S02 36C25625Q1423-Zimmer ROSA INOMED Frame 08-28-25.pdf

A.1 COMBINE SYNOPSIS SOLICITATION

Solicitation Number: 36C25625Q1423

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, in conjunction with FAR Part 13

Simplified Acquisition Procedures for Certain Commercial Items as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation will not be issued.

2. This solicitation document incorporates provisions and clauses are those in effect through Deviations

JUL 2025 (eff. 07/11/2025) VAAR DEVIATION APR 2025 (eff. 04/01/2025) VAAM Alert 24-10 (eff.

04/09/2024) Acquisition Policy Flash 25-12 eff. 07/11/2025)

3. This requirement is solicited as total small business setaside The North American Industry

Classification System number is 339112 with a size standard in number of 1000

4. Place of Performance: Michael E. DeBakey VAMC located in Houston, TX. 77030.

5. Period of Performance: Five Days (5) Days after receipt of order (ARO).

6. All questions regarding this solicitation shall be submitted via email to Anthony Marion at anthony.marion2@va.gov no later than 10:00am. Central Standard Time on 9/02/2025.

7. Quotes are due no later than 9/04/2025 at 10:00am (CST) and shall be submitted electronically via e-mail to anthony.marion2@va.gov.

The following provisions apply to this acquisition:

The provision at 52.212-1 Introduction to Offerors – Commercial, applies to this acquisition.

The provision at 52.212-2 ADDENDUM, EVALUATION – COMMERCIAL ITEMS (Nov

2021) apply to this acquisition.

All offers shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications –Commercial Items.

The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition and a statement. The addendum to FAR 52.212-4 also applies to this acquisition.

The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or

Executive Orders – Commercial Items, applies to this acquisition and all additional FAR clauses cited in the clause are applicable to the acquisition.

Addendum to FAR 52.212-4 shows FAR clauses followed by VAAR clauses in numeric order.

Solicitation contains a list of all clauses incorporated by reference in numeric order under

52.252-2 (see below), starting first with FAR and followed by VAAR.

mailto:anthony.marion2@va.gov

36C25625Q1423

Table of Contents

A.1 COMBINE SYNOPSIS SOLICITATION

SECTION B - CONTINUATION OF COMBINE SYNOPSIS SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 SCOPE OF WORK (SOW)

SECTION C - CONTRACT CLAUSES

C.1 52.225-1 BUY AMERICAN—SUPPLIES (OCT 2022)

C.2 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 FAR 52.212-1 ADDENDUM, INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.225-2 BUY AMERICAN CERTIFICATE (OCT 2022)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION FEB 2025)

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 36C256 Anthony Marion

Department of Veterans Affairs

Network Contracting Office 16

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [x] After Delivery and Acceptance

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.

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp

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/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

The contractor shall provide all shipping and delivery for two Zimmer

Biomet INOMED head frames or equal that is also compatible with

MEDVAMCs’ own Robotic Stereotactic Assistance (ROSA) one brain system, which is manufactured by Zimmer Biomet Inc (ZBI). The

INOMED or equal ceramic stereotactic head frame shall provide surgeons the following but are not limited to a complete solution for stereotactic procedures. The INOMED or equal stereotactic system shall be particularly beneficial during imaging procedures similar to magnetic resonance imaging (MRI) due to its ability to minimize imaging artifacts.

The INOMED head frames or equal shall have a semi-open design of the ceramic head ring that improves patient comfort, especially during awake brain surgeries and have the center-of-arc principle and allow for nearly unlimited access to intracranial regions with precise targeting capabilities.

