Combined Attachments (25-003637).pdf

PURCHASE DESCRIPTION

Replacement and Upgrade of 3T MRI Scanner for FMRIF/NIMH

1. Statement of Need and Purpose:

To continue the cutting-edge research performed by the NIH, the functional MRI Facility (FMRIF) must provide researchers with access to the latest equipment, tools, and techniques for their experiments. Our facility maintains two General Electric 3 Tesla (3T) systems, and support for these systems is being phased out by the vendor. To remain at the forefront of research, it is necessary for the FMRIF to maintain access to the most modern equipment available so users can utilize the latest tools and techniques for their experiments.

This acquisition addresses a gap in our equipment by replacing one of our aging 3T scanners with a state-of-the-art 3T MRI system equipped with a local high-performance gradient. There is increasing demand for high-quality, high temporal-resolution scanning with multi-echo data collection in routine functional MRI studies performed in our center. The high-performance local gradient system integrated in the proposed scanner will provide the capability to acquire these data, significantly enhancing the quality of patient data used to characterize functional activation and connectivity.

2. Background Information and Objective:

The National Institute of Mental Health (NIMH) FMRIF is a core resource of the National Institutes of Health (NIH) intramural research program. The FMRIF was created by the NIMH and the NINDS in 1999. Its function is to serve as a resource by which all NIH institutes can perform Magnetic Resonance Imaging (MRI) studies that further the understanding of healthy and diseased brain anatomy, function and physiology. The FMRIF currently operates three 3T and two 7T MRI human MRI systems.

The specific objective of this purchase is the acquisition of a 3T MRI System which includes a dedicated, high-performance, local gradient subsystem. The acquisition will allow the FMRIF to be able to provide the latest tools and techniques to NIH researchers to collect high quality brain imaging data from patients and research volunteers and develop novel scanning protocols advancing the state-of-the-art for structural and functional brain imaging. The upgraded system is to be used for clinical and preclinical human MRI research.

3. Generic Name of Product:

3T Human MRI System with an Integrated Local High Performance Gradient Subsystem

4. Purchase Description:

The purchase includes acquisition of a new 3T MRI system, turnkey installation of the system within the FMRIF Center, and the trade-in and removal of an existing GE Signa MR750 3T MRI.

Replacement or upgraded MRI System:

The characteristics of an MRI system suitable for this application should meet the following performance requirements:

• A whole-body 3T actively shielded magnet

• High power (2 MVA) gradient driver amplifier and power supplies

• Local gradient with (at least) 37 cm free, available internal diameter providing with 250 mT/m max amplitude and 500 T/m/s slew rate

• A RF receiver system with at least 64-channels, with two 32-channel P-ports available for RF coil connections

• RF receivers providing digital sampling bandwidth of (at least) 1 MHz, sampling with at least 16-bit resolution and providing user access to raw (i.e. pre-image reconstruction) MR sampled data.

• Head RF receiver coil suitable for high performance, accelerated (i.e. GRAPPA, SENSE and Simultaneous Multislice or Multiband) imaging.

• A high-end, dedicated image reconstruction computer incorporating software for advance image reconstruction algorithms

• A high-end host computer operator console for MRI protocol planning, scanner operations, and image storage and review.

• Customer available and configurable 10Gb network interfaces for data transfer on host and reconstruction computers.

Trade-in and removal of Obsolete MRI equipment: The existing GE Signa MR750 3T system, designated FMRIF 3TA (Vendor ID: 301496MR3T5MR), will be available as trade-in value as part of the purchase. The obsolete system will be extracted and removed from the FMRIF Center as part of this purchase.

Turnkey Installation: The purchase will include the turnkey installation of the new, replacement MRI system, including installation of the MRI system magnet, electronic equipment and system console; in-suite connections to the facility power and cooling supplies; and all construction necessary to bring the MRI system console and magnet rooms to meet environmental standards required for clinical and research usage in the NIH Clinical Center. Additionally, installation of the current system should not adversely affect the operational state of any other MRI systems in the facility at system handover.

