Eliminating Medication Misadventures · 2016-06-22 · Coriell Life Sciences Account Integration Guidelines describes the data structures and operations supported by Coriell Life

Project: CLS Lab Proposal

Client: Personalized Genetic Testing, Inc

Delivered on: May 12, 2016

Submitted by: Jeffrey Shaman

PGx Interpretation ServicesEliminating Medication Misadventures

GeneDose ~ GeneDose LIVE ~ SafeTRx

Introduction

Dear Irina,

We are excited to begin work with Personalized Genetic Testing, Inc. It is clear from our conversations

that we share the same desire to provide cutting edge healthcare services to the wide market of

patients suffering with medication management issues. I have no doubt that together we will be a

strong force for change, ushering in a new era of patient-centered, precision care.

Please find here our proposal for how we might work together. It includes information about the

services we will provide to Personalized Genetic Testing, Inc both during the integration/

implementation start up phase and beyond.

Please let me know if you have any questions or concerns.

Sincerely,

Jeffrey Shaman

Director, Business Development, Coriell Life Sciences

856-533-0484 - [email protected]

Page 1 CONFIDENTIAL

Why Us?Company Background

Coriell Life Sciences (CLS) is dedicated to assisting physicians in their mission to provide personalized

precision medical care.

Founded in 2012 by a scientific leadership and technical team from the 62 year old Coriell Institute for

Medical Research, CLS provides complete decision support tools for laboratories, hospitals, ACOs, and

healthcare professionals. Named IBM's Global Entrepreneur of the Year, Philadelphia Business

Journal's Rising Star, and Beacon Award winner for Innovative Solution of the Year - Coriell Life Sciences

has been recognized as a global leader in personalized medicine and big data analytics.

Page 2 CONFIDENTIAL

Complete Medication SolutionWhat's the big deal?

Adverse reactions to prescription medications are killing 120,000 people a year in the U.S. alone. More

than 2 million serious injuries are the direct result of the wrong drugs being taken by the wrong people.

These adverse medical events increase hospital stays by three to seven days each--increasing the cost

to the healthcare system and resulting in lost employee work days. These cost the US economy more

than $130 billion every year. Furthermore, the FDA has said that only about half of the drugs we take

are effective in treatment.

Coriell GeneDose™, GeneDose LIVE and SafeTRx are designed to address healthcare's triple aim

concerns of improving care, improving population health, and reducing medical costs per capita.

Coriell partners with laboratories like Personalized Genetic Testing, Inc to bring these tools to patients,

providers and healthcare systems.

GeneDose™

GeneDose™ leverages the scientific data and pharmacogenomic expertise of the 62 year old Coriell

Institute for Medical Research. The GeneDose™ Genetic Response Report provides physicians with

straightforward recommendations that they can understand - changes in dosages, suggested

medications by therapeutic class, and risk warnings. Gone are the days of trying to translate genotypes

into clinically useful information; no more trial and error medication management before seeing

patient improvement.

The GeneDose technical system is available for use anywhere as a secured, cloud hosted infrastructure.

After Personalized Genetic Testing, Inc generates appropriate sequencing/genotyping data from a

patient sample, a GeneDose report can be created in seconds by invoking the well documented

GeneDose Application Programming Interfaces (APIs).

Page 3 CONFIDENTIAL

GeneDose LIVE

GeneDose™ LIVE merges more than a dozen precision prescription decision vectors and builds on the

genetic insight in the GeneDose™ Genetic Response Report provides. In real-time, the visuals in the

application display a holistic summary of which drugs present the highest degree of risk for that

patient. GeneDose LIVE provides physicians with a tool to model alternative choices and assess the

treatment plan to find the scenario that presents the least amount of risk, while still accomplishing the

intended therapy. The power lies in the ease in which alternative medication regimens can be vetted, in

real-time, before being tried in the patient.

Doctors ordering the GeneDose lab test from Personalized Genetic Testing, Inc will immediately have

access to use GeneDose LIVE to gain the complete picture of therapy safety for their patient at no

additional charge.

SafeTRx

SafeTRx by Coriell Life Sciences is a secure, HIPAA compliant, cloud hosted application for use by

patients and their families. SafeTRx empowers patients with the best available information about all

types of risk associated with their medications.

These include:

• Genetic metabolism risks • Anticholinergic burden risks

• Genetic adverse reaction risks • Geriatric toxicity risks

• Genetic competitive inhibition • Lifestyle risks

• Drug interaction risks • Duplicative therapies

• Contraindications • FDA Black Box warnings

• Pregnancy/lactation risks • FDA reported side effects

• Pediatric risks • Drug label warnings

Page 4 CONFIDENTIAL

SafeTRx also allows the patients to fill out their own demographic, lifestyle and medication information

to pre-populate the GeneDose LIVE application for the doctor. Moreover, since SafeTRx allows the

patients to profile family members as well, the system promotes genetic testing beyond just the subject

of the original lab order.

In effect, the patients become an extension of your sales force.

SafeTRx leverages the scientific data and pharmacogenomic expertise of the 62 year old Coriell Institute

for Medical Research along with the industry leading drug compendiums from Reed Elsevier, the U.S.

FDA, the American Geriatric Society, the American Pharmacist Association, and others. After entering

some information about their treatment plan and lifestyle, users are given a comprehensive analysis of

what drugs are safe and which are likely to cause adverse effects.

