S02 36C24824Q0004.pdf

COMBINED SYNOPSIS/SOLICITATION RFQ 36C24824Q0004

General Information

Action Code: Combined Synopsis Solicitation

Document Type: RFQ

RFQ Number: 36C24824Q0004

Posted Date: 7/13/2023

Response Date: 08/15/2023 by 4:00PM EST

Classification Code: 6640

Set Aside: Unrestricted

NAICS Code: 325413

Contracting Office Address

NCO 8

ATTN: John H. Shultzaberger

1601 SW Archer RD

Gainesville, FL 32608

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

FAR Subpart 12.6 in conjunction with Part 13, as supplemented with additional information included in this notice. This procurement is being conducted under Subpart 13.5 Simplified Procedures for Certain

Commercial items. This announcement constitutes the only solicitation for this action. Quotes are being requested, and a written solicitation will not be issued.

This solicitation is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04 Effective

June 2, 2023.

The Network Contracting Office 8-SAO East intends to award a firm fixed priced contract, providing for all supplies, materials, equipment, labor, supervision, management, and transportation, necessary to furnish Histology Cost Per Test in accordance with the attached Price Schedule.

Prospective offerors shall be a registered in the System for Award Management (SAM) at http://www.sam.gov to be considered for an award of a federal contract, and registration shall be complete and not missing elements such as representations and certifications.

Tiered Evaluations

TIERED EVALUATIONS INCLUDING LARGE BUSINESS CONCERNS: This solicitation is being issued as tiered evaluation with the following tiers: (1) SDVOSB concerns, (2) VOSB concerns, (3) small business concerns with HUBZone small business concerns and 8(a) participants having priority; and (4) large business concerns. If award cannot be made, the solicitation will be cancelled, and the requirement resolicited.

VENDOR QUESTIONS: All questions regarding this RFQ must be in writing and shall be sent by e‐mail to John.Shultzaberger@va.gov no later than 08/05/2023.

ANSWERS TO VENDOR QUESTIONS: Answers to vendor questions will be posted on SAM.gov.

You are reminded that representatives from your company SHALL NOT contact any North Florida/South

Georgia Veterans Health System staff to discuss this RFQ during this RFQ process. All questions and concerns regarding this RFQ shall be directed to John H. Shultzaberger, the Contracting Officer.

QUOTE SUBMISSION: Offers are due on/or before Tuesday, 08/15/2023 by 4:00 PM Eastern.

Quotes shall be sent by e‐mail “only” to the Contracting Officer (John H. Shultzaberger) at

John.Shultzaberger@va.gov. The Government intends to award a Firm Fixed Priced (FFP) contract resulting from this RFQ.

mailto:John.Shultzaberger@va.gov

36C24824Q0004

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

COMBINED SYNOPSIS/SOLICITATION RFQ 36C24824Q0004

General Information

Contracting Office Address

Description

Tiered Evaluations

VENDOR QUESTIONS

ANSWERS TO VENDOR QUESTIONS

QUOTE SUBMISSION

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE

ITEM (MAR 1989)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 19

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 20

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT:

John H. Shultzaberger, Contracting Officer John.Shultzaberger@va.gov 352-214-5135 Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment

Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

STATEMENT OF NEED

Histology Automation Staining and Tracking System

1. GENERAL: The Contractor shall provide the Name Brand or equivalent Special Stainer, Immunohistochemistry (IHC), In Situ Hybridization (ISH), Hematoxylin and Eosin (H&E) Staining System and Workflow Tracking System at NF/SG Veterans Health System as outlined below. All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances, with the FDA and manufacturer’s guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein.

2. SCOPE: The NF/SG Veterans Health System anticipates the award of a firm, fixed-price contract from this Request for Proposals using commercial item procedures. The NF/SG Veterans Health System plans a Reagent Usage contract for use of the instrument (lease), supplies, installation, training, and service of the equipment (for life of agreement) as identified below.

3. COST-PER-TEST: The contractor is required to furnish NF/SG Veterans Health System, as listed in paragraph 7, the laboratory instrument(s) system(s), reagents to include detection kits for immunohistochemistry (IHC) and for probes/in situ, hybridization (ISH) and reagents for Hematoxylin and Eosin (H&E). Choice of detection kit will be determined based on tests performed simple stains and complex stains as applicable (unless stains excluded below)* necessary to operate the contractor’s equipment, hardware and software upgrades, training for personnel and equipment maintenance necessary to fulfill the test requirements. The NF/SG facility will select the equipment and associated package tailored to its requirements and only will pay for the test assays run on the contractor’s equipment (payment rate is at an established average “cost-per test” figure).

The per-test price includes costs covering (a) equipment use, (b) detection kits, simple stains and complex stains, (c) all necessary maintenance to keep the equipment in good operating condition, (d) operational hardware and software upgrades, (e) user training for government personnel, (f) Business hours service for instrument operation. Contractor is required to provide delivery and installation of equipment at no additional charge, and return shipping costs at end of contract.

4. EQUIPMENT:

The purpose of this solicitation is to identify the salient characteristics of the NAME BRAND OR EQUIVALENT IHC/ISH Staining System, Special Stainer, H&E Stainer and Workflow tracking system, and specify functionality and performance-based requirements of this system. The proposal shall provide descriptive literature that meets the following specifications:

a. Required Characteristics/ Functionality and Performance Specifications for Special Stainer:

• All the following Special Stains must be fully automated and available at the time of bid: AFB III, Alcian Blue, Alcian Yellow, Congo Red, Elastic/VVG, Giemsa, GMS Fungus, GMS Pneumocystis, Iron, Jones Methenamine Silver H & E, Jones Methenamine Silver Lt. Green, Mucicarmine, PAS

lt. green, PAS diastase, PAS Alcian blue, Reticulum, Steiner, Trichrome Blue and Trichrome Green.

• General instrument characteristics include special stains processing, slide carousel holds 1-20 slides for 25 x 75mm, 1 x 3” or 26 x 76mm superfrost plus, 25 reagent positions, uses NCCLS type II water or equivalent, two bulk fluid containers, bench mounted with 20 liter waste bottle, CSA, CE and Y2K compliant.

• Individual slide staining to eliminate cross-contamination.

• Parallel staining of different tests to allow for faster turnaround time.

• Electrical characteristics 120 VAC plus or minus 10%, 8 amps, 60 Hz.

• Computer system (CPU, Monitor, Keyboard, Printer, Speakers), Ebar label system, software revision upgrade.

• Must have at least 20 slides spaces

• Automation and minimal daily maintenance, with ready to use reagents where possible.

• Customizable staining protocols allowing for optimization based upon facility standards.

b. Required Characteristics/Functionality and Performance Specifications for Immunohistochemical Stainer:

• General instrument characteristics include automated IHC, ISH, FITC, baking, deparaffinization, cell conditioning and staining, 1-20 slides with independent temperature control for 25 X 75mm, 1 x 3: or 26 x 76 mm, 25 reagent position in carousel, uses NCCLS Type II water, up to seven bulk reagents, floor mounted using 20 liter waste bottle, CE and Y2K compliant.

• Physical characteristic include NTE 55 lbs., and 16”x21.5”x13.5”(SM), 20”x21.5”x15”(AFM), and 20”x21.5”x20.5” (BCM).

• Electrical characteristics 120 VAC plus or minus 10%, 4/2amps, 50/60 Hz.

• Computer system (CPU, Monitor, Keyboard, Printer, Speakers), Ebar label system, and software revision upgrade.

• The systems should be barcode driven, random access, have a precision reagent delivery, precision heat induced staining reaction, horizontal kinetic mode Immunohistochemistry, and Chromogenic in situ Hybridization and Special Stains System.

• The systems should be modular, flexible, with the ability to reconfigure modules, and scalable to allow for volume increases in throughput and to fit in limited bench space.

• The systems should utilize self-contained, pre-diluted, Antibodies and Detection kits that are ready to use out of the box.

• Individual slide heating and microcontrolled smart carousel with ambient, 37 and 42 deg. -> 100 deg C in under 3 min. and 100 deg ->37 deg C in under 7 minutes.

• Use no more than 100 uL of reagent per slide.

• Must have at least 30 slide spaces that can each run IHC, ISH, and FITC simultaneously.

• Must be able to run all protocols during the same slide run.

• Must be able to hold 35 reagents for dispensing.

• Must have ability to use detection that is not polymer and does not use AB blocker

• Must be able to run paraffin embedded slides (1 protocol), non-paraffin embedded slides (total of 2 protocols), slides using different type 1 cell conditioning (total of 3 protocols) and/or type 2 cell conditioning (total of 5 protocols) with and without enzyme digestion (total of 7 protocols) and enzyme digestion by itself (total of 8 protocols).

• Must be able to incubate PAbs for up to 2.5 hours

• The self-contained dispenser vials should be environmentally safe. The systems should have a self-contained waste system.

• The systems should utilize flash memory technology and barcodes on dispensers or other similar system to track reagents and for quality control and quality assurance.

• The systems should use Liquid Coverslip, Air Vortex Mixing, and Buffer Jet Slide Washing to include strict protocol timing to assure run-to-run consistency to improve overall staining quality, minimize slide-to-slide variability, and reduce background staining.

• The systems must improve overall productivity in the Histology Lab, reduce need for repeat testing thus reducing reagent waste. The system should not require monitoring during a run and should be 100% “walk-away” system.

c. Required Characteristics/Functionality and Performance Specifications for H&E Stainer:

• One touch complete processing

• Slide identification (without the use of patient identifiers)

• Drying through coverslipping

• Random-access slide processing

• STAT on demand

• Pre-packaged and ready to use reagents with continuous access

• Modular design

• Forward-stocking locations

• Remote system monitoring

• Xylene-free processing

• Discrete slide staining

• Throughput of at least 180 slides/hour

d. Contractor shall provide an upgrade equivalent to the current Ventana XT Immunohistochemical Stainer.

e. Required Characteristics/Functionality and Performance Specifications for Workflow Tracking System

• Tracking that covers key steps in the Histology workflow to include accessioning, staining, pathologist review and sendout.

• Safeguards patient information

• Assists with monitoring workload, problem areas and trends.

• Helps minimize identification errors.

5. General requirements:

The contractor is required to provide new state-of the art equipment. Discontinued models are not acceptable. The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These enhancements to the contractor’s equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability. Instruments will come with either a warranty for repair within 48 hrs or service agreement included in the CPT.

Note: The C& A Requirements do not apply. A Security Accreditation Package is not necessary.

All models shall perform satisfactorily at any laboratory temperature between 59 and 86 degrees F (15 and 30 degrees Celsius). All models shall perform satisfactorily at any laboratory relative humidity between 10 and 70%. An electronic operator’s manual must be furnished with each model supplied.

Trade-in of existing equipment will be negotiated.

6. Site Preparation:

Specifications shall be furnished in writing by the contractor as part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer’s claimed specifications. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation which are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the government, shall be made at the expense of the contractor.

7. Ownership of Equipment:

Equipment shall remain under the ownership of the contractor. All equipment accessories (hardware are software) furnished by the contractor shall accompany the equipment when returned to the contractor.

The contractor, upon expiration of order(s) at termination and/or replacement of equipment, will remove the equipment. The contractor will disconnect the equipment (gas, water, air, etc.) and will be responsible for all packing and shipping required to remove the equipment within ten business days.

8. Trade in Program After four (4) years from original install date of NAME BRAND OR EQUIVALENT, the VAMC may have the option to upgrade in September of each year. The trade in will be the following:

One (1) NAME BRAND OR EQUIVALENT Original for one (1) NAME BRAND OR EQUIVALENT One (1) NAME BRAND OR EQUIVALENT for one (1) NAME BRAND OR EQUIVALENT The VAMC agrees to sign a modification for the new instrument and pricing. Contractor will pick up the old instrument.

9. Standard and acceptance of performance shall begin on the installation date. It shall end on the earlier date of when a certificate of acceptance has been signed or the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor’s technical specification or as quoted in any contract at an effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order upon mutual agreement and in accordance with the provisions of FAR 52.212-4(m) “Contract terms and conditions – Commercial Items, Termination for cause.

Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fine attempt to contact the contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.

10. Government’s Responsibility:

The user will perform daily routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period.

11. Training of Operating Personnel:

The contractor shall provide the services of a qualified technical person, at the time of equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Technical Representative (COTR) to on-site orientation and training to designated personnel in: (1) operation and care of equipment; 2 techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause. This training shall include at least (2) two-day on-site training sessions, all day, upon installation and acceptance of equipment and later, for refresher training. Vendor based training, if necessary for key operators, is the responsibility of the Vendor and will include transportation, meals and lodging.

12. Installation procedures:

The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

Upon completion of installation the equipment will be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government shall accept installation with guarantee date commencing ten calendar days after installation

13. Quality of Reagents, Supplies and Disposables:

The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality slide product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO). In the event that the supplies to include detection kits, stains, and/or consumables are found to be defective and unsuitable for use with the contractor’s equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order for priority delivery from the government activity. This will be done at no cost to the government, in sufficient quantity as required to allow operation of the contractor’s equipment for one week (under normal government test load volume).

14. Returned goods:

The VA is responsible for inspecting all products shipped hereunder and give the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor. After acceptance, no products purchased hereunder may be returned without the prior authorization of the contractor and in conformity with their return policy. All returns of non-defective products are subject to a restocking charge. No returns will be authorized after 120 days following shipment to VA.

15. MAINTENANCE:

The contractor shall provide maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services. Preventive maintenance by contractor will provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment. Emergency repairs shall be performed after notification that the equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification.

The contractor will make its best efforts to perform emergency repair service within 48 hours of the time of notification of the malfunction except when an ordering facility elects reduced service at contract agreed reduction. The contractor will provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair will be borne by the contractor.

The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a date and time of notification,

(b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

16. TRAINING AND TECHNICAL SERVICE:

The contractor, without additional charge to the government, shall provide training at a government location for two operating personnel at the time of installation of the contractor’s equipment. Additionally, the contractor, at his/her discretion, may make training available at his/her facility on terms and conditions mutually agreed upon by the agency and the contractor. In addition, the contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of the upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

17. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: The VA shall require the contractor to deliver the equipment ordered under this contract not later than SIXTY (60) calendar days after receipt of notice of award. The VA reserves the right to thoroughly inspect and investigate the contractor and manufacturer business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance. Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training. The VA reserves the right to request a ninety (90) day test and evaluation of one or both pieces of equipment prior to placing a delivery order under the contract. If the test and evaluation is not successful as determined by the CO and COTR for that VA, those individual VA’s will not be required to continue with placing a delivery order under this contract, and no default or penalty will accrue.

18. SERVICE: Contractor will make its best efforts to provided Maintenance and other service under guarantee within 48 hours of notice from the Contracting Officer or COTR. Emergency service by a qualified engineer must be provided within 8 working hours of notification. Telephone response does not satisfy this requirement. During the guarantee period, if service needed at other than normal working hours (8:00 am - 5:00 p.m., excluding weekends and holidays), the Government will be charged at an hourly rate which is the prevailing time and materials rate. Otherwise, all services will be performed at no charge to the Government during this period.

19. AVAILABILITY OF SERVICE: The contractor guarantees availability of servicing and replacement parts for a period of five (5) years, which is the term of this contract.

20. CONTRACTOR TESTING AND INSPECTION: The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services furnished under the contract conform to contract requirements. The VA has the right to test all services ordered under the contract at all times and places throughout the term of the contract. Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract.

21. REGULATORY REQUIREMENTS: If the product(s) included in this solicitation are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder.

22. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all applicable equipment offered under this contract shall conform to all common industry standards.

23. REFERENCE SPECIFICATIONS AND PUBLICATIONS: Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency.

24. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.

See attached document: SCHEDULE.

See attached document: DELIVERY.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(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; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and

41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with

Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service

(TOS), or similar legal instrument or agreement, that includes any clause requiring the

Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

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

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

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

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

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

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED

LINE ITEM (MAR 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting

Officer may exercise the option by written notice to the Contractor within 30 Days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of Clause)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 Days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 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 (5) years.

(End of Clause)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT

REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a

Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National

Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting

Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT

2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer

(ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS

AND REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS

JUN 2020

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.232-18 AVAILABILITY OF FUNDS APR 1984

852.203-70 COMMERCIAL ADVERTISING MAY 2018

852.246-71 REJECTED GOODS OCT 2018

(End of Addendum to 52.212-4)

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEM…