ALP: CDER-2026-135968

Human Hindbrain Organoid Functional Assay Services 1

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COMBINED SYNOPSIS/SOLICITATION

1. GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number RFQ_CDER-2026-135968 is issued as a/an RFQ for Human Hindbrain Organoid Functional Assay Services.

This acquisition [☐ is / ☒ is not] set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov/ | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

This acquisition is being solicited on a sole-source basis to OrganoTherapeutics SARL pursuant to RFO FAR 12.102(a). The Government's market research determined that only one source is available to satisfy the complete requirement. All responsible sources may submit a quotation and supporting capability information by the closing date, which will be considered by the agency.

All responsible sources may submit a [☒ quotation ☐ bid ☐ proposal], which will be considered by the agency.

NAICS Code: 541714 - Research and Development in Biotechnology (except Nanobiotechnology) Small Business Size Standard: 1,000 employess Set-Aside: ☒ None ☐ Total Small Business ☐ WOSB ☐ SDVOSB ☐ 8(a) ☐ HUBZone ☐ Other: [specify]

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: Functional characterization services shall be performed at the Contractor's laboratory. Deliveries, returned samples, data, and reports shall be provided to U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 64, Room 2069, Silver Spring, MD 20993, Attn: Jun Zhao, in accordance with the PWS.

FOB Point: Destination Inspection and Acceptance: Inspection and acceptance shall be performed in accordance with clause 52.246-4, Inspection of Services—Fixed-Price, and the acceptance criteria in the Performance Work Statement.

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Period of Performance

The period of performance shall be eighteen (18) months from the date of award.

3. CONTRACT LINE ITEMS (CLINs)

CLIN Description Qty Unit Unit Price Total Price

0001 Human Hindbrain Organoids and Associated Culture Materials, including twelve

(12) scheduled deliveries in accordance with PWS Task 1

1 LOT

Functional Characterization Services, including 3D MEA testing, drug-response studies, data analysis, study reports, and sample return in accordance with PWS Task 2

1 LOT

4. POINTS OF CONTACT

Contracting Officer:

Name: Iris Johnson Email: Iris.Johnson1@fda.hhs.gov Phone: (301) 796-3353

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5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

Appl. Clause/Prov.

No.

Title Date

REQ 52.212-4 Terms and Conditions—Commercial Products and Commercial Services

Nov 2025

REQ 52.203-17 Contractor Employee Whistleblower Rights Nov 2025

X 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

Jan 2017

REQ 52.204-13 System for Award Management—Maintenance Nov 2025

REQ 52.204-91 Contractor Identification Nov 2025

X 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

Nov 2025

REQ 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations

Nov 2025

X 52.222-50 Combating Trafficking in Persons Nov 2025

REQ 52.222-90 Addressing DEI Discrimination by Federal Contractors Apr 2026

X 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving

May 2024

REQ 52.232-33 Payment by Electronic Funds Transfer—System for Award Management

Oct 2018

X 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

Mar 2023

REQ 52.233-3 Protest After Award Nov 2025

REQ 52.233-4 Applicable Law for Breach of Contract Claim Nov 2025

REQ 52.240-91 Security Prohibitions and Exclusions (or with Alt I) Nov 2025

X 52.240-93 Basic Safeguarding of Covered Contractor Information Systems

Nov 2025

REQ 52.244-6 Subcontracts for Commercial Products and Commercial Services

Nov 2025

REQ 52.246-4 Inspection of Services—Fixed-Price Nov 2025

REQ HHSAR

352.232-71

Electronic Submission of Payment Requests APR 2026

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5B. 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. 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://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar (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 FAR 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 Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the 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 Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. 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.

3. 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 receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. 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 hours 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).

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

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

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, 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 Delivery 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 U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, 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.

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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. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(End of clause)

6. PERFORMANCE WORK STATEMENT

Attachment 1, Performance Work Statement (PWS), OCP/DARS Human Hindbrain Organoids and Functional Assay Services, is incorporated into this solicitation. The Contractor shall provide the human hindbrain organoids, associated culture materials, scheduled deliveries, functional characterization services, data, reports, and sample returns in accordance with the

PWS.

Sole-Source Restriction: This acquisition is restricted to OrganoTherapeutics SARL pursuant to RFO FAR 12.102(a). The Government's sole-source documentation is maintained in the contract file. Any responsible source that believes it can satisfy the complete requirement may submit a quotation and supporting capability information by the solicitation closing date for consideration.

A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Appl. Clause/Prov.

No.

Title Date

REQ 52.204-7 System for Award Management—Registration Nov 2025

X 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions

Sep 2024

X 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements— Representation

Jan 2017

X 52.204-90 Offeror Identification (use in lieu of 52.204-7 if SAM registration not required — see RFO 12.205(a)(4))

Nov 2025

Basis for Award Basis for Award - Best Value: The Government intends to issue a single firm-fixed-price purchase order. Award will be made to the responsible quoter whose quotation represents the best value to the Government, considering Technical Capability, Past Performance, and Price.

Technical Capability and Past Performance, when combined, are more important than Price.

Technical Capability will be evaluated based on the quoter's demonstrated ability to satisfy all

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FDA OAGS | Simple Services | Page 7 of 8 requirements of the PWS. Past Performance will be evaluated for relevance and quality; a quoter without relevant past performance will not be evaluated favorably or unfavorably solely for that reason. Price will be evaluated for reasonableness and shall be inclusive of all transportation and shipping charges to the FDA delivery destination.

A2. Addenda to 52.212-1

Offer Acceptance Period (if applicable):

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of offers from 60 calendar days to 90 calendar days from the date specified for receipt of offers.

B. OFFER SUBMISSION

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice no later than September 14, 2026, 10:30 AM ET.

Questions and answers may be posted as an amendment to this solicitation on SAM.gov.

Offers Due: As listed on the SAM.gov notice.

Submission Method: Email to the POCs listed in the SAM.gov posting.

Preferred File Format: Searchable PDF and Excel Page Limit (if applicable): N/A

Offerors Shall Submit:

• Technical quotation demonstrating compliance with the PWS, including the required organoid characteristics, delivery capability, functional characterization approach, controlled-substance laboratory capability, and data/report deliverables.

• Price quotation by CLIN. Prices shall be firm-fixed-price and inclusive of all shipping, transportation, and other costs necessary to satisfy the PWS.

• Past performance information for up to three recent and relevant Government or commercial contracts/orders performed within the past five years. If no relevant past performance is available, state so.

• Unique Entity Identifier (UEI) and confirmation of active SAM.gov registration.

• Proposed delivery/performance schedule confirming the ability to meet the PWS requirements.

• Statement confirming acceptance of the solicitation terms and conditions, or identification of any exception taken.

Points of Contact As listed on the SAM.gov notice.

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C. ADDITIONAL INFORMATION

Amendments:

Any amendments to this solicitation will be posted to SAM.gov. It is the offeror's responsibility to monitor SAM.gov for any amendments.

Attachments:

Attachment 1 - Performance Work Statement, OCP/DARS Human Hindbrain Organoids and Functional Assay Services