0. CSS_75N95020Q00018 Package.pdf

TEMPLATE

STREAMLINED SOLICITATION FOR COMMERCIAL ITEMS

NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Testing of small molecule compounds

(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 75N95020Q00018 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. This acquisition is NOT expected to exceed the simplified acquisition threshold of $250,000.00.

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 Institutes of Health intends to negotiate and award a purchase order without providing for full and open competition (Including brand-name) to Cyprotex US, LLC, 313 Pleasant St. Watertown, MA 02472.

This acquisition is conducted as non-competitive for a commercial service and is conducted under the authority of the FAR Part 13 - Simplified Acquisition Procedures, and FAR 13.106-1(b) – Soliciting from a single source. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted that produced no other sources capable of providing this Government requirement.

Pursuant to FAR Subpart 13.501 (a) (1) (iv) the rationale for the brand name justification is that use of the Cyprotex assay platform is required to provide continuity of service, and to allow an apples-to-apples comparison of the data generated from this service with data previously generated using the Cyprotex assay platform.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Regulation (FAR) Federal Acquisition Circular (FAC) Number/Effective Date December 13, 2019.

(iv) The North American Industry Classification System (NAICS) code for this procurement is

541380-Testing Laboratories with associated small business size standard of 15 Million USD. This requirement is released with no set-aside restriction.

(v) This requirement is for four (4) separate compound testing studies.

1. Caco2 Assay for the IRAK4 Project with the DPI Group at NCATS.

2. PXR activation for the IRAK4 Project with the DPI Group at NCATS.

3. AhR activation for the IRAK4 Project with the DPI Group at NCATS.

4. CYP inhibition for the IRAK4 Project with the DPI Group at NCATS.

(vi) The Statement of Work with a description of the services to be performed is included as

Attachment 1 to this Solicitation.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition. The Period of performance is within twelve (12) months from the contract award and receipt of first batch of material.

EVALUATION AND AWARD

(viii) The award resulting from this solicitation will be made to the responsible offeror whose proposal is most advantageous to the Government, price and other factors considered.

The following factors shall be used to evaluate quotations: Technical Capability and Price. In the event that multiple quotations are received comparative evaluations will be conducted in accordance with FAR 13.106-2(b)(3). In that case, award will be made to the responsible offeror whose response meets the solicitation’s requirements and, as a whole, will be most advantageous to the Government, price and other factors considered.

(ix) The anticipated award date is January 31, 2020.

VENDOR AND SUBMISSION REQUIREMENTS

(x) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition, and is incorporated by reference. Offerors must submit a quote addressing the requirements listed in the attached Purchase Description and price.

(xi) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with their business proposal.

(xii) Offerors are to include a completed copy of the provision at FAR 52.204-2, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment, with their business proposal—see attached.

(xiii) 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 by 3:00 p.m., Eastern Time, on Thursday, January 9, 2020, and reference Solicitation Number 75N95020Q00018. Responses must be submitted electronically to Anna Chiang, Contracting Officer, at anna.chiang@nih.gov.

Fax responses will not be accepted.

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

Anna Chiang, Contracting Officer, 301-496-5916, anna.chiang@nih.gov.

PROVISIONS AND CLAUSES

(xv) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. Additional contract terms and conditions are as follows:

Addendum to FAR 52.212-4, Supplier License Agreements.

The following FAR provisions or clauses are incorporated by reference:

52.204-7, System for Award Management (Oct 2018) 52.204-13, System for Award Management Maintenance (Oct 2018) 52.204-16, Commercial and Entity Code Reporting (Jul 2016) 52.204-18, Commercial and Entity Code Maintenance (Jul 2016) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015).

52.212-4(g), Invoice, is supplemented by the NIH Invoice and Payment Instructions http://www.sam.gov/ http://www.sam.gov/ mailto:anna.chiang@nih.gov mailto:anna.chiang@nih.gov mailto:anna.chiang@nih.gov mailto:anna.chiang@nih.gov

(2/2014).

(xvi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition and is attached.

