D 75N95021Q00015_Request for Quotations.pdf

COMBINED SYNOPSIS / SOLICITATION

75N95021Q00015

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

(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 75N95021Q00015 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. This acquisition is being conducted as a commercial item under the authority of FAR 13.500(c)(1).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-09, dated October 26, 2020.

(iv) The associated NAICS code is 325412 and the Small Business size standard is 1,250 employees. This requirement is 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 provide Chemistry, Manufacturing and Controls (CMC) support for the preclinical and clinical development of GS-441524 as a potential antiviral against SARS-CoV-2, the causative agent of the pandemic disease COVID-19. NCATS will perform preclinical and Phase 1 clinical studies with GS-441524, and gather information on its safety and tolerability, efficacy, pharmacokinetics, and dose-range in human. To cover the requirements of the studies, NCATS will need a batch of GS-441524 adhering to current Good Manufacturing Practice (cGMP) guidelines from a qualified Contract Manufacturing Organization (CMO).

This requirement includes the following items:

Line Item 1: Two (2) kg of cGMP-grade GS-441524.

This batch must be developed using the same manufacturing processes and criteria used for previous batches manufactured for Gilead Sciences, and must be accompanied by a Quality Assurance (QA)-approved Certificate of Analysis.

Line Item 2: A Chemistry, Manufacturing and Controls (CMC) report in the electronic Common Technical Document (eCTD) format utilized by the US Food and Drug Administration (FDA) for regulatory filings.

Line Item 3: OPTION: Two (2) kg of cGMP-grade GS-441524.

This batch must be developed using the same manufacturing processes and criteria used for the batch in Line Item 1, and must be accompanied by a Quality Assurance (QA)-approved Certificate of Analysis. The contractor will make any necessary updates to the CMC report as a result of this second batch.

(vi) The anticipated delivery date is six (6) months after the date of award but is dependent on the awardee’s capabilities. 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.

Chicago, IL 60616

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.

CONTRACTOR REQUIREMENTS

(vii) The Contractor must have current authorization to manufacture and sell cGMP-grade GS- 441524 to NIH/NCATS. Respondents must document this authorization in their responses to this solicitation.

EVALUATION AND AWARD

(viii) The anticipated award date is December 7, 2020.

(ix) The Government plans to award a purchase order resulting from this solicitation. The resulting award will be made to the responsible respondent whose quotation will be most advantageous to the Government, price and other factors considered. Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate quotations for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

The factors listed below shall be used to evaluate quotations. Comparative evaluations will be conducted if multiple quotations are received.

1. Technical Capability: In-house ability to manufacture a 2 kg batch of GS-441524 adhering to current Good Manufacturing Practice (cGMP) guidelines; and ability to produce a Chemistry, Manufacturing and Controls (CMC) report in the electronic Common Technical Document (eCTD) format utilized by the US Food and Drug Administration (FDA) for regulatory filings.

1.A. Delivery timeline

2. Past Performance: Prior experience in manufacturing cGMP material at factory scale, including analytical methods to qualify cGMP active pharmaceutical ingredient (API); and prior experience manufacturing GS-441524 on multi-kilogram scale.

3. Price

SUBMISSION INSTRUCTIONS

(x) All responses to this RFQ must be received by 8:59am Eastern Time on December 1, 2020 and must reference the solicitation number cited above. Responses must be submitted via email to Kimberly Espinosa at kimberly.espinosa@nih.gov.

(xi) 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.

(xii) Responses to this RFQ must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses must also include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), the certification of business size, and the completed representation in FAR Provisions 52.204-24 and 52.204-26 (attached).

(xiii) The response shall contain 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.

mailto:kimberly.espinosa@nih.gov

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

827-3546 or kimberly.espinosa@nih.gov.

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

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xvi) 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 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. The provision at FAR 52.204-7, System for Award Management (Oct 2018)

2. The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting

(Aug 2020)

4. The provision at FAR 52.212-2 Evaluation—Commercial Items (Oct 2014).

5. The provision at 52.212-3, Offeror Representations and Certifications—Commercial

Items (Aug 2020)

(xvii) 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 Items (Oct

2018)

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

Opportunity Investigations (December 18, 2015)

(xviii) Option Clause: The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option at any time during the term of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to exercise at least 15 days prior to the end of the term of the contract.

(xix) The clause at FAR Clause 52.217-9, Option to Extend the Term of the Contract (Mar 2000).

(a) The Government may extend the term of this contract by written notice to the Contractor at least 15 days before the end of the contract term; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 days before the end of the contract term. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months (five years).

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

(xxi) One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements. Responses must be submitted in the English language and quotations must include the price(s) in U.S. dollars.

(xxii) Any resultant award from this solicitation will include the following language: 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

(xxiii) The following are attached in full text:

1. The provision at FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)

2. The provision at FAR 52.204-26, Covered Telecommunications Equipment or Services- Representation (Oct 2020)

3. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items (Oct 2020)

4. The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (Jun 2020) (Tailored)

5. NIH Invoice and Payment Provisions (2/2014)

6. NIH Electronic Invoice Submission Instructions (Oct 30, 2020)