SOLICITATION NOTICE
66 -- myControl Cell Culture Bioreactors
- Notice Date
- 9/15/2022 10:51:01 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- NIAID-RFQ-22-2130275
- Response Due
- 9/21/2022 12:00:00 PM
- Archive Date
- 10/06/2022
- Point of Contact
- Tonia Alexander, Phone: 2406695124
- E-Mail Address
-
talexander@niaid.nih.gov
(talexander@niaid.nih.gov)
- Description
- 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-22-2132593 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 2022-07 Effective August 10, 2022. 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 restriction, 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. � STATEMENT OF NEED The National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Production Program (VPP) has a requirement to obtain eight (8) my-Control Cell Culture Bioreactors.� It is the function of the VPP to ensure that all VRC projects which are projected to proceed to clinical trials, go through a rigorous development phase prior to the Good Manufacturing Practices (GMP) manufacturing of candidates, such that the Chemistry, Manufacturing Controls (CMC) section of the Federal Drug Administration (FDA), Investigation New Drug Application (INDA) can be properly vetted to ensure success at the 2000L scale GMP manufacturing scale.� The VRC, VPP development of the vaccine candidates require complete functional mammalian bioreactor control systems for a variety of reactor types and sizes from 3L to 50L which can mimic the GMP manufacturing equipment.� This development requires equipment capable of providing constant readings of multi parameters such as dissolved gas control, temperature control, agitation, and pH control.� To ensure the VPP mission continues to develop these potentially life-saving vaccine candidates and biotherapeutic candidates it is in great need of a state-of-the-art bioreactor control systems with capabilities that can address the multiple projects of the laboratory and must replace and upgrade the current aged equipment.� The main objective is to replace of aged controllers that have reached its life expectancy with new equipment that has the capability to provide the necessary control and monitoring parameters for the scale up of mammalian cell culture, which is for the advancement of vaccine and biotherapeutic candidates for investigational new drug submission and good manufacturing practice manufacturing.� BRAND NAME OR EQUAL REQUIREMENTS/SPECIFICATIONS This acquisition is for Brand Name or Equal products/services.� The brand name and model numbers for the products are summarized below. Quantity - Eight (8) my-Control Cell Culture Bioreactors, #ZCX03MY04786 Quantity � One (1) Standard Installation and Hardware Training Quantity � One (1) Transportation (shipment) The systems must meet the following: - control up to 8 parallel bioreactor systems during fed-batch or perfusion cell culture operations. -control bioprocess parameters including pH, temperature, dissolved oxygen, agitation, foam and volume level. -provide PID (Proportional-Integral-Derivative) control with selectable autotuning adaptive control. - compatibility with 3L, 15L, and 20L glass bioreactor vessels to avoid with minimal retrofitting to avoid additional expenditure on purchase of multiple vessels and headplates: � a. 3L Single Wall Glass Bioreactor Vessel (Applikon V3MC010021) � b. 3L Glass Vessel Head (top) Plate (Applikon V3MC010011) � c. 15L Single Wall Glass Bioreactor Vessel (Applikon V3ME010041) � d. 15L Glass Vessel Head (top) Plate (Applikon V3ME010023) -utilize electrical heating (and cooling if applicable) system for both the bioreactor and condenser (water/glycol cooled connections are not acceptable). -control customizable single use reactors specifically, Appliflex ST from Applikon and Mobius� from EMD Millipore to allow flexibility in experimental design. -accommodate third party sensors used in either real or near real time analytical technologies, such as but not limited to pH, DO and like Raman fiber optic probes. -support up to three mass flow control requirements at or above 1500 sccm or 1.5 LPM. -seamlessly integrate with VPP�s Lucullus bioprocess automation system without the additional need to acquire new licensing agreement (Explanation: The VPP�s Lucullus license only covers Applikon controllers. An additional licensing agreement will need to be executed if we decide to purchase controllers from a different vendor, with added cost). -compatibility with existing XCell ATF System (ATF2 C24 V2 controller system � Refine Technology, Pine Brook, NJ) for upstream perfusion applications. -utilize up to 4 built-in pumps per controller and support usage of existing pump-related consumables (e.g. tubing sizes with I.D. of 0.063 - 0.125 in. and O.D of 0.189 - 0.250 in.). -utilize a USB connection to access peripheral equipment like balances and computer keyboard. -Preferred Space-saving footprint to maximize limited lab counterspace. 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 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 is 22 � 24 weeks from date and acceptance of award.� SHIPPING/DELIVERY FOB Point shall be Destination, Gaithersburg, MD 20878.� Place of delivery is Vaccine Production Program (VPP), 9 West Watkins Mill Road, Suite 250, Gaithersburg, MD 20878.