2027438 - JA Redacted.pdf

Attachment 5 Page 1

Justification & Approval/Justification for Other than Full and Open Competition Sole Source over the Simplified Acquisition Threshold

“Source Selection Information – see FAR 2.101 and 3.104”

Project Title: Waters Technologies Corporation - BioAccord System Purchase

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. DHHS/National Institutes of

Health (NIH)/National Institute of Allergy & Infectious Diseases (NIAID)/Acquisitions Management Operations Branch (AMOB)

b. Sponsoring organization. Division of Intramural Research (DIR), Laboratory of Viral Diseases (LVD)

c. Project Officer Information:

• Project Officer Name.

• Mailing address.

• E-mail address.

• Telephone number.

d. Contract Specialist:

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

Waters Technologies Corporation (aka Vendor, Waters) liquid chromatography mass spectrometer (LC-MS) equipment is required, specifically the BioAccord liquid chromatography mass spectrometer.

Much of the research performed by LVD requires the use of these Waters mass spectrometers for the examination, collection, and identification of data from samples. For example, the LVD needs the ability to analyze N-linked glycans via mass spectrometry daily. For the most accurate and reproducible results, released glycans are fluorescently labeled and tagged with an amine group to enhance ionization and detection. The Waters BioAccord System provides a comprehensive and streamline approach for data collection and analysis of these labeled glycans. This system includes the ultra-performance liquid-chromatography, fluorescence detector, and mass spectrometer, as well as the required software and accessories, which allow for accurate fluorescence and mass identification of glycans.

Additionally, it allows the LVD to use complementing kits from Waters that accelerate the processing and preparation time to release, stain, and

Attachment 5 Page 2 purify glycans from antibody samples. Normally, this process can take days and is labor intensive and time consuming, with the BioAccord associated labeling kits, it reduces the processing time to a few hours. The Waters preparation kits and BioAccord system provide high sensitivity of the sample which will reduce the quantity of starting material required for analysis. This is beneficial since the majority of the samples will be derived from expensive and irreplaceable murine experiments.

The purchase of the Waters BioAccord System, which is a new/updated type of liquid chromatography mass spectrometer (LC-MS) will provide upgraded capabilities for fluorescence detector and mass spectrometer data that is compatible with current equipment and research protocols within the LVD and NIAID. Thus, this increased capability/equipment upgrade is essential for research efforts.

b. Project background.

NIAID’s Laboratory of Viral Diseases (LVD) conducts research to study cellular immune responses and to better understand the mechanisms of arbovirus disease progression and protective immune responses against these viruses. The LVD conducts a comprehensive program of research on the NIH intramural campus and works with scientists in academic and clinical laboratories through a program of national collaborations. One of the focuses of the LVD is to study antibody effector functions for protection and pathogenesis of arbovirus infection using murine models.

Antibodies can modulate immunity through Fc-Fc receptor interaction on immune cells and through complement activation. An N-linked glycan present on the antibody is critical for these interactions and changes in the glycan pattern can dramatically alter the functional activity of the antibody, which can impact viral infections and disease outcomes. In order to accurately identify the glycans present on these antibodies, the laboratory relies on an ultra-performance liquid-chromatography (UPLC) with a fluorescence detector and mass spectrometer for the majority of its research experiments and studies.

This is a new requirement for additional equipment. The manufacturer of this equipment is Waters Technology Corporation. This company sells directly to the public and does not have any resellers.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. BioAccord System (LC-MS) from Waters Technology Corporation

b. Project description.

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Waters Technology Corporation’s BioAccord System (liquid chromatography-mass spectrometry equipment) is required.

• Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) X Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action.

X New requirement Follow-on to Other (specify): ______________________

• Proposed contract/order type:

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

• Acquisition identification number.

c. Total estimated dollar value is This price includes the following: BioAccord system for glycans system; installation, computer work station, training plans, and other supplementary equipment.

Performance/delivery period is within 90 days after receipt of an approved purchase order

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

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X This acquisition is conducted under the authority of 41 USC 3304(a)(1) and FAR Part 6.302-1 – Only one responsible source.

This acquisition is conducted under the authority of section 4202 of the

Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a).

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

a. Name and address of the proposed contractor(s).

Waters Technologies Corporation

34 Maple St., Milford MA 01757

b. Nature of the acquisition and proposed unique qualifications of the contractor(s)

Waters Technologies Corporation is the manufacturer of the BioAccord system and they do not have any resellers for this product. This equipment expansion must utilize the same equipment and software currently being utilized to maintain continuity and data integrity. With that being said, to maintain research/project parameters and perform proper analysis/manipulation of experimental samples, it is essential to utilize the same equipment, biologicals, chemicals, and consumables throughout the life span of the research efforts. Products, reagents, and materials may appear to be similar, however, small factors in their production can lead to vastly different and inconsistent results. A change in the equipment and/or reagents used in the project might therefore cause an unacceptable variation in results. In addition to the significant loss in time and effort this would cause, the experimental samples being used are extremely limited and, in many cases, cannot be replaced. The use of other products, supplies, and reagents may put these experiments at risk.

Current Waters LC-MS systems do not have enough capacity to meet research analysis requirements. This BioAccord LC-MS system is required.

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6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Pre-solicitation was publicized on beta.SAM.gov (formerly known as FedBizOpps). Posted from 09/18/2020 to 09/23/2020 with the following results:

One (1) contractor other than Waters responded to the posting. This contractor was Agilent Technologies (Agilent). The relevant program staff at LVD evaluated Agilent’s proposal and concluded that it was not technically sufficient. Agilent is proposing a different instrument that is not capable of performing the functions that LVD requires. For example, the BioAccord system is a time-of-flight mass spectrometer that is capable of exact mass measurements. In comparison, the instrument proposed by Agilent is a single-quadrupole mass spectrometer that is not capable of exact measurements. This is one of several examples where the Agilent instrument is not capable of meeting the required specifications.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable based on comparison to similar equipment.

