Clinical Terms & Conditions

STANDARD TERMS

The Customer (“Customer”) and Variantyx Inc. incorporated under the laws of Delaware US, with principal place of business in 1671 Worcester Rd. Framingham MA 01701, NPI #, 1629512140 (“Variantyx”) have prepared a quote or similar document that describes pricing and technical terms for Variantyx’s products and services (the “Purchase Order”). The Purchase Order and the terms of this document constitute the agreement between Customer and Variantyx for the deliverables thereof (the “Agreement”).

These Variantyx Clinical Terms and Conditions (the “CT&Cs”) as amended from time to time apply to all contractual relations entered into effect between Variantyx and Customer and represent an integral part of any Agreement between the Parties. Any separate Agreement between the Parties and the specific provisions agreed therein shall prevail over these CT&Cs. Any deviating terms and conditions do not apply to any Agreement between the Parties unless explicitly agreed in writing by the Parties.

Variantyx’s Services are comprised of three major components including Wet Bench Services, Bioinformatic Data Processing, and interpretation of data. The Service components may be sold as a bundle or independently as stand alone offerings. The CT&Cs cover all Service components. In cases where only a portion of the Service components are purchased, only the relevant parts of these CT&Cs will apply.

Definitions

Commercial Terms

Provisions of Service

Medico Legal Forms

Samples Collection, Shipping and Handling

DNA Extraction and QA

NGS Sequencing and Validations

Data Storage, Retention and Release

Data Processing and Bioinformatics

Interpretation, Diagnosis and Reporting

Results Delivery

Platform Use

General Provisions

1. Definitions

“Affiliate” of a person means any other person that directly or indirectly Controls, is controlled by, or is under common Control with, the person.
“Bioinformatic Data Processing” means processing of sequenced data including alignment, variant calling, annotation and filtration as commonly defined.
“CLIA” : Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
“Confidential Information” of a party (the “Disclosing Party”) means all information and materials disclosed by or on behalf of the party to the other party (the “Receiving Party”) or its Related Persons in connection with the Agreement that is reasonably considered to be confidential. The Confidential Information of both parties includes the existence, terms and objectives of the Agreement, and the nature of any dispute and the outcome of any arbitration proceedings arising out of or in connection with the Agreement.
“Content” means any information or content used by, or made available by Variantyx in connection with Products or Services provided to Customer, including without limitation, Variantyx’s proprietary biological database, Third party proprietary biological databases, diagrams, graphs, analysis reports and any third-party content made available to Customer in connection with Customer’s access to or use of the Genomic Intelligence®, including but not limited to the BIOBASE databases HGMD®, TRANSFAC® and PROTEOME™, the Broad Institute GATK,and OMIM.
“Control” over a person means (a) owning 50% or more of the voting securities or other ownership interests of the person or (b) having the power to direct the management or policies of the person,
“Customer” means any person or a legal entity who is legally entitled to place Purchase Orders to Variantyx, relating to Variantyx’s Services and Products, including but not limited to physicians, hospitals, pharmaceutical companies, laboratories, reference laboratories and any other entity.
“Customer Representative” shall mean any employee, agent, officer or contractor of Customer who accesses Genomic Intelligence® , Content, Results; or any component thereof for use on behalf of Customer.
“Customer Biological Data” means all data that Customer provided to Variantyx, including without limitation raw sequenced data (such as FASTQ files) and any derivatives thereof, gene lists, custom variant lists or other data.
“Diagnostic Service” means a genomic analysis and interpretation service used for diagnosis of patients.
“Documentation” means written, audio, visual, and/or other user materials provided to Customer related to Genomic Intelligence® which may include, without limitation, on-line help, ‘getting started’ and tutorial information made available through Variantyx’s website.
“Genomic intelligence®” is a trademark of Variantyx used to describe the Variantyx diagnostic platform.
“Informed Consent” : Before a person undergoes a genetic test, some Jurisdictions require that he or she fully understands the testing procedure, the benefits and limitations of the test, and the possible consequences of the test results. The process of educating a person about the test and obtaining permission to carry out testing is called informed consent. “Informed” means that the person has enough information to make an educated decision about testing; “consent” refers to a person’s voluntary agreement to have the test done.
“Institutional Review Board” (IRB), also known as an ‘independent ethics committee’ (‘IEC’), ‘ethical review board’ (‘ERB’), or ‘research ethics board’ (‘REB’), is a committee used in research that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans.
“Intellectual Property” means patents and patent applications, trademarks, trade names, service marks, domain names, copyrights and copyright applications and registrations, schematics, industrial models, inventions, know-how, trade secrets, computer software programs and other intangible proprietary information.
“Jurisdiction” means any market Jurisdiction for which the Services and Products are provided by Variantyx, as agreed between the Parties.
“Ordering Physician” means a person legally qualified and licensed to practice medicine and legally authorized to request genomics testing.
“Patient” means any individual person whose biological materials or data are subject of genomic testing Services provided by Variantyx.
“Patient Biological Data” means all data resulting from Patient Sample provided to Variantyx, including without limitation raw sequenced data (such as FASTQ files) and any derivatives thereof, gene lists, custom variant lists or other data.
“Patient’s Medical Record” or “Medical records”: A patient’s identification and information regarding the patient’s case history (including, without limitation); medical history, various test results and phenotypes.
“Products” means any products developed, produced and supplied by Variantyx.
“Report” means any written and/or electronic medical report on the Results of an analyzed Sample.
“Results” means the results generated by the Research Service or Diagnostic Service based on analysis performed by Variantyx or by Customer using Genomic Intelligence®.
“Research Sample Submission Form” : A standard form provided by Variantyx to identify Samples and provide additional information needed for the processing of the Samples.
“Research Service” means genomic analysis and interpretation Service used for research purposes and is not intended for use in diagnosis of patients.
“Samples” or “Sample” means samples of Patients tissue or DNA, collected, processed and stored in accordance with applicable regulations and provided to Variantyx for the provision of the Services.
“Services” or “Service” means any services provided by Variantyx, including but not limited to NGS sequencing, Bioinformatic Data Processing, interpretation and diagnosis.
“Test Requisition Form” or “TRF” is a communication from the Ordering Physician/practitioner requesting that a diagnostic test be performed for a beneficiary and identifies the test or tests to be performed.
“Website” means Variantyx’s website www.Variantyx.com as amended from time to time.
“Wet Bench Services” means any service performed on a biological sample through the point of generation of sequence data.

