36C24426Q0241.docx
DOCX document 147 KB Posted
- Attached to
- 6515--Velys Spine Robot Brand Name or Equal
- Solicitation number
- 36C24426Q0241
About this file
This is a Standard Form 1449 Solicitation/Contract/Order for Commercial Products and Commercial Services issued by the Department of Veterans Affairs (VA) Network Contracting Office 4 in Pittsburgh for the acquisition of a Velys Spine Robotic System and associated components. The solicitation number is 36C24426Q0241, with an offer due date of March 24, 2026 at 4:00 PM EDT. The award is anticipated for January 18, 2026, with a 60-day delivery requirement after receipt of order (ARO) to the VA Pittsburgh Healthcare facility at University Drive C, Pittsburgh, PA 15240.
The acquisition comprises 147 line items totaling a Velys Robotic Spine System including navigation and robotic assist stations, camera stations, surgical instruments, specialized tools, and various component modules. The Statement of Need specifies that Pittsburgh VA Medical Center (646) requires this brand-name-or-equal robotic system to support expanding neurosurgery workloads, specifically for spinal navigation and fusion procedures. The system must be compatible with existing DePuy Synthes Spine Systems (CROSSNAV, EXPEDIUM VERSE, VIPER PRIME, SYMPHONY OCT, TriALTIS, and ANSPACH EG1), image-agnostic with 3D CT/CBCT imaging devices, and feature single-use arrays, modular design, active robotic assist capability with infrared tracking, and software enabling screw release mode functionality. The contractor must provide a one-year warranty commencing upon successful installation, coordinate installation to minimize disruptions, and furnish training for surgical and support staff upon request. Invoices will be submitted upon acceptance and full operational status. The solicitation is unrestricted and evaluated on technical capability, past performance, veterans involvement (with preference for SDVOSB or VOSB concerns), and price using a comparative evaluation approach, with award anticipated to the offeror providing the best overall value to the Government.
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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
646-26-1-633-0003 36C24426Q0241 03-1 -2026 Andrew Taylor | andrew.taylor3@va.gov 724-679-2327 03-24-2026
4:00PM
EDT
00244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh PA 15240 X 339113 800 Employees N/A X 36C646 VA Pittsburgh Healthcare University Drive C (Warehouse) Pittsburgh PA 15240 00244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh PA 15240
Austin Payment Center Department of Veterans Affairs PO Box 149971 Austin TX 78714-9971
(877) 353-9791
(512) 460-5429 See CONTINUATION Page Surgical Robot - Spine Schedule on page
– 4 - 12 Instructions to Vendors on page - See CONTINUATION Page X X X Andrew Taylor Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 3 |
| B.1 CONTRACT ADMINISTRATION DATA | 3 |
| B.2 PRICE/COST SCHEDULE | 4 |
| ITEM INFORMATION | 4 |
| B.3 DELIVERY SCHEDULE | 22 |
| SECTION C - CONTRACT CLAUSES | 32 |
| C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 32 |
| C.2 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025) (DEVIATION) | 33 |
| C.3 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) | 42 |
| C.4 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) | 44 |
| C.5 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018) | 44 |
| C.6 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION FEB 2025) | 44 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 53 |
| SECTION E - SOLICITATION PROVISIONS | 54 |
| E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 57 |
| E.2 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION) | 57 |
| E.3 52.233-2 SERVICE OF PROTEST (SEP 2006) | 58 |
| E.4 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS AND CERTIFICATIONS (NOV 2025) (DEVIATION) | 58 |
| ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEVIATION AUG 2025) | 62 |
| E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION FEB 2025) | 64 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
1. Contract Administration: All contract administration matters will be handled by the following individuals:
a. CONTRACTOR:
b. GOVERNMENT: Andrew Taylor, Contracting Officer 36C244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh PA 15240
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 and Fully Operational |
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.
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 PRICE/COST SCHEDULE
ITEM INFORMATION
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES |
| QTY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE NAVIGATION STATION
LOCAL STOCK NUMBER: 45161100
| 1.00 |
| EA |
| __________________ |
| __________________ |
VELYS ROBOTIC ASSIST STATION
LOCAL STOCK NUMBER: 451611001
| 1.00 |
| EA |
| __________________ |
| __________________ |
VELYS CAMERA STATION
LOCAL STOCK NUMBER: 451611002
| 1.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE NAVIGATION STATION
LOCAL STOCK NUMBER: 451611000
| 1.00 |
| EA |
| __________________ |
| __________________ |
VELYS CAMERA STATION
LOCAL STOCK NUMBER: 451611002
| 2.00 |
| EA |
