Combined Synopsis-Solicitation Maestro Pro Microelectrode Array System Document.docx

COMBINED SYNOPSIS/SOLICITATION

REQUEST FOR QUOTATION

AXION BIOSYSTEMS MAESTRO PRO MICROELECTRODE ARRAY (MEA) SYSTEM – BRAND NAME OR EQUAL Solicitation Number: CBER-2026-135659 Agency: U.S. Department of Health and Human Services Operating Division: U.S. Food and Drug Administration Center: Center for Biologics Evaluation and Research Office: Office of Therapeutic Products / Office of Gene Therapy Contracting Office: FDA Office of Acquisitions and Grants Services (OAGS) Contracting Officer: Michele Jackson Notice Type: Combined Synopsis/Solicitation – Request for Quotation (RFQ) Acquisition Type: Commercial Products and Commercial Services Set-Aside: None – Unrestricted Contract Type: Firm-Fixed-Price Purchase Order NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing PSC: 6640 – Laboratory Equipment and Supplies Place of Performance: Silver Spring, Maryland FOB: Destination Quotation Due Date: September 16, 2026 @ 9:00am Eastern Time Questions Due: September 11, 2026 @ 9:00am Eastern Time

1. COMBINED SYNOPSIS/SOLICITATION NOTICE

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with Federal Acquisition Regulation (FAR) Part 12, as implemented through the Revolutionary FAR Overhaul (RFO) model deviation and applicable Department of Health and Human Services (HHS) class deviations.

This announcement constitutes solicitation. Quotations are being requested, and a separate written solicitation will not be issued.

Solicitation No. CBER-2026-135659 is issued as a Request for Quotation (RFQ) for the purchase of an Axion BioSystems Maestro Pro Microelectrode Array (MEA) System, brand name or equal, together with the required software, consumables, installation, training, warranty, and an option for preventive maintenance.

This acquisition is not set aside for small business concerns and is being competed on an unrestricted basis.

The Government intends to issue a Firm-Fixed-Price purchase order using simplified procedures for commercial products and commercial services under RFO FAR Part 12.

The Government intends to make award to the responsible quoter submitting the Lowest-Priced Technically Acceptable (LPTA) quotation, considering:

1. Technical Acceptability;

1. Past Performance; and

1. Price.

There will be no tradeoff between price and non-price factors.

This solicitation incorporates FAR provisions and clauses by reference. Full text of FAR provisions and clauses is available through Acquisition.gov.

2. BACKGROUND

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Gene Therapy (OGT), requires acquisition of a new high-throughput Microelectrode Array (MEA) platform.

The equipment will support a newly funded regulatory science project involving development of a human brain assembloid platform integrated with real-time electrophysiological profiling as a New Approach Methodology (NAM) to support regulatory evaluation of adeno-associated virus-mediated gene therapies for central nervous system disorders.

This is a new requirement. The FDA laboratory does not currently possess an MEA platform with the capabilities required for this project.

3. REQUIREMENT

The Contractor shall furnish a new Axion BioSystems Maestro Pro Microelectrode Array System, brand name or equal, including all hardware, software, licenses, modules, consumables, computer equipment, shipping, installation, system setup, calibration, verification, onsite training, warranty coverage, and associated services required by the Statement of Work.

An equal product must satisfy all salient physical, functional, and performance characteristics identified in this solicitation and the attached Statement of Work.

All equipment provided shall be new and shall not be used, refurbished, remanufactured, demonstrator, prototype, or previously installed equipment unless expressly authorized in writing by the Contracting Officer.

4. SALIENT CHARACTERISTICS

The proposed system shall meet or exceed the following minimum requirements.

4.1 General System Capability

The system shall:

· Provide a high-throughput, non-invasive, label-free bioelectronic assay platform;

· Support real-time in-vitro electrophysiology;

· Provide impedance measurement capability;

· Support 2D monolayer cultures and 3D biological models, including spheroids and organoids;

· Be capable of use with iPSC-derived neurons and cardiomyocytes; and

· Include all components required to deliver a complete and operational system.

4.2 Recording and Stimulation

The system shall provide:

· A minimum of 768 simultaneous recording and stimulation channels;

· Sampling rate of at least 12.5 kHz;

· Bandwidth of approximately 0.01 Hz through 5 kHz;

· Electrical stimulation capability up to approximately +/-1.2 V and +/-250 microamps across channels; and

· Technology functionally equivalent to Axion BioCore v4 chip technology.

