MULTIPLE DELIVERY STANDING ORDER FOR EMD MILLIPORE/SIGMA BRAND DOWNSTREAM PROCESS DEVELOPMENT SUPPLIES (AMBIS 2224471)

This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and solicitation for commercial Items,” as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested.

The Solicitation number is RFQ-NIAID-24-2224471 and the solicitation is issued as a Request for Quotes (RFQ). This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP).

The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-04 May 22, 2024. The North American Industry Classification System (NAICS) code for this procurement is 334516, Analytical Laboratory Instrument Manufacturing, with a size standard of 1000 employees. The requirement is being competed with a brand name restriction and required delivery schedule, and without a small business set-aside.

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 50 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world.

Within NIAID, the Vaccine Research Center (VRC) is an intramural research center within NIAID dedicated to discovery and translational science for infectious disease indications. The VRC has full bench-to-bedside capabilities that enable rapid clinical evaluation of VRC discoveries. The VRC’s Vaccine Production Program Laboratory has process, formulation, and analytical development groups and oversees cGMP manufacturing at the VRC’s pilot plant.

Since the VRC/Vaccine Production Program (VPP) group is responsible for developing a scale able GMP process the items requested need to be standardized with what will be utilized in the VRC’s pilot plant and applicable to a GMP process and analytical standards that are used to characterize and release therapeutic and vaccine candidates to treat diseases including Covid-19 (SARS2-CoV), HIV, Influenza, Malaria, and Ebola.

Understanding these attributes are required for moving forward with a candidate to GMP manufacturing and clinical trials. We are requesting these Downstream Process Development supplies in support of vaccine and therapeutic candidates under a period of performance of July 2024 to July 2025. VPP requests receiving these listed replacement supplies in 4 shipments.

Clarisolve 20um Process Scale Depth Filters, 0.55 m2 (5.92 ft2), CAT# CS20MS05F1-X, Total Qty of 20, 5 per shipment Viresolve Prefilter Pod 0.1 m2 Flat Seal 1pk, CAT# MSPV01FS1, Total Qty of 4, 1 per shipment Millistak+ MicroPod X0HC 23 cm2 Luer 3pk, CAT# MX0HC23CL3, Total Qty of 4, 1 per shipment Shipping and Handling for 4 scheduled deliveries:

Shipment 1:

7/24/24 Shipment 2:

10/23/24 Shipment 3:

2/19/25 Shipment 4:

4/23/25 Place of Performance: NIH, 9 West Watkins Mill Road, Gaithersburg, MD 20878, United States.

FOB: Destination The government intends to award a firm fixed price purchase order to the responsible contractor as a result of this RFQ that will include the terms and conditions set forth herein. The award will be based on the following:

technical capability to meet the requirements, price and delivery. By submitting a quote in response to this solicitation, vendor is accepting the following terms and conditions: The following FAR provisions apply to this acquisition:

FAR 52.212-1 Instructions to Offerors Commercial Items (SEP 2023)

FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (MAY 2024)

FAR 52.204-7 System for Award Management (OCT 2018) (Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure FAR 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Nov 2015) is updated in your SAM record)

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements – Representation (JAN 2017)

FAR 52.204–26 Covered Telecommunications Equipment or Services-Representation (OCT 2020)

Must complete representation if attached to this solicitation- see attachment 52.204-26 The following FAR contract clauses apply to this acquisition: FAR 52-212-4 Contract Terms and Conditions Commercial Items (NOV 2023) FAR 52-212.5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (MAY 2024) *The applicable subparagraphs of FAR52.212-5 are included in the attachment to this posting.

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023)

FAR 52.204-13 System for Award Management Maintenance (OCT 2018)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (DEC 2015) 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 address: http://farsite.hill.af.mil/vffara.htm By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov).

Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov/far/loadmainre.html & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax. Submission shall be received not later than July 8, 2024 @ 4:00 PM EST All quotations and required documents must be submitted via the NIAID electronic Simplified Acquisition Submission System (eSASS) website at https://esass.nih.gov. All vendors must register in the eSASS system to submit a quotation.

Instructions on how to register / submit quotes are included on the website. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responsible sources may submit an offer that will be considered by this Agency.