PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C10B26Q0459 07-14-2026

Joshua McGarry 848-377-5136 07-16-2026

10:00 EDT

36C10B

Department of Veterans Affairs

Technology Acquisition Center

23 Christopher Way

Eatontown NJ 07724

X

513210

$47 Million

N/A

X

See Delivery Schedule

36C10B

Department of Veterans Affairs

Technology Acquisition Center

36C10A

Technology Acquisition Center

Financial Services Center

PO Box 149971

Austin TX 78714-8971 iMedRIS iRIS Software/Maintenance

Points of Contact:

Contracting Officer: Mina Awad, Mina.Awad@va.gov

Contract Specialist: Joshua McGarry, Joshua.McGarry@va.gov

Mina Awad

Contracting Officer

36C10B26Q0459

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 GOVERNING LAW CLAUSE

B.2 SOFTWARE LICENSE, SOFTWARE MAINTENANCE AND SOFTWARE

TECHNICAL SUPPORT

B.3 SHARE IT ACT

B.4 CONTRACT ADMINISTRATION DATA

B.5 PRICE SCHEDULE

B.6 PRODUCT DESCRIPTION

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

C.3 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL

CONTRACTORS (DEVIATION DATE)

C.4 852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY (FEB 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

E.2 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS

(AUG 2020)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT

2018)

E.4 52.209-11 REPRESENTATION BY CORPORATIONS REGARDING

DELINQUENT TAX LIABILITY OR A FELONY CONVICTION UNDER ANY

FEDERAL LAW (FEB 2016)

E.5 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS

REPRESENTATIONS AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.8 BASIS FOR AWARD

E.9 QUOTES SUBMISSION INSTRUCTIONS

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 ARTIFICIAL INTELLIGENCE IN VA CONTRACTS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 GOVERNING LAW CLAUSE

Federal law and regulations, including the Revolutionary Federal Acquisition

Regulations (FAR) Overhaul (RFO), shall govern this Contract/Order. Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrinkwrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR RFO clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order.

Federal law and regulation including, without limitation, the Contract Disputes Act (41

U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the

Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31

U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC §

5725), Source Code Harmonization and Reuse in Information Technology Act “SHARE

IT Act” (P.L. 118-187), and FAR RFO clauses 52.212-4, 52.227-14 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR

52.227-14, this includes any custom code developed for the purpose of performing under this contract. Claims of patent or copyright infringement brought against the

Government as a party shall be defended by the U.S. Department of Justice (DOJ) in accordance with 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

B.2 SOFTWARE LICENSE, SOFTWARE MAINTENANCE AND SOFTWARE

TECHNICAL SUPPORT

(1). Definitions.

a) Licensee. The term “licensee” shall mean the U.S. Department of

Veterans Affairs (“VA”) and is synonymous with “Government.”

b) Licensor. The term “licensor” shall mean the Contractor having the necessary license or ownership rights to deliver license, software maintenance and support of the computer software being acquired. The term “Contractor” is the party identified in Block 17a on the SF1449. If the Contractor is a reseller and not the Licensor, the Contractor remains responsible for performance under this Contract/Order.

c) Software. The term “software” shall mean the licensed computer software product(s) cited in the Schedule of Supplies/Services.

d) Maintenance. The term “maintenance” is the process of enhancing and optimizing software, as well as remedying defects. It shall include all new fixes, patches, releases, updates, versions and upgrades, as further defined below.

e) Technical Support. The term “technical support” refers to the range of services providing assistance for the software via the telephone, email, a website or otherwise.

f) Release or Update. The term “release” or “update” are terms that refer to a revision of software that contains defect corrections, minor enhancements, or improvements of the software’s functionality. This is usually designated by a change in the number to the right of the decimal point (e.g., from Version 5.3 to 5.4). An example of an update is the addition of new hardware.

g) Version or Upgrade. The term “version” or “upgrade” are terms that refer to a revision of software that contains new or improved functionality. This is usually designated by a change in the number to the left of the decimal point (e.g., from Version 5.4 to 6).