4.3 Impedance Measurement

The system shall provide:

· Electrode impedance measurement capability;

· MEA viability impedance capability;

· Automatic and integrated impedance monitoring; and

· Real-time measurement capability.

The required dynamic ranges are approximately:

· 50 ohms to 5 kohms for electrode impedance; and

· 5 kohms to 100 kohms for MEA viability measurements.

4.4 Plate Compatibility

The proposed system shall support, at a minimum:

· 6-well MEA plates;

· 24-well MEA plates;

· 48-well MEA plates;

· 96-well MEA plates; and

· Impedance measurement formats up to 384 wells.

The system shall be compatible with the plate types required for the Government’s intended applications, including functionality equivalent to:

· BioCircuit MEA;

· CytoView MEA;

· Lumos MEA;

· CytoView-Z; and

· 3D MEA applications.

4.5 Environmental Control

The system shall provide an integrated environmental chamber capable of controlling:

· Temperature;

· Carbon dioxide; and

· Humidity.

The system shall permit extended experimentation without requiring an external incubator during data acquisition.

4.6 Software

The system shall include an integrated software platform for:

· Data acquisition;

· Real-time visualization;

· Data analysis;

· Neural electrophysiology;

· MEA viability;

· Impedance analysis; and

· Automation functionality.

The required configuration shall include software functionality equivalent to AxIS Navigator and AxIS Analysis.

The Contractor shall provide all licenses necessary to operate the system, including at least two seats for the applicable analysis software.

Software shall be installed, licensed, and fully functional upon completion of installation.

4.7 Computer Equipment

The Contractor shall furnish the computer and monitor required to operate the proposed system.

The furnished computer shall meet the manufacturer’s recommended specifications for all hardware and software included in the quotation.

4.8 Installation

The Contractor shall provide onsite installation, including:

· Unpacking and setup;

· Hardware installation;

· Software installation;

· Software licensing;

· Calibration;

· Configuration;

· Functional testing; and

· Verification that the system operates in accordance with manufacturer specifications.

4.9 Training

The Contractor shall provide up to two days of onsite user training.

Training shall include, as applicable:

· Hardware operation;

· Software operation;

· AxIS Navigator or equal;

· AxIS Analysis or equal;

· Neural electrophysiology workflows;

· Neural organoid applications;

· Data acquisition;

· Data analysis; and

· Routine equipment operation.

4.10 Warranty

The base requirement shall include the manufacturer’s standard one-year warranty covering defects in design, workmanship, and materials.

The warranty shall commence in accordance with the manufacturer’s standard commercial warranty terms described in the Statement of Work.

5. CONTRACT LINE ITEM / PRICING SCHEDULE

Quoters shall provide a Firm-Fixed-Price for each applicable line item.

The Government’s pricing spreadsheet (Attachment II – Pricing Spreadsheet) shall be completed and submitted with the quotation.

All quoted prices shall be Firm-Fixed-Price.

Prices shall include all costs required to successfully perform the requirement, including labor, materials, hardware, software, software licenses, consumables, packaging, shipping, freight, travel, installation, calibration, training, warranty administration, and any other costs associated with complete performance.

6. DELIVERABLES

D1 – MEA SYSTEM AND COMPONENTS

The Contractor shall deliver the complete Maestro Pro 768-channel MEA/impedance system or equal, including all required hardware, modules, software, consumables, computer, monitor, accessories, and supporting documentation.

Due: Within 90 calendar days after award.

Acceptance: The Government will verify that all required equipment and components have been received undamaged and that the packing list is complete.

D2 – INSTALLATION AND SYSTEM VALIDATION

The Contractor shall install, configure, calibrate, and verify the equipment and software.

The Contractor shall provide written confirmation that the system has been installed and operates in accordance with manufacturer specifications.

Due: Within 30 calendar days after equipment delivery.

Acceptance: Government confirmation that the system is installed and operates in accordance with the Statement of Work and manufacturer specifications.

D3 – SOFTWARE LICENSES

The Contractor shall provide and activate all required software licenses, including the applicable acquisition and analysis software and at least two analysis seats.

