HomeMy WebLinkAboutAGMT - DXTerity (COVID-19 Testing)DocuSign Envelope ID: 25DCOB11-7EDA-4EM-94CF-E839D26FA6171
DxTerity
DxTerity Employer Testing Agreement
Between
DxTerity, Inc. and The City of Seal Beach
THIS AGREEMENT is entered effective as of January 12, 2021 (the "Effective Date"), between DxTerity Diagnostics, Inc.,
with offices located at 19500 South Rancho Way Suite 116, Rancho Dominquez, California, 90220 ("DxTerity") and The
City of Seal Beach with offices located at 211 Eighth Street, Seal Beach, CA 90740 ("Company"). DxTerity and Company
shall be referred to hereafter individually as a "Party' and collectively as the "Parties" to this Agreement.
Company wishes to engage DxTerity as a provider for the SafeWorkDx Employer Testing Services ("Services") as defined
in Exhibits A and B, upon the terms and conditions set forth in this Agreement and DxTerity wishes to provide to
Company's employees and individuals the Services upon those terms and conditions described below.
The Company understands that the Services under this Agreement are offered in accordance with Emergency Use
Authorizations from the FDA for COVID-19 Testing and Clinical Laboratory guidelines as required. The Services are not
reimbursable by any federal health care program or commercial insurance companies. The Company is responsible for
all costs associated with the Services.
Important limitations of the COVID-19 Employer Testing Service:
I. All employees using the Services must sign a voluntary informed consent form prior to the collection of samples
for shipment to DxTerity. It is the Company's responsibility to obtain the consent.
II. The Company Understands the instructions provided to company representatives must be followed both by the
individual and the responsible representatives to conduct this service.
III. Further the Company understands:
a. As with all tests, there are risks of false positives.
b. As with all tests, there is a risk of false negatives. There is also a risk that some infected individuals may
have some level of COVID-19 infection below the sensitivity of the testing method.
c. There is an on-going risk of COVID-19 infection, so repeat testing of employees on a regular basis
should be considered as appropriate.
d. This Service tests only for the presence of the virus that causes COVID-19 (SARS-CoV-2).
e. Company should guide employees on CDC guidelines instructing employees displaying flu-like, or
COVID-like symptoms to be sent home, and to contact their medical provider and self -isolate.
In consideration of the mutual covenants hereinafter set forth, the parties, intending to be legally bound, agree as
follows:
1. Term
This Agreement shall begin on the Effective Date and continue for a period of six -months or as specified in the
quotation (the "Initial Term") and automatically renewed thereafter for a six-month term within 15 days of the expiry
of the then active term (collectively, the "Term").
2. Testing Services; DxTerity Certification and Standard of Work
(a) Services: Upon the request of Company, DxTerity shall provide Company with COVID-19 Employer
Testing Services in accordance with service ordering and delivery instructions. DxTerity represents and warrants to
Company that it will perform all Services under this Agreement in a professional and timely manner consistent with
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
DxTerity
applicable laws as they relate to testing methods and CLIA requirements. For clarity, for purposes of CLIA regulations,
the Company's Administrator is the authorized person to determine which employees and individuals shall be tested.
(b) Turn Around Time/Non-Reportable Rate: DxTerity shall use its best efforts, but not less than
commercially reasonable efforts, to ensure that its turnaround time for electronic delivery of COVID-19 testing results
to the designated Company Administrator is within 48 hours from the time of specimen receipt at DxTerity. Valid
testing results include a negative, positive or indeterminate result. Some percentage of samples fail quality control and
have a non -reportable result. DxTerity shall retest at no charge for samples which fail due to DxTerity procedures.
Samples which fail due to failure of the individual collecting the specimen to follow instructions shall be the
responsibility of the Company.
(c) The Company Administrator will assign a Site Representative to serve as the point of contact and the
Site Representative will be required to follow prescribed instructions for shipping, safe handling of biospecimens and
Protected Health Information (PHI). For shipment of samples from home each individual shall be responsible for
completing the specimen collection in accordance with the instructions for use which includes the ordering, registering,
and shipment of a self -collected sample.
3. Certifications
All testing performed by DxTerity shall be in accordance with applicable state and federal requirements. DxTerity shall
maintain, and hereby certifies its employees are in possession of, all appropriate training, licenses, permits,
accreditation and certifications required under applicable law, rule or regulation for DxTerity to perform the Services
("Required Approvals"). If for any reason DxTerity loses or is denied any Required Approval to perform one or more
tests pursuant to this Agreement, DxTerity shall immediately notify Company at the address provided above and
Company shall discontinue referral of any such services, in the state, or states, affected until such time as DxTerity can
demonstrate it has the Required Approval.
4. Pricing, Invoicing, Purchase Orders
"Pricing for Services provided by DxTerity to Company is via a DxTerity Quotation for Services. For Exhibit A Testing
Services (Site Based Collection) an invoice shall be provided via email to the Accounts Payable personnel. Payment
terms for the Site Based service are payable in advance for the coming month of testing service provided or unless as
provided in the DxTerity Quotation for Services. The obligations to deliver testing for the shipped Covid-19 Saliva
Collection kits expires three months from the date of shipment. For Exhibit B Testing for At Home Service the Company
shall be invoiced for all kits shipped from a valid order placed by the Site Representative and ordered by the individual
being tested. The obligation to deliver testing for the shipped Covid-19 Saliva Collection kits expires 30 days from the
shipment of the kit. DxTerity will not be entitled to receive payment for Services that produce invalid or inconclusive
results, except where the cause of such invalid result is due to the negligence of the Company or deliberate alteration
of the sample. COVID-19 saliva collection kits cannot be returned or refunded once shipped to the site or home of an
individual. Company shall issue a valid purchase order (s) to DxTerity before an order for Covid-19 Saliva Collection kits
can be processed/shipped and delivered under Exhibit A or B."
S. Representations and Warranty
(a) DxTerity represents that all Personal Health Information (PHI) is encrypted and protected within
DxTerity's SafeWorkDx Platform in compliance with HIPAA regulations. DxTerity will use this PHI solely for the Services
provided for herein and reported as mandated by public health agencies.
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(b) Warranty: DxTerity warrants the Services will be performed by CLIA -licensed and CAP -accredited
personnel and in accordance with established protocols for COVID-19 Testing under EUA.
(c) Warranty; Limitation of Damages. EXCEPT AS OTHERWISE SET FORTH IN THE AGREEMENT, DXTERITY
MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE SERVICES AND ALL OTHER WARRANTIES,
EXPRESS OR IMPLIED, ARE HEREBY DISCLAIMED. DXTERITY DISCLAIMS ANY LIABILITY ARISING FROM ANY DECISION OR
DETERMINATION BY COMPANY OR BY A THIRD PARTY CONCERNING WHETHER ANY EMPLOYEE OR CONTRACTOR'S
PRESENCE IN THE WORKPLACE IS SAFE IF SUCH DECISION IS BASED, IN WHOLE OR IN PART, ON THE RESULTS OF THE
SERVICES PROVIDED UNDER THE TERMS OF THIS AGREEMENT. IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE
OTHER PARTY FOR ANY LOSS OF PROFITS, LOSS OF USE, BUSINESS INTERRUPTION, COST OF COVER, OR INDIRECT,
SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND IN CONNECTION WITH OR ARISING OUT OF THE
PERFORMANCE OF THIS AGREEMENT, WHETHER ALLEGED AS A BREACH OF CONTRACT OR TORTIOUS CONDUCT,
INCLUDING NEGLIGENCE.
6. Methods Modified or Added During the Contract Period
Due to the evolving nature of the COVID-19 crisis and available test solutions, DxTerity may provide additional service
options, collection devices or reporting, or may modify the existing Service offering. DxTerity shall notify Company of
the change and provide training to Company as necessary to provide these Services.
7. Promotional Material
DxTerity understands and agrees that it shall not reference the Company by name, logo, or in any other capacity as a
user of the service or otherwise in DxTerity's client letters, marketing information and other promotional materials
without advance written consent from the Company.