| __________________ |
| __________________ |
UNIUM MODULAR HANDPIECE
LOCAL STOCK NUMBER: 05.001.601
| 2.00 |
| EA |
| __________________ |
| __________________ |
UNIUM POWER UNIT
LOCAL STOCK NUMBER: 05.001.602
| 2.00 |
| EA |
| __________________ |
| __________________ |
UNIUM STERILE COVER
LOCAL STOCK NUMBER: 05.001.603
| 2.00 |
| EA |
| __________________ |
| __________________ |
UNIUM ADAPTER FOR UBC II
LOCAL STOCK NUMBER: 05.001.604
| 2.00 |
| EA |
| __________________ |
| __________________ |
WASH AND STERILE BSKT,1/3,UNIUM MOD
LOCAL STOCK NUMBER: 68.001.657
| 2.00 |
| EA |
| __________________ |
| __________________ |
LID,WASH AND STERILIZATION BSKT,1/3
LOCAL STOCK NUMBER: 68.001.659
| 1.00 |
| EA |
| __________________ |
| __________________ |
UNIVERSAL BATTERY CHARGER II
LOCAL STOCK NUMBER: 05.001.204
| 1.00 |
| EA |
| __________________ |
| __________________ |
LUBRICANT FOR ANSPACH SYSTEMS
LOCAL STOCK NUMBER: 05.001.078
| 1.00 |
| EA |
| __________________ |
| __________________ |
ATTACHMENT CLEANING BRUSHES
LOCAL STOCK NUMBER: ACB
| 1.00 |
| EA |
| __________________ |
| __________________ |
ELECTRIC SYSTEMS FOOT CONTROL
LOCAL STOCK NUMBER: E-FP
| 1.00 |
| EA |
| __________________ |
| __________________ |
HIGH SPEED ELEC G1 HANDPIECE AIR COOLED
LOCAL STOCK NUMBER: EG1A
| 1.00 |
| EA |
| __________________ |
| __________________ |
G1 CLEANING & STERILE BSK - BOTTOM
LOCAL STOCK NUMBER: G1-BSKT-BTM
| 1.00 |
| EA |
| __________________ |
| __________________ |
G1 CLEANING AND STERILE BSKT - INSERT
LOCAL STOCK NUMBER: G1-BSKT-INS
| 1.00 |
| EA |
| __________________ |
| __________________ |
G1 CLEANING AND STERILE BSKT - LID
LOCAL STOCK NUMBER: G1-BSKT-LID
| 1.00 |
| EA |
| __________________ |
| __________________ |
SLEEVE, G1 CLEANING AND STERILE BSKT
LOCAL STOCK NUMBER: G1-BSKT-SLV
| 1.00 |
| EA |
| __________________ |
| __________________ |
BEARING SLEEVE, 15CM CURVED
LOCAL STOCK NUMBER: MA-15C
| 1.00 |
| EA |
| __________________ |
| __________________ |
BEARING SLEEVE, 15CM STRAIGHT
LOCAL STOCK NUMBER: MA-15S
| 1.00 |
| EA |
| __________________ |
| __________________ |
MINIMAL ACCESS DRIVER, ANGLED
LOCAL STOCK NUMBER: MA-D20-G1
| 1.00 |
| EA |
| __________________ |
| __________________ |
8CM MEDIUM ATTACH
LOCAL STOCK NUMBER: medium-g1
| 1.00 |
| EA |
| __________________ |
| __________________ |
11CM MEDIUM, QD ANGLE ATTACHMENT
LOCAL STOCK NUMBER: QD11-G1
| 1.00 |
| EA |
| __________________ |
| __________________ |
RECEIVER FOR WIRELESS HAND CONTROL, EG1A
LOCAL STOCK NUMBER: RECEIVER-HC
| 1.00 |
| EA |
| __________________ |
| __________________ |
CONSOLE, ELECTRIC WITH IRRIGATION
LOCAL STOCK NUMBER: SC3002
| 1.00 |
| EA |
| __________________ |
| __________________ |
SMALL DIAMETER CLEANING BRUSH
LOCAL STOCK NUMBER: SDCB
| 20.00 |
| EA |
| __________________ |
| __________________ |
VELYS INSTRUMENT CASE BASE
LOCAL STOCK NUMBER: 451611051
| 20.00 |
| EA |
| __________________ |
| __________________ |
VELYS INSTRUMENT CASE LID
LOCAL STOCK NUMBER: 451611052
| 2.00 |
| EA |
| __________________ |
| __________________ |
CROSSNAV ADAPTOR MOD CADDIE
LOCAL STOCK NUMBER: 291490005
| 2.00 |
| EA |
| __________________ |
| __________________ |
CROSSNAV ADAPTOR MOD CAD LID
LOCAL STOCK NUMBER: 291490015
| 10.00 |
| EA |
| __________________ |
| __________________ |
CROSSNAV ADAPTOR
LOCAL STOCK NUMBER: 3020.20-001
| 2.00 |
| EA |
| __________________ |
| __________________ |
DRIVE ADAPTOR QC FOR 4.0 SCHANZ SCREWS
LOCAL STOCK NUMBER: 393.101
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS TOOL HOLDER M
LOCAL STOCK NUMBER: 451611031
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS TOOL HOLDER L
LOCAL STOCK NUMBER: 451611032
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SCREWDRIVER T20
LOCAL STOCK NUMBER: 451611037
| 4.00 |
| EA |
| __________________ |
| __________________ |
VELYS PATIENT ARRAY CONNECTOR
LOCAL STOCK NUMBER: 451611038
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SURVEILLANCE MARKER COUPLER
LOCAL STOCK NUMBER: 451611039
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE SPINOUS PROCESS CLAMP HOLDER
LOCAL STOCK NUMBER: 451611042
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE ILIAC FIXATION SLEEVE S
LOCAL STOCK NUMBER: 451611043
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE ILIAC FIXATION SLEEVE L
LOCAL STOCK NUMBER: 451611044
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS ILIAC FIXATION IMPACTOR
LOCAL STOCK NUMBER: 451611045
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE THORACOLUMBAR CLAMP S
LOCAL STOCK NUMBER: 451611048
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE THORACOLUMBAR CLAMP L
LOCAL STOCK NUMBER: 451611049
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS POINTER
LOCAL STOCK NUMBER: 451611050
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS INSTRUMENT CASE BASE
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS INSTRUMENT CASE LID
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE TL CORE INSTRUMENT TRAY
LOCAL STOCK NUMBER: 451611054
| 4.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE DRAPE CAP
LOCAL STOCK NUMBER: 451611063
| 2.00 |
| EA |
| __________________ |
| __________________ |
AO SCREW ATTACHMENT
