D 75N95021Q00202_RFQ.pdf

COMBINED SYNOPSIS / SOLICITATION

75N95021Q00202

TITLE: Synthesized PKM2 activators

(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 75N95021Q00202 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 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 2021-05, effective March 10, 2021.

(iv) The associated NAICS code is 325199 and the Small Business size standard is 1250 employees. This requirement is competitive and is set aside exclusively for Small Business.

DESCRIPTION

(v) Prior work at NCATS has produced a series of small molecule inhibitors, including TEPP-46 and its structural analogs as potent activators of the M2 isoform of pyruvate kinase.

Compounds such as TEPP-46 have shown promising results in cellular and mouse models of cancer, inflammation and diabetes. Further optimization of the biochemical, physiochemical and pharmacokinetic properties of these compounds is required, and may eventually produce a clinical candidate that could be used to treat these disorders. To explore the activity of two new agents, NCATS requires one (1) gram each of NCGC00344932 and NCGC00319092 (structural analogs of TEPP-46), and to compare advanced analogs versus existing PKM2 activators, NCATS requires 200 mgs of lead investigational agents TP-1158 and FT-4202.

The contractor shall provide one (1) gram each of NCGC00344932 and NCGC00319092

(structural analogs of TEPP-46), and 200 mgs each of lead investigational agents TP-1158 and FT-4202. The chemical structures are provided in Attachment 1: Chemical Structures.

Required Characteristics:

1. The final product and all key intermediates must be characterized using standard tests (1H NMR, 13C NMR, LCMS trace confirming purity and HRMS confirming identity).

2. The analogs must be synthesized using standard methods in accordance with best practices.

3. Standard synthetic procedures and reporting must be used for all studies and all report must include standard reporting metrics.

4. Contractor shall perform the step-wise synthesis of each requested analog resulting it the required amount of each analog and provide this material.

CLIN 01: Synthetic Plans, PKM2 Activators, Investigational Agents, and Comprehensive Report This includes:

• A synthetic plan for the synthesis of both analogs that builds on published methods for the synthesis of TEPP-46

• A synthetic plan for the synthesis of both analogs that builds on published methods for the synthesis of TP-1158 and FT-4202

• one gram of NCGC00319092

• one gram of NCGC00344932

• 200 mgs of TP-1158

• 200 mgs of FT-4202

• a comprehensive report for the synthesis of each analog including all characterization data (1H NMR, 13C NMR, LCMS trace confirming purity and HRMS confirming identity).

(vi) The delivery deadline is six months from the date of award. The synthetic plans and comprehensive report shall be submitted via email to the NCATS Point(s) of Contact designated on the purchase order. The activators shall be delivered FOB destination to the below address:

9800 Medical Center Drive Rockville, MD 20850

EVALUATION AND AWARD

(vii) The anticipated award date is June 10, 2021.

(viii) The Government plans to award a fixed-price purchase order resulting from this solicitation.

The resulting 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: Technical Capability, Past Performance, and Price.

SUBMISSION INSTRUCTIONS

(ix) All responses to this RFQ must be received by 3:00pm Eastern Time on June 4, 2021 and must reference the solicitation number cited above. Responses must be submitted via email to Kimberly Espinosa at kimberly.espinosa@nih.gov.

mailto: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 52.204-24, 52.204-26, and 52.225-2 (attached), and a quotation that includes:

1. The total price (inclusive of all costs, fees, shipping, etc.),

2. Individual prices for each listed line item,

3. Prompt payment discount terms,

4. Product or catalog number(s),

5. Product/service description, and

6. 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 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)

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

Items (Nov 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 Items (Oct

2018)

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.

ATTACHMENTS

(xviii) The following are attached in full text:

1. Chemical Structures

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

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

Representation (Oct 2020)

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

Statutes or Executive Orders–Commercial Items (Jan 2021)

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

(Tailored)

6. NIH Electronic Invoice Submission Instructions (Feb 2021)

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