PLATFORM AND TESTING SERVICES

ORDER TERMS AND CONDITIONS

 

DEFINITIONS (in addition to terms defined in the Order)

Applicable Laws: means, when and to the extent applicable, those U.S. laws, rules and regulations that apply to Color’s provision of Services in an Order, which may involve: the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); the Affordable Care Act; the Americans with Disabilities Act; (iv) applicable governmental reporting and disclosure requirements; and (v) if federal or state insurance programs are billed, the Medicare/Medicaid Anti-Kickback Statute and the Stark Law and related regulations.

Claims: means any claims, actions, suits, proceedings, demands, losses, fines, damages, costs, (including, reasonable attorneys’ fees, expert witness fees, and court costs) brought by a third party.

Client: means the business entity listed under Client Information in the Order. 

Color Property: means Color’s Tests and related documentation; its web portal and software; its marketing materials and content displayed or provided as part of the Services and Tests, and all copies and derivative works thereof related to the Services, as well as all associated patent rights, copyrights, trade secret rights, mask work rights, trademark rights, and all other intellectual property rights of any kind throughout the world.

Color Test: means Color’s test to detect the presence of SARS-CoV-2, the virus known to cause coronavirus disease 2019 (“COVID-19”), used pursuant to an Emergency Use Authorization (the “EUA”) received from the U.S. Food and Drug Administration (“FDA”), as such may be updated or modified from time to time (pursuant to a new EUA, amendment to an existing EUA, or FDA regulations and guidance regarding the performance of lab-developed tests without an EUA).  

Eligible Individuals: means the individuals eligible to participate in the Services as Client determines, including the frequency of Testing or reporting, pursuant to Client’s policies and applicable guidelines and regulations. 

Fees: means the total amounts paid by Client for the Services as specified in the Order.

Indemnitees: means Color or Client as applicable and its affiliates, its subcontractors, respective successors and permitted assigns, and all of its respective directors, trustees, officers, employees, representatives, and agents.

Payers: means third party payers, insurance companies, and/or Eligible Individuals.

Per-Test Rate: means the Price per Test stated on the Order.

Sample: means the biological sample collected per the testing sample collection kit.

Services: means the services described in an Order accepted by Color.

Term: means the period commencing on the Start Date through termination subject to renewal.

Test or Testing: means the Color Test, or any other third-party test (“Third Party Test”) used to detect the presence of COVID-19. 

Third-Party Pass-Through Fees: means third-party fees for which Color is not the ultimate beneficiary, such as OHR-POR Services, and Shipping and Handling. 

  1. TERMS AND CONDITIONS: ALL SERVICES

1.1 Standard of Services; Subcontractors; Intellectual Property; Authorizations; Information Use; Consent

(a) Standards. Color will perform the Services (on a non-exclusive basis) for or on behalf of Client pursuant to all Applicable Laws, to the extent applicable, and Color’s standard protocols then in effect. Color does not practice medicine, or provide medical treatment or medical advice, and does not make any representations, warranties, guarantees, or endorsements regarding any healthcare services or advice that may be obtained through Color’s Services. 

(b) Subcontractors. Client agrees that Color may engage subcontractors in the performance of the Services. Color is responsible for all subcontractors engaged by Color and shall be liable to Client for the acts or omissions of such subcontractors in the performance of Services authorized by Color.

(c) Intellectual Property. Color owns all right, title and interest in and to the Color Property. For use on its website in general listings of customers or in other marketing materials Color may (i) identify Client as a Color customer using Customer’s name and logo, and (ii) with Customer’s written approval, publish a Client testimonial.

(d) Authorizations and Consents. If the Services or disclosure of information to Client requires a HIPAA Authorization from an Eligible Individual, Color shall not be obligated to perform Services, or to disclose such information to Client until it receives such consent. Client shall be solely responsible for any use of information received in connection with the Services.  

(e) Use of Services-Related Information.  Color shall have no liability related to Client’s or any HCP’s use or disclosure of information provided in connection with the Services. Client shall not manipulate, aggregate, integrate, compile, merge, reorganize, regenerate or otherwise use the information and shall not provide the information to any person or entity, except as required or authorized by Applicable Laws and/or the Eligible Individual.  Client acknowledges that Color, as a clinical laboratory certified under the Clinical Laboratory Improvements Act of 1988 and accredited by the Client of American Pathologists, in accordance with Applicable Law, must retain Data generated pursuant to the Order and may not destroy such Data for applicable retention periods.

