75N95024Q00494

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Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Human and Mouse Hepatopac plates for the National Center for Advancing Translational Sciences
Contracting Office
National Institute on Drug Abuse (NIDA)

Contact Points

Primary Contract Specialist

Nick
Niefeld
nick.niefeld@nih.gov
NAICS Code Number
325414
Biological Product (except Diagnostic) Manufacturing
Small Business Size Standard
1,250
FPDS Classification Code
6505
Estimated Period of Performance
60 Days ARO
Competition Status
Non-Competitive
Vendor Name
Bioivt, LLC
Vendor Address
123 Frost Street, Suite 115, Westbury, NY 11590-5030
Single-Sole Source Determination
A patent, copyright, proprietary data, or licensing agreement limits competition. The proprietary data are described as “HEPATOPAC cultures, formed using a proprietary patterning method, consist of hepatocyte “islands” surrounded with supportive stromal cells. This specialized architecture replicates the physiological microenvironment of the liver. Hepatocytes remain healthy and viable in the HEPATOPAC platform and demonstrate physiologically-relevant transporter function and phase I and phase II metabolic activity for over four weeks. HEPATOPAC models show better in-vitro in-vivo correlations (IVIVC) than conventional hepatocyte models, especially for medium- and low-turnover compounds.” In the interest of continuity of science and the information provided that no other company can provide for NCATS requirements. This is in the best interest of the government.
Background/Description of Requirement

NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

 

Title: Hepatopac Sample Well Plates

 

 (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 75N95024Q00494 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;  and FAR Part 12—Acquisition of Commercial Items, and is not 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), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Bioivt, LLC, 123 Frost Street, Suite 115, Westbury, NY  11590-5030 for Hepatopac sample well plates.

 

This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).

The Hepatopac sample well plates must be purchased from BioIVT, LLC as they are the sole source distributor of this technology that is patented by Massachusetts Institute of Technology and it is exclusively licensed to BioIVT, LLC. 

 

(iii)       The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-05, with effective date May 22, 2024.

 

(iv)       The associated NAICS code is 325414 and the small business size standard is 1,250 employees.   This requirement is full and open with no set-aside restrictions.

 

(v)        This requirement is for the following:

 

1 – 2x Human Hepatopac plates 

2 – 2x Mouse Hepatopac Plates

3 – 2x Stromal control plates

4 – 2x Acellular control plates

5 – 2x Maintenance medium

6 – 2x Assay medium

 

(vi)       The plates will be used in a DMPK study.

 

(vii)      The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date is 60 days after receipt of order (ARO).. Delivery will be f.o.b. destination. 

 

(viii)     The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:  https://www.acquisition.gov/browse/index/far   https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html   

(End of provision)

 

The following provisions apply to this acquisition and are incorporated by reference:

 

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:

https://www.acquisition.gov/browse/index/far     https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html  

 

(End of clause)


The following clauses apply to this acquisition and are incorporated by reference:

  • FAR 52.204-13, System for Award Management Maintenance (Oct 2018)
  • FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)
  • FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached.
  • HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015).
  • HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015)

 

The following provisions and clauses apply to this acquisition and are attached in full text.  Offerors MUST complete the provisions below and submit completed copies as separate documents with their proposal.

 

  • 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 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (Feb 2024)
  • NIH Invoice and Payment Provisions 

 

(ix)       The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the item offered to meet the Government requirement;

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3)].


(x)        Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Feb 2024), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. 

 

(xi)       The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. 

 

            The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (Nov 2023), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

 

(xii)      The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 

 

(xiii)     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. 

 

 

 

 

 

The Unique Entity ID from SAM.gov, 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 quotations must be received by 11:00 a.m. Eastern Daylight/Standard Time, on August 30, 2024 and reference Solicitation Number 75N95024Q00494. Responses must be submitted electronically to Nick Niefeld, Contracting Officer at nick.niefeld@nih.gov.

 

Fax responses will not be accepted.

 

 

 

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.