MRI Systems Training: The offeror shall provide on-site training to FMRIF staff in the operation of all hardware and software / applications that will be required for routine operation of the upgraded or replaced MRI Systems. The Contractor shall additionally provide access to training in pulse sequence and reconstruction software development for staff involved in methods development.

5. Salient characteristics The FMRIF/NIMH requires a 3T MRI system suitable for human patient studies with the following components:

- 3T superconducting magnet

- Local gradient system with:

o Maximum gradient strength of at least 250 mT/m o Maximum slew rate of at least 500 T/m/s

- Radio frequency electronics and an operator console

- Vendor-specified documentation for non-significant risk for human subject scanning is required for this system; FDA 510(k) clearance is preferred.

The characteristics needed for each component are given below. However, the vendor is encouraged to offer a system with best possible specifications, and the proposed enhancements will be considered and evaluated during the technical review of the quotations.

1) Magnet

a) Superconducting and actively shielded magnet with a field strength of 3.0 T (Tesla).

b) Field homogeneity (fully shimmed with superconducting and/or passive shims) less than

5 ppm peak-to-peak over a 45 cm diameter spherical volume (DSV) and a water spectral linewidth of less than 0.1 ppm full width half height (FWHH) over a 25 cm DSV.

c) Drift of the main field less than 0.1 ppm/hour.

d) The magnet will employ zero boil-off technology.

e) The system will include a switch to shut-off the main field quickly and safely in case of an emergency. The location of the switch is to be determined during system installation.

f) Ramp time: The time required to ramp the magnet up and down to and from field following installation or service procedures will be specified by the vendor. A faster ramp time is preferred.

g) It is important that the 0.5 mT contour of the magnet fringe field shall be contained within the installation room.

h) The magnet shall be delivered to the site via a 10 ft x 10 ft ceiling hatch.

2) Room temperature shim and gradient coils

a) The room temperature active shim coil set should consist of at least 8 channels (3 first order and 5 second order terms) and a power supply. All room temperature active shims will be under computer control within the software environment used to run the rest of the console.

b) The gradient amplifiers will be capable of generating at least 250 mT/m magnetic field gradient along each axis with a slew rate of at least 500 T/m/s with the system’s supplied coil.

c) The gradient waveform control unit should operate with at least 10 us time resolution, 16-bit amplitude resolution.

d) The gradient field stability will be better than 0.5% at maximum gradient strength on each axis.

e) The system will be equipped with a hardware/software mechanism to protect the gradients and gradient amplifiers from overheating.

3) RF Electronics

a) Transmitter system

i. The transmitter system will be capable of operating 2-port, independently controllable RF transmit channels capable of operating at frequencies suitable for protons.

ii. RF transmit amplifiers should independently supplied at least 3 kW pulsed, linear, power on-resonance.

iii. All RF channels will be driven by independent waveform generators with adequate waveform memory and capable of amplitude and phase modulation.

iv. RF transmit power monitoring will be provided on all individual channels with an automatic mechanism to ensure that the estimated local and average SAR remains below the FDA/IEC guidelines. There will also be a system to limit the RF power to individual transmit elements.

b) Receiver system

i. The receiver system will include a minimum of 64 digital receivers capable of receiving on-resonance MRI signal in parallel.

ii. Receivers will have a minimum of 1 MHz bandwidth with at least 16-bit dynamic range.

iii. The system will include software that enables all receivers to be used within the full range of imaging sequences.

c) RF coils and T/R switches

i. The system will be delivered with a minimum of one RF coil suitable for MRI of the human head, a dual-channel transmit, and 32-channel receive array (2Tx/32Rx)

ii. The vendor will provide specifications and tools to allow the use of customer developed

RF coils.

d) External gating and Monitoring

i. A subsystem for gated acquisition of data with a minimum of two (2) independent external signals will be included, with a minimum of 4 BNC TTL output lines.

ii. The system will provide digital recording and real-time display of respiratory and cardiac signals.

