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Testing of compounds for kinase inhibition


Maryland, United States
Government : Federal
RFP
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(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 75N95019Q00202 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 at $250,000.


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 Reaction Biology Corporation, located at 1 Great Valley Pkwy, Ste 2, Malvern, PA 19355-1423 for services for compound testing using the Kinase HotSpot profiling and screening platform.


This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).


(iii)    The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2019-03, with effective date July 12, 2019.


(iv)    The associated NAICS code is 541380-Testing Laboratories with associated small business size standard of 15 Million USD.


(v)    This requirement is for the following 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 described herein. This acquisition provides for initial testing of 100 novel small molecule compounds for inhibition of the kinase enzymes IRAK1, IRAK4, FLT3, and related kinases. This testing will inform on kinase inhibitory activity in our compound series and will facilitate further optimization and development of these IRAK4 / FLT3 inhibitor compounds.


Specifically, the Contractor will perform the following tasks:


1. Perform experiments using the Kinase HotSpot assay platform testing each of 100 small molecule compounds for inhibitory activity against IRAK1, IRAK4, FLT3, and two additional kinases, to be selected from the following: FLT3 (D835Y), FLT3 (F594_R595insR), FLT3 (F594_R595insREY), FLT3 (ITD), FLT3 (ITD)-NPOS, FLT3 (ITD)-W51, FLT3 (R595_E596insEY), FLT3 (Y591_V592insVDFREYEYD), BLK, LCK, and RET.


2. Provide a comprehensive report with the results of the 10-dose IC50 titrations of each of the 100 compounds against IRAK1, IRAK4, FLT3, and two additional kinases.


(vi)    The salient characteristics of project requirements for this procurement, deemed essential features needing to be achieved, include the following types of testing: Prior work at NCATS has produced a series of small molecule IRAK4 / FLT3 kinase dual inhibitors, including NCGC00371481 and its structural analogs. Compounds such as ‘1481 have shown promising results in cellular and mouse models of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). 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 cancers such as MDS and / or AML.


NCATS is currently synthesizing structurally novel analogs of NCGC00371481 that may show improved properties relative to previous analogs. To assess these analogs' abilities to inhibit their desired targets, NCATS needs to test them for inhibitory activity against the kinase enzymes IRAK1, IRAK4 and FLT3. Once that ‘on-target' activity is assessed, a subset of the most promising analogs will be selected and tested for additional activity against clinically relevant mutant forms of FLT3, as well as against related ‘off-target' kinase enzymes that compounds such as NCGC00371481 are known to inhibit.


The testing of 100 small molecule compounds against the kinase enzymes IRAK1, IRAK4, FLT3 and two related kinases will allow a determination of their activity. Results from this data will facilitate the further optimization of these compounds for therapeutic use against a variety of cancers, including MDS and AML.


Prior analogs in this series were tested against IRAK1, IRAK4, FLT3, and other relevant kinase enzymes using Kinase HotSpot assay technology. To ensure consistency in the data and to make a direct comparison, there is no other known technology for the current set of compounds to be tested other than using Kinase HotSpot assay technology.


GOVERNMENT RESPONSIBILITIES
Government will not furnish property, facilities, workspace, computers, or other equipment. Contractor will not use federal facilities. Government will have the responsibility to review and approve the final report. Government will have the responsibility to provide sufficient quantities of the lead compound in order to contractor to accomplish the necessary work.


DELIVERABLES
Deliverables shall consist of providing results for the testing described herein. Contractor will provide monthly updates on the progress of the project, or more often as appropriate. Contractor will provide the data analysis and report for the contents of this statement of work.


TRAVEL
No travel cost will be reimbursed.


CONTRACTOR EXPERIENCE REQUIREMENTS - KEY PERSONNEL
N/A


DATA RIGHTS
NCATS shall have unlimited rights to and ownership of all data including reports. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and made a part of this contract/order. Any data schemas will be the exclusive right of the government.
Publications and Publicity: The Contractor shall not write or publish articles of data produced as a result of the requirements of the SOW.
SECTION 508 - ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS
No EIT is anticipated to be generated as a result of this requirement.