2. Commercial Terms

All offers and prices quoted for Variantyx’s Products and Services, as provided on the Website, by written quote or by email, are non-binding and free of any obligation until the respective offer contains an acceptance term. Each offer shall only be valid for a period of thirty days unless explicitly stated otherwise.
Any prices quoted by Variantyx and its Affiliates shall be exclusive of VAT and other government levies, as well as of shipment and handling costs, unless explicitly stated otherwise.
A Customer may order Products and Services from Variantyx by written or electronic Purchase Order.
Any Purchase Order sent to Variantyx shall be invalid if it deviates from the respective quote, unless Variantyx provides an explicit acceptance in writing.
Variantyx shall provide certain Products and Services to Customer pursuant to the Purchase Order. If there is a contradiction between a provision of these CT&Cs and the Purchase Order, then the provision of the Purchase Order will prevail.
An Agreement shall be concluded when Variantyx either confirms a Purchase Order in writing or starts to execute the respective Purchase Order.
Variantyx shall invoice the Customer directly or indirectly together with the provision of the Services or delivery of the Product, in each case in USD or any other currency set forth in the Purchase Order. Customer shall pay each invoice within a period of 30 calendar days (or as set forth in the Purchase Order) of the date of the respective invoice to Variantyx by bank transfer, credit card or check free of charge for Variantyx and without any deductions whatsoever.
Payment Instructions. Payment Instructions are found in the “Payment Terms,” section of the quote.
Unless otherwise specified in writing by Variantyx, the prices are exclusive of transportation costs, insurance costs, license fees, customs duties, or sales or other similar taxes. Customer shall pay all such duties or taxes except for the taxes imposed on Variantyx´s net income.
In the event of untimely payment, Variantyx may calculate and claim the interest on the amount due at a monthly rate of one and one-half percent (1.5%).