SafeTRx features

SafeTRx is a cloud hosted application available from any internet connected computer, tablet, or

smartphone. The application allows users to create profiles for themselves and for members of their

families who are suffering with medication related issues. The main application features include:

• Comprehensive U.S. drug information database updated twice a day

• Complete risk analysis: available in real time and presented as compelling visuals and 'consumer

grade' language

• "Side Effect Detective" that quickly shows which drug in the treatment plan is most likely causing

side effects

• Possible genetic risk assessment answering if genetic testing would help

• Generation of Physician advisory letters that highlights the findings of SafeTRx and invites the

doctor into a Healthcare Professional version of the tool at no additional cost where they can

perform real-time risk modeling of safer alternatives

SafeTRx is available on all browser enabled devices including smartphones, tablets,

laptops and desktops. Three months of use of SafeTRx is included in the cost of

GeneDose. After three months the user will be prompted to continue service if

they so choose by subscribing to SafeTRx for $3 per month.

SafeTRx can also be used as a pilot tool to break into new client accounts. Low

cost per user implementations of SafeTRx have shown to drive new genetic testing

orders without prospects needing to commit to costly up front implementations.

Page 5 CONFIDENTIAL

Initiation ServicesClient Overview

Personalized Genetic Testing, Inc is a CLIA certified institution that strives to further patient-centric care

by providing physicians with detailed information about medication safety and treatment alternatives

unique to each individual patient.

Personalized Genetic Testing, Inc is contracting with Coriell Life Sciences to provide pharmacogenetic

data interpretation, medication risk reports, and associated decision support tools required for their

individualized dynamic testing.

This document will cover the business requirements to implement GeneDose™, GeneDose LIVE,

and SafeTRx at Personalized Genetic Testing, Inc.

Project Scope

Phase I: PROJECT INITIATION

1. Project kickoff meeting

2. Gather systems integration requirement details

3. Detail customizations to test requisition and consent forms

4. Detail customizations to GeneDose™ Report Template(s)

5. Document review and approval (signatures)

Phase II: DESIGN AND TESTING

1. Code for data transfer; bi-directional, including:

1. New client/physician on-boarding

2. Genotyping/CNV results and CLIA report

3. Acknowledgment of GeneDose™ and CLIA report delivery

2. Customize GeneDose™ Report Template(s)

3. User Acceptance Testing (UAT)

4. UAT approval and signoff

Phase I Details

Requirements necessary for the planning and execution of the Project will be collected during

scheduled meetings of the Lead Project Manager from CLS and the Personalized Genetic Testing, Inc

Teams. An understanding of the laboratory process from physician on-boarding and kit production

through sample accessioning and report delivery will be detailed, collected, and documented during

this Phase I of the Project.

Page 6 CONFIDENTIAL

Genes, SNPs, and CNV

All genes, SNPs/ genotypes, by rs number, and CNV that are assayed by LAB will be documented.

Information includes gene, SNP, chromosome number, chromosome location (and source/build

information), variant alleles, SNP reporting format (Heterozygous order information; e.g. A/G vs G/A),

and assay catalog number (when available; e.g. ABI cat no.). Additionally, all assay result options are to

be documented including "not able to test," "inconclusive results," "ambiguous results," "no results,"

etc. The genes and genotype documents should provide reference values and population or source data

for wild type and variant options to ensure correct assigning of "normal" and "variant" values.

Test Requisition and Consent Form

CLS will provide required consent language that may be included in the sample collection kit. Data

extracted from the Laboratory Test Requisition and Consent should be passed to CLS with accessioned

patient information and may include the language from the patient consent. Specific lifestyle,

demographic, medication information will empower GeneDose™ LIVE and will be detailed for possible

inclusion in the Clients Test Requisition form. All information that will be passed to CLS from sample

accessioning will be documented.

GeneDose™ Report Customization

The GeneDose™ Report is built around a customizable template. Main Report sections are modular and

can be added and removed during the Execution phase. Company logos, addresses, and contact

numbers are customizable. CLS is not responsible for designing logos for the Report. Some colors that

are utilized throughout the report are customizable and will be specified and documented.

Data Transfer

CLS will collect information on Personalized Genetic Testing, Inc's data structures for integration and

provide documentation for data structures and operations supported by CLS. These will cover Account

Integration, Accessioning Data Integration, and Reporting Integration.

Coriell Life Sciences Account Integration Guidelines describes the data structures and operations

supported by Coriell Life Sciences' (CLS) account provisioning and management services. CLS makes

these services available as a set of secure, broadly-compatible web services based on HTTP and JSON,

conforming generally to REST principles. The common goal of these web services is to enable CLS's

partners and Clients to describe the organizations and physicians to which CLS will deliver GeneDose™

reports and/or other services, and to allow CLS's partner organizations and Clients to query the delivery

status of such reports.

Page 7 CONFIDENTIAL

Phase II Details

Code and Documentation will be developed for the items specified in the Scope of Services and to the

specifications detailed in the Electronic Data Transfer document developed and approved in Phase I.

User Acceptance Testing will be conducted to ensure that the system satisfies the needs of the business

as specified in the Scope of Services requirements and provides confidence in its use. Details of the UAT

will be documented by CLS and Client and agreed upon by both (signatures) during this phase.

Assumptions:

1. Samples collection kits, shipping supplies, and laboratory accessioning and processing are the

responsibility of Personalized Genetic Testing, Inc and their affiliate laboratories.

2. Retaining appropriate clinical certifications and licenses are the responsibility of Personalized

Genetic Testing, Inc and their affiliate laboratories.

