RFP_36C10G25R0048.pdf

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

TBD

36C10G25R0048 08-06-2025

Trevor Mason Trevor.Mason@va.gov 08-21-2025

0900 EDT

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

X 100

X

334510

1250 Employees

N/A

X

Deliveries IAW each order

36C10G

U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

TBD

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section B.1 Contract Admin Data) Austin TX 78714-8917

1 (877) 489-6135

See CONTINUATION Page

Department of Veteran Affairs (VA), Veteran Health Administration (VHA), Equipment Life Cycle Management (ELCM)

Request for Proposal Requirements Contract: NX EQ Microwave Therapy Systems Tissu Ablation Period of Performance Effective date will be 14 or more days after award date.

Anticipated Award Date: TBD Base: 12-months Option Year 1: 12-months Option Year 2: 12-months Option Year 3: 12-months Option Year 4: 12-months

Questions Due: 08/12/2025 at 0900 EDT Bid Intentions Due: 08/15/2025 at 0900 EDT Proposal Due: See block 8 for due date and time.

See CONTINUATION Page

X X

Sara Vickroy Contracting Officer

36C10G25R0048 | NX EQ Microwave Therapy Systems Tissue Ablation Request for Proposal

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

B.2 CONTRACTOR REMITTANCE ADDRESS

B.3 INVOICES

B.4 GOVERNMENT INVOICE ADDRESS

B.5 FSC MANDATORY ELECTRONIC INVOICE SUBMISSION

B.6 REPORTS

B.7 TERMS AND CONDITIONS

B.8 ACKNOWLEDGMENT OF AMENDMENTS

B.9 PRICE/COST SCHEDULE

CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

All Contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C10G

Sara Vickroy U.S. Department of Veterans Affairs

Strategic Acquisition Center 10300 Spotsylvania Ave., Suite 400 Fredericksburg, VA 22408 Sara.Vickroy@va.gov

Contract Specialist 36C10G Trevor Mason U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave., Suite 400 Fredericksburg, VA 22408 Trevor.Mason@va.gov

Deputy Program Manager, ELCM

Annette Holland VHA Office of Supply Chain Department of Veterans Affairs Annette.Holland@va.gov

Contracting Officer Representative (COR), ELCM Robert Scott VHA Office of Supply Chain Department of Veterans Affairs Robert.Scott1@va.gov

B.2 CONTRACTOR REMITTANCE ADDRESS

All payments by the Government to the Contractor will be made in accordance with 52.232-33, Payment by Electronic Funds Transfer—System for Award Management.

B.3 INVOICES

Payment shall be submitted monthly in arrears based upon delivery, acceptance, and receipt of a properly prepared invoice within 30 days of delivery.

In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs mailto:Sara.Vickroy@va.gov mailto:Trevor.Mason@va.gov mailto:Annette.Holland@va.gov mailto:Robert.Scott1@va.gov

Financial Services Center (VAFSC). The contractor shall submit the invoice within 30 days of delivery.

B.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 Request.

B.5 FSC MANDATORY ELECTRONIC INVOICE SUBMISSION

Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Contracting POC: Trevor Mason (Contract Specialist); Sara Vickroy (Contracting Officer) COR (Contracting Officers Representative): Robert Scott Contract/Task Order Number:

a. Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

1. 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 begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

b. Vendor e-invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

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

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.x12.org/ mailto:VA.Registration@Tungsten-Network.com

3. FSC e-Invoice Contact Information: 1-877-353-9791

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

See https://www.fsc.va.gov/einvoice.asp for more information.

B.6 REPORTS

Monthly Report: In order for the contracting office to submit the required financial reporting on FPDS-NG the contractor needs to submit ATTACHMENT E –

REPORTING TOOL – NX EQ MICROWAVE THERAPY SYSTEMS TISSUE

ABLATION on a monthly basis to the Contract Specialist and Contracting Officer Representative. The report is due by the 5th of each month.

Quarterly Report: In addition to the monthly submission, the same ATTACHMENT E

– REPORTING TOOL – NX EQ MICROWAVE THERAPY SYSTEMS TISSUE

ABLATION needs to be submitted quarterly as outlined below.

In order to track compliance, VA requires the contractor to submit the quarterly report of sales in the approved format listed in ATTACHMENT E – REPORTING TOOL – NX EQ MICROWAVE THERAPY SYSTEMS TISSUE ABLATION based on the Governments fiscal calendar year. See below.