3. Provisions of Service

Time Frame, Turn Around
1. Dates and time given for completion of a Service and delivery of ordered Products are given as estimates only and shall not constitute a term or condition.
2. Variantyx shall use its best efforts to render the Services and to deliver Products within the estimated time frames as communicated on the Website or as agreed in the Purchase Order or Agreement. Variantyx shall, as soon as reasonably possible, notify the Customer if any circumstances arise, which hinder or delay the performance of the Services and delivery of the Products. The execution time shall be extended accordingly upon the occurrence of any such circumstances. While Variantyx will use all reasonable endeavors to meet any time estimation, it reserves the right to amend such estimation if it is absolutely necessary due to unforeseeable situations.
3. Failure by Variantyx to timely deliver one or more deliveries of Services and/or Products shall not entitle Customer to claim compensation or to terminate or suspend the respective Purchase Order or Agreement or reject those or subsequent deliveries.
4. Variantyx may withhold any further performance of the Services or deliveries of the Products if the payments are due and not paid by Customer within thirty (30) days of the respective due date, unless otherwise agreed in a Purchase Order or Agreement.
Delegation of Service. Variantyx partners with sequencing labs for DNA extraction, biobanking, DNA quality control, sequencing, validations and other services. Accordingly, Variantyx may delegate or subcontract the Services or part thereof to a third party. If the Services are provided by a third party, then references to Variantyx in these Standard Terms will be deemed to be references to the third party with the necessary modifications.
Compliance. Variantyx shall provide the Services in compliance with applicable laws.

4. Medico Legal Forms

All Diagnostic Service Samples must be accompanied by a Test Requisition Form and an Informed Consent Form signed by the Ordering Physician and, by all Patients or their legal guardians. A Test Requisition Form must be submitted for each Patient.
All Research Service Samples must be accompanied by Research Sample Submission Form.
Variantyx retains the right to decline processing of any Sample for which the Informed Consent or Test Requisition Form have not been adequately filled in.

5. Samples Collection, Shipping and Handling

Samples will be collected by Customer packaged and shipped according to guidelines published by Variantyx from time to time.
All Samples have to be identified by Variantyx provided barcodes.
Samples for Diagnostic Service have to be marked with Variantyx provided barcodes and have additional identifiers of date of birth and Patient name
International shipping of Samples may require the Customer to fill in Airway Bill, customs declarations, Proforma invoice, Hazardous materials declaration and other documents as needed.
Variantyx will not be liable for Samples delayed or lost in transit. In case of lost or delayed Sample, Customer will need to collect and ship a new Sample.

6. DNA Extraction and QA

DNA Samples may be provided by Customer or extracted from Sample by Variantyx or its partnering labs.
Each DNA Sample will undergo Sample QC process to verify quality and quantity requirements as published by Variantyx from time to time.
In case of DNA QC failure, Variantyx will communicate the results to Customer for further instructions of whether to proceed with sequencing of the low quality Sample or to ship a new Sample. Sequencing Samples that failed QC may result in low coverage and low diagnostic yield.
Sequencing turnaround time starts after Sample passed DNA QC.
DNA Samples will be biobanked by Variantyx or its partnering labs for three months to allow for validation if needed, afterwhich, the Sample will be discarded.
DNA will not be returned to the Customer unless explicitly requested in writing and shipping and handling paid.
Samples that failed QC will be discarded after 3 months upon delivery of QC report. Upon request, Samples can be returned to Customer at Customer’s expense.

7. NGS Sequencing and Validations

Extracted DNA will be sequenced according to Products and Services specified in the Purchase Order.
CLIA Products will be provided with a signed CLIA Sequencing Report.
Raw data (FASTQ) will be made available for the Customer to download within six months of sequencing or for an extended period if required by law.
Bio-banked DNA Samples will be available for Sanger validation within the Sample retention timeframe. Sanger validations are not included in the pricing of the Services unless explicitly mentioned.

8. Data Storage, Retention and Release

Records Storage: All materials such as: Patient’s Medical Record, Patient Biological Data, Customer Biological Data, and, related documentation obtained or generated by Variantyx in the course of providing the Services, including all computerized records and files, will be maintained in a secure digital storage in accordance with HIPAA standards.
Retention: Variantyx will store Data and Results for a term of seven (7) years “Data Retention Term”. Following the expiration of the Data Retention Term, Variantyx may permanently delete the Data and Results.
Data Release: Data release is subject to release consent forms filled in by Customer. Data release can be done through online download free of charge, or at an additional payment for physical media delivery. If data release is required we release raw data (FASTQ files) only. Data is not shared with any third party unless mandated by law.