3. CLS is to house all data and applications proprietary to delivering GeneDose™, SafeTRx and

GeneDose LIVE.

4. Pricing for GeneDose™ includes the GeneDose™ Report, delivery of GeneDose™ and CLIA

Report, notification of Report delivery, patient-specific access to GeneDose LIVE for one year after

initial report delivery, patient access to SafeTRx for three months after initial report delivery.

5. Raw genetic data reported by Personalized Genetic Testing, Inc is by rs number (i.e., genotype).

Genotype processing is performed by CLS.

6. Final report to physician must include laboratory CLIA-certified report.

Communication

CLS will designate a single point of contact, a Lead Project Manager, to be the spokesperson for CLS

with Personalized Genetic Testing, Inc Teams. While communications can and will occur outside of this

single point of contact, all decisions will be made through the Lead Project Manager and the

Personalized Genetic Testing, Inc team. Should communication be ineffective or decisions need higher

authorization, the escalation path will begin with the Personalized Genetic Testing, Inc representative

who contacted the team at the time of initiation.

Personalized Genetic Testing, Inc will communicate directly with the Clinician/treatment center

personnel throughout all phases of this Project.

Page 8 CONFIDENTIAL

On Going ServicesSample report generation

Coriell Life Sciences will provide access to the GeneDose™ Software as a Service (SaaS) platform for the

generation of patient specific physician advisory information. The GeneDose™ Report combines the

best of available scientific knowledge focused only on actionable results as they relate to drug efficacy

and risk of adverse reactions. The GeneDose™ genetic interpretations are the result of the patented,

published and peer reviewed process created within the Coriell Personalized Medicine research

project. As new genetic associations are added to the GeneDose interpretation engine, they will

become available for use by Personalized Genetic Testing, Inc and its customers.

Use of the GeneDose™ engine will be available via web services as documented by CLS in a provided

technical design document.

The GeneDose™ Report will be generated using one or more custom templates developed during the

project initiation.

Coriell Life Sciences is also happy to work with Personalized Genetic Testing, Inc to expand the

GeneDose™ results to include additional risk factors or gene:drug associations if the scientific evidence

meets the standards of the Coriell Phaesis™ reporting process.

Page 9 CONFIDENTIAL

GeneDose LIVE physician access

GeneDose LIVE is a unique offering that goes well beyond simple pharmacogenomic and genetic

metabolizer results. GeneDose LIVE brings together information from thousands of data sources to

present a total picture of risk and efficacy for a patient's treatment plan. Healthcare providers can use

GeneDose LIVE to model alternative choices for risky medications to see what impact those new drugs

would have tailored specifically to their individual patient.

GeneDose LIVE will be provided in conjunction with each delivered GeneDose™ Report as a unique Link/

URL for the physician to use as needed. Within the application the physician is able to modify

demographic, lifestyle, treatment and indication information as needed to receive a real-time view of

the risks of a total treatment plan.

Access to each patient GeneDose LIVE record will be provided at no additional cost for no less than 6

months following the delivery of the initial GeneDose™ Report. After 6 months, Coriell Life Sciences

reserves the right to remove access to that patient record or seek further remuneration from the

physician for continuing access to the GeneDose LIVE modeling tool.

Support

Telephone based technical support for both the GeneDose™ Report generation SaaS solution and

GeneDose LIVE risk modeling tool will be available during business hours eastern standard time,

Monday through Friday.

SafeTRx end user support will be provided via email only at this time. Live technical support can be

provided at additional cost.

EMail based technical support will be provided 24x7 with a 24 hour turn around time for issue

acknowledgement and status updates.

Page 10 CONFIDENTIAL

Timeframe

To complete the work outlined in the project scope, we will need

approximately 3 to 4 weeks from beginning to end, depending on when we

receive feedback at each milestone and depending on the complexity of

systems integration required as determined during requirements gathering.

Upon signing the proposal we are prepared to start work immediately.

Phase Week

Project kick-off, requirements gathering & documentation 1

Systems integration coding 2

Report Template Design 2

Systems integration testing 3

Final Review & Sign Off 3

Go live 4


4 weeks to Go Live!

Page 12

Project PricingBelow is the pricing for the scope of services detailed above. Pricing is tiered based on volume for

ongoing report production and access to the GeneDose LIVE medication risk modeling tool.

There are no monthly minimum costs and no startup fees.

You will only be charged for services you use month to month. Invoices for services rendered will be

generated on the first of each calendar month with payment terms as defined in the contract terms in

this document.

Description Price

1 to 500 per month - GeneDose Report Production Services

per production report generated

$20

501 to 1000 per month - GeneDose Report Production Services


$17.50

1000+ per month - GeneDose Report Production Services


$15

Physician Access to GeneDose LIVE & Patient access to SafeTRx

as detailed above

Included

SafeTRx Access for Patients receiving GeneDose Report

3 months access

Included

SafeTRx Access not receiving GeneDose PGX report

Per patient per month

$3

Professional Services (e.g. custom report design, systems integration)

Per hour as incurred

$150

Total $205.50

On Going Services

CONFIDENTIAL

Contract and Terms of ServiceTHIS AGREEMENT ("Agreement"), effective as of May 13, 2016 ("Effective Date"), is made between

Coriell Life Sciences, Inc., with an address of 403 Haddon Avenue, Camden, New Jersey 08103 ("CLS")

and Personalized Genetic Testing, Inc, with an address of 12855 SW 132 Street, Miami, Florida 33186

("Customer").