8. Confidential Information and Privacy Protection
(a) Confidential Information: DxTerity acknowledges that it may gain access to Company's confidential
business information in the course of performing DxTerity's obligations under this Agreement. Except as required by
law or legal process, DxTerity agrees that it will hold in confidence, safeguard, and not use (except as required by those
employees, officers, directors, or consultants, acting pursuant to this Agreement or as required by law or legal process)
or disclose, disseminate or make available to third parties, patient information (including but not limited to, social
security numbers, addresses, insurance information, results, and diagnosis information), and any other Company
confidential information ("Confidential Information"). DxTerity agrees to treat such Company Confidential Information
with the same degree of care that it treats its own proprietary information, but with no less than a reasonable degree
of care.
(b) Exceptions to Confidential Information: Notwithstanding subsection (a) above, information shall not be
deemed Confidential Information if it (i) is or becomes generally known to the public through no unlawful act of
DxTerity; (ii) was known to DxTerity at the time of disclosure; (iii) is disclosed with the prior written approval of
Company; (iv) was independently developed by DxTerity without any use of Company's Confidential Information; (v)
becomes known to DxTerity from a source other than Company without breach of this Agreement and otherwise not in
violation of Company's rights; or (vi) is required to be disclosed in accordance with law or court order.
(c) Return of Confidential Information: DxTerity shall promptly return or destroy all Company Confidential
Information it holds in written form and all copies of it, in any format, upon Company's written demand or the
expiration or termination of this Agreement, except for Confidential Information that may be incorporated into any
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DxTerity
information that DxTerity is required to maintain by law to verify the work that it performed, which may be retained by
DxTerity subject to the restrictions contained in this Section 11.
(d) Confidential Health Information. DxTerity acknowledges that, in the performance of the Services under
this Agreement, DxTerity may gain access to certain sensitive or private information related to the health or well-being
of an individual or individuals ("Confidential Health Information"), which information is stored by or accessible to
Company. DxTerity agrees to: (i) use or disclose the Confidential Health Information only as is required to perform
services pursuant to this Agreement; (ii) safeguard such information to the same extent as it does its own Confidential
Health Information and proprietary information, but with no less than a reasonable degree of care; (iii) limit the making
of any copies, extracts or reproductions of Confidential Health Information to those occasions which are necessary to
carry out DxTerity's obligations under this Agreement and safeguard the copies, extracts or reproductions made of such
information; (iv) not use such information after termination of this Agreement for any reason unless otherwise agreed;
and (v) access only the Confidential Health information necessary to perform the duties under this Agreement.
(e) HIPAA PHI. DxTerity will receive all Biospecimens in a de -identified, coded format that protects
patients' identity and privacy. In the event that any protected health information ("PHI') within the meaning of the
Health Insurance Portability and Accountability Act of 1996, and its amendments thereto, including 45 CFR Parts 160
and 164, as amended by the Health Information Technology for Economic and Clinical Health Act and the Final Omnibus
Rules (collectively "HIPAA") is received by DxTerity, DxTerity shall comply with all applicable requirements under HIPAA
to safeguard such PHI and prevent the use or disclosure of such PHI other than as provided for under this Agreement.
Each of the Parties will, and will cause their respective personnel to, comply with its own applicable obligations under
HIPAA and other guidelines, policies and regulations pertaining to using patient samples and PHI.
9. Indemnification, Insurance
(a) Indemnification. Subject to Section 5(c), each Party agrees to indemnify, defend and hold harmless the
other Party and its members, managers, directors, officers, employees, representatives and agents from and against
any and all claims, demands, actions, losses, expenses, damages, liabilities, costs (including, without limitation, interest,
penalties and reasonable attorney's fees) and judgments for any bodily injury, property damage or any other damage
or injury to the extent caused by the negligence or willful misconduct of the indemnifying Party or any of its employees
or agents in performing their obligations under this Agreement.
(c) Insurance: DxTerity agrees to maintain professional liability and commercial general liability insurance
to cover its Services provided hereunder in the minimum amounts of One Million Dollars ($1,000,000) per occurrence
and Two Million Dollars ($2,000,000) annual aggregate. DxTerity agrees to furnish Company upon request with a
current and valid certificate of insurance from DxTerity's insurance carrier verifying the nature and amounts of
coverage and DxTerity agrees to keep and maintain such insurance coverage in full force and effect during the term of
this Agreement.
10. Regulatory Compliance
Compliance with Law/Material Breach: Each party represents and warrants that in the performance of its obligations
under this Agreement, it will comply with all applicable laws, rules or regulations ("Applicable Laws"), including, but not
limited to, the federal Physician Self -Referral Law, 42 U.S.C. 1395nn ("Stark Law"), and the regulations promulgated
thereunder, similar state physician self -referral laws and regulations, the federal Medicare/Medicaid Anti -kickback Law
(42 USC 13202-7b) and regulations promulgated thereunder and similar state Anti -kickback laws and regulations, and
HIPAA. Failure by either party to comply with any Applicable Law as required hereby shall be considered a material
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breach of this Agreement. In the event of a determination that this Agreement is not in compliance with any Applicable
Law, then the parties shall negotiate in good faith to bring this Agreement into compliance. All amendments to this
Agreement to bring this Agreement into compliance must be mutually agreed to by both parties in writing. If such
agreement cannot be reached, either party may terminate this Agreement by written notice to the other party.
11. Legislative / Regulatory Modification
In the event any Medicare and/or Medicaid laws, rules, regulations or payment policies; or any rules or policies of any
third -party payer; or any other federal, state or local law, rule, regulation or policy; or any interpretation thereof at any
time during the term of this Agreement is modified, implemented, threatened to be implemented, or determined to
prohibit or in any way materially change the method or amount of reimbursement or payment (1) for services under
this Agreement, or (2) for services to patients of a party necessitated as a result of this Agreement, or by virtue of the
existence of this Agreement has or will materially affect the ability of DxTerity to engage in any commercial activity on
terms at least as favorable to Company as those reasonably attributable as of the date hereof (all of the foregoing
being hereinafter collectively referred to as "Changes," and individually, a "Change"), then the parties to this
Agreement shall negotiate in good faith to amend this Agreement to provide for payment of compensation hereunder
to the extent applicable.
DxTerity shall provide Company prompt notification if any If action is taken against DxTerity to revoke, suspend, or
terminate its applicable federal or state license(s) to operate a clinical laboratory, or to revoke, suspend or terminate
participation in Medicaid, Medicare or other federally funded programs.
12. Termination
Company may terminate this Agreement within 60 -days' notice subject to any payments due DxTerity for the periods
contracted testing service. DxTerity may terminate this Agreement in the event that Company materially breaches this
Agreement upon 60 days' written notice specifying the nature of the breach, if such breach has not been cured within
such 30 -day period.
13. Miscellaneous
(a) Assignment: Without the prior written consent of the other party hereto, which consent shall not be
unreasonably withheld, neither party may assign any of its rights or obligations hereunder. Notwithstanding anything to
the contrary herein contained, either party may assign its rights or obligations hereunder in the entirety to its parent or
any subsidiary or successor corporation without prior written consent; provided, however, that nothing contained
herein shall release the assigning party from its obligations hereunder. Subject to the foregoing, this Agreement inures
to the benefit of, and is binding upon, the successors and assigns of the parties hereto.
(b) Notice: Except as otherwise expressly provided in this Agreement, all notices hereunder shall be in
writing, personally delivered, sent by certified mail, return receipt requested, or by confirmed email, addressed to the
other party as follows:
If to DxTerity:
James B. Healy
CFO SVP Business Development
DxTerity Diagnostics, Inc. If to Company: As Noted in Quotation for Service
Phone: (310) 537-7857
Email: jhealy@dxterity.com
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DxTerity
Either party may change its address to which notices shall be sent by a notice that conforms to the requirements of this
subsection.
(c) Entire Agreement: This Agreement, including Exhibits, together with any duly executed Non -Disclosure
agreement between the parties, contains the entire understanding between Company and DxTerity and supersedes all
prior agreements, understandings, and arrangements between them relating to the subject matter hereof. No
amendment, change, modification or alteration of the terms and conditions hereof shall be binding unless in writing and
signed by the parties to be bound.
