Amendment 001_RFQ - Mammalian Bioreactor Control System.pdf

Request for Quotes (RFQ) Solicitation ID: RFQ-NIAID-23-2177803

Mammalian Bioreactor Control System – Brand Name or Equal Amendment #001

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-23-2177803 and the solicitation is issued as a Request for Quotes (RFQ).

This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP), FAR Subpart

13.5 – Simplified Procedures for Certain Commercial Items. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2023-04 Effective June 2, 2023.

The North American Industry Classification System (NAICS) code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing with a size standard of 1,000 employees. The Product or Service Code (PSC) is 6640 – Laboratory Equipment and Supplies. The requirement is being competed as full and open competition, with a brand name or equal purchase description, and without a small business set-aside.

The government intends to award a firm-fixed-price purchase order to the responsible offeror as a result of this RFQ that will include the terms and conditions set forth herein. By submitting a quote, the offeror is accepting that all government terms and conditions shall prevail over the award.

By submission of a quote, the Offeror acknowledges the requirement that a prospective awardee shall be registered and viewable in the System for Award Management (SAM) database prior to award, during performance, and through final payment resulting from this solicitation (www.sam.gov).

STATEMENT OF NEED

The purpose of the acquisition is to procure a mammalian bioreactor control system for the Vaccine Production Program (VPP)/Vaccine Research Center (VRC).

The Vaccine Production Program (VPP) is the development arm of the Vaccine Research Center. The mission of the VRC is to create and develop potentially lifesaving vaccines for HIV, Ebola, Zika, and other known pathogens and get these potentially lifesaving products into the clinic.

The Cell Culture Development (CCD) team feeds into and generates work for the Downstream, Analytical, and Formulations departments at the VPP. This acquisition ensures CCD has a fleet of reliable bioreactor controllers compatible with:

• Stocked bioreactor vessels

• Available bench space and power supply

• Current SCADA software

• VLAN restrictions

• Built in data redundancy

• Existing operational training and method development

Objectively, robust Cell Culture Development (CCD) prevents bottlenecks and work stoppage, and improves rapid response, available throughput, and operational preparedness for the entire VPP.

Replacement of all Bioreactor Controllers utilized by the VPP’s CCD team for mammalian cell culture at 3 L, http://www.sam.gov/

15 L, and 3 L perfusion development processes is overdue. The Controllers have all been in service for 10 years or longer and reached or exceeded the threshold for lifecycle replacement. Additionally, eight (8) 3 L bioreactor vessels have sustained damage, in the form of chips and cracks, over the years. Four (4) of these vessels no longer form a seal and must be replaced, the remaining four may fail but at present appear to form and keep a sterile seal during operation. This is normal wear and tear, however maintaining the stock of 3 L bioreactor vessels is essential to VPP’s operational preparedness and ability to support the VRC mission.

These types of instruments are needed to fulfill this requirement.

The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for a brand name or equal Mammalian Bioreactor Control Systems. The brand name and part numbers for the products/services are provided in full detail in the attached Bill of Materials (BOM) – Attachment 1. If quoting an equal product, you must show in your quote how the quoted instruments meet the minimum requirements/specifications listed below.

This is for the procurement of one Mammalian Bioreactor Control System and associated Controller instruments to produce vital organisms for vaccine production of various known pathogens, with brand name or equal products capable of the following:

• Support 2 bioreactor vessels simultaneously, running separate experiments

• Enable day-of configuration of gas flow via built in mechanism

• Functionality with in-house gas pressure of 22 psi gas flow

• Can operate 1 – 20 L bioreactor vessels

• Microbial Fuel Cell (MFC) fully configurable

• 5th MFC for 3 L bioreactor runs

• Compatible with in-house gas pressure

• Local and networked control

• Archive Run Data

• Integrate with Lucullus software

• Self-contained modular set-up

• Integrates with existing VRC hardware, network, and Lucullus software infrastructure

The mammalian bioreactor controller needs are as follows:

• 4 EA ATF EZ Controllers (2 dual Livits) (brand name or equal)

• 6 EA 15-20 L EZ Controllers (3 dual Livits) (brand name or equal)

• 12 EA 3 L EZ Controllers (6 dual Livits) (brand name or equal)

The bioreactor control system and the associated controllers must be compatible with VRC’s needs. The contractor must provide installation services and bioreactor control system training support.

QUOTING REQUIREMENT

All elements below must be included in the quote for your quote to be considered responsive:

• If not brand name, documentation to prove how the “of equal” model/part meets the salient physical, functional, or performance characteristic specified in this solicitation.

• Country of Origin

• Place of Manufacture

• Estimated date of delivery

• Estimated shipping fees

PERIOD OF PERFORMANCE

Delivery is requested as soon as possible. Estimated lead time for delivery of equipment is 180 days upon

Vendor’s receipt of the purchase order.

SHIPPING/DELIVERY INSTRUCTIONS

Delivery location is VRC’s Gaithersburg, Maryland facility at 9 West Watkins Mill Road, Gaithersburg, MD 20878. FOB: Destination. All equipment delivered shall contain a Packing Slip (with serial numbers when applicable).

INSTRUCTIONS

All interested offerors shall provide a quote for the requirement as outlined above. All quotes shall include price(s) (unit price, extended price, total price); shipping fees; manufacturing country of origin of the products, including components; documentation demonstrating vendor is either the manufacturer or authorized distributor/reseller of the product(s); estimated date of delivery; point of contact: name, phone number & email; UEI#; Cage Code; business size under NAICS 334516; and payment terms. Each response must clearly indicate the capability of the vendor to meet all specifications and requirements. The Government may evaluate only those quotes that fully meet the requirements as outlined above and respond to the instructions and requirements provided in this solicitation. Failure to furnish a full and complete quote as instructed may result in the Offeror’s response being considered non-responsive and will therefore be eliminated from further consideration and award.

If providing an equal product(s)/services(s), please supply descriptive data for evaluation purposes to determine the validity of how it is an EQUAL. The following FAR provision applies to this a solicitation FAR 52.211-6 Brand Name or Equal (Aug 1999):

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

Quotes are due by 9:00 am EDT on September 25, 2023. Quotes must be emailed to Kelly Dempsey, Contract Specialist, at kelly.dempsey@nih.gov. Late quotes will not be considered. All responsible sources may submit an offer that will be considered by this Agency. Any questions or concerns regarding this combined synopsis/solicitation should be emailed to kelly.dempsey@nih.gov.

EVALUATION

NIAID will evaluate quotes to determine the best value to the government. NIAID will make that determination based on technical acceptability, price, and past performance. NIAID will evaluate past performance and price only for those quotes which are rated as technically acceptable. In the event quotes are evaluated as technically equal, price will become a major consideration in selecting the successful Offeror.

SPECIAL NOTICE TO OFFERORS

Offerors are advised that the Government may share your information with non-government personnel who are assisting with the evaluation of quotes. The exclusive responsibility for source selection will reside with the Government. By submitting your quote, you will be consenting to disclosure of your quote to non-government personnel for purposes of evaluation.

ELECTRONIC INVOICING

The successful offeror may submit an invoice once a shipment is delivered. NIAID will only accept invoices for units that have been delivered to NIAID.

NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). For contractors that have transitioned to IPP, the Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov. For contractors that have not transitioned to IPP, the Contractor shall submit invoices to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at invoicing@nih.gov with a copy to the approving official until the Contractor has been notified of its transition to IPP.

PROVISIONS AND CLAUSES

FAR 52.252-21 Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions 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.

The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquistion.gov/

The following FAR provisions apply to this acquisition:

FAR 52.203-18 – Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements – Representations (Jan 2017) FAR 52.204-7 – System for Award Management (Oct 2018) FAR 52.204-16 – Commercial for Government Entity Code Reporting (Aug 2020) FAR 52.204-24 – Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 – Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.209-7 – Information Regarding Responsibility Matters (Oct 2018) FAR 52.211-6 – Brand Name or Equal (Aug 1999) FAR 52.212-1 – Instructions to Offerors – Commercial Products and Commercial Services (Nov 2021) mailto:daveta.brown@nih.gov mailto:kelly.dempsey@nih.gov https://www.ipp.gov/ https://ofm.od.nih.gov/Pages/Home.aspx https://ofm.od.nih.gov/Pages/Home.aspx https://ofm.od.nih.gov/Pages/Home.aspx mailto:invoicing@nih.gov https://www.acquistion.gov/

FAR 52.212-3 – Offeror Representations and Certifications – Commercial Products and Commercial Services (May 2022) FAR 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://www.acquistion.gov/

FAR 52.204-13 – System for Award Management Maintenance (Oct 2018) FAR 52.204-18 – Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.204-21 – Basic Safeguarding of Covered Contractor Information Systems (Nov 2021) FAR 52.212-4 – Contract Terms and Conditions – Commercial Products and Commercial Services (Dec 2022) FAR 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)

The following additional clauses are applicable to this requirement and provided in full text as an Attachment:

FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Products and Commercial Services (Sept 2023)

By reference the Department of Health and Human Services Acquisition Regulation (HHSAR) provisions and clauses that are applicable to this requirement. Copies are available from http://www.hhs.gov/policies/hhsar/:

Provisions HHSAR 352.239-73 – Electronic and Information Technology Accessibility Notice (Dec 2015)

Clauses HHSAR 352.203-70 – Anti-lobbying (Dec 2015) HHSAR 352.208-70 – Printing and Duplication (Dec 2015) HHSAR 352.222-70 – Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR 352.239-74 – Electronic and Information Technology Accessibility (Dec 2015)

By full text the Department of Health and Human Services Acquisition Regulation (HHSAR):

HHSAR 352.232-71 - Electronic Submission of Payment Requests (February 2, 2022)

LIST OF ATTACHMENTS

Attachment 1 – Bill of Materials (BOM) Attachment 2 – Full Text Clauses https://www.acquistion.gov/