(xvii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

ATTACHMENTS

1. Statement of Work

2. FAR 52.212-5

3. FAR 52.212-4 Addendum

4. FAR 52.204-24

5. Invoice Instructions

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Cyprotex US, LLC – Testing of Compounds

1. Caco2 Assay for the IRAK4 Project with the DPI Group at NCATS.

2. PXR activation for the IRAK4 Project with the DPI Group at NCATS.

3. AhR activation for the IRAK4 Project with the DPI Group at NCATS.

4. CYP inhibition for the IRAK4 Project with the DPI Group at NCATS.

Statement of Need and Purpose:

This requisition is for four (4) separate studies:

1. This order provides for testing of 60 small molecule compounds for permeability in Caco-2 cells.

These compounds are drug molecules being evaluated for the dual IRAK4-FLT3 kinase program.

Testing of the compounds for permeability and active transport in Caco-2 cells will provide critical information on their transport properties, and will allow us to prioritize the development of compounds with optimal transport properties.

2. This order provides for testing of 40 small molecule compounds for activation of the PXR nuclear receptors. These compounds are drug molecules being evaluated for the dual IRAK4-FLT3 kinase inhibitor program. To optimize the overall biological activity profiles of our compounds, we need to test for activation of PXR, and to confirm that the compounds are not potent activators of this receptor.

3. This order provides for testing of 40 small molecule compounds for activation of the AhR nuclear receptors. These compounds are drug molecules being evaluated for the dual IRAK4-FLT3 kinase inhibitor program. To optimize the overall biological activity profiles of our compounds, we need to test for activation of AhR, and to confirm that the compounds are not potent activators of this receptor.

4. This order provides for testing of 100 small molecule compounds for inhibition of the CYP enzymes CYP2C9, CYP2D6 and CYP3A4. These compounds are drug molecules being evaluated for the dual IRAK4-FLT3 kinase program. Testing of the compounds for their capacity to inhibit major hepatic CYPs will help to identify their propensity for creating drug-drug interactions, and alert us to any such issues that would need to be solved in order for drug candidates to advance into human clinical testing.

Background Information and Objective:

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 translational science center that prides itself on its productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people’s lives. Included in this process is the development of unique small molecules as potential anticancer agents.

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.

In order for a candidate compound to advance into clinical trials, it must display a wide range of acceptable properties. For this program, a potential clinical candidate must display potent inhibition of the desired targets (IRAK4 and FLT3). It must also display good cell permeability, so that it can effectively absorbed across cell membranes into systemic circulation, and ultimately be delivered to the target tissue of interest.

Caco-2 cells are widely used as a model cell line for determining a compound’s cell permeability. In these experiments, a test compound can be applied to either the apical (A) or basolateral (B) side of the cell membrane. If a compound is applied to the apical (A) side, one then takes samples from the basolateral (B) side to see how well the compound permeates the cell membrane. The experiment can also be run in reverse, wherein compound is applied first to the basolateral (B) side, with samples then being taken from the apical (A) side. If the experiment is run in two parts – first applying compound to side A and sampling from side B, and then vice versa – one can determine if a compound is being preferentially pumped into or out of the cell. This bidirectional Caco-2 cell experiment provides information not only on passive cell permeability, but also on whether the test compound is a substrate for active transport into or out of the cell (uptake or efflux transport).

Testing of a set of 60 small molecule compounds for permeability in bidirectional Caco-2 cell assays will allow a determination of the compounds’ passive cell permeability, as well as a determination of whether they are substrates for active uptake or efflux transporters. This will allow us to identify compounds with optimal transport properties, and to preferentially select those for subsequent, more advanced experiments.

Period of Performance:

1. Period of performance is within twelve (12) months from the contract award and receipt of first batch of material

2. Period of performance is within twelve (12) months from the contract award and receipt of first batch of material

3. Period of performance is within twelve (12) months from the contract award and receipt of first batch of material

4. Period of performance is within twelve (12) months from the contract award and receipt of first batch of material

SCOPE OF WORK

General Requirements:

Instructions:

The contractor will perform pharmacokinetic assessment of desired compounds within CD-1 male mice, with an emphasis being placed on the plasma exposure of the desired compounds over a given time frame. These studies will commence within 5 business days of receipt of the compounds by the contractor. These studies will be completed within 10 business days of receipt of the compounds.