(d) Choice of Law: This Agreement shall be governed by and construed in accordance with the laws of
California.
(e) Waiver: The failure of either party to this Agreement to exercise or enforce any right conferred upon it
hereunder shall not be deemed to be a waiver of any such right nor operate to bar the exercise or performance thereof
at any time or times thereafter, nor shall a waiver of any right hereunder at any given time be deemed a waiver thereof
for any other time.
(f) Severability: It is the intention of the parties that the provisions of this Agreement shall be enforceable
to the fullest extent permissible under applicable laws, and that the invalidity or unenforceability of any provisions
under such laws will not render unenforceable, or impair, the remainder of the Agreement. If any provisions hereof are
deemed invalid or unenforceable, either in whole or in part, this Agreement will be deemed amended to modify, or
delete, as necessary, the offending provisions and to alter the bounds thereof in order to render it valid and
enforceable.
(g) Non -Exclusive Arrangement: DxTerity acknowledges that this is a non-exclusive arrangement and that
this Agreement places no restrictions on Company's ability to use other laboratories and that Company does not
guarantee any minimum volume of specimens to be referred to DxTerity for Testing Services under this Agreement.
(h) Relationship of the Parties: Nothing contained in this Agreement shall be construed as creating a joint
venture, partnership, or employment relationship between the parties. Neither party is an agent of the other, and
neither party has any authority whatsoever to bind the other party, by contract or otherwise.
(i) Force Majeure: Either party shall be excused from non-performance or delay in performance to the
extent that such non-performance or delay in performance arises out of causes beyond the control and without the fault
or negligence of the non-performing party. Such cases include, but are not limited to, acts of God, acts of a public enemy
or terrorism, laws or acts of any government in either its sovereign or contractual capacity, fires, floods, epidemics,
pandemics, strikes or freight embargo. Each party shall promptly notify the other of any such circumstance and its
probable duration as a result of which such party claims its inability to perform this Agreement.
(j) Section Headings: Section headings contained in this Agreement are for reference purposes only and
shall not affect, in any way, the meaning and interpretation of this Agreement.
(k) Execution in Counterparts: This Agreement may be executed simultaneously in one or more
counterparts, each of which shall be deemed an original, but all of which shall constitute the same instrument.
(L) Third Parties. Nothing in this Agreement, whether express or implied, is intended to confer any rights or
remedies under or by reason of this Agreement on any person other than the parties to it.
N.
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DxTerity
IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Agreement effective as of
the Effective Date.
COMPANY: DxTerity Diagnostics, Inc.
Docuftfwd by:
Name: James B. Healy
Title: CFO SVP Business Development
1/12/2021
COMPANY: The City of Seal Beach
By:F;cuSiyned by:
(L l"
Name: Jill Ingram
Title: City Manager
1/14/2021
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DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
DxTerity
Exhibit A
SafeWorkDx Employer Testing Service
Site Based Service
Product Description:
On Site Employer Testing for COVID-19
DxTerity Diagnostics Inc. "DxTerity" has developed COVID-19 testing that provides employers with cost-effective,
confidential access to RNA testing for their employees and contractors that may have the SARS CoV-2 virus ("SARS-CoV-2
RNA Testing"). DxTerity is a CLIA -licensed, CAP -accredited clinical laboratory. DxTerity's SARS-CoV-2 test has been CLIA -
validated and approved for FDA Emergency Use Authorization. The DxTerity Employer Testing Service uses a saliva
collector for collection by employees from their workplace of site utilizing our SafeWorkDx' Platform ("Services"). The
platform allows the Company to place batch orders for sites to conduct testing of authorized individuals. Once the
company account is established, designated representatives can conduct testing events, place orders, process shipping
and view results within the SafeWorkDxT"" Platform.
The service requires the Company representative to:
1) Complete Consent Forms and populate required information in the SafeWorkD)J' Platform.
2) Schedule collection events, places orders and conduct collection events.
3) Register manifest and specimens in the platform.
4) View reports in the platform to review results and share with individuals as needed.
The Company Administrator oversees the ordering and the administration of Company protocols regarding workplace
safety. All test results are reported back to the Company Administrator with both group and individual reports. The
Company representative provides reports to the individual Employee/Contractor.
The "Services" include:
• Supply of saliva collection kits, specimen labels and packaging materials for shipment of saliva collection kits
to DxTerity.
• Company sample collection interface and online testing portal SafeWorkDx.
• Training a Company Administrator, Site Representative and/or delegates to manage sample collection,
shipping, safe handling, and handling of PHI,
• SARS-CoV-2 RNA testing and reporting.
Attachments for instructions to perform Exhibit A:
• Quote for Services
• Example Consent Form
• Shipping of Biohazardous Materials
• Responsibilities of Site Representative
• Patient Fact Sheet
• FAQs
• Instructions for Use of Saliva Collection Device
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DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
DxTerity
Exhibit B
SafeWorkDx Employer Testing Service
From Home
Product Description:
Employer Testing for COVID-19 From Home
DxTerity Diagnostics Inc. "DxTerity" has developed COVID-19 testing that provides employers with cost-effective,
confidential access to RNA testing for their employees and contractors that may have the SARS CoV-2 virus ("SARS-CoV-2
RNA Testing"). DxTerity is a CLIA -licensed, CAP -accredited clinical laboratory. DxTerity's SARS-CoV-2 test has been CLIA -
validated and approved for FDA Emergency Use Authorization. The DxTerity Employer Testing Service uses a saliva
collector for collection by employees from home utilizing our SafeWorkDxT^^ Platform ("Services").
The platform allows the Company to place individual orders for employees or other authorized individuals to receive
testing kits at their home address. Once the order is placed by the Company the individual receives account creation and
login to the platform. In the platform the employee performs the following:
1) Employee/Contractor completes Consent Form and required Information in SafeWorkDxT"" Platform.
2) Employee/Contractor completes a screener for symptoms.
3) Employee/Contractor places order.
4) Employee/Contractor receives kit and registers order and specimen in platform and collects sample.
S) Employee/Contractor and Company representative returns to platform to review results.
The Company must designate a Company Administrator who oversees the ordering of from home kits and the
administration of Company protocols regarding workplace safety. All test results are reported back to the Company
Administrator, and the individual Employee/Contractor.
The "Services" include:
• Supply of saliva collection kits, specimen labels and packaging materials for home shipment of saliva collection
kits to DxTerity
• Individual and company online testing portal access for SafeWorkDxT"
• Training a Company Administrator, Site Representative and/or delegates to manage the process.
• SARS-CoV-2 RNA testing
Orders for the From Home COVID-19 Employer Testing Service:
Orders properly executed from the platform will be delivered to the individual Employee/Contractor within 2-3 days of
order. Return shipment as described in the DxTerity Test Kit Instructions for Use, must be delivered to FedEx before
shipment cutoff for next day delivery. DxTerity is not responsible for re -testing Employees/Contractors for non -
reportable results due to the failure of an Employee/Contractor to follow the DxTerity Test Kit Instructions for Use.
DxTerity will replace any orders/tests which are damaged in shipment or lost by shipper.
Attachments for instruction to perform Exhibit -B•
• Quote for Services
• Online Consent Form
• DxTerity Test Kit Instructions for Use
• Responsibilities of Site Representative
• Patient Fact Sheet
• Instructions for Use of Saliva Collection Device
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DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
DxTerity
Contact:
Brett Swansiger
Chief Commercial Officer
Office: (310) 537-7857
Email: bswansiger@dxterity.com
For:
Jennifer Robles
Executive Assistant to the City Manager
City of Seal Beach
211 Eighth Street, Seal Beach, CA 90740
irobles@sealbeachca.gov
Phone: (562) 431-2527 Ext. 1326
COVID-19 Project Services, Materials & Support:
DxTerity Diagnostics
19500 S Rancho Way, Suite 116
Rancho Dominguez, CA 90220
Number: CVD -1000915
Created: January 12, 2021
Expires: July 12, 2021
• Qualitative detections of nucleic acid from SARS-CoV-2 in saliva
• Site Representative training, software and supporting documentation
• Biohazard shipping return containers and packaging materials with instructions and FedEx return air bills
• Confidential COVID-19 reporting to Company Administrator via "From Work" testing program
• Confidential COVID-19 reporting to Employee and Company Administrator via "At -Home" testing program
• Results provided within 24 hours from receipt at DxTerity testing facility excluding samples requiring retest
due to sample quality or indeterminate results. Retest results reported within 48 hours.
