36C26126Q0824_2.docx

36C26126Q0824

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

36C261-26-AP-4045

640-26-3-163-0239 36C26126Q0824 08-05-2026 Tawnya Krommenhoek tawnya.krommenhoek@va.gov 08-07-2026

10AM

MDT

36C261 Department of Veterans Affairs Network Contracting Office 21

X 339112 1000 Employees N/A X See Delivery Schedule

36C261 Department of Veterans Affairs Network Contracting Office 21

Financial Services Center P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page VA Palo Alto Health Care System Pneumatic Bone Punch System ** See Schedule of Supplies for full description ** This RFQ is a Sole Source Procurement to Trillamed, LLC for the procurement of Pneumatic Bone Punch System IAW RFO 6.103-1. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency.

Quotation shall be submitted to Tawnya Krommenhoek, Contracting Officer, by the date/time listed in box 8.

tawnya.krommenhoek@va.gov See CONTINUATION Page X X Tawnya Krommenhoek

VA-VHA-RPOW-2025-0057

Table of Contents

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: Contracting Officer 36C261 Tawnya Krommenhoek

Network Contracting Office 21

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

3. INVOICES: Invoices shall be submitted in arrears:

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:

All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. VA's Electronic Invoice Presentment and Payment System - The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to register and begin submitting electronic invoices, free of charge. The Department of Veterans Affairs Tungsten Number is: AAA544240062 (this allows you to file invoices online for free.)

More information on the VA Financial Services Center is available at:

http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

KAIRISON PNEUM. PUNCH HANDLE

Contract Period: Base POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK899R

LOCAL STOCK NUMBER: FK899R

KAIRISON PNEUM. PUNCH PRESSURE REDUCER

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK898R

LOCAL STOCK NUMBER: FK898R

KAIRISON SHAFT DET.UP 235MM 2MM

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK882R

LOCAL STOCK NUMBER: FK882R

KAIRISON SHAFT DET.UP 235MM 3MM

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK883R

LOCAL STOCK NUMBER: FK883R

KAIRISON SHAFT DET.UP 235MM 4MM

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK884R

LOCAL STOCK NUMBER: FK884R

KAIRISON SHAFT DET.UP 235MM 5MM

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK885R

LOCAL STOCK NUMBER: FK885R

KAIRISON SHAFT DET.UP 285MM 2MM

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK892R

LOCAL STOCK NUMBER: FK892R

KAIRISON SHAFT DET.UP 285MM 3MM

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK893R

LOCAL STOCK NUMBER: FK893R

KAIRISON SHAFT DET.UP 285MM 4MM

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK894R

LOCAL STOCK NUMBER: FK894R

KAIRISON SHAFT DET.UP 285MM 5MM

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK895R

LOCAL STOCK NUMBER: FK895R

AIR HOSE 5.0M SCHRADER/AESCULAP LARGE

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): GA468R

LOCAL STOCK NUMBER: GA468R

STERILIT POWER SYSTEMS OIL SPRAY- 6 per carton

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): GB600

LOCAL STOCK NUMBER: GB600

KAIRISON WIRE BASKET

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK881R

LOCAL STOCK NUMBER: FK881R

WIRE BASKET FOR KAIRISON SHAFTS

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK891R

LOCAL STOCK NUMBER: FK891R

COPPER CAP FOR COMPRESSED AIR SUPPLY

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK898214

LOCAL STOCK NUMBER: FK898214

SEALING CAP WITH VENT

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK898215

LOCAL STOCK NUMBER: FK898215

BOTTOM FOR 3/4 CONTAINER HEIGHT:120MM

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): JK741

LOCAL STOCK NUMBER: JK741

3/4-SIZE LID W/RETENTION PLATE SILVER

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): JK789

LOCAL STOCK NUMBER: JK789

KAIRISON DISPOSABLE TUBES

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK888SU

LOCAL STOCK NUMBER: FK888SU

KAIRISON PUNCH BRACKET PRESSURE REDUCER

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): FK887R

LOCAL STOCK NUMBER: FK887R

Installation / Training

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies MANUFACTURER PART NUMBER (MPN): Installation, Training LOCAL STOCK NUMBER: Installation, Training

Warranty

POP Begin: 08-17-2026 POP End: 10-16-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies MANUFACTURER PART NUMBER (MPN): Warranty LOCAL STOCK NUMBER: Warranty

B.3 DELIVERY SCHEDULE

VA Palo Alto Health Care System 3801 Miranda Ave Palo Alto, CA 94304 1207

USA

B.4 STATEMENT OF WORK

STATEMENT OF WORK (SOW)

