RFQ_75N91023Q00156.pdf

National Institutes of Health / National Cancer Institute / Office of Acquisitions Request for Quote No.: 75N91023Q00156

Title: Varian ARIA-Eclipse-InSightive Software Support Notice Type: Combined Synopsis / Solicitation Solicitation Number: 75N91023Q00156 Posted Date: 08/04/2023 Response Date: 08/15/2023 by 10:00 AM EST PSC Code: J065 (Maint/Repair/Rebuild of Equipment – Medical, Dental, Veterinary Equipment and Supplies NAICS Code: 811210 (Other Electronic Equipment Repair and Maintenance)

ISSUED BY: National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA)

DESCRIPTION:

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB) has a need for additional ARIA software licenses, and software maintenance services for Varian ARIA, Eclipse, and InSightive Radiotherapy Treatment Planning Systems.

This is a Combined Synopsis/Solicitation for commercial items, prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, as supplemented with additional information included in this notice, and shall be processed in accordance with FAR 13.5 - Simplified Procedures for Certain Commercial Products and Commercial Services. This announcement constitutes the only solicitation that will be provided in relation to the stated need contained herein. This solicitation is issued as a Request for Quote (RFQ) and includes applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2023-04 (06/02/2023) (Enter most recent FAC number and date from www.Acquisition.gov prior to posting.).

The requirement’s North American Industry Classification System (NAICS) code is 811210 (Other Electronic Equipment Repair and Maintenance) with a size standard of $34.0 Million.

One Firm-Fixed-Priced award is anticipated to be made as a result of this solicitation.

1.0 BACKGROUND

The Radiation Oncology Branch (ROB) at the Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), designs and conducts pre-clinical and clinical research on the biologic and therapeutic effect of radiation therapy. The ROB also provides treatment via radiosurgery, intensity-modulated 3-D conformal radiotherapy (IMRT), real-time dose measurement, brachytherapy, and magnetic resonance (MR)-guided procedures.

For this purpose, the ROB uses Varian’s ARIA-Eclipse-TrueBeam systems for radiation treatment of cancer patients. These radiation systems include base units, peripheral devices, and software. The software component ARIA functions as radiation oncology information system whereas the software component Eclipse is used for radiation treatment planning. The TrueBeam linear accelerator systems allow stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. The mature software system ARIA-Eclipse works in concert and seamlessly exchanges data with Varian’s oncology radiation equipment, and it securely interfaces with NIH health systems.

The Varian ARIA-Eclipse-TrueBeam system is an FDA-approved medical treatment Regulatory Class II Medical Charged-Particle Radiation Therapy System (21 CFR 892.5050) which must follow radiation safety regulations for manufacturers of radiation-emitting electronic products (21 CFR 1000-1050) and is further governed by 42 CFR 482.26(b)(2) and 42 CFR 485.623(b)(1). In addition, the ROB must follow processes and documentation defined by The Centers for Medicare & Medicaid Services (CMS, Ref:S&C:14-07-Hospital: Hospital Equipment Maintenance Requirements). A failure or latent flaw in the radiation treatment system could result in serious injury or death to a patient or the operator. The CMS and The Joint Commission thus define imaging/radiologic systems, whether used for diagnostic or therapeutic purposes, as “critical” equipment, which must be maintained per manufacturer’s recommendations.

The Varian radiation therapy system is continually improved by its manufacturer in accordance with ISO 9001:2000 (quality management system) and ISO 13485:2016 (quality management system of medical devices). Therefore, Varian software updates are being released at a high frequency. At the time of writing, ROB uses the following Varian software applications:

ARIA-RO v. 16.1: This electronic health record radiation oncology information system is supported by several agent servers for the integration of all radiation planning, treatment, and CT imaging data in one central database, including archiving and restoration.

Eclipse: This radiation treatment planning system integrates with ARIA and incorporates information about the size, shape, and location of the tumor to be treated with radiation. It is used to design, simulate, and optimize radiotherapy treatment based on a physician’s dose instructions. ROB uses the following three Eclipse versions:

o Eclipse Calculation Workstations v.16.1, Product Code Serial Numbers (PCSNs) H489559, H487708, H480732, H480748, and H48J463, o Eclipse Non-Calculation Workstation v.16.1, PCSN H48DG00, o ECLIPSE FAS Servers v.16.1, PCSNs H480598 and H480599, and o Eclipse Proton v.13.6, PCSN H48A941.

InSightive v. 1.9, PSCN HIN0043: The stand-alone, cloud-based data platform application (virtual server) supports oncology data analytics with data pulled from ARIA through a dynamic dashboard.

1.1 OBJECTIVE

The ROB requires Support and Software Assurance (SSA) services and hardware refreshes for ARIA and Eclipse software platforms, to ensure safety of patient and operator and to conduct patient radiation therapy at optimal levels while staying within all applicable standards and regulations. Furthermore, ROB requires additional software licenses for ARIA and Software as a Service (SaaS) for Varian InSightive used for oncology data analytical purposes.

2.0 SCOPE

The Contractor shall provide all labor, material, and equipment necessary to provide the services required under this purchase order. The Contractor shall provide additional licenses for ARIA, Support and Software Assurance (SSA) services for ARIA and Eclipse including hardware refresh, and Software as a Service (SaaS) for InSightive. All services shall be performed in accordance with the Original Equipment Manufacturer (OEM) most current standard commercial practices. Whenever possible, software and applications support services shall be performed remotely.

Where an issue cannot be resolved by telephone or remote support services, the Contractor shall provide onsite support services during standard business hours (defined as 8:00 am – 5:00 pm EST, Monday through Friday, excluding Federal Holidays, see www.opm.gov/policy-data-oversight/pay-leave/federal-holidays; at no additional cost to the Government.

Onsite and emergency services shall be provided during standard business hours and during extended hours (defined as 5:00 pm – 9:00 pm EST, Monday through Friday). All travel, labor, materials, and related charges shall be included in the purchase order price.

3.0 CONTRACT REQUIREMENTS AND PERSONNEL QUALIFICATIONS

3.1 ARIA LICENSE EXPANSION

The Contractor shall provide the Government with additional licenses for staff access for the following software’s:

a. Ten (10) additional licenses for ARIA-RO Smart Space.

b. One (1) additional license for ARIA eDoc.

Deliverable:

Within ten (10) days of award the Contractor shall coordinate the implementation, and access for additional users with the Governments Contracting Officer’s Representative (COR). The Contractor will then be responsible for ensuring all the required licenses are activated and users are able to use the licenses in conjunction with Eclipse, Insightive, and TrueBeam systems. An electronic report or email shall be provided to the COR within three (3) business days after successful performance of software licenses implementation confirming that all licenses are currently active, and that all systems are function as intended.

3.2 MONITORING SERVICES

The Contractor shall provide remote monitoring software for ARIA, Eclipse, and Insightive software systems which can automatically detect fault conditions and automatically send alerts in real time. The Contractor shall then evaluate the alerts and initiate appropriate actions to correct system issues.

3.3 SOFTWARE UPDATE SERVICES

The Contractor shall provide the most recent software product versions for ARIA, Eclipse, and Insightive, to include service packs, maintenance releases, upgrade releases, and newly released versions, at no additional cost to the Government. All software update services shall be conducted in accordance with the OEM’s latest established service procedures, at no additional cost to the Government. Defective software shall be replaced at no additional cost to the Government.

The Contractor shall provide diagnostic and remedial support services for the software products remotely through secure remote service tools to the greatest extent possible. For this purpose, the Contractor shall provide a remote service connection (see Section 3.1 above), and an automated software deployment tool to the Government.

Software update services shall include:

c. Mandatory safety releases: updates, error corrections, or modifications to OEM software issued by OEM for safety reasons.

d. Maintenance releases/updates: bug fixes, patches, and other error corrections by OEM to a OEM software product designed to enable this software to conform to its documentation. (Updates may be indicated by the number to the right of the second decimal in a software version number.)

e. Upgrades/Upgrade releases: upgrades, enhancements, and improvements by OEM to the features or functionality of its software. (Upgrades may be indicated by the number to the right of the first decimal in a software version number.)

f. Newly released versions: applications, modules, or releases of the software that include new features or functionality and that are released and marketed by OEM as versions or purchase options. (Versions may be indicated by the number to the left of the first decimal in a software version number.)

Note: Potential at-cost upgrades to newly released versions shall be agreed upon and arranged in conjunction with the Contracting Officer (CO) and the Contracting Officer’s Representative (COR).

IT Upgrades Maintenance:

The Contractor shall notify the CO and the COR in advance if the current specifications of the IT hardware do not meet the technical requirements of an upgrade or a new version and arrange the replacement of the affected hardware with the Government.

Interoperability Upgrades Maintenance:

The Contractor shall maintain the functionality of existing interfaces that were originally created by OEM for the Government. The Contractor shall perform all modifications and changes to existing and working interfaces that are required due to a OEM software update or upgrade.

Deliverable:

The Contractor shall provide an electronic report to the COR within three (3) business days after successful performance of software update services. This report shall also include the reason for the release, and any effect it may have on OEM radiation system operation.

Government Responsibilities:

a. The Government will enable the Varian’s remote service connection SmartConnect and have Varian’s automated software deployment tool installed to receive timely software upgrades.

b. Where Contractor needs to install software on site, the Government will make its site available to Contractor personnel to install the software no later than thirty (30) days after delivery of the applicable software and provide a Contracting Officer’s Representative (COR) who will be present at all times during installation, including installation of interfaces. This COR will be capable of either assisting the Contractor where necessary or waiving installation of interfaces to the extent that the Government has decided not to install products requiring such interfaces. The Government will make its site available to Contractor personnel to begin performing before 1:00 pm to enable the services to be completed during standard business hours (see Section 3.0 above).

3.4 ECLIPSE PROTON TPS SOFTWARE SERVICES

The Contractor shall provide the most recent software product version for the non-clinical Eclipse Proton treatment Planning System (TPS), to include service packs, maintenance releases, upgrade releases, and newly released versions, at no additional cost to the Government. Thereby, the Contractor shall follow the instructions provided in Section 3.3 above. Successful performance of Eclipse Proton software update services shall be included in the reporting deliverable described in Section 3.3 above.

Note: See Section 3.14.2 below for associated hardware refresh and Section 5.0 below for Period of Performance.

3.5 INSIGHTIVE SOFTWARE SERVICES

The Contractor shall provide Software as a Service (SaaS) by providing the most recent software product version for Varian InSightive analysis software, to include service packs, maintenance releases, upgrade releases, and newly released versions, at no additional cost to the Government.

Thereby, the Contractor shall follow the instructions provided under Section 3.03 as applicable.

3.6 ON-SITE SUPPORT SERVICES

Where an issue cannot be resolved by telephone or via remote support services, the Contractor shall provide onsite support services for covered products during standard business hours (see Section 2.0 above) at no additional cost to the Government.

3.7 EMERGENCY SERVICE

Emergency service shall be provided during the term of this contract at no additional cost to the Government for any issues that cannot be resolved by telephone or via remote service.

Emergency services shall be provided during standard business hours (see Section 2.0 above).

Upon receipt of notice that any part of the software or its associated hardware is not functioning properly, the Contractor shall provide an initial response within 30 minutes when the issue either prevents or significantly impairs performance of critical system functions (“Severity Level 1” and “Severity Level 2”); and provide an initial response until the end of the following business day when the issue can be circumvented or avoided on a temporary basis by the end user or is a low impact issue (“Severity Level 3” and “Severity Level 4”). The Contractor shall continue working on the issue until a solution or acceptable workaround is provided. The Contractor shall notify the Government promptly if an issue cannot be resolved.

Deliverable:

The Contractor shall provide an electronic report to the COR within three (3) business days after successful performance of emergency services.

Government Responsibilities:

The Government acknowledges that permanent resolutions of “Severity Level 3” and “Severity Level 4” issues may appear in future software product releases.

3.8 REPLACEMENT PARTS

The Contractor shall furnish all required replacement parts required in conjunction with support services or covered products at no additional cost to the Government. Parts shall be new to original equipment specifications. All replacement parts shall be functionally equivalent to or superior to the OEM parts that were included in the original FDA 510(k) clearance. Parts that were repaired or replaced must also demonstrate compatibility with the device’s processes and modalities that were validated in the medical device’s Instructions For Use (IFU).

3.9 TELEPHONE SUPPORT SERVICES

The Contractor shall provide unlimited application help desk telephone support and technical telephone support during standard business hours (see Section 2.0 above) at no additional cost to the Government.

3.10 CONTRACTOR QUALIFICATIONS/CERTIFICATIONS

To demonstrate qualified services and to safeguard patient information, the Contractor shall be certified for ISO 9001 – for a quality management system, and additionally for at least one the following standards:

ISO 13485:2016 – for a quality management system of medical devices and related services.

ISO 14971:2019 – for the application of risk management to medical devices.

ISO/IEC 27001 – for establishing, implementing, maintaining, and continually improving information security management systems.

As proof of adequate up-to-date training of its field engineers and the use of parts that meet the original specifications, the Contractor shall be certified and/or be accredited by:

the FDA, or the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), or the Health Care Facilities Code (NFPA), or the Emergency Care Research Institute (ECRI), or the American Society for Health Care Engineering (ASHE), or the Advancement of Medical Instrumentation (AAMI).

Deliverable:

Upon request by the COR, the Contractor shall provide the appropriate certificate to demonstrate qualification.

3.11 PERSONNEL QUALIFICATIONS

Only technically qualified personnel shall provide service and applications support to the software and hardware systems for the NIH/NCI/ROB clinic, as covered by this contract. The following educations or certifications are deemed as appropriate qualification:

Varian Medical Systems certification level I or level II testing;

certified biomedical equipment service technicians (CBET), certified biomedical engineers, certified clinical engineers, certified IR/CT technicians, or equivalent;

CAST (Certified Associate in Software Testing), CSQA (Certified Software Quality Analyst Certification), International Software Testing Qualifications Board (ISTQB) Certification, Certified Quality Engineer (CQE), Certified Manager of Software Testing (CMST), Certified Software Tester (CSTE), ISTQB Foundation Level (CTFL), or equivalent.

Deliverable:

Upon request by the COR, the Contractor shall provide the education or training certificate(s) of personnel providing services to ROB under this contract to demonstrate appropriate qualification.

3.12 TRAINING

The Contractor shall provide software application training to NIH staff who is authorized to use ARIA and Eclipse (approximately 24 end users) during normal business days, excluding holidays (see Section 2.0 above). Software training shall be provided by fully trained service and applications personnel at no additional cost to the Government.

For any newly released software version (see Section 3.3 above),

i. An initial one-day training shall be conducted as an instructor-led webinar at least 10 business days prior software version upgrade.

ii. A second one-day training shall be conducted on-site (NIH main campus) no more than 5 business days after software version upgrade.

In a service year in which there is no major software version upgrade, a one-day training shall be conducted as an instructor-led webinar.

Deliverable:

The Contractor shall provide the COR with training materials in pdf or similar electronic media form at least five (5) business days prior scheduled training event.

Government Responsibilities:

The Government will ensure that the software and hardware to be used for training is available, and that staff to be trained will be available during the scheduled time of the training event.

3.13 SERVICE EXCLUSIONS

The Contractor shall not be responsible for any repairs necessitated by abuse, neglect, vandalism, Acts of God, fire, or water.

3.14 OPTIONS

3.14.1 OPTION 1: ECLIPSE HARDWARE REFRESH

The Contractor shall conduct one (1) hardware refresh to replace all computer hardware for all Eclipse workstations and servers with the latest versions provided by Varian. This shall include the re-installation and the configuration of software (ARIA, Eclipse calculation, and Eclipse non-calculation) as appropriate, and system testing.

Note: see Section 3.14.2 for a separate hardware refresh associated with Eclipse Proton.

The following computer hardware components shall be covered under the hardware refresh:

i. Five (5) clinical Eclipse calculation workstations (Current Dell service tags: FZBMZB3, FZBRZB3, FZBPZB3, FZBLZB3 and

FZBNZB3)

ii. One (1) non-clinical Eclipse non-calculation workstation (non-clinical) (Current Dell service tag: 2TMLZB3)

iii. Two (2) Framework Agent Servers (FAS) (Current Dell service tags: 2WCC8B3 and 11KH8B3)

iv. Two (2) Graphics Processing Unit (GPU) Enabled FAS kits for FAS Servers

Deliverable:

The Contractor shall provide an electronic report to the COR within three (3) business days after successful performance of IT hardware refresher services.

Government Responsibilities:

The Government acknowledges that:

a. The hardware refresh does not include monitors.

b. The initial three year warranty of the workstations are with the original manufacturer.

c. The FAS and FAS kit refreshers require (i) a networked environment connected at 1 Gbps, (ii) the installation of the servers into pre-existing racks, (iii) the installation into an existing customer domain, and (iv) FAS R740 is to be used for the FAS kits.

3.14.2 OPTION 2: ECLIPSE PROTON HARDWARE REFRESH

The Contractor shall conduct one (1) hardware refresh to replace all computer hardware associated with the software Eclipse Proton with the latest versions provided by Varian. This shall include the re-installation and the configuration of the Eclipse Proton software as appropriate, and system testing.

Deliverable:

The Contractor shall provide an electronic report to the COR within three (3) business days after successful performance of IT hardware refresher services.

