18
– 1 – COVID-19 TEST KIT PURCHASE AGREEMENT 2. PRICING a. The purchase prices are $400.00 (Four Hundred Dollars) per Reader, $900.00 (Nine Hundred Dollars) per Box of 10 Test Cartridges, and $175.00 (One Hundred Seventy-Five Dollars) per package of Control Swabs (3 Posive Control Swabs and 3 Negave Control Swabs per package). Prices for any future orders may be subject to change. b. The purchase price for the Test Kits are exclusive of all local, state and federal taxes, including sales, use and similar taxes. Customer shall be responsible for the payment of any and all taxes. All amounts payable under this Agreement shall be paid in U.S. dollars within 30 days of the invoice date. c. All orders are subject to (a) a shipping charge of $9.49 plus (b) a fuel surcharge. Rush orders requested to be upgraded to next day air and any order of Test Kits that require special handling, will incur addional charges in accordance with UPS shipping zone schedules for the weight of the package. 1. TERMS AND CONDITIONS a. Customer hereby agrees to purchase the Cue COVID-19 Test, which consists of the Cue Health Monitoring System (Cue Cartridge Reader) (the “Reader ”), the Cue COVID-19 Test Cartridge and Cue Sample Wand (the “Test Cartridge”), and the Cue COVID-19 Test Posive Control Swab and Negave Control Swab (the “Control Swabs”, each of the Reader, the Test Cartridge and the Control Swabs are a “Test Kit” and together collecvely, the “ Test Kit”). At the me of execuon of this Agreement, Customer agrees to make an inial purchase of _______ Reader(s), ________ boxes of the Test Cartridges and ________ packages of the Control Swabs. Any and all future orders of Test Kits made pursuant to a separate purchase order or otherwise shall be subject to the terms and condions of this Agreement. b. All purchases are non-cancelable and non-refundable. The Test Kits are not returnable. c. Except as otherwise set forth in this Agreement, sales of the Test Kits to Customer shall be subject to HSI’s “Legal Terms and Condions” available at hps://www.henryschein.com/us-en/medical/LegalTerms.aspx (or such other URL of HSI’s website www.henryschein.com), as in effect from me to me. This COVID-19 Test Kit Purchase Agreement (this “Agreement”) is entered into as of ____________________, 2021 (“Effecve Date”), by and between Henry Schein, Inc. (“HSI”) and ______________________________ (“Customer ”). CUSTOMER SHIP TO ACCOUNT NUMBER: ________________________________ CLIA LICENSE NUMBER: ______________________________________________ ITEM NUMBER DESCRIPTION 138-7509 Cue Reader 138-7511 Cue Test Cartridge 138-7516 Cue Control Swabs

COVID-19 TEST KIT PURCHASE AGREEMENT

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: COVID-19 TEST KIT PURCHASE AGREEMENT

– 1 –

COVID-19 TEST KIT PURCHASE AGREEMENT

2. PRICING

a. The purchase prices are $400.00 (Four Hundred Dollars) per Reader, $900.00 (Nine Hundred Dollars) per Box of 10Test Cartridges, and $175.00 (One Hundred Seventy-Five Dollars) per package of Control Swabs (3 Positive ControlSwabs and 3 Negative Control Swabs per package). Prices for any future orders may be subject to change.

b. The purchase price for the Test Kits are exclusive of all local, state and federal taxes, including sales, use and similartaxes. Customer shall be responsible for the payment of any and all taxes. All amounts payable under this Agreementshall be paid in U.S. dollars within 30 days of the invoice date.

c. All orders are subject to (a) a shipping charge of $9.49 plus (b) a fuel surcharge. Rush orders requested to beupgraded to next day air and any order of Test Kits that require special handling, will incur additional charges inaccordance with UPS shipping zone schedules for the weight of the package.

1. TERMS AND CONDITIONS

a. Customer hereby agrees to purchase the Cue COVID-19 Test, which consists of the Cue Health Monitoring System (CueCartridge Reader) (the “Reader”), the Cue COVID-19 Test Cartridge and Cue Sample Wand (the “Test Cartridge”), andthe Cue COVID-19 Test Positive Control Swab and Negative Control Swab (the “Control Swabs”, each of the Reader, theTest Cartridge and the Control Swabs are a “Test Kit” and together collectively, the “Test Kit”). At the time of executionof this Agreement, Customer agrees to make an initial purchase of _______ Reader(s), ________ boxes of the TestCartridges and ________ packages of the Control Swabs. Any and all future orders of Test Kits made pursuant to aseparate purchase order or otherwise shall be subject to the terms and conditions of this Agreement.

b. All purchases are non-cancelable and non-refundable. The Test Kits are not returnable.c. Except as otherwise set forth in this Agreement, sales of the Test Kits to Customer shall be subject to HSI’s “Legal

Terms and Conditions” available at https://www.henryschein.com/us-en/medical/LegalTerms.aspx (or such other URLof HSI’s website www.henryschein.com), as in effect from time to time.