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:

1. Testing of 60 small molecule compounds for permeability in Caco-2 cells – Contractor will:

a. Test each of 60 small molecule compounds for permeability and active transport in bidirectional Caco-2 cell assays.

b. Provide a comprehensive report with the results of the experiments of each of the 60 compounds tested for permeability and active transport in bidirectional Caco-2 cell assays.

2. Testing of 40 small molecule compounds for activation of the PXR nuclear receptors – Contractor will:

a. Test each of 40 small molecule compounds for activation of the PXR nuclear receptor.

b. Provide a comprehensive report with the results of testing the 40 compounds for activation of PXR.

3. Testing of 40 small molecule compounds for activation of the AhR nuclear receptors –

Contractor will:

a. Test each of 40 small molecule compounds for activation of the AhR nuclear receptor.

b. Provide a comprehensive report with the results of testing the 40 compounds for activation of AhR.

4. Testing of 100 small molecule compounds for inhibition of the CYP enzymes CYP2C9, CYP2D6 and CYP3A4 – Contractor will:

a. Test each of 100 small molecule compounds for inhibition of CYP2C9, CYP2D6 and

CYP3A4. Each compound must be tested in singlicate (n = 1) at seven different concentrations that cover a range of 0.1 uM to 30 uM.

b. Provide a comprehensive report with the results of the experiments of each of the 100 compounds tested for inhibition of CYP2C9, CYP2D6 and CYP3A4. The report must include an IC50 determination for each of the above experiments.

Specific Requirements:

Instructions:

1. Testing of 60 small molecule compounds for permeability in Caco-2 cells:

- Contractor will run the assays using scientists that have significant experience (>5 years) in the testing of small molecule compounds for permeability and active transport in bidirectional Caco-2 cell assays.

- Contractor will have significant experience (>5 years) in running assays that test for permeability and active transport in bidirectional Caco-2 cell assays.

- Contractor will test compounds in a bidirectional Caco-2 cell assay at a compound concentration of 10 uM. First, the Contractor will apply the test compound to the apical

(A) side, and will determine permeation to the basolateral (B) side as described below.

The Contractor will then repeat the experiment in reverse, first applying test compound to the basolateral (B) side, and determining permeation to the apical (A) side. These experiments will begin with incubation of Caco-2 cells and test compound (applied to either the A or B side) for 2 hours. At the end of the incubation, solution samples will be taken from each side (A and B) and quenched with 100% methanol containing an internal standard. The samples will then be centrifuged, and the supernatant liquids will then be analyzed by LC/MS to determine peak area ratios of test compound. A written data report will be generated that includes permeability (Papp), as well as the efflux ratio (Papp for the experiment when compound is applied to the basolateral B side, divided by Papp for the experiment where compound is applied to the apical A side).

- Contractor will have access to all critical instrumentation necessary for this statement of work.

- Contractor will be capable of testing the aforementioned 60 compounds in all the assays described above in <12 months’ time after receipt of compounds.

2. Testing of 40 small molecule compounds for activation of the PXR nuclear receptors:

- Contractor will run the assays using scientists that have significant experience (>5 years) in the testing of small molecule compounds for activation of PXR.

- Contractor will have significant experience (>5 years) in running assays that test for activation of PXR.

- Contractor will have access to all critical instrumentation necessary for this statement of work.

- Contractor will be capable of testing the aforementioned 16 compounds in all the assays described above in <12 months’ time after receipt of compounds.

3. Testing of 40 small molecule compounds for activation of the AhR nuclear receptors:

- Contractor will run the assays using scientists that have significant experience (>5 years) in the testing of small molecule compounds for activation of AhR.

- Contractor will have significant experience (>5 years) in running assays that test for activation of AhR.

- Contractor will have access to all critical instrumentation necessary for this statement of work.

- Contractor will be capable of testing the aforementioned 40 compounds in all the assays described above in <12 months’ time after receipt of compounds.

