Attachment 5 CountryofOrigin and Trade Agreements Certificate.docx

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Attached to
AXION BIOSYSTEMS MAESTRO PRO MICROELECTRODE ARRAY (MEA) SYSTEM – BRAND NAME OR EQUAL
Solicitation number
CBER-2026-135659
Issued by

About this file

This is a Country of Origin and Trade Agreements Certificate template designed for use in federal procurement. The document serves as an attestation form that vendors must complete to certify the country of origin of products and their compliance with applicable trade agreements, including the Buy American Act, Trade Agreements Act, and relevant HHS class deviations specific to this procurement.

The certificate requires the vendor to declare whether the end product(s) being offered are manufactured or produced in the United States or in a country designated as eligible under applicable trade agreements. Vendors must identify the specific country of origin for items included in their quotation and certify compliance with domestic preference requirements and trade agreement stipulations. This form is a standard requirement for federal solicitations and must be completed and submitted with the quotation for the Axion BioSystems Maestro Pro Microelectrode Array (MEA) System and associated consumables, software, and services under solicitation CBER-2026-135659 issued by the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER).

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ATTACHMENT 5

MANDATORY COUNTRY-OF-ORIGIN, PLACE-OF-MANUFACTURE INFORMATION AND TRADE AGREEMENTS CERTIFICATE Axion BioSystems Maestro Pro Microelectrode Array (MEA) System – Brand Name or Equal Solicitation Number: __________________________________________ Quoter/Contractor Legal Business Name:

UEI:

CAGE Code:

Business Address:

Authorized Representative:

Title:

Telephone:

Email:

1. PURPOSE

This attachment shall be completed and submitted with the quoter’s quotation.

The purpose of this attachment is to obtain the information necessary for the Government to evaluate compliance with applicable requirements of FAR Part 25, including:

· Trade Agreements;

· Country of origin;

· Place of manufacture;

· U.S.-made end-product status;

· Designated-country end-product status; and

· FAR 52.225-6, Trade Agreements Certificate.

Completion of this attachment is mandatory.

The quoter shall identify the country of origin and place of manufacture for each equipment item, manufactured end product, component offered as a separately priced end product, and supply item proposed under this solicitation.

The Government may request additional supporting information when necessary to determine the status of an offered end product.

2. GENERAL INSTRUCTIONS

For each item offered, the quoter shall provide:

1. CLIN or item number;

1. Item description;

1. Manufacturer’s legal name;

1. Brand name and model;

1. Manufacturer part number;

1. Physical place of manufacture;

1. Country of origin;

1. Whether the item is a U.S.-made end product;

1. Whether the item is a designated-country end product;

1. If neither, identification as an “Other End Product”; and

1. Supporting documentation or explanation when necessary.

The quoter shall not enter only “USA,” “Domestic,” “TAA Compliant,” or similar general statements when the actual place of manufacture is known.

The place of manufacture should identify, to the extent known:

City, State and United States, for domestic manufacture; or City and Country, for manufacture outside the United States.

If final assembly and country of origin are different, both shall be disclosed.

If an offered end product consists of components or materials originating in more than one country, the quoter shall identify the country in which the end product was substantially transformed into the final article of commerce for purposes of its Trade Agreements representation.

3. MANDATORY ITEM-BY-ITEM COUNTRY-OF-ORIGIN AND PLACE-OF-MANUFACTURE DISCLOSURE

The quoter shall complete Attachment VI - Mandatory Item-By-Item Country-Of-Origin And Place-Of-Manufacture Disclosure Form .

4. ADDITIONAL MANUFACTURING INFORMATION

For each manufactured end product, provide the following information when applicable.

A. Final Assembly Location Item: __________________________________________ Final Assembly Location:

Country:

B. Manufacturer Is the identified manufacturer the entity that actually manufactures or substantially transforms the end product?

☐ Yes ☐ No If no, identify the actual manufacturer or manufacturing entity:

C. Multiple Manufacturing Locations Is the offered product manufactured or assembled at more than one possible location?

☐ Yes

If yes, identify all possible manufacturing locations and state which location will supply the products delivered under this purchase order:

5. SUBSTANTIAL TRANSFORMATION INFORMATION

Complete this section for any item for which the country of origin depends upon substantial transformation.

Item/CLIN:

Country where final substantial transformation occurs:

Briefly describe the manufacturing or processing performed in that country that results in the final end product:

Supporting Documentation Attached:

☐ Yes

If yes, identify document:

6. U.S.-MADE AND DESIGNATED-COUNTRY END PRODUCTS

For purposes of completing this attachment, the quoter shall apply the definitions contained in FAR 52.225-5, Trade Agreements, as incorporated into the solicitation.

The quoter is responsible for determining whether each proposed end product qualifies as:

☐ U.S.-made end product ☐ Designated-country end product ☐ Other end product The quoter shall not classify an item solely according to the location of the seller, distributor, reseller, corporate headquarters, warehouse, or shipping point.

The classification shall be based on the applicable FAR country-of-origin requirements.

7. SUMMARY OF OFFERED END PRODUCTS

The quoter shall summarize the status of all end products offered.

A. U.S.-Made End Products ☐ All proposed end products are U.S.-made end products.

OR

☐ The following proposed end products are U.S.-made end products:

CLIN / Item
Product
Country of Origin

B. Designated-Country End Products ☐ No designated-country end products are proposed.

OR

☐ The following designated-country end products are proposed:

CLIN / Item
Product
Country of Origin

C. Other End Products ☐ No other end products are proposed.

OR

☐ Other end products are proposed and are identified below and in the FAR 52.225-6 certification.

CLIN / Item
Product
Country of Origin

8. FAR 52.225-6 – TRADE AGREEMENTS CERTIFICATE

(FEB 2021)

The following certification is required in connection with the Trade Agreements clause incorporated into this solicitation.

(a) Certification The offeror certifies that each end product, except those listed in paragraph (b) below, is a U.S.-made or designated-country end product, as those terms are defined in the solicitation clause entitled “Trade Agreements.”

☐ The quoter certifies the statement above.

(b) Other End Products The offeror shall identify below all supplies that are not U.S.-made or designated-country end products.

OTHER END PRODUCTS

Line Item Number
Item Description
Country of Origin

☐ None – The quoter is not offering any Other End Products.

Attach additional pages if necessary.

(c) Government Evaluation The Government will evaluate quotations in accordance with FAR Part 25.

For line items covered by the WTO Government Procurement Agreement, U.S.-made and designated-country end products will be evaluated without application of the restrictions of the Buy American statute.

The Government generally will consider for award only U.S.-made or designated-country end products unless the Contracting Officer makes a determination permitted under the applicable FAR requirements.

9. FAR 52.225-18 – PLACE OF MANUFACTURE REPRESENTATION

The quoter shall also provide the representation required by FAR 52.225-18, Place of Manufacture, when applicable to this solicitation.

For purposes of this acquisition, the quoter shall identify whether the place of manufacture of the end products it expects to provide is predominantly:

☐ In the United States ☐ Outside the United States For this solicitation, the above representation does not replace the item-by-item information required in Section 3 of this attachment.

The contractor shall provide the actual place of manufacture and country of origin for each applicable equipment or supply item, regardless of the response selected above.

10. CHANGES IN COUNTRY OF ORIGIN OR PLACE OF MANUFACTURE

The quoter shall notify the Contracting Officer promptly if, before award, it learns that any country-of-origin or place-of-manufacture information submitted with its quotation is inaccurate or has changed.

After award, the Contractor shall not substitute an end product having a different country of origin or place of manufacture when the substitution would affect compliance with the Trade Agreements requirements or other material terms of the purchase order without prior written authorization from the Contracting Officer.

If the manufacturer changes the manufacturing location before delivery, the Contractor shall notify the Contracting Officer in writing and provide updated information sufficient for the Government to determine continued compliance.

11. SUPPORTING DOCUMENTATION

The Government reserves the right to request documentation supporting any country-of-origin or place-of-manufacture representation.

Supporting documentation may include, as appropriate:

· Manufacturer certification;

· Manufacturer letter;

· Certificate of origin;

· Product data sheet;

· Manufacturing statement;

· Customs determination;

· Country-of-origin ruling;

· Product labeling;

· Manufacturing records;

· Technical literature;

· Commercial invoice;

· Supply-chain documentation; or

· Other documentation reasonably sufficient to establish origin.

Supporting documentation is:

☐ Attached ☐ Available upon Government request ☐ Not applicable Description of documentation attached:

12. CONTRACTOR CERTIFICATION

By signing below, the authorized representative certifies that:

1. The information provided in this attachment is complete and accurate to the best of the quoter’s knowledge;

1. The country of origin identified for each offered end product is based on the applicable FAR Part 25 requirements and is not based merely upon the location of the distributor, reseller, warehouse, or shipping point;

1. The place of manufacture identified for each item accurately reflects the location where the item is manufactured or substantially transformed into the end product being offered;

1. Each proposed end product, except any product specifically identified as an Other End Product, is represented as a U.S.-made or designated-country end product in accordance with FAR 52.225-6;

1. All Other End Products have been disclosed;

1. The quoter understands that the Government may rely upon these representations in determining eligibility for award;

1. The quoter will promptly notify the Contracting Officer of any material change to the information before award; and

1. The Contractor will notify the Contracting Officer of any proposed post-award change in country of origin or place of manufacture that could affect compliance with the purchase order.

Quoter/Contractor Legal Business Name:

Authorized Representative:

Title:

Signature:

Date:

Telephone:

Email:

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