9. Data Processing and Bioinformatics

By providing a Purchase Order to Variantyx, the Customer agrees, confirms and warrants to Variantyx that, subject to the Patient’s provided Test Requisition Form, Variantyx is entitled and is legally permitted to store, retain and utilize any and all Data received from Customer or generated by Variantyx for the provisioning of the Service.
By providing a Purchase Order, the Customer acknowledges that they have undertaken all means necessary to obtain all necessary approvals (including that of the Patient), contractual undertakings and/or other necessary permissions as may be required in accordance with applicable laws in order to ensure that Variantyx can store, retain and utilize the Data as aforesaid. The Customer shall – insofar as possible – use Variantyx’s Test Requisition Form and Informed Consent to obtain all necessary approvals.
Data Reprocessing: Data will be available for reprocessing at an additional cost during the Data Retention Term. Reprocessing results may vary due to changes in the reference genome, variants reclassification and pipeline and databases changes among other reasons.
Research Use of Data: Anonymized data may be used by Variantyx for research purposes in accordance with patient’s consent in the Test Requisition Form
Submissions to Public Variant Databases: Variantyx may at its own discretion submit anonymized genomic and phenotypic data to public databases such as ClinVar.

10. Interpretation, Diagnosis and Reporting

Variantyx will analyze the Data in accordance with the specific Purchase Order and whenever needed will prepare Reports for the Customer in relation to all provided Samples that are analyzed and in respect to which it renders the Services in terms hereof (“Reports”).
Depending on the specific Purchase Order, Variantyx will provide or make available the Reports to the Ordering Physician either by fax or through Variantyx’s secured download method available at the time.
Any issued Report applies only to a specific Sample tested under the stated test conditions and the test results are not necessarily indicative of the qualities of apparently identical or similar test or operating conditions. Variantyx shall have no liability for any deductions, inferences or generalizations drawn by the Ordering Physician, the Customer (or any other parties) from a report.
Customer’s Ordering Physician may provide the Reports to the Patient, primary care physician or third parties (depending on the Patient’s consent and local laws) absolutely unchanged (including, but not limited to Variantyx´s letterhead, the content and the format of Variantyx´s original Report), and under no circumstances under its own, or the label of a third party unless explicitly agreed upon otherwise in the Purchase Order.
In case of any uncertainties, deficiencies or any other possible defect in the provided Report, the Ordering Physician shall immediately notify Variantyx and request further clarifications and eventual amendments to the provided Report. Variantyx shall without delay investigate assumed shortcomings of the Report, and if objections are justified amend the Report accordingly.
Limitations of the Test
1. Any preparation of a Sample, processing of the Data and interpretation of the results is based on the highest and most current scientific and analytical standard. The test is designed to look at the sequence of the protein coding regions of the DNA; however the current technology is not able to look at all of the sequence, and certain percentage of coding regions will not have sufficient coverage for analysis.
2. In some cases, Results may not identify an abnormality even though a genetic abnormality may exist. This may be due to limitations in current knowledge about a gene’s complete structure. It may be due to the fact that some types of genetic abnormalities causing a specific disorder have not yet been identified. The methods used by Variantyx are highly accurate. However, the chance of a false positive or false negative result, due to errors incurred during any phase of testing cannot be completely excluded. Certain mutation types may not be detectable.
3. The Results may not completely predict the severity of the disease, possible future problems, or response to treatment even in cases that the test finds genetic differences that are responsible for the symptoms.

11. Results Delivery

Report results will be made available for the Customer to download via the Variantyx Genomic Intelligence® secure online console or by fax.

12. Platform Use

Standard End User License. Variantyx grants to Customer a limited, nonexclusive, nontransferable license: (i) to access and use Genomic Intelligence® online console in accordance with Documentation supplied by Variantyx, solely for Customer’s internal use; (ii) to upload Customer Biological Data on behalf of and for the benefit of a Customer into Genomic Intelligence®; (iii) to generate Results and Reports solely on behalf of and for the benefit of Customer for Customer’s use.
User Accounts. The Customer account contact will provide Variantyx with relevant information to enable Variantyx to provide Customer with a user account for each Customer Representative that Customer identifies for access to the Genomic Intelligence® online console; “User Accounts”. Customer understands and agrees that User Accounts may not be shared by multiple individuals. Customer agrees that activities or inactivity of Customer Representative will be deemed actions or inactions of Customer and Customer is responsible and liable for any Customer Representative’s activities or inactivity in connection with this Agreement.
Content.
1. Variantyx may require separate Content licenses directly with Customer and Content rights owner(s), and Variantyx may restrict access to any such third party Content until the Content rights owner notifies Variantyx that Customer may access such third party Content.
2. Except as expressly set forth in this Agreement, Variantyx grants Customer no licenses of any kind to use or access the Content, whether by implication, estoppel, or otherwise. All rights in and to Content not expressly granted to Customer in this Agreement are expressly reserved for Variantyx and its suppliers.
3. Although most Content is obtained from sources considered by Variantyx to be reliable, some Content is sourced from the community of users and labs worldwide. The accuracy and completeness of Content is not guaranteed, neither by Variantyx nor any of its third party licensors or Content. Variantyx assumes no responsibility or liability for errors, delays, interruptions, omissions, or malfunctions with respect to Content or its delivery, regardless of the cause or source thereof. Variantyx assumes no responsibility for unintended, objectionable, inaccurate, misleading or unlawful third party Content made available through Genomic Intelligence®.
Variant Filtration, Classification and Reports
1. Variant filters are customizable and are intended for reference and decision support purposes only, and under no circumstances represent Variantyx’s recommendations. Customer acknowledges and agrees that Content and Results are not intended to be statements of fact or truth. Variantyx assumes no responsibility for the accuracy of underlying Content, literature and databases nor for the opinions and recommendations of authors of curated literature and databases.
2. Customer acknowledges that Variantyx provides multiple, configurable options for variant filtering and classification, and Customer accepts full responsibility for specifying and/or selecting the appropriate variant classification and/or filtering options, as appropriate. Customer also acknowledges and agrees that Content and Results are not intended to be medical advice or instructions for medical diagnosis, treatment or care, and no physician-patient relationship is, or is intended to be, created by Content provided through the Services. The Content is not a substitute for professional medical advice, examination, diagnosis or treatment and should not be used to diagnose, treat, cure, or prevent disease without supervision of a doctor or qualified healthcare.
3. Variantyx is not responsible for any liability or damages arising from Customer uploading Biological Data, opting-in for research features (including, but not limited to, sharing of anonymous allele frequency information), or sharing Results in violation of any agreement or law or policy or any third party agreement or rights; Customer is solely liable and responsible for these actions by Customer and Customer representatives.
General Restrictions. Except as expressly permitted in this Agreement, Customer and Customer Representatives agree not to: (i) access or use the Genomic Intelligence® in any way other than expressly permitted herein; (ii) use Genomic Intelligence® to develop functionality, data or Content similar to or competitive with any component of Genomic Intelligence® ; (iii) extract Content from Genomic Intelligence® or Results and incorporate it into any competitive application or service or offering; (iv) modify or translate any portion of the Content or Results to create any derivative work based on all or any portion of the Content or Results; (v) allow or permit any person other than named user to use Customer’s User Account; (vi) sell, rent, lease, loan, distribute or otherwise transfer all or any portion of the Content to a third party excluding the publishing or disclosing Results in a manner expressly permitted herein; (vii) reverse engineer, decompile, decrypt, disassemble or reduce any component of Genomic Intelligence® provided herewith to human readable form, or otherwise attempt to recreate all or any portion thereof, except and only to the extent otherwise expressly permitted under applicable law; (viii) display or disclose the Content or copies or parts thereof to any person other than for Customer’s internal purposes, excluding export, sharing or publication of Results in the manner expressly permitted herein; (ix) remove, alter, cover or obfuscate any copyright notices or other proprietary rights notices placed or embedded on or in any Content or Results; (x) fail to use commercially reasonable efforts to prevent the transmission of any code, files, scripts, agents, or programs containing viruses, worms, Trojan horses or other harmful or deleterious computer code, files, scripts, agents, or programs; (xi) perform any general or mass downloads of the Content or Results; (xii) use the Content for any purpose other than generating Results using the Genomic Intelligence® ; (xiii) represent to any third parties that Content or Results provide any diagnosis of any disease or condition; (xiv) use Results from Genomic Intelligence® for interpretation of Variant Samples outside Genomic Intelligence® ; (xv) falsify a Variant Sample by uploading a dataset not derived from bona fide biological samples, including but not limited to simulated, computer-generated, edited, engineered, reshuffled, or combined variant datasets. and/or (xvi) cause, authorize, or assist any third party (including Customer Representatives) to do any of the foregoing.
Other Customer Responsibilities and Limitations. Customer shall (i) be responsible and liable for any action or inaction of Customer Representatives which is in violation of this Agreement, (ii) not upload (or cause to be uploaded) any Customer Biological Data if uploading it is unlawful, illegal, or otherwise in violation of a third party right or obligation Customer has to a third party, (iii) be responsible, assume the risk and be liable for the accuracy, quality, integrity and legality of Customer Biological Data and of the means by which Customer and Customer Representatives acquire, upload, transmit and process Customer Biological Data, (iv) use commercially reasonable efforts to prevent unauthorized access to or use of the Genomic Intelligence® by anyone other than a Customer Representative and notify Variantyx promptly of any such unauthorized access or use, (v) use the Genomic Intelligence® only in accordance with Variantyx Documentation, this Agreement and applicable laws and government regulations, (vi) make any disclosures to and obtain any consents or permission as required by any applicable law, rule or regulation (including privacy laws) or contractual obligation (including confidentiality obligations) for the use, uploading, processing, transfer, disclosure, sharing, storage or access to Customer Biological Data; and (vii) be responsible for obtaining and maintaining appropriate equipment and ancillary services needed to connect to, access or otherwise use the Genomic Intelligence® , including, without limitation, computers, computer operating system and web browser.
Publishing Results Outside Genomic Intelligence®. In addition to Customer’s license rights set forth in this Agreement, Customer may publish in a scientific journal or otherwise publish or disclose to third parties the Results provided, however, that (i) any such publication that discloses Content shall require Variantyx’s and, as applicable, any Third Party Content rights owners prior written consent and (ii) any such publication shall include recognition of the contributions of Variantyx and/or use of Genomic Intelligence® , as appropriate.