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

0001AA

2.00 EA __________________ __________________

Titanium Head Ring Kit

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803004

0001AB

1.00 EA __________________ __________________

Fixing Posts M

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803223

0001AC

Fixings Posts XL

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803225

0001AD

Carrier for head fixing posts

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803226

0001AE

Opti pin fixing pin 40mm

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803362

0001AF

Opti pin fixing pin 50mm

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803363

0001AG

Opti pin fixing pin 60mm

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803364

0001AH

Opti pin fixing pin 70mm

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803365

0001AJ

3.00 EA __________________ __________________

Socket Wrench

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803405

0001AK

Sterilization Tray

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803940

0001AL

Opti pin fixing pin 30mm

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803361

0001AM

Torque Wrench 70 Ncm

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803340

0001AN

HeadRing Holder for Mayfield

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 809101

0001AP

Imaging Markers Short (4)

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803012

0001AQ

Imaging Markers Long (4)

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument

Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, MANUFACTURER PART NUMBER (MPN): 803013

GRAND TOTAL __________________

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001 SHIP

TO:

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston, TX 77030

USA

5 Days ARO

MARK

FOR:

Thomas Hewett/Lesley Ramirez

(254) 285-4347/(713) 794-7931

Thomas.Hewett@va.gov>/Lesley.Ramirez@va.gov

FOB: DESTINATION

0001AA SHIP

TO:

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

2.00 5 Days ARO

MARK

FOR:

Thomas Hewett/Lesley Ramirez

0001AB SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

1.00 5 Days ARO

FOR:

Thomas Hewett/Lesley Ramirez

0001AC SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AD SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AE SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AF SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AG SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AH SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AJ SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

3.00 5 Days ARO

FOR:

Thomas Hewett/Lesley Ramirez

0001AK SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AL SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AM SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AN SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AP SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

0001AQ SHIP

Michael E.DeBakey VA Medical Center

2002 Holcombe Boulevard

FOR:

Thomas Hewett/Lesley Ramirez

B.4 SCOPE OF WORK (SOW)

SCOPE OF WORK AND GENERAL SPECIFICATIONS

FOR Zimmer Biomet Intraoperative Neuromonitoring (INOMED) Head Frame

1. Background: The Michael E. DeBakey VA Medical Center (MEDVAMC) is currently requesting the acquisition of the Zimmer Biomet INOMED head frame. The INOMED ceramic stereotactic headframe provides surgeons with a more complete solution for stereotactic procedures, particularly when using the ROSA One Brain system manufactured by Zimmer

Biomet (ZB). The INOMED stereotactic system is particularly beneficial during imaging procedures like MRI due to its ability to minimize imaging artifacts. The semi-open design of the ceramic head ring improves patient comfort, especially during awake brain surgeries and based on the center-of-arc principle, allows for nearly unlimited access to intracranial regions with precise targeting capabilities.

2. Project Scope: Contractor shall provide all shipping and delivery for two Zimmer Biomet

INOMED head frames or equal that is compatible with MEDVAMCs’ owned Robotic

Stereotactic Assistance (ROSA) one brain system, which is manufactured by Zimmer Biomet

Inc (ZBI). The INOMED or equal ceramic stereotactic head frame shall provide surgeons the following but are not limited to a complete solution for stereotactic procedures. The

INOMED or equal stereotactic system shall be particularly beneficial during imaging procedures similar to magnetic resonance imaging (MRI) due to its ability to minimize imaging artifacts. The INOMED head frames or equal shall have a semi-open design of the ceramic head ring that improves patient comfort, especially during awake brain surgeries and have the center-of-arc principle and allow for nearly unlimited access to intracranial regions with precise targeting capabilities.

3. The following salient characteristics include, but are not limited to the following:

• Center-of-arc principle: This feature ensures that the target point within the brain remains constant, even if the entry point on the skull is changed. This allows surgeons to choose the safest, most effective trajectory.

• Sub-millimeter accuracy: High precision features like Vernier scales and fine adjustment controls. This level of accuracy is critical for minimally invasive procedures like deep brain stimulation (DBS).

• Verification with simulator: A target point simulator used to verify the coordinates and settings before surgery, providing an additional safety check.

Imaging compatibility

• Artifact-free materials: Inomed offers head rings made from radiolucent materials, including titanium and ceramic. These materials are transparent to X-rays and do not produce artifacts in CT or MRI scans, ensuring clear and accurate imaging.

• Comprehensive imaging support: The frames are compatible with all standard imaging modalities used in functional neurosurgery.