WHEREAS, CLS has developed a hosted application relating to drug effectiveness and/or safety for

patients;

WHEREAS, Customer desires to obtain access and use to such hosted application and other related

services of CLS on a non-exclusive basis; and

WHEREAS, CLS is willing to grant Customer access to such hosted application and provide other related

services to Customer pursuant to the terms and conditions set forth in this Agreement.

NOW, THEREFORE, in consideration of the following mutual promises and other good and valuable

consideration, the receipt and sufficiency of which are hereby acknowledged, the parties, intending to

be legally bound, agree as follows:

1. Services

1.1 Services. CLS will provide the CLS hosted application, GeneDose™, and related services subscribed

for by Customer (collectively, the "Services") for Customer's purposes for the duration of the "Term of

Access" period.

Services shall include the generation of a physician advisory report comprised of information derived

from the proprietary Coriell data curation, risk reporting and data analytics processes as well as access

to the hosted GeneDose LIVE application for the ordering physician. The GeneDose report will be

generated as a PDF file using a design template specified by the Customer and a fielded data file in a

format of the Customer's choosing such as JSON, XML, Tab Delimited Text or similar format. The report

files will be electronically delivered to Customer and simultaneously to any additional representative of

Customer so designated by Customer.


1.2 Services to Affiliates. CLS will provide Services under this Agreement to those business entities in

which Customer owns in the aggregate, more than fifty percent (50%) of the voting securities (each

entity, an "Affiliate") provided that (a) each Affiliate will first sign and deliver to CLS its agreement to be

bound by the terms of this Agreement; and (b) the Affiliate's use of the Services is subject to the

following: (i) Customer accepts responsibility for the acts or omissions of such Affiliate as if they were

Customer's acts or omissions; and (ii) Customer will indemnify CLS against losses or damages suffered

by CLS arising from breach of this Agreement by any such Affiliate as if effected by Customer. Upon

acceptance of the provisions of this Section 1.2 by Customer and an Affiliate, the Affiliate will be

deemed to be Customer for purposes of these terms and conditions other than this Section 1.2.

2. Fees

2.1 Fees. Customer will pay to CLS a fee per use of its GeneDose report generation services as detailed

in the fee schedule set out in this proposal. The total amounts due to CLS shall be calculated each

month by CLS and reported to Customer in accordance with Section 2.3. Customer shall make such

payment to CLS net 30 days following the delivery of the report set forth in Section 2.3.

2.2 Taxes. Customer will be responsible for paying all taxes, fees, charges and assessments, however

designated, levied or based upon the Services, including federal, state and local property, privilege,

sales, use, excise or similar taxes. CLS will not be responsible for the calculation, collection, reporting or

remittance of any such taxes. CLS shall be solely responsible for the payment of any taxes accruing to

CLS as a result of payments received by CLS under this Agreement.

2.3 Reporting. Within thirty (30) days after the end of each calendar month, CLS shall provide a report

to Customer setting forth (a) the amount of times the GeneDose™ hosted application was Used by

Customer in the previous month, (b) payment due to CLS in accordance with Section 2.1, and (c) any

additional information reasonably requested by Customer relating to the amounts due to CLS under

Section 2.1. The report shall be the confidential information of Customer, it being understood that CLS

may disclose any such reports internally and use the data in such reports on a deidentified, aggregated

basis.

3. Access to and Use of Services

3.1 Access.

3.1.1 Customer will identify one (1) or more employees of Customer who will be authorized by

Customer to have access to and use the Services on behalf of Customer ("Authorized Users"). Secured

system accounts may also be designated for access for the purposes of automated data interchange.


3.1.2 Customer will only permit Authorized Users to access and use of the Services throughout the

Term of Access specified. The initial term of this Agreement shall commence on the Effective Date and

continue until for two (2) years ("Initial Term"). Following expiration of the Initial Term, this Agreement

will automatically renew annually for one (1) year (each a, "Renewal Term"); provided that either party

may terminate this Agreement upon sixty (60) days written notice prior to the expiration of the Initial

Term, or any Renewal Term.

3.1.3 Customer will appoint one (1) Authorized User to be Customer's primary agent in authorizing

Customer's Authorized Users to access the Services. Customer may also appoint secondary agents of

Customer in authorizing Customer's Authorized Users to access the Services. Passwords conform to

Customer rules and upon request may be system-generated ("Access ID"). CLS has no obligation to

verify the identity of any person who gains access to the Services by means of Access ID. Customer is

solely responsible for monitoring its Authorized Users' access to and use of the Services, and for any

failure by any Authorized User to comply with this Agreement; a failure to comply with this Agreement

by an Authorized User is a failure by Customer. Customer must immediately take all necessary steps,

including providing notice to CLS, to effect the termination of an Access ID for any Authorized User if

there is any compromise in the security of that Access ID or if unauthorized use is suspected or has

occurred. CLS is not liable to Customer or anyone else for damages arising from Customer's use of

multiple Access IDs.

3.2 Security. Customer will maintain commercially reasonable security procedures for the transmission

of data to the Services. Customer will notify CLS immediately of any suspected security breach

regarding transmissions to or from the Services.

3.3 Suspension of Access. CLS may suspend Customer's access to the Services temporarily, or

temporarily restrict any use thereof, in whole or in part, if, and so long as, in CLS's sole reasonable

judgment, there is a security risk that may interfere with the proper continued provision of the Services.