 

1.2.  Fees and Payment. 

(a) Payments. Client will pay Color all Fees set forth in each Order without offset or deduction. Payment shall be made in USD via ACH or wire transfer.  If Color approves another method of payment used by Client, Client agrees to reimburse Color, to the maximum extent permitted by law, for any additional platform or transaction-related fees incurred by Color associated with such payment method.  Color is not responsible for any fees charged by any third-party service provider of Client in connection with submitting invoices or receiving payment.  Color reserves the right to change its Services Fees with thirty (30) days prior written notice to Client.  All fees are due Net 30 from the date of any applicable invoice.

(b) FMV.  Client acknowledges that the Fees have been priced at fair market value and are not intended to provide any remuneration in cash or in kind for the referral of any patient.

(c) Cancellations and Refunds.  All fees are non-refundable and non-cancellable.

(d) Population Size: Where Client pays for a Service Per Eligible Individual, pricing during such Term is calculated based on each unique person granted Platform access based on Eligible Individual information provided by Client to Color.  The initial payment for any Term shall be for the estimated population of unique Eligible Individuals who will be provided access to the Platform during such Term.  If client’s monthly Eligible Users exceeds the purchased number by ten percent (10%) or more during the Term, Client shall be invoiced quarterly in arrears for all additional Eligible Individuals, beyond the initial estimate, that are provided access to the Platform during the prior quarter.  Fees for such additional Eligible Individuals shall be prorated as follows: divide the Term by the number of quarters (partial or full) during which such person was provided access to the Platform multiplied by the applicable fee. Pricing shall be based on the tier into which such Eligible Individual falls (based on the total population during any Term).   

 

1.3. Confidentiality 

Client and Color each agree to hold each other’s confidential and proprietary information (e.g., pricing, operations, facilities, methods, processes, protocols, procedures and business) in strict trust and confidence and will not disclose any such information to any third party without the other party’s prior written approval, except as may be required by Applicable Laws.  On termination or earlier request, all confidential information of Color acquired by Client, including any and all copies thereof made by Client shall be returned to Color or destroyed.

 

1.4. Term and Termination 

(a) Term. This Order is effective as of the Start Date for a period of 12-months (“Initial Term”).  At the end of the Initial Term the Order shall renew for additional 12-month terms (each a “Renewal Term”), unless earlier terminated. If terminated for any reason, Client shall pay Color for any Services rendered prior to the date of termination.

(b) Termination. Either Party may terminate the Order on written notice due to a material breach by the other party that is not cured within thirty (30) days following written notice of such breach by the non-breaching party.

 

1.5. Limited Warranty 

(a) Services Warranty. If Color fails to perform its Services in accordance with the standards described in Section 1.1 above, Client’s sole and exclusive remedy will be that Color shall re-perform the affected Services at no additional cost to Client. EXCEPT AS EXPRESSLY PROVIDED HEREIN, COLOR PROVIDES ALL SERVICES “AS IS” AND WITHOUT WARRANTY OF ANY KIND. COLOR DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, OR STATUTORY, INCLUDING BUT NOT LIMITED TO NON-INFRINGEMENT AND THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

(b) Limited Liability. Neither party is liable to the other for any consequential, indirect, special, exemplary, punitive, or incidental damages, including lost profits, loss of business, or any other commercial damage, regardless of the form of action or theory of liability. Furthermore, to the extent permitted by Applicable Laws, the maximum liability of either party arising out of or relating to this Order, excluding non-payment for non-refundable or non-cancellable fees by Client, whether arising from any claim(s) based on breach of contract, tort, products liability, strict liability, warranty, or otherwise, shall in no case exceed the actual fees paid to Color in the twelve (12) months immediately preceding the claim, exclusive of aggregate Third Party Pass-Through Fees. 

 

1.6Indemnification 

(a) Color. Color will defend, indemnify, and hold harmless Client Indemnitees from and against any and all Claims resulting from Color’s gross negligence or willful misconduct hereunder, except to the extent such Claim relates to: (i) the use by Client, Eligible Individuals, or any third party of the Test results; or (ii) the negligence or willful misconduct by Client, an Eligible Individual, or any Client Indemnitee.

(b) Client. Client will defend, indemnify, and hold harmless Color Indemnitees from and against any and all Claims resulting from Client’s gross negligence or willful misconduct, except to the extent such Claim relates to the negligence or willful misconduct of Color or any Color Indemnitee; additionally, Client’s indemnification obligations herein shall extend to: (i) any information or instructions that Client provides to Color; (ii) Client’s unauthorized disclosure of any Test results to any third party for any reason, or any unauthorized use by Client of any of the results provided hereunder; and (iii) any failure of Client to comply with any Applicable Laws.