(vii)    Period of Performance: The contractor is expected to deliver results within six (6) months of the effective date of contract award and batch of material to analyze. The Government will send the contractor the material to synthesize after the effective date of contract award.


A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated for any contract resulting from this requirement. The anticipated award date is August 1, 2019.


(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 (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)


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)


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).


The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (OCT 2018) is applicable to this solicitation:
52.222-3 Convict Labor (June 2003)
52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2018)
52.222-21 Prohibition of Segregated Facilities (Apr 2015)
52.222-26 Equal Opportunity (Sep 2016)
52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014)
52.222-50 Combating Trafficking in Persons (Jan 2019)
52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011)
52.225-13 Restriction on Certain Foreign Purchases (Jun 2008)
52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Oct 2018)


The following provisions and clauses apply to this acquisition and are incorporated in full text:
• NIH Invoice and Payment Provisions (2/2014)


(ix)    The provision at FAR clause 52.212-2, Evaluation-Commercial Items, applies to this acquisition.


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.


A tradeoff approach will be used to evaluate and select a contractor. Price will be considered in the evaluation and selection, but Price will not be rated. Price will be considered to be of lesser importance than technical factors. Quotations will be evaluated using adjective ratings and no numeric point system will be used. Excellent (Risk level: Very low); Good (Risk level: Low); Acceptable (Risk Level: Neutral); Marginal (Risk level: High); Unacceptable (Risk level: Very high).


Offerors' responses to this RFQ should address all contractor requirements contained in the statement of work in sufficient detail to demonstrate a clear understanding of the work objectives and compliance with requirements. Quotations will be evaluated based on the following Sub-factors, equally weighted:

a)    Technical Approach:
Ability of the Offeror to understand the SOW and requirements, adequately describe the proposed approach, identify problems and potential challenges, and demonstrate how all contract requirements will be met. Offerors shall provide evidence of sufficient planning to show that the work will be accomplished and how it will be accomplished within time and other constraints specified in the SOW or as applicable. The Offeror shall utilize all available resources to include controlling the execution of assigned activities, tasks, sub-tasks, monitoring progress, status reporting, resolving critical issues and/or mitigating risks and fulfilling all delivery requirements.


b)    Organizational Experience:
Offerors shall show documented evidence of personnel experience related to the subject requirement. Specific and specialized relevant experience, knowledge, skills, abilities, and education of proposed personnel shall be clearly documented. The offeror must submit with their proposal a list of the last two (2) contracts completed during the past three (3) years and / or contracts awarded currently in process that are similar in nature to the work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Newly formed entities without prior contracts should list contracts and subcontracts as required above for such key personnel. For each contract, subcontract, or reference include: (i) Name of Contracting Organization; (ii) Contract Number (for subcontracts, provide the prime contract number and the subcontract number); (iii) Contract Type; (iv) Total Contract Value; (v) Description of Requirement; (vi) North American Industry Classification System(NAICS) Code.


Cost: The Offeror(s) cost/price quotation will be evaluated for reasonableness and best value to the government. Basic cost and price information in the Offerors' quote must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required services and/or supply. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. The Government intends to make an award(s) to that offeror whose proposal provides the best overall value to the Government. Discounts may be taken into account for this selection criterion, however the government reserves the right to make a selection decision with tradeoffs.


Price Quote: The Vendor shall submit a Fixed-price quote for the period of performance including unit pricing, total price proposed and all other relevant information and documentation that the item(s) quoted meets the salient physical, functional, or performance characteristics as specified in this solicitation.
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, with its offer.


(xi)    The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition.


(xii)    The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is incorporated in full text.


(xiii)    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.
There are no additional contract requirement(s) 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 proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, 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 quotations must be received no later than the closing date and time specified in the solicitation. The solicitation number must be referenced on all correspondence submitted for this requirement. Responses must be submitted electronically to Hunter Tjugum at Hunter.Tjugum@nih.gov.


Fax responses will not be accepted.


(xvi)    The name and telephone number of the individual to contact for information regarding the solicitation: Hunter Tjugum, Contract Specialist, 301-827-5304, hunter.tjugum@nih.gov.


Hunter A Tjugum, Contract Specialist, Phone 3018275304, Email hunter.tjugum@nih.gov

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