• Specialized localization sets: These sets, designed for both titanium and ceramic rings, feature V-shaped fiducials that prevent movement during the planning phase, ensuring precise registration.

Adaptable and stable design

• Customizable fixation: Can be attached to a patient's head at various positions and angles, with options for different pin lengths and head sizes. This provides superior access to different brain regions, including the posterior fossa.

• Flexible mounting: 1-point fixation that makes mounting easy and flexible for the surgical team.

Integration and versatility

• Modular design: The system is modular, accommodating a wide range of diagnostic and therapeutic stereotactic procedures, such as DBS, biopsy, and neuromodulation.

• Accessory compatibility: Inomed head frames can be used with a variety of accessories, including the MicroDrive for microelectrode recordings.

• Integrates into the current ROSA Surgical Robot equipment, which is in use in the operating room (OR).

4. Product description, part number and Quantity government requires include but are not limited to the following:

Description Part Number QTY

1. Titanium Head Ring Kit 803004 2 EA

2. Fixing Posts M 803223 1 EA

3. Fixings Posts XL 803225 1 EA

4. Carrier for head fixing posts 803226 2 EA

5. Opti pin fixing pin 40mm 803362 1 EA

6 Opti pin fixing pin 50mm 803363 1 EA

7 Opti pin fixing pin 60mm 803364 1 EA

8. Opti pin fixing pin 70mm 803365 1 EA

9. Socket Wrench 803405 3 EA

10 Sterilization Tray 803940 2 EA

11 Opti pin fixing pin 30mm 803361 3 EA

12. Torque Wrench 70 Ncm 803340 3 EA

13. HeadRing Holder for Mayfield 809101 2 EA

14. Imaging Markers Short (4) 803012 3 EA

15. Imaging Markers Long (4) 803013 3 EA

5. Supply/Product Manual: Contractor shall provide current operating manual and literature for product. The manual, literature, and instructions for use will assist the government in proper operations and cleaning.

6. Warranty and Support: The warranty and support shall cover all components of the requirement in accordance with the standard manufacturer’s warranty.

7. Delivery/Shipping: Contractor shall deliver products within five days after receipt of order

(ARO).

8. Delivery Location:

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

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 52.225-1 BUY AMERICAN—SUPPLIES (OCT 2022)

(a) Definitions. As used in this clause—

Commercially available off-the-shelf (COTS) item—(1) Means any item of supply (including construction material) that is—

(i) A commercial product (as defined in paragraph (1) of the definition of ‘‘commercial product’’ at

Federal Acquisition Regulation (FAR) 2.101;

(ii) Sold in substantial quantities in the commercial marketplace; and

(iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and

(2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products.

Component means an article, material, or supply incorporated directly into an end product.

Cost of components means—

(1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the end product (whether or not such costs are paid to a domestic firm), and any applicable duty (whether or not a duty-free entry certificate is issued); or

(2) For components manufactured by the Contractor, all costs associated with the manufacture of the component, including transportation costs as described in paragraph (1) of this definition, plus allocable overhead costs, but excluding profit. Cost of components does not include any costs associated with the manufacture of the end product.

Critical component means a component that is mined, produced, or manufactured in the United States and deemed critical to the U.S. supply chain. The list of critical components is at FAR 25.105.

Domestic end product means—

(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—

(i) An unmanufactured end product mined or produced in the United States;

(ii) An end product manufactured in the United States, if—

(A) The cost of its components mined, produced, or manufactured in the United States exceeds 60 percent of the cost of all its components, except that the percentage will be 65 percent for items delivered in calendar years 2024 through 2028 and 75 percent for items delivered starting in calendar year 2029.

Components of foreign origin of the same class or kind as those that the agency determines are not mined, produced, or manufactured in sufficient and reasonably available commercial quantities of a satisfactory quality are treated as domestic. Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic; or

(B) The end product is a COTS item; or

(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of foreign iron and steel constitutes less than

5 percent of the cost of all the components used in the end product. The cost of foreign iron and steel includes but is not limited to the cost of foreign iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the end product and a good faith estimate of the cost of all foreign iron or steel components excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the definition of

‘‘cost of components’’.