 

1.7. Notice 

Any notice or communication required under this Agreement shall be served personally, sent by United States certified mail or Priority Mail with electronic Delivery Confirmation, sent by overnight delivery or courier, or sent by email to the following address: (i) if to Client as set forth in the Order Form; (ii) if to Color: Color Health Inc., 831 Mitten Road, Suite 100 Burlingame, CA 94010, Email: contracts@color.com.  Any change to the notice address listed must be given to the other party in the same manner. The date of notice shall be: the date of delivery if the notice is personally delivered or sent by overnight delivery, courier service or Priority Mail (as confirmed by electronic delivery confirmation); three (3) business days following the date of mailing if the notice is sent by United States certified mail; or the first business day following the date of transmission if the notice is sent by email.  In all events, a courtesy copy of such notice shall be provided by each party to the other by email to the notice email address.

 

1.8. Miscellaneous 

A party’s failure to perform in timely fashion shall not be a breach if such failure to perform results from circumstances beyond the party’s reasonable control, including, but not limited to, labor disputes, civil disturbances, acts or non-actions of governmental authorities or suppliers, war, embargoes, severe weather, fire, earthquakes, Internet outage, Acts of God, or default of a common carrier.  This Order and the Order Terms and Conditions shall be governed by and interpreted in accordance with the laws of the State of Delaware, excluding its conflicts of law principles. The Order and these Order Terms and Conditions are the entire agreement between the parties as to the subject matter hereof and supersedes all prior written and oral communications or agreements.  No change shall be made except by written agreement.  The parties are independent contractors and are not considered partners, joint venturers, co-owners, or participants in any joint or common undertaking. Neither party may act as an agent of the other or create or assume any obligation on behalf of the other. Neither party may assign this Agreement without the other party’s prior written consent; however, Color shall have the right to freely assign this Agreement to any affiliate or successor to substantially all of its business or assets to which this Agreement relates, whether by merger, sale of assets, sale of stock, reorganization or otherwise. This Agreement shall be binding on and inure to the benefit of each of the parties’ successors and permitted assigns, if any.

  1. TERMS AND CONDITIONS: PLATFORM SERVICES

2.1 Testing Platform

Testing Platform Services include all services related to the use of the Platform to manage testing services and reporting for Eligible Individuals.  

(a) Eligibility. Client shall solely determine the Eligible Individuals who participate in the Platform within its population, and Client shall cooperate with Color to develop a process through which Color can securely and reliably identify Eligible Individuals.

(b) Data.  Client is responsible for ensuring any test results entered by a Client appointed party (i.e. a testing coordinator) or Eligible Individuals are accurately reported using the Platform. Color hereby expressly disclaims any responsibility or liability for Eligible Individual eligibility criteria or Client’s use of data provided or through the Platform, or the accuracy of data input into the platform by any third party (including but not limited to Client, Client’s representatives, or Eligible Individuals).

(c) Other Terms.  Use of the Platform is subject to the Terms of Service and Privacy Policy on the Color website, available at www.color.com/covid19-tos and www.color.com/privacy-policy.

 

2.2 Vaccination Status Tracking 

(a) Eligibility. Client shall solely determine eligibility and frequency of Vaccination Tracking within its population, and Client shall cooperate with Color to develop a process through which Color can securely and reliably identify Eligible Individuals.  

(b) Data. Client is responsible for ensuring results are accurately reported using the Platform and advising Eligible Individuals to do the same, and for validating any such results. Color hereby expressly disclaims any responsibility or liability for Eligible Individual eligibility criteria or Client’s use of Vaccination Tracking results, or the accuracy of any data input into Color’s platform by any third party (including but not limited to Client, Client’s representatives, or Eligible Individuals).

(c) Other Terms.  Use of the Platform is subject to the Terms of Service and Privacy Policy on the Color website, available at www.color.com/covid19-tos and www.color.com/privacy-policy.

  1. TERMS AND CONDITIONS: COVID-19 TESTING SERVICES

3.1. Consent 

(a) Standard Consents. Prior to allowing an Eligible Individual to use and access Services, to the extent applicable or required under Applicable Law, each Eligible Individual shall be required to provide consent to the Testing and/or reporting. Color shall use an Eligible Individual’s Data solely to perform the Services and as otherwise authorized by the Eligible Individual or as permitted by Applicable Law or health order (for example, use of de-identified data provided by an Eligible Individual and/or their Test results for quality assurance, lab validation, Testing improvement, or other data for product improvement and support purposes).