LOCAL STOCK NUMBER: 05.001.251
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS TOOL HOLDER S
LOCAL STOCK NUMBER: 451611030
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SCREWDRIVER T20
LOCAL STOCK NUMBER: 451611037
| 4.00 |
| EA |
| __________________ |
| __________________ |
VELYS PATIENT ARRAY CONNECTOR
LOCAL STOCK NUMBER: 451611038
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SURVEILLANCE MARKER COUPLER
LOCAL STOCK NUMBER: 451611039
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE SKULL FRAME ADAPTOR WIDE
LOCAL STOCK NUMBER: 451611040
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE SKULL FRAME ADAPTOR NARROW
LOCAL STOCK NUMBER: 451611041
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE SPINOUS PROCESS CLAMP HOLDER
LOCAL STOCK NUMBER: 451611042
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE CERVICAL CLAMP S
LOCAL STOCK NUMBER: 451611046
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE CERVICAL CLAMP L
LOCAL STOCK NUMBER: 451611047
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS POINTER
LOCAL STOCK NUMBER: 451611050
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS INSTRUMENT CASE BASE
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS INSTRUMENT CASE LID
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE CERVICAL CORE INSTRUMENT TRAY
LOCAL STOCK NUMBER: 451611053
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE SKULL FRAME ADJUSTMENT WRENCH
LOCAL STOCK NUMBER: 451611061
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE SKULL FRAME SUPPORT BRACKET
LOCAL STOCK NUMBER: 451611062
| 4.00 |
| EA |
| __________________ |
| __________________ |
VELYS SPINE DRAPE CAP
LOCAL STOCK NUMBER: 451611063
| 6.00 |
| EA |
| __________________ |
| __________________ |
RI THORACOLUMBAR ARRAY SLEEVE
LOCAL STOCK NUMBER: 291489000
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI TL DRILL 2.4
LOCAL STOCK NUMBER: 291489118
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI TL DRILL 3.2
LOCAL STOCK NUMBER: 291489119
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI ARRAY GUIDE
LOCAL STOCK NUMBER: 291489401
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SCALPEL HOLDER
LOCAL STOCK NUMBER: 291489402
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI CORE INSTRUMENT
LOCAL STOCK NUMBER: 291489403
| 2.00 |
| EA |
| __________________ |
| __________________ |
THORACOLUMBAR BASE TRAY
LOCAL STOCK NUMBER: 291489603
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI MODULE LID
LOCAL STOCK NUMBER: 291489609
| 2.00 |
| EA |
| __________________ |
| __________________ |
NAV RING SIZE 12
LOCAL STOCK NUMBER: 302011012
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS NAV G1 ATTACHMENT XL-HD
LOCAL STOCK NUMBER: 451611056
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS BURR-ADAPTOR
LOCAL STOCK NUMBER: 451611055
| 2.00 |
| EA |
| __________________ |
| __________________ |
SQUARE QC, FOR DRILLING, SBDII/UNIUM
LOCAL STOCK NUMBER: 05.001.261
| 2.00 |
| EA |
| __________________ |
| __________________ |
SQUARE QC,TAP/SCREW, SBDII/UNIUM
LOCAL STOCK NUMBER: 05.001.2621
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TL TAP 4.5
LOCAL STOCK NUMBER: 291489240
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TL TAP 5
LOCAL STOCK NUMBER: 291489241
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TL TAP 5.5
LOCAL STOCK NUMBER: 291489242
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TL TAP 6
LOCAL STOCK NUMBER: 291489243
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TL TAP 6.5
LOCAL STOCK NUMBER: 291489244
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TL TAP 7
LOCAL STOCK NUMBER: 291489245
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TL TAP 7.5
LOCAL STOCK NUMBER: 291489246
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TL TAP 8
LOCAL STOCK NUMBER: 291489247
| 2.00 |
| EA |
| __________________ |
| __________________ |
TAP MODULE TRAY
LOCAL STOCK NUMBER: 291489608
| 2.00 |
| EA |
| __________________ |
| __________________ |
TAP MODULE LID
LOCAL STOCK NUMBER: 291489610
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI INCISION TUBE 16
LOCAL STOCK NUMBER: 291489013
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI THORACOLUMBAR AXGUIDE 16X8
LOCAL STOCK NUMBER: 291489104
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI TRIALTIS DRIVER SHAFT
LOCAL STOCK NUMBER: 291489307
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI TRIALTIS DRIVER GUIDE
LOCAL STOCK NUMBER: 291489308
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI TRIALTIS THREADH LOCKER
LOCAL STOCK NUMBER: 291489309
| 2.00 |
| EA |
| __________________ |
| __________________ |
TRIALTIS MODULE TRAY
LOCAL STOCK NUMBER: 291489606
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI MODULE LID
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI INCISION TUBE 16
LOCAL STOCK NUMBER: 291489013
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI SAI AXGUIDE 16X12
LOCAL STOCK NUMBER: 291489106
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI SAI DRILL 4.2
LOCAL STOCK NUMBER: 291489121
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SAI TAP 8
LOCAL STOCK NUMBER: 291489211
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SAI TAP 8.5