4) Console

a) The vendor will supply a state-of-the-art host computer with current scanner operation and image viewing software. The system will be equipped with software for acquisition and processing of advanced neuro-MRI applications. The system will be equipped with automatic shimming software to optimize all active shims for each subject.

b) The system will be capable of acquiring reconstructing in real-time 64-channel data with accelerated (R4) gradient-echo echo planar imaging (GE-EPI) for 30 min at 128x96 resolution and maximum slices per TR.

c) At least 1TB of disk storage for reconstructed images and at least 1TB for raw data storage shall be provided.

d) A 10 Gb ethernet for general network communications with external systems is preferred.

e) The vendor will supply the source code of purchased pulse sequences and off-line software tools to enable local development of pulse sequences and image reconstruction techniques.

5) Scanner table

a) A dockable scanner table with accurate landmarking will be provided for precise positioning of subjects at the isocenter of the magnet that must be compatible with supplied gradients and designed to minimize vibrations.

6) Warranties

The vendor shall:

a) Provide warranty for all parts and labor to repair any defects or failure in supplied items for one year from the date of Government acceptance of the system.

b) Guarantee to upgrade at no additional cost any components that become outdated due to advances in design made by the vendor for within the one-year warranty period.

c) Supply any software upgrades free of charge within the one-year warranty period.

7) Delivery, Installation and Training:

a) The vendor shall deliver and install the complete system on-site (including all connections to quench ducts, vacuum pumps, cryogens for magnet ramp up, etc.) and ensure that the initial performance of all equipment satisfies the required specifications within 12 months following contract award.

b) The vendor will provide a minimum, ten days of applications training in which staff of the FMRIF are trained in the operation of the new head gradient system. Such training is to include patient handling and basic upkeep tasks, as well as operation of the system for acquisition of images. Training must also cover functions for data viewing and any online analysis features provided on the scanner.

8) Acceptance and evaluation:

a) The vendor shall demonstrate minimum specifications for all of the items listed including magnetic field drift and homogeneity, gradient performance, multiple receiver acquisition, image reconstruction, RF coils, RF power delivery and monitoring are met or exceeded.

b) Acquire T2*-weighted spoiled gradient-echo (SPGR) imaging with multiple echoes, at high spatial resolution suitable for applications such as quantitative susceptibility mapping in brain.

c) Acquire whole-brain echo-planar imaging (EPI) suitable for neuro-functional MRI applications, at high spatial and temporal resolution (1mm, TR=800ms) with real-time reconstruction for acquisition times of 20 minutes. Capabilities of the system for simultaneous multi-slice EPI should be demonstrated.

d) Demonstrate the ability, using a graphical user interface, to prescribe the geometry and location of targeted area of interest, the imaging experiments listed below in principal and oblique scan planes with minimal field of view allowed by the maximum gradient strength and receiver bandwidth. In all cases, the ghosting artifacts shall be less than 1% of average image intensity. There shall be no evidence of RF noise in the images.

e) Multiple-slice, multiple-echo image sets of up to at least 1024 x 1024. Capability for T1 weighting with inversion recovery. Capability of fat suppression.

f) Demonstrate the ability to perform sequences such as magnetization prepared rapid acquisition gradient-echo, fluid attenuated inversion recovery, fast spin-echo and MR angiography.

g) Gradient-echo (GE) and spin-echo (SE) echo-planar imaging (EPI). The pixel-wise temporal standard deviation (tSD) of the image signal (GE-EPI, 32 channel coil, 2.5 mm isotropic resolution, TR 2 s, minimum-full TE, unaccelerated, 150 volumes, oil phantom) without detrending shall be less than 3 times the tSD of a noise region without signal. The tSD of the mean signal within an ROI (400 pixels, at the center of the slice at iso-center) shall be less than 0.3% of the mean signal. The amplitude of the EPI image ghosts shall be less than 3% of the mean signal intensity.