(b) Special Consents. To the extent Client requests Color to provide or make available Testing Services to Eligible Individuals under 18 years of age or who otherwise lack capacity to provide consent or are incapcaitated (each, a “Minor/Incapacitated EI”), Client represents and warrants that Client has previously obtained, or will obtain prior to testing, consent from the parent/guardian or other duly authorized decision-maker of each such Minor/Incapacitated EI to perform Testing Services (“Guardian Consent”) and authorization for Color to release the results of such Testing Services to Client for non-treatment purposes (“Guardian Authorization”). Client further represents and warrants that each such Guardian Consent and each such Guardian Authorization will be compliant with applicable state and federal laws, and agrees to provide copies of such Guardian Consents and Guardian Authorization to Color upon Color’s request (e.g. for regulatory audits).

 

3.2.  Test Ordering; Re-Testing 

(a) HCP Ordered Test. The Color Test is a physician-ordered test.  Color only provides Testing Services on Samples provided by Eligible Individuals upon receipt of an order submitted by an authorized healthcare provider (“HCP”) (each a “Test Order”) using Color’s Test Requisition Form (“TRF”).  Client is responsible for engaging an HCP and obtaining Test Orders for Eligible Individuals to obtain the Color Test.  Nothing herein relieves an HCP of patient care responsibilities, including but not limited to the: (i) proper ordering of the Color Test based on occupational health purposes and/or clinical criteria, including but not limited to criteria for determining Eligible Individuals (such as minors or individuals adjudicated as incapacitated); (ii) cadence of repeat testing; and (iii) use of Color Test results or information provided by Color in connection therewith, for which Color specifically disclaims any all liability (including for indemnification claims).  Client shall adhere to all requirements of the EUA applicable for At-Home Sample Collection (where used).  If Client elects to purchase Physician Ordering Services, additional terms below shall apply.

(b) Re-Testing. If Color fails to perform its Testing Services in accordance with the standards described in Section 1 of the General Terms and Conditions, Client’s sole and exclusive remedy will be that Color shall re-perform the affected Testing Services, provided that Color receives any additional Samples necessary to re-perform the affected Services. Client shall have ten (10) days from an Eligible Individual’s or ordering HCP’s receipt of the Test result to inform Color in writing of any claim that the Services fail to comply with the Limited Warranty in Section 1 of the General Terms and Conditions.  

(c) TRF. Color may use the Samples and all information that is provided to Color in a TRF (“Data”) as necessary in connection with its performance of Services hereunder.

(d) Materials. Client shall review and adhere to all Test materials and instructions provided with the Tests (including disclosures of test type and manufacturer, test performance, result types, test reliability and limitations, potential benefits, and potential risks of harm and discomfort).  Color is responsible for ensuring that all Third-Party Testing kits provided by Color (but not those otherwise purchased by Client) include instructions for use and other test information provided by the test manufacturers along with the tests.

 

3.3. Collection and Shipping and Acceptance  

(a) Sample Collection and Shipping. Client agrees to adhere strictly to all of Color’s then current collection, shipping, and handling SOPs and written instructions, including without limitation timelines for collection and receipt of Samples for lab processing (“Collection and Shipping Instructions”). Color shall have no liability with respect to Samples or results not adhering to such Collection and Shipping Instructions. Client is responsible for managing collection protocols and standards when utilizing a testing administrator.

(b) Sample Acceptance. A Sample is considered accepted only when the processing lab has received and inspected the Sample, received a TRF containing all correct, required information, and has determined that the Sample was collected and sent in accordance with Collection and Shipping Instructions and determined that it can perform the Test as requested (collectively “Acceptance”). If a Sample is not Accepted, Color shall have no further liability or obligation to Client or the Eligible Individual or the ordering HCP in relation to such Sample, and Color shall retain or destroy Samples in compliance with Applicable Laws. 

 

3.4  Test Fees; Payer Fees  

(a) Test Fees. Tests shall be drawn down upon applicable pre-paid fees until depleted. Pre-paid Test fees must be paid prior to Color shipping additional Collection Kits.  Other tests shall be invoiced in arrears and shall be paid by the Client within thirty (30) days from the date of the invoice. 