Service Options
List Price
Discount Price
Monthly
Quantity
Total
One-time Account Set-up per Site/Business Unit
Account registration, software and training. Outbound shipment
of saliva collection devices, bar code scanner(s), Class B
packaging materials for return to DxTerity and FedEx pre -label
for shipment
$ 2,500
Ds
A�
J
1
Waved
"From Work" SARS-CoV-2 (COVID-19) Testing Forecast per client. Discounted subscription requires 6 -month commitment
First 30 days: employee weekly testing
$ 125
$ 50
1 500
$ 25,000
Month One Sub -Total
$ 25,000
Each Additional 30 days: employees 1x weekly
$ 125
$ 50
1 500
$ 25,000
"At -Home" SARS-CoV-2 (COVID-19) Single Collection Kit. Includes priority FedEx return shipping
First 30 days: Estimated Single Collection Testing Services
$ 125
n/a
$
Month One Sub -Total
—125
$
Each Additional 30 days: employees 1 x weekly --Fs
n/a
$
Page 1 of 3 CONFIDENTIAL DxTerity Diagnostics Inc. 19500 S. Rancho Way, Suite 116, Rancho Dominquez, CA 90220
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
DxTerity
Special Notes and Instructions: This non-binding quote assumes an executed agreement between The City of Seal
Beach and DxTerity for the Employer COVID-19 Testing Solution. Accounts will be shipped saliva collection and return
shipping supplies in one-month intervals or otherwise mutually agreed upon for the "From Work" testing solution.
"At -Home" testing kits will be delivered via UPS priority shipping; 1 -2 -day delivery depending on location.
Invoicing:
1. One-time account set-up fee and first month's saliva collection supplies for testing services due upon receipt.
2. Subsequent monthly supplies will be billed for the coming months testing requirements and shipment of that
month's collection materials.
Signatory
Name: Jill Ingram
Title: City Manager
Email: jingram@sealbeachca.>;ov
Phone: (562) 431-2527 Ext. 1300
Account Registration Information
1. Total number of employees:
2. Target Start Date: Jan 12, 2021
3. Designated Company Administrator (test result management)
a. Name: Brian Gray, Sergeant
b. Email: bgray@sealbeachca.gov
c. Phone: (562) 799-4100 ext.1658
Legal Notifications
Name: Gloria Harper
Title: City Clerk
Email: gharper@sealbeachca.gov
Phone: (562) 431-2527 Ext. 1305
4. Testing plan
a. Testing interval: Weekly
b. Monthly (30 day) projections: 125 per week/ 500 per month
5. At -Home testing will be ordered directly via DxTerity's portal and managed by Company/Site Administrator
The price for At -Home testing is fixed at $125 per unit and is not impacted by monthly volumes
Specimen Collection and Shipping
SafeWorkDx "From Work" saliva specimens can be collected Monday thru Friday for FedEx pick-up the same day.
Express return delivery to DxTerity by 10:00 am next business day is required. "From Work" saliva samples should not
be collected Saturday or Sunday based on Spectrum solutions established 48-hour stability from time of sample
collection to PCR testing.
SafeWorkDx "At -Home" saliva specimens should only be collected Monday thru Friday for return same day via FedEx
using any FedEx drop box location utilizing the pre -paid return shipping materials provided. "At -Home" saliva samples
should not be collected Saturday — Sunday due to some limitations within FedEx regarding single sample Saturday
delivery to DxTerity.
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Confidential DxTerity Diagnostics Inc.
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
DxTenty
All specimens must be properly prepared and packed for shipment in accordance with the packaging requirements
found in International Air Transportation (IATA) UN3733 Biological Substance Category B instruction 650 (Dangerous
Goods Regulations) and Department of Transportation (DOT) regulations.
City of Seal Beach
Accepted Quote:—Dm°ft°°dby:
,�i(L ( a
By: =r az�aze�ooaassf...
Date:
Jill Ingram
City Manager
1/14/2021
Page 3 of 3 Confidential DxTerity Diagnostics Inc.
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
DxTerity SARS-CoV-2 RT -PCR CE Test
DxTerityDisease%Coronavirus
2019
Fact Sheet for Patients (COVID-19)
You are being given this Fact Sheet because your
sample(s) was tested for the Coronavirus Disease 2019
(COVID-19) using the DxTerity SARS CoV-2 RT -PCR CE Test.
This Fact Sheet contains information to help you
understand the risks and benefits of using this test for the
diagnosis of COVID-19. After reading this Fact Sheet, if you
have questions or would like to discuss the information
provided, please talk to your healthcare provider.
For the most up to date information on COVID-19 please
visit the CDC Coronavirus Disease 2019 (COVID-19)
webpage: www.cdc.gov/COVID19
What is COVID-19?
COVID-19 is caused by the SARS-CoV-2 virus which is a
new virus in humans causing a contagious respiratory
illness. COVID-19 can present with a mild to severe illness,
although some people infected with COVID-19 may have
no symptoms at all. Older adults and people of any age
who have underlying medical conditions have a higher
risk of severe illness from COVID-19. Serious outcomes of
COVID-19 include hospitalization and death. The SARS-
CoV-2 virus can be spread to others not just while one is
sick, but even before a person shows signs or symptoms
of being sick (e.g., fever, coughing, difficulty breathing,
etc.). A full list of symptoms of COVID-19 can be found at
the following link: www.cdc.gov/coronavirus/2019-ncov/
symptoms-testing/symptoms
What is the DxTerity SARS CoV-2 RT -PCR CE Test?
The test is designed to detect the virus that causes
COVID-19 in saliva specimens.
Why was my sample tested?
You were tested because your healthcare provider believes
you may have been exposed to the virus that causes
Where can I go for updates and more information?
COVID-19 based on your signs and symptoms (e.g., fever,
cough, difficulty breathing), and/or because:
• You live in or have recently traveled to a place where
transmission of COVID-19 is known to occur, and/or
• You have been in close contact with an individual
suspected of or confirmed to have COVID-19.
• You and your healthcare provider believe there is
another reason to investigate your COVID-19
infection status.
Testing of the samples will help find out if you may
have COVID-19.
What are the known and potential risks and benefits
of the test?
Potential risks include:
• Possible discomfort or other complications that
can happen during sample collection.
• Possible incorrect test result (see below for
more information).
Potential benefits include:
• The results, along with other information, can help your
healthcare provider make informed recommendations
about your care.
• The results of this test may help limit the spread
of COVID-19 to your family and those you come in
contact with.
What does it mean if I have a positive test result?
If you have a positive test result, it is very likely that you
have COVID-19. Therefore, it is also likely that you may be
placed in isolation to avoid spreading the virus to others.
You should follow CDC guidance to reduce the potential
transmission of disease.
The most up-to-date information on COVID-19 is available at the CDC General webpage: www.cdc.gov/COVID19.
In addition, please also contact your healthcare provider with any questions/concerns.
DxTel 14.y www.dxterity.com
LAB -0297 02
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
DxTerity SARS-CoV-2 RT -PCR CE Test
There is a smaller possibility that this test can give a
positive result that is wrong (a false positive result)
particularly when used in a population without many
cases of COVID-19 infection. Your healthcare provider
will work with you to determine how best to care for you
based on the test results along with medical history,
and your symptoms.
What does it mean If I have a negative test result?
A negative test result means that the virus that causes
COVID-19 was not found in your sample.
However, it is possible for this test to give a negative
result that is incorrect (false negative) in some people
with COVID-19. You might test negative if the sample was
collected early during your infection. You could also be
exposed to COVID-19 after your sample was collected and
then have become infected. In particular, people infected
with COVID-19 but who have no symptoms may not shed
enough virus to trigger a positive test.
This means that you could possibly still have COVID-19
even though the test result is negative. If your test is
negative, your healthcare provider will consider the test
result together with all other aspects of your medical history
(such as symptoms, possible exposures, and geographical
location of places you have recently traveled) in deciding
how to care for you. If you have no symptoms but have
been tested because your doctor thought you may have
been exposed to COVID-19, you should continue to
monitor your health and let your healthcare provider know
if you develop any symptoms of COVID-19. If you develop
symptoms you may need another test to determine if you
have contracted the virus causing COVID-19.
It is important that you work with your healthcare provider
to help you understand the next steps you should take.
If you develop symptoms or your symptoms
get worse you should seek medical care.
If you have the following symptoms you should
seek Immediate medical care at the closest
emergency room:
• Trouble breathing
• Persistent pain or pressure in the chest
• New confusion
• inability to wake up or stay awake
• Bluish lips or face
Is this test FDA -approved or cleared?
No. This test is not yet approved or cleared by the United
States FDA. When there are no FDA -approved or cleared
tests available, and other criteria are met, FDA can make
tests available under an emergency access mechanism
called an Emergency Use Authorization (EUA). The EUA
for this test is supported by the Secretary of Health and
Human Service's (HHS's) declaration that circumstances
exist to justify the emergency use of in vitro diagnostics
for the detection and/or diagnosis of the virus that causes
COVID-19. This EUA will remain in effect (meaning this test
can be used) for the duration of the COVID-19 declaration
justifying emergency of IVDs, unless it is terminated or
revoked by FDA (after which the test may no longer be
used).
What are the approved alternatives?
There are no approved available alternative tests.
FDA has issued EUAs for other tests that can be found at:
www.fda.gov/emerqency-preparedness-and-response/
mcm-legal-regulatory-and-pol icy-framework/emergeng-
use-authorization
Where can I go for updates and more information?
The most up-to-date information on COVID-19 is available at the CDC General webpage: www.cdc.gov/COVID19.
In addition, please also contact your healthcare provider with any questions/concerns.
DxTe~ty www.dxterity.com
LAB -0297 02
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
Site Representative Responsibilities
DxTerity
Site Representative
Responsibilities
The Company's Site Representative performs important responsibilities in the
conduct of employer COVID-19 Testing processes. The Site Representative
is the authorized person that determines which employees should be tested
based on CDC guidelines.
The Site Representative shall be deemed qualified
by the Company to serve as a primary point of contact
and will be required to complete prescribed safety
and privacy training prior to assuming this role.
The Key Responsibilities of this role include:
1. Being trained and certified for Universal
Precautions and Personal Protective
Equipment (PPE) use.
2. Organizing company safety measures to
conduct the collection of the samples.
3. Determination of testing requirement for
site employees.
4. Ensuring safe collection and handling
of specimens.
5. Being trained to use and maintain the DxTerity
COVID-19 Samples and Reporting Platform.
6. Understanding of HIPAA and associated security
necessary to protect employee private health
information and accurate recording of samples
within the platform.
DxTe~ty www.dxterity.com
Determination of Testing
The Site Representative will perform the critical role
on behalf of the company to ascertain Direct Threat
assessment per the EEOC Pandemic preparedness
In the workplace and the American with Disability
Act as modified on March 21, 2020 or subsequent
modifications for COVID-19 and determine the
requirements for testing. Criteria for testing to follow
the CDC guidance for Evaluating and Testing
Persons for Coronavirus Disease 2019 (COVID-19),
which can be found at https://www.cdc.gov/
coronavirus/2019-nCoV/hcp/clinical-criteria.html.
Safe Handling and Shipping of Specimens
Samples will be collected in a suitable setting
under the supervision of a trained representative.
Employee will be provided Instructions for Use
(IFU) for the collection of saliva samples and the
Site Representative will be trained to supervise
employee collections and answer any questions on
the use of the device. The Site Representative will
follow the DxTerity "Instructions for Preparing
Samples for Shipping:' Generally, potentially
pathogenic specimens and shipments containing
these specimens shall be handled while wearing
PPE (lab coat, gloves, mask, safety goggles) and
following Universal Safety Precautions.
LAB -0300 01
DocuSign Envelope ID: 25DC01311-7EDA4E7D-94CF-E839D26FA6F1
Site Representative Responsibilities
Shipment procedures for all specimens shall be
according to the provisions governing the transport
of biological substances (Category B UN3373),
IATA requirements, and diagnostic specimens. The
specimen tubes are required to be sealed, leakproof,
and organized in a box/rack. The tubes should not be
loose and shall be packed securely to avoid breaking
and leakage. The box/rack with tubes shall be placed
in a secondary leakproof packaging such as a box/
bag containing absorbent material in case of leakage.
This in turn should be placed in a DxTerity prescribed
shipping container or DOT equivalent. The shipment
shall include a de -identified samples manifest with
subject and container identifiers. All samples shall be
shipped for next -day arrival. Courier service must be
qualified to handle the UN3372 requirements.
Universal Precautions and Personal Protective
Equipment (PPE)
Site Representative is required to be trained in
Universal Precautions for Infectious Diseases.
The Company may choose to use a service provider
who is certified in these measures or undergo
training for them.
Universal Precautions are a method of infection
control recommendations issued by CDC in which
all human body fluids are treated as if known to be
potentially infectious. These precautions include
measures such as prohibiting eating, drinking, using
cell phones or other personal electronic devices,
smoking, applying cosmetics or lip balm, or handling
contact lenses in a work area where there is a
reasonable likelihood of occupational exposure
to infectious substances and pathogens. Key to
Universal Precautions is the requirement for the use
of Personal Protective Equipment (PPE) such as a
laboratory coat (resistant to liquid penetration), gloves,
and safety glasses. When transporting and handling
specimens containing or suspected of containing
pathogens on the ATPS -L list (air transmittable
pathogens, such as SARS-CoV-2) a face shield is
required in addition to a face mask, goggles, gloves
and lab coat.
DxTerity www.dxterity.com
Laboratory coats must be removed when exiting the
designated collection area to go to a lunchroom,
bathroom, offices, conference rooms, or any other
area not designated to handle samples. Remove PPE
before leaving the work area and place gloves and
lab coats in the appropriate container for disposal.
After removal of gloves or other personal protective
equipment, hands must be washed with soap
and water immediately (or as soon as feasible), or
decontaminated with an approved hand sanitizer and
then washed with soap and water as soon as possible.
Decontamination
Work surfaces should either be covered with
disposable materials or be decontaminated with 1:10
bleach dilution in water, 10% stabilized bleach, or any
disinfectant spray that has been approved for use
to inactivate viruses and bacteria. Decontamination
steps include a wipe down of exposed area after each
use with bleach, followed by 70% alcohol (ethanol
or isopropanol) wipe down and dry. Saliva specimen
spills should be treated by wiping down the spill with
absorbent paper towels moistened with 1:10 bleach,
then 70% alcohol.
COVID-19 Platform Sample Input and Reporting
DxTerity will authorize the Site Representative to
perform employee registration and sample collection
recording for shipping site collection devices. The
Site Representative will be provided the COVID-19
Samples and Reporting Platform login for processing
and User Manual for training on the system functions.
The system provides security measures such as
encryption and de -identification of employee identity
so that the Site Representative is the only person
authorized to view the specific employee results.
This Site Representative will be responsible for
coordination with Company Human Resources and
any privacy related issues. DxTerity lab personnel will
not have access to any employee identity information.
LAB -0300 01
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
Instructions for Preparing Samples for Ambient Shipping
DxTenty
Instructions for Preparing
Samples for Ambient Shipping
This Function is Critical and Required
This document is written to provide the site coordinator, or other
Employer designee, instructions on how to properly prepare and pack
collected samples for shipment in accordance with the packaging
requirements found in International Air Transportation (IATA) UN3733
Biological Substance Category B instruction 650 (Dangerous Goods
Regulations) and Department of Transportation (DOT).