End product means those articles, materials, and supplies to be acquired under the contract for public use.

Fastener means a hardware device that mechanically joins or affixes two or more objects together.

Examples of fasteners are nuts, bolts, pins, rivets, nails, clips, and screws.

Foreign end product means an end product other than a domestic end product.

Foreign iron and steel means iron or steel products not produced in the United States. Produced in the

United States means that all manufacturing processes of the iron or steel must take place in the United

States, from the initial melting stage through the application of coatings, except metallurgical processes involving refinement of steel additives. The origin of the elements of the iron or steel is not relevant to the determination of whether it is domestic or foreign.

Predominantly of iron or steel or a combination of both means that the cost of the iron and steel content exceeds 50 percent of the total cost of all its components. The cost of iron and steel is the cost of the iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the product and a good faith estimate of the cost of iron or steel components excluding

COTS fasteners.

Steel means an alloy that includes at least 50 percent iron, between 0.02 and 2 percent carbon, and may include other elements.

United States means the 50 States, the District of Columbia, and outlying areas.

(b) 41 U.S.C. chapter 83, Buy American, provides a preference for domestic end products for supplies acquired for use in the United States. In accordance with 41 U.S.C. 1907, the domestic content test of the

Buy American statute is waived for an end product that is a COTS item (see 12.505(a)(1)), except that for an end product that consists wholly or predominantly of iron or steel or a combination of both, the domestic content test is applied only to the iron and steel content of the end product, excluding COTS fasteners.

(c) Offerors may obtain from the Contracting Officer a list of foreign articles that the Contracting

Officer will treat as domestic for this contract.

(d) The Contractor shall deliver only domestic end products except to the extent that it specified delivery of foreign end products in the provision of the solicitation entitled "Buy American Certificate."

Alternate I (OCT 2022). As prescribed in 25.1101(a)(1)(ii) substitute the following sentence for the first sentence of paragraph (1)(ii)(A) of the definition of ‘‘domestic end product’’ in paragraph (a): (A) The cost of its components mined, produced, or manufactured in the United States exceeds ___ percent of the cost of all its components. [Contracting officer to insert the percentage.]

(End of Clause)

C.2 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT

2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.3 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

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2023

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

JAN 2025

852.203-70 COMMERCIAL ADVERTISING MAY 2018

852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS NOV 2018

852.246-71 REJECTED GOODS OCT 2018

852.247-73 PACKING FOR DOMESTIC SHIPMENT OCT 2018

(End of Addendum to 52.212-4)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

Not Used

SECTION E - SOLICITATION PROVISIONS

E.1 FAR 52.212-1 ADDENDUM, INSTRUCTIONS TO OFFERORS-

COMMERCIAL ITEMS

This combined synopsis/solicitation is issued under Federal Acquisition Regulation 12 and 13, Simplified Procedures for Certain Commercial Items.

QUOTE PREPARATION INSTRUCTIONS:

1. Quote Preparation

a. These instructions are designed to ensure the proper submission of information necessary to provide for comprehensive evaluation of quotes. Quoters shall carefully review this section prior to commencing preparation of quotes and take the necessary measures to ensure that the information submitted is factual, accurate, and complete.

2. Submission Instructions

a. One electronic copy (email) of all sections of the quote (Technical and Price) shall be submitted to the Contracting Officer via email to Anthony.marion2@va.gov on or before the due date and time listed in this solicitation. The contractor’s email shall include in the subject line

“RFQ 36C25625Q1423- Zimmer ROSA INOMED Frame.

b. Faxed quotes are NOT permitted under any circumstances.

3. Quote Format

a. Electronic Copy: Provide one (1) electronic copy of the complete quote. Electronic copies must be in Microsoft Word or Adobe Acrobat format and virus checked prior to submission.

b. The quoters shall be held responsible for the validity of all information supplied in their quote.

c. Please complete and submit, with the completed price quote (volume 2), paragraph B.1

Contract Administration. In addition, all prior solicitation amendments must be acknowledged.