QUARTER PERIOD OF SALES SUBMISSION DUE DATE

1st October – December Due last day in February 2nd January – March May 31st 3rd April – June August 31st 4th July – September November 30th

The contractor agrees that they shall adhere to this requirement. The contractor shall provide a quarterly report, no later than 60 calendar days after the end of each fiscal quarter ending December, March, June, and September. Reports shall be sent electronically to the SAC Government points of contact until the contractor is notified, in writing, of a different point of contact.

a. Contracting Officer: Sara Vickroy

b. Contract Specialist: Trevor Mason

c. COR: Robert Scott

B.7 TERMS AND CONDITIONS

THE FOLLOWING TERMS AND CONDITIONS ARE MANDATORY

1. By establishing a contract, the Vendor agrees to supply established items(s) to satisfy the Government’s requirement when an order is place under the contract during the effective period of performance. If, however, the Vendor determines to terminate production of the selected item and contemplates replacement with an alternative item, the Government reserves the right to evaluate the potential replacement item(s). There is no guarantee that the Government will evaluate any replacement item(s) favorably. If the Government determines the mailto:vafsccshd@va.gov https://www.fsc.va.gov/einvoice.asp replacement item(s) as unacceptable, the individual item(s) or the entire contract may be canceled.

2. EXTENT OF OBLIGATION:

The Government is obligated only to the extent of authorized purchases made under the resultant contract. This contract does not obligate any funds, nor is the Government obligated to make any purchases under this contract. The Government does not guarantee any volume of purchases through a contract.

The terms and conditions included in this contract apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this contract and the contract holder’s invoice, the provisions of this contract will take precedence.

a. Uninterrupted Source of Supply - By establishing a contract, the Quoter agrees to supply established item(s) to satisfy the Government’s requirement when an order is placed under the contract during the effective period of the established contract. If the quoter decides to terminate production of the selected item and contemplates replacement with an alternative item; the Government reserves the right to evaluate the potential replacement item(s). There is no guarantee that the Government will evaluate any replacement item(s) favorably.

If the Government determines the replacement item(s) is unacceptable, the individual item(s) or the entire contract may be cancelled.

b. Inspection and Acceptance - The acceptance paragraph in FAR 52.212-4 is based upon the assumption that the Government will rely on the Contractor’s assurances that the commercial item tendered for acceptance conforms to the contract requirements. The Government inspection of commercial items will not prejudice its other rights under the acceptance paragraph. The provisions of FAR 52.212-4 are incorporated by reference.

3. PURCHASE/ORDERING LIMITATIONS:

Orders placed against this contract are limited to FAR Clause 52.216-19 Order Limitations, as noted in the contract. The estimated total quantities are listed on

ATTACHMENT A – PRICE COST SCHEDULE – NX EQ MICROWAVE

THERAPY SYSTEMS TISSUE ABLATION. The quantities provided are estimates only, and VA makes no guarantee regarding the actual quantities that may be purchased.

The Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program identified the Varian Medical Systems IntelliBlate™ Microwave Ablation System or Equal product line as a candidate for a VA-wide (otherwise referred to as “national”) single award Requirements contract. The Government's intent for this Requirements contract is to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required. The Government may through bilateral modification, add or remove items to this contract that are determined to be within scope of the solicited product line, not limited to the original items awarded. Additionally, any discontinued items may be replaced via future contract modification by the replacement part identified by the

OEM, so long as the replacement part serves the same clinical purpose and function as the originally awarded item. Furthermore, any new technology that is presented during the performance of this contract may be evaluated by the Government for inclusion into the contract, via bilateral modification. This new technology must be determined to be within scope of the original contract.

4. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE CONTRACT:

This is a Strategic Acquisition Center (SAC) decentralized contract. Orders are placed by VA Government Ordering Officer (OO) in accordance with the terms and conditions of the specific contract identified in the OO appointment memorandum approved by a SAC Contracting Officer. OOs may only place orders for those contracts that are specifically appointed. Ordering Officers are responsible for issuing and administering orders placed under this contract.

Ordering Officers may revise or modify their orders, but only within the scope of this contract. Ordering Officers have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the SAC Contracting Officer responsible for this contract. Orders placed only by designated VHA ELCM Ordering Officers shall be submitted on a fully funded and completed Delivery Order. No orders shall be placed without first obtaining approved funding from a VA facility. Requesting Facility submits order requests through the NEC Order Portal ELCM NEC Ordering Portal - Power Apps for verification. Questions may be submitted to the VHAELCM OO Team via email at vaelcmnxeqorderingofficer@va.gov.