(2). Software License.

a) Unless otherwise stated in the Schedule of Supplies/Services, the Performance Work Statement, or Product Description, the software license provided to the Government is a perpetual, nonexclusive license to use the software.

b) The Government may use the software in a networked environment.

c) All limitations of software usage are expressly stated in the Schedule of Supplies/Services and the Performance Work Statement/Product Description.

d) The commercial computer software delivered under this contract may not be used, reproduced, or disclosed by the Government except as provided below or as expressly stated otherwise in this contract. The commercial computer software may be-

i. Used or copied for use with the computer(s) for which it was acquired, including use at any Government installation or agency to which the computer(s) may be transferred;

ii. Used or copied for use with a backup computer if any computer for which it was acquired is inoperative;

iii. Reproduced for safekeeping (archives) or backup purposes;

iv. Modified, adapted, or combined with other computer software;

v. Disclosed to and reproduced for use by support service Contractors or their subcontractors, subject to the same restrictions set forth in this contract; and

vi. Used or copied for use with a replacement computer.

e) Unauthorized Obligations.

i. Except as stated in paragraph (ii), when any supply or service acquired under this contract is subject to any commercial supplier agreement (as defined in 502.101) that includes any language, provision, or clause requiring the Government to pay any future fees, penalties, interest, legal costs or to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation ( 31 U.S.C. 1341), the following shall govern:

1) Any such language, provision, or clause is unenforceable against the Government.

2) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the commercial supplier agreement. If the commercial supplier agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

3) Any such language, provision, or clause is deemed to be stricken from the commercial supplier agreement.

ii. Paragraph (u)(1) of this clause does not apply to indemnification or any other payment by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

f) Commercial supplier agreements unenforceable clauses.

i. This agreement is a part of a contract between the commercial supplier and the U.S. Government for the acquisition of the supply or service that necessitates a license or other similar legal instrument (including all contracts, task orders, and delivery orders under FAR

RFO 12).

https://www.acquisition.gov/gsam/part-502#GSAM_502_101 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

ii. End user. This agreement shall bind the ordering activity as end user but shall not operate to bind a Government employee or person acting on behalf of the Government in his or her personal capacity.

iii. Law and disputes. This agreement is governed by Federal law. Any language purporting to subject the U.S.

Government to the laws of a U.S. state, U.S. territory, district, or municipality, or a foreign nation, except where Federal law expressly provides for the application of such laws, is hereby deleted.

1) Any language requiring dispute resolution in a specific forum or venue that is different from that prescribed by applicable Federal law is hereby deleted. Any dispute regarding the license grant or usage limitations shall be resolved in accordance with the Disputes Clause incorporated in FAR 52.212-4(e).

2) Any language prescribing a different time period for bringing an action than that prescribed by applicable Federal law in relation to a dispute is hereby deleted.

3) Continued performance. The supplier or licensor shall not unilaterally revoke, terminate or suspend any rights granted to the Government except as allowed by this contract. If the supplier or licensor believes the ordering activity to be in breach of the agreement, it shall pursue its rights under the Contract Disputes Act or other applicable Federal statute while continuing.

4) Arbitration; equitable or injunctive relief. In the event of a claim or dispute arising under or relating to this agreement, a binding arbitration shall not be used unless specifically authorized by agency guidance, and equitable or injunctive relief, including the award of attorney fees, costs or interest, may be awarded against the U.S.

Government only when explicitly provided by statute (e.g., Prompt Payment Act or Equal Access to Justice Act).

iv. Updating terms. After award, the contractor may unilaterally revise commercial supplier agreement terms if they are not material. A material change is defined as:

1) Terms that change Government rights or obligations;

2) Terms that increase Government prices;

3) Terms that decrease overall level of service; or

4) Terms that limit any other Government right addressed elsewhere in this contract.

5) For revisions that will materially change the terms of the contract, the revised commercial supplier agreement must be incorporated into the contract using a bilateral modification.

6) Any agreement license terms or conditions unilaterally revised subsequent to award that are inconsistent with any material term or provision of this contract shall not be enforceable against the Government, and the Government shall not be deemed to have consented to them.

v. No automatic renewals. If any license or service tied to periodic payment is provided under this agreement (e.g., annual software maintenance or annual lease term), such license or service shall not renew automatically upon expiration of its current term without prior express consent by an authorized Government representative.

vi. Indemnification. Any clause of this agreement requiring the commercial supplier or licensor to defend or indemnify the end user is hereby amended to provide that the U.S. Department of Justice has the sole right to represent the United States in any such action, in accordance with 28 U.S.C. 516.

vii. Audits. Any clause of this agreement permitting the commercial supplier or licensor to audit the end user's compliance with this agreement is hereby amended as follows:

1) Discrepancies found in an audit may result in a charge by the commercial supplier or licensor to the ordering activity. Any resulting invoice must comply with the proper invoicing requirements specified in the underlying Government contract or order.