� All equipment delivered shall contain a Packing Slip (with serial numbers when applicable). INSTRUCTIONS All interested offerors shall provide a Quote to include a point of contact (name, phone number & email) and company information (Unique Entity Identifier (UEI) and Cage Code).� Each response must clearly indicate the capability of the vendor to meet all specifications and requirements.� State whether the Offeror is the manufacturer and include Country of Origin information.� The Government may evaluate only those quotes that fully meet the requirements as outlined and respond to the solicitation instructions and requirements.� Failure to furnish a full and complete quote as instructed may result in the Vendor being considered non-responsive and eliminated from further consideration and award. By submission of an offer, the offeror acknowledges the requirement that a prospective awardee must be registered in the System for Award Management (SAM) www.sam.gov 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).� [Note: Lack of registration in the SAM will make a vendor ineligible for award]. Quotes are due by 3:00pm EST on Wednesday, September 21, 2022.� Quotes must be emailed to the attention of Tonia Alexander at talexander@niaid.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 talexander@niaid.nih.gov. �� EVALUATION NIAID will evaluate quotes to determine the best value to the government.� NIAID will make that determination based on technical acceptability, warranty, price, and delivery.� NIAID will evaluate 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).� 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.� The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment on the website at https://oamp.od.nih.gov/DGS/DGS-workform- information/attachment-files.� The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF).� The Contractor must submit only one invoice per email.� Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer. REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (SECTION 889) All offerors shall have current documentation showing representation of compliance with �Section 889 provisions.� Prior to award of delivery order resulting from solicitation, quoters shall be prepared to provide copy of section 889 compliance if requested by the Contracting Officer.� SECTION 508 Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. �Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities. Vendors must identify whether a quoted Information and Communication Technology (ICT) product or service is compliant with the Section 508 accessibility standards at 36 CFR 1194. �The quote must also identify where full details of compliance can be found (e.g., vendor's website or other exact location.)� For more information on Section 508 standards visit https://www.section508.gov/. PROVISIONS AND CLAUSES The following Federal Acquisition Regulation (FAR) provisions and clauses apply to this acquisition: FAR 52.203-18 - Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements - Representations FAR 52.203-19 - Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements FAR 52.204-7 - System for Award Management FAR 52.204-13 - System for Award Management Maintenance FAR 52.204-16 - Commercial for Government Entity Code Reporting FAR 52.204-21 - Basic Safeguarding of Covered Contractor Information Systems FAR 52.204-24 - Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment �FAR 52.204-25 - Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment FAR 52.204-26 - Covered Telecommunications Equipment or Services-Representation. FAR 52.209-7 - Information Regarding Responsibility Matters FAR 52.211-6 - Brand Name or Equal (Aug 1999).� (a) If an item in this solicitation if 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 characteristics specified in the 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 modification 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� products, the offeror shall provide the brand name product referenced in the solicitation.� (End of provision). FAR 52.212-1 - Instructions to Offerors � Commercial Items FAR 52.212-3 - Offeror Representations and Certification � Commercial Items FAR 52.212-4 - Contract Terms and Conditions � Commercial Items FAR 52.212-5 - Contract Terms and Conditions Required to Implement Status or Executive Orders Statements � Representation (see attached) FAR 52.232-25 - Prompt Payment FAR 52.232-40 - Providing Accelerated Payments to Small Business and Subcontractors FAR 52.242-15 - Stop-Work Order FAR 52.252-2 - Clauses Incorporated by Reference By reference the Department of Health and Human Services Acquisition Regulation (HHSAR) provisions and clauses that are applicable to this requirement: HHSAR 352.203-70 - Anti-lobbying HHSAR 352.208-70 - Printing and Duplication HHSAR 352.222-70 - Contractor Cooperation in Equal Employment Opportunity Investigations HHSAR 352.223-70 - Safety and Health HHSAR 352.224-71 - Confidential Information HHSAR 352.232-71 - Electronic Submission of Payment Requests HHSAR 352.239-73 - Electronic and Information Technology Accessibility Notice
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/a7f281f465e746fdba21a1329b7d1b86/view)
- Place of Performance
- Address: Gaithersburg, MD 20878, USA
- Zip Code: 20878
- Country: USA
- Zip Code: 20878
- Record
- SN06467544-F 20220917/220915230136 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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