13. General Provisions

Representations and Warranties; Compliance with Laws and Permit: Each Party represents and warrants to the other Party that:
1. It is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation.
2. By entering into an Agreement each Party will comply with all laws, rules, regulations, orders and/or bylaws applicable to its performance of the Agreement, and will adhere to the principles of good clinical practice. Each Party is responsible for obtaining all and any such permits, consents and approvals as it may require to carry out and to perform its tasks under the Agreement.
3. It has all requisite power and authority to carry on its business and to own and operate its properties and assets. The execution, delivery and performance of any Agreement has been duly authorized by its authorized body. Such Party has obtained all authorizations, consents and approvals, governmental or otherwise, necessary for the execution and delivery under the Agreement, and to otherwise perform such Party’s obligations under the Agreement.
4. There is no pending or, to its knowledge, threatened litigation or other legal process involving it which would have any material adverse effect on the Agreement or on its ability to perform its obligations hereunder.
5. There is no indenture, contract, or agreement to which it is a Party or by which it is bound which prohibits or would prohibit the execution and delivery by it under the Agreement or the performance or observance by it of any material term or condition under the Agreement.
6. Infringement. Each party represents and warrants that, to the best of its knowledge, the Services will not infringe the Intellectual Property rights of any third party.
Term and Termination. The Agreement may be terminated as follows: (i) by expiration of or conclusion of the Agreement; (ii) by agreement in writing between the Parties; (iii) by Variantyx, if Customer has failed to pay three (3) subsequent invoices; (iv) By any party if a material breach of the Agreement by the other party remains uncured 60 days after notice of the material breach was received by the other party and (v) by any Party upon the other Party’s institution insolvency, receivership or bankruptcy proceedings or any other proceedings for the settlement of its debts.
Indemnification, Limitation of Liability, Insurance
1. Third Party Claims. Each party shall defend, indemnify and hold the other party and its Affiliates and its and their directors, officers, employees, agents and consultants and legal, financial, accounting and other advisors (“Related Persons”) harmless from and against any and all liabilities and damages (including reasonable attorneys’ fees) (“Losses”) resulting from any third party claims, demands, suits or proceedings (“Claims”) to the extent arising out of or relating to (a) in the case that Variantyx is the indemnifying party, its performance of the Services, (b) in the case that Customer is the indemnifying party, its use of Project IP or deliverables produced under the Agreement, (c) a material breach of the Agreement by the indemnifying party, (d) a material violation of applicable law by the indemnifying party or any of its Related Persons or (e) the negligence, recklessness or willful misconduct of the indemnifying party or any of its Related Persons during the course of activities carried out in connection with the Agreement. The indemnification obligations set forth in this Section do not apply to the extent that the Loss arises in whole or in part from the negligence, recklessness or willful misconduct of the indemnified party or any of its Related Persons.
2. Defense: Each party shall notify the other party promptly upon learning of a Claim that is subject to indemnification pursuant to the terms of this Agreement. The indemnifying party may control, at its own expense, the defense of the Claim in good faith with counsel of its choice as long as such counsel is reasonably acceptable to the indemnified party. The indemnified party shall use reasonable efforts to cooperate in the defense and may participate at its own expense using its own counsel. No compromise or settlement of any Claim may be made by the indemnifying party without the indemnified party’s written consent unless (a) there is no finding or admission of any violation of law or any violation of the rights of any person and no effect on any other claims that may be made against the indemnified party, (b) the sole relief provided is monetary damages that are paid in full by the indemnifying party and (c) the indemnified party’s rights under the Agreement are not adversely affected.
3. Limitations on Liability. Except for Losses resulting from Claims for which a party has indemnification obligations or damages arising from breach of confidentiality obligations or from a party’s gross negligence or willful misconduct: (a) neither party will be liable to the other party for breach-of-contract damages that (i) the breaching party could not reasonably have foreseen on entry into the Agreement or (ii) result from special circumstances of the non-breaching party; and (b) Variantyx’s maximum aggregate total liability in connection with the Agreement will not exceed the total payments received under the Agreement.
4. Basis of the Bargain. Customer acknowledges and agrees that Variantyx has set its prices and entered into this Agreement in reliance upon the disclaimers of warranty and the limitations of liability set forth herein, that the same reflect an allocation of risk between the parties (including the risk that a contract remedy may fail of its essential purpose and cause consequential loss), and that the same form an essential basis of the bargain between the parties Intellectual Property
5. Insurance. Each party shall ensure that insurance coverage is carried and maintained with a financially sound and reputable insurer against loss from such risks and in such amounts as is sufficient to support its obligations under the Agreement. Each party shall provide a copy of the applicable insurance policy if requested by the other party.
Warranty Disclaimer. Variantyx and its suppliers provide the Licensed Materials and any services provided in connection herewith “AS IS” and make no warranty express, implied, statutory, or arising from course of performance, dealing, usage or trade, with respect to Licenses Materials, services delivered hereunder or any part thereof, including without limitation any implied warranty of title, availability, reliability, usefulness, data accuracy, completeness, merchantability, fitness for a particular purpose or non-infringement. Neither Variantyx nor any of its suppliers warrants that the licensed materials or any part thereof or service delivered hereunder will meet customer’s requirements or be uninterrupted, timely, available or error free.
Intellectual Property and Trademarks
1. Ownership. (a) Except as otherwise provided in the Agreement, (i) Variantyx has no rights in any Intellectual Property that is owned by or licensed to Customer or any of its Affiliates (“Customer IP”) and (ii) Customer has no rights in any Intellectual Property that is owned by or licensed to Variantyx or any of its Affiliates (“Variantyx IP”).
2. Licensed Materials. Customer acknowledges that Variantyx and its supplier(s) own and shall retain all intellectual property rights and other proprietary rights in and to the Licensed Materials and any other materials and information Variantyx provides to Customer as part of this Agreement, including without limitation any derivatives, improvements or modifications of the foregoing, whether or not made by Variantyx.
3. Feedback. To the extent Customer (and/or Customer Representatives) provide or make available to Variantyx any suggestions; ideas; improvements; modifications; feedback; error identifications; Content corrections or additions; variant classifications; pooled anonymized allele frequency data, opinions regarding the appropriateness of a particular curated article to the clinical assessment of one or more variants; or other content or information related to the Licensed Materials (other than the Customer Biological Data) (“Feedback”), Customer and Customer Representatives hereby grant Variantyx a fully paid-up, irrevocable, perpetual, worldwide, nonexclusive license, with full rights to sublicense, to: (i) use and exploit such Feedback to improve Variantyx’s products and services and, (ii) use, reproduce, prepare derivative works of, perform, display, make, sell and otherwise distribute products and services incorporating or utilizing such Feedback.
4. Products and Services supplied to the Customer are marked with the respective trademarks (“Product Trademarks”), which may not be modified or removed and no further materials, documents, stickers, etc. may be added to the Products or Results of the Services.
5. Customer may use the Product Trademarks and those other trademarks, trade names, service marks and logos of Variantyx contained in or on the Products and the Reports provided under the Services (“Variantyx Marks”), but only as set forth, and in the manner indicated. Prior to any such use, Customer shall, in writing or by email, provide to Variantyx copies of any such materials at least ten (10) business days before their proposed release and obtain Variantyx’s prior approval (in writing or by email) to use Variantyx Marks in connection therewith. Variantyx shall not unreasonably withhold or delay its approval of such materials.
Confidentiality, Non-Disclosure
1. Each Party may, for purposes of the implementation and performance of the Agreement, exchange with or disclose to the other Party non-public information and/or data, which either has been identified in writing as being of a confidential nature, or is of such a nature (or has been disclosed in such a way) that it should be obvious to the other Party that it is claimed as being confidential (hereinafter “Confidential Information”).
2. Unless otherwise agreed in writing, the Receiving Party shall keep the Confidential Information strictly confidential, shall only use the Confidential Information for the purpose of the Agreement, disclose it only to such of its employees as have a need to know, and not disclose the Confidential Information to third parties without the prior written consent of the Disclosing Party. Each Party shall also treat the details of this Agreement, the details of the negotiations leading to this Agreement, and the information handed over to such Party during the course of negotiations strictly confidential.
3. The aforesaid confidentiality obligations shall not apply to any information that (i) is, at the time of disclosure, already in the Receiving Party’s possession; (ii) is or becomes generally available to the public other than as a result of a breach of the Agreement; or (iii) becomes available on a non-confidential basis to the Receiving Party from a source other than the Disclosing Party, provided that such source is not bound by a confidentiality agreement or other legal or fiduciary obligation of secrecy; or (iv) is required to be disclosed by applicable law or order of a court of competent jurisdiction (provided, that in either case if Receiving Party is required to make such disclosure, it shall immediately give written notice to Disclosing Party of its obligation to make such disclosure).
4. The Parties furthermore expressly undertake to maintain data confidentiality with respect to the personal data of Patients. Customer shall ensure that its obligations owed to Variantyx in terms hereof do not conflict with any data protection regulations.
Force Majeure
1. Neither party shall be liable for non-fulfillment of its obligations under the Agreement if such non-fulfillment is due to an occurrence of force majeure. Each party shall use reasonable efforts to mitigate adverse consequences.
2. In the event of force majeure, the Parties shall immediately consult with each other in order to find an equitable solution and shall use all reasonable endeavors to minimize the consequences of such force majeure.
Assignment. No Party shall assign the Agreement to any third party without the prior written consent of the other Party.
Entire Agreement; Non-Reliance. The Agreement contains the entire agreement between the parties with respect to the subject matter of the Agreement. Prior agreements are hereby superseded.
Amendment. No modification or waiver of any term of the Agreement or any other form of amendment to the Agreement will be binding unless made expressly in writing and signed by both parties.
No Third Party Beneficiaries. The provisions of the Agreement are for the sole benefit of the parties.
Waiver. The waiver by either party of any breach of any term of the Agreement will not constitute a waiver of any other breach of the same or any other term. Failure or delay on the part of either party to fully exercise any right under the Agreement will not constitute a waiver or otherwise affect in any way the same or any other right.
Severability. If any provision in the Agreement is held to be invalid, illegal or unenforceable in any respect, then (a) the provision will be replaced by a valid and enforceable provision that achieves as far as possible the intention of the parties and (b) all other provisions of the Agreement will remain in full force and effect as if the original Agreement had been executed without the invalidated, illegal or unenforceable provision
Language. This Agreement, any disputes hereunder, and all services to be provided hereunder by Variantyx to Customer (if any) shall be conducted and provided in the English language. Any translated version of this Agreement shall be only for convenience and filing with the appropriate government agency, if required, and not for interpretation of this Agreement.
Anonymous Data. Variantyx may utilize data capture and analysis tools, to create non-personally identifiable and aggregate data or information resulting from its customers’ use of Genomic Intelligence®, which may include non-personally identifiable and aggregate Customer Biological Data, Results and Customer’s usage patterns (“Anonymous Data”). Variantyx may (i) use and analyze the Anonymous Data to develop and improve its Products and Services. Variantyx will ensure that no personally identifiable information is disclosed through the Variantyx products and services to any third party without Customer’s consent.
Choice of Law; Venue. This Agreement is governed and interpreted in accordance with the laws of the State of Massachusetts, U.S.A..
Notice. Any and all notices or other information to be given by one of the parties to the other shall be deemed sufficiently given when sent by certified mail (receipt requested), or by courier, or by hand delivery to the other party. Such notices shall be deemed to have been effective on the first business day following the day of such delivery.
Headings. Headings are solely for reference and shall not affect the meaning of any term.