2) This charge, if disputed by the ordering activity, will be resolved in accordance with FAR 52.212- 4(e); no payment obligation shall arise on the part of the ordering activity until the conclusion of the dispute process.

3) Any audit requested by the contractor will be performed at the contractor's expense, without reimbursement by the Government.

(3). Software Maintenance and/or Technical Support.

a) If the Government desires to continue software maintenance and support beyond the period of performance identified in this Contract/Order, the Government will issue a separate contract or order for maintenance and support. Conversely, if a contract or order for continuing software maintenance and technical support is http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/gsam/part-552#GSAM_552_212_4 https://www.acquisition.gov/gsam/part-552#GSAM_552_212_4 not received, the Contractor is neither authorized nor permitted to renew any of the previously furnished services.

b) The Contractor shall provide software support services, which includes periodic updates, enhancements and corrections to the software, and reasonable technical support, all of which are customarily provided by the Contractor to its commercial customers to cause the software to perform according to its specifications, documentation or demonstrated claims.

c) Any telephone support provided by Contractor shall be at no additional cost.

d) The Contractor shall provide all maintenance services in a timely manner in accordance with the Contractor’s customary practice or as defined in the Performance Work Statement or Product Description. However, prolonged delay (exceeding two business days) in resolving software problems will be noted in the Government’s various past performance records on the Contractor (e.g., www.cpars.gov).

e) If the Government allows the maintenance and support to lapse and subsequently wishes to reinstate it, any reinstatement fee charged shall not exceed the amounts that would have been charged if the Government had not allowed the subscription to lapse.

(4). Disabling Software Code.

The Government requires delivery of computer software that does not contain any code that will, upon the occurrence or the nonoccurrence of any event, disable the software. Such code includes but is not limited to a computer virus, restrictive key, node lock, time-out, or other function, whether implemented by electronic, mechanical, or other means, which limits or hinders the use or access to any computer software based on residency on a specific hardware configuration, frequency of duration of use, or other limiting criteria. If any such disabling code is present, the Contractor agrees to indemnify the Government for all damages suffered as a result of a disabling caused by such code, and the contractor agrees to remove such code upon the Government’s request at no extra cost to the Government. Inability of the Contractor to remove the disabling software code will be considered an inexcusable delay and a material breach of contract, and the Government may exercise its right to terminate for cause. In addition, the Government is permitted to remove the code as it deems appropriate and charge the Contractor for consideration for the time and effort expended in removing the code.

(5). Manuals and Publications.

Upon Government request, the Contractor shall furnish the most current version of the user manual and publications for all products/services provided under this Contract/Order at no cost.

http://www.cpars.gov/

B.3 SHARE IT ACT

The Contractor shall comply with the Source Code Harmonization and Reuse in Information Technology (SHARE IT) Act, P.L. 118-187, when developing and delivering custom code first produced for the VA in the performance of this Contract/Order. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR RFO 52.227-14, to include without limitation, all custom-developed code and other key technical components of the code (including documentation, data models, schemas, metadata, architecture designs, configuration scripts, and artifacts required to develop, build, test, and deploy the code). Custom-developed code includes source code, or segregable portions of source code and all documentation created in support thereof to include source code written for a software project, product, module, plugin, script, middleware, or application programming interface.

https://www.congress.gov/118/plaws/publ187/PLAW-118publ187.pdf

B.4 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C10B

Technology Acquisition Center

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon acceptance of Deliverables in accordance with Section B.5, Price Schedule

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic

Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-8971

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.5 PRICE SCHEDULE

NOTE: Vendors are instructed to complete Section B.5 and submit with their quote.

Vendors are cautioned that alterations to the line items as specified below may render quotes unacceptable. All questions shall be directed to the Contract Specialist, Joshua

McGarry, Joshua.McGarry@va.gov prior to the closing date and time specified in the

Request for Quote (RFQ).

Inspection: Destination Acceptance: Destination Free on Board (FOB): Destination

BASE PERIOD

CLIN Description Qty Unit Unit Price

Total Price

0001 Brand Name iMedRIS Software Maintenance Support Agreement in accordance with (IAW) PD paragraph 1.0

Part Number: Software Rental and License-T4GCZAB55

Product Service Code (PSC): 7A21

The period of performance shall be 12 months from date of award

1 EA $ $

Base Period Total $

OPTION PERIOD ONE

This Option Period may be exercised IAW FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000). Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer. If exercised, this Option Period shall commence immediately after the expiration of the Base Period.

1001 Brand Name iMedRIS Software Maintenance Support Agreement IAW PD paragraph 1.0

Part Number: Software Rental and

PSC: 7A21

The period of performance shall be 12 months

Option Period One Total $

OPTION PERIOD TWO

issued by the Contracting Officer. If exercised, this Option Period shall commence immediately after the expiration of Option Period One.

2001 Brand Name iMedRIS Software Maintenance Support Agreement IAW PD paragraph 1.0

Part Number: Software Rental and License-T4GCZAB55

PSC: 7A21

The period of performance shall be 12 months

Option Period Two Total $

OPTION PERIOD THREE

issued by the Contracting Officer. If exercised, this Option Period shall commence immediately after the expiration of Option Period Two.

3001 Brand Name iMedRIS Software Maintenance Support Agreement IAW PD paragraph 1.0

Part Number: Software Rental and License-T4GCZAB55

PSC: 7A21

The period of performance shall be 12 months

Option Period Three Total $

OPTION PERIOD FOUR

issued by the Contracting Officer. If exercised, this Option Period shall commence immediately after the expiration of Option Period Three.

4001 Brand Name iMedRIS Software Maintenance Support Agreement IAW PD paragraph 1.0

Part Number: Software Rental and License-T4GCZAB55

PSC: 7A21

The period of performance shall be 12 months

1 EA $ $

Option Period Four Total $

Total Order Value (inclusive of all options) $

B.6 PRODUCT DESCRIPTION

PRODUCT DESCRIPTION (PD)

DEPARTMENT OF VETERANS AFFAIRS

Office of Information & Technology (OIT)

End User Operations (EUO) iMedRIS Integrated Research Information System (iRIS) Software/Maintenance Renewal

Date: May 15, 2026

VA-26-00065187

PD Version Number: 1.1

1.0 PRODUCT REQUIREMENTS

The Department of Veterans Affairs (VA) Office of Information and Technology (OIT)

End User Operations (EUO) requires renewal of licensing, maintenance, and support for the iMedRIS Integrated Research Information System (iRIS) currently deployed at multiple VA sites. iRIS is a VA‑approved, modular research compliance platform supporting the Institutional Review Board (IRB), Institutional Animal Care and Use

Committee (IACUC), Subcommittee on Research Safety and Security/Institutional

Biosafety Committee (SRSS/IBC), Research and Development Committee (RDC), and the Veterinary Medical Unit (VMU). The system facilitates centralized document management, electronic routing, automated notifications, reporting, and regulatory oversight activities required by VA research governance and federal compliance bodies.

This requirement ensures continued operational availability of the system through routine and corrective maintenance, including software updates, bug fixes, security patches, version upgrades, and configuration support. The contractor shall provide functional and technical assistance for issues affecting workflow processing, committee operations, and integrations such as the CITI training interface. Maintenance services are required to sustain cybersecurity compliance, preserve data integrity, and maintain interoperability with VA enterprise services, including authentication, role‑based access controls, and audit logging.

The continued support for iRIS is essential to ensure uninterrupted processing of research protocols, committee reviews, safety assessments, and associated oversight functions. The system has been in use within VA since 2012 and incorporates extensive local workflow configurations designed to align with VA research processes and compliance needs. Ongoing support allows VA sites to retain these efficiencies, prevent delays in research review cycles, and maintain adherence to human subjects protections, biosafety requirements, animal welfare standards, and VA Office of

Research & Development policy.

Performance shall be a 12-month base period with four 12-month option periods.

Description Part No. Quantity iMedRIS Software Maintenance Support

Agreement

Software Rental and

1 EA

1.1 SOFTWARE SUPPORT

The contractor shall provide technical support for all subscriptions purchased. All technical support will be provided 24 hours a day, 7 days a week, 365 days a year, to include access to Clarivate online and phone support. All technical support will include but not be limited to major product and technology releases, technical support, updates, fixes, security alerts, data fixes, and critical patch updates, upgrade scripts, tax, legal, and regulatory updates and certification with most existing third-party products/versions.

2.0 NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL

INFORMATION AND COMMUNICATION TECHNOLOGY (ICT)

PROCUREMENTS (SECTION 508)

On January 18, 2017, the Access Board issued a final rule that updated accessibility requirements covered by Section 508 and refreshed guidelines for telecommunications equipment subject to Section 255 of the Communications Act. The final rule went into effect on January 18, 2018. The revisions and updates to the Section 508-based standards and Section 255-based guidelines are intended to ensure that information and communication technology (ICT) covered by the respective statutes is accessible to and usable by individuals with disabilities.

2.1 SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY (ICT)

STANDARDS

The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT.

These standards are found in their entirety at: Revised 508 Standards and 255

Guidelines (access-board.gov). A single PDF file version of the Revised Section 508

Standards and 255 Guidelines will be supplied upon request, or can be obtained from the Access Board website. Federal agencies must comply with the Rehabilitation Act of

1973, as amended.

The Contractor shall comply with “508 Chapter 2: Scoping Requirements” for all electronic ICT and content delivered under this contract. Specifically, as appropriate for the technology and its functionality, the Contractor shall comply with the technical standards marked here:

☐ E205 Electronic Content – (Accessibility Standard -WCAG 2.0 Level A and AA Guidelines)

☐ E204 Functional Performance Criteria

☐ E206 Hardware Requirements

☒ E207 Software Requirements

☐ E208 Support Documentation and Services Requirements

2.2 COMPATABILITY WITH ASSISTIVE TECHNOLOGY

The standards do not require installation of specific accessibility-related software or attachment of an assistive technology device. Section 508 requires that ICT be compatible with such software and devices so that ICT can be accessible to and usable https://www.access-board.gov/ict/ https://www.access-board.gov/ict/ by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.

2.3 ACCEPTANCE AND ACCEPTANCE TESTING

Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.

The Government reserves the right to test for Section 508 Compliance before delivery.

The Contractor shall be able to demonstrate Section 508 Compliance upon delivery.

3.0 INFORMATION TECHNOLOGY USING SUSTAINABLE PRODUCTS

The Contractor shall comply with Sections 524 and Sections 525 of the Energy Independence and Security Act of 2007; Section 104 of the Energy Policy Act of 2005; Executive Order 14148, “Initial Rescissions of Harmful Executive Orders and Actions,” dated January 20, 2025;

Executive Order 13221, “Energy-Efficient Standby Power Devices,” dated August 2, 2001; and the Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) to provide ENERGY STAR® certified and Federal Energy Management Program (FEMP) Designated Low Standby

Power information technology products, see https://www.energy.gov/femp/search-energy-efficient-products. See http://www.energystar.gov for complete product specifications and updated lists of Energy Star certified products. FEMP low standby power product listing can be found at https://www.energy.gov/femp/low-standby-power-product-list.

The Contractor shall provide products that meet the definition of sustainable products if the products are delivered to the Government; furnished by the Contractor for use by the Government, incorporated into the construction of a public building or public work, or acquired by the Contractor for use in performing services under a Government contract where the cost of the products is a direct cost to a Government contract (versus costs which are normally applied to a contractor's general and administrative expenses or indirect costs).

Specifically, the Contractor shall provide sustainable products under this contract in accordance with RFO 52.223-23 (NOV 2025). The applicable products with their associated certification and/or designation required (e.g. Energy Star, FEMP Low Standby Power) are identified within the product requirements specifications in this PD. The Contractor shall self-certify that its proposed products meet the certification(s) and/or designation(s) specified.

4.0 SHIPMENT OF HARDWARE OR EQUIPMENT

All items listed in Section 1 as part of this Order shall be delivered electronically to the primary and alternate points of contact identified below.

Inspection: Destination Acceptance: Destination Free on Board (FOB): Destination

Ship To and Mark For:

Primary Alternate

Name: Will provide at award Name: Will provide at award

Address: Address:

Voice: Voice:

https://www.energy.gov/femp/search-energy-efficient-products https://www.energy.gov/femp/search-energy-efficient-products http://www.energystar.gov/ https://www.energy.gov/femp/low-standby-power-product-list

Primary Alternate

Email: Email:

5.0 GENERAL REQUIREMENTS

5.1 VA TECHNICAL REFERENCE MODEL

The Contractor shall comply with the VA OIT Technical Reference Model (VA TRM).

Compliance with the VA TRM is achieved by using only technologies and standards that are listed as approved for use in the VA TRM. The Contractor shall provide all necessary information requested by VA to ensure TRM approval is obtained prior to use on VA’s network.

