combined synopsis-Solicitation-123503 cryopreservation of cell lines.pdf

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) 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. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures. The solicitation number is 75F40124Q123503. This solicitation is issued as a Request for Quote

(RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05 May 22, 2024.

The associated North American Industry Classification System (NAICS) Code is-541990 – All Other Professional, Scientific and Technical Services; the applicable Small Business Size Standard is $19.5 M. This RFQ is issued as full and open competition.

Statement of Work: Crypreservation of two cell lines. Expansion, vialing and storage of clonal simian retrovirus infected cell line

Part I: General Information

A. Introduction/background Our lab has developed cell lines that are stably infected with simian retrovirus and produce different levels of viral RNA. Currently we need large scale production and cryopreservation of two of these cell lines as virus reagents.

B. Scope The company will expand, vial at specified viable cell concentration, and cryopreserve the cell lines in liquid nitrogen. They will also perform quality check of the cells by sterility and mycoplasma testing. The vendor will also provide documentation of the protocols and certificates of analysis and a final report. The cells will be stored by the contractor for one-year.

Part II: Work Requirements

A. Technical Requirements

Preparation and quality control (QC) of 250 vials (at 4 x 106 cells/vial) of two different adherent cell lines infected with a retrovirus. The vials of the clonal cell lines to be used for expansion will be provided in dry ice to the contractor within 30 calendar days after award. The contractor shall store the cells at a temperature equal or lower than -196 °C until they are ready to start the cell expansion.

1. Contractor shall prepare at least 250 vials with 4 x 106 cells/mL/vial for each cell line.

Cell concentration is for live cells.

a. Long-term storage, 2mL cryogenic Nalgene vials (or equivalent) shall be used for storing the cells.

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2. Each cell line shall be expanded as follows:

a. Grown in DMEM media supplemented 10% heat inactivated fetal bovine serum, 1mM Sodium Pyruvate, 2mM L-glutamine, 100 U of penicillin per mL, 100 µg of streptomycin per mL.

i. FBS used for cell growth must be characterized (9 CFR 113.53 tested), heat inactivated and from non-BSE country of origin. The COAs should be provided upon completion of the contract.

b. Incubation at 37 °C and 5% CO2 in a dedicated incubator.

c. Cells shall be split when they reach 80-90% confluence in a biosafety cabinet to maintain sterile conditions.

i. Details of cell passage shall be discussed prior to initiation of the work and any unexpected observations of the cells shall be reported to the

FDA.

d. Only one cell line shall be grown and cryopreserved at a time. Cells will be handled in a biosafety cabinet with at least one hour prior to any other cell line being used in the cabinet.

e. Cells shall be grown in flasks of up to 225cm2.

f. Composition of medium used for freezing the cells shall be discussed with the

FDA prior to vialing and storage of the cells.

g. Cells shall be pooled and maintained in a homogenous suspension for aliquoting and cryopreservation.

h. The information for labeling the vials will be provided by FDA.

3. Records shall be provided for all biological raw materials used in cell line expansion and preparation of the final vialed product, including information on source/origin, any treatment (if applicable) and Certificate of Analysis (sera, trypsin, media and media components, etc).

4. Contractor shall keep detailed electronic records of the production and vialing of the cells and send to FDA at the completion of the work. Records must include details of cell passage (split ratio or cell counts) and include observation for health and confluence of the cells. Records need to be organized chronologically with dates and clearly readable.

5. Sterility testing, mycoplasma testing and viability check of the cryopreserved cell lines shall be performed at least two weeks after the cells have been frozen; the results of the sterility and mycoplasma test must be negative. A COA of each cell line shall be provided to the FDA.

6. Contractor shall provide the FDA principal investigator identified at time of award all timelines and updates during the production and testing of the cell lines; if any changes are required, the company shall discuss with investigator prior to proceeding.

7. Contractor shall provide demonstrated capability for long-term in-house storage of cell lines in liquid nitrogen temperature-controlled vessels at two locations to include detailed logs kept for production, testing, managing, orders, and shipping of biological materials.

8. Contractor shall send the FDA 20 frozen vials of each cell line at the end of production. Include all shipping charges FOB Destination for the shipment of the 20 vials of each cell line upon completion of production, and all shipping charges FOB Destination for additional shipments as required from cell lines stored at contractor’s facility.

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9. Contractor shall transfer all the cryopreserved cell lines in liquid nitrogen to a specified repository in Maryland or Virginia within one year of vialing. Cost of transfer shall be included in the contract.

B. Deliverables

*Within 60 days of completion of the production and testing for each cell line the following shall be provided to the FDA principal investigator identified at the time of award:

• Twenty vials of each cell line meeting the minimum technical requirements set forth above shall be shipped to the FDA principal investigator identified at time of award, in a suitable container to maintain temperature equal or lower than -196 °C, cell viability and vial integrity.

• The detailed electronic report shall be provided to the FDA principal investigator. Report shall be provided containing production batch records, including details on the raw materials used for production (i.e., catalog number and lot numbers, for the serum, trypsin, etc), dates of passage, split ratio or cell counts, confluence and conditions of the cells during passage and the results of the sterility and mycoplasma testing. Records need to be organized chronologically with dates and clearly readable. The report will also include a table of contents and a summary of the workflow.

*Within 90 days from completion of the production and testing for each cell line the certificate of Analysis shall be provided.

Deliverables should be shipped to:

Name: to be completed at time of award Bldg 52/72, Room 1216 10903 New Hampshire Avenue Silver Spring, MD 20993 Tel:

Email:

Part III: Supporting Information

A. Security -N/A-

B. Place of Performance Cell line expansion and storage will be completed at the company site.

Deliverables should be shipped to:

Name: to be completed at time of award Bldg 52/72, Room 1238 10903 New Hampshire Avenue

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Silver Spring, MD 20993 Tel:

Email:

C. Period of Performance 12 months from the effective date of contract award.

D. Special Considerations:

These are non-severable biological/scientific services.

The Contractor does not own the data (i.e., intellectual property). FDA is the owner of the data/cell lines.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons or entity except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein. The information shall not be disclosed to any other entity without prior FDA approval.

Schedule of Items (all shipping and handling shall be included in the price)

Contract

Line Item

Description Quantity Extended Price

Cryopreservation of two cell lines as specified herein.

2 Cell Lines $___________

Contract clauses-

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

75F40124Q123503 4 of 33 http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (NOV 2023), applies to this acquisition.

The following addenda apply:

FAR Clause 52.204-13 System for Award Management and Maintenance (Oct 2018) FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance. (Aug 2020) FAR Clause 52.232-18 Availability of Funds (Apr 1984)

HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations DEC 2015 HHSAR Clause 352.223-70 Safety and Health (Dec 2015) HHSAR Clause 352.224-71 Confidential Information. (FEB 2024) (DEVIATION)

(a) Definition. As used in this clause—

Confidential information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Identification of information. Specific confidential information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, is identified in this contract.

(c) Disclosure. The Contractor shall not disclose confidential information or records until written notice is provided to the Contracting Officer at least 45 days in advance of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency. The Contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Government furnished or provided information: For information provided by or on behalf of the government—

(1) The publication or dissemination of the following types of information are restricted under this contract: All data and cell lines related to this procurement is restricted.

(2) The reason(s) for restricting the types of information identified in subparagraph

(d)(1) is/are:

The cell lines are not to be provided to any foreign country or entity without the FDA approval.

(e) The Contractor shall consult with the Contracting Officer when there is uncertainty with regard to the confidentiality of, or a property interest in, information under this contract prior to the release, disclosure, dissemination, or publication of such information.

(End of clause)

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HHSAR Clause 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

HHSAR Clause 352.239-79 Information and Communication Technology Accessibility (Feb 2024) (Deviation)

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the contracting officer.

Contract Administration

a. Contracting Officer/Contract Administrator Nick Sartain, Contracting Officer Phone: 870-543-7370 Email: nick.sartain@fda.hhs.gov

b. Technical Point of Contact – The following TPOC will represent the Government for the purpose of this contact:

(To be completed at time of award) Name:

Phone:

Email:

The TPOC/COR is responsible for:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

75F40124Q123503 6 of 33 mailto:nick.sartain@fda.hhs.gov

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

(5) Assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

(1) Direct or negotiate any changes in the statement of work;

(2) Modify or extend the period of performance;

(3) change the delivery schedule;

(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

Payments

Payment terms Net 30 days after government acceptance. No advance payments will be made.

Contractor may submit invoices monthly, quarterly or annually, in arrears.

Invoice Submission

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the

U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

75F40124Q123503 7 of 33 http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other

Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301- 827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Notice Regarding the Use of Macros in Submitted Documents

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services (May 2024)

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(a) 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 products and commercial services:

(1) 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)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) 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 products and commercial services:

[Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C.

3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) (41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

X (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (6) [Reserved].

__ (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

__ (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) (Pub. L. 115–390, title II).

__ (11)(i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) (Pub. L. 115–390, title II).

__ (ii) Alternate I (Dec 2023) of 52.204–30.

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X (12) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) (31 U.S.C. 6101 note).

__ (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

__ (14) [Reserved].

__ (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C.

657a).

X (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (17) [Reserved] __ (18)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (19)(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

__ (20) 52.219-8, Utilization of Small Business Concerns (Feb 2024) (15 U.S.C. 637(d)(2) and (3)).

__ (21)(i) 52.219-9, Small Business Subcontracting Plan (Sep 2023) (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 (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Sep 2023) of 52.219-9.

__ (22)(i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

__ (23) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637s).

__ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C.

637(d)(4)(F)(i)).

__ (25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran- Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) (15 U.S.C. 657f).

X (26)(i) 52.219-28, Post Award Small Business Program Rerepresentation (Feb 2024) (15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (Mar 2020) of 52.219-28.

__ (27) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

__ (28) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) (15 U.S.C. 637(m)).

__ (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

__ (30) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15 U.S.C. 637(a)(17)).

X (31) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

X (32) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2024).

X (33) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (34)(i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

__ (35)(i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

75F40124Q123503 11 of 33 https://www.acquisition.gov/far/part-52#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_7 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_14 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_16 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_27 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_28 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_29 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_30 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_32 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.acquisition.gov/far/part-52#FAR_52_219_33 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm https://www.acquisition.gov/far/part-52#FAR_52_222_3 https://www.acquisition.gov/far/part-52#FAR_52_222_19 https://www.acquisition.gov/far/part-52#FAR_52_222_21 https://www.acquisition.gov/far/part-52#FAR_52_222_26 https://www.acquisition.gov/far/part-52#FAR_52_222_26 https://www.acquisition.gov/far/part-52#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim

__ (ii) Alternate I (Jul 2014) of 52.222-35.

X (36)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C.

793).

__ (ii) Alternate I (Jul 2014) of 52.222-36.

__ (37) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

__ (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

X (39)(i) 52.222-50, Combating Trafficking in Persons (Nov 2021) (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).

__ (40) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989).

(Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (41)(i) 52.223-9, 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.)

__ (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.)

_ (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (44) 52.223-20, Aerosols (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (45) 52.223-21, Foams (May 2024) ( 42 U.S.C. 7671, et seq.).

X (46) 52.223-23, Sustainable Products and Services (May 2024) ( E.O. 14057, 7 U.S.C.

8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

__ (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

__ (48)(i) 52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

__ (ii) Alternate I (Oct 2022) of 52.225-1.

X (49)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Nov 2023) (19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C.

chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109- 53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I [Reserved].

X (iii) Alternate II (Dec 2022) of 52.225-3.

__ (iv) Alternate III (Feb 2024) of 52.225-3.

__ (v) Alternate IV (Oct 2022) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (NOV 2023) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (51) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 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. Subtitle A, Part V, Subpart G Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

75F40124Q123503 12 of 33 https://www.acquisition.gov/far/part-52#FAR_52_222_35 https://www.acquisition.gov/far/part-52#FAR_52_222_36 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_36 https://www.acquisition.gov/far/part-52#FAR_52_222_37 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_40 https://www.acquisition.gov/far/part-52#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_222_54 https://www.acquisition.gov/far/part-22#FAR_22_1803 https://www.acquisition.gov/far/part-52#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_223_11 https://www.govinfo.gov/link/uscode/42/7671 https://www.acquisition.gov/far/part-52#FAR_52_223_12 https://www.govinfo.gov/link/uscode/42/7671 https://www.acquisition.gov/far/part-52#FAR_52_223_20 https://www.govinfo.gov/link/uscode/42/7671 https://www.acquisition.gov/far/part-52#FAR_52_223_21 https://www.govinfo.gov/link/uscode/42/7671 https://www.acquisition.gov/far/part-52#FAR_52_223_23 https://www.federalregister.gov/executive-order/14057 https://www.govinfo.gov/link/uscode/7/8102 https://www.govinfo.gov/link/uscode/7/8102 https://www.govinfo.gov/link/uscode/42/6962 https://www.govinfo.gov/link/uscode/42/8259b https://www.govinfo.gov/link/uscode/42/7671l https://www.acquisition.gov/far/part-52#FAR_52_224_3 https://www.acquisition.gov/far/part-52#FAR_52_225_1 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.govinfo.gov/link/uscode/19/3301 https://www.govinfo.gov/link/uscode/19/3301 https://www.govinfo.gov/link/uscode/19/2112 https://www.govinfo.gov/link/uscode/19/3805 https://www.govinfo.gov/link/uscode/19/4001 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_5 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section2501&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section3301&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_225_13 https://www.acquisition.gov/far/part-52#FAR_52_225_26 https://www.acquisition.gov/far/part-52#FAR_52_226_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

X (55) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ( E.O. 13513).

__ (56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

__ (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

X (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).

__ (60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (61) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (63) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (64)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631).

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

__ (iii) Alternate II (Nov 2021) 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 products and commercial services:

[Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).

__ (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).

__ (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 for Contractor Workers Under Executive Order 14026 (Jan 2022).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792).

(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, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

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(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 products or commercial services. 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 (Nov 2021) (41 U.S.C. 3509).

(ii) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) (41 U.S.C. 4712).

(iii) 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)).

(iv) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(v) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(vi) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

(vii)

(A) 52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) (Pub. L. 115–390, title II).

(B) Alternate I (Dec 2023) of 52.204–30.

(viii) 52.219-8, Utilization of Small Business Concerns (Feb 2024) (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 the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

(x) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

(xi) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C.