RFQ 75F40126Q00120 final.pdf

REQUEST FOR QUOTATION: 75F40126Q00120

U.S. FOOD AND DRUG ADMINISTRATION (FDA) REQUEST FOR QUOTE

FLOWSHEET MODELING AND SIMULATION SOFTWARE LICENSE SUPPORT AND MAINTENANCE

SERVICES – gPROMS

RFQ-75F40126Q00120

This is a combined/synopsis solicitation issued under FAR Part 12.201 and 13 procedures. This is an unrestricted Full and Open Competition. The NAICS code is 423430; Computer and Computer Peripheral

Equipment and Software Merchant Wholesalers.

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote.

1. Background

Continuous pharmaceutical manufacturing is an emerging technology that has the potential to improve the efficiency and quality assurance of the pharmaceutical sector. Continuous manufacturing processes are dynamic systems, unlike batch manufacturing processes. During the normal operation, a set of critical process parameters and/or quality attributes are kept close to the target values, rather than at a steady-state condition. Transient disturbances (deviations from these target values) may occur during normal operation. These are usually small enough to be controllable (i.e., being kept within a desired range). Larger changes in process parameters and quality attributes can happen when a process is in a transient state, such as during startup and shutdown, a change from one operating condition to another, or significant deviations such as those due to equipment failure or unexpected change in material attributes. Understanding of process dynamics as a function of input material attributes (e.g., material flow properties), process conditions (e.g., mass flow rates) or equipment design elements (e.g., blade types for a continuous blender) enables material traceability (the ability to preserve and access the identity and attribute of a material throughout the system) during and after production. This knowledge is essential for identification and mitigation of risks to product quality.

Therefore, due to the dynamic nature of continuous processing, the risk assessment for a continuous manufacturing process may likely need to consider process understanding of the integrated system in addition to each unit operation. Continuous manufacturing also promotes the adoption of advanced control strategies where the Food and Drug Administration (FDA) has limited experience.

Therefore, specific modeling and simulation tools are needed to investigate the impact of process dynamics on product quality and the effectiveness of advanced control strategy approaches to mitigate the impact of disturbances to support FDA’s quality assessment of the emerging technology continuous manufacturing. These tools can improve understanding of the continuous manufacturing process by characterizing material flow, residence time distribution, and the propagation of variability across interconnected unit operations. They can also be used to predict how changes in raw material attributes, operating conditions, or equipment parameters affect intermediate and final product quality. In addition, modeling and simulation can support virtual experimentation, evaluation of control strategies, and development of material traceability and diversion approaches without relying solely on extensive physical testing.

2. Objective

The objective is to purchase a new license for gPROMS or equal to flowsheet modeling and simulation platform including model libraries for blending, granulation, milling, feeding, compression, tablet coating, oral absorption, crystallization, and drying.

3. Requirements

The Contractor shall provide a flowsheet modeling and simulation platform, gPROMS or equal, to study emerging pharmaceutical manufacturing technologies or equal to software license. For a Vendor’s software to be deemed acceptable, the following salient characteristics shall be met:

3.1 Salient Characteristics – gPROMS or equal License

1. Flowsheet modeling environment for conventional pharmaceutical processes including a graphical interface with drag and drop functionality

2. Intelligent line routing and clearly differentiated stream types

3. Steady state and dynamic process models for all common process equipment including reactors, separators, flow transportation, heat exchangers, and process control

4. Steady-state and dynamic modeling of multiple process unit models connected together in a single flowsheet

5. Custom modeling capabilities to create user defined models

6. Dynamic flowsheet models that include elements of process control for studying the impact of process disturbances

7. Parameter estimation from experimental data to support model validation

8. Global sensitivity analysis to analyze the impact of inputs, and model parameters on process outputs

9. Ability to estimate physical properties of components and mixture for example using

Multiflash or Design Institute for Physical Properties (DIPPR) database

10. Ability to run steady-state optimization that are capable of handling many decision variables simultaneously

11. Multiple activities using the same model: steady-state and dynamic simulation, parameter estimation, steady-state and dynamic optimization

12. Modeling and solution power specifically designed to handle the simultaneous solution of large number of equations

13. Model initialization procedures for ensuring robust solution without user provided initial guesses

14. Mechanistic model libraries for synthesis and crystallization including well-mixed reactor, well mixed crystallizer, plug flow reactor, and plug flow crystallizer

15. Mechanistic model libraries for solids processing including roller compactor, twin granulation, two dimensional population balance granulation framework, fluid-bed drying, spray drying, continuous blenders, compression, and tablet coating

16. Mechanistic model libraries for product performance including oral adsorption, in-vitro dissolution, and pharmacokinetics

17. Integrated modelling and optimization platform for formulated product design and manufacture for Pharmaceuticals, Food & Consumer products

18. Custom modelling option for first principles model development for conventional pharmaceutical processes including a graphical interface with drag and drop functionality

19. Flowsheet Construction & Modification- Graphical definition and editing of process flowsheets, Intelligent line routing and clearly differentiated stream types, Custom modeling capabilities to create user defined models