The cost is within industry norms and is fair and reasonable.

The current product price is derived from an open market quote. Open market prices for these types of equipment were not readily available, and attempts at obtaining detailed open market quotes after reaching out to vendors experienced setbacks due to the complexity of the equipment & requirements. This came up against the time constraints to award this order. Thus, we are using GSA comparisons in market research and IGE.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Several market research techniques were used to identify other possible sources, including review of acquisitions on similar items, queries of internet information sources, contact of knowledgeable individuals in the government and in industry, and review of catalogs and product literature. The results of this research indicated there is only one manufacturer/source for this specific product that would retain compatibility with existing systems.

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Market research was conducted on August 3, 2020. Some of the venues researched are as follows:

# Source Vendor/Manufacturer Description 1 Emailing

Waters Technologies Corporation Sales Specialists

Waters Technologies Corporation

Discussed sole source aspects (Waters is the manufacturer and directly sells it)

2 GSA

Advantage

Technical Communities Inc./ Agilent Life Sciences

Researched comparable products on GSA advantage

3 GSA

Advantage

Government Scientific Sources, Inc./ Bruker Daltonics/ Bruker Life Science

Researched comparable products on GSA advantage

4 AMBIS Waters Technologies Corporation

Research previous history - orders within AMBIS

5 FPDS (aka

DCIS)

Waters Technologies Corporation

Research previous history - orders within FPDS/DCIS

A search on AMBIS and FPDS yielded did not reveal that Waters Technologies Corporation had sold similar products (LC-MS) for similar prices in the past.

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

The equipment and accompanying supplies from Waters Technology

Corporation (Waters) not only provide an upgrade that allows greater research capabilities, but also retains compatibility with existing supplies.

The LVD needs the ability to analyze N-linked glycans via mass spectrometry daily. For the most accurate and reproducible results, released glycans are fluorescently labeled and tagged with an amine group to enhance ionization and detection. The Waters BioAccord System provides a comprehensive and streamline approach for data collection and analysis of these labeled glycans. This system includes the ultra-performance liquid-chromatography, fluorescence detector, and mass spectrometer, as well as the required software and accessories, which allow for accurate fluorescence and mass identification of glycans. Furthermore, it allows the LVD to use complementing kits from Waters that accelerate the processing and preparation

Attachment 5 Page 7 time to release, stain, and purify glycans from antibody samples. The newer kits from Waters are significantly improved from older kits and/or kits from other vendors. Normally, this process can take days and is labor intensive and time consuming. With the BioAccord associated labeling kits, it reduces the sample preparation and processing time from several days to a few hours. This is possible because the BioAccord LC-MS system includes a glycan library that was designed using Water’s RapiFluor MS kits, thus improving specificity and confidence in glycan analyses over other LC-MS systems. The BioAccord LC- MS system has a unique workflow which provides confirmation of glycan identity without manual data processing and external database searching that are needed with other LC-MS systems. The BioAccord LC-MS system completes this per sample analysis in less than 10 minutes rather than hours of data analysis by a scientific expert. The Waters preparation kits and BioAccord system provide high sensitivity of the sample which will reduce the quantity of starting material required for analysis. This is beneficial since the majority of the samples will be derived from expensive and irreplaceable murine experiments.

Procurement of a new Waters Technologies Corporation instrument will allow facility staff and users to utilize these existing protocols and supplies whereas switching to a different manufacturer would require development of new protocols and the purchase of new supplies – taking more time and incurring more costs and expenses. This alternative would put research at risk. For example, the BioAccord system typically takes half of a day to train novice level users compared to a week for other LC-MS systems. This would include individuals that have no prior experience and individuals with previous LC-MS training. A recent talk by a major biopharmaceutical company stated that they trained undergraduate college interns in 4 hours. In the past, they had been unsuccessful in training interns on more complex LC-MS systems. Waters' standard training of the complex LC-MS systems is typically five days for an expert user. The estimated cost and time savings would include the reduced number of workdays dedicated to training.

Furthermore, no other vendor sells comparable equipment to the Waters Technology Corporation that would be compatible to the reagents, kits, platforms, and/or computer software that are currently used within the LVD lab. Only LC- MS systems from Waters can use the kits, reagents, and/or other supplies from Waters. Since the LVD has performed a significant portion of past research studies on existing Waters equipment, much of the existing kits, reagents, supplies, etc that the LVD has are specifically designed for the company’s equipment. Thus, Waters Technologies Corporation’s BioAccord system is the only available LC-MS that will meet the laboratory needs.

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

No other sources have expressed an interest in the proposed acquisition.

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11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government’s requirement. The staff meets regularly with products manufacturers and vendors and attends manufacturer and industry training to keep current on technology. Vendor and trade magazines are scanned for new, open technologies that can satisfy future infrastructure requirements. The agency will continually re-evaluate the products currently being used and will research for the manufacturers and products that will be in the Government’s best interest as best value for future replacement products at the agency’s site and at sites the agency supports. The current situation requires a sole source justification to satisfy requirements. Since there is a continual re-evaluation to products currently being used by the agency for the present requirement, if/when alternatives become available, they will be evaluated for use.

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12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Requestor Certification

Project Officer

Project Officer’s

Immediate Supervisor

Head of the Sponsoring Program

Office

13. Contracting Officer & Requestor Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

352.208-70 - Printing and Duplication.