36C79119R0009-001.docx

36C79119R0009

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C79119R0009 07-16-2019 Miguel Vasquez 303.273.6219 08-16-2019 Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621 X X 339113 750 Employees N/A X Department of Veterans Affairs Commodities & Services Acquisition Svc 555 Corporate Circle Golden CO 80401-5621 Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621

Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621 Tiered Evaluation X Miguel Vasquez Table of Contents

E.4 SPECIFIC INSTRUCTIONS TO OFFERORS REGARDING PROPOSAL PREPARATION

E.5 DESCRIPTIVE LITERATURE 73

E.6 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS

SECTION A

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

A.2 ABBREVIATIONS

As used through this solicitation, the following abbreviations, words or terms are used as defined.

Abbreviations ADAS Associate Deputy Assistant Secretary CD-ROM Compact Disc-Read-Only Memory CSAS Commodities and Services Acquisition Service

SAM System for Award Management SB Small Business SDB Small Disadvantaged Business SDC Service and Distribution Center

VOSB Veteran Owned Small Business WTO GPA World Trade Organization Government Procurement Agreement

A.3 NOTES TO OFFERORS

(a) See Section E for instructions regarding proposal requirements and information.

(b) The Price Schedule and Technical Requirements are at Section B.4 and attachments E and D, respectively.

(c) Offers will be received at the address specified in Block 9 of SF 1449, until the date and time specified in Block 8. CAUTION - LATE Submissions, modification, and Withdrawals: See provision 52.212-1 in Section E. All offers are subject to all terms and conditions of this solicitation.

(d) This acquisition will be conducted using tiered Cascading Set-aside Procedures (IAW VHA Memorandum #17-09, June 21,2017 and in compliance with 38 U.S.C 8127) to include only SDVOSB, VOSB, and Small Business firms (See Section E.8).

A.4 UNIQUE ENTITY IDENTIFIER / TAX IDENTIFICATION NUMBER

(a) Offeror must provide Unique Entity Identifier: ____________________

(b) Offeror must provide its CAGE number: ____________________

(c) Offeror must provide Tax Identification Number: _____________________

A.5 ACKNOWLEDGMENT OF AMENDMENTS

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 BACKGROUND

The Department of Veterans Affairs (VA) National Acquisition Center, Commodities and Services Acquisition Service (CSAS) provides professional acquisition services for the VA and other Government agencies. The CSAS has been tasked with a requirement to procure positive airway pressure (PAP) devices and associated accessories/replacement parts, facial interfaces and mask liners for the VA Prosthetic and Sensory Aids Service (PSAS) to supply VA Medical Facilities. The CSAS will manage all contracts awarded under this solicitation on behalf of the Denver Logistic Center (DLC). The VA Denver Logistics Center is a national distribution center that manages holistic supply chain management for the VA and supports VA and other Government agencies with professional logistical services.

B.2 PURPOSE AND OBJECTIVE

(a) VA's purpose under this solicitation is to obtain PAP technologies while securing a continuous supply of products to support usage of these technologies in VA clinical programs such as Sleep Medicine, Respiratory Care, and others. These items are purchased by the VA CSAS and DLC/SDC for stocking, distribution and assignment to individual VA medical facilities and subsequent issue to Veteran patients. The delivery, registration, and activation of items procured under this contract, along with invoicing requirements and payment procedures, are identified by the DLC and its respective business functions. This provides the contractor with a single point of contact for all activity under the contract.

(b) The objective is to award multiple fixed price, indefinite delivery indefinite quantity (IDIQ) contracts. The IDIQ contracts will be five-year contracts consisting of a 12-month base period and four (4) 12-month option periods. Option periods will or will not be exercised at the sole discretion of the Government.

(c) Estimated Contract period(s) of performance:

Base Year: Date of Award or December 13, 2019 (whichever is later), through December 12, 2020

Option Year I: December 13, 2020 through December 12, 2021

Option Year II: December 13, 2021 through December 12, 2022

Option Year III: December 13, 2022 through December 12, 2023

Option Year IV: December 13, 2023 through December 12, 2024

B.3 SCOPE

(a) The scope of the contract is the procurement of PAP devices and associated accessories/replacement parts, Facial Interfaces and Mask Liners.

More than one award may be made for each Contract Line Item Number (CLIN), however, only one award will be made for any particular PAP device and/or Facial Interface Make and Model selected. The contract(s) will provide the normal supply requirements for VA Medical Facilities.