Government Responsibilities:

The Government acknowledges that:

a. The hardware refresh does not include monitors.

b. The initial three-year warranty of the workstations are with the original manufacturer.

4.0 TYPE OF ORDER

This is a firm fixed-price purchase order.

5.0 PERIOD OF PERFORMANCE

The Period of Performance shall consist of one (1) 12-month base period and four (4) 12-month option periods as follows:

Base period: 9/22/2023 through 9/21/2024 Option period 1: 9/22/2024 through 9/21/2025 Option period 2: 9/22/2025 through 9/21/2026 Option period 3: 9/22/2026 through 9/21/2027 Option period 4: 9/22/2027 through 9/21/2028

The Period of Performance for Eclipse Proton Software Services shall begin on 9/22/2024.

6.0 PLACE OF PERFORMANCE

All services able to be provided remotely, or off-site may be performed from the Contractor’s facilities. All other services requiring the Contractor to be on-site shall be performed at the following locations:

Workstations:

NIH Main Campus Bld. 10 CRC 10 Center Dr.

Bethesda, MD 20892

Servers:

NCI at Shady Grove CBIIT East Data Center 9609 Medical Center Dr.

Rockville, MD 20850

7.0 REPORTS/DELIVERABLES

All deliverables shall be sent electronically (MS Word, MS Excel, or Adobe PDF, unless approved by the COR) per the following deliverable schedule. See page below:

Section Deliverable Due Date

3.1 Electronic report or email shall be provided to the COR within three (3) business days after successful establishment of additional ARIA Licenses.

Within three (3) business days after successful performance

3.3 Electronic report or email to the COR after successful performance of software update services for ARIA and/or Eclipse

Within three (3) business days after successful performance

3.7 Electronic report to the COR after successful performance of emergency services

Within three (3) business days after successful performance

3.10 Certificate or accreditation of the Contractor as requested by the COR

Within three (10) business days after request

3.11 Education or training certificate(s) of personnel providing services to ROB as requested by the COR

Within three (10) business days after request

3.12 Training materials in pdf or similar electronic media form to the COR

At least five (5) business days prior scheduled training event

3.14.1 OPTION 1: Electronic report to the COR after successful performance of IT hardware refresher services for ARIA/Eclipse

Within three (3) business days after successful performance

3.14.2 OPTION 2: Electronic report to the COR after successful performance of IT hardware refresher services for Eclipse Proton

Within three (3) business days after successful performance

3.5 OPTION 3: Electronic report or email to the COR after successful performance of software services for InSightive

Within three (3) business days after successful performance

8.0 PRICE SCHEDULE

Item # Description Price

1 ARIA License Expansion tbd

2 Base Period - SSA - ARIA Eclipse SaaS - InSightive tbd

3 Option Period 1 -SSA - ARIA Eclipse and SaaS - InSightive tbd

4 Option Period 2 - SSA - ARIA Eclipse and SaaS - InSightive tbd

5 Option Period 3 - SSA - ARIA Eclipse and SaaS - InSightive tbd

6 Option Period 4 - SSA - ARIA Eclipse and SaaS - InSightive tbd

7 Option Period 1 - SSA - Eclipse Proton tbd

8 Option Period 2 - SSA - Eclipse Proton tbd

9 Option Period 3 - SSA - Eclipse Proton tbd

10 Option Period 4 - SSA - Eclipse Proton tbd

11 Option Period 4: SaaS - InSightive tbd

12 Optional Line-Item: Version upgrade as required – ARIA/Eclipse tbd

13 Optional Line-Item: Version upgrade as required – Eclipse Proton tbd

14 Optional Line-Item: Version upgrade as required - Insightive tbd

15 Optional Line-Item: Hardware refresh – ARIA/Eclipse tbd

16 Optional Line-Item: Hardware refresh – Eclipse Proton tbd

(SSA: Support and Software Assurance; SaaS: Software as a Service)

9.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR Clause 52.212-4, all items, services, materials, or supplies to be provided by the Contractor in relation to this Purchase Order are subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Contracting Officer’s Representative identified below in Section 10.0.

10.0 CONTRACTING OFFICER’s REPRSENATIVE

A Contracting Officer’s Representative (COR) will be assigned to represent the Government for this purpose of this contract. The COR representing the Government on this contract shall be:

TBD UPON AWARD

The NCI COR will be responsible for reviewing the work done by the Contractor, making sure that it is consistent with the terms of the Contract, and approving the reports/deliverables provided by the contractor.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Government may unilaterally change its COR designation.

11.0 PAYMENT

Payment shall be made quarterly in arrears. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25.

Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements 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 considered in the computation of any interest penalty owed the Contractor.

1. Vendor/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 vendor 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) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

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

The VIN is the number that appears after the contractor’s name on the face page of the award document.

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

10. Description of supplies/services that match 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 match 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.

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.

B. The Contractor shall submit invoices to the Department of Treasury’s

Invoice Processing Platform (IPP) at https://www.ipp.gov mailto:with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Purchasing Agent) and Contracting Officer’s Representative:

Approving Official: Purchasing Agent Name- Email Address-

II. Invoice Payment

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.

III. Interest Penalties

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 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.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL

BUSINESS SUBCONTRACTORS, FAR 52.232-40 (November 2021)

(a) 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.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of Clause)

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause—

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

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

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

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

(End of Clause)

12.0 CONTRACT CLAUSES

FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems

(NOV 2021)

(a) Definitions. As used in this clause—

Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems

Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information ( 44 U.S.C. 3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract

Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial products or commercial services, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of clause)

FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Jun 2023)

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

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

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

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

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

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

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

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

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN

2020), with Alternate I (NOV 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV

2021) (41 U.S.C. 3509)).

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

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

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

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

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

_X_ (9) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV

2021) (31 U.S.C. 6101 note).

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

__ (11) [Reserved].

__ (12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (SEP

2021) (15 U.S.C. 657a).

_X_ (13) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (SEP 2021) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (14) [Reserved]

__ (15) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV

2020) (15 U.S.C. 644).

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

__ (16) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV

2020) (15 U.S.C. 644).

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

_X_ (17) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (18) (i) 52.219-9, Small Business Subcontracting Plan (NOV 2021) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (NOV 2016) of 52.219-9.

__ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (SEP 2021) of 52.219-9.

__ (19) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

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

__ (20) 52.219-14, Limitations on Subcontracting (SEP 2021) (15 U.S.C. 637s).

__ (21) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP

2021) (15 U.S.C. 637(d)(4)(F)(i)).

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (SEP 2021) (15 U.S.C. 657f).

_X_ (23) (i) 52.219-28, Post Award Small Business Program Representation (SEP

2021) (15 U.S.C. 632(a)(2)).

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

__ (24) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (SEP

2021) (15 U.S.C. 637(m)).

__ (25) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (SEP 2021) (15 U.S.C. 637(m)).

__ (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR

2020) (15 U.S.C. 644(r)).

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

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

_X_ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (DEC

2022) (E.O.13126).

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

_X_ (31) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

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

_X_ (32) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

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

_X_ (33) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN

2020) (29 U.S.C. 793).

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

_X_ (34) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

_X_ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

_X_ (36) (i) 52.222-50, Combating Trafficking in Persons (NOV 2021)

(22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O.

13627).

_X_ (37) 52.222-54, Employment Eligibility Verification (MAY 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in

FAR 22.1803.)

__ (38) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA– Designated Items (MAY 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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

__ (39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

__ (40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (41) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN

2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (OCT 2015) of 52.223-13.

__ (42) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN

2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (JUN 2014) of 52.223-14.

__ (43) 52.223-15, Energy Efficiency in Energy Consuming Products (MAY 2020) (42 U.S.C. 8259b).

_X_ (44)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (JUN 2014) of 52.223-16.

_X_ (45) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

__ (46) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (47) 52.223-21, Foams (JUN 2016) (E.O. 13693).

__ (48) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

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

__ (49) 52.225-1, Buy American-Supplies (NOV 2021) (41 U.S.C. chapter 83).

__ (50) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Dec 2022) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I [RESERVED]

__ (iii) Alternate II (DEC 2022) of 52.225-3.

__ (iv) Alternate III (JAN 2021) of 52.225-3.

_X_ (51) 52.225-5, Trade Agreements (DEC 2022) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (52) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (53) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

__ (54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150).

__ (55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area

(NOV 2007) (42 U.S.C. 5150).

_X_ (56) 52.229-12, Tax on Certain Foreign Procurements (FEB 2021).

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

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

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

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

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

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

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

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

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

__ (iii) Alternate II (NOV 2021) of 52.247-64.

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

__ (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (MAY 2014) (29U.S.C.206 and 41 U.S.C. chapter 67).

_X_ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (MAY 2014) (41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (MAY 2014) (41 U.S.C. chapter 67).

__ (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order

14026 (JAN 2022).

__ (8) 52.222-62, Paid Sick Leave Under…