Inactive

COMBINED SYNOPSIS / SOLICITATION Title: Synthesis of GMP grade of NCGC00413972 (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 ... COMBINED SYNOPSIS / SOLICITATION Title: Synthesis of GMP grade of NCGC00413972 (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 75N95023Q00020 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 2022-08, with effective date October 28,2022. (iv) The associated NAICS code 325199 and the small business size standard is 1,250 employees. This requirement is set-aside to small business interests. (v) Set-aside Status: N/A (vi) Competition Status: This requirement is posted as competitive, unrestricted. DESCRIPTION Quantity: Synthesis of 200g GMP grade of NCGC00413972. Salient characteristics: The final product should be >97% purity by NMR, LCMS and other analytical tools that help establish the identity and purity of the product. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date is 90 days after receipt of order (ARO). Delivery will be f.o.b. destination. The place of delivery and acceptance will be 9800 Medical Center Drive, Bldg. A room 248, Rockville, MD 20850. The Government is requiring that the compounds be delivered in ONE delivery only. (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 (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2022) FAR 52.225-2, Buy American Certificate (Oct 2022) FAR 52.225-4, Buy American-Free Trade Agreements-Israel Trade Act Certificate (Oct 2022) 52.212-5 attachment, then also include Alternate I, II, or III (Oct 2022) FAR 52.225-6, Trade Agreements Certificate (Feb 2021) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 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 (Nov 2021). Addendum to this FAR clause applies to this acquisition and is attached. HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 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 (Oct 2022) NIH Invoice and Payment Provisions (Feb 2021) Notice of Total Small Business Set-Aside (Mar 2020) EVALUATION (ix) The government reserves the right to select a response that provides benefit to the government that exceeds the minimum; the government is not required to select a response that exceeds the minimum; responses may exceed the requirements; each response must meet the solicitation requirement statement at a minimum; and the government is not requesting or accepting alternate proposal(s). 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 Approach; (ii) Past Performance; and (iii) Price. Technical and past performance, when combined, are significantly more important than cost or price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) 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 (Oct 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 (Nov 2021), 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. Quote must include shipping and handling costs to provide single delivery of compounds to NCATS. ** Please provide two quotes if pricing varies based on foreign vs. domestic sourcing. Each quote must state whether the quote is a domestic and/or foreign quote. 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 submit a Buy American Certificate and TAA Compliance Certificate with their quote. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All quotations must be received by 3:00 p.m., EST, on December 23, 2022, and reference Solicitation Number 75N95023Q00020. Responses must be submitted electronically to Claudia Ventola, Contract Specialist, at claudia.ventola@nih.gov. Fax responses will not be accepted. (xv) The name and telephone number of the individual to contact for information regarding the solicitation: Claudia Ventola, Contract Specialist Phone: (301) 496 - 0870 Email: claudia.ventola@nih.gov ATTACHMENTS Purchase Description FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Executive Orders–Commercial Items (Oct 2022) NIH Invoice and Payment Instructions without IPP (Oct 2022) NIH Invoice and Payment Instructions with IPP (April 2022) FAR 52.212-4_Addendum_Supplier_LicensesRevised: February 10, 2021 FAR 52.225-2 Buy American Certificate

Inactive Total Small Business Set-Aside (FAR 19.5)

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. This amended notice includes the name and chemical structure in the purchas... This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. This amended notice includes the name and chemical structure in the purchase description. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: NCGC00413972 was discovered in NCATS and has proven to be orally bioavailable agent against various types of cancers where the population of M2 macrophages predominate in the tumor microenvironment. After carrying out several studies on its stability in mouse, rats and dogs, and measuring its efficacy in various animal cancer models, the team has decided to advance the compound to the next stage of testing in higher animals and perhaps in humans. For this work, GMP grade compound is needed. Our leading compound, NCGC00413972, has demonstrated efficacy against cancer and its ability to activate the immune system. We are now in need of preliminary clinical supplies of GMP NCGC00413972 to carry out pilot studies on the toxicity and efficacy of this compound in humans. The initial amount of 200g will help us study its stability and preliminary toxicity studies. The compound is First-in-Class for a small molecule that activates and induces reprogramming of the Macrophages involved in the immune system. Purpose and Objectives: The purpose of this procurement is the acquisition of Synthesis of 200g GMP grade of NCGC00413972. Project requirements: The synthesis of the GMP grade of NCGC00413972 using equipment appropriate for the various transformations. The final product’s specifications should include NMR, LCMS data that is consistent with a final product purity of greater than 97% and the structure matching the analytical/characterization studies mentioned above. NCATS will provide whatever spectrum and intermediate compounds that it has inhouse to help with the characterization. Anticipated period of performance: One-time delivery 90 days after receipt of order. Capability statement /information sought. Respondents must provide clear and convincing documentation of their capability of providing the equipment specified in this notice. The respondent must also provide their UEI number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the service requirement and in the capability statement /information sought paragraphs stated herein. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses.Your response MUST also contain a completed 52.225-2, Buy American Certificate. Please indicate if there are domestic and/or foreign products that meet the requirements listed above. All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Claudia Ventola, Contract Specialist at email address claudia.ventola@nih.gov The response must be received on or before November 25th, 2022, @ 3:00 PM Eastern Time. “Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).