It is important to schedule pickup of your properly
packaged sample with FedEx on the same day you
collect it before the last pickup for Express overnight
shipping. Do not collect or schedule pickups on
Saturday or Sunday. Do not bring to a FedEx office.
Failure to do so may result in a failure to process
your sample.
The designee should read through and be trained
to these instructions prior to preparing samples for
shipment. DxTerity has made every effort to provide
the required key shipping materials. It is highly
recommended the Employer only uses shipping kits
provided by DxTerity or purchase shipping kits and
packaging specifically designed for the shipment
of diagnostic and clinical specimens in compliance
with IATA UN3733 Biological Substance Category B
instruction 650 (Dangerous Goods Regulations).
The Shipper bears the ultimate legal responsibility and liability for properly performing these tasks in accordance with the Department of Transportation
(DOT) and International Air Transport Association (IATA) Regulations. It is the shipper's responsibility to receive training on the proper packaging,
documentation and shipping requirements in order to comply with the International Air Transport Association (IATA) and the Federal Department of
Transportation (DOT) regulations.
DxTeritywww.dxterity.com
LAB -0302 02
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
Instructions for Preparing Samples for Ambient Shipping
Standard Shipping Kits
These are the standard shipping kits the Employer may receive from DxTerity.
These kits may vary as each Employer's requirements may be unique.
Specimen Specimen Transport Bag De4dentified
Rack with Absorbent Material Sample Manifest
.v
Outer Packing
Transport Box Materials
FedEx List of Packing Tape
Labels Label Contents not Included
Card
Kit A — Rack Style
Box Size 12" x 10" x 6"
Kit is best to ship 20 — 80 samples per box
• 1 - 2 Specimen Racks
• 1 - 2 Specimen Transport Bags with Absorbent Material
• Labels: (1) UN3373, (2) Arrow Labels, (1) List of Contents card
• Packing Materials
• (1) FedEx Express Airway Bill Label for overnight
shipment (may or may not be included)
• (1) Outer Transport Box
• Packing Tape to seal box (not included)
2 DxTel 1 `y www.dxterity.com
Note: For ease of handling, a single
box should never contain more than
80 samples unless first discussed
and approved by DxTerity prior to
preparing shipment. IATA and DOT
regulations limit to 4L of Specimen
per shipping box.
r,
(
Absorbent Specimen De -Identified
Specimen Pouch Transport Bag Sample Manifest
Fed'Ex
Outer Packing FedEx UN3373
Transport Box Materials OverPak
CD
FedEx List of Packing Tape
Labels Label Contents not included
Card
Kit B — Absorbent Specimen Pouch Style
Box Size Varies
Kit Is best to ship 1 — 20 samples per box
1 — 20 Absorbent Specimen Pouches
• 1-2 Specimen Transport Bags
• Labels: (1) UN3373, (2) Arrow Labels, (1) kit Contents card
• Packing Materials
(1) FedEx Express Airway Bill Label for overnight
shipment (may or may not be included)
• (1) Outer Transport Box
• (1) FedEx UN3373 OverPack
• Packing Tape to seal box (not included)
LAB -0302 02
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
Instructions for Preparing Samples for Ambient Shipping
Packaging Instructions
These Instructions are designed to assist In the packaging of samples in
Note: Always wear appropriate
DxTerity provided ambient biological substance category B shipping system.
Personal Protective Equipment (PPE)
Completed Samples will either be placed In cardboard disposable racks or
and follow washing and sanitizing
absorbent tube pouches. The below Instructions will provide a guide for both.
guidelines as outlined by the
Centers for Disease Control and
Prevention (CDC).
1 sample rack in Specimen Bag
with Absorbent Material.
Tubes in Absorbent Specimen
Pouch(s) placed In Specimen
Bag (Pouches act as absorbent
material).
2.2
3 DxTel • Y www.dxterity.com
Step 1
Place Completed Samples in provided Specimen Rack or
Absorbent Specimen Pouches
During employee collection, sample collection tubes should have been
placed in disposable racks or in absorbent tube pouch. If this has not been
done, then do so. Ensure all employee linkage activities and consent forms
have been completed before shipping.
Note: The buffer in the collection device is designed to inactivate the virus,
however a small risk of external sample collector contamination does exist.
Step 2
Place Racks in Specimen Bag containing Absorbent sheet
Important: The absorbing material must be sufficient to absorb the entire
contents of all primary receptacles. The closed saliva sample tube is
considered the primary receptacle and is 95kpa rated. The Specimen
Bag is considered secondary receptacle. Secondary receptacle must
also be leak proof, so it is important to completely seal the Specimen
Bag. If using Specimen Tube Absorbent Pouch, one tube pouch is rated
to absorb contents of one tube. Additional absorbent material is not
necessary, but acceptable to have.
2.1 If using Absorbent Specimen Pouches skip to step 2.2. Place each
completed Specimen Rack in the provided 13" x 18" Specimen Bag with
biohazard symbol containing the provided absorbent material, (2) 6"x6"
absorbent sheets or (1)12" x 12" sheets per bag. Only one rack (up to 40
tubes) is to be placed in a single Specimen Bag. Completely seal the
Specimen Bag.
2.2 Place sample tubes stored in Absorbent Specimen Pouches into
provided Specimen Bag. Completely seal the Specimen Bag. Do Not
overfill Specimen Bag as it will prevent the bag to completely seal
when closing.
LAB -0302 02
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
Instructions for Preparing Samples for Ambient Shipping
Step 3
Package Samples sealed in Specimen Transport Bags into the Outer Transport Box
Important: Secondary packaging must be in a rigid outer packaging (no envelopes). At least one side of
the outer packaging must have a minimum dimension of 100mm x 100mm (4in x 4in). You must include an
itemized list of contents between the secondary packaging (Specimen Bag) and the outer packaging. Ensure the
De -Identified Sample Manifest for all samples being shipped is included with the shipment.
3.1 Place the bagged Specimen Racks or bagged Absorbent Specimen Pouches containing samples in the
box using the provided packing material as cushioning. When using Specimen Racks, place the racks
side by side. Ensure to place racks upright in box. Orientation when using pouches does not matter.
Note: If only shipping a single rack, place the rack in the bottom middle of the box. if the kit came with an extra
empty rack, it is acceptable to use the empty rack placed side by side of the filled rack to act as packing filler.
3.2 Fill in the remaining space in the box with packing material.
3.3 Place the De -Identified Shipping Manifest into one of the boxes included in the shipment.
3.4 Properly fill out List of Contents Card and place on top of packing material. The List of Contents card
should specify the contents in the box. If not marked already, ensure to check off: Diagnostic Specimens,
Glass and/or Plastic Tubes, Tube Separator Bag(s), Secondary Container, Absorbent Pad(s), Transport
Media or Preservative. Close and seal the box.
Kit A - Specimen
Rack Style
111�-
De-Identified
Shipping Manifest
Kit B - Absorbent Specimen
Pouch Style
t
1�
4 DxTel 1 ly www.dxterity.com LAB -0302 02
DocuSign Envelope ID: 25DC01311-7EDA-4E7D-94CF-E839D26FA6F1
Instructions for Preparing Samples for Ambient Shipping
2
ii
O
raea�r
1,
FedEx UN3373
OverPak
'For Sorurday Delivery
�S4TtxtW1Y orw,
Yes
�C O'tl""" FedEx Paper
Airway Bill
O4:OOPM — 5PM
Last Pick up
Step 4
Labeling. Applies to all provided shipping kits
Important: One "UN3373 Biological Substance Category B" Label must be
on the box. There are specific requirements for this label so use the one
provided or purchase from a vendor if not supplied. You must have a "to"
and a "from" listed on the package. The FedEx Airway Bill Label will show
this when preprinted Airway Bills are provided by DxTerity. If Shipper
creates the Airway Bill, it is ultimately their responsibility to ensure it is
created and applied correctly.
If not already applied, apply the labels to outer box
4.1 Apply one (1) UN3373 label to one of the long sides of the box.
4.2 Only applicable when shipping with specimen rack style shippers:
Apply two (2) arrow sticker on the box. One each on opposing box
faces with arrows facing up.
4.3 If the outer box is too small to properly apply the FedEx Airway Bill,
insert the sealed package into a FedEx UN3373 OverPak. Seal the
OverPak and apply the airway bill to the center of the OverPak.
DO NOT cover the UN3373 marking with the airway bill
4.4 Apply the FedEx Express Airway Bill Label. If a FedEx Paper
Airbill is used check the box "Yes - Shipper's Declaration is not
required" under "6. Special Handling". `If shipping on a Friday
for Saturday delivery check the box "Saturday Delivery" under
"6. Special Handling".
Step 5
Schedule Pick Up with FedEx
\ Important: It is important to schedule pickup of your properly packaged
sample with FedEx on the same day you collect it before the last pickup for
Express overnight shipping. Do not collect or schedule pickups on Saturday
or Sunday. Do not bring to a FedEx office. Failure to do so may result in a
failure to process your sample. It is typically required to schedule pickups
2.5hrs ahead of needed pick up. Last pick up is usually between 4:00 PM
and 5:00 PM local time, but verify with your local office.
A. Visit FedEx Ship Manager' at fedex.com or Schedule a Pickup
under the Ship tab.
B. Or Call 1.800.GoFedEx 1.800.463.3339 and speak to a customer
% service representative.
5 DxTelv WWWAxterity.com
LAB -0302 02
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
DxTenty Funnel / Embudo
Solution / Soluci6n
Cap
pa
Saliva Collection Tube rb
Tube Tubo
Dev i e e Fill Line /Linea de Ilenado
English
Fill the tube with saliva to the black wavy line.
Fill the tube until your saliva (not including
bubbles) is at or just above the wavy line.
DO NOT OVERFILL.
Replace the funnel with the fluid cap.
Remove the funnel from the tube. Screw on
the enclosed cap TIGHTLY to release the viral
RNA inactivating and stabilization solution into
your saliva.
t� Firmly screw cap down to release solution
and seal tube.
You will know it works when the blue solution
from the cap is released into the tube. Firmly
tighten cap to assure the cap and tube is
completely sealed.
0
Shake the tube for at least five seconds.
5 SEC{
This will ensure your sample mixes thoroughly
1
with the stabilizing solution.
REF SDNA-1000
Cap choking hazard. Keep out of reach of children. Wash with water if liquid
solution comes in contact with eyes or skin. DO NOT INGEST LIQUID. This kit
is designed for the collection of human saliva samples. Made in USA, Patent
Pending. For research use only. Not for use in diagnostic procedures.
LABEL LEGEND -
U, Consult instructions for use E: Caut,on,consultinstructions for use
j7 Use by date (Collect saliva by) I Temperature limit
v; Catalog number md Manufacturer
cc CE Marking - Batch code
Espanol
Llene el tubo con saliva hasta la linea
negra ondulada.
Llene el tubo hasta que su saliva (sin considerar
las burbujas) alcance o se encuentre justo sobre
la linea ondulada. NO LO LLENE EN EXCESO.
Reemplace el embudo por la tapa del Ifquido.
Extraiga el embudo del tubo. Enrosque
FUERTEMENTE la tapa adherida para liberar la
soluci6nque estabilizara y inacitiba el viral RNA
en su saliva.
Enrosque con firmeza la tapa hacia abajo para
liberar la soluclon y sellar el tubo.
Sabra si funciona cuando la solution azul de la
capa se libere en el tubo. Enrosque con firmeza la
tapa para asegurarse de que la tapa y el tubo fasten
totalmente sellados.
Agite el tubo al menos cinco segundos.
Esto garantizara que su mustra se mezcle bien
con la solucidn estabilizante.
Riesgo de asfizia con la tape. Mantenga fuera del alcance de los ni6as. Lavese con
agua si la solucibn liquida entra en contacto con los ojos o la pieL NO INGIERA EL
LIQUIDO. Este kit este disenado para to recoleccian de muestras de saliva humana.
Hecho en EE. UU. Patente pendiente. Solo para use con fines investigativos.
No debe utitizarse en procedimientos de diagn6stico.
LEYENDA DE LA EnQUEFA.
LIJ Consulte las instructions de use Ln Precaucion: consulte las inst rucciones ee use
8 Fecha de vencimiento ljunte la saliva antes del i Limite de temperatura
Numero de catalogo ri Fabneante
cc DistintivoCE w: C6digodel tote
DocuSign Envelope ID: 25DCOBI1-7EDA-4E7D-94CF-E839D26FA6F1
EXAMPLE EMPLOYEE CONSENT FOR EMPLOYER TESTING
Your Company, COMPANY NAME, is offering eligible U.S. employees and contingent workers, as determined by a
healthcare provider, coronavirus disease 2019 (COVID-19) diagnostic testing in an effort to: (1) allow individuals to
know their current COVID-19 status and to follow the appropriate public health authority guidance(s) depending on
the results and their health status; and (2) help them make decisions to protect the health and safety of their
employees and contingent workers including, as applicable, allowing Your Company to determine a tested
individual's eligibility to enter facilities or the facilities of customers and to allow Your Company to conduct analyses
to determine whether additional precautions need to be taken to protect you or other individuals in the workplace.
In order for you to make an informed decision whether or not to voluntarily be tested for COVID-19 with a test
provided by your Company, you should understand the risks and benefits of the testing process and how your test
results will be shared.
PRIVACY NOTICE
When you participate in COVID-19 testing, required personal information collected include your test results and
demographic information such as name, home address, date of birth, gender, race, ethnicity, email, and phone (See
Attachment A). This information will be provided to your Company, the testing laboratory, healthcare provider(s)
and to public health agencies as required by law. The use of this information for the purposes of detecting COVID-19
only.
I confirm that the Company is offering this test to: (1) provide me with information on my current COVID-19 status
and to help me and the Company to follow the appropriate public health authority guidance(s) consistent with the
test results; and (2) allow the Company to make decisions to protect the health and safety of its employees and
contingent workers, including, as applicable, allowing them to determine my eligibility to enter facilities, the
facilities of its customersand to conduct analyses to determine whether additional precautions need to be taken to
protect me or others in the workplace. Further that:
1. My biological saliva specimens will be collected and analyzed for COVID-19 only in aprocess facilitated
by DxTerity Diagnostics Inc."DxTerity", a CLIA certified high complex laboratory, authorized under FDA
Emergency Use Authorization No. 20210 to perform COVID-19 Testing.
2. 1 confirm that I have read and understand the testing process as described in the FAQs, Fact Sheet for
Patients and privacy disclosures provided on the DxTerity Website (https:Hdxterity.com/sars-cov-2-test-
covid-19) and that both I and the Company will receive the COVID-19 test results.
3. This consent will cover recurring testing, at an interval specified by Company, and any repeat testing, if
required.
4. That the Company will use and disclose my test results only as set forth in this consent and will take
steps to protect the confidentiality of my test results and my test results will be reported to the United
States Health and Human Services and state orlocal public health agencies, as required by law.
5. My decision to participate in the COVID-19 diagnostic testing is entirely voluntary, and I understand that
there will be no adverse consequences to my employment or assignment or contract with the Company
should I participate orrefuse to participate in the COVID-19 testing.
6. 1 understand that I may revoke this authorization at any time by notifying Company authorized
representative(s) in writing. However, I understand that such notice will not affect disclosures made before
the revocation.
7. 1 understand that the results from this test may affect my ability to work. If my test result is positive, I will
be required to undergo a second confirmatory test after receiving a prescription for such test from my
treating health care provider or other equivalent source before I will be permitted to return to work.
8. 1 understand that I am not entering into a doctor -patient relationship with Company. DxTerity, or the
ordering healthcare provider, and that any questions or required follow up shall be my responsibility to
arrange with my own physician
BY SIGNING BELOW, I PROVIDE MY CONSENT TO COMPANY TO ORDER TESTING FROM DXTERITY AND PROVIDE
RESULTS BACK TO THE APPOINTED COMPANY REPRESENTATIVES.
Print Name
Signature
Date
DocuSign Envelope ID: 25DCOB11-7EDA-4E7D-94CF-E839D26FA6F1
EXAMPLE EMPLOYEE CONSENT FOR EMPLOYER TESTING
ATTACHMENT AEMPLOYEE DEMOGRAPHICS DATA SHEET
FOR COVID-19 PUBLIC HEALTH REPORTING
This represents the required information necessary to complete input into the platform for COVID-19 Reporting.
USE OF THIS SPECIFIC FORM IS NOT REQUIRED
First Name
Middle Initial
Last Name
Date of Birth (MM/DD/YYY)
Sex
Pregnancy Status?
❑ Male ❑Other
❑Yes
❑ Female ❑ Unknown
❑No
❑Unknown
Race
Ethnicity
❑ American Indian/Alaska Native
❑ Hispanic
❑ Asian
❑ Non -Hispanic
❑ Black
❑ Unknown
❑ Hawaiian/Pacific Islander
❑ White
❑ Other
❑ Unknown
Email
Phone
Address Line 1
Address Line 2
City
State
Zip Code
Jennifer Robles
From: Brett Swansiger <bswansiger@dxterity.com>
Sent: Thursday, January 14, 2021 2:37 PM
To: Jennifer Robles
Subject: RE: Final Questions on Agreement
See below
Brett A. Swansiger
Chief Commercial Officer
DxTerit y and SVP of Managed Care
bswansiger@DxTerity.com
M: (253) 217-8988
DxTerity.com In [13 13
DxTerity's At -Home COVID-19 Testing
available at
--- amazon
From: Jennifer Robles <JRobles@sea Ibeachca.gov>
Sent: Thursday, January 14, 20213:26 PM
To: Brett Swansiger <bswansiger@dxterity.com>
Subject: Final Questions on Agreement
Hi Brett,
We are hoping to get signature on our agreement today. I wanted to confirm a couple of items.
1. We will be billed based on the number of kits we use the number of kits ordered for delivery.
a. We are not committed to having to use a certain amount during the 6 month term, No and we can
decide the number of testing we want to during that time correct? yes Example: If we want to test once
a week or once every other week or once during that 6 month period, we are able to. yes
2. Also, after the 6 month term, the contract will automatically be renewed within 15 days and if we wanted to
terminate, we would have to send a notification to you 60 days prior correct? You can notify us prior to the
automatic renewal at any time that you do not want to renew.
If at any time, the tests were to be priced differently, will we be notified? yes
4. Lastly, are we still able to drop off and pick up testing kits in case we prefer to do that? Instead of shipping? yes
Thank you,
Jenn
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
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PRODU-2 OP ID- CAT
CERTIFICATE OF LIABILITY INSURANCE
DA11/04/2020Y)
11 /04/2020
THIS CERTIFICATE IS ISSUED AS A MATTER OF INFORMATION ONLY AND CONFERS NO RIGHTS UPON THE CERTIFICATE HOLDER. THIS
CERTIFICATE DOES NOT AFFIRMATIVELY OR NEGATIVELY AMEND, EXTEND OR ALTER THE COVERAGE AFFORDED BY THE POLICIES
BELOW. THIS CERTIFICATE OF INSURANCE DOES NOT CONSTITUTE A CONTRACT BETWEEN THE ISSUING INSURER(S), AUTHORIZED
REPRESENTATIVE OR PRODUCER, AND THE CERTIFICATE HOLDER.
IMPORTANT: If the certificate holder is an ADDITIONAL INSURED, the policy(ies) must have ADDITIONAL INSURED provisions or be endorsed.
If SUBROGATION IS WAIVED, subject to the terms and conditions of the policy, certain policies may require an endorsement. A statement on
this certificate does not confer rights to the certificate holder in lieu of such endorsement(s).
PRODUCER 626-796-1313
A.J. Longo & Associates
Ca. Ins. License 80524739
CN AMEACT John P. De Spirito
PHONE 626-796-1313FAX 626-795-1313
(A/C, No, Ext): (A/c, No):
253 N. Lake Avenue
Pasadena, CA 91101
E-MAIL S:
INSURER(S) AFFORDING COVERAGE
NAIC #
John P. De Spirito
INSURER A: Kinsale Insurance Company
0100131063
10/27/2020
INSURED Production Rx, LLC
Marie Dunaway
INSURER B
INSURER C,
2633 Lincoln Blvd #933
Santa Monica, CA 90405
INSURER D:
INSURER E:
INSURER F:
COVFROrF3 RFRTIPICATF NI IURPD- ocvlclnal w uaoco.
THIS IS TO CERTIFY THAT THE POLICIES OF INSURANCE LISTED BELOW HAVE BEEN ISSUED TO THE INSURED NAMED ABOVE FOR THE POLICY PERIOD
INDICATED. NOTWITHSTANDING ANY REQUIREMENT, TERM OR CONDITION OF ANY CONTRACT OR OTHER DOCUMENT WITH RESPECT TO WHICH THIS
CERTIFICATE MAY BE ISSUED OR MAY PERTAIN, THE INSURANCE AFFORDED BY THE POLICIES DESCRIBED HEREIN IS SUBJECT TO ALL THE TERMS,
EXCLUSIONS AND CONDITIONS OF SUCH POLICIES. LIMITS SHOWN MAY HAVE BEEN REDUCED BY PAID CLAIMS.
INSR
TYPE OF INSURANCE
DDL
NSDPOLICY
UBR
NUMBER
POLICY EFF
POLICY EXPIML
LIMITS
A
X COMMERCIAL GENERAL LIABILITY
X CLAIMS -MADE [:] OCCUR
X
j
0100131063
10/27/2020
10/27/2021
EACH OCCURRENCE $ 1,000,000
DAMAGE To RENTTu encs $ 50'000
IREMMED
EXP (Any one person $ EXCLUDED
PERSONAL &ADV INJURY $ 1,000,000
GEN'L AGGREGATE LIMIT APPLIES PER
POLICY F7 EPT :] LOCf
GENERAL AGGREGATE $ 2,000,000
1
PRODUCTS-COMP/OPAGG $ 2'000'000
OTHER:
A
AUTOMOBILE
LIABILITY
EOM�BBIINdeD SINGLE LIMIT nt)$ 1,000,000
BODILY INJURY Perperson) $
ANY AUTO
OWNED SCHEDULED
AURTEO�S ONLY AUTOS
X
0100131063
10/27/20201
10/27/2021
BODILYBODILY INJURY Per accident $
X
'AUTOS ONLY X AUOTO� ONLY
Pea TY DAMAGE $
$
14IUMBRELLA
LIAB
OCCUR
EACH OCCURRENCE $
AGGREGATE $
EXCESS LIAR
CLAIMS -MADE
DED RETENTION $
$
WORKERS COMPENSATION
AND EMPLOYERS' LIABILITY Y / N
ANY PROPRIETOR/PARTNER/EXECUTIVE
�FFICERIMFMg ER EXCLUDED 7
Ylandatory
N I A
PER OTH-
'STATUTE ER
E.L. EACH ACCIDENT $
m NH)
If yes, describe under
DESCRIPTION OF OPERATIONS below
E.L. DISEASE - EA EMPLOYE $
E.L. DISEASE - POLICY LIMIT $
DESCRIPTION OF OPERATIONS / LOCATIONS / VEHICLES (ACORD 101, Additional Remarks Schedule, may be attached if more space is required)
Certificate holder is included as additional insured with respects to
General Liability and Hired Non Owned Auto.
CFRTIFICATF wii nF;R rauro . al.—
U 1968-2015 ACORD CORPORATION. All rights reserved.
The ACORD name and logo are registered marks of ACORD
SHOULD ANY OF THE ABOVE DESCRIBED POLICIES BE CANCELLED BEFORE
DxTerity Diagnostics, Inc.
THE EXPIRATION DATE THEREOF, NOTICE WILL BE DELIVERED IN
ACCORDANCE WITH THE POLICY PROVISIONS.
19500 South Rancho Way Ste 116
AUTHORIZED REPRESENTATIVE
�
Rancho Dominguez, CA 90220
U 1968-2015 ACORD CORPORATION. All rights reserved.
The ACORD name and logo are registered marks of ACORD