CLS may permanently terminate Customer's access to the Services if, in CLS's sole reasonable

judgment, Customer is misusing the Services, has breached this Agreement, or is or may be engaged in

illegal activity.

3.4 Availability. Customer may access the Services at any time the CLS servers are available. CLS has

taken all reasonable effort to ensure full time server availability by providing multiple, redundant

production servers with enterprise class fail-over and backup features. In the unlikely event that CLS

services are not available and it is anticipated the outage will result in more than four (4) hours of

service interruption, CLS will make every reasonable effort to alert Customer of the interruption and

will provide continual updates throughout the interruption until service is restored.

4. Consent to Electronic Communications. Customer and CLS consent to receive notices or other

communications ("Communications") from each other in connection with the Services by electronic

means, or in writing. CLS may also provide Communications to Customer in writing.


5. Termination for Cause. If either party materially breaches this Agreement, the other party will have

a right to terminate this Agreement, provided that such party notifies the other party in writing of the

breach, gives the breaching party thirty (30) days from receipt of such notice to cure the breach, and

the breach is not cured within the 30-day period. Notwithstanding the foregoing, if CLS has reasonable

grounds to believe that Customer has committed a breach that relates to Customer conduct or

confidentiality as set forth in Sections 6.6 and 7, respectively, then CLS may, in its sole reasonable

discretion, immediately terminate this Agreement.

6. Ownership; Licenses; Customer Conduct

6.1 Ownership. Each party acknowledges that CLS owns the Services (excluding third party content and

services in the Services), and except for the license granted in this Agreement, nothing in this

Agreement confers in Customer any right of ownership in the Services.

6.2 License of Services. CLS grants Customer a non-exclusive, non-transferable license during the

Term to access, to display and use the Services in accordance with this Agreement.

6.3 Data. CLS is not responsible for the accuracy or comprehensive coverage of any data submitted to

the Services. All data that is Customer's Confidential Information (as defined in Section 7) submitted to

the Services is and will remain the property of Customer ("Customer Data") and CLS disclaims

ownership rights in Customer Data. CLS will use, and Customer grants to CLS a non-exclusive,

perpetual, royalty-free, worldwide license, with right to sublicense and assign, to use and disclose data

solely for the purpose of enabling CLS to (a) test, modify, develop and otherwise enhance the Services;

and (b) provide the Services to Customer. With respect to patient information submitted to the Services,

Customer shall notify CLS upon submission of such patient information whether such patient has

granted CLS the right to use such de-identified patient data for commercial and research purposes.

Customer acknowledges that CLS may compile aggregated data related to usage by Customer of the

Services, and that CLS may disclose such aggregated data to third parties to the extent that neither

Customer nor its Affiliates may be identified as the source of such data.

6.4 License of Marks. Subject to the terms and conditions of this Agreement and only during the Term,

CLS grants to Customer a limited, non-exclusive, worldwide license to include the GeneDose(TM)

trademark ("Licensed Marks") owned and used by CLS on Customer's website solely for purposes of

linking to the Services; and to include the CLS Licensed Marks in hardcopy marketing materials and

Customer's website to advertise the availability of the Services, subject to the written approval of CLS.

Customer will use the Licensed Marks in conformance with CLS's trademark usage policies as

communicated from time to time. CLS may immediately terminate, in whole or with respect to specific

use, Customer's license to use the Licensed Marks if CLS reasonably believes that such use does not

comply with its usage policies or this Agreement.


6.5 Intellectual Property Indemnification. CLS will indemnify Customer for any and all liabilities to

third parties and verifiable costs and expenses (including, without limitation, reasonable attorney's

fees) incurred by Customer arising out of claims brought by third parties that the Services constitutes

an infringement of any U.S. patent, trademark, or copyright or constitutes misappropriation of a trade

secret; provided that Customer gives CLS prompt notice in writing of a claim, permits CLS to defend the

same and give CLS all available information assistance and authority in connection therewith. CLS will

have control of the defense of any such proceeding including appeals. CLS shall have full authority to

settle any such proceeding without prior notice to or consent from Customer if i) CLS agrees to pay all

amounts due under such settlement; ii) if there is no admission of wrongdoing or liability on the part of

Customer and iii) there is no representation or admission related to Customer or its operations.

Notwithstanding the foregoing, CLS shall give prompt written notice to Customer of any such

settlement to which CLS agrees and shall provide Customer a copy of any settlement document(s)

related to such proceeding. In the event of such a claim, CLS may, at its option and expense, to the

extent necessary to substantially provide the Services, procure for Customer the right to continue using

the Services, replace the same with non-infringing Services, or modify the same so that it becomes

non-infringing, or discontinue the infringing portion of the Services and ratably refund a portion of the

then-applicable Services fee. CLS, however, will not have any liability to Customer if any such

infringement, or claim thereof, is based upon or arises out of (a) the use of apparatus or devices not

used, supplied, or approved in writing by CLS; (b) the use of the Services in a manner for which the

same was neither designated nor contemplated, or in contravention of license granted in Section 6.2; or

(c) the claimed infringement of any patent in which Customer or any subsidiary or affiliate of Customer

has any direct or indirect interest, by license or otherwise. The foregoing states the entire liability of CLS

for or resulting from such infringement or claim thereof.

6.6 Customer Conduct.

6.6.1 Compliance. Customer will use the Services in accordance with this Agreement and will

indemnify CLS for all liabilities, costs and expenses (including without limitation, reasonable attorneys'

fees) incurred by CLS from (a) a failure by Customer to comply with the terms and conditions set forth

herein, or (b) a grossly negligent act or omission of Customer, its agents, or employees arising out of

the use of the Services. If CLS has reasonable grounds to believe that Customer is using the Services for

any improper purpose, CLS may suspend the Services immediately or terminate the Services upon

reasonable written notice to Customer.

6.6.2 Unauthorized Content. Neither party will use the Services to transmit content that is defamatory,

libelous, obscene, unlawfully threatening, or unlawfully harassing or that infringes the intellectual

property rights or rights of publicity or privacy of any third party.


6.6.3 Unauthorized Code. Neither party will knowingly directly or indirectly transmit to any CLS or

Customer server any virus, software program or segment of code known as a "Trojan horse," "trap

door," "back door," "Easter egg," "worm," "time bomb," or other programming design, instruction, or

routine that permits unauthorized access to any apparatus or device delivering the Services and is

intended to damage, detrimentally interfere with, surreptitiously intercept, or expropriate any of the

foregoing or any system, data or personal information, or permit or engage in any other fraudulent,

illegal, harassing or unauthorized use of the Services. Both parties will take commercially reasonable

precautions to prevent a security breach of their own systems, including employing an enterprise level

anti-virus protection and firewall.

6.6.4 Breaches of Security. Customer will not (a) breach or attempt to breach the security of the

Services or any network, servers, data, computers or other hardware relating to or used in connection

with the Services or belonging to or used or leased by any other customer of CLS or any third party that

is hosting or interfacing with any part of the Services; or (b) use or distribute through the Services any

software, files or other tools or devices designed to interfere with or compromise the privacy, security

or use of the Services or the operations or assets of any other customer of CLS or any third party.

6.6.5 Modifications, Reproductions or Reverse Engineering. Customer will not modify or tamper

with the Services, except as expressly permitted in this Agreement. Customer will not reproduce, copy,

translate, modify, adapt, create derivative works from, distribute, transmit, transfer, republish, reverse

engineer, decompile, disclose or otherwise attempt to discover any information used to deliver the

Services, or compile, remove or delete the Services.

6.6.6 Unauthorized Disclosure. Customer will not allow unauthorized disclosure or copying of any

part of the Services.

6.6.7 Removal of Notices. Customer will not remove, obscure or alter any copyright notice, trademark

or other proprietary rights notices affixed to or contained within the Services.


7. Confidentiality.

7.1 Confidential Information. Each party will diligently preserve the confidential information or

intellectual property of the other, including all such information that is designated as confidential, or

that by its nature would reasonably be expected to be kept confidential ("Confidential Information")

and will exercise at least such care as the party employs to preserve the confidentiality of its own

Confidential Information. CLS's Confidential Information also includes the Services. Customer consents

to the disclosure of its Confidential Information to service providers of CLS (such service providers

being subject to appropriate confidentiality obligations) solely to the extent necessary or appropriate to

provide the Services. CLS shall provide prompt notice to Customer of any such disclosure to a CLS

service provider. Confidential Information of a party does not include information that (a) was known to

the party receiving such Confidential Information prior to the receipt of the Confidential Information

from the disclosing party; (b) was independently discovered, developed, or received by the receiving

party; (c) was generally known to the public prior to disclosure to the receiving party; or (d) becomes

generally known to the public through no fault of the receiving party. The receiving party shall notify the

disclosing party promptly in the event the receiving party receives legal process that would require

disclosure of Confidential Information and provide the disclosing party a reasonable opportunity to

secure confidential protection of such Confidential Information. Notwithstanding the foregoing, each

party is authorized to retain one (1) copy of any Confidential Information in its legal department for the

purpose of determining any continuing obligation under this Agreement, and nothing herein shall

require either party to delete electronic copies of Confidential Information (including emails) that have

become embedded in such party's electronic records system through normal back-up procedures;

provided that all such copies shall be subject to the obligations of non-disclosure set forth herein.

7.2 Equitable Relief. Each party acknowledges and agrees that due to the unique nature of the

Confidential Information, any breach of this agreement may cause irreparable harm to the other party

for which monetary damages may not be an adequate remedy, and, accordingly, each party shall be

entitled to seek equitable relief in addition to all other remedies available at law.

8. Representations and Warranties; Regulatory Compliance; Disclaimers of CLS

8.1 Representations and Warranties; Regulatory Compliance.

8.1.1 Limited Warranty. CLS warrants the following: CLS will use commercially reasonable efforts

to provide the Services in a timely and professional manner in accordance with industry standards. CLS

will comply with all applicable laws and regulations in providing the Services. CLS and its personnel

have the capability and experience required to perform the Services. Except as expressly set forth in

this Agreement, the foregoing sets forth the sole warranty of CLS regarding the Services.


8.1.2 CLS represents and warrants the following: (a) to CLS's knowledge, CLS owns all right, title and

interest, including all related intellectual property rights, in the Services; (b) there is no pending or

threatened litigation, claim, action, suit, mediation, investigation, hearing, grievance or similar

proceeding (in each case, whether civil, criminal, administrative, investigative or informal) against CLS

relating to the Services; (c) CLS is free to license the Services to Customer and to CLS' knowledge, such

license granted by CLS to Customer under this Agreement does not violate the rights of any third party;

(d) as of the Effective Date, the Services do not contain any errors, defects, viruses, and other harmful

components, and CLS will use commercially reasonable efforts to detect and remedy any and all errors,

defects, viruses, and other harmful components in the Services; (e) CLS will use commercially

reasonable efforts to provide the Services in a timely and professional manner in accordance with

industry standards; (f) CLS and its personnel have the capability and experience required to perform

the Services; and (g) CLS shall at all times abide by all applicable local, state and federal laws, rules and

regulations and such authorities, including but not limited to the Food, Drug and Cosmetic Act, the

federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), and

similar state health care fraud and abuse laws and regulations.

8.1.3 Each party represents and warrants that neither it nor any of its employees have been

suspended or excluded from participation in any state or federal health care programs. Each party

agrees to notify the other party in writing of any exclusions/suspension within ten (10) days of learning

of any such action and to provide the other party with the basis of the exclusion/suspension and will

notify the other party immediately of any action, suit, proceeding or investigation brought against the

party or its owners, partners, directors, officers, employees or agents by a governmental authority that

would have a material adverse effect on the ability of such party to perform its obligations under this

Agreement. If Customer is denied payment from any third-party payor solely because of the existence

of any such action, suit, proceeding or investigation of CLS, CLS will reimburse Customer for the amount

of such denied payments and for any related losses and expenses incurred by Customer.

8.1.4 Each party shall provide the other party with copies of all written reports, including all

applicable documentation, made to any governmental or regulatory agency that implicates the other

party in any manner. The obligation shall include the provision of a written summary of any oral or

telephonic report involving the other party in any respect made to any governmental or regulatory

agency. Unless compelled to do so by law, neither party shall respond to any agency without the prior

written consent of the other party if such response implicates the other party.

8.1.5 Each party shall notify the other party of any information it receives regarding any threatened

or pending action by a government or regulatory agency that may affect the other party or the Services.


8.1.6 Customer and CLS acknowledge and agree that (a) the aggregate services contracted for do

not exceed those which are reasonably necessary to accomplish the commercially reasonable business

purposes of Customer, (b) the compensation set forth herein represents the fair market value of the

services provided by CLS to Customer negotiated in an arm's-length transaction and has not been

determined in a manner which takes into account the volume or value of referrals or business, if any,

that may otherwise be generated between the parties, and (c) this Agreement covers all of the services

CLS provides to Customer. Customer and CLS further agree that this Agreement does not involve the

counseling or promotion of a business arrangement that violates federal or state law. Notwithstanding

any other provision set forth herein, Customer and CLS further acknowledge and agree that CLS is not

being engaged to and shall not any time provide any form of marketing and/or promotion of Customer

as a provider of laboratory services of any kind, including those provided in conjunction with

GeneDose™.

8.1.7 As between CLS and Customer, Customer shall bill its customers and third party payors for

laboratory testing conducted by Customer in conjunction with the Services.

8.2 Disclaimer of Warranties. EXCEPT AS SPECIFIED IN THIS AGREEMENT, NEITHER PARTY MAKES

ANY WARRANTIES IN RESPECT OF ANY MATTER, INCLUDING WITHOUT LIMITATION, THE SERVICES, THE

GENEDOSE™ HOSTED APPLICATION, AND THE PARTIES EXPLICITLY DISCLAIMS ALL OTHER WARRANTIES,

EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY, OR FITNESS FOR A

PARTICULAR PURPOSE. INFORMATION RESULTING FROM THE USE OF ANY OF THE SERVICES

(INCLUDING ANY REPORT PRODUCED USING THE GENEDOSE™ HOSTED APPLICATION) IS NOT MEDICAL

ADVICE AND CLS WILL NOT BE RESPONSIBLE FOR THE USE OF ANY SUCH REPORT BY CUSTOMER OR

ANY THIRD PARTY. CLS WILL NOT BE RESPONSIBLE FOR ANY THIRD PARTY'S SOFTWARE, SERVICE OR

HARDWARE CLS PROVIDES OR USES IN THE PERFORMANCE OF THE SERVICES UNDER THIS AGREEMENT.

CLS DOES NOT WARRANT THAT (A) THE OPERATION OF THE SERVICES WILL BE UNINTERRUPTED OR

ERROR FREE; OR (B) ANY DEFECT OR MALFUNCTION IN THE SERVICES IS CORRECTABLE OR WILL BE

CORRECTED.

8.3 Actions of Others. CLS is not liable for claims, losses or damages that solely arise by reason of (a)

the actions of third parties (other than agents, licensors or subcontractors used by CLS in providing the

Services); and (b) the interception or delay of data transmitted to or from Customer.


9. Limitation of Liability. Except for damages arising from (i) CLS's intellectual property

indemnification obligations under Section 6.5, and/or (ii) a party's breach of the confidentiality

obligations set forth in Article 7, and except as otherwise provided in this Agreement, each party's

liability under this Agreement is limited to damages arising solely out of the gross negligence or willful

misconduct of that party (including its agents or employees), and each party hereby releases one

another from all other claims, demands or damages for other losses. In addition to any other limitation

and except for damages arising out of either party's (z) breach of confidentiality, (y) gross negligence,

willful misconduct, or (z) intellectual property indemnification obligations under Section 6.5, in no event

will either party's total liability for any and all losses arising out of or relating to this Agreement or any

Services provided or to be provided under this Agreement exceed the amount paid by Customer to CLS

for all Services during the 12 months preceding the event for which claims, losses or damages arise.

Under no circumstances will either party be liable for indirect, special, incidental, punitive or

consequential damages, including without limitation, lost profit or loss resulting from business

interruption even if the party has been advised of the possibility or likelihood of such damages. Neither

party will be liable for any delay, loss or damage attributable to any service, product or action of any

person other than the other party. The limitation and exclusions of liability and disclaimers specified in

this Agreement will survive expiration and termination of this Agreement.

10. Miscellaneous.

10.1 Amendments. This Agreement may be amended, supplemented or modified only by a record

signed or otherwise authenticated by both parties. CLS will have the right to improve or otherwise

modify the Services at any time, provided the modifications are not materially adverse to the basic

functionality of the Services and CLS provides Customer prompt notification of such changes. CLS will

provide to Customer the validation data developed by CLS upon request for any such modifications in

the Services. Customer shall keep such validation data strictly confidential, and shall disclose it solely as

required by Customer's accrediting agencies in order for Customer to be accredited to use the Services

as part of Customer's issued laboratory reports.

10.2 Force Majeure. Each party will be excused from delays in performing or from its failure to

perform under this Agreement (other than delays in payment of fees) to the extent that the delays or

failures result from causes beyond the reasonable control of the party.

10.3 Binding Effect; Assignment. This Agreement will be binding upon, and inure to the benefit of,

CLS's and Customer's respective successors and assigns; provided that neither this Agreement nor any

of Customer's rights, privileges, duties or obligations under this Agreement may be assigned,

sublicensed, sold, mortgaged, pledged or otherwise transferred or encumbered by Customer without

the prior written consent of CLS. CLS shall not subcontract the performance of the Services or portions

thereof without the prior written consent of Customer.


10.4 Governing Law. This Agreement shall be governed by and interpreted in accordance with laws of

the State of Delaware without giving effect to any conflict of laws provisions. Customer agrees that any

dispute or controversy arising out of or relating to any interpretation, construction, performance or

breach of this Agreement may be brought in any court of general jurisdiction in the State of Delaware.

10.5 Severability. If any provision of this Agreement is invalid or unenforceable in any circumstances,

its application in any other circumstances and the remaining provisions of this Agreement will not be

affected thereby.

10.6 Entire Agreement. This Agreement constitutes the entire agreement and understanding of the

parties relating to the subject matter thereof. This Agreement supersedes all prior written and oral

agreements and all other communications between CLS and Customer.

10.7 Waiver of Breach. No waiver by a party of any breach of this Agreement will constitute a waiver of

any other breach of the same or other provisions of this Agreement. No waiver by a party will be

effective unless made in a record signed or otherwise authenticated by an authorized representative of

the waiving party.

10.8 Third Party Beneficiaries. Each party intends that this Agreement will not benefit, or create any

right or cause of action in or on behalf of, any person or entity other than Customer and CLS.

10.9 Relationship of the Parties. The parties are independent contractors. Nothing in this Agreement

or in the activities contemplated by the parties will be deemed to create an agency, partnership,

employment or joint venture relationship between the parties.

10.10 Headings. Any headings of sections herein are for convenience only and do not affect in any way

the scope, intent or meaning of the provisions to which they refer.

10.11 Counterparts. This Agreement may be executed in separate counterparts, each of which will be

an original and all of which together will constitute one and the same agreement binding on each of the

parties to this Agreement. The exchange of executed copies of this Agreement by facsimile, portable

document format (PDF) transmission or other reasonable form of electronic transmission shall

constitute effective execution and delivery of this Agreement.

10.12 Survival. Sections 7 and 8 will survive the expiration or earlier termination of this Agreement.


Privacy and Security GuidelinesCLS is committed to protect the privacy of an individual's health information, and to comply with

applicable laws that protect the privacy and security of individual's health information. This policy,

consistent with this commitment, establishes the basic requirements for the use or disclosure of an

individual's protected health information and is subject to:

• MINIMUM NECESSARY RULE

• BUSINESS ASSOCIATE AGREEMENT

• CORIELL LIFE SCIENCES PRIVACY POLICIES

CLS may use and disclose protected health information, without the written consent or authorization of

the individual to whom the information pertains, as follows:

• To provide treatment

• For CLS's health care operations

When Personally Identifiable Information (PHI) is required in the course of business:

• Communications will be encrypted using a secure delivery method.

• Contacts will require authorization prior to reporting of patient result.

• Fax numbers and email addresses will require validation of information prior to reporting of

patient results.


NEXT STEPS1. Please read the contract on the previous pages to make sure you understand all the details

involved with us working together. It’s really important to us that everything is transparent and

understood from the beginning so that we lay a solid foundation for a great working

relationship.

2. If you have any questions at all, please let us know. We’re happy to clarify any points and there

may be some items that we can sort out together. We’re committed to finding the best way to

work together.

3. Once you feel confident about everything and are ready to move forward, please click the 'sign

here' button below.

4. Sign in the box that pops up to make the acceptance official.

5. Once we receive notification of your acceptance, we’ll contact you shortly to schedule our

kick-off call and get the project rolling.

6. We’ll email you a separate copy of the signed contract for your records.

7. If you’d like to speak to us by phone, don’t hesitate to call me at 856-533-0484

Page 25

Jeffrey Shaman

Director, Business Development, Coriell Life Sciences

Irina Borodowsky

President, Personalized Genetic Testing, Inc

CONFIDENTIAL

Eliminating Medication Misadventures · 2016-06-22 · Coriell Life Sciences Account Integration Guidelines describes the data structures and operations supported by Coriell Life

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