Due: Concurrent with installation.

Acceptance: Government confirmation that required software is properly installed, licensed, and operational.

D4 – USER TRAINING

The Contractor shall provide up to two days of onsite user training.

The Contractor shall provide attendance or training-completion documentation.

Due: Within 60 calendar days after equipment delivery.

Acceptance: Government confirmation that training has been completed.

D5 – OPTION YEAR 1 PREVENTIVE MAINTENANCE

If exercised, the Contractor shall provide onsite performance assurance and preventive maintenance services equivalent to Part No. PASPM768PRO-OS.

Service shall include:

· Required parts;

· Labor;

· One onsite preventive maintenance visit;

· System performance verification; and

· Written service report.

The written service report shall identify:

· Services performed;

· Parts replaced, if any;

· Testing conducted; and

· System operational status.

7. PERIOD OF PERFORMANCE

Base Period The base period begins on the date of award and continues through completion and acceptance of all base-period deliverables.

Equipment delivery shall occur within 90 calendar days after award.

Installation and system validation shall be completed within 30 calendar days following equipment delivery.

User training shall be completed within 60 calendar days following equipment delivery.

The base requirement includes the standard one-year manufacturer warranty.

Option Year 1 Option Year 1 consists of 12 months of onsite performance assurance and preventive maintenance services.

The option period is intended to commence immediately following expiration of the standard one-year manufacturer warranty and shall not overlap with the manufacturer’s standard warranty coverage.

Exercise of the option is at the sole discretion of the Government and is subject to availability of funds and a determination that exercise of the option is in the Government’s best interest.

8. PLACE OF DELIVERY AND PERFORMANCE

All deliveries, installation, system validation, and onsite training shall be performed at:

U.S. Food and Drug Administration Center for Biologics Evaluation and Research Building 52/72, Room 3148 10903 New Hampshire Avenue Silver Spring, MD 20993 FOB: Destination The Contractor shall coordinate delivery, building access, installation, and onsite activities with the Contracting Officer’s Representative or other designated Government representative at least five business days in advance.

9. INSPECTION AND ACCEPTANCE

Inspection and acceptance will occur at destination.

The Contracting Officer’s Representative or other designated Government representative will inspect delivered equipment to determine conformity with the purchase order and Statement of Work.

Inspection may include verification of:

· Manufacturer;

· Make;

· Model;

· Part number;

· Serial number;

· Quantity;

· Country of origin;

· Place of manufacture;

· Physical condition;

· Completeness;

· Accessories;

· Software;

· Software licenses;

· Manuals;

· Warranty documentation;

· Certificates of conformance;

· Installation documentation;

· Calibration;

· System operation; and

· Compliance with the required technical characteristics.

The Government may reject supplies or services that do not conform to the purchase order requirements.

The Contractor shall correct, repair, replace, or otherwise remedy nonconforming supplies or services at no additional cost to the Government.

Acceptance shall be documented by the authorized Government representative.

10. BRAND NAME OR EQUAL REQUIREMENTS

The Government has identified the Axion BioSystems Maestro Pro Microelectrode Array System as the brand-name product that represents the level of quality, functionality, and performance required.

Quoters may propose the brand-name system or an equal product.

A quotation offering an equal product shall:

1. Clearly identify the proposed manufacturer;

1. Identify the brand name, if applicable;

1. Identify the model and part number;

1. Provide complete product literature and specifications;

1. Provide sufficient information for the Government to independently determine compliance;

1. Address each salient characteristic contained in this solicitation;

1. Identify any differences between the proposed product and the identified brand-name product; and

1. Identify any modifications required for the offered product to satisfy the Government’s requirements.

The Government is not responsible for locating technical data that the quoter fails to identify in its quotation.

Merely stating that a product is “equal,” “compliant,” “meets specifications,” or words to that effect, without supporting documentation, will be insufficient to establish technical acceptability.

Unless a quoter clearly identifies that it is proposing an equal product, the Government will understand the quotation to offer the brand-name product identified in the solicitation.

11. QUOTATION SUBMISSION INSTRUCTIONS

Quotations shall be clear, concise, and contain sufficient information for the Government to evaluate the quotation without requesting additional information.