The Contractor shall accept orders against this contract only from the designated VHA ELCM OO when the Delivery Order has been reviewed by the OO for this contract. Fulfilling orders from persons other than the approved Ordering Officer may result in loss or delay in payment for supplies/services provided under such orders. When a Contracting Officer appoints an Ordering Officer in writing after award, the Contracting Officer will furnish the contractor with an updated list of individual Ordering Officers authorized to place orders against the contract.

Contractor will acknowledge receipt of any order submitted by an individual Ordering Officer specified by appointment against the contract.

5. DELIVERY TICKETS:

The following provisions apply to all shipments:

Inspection: Destination Acceptance: Destination Shipping: FOB Destination Ship To and Mark For: Deliveries shall be marked and shipped to various VHA locations identified in each order placed against the contract.

All shipments, either single or multiple container deliveries, shall bear and contain them on the delivery tickets or sales slips (external shipping labels and associated manifests or packing lists) the following at a minimum:

(i) Name of supplier;

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fapps.gov.powerapps.us%2Fplay%2Fe%2Fdefault-e95f1b23-abaf-45ee-821d-b7ab251ab3bf%2Fa%2Ff5a4b923-8e9a-4db8-85d0-d00eb0ca1d07%3FtenantId%3De95f1b23-abaf-45ee-821d-b7ab251ab3bf%26hint%3D4065f86d-3290-468a-93da-5e182e642f3e%26sourcetime%3D1707251534292&data=05%7C02%7C%7C99f912a006124f21351308dc58a3cca1%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638482707742636597%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=PIgCdabLBHhw9mDSlAWIbA06V9opReZU4rMUVyIHB4Y%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fapps.gov.powerapps.us%2Fplay%2Fe%2Fdefault-e95f1b23-abaf-45ee-821d-b7ab251ab3bf%2Fa%2Ff5a4b923-8e9a-4db8-85d0-d00eb0ca1d07%3FtenantId%3De95f1b23-abaf-45ee-821d-b7ab251ab3bf%26hint%3D4065f86d-3290-468a-93da-5e182e642f3e%26sourcetime%3D1707251534292&data=05%7C02%7C%7C99f912a006124f21351308dc58a3cca1%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638482707742636597%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=PIgCdabLBHhw9mDSlAWIbA06V9opReZU4rMUVyIHB4Y%3D&reserved=0 mailto:vaelcmnxeqorderingofficer@va.gov

(ii) Contract/Delivery Order/Task Order number;

(iii) Date of purchase;

(iv) Contract number;

(v) Itemized list of supplies or services furnished; and

(vi) Quantity, unit price, and extension of each item, less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided the invoice is itemized to show this information).

(vii) Date of delivery or shipment

In the case of multiple container deliveries, a statement readable near the VA Order number will indicate total number of containers for the complete shipment

(ex. “Package 1 of 2”), clearly readable on manifests and external shipping labels.

The Contractor shall provide an order confirmation within four (4) working days of receipt of the delivery order.

The Contractor will provide tracking information or use of a website to obtain delivery status and proof of delivery.

The After Receipt of Order (ARO) is defined as the established number of days from Contractor’s receipt of order date to the line-item delivery date. The Contractor ARO is # days.

Packing Slips/Labels and Lists shall include the following:

IFCAP PO # ____________ (i.e., 166-E11234) Total number of Containers: Package ___ of ___. (i.e., Package 1 of 3)

B.8 ACKNOWLEDGMENT OF AMENDMENTS

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

AMENDMENT NO DATE

B.9 PRICE/COST SCHEDULE

This is a nationwide Department of Veterans Affairs Requirements Contract for the procurement of the Varian Medical Systems IntelliBlate™ Microwave Ablation System or Equal, to include accessories, consumables, installation, training, proctoring services, annual warranty and maintenance services, in accordance with ATTACHMENT B -

PRODUCT DESCRIPTION - NX EQ MICROWAVE THERAPY SYSTEMS TISSUE

ABLATION. The quantity delivered will be dependent on the numbers ordered by the VA Medical Centers.

ATTACHMENT A - PRICE COST SCHEDULE - NX EQ MICROWAVE THERAPY

SYSTEMS TISSUE ABLATION shall be updated, as applicable, to capture all current items for sale, their respective price, as well as the imbedded 3% SLA fee, and shipping. Currently, the shipping fee for Instruments and Accessories is capped at $25.00 per item through any qualified third-party carrier. Any pricing which is rounded down in the VA’s favor shall be identified. The standard Government CLIN structure lists items sequentially, and each option period is generally designated with the first digit as corresponding to that option period. The Contractor will provide literature for each CLIN listed in Attachment A with Technical Specifications, Product Brochure, and Color Swatch (if applicable) at no additional cost prior to the contract effective date.

INSTALLATION

At no additional cost, and as configured at the time of acquisition, Customer will be entitled to the installation and setup of the Microwave Therapy Systems Tissue Ablation and all associated accessories and software for the system’s intended purpose(s) by manufacturer trained/authorized personnel. Installation and setup shall include the assembly/installation of all hardware components configured per end user preferences, customized setup of applicable Patient Monitoring Systems, training and education for Clinical staff on the operational use and end user maintenance of the overall system, technical training and education for Biomedical Engineers on the operational use and any intermediate/advanced maintenance of the overall system, as well as data integration setup (to include when/if VA Facilities have met all VA Directive and Handbook 6500 Information Security requirements/approvals for the heart-lung bypass unit(s) to securely transmit and receive data across the VA network).

SOFTWARE INSTALLATION AND UPDATES

The Contractor grants to VA non-exclusive, non-transferrable licenses to use the Microwave Therapy Systems Tissue Ablation and all associated accessories and software, including any documentation, for the system’s intended purposes. At no additional cost, Customer will be entitled to Software updates when such updates are made generally available without cost to other licensees of the software. The Contractor shall coordinate the installation of any software upgrades with designated facility POC and Biomedical Engineer.

MAINTENANCE, REPAIRS AND REPLACEMENT

Preventative Maintenance will be performed as prescribed by the manufacturer’s specifications. Maintenance, repairs, and replacement will be performed by authorized technicians and will be coordinated through the designated facility POC and Biomedical Engineer. At the time of installation, and/or for any reoccurring onsite visit(s) to perform preventative maintenance, repairs, replacement, etc., the Contractor must comply with all local policies to gain access to individual VA Medical Centers.

PRODUCT REFRESH

Product refresh is when a current CLIN is no longer being manufactured due to obsolescence and the product item is being replaced with a newer, and more often, a superior version of the same item. The current CLIN product will be revised to reflect the refreshed product information, manufacturer’s part number, IDIQ price (inclusive of Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under product refresh. The contractor will be notified in writing if a product refresh is not accepted. All products offered shall be provided with the warranty that is agreed upon for this contract. The contractor agrees to ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements, see attachment 5.

The contractor shall provide the COR and CO the following information for product refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee));

(2) Product literature for the item(s) refreshed;

(3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added;

(4) Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded;

(5) FDA approval, if applicable;

(6) Provide historical sales to VA by item(s), if applicable; and

(7) Copy of Commercial Warranty

The request shall be submitted to the COR, copy to the Contract Specialist and Contract Officer, for review and recommendation of approval to be submitted to the CO.

The CO shall prepare a bilateral modification for execution.

PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer shall resolve any defects or potential dangers by repairing or replacing the product at no cost to the government. The manufacturer agrees to take following steps immediately:

Notify the Contracting Officer (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to CO, Contracting Specialist, Contracting Officer Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an issuance on the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective action.

A copy of the notification will be provided to:

Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106

System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

1. ATTACHMENT A - PRICE COST SCHEDULE - NX EQ Microwave Therapy

Systems Tissue Ablation

2. ATTACHMENT B - PRODUCT DESCRIPTION - NX EQ Microwave Therapy

Systems Tissue Ablation

3. ATTACHMENT C - CONTRACT CLAUSES - NX EQ Microwave Therapy

Systems Tissue Ablation

4. ATTACHMENT E -QUARTERLY SALES REPORTING TOOL - NX EQ

Microwave Therapy Systems Tissue Ablation

5. ATTACHMENT F - PAST PERFORMANCE QUESTIONNAIRE - NX EQ

Microwave Therapy Systems Tissue Ablation

6. ATTACHMENT G - PAST PERFORMANCE REFERENCE - NX EQ Microwave

Therapy Systems Tissue Ablation

CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS