ERP PR 1301275722_JNA_REDACTED.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements and the

Naval Medical Research and Development mission. The contracting activity (equipment purchase and installation) is with EMD Millipore Corporation (MilliporeSigma), 400 Summit

Drive, Burlington, MA 01803.

2. Nature and/or description of the action.

The proposed action is for the purchase and installation of eight (8) Millipore Milli-Q water purification systems, consisting of seven (7) Milli-Q EQ 7016 systems and one (1) Milli-Q IQ

7010 system, to replace the currently existing Millipore Milli-Q Direct 16 laboratory water purification systems which have been discontinued and need replacement. These water purification systems are located in the Infectious Diseases Directorate laboratories at NMRC.

Since purified water is essential to all laboratory functions, these systems are considered critical and essential pieces of equipment to maintain daily laboratory functions. The Government intends on awarding a Firm Fixed Price contract. The proposed source is EMD Millipore

Corporation (MilliporeSigma), 400 Summit Drive, Burlington, MA 01803.

3. Description of Supplies or Services:

The Infectious Diseases Directorate laboratories at NMRC have a critical need to purchase and install eight (8) Millipore Milli-Q water purification systems, consisting of seven (7) Milli-Q EQ

7016 systems and one (1) Milli-Q IQ 7010 system, to replace the currently existing Millipore

Milli-Q Direct 16 laboratory water purification systems which have been discontinued and need replacement through EMD Millipore Corporation (MilliporeSigma). The old systems will be

Traded-In and replaced with these comparable newer models. Since purified water is essential to all laboratory functions, these systems are considered critical and essential pieces of equipment to maintain daily laboratory functions. There are two newer models available from EMD

Millipore, the Milli-Q IQ 7010 and the Milli-Q EQ 7016 systems. Both models replace the older

Milli-Q Direct 16 model 60 Liter RO tank with a newer 50 Liter tank. The Milli-Q IQ 7010 is fed with cold tap water, which passes through a smart RO filter and EDI technology to produce

Type 2 pure water in the storage tank. Then, at the QPOD remote dispenser, it delivers Type 1 ultra-pure water. The Milli-Q IQ 7010 features mercury-free UV technology, eliminating hazardous waste. It also includes an in-line TOC monitoring, smart RO technology that ensures a consistent 10 liters per hour make-up rate, and the patented EDI technology for generating Type-

2 pure water into the storage tank. Additionally, it has the remote QPOD with a touchscreen HMI and dispense assist features in assisting streamline workflow and improved efficiency. The quoted price for this system with all the necessary additional parts, including the Loyalty

Customer Trade-In Discount, installation, travel and shipping is estimated at $30,106.12 per system (refer to Quote Ref R-10896612.1). The Directorate will only be purchasing one (1) of these systems, for use in the Operationally Infectious Diseases Department’s Molecular Biology laboratory where the QPOD remote dispenser is necessary for laboratory functions. The remaining seven (7) current water filtration systems will be replaced with the Milli-Q EQ 7016 system, a Type 1 ultra-pure water system that uses a cold tap feed. It features a built-in or wall-mounted point-of-use dispenser instead of the remote QPOD dispenser, an HMI display on the system, and smart RO technology for a consistent 16 liters per hour make-up rate. The Milli-Q

EQ 7016 transforms the cold tap feed into RO Type 3 water within the storage tank. Then, at the point of use, the water from the storage tank is polished to Type 1 ultra-pure quality. This system features a TOC indicator and utilizes mercury-based UV lamps. The quoted price for this system with all the necessary additional parts, including the Loyalty Customer Trade-In Discount, installation, travel and shipping is estimated at $19,007.85 per system (refer to Quote Ref R-

10896612.1). NICE Funds and additional Navy funding Fiscal Year 2025 from the Operationally

Relevant Infections Department in the estimated amount of $163,161.04 will be used to procure these replacement water filtration systems (refer to Quote Ref R-10896612.1).

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10

U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions.

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

The EMD Millipore Corporation (MilliporeSigma) delivers the following water purification systems and installation which cannot be found through other competitor companies when it comes to replacing current Millipore water purification systems. Since the current water purification systems are Millipore, then EMD Millipore (MillliporeSigma) is the only source that can replace these systems with a comparable unit since they are ‘the sole manufacturer of its laboratory water products including new products and spare parts and the sole provider of maintenance and repair services. No third parties are authorized to sell spare parts or provide maintenance and repair services or technical support for MilliporeSigma laboratory water products.’ (refer to sole source justification letter). Also, Millipore offered a Trade-In Discount:

ranging from 35% discount on the main systems, 35% -100% on the necessary additional parts, and a 10% discount on installation and travel. The Trade-In Discount is only offered by EMD

Millipore (MilliporeSigma) for replacing existing Millipore systems, where the old systems are dismantled, removed, turned in to Millipore and replaced with a new Millipore system. EMD

Millipore also has the technical expertise when it comes to removing and installing their own equipment since ‘No third parties are authorized to sell spare parts or provide maintenance and repair services or technical support for MilliporeSigma laboratory water products.’ (refer to sole source justification letter). Use of any competitor service vendor would result in extended down time, possible loss of current equipment functionality and additional replacement costs.

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

EMD Millipore Corporation (MilliporeSigma) was contacted by email and/or website to obtain information on replacing the existing discontinued Direct 16 water filtration systems with comparable newer model systems and obtain an estimate. EMD Millipore Corporation replied with an estimate. After reviewing this information and online resources determined that an additional market research survey was not needed since EMD Millipore Corporation

(MilliporeSigma) is the only source that can meet the Government’s requirements when it comes to replacing existing Millipore water purification systems. As stated, ‘MilliporeSigma is the sole manufacturer of its laboratory water products including new products and spare parts and the sole provider of maintenance and repair services. No third parties are authorized to sell spare parts or provide maintenance and repair services or technical support for MilliporeSigma laboratory water products.’ (refer to sole source justification letter). Since the current water filtration systems are Millipore, then EMD Millipore (MillliporeSigma) is the only source that can replace these systems with a comparable unit since they are ‘the sole manufacturer of its laboratory water products including new products and spare parts’ (refer to sole source justification letter). Also, Millipore offered a Trade-In Discount: ranging from 35% discount on the main systems, 35% - 100% on the necessary additional parts, and a 10% discount on installation and travel. The Trade-In Discount is only offered by EMD Millipore

(MilliporeSigma) for replacing existing Millipore systems, where the old systems are dismantled, removed, traded in to Millipore and replaced with new Millipore systems.

7. 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 EMD Millipore Corporation will be determined fair and reasonable.

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

Market research was performed by: (1) Participating in interactive, on-line communication among industry, acquisition personnel, and customers.; and (2) Reviewing catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available on-line. EMD Millipore Corporation (MilliporeSigma) was contacted by email and/or website to obtain information on replacing the existing discontinued Direct 16 water purification systems with comparable newer model systems and obtain an estimate. EMD Millipore

Corporation replied with an estimate. After reviewing this information and online resources determined that a market research survey was not needed since EMD Millipore Corporation

(MilliporeSigma) is the only source that can meet the Government’s requirements when it comes to replacing existing Millipore water purification systems. Since the current water purification systems are Millipore, then EMD Millipore (MillliporeSigma) is the only source that can replace these systems with a comparable unit since they are ‘the sole manufacturer of its laboratory water products including new products and spare parts’ (refer to sole source justification letter).

As stated in the sole source justification letter, ‘MilliporeSigma is the sole manufacturer of its laboratory water products including new products and spare parts and the sole provider of maintenance and repair services. No third parties are authorized to sell spare parts or provide maintenance and repair services or technical support for MilliporeSigma laboratory water products.’

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

The requirement for the purchase and installation of eight (8) Milli-Q water purification systems, consisting of seven (7) Milli-Q EQ 7016 systems and one (1) Milli-Q IQ 7010 system (including all the necessary parts, installation, travel and shipping), needs to be sole sourced with EMD

Millipore Corporation (MilliporeSigma) (refer to section 6).

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

N/A

11. 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.

N/A

12. Point of Contact:

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management

Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

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.

Technical Cognizance

Frederic Poly, Dpt. Head, ORI/IDD/NMRC 301-319-3232 June 23rd 2025

Name

Title

Digitally signed by

POLY.FREDERIC.M.1286953308 POLY.FREDERIC.M.1286953308

Date: 2025.06.23 14:32:53 -04'00'

Phone Date

Department/Command

Requirements Cognizance

Name Phone Date

Title

Department/Command mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

CONTRACTING OFFICER CERTIFICATION

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

(301) 319-9955 8/6/2025

Contracting Officer Phone Date