(b) Payer Fees. The Fees charged by Color are separate from any fees charged by Client to Payers. Color shall have no responsibility for collecting, or assisting in the collection of, payment from any Payers. Client’s obligations to pay Color hereunder are not contingent upon Client receiving payment for any Tests from or on behalf of any Payers, and Client is responsible for paying Color as provided for herein without regard to if or when Client receives payment from  Payers. As between the parties, Client is solely responsible for ensuring its compliance with all applicable insurance billing regulations. Further, Client agrees that it shall not, directly or indirectly, seek insurance reimbursement, in whole or in part, for any Testing that is requested/ordered through the OHS-POR Services. 

 

3.5.  Test Results and Reporting 

(a) Test Benefits and Limitations.  Color and Client acknowledge and agree that: (i) the intended use of the Test is to help a treating HCP guide care for an Eligible Individual; (ii) a positive Test result indicates it is very likely that the subject has COVID-19 and a negative Test result indicates that the virus that causes COVID-19 was not found in the Test Sample; (iii) Test results are not 100% accurate, so there is a small chance that the Test will return a false negative or false positive result; (iv) a definitive Test result may not be received because of early infection or inadequate sampling; and (v) additional warnings, limitations and advisories regarding the Test are available at: www.color.com/covid19-details and www.color.com/covid19-tos.      

(b) Reporting. The parties acknowledge and agree that COVID-19 is a reportable disease and that Color shall promptly report or shall direct its subcontractor(s) to promptly report test results to the applicable federal, state, county, and local public health reporting agencies as required by Applicable Law. 

 

3.6. Responsibilities and Compliance      

(a) Testing and Eligible Individuals. Client shall solely determine eligibility and frequency of Testing within its population, and Client shall cooperate with Color enable Color to securely and reliably identify Eligible Individuals. Color disclaims any responsibility or liability for Eligible Individual eligibility criteria or Client’s use of Test results. Client shall comply with all Applicable Laws in connection with eligibility criteria, availability of Testing Services, receipt and use of Test results, and handling and transmission of Eligible Individual information to Color as provided for hereunder, including, Applicable Laws relating to patient privacy, the transmission of personally identifiable information, and non-discrimination in employment, insurance, and other benefits. 

(c) PHI. The parties agree that clinical records and results of Eligible Individuals related to the ordering of laboratory tests and/or test reports shall be regarded as protected health information. Both parties shall comply with all Applicable Laws regarding the use and disposition of such information. 

 

3.7 Third Party Test Kits

(a) Third Party Tests. All Third-Party Test Kit Orders through Color are subject to the manufacturer availability. Color does not manufacture Third Party Test Kits and makes no warranty or representation regarding their accuracy, effectiveness, expiration, or defects. Color does not provide any refunds for Third Party Test Kit orders for any reason.

(b) Third Party Test Materials and Instructions. Client shall review, adhere to, and distribute to test recipients  all test materials and instructions provided with the Tests (including disclosures of test type and manufacturer, test performance, result types, test reliability and limitations, potential benefits, and potential risks of harm and discomfort).  Client is responsible for managing collection protocols and standards.

(c) Reporting. Client is responsible for: (i) ensuring results are accurately reported using the Platform and advising Eligible Individuals to do the same; and (ii) managing collection protocols and standards when utilizing a testing administrator. 

  1. TERMS AND CONDITIONS: PHYSICIAN LAB TEST ORDERING SERVICES 

(a) OHS Services. If Client elects Physician ordering services, Color shall contract with an HCP service on Client’s behalf, which service shall be duly licensed to act as Client’s physician of record to request Color Testing for, and reporting of results directly to, Eligible Individuals for occupational health and safety purposes (“OHS-POR Services”).  In such cases, Color has been authorized and appointed by the OHS-POR Service to act as its billing agent for such OHS-POR Services, and to bill, receive, and transmit such payment from Client to such healthcare provider service as a direct pass-through, provided that the OHS-POR Service provider shall not be deemed a subcontractor of Color under this Agreement. Client agrees that it shall not, directly or indirectly, seek insurance reimbursement, in whole or in part, for any Testing that is requested/ordered through the OHS-POR Services.

(b) OHS Billing. For any OHS-POR subcontracted Services, Color shall act as the billing agent for such Services, and Color shall charge and invoice the fees described in the Order Form. Color shall issue an invoice upfront and following the end of each calendar month during the Term and accept payment from Client as a pass through for subcontracted services.