A “Make” refers to the manufacturer or company of the product. A “Model” refers to the specific name or number given to a product by its manufacturers. For example, Resmed is a Make and a ResMed AirSense ™ 10 Elite CPAP Machine with Heated Humidifier is a Model of Resmed or for Facial Interfaces, a RemZzzs is a Make and an AirTouch F20 Memory Foam Mask with Headgear is a Model of Resmed.

(b) Contracted items will be ordered from time to time and in such quantities as needed to fill agency requirements in accordance with current applicable supply procedures.

(c) Prices shall remain fixed for the 12-month base period and all four (4) 12-months option periods as identified in the Price Schedule.

B.4 SCHEDULE OF ITEMS

(a) The following CLINs identify the products required by this solicitation:

CLIN 01 Auto-Titrating Continuous Positive Airway Pressure Machine (APAP);

CLIN 02 Adaptive Servo-Ventilation Machine (ASV);

CLIN 03 Bi-Level Positive Airway Pressure Machine (BPAP);

CLIN 03A BPAP (Without spontaneous timed capabilities);

CLIN 03B BPAP (With spontaneous timed capabilities);

CLIN 03C BPAP (Auto-titrating);

CLIN 04 Volume Assured Pressured Support Machine (VAPS);

CLIN 05: Full Face Interface;

CLIN 06: Nasal Interface;

CLIN 07: Oral Interface;

CLIN 08: Nasal Pillow Interface;

CLIN 09: Total Facial Interface;

CLIN 10: PAP Mask Liners

(b) The following are the Associated Accessories and Replacement Parts. Associated accessories and replacement parts must be offered only in conjunction with offers for PAP devices and/or Facial Interfaces (i.e., masks) and must be compatible with the offered makes and models of PAP devices.

(1) Associated Accessories (Limited to the following: Chin Straps, and Tubing); and

(2) Replacement Parts (Limited to the following: Power Cords, Filters, Cushions, Power Supply, Humidifier Water Chamber, and SD Cards). Please note: Replacement parts are separate from the items included with PAP device (s) as listed in E.1. (i). Replacement parts are separately offered products.

DESCRIPTION

See Solicitation’s Attachment D in support of the schedule of item’s Minimum Technical Requirements for the items listed above.

B.5 MINIMUM WARRANTY REQUIREMENTS

The warranty requirements listed in the minimum technical requirement (See attachment D) are considered minimum, unless otherwise stated. If the manufacturer’s/vendor’s standard warranty exceeds the specified warranty, the manufacturer’s/vendor’s standard warranty will apply. An Offeror’s warranty terms that are unfavorable or places greater restrictions on the Government than stated in 52.212-4(p) will not be accepted.

B.6 COMMERCIAL WARRANTY

CLIN/MAKE AND MODEL/BRAND/COMMERCIAL WARRANTY AVAILABLE FOR EACH ITEM OFFERED

(Add as needed for offered products)

B.7 CONTRACT USERS

VA CSAS (or duly appointed ordering officers at the DLC and the Service and Distribution Center (SDC)) are authorized to place orders directly with the Contractor.

B.8 ORDERING INFORMATION

(a) VA CSAS (or duly appointed ordering officers at the DLC/SDC) will place delivery orders directly with the Contractor. Delivery orders will include the specific item description, item quantities and product number contained in the contract. Delivery orders will also provide delivery information and invoicing instructions, and any other special instructions in accordance with the terms conditions of the contract.

(b) Purchases made under this contract by the VA CSAS (or by duly appointed ordering officers at the DLC/SDC), for delivery to the address shown in B.16, below, will be made at the contract price, which includes shipping. All delivery orders shall be subject to the terms and conditions of this contract. In the event of any conflicts between contract and delivery order terms shall resolved giving preference to the delivery order.

(c) Upon a receipt of delivery order from the VA CSAS, the Contractor shall fulfill the order and ship the items to the address noted in Section B.16. Delivery is f.o.b. destination, shipping included.

(d) Contractors will receive orders via Computer-to-Computer Electronic Data Interchange (EDI), FAX, or Email.

1. EDI. The contractor designates the following individual as its authorized representative to be contacted regarding establishment of an EDI interface. The Contractor must confirm receipt of delivery orders from VA CSAS (or duly appointed ordering officers at the DLC/SDC).

NAME: ________________________________

ADDRESS: _____________________________

TELEPHONE: ___________________________

FAX: ___________________________________

EMAIL ADDRESS: ________________________

2. Facsimile Transmission. Indicate the telephone number(s) and point of contact where orders should be forwarded. The Contractor must confirm receipt of delivery orders from VA CSAS (or duly appointed ordering officers at the DLC/SDC) via e-mail or fax within two (2) business days.

NAME: ________________________________

ADDRESS: _____________________________

TELEPHONE: ___________________________

FAX: ___________________________________

EMAIL ADDRESS: ________________________

3. Email. The below-named individuals are designated by the contractor to receive delivery orders placed via email:

NAME: ________________________________

ADDRESS: _____________________________

TELEPHONE: ___________________________

B.9 PAP DEVICE/ASSOCIATED ACCESSORIES SELECTION (FAIR OPPORTUNITY PROCESS)

Due to the highly specialized nature of these items, critical timeframes, and individual physicians’ sleep specialty, Sleep Clinicians must determine which medical device is best suited for each patient based on an assessment that takes into consideration the specific features of the PAP products and clinical needs of the patients as assessed by the medical professionals. As a result of the individual needs of the Veteran patients, the exception at FAR 16.505 (b)(2)(i)(B) applies to all orders placed under this contract. This exception states: “Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized”. Thus, after award, individual orders for these highly specialized items will be based on the unique circumstances and medical needs of each patient.

Clinicians will submit requests for specific devices for a specific Veteran patient through the DLC’s Remote Order Entry System (ROES). DLC/SDC’s inventory totals of PAP devices, Facial Interfaces, PAP Mask Liners, and associated accessories/replacement parts are adjusted according to orders placed in ROES by clinicians from VA medical facilities in the U.S and outlying territories. Orders placed against these contracts will be issued to the appropriate vendor to replenish depleted stock.

B.10 DELIVERY ORDER OMBUDSMAN

The delivery-order ombudsman for VA is the Associate Deputy Assistant Secretary (ADAS) for Procurement Policy, Systems and Oversight. The VA Ombudsman shall review and resolve complaints from contractors concerning all task and delivery order actions. Current contact information is as follows:

Name: D. Edward Keller / Telephone: (202) 461-0604 / Address: 810 Vermont Ave. NW, Washington DC 20420. Email: Donald.Keller2@va.gov .

B.11 CONTRACT ADMINISTRATION DATA

(a) The Contractor shall contact the Contracting Officer on all matters pertaining to administration. Only the contracting officer is authorized to make commitments or issue changes that will affect the price, quantity, delivery or terms of the contract. The Contractor shall designate a person to serve as the contract administrator for the contract. The contract administrator is responsible for overall compliance with contract terms and conditions. The Contractor’s designation of representatives to handle certain functions under this contract does not relieve the contract administrator of responsibility for contract compliance. Any changes to the designated individual must be provided to the contracting officer, in writing, with the proposed effective date of the change. The following individuals will handle all contract administration issues:

(b) Contractor:

NAME: ________________________________

ADDRESS: _____________________________

TELEPHONE: ___________________________

FAX: ___________________________________

EMAIL ADDRESS: ________________________

(c) Government Agency:

Department of Veterans Affairs/National Acquisition Center Commodities and Services Acquisition Service

Mail and Parcel Address: PO Box 25166, Denver, Colorado 80225-0166

Overnight and Common Carrier: 555 Corporate Circle, Golden, CO 80401

Primary: Miguel Vasquez, Contracting Officer, Phone No: 303-273-6219 E-mail Address: miguel.vasquez@va.gov

Secondary: Stephen Wilson, Contract Specialist Phone No: (303) 273-6215 E-mail Address: Steve.Wilson4@va.gov

B.12 CONTRACTOR REMITTANCE ADDRESS:

All payments by the Government to the contractor will be made in accordance with:

B.13 INVOICES

(a) Invoices shall be submitted in arrears as supplies are ordered:

(b) Invoices must match any partial orders shipped

(c) Invoices for payment shall be in accordance with FAR 52.212-4(g)

(a) GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be sent in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests (NOV 2018).

B.14 INVOICING/ELECTRONIC COMMERCE SYSTEMS

The contractor shall comply with VA Acquisition Regulation (VAAR) 852.232-72, Electronic Submission of Payment Requests, and the following business processes regarding invoicing. Invoices submitted for payment shall be in accordance with FAR 52.212-4(g) and shall be submitted in arrears as supplies are delivered.

(a) Vendor Electronic Invoice Submission Methods:

Fax, email and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted data transmissions below.

(1) VA’s Electronic invoice presentment and payment system-The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, for free.

(2) A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI).

(b) Vendor e-invoice Set-up information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center in Austin, TX for payment processing, free of charge. If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

(1) Tungsten e-Invoice setup information: 1-877-489-6135

(2) Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

(3) FSC e-Invoice contact information: 1-877-353-9791

(4) FSC e-Invoice email: vafsccshd@va.gov

(5) FSC e-invoice email: vafsccshd@va.gov

(6) http://www.fsc.va.gov/einvoice.asp

B.15 SHIPPING REQUIREMENTS

(a) The shipping container (box/package) shall be clearly marked to indicate the following:

(b) A packing list, which includes the description of material shipped, including name of item, item number, quantity, number of containers, and package number (if any).

(c) If more than one order is shipped per container, each order shall be packaged in a separate internal container or package and must contain an individual packing list, as specified above, for that order.

(d) Items supplied under the contract shall be individually commercially packaged in a manner which insures arrival at destination in a satisfactory condition (not damaged due to packaging failures during normal handling) for further redistribution to individual users. Packaging shall not include cross-selling literature for other products, which have not been specifically awarded.

B.16 DELIVERY INFORMATION

(a) Delivery schedule specified on delivery orders issued against resultant contract is the date material is due, not the shipping date. Orders may be shipped early in order to ensure delivery prior to the due-in date. Refer to C.4 for delivery time frames.

(b) Partial deliveries are authorized; however, the complete order is due within the agreed contract delivery period. Any items not received within the agreed period will be considered delinquent.

(c) Deliveries to VA Service and Distribution Center (SDC) can be made to the following address:

Department of Veterans Administration, Service and Distribution Center: 1st Ave; One Block North of 22nd Cermak, Building 37 Hines, IL 60141.

Urgent Delivery. When the contract delivery schedule does not meet the urgent delivery requirements, the VA CSAS may contact the Contractor for the purpose of obtaining accelerated delivery. The Contractor shall reply to the inquiry within one (1) workday after receipt. (The Contractor shall confirm telephonic replies in writing.) If the Contractor agrees to accelerate the delivery, the ordering facility would be responsible only for the difference between the standard shipping charges and any excess charges related to the accelerated delivery.

(d) This does not apply if the Contractor is accelerating the shipping in order to meet the contract delivery time frame.

B.17 GUARANTEED MINIMUM

The minimum amount of supplies that the Government agrees to order per contract is $5,000.00. If option periods are exercised, the contract will be deemed to be extended by the terms of the option and there will be no change to the stated guaranteed minimum. The Government may fulfill the guarantee by a single delivery order or by any number of delivery orders.

B.18 CONTRACT CEILING AMOUNT

The maximum value of supplies that the Government may order during the contract performance period is $5 Billion. This amount shall be a shared ceiling among all awarded contracts and shall apply for the life of the contract, including the base year and all option years, if exercised.

B.19 CUSTOMER SERVICE INFORMATION

Offeror must provide the name, telephone number and e-mail address of individuals that can be contacted by the DLC/SDC for product information, delivery status, invoicing issues, product returns, etc.

POINT OF CONTACT FOR CUSTOMER SERVICE / PRODUCT SUPPORT

NAME: ________________________________

ADDRESS: _____________________________

TELEPHONE: ___________________________

FAX: ___________________________________

EMAIL ADDRESS: ________________________

B.20 RETURN MERCHANDISE AUTHORIZATION (RMA)

The following procedures for returned merchandize authorization shall apply only for products ordered by CSAS/DLC/SDC and delivered to the SDC.

For products delivered and found to have defects, the VA will contact the contractor to discuss warranty applicability. If it is determined that warranty replacement is authorized, a credit or replacement will be issued by the contractor. The Government will complete the RMA form (Attachment G) and include the completed form in the carton with the item being returned. All replacement product shipments delivered to the SDC shall have the RMA number displayed on the outside of the return carton. Replacement product shipments delivered to the SDC without the RMA number displayed on the outside of the return carton will be returned to the contractor.

(a) The contractor shall have a single customer service email contact point for all Return Merchandise Authorization (RMA) activities, to be identified after contract award.

(b) The contractor shall confirm receipt of RMA items within 24 hours of receipt.

(c) The contractor shall replace all defective RMA items with a new replacement item. This item shall be the same make and model of the item that was returned to the contractor. Repaired items will be accepted if they are reconfigured into a “like new” condition with regards to sanitation, functionality and appearance.

(e) The contractor shall use a standardized sticker to clearly identify all replacement product shipments to the SDC. The sticker shall be approximately 4 x 4 inches and say “REPLACEMENT PRODUCT” in bold letters. Stickers are to be affixed by the contractor for all replacement product shipments from the contractor to the VA SDC.

(f) The contractor shall ensure that all serialized barcode labels for the RMA items are on the inside and outside of the RMA carton. The serialized barcodes for the defective items shall be clearly identified along with the serialized barcodes for the replacement items.

B.21 PRODUCT RECALLS

(a) If any product awarded under this solicitation requires correction1, is removed or modified2 or recalled3 by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if any required correction, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the contractor:

1. Notify the following offices and points of contact:

(i) Contracting Officer’s Representative and Contracting Officer, in writing, by the most expeditious manner possible.

(ii) Manager, Product Recall Office, National Center for Patient Safety (NCPS), Veterans Health Administration, 24 Frank Lloyd Wright Drive, Lobby M, Ann Arbor, MI 48106, in writing, by the most expeditious manner possible.

(iii) Biomedical Engineer, Center for Engineering & Occupational Safety and Health (CEOSH) (138F), Veterans Health Administration, 1 Jefferson Barracks Rd. Bldg. 65, St. Louis, MO 63125, in writing, by the most expeditious manner possible.

2. The following information shall be provided in each individual notification that is forwarded to all above offices and points of contact:

(i) Complete item description and/or identification, delivery order numbers from customers, and the contract number assigned as a result of an award on this solicitation.

(ii) Reasons for modification, corrections, removal, or recall.

(iii) Proposed offers for return for credit, replacement, or corrective action shall be forwarded to the facility POC and Contracting Officer, for consideration by the Government.

3. The following additional information shall be provided, in writing, to the above points of contact at the National Center for Patient Safety (NCPS) and the Center for Engineering & Occupational Safety and Health (CEOSH) regarding each individual notification that is forwarded to all above offices and points of contact:

(i) National summary detailing the status of the actions being taken by the contractor or manufacturer regarding the product correction, removal, or recall.

(ii) Confirmation that all affected products were corrected, removed, or recalled and all expected actions were completed.

1A correction, as defined by FDA, means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.

2A removal, as defined by FDA, means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

3A recall, as defined by FDA, means a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action (e.g., seizure).

B.22 TECHNOLOGY REFRESH AND EXCHANGE

(a) All items/devices offered shall be state-of-the-art technology. State-of-the-art is defined as the most recently designed components and products in current production that are announced for marketing purposes, available, maintained and supported in accordance with requirement specified in the solicitation. Absolute components and products are not acceptable.

(b) In the event a manufacturer announces that contract products, devices and parts are to be upgraded, discontinued, or are discontinued, within the first year of contract award, or the first six months of any exercised option, the VA CSAS shall have the following right under the contract with regard to items it has ordered from the contractor.

The VA CSAS, at its option, may exchange, at no cost to the VA CSAS, the previously ordered products, devices and parts for the manufacturer’s upgraded items. VA DLC/SDC will pay for return shipping costs on exchanged products, devices, and parts for the manufacturer’s upgraded items.

(c) If upgrades become available after award of this contract, the contractor may request that the upgraded items be substituted in the contract for the awarded items per paragraph (d) below. The contractor will add or substitute them for the awarded items following evaluation and approval by the technology refresh process.

(d) The contractor shall provide the following information to the Contracting Officer:

(i) A list of specific awarded items that the contractor proposes to update.

(ii) Product literature for the new item(s), a detailed description of the differences between the awarded item(s) and the new items(s) and a specific analysis of the comparative advantages and disadvantages of the new item(s).

(iii) A pricing proposal for the proposed substituted items.

(e) If the Contracting Officer agrees to any substitution, a bilateral contract modification adding the upgraded items to the contract shall be required prior to any orders placed for the new item.

(f) New technology products shall be available for a period of no less than 1 year.

36C79119R0009

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

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

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

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

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

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

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

(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 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

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

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

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

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

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

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

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

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

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

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

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

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

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

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

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(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 ITEMS C.2 52.212-4 (p) (TAILORED) LIMITATION OF LIABILITY Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government in a breach of warranty action for consequential damages resulting from any defect or deficiencies in accepted items.

C.3 52.211-9 - (TAILORED) DESIRED AND REQUIRED TIME OF DELIVERY (JUNE 1997)

(a) The Government desires delivery to be made according to the following schedule:

DESIRED DELIVERY SCHEDULE

Within (15) Calendar Days after Receipt of Order

If the offeror is unable to meet the desired delivery schedule, it may, without prejudicing evaluation of its offer, propose a delivery schedule below. However, the offeror’s proposed delivery schedule must not extend the delivery period beyond the time for delivery in the Government’s required delivery schedule as follows:

REQUIRED DELIVERY SCHEDULE

Within (30) Calendar Days after Receipt of Order

Offers that propose delivery of a quantity under such terms or conditions that delivery will not clearly fall within the applicable required delivery period specified above, will be considered nonresponsive and rejected. If the offeror proposes no other delivery schedule, the desired delivery schedule above will apply.

OFFEROR’S PROPOSED DELIVERY SCHEDULE

(End of clause)

C.4 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task…