Quotations shall contain the following sections:

Volume/Section I – Technical Capability The technical quotation shall:

· Identify the manufacturer;

· Identify all model and part numbers;

· State whether the quoter is offering the specified brand name or an equal product;

· Provide technical specifications.

· Address all salient characteristics.

· Describe installation;

· Describe training;

· Describe warranty coverage;

· Identify software and license terms;

· Identify included consumables;

· Identify proposed delivery schedule; and

· Provide sufficient technical literature for evaluation.

A quoter proposing an equal product should provide a side-by-side compliance matrix identifying:

· Government requirement;

· Proposed specification;

· Supporting literature/page reference; and

· Compliance status.

Volume/Section II – Past Performance The quoter shall submit up to three recent and relevant past-performance references involving sales, installation, maintenance, or support of laboratory instrumentation of similar scope, complexity, and magnitude.

For each reference, provide:

· Customer name;

· Contract/order number, if applicable;

· Description of equipment or services;

· Dollar value;

· Period of performance;

· Customer point of contact;

· Telephone number; and

· Email address.

The Government may consider information obtained from:

· CPARS;

· Government databases;

· Other Federal agencies;

· Commercial customers;

· References provided by the quoter; and

· Other sources reasonably available to the Government.

The Government is not required to limit its evaluation to references submitted by the quoter.

Volume/Section III – Price The quoter shall submit the completed pricing schedule.

Pricing shall identify:

· Unit price;

· Extended price;

· Base total;

· Option Year 1 total; and

· Total evaluated price.

The quoter shall identify any shipping or miscellaneous charge separately.

Volume/Section IV – Country of Origin and Place of Manufacture The quoter shall provide the required country-of-origin and place-of-manufacture information described in Section 12 below.

12. TRADE AGREEMENTS, BUY AMERICAN STATUTE, COUNTRY OF ORIGIN, AND PLACE OF MANUFACTURE This acquisition is unrestricted and is expected to be subject to the applicable requirements of FAR Part 25 and the Trade Agreements Act, including the World Trade Organization Government Procurement Agreement, unless the Contracting Officer determines that an applicable FAR Part 25 exception applies.

The Buy American statute generally establishes a preference for domestic end products in Federal supply acquisitions. However, when an applicable trade agreement applies, the Trade Agreements Act authorizes waiver of Buy American restrictions for eligible products from designated countries.

Accordingly, this solicitation applies the Trade Agreements requirements, including FAR 52.225-5, Trade Agreements, and FAR 52.225-6, Trade Agreements Certificate, as applicable.

The Contractor shall provide only U.S.-made or designated-country end products except as otherwise permitted under the applicable FAR provisions and clauses or authorized by the Contracting Officer.

Mandatory Country-of-Origin and Place-of-Manufacture Information Regardless of whether a product is identified as U.S.-made or a designated-country end product, the quoter must identify the country of origin and place of manufacture for every equipment item and supply item offered under this solicitation.

The quoter shall complete Attachment V and Attachment VI For purposes of the Trade Agreements Act, the Government will determine country of origin in accordance with the applicable FAR Part 25 rules.

The Government may request supporting documentation necessary to verify:

· Country of origin;

· Place of manufacture;

· Substantial transformation;

· Manufacturer identity; or

· Designated-country status.

Failure to provide sufficient information regarding country of origin or place of manufacture may prevent the Government from determining compliance with the solicitation and may result in the quotation being determined technically unacceptable.

13. BASIS OF AWARD – LOWEST-PRICED TECHNICALLY ACCEPTABLE

The Government intends to make award using a Lowest-Priced Technically Acceptable (LPTA) evaluation methodology.

The evaluation factors are:

1. Technical Acceptability

1. Past Performance

1. Price The Government will not conduct a tradeoff.

Technical superiority or past-performance superiority will not justify payment of a price premium once the Government determines that a quotation satisfies the applicable acceptability requirements.

14. FACTOR 1 – TECHNICAL ACCEPTABILITY

Technical capability will be evaluated on an Acceptable/Unacceptable basis.

Acceptable The quotation clearly demonstrates that the proposed equipment, software, supplies, installation, training, warranty, delivery, and associated services satisfy all material requirements and salient characteristics of the solicitation and Statement of Work.

Unacceptable The quotation fails to demonstrate compliance with one or more material requirements or salient characteristics.

A quotation receiving an Unacceptable rating under Technical Acceptability is ineligible for award.

The Government will evaluate the information contained in the quotation and information specifically referenced by the quoter that is reasonably available to the Government.

The Government is not responsible for locating information not identified in the quotation.

15. FACTOR 2 – PAST PERFORMANCE

Past performance will be evaluated as:

· Acceptable

· Unacceptable

· Neutral The Government will consider the recency, relevancy, and quality of available past-performance information.

Acceptable Relevant past-performance information provides reasonable confidence that the quoter will successfully perform the requirement.

Unacceptable Relevant past-performance information demonstrates performance risk that does not provide reasonable confidence that the quoter will successfully perform the requirement.

Neutral The quoter has no relevant past-performance record or relevant past-performance information is not reasonably available.

A quoter without relevant past performance will not be evaluated favorably or unfavorably solely because it lacks a relevant performance history.

A Neutral past-performance rating will be considered eligible for award.

Past performance will be used as an acceptability factor and will not be comparatively ranked for a tradeoff.

16. FACTOR 3 – PRICE

The Government will evaluate price for:

· Completeness;

· Mathematical accuracy;

· Reasonableness; and

· Material imbalance.

The Government may correct apparent mathematical errors after obtaining appropriate verification from the quoter.

The Government will calculate the Total Evaluated Price as follows:

Base Requirement Total + Option Year 1 Total = Total Evaluated Price The Government will evaluate the Option Year 1 price for award purposes.

Evaluation of the option does not obligate the Government to exercise the option.

The Contracting Officer will determine whether the apparent successful quoter’s price is fair and reasonable.

17. AWARD DETERMINATION

The Government will determine whether each quotation is:

1. Technically Acceptable;

1. Acceptable or Neutral for Past Performance;

1. Complete and reasonable in price;

1. Submitted by a responsible quoter; and

1. Otherwise eligible for Federal award.

Award will be made to the responsible quoter submitting the lowest Total Evaluated Price among quotations determined Technically Acceptable and Acceptable or Neutral for Past Performance.

There will be no tradeoff.

A higher-priced quotation will not be selected based on superior technical features or superior past performance after the quotation has satisfied the Government’s stated acceptability requirements.

The Government reserves the right to make award without requesting revised quotations.

The Government may communicate with quoters when clarification or additional information is necessary to efficiently evaluate a quotation.

18. FAR SOLICITATION PROVISIONS – RFO

The following FAR provisions apply to this solicitation as prescribed and as implemented through applicable RFO model deviations in effect on the date of solicitation:

FAR 52.203-18

Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements – Representation

FAR 52.204-7

System for Award Management – Registration

FAR 52.212-1

Instructions to Offerors – Commercial Products and Commercial Services RFO applicable text/deviation The instructions contained in this combined synopsis/solicitation supplement FAR 52.212-1.

FAR 52.212-2

Evaluation – Commercial Products and Commercial Services RFO applicable text/deviation Paragraph (a) is completed by Sections 13 through 17 of this solicitation.

The basis of award is Lowest-Priced Technically Acceptable.

FAR 52.217-5

Evaluation of Options The Government will evaluate the price of the option by adding the total price for Option Year 1 to the total base requirement price.

Evaluation of the option does not obligate the Government to exercise the option.

FAR 52.225-6

Trade Agreements Certificate The quoter shall complete all representations required by this provision and identify applicable end products that are not U.S.-made or designated-country end products.

FAR 52.240-90

Security Prohibitions and Exclusions Representations and Certifications

RFO

The quoter shall complete the applicable representations and certifications required by this provision.

Provisions Incorporated by Full Text 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) This solicitation incorporates one or more provisions by reference with the same force and effect as if they were given in full text. The full text of provisions may be accessed electronically at:

· https://acquisition.gov

· https://acquisition.gov/far-overhaul

· https://acquisition.gov/hhsar (End of Provision)

19. FAR CONTRACT CLAUSES – RFO

The resulting purchase order will include applicable FAR clauses prescribed for this commercial acquisition, including:

5.1 Clauses Incorporated by Reference

The following clauses are incorporated by reference and have the same force and effect as if given in full text.

Full text may be accessed at https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar.

20. RFO COMMERCIAL ACQUISITION CLAUSE STRUCTURE

The Government is using the current Revolutionary FAR Overhaul commercial-acquisition structure.

Accordingly, applicable statutory and Executive Order provisions and clauses are incorporated individually in accordance with current RFO FAR Part 12 prescriptions.

The solicitation and resulting award will use the RFO versions of applicable FAR provisions and clauses in effect on the date of solicitation and award.

Clauses Incorporated by Full Text 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. The full text of clauses may be accessed electronically at:

· https://acquisition.gov

· https://acquisition.gov/far-overhaul

· https://acquisition.gov/hhsar (End of Clause) 52.217-9 Option to Extend the Term of the Contract.

(a) The Government may extend the term of this contract by written notice to the Contractor within 90 days of the end of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 2 years 6 months).

(End of clause) 52.217-8 Option to Extend Services (NOV 1999) The Government may require continued performance of services within the limits and rates specified in the contract. The option may be exercised more than once but shall not exceed six months.

(End of Clause) FDA Electronic Invoicing and Payment Requirements – Invoice Processing Platform (IPP) (JAN 2022)

a. All invoice submissions for goods and/or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in RFO 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services included in commercial item contracts. The IPP website address is: https://www.ipp.gov

c. The Agency will enroll Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive a Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3–5 business days of contract award for new contracts or date of modification for existing contracts. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131. The Contractor POC will receive two emails from IPP Customer Support. The first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of the first, contains a temporary password. You must log in with the temporary password within 30 days. If your company is already registered to use IPP, you will not be required to re-register. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time-and-materials or labor-hour line items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement line items must be submitted in a format showing expenditures for that month and contract cumulative amounts. At a minimum, the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred:

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum: (1) a list of all invoices submitted to date under the subject award, including invoice number, amount, and date submitted, as well as corresponding payment amount and date received; (2) total amount of all payments received to date under the subject contract or order; and (3) for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of the U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or by email at ERIC@fda.hhs.gov. When emailing, please include the contract number, invoice number and date, your name, phone number, and a detailed description of the issue.

(End of Clause)

21. HHSAR CLAUSE

The following HHS Acquisition Regulation clause applies:

HHSAR 352.232-71 – ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(APR 2026) (RFO DEVIATION)

Except when the Contracting Officer authorizes alternate procedures in writing, the Contractor shall submit payment requests electronically using the Department of the Treasury Invoice Processing Platform (IPP) or successor system in accordance with HHSAR 352.232-71.

A payment request includes a bill, voucher, invoice, or request for contract financing payment together with required supporting documentation.

If the Contracting Officer authorizes an alternate payment procedure, the Contractor shall include a copy of the written authorization with each payment request submitted under the alternate procedure.

22. INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY

Information and Communication Technology Accessibility

23. SYSTEM FOR AWARD MANAGEMENT

The successful quoter shall be registered and active in the System for Award Management (SAM) at the time of award, unless an applicable exception applies.

The quoter shall maintain its SAM registration throughout the period required by the applicable FAR provisions and clauses.

The Government will verify the prospective contractor’s eligibility and responsibility before award.

The Government will not make an award to an entity that is suspended, debarred, or otherwise excluded from Federal contracting.

24. OPTION YEAR 1

The Government may exercise Option Year 1 for onsite performance assurance and preventive maintenance.

The option consists of 12 months of maintenance coverage commencing after expiration of the standard one-year manufacturer warranty.

The Government anticipates that the maintenance option will include:

· Parts;

· Labor;

· One onsite preventive maintenance visit;

· System inspection;

· Performance testing;

· Required adjustments;

· Verification of operational status; and

· Service documentation.

The Government’s evaluation of the Option Year 1 price does not obligate the Government to exercise the option.

25. WARRANTY

The base requirement shall include the manufacturer’s standard one-year warranty.

The Contractor shall provide all manufacturer warranty documentation at the time of installation or acceptance.

The Contractor shall identify:

· Warranty commencement date;

· Warranty expiration date;

· Covered equipment;

· Covered components;

· Parts coverage;

· Labor coverage;

· Technical support contact information; and

· Procedures for obtaining warranty service.

26. INVOICING AND PAYMENT

Invoices shall be submitted in accordance with:

· FAR 52.212-4;

· FAR 52.232-33; and

· HHSAR 352.232-71.

Invoices shall be submitted electronically through the Department of the Treasury Invoice Processing Platform unless an alternate procedure is authorized in writing by the Contracting Officer.

Invoices shall identify, as applicable:

· Contract/purchase order number;

· CLIN;

· Description;

· Quantity;

· Unit price;

· Extended amount;

· Delivery date;

· Acceptance information; and

· Any other information required by the purchase order.

Payment is contingent upon Government acceptance of the applicable supplies or services.

27. QUESTIONS

Questions concerning this solicitation shall be submitted by email to:

Michele Jackson Contracting Officer FDA Office of Acquisitions and Grants Services Email: michele.jackson@fda.hhs.gov Questions shall be received no later than:

September 10,2026 at 9:00 AM Eastern Time The email subject line shall state:

Questions – CBER-2026-135639 – Maestro Pro MEA System The Government may consolidate responses to questions and post the responses as an amendment or update to the SAM.gov notice.

Quoters shall not rely upon oral representations regarding this solicitation.

Only written information issued by the Contracting Officer may amend or modify the solicitation.

28. QUOTATION SUBMISSION

Quotations are due no later than:

September 16, 2026 at 9:00am Eastern Time Quotations shall be submitted electronically to:

Michele Jackson Contracting Officer michele.jackson@fda.hhs.gov Email subject:

Quotation – CBER-2026-135639 – Maestro Pro MEA System The quotation shall include:

1. Technical Capability;

1. Past Performance;

1. Completed Pricing Schedule;

1. Country-of-Origin and Place-of-Manufacture Table;

1. Trade Agreements information/certification;

1. Manufacturer/product literature for equal products;

1. Proposed delivery schedule;

1. Warranty information;

1. Quoter’s legal business name;

1. Unique Entity Identifier (UEI);

1. CAGE Code, if applicable;

1. Business address;

1. Point of contact;

1. Telephone number;

1. Email address; and

1. Quotation validity period.

The Government recommends that quotations remain valid for at least 60 calendar days after the quotation due date.

29. QUOTATION ACCEPTANCE AND PURCHASE ORDER

A quotation submitted in response to this RFQ is not an offer that creates a binding contract upon Government acceptance.

The Government may issue a purchase order to the successful quoter.

The purchase order constitutes the Government’s offer to purchase the products and services identified in the order under the stated terms and conditions.

A binding contract will be formed upon the supplier’s acceptance of the Government’s purchase order in accordance with applicable RFO FAR Part 12 procedures, including written acceptance when requested or substantial performance.

30. GOVERNMENT RIGHTS

The Government reserves the right to:

· Amend or cancel this solicitation;

· Request clarifications;

· Request additional supporting documentation;

· Verify technical representations;

· Verify past-performance information;

· Verify country-of-origin information;

· Verify place-of-manufacture information;

· Verify pricing;

· Determine price reasonableness;

· Reject incomplete quotations;

· Reject technically unacceptable quotations;

· Reject quotations that do not comply with applicable Trade Agreements requirements; and

· Make no award if award is not in the Government’s best interest.

The Government is not responsible for costs incurred by quoters in preparing or submitting quotations.

31. ATTACHMENTS

The following documents are incorporated into this solicitation:

Attachment 1 – Statement of Work Attachment 2 – Government Pricing Spreadsheet Microelectrode Array System – Brand Name or Equal Quoters shall use the applicable pricing tab for:

· Brand Name; or

· Equal Product.

Attachment 3 – Technical Compliance Matrix Attachment 4 – Past Performance Form Attachment 5 – Country of Origin / Trade Agreement Certificate Attachment 6 – Mandatory Country of Origin Spreadsheet

32. ORDER OF PRECEDENCE

In the event of an inconsistency among solicitation requirements, the resulting purchase order will be interpreted in accordance with the applicable order-of-precedence requirements contained in FAR 52.212-4 and the final award document.

Quoters shall notify the Contracting Officer before the quotation due date of any apparent conflict, ambiguity, or inconsistency in the solicitation documents.

33. CONTRACTING OFFICER

Michele Jackson Contracting Officer FDA Office of Acquisitions and Grants Services (OAGS) U.S. Food and Drug Administration michele.jackson@fda.hhs.gov

END OF COMBINED SYNOPSIS/SOLICITATION

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