CSS-NONCOMPETITIVE.pdf

NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Custom Service - Human cytotrophoblasts

(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 75N95C22Q00011 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 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 Amnion Foundation, 111 N. Chestnut St, STE 100, Winston- Salem, NC 27101 for Custom Services - Human cytotrophoblasts The anticipated award date is September 23, 2022.

This acquisition is non-competitive due to the reason that cell line services listed herein are available from only one source, and competition is precluded due to the need for consistency of results with prior cell lines provided by this contractor. See FAR 13.106(b).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-07 dated 8/10/2022.

(iv) The associated NAICS code is 541715 and the small business size standard is 1,000 employees. No set-aside restriction is applicable.

(v) The purpose of this acquisition is to obtain custom Services for Human cytotrophoblasts

Cytotrophoblasts (CTBPRO2®)

(vi) It is well known that It has been challenging to secure cytotrophoblasts to improve robustness of the protocol for engineering 3D vascularized placental tissue to model virus infections such as SARS-COV2 and ZIKV. Thus, this acquisition of cytotrophoblsts, which we have confirmed compatibility with the our protocol development, allows us to improve our tissue quality control and expand our current 3D placental barrier tissue models for drug development.

(vii) Delivery shall be to:

The National Center for Advancing Translational Sciences (NCATS) 9800 Medical Center Drive Rockville, MD 20850

Delivery shall be made within 30 to 45 days after receipt of order, FOB destination.

Offers must include shipping costs, if any.

(viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

(ix) The award resulting from this solicitation will be made to the responsible offeror whose proposal is most advantageous to the Government, price and other factors considered.

(x) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with offers.

(xi) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

The following FAR provisions or clauses are incorporated by reference:

52.204-7, System for Award Management (Oct 2018) 52.204-13, System for Award Management Maintenance (Oct 2020) 52.204-16, Commercial and Entity Code Reporting (Aug 2020) 52.204-18, Commercial and Entity Code Maintenance (Aug 2020) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015).

FAR 52.227-14, Rights in Data – General (May 2014), is incorporated by reference.

Pursuant to paragraph 52.227-14(d), the Contractor may not assert copyright, make use of, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract without prior approval of the contracting officer.

Offerors must complete and return the FAR representation 52.204-24 Representation

Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021), attached.

(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) 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:

Confidentiality: Any information provided to the contractor by NCATS or collected by the contractor on behalf of NCATS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract.

(xiv) HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A - Health Resources Priorities and Allocations System.

(xv) This synopsis is not a request for competitive proposals. All responsible sources may submit a bid, proposal or quotation which shall be considered by the agency.

(xvi) In addition, the Unique Entity Identifier (UEI), 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 September 22, 2022, 2022 at 9:00 AM Eastern Daylight Time (EDT) and reference solicitation number 75N95C22Q00011. Responses must be submitted by email to Brian Lind, Contracting Officer, brian.lind@nih.gov.

Attachments:

- Product Description

- FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or

Executive Orders–Commercial Items

- NIH Invoice and Payment Instructions