3.1. Volume 1 contains one section, Technical.

A summary of the Technical Volume 1 requirement is listed below. The detailed requirement for the technical volume is listed in section 4.

a. Technical

i. Offeror’s Technical/Product Capability

ii. Offeror’s Qualifications

3.1.1 Past Performance - The contractor does not need to turn in any information for past performance. CPARS and sam.gov will be reviewed.

3.2. Volume 2 contains Pricing Information, Contract Administration and solicitation amendments.

A summary of the Price Volume 2 requirement is listed below.

a. Completed Section B.1 Contract Administration

b. Completed Section B.2 Price Schedule

c. Signed/acknowledgment of all amendments

4. Quote Volume Requirements

a. Volume 1 – TECHNICAL

i. Offeror’s Technical/Product Capability

Offeror shall communicate in detail how its product meets the salient characteristics required by this Solicitation/SOW. Offeror shall further communicate how its product integrates with the current government ROSA Surgical Robot equipment.

ii. Offeror’s Qualifications

Offeror shall provide documentation/evidence that its company is authorized to sell/distribute products required for this Solicitation/SOW. Offerors shall submit a copy of its original equipment manufacturer (OEM) authorization with their technical quote. Failure to submit OEM authorization, if not the manufacturer shall deem quote technical unacceptable.

ii. Delivery

Offeror shall communicate in technical quote its capability to deliver products within five days after receipt of order (ARO).

The Government will evaluate quotations using the comparative evaluation process outlined in

FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. All factors are equal in the comparative evaluation. Contracting Officer (CO) will conduct an initial review for compliance with

Section E.1(3) Quote Format and Section E.4 Quote Volume Requirements in Section E, Addendum to 52.212-1 Instructions to Offerors and Offerors may be rejected for failure to comply. Under Factor 1 Technical, the quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the SOW/Solicitation and based on the information requested in the instructions to offerors section of this solicitation.

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

Provisions 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 provisions are incorporated into 52.212-1 as an addendum to this solicitation:

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR

EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it ‘‘does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument’’ in paragraph (c)(1) in the provision at 52.204–26, Covered Telecommunications

Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212–3, Offeror

Representations and Certifications–Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it

‘‘does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services’’ in paragraph (c)(2) of the provision at

52.204–26, or in paragraph (v)(2)(ii) of the provision at 52.212–3.

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment.

(b) Prohibition. (1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for

Fiscal Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service 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. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover 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) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year

2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service 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. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover 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) Procedures. The Offeror shall review the list of excluded parties in the System for Award

Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for

“covered telecommunications equipment or services.”

(d) Representations. The Offeror represents that—

(1) It [ ] will, [ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds “will’’ in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It [ ] does, [ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds

“does’’ in paragraph (d)(2) of this section.

(e) Disclosures. (1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded “will’’ in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer

(OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services— https://www.sam.gov/

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded

“does’’ in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of Provision)

E.3 52.225-2 BUY AMERICAN CERTIFICATE (OCT 2022)

(a)(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select ‘‘no’’.

(3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(4) The terms ‘‘commercially available off-the-shelf (COTS) item,’’ ‘‘critical component,’’ ‘‘domestic end product,’’ ‘‘end product,’’ and ‘‘foreign end product’’ are defined in the clause of this solicitation entitled ‘‘Buy American—Supplies.”

(b) Foreign End Products:

Line item No. Country of origin Exceeds 55% domestic content

(yes/no)

[List as necessary]

(c) Domestic end products containing a critical component:

Line item No.

(d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the

Federal Acquisition Regulation.

(End of Provision)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

(a) Definitions. As used in this provision, Covered article, FASCSA order, Intelligence community, National security system, Reasonable inquiry, Sensitive compartmented information, Sensitive compartmented information system, and Source have the meaning provided in the clause 52.204–30, Federal Acquisition Supply Chain Security Act Orders— Prohibition.

(b) Prohibition. Contractors are prohibited from providing or using as part of the performance of the contract any covered article, or any products or services produced or provided by a source, if the prohibition is set out in an applicable Federal Acquisition Supply Chain Security Act (FASCSA) order, as described in paragraph (b)(1) of FAR 52.204–30, Federal Acquisition Supply Chain Security Act

Orders—Prohibition.

(c) Procedures. (1) The Offeror shall search for the phrase ‘‘FASCSA order’’ in the System for Award

Management (SAM)(https://www.sam.gov) for any covered article, or any products or services produced or provided by a source, if there is an applicable FASCSA order described in paragraph (b)(1) of FAR

52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition.

(2) The Offeror shall review the solicitation for any FASCSA orders that are not in SAM, but are effective and do apply to the solicitation and resultant contract (see FAR 4.2303(c)(2)).

(3) FASCSA orders issued after the date of solicitation do not apply unless added by an amendment to the solicitation.

(d) Representation. By submission of this offer, the offeror represents that it has conducted a reasonable inquiry, and that the offeror does not propose to provide or use in response to this solicitation 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 in effect on the date the solicitation was issued, except as waived by the solicitation, or as disclosed in paragraph (e).

(e) Disclosures. The purpose for this disclosure is so the Government may decide whether to issue a waiver. For any covered article, or any products or services produced or provided by a source, if the covered article or the source is subject to an applicable FASCSA order, and the Offeror is unable to represent compliance, then the Offeror shall provide the following information as part of the offer:

(1) Name of the product or service provided to the Government;

(2) Name of the covered article or source subject to a FASCSA order;

(3) If applicable, name of the vendor, including the Commercial and Government Entity code and unique entity identifier (if known), that supplied the covered article or the product or service to the

Offeror;

(4) Brand;

(5) Model number (original equipment manufacturer number, manufacturer part number, or wholesaler number);

(6) Item description;

(7) Reason why the applicable covered article or the product or service is being provided or used;

(f) Executive agency review of disclosures. The contracting officer will review disclosures provided in paragraph (e) to determine if any waiver may be sought. A contracting officer may choose not to pursue a waiver for covered articles or sources otherwise subject to a FASCSA order and may instead make an award to an offeror that does not require a waiver.

(End of Provision)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision 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 Provision)

FAR

Number

Title Date

52.204-7 SYSTEM FOR AWARD MANAGEMENT NOV 2024

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE

REPORTING

AUG 2020

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

SEP 2023

52.214-21 DESCRIPTIVE LITERATURE APR 2002

(End of Addendum to 52.212-1)

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

(1) Technical

(2) Price

(3) Past Performance

Technical:

Sub Factor 1: Offeror’s Technical/Product Capability

Offeror shall communicate in detail how its product meets the salient characteristics required by this

Solicitation/SOW. Offeror shall further communicate how its product integrates with the current government ROSA Surgical Robot equipment.

Sub Factor 2: Offeror’s Qualifications

Offeror shall provide documentation/evidence that its company is authorized to sell/distribute products required for this Solicitation/SOW. Offerors shall submit a copy of its original equipment manufacturer

(OEM) authorization with their technical quote. Failure to submit OEM authorization, if not the manufacturer shall deem quote technical unacceptable.

Sub Factor 3: Delivery

Offeror shall communicate in technical quote its capability to deliver products within five days after receipt of order (ARO). (

The Government will evaluate quotations using the comparative evaluation process outlined in FAR

13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. All factors are equal in the comparative evaluation. Contracting Officer (CO) will conduct an initial review for compliance with Section E.1(3) Quote Format and Section E.4 Quote

Volume Requirements in Section E, Addendum to 52.212-1 Instructions to Offerors and Offerors may be rejected for failure to comply. Under Factor 1 Technical, the quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the SOW/Solicitation and based on the information requested in the instructions to offerors section of this solicitation.

b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

(DEVIATION FEB 2025)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision—

Covered telecommunications equipment or services has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or

Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR 127, and the concern is identified by

SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the

Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204–25, Prohibition on Contracting for

Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174).

Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern

Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the

Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology…