36C10B26Q0829 - FINAL.docx

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7A21 - Lunit Patient Hub Software Licensing, Maintenance and Technical Support
Solicitation number
36C10B26Q0829
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This is a solicitation document for a sole source acquisition of Lunit Patient Hub Software Licensing, Maintenance and Technical Support from the Department of Veterans Affairs Technology Acquisition Center Austin. The acquisition supports a mammography tracking and patient notification platform to be used by the VA. The contract period of performance is October 1, 2026 through September 30, 2027, with three optional 12-month renewal periods exercisable at the Government's discretion, for a total potential contract duration of four years.

The solicitation number is 36C10B26Q0829, and this is identified as a sole source acquisition, indicating that Lunit has been determined to be the only responsible source capable of meeting the Government's requirements. The required services include software licensing, maintenance, and technical support for the Patient Hub platform. Additional details regarding pricing terms, specific performance requirements, delivery schedules, and evaluation criteria are contained in the attached solicitation and Justification and Approval (J&A) documentation referenced in this notice.

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36C10B26Q0829

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

09-25-2026 Crystal Lomonaco, crystal.lomonaco@va.gov 848-377-5156 09-28-2026

1PM

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

23 Christopher Way Eatontown NJ 07724

Lunit Americas Inc 3500 188th Street SW Suite 335 Lynnwood, WA, 98037

36C10A Department of Veterans Affairs Technology Acquisition Center Financial Services Center PO Box 149971 Austin TX 78714-8971

See CONTINUATION Page

Patient Hub Software Licensing, Maintenance, and Technical Support Support

See B.4 Price Schedule

See B.5 Product Description x x

Kendra Casebolt

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS4
B.1 GOVERNING LAW4
B.2 SOFTWARE LICENSE, MAINTENANCE AND TECHNICAL SUPPORT5
B.3 CONTRACT ADMINISTRATION DATA9
B.4 PRICE SCHEDULE10
B.5 PRODUCT DESCRIPTION15
SECTION C - CONTRACT CLAUSES23
C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)23
C.2 52.212-4 TERMS AND CONDITIONS - COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025 DEVIATION)24
C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)30
C.4 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS (NOV 2025 DEVIATION)30
C.5 52.233-3 PROTEST AFTER AWARD (NOV 2025 DEVIATION)31
C.6 52.252-6 PROTEST AFTER AWARD (NOV 2020)32
C.7 VAAR 852.201-70 CONTRACTING OFFICER’S REPRESENTATIVE (DEC 2022)32
C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)33
C.9 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899 (DEVIATION) (APR 2025)33
C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)33
C.11 VAAR 852.239-70 SECURITY REQUIREMENTS FOR INFORMATION TECHNOLOGY RESOURCES (FEB 2023)34
C.12 VAAR 852.239-76 INFORMATION AND COMMUNICATIONS TECHNOLOGY ACCESSIBILITY (FEB 2023)37
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS39
SECTION E - SOLICITATION PROVISIONS40
E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)40
E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025 DEVIATION)41
E.3 52.216-1 TYPE OF CONTRACT (NOV 2025 DEVIATION)42
E.4 52.219-1 SMALL BUSINESS PROGRAM REPRESENTATIONS (NOV 2025 DEVIATION)42
E.5 52.233-2 SERVICE OF PROTEST (NOV 2025 DEVIATION)45
E.6 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS AND CERTIFICATIONS (NOV 2025 DEVIATION)46
E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (SEP 2018)50
E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (SEP 2018)50
E.9 VAAR 852.239-71 INFORMATION SYSTEM SECURITY PLAN AND ACCREDITATION (FEB 2023)51
E.10 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE (FEB 2023)51
E.11 ARTIFICIAL INTELLIGENCE EFFORTS51
E.12 BASIS FOR AWARD52
E.13 QUOTE SUBMISSION INSTRUCTIONS53

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 GOVERNING LAW

Federal law and regulations, including the Federal Acquisition Regulations (FAR), 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 (shrink wrap), 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 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 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, MAINTENANCE AND 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 12).

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(d).

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(d); 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 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 (i.e.: www.cpars.com).

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.

B.3 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:Lunit Americas, Inc.
3500 188th Street SW
Suite 335
Lynnwood, WA, 98037

b. GOVERNMENT: Contracting Officer 36C10B Kendra Casebolt Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown NJ 07724

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] After Government acceptance of Deliverables in Section B.4, Price Schedule and in accordance with Section B.5, Product Description.

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.

36C10B26Q0829

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

Page 1 of Page 1 of

AMENDMENT NO
DATE

B.4 PRICE SCHEDULE

NOTE: Vendor is instructed to complete Section B.4, in its entirety, and submit it with their respective quote. Vendor is cautioned that alterations to, or failure to propose pricing for any of, the line items specified below may render quote unacceptable and therefore, ineligible for award. Please be advised that any quote submitted in response to this Request for Quotation will be incorporated into a resulting award and thereby serve as the Offeror’s Firm-Fixed Unit Pricing for the life of the contract. All questions shall be directed to Contract Specialist, Crystal Lomonaco at crystal.lomonaco@va.gov, prior to the closing date and time specified in Block 8 on page 1 of the SF 1449.

BASE PERIOD

Period of Performance shall be October 1, 2026 to September 30, 2027.

CLIN
Description
Unit
Qty
Unit Price
Extended Price
0001
Patient Hub / Risk Site Licenses:

Customizable patient tracking and reporting software - custom worklists, patient record set up, and personal statistical report folders. One-touch buttons to submit findings, assessment, conclusions, and final reports. Risk calculations using multiple models, including Tyrer-Cuzick v8. Seamless integration into RIS, PACS, workstation, and voice recognition workflows. Easy and accelerated statistical reporting for FDA MQSA EQUIP inspection or ACR accreditation with simple exports.

EA
14
$
$
0002
Staff User Licenses: Staff access to all features and functionality of Patient Hub and OEM Risk.

Licenses may be reassigned among staff as needed.

EA
152
$
$
0003
Patient Hub / Standard Interface: HL7 interface between Patient Hub and a third-party software system via transfer of ADT, ORM,

and/or ORU messages.

EA
7
$
$
0004
Integrations: Custom integration between Patient Hub and a third-party software system (e.g., PACS, RIS, digital reading workstations, and/or voice recognition systems) via DICOM Mammography CAD

Structured Report or Fast Healthcare Interoperability Resource (FHIR). Unlimited Integration quantity includes the existing 25 integrations with PowerScribe and 15 with Hologic.

JB
1
$
$
Base Period Total:
$

OPTION PERIOD ONE

Period of Performance shall be October 1, 2027 to September 30, 2028.

This 12-month option may be exercised in accordance with the clause in Section C entitled, “FAR 52.217-9 Option to Extend the Term of the Contract.” Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer. If exercised, the period of performance for Option Period One shall commence immediately upon the expiration of the Base Period.

CLIN
Description
Unit
Qty
Unit Price
Extended Price
1001
Patient Hub / Risk Site Licenses:

Customizable patient tracking and reporting software - custom worklists, patient record set up, and personal statistical report folders. One-touch buttons to submit findings, assessment, conclusions, and final reports. Risk calculations using multiple models, including Tyrer-Cuzick v8. Seamless integration into RIS, PACS, workstation, and voice recognition workflows. Easy and accelerated statistical reporting for FDA MQSA EQUIP inspection or ACR accreditation with simple exports.

EA
14
$
$
1002
Staff User Licenses: Staff access to all features and functionality of Patient Hub and OEM Risk.

Licenses may be reassigned among staff as needed.

EA
152
$
$
1003
Patient Hub / Standard Interface: HL7 interface between Patient Hub and a third-party software system via transfer of ADT, ORM,

and/or ORU messages.

EA
7
$
$
1004
Integrations: Custom integration between Patient Hub and a third-party software system (e.g., PACS, RIS, digital reading workstations, and/or voice recognition systems) via DICOM Mammography CAD

Structured Report or Fast Healthcare Interoperability Resource (FHIR). Unlimited Integration quantity includes the existing 25 integrations with PowerScribe and 15 with Hologic.

JB
1
$
$
Option Period One Total:
$

Option Period Two Period of Performance shall be October 1, 2028 to September 30, 2029.

This 12-month option may be exercised in accordance with the clause in Section C entitled, “FAR 52.217-9 Option to Extend the Term of the Contract.” Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer. If exercised, the period of performance for Option Period Two shall commence immediately upon the expiration of Option Period One.

CLIN
Description
Unit
Qty
Unit Price
Extended Price
2001
Patient Hub / Risk Site Licenses:

Customizable patient tracking and reporting software - custom worklists, patient record set up, and personal statistical report folders. One-touch buttons to submit findings, assessment, conclusions, and final reports. Risk calculations using multiple models, including Tyrer-Cuzick v8. Seamless integration into RIS, PACS, workstation, and voice recognition workflows. Easy and accelerated statistical reporting for FDA MQSA EQUIP inspection or ACR accreditation with simple exports.

EA
14
$
$
2002
Staff User Licenses: Staff access to all features and functionality of Patient Hub and OEM Risk.

Licenses may be reassigned among staff as needed.

EA
152
$
$
2003
Patient Hub / Standard Interface: HL7 interface between Patient Hub and a third-party software system via transfer of ADT, ORM,

and/or ORU messages.

EA
7
$
$
2004
Integrations: Custom integration between Patient Hub and a third-party software system (e.g., PACS, RIS, digital reading workstations, and/or voice recognition systems) via DICOM Mammography CAD

Structured Report or Fast Healthcare Interoperability Resource (FHIR). Unlimited Integration quantity includes the existing 25 integrations with PowerScribe and 15 with Hologic.

JB
1
$
$
Option Period Two Total:
$

Option Period Three Period of Performance shall be October 1, 2029 to September 30, 2030.

This 12-month option may be exercised in accordance with the clause in Section C entitled, “FAR 52.217-9 Option to Extend the Term of the Contract.” Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer. If exercised, the period of performance for Option Period Three shall commence immediately upon the expiration of Option Period Two.

CLIN
Description
Unit
Qty
Unit Price
Extended Price
3001
Patient Hub / Risk Site Licenses:

Customizable patient tracking and reporting software - custom worklists, patient record set up, and personal statistical report folders. One-touch buttons to submit findings, assessment, conclusions, and final reports. Risk calculations using multiple models, including Tyrer-Cuzick v8. Seamless integration into RIS, PACS, workstation, and voice recognition workflows. Easy and accelerated statistical reporting for FDA MQSA EQUIP inspection or ACR accreditation with simple exports.

EA
14
$
$
3002
Staff User Licenses: Staff access to all features and functionality of Patient Hub and OEM Risk.

Licenses may be reassigned among staff as needed.

EA
152
$
$
3003
Patient Hub / Standard Interface: HL7 interface between Patient Hub and a third-party software system via transfer of ADT, ORM,

and/or ORU messages.

EA
7
$
$
3004
Integrations: Custom integration between Patient Hub and a third-party software system (e.g., PACS, RIS, digital reading workstations, and/or voice recognition systems) via DICOM Mammography CAD

Structured Report or Fast Healthcare Interoperability Resource (FHIR). Unlimited Integration quantity includes the existing 25 integrations with PowerScribe and 15 with Hologic.

JB
1
$
$
Option Period Three Total:
$
Total Contract Value (Base + All Option Periods):
$

B.5 PRODUCT DESCRIPTION

PRODUCT DESCRIPTION (PD)

DEPARTMENT OF VETERAN AFFAIRS

Health Service Area 2.3 Brand Name Patient Hub Software Licensing, Maintenance, and Technical Support

August 21, 2026

VA-26-00004764

PD Version Number: 12.0

1.0 PRODUCT REQUIREMENTS

The Department of Veterans Affairs (VA), Health Service Area (HSA) 2.3 requires Brand Name Patient Hub software licensing, maintenance, and technical support for mammography tracking and patient notification platform services. Patient Hub is a proprietary software solution developed and maintained exclusively by Lunit International and is currently integrated within the VA HSA 2.3 breast imaging clinical workflow at all seven of the following VA Healthcare System locations for mammography patient tracking, results notification, and recall management: Bay Pines VA Healthcare System, Miami VA Healthcare System, North Florida/South Georgia Veterans Health System, Orlando VA Healthcare System, VA Caribbean Healthcare System, James A. Haley Veterans' Hospital, and West Palm Beach VA Healthcare System. The software supports breast imaging programs used to track screenings and diagnostic mammography, breast ultrasound, and breast MRI examinations; manage patient follow-up and recall notifications; and support compliance with American College of Radiology (ACR) and VA mammography quality standards. Continuity of this software is essential to maintain compliance with VA mammography policy directives and ACR accreditation requirements and to avoid disruption to Veteran patient care.

1.1 SOFTWARE LICENSE REQUIREMENTS

The Contractor shall provide software licensing for Patient Hub covering all seven HSA 2.3 healthcare systems identified in Section 1.0. Licensing shall support all system users (radiologists, technologists, and administrative staff) at each facility with no per-user or per-seat restrictions beyond the enterprise license terms.

1.2 SOFTWARE MAINTENANCE AND UPDATES

The Contractor shall provide all software updates, patches, bug fixes, and version upgrades released during the contract period at no additional cost to the Government. Updates shall be provided in a manner compatible with VA enterprise IT security requirements and Authority to Operate processes.

1.3 TECHNICAL SUPPORT SERVICES

The Contractor shall provide technical support services, including telephone and electronic helpdesk support during normal business hours (Monday through Friday, 8:00 AM – 5:00 PM Eastern Time, excluding Federal holidays); after-hours support for system outages that prevent clinical operations; a dedicated technical point of contact for HSA 2.3; response to critical (Severity 1) issues within two hours of notification; and response to non-critical (Severity 2/3) issues within one business day.

1.4 SOFTWARE SYSTEM INTEGRATION

The Contractor shall provide unlimited integration to the existing 25 integrations with PowerScribe and 15 with Hologic Custom integration between Patient Hub and a third-party software systems (e.g., PACS (Picture Archive and Communication System), RIS (Radiology Information System), digital reading workstations, and/or voice recognition systems) via DICOM (Digital Imaging Communication for Medicine) Mammography CAD (Computer Aided Diagnosis) Structured Report or Fast Healthcare Interoperability Resource (FHIR).

1.5 PERIOD OF PERFORMANCE

The base period of performance shall be October 1, 2026, to September 30, 2027, with three 12-month option periods, to be exercised at the discretion of the Government.

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 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 ELECTRONIC DELIVERY OF SOFTWARE

3.1 SPECIAL DELIVERY INSTRUCTIONS

Contractors shall coordinate deliveries with Site POCs prior to Digital Delivery.

4.0 GENERAL REQUIREMENTS

4.1 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.

4.2 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.

4.3 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 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.

4.4 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.

4.5 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.

4.6 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 Cybersecurity & Infrastructure Security Agency (CISA) (https://www.cisa.gov/publication/tic-30-core-guidance-documents.)

4.7 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.

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:

1. Statement of Attestation

5.0 POINTS OF CONTACT

VA Program Manager:

Name:Thomas Stewart
Voice:727-410-5196
Email:thomas.stewart3@va.gov

Contracting Officer:

Name:Kendra Casebolt
Email:kendra.casebolt@va.gov

Contract Specialist:

Name:Crystal Lomonaco
Email:crystal.lomonaco@va.gov

6.0 INFORMATION SECURITY CONSIDERATIONS

All VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this Product Description.

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):

http://www.acquisition.gov/far/index.html http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm

FAR Number
Title
Date
52.203-3
GRATUITIES
APR 1984
52.203-6
RESTRICTIONS ON SUBCONTRACTOR SALES TO THE GOVERNMENT
JUN 2020
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
52.204-10
REPORTING EXECUTIVE COMPENSATION AND FIRST-TIER SUBCONTRACT AWARDS
NOV 2025

(DEVIATION)

52.204-19
INCORPORATION BY REFERENCE OF REPRESENTATIONS AND CERTIFICATIONS
DEC 2014
52.209-6
PROTECTING THE GOVERNMENT’S INTEREST WHEN SUBCONTRACTING WITH CONTRACTORS DEBARRED, SUSPENDED, PROPOSED FOR DEBARMENT, OR VOLUNTARILY EXCLUDED
NOV 2025

(DEVIATION)

52.209-9
UPDATES OF PUBLICLY AVAILABLE INFORMATION REGARDING RESPONSIBILITY MATTERS
NOV 2025 (DEVIATION)
52.209-10
PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC COPRORATIONS
NOV 2025 (DEVIATION)
52.219-8
UTILIZATION OF SMALL BUSINESS CONCERNS
NOV 2025

(DEVIATION)

52.219-28
POSTAWARD SMALL BUSINESS PROGRAM REPRESENTATION
NOV 2025

(DEVIATION)

52.222-3
CONVICT LABOR
NOV 2025

(DEVIATION)

52.222-35
EQUAL OPPORTUNITY FOR VETERANS
NOV 2025

(DEVIATION)

52.222-36
EQUAL OPPORTUNITY FOR WORKERS WITH DISABILITIES
NOV 2025 (DEVIATION)
52.222-40
NOTIFICATION OF EMPLOYEE RIGHTS UNDER THE NATIONAL LABOR RELATIONS ACT
NOV 2025 (DEVIATION)
52.222-50
COMBATTING TRAFFICKING IN PERSONS
NOV 2025 (DEVIATION)
52.226-8
ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MESSAGING WHILE DRIVING
MAY 2024
52.227-1
AUTHORIZATION AND CONSENT
JUN 2020
52.227-2
NOTICE AND ASSISTANCE REGARDING PATENT AND COPYRIGHT INFRINGEMENT
JUN 2020
52.227-20
RIGHTS IN DATA-SBIR PROGRAM
MAY 2014
52.232-33
PAYMENT BY ELECTRONIC FUNDS TRANSFER-SYSTEM FOR AWARD MANAGEMENT
OCT 2018
52.232-39
UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS
JUN 2013
52.232-40
PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS
MAR 2023
52.233-1
DISPUTES
NOV 2025

(DEVIATION)

52.233-4
APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM
NOV 2025

(DEVIATION)

52.240-91
SECURITY PROHIBITIONS AND EXCLUSIONS
NOV 2025 (DEVIATION)
52.242-13
BANKRUPTCY
JUL 1995

(End of Clause) C.2 52.212-4 TERMS AND CONDITIONS - COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025 DEVIATION)

(a) Definitions. The clause at Federal Acquisition Regulation (FAR) 52.202-1, Definitions, is incorporated by reference.

(b) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(c) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in…

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