Acquisition of an integrated cell processing device for automated, closed-environment manufacturing of cellular products by automation in a functionally closed ...

NON-COMPETITIVECOMBINED SYNOPSIS / SOLICITATIONTitle: Acquisition of an integrated cell processing device for automated, closed-environment manufacturing of cellular products by automation in a functionally closed environment(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.(ii) The solicitation number is NIHDA201800176 and the solicitation is issued as a request for quotation (RFQ).This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5- Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is expected to exceed the simplified

acquisition threshold.THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Center for Advancing Translational Sciences (NCATS) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to Miltenyi Biotec for a CliniMACS Prodigy Instrument.This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source.Pursuant to FAR Subpart 13.501 (a) (1) (iv) the rationale for the brand name justification is that the CliniMACS Prodigy instrument offers a number of features and specifications that are unquie to this specific vendor/instrument.(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-96, dated 11/6/2017.(iv) The associated NAICS code 334516 - Analytical Laboratory Instrument Manufacturing and the small business size standard is 1000 employees. This requirement has no set-aside restrictions.(v) The National Center for Advancing Translational Sciences (NCATS) is in need of an integrated cell processing device that allows manufacturing of cellular products by automation in a functionally closed environment. The requested automated, standardized cell manufacturing processes will enable NCATS to conduct research with innovative cellular therapies not currently accessible to NCGC.(vi) Purchase Description: CliniMACS Prodigy, Installation Service for CliniMAC Prodigy, and One-Time Planned Maintenance for CliniMAC prodigy.Specific Requirements:" Compact benchtop cell processing device (730.5×400×480 mm, w/o bag hangers)" Internal 8.4" TFT touchscreen monitor" Integrated cell processing from blood, bone marrow, leukapheresis product, or tissue" preparations to final product" Various single-use tubing sets for standardized processes and customized applications" Closed fluid path channeled by roller pump and 24 pinch valves" CentriCult Unit for centrifugation, temperature-controlled incubations, and cell culture" Disposable centrifugation chamber (400 ml) for up to 400 g acceleration" Automatic boundary layer detection" Controlled atmosphere via gas-mix unit for CO2, N2 and air" Temperature control from 4 - 38°C" Automated feeding and harvesting" Integrated cell culture microscope" MACS® cell separation unit for CliniMACS® Separation Columns" Multiple CliniMACS® Reagents for separation of various cell types" Network access via Ethernet interface (10/100Mbit) - upcoming feature" Remote diagnostics and support via internet access - upcoming feature" Two-dimensional bar code reader" 3 x USB-2, CompactFlash card reader" Status monitoring via indicator lamp on left bag hanger" Integrated speaker and alarm buzzer" Two independent, potential free relays for integration into alarm systemThese specifications are crucial to NCATS's stated need for "an integrated cell processing device that allows manufacturing of cellular products by automation in a functionally closed environment."(vii) Anticipated period of performace: One-time delivery within eight (8) weeks ARO.(viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition.(ix) The provision at FAR clause 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 will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:1. Technical Evaluation Factor: Offeror's technical approach will be evaluated for completeness, feasibility, soundness, and practicality for accomplishing the requirements of the Statement of Work (SOW).2. Delivery/Period of Performance Evaluation Factor: Contractor's ability to meet or exceed the delivery date/period of performance in the SOW.3. Cost/Price Evaluation Factor: Offeror(s) cost/price will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404.The Government will evaluate quotations on the basis of a tradeoff process. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price.(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.(x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer.(xi) The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition(xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition.(xiii) There are no additional contract requirement(s) or term and conditions applicable to this acquisition.(xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.(xv) Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order.In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."All responses must be received by 1:00pm, Eastern Standard Time, Friday, May 11, 2018 and reference number NIHDA201800176. Responses may be submitted electronically to Jessica Adams, Contract Specialist, at jessica.adams@nih.gov.Fax responses will not be accepted.(xvi) The name and telephone number of the individual to contact for information regarding the solicitation: Jessica Adams, Contract Specialist, at jessica.adams@nih.gov.