5.2 ZERO TRUST – VA CRITICAL SECURITY CONTROLS

VA has established minimum mandatory security requirements and requires that any network connected software system or service must meet the VA Critical Security

Controls as outlined in the VA Memorandum, “VA Security Controls”, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010. VA Critical Security

Controls identify the minimum mandatory requirements that must be implemented across all VA enterprise infrastructure, cloud computing environments, information systems, networks, and specialized devices (medical devices/systems, special-purpose systems, and research scientific computing devices) that process, store, and/or transmit

VA data. Effective July 1, 2025, the Contractor shall implement these VA Critical

Security Controls, within any network connected software system or service prior to being authorized for use in the VA. This functional requirement is not negotiable, and

Plan of Action & Milestones (POAM) will not be accepted in the event these controls cannot be implemented for new systems. Critical Security Controls are intended to increase VA’s security posture and provide security and privacy risk visibility into the VA network and is not a new requirement. The Contractor’s failure to maintain these VA

Critical Controls after implementation will result in VA discontinuing the use of the system.

5.3 SOCIAL SECURITY NUMBER (SSN) REDUCTION

The Contractor solution shall support the Social Security Number (SSN) Fraud

Prevention Act (FPA) of 2017 which prohibits the inclusion of SSNs on any document sent by mail. The Contractor support shall also be performed in accordance with

Section 240 of the Consolidated Appropriations Act (CAA) 2018, enacted March 23, 2018, which mandates VA to discontinue using SSNs to identify individuals in all VA information systems as the Primary Identifier. The Contractor shall ensure that any new

IT solution discontinues the use of SSN as the Primary Identifier to replace the SSN with the Integrated Control Number (ICN) in all VA information systems for all individuals. The Contractor shall ensure that all Contractor delivered applications and systems integrate with the VA Master Person Index (MPI) for identity traits to include the https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010 use of the ICN as the Primary Identifier. The Contractor solution may only use a Social

Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA.

5.4 INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support IPv6-Only based upon the memo issued by the

Office of Management and Budget (OMB) on November 19, 2020

(https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). Which defines

IPv6-only as the state of an operational system or service when IPv4 protocol functions

(addressing, packet forwarding) are not in use. The NIST USGv6 profile defines technical requirements for a product to be capable of operating in IPv6-Only environments. IPv6-Only technology, in accordance with the USGv6 Program

(https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special

Publication (SP) 500-267B Revision 1 “USGv6 Profile”

(https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices, applications, and systems shall support all applicable functionality on native IPv6-Only as well as dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services

(e.g., web, email, DNS, ISP services, etc.) shall support native IPv6-Only and dual stack

(IPv6 / IPv4) users and all internal infrastructure and applications shall support using native IPv6-Only and dual stack (IPv6 / IPv4) for all functionality and operations.

5.5 SOFTWARE AND LICENSING REQUIREMENTS

The Contractor shall be responsible for the provision of all software licenses and any associated licensing maintenance required for any development, delivery, integration, operation, and/or maintenance associated with its proposed application(s), software products, software solution, and/or system including, but not limited to, any and all application(s), software and/or software products that comprise, are a part of, or integrate with the Contractor’s proposed application(s), software products, software solution, and/or system for the life of any resulting contract.

5.6 TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC)

Initiative“ (https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf), VA

Directive 6513 “Secure External Connections”, and shall comply with the TIC 3.0 Core

Guidance Documents, including all Volumes and TIC Use Cases, found at the https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1 https://doi.org/10.6028/NIST.SP.500-267Br1 https://doi.org/10.6028/NIST.SP.800-119 https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf

Cybersecurity & Infrastructure Security Agency (CISA)

(https://www.cisa.gov/publication/tic-30-core-guidance-documents.)

5.7 GENERATIVE ARTIFICIAL INTELLIGENCE REQUIREMENTS

If Artificial Intelligence (AI) is part of the Contractor system/solution, the Contractor shall be in compliance with E.O. 13960 and 14319, OMB Memorandums M-25-21, M-25-22, and M-26-04, and VA Directive and Handbook 6500 to support VA in trustworthy, secure, responsible, accountable, Truth Seeking, and Ideologically Neutral AI innovation.

No web-based, publicly available generative AI service has been approved for use with

VA-sensitive data including, but not limited to OpenAI’s ChatGPT, Microsoft’s Copilot, Google’s Gemini, and Anthropic’s Claude. No PII, protected health information (PHI), or

VA-sensitive data should be entered into these unapproved services. The entire definition of VA Sensitive Data can be found at 38 U.S.C. § 5727 (23). The Contractor shall protect VA Sensitive data from unauthorized disclosure or use, and from being used to train or improve the functionality of the vendor's commercial offerings without express permission from VA. Only VA-hosted instances of generative AI services may be approved for use with VA-sensitive data.

