fixed Price ☐ Time & Materials/Labor Hours ☐ Cost Reimbursable ☐ Hybrid

Funds:

☐ Operations & Maintenance, Army (OMA) ☒ Other Funds: Fiscal Year 2023-2024, Army Research, Development, Testing, and Evaluation (RDT&E), 2-Year funding or Defense Health Program (DHP) Research, Development (R&D) 2-Year funding.

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA Acquisition CUI Category: Source Selection Distribution/Dissemination Control:

Name of Proposed Contractor(s) and Address:

Name of Contractor Website Address Physical Address INTEGRA Biosciences Corp. (INTEGRA) www.integra-biosciences.com

22 Friars Drive, Hudson, NH 03051

Brand Name Buy: ☒ Yes ☐ No

3. Description of Services or Supplies:

This acquisition is for three (3) INTEGRA Biosciences Corporation (INTEGRA) WELLJET dispensers, proprietary pipettes, software, accessories, disposables, training, and a preventative maintenance plan for the dispensers.

Model/Part Description Quantity (Each) 3011 EVOLVE Pipette 1-Channel, 0.2 - 2 μl 5 3012 EVOLVE Pipette 1-Channel, 1 - 10 μl 20 3013 EVOLVE Pipette 1-Channel, 2 - 20 μl 5 3015 EVOLVE Pipette 1-Channel, 10 - 100 μl 5 3016 EVOLVE Pipette 1-Channel, 20 - 200 μl 20 3018 EVOLVE Pipette 1-Channel, 100 - 1000 μl 20 3019 EVOLVE Pipette 1-Channel, 500 - 5000 μl 5 4539 D-ONE "All in one" Bundle 1 5000 WELLJET Dispenser 3

4500 ASSIST 1

5101 8-Channel Cassette 6 990153 WELLJET Preventative Maintenance 3 999119 ASSIST Training for D-ONE 1 999121 WELLJET Installation and Training 1 999401 Freight Shipment 1 990070 ASSIST PM Program 1 999113 ASSIST Installation and Training 1

The purchase order/contract shall be awarded not later than 30 September 2023. There is an approximate six (6) week delivery time after receipt of award. This is a new requirement for equipment/supplies.

The estimate value of this procurement

This acquisition is for commercial supplies and is not for (performance based) services.

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

☐ 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

Or

☐ 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:

Market research indicates that INTEGRA is the sole provider of the WELLJET with the locking tip design. The locking tip design significantly reduces the risk of the pipettes falling off during pipetting. This is especially crucial when working with infectious materials in high containment areas such as (Biosafety Level) BSL-3 and BSL-4 as this design eliminates cross contamination and/or spillage. Additionally, USAMRIID already utilizes onsite INTEGRA equipment with proprietary pipettes and software which will be used interchangeably with the proposed new equipment. The acquisition of a different brand will result in the incompatibility of existing software, equipment and supplies. The incompatibility of existing INTEGRA systems to a brand other than INTEGRA may have an adverse impact on meeting mission requirements. Lastly, it is for the safety of USAMRIID personnel that the tip design be utilized to prevent cross contamination and spillage in high containment areas. It is for the reasons stated above that procurement of the pipettes, software, accessories, and disposables are in the best interest of the Government. INTEGRA, the manufacturer, does not utilize authorized retailers and is the only source for this requirement.

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, ☐ apply and will be followed, or ☒ do not apply due to an exception at 5.202(a)(13)(i) Is for an amount not expected to exceed the simplified acquisition threshold.

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 ☒ Action is a brand name restriction, over $25K. It 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 was conducted during the May 2023 timeframe, in accordance with FAR Part 10, and was multifaceted and undertaken to ascertain 1) if the requirement meets the FAR definition of a Commercial Service and 2) if two or more small businesses exist that can meet the government’s requirement. Market research examined if the required product(s) met the FAR definition of a commercial products.

Market research determined that the required product(s) do meet the definition of a Commercial Product and are commercially available; thus, standard commercial terms and conditions will apply.

Of the five (5) possible vendors contacted only one (1) was identified has having the capability to supply the requested products (INTEGRA). Thermo Fisher Scientific, Avantor Sciences, Labconco and Beckman Coulter were all researched to determine if they could meet the requirements of the Government. Market research indicates that INTEGRA is the sole provider of the WELLJET Dispenser system(s) and proprietary pipettes with the locking tip design. The locking tip design significantly reduces the risk of the pipettes falling off during pipetting. This is especially crucial when working with infectious materials in high containment areas such as (Biosafety Level) BSL-3 and BSL-4 as this design eliminates cross contamination and/or spillage. Additionally, USAMRIID already utilizes onsite INTEGRA equipment and software which will be used interchangeably with the proposed new equipment. The acquisition of a different brand will result in the incompatibility of existing software, equipment and supplies. The incompatibility of existing INTEGRA systems to a brand other than INTEGRA may have an adverse impact on meeting mission requirements.

Lastly, it is for the safety of USAMRIID personnel that the proprietary INTEGRA locking tip design be utilized to prevent cross contamination and spillage in high containment areas. It is for the reasons stated above that procurement of the INTEGRA WELLJET dispensers with propriety (locking tip) pipettes, software, accessories, and disposables are in the best interest of the Government. INTEGRA, the manufacturer, does not utilize authorized retailers and is the only source for this requirement. INTEGRA is identified as a small business under NAICS code 334516 – Analytical Laboratory Instrument Manufacturing.

8. Other Facts: There are no additional facts to present.