SOLE SOURCE OR LIMITED SOURCES JUSTIFICATION

(APPLICABLE TO PURCHASES >Micro purchase threshold < SAT)

1. Contracting Activity: ASA/OMAS

2. Purchase Request Number: VRC CDMS Extended System Access

3. Authority for Action:

FAR 8.405-6(a), Orders exceeding the micro-purchase threshold based on a limited justification.

FAR 8.405-6(b), Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer.

FAR 13.106-1(b), Soliciting from a Single Source.

FAR16.505(b)(2), Exceptions to the fair opportunity process.

4. Describe the supply or service to be acquired and the total estimated dollar value:

The Government requires continued operation, maintenance, support, user access administration, read-only access, and planned decommissioning of the Vaccine Research Center (VRC) websites and associated data systems, including the VRCStudy website, VRCReportingTool, VRC Data Warehouse, and two Advantage eClinical platforms. The period of performance is September 15, 2026, through September 14, 2027. The total estimated value of the acquisition is $185,000.

5. List the proposed contractor (name, contact, and phone number) or brand name and describe the unique knowledge or capabilities:

The Emmes Company, LLC 401 N.Washington Street, Suite 700 Rockville, MD 20850 Contact: Kim Linton or Jeanine May Phone: 301-251-1161

Emmes built the databases and websites. Emmes possesses unique technical knowledge and operational capabilities specific to the existing VRC websites and associated data systems.

As the incumbent contractor responsible for the operation and maintenance of the VRCStudy website, VRCReportingTool, VRC Data Warehouse, and Advantage eClinical platforms, Emmes has established knowledge of the systems' architecture, configurations, user access controls, security requirements, hosting environment, and decommissioning processes. The requirement is to maintain these existing systems in their current state, provide secure read-only access, administer user accounts, apply required security patches, and execute an orderly decommissioning.

6. Describe your market research efforts and efforts to ensure that offers/quotes are solicited from as many potential sources as is practicable:

The Government conducted market research to identify potential sources capable of providing the required operation, maintenance, security support, read-only access, and decommissioning services for the existing Vaccine Research Center (VRC) websites and associated data systems. Market research included consultation with the Program Director and Sponsor Oversight Lead to validate the Government's minimum technical requirements and identify known capable sources. In addition, the Government contacted The Emmes Company, LLC to obtain information regarding the technical approach, operational assumptions, period of performance, and estimated costs associated with maintaining and decommissioning the existing systems.

The market research also included an assessment of commercially available sources and

Government-wide acquisition vehicles to determine whether another contractor or authorized reseller could provide the required services. No alternative sources were identified that possess the technical knowledge, proprietary hosting environment, operational control, and system specific expertise necessary to maintain the existing VRCStudy website, VRCReportingTool, VRC Data Warehouse, and Advantage eClinical platforms through the required transition and decommissioning period.

The Government posted a Notice of Intent on August 4, 2026 requesting for capability statements from vendors that think they are capable of doing the work as specified in the notice. The response date was August 10, 2026 by 9:00am. Four vendors responded by the time noted, but all four were found to be technically unacceptable to do perform the services required; therefore, a sole source will be done to obtain services.

The estimated cost of selecting a different vendor is based on comparable competitive procurements and available commercial pricing. A previous full and open competition for clinical data management and data warehousing services received multiple offers within the competitive range, resulting in an average annual contract value of approximately $2 million.

Accordingly, it is reasonable to estimate that engaging a new vendor to migrate, host, validate, secure, and maintain the VRC clinical trial data during the transition period would incur costs in excess of $1 million, even though the requirement is temporary.

Commercial website access services are available at significantly lower prices, ranging from hundreds to several thousand dollars annually; however, these offerings are not comparable because they are multi-tenant solutions that distribute costs across many customers. In contrast, the VRC requirement involves a dedicated, single-client environment with exclusive hosting, data management, security, and operational support.