The Contractor shall deliver the services, technical data, configurations, models, weights, documentation or other information, including source code, developed during contract performance. The Contractor, in collaboration with VA, must evaluate the output of any AI tool for accuracy prior to using the output in VA efforts. All data, including models, weights, algorithms, and outputs generated using either Government-furnished data or data first developed under this contract shall be the property of the

Government with unlimited rights as defined by FAR 52.227-14. The Contractor shall also deliver any custom-developed code developed with AI methodologies in accordance with the SHARE IT Act, if applicable. VA shall also retain unlimited rights to any improvements to that data, including the continued design, development, testing, and operation of AI systems and/or systems utilizing AI.

The Contractor shall ensure that all AI Systems, including Large Language Models

(LLM), whether standalone LLMs or integrated into broader software platforms, procured under this effort and/or used in performance of this contract complies with the

Unbiased AI Principles as defined in Executive Order 14319 and OMB Memorandum M-

26-04, e.g. Truth Seeking and Ideologically Neutral, as applicable to the intended use of the system.

The Contractor shall ensure that AI System/LLM generated outputs are truthful in responding to user prompts seeking factual information or analysis, prioritize historical accuracy, scientific inquiry, and objectivity, as well as acknowledge uncertainty where reliable information is incomplete or contradictory and do not fabricate, hallucinate, or present unverifiable information as fact.

https://www.cisa.gov/publication/tic-30-core-guidance-documents

The Contractor shall ensure that LLMs and AI outputs are neutral, nonpartisan tools that do not manipulate responses in favor of ideological dogmas such as Diversity, Equity, and Inclusion (DEI). The Contractor shall ensure that the LLMs, including the AI

System, are not intentionally encoded with partisan or ideological judgments within an

AI System’s/LLM’s outputs unless those judgments are prompted by or otherwise readily accessible to the end user.

Compliance with the AI requirements of this contract, including adherence to the

Unbiased AI Principles, Truth-Seeking and Ideological Neutrality requirements, disclosure obligations, monitoring and reporting requirements, and corrective action responsibilities, is a material condition of eligibility for payment and continued performance. In accordance with OMB Memorandum M-26-04, failure to comply with these requirements, or refusal to take timely and appropriate corrective action to remedy identified noncompliance, may constitute a material breach of contract and may result in remedies consistent with the terms of the contract and applicable law including but not limited to withholding of payment, termination for cause/default, or other appropriate contractual remedies, as determined by the Contracting Officer.

All AI for delivery and/or use in performance of the contract shall adhere to the VA

Trustworthy AI Framework, available at https://department.va.gov/ai/trustworthy/. Once the Contractor has obtained CO authorization to use specific AI in contract performance, the Contractor shall provide the COR a signed Statement of Attestation prior to AI implementation as identified in the Artificial Intelligence in VA Contracts clause, to include its associated list of AI being used in contract performance.

Deliverable:

A. Statement of Attestation

5.7.1 AI SYSTEM/LLM DEVELOPMENT AND OPERATION DOCUMENTATION

REQUIREMENTS

To enable Government continued assessment of compliance with Trustworthy AI requirements and both Unbiased AI Principles, Truth-seeking and Ideological Neutrality, in accordance with OMB M-26-04, the Contractor shall provide AI System/LLM

Development and Operation Documentation Package to include, at a minimum:

1. Acceptable Use Policy

The Contractor shall provide an Acceptable Use Policy document governing its AI operation that characterizes and differentiates appropriate and inappropriate use of their product offering

2. Model Cards, System Cards and/or Data Cards https://department.va.gov/ai/trustworthy/

The Contractor shall provide documentation describing essential information about the model, system, and or data as it relates to the AI/LLM product offering. The documentation shall address summaries of training process, identified risks and mitigations, and model evaluation scores on LLM benchmarks at a minimum, where appropriate

3. End User Resources

The Contractor shall provide documentation to include product tutorials, developer guides, and/or other tools to assist VA in ensuring proper use of the AI/LLM to maximize utility

4. Mechanism for End User Feedback

The Contractor shall provide documentation describing the mechanism employed to provide feedback to the Offeror on outputs identified that violate the Unbiased AI

Principles. This may be satisfied by a general inbox, specific Point of Contact, or similar feedback mechanism.

5. Pre-Training and Post-Training Activities of the AI System/LLM

The Contractor shall provide documentation of Pre-Training and Post Training

Activity that provides details on:

a. Actions taken that impact the factuality and grounding of AI System/LLM outputs

b. System-level prompts that provide natural language instructions to the model specifying guidelines on responding to user-generated queries, to include how a model responds when reliable information is incomplete, contradictory, or subject to individual interpretation

c. The type of outputs restricted via content moderation and safety filters

d. The use of red teaming as a means of continuously assessing the model to protect against incidents of bias in generated output.

e. Training or development, if any, that occurred outside the United States, to include the type of activity and the country in which it occurred.

f. Any modifications or configurations undertaken to comply with any regulation from a government other than the U.S. Federal Government.

6. Model Evaluation Results and Methodologies

The Contractor shall provide documentation describing the Evaluation Results of bias evaluations conducted by the Vendor to include the methodology for performing such tests (e.g., testing prompt pairs for politically oriented topics).

The documentation shall also include Benchmark scoring results measuring the model’s bias, helpfulness, honesty, or accuracy when provided with ambiguous versus straightforward questions. (Including any benchmarks comparing performance across multiple languages, where applicable).

7. Description of Enterprise-Level Controls

The Contractor shall provide documentation describing the Enterprise

Governance tools and controls, such as:

a. Customizable system instructions that are additive to a base model’s system prompts or content generation filters.

b. Product features that require a model to cite sources of its outputs or otherwise provide visibility into the provenance of the model’s outputs.

c. AI System/LLM model evaluation tools that enable comparisons either between a model’s outputs, or across various models.

8. Third Party Modification Disclosure

The Contractor shall disclose of any additional controls to modify an AI

Model’s/LLM’s output applied by the Contractor if the Contractor is not a direct developer of the LLM (e.g., classifiers, system prompts, fine-tuning, content moderation and filters, etc.)

Deliverable:

A. AI System/LLM Development and Operation Documentation Package

5.7.2 MONITORING, REPORTING, AND CORRECTIVE ACTION

The Contractor shall develop and implement a Compliance Monitoring and Reporting

Plan supporting ongoing monitoring processes to evaluate AI outputs for compliance with Trustworthy AI and Unbiased AI principles. This plan shall include the mechanism for authorized users to provide end user feedback to report suspected violations of

Truth-Seeking or Ideological Neutrality requirements.

The Contractor shall notify the PM within 10 business days of identifying any material deviation from these principles and shall submit a written Corrective Action Plan describing mitigation steps, responsible parties, and timelines. Any material deviation, corrective action taken, and results shall be detailed in the Progress Reports.

Deliverable:

A. Compliance Monitoring and Reporting Plan

B. Corrective Action Plan

5.7.3 AI MODEL UPDATES AND CHANGE DISCLOSURES

The Contractor, in an AI Model/LLM Change Disclosure, shall notify the Government throughout the PoP in advance of any material changes to AI models, including new AI enhancements, features and/or components, controls, retraining, classifiers, system prompts, fine-tuning, content moderation, filters, version replacement, or architectural changes, that could reasonably affect compliance with Trustworthy AI or Unbiased AI principles. Updated documentation shall be provided to VA for VA approval prior to implementation of such changes.

Deliverable:

A. AI Model/LLM Change Disclosure

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

FAR: http://www.acquisition.gov/far-overhaul VAAR: https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR/VAAR

Number

Title Date

52.203-12 LIMITATION ON PAYMENTS TO INFLUENCE

CERTAIN FEDERAL TRANSACTIONS

JUN 2020

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER

RIGHTS

NOV 2023

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS OR

STATEMENTS

JAN 2017

52.204-13 SYSTEM FOR AWARD MANAGEMENT—

MAINTENANCE (DEVIATION)

NOV 2025

52.209-10 PROHIBITION ON CONTRACTING WITH INVERTED

DOMESTIC CORPORATIONS (DEVIATION)

NOV 2015

52.212-4 CONTRACT TERMS AND CONDITIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (DEVIATION)

OCT 2025

52.219-4 NOTICE OF PRICE EVALUATION PREFERENCE FOR

HUBZONE SMALL BUSINESS CONCERNS

(DEVIATION)

OCT 2022

52.219-28 POST AWARD…