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COMBINED SYNOPSIS / SOLICITATION

Title: Develop manufacturable tablet formulation of CD206 compound NCGC00413972, N-(3-(2-oxopyrrolidin-1-yl)propyl)-4-(6-phenylimidazo[1,5-a]pyrazin-3-yl)benzamide, for use in dog sarcoma clinical studies.

(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 75N95023Q00629 and the solicitation is issued as a Request for Quote (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.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04, with effective date June 2, 2023.

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

(v) DESCRIPTION

Quantity: See attached Statement of Work

Description: See attached Statement of Work.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 6 months after receipt of order. All costs of shipping and handling must be included in the quote.

(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:

• FAR 52.204-7, System for Award Management (Oct 2018)


• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)


• FAR 52.212-1, Instructions to Offerors-Commercial Items (Mar 2023)


• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Dec 2022)


• 52.212-5 attachment (Jun 2023)


• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (Dec 2015)

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

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 Items (Dec 2022). Addendum to this FAR clause applies to this acquisition and is attached.


• The clause at FAR 52.227-14, Rights in Data-General (May 2014). Under 52.227-14(c)(1), the contractor must obtain approval from the contracting officer to assert copyright in any data first produced in performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. Under 52.227-14(d)(2), the contractor must obtain approval from the contracting officer to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the contractor in the performance of this contract.


• HHSAR 352.239-74, Electronic and Information Technology Accessibility (Dec 2015)


• HHSAR 352-232-71 Electronic Submission of Payment Requests (Feb 2022)


• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Jun 2023)


• NIH Invoice and Payment Provisions (Mar 2023)

Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

EVALUATION

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items (Nov 2021), 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: (i)Technical Capability of the item offered to meet the Government requirement; (ii) Past Performance; and (iii) Cost/Price.

Technical Capability of the item offered to meet the Government requirement and past performance, when combined, are significantly more important than cost or price.

(b) 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 (Dec 2022), 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 clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2022), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

(xii) 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.

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

SUBMISSION INSTRUCTIONS

(xiv) 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.

The Unique Entity ID from SAM.gov, UEI Number, 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 4:00 p.m., EST, on August 23, 2023, and reference Solicitation Number 75N95023Q00629. Responses must be submitted electronically to Michele Pastorek, Contract Specialist, at michele.pastorek@nih.gov.

Fax responses will not be accepted.

(xv) The name and telephone number of the individual to contact for information regarding the solicitation:

Michele Pastorek, Contract Specialist

Phone: (301) 827-1739

Email: michele.pastorek@nih.gov

ATTACHMENTS

1. Statement of Work


2. FAR 52.212-4 Addendum


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


4. NIH Invoice and Payment Instructions with IPP (Mar 2023)

Attachments/Links