4. Testing of 100 small molecule compounds for inhibition of the CYP enzymes CYP2C9, CYP2D6 and CYP3A4:

- Contractor will run the assays using scientists that have significant experience (>5 years) in the testing of small molecule compounds for inhibition of CYP enzymes.

- Contractor will have significant experience (>5 years) in running assays that test for inhibition of CYP3A4, CYP2C9 and CYP2D6.

- Contractor must offer the option of follow-up testing in the following additional CYP enzymes: CYP1A2, CYP2B6, CYP2C8 and CYP2C19. This will allow continuity of service, and an ‘apples-to-apples’ comparison of data for the inhibition of all seven CYP enzymes.

- Contractor will have access to all critical instrumentation necessary for this statement of work.

- Contractor will be capable of testing the aforementioned 100 compounds in all the assays described above in <12 months’ time after receipt of compounds.

LEVEL OF EFFORT:

1st Study: Estimated personnel: 1 PhD level-Manager. 1 Ph.D. level scientist. 1-2 months total.

2nd Study: Estimated personnel: 1 PhD level-Manager. 1 Ph.D. level scientist. 1-2 months total.

3rd Study: Estimated personnel: 1 PhD level-Manager. 1 Ph.D. level scientist. 1-2 months total.

4th Study: Estimated personnel: 1 PhD level-Manager. 1 Ph.D. level scientist. 1-2 months total.

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

DELIVERY OR DELIVERABLES

Contractor will provide the data analysis and report for the contents of this statement of work.

REPORTING REQUIREMENTS

Contractor will provide monthly updates on the progress of the project, or more often as appropriate

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

Information System Security Plan:

Data Rights:

Data is the right of NCATS.

Section 508—Electronic and Information Technology Standards:

Contractor will not be involved in EIT Standards.

Publications and Publicity:

Contractor will not publish results of the work.

Confidentiality of Information:

Contractor will keep the results of the acquisition confidential.

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

ITEMS ( 0 )

The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.

113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

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Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L.

109-282) (31 U.S.C. 6101 note).

[Reserved].

Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L.

111-117, section 743 of Div. C).

Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.

2313).

[Reserved].

Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C.657a).

(ii) Alternate I (Nov 2011) of 52.219-3.

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(i), Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

(ii) Alternate I (JAN 2011) of 52.219-4.

[Reserved].

(i) Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

(ii) Alternate I (Nov 2011).

(iii) Alternate II (Nov 2011).

(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

(ii) Alternate I (Oct 1995) of 52.219-7.

(iii) Alternate II (Mar 2004) of 52.219-7.

Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

(i), Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637(d)(4)).

(ii) Alternate I (Nov 2016) of 52.219-9.

(iii) Alternate II (Nov 2016) of 52.219-9.

(iv) Alternate III (Nov 2016) of 52.219-9.

(v) Alternate IV (Aug 2018) of 52.219-9.

Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). May require contractor completion.

Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

Convict Labor (June 2003) (E.O. 11755).

Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

Prohibition of Segregated Facilities (Apr 2015).

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(i) Equal Opportunity (Sept 2016) (E.O. 11246).

(ii) Alternate I (Feb 1999) of 52.222-26. Alt I requires CO completion.

(i) Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

(ii) Alternate I (July 2014) of 52.222-35. Alt I requires CO completion.

(i) Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(ii) Alternate I (July 2014) of 52.222-36. Alt I requires CO completion.

Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

(i) Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O. 13627).

(ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). Alt I requires CO completion.

Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

(i) Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) Requires CO completion.

(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) Alt I requires contractor certification.

Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693). Requires contractor completion.

Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

(i), Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Oct 2015) of 52.223-13.

(i) Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-14.

Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

(i), Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-16.

Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513).

Aerosols (JUN 2016) (E.O. 13693).

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Foams (JUN 2016) (E.O. 13693).

(i), Privacy Training (JAN 2017) (5 U.S.C. 552a).

(ii) Alternate I (JAN 2017) of 52.224-3.

Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

(i), Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L.

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(ii) Alternate I (May 2014) of 52.225-3.

(iii) Alternate II (May 2014) of 52.225-3.

