Scale Up Synthesis of Three Synthetic Intermediates

(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 75N95019Q00102 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; FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items; 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 2019-01 with effective date January 22, 2019.

(iv) The associated NAICS code 325413 and the small business size standard 1,250 employees. This requirement is a total small business set-aside.

(v) Project Purpose or Objectives: NCATS needs the scale up synthesis of three compounds. These intermediates will be used to synthesize antibody conjugates.

(vi) Background Information: The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives.

The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), whose mission it is 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 in need of scaling up a promising NCATS Chemical Genomics Center (NCGC) compound, as well as the general scaffold leading to the compound. The lead NCGC compound will be used for efficacy studies in animal models to determine its feasibility as a pre-clinical candidate. In addition, the key intermediate scaffold will be used to further develop the SAR.

SCOPE OF WORK:
General Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements: The Contractor shall provide the scale up synthesis and delivery of three synthetic intermediates that will enable NCATS to make analogs. The structures of the three intermediates are included herein under SOW EXHIBIT A.

The Contractor shall provide the following services and deliverables:
1. Execute a multistep synthesis and produce 20 grams of intermediate 1.
2. Execute a multistep synthesis and produce 20 grams of intermediate 2.
3. Execute a multistep synthesis and produce 20 grams of intermediate 3.

The intermediates must be packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.

Delivery shall be FOB Destination and delivery location for the intermediates shall be:
Attn: Juan Marugan
NCATS/NIH
9800 Medical Center Drive
Room C201W
Rockville, MD 20850

GOVERNMENT RESPONSIBILITIES:
NCATS will place the order for the three intermediates

DELIVERY OR DELIVERABLES:
Vendor is responsible for providing the following deliverables:
1. 20 grams of each of the three intermediates

2. Material shall have a purity greater than 95% (>95% by HPLC).

3. Material shall have certificate of analysis, including, but not limited to 1H-NMR, LC-MS.

4. Weekly progress reports and final report including detailed protocols of synthesis, chromatography conditions and analytics for each step provided to Raul Calvo (raul.calvo@nih.gov) and Juan Marugan (maruganj@mail.nih.gov) at NCATS via email.

REPORTING REQUIREMENTS:
Vendor will be responsible for providing weekly progress reports and presentations to Raul Calvor (raul.calvo@nih.gov) and Juan Marugan (maruganj@mail.nih.gov) at NCATS via email or conference calls as service work is rendered.

(vii) Period of Performance is anticipated to be March 2019 through September 2019.

The Government anticipates award of a firm fixed price purchase order for this acquisition.

(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)

(ix) 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 (Jul 2016)
• FAR 52.212-1, Instructions to Offerors-Commercial Items (Oct 2018)
• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018)
• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)

(x) 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

(End of clause)

(xi) 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 (Jul 2016)
• FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Oct 2018) Paragraph (g) is supplemented by the NIH Invoice and Payment Provisions (2/2014)
• FAR 52.225-4, Buy American-Free Trade Agreements-Israel Act Certificate (May 2014) Alternate II (May 2014)
• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

(xii) The following provisions and clauses apply to this acquisition and are attached in full text:

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Oct 2018)
• NIH Invoice and Payment Provisions (2/2014)
• Service Contract Labor Standards / Wage Rate Determination. Area: Maryland Counties of Frederick, Montgomery; No. 2015-4269; Dated 12/26/2018; 11 pages.

(xiii) The provision at FAR clause 52.212-2, Evaluation--Commercial Items, does not apply to this acquisition. The evaluation procedures and factors to be used for this acquisition under FAR 13.106 are attached in full text.

There are no additional contract requirements or terms and conditions applicable to this acquisition.

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

(xv) Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price quote must include a breakdown and rationale for all costs and the total amount.

The Dun & Bradstreet Number (DUNS), 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 questions must be received by 12:00 p.m., Eastern Standard Time, on Wednesday, March 13, 2019, and reference Solicitation Number 75N95019Q00102. Questions may be submitted electronically to Mark McNally, Contract Specialist, at mark.mcnally@nih.gov.

All responses must be received by 12:00 p.m., Eastern Standard Time, on Wednesday, March 20, 2019, and reference Solicitation Number 75N95019Q00102. Responses shall be submitted electronically to Mark McNally, Contract Specialist, at mark.mcnally@nih.gov.

Fax responses will not be accepted.

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

Mark McNally, Contract Specialist, 301-827-5869, mark.mcnally@nih.gov

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