h) Demonstrate acquisition and real time reconstruction of 32 channel data with accelerated (R4) gradient-echo echo planar imaging (GE-EPI) for 30 min at 128x128 resolution and maximum slices per TR.

i) Demonstrate acquisition and reconstruction of simultaneous multi-slice (SMS) EPI using a 32-channel receiver array. Demonstrate that image reconstruction can keep pace with an 8x SMS, 2mm isotropic EPI acquisition with maximum number of slices per TR for a continuous total scan period of at least 20 minutes.

j) Demonstrate diffusion-weighted MRI with SE-EPI on an oil phantom with following parameters: 2 mm isotropic resolution, 80 slices, b-value =3000 s/mm2, greater than 60 diffusion directions, TE= 100 ms (full k-space), TR=11 s, and in-plane acceleration factor =2. The amplitude of the EPI image ghosts shall be less than 3% of the mean signal intensity without diffusion weighting.

6. Quantity 1 x MRI system

7. Delivery Date: The vendor will prepare the site, deliver and install the complete system on-site (including all connections to quench ducts, vacuum pumps, cryogens for magnet ramp up etc.)

and ensure that the initial performance of all equipment satisfies the required specifications within 18 -24 months following contract award.

8. Delivery Location: Functional MRI Facility (FMRIF), NIH Clinical Center, 10 Center Drive, Rm

10-B1D65, Bethesda, MD 20892

9. Period of Performance: One year warranty from the date of delivery.

10. Options(s): The vendor should provide four (4) one-year options for warranty of the magnet and cryo-refrigeration system as well as service for the 3T MRI Scanner.

11. Evaluation Criteria

The award resulting from this solicitation will be made to the responsible Offeror whose Proposal is most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotations: Technical, Cost/Price (including Options) and Past Performance.

A tradeoff process shall be used for this acquisition because it has been determined to be in the best interest of the Government to consider award to other than the lowest priced Offeror or other than the highest technically rated offeror. All evaluation factors and significant sub-factors are listed below in terms of their relative importance. Technical Factors and Past Performance when combined, are significantly more important than cost or price.

Evaluations will be based on the demonstrated capabilities of the prospective Offeror in relation to the needs of the project as set forth in the Solicitation. The merits of each Proposal will be evaluated carefully. Each Proposal must document the feasibility of successful implementation of the requirements of this solicitation. The Offeror must submit information sufficient to evaluate its Proposal based on the detailed factors listed below.

The NIMH shall use the following methodology for evaluating each criterion:

TECHNICAL EVALUATION FACTORS

The evaluation factors are used by the technical evaluation committee when reviewing the technical quotes. The factors below are listed with weights assigned indicating relative importance for evaluation purposes, i.e., a higher weight indicates higher importance.

Performance Specifications 20 Points

NIMH shall evaluate the offeror’s performance specifications of the new system in relation to the required minimum specifications

Compatibility 10 Points

NIMH shall evaluate the extent of compatibility of the proposed system with existing MRI scanners in the NIH NMR Center.

Software 15 Points

NIMH shall evaluate the research support and provision of source code, software environments and documentation for MRI pulse sequences and reconstruction software development for the proposed MRI scanner.

Experience and Capability 10 Points

NIMH shall evaluate the offeror’s experience and demonstrated ability to design and construct local gradient MRI systems (i.e. Max Grad. Strength ≥ 250 mT/m and Max Slew Rate ≥ 500 T/m/s) similar to the one specified in this solicitation.

Installation 15 Points NIMH shall evaluate the offeror’s ability to provide a turnkey installation of the system, including the renovation of the magnet and console rooms to meet NIH environmental standards for clinical and research usage; and removal of the obsolete MRI equipment.

Novel Technologies or Capabilities 10 Points NIMH shall evaluate the feasibility and technical soundness of any proposed novel technologies or capabilities by the Offeror.

Contract Management and Customer Support 20 Points

NIMH shall evaluate the offeror’s ability to provide a high level of customer service, particularly in the area of initial responsiveness and resolution of device and service problems. Specifically, the Government will evaluate the Offeror’s capability based on its description of any applicable warranty, customer support process.

PAST PERFORMANCE

The Offeror shall provide past performance information. Past performance information shall cover a minimum of 1 year in relevant services and deliveries of comparable systems. The Offeror shall provide at least one reference for any project identified under the experience factor that has a performance period within the past three years. For each reference, the offeror shall provide: (1) organization/contracting partner's name; (2) point of contact's (POC) name and contact information, including current phone numbers and valid email addresses; and (3) description that precisely explains both the general scope and specific requirements of the contract.

Offerors will be evaluated based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. Furthermore, the Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information.

EVALUATION OF OPTIONS

It is anticipated that any contract awarded from this solicitation will contain option quantities and periods. In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of option periods and/or quantities will not obligate the Government to exercise the options. An evaluation of this factor will only be conducted on offerors and quotes who have been determined to be technically acceptable.

PRICE EVALUATION

Offerors price quote will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques.

Price evaluation will not be conducted on any Offeror determined to be technically unacceptable.

FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services (NOV 2023)

(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 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 (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.

(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 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; 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 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.

Addenda to FAR 52.212-4

FAR 52.242-15 Stop-Work Order (AUG 1989()

(a) The Contracting Officer may, at any time, by written order to the Contractor, require the Contractor to stop all, or any part, of the work called for by this contract for a period of 90 days after the order is delivered to the Contractor, and for any further period to which the parties may agree. The order shall be specifically identified as a stop-work order issued under this clause. Upon receipt of the order, the Contractor shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the Contractor, or within any extension of that period to which the parties shall have agreed, the Contracting Officer shall either-

(1) Cancel the stop-work order; or

(2) Terminate the work covered by the order as provided in the Default, or the Termination for Convenience of the Government, clause of this contract.

(b) If a stop-work order issued under this clause is canceled or the period of the order or any extension thereof expires, the Contractor shall resume work. The Contracting Officer shall make an equitable adjustment in the delivery schedule or contract price, or both, and the contract shall be modified, in writing, accordingly, if-

(1) The stop-work order results in an increase in the time required for, or in the Contractor’s cost properly allocable to, the performance of any part of this contract; and

(2) The Contractor asserts its right to the adjustment within 30 days after the end of the period of work stoppage; provided, that, if the Contracting Officer decides the facts justify the action, the Contracting Officer may receive and act upon the claim submitted at any time before final payment under this contract.

(c) If a stop-work order is not canceled and the work covered by the order is terminated for the convenience of the Government, the Contracting Officer shall allow reasonable costs resulting from the stop-work order in arriving at the termination settlement.

(d) If a stop-work order is not canceled and the work covered by the order is terminated for default, the Contracting Officer shall allow, by equitable adjustment or otherwise, reasonable costs resulting from the stop-work order.

FAR 52.217-5 Evaluation of Options (JULY 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

FAR 52.217-8 Option to Extend Services (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 15 calendar days before the contract expires.

FAR 52.217-9 Option to Extend the Term of the Contract (MAR 2000) https://www.acquisition.gov/far/part-17#FAR_17_206

(a) The Government may extend the term of this contract by written notice to the Contractor; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 calendar days before the contract expires. The preliminary notice does not commit the Government to an extension.

(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 years.

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

EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (Jan 2025)

[Contracting officer check as appropriate.] https://www.acquisition.gov/far/52.203-6 https://www.acquisition.gov/far/52.203-13 https://www.acquisition.gov/far/52.203-15 https://www.acquisition.gov/far/52.204-10 https://www.acquisition.gov/far/52.204-14 https://www.acquisition.gov/far/52.204-15 https://www.acquisition.gov/far/52.204-28 https://www.acquisition.gov/far/52.204-27 https://www.acquisition.gov/far/52.203-17 https://www.acquisition.gov/far/52.204-30 https://www.acquisition.gov/far/52.219-4 https://www.acquisition.gov/far/52.219-6 https://www.acquisition.gov/far/52.219-7 https://www.acquisition.gov/far/52.219-8 https://www.acquisition.gov/far/52.219-9 https://www.acquisition.gov/far/52.219-13 https://www.acquisition.gov/far/52.219-14 https://www.acquisition.gov/far/52.219-16 https://www.acquisition.gov/far/52.219-27 https://www.acquisition.gov/far/52.219-28 https://www.acquisition.gov/far/52.219-29 https://www.acquisition.gov/far/52.219-30 https://www.acquisition.gov/far/52.219-32 https://www.acquisition.gov/far/52.219-33 https://www.acquisition.gov/far/52.219-3 https://www.acquisition.gov/far/52.209-9 https://www.acquisition.gov/far/52.209-6 https://www.acquisition.gov/far/52.209-9 https://www.acquisition.gov/far/52.222-3 https://www.acquisition.gov/far/52.222-21 https://www.acquisition.gov/far/52.222-26 https://www.acquisition.gov/far/52.222-35 https://www.acquisition.gov/far/52.222-36 https://www.acquisition.gov/far/52.222-37 https://www.acquisition.gov/far/52.222-40 https://www.acquisition.gov/far/52.222-50 https://www.acquisition.gov/far/52.222-54 https://www.acquisition.gov/far/52.223-9 https://www.acquisition.gov/far/52.223-11 https://www.acquisition.gov/far/52.223-12 https://www.acquisition.gov/far/52.223-20 https://www.acquisition.gov/far/52.223-21 https://www.acquisition.gov/far/52.223-23 https://www.acquisition.gov/far/52.222-19 https://www.acquisition.gov/far/52.224-3 https://www.acquisition.gov/far/52.225-1 https://www.acquisition.gov/far/52.225-3 https://www.acquisition.gov/far/52.225-5 https://www.acquisition.gov/far/52.225-13 https://www.acquisition.gov/far/52.225-26 https://www.acquisition.gov/far/52.226-4 https://www.acquisition.gov/far/52.226-5 https://www.acquisition.gov/far/52.232-29 https://www.acquisition.gov/far/52.232-30 https://www.acquisition.gov/far/52.232-33 https://www.acquisition.gov/far/52.232-34 https://www.acquisition.gov/far/52.232-36 https://www.acquisition.gov/far/52.239-1 https://www.acquisition.gov/far/52.240-1 https://www.acquisition.gov/far/52.229-12 https://www.acquisition.gov/far/52.226-8 https://www.acquisition.gov/far/52.222-41 https://www.acquisition.gov/far/52.222-42 https://www.acquisition.gov/far/52.222-43 https://www.acquisition.gov/far/52.222-44 https://www.acquisition.gov/far/52.222-51 https://www.acquisition.gov/far/52.222-53 https://www.acquisition.gov/far/52.222-55 https://www.acquisition.gov/far/52.222-62 https://www.acquisition.gov/far/52.226-6 https://www.acquisition.gov/far/52.247-64 https://www.acquisition.gov/far/52.242-5 https://www.acquisition.gov/far/52.247-69

FAR 52.212-5 as of FAC 2025-03 (01/17/2025) Edited 01/17/2025

Revised:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Orders/Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per contractor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract Number;

Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) as registered in the System for Award Management (SAM).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that the line items specified in the award.*

* NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

RFP 75N95023Q00050 Attachment 4

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

For inquiries regarding the status of invoices such as receipt of invoices, due date, request for payment of invoices, etc., contact NIH/OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods see the NIH/OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

The NIH/OFM Customer Service is open Eastern Standard Time Monday Friday from 8:30 a.m. to 5:00

m. and is closed between 12:00 p.m. to 1:00 p.m.

A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and

Attachment 4RFP 75N95023Q00050 there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

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

Except as provided in paragraph (c) of this clause, the…