This COVID-19 Test Kit Purchase Agreement (this “Agreement”) is entered into as of ____________________, 2021 (“Effective Date”), by and between Henry Schein, Inc. (“HSI”) and ______________________________ (“Customer”).

CUSTOMER SHIP TO ACCOUNT NUMBER: ________________________________

CLIA LICENSE NUMBER: ______________________________________________

ITEM NUMBER DESCRIPTION

138-7509 Cue Reader

138-7511 Cue Test Cartridge

138-7516 Cue Control Swabs

Page 2: COVID-19 TEST KIT PURCHASE AGREEMENT

– 2 –

COVID-19 TEST KIT PURCHASE AGREEMENT

3. CUSTOMER REPRESENTATIONS, WARRANTIES AND COVENANTS

a. Customer represents, warrants and covenants that it is purchasing the Test Kits solely for its own use within the United States and will not resell the Test Kits to any third party.

b. Customer acknowledges, understands and agrees that the Test Kits are only authorized for use at Authorized Laboratories and covenants to ensure that the Test Kits are only administered at Authorized Laboratories. For purposes of this Agreement, “Authorized Laboratories” means laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high, moderate or waived complexity tests. The Test Kits are also authorized for use at patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

c. CUSTOMER REPRESENTS, WARRANTS AND COVENANTS THAT IT IS AN AUTHORIZED LABORATORY.

d. Customer acknowledges and understands that the Test Kits have not been FDA cleared or approved. The Test Kits have been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The Test Kits have been authorized only for the qualitative detection of nucleic acid from SARS-CoV-2 (and not for any other viruses or pathogens) in direct nasal swabs from individuals who are suspected of COVID-19 by their healthcare provider, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

e. Customer has read the Emergency Use Authorization (EUA) attached hereto as Exhibit A and agrees that it will comply with all provisions in the EUA that apply to Authorized Laboratories.

f. Customer agrees to provide each patient whose specimens are tested with the Test Kits the Fact Sheet for Patients attached hereto as Exhibit C.

g. Customer shall collect information on the performance of the Test Kits, including any suspected occurrence of false positive results, false negative results, significant deviations from the established performance characteristics of the Test Kits, and other complaints about the Test Kits and Customer shall promptly inform HSI via telephone at 1-800-472-4346, as well as other entities as required by the EUA. For the avoidance of doubt, Customer shall not provide HSI with any Protected Health Information as defined by the Health Insurance Portability and Accountability Act, as amended

h. Customer has read and hereby acknowledges the Fact Sheet for HealthCare Providers attached hereto as Exhibit B. Further, and Customer agrees to provide such Fact Sheet for HealthCare Providers to any authorized person utilizing the Test Kits.

i. Customer shall keep all records associated with the EUA until otherwise notified by the FDA, and Customer shall make such records available for inspection upon request by the FDA.

j. Customer agrees to look solely to the Manufacturer for any claims related to defect or breach of warranty. HSI shall have no obligation or liability to take back or replace any Test Kits. Attached hereto as Exhibit D is a copy of the Manufacturer’s limited warranty that applies solely with respect to the Reader (and not the Test Cartridges and Wand).

k. Customer agrees that it shall not, and shall not assist, direct or permit anyone else to: (i) reverse engineer, reverse analyze or disassemble any portion of a Test Kit or (ii) attempt to disable or circumvent any safety, security or restricted access features of a Test Kit.

Customer will defend, indemnify and hold harmless HSI and its affiliates, successors and assigns and all their respective directors, officers, and employees against any and all loss, injury, death, damage, liability, claim, deficiency, action, judgment, interest, award, penalty, fine, cost or expense, including without limitation reasonable attorney fees and costs, arising from or related to Customer’s breach of Section 3 of this Agreement. This Section 3 shall survive termination of this Agreement.

Page 3: COVID-19 TEST KIT PURCHASE AGREEMENT

– 3 –

COVID-19 TEST KIT PURCHASE AGREEMENT

IN WITNESS WHEREOF, the parties have executed this Agreement under seal effective the date first written above.

Henry Schein, Inc.

By:

____________________________________________

Name: ______________________________________

Title: _______________________________________

Dominick Gallo

V.P. Business Process Improvement,Global Dental Group

Customer Business Name: _____________________________________

PLEASE SIGN HERE:(Signature):

__________________________________

Name: ____________________________________

Title: ____________________________________

PLEASE PROVIDE ADDITIONAL CONTACT DETAILS:

Email: ____________________________________

Phone: ____________________________________

Address: ____________________________________

____________________________________

____________________________________

PLEASE RETURN SIGNED FORMS TO YOUR SALES REPRESENTATIVE OR EMAIL TO: [email protected]

