Sol_75N98026Q00718.pdf

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

THIS RFQ IS IS NOT A SMALL BUSINESS SET-ASIDE

15. DATE OF QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

b. TELEPHONE

AREA CODE

NUMBER

STANDARD FORM 18 (REV. 6/1995)

Prescribed by GSA-FAR (48 CFR) 53.215-1(a)

AUTHORIZED FOR LOCAL REPRODUCTION

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8. TO:

b. COMPANYa. NAME

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d. CITY e. STATE f. ZIP CODE

9. DESTINATION

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7. DELIVERY

FOB DESTINATION

OTHER

(See Schedule)

10. PLEASE FURNISH QUOTATIONS TO THE

ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

IMPORTANT: This is a request for information and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotation must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NUMBER

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS (%) b. 20 CALENDAR DAYS (%) c. 30 CALENDAR DAYS (%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER

a. NAME OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

PAGE OF PAGES

1. REQUEST NUMBER 2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NUMBER 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY 6. DELIVER BY (Date)

NAME TELEPHONE NUMBER

AREA CODE NUMBER

c. CITY

5b. FOR INFORMATION CALL (NO COLLECT CALLS)

National Institutes of Health OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05 Bethesda, MD 20892-7511

75N98026Q00718

JADDUA JOHNSTON

+10

000-000000

06/30/2026

07/22/2026 1200 ED

Multiple

The purpose of this COMPETITIVE COMBINED

SYNOPSIS / SOLICITATION is to acquire

Lipid Nanoparticle Generator System

Period of Performance: 08/03/2026 to

11/30/2026

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 address:

HTTPS://ACQUISITION.GOV/FAR

Continued...

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGES

NAME OF OFFEROR OR CONTRACTOR

SUPPLIES/SERVICES

(B)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

OPTIONAL FORM 336 (4-86)

Sponsored by GSA FAR (48 CFR) 53.110

ITEM NO.

(A)

QUANTITY

(C)

NSN 7540-01-152-8067

75N98026Q00718

The following FAR clauses and Provisions are applicable to this award.

FAR 52.204-13 System for Award Management

Maintenance (Oct 2018);

FAR 52.204-18 Commercial and Government Entity

Code Maintenance (Aug 2020);

HHSAR 352.222-70, Contractor Cooperation in

Equal Employment Opportunity Investigations

(Dec 2015).

FAR 52.212-4 Contract Terms and Conditions -In addition to all the applicable commercial

Products and Commercial Services (Nov 2023)

FAR 52.212-5 Contract Terms and Conditions

Required to Implement Statutes or Executive

Orders/Commercial Products and Commercial

Services (Jan 2025)

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE

Award enclosure:

Quote

IPP Invoicing and Payment Provisions

To avoid delay in payment, all invoices must be uploaded into the invoicing processing platform

(IPP) (https://www.ipp.gov). The invoice must match the line item description on the purchase order. It must also state that payment is to be made using a three-way match.

You are reminded that only the contracting officer of record can make any changes to this award any changes made at the direction of the program without an executed modification and null and void and are done at the contractor's own risk.

COMBINED SYNOPSIS / SOLICITATION (COMPETITIVE)

Title: Lipid Nanoparticle Generator System

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N98026Q00718. This solicitation is issued as a competitive combined synopsis/solicitation for commercial products or commercial services. The Government intends to award a contract or purchase order resulting from this solicitation using full and open competition.

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Services, and is not expected to exceed the simplified acquisition threshold (if applicable).

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, seeks to award a (Firm-Fixed-Price) to the responsible offeror whose proposal represents the best value to the Government.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular effective May 29, 2026

(iv) The associated NAICS code is 334516 – Analytical Laboratory Instrument Manufacturing and the small business size standard is 1,000 Employees.

This requirement is unrestricted.

(v) Description of Requirement:

Generic Name of Product: Lipid Nanoparticle Generator System, including required accessories, software, training, and warranty..

Purchase Description: For reference purposes, the PreciGenome NanoGenerator Flex-M is identified as a representative system; however, brand name or equal products will be considered that meet or exceed the salient characteristics outlined below.

Note: If a foreign-manufactured product is selected, applicable regulatory requirements (e.g., Buy American Act considerations) will be addressed as part of the acquisition process.

4. Salient characteristics The system must meet the following minimum physical, functional, and performance requirements:

• Utilize microfluidic technology (or equivalent) to enable controlled and reproducible nanoparticle synthesis

• Throughput capability of approximately 0.1 to 15 mL per sample, with the ability to process 1 to 4 samples per run

• Adjustable flow parameters, including total flow rate (approximately 3–4 mL/min) and flow rate ratio (approximately 3:1 or equivalent tunability)

• Capability to produce nanoparticles with:

o Size range: ~40–200 nm o Polydispersity Index (PDI): ~0.05–0.2

• Encapsulation efficiency of approximately 85–95% (or equivalent performance)

• Ability to encapsulate multiple payload types, including DNA, mRNA, siRNA, proteins, and small molecules

• Integrated control interface (e.g., touchscreen or software-based system) for parameter adjustment and automation

• Compact, benchtop-compatible design suitable for laboratory environments

• Inclusion of essential components (e.g., controller, microfluidic chips, reservoirs, tubing, connectors)

• Warranty and on-site or virtual training included

Quantity: One (1) system, including required accessories and components.

Installation: Installation and initial system setup shall be coordinated with NCATS personnel and completed at a mutually agreed-upon date and time.

(vi) Delivery Location:

Delivery Address: 9808 Medical Center Drive, Building E, Room 205, Rockville, MD 20850

(vii) [Reserved, if needed]

(viii) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition. Add any agency-specific instructions as required.

(ix) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation represents the best value to the Government, price and other factors considered.

(b) Evaluation Factors:

• Price

• Technical capability

• Past performance

• Delivery schedule

(c) A written notice of award or acceptance of an offer, issued within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer before the expiration date.

(x) Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, with their offer.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items, applies to this acquisition.

(xiii) Additional contract requirements or terms and conditions, as determined necessary by the Contracting Officer and consistent with customary commercial practices:

NONE

(xiv) The Defense Priorities and Allocations System (DPAS) is not applicable.

(xv) Submission Requirements:

Responses must include sufficient information to demonstrate the offeror’s capability to provide the required product or service. Quotes shall include, at a minimum:

• Unit and total price

• Shipping and handling costs

• Delivery timeframe after award

• Delivery terms

• F.O.B. point (destination or origin)

• Product or catalog numbers (if applicable)

• Product/service description

Additional evaluation considerations may include past performance, warranty, lifecycle cost, maintenance availability, and environmental or energy efficiency.

Responses must include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by (July 22, 12:00PM, EST) and must reference solicitation number 75N98026Q00718. Responses may be submitted electronically to Jaddua.johnston@nih.gov

(xvi) Point of Contact:

Jaddua Johnston

Contracting Specialist

240-569-0006

Jaddua.Johnston@nih.gov mailto:Jaddua.johnston@nih.gov

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

Lipid Nanoparticle (LNP) Generator System (Brand Name or Equal to PreciGenome NanoGenerator Flex-M)

1. Statement of Need and Purpose: This requisition is to procure a lipid nanoparticle

(LNP) generator system, brand name or equal to the PreciGenome NanoGenerator Flex- M, for the Formulation Lab within the Therapeutic Development Branch (TDB), Division of Preclinical Innovation (DPI) at NCATS. The system will support ongoing projects focused on the development of lipid nanoparticle (LNP) formulations for drug delivery applications, enabling encapsulation of therapeutic agents to improve stability, bioavailability, and targeted delivery.

2. Background Information and Objective:

The NCATS TDB supports the advancement of therapeutics from early-stage discovery through preclinical development, including activities required to enable Investigational New Drug (IND) applications. The Formulation Lab plays a critical role in developing drug delivery systems, including lipid-based nanoparticles, to ensure therapeutic candidates are safe, stable, and effective.

An LNP generator system is required to enable reproducible, small-scale formulation development and process optimization. The system must support the synthesis of lipid nanoparticles for a variety of payloads (e.g., RNA, DNA, proteins, and small molecules) and allow precise control over formulation parameters to ensure consistency and scalability.

3. Generic Name of Product: Lipid Nanoparticle Generator System, including required accessories, software, training, and warranty..

4. Purchase Description: For reference purposes, the PreciGenome NanoGenerator Flex-M is identified as a representative system; however, brand name or equal products will be considered that meet or exceed the salient characteristics outlined below.

Note: If a foreign-manufactured product is selected, applicable regulatory requirements (e.g., Buy American Act considerations) will be addressed as part of the acquisition process.

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

5. Salient characteristics The system must meet the following minimum physical, functional, and performance requirements:

• Utilize microfluidic technology (or equivalent) to enable controlled and reproducible nanoparticle synthesis

• Throughput capability of approximately 0.1 to 15 mL per sample, with the ability to process 1 to 4 samples per run

• Adjustable flow parameters, including total flow rate (approximately 3–4 mL/min) and flow rate ratio (approximately 3:1 or equivalent tunability)

• Capability to produce nanoparticles with:

o Size range: ~40–200 nm o Polydispersity Index (PDI): ~0.05–0.2

• Encapsulation efficiency of approximately 85–95% (or equivalent performance)

• Ability to encapsulate multiple payload types, including DNA, mRNA, siRNA, proteins, and small molecules

• Integrated control interface (e.g., touchscreen or software-based system) for parameter adjustment and automation

• Compact, benchtop-compatible design suitable for laboratory environments

• Inclusion of essential components (e.g., controller, microfluidic chips, reservoirs, tubing, connectors)

• Warranty and on-site or virtual training included

6. Quantity: One (1) system, including required accessories and components.

7. Delivery Date: Delivery shall be made as soon as practicable after award.

8. Delivery Address: 9808 Medical Center Drive, Building E, Room 205, Rockville, MD

20850

9. Installation: Installation and initial system setup shall be coordinated with NCATS personnel and completed at a mutually agreed-upon date and time.

Title