D 75N95022Q00102_RFQ.pdf

COMBINED SYNOPSIS / SOLICITATION

75N95022Q00102

TITLE: Acquisition of cGMP-grade GS-441524 for the Treatment of COVID-19

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 Avisa Pharma Solutions, Inc. (dba Cambrex), 3501 Tricenter Blvd Ste C, Durham, NC

27713-1868. To ensure consistency among material, the current requirement must be manufactured by the same vendor that is manufacturing the non-GMP material for the same project under Contract No. 75N95021P00063. Therefore, this acquisition is restricted to Avisa

Pharma Solutions, Inc. (dba Cambrex).

(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; quotations are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95022Q00102 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item 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.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2022-04 effective January 30, 2022.

(iv) The associated NAICS code is 325412 and the Small Business size standard is 1,250 employees. This requirement is non-competitive and no set-aside restrictions are applicable.

DESCRIPTION

(v) The National Center for Advancing Translational Sciences (NCATS) is a part of the National

Institutes of Health (NIH), with a mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

NCATS is evaluating GS-441524 as a potential treatment for SARS-CoV-2 infection. GS-

441524 is the parent nucleoside of remdesivir and has similar efficacy to remdesivir in vitro.

GS-441524 is a stable crystalline compound with good physical properties for formulation, and the 3-step synthesis of GS-441524 makes it suitable for large scale production.

The purpose of this acquisition is to obtain 2-3Kg of cGMP GS-441524.

This requirement includes the following items:

CLIN 1: 2-3 kg of cGMP-grade GS-441524.

This batch must be developed using the same manufacturing processes used for non-GMP material manufactured for this project under Contract No. 75N95021P00063, and accompanied by a Certificate of Analysis (COA).

(vi) The material shall be delivered within 18 weeks after the date of award. Delivery of the GS-

441524 shall be made to the below city / state, FOB Destination. The exact address and point of contact will be included on the resultant award.

Rockville, MD 20851

The GS-441524 shall be shipped in a manner that does not adversely affect its quality. The contractor shall ensure that the vendor transporting the GS-441524 knows and follows the appropriate transport and storage conditions.

EVALUATION AND AWARD

(vii) The anticipated award date is February 10, 2022.

(viii) The Government plans to make an award resulting from this solicitation. The resulting award will be made to Avisa Pharma Solutions, Inc. (dba Cambrex) as long as it is technically acceptable and at a fair and reasonable price. If additional quotations are received, the award will be made to the vendor who represents the best value to the Government, price and other factors considered. The Government will use comparative evaluations to determine which quotation is the best value, in consideration of the following evaluation criteria:

1. Technical Capability: In-house ability to manufacture 2-3Kg of cGMP GS-441524 within 18 weeks; legal authority to manufacture cGMP GS-441524.

2. Past Performance: Prior experience in manufacturing cGMP GS-441524 material at factory scale.

3. Price

SUBMISSION INSTRUCTIONS

(ix) All responses to this RFQ must be received by 9:00am Eastern Time on February 7, 2022 and must reference the solicitation number cited above. Responses must be submitted via email to Kimberly Espinosa at kimberly.espinosa@nih.gov.

(x) This is an RFQ. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service.

Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this RFQ must be completed by the quoter.

(xi) Responses to this RFQ must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses may exceed capability or performance characteristics of the solicitation's requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation's requirements if it provides a benefit to the Government.

(xii) Responses must also include the Dun & Bradstreet Number (DUNS), the Taxpayer

Identification Number (TIN), the certification of business size, the completed representation in

FAR Provisions 52.204-26, 52.225-2, and 52.229-11 (all attached), and a quotation that includes:

1. The total price (including shipping),

2. Individual prices for each listed line item,

3. Delivery days after contract award for the submission of all line items (total),

4. Delivery terms,

5. Prompt payment discount terms,

6. Product or catalog number(s),

7. Product description, and

8. Any other information or factors that may be considered in the award decision. Such factors may include: 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.

(xiii) For information about this RFQ, contact Kimberly Espinosa, Contracting Officer, at 301-827-

3546 or kimberly.espinosa@nih.gov.

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

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xv) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb

1998). 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 mailto:kimberly.espinosa@nih.gov 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 www.acquisition.gov.

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

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

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

3. 52.212-3, Offeror Representations and Certifications—Commercial Products and

Commercial Services (Nov 2021)

4. FAR 52.214-34, Submission of Offers in the English Language (Apr 1991)

5. FAR 52.214-35, Submission of Offers in U.S. Currency (Apr 1991)

6. FAR 52.229-11, Tax on Certain Foreign Procurements – Notice and Representation (Jun

2020)

(xvi) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). 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 www.acquisition.gov.

In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference:

1. The clause at FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

2. The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug

2020)

3. The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Products and

Commercial Services (Nov 2021)

4. The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment

Opportunity Investigations (December 18, 2015)

5. The clause at HHSAR 352.224-71, Confidential Information (December 18, 2015)

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

However, 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.

ATTACHMENTS

(xviii) The following are attached in full text:

1. The provision at FAR 52.212-1, Instructions to Offerors – Commercial Products and

Commercial Services (Nov 2021)

(Tailored)

2. The provision at FAR 52.225-2, Buy American Certificate (Feb 2021)

3. The provision at FAR 52.204-26, Covered Telecommunications Equipment or Services-

Representation (Oct 2020)

4. The provision at FAR 52.229-11, Tax on Certain Foreign Procurements—Notice and

Representation (Jun 2020)

5. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement

Statutes or Executive Orders–Commercial Products and Commercial Services (Jan 2022)

6. NIH Electronic Invoice Submission Instructions (Feb 2021)