VA Palo Alto Health Care System Aesculap KAIRISON Pneumatic Bone Punch System

1.0 PURPOSE

The purpose of this procurement is to request to acquire one (1) Aesculap KAIRISON pneumatic bone punch system, including pneumatic handles, detachable shafts, pressure reducers, air hoses, storage baskets, container components, and accessories, for use at VA Palo Alto Health Care System (VAPAHCS). The system is required to support neurosurgical procedures, including spinal decompressions, by providing an efficient, pneumatically powered Kerrison‑type bone punch to remove bone, cartilage, and tissue while reducing surgeon fatigue and maintaining decompression quality.

2.0 SCOPE OF WORK

The Contractor shall furnish one (1) complete KAIRISON pneumatic bone punch system, including all labor, supervision, tools, materials, transportation, delivery coordination, setup, operational verification, training, and documentation required to deliver and prepare the system for clinical use at VAPAHCS. The scope includes KAIRISON pneumatic punch handles, pressure reducers, detachable shafts in multiple sizes and lengths, compressed‑air hose and fittings, wire baskets, sterilization container components, single‑use tube set, and maintenance oil spray as identified in the awarded vendor quotation.

3.0 DELIVERABLES

The Contractor shall furnish the following:

· Two (2) KAIRISON Pneumatic Punch Handles, Part Number FK899R

· Two (2) KAIRISON Pneumatic Punch Pressure Reducers, Part Number FK898R

· Two (2) KAIRISON Shaft Detachable Up 235 mm x 2 mm, Part Number FK882R

· Two (2) KAIRISON Shaft Detachable Up 235 mm x 3 mm, Part Number FK883R

· Two (2) KAIRISON Shaft Detachable Up 235 mm x 4 mm, Part Number FK884R

· Two (2) KAIRISON Shaft Detachable Up 235 mm x 5 mm, Part Number FK885R

· Two (2) KAIRISON Shaft Detachable Up 285 mm x 2 mm, Part Number FK892R

· Two (2) KAIRISON Shaft Detachable Up 285 mm x 3 mm, Part Number FK893R

· Two (2) KAIRISON Shaft Detachable Up 285 mm x 4 mm, Part Number FK894R

· Two (2) KAIRISON Shaft Detachable Up 285 mm x 5 mm, Part Number FK895R

· Two (2) Air Hose 5.0 m, Schrader / Aesculap large, Part Number GA468R

· Two (2) STERILIT Power Systems Oil Spray, 6 per carton, Part Number GB600

· Two (2) KAIRISON Wire Basket, Part Number FK881R

· Two (2) Wire Basket for KAIRISON Shafts, Part Number FK891R

· Four (4) Copper Cap for Compressed Air Supply, Part Number FK898214

· Four (4) Sealing Cap with Vent, Part Number FK898215

· Two (2) 3/4‑size Container Bottom 120 mm, Part Number JK741

· Two (2) 3/4‑size Lid with Retention Plate, Silver, Part Number JK789

· One (1) KAIRISON Disposable Tube Set, Part Number FK888SU

· Installation / Training

· OEM Warranty

4.0 PERIOD OF PERFORMANCE

The period of performance begins upon award and continues through equipment delivery, installation, training, and acceptance. Expected completion is within 30 calendar days after receipt of order (ARO), subject to the manufacturer’s stated lead time.

5.0 ROLES AND RESPONSIBILITIES

· Contractor: Delivery, setup and assembly of the KAIRISON system, operational verification with compressed air, basic user training, documentation, and warranty support.

· Contracting Officer’s Representative (COR): Oversight, scheduling, and acceptance verification.

· Biomedical Engineering: Equipment inspection, incoming safety testing as applicable, verification of compatibility with existing compressed‑air infrastructure, and technical approval.

· Clinical Service (Neurosurgery / OR): Confirm workflow requirements, identify end users, and coordinate training schedules.

6.0 ACCEPTANCE CRITERIA

Final acceptance requires:

· Delivery of all items in new, unused condition that match the awarded quotation and meet salient characteristics.

· Successful Biomedical Engineering inspection and any required safety checks.

· Successful operational verification of the KAIRISON pneumatic bone punch with compressed air, demonstrating proper function of handles, shafts, and safety features (safety switch, locking slider, trigger action, and bone ejection).

· Completion of user training for designated neurosurgical and operating room staff (basic operation, safety, and care/handling).

· Receipt of all required documentation (instructions for use, technical specifications, warranty certificates, and any installation/verification reports).

7.0 POINT OF CONTACT (POC)

ADMINISTRATIVE POC:

Service: Surgical Service Facility: VA Palo Alto Health Care System (VAPAHCS) Email:

CLINICAL POC:

Service: OR Clinical Resources Nurse Facility: VA Palo Alto Health Care System (VAPAHCS) Email:

8.0 EQUIPMENT DESCRIPTION

The equipment shall be new and unused and shall consist of an Aesculap KAIRISON pneumatic bone punch system including pneumatic handles, detachable shafts in multiple sizes, pressure reducers, compressed‑air hose, storage baskets, container components, single‑use tube set, and maintenance oil. The system shall provide a pneumatically powered Kerrison‑type bone punch for removal of bone, cartilage, and tissue in neurosurgical procedures, particularly spinal decompression surgeries, in order to maintain procedural efficiency and reduce surgeon fatigue.

9.0 PERFORMANCE REQUIREMENTS

The system shall:

· Operate using compressed air or compressed nitrogen via manufacturer‑approved connectors, with nominal operating pressure approximately 8 bar and minimum operating pressure of at least 7 bar to ensure full cutting performance.

· Provide controlled, repeatable punching of bone and tissue via the KAIRISON pneumatic punch handle, with a two‑step actuation (positioning and punching) or single‑step punch using the trigger/actuator lever, and an integrated bone ejector mechanism in the shaft.

· Include detachable shafts in 2–5 mm diameters and 235 mm / 285 mm lengths to accommodate various neurosurgical approaches and working depths.

· Incorporate safety features including a safety switch to lock the trigger, shaft locking mechanism, and shaft release/locking slider as described in the manufacturer instructions for use.

· Be suitable for operating room use and meet all manufacturer operational, mechanical, and safety requirements, including sterilization and reprocessing requirements for reusable components and single‑use labeling for the disposable tube set.

· Include all accessories necessary for full functionality as intended in the manufacturer’s user manual and technical specifications.

10.0 DELIVERY AND RECEIVING

Contractors must communicate deliveries and provide 120 hours’ advance notice of any changes.

All deliveries, shipments, and vendor packages shall be made to the Supply Chain Services Warehouse, building 50, Palo Alto Division (PAD), 3801 Miranda Avenue, Palo Alto, CA 94304, unless otherwise directed. The contractor shall provide an estimated delivery date/time and tracking information prior to shipment.

Contractors using their own logistics personnel must review the VAPAHCS campus map to ensure delivery to the correct division. Coordination and communication shall include the Contracting Officer (CO), the requesting Service point of contact(s), and the Warehouse team email.

Delivery shall occur during normal dock business hours:

7:30 AM to 2:30 PM Pacific Time, Monday through Friday, excluding Federal Holidays.

Warehouse main line: 650-493-5000, extension 65300.

The final installation shall occur in Building 100 Operating Room.

11.0 DOCUMENTATION AND SUBMITTALS

The Contractor shall provide:

· Manufacturer instructions for use (IFU) for the KAIRISON pneumatic bone punch, shafts, pressure reducers, and accessories.

· Technical specifications, including operating pressure, materials, and reprocessing instructions.

· Warranty documents and service contact information.

· A brief functional verification/installation report summarizing setup and operational checks.

12.0 COMPLIANCE REQUIREMENTS

The Contractor shall comply with all applicable federal regulations, FDA requirements, VA safety protocols, infection control standards, and manufacturer installation and reprocessing standards for surgical instruments and pneumatic systems.

13.0 SERVICES

The Contractor shall:

· Deliver the KAIRISON system and all listed components.

· Perform initial setup and assembly, including connection to facility compressed‑air outlets where applicable.

· Provide basic user training for clinical staff on safe operation and care of the KAIRISON system.

· Remove and dispose of all shipping and packing materials from VA premises

14.0 WARRANTY

A minimum 12‑month manufacturer warranty covering parts and labor for the KAIRISON pneumatic bone punch system is required. Any additional warranty coverage offered in the vendor quotation shall be clearly documented and honored, including terms for repair or replacement of defective components.

15.0 HOURS OF OPERATION

Normal business hours: 0730–1630, Monday–Friday, excluding Federal Holidays.

16.0 PROTECTION OF PROPERTY

The Contractor shall protect VA property and repair any damage caused during delivery or installation.

17.0 SECURITY REQUIREMENTS

Contractor personnel shall comply with VA security and identification requirements. The equipment does not connect to VA networks; no cybersecurity documentation is required.

18.0 VA (REQUESTOR’S) RESPONSIBILITIES

· Provide access to delivery and installation areas.

· Coordinate escorting of Contractor personnel if required.

· Ensure availability of appropriate compressed‑air and electrical infrastructure in the installation area.

· Provide final acceptance through VA Biomedical Engineering Services and the requesting clinical service

19.0 GOVERNMENT-FURNISHED PROPERTY (GFP)

No Government‑Furnished Property will be provided to the contractor.

Based upon a review of the PWS/SOW and Appendix A as presented, the contractor will not have access to VA sensitive information or PII/PHI to fulfill the terms of the contract. A BAA will not be required. Please contact the V21PALPrivacyoffice@va.gov with any questions.

36C26126Q0824 (END of SOW) Page 1 of Page 1 of

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):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.2 52.212-4 CONTRACT 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 accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(d) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(e) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause FAR 52.233-1, Disputes, which is incorporated in this contract by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence. Examples of occurrences include acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. When an excusable delay occurs, the Contractor shall—

(1) Notify the Contracting Officer in writing as soon as possible;

(2) Remedy the delay as quickly as possible; and

(3) Notify the Contracting Officer when the occurrence is over.

(g) Invoice. The Government will handle invoices according to the Prompt Payment Act (31 U.S.C. 3903) and 5 CFR part 1315. The Contractor shall submit invoices to the address designated in the contract to receive invoices. An invoice must include the information required by 5 CFR part 1315.9(b).

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees, and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark, or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date that appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(4) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable;

(D) Contractor point of contact; and

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(5) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by FAR part 33 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see FAR part 32).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a termination for cause.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on-

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures for interest credits prescribed in FAR part 32 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon—

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. The Government will send a cure notice to the Contractor, unless the reason for the termination is late delivery. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered under this contract are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Government-financed air transportation; and 41 U.S.C. chapter 21 relating to procurement integrity.

(r) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Disputes, Payments, Invoice, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) Other contract clauses incorporated in the solicitation or contract;

(4) Addenda to this solicitation or contract,

(5) Solicitation provisions incorporated in the solicitation.

(6) Other paragraphs of this clause.

(7) Other documents, exhibits, and attachments; and

(8) The specification.

(s) Unauthorized obligations.

(1) Except as stated in paragraph (s)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government 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:

(i) Any such clause is unenforceable against the Government.

(ii) 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 EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or 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.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (s)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(t) Comptroller General examination of record. This paragraph applies if this contract was awarded using other than sealed bid procedures and is in excess of the simplified acquisition threshold on the date of award of this contract.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices, at all reasonable times, the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR part 4, longer period required by statute, or periods specified in other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This clause does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(u) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) 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.3 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS (DEVIATION APR 2026) (a)Definitions. As used in this clause— Program participation means membership or participation in, or access or admission to: training, mentoring, or leadership development programs; educational opportunities; clubs; associations; or similar opportunities that are sponsored or established by the contractor or subcontractor.

Racially discriminatory diversity, equity, and inclusion (DEI) activities means disparate treatment based on race or ethnicity in the recruitment, employment (e.g., hiring, promotions), contracting (e.g., vendor agreements), program participation, or allocation or deployment of an entity's resources.

(b) In connection with the performance of work under this contract, the Contractor agrees as follows:

(1) The Contractor will not engage in any racially discriminatory DEI activities;

(2) The Contractor will furnish all information and reports, including providing access to books, records, and accounts, as required by the Contracting Officer, for purposes of ascertaining compliance with this clause;

(3) In the event of the Contractor's or a subcontractor's noncompliance with this clause, this contract may be canceled, terminated, or suspended in whole or in part, and the Contractor or subcontractor may be declared ineligible for further Government contracts;

(4) The Contractor will report any subcontractor's known or reasonably knowable conduct that may violate this clause to the Contracting Officer and take any appropriate remedial actions directed by the Contracting Officer; and

(5) The Contractor will inform the Contracting Officer if a subcontractor sues the Contractor and the suit puts at issue, in any way, the validity of this clause.

(6) The Contractor recognizes that compliance with the requirements of this clause are material to the Government's payment decisions for purposes of 31 U.S.C. 3729(b)(4).

(c) The Contractor must include the substance of this clause, including this paragraph (c), in subcontracts at any tier, including those for commercial products and commercial services, except those where the place of delivery or performance is outside the United States.

(End of Clause)

C.4 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.