(iv) Alternate III (May 2014) of 52.225-3.

Trade Agreements (AUG 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). Requires CO completion.

Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C.

3332).

Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). Requires CO completition.

Payment by Third Party (May 2014) (31 U.S.C. 3332).

Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

(i), Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.

1241(b) and 10 U.S.C. 2631).

(ii) Alternate I (Apr 2003) of 52.247-64.

(iii) Alternate II (FEB 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

(1) 52.222-17 Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

52.222-41 Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67). (2)

52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). Requires CO completion.

(3)

52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(4)

52.222-44 Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(5)

✔ 52.222-51 Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C.

chapter 67).

(6)

52.222-53 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).

(7)

52.222-55 Minimum Wages Under Executive Order 13658 (Dec 2015). (8)

52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). (9)

52.226-6 Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). (10)

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(v) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

(vii) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(xiii)

(A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O 13627).

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xix)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause” in the redesignated paragraph (d) to read “paragraphs (a), (b), and (c) of this clause.”

Alternate II (Oct 2018). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:

(d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and

(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(A) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).

(C) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(D) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(E) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(F) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

(G) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(H) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(I) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(J) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(K) ___(1) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O 13627).

___(2) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627).

(L) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C. chapter 67).

(M) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services— Requirements (May 2014) (41 U.S.C. chapter 67).

(N) 52.222-54, Employment Eligibility Verification (Oct 2015) (Executive Order 12989).

(O) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(P) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(Q)(1)52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(2)Alternate I (JAN 2017) of 52.224-3.

(R) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note)

(S) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(T) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

Addendum to FAR 52.212-4 Terms and Conditions – Commercial Items

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, Unauthorized Obligations, and Commercial Supplier Agreements – Unenforceable Clauses paragraphs of this clause.

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any commercial supplier agreements as amended by the Commercial Supplier Agreements – Unenforceable Clauses provision.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments.

(9) The specification.

(w) Commercial supplier agreements–unenforceable clauses.

(1) Definition. For the purpose of this contract, “Commercial supplier agreements” (referred to at FAR 12.216 as “Supplier License Agreements”) means terms and conditions customarily offered to the public by vendors of supplies or services that meet the definition of “commercial item” set forth in FAR 2.101 and intended to create a binding legal obligation on the end user. Commercial supplier agreements are particularly common in information technology acquisitions, including acquisitions of commercial computer software and commercial technical data, but they may apply to any supply or service. The term applies–

(a) Regardless of the format or style of the document. For example, a commercial supplier agreement may be styled as standard terms of sale or lease, Terms of Service (TOS), End User License Agreement (EULA), or another similar legal instrument or agreement, and may be presented as part of a proposal or quotation responding to a solicitation for a contract or order;

(b) Regardless of the media or delivery mechanism used. For example, a commercial supplier agreement may be presented as one or more paper documents or may appear on a computer or other electronic device screen during a purchase, software installation, other product delivery, registration for a service, or another transaction.

Solicitation No. 75N95020Q00009

(2) When any supply or service acquired under this contract is subject to a commercial supplier agreement, and notwithstanding any other provision of this agreement, when the end user is an agency or instrumentality of the U.S. Government, the following language shall be deemed incorporated into the commercial supplier agreement. As used herein, “this agreement” means the commercial supplier agreement.

(i) Applicability. This agreement is a part of a contract between the commercial supplier and the U.S. Government for the acquisition of the supply or service that necessitates a license or other similar legal instrument (including all contracts, task orders, and delivery orders under FAR Part 12).

(ii) End user. This agreement shall bind the ordering activity as end user but shall not operate to bind a Government employee or person acting on behalf of the Government in his or her personal capacity.

(iii) Law and disputes. This agreement is governed by Federal law.

(A) Any language purporting to subject the U.S. Government to the laws of a U.S. state, U.S. territory, district, or municipality, or a foreign nation, except where Federal law expressly provides for the application of such laws, is hereby deleted.

(B) Any language requiring dispute resolution in a specific forum or venue that is different from that prescribed by applicable Federal law is hereby deleted.