20. Convection-dispersion models of horizontal and vertical blenders with adhesion to blender surfaces and fluctuating levels

21. Mill and screen (classifying) mill, accounting for breakage using one of several kernels

22. Fluid Bed creation of a wet granulate phase from fine powder particles by addition of liquid and evolution of granule liquid content due to drop nucleation and wetting mechanisms, granule growth via liquid-dependent layering and agglomeration

23. Dynamic high shear wet granulation with detailed models for creation of wet granulate phase, evolution of granule liquid content, granule growth and reduction in granule porosity

24. Dynamic dry granulation with detailed models for creation of compacted ribbon between rotating cylinders and accounting for side seal leakage, material compressibility and friction properties and spring back

25. Dynamic twin screw wet granulation compartmental model with configurable screw elements

26. Steady-state tablet compaction model and dynamic convection-dispersion model of the feed frame with adhesion to surfaces

27. Steady-state film coater model for predicting target operating conditions for optimization, scale-up and robustness studies

28. Prediction of oral absorption performance in the human gastrointestinal tract as a function of product formulation and drug substance properties, patient physiology and ingestion conditions

29. Generic in vitro dynamic vessel model for dissolution and precipitation (e.g. USP II and Amorphous Solid Dispersion (ASD)) as a function of the experimental system, operating procedure, product formulation and drug substance properties

30. Single, two and three compartment models characterizing the pharmacokinetics in the body of an externally administered drug substance) or equal

31. Steady-state and dynamic (including mixed-integer) optimization

32. Estimate model parameters from experimental data, with statistical analysis of significance

33. Utilize multiple processors for parallel execution where applicable

34. Multistage Continuous Mixed-Suspension, Mixed-Product Removal (MSMPR) crystallizer for batch and continuous operation and supersaturation generated by cooling, anti-solvent addition, reaction or evaporation

35. Psychrometric dryer, single droplet drying kinetics and fluid bed dryer) or equal

36. Spray dryer with evolution of droplet/particle size distribution, uniform vapor conditions, multi-component solvents

37. The transport and flow rate of material through a screw powder feeder

3.2 Maintenance and Technical Support: At minimum the contractor shall:

1. Delivery of software updates

2. One business-day response to all software defect inquiries

3. Availability of feature (level) upgrades

3.3 Training:

The Contractor shall provide:

• Access to one on-project training by the vendor

4. Deliverables/Schedule of Pricing

Base Year Ref Numbers of Users Descriptions QTY Unit

Price Extended Price

3.1

Flowsheet Modeling and Simulation Software License – gProms or equal

Option Year 1

Ref Numbers of Users

Descriptions QTY Unit Price and Simulation Software License -

Option Year 2

Descriptions QTY Unit

Price and Simulation

Option Year 3

Descriptions QTY Unit

Price and Simulation

Option Year 4

Descriptions QTY Unit

Price and Simulation

Software and licensing key, Software and User Manuals or equal to in a digital copy provided on a CD, DVD or digital download. CD, DVD and hard copies of deliverables shall not be required to be returned to the contractor.

5. Inspection and Acceptance Criteria

Working media: FDA will load the software and licensing to verify that the platform can execute example project files

Pursuant to FAR clause 52.212-4, the Government shall have 30 working days to inspect and verify that the software is operational, functional and compatible with FDA server and software.

6. Terms of Use

Fixed Term License: FDA shall the ability to purchase a new subscription after the original subscription expires to continue the use of the software and to gain access to technical support and product upgrades.

7. Period of Performance

Base Year: 07/12/2026 to 07/11/2027 Option Year 1: 07/12/2027 to 07/11/2028 Option Year 2: 07/12/2028 to 07/11/2029 Option Year 3: 07/12/2029 to 07/11/2030 Option Year 4: 07/12/2030 to 07/11/2031

8. Place of Performance

Deliverables are delivered to the following address:

U.S Food and Drug Administration Center for Drug Evaluation and Research Office of Pharmaceutical Quality / Office of Testing and Research Division of Product Quality Research 10903 New Hampshire Avenue Building 64 Silver Spring, MD 20993

9. Points of Contacts

Contract Specialist (CS) Robert Waite Robert.waite@fda.hhs.gov

Contracting Officer (CO) Narissa Charles Narissa.charles@fda.hhs.gov

Contracting Officer Representative (COR)

Entered at Award

10. Contracting Officer’s Authority

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the Contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

11. Contract Type

The resultant contract type of this order will be firm-fixed-price (FFP).

12. Order of Precedence

The Contractor shall follow the terms and conditions of this order. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4.

The contractor shall not auto-renew any subscriptions, licenses, maintenances and services not authorized under this contract. Any auto-renewals are at the risk of the contractor, and the Government will not reimburse the Contractor.

In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.

13. Authorized Reseller/Servicing Agents

The Contractor shall be the software Original Equipment Manufacturer (OEM) or an authorized reseller/servicing agent of the software OEM.

14. Invoicing Instructions/Payment Terms

(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 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 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) 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.

(1) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. or phone (866)

973-3131.

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.

(2) 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.

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

(4) If the Contractors 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.

(1) 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 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– amountasallowableinaccordancewiththeScheduleandFAR52.216-8ifapplicable.

(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:

(1) list of all invoices submitted to date under the subject award, including the following: invoice number, amount, & date submitted-corresponding payment amount &date received http://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

-totalamountofallpaymentsreceivedtodateunderthesubjectcontractororder-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.

14.1 Payment Terms

Payment terms Net 30 days after government acceptance of the supply item/service. Payments shall not be made more frequently than monthly in arrears. Advance payments will not be made.

15. Contractor Performance Evaluation

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete a final contractor performance evaluation upon completion of the work. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation.

mailto:ERIC@fda.hhs.gov

The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

16. The below Provisions & Clauses apply to this solicitation and resulting contract:

16.1 FAR PROVISIONS

Federal Acquisition Regulation (FAR)

52.252-1 – Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address https://www.acquisition.gov/far/current/html/FARTOCP52.html#wp372482

52.203-18 – Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (Jan 2017)

52.204-24 – Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)

52.204-26 – Covered Telecommunications Equipment or Services-Representation (Oct 2020) 52.217-5 – Evaluation of Options

16.2 HHSAR PROVISIONS

The below Health and Human Services Acquisition Regulation (HHSAR) provision apply. HHSAR Clauses can be viewed in full text at:

http://www.hhs.gov/policies/hhsar/subpart352.html

352.239-73: Electronic and Information Technology Accessibility Notice (Dec2015) https://www.acquisition.gov/far/current/html/FARTOCP52.html#wp372482 http://www.hhs.gov/policies/hhsar/subpart352.html

16.3 FAR CLAUSES

52.252-2 – Clauses Incorporated by Reference (Feb 1998)

The 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 address:

https://www.acquisition.gov/browse/index/far

(End of Clause)

52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40 – Providing Accelerated Payment to Small Business Subcontractors (Dec 2013) 52.217-9 –

(End of clause)

FAR 52.212-4: Contract Terms and Conditions – Commercial Items (NOV 2025)

(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.

(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 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.

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(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 (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include-

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order 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.

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063244 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050674 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050705

(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 and delivery order number, if applicable;

(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 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_212_5 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 32.608-2 of the Federal Acquisition Regulation 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:

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(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 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3

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.

(9) The specification.

(t)[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 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_212_5 https://www.gsa.gov/forms-library/solicitationcontractorder-commercial-items expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) 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)

52.217-9; Option to Extend the Term of the Contract (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time prior to contract expiration.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed Five (5) years.

16.3 HHSAR CLAUSES

The below Health and Human Services Acquisition Regulation (HHSAR) Clauses apply. HHSAR Clauses can be viewed in full text at:

http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1-- InstructionsforUsingProvisionsandClauses

352.222-70 – Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

352.239-74 – Electronic Information and Technology Accessibility (Dec 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1--InstructionsforUsingProvisionsandClauses http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1--InstructionsforUsingProvisionsandClauses http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1--InstructionsforUsingProvisionsandClauses http://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-

Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping

Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping

Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-files-accessible/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section- 508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical

Requirements)

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website:

(http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering https://www.hhs.gov/web/section-508/making-files-accessible/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html http://www.hhs.gov/web/508)

Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

17. INSTRUCTIONS TO QUOTERS and EVALUATION CRITERIA

Please read these instructions carefully. All items required to be included in the quotation as delineated in these instructions must be provided in Quoter’s quotations.

A. Instructions to Quoters:

Special Notice and Agreement regarding Software EULA/TOS Computer software and services are often subject to license agreements, referred to as End User License Agreements (EULA), Terms of Service (TOS), or other similar legal instruments or agreements. Many of these agreements contain indemnification clauses that are inconsistent with Federal law and unenforceable, but which could create a violation of the Anti-Deficiency Act (31 U.S.C. 1341) if agreed to by the Government. Therefore, by submitting a quotation the quoter shall agree that the inclusion of any Limitation of Liability, Indemnification, and any other clauses that conflict with Federal law or regulation in any EULA or TOS are NULL AND VOID. The quoter agrees that any EULA/TOS clauses conflicting with Federal law or regulation and are not agreed to by the Government if included with the submission of a quotation.

Pursuant to FAR provision 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (Deviation) (RFO AUG 2025) is applicable to this procurement. Addenda to the provision are as follows:

Quoters shall submit a quote for all requirements (base and all optional line items) listed in this RFQ.

Quotes shall clearly state the overall quoted price to the Government, inclusive of optional line items.

The evaluated, and subsequently accepted prices will apply to the resulting order. The Quoter shall provide all business notes and assumptions used in deriving pricing. Any assumptions which directly impact price shall be clearly stated in the quote. An alternate price quote may be submitted. Quoter shall fully explain any deviations and assumptions which impact price not otherwise detailed in the RFQ response.

http://www.hhs.gov/web/508

18. BASIS FOR AWARD

Pro…