4. OTHER (continued)

This Agreement shall have a term of 2 years. Termination shall not affect the rights or obligations of either party accrued as of the effective date of such termination or that may arise subsequently with respect to transactions initiated or completed prior to the effective date of such termination. This Agreement may not be assigned without HSI’s prior written consent. This Agreement shall be governed by the laws of the State of New York, without reference to conflict of laws principles. This Agreement, including the exhibits attached hereto, and the terms and conditions referred to herein, each of which is incorporated herein by reference in its entirety, constitutes the entire agreement between Customer and HSI with respect to the Test Kits. The terms contained in this Agreement shall supersede any conflicting terms contained in any document used or submitted by either party, including any purchase order, in connection with the purchase of Test Kits covered by this Agreement. This Agreement may not be amended, nor any obligation waived, except by a writing signed by both parties. This Agreement may be executed in any number of counterparts, each of which is deemed an original but all of which constitute the same instrument. This Agreement may be executed by the exchange of faxed, executed copies, certified electronic signatures or copies delivered by electronic mail in Adobe Portable Document or similar format, and any signature transmitted by such means for the purposes of executing this Agreement shall be deemed an original for purposes of this Agreement.

Page 4: COVID-19 TEST KIT PURCHASE AGREEMENT

– 4 –

EXHIBIT AEmergency Use Authorization

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 5: COVID-19 TEST KIT PURCHASE AGREEMENT

– 5 –

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

EXHIBIT AEmergency Use Authorization

Page 6: COVID-19 TEST KIT PURCHASE AGREEMENT

– 6 –

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

EXHIBIT AEmergency Use Authorization

Page 7: COVID-19 TEST KIT PURCHASE AGREEMENT

– 7 –

EXHIBIT AEmergency Use Authorization

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 8: COVID-19 TEST KIT PURCHASE AGREEMENT

– 8 –

EXHIBIT AEmergency Use Authorization

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 9: COVID-19 TEST KIT PURCHASE AGREEMENT

– 9 –

EXHIBIT AEmergency Use Authorization

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 10: COVID-19 TEST KIT PURCHASE AGREEMENT

– 10 –

EXHIBIT AEmergency Use Authorization

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 11: COVID-19 TEST KIT PURCHASE AGREEMENT

– 11 –

EXHIBIT AEmergency Use Authorization

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 12: COVID-19 TEST KIT PURCHASE AGREEMENT

– 12 –

EXHIBIT AEmergency Use Authorization

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

EXHIBIT B

Fact Sheet for Health Care Providers

Page 13: COVID-19 TEST KIT PURCHASE AGREEMENT

– 13 –

EXHIBIT BFact Sheet for Healthcare Providers

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 14: COVID-19 TEST KIT PURCHASE AGREEMENT

– 14 –

EXHIBIT BFact Sheet for Healthcare Providers

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 15: COVID-19 TEST KIT PURCHASE AGREEMENT

– 15 –

EXHIBIT BFact Sheet for Healthcare Providers

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 16: COVID-19 TEST KIT PURCHASE AGREEMENT

– 16 –

EXHIBIT CFact Sheet for Patients

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 17: COVID-19 TEST KIT PURCHASE AGREEMENT

– 17 –

EXHIBIT CFact Sheet for Patients

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

Page 18: COVID-19 TEST KIT PURCHASE AGREEMENT

– 18 –

EXHIBIT DLimited Manufacturer’s Warranty

Form 4/7/2020 DMSLIBRARY01\98901\000200\36787871.v1-4/20/20

EXHIBIT D

LIMITED MANUFACTURER’S WARRANTY Cue Health Inc. (the “Manufacturer”) warrants that the Reader shall be free from defects in material and workmanship, when subjected to normal, proper and intended usage by qualified personnel, for the period of time set forth in the documentation/labels, published specifications, or IFU. The warranty period for the Reader is twelve (12) months from the date of shipment. If the Manufacturer verifies a claim of defect or non-conformity of the Reader, the Manufacturer will provide Customer with a replacement unit or parts thereof; in each case only to extent the Manufacturer deems necessary. The Manufacturer also shall have no obligation to replace, in whole or in part, any Reader where any defect is a result of (1) normal wear and tear, (ii) accident, disaster or event of force majeure, (iii) misuse, fault or negligence of or by Customer or any third party, (iv) use of the Reader in any manner for which it was not designed, including any use that is mot in accordance with the Test Kits’ labeling or IFU, (v) causes external to the Reader, such as, but not limited to, power failure or electrical power surges, (vi) improper storage and handling of the Reader, (vii) use of the Reader in combination with equipment or software not supplied by the Manufacturer, (viii) any repair, service, alteration or tampering of the Reader by any entity other than the Manufacturer. THE MANUFACTURER’S SOLE OBLIGATION AND CUSTOMER’S EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY SHALL BE, AT MANUFACTURER’S OPTION, TO REPLACE THE READER OR REFUND THE PURCHASE PRICE. THE MANUFACTURER DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO THE TEST KITS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.