(C) Any language prescribing a different time period for bringing an action than that prescribed by applicable Federal law in relation to a dispute is hereby deleted.

(iv) Continued performance. The supplier or licensor shall not unilaterally revoke, terminate or suspend any rights granted to the Government except as allowed by this contract. If the supplier or licensor believes the ordering activity to be in breach of the agreement, it shall pursue its rights under the Contract Disputes Act or other applicable Federal statute while continuing performance as set forth in subparagraph 52.212-4(d) (Disputes).

(v) Arbitration; equitable or injunctive relief. In the event of a claim or dispute arising under or relating to this agreement, a binding arbitration shall not be used unless specifically authorized by agency guidance, and equitable or injunctive relief, including the award of attorney fees, costs or interest, may be awarded against the U.S. Government only when explicitly provided by statute (e.g., Prompt Payment Act or Equal Access to Justice Act).

(vi) Updating terms.

(A) After award, the contractor may unilaterally revise commercial supplier agreement terms if they are not material. A material change is defined as:

(1) Terms that change Government rights or obligations;

(2) Terms that increase Government prices;

(3) Terms that decrease overall level of service; or

(4) Terms that limit any other Government right addressed elsewhere in this contract.

(B) For revisions that will materially change the terms of the contract, the revised commercial supplier agreement must be incorporated into the contract using a bilateral modification.

(C) Any agreement terms or conditions unilaterally revised subsequent to award that are inconsistent with any material term or provision of this contract shall not be enforceable against the Government, and the Government shall not be deemed to have consented to them.

(vii) No automatic renewals. If any license or service tied to periodic payment is provided under this agreement (e.g., annual software maintenance or annual lease term), such license or service shall not renew automatically upon expiration of its current term without prior express consent by an authorized Government representative.

(viii) Indemnification. Any clause of this agreement requiring the commercial supplier or licensor to defend or indemnify the end user is hereby amended to provide that the U.S.

Department of Justice has the sole right to represent the United States in any such action, in accordance with 28 U.S.C. 516.

(ix) Audits. Any clause of this agreement permitting the commercial supplier or licensor to audit the end user’s compliance with this agreement is hereby amended as follows:

(A) Discrepancies found in an audit may result in a charge by the commercial supplier or licensor to the ordering activity. Any resulting invoice must comply with the proper invoicing requirements specified in the underlying Government contract or order.

(B) This charge, if disputed by the ordering activity, will be resolved in accordance with subparagraph (d) (Disputes); no payment obligation shall arise on the part of the ordering activity until the conclusion of the dispute process.

(C) Any audit requested by the contractor will be performed at the contractor's expense, without reimbursement by the Government.

(x) Taxes or surcharges. Any taxes or surcharges which the commercial supplier or licensor seeks to pass along to the Government as end user will be governed by the terms of the underlying Government contract or order and, in any event, must be submitted to the Contracting Officer for a determination of applicability prior to invoicing unless specifically agreed to otherwise in the Government contract.

(xi) Non-assignment. This agreement may not be assigned, nor may any rights or obligations thereunder be delegated, without the Government's prior approval, except as expressly permitted under subparagraph (b) of this clause.

(xii) Confidential information. If this agreement includes a confidentiality clause, such clause is hereby amended to state that neither the agreement nor the contract price list, as applicable, shall be deemed “confidential information.” Issues regarding release of “unit pricing” will be resolved consistent with the Freedom of Information Act. Notwithstanding anything in this agreement to the contrary, the Government may retain any confidential information as required by law, regulation or its internal document retention procedures for legal, regulatory or compliance purposes; provided, however, that all such retained confidential information will continue to be subject to the confidentiality obligations of this agreement.

(3) If any language, provision, or clause of this agreement conflicts or is inconsistent with the preceding paragraph (1), the language, provisions, or clause of paragraph (1) shall prevail to the extent of such inconsistency.

(End of clause)

52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or

Equipment (AUG 2019)

(a) Definitions. As used in this provision--

Covered telecommunications equipment or services, Critical technology, and Substantial or essential component have the meanings provided in clause 52.204-25, Prohibition on Contracting for Certain

Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal

Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract…