75F40125R000114 Combined Synopsis Solicitation.pdf

Nitrogen Generator Service Maintenance FDA Solicitation # 75F40125R00114

Table of Contents

PART 1 – SYNOPSIS/SOLICITATION INFORMATION

PART 2 – DESCRIPTION OF REQUIREMENT

PART 3 – PRICES

3.1 Pricing Table

PART 4 – Statement of Objectives (SOO)

4.1 PURPOSE

4.2 BACKGROUND

4.3 SCOPE OF WORK

4.3.1 Equipment Specifications:

4.3.2 Service Requirements:

4.4 PERFORMANCE OBJECTIVES

4.4.1 Task 1 - Annual Preventative Maintenance

4.4.2 Task 2 - Technical Support Services

4.4.3 Task 3 - Repair Services

4.5 DELIVERABLES

4.6 CONTRACTOR-PROVIDED MATERIALS

4.7 OPERATING CONSTRAINTS

4.7.1 Security Requirements

4.8 INSURANCE REQUIREMENTS

4.9 PLACE OF PERFORMANCE

4.10 ANTICIPATED PERIOD OF PERFORMANCE

4.11 PERSONNEL QUALIFICATIONS

4.12 GOVERNMENT CLOSURE PROVISIONS

4.13 PERFORMANCE MONITORING AND EVALUATION

4.14 POINTS OF CONTACT

PART 5 – CONTRACT ADMINISTRATION DATA

5.0 CONTRACTING OFFICER TECHNICAL REPRESENTATIVE CONTACT INFORMATION

5.1 CONTRACTING OFFICER (CO) CONTACT INFORMATION

5.2 CONTRACTORS POINT OF CONTACT INFORMATION*

5.3 CONTRACTOR PERFORMANCE EVALUATION

5.4 ORGANIZATIONAL CONFLICT OF INTEREST DISCLOSURE/MITIGATION

5.5 GENERAL INVOICING INSTRUCTIONS

PART 6 – CONTRACT PROVISIONS AND CLAUSES

6.0 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES.

(DEC 2022

6.1 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS - COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES. (JUN 2025)

6.2 FAR 52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION (JUN 2023)

6.3 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION

REGULATION (HHSAR) (48 CFR CHAPTER 3) CONTRACT CLAUSES

(End of Clause)

6.4 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

PART 7 - SOLICITATION PROVISIONS

7.0 52.212-1 INSTRUCTIONS TO CONTRACTORS - COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES.

(SEP 2023)

7.1 52.212-2 Evaluation - Commercial Products and Commercial Services. (NOV 2021)

7.2 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES. MAY 2024)

7.3 352.215-70 LATE PROPOSALS AND REVISIONS. (DEC 2015)

7.4 RFP INQUIRIES AND QUESTIONS DUE DATE

7.5 PROPOSAL SUBMISSION DATE

PART 8 ATTACHMENTS

PART 9 PROPOSAL INSTRUCTIONS

9.1 VOLUME I

9.2 VOLUME II

9.3 VOLUME III

PART 10 – EVALUATION FACTORS FOR AWARD

10.1 EVALUATION FACTORS

10.1.1 Evaluation of Factor 1 – Technical Approach

10.1.2 Evaluation of Factor 2 – Experience

10.1.3 Evaluation of Factor 3 – Past Performance

10.1.4 Evaluation of Factor 4 – Price

PART 11 - BASIS FOR AWARD

PART 1 – SYNOPSIS/SOLICITATION INFORMATION

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6 and 13, as supplemented with additional information included in this notice. Proposals are being requested and this announcement constitutes the only solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-04 effective June 11, 2025.

1. Contracting Office Address: 10903 New Hampshire Avenue, Silver Spring Maryland

20903

2. Solicitation Number: 75F40125R000114

3. Subject: Comprehensive service maintenance agreement for three (3) nitrogen generators

4. Product Service Code: J066 - Maint/Repair/Rebuild of Equipment- Instruments and

Laboratory Equipment

5. NAICS Code: 811210 - Electronic and Precision Equipment Repair and Maintenance

6. Response Date: 10:00am EST on 08/29/2025 due via email to the Primary Point of

Contact: Michele Jackson at Michele.Jackson@fda.hhs.gov.

THIS ANNOUCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40125R00114 and is being issued as a Request for Proposal (RFP). This will be awarded as a Firm-Fixed Price contract. Prospective contractors are responsible for downloading the solicitation and any amendments. The Government reserves the right to award without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

PART 2 – DESCRIPTION OF REQUIREMENT

The U.S. Food and Drug Administration (FDA), Division of Seafood Science and Technology (DSST), requires a comprehensive service maintenance agreement for three (3) nitrogen generators supporting Liquid Chromatography/Mass Spectrometry (LC/MS) systems.

The requirement will be awarded as a Firm-Fixed-Price (FFP) contract with one (1) base year and four (4) one-year option periods.

PART 3 – PRICES

3.1 Pricing Table

Table 1: Services and Firm-Fixed-Price

Contract Line-Item Number

(CLIN)

Services being provided AMT Total Firm-Fixed CLIN Price

0001 Base Year Maintenance Services $ $

0002 Option Year 1 Maintenance Services $ $

0003 Option Year 2 Maintenance Services $ $

0004 Option Year 3 Maintenance Services $ $

0005 Option Year 4 Maintenance Services $ $

PART 4 – Statement of Objectives (SOO)

4.1 PURPOSE

The purpose of this requirement is to acquire a comprehensive service maintenance agreement for three

(3) nitrogen generators that support Liquid Chromatography/Mass Spectrometry (LC/MS) systems utilized in research projects and outbreak support conducted at the Division of Seafood Science and Technology (DSST), Office of Applied Microbiology and Technology (OAMT).

4.2 BACKGROUND

This acquisition establishes a maintenance service agreement for three (3) nitrogen generator systems that are integral to the operation of mass spectrophotometers used for the analysis of research and outbreak samples pertaining to aquaculture drugs and marine toxins. These instruments must be maintained in optimal operational condition to ensure uninterrupted function for public health protection.

The previous service agreement has expired, necessitating immediate establishment of a new agreement to prevent work interruption. This requirement establishes a base year plus four (4) option years contract to provide excellent performance supporting various research projects and outbreak sample analysis at DSST for enhanced food safety and public health protection.

4.3 SCOPE OF WORK

The Contractor shall provide comprehensive maintenance services for three (3) nitrogen generator systems to maintain optimal operational condition:

4.3.1 Equipment Specifications:

• Unit 1: Parker, Model LCMS-5000NA, Serial Number LCMS1120

• Unit 2: Parker, Model LCMS-5000NA, Serial Number LCMS50001443B

• Unit 3: Peak, Model GENIUS 1024, Serial Number 771044562

4.3.2 Service Requirements:

a) Annual preventative maintenance and system health assessments

b) Coverage of Original Equipment Manufacturer (OEM) or manufacturer-certified parts, labor, travel, and accommodations

c) Full breakdown coverage with onsite remedial services

d) Coordinated service delivery for all systems to minimize downtime.

e) Services performed by OEM (or OEM-equivalent) factory-trained and certified technicians using manufacturer diagnostic tools.

f) Rapid response time for remedial repairs, with a maximum of 2 (two) business days

g) Minimum sixty (60) day warranty on all workmanship

4.4 PERFORMANCE OBJECTIVES

4.4.1 Task 1 - Annual Preventative Maintenance

a) Deploy OEM (or OEM-equivalent) factory-trained and certified technicians for annual onsite calibration and maintenance.

b) Perform all necessary maintenance to achieve and maintain equipment compliance.

c) Provide annual parts replacement including valves, filters, compressor refits, and compressor servicing/replacement.

d) Include all travel, accommodation, and labor costs.

e) Utilize exclusively OEM-made or manufacturer-certified parts.

4.4.2 Task 2 - Technical Support Services

a) Provide technical support during standard business hours (Monday-Friday, 9:00 AM - 5:00 PM

Central Time)

b) Offer remote tele diagnostic capabilities for efficient troubleshooting.

c) Initial response time of one (1) business day maximum to support requests.

d) Deliver technical support via internet, email, phone, and in-person methods until case resolution.

e) Maintain response protocols for support requests.

4.4.3 Task 3 - Repair Services

a) Provide repair services using OEM (or OEM-equivalent) factory-trained and certified technicians with manufacturer diagnostic tools.

b) Two (2) business day response time for remedial repairs

c) Cover all engineer dispatch charges, travel, labor, and accommodation costs.

d) Provide minimum sixty (60) day warranty on all repair workmanship.

e) Limit downtime to 72 hours from initial on-site visit/evaluation.

4.5 DELIVERABLES

a) Supply all parts required for equipment maintenance and repair.

b) Execute scheduled annual maintenance services.

c) Execute remedial repairs.

d) Provide comprehensive service and support for equipment located at Gulf Coast Seafood

Laboratory (GCSL), 1 Iberville Drive, Dauphin Island, AL 36528

e) Submit signed maintenance and repair reports documenting all work performed, delivered in paper and/or PDF format to the Contracting Officer's Representative (COR) and Program Management Office Point of Contact (PMO POC)

4.6 CONTRACTOR-PROVIDED MATERIALS

All parts must be OEM-made or manufacturer-certified components.

4.7 OPERATING CONSTRAINTS

4.7.1 Security Requirements

a) No FDA network access.

b) Contractor personnel must provide REAL ID photo identification for security clearance.

c) PMO POC or Technical Point of Contact (TPOC) supervision required during onsite visits.

d) Minimum two (2) business days advance notice required for site visits unless emergency visits,

e) Name(s) of visiting technician(s)/engineer(s) and expected arrival time must be provide when scheduling the visit with FDA’s Point of contact.

f) Standard visitor check-in/check-out procedures must be followed.

g) Compliance with all facility policies and procedures mandatory.

h) Risk level classified as non-sensitive.

4.8 INSURANCE REQUIREMENTS

Contractor must obtain liability and property damage insurance at a minimum $750,000.00.

4.9 PLACE OF PERFORMANCE

All services shall be performed at FDA Gulf Coast Seafood Laboratory, 1 Iberville Drive, Dauphin Island, AL during standard business hours (Monday-Friday, 9:00 AM - 5:00 PM Central Time), excluding federal holidays and facility closures.

4.10 ANTICIPATED PERIOD OF PERFORMANCE

• Base Year: September 15, 2025 - September 14, 2026

• Option Year 1: September 15, 2026 - September 14, 2027

• Option Year 2: September 15, 2027 - September 14, 2028

• Option Year 3: September 15, 2028 - September 14, 2029

• Option Year 4: September 15, 2029 - September 14, 2030

4.11 PERSONNEL QUALIFICATIONS

All engineers and technicians performing services must have the expertise, knowledge and be well trained in performing maintenance on nitrogen generators in accordance with the equipment specifications listed in the scope of work (equipment specifications) of this document.

4.12 GOVERNMENT CLOSURE PROVISIONS

a) No onsite services required during federal holidays.

b) No onsite services required during government closures due to inclement weather.

c) No billing permitted for work not performed due to government closures.

4.13 PERFORMANCE MONITORING AND EVALUATION

The Government will monitor contractor performance through:

a) Annual comprehensive performance evaluations utilizing Contractor Performance Assessment Reporting System (CPARS)

b) Real-time monitoring of response times and service quality

c) Customer feedback collection and analysis

4.14 POINTS OF CONTACT

• Contracting Officer's Representative (COR): To be provided at award.

• Program Management Office Point of Contact (PMO POC): To be provided at award.

• Technical Point of Contact (TPOC): To be provided at award.

PART 5 – CONTRACT ADMINISTRATION DATA

5.0 CONTRACTING OFFICER TECHNICAL REPRESENTATIVE CONTACT

INFORMATION

The following personnel shall represent the Government:

Contracting Officer Technical Representative:

The Technical Representative 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; (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.

“To be determined upon contract award”

5.1 CONTRACTING OFFICER (CO) CONTACT INFORMATION

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 RFP; (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.

Michele Jackson 1090 New Hampshire Avenue

Silver Spring, MD 2070 Michele.Jackson@fda.hhs.gov

5.2 CONTRACTORS POINT OF CONTACT INFORMATION*

Name: “To be completed at award” Title: “To be completed at award” Address: “To be completed at award” Email Address: “To be completed at award” Telephone number: “To be completed at award”

*All changes to the contractors point of contact information will be issued via email from the contractor to the CO.

5.3 CONTRACTOR PERFORMANCE EVALUATION

Contractor performance will be evaluated on the final basis pursuant to FAR Subpart 42.15. The Contractor Performance Assessment Reporting System (CPARS) will be utilized for these reviews. Information on CPARS can be located at http://www.cpars.gov.

5.4 ORGANIZATIONAL CONFLICT OF INTEREST DISCLOSURE/MITIGATION

Organizational Conflict of Interest

a) The purpose of this section is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The language of section VII applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co- sponsor, joint venture, consultant, or in any similar capacity.

(c) Definition of Conflict of Interest Conflict of interest means that because of other activities or relationships with other persons or organizations, a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR http://www.cpars.gov/

9.501).

(d) Contractor’s Conflict of Interest Responsibilities The individual contractor must be free of interest prior to performing under this contract. Any time prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the contract officer and project officer. The contract officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the contract officer.

(e) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

Prior to award, contractors that disclose potential or actual conflicts of interest shall submit a mitigation of conflicts of interest plan along with their technical and business proposals.

(f) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(g) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(h) Prime Contractor Responsibilities. – The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(i) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

5.5 GENERAL INVOICING INSTRUCTIONS

7.5.1 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.

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.

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 http://www.ipp.gov/vendors/index.htm http://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

c. 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).

• 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 Indirect)- 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.

d. 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

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

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

e. Payment of invoices will be made based upon acceptance by the Government of the entire CLIN 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.

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

g. 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.

h. 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.

i. 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.

PART 6 – CONTRACT PROVISIONS AND CLAUSES

6.0 52.212-4 CONTRACT TERMS AND CONDITIONS -

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES. (DEC

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post acceptance rights

(1) within a reasonable time after the defect was discovered or should have been discovered; and

(2) before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

mailto:ERIC@fda.hhs.gov

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233- 1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies to the address designated in the FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) clause located in Section 7.5.1 of this document. An invoice must include-

(i) Name and address of the Contractor.

(ii) Invoice date and number.

(iii) Contract number, line item number.

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered.

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading.

(vi) Terms of any discount for prompt payment offered.

(vii) Name and address of official to whom payment is to be sent.

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer- Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment-

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall-

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the-

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment).

(B) Affected contract number.

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if-

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days.

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on-

(A) The date on which the designated office receives payment from the

Contractor.

(B) The date of issuance of a government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin;

or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C.

4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C.

40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(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, and Unauthorized Obligations paragraphs of this clause; (3) the clause at 52.212-5;

(4) addenda to this solicitation or contract, including any license agreements for computer software; (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; and (9) the specification.

(t) Removed and reserved.

(u) Unauthorized Obligations. (1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti- Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an "I agree" click box or other comparable mechanism (e.g., "click-wrap" or "browse-wrap" agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(iv) Incorporation by reference. The Contractor's representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of clause)

6.1 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS - COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES. (JUN 2025)

(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 and Other 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:

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Jun 2020) (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) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun

2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

(5) [Reserved].

_X_ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

(8) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

_X_ (9) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jan 2025) (31 U.S.C. 6101 note).

(10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

X (11) 52.210-1 Market Research (DEVIATION) (RFO MAY 2025)

(12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C.

657a).

_X_ (13) 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).

(14) [Reserved]

(15) (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.

(16) (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.

(17) 52.219-8, Utilization of Small Business Concerns (Oct 2022) (15 U.S.C. 637(d)(2) and (3)).

(18) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) (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 2021) of 52.219-9.

(19) (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.

(20) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637s).

(21) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C.

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

(22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Oct 2022) (15 U.S.C. 657f).

(23) (i) 52.219-28, Post Award Small Business Program Re-representation (Mar 2023) (15 U.S.C. 632(a)(2)).

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

(24) 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)).

(25) 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)).

(26) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

(27) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15U.S.C. 637(a)(17)).

_X_ (28) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2025) (E.O.13126).

_X_ (30) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (31) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

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

_X_ (32) 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.

_X_ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

_X_ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (35) 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).

(36) 52.222-54, Employment Eligibility Verification (Jan 2025) (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.)

(37) 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.)

_X_ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) (E.O. 13693).

(39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

(40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

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

(41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun2014) of 52.223-14.

(42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C.

8259b).

(43) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

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

_X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

(45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

(46) 52.223-21, Foams (Jun2016) (E.O. 13693).

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

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

(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.

(49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Dec 2022) (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].

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

(iv) Alternate III (Jan 2021) of 52.225-3.

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

_X (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.

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).

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

(55) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

(56) 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).

(57) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

_X_ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

(59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

(60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

(61)52.234-1, Industrial Resources Developed Under Title III, Defense Production Act

(DEVIATION)

(62)52.234-4 Earned Value Management System (DEVIATION)

(63) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

(64) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

(65) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) 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…