LOCAL STOCK NUMBER: 291489212
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SAI TAP 9
LOCAL STOCK NUMBER: 291489213
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SAI TAP 9.5
LOCAL STOCK NUMBER: 291489214
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SAI TAP 10
LOCAL STOCK NUMBER: 291489215
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SAI TAP 10.5
LOCAL STOCK NUMBER: 291489216
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SAI TAP 11
LOCAL STOCK NUMBER: 291489217
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SAI TAP 12
LOCAL STOCK NUMBER: 291489218
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SAI BURR GUIDE
LOCAL STOCK NUMBER: 291489404
| 2.00 |
| EA |
| __________________ |
| __________________ |
TRIALTIS SAI MODULE TRAY
LOCAL STOCK NUMBER: 291489607
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI MODULE LID
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI INCISION TUBE 14
LOCAL STOCK NUMBER: 291489012
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI THORACOLUMBAR AXGUIDE 14X8
LOCAL STOCK NUMBER: 291489102
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI VIPER PRIME DRIVER SHAFT
LOCAL STOCK NUMBER: 291489304
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI VIPER PRIME DRIVER GUIDE
LOCAL STOCK NUMBER: 291489305
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI VIPER THREAD LOCKER
LOCAL STOCK NUMBER: 291489306
| 2.00 |
| EA |
| __________________ |
| __________________ |
VIPER PRIME MODULE TRAY
LOCAL STOCK NUMBER: 291489604
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI MODULE LID
| 2.00 |
| EA |
| __________________ |
| __________________ |
T HANDLE, RATHCETING
LOCAL STOCK NUMBER: 5161005010
| 2.00 |
| EA |
| __________________ |
| __________________ |
INLINE HANDLE, RATCHETING
LOCAL STOCK NUMBER: 5161005011
| 4.00 |
| EA |
| __________________ |
| __________________ |
CERVICAL ARRAY SLEEVE
LOCAL STOCK NUMBER: 291489001
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SLEEVE CERVICAL WITH STOP
LOCAL STOCK NUMBER: 291489002
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI INCISION TUBE 10
LOCAL STOCK NUMBER: 291489011
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI CERVICAL AXGUIDE 10X8
LOCAL STOCK NUMBER: 291489108
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI CERVICAL DRILL AXGUIDE 10X8
LOCAL STOCK NUMBER: 291489114
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI CERV DRILL 2.4
LOCAL STOCK NUMBER: 291489123
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TAP SYMPHONY 3.0
LOCAL STOCK NUMBER: 291489221
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TAP SYMPHONY 3.5
LOCAL STOCK NUMBER: 291489222
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TAP SYMPHONY 4.0
LOCAL STOCK NUMBER: 291489223
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TAP SYMPHONY 4.5
LOCAL STOCK NUMBER: 291489224
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TAP SYMPHONY CFX 4.5
LOCAL STOCK NUMBER: 291489225
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TAP SYMPHONY CFX 5.0
LOCAL STOCK NUMBER: 291489226
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI TAP SYMPHONY CFX 5.5
LOCAL STOCK NUMBER: 291489227
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI SYMPHONY DRIVER SHAFT
LOCAL STOCK NUMBER: 291489310
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI SYMPHONY DRIVER GUIDE
LOCAL STOCK NUMBER: 291489311
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI SYMPHONY THREAD LOCKER
LOCAL STOCK NUMBER: 291489312
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI ARRAY GUIDE
LOCAL STOCK NUMBER: 291489401
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI SCALPEL HOLDER
LOCAL STOCK NUMBER: 291489402
| 2.00 |
| EA |
| __________________ |
| __________________ |
RI CORE INSTRUMENT
LOCAL STOCK NUMBER: 291489403
| 2.00 |
| EA |
| __________________ |
| __________________ |
SYMPHONY MODULE I TRAY
LOCAL STOCK NUMBER: 291489601
| 4.00 |
| EA |
| __________________ |
| __________________ |
RI MODULE LID
| 2.00 |
| EA |
| __________________ |
| __________________ |
NAV RING SIZE 12
LOCAL STOCK NUMBER: 302011012
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS BURR-ADAPTOR
LOCAL STOCK NUMBER: 451611055
| 2.00 |
| EA |
| __________________ |
| __________________ |
VELYS NAV G1 ATTACHMENT XL-HD
LOCAL STOCK NUMBER: 451611056
| 2.00 |
| EA |
| __________________ |
| __________________ |
AO/ASIF QUICK COUPLING FOR DRILL BITS
LOCAL STOCK NUMBER: 05.001.250
| 2.00 |
| EA |
| __________________ |
| __________________ |
AO SCREW ATTACHMENT
LOCAL STOCK NUMBER: 05.001.251
| 2.00 |
| EA |
| __________________ |
| __________________ |
SYMPHONY MODULE II TRAY
LOCAL STOCK NUMBER: 291489602
| GRAND TOTAL |
| __________________ |
B.3 DELIVERY SCHEDULE
| ITEM NUMBER |
| SHIPPING INFORMATION |
| QUANTITY |
| DELIVERY DATE |
0001 - 0147
VA Pittsburgh Healthcare University Drive C Pittsburgh PA 15240
| ALL |
| 60 Days ARO |
DEPARTMENT OF VETERAN AFFAIRS
STATEMENT OF NEED
Velys Robotic System (Brand Name or Equal)
Introduction: The Pittsburgh VA Medical Center (646) located at University Drive C., Pittsburgh, PA 15240, has a brand name or equal requirement for one (1) Robotic Spine System, and components.
Background and Scope of Work: The Pittsburgh VAMC (646) is requesting a brand name or equal requirement for one (1) Velys Spine Robot, along with components. The purpose of this Statement of Need is to outline the necessity for the acquisition of the Velys Robotic Spine System to support the expansion of neurosurgery workloads, specifically for spinal navigation surgeries at our facility. The advanced capabilities of this robotic system will enhance the precision and efficiency of spinal surgeries, ultimately improving patient outcomes.
Pittsburgh Surgical Services currently have four (4) Neuro/Spine Surgeons that have agreed upon the Salient Characteristics for a Robotic Surgical System. This additional system will help with the caseload of 2-4 procedures a week.
Salient Characteristics:
· Robotic-assisted Surgical System overall must assist the surgeon in the following:
· Be able to Identify anatomical structures and placement of spinal implants for spinal fusion procedures.
· Help position and orientate surgical instruments.
· To be used in Freehand Navigation Guidance Mode and Robotic-Assisted Guidance mode.
· Spinal Fusion Implant compatibility:
· Must be compatible with the existing DePuy Synthes Spine Systems; CROSSNAV™, EXPEDIUM VERSE™ Spine System, VIPER PRIME™ System, SYMPHONY™ OCT System, TriALTIS™, ANSPACH™ EG1™ High Speed Electric System already in-use at the Pittsburgh VA Healthcare System.
· Imaging Requirements:
· Must be image agnostic (able to be utilized with any 3D CT or CBCT intraoperative imaging device on the market) such as the GE 3D C-Arm, O-Arm System, Ziehm 3D CArm system, BrainLab Airo, Siemens C-Artic Move, and Siemens Cios Spin arm.
· Single-Use Arrays:
· The system must have Single-Use arrays that are opened for each spine procedure.
· Active-Robotic Assist Station/Hardware:
· The system must have the ability to be a modular system; the Navigation system can act independently of the Robotic Assist station.
· Must have the ability to manually manipulate the robotic arm in any direction that the surgeon desires.
· The Robotic arm must have a handgrip that has infrared LEDs at its proximal and distal ends; these infrared LEDs must create the Robotic arm array which allows the robotic arm to be tracked by the camera.
· The arm must have the ability to actively track patient movement based on the patient reference array; and thereby will also maintain alignment to the target.
· Must have the ability to when an external force is placed on the robotic arm or tool holder, the robotic arm will maintain its alignment.
· The system must have the ability to be a modular system which the Navigation system can act independently of the Robotic Assist station.
· The robotic system must have the ability to activate screw release mode; allowing for to ease the removal of the Screwdriver once the inserted screw tip reaches 20% of the length to tip of planned screw length.
· Technology/Software:
· System software must assist in planning pedicle screws for spinal fusion procedures.
· System software must track the positioning of the arrays in real-time.
· Must contain graphical user interface (GUI) with touchscreen technology.
· Software must contain a feature known as screw release mode - standout innovation, this feature automatically manages the controlled release of the screwdriver once a pedicle screw reaches its target. By sensing positional relationships and adjusting accordingly, it prevents mechanical “shudder” and workflow interruptions—a direct response to challenges in earlier robotic designs.
· The system must have a simplified and user-friendly interface that is designed based on click efficiency. Streamlined icons, thoughtful button placement, and a deliberate color scheme.
· Ability to toggle between Robotic Assist mode and Freehand Mode throughout the procedure.
The acquisition and integration of the Velys Robotic Spine Robot System is crucial for the neurosurgery department to keep pace with increasing surgical demands and advancements in spinal surgery technology. This investment will enhance our facility’s ability to provide high-quality patient care, improve surgical outcomes, and maintain our position at the forefront of medical innovation.
Delivery Requirement: Deliver all line items specified under Data/Deliverables to:
VAMC Pittsburgh ATTN: Warehouse/BioMed University Drive C. Room 2A118 Pittsburgh, PA 15240 During normal operating hours, M-F 8:00am – 3:30pm
Reports/Deliverables:
Delivery confirmation of equipment and commodities will be made through the Logistics Department of the VAMC Pittsburgh (646). This will include documentation of receipt and assignment of a facility based “EE” number for identification and tracking purposes. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving Facility and/ or Service. The Contractor will provide training sessions for any relevant surgical and support staff upon request, coordinate installation with facility POC/COR to minimize disruptions and provide timely and
Warranty:
The Contractor will provide a one (1) year warranty covering equipment.
This one (1) year warranty period will commence upon successful installation and validation of the Velys Robotic Spine System.
Security:
The Contractor will come on-site to Pittsburgh VAMC located at University Drive C. Pittsburgh, PA 15240 to provide installation. The Contractor will not have access to any sensitive data.
36C24426Q0241 End of Statement of Work Page 1 of Page 1 of
SECTION C - CONTRACT CLAUSES
ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
The following clauses are incorporated into 52.212-4 as an addendum to this contract:
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):
https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/
(End of Clause)
| FAR Number |
| Title |
| Date |
| 52.203-6 |
| RESTRICTIONS ON SUBCONTRACTOR SALES TO THE GOVERNMENT ALTERNATE I (NOV 2021) |
| JUN 2020 |
| 52.203-16 |
| PREVENTING PERSONAL CONFLICTS OF INTEREST |
| 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 |
| 52.204-9 |
| PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL |
| JAN 2011 |
| 52.204-13 |
| SYSTEM FOR AWARD MANAGEMENT—MAINTENANCE (DEVIATION) |
| NOV 2025 |
| 52.209-6 |
| PROTECTING THE GOVERNMENT'S INTEREST WHEN SUBCONTRACTING WITH CONTRACTORS DEBARRED, SUSPENDED, PROPOSED FOR DEBARMENT, OR VOLUNTARILY EXCLUDED |
| JAN 2025 |
| 52.209-9 |
| UPDATES OF PUBLICLY AVAILABLE INFORMATION REGARDING RESPONSIBILITY MATTERS |
| OCT 2018 |
| 52.209-10 |
| PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS |
| NOV 2015 |
| 52.212-4 |
| CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES |
| NOV 2023 |
| 52.219-8 |
| UTILIZATION OF SMALL BUSINESS CONCERNS (DEVIATION) |
| NOV 2025 |
| 52.219-33 |
| NONMANUFACTURER RULE (DEVIATION) |
| NOV 2025 |
| 52.219-4 |
| NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZONE SMALL BUSINESS CONCERNS (DEVIATION) |
| NOV 2025 |
| 52.222-19 |
| CHILD LABOR—COOPERATION WITH AUTHORITIES AND REMEDIES (DEVIATION) |
| NOV 2025 |
| 52.222-40 |
| NOTIFICATION OF EMPLOYEE RIGHTS UNDER THE NATIONAL LABOR RELATIONS ACT (DEVIATION) |
| NOV 2025 |
| 52.222-50 |
| COMBATING TRAFFICKING IN PERSONS (DEVIATION) |
| NOV 2025 |
| 52.225-5 |
| TRADE AGREEMENTS |
| NOV 2023 |
| 52.225-8 |
| DUTY-FREE ENTRY |
| OCT 2025 |
| 52.228-5 |
| INSURANCE—WORK ON A GOVERNMENT INSTALLATION |
| JAN 1997 |
| 52.233-3 |
| PROTEST AFTER AWARD |
| AUG 1996 |
| 52.233-4 |
| APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM |
| OCT 2004 |
| 852.203-70 |
| COMMERCIAL ADVERTISING |
| MAY 2018 |
| 852.204-70 |
| PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL |
| MAY 2020 |
| 852.211-70 |
| EQUIPMENT OPERATION AND MAINTENANCE MANUALS |
| NOV 2018 |
| 852.212-71 |
| GRAY MARKET AND COUNTERFEIT ITEMS |
| FEB 2023 |
| 852.215-70 |
| SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (DEVIATION) |
| JAN 2023 |
| 852.222-71 |
| COMPLIANCE WITH EXECUTIVE ORDER 13899 (DEVIATION) (APR 2025) |
| APR 2025 |
| 852.239-75 |
| INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE |
| FEB 2023 |
| 852.246-71 |
| REJECTED GOODS |
| OCT 2018 |
C.2 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025) (DEVIATION)
(a) Definitions. As used in this clause— American Security Drone Act-covered foreign entity means an entity included on a list that the Federal Acquisition Security Council (FASC) develops and maintains and publishes in the System for Award Management (SAM) at https://www.sam.gov (section 1822 of Pub. L. 118-31, 41 U.S.C. 3901 note prec.).
Backhaul means intermediate links between the core network, or backbone network, and the small subnetworks at the edge of the network (e.g., connecting cell phones/towers to the core telephone network). Backhaul can be wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).
Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.
Covered article, as defined in 41 U.S.C. 4713(k), means:
(1) Information technology, as defined in 40 U.S.C. 11101, including cloud computing services of all types;
(2) Telecommunications equipment or telecommunications service, as those terms are defined in section 3 of the Communications Act of 1934 (47 U.S.C. 153);
(3) The processing of information on a Federal or non-Federal information system, subject to the requirements of the Controlled Unclassified Information program (see 32 CFR part 2002); or
(4) Hardware, systems, devices, software, or services that include embedded or incidental information technology.
Covered foreign country means The People’s Republic of China.
Covered telecommunications equipment or services means—
(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);
(2) For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);
(3) Telecommunications or video surveillance services provided by such entities or using such equipment; or
(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.
Critical technology means—
(1) Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;
(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled—
(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or
(ii) For reasons relating to regional stability or surreptitious listening;
(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);
(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);
(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or
(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).
FASC-prohibited unmanned aircraft system means an unmanned aircraft system manufactured or assembled by an American Security Drone Act—covered foreign entity.
FASCSA order means any of the following orders issued under the Federal Acquisition Supply Chain Security Act (FASCSA) requiring removing covered articles from executive agency information systems or excluding one or more named sources or named covered articles from executive agency procurement actions, as described in 41 CFR 201-1.303(d) and (e):
(1) The Secretary of Homeland Security may issue FASCSA orders that apply to civilian agencies, to the extent not covered by paragraph (2) or (3) of this definition. This type of FASCSA order may be referred to as a Department of Homeland Security (DHS) FASCSA order.
(2) The Secretary of Defense may issue FASCSA orders that apply to the Department of Defense (DoD) and national security systems other than sensitive compartmented information systems. This type of FASCSA order may be referred to as a DoD FASCSA order.
(3) The Director of National Intelligence (DNI) may issue FASCSA orders that apply to the intelligence community and sensitive compartmented information systems, to the extent not covered by paragraph (2) of this definition. This type of FASCSA order may be referred to as a DNI FASCSA order.
Information technology, as defined in 40 U.S.C. 11101(6)—
(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—
(i) Of that equipment; or
(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;
(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but
(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.
Intelligence community, as defined by 50 U.S.C. 3003(4), means the following—
(1) The Office of the Director of National Intelligence;
(2) The Central Intelligence Agency;
(3) The National Security Agency;
(4) The Defense Intelligence Agency;
(5) The National Geospatial-Intelligence Agency;
(6) The National Reconnaissance Office;
(7) Other offices within the Department of Defense for the collection of specialized national intelligence through reconnaissance programs;
(8) The intelligence elements of the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard, the Federal Bureau of Investigation, the Drug Enforcement Administration, and the Department of Energy;
(9) The Bureau of Intelligence and Research of the Department of State;
(10) The Office of Intelligence and Analysis of the Department of the Treasury;
(11) The Office of Intelligence and Analysis of the Department of Homeland Security; or
(12) Such other elements of any department or agency as may be designated by the President, or designated jointly by the Director of National Intelligence and the head of the department or agency concerned, as an element of the intelligence community.
Interconnection arrangement means arrangements governing the physical connection of two or more networks to allow the use of another’s network to hand off traffic where it is ultimately delivered (e.g., connecting a customer of telephone provider A to a customer of telephone company B) or sharing data and other information resources.
Kaspersky Lab-covered article means any hardware, software, or service that—
(1) Is developed or provided by a Kaspersky Lab-covered entity;
(2) Includes any hardware, software, or service developed or provided in whole or in part by a Kaspersky Lab-covered entity; or
(3) Contains components using any hardware or software developed in whole or in part by a Kaspersky Lab-covered entity.
Kaspersky Lab-covered entity means—
(1) Kaspersky Lab;
(2) Any successor entity to Kaspersky Lab, including any change in name, e.g., “Kaspersky”;
(3) Any entity that controls, is controlled by, or is under common control with Kaspersky Lab; or
(4) Any entity of which Kaspersky Lab has a majority ownership.
National security system, as defined in 44 U.S.C. 3552, means any information system (including any telecommunications system) used or operated by an agency or by a contractor of an agency, or other organization on behalf of an agency—
(1) The function, operation, or use of which involves intelligence activities; involves cryptologic activities related to national security; involves command and control of military forces; involves equipment that is an integral part of a weapon or weapons system; or is critical to the direct fulfillment of military or intelligence missions, but does not include a system that is to be used for routine administrative and business applications (including payroll, finance, logistics, and personnel management applications); or
(2) Is protected at all times by procedures established for information that have been specifically authorized under criteria established by an Executive order or an Act of Congress to be kept classified in the interest of national defense or foreign policy.
Roaming means cellular communications services (e.g., voice, video, data) received from a visited network when unable to connect to the facilities of the home network either because signal coverage is too weak or because traffic is too high.
Sensitive compartmented information means classified information concerning or derived from intelligence sources, methods, or analytical processes, which is required to be handled within formal access control systems established by the Director of National Intelligence.
Sensitive compartmented information system means a national security system authorized to process or store sensitive compartmented information.
Source means a non-Federal supplier, or potential supplier, of products or services, at any tier.
Subsidiary means an entity in which more than 50 percent of the entity is owned directly by a parent corporation or through another subsidiary of a parent corporation.
Substantial or essential component means any component necessary for the proper function or performance of a piece of equipment, system, or service.
Unmanned aircraft means an aircraft that is operated without the possibility of direct human intervention from within or on the aircraft (49 U.S.C. 44801(11)).
Unmanned aircraft system means an unmanned aircraft and associated elements (including communication links and the components that control the unmanned aircraft) that are required for the operator to operate safely and efficiently in the national airspace system (49 U.S.C. 44801(12)).
(b) Prohibitions on providing or using specific products or services in performance of contract. Unless a waiver or exception applies, the Contractor is prohibited from providing any products or services to the Government or using in the performance of the contract any of the following:
(1) A covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees (section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328));
(2) A Kaspersky Lab-covered article (Section 1634 of Division A of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91));
(3) Covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system (paragraphs (a)(1)(A) of section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232)). This does not prohibit contractors from providing—
(i) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or
(ii) Telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.
(c) Prohibition on unmanned aircraft systems manufactured or assembled by American Security Drone Act—covered foreign entities.
(1) Prohibition. The Contractor is prohibited from—
(i) Delivering any FASC-prohibited unmanned aircraft system, which includes unmanned aircraft (i.e., drones) and associated elements (sections 1823 and 1826 of American Security Drone Act of 2023, within the National Defense Authorization Act for Fiscal Year 2024, Pub. L. 118-31, Div. A, Title XVIII, Subtitle B, 41 U.S.C. 3901 note prec.);
(ii) On or after December 22, 2025, operating a FASC-prohibited unmanned aircraft system in the performance of the contract (section 1824 of Pub. L. 118-31); and
(iii) On or after December 22, 2025, using Federal funds to procure or operate a FASC-prohibited unmanned aircraft system (section 1825 of Pub. L. 118-31).
(2) Procedures. The Contractor shall search SAM for the FASC-maintained list of American Security Drone Act—covered foreign entities before proposing, or using in performance of the contract, any unmanned aircraft system. Also, the Contractor shall ensure any effort or expenditure associated with a FASC-prohibited unmanned aircraft system is consistent with a corresponding exemption, exception, or waiver determination expressly stated in the contract.
(3) Exemptions, exceptions, and waivers. The prohibitions in paragraph (c) of this clause do not apply where the agency has determined an exemption, exception, or waiver applies, and the contract indicates that such a determination has been made. See sections 1823 through 1825 and 1832 of Public Law 118-31 for statutory requirements pertaining to exemptions, exceptions, and waivers.
(d) Prohibition on using or providing specific products or services or conducting certain transactions regardless of connection to contract.
(1) Certain telecommunications and video surveillance equipment, systems, or services.
(i) Unless an applicable waiver has been issued by the Government, the Contractor cannot use any equipment, systems, or services that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system (paragraph (a)(1)(B) of section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232)).
(ii) This prohibition applies to using covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. This does not prohibit the contractor from using—
(A) A service that connects to the facilities of a third party, such as backhaul, roaming, or interconnection arrangements; or
(B) Telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.
(2) Office of Foreign Assets Control Restrictions.
(i) Except as authorized by the Office of Foreign Assets Control (OFAC) in the Department of the Treasury, the Contractor shall not acquire, for use in the performance of this contract, any supplies or services if any proclamation, Executive order, or statute administered by OFAC, or if OFAC’s implementing regulations at 31 CFR chapter V, would prohibit such a transaction by a person subject to the jurisdiction of the United States.
(ii) Except as authorized by OFAC, most transactions involving Cuba, Iran, and Sudan are prohibited, as are most imports from Burma or North Korea, into the United States or its outlying areas.
(A) For lists of entities and individuals subject to economic sanctions, see OFAC’s List of Specially Designated Nationals and Blocked Persons at https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists.
(B) For more information about these restrictions, as well as updates, see OFAC’s regulations at 31 CFR chapter V and at https://home.treasury.gov/policy-issues/office-of-foreign-assets-control-sanctions-programs-and-information.
(C) To conduct electronic screens of potential parties to regulated transactions, see the consolidated screening list at https://www.trade.gov/consolidated-screening-list, which consolidates multiple export screening lists of the Departments of Commerce, State, and the Treasury.
(3) Sudan prohibition. The Contractor is prohibited from conducting any restricted business operations in Sudan in accordance with Accountability and Divestment Act of 2007 (Pub. L. 110-174).
(4) Iran prohibitions.
(i) Unless an exception applies according to paragraph (d)(4)(iii) or the Government grants a waiver, the contractor shall not engage in certain activities or transactions relating to Iran (section 6(b)(1)(A) of Iran Sanctions Act (50 U.S.C. 1701 note).
(ii) Unless an exception applies according to paragraph (d)(4)(iii) or the Government grants a waiver, contractor shall not export certain sensitive technology to Iran, as determined by the President, and has an active exclusion in SAM (22 U.S.C. 8515).
(iii) The prohibition in paragraphs (d)(4)(i) and (d)(4)(ii) do not apply if the acquisition is subject to trade agreements and the offeror certifies that all the offered products are designated country end products or designated country construction material (see part 25).
(iv) Unless an exception applies or the Government grants a waiver, contractors are prohibited from knowingly engaging in any significant transaction (i.e., over $15,000) with Iran’s Revolutionary Guard Corps or any of its officials, agents, or affiliates, the property and interests in property of which are blocked according to the International Emergency Economic Powers Act (section 6(b)(1)(B) of Iran Sanctions Act (50 U.S.C. 1701 note)).
(e) Governmentwide exclusion and removal orders.
(1) Unless the Government has issued an applicable waiver, contractors shall not provide or use as part of the performance of the contract any covered article, or any products or services produced or provided by a source, if the covered article or the source is prohibited by an applicable FASCSA order as follows:
(i) For solicitations and contracts awarded by a Department of Defense contracting office, DoD FASCSA orders apply.
(ii) For all other solicitations and contracts, DHS FASCSA orders apply.
(2) The Contractor shall search for the phrase “FASCSA order” in the System for Award Management (SAM) at https://www.sam.gov to locate applicable FASCSA orders.
(3) The Government may identify in the solicitation other FASCSA orders that are not in SAM, which are effective and apply to the solicitation and resulting contract.
(4) A FASCSA order issued after the date of solicitation applies to this contract only if added by an amendment to the solicitation or modification to the contract (see FAR 40.204-1(c)).
(f)Reasonable inquiry. The contractor shall conduct a reasonable inquiry to determine if there are any prohibited products or services. The inquiry will look at any information in the entity’s possession but does not need to include an internal or third-party audit.
(g) Removal of prohibited products and services. For Federal Supply Schedules, Governmentwide acquisition contracts, multi-agency contracts or any other procurement instrument intended for use by multiple agencies, upon notification from the Contracting Officer, during the performance of the contract, the Contractor shall promptly make any necessary changes or modifications to remove any product or service produced or provided by a source that this clause prohibits.
(h) General report.
(1) If the Contractor identifies or is notified by any source, (including a subcontractor at any tier), that any product or service provided or used (or to be provided or used) during contract performance does not comply with any prohibition in this clause, then the Contractor shall report the following information, or as much information is known, in writing to the contracting office as identified in paragraph (h)(2) within 72 hours:
(i) Contract number and order number, if applicable;
(ii) The specific prohibition the product or service is not complying with;
(iii) A description of the products or services that the Contractor identifies or has reason to suspect is prohibited (include brand; model number, such as the original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable);
(iv) The entity that produced the product or service (include entity name, unique entity identifier, Contractor and Government Entity (CAGE) code, facilities responsible for design, fabrication, assembly, packaging, and test of the product, and whether the entity was the OEM or a distributor (provide manufacturer codes and distributor codes used for the product));
(v) Description of the functionality of the product or service and how that functionality impacts the risk to the product or service;
(vi) An explanation of any factors relevant to determining if the product or service…
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