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GET STARTED TODAYSUN GENOMICS, INC. TERMS AND CONDITIONS
Effective Date: May 25, 2018
PLEASE READ THESE TERMS OF SERVICE CAREFULLY. BY ACCESSING OR USING THE PRODUCT AND SERVICES (AS DEFINED BELOW), YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS DESCRIBED HEREIN AND ALL TERMS, POLICIES, GUIDELINES AND DISCLOSURES INCORPORATED BY REFERENCE. IF YOU DO NOT AGREE TO ALL OF THESE TERMS, DO NOT USE THE SERVICE.
These Sun Genomics, Inc. Terms and Conditions (“Terms”) govern your (“you” or “user”) access to and use of the, products, services, programs, websites, software applications and any other part, section, trial, and/or component (including knowledge gained) (collectively, the “Service”) provided by Sun Genomics, Inc. (hereinafter referred to as, “Sun Genomics,” “we,” or “us”). These Terms do not alter in any way the terms or conditions of any prior written agreement you may have with Sun Genomics. By subscribing to or otherwise using the Service or accessing any content or material that is made available by Sun Genomics through the Service, you agree to be bound by these Terms.
Please note that some features of the Service may be provided under additional and separate legal agreements. If that is the case, when you first participate in or use this Service, you will be provided an opportunity to review and agree to the terms that govern this Service. If there is a conflict between these Terms and the specific terms of service for a particular Service, the specific, applicable terms will apply.
Right to Change/Modify
Sun Genomics reserves the right to change or modify these Terms or any policy or guideline incorporated herein at any time and in its sole discretion. Any changes or modifications will be effective immediately upon posting of the revisions on the Service. Your continued use of the Service following the posting of such changed or modified Terms will constitute your acceptance of such changes or modifications. Therefore, you should frequently review these Terms and any applicable policies from time to time to understand the terms and conditions that apply to your use of the Service.
Right of Refusal
Sun Genomics reserves the right to refuse to provide Services as defined herein to any customer and/or potential customer and shall not be required to be provide a basis for such a decision to the customer.
Intellectual Property
The Service, and all designs, text, graphics, pictures, material (physical and digital), videos, information, data, and software contained in or comprising the Service, except for the User Content, as defined below (collectively, the “Materials”) are the property of Sun Genomics or Sun Genomics’ licensors and are protected by U.S. and international copyright, trademark laws, patent, and other intellectual property laws.
Limited License
Sun Genomics grants you a limited, non-exclusive, revocable license to make personal, non-commercial use of the Service and the Materials. This license shall remain in effect until and unless terminated by you or Sun Genomics. You promise and agree that you are using the Service for your own personal, non-commercial use and that you will not redistribute or transfer the Service.
Sample Testing
Sun Genomics offers a host of products and services (hereinafter, “Products”) available for order on its Website. These Products, including, but not limited to, FLORÉ and the representations regarding the same are subject to these Terms. Sun Genomics’ offered Products include an opportunity for you to submit various samples which may include one or more of stool, blood, saliva, cheek swab, and/or urine, using test kits provided by Sun Genomics (hereinafter, “Sample”). ANY SAMPLE, ONCE SUBMITTED TO SUN GENOMICS IS ANALYZED AND PROCESSED IN AN IRREVERSIBLE MANNER AND NO SUCH SAMPLE MAY BE RETURNED TO YOU AFTER SUBMISSION. FURTHERMORE, NO REFUND WILL BE GIVEN ONCE A USER’S SAMPLE HAS BEEN SENT FOR SEQUENCING.
You understand and agree that you transfer and assign all right and title to that Sample after submission of the same and the information derived there is property of Sun Genomics and/or its assignees.
Sun Genomics may not be able to process your Sample and the laboratory process may result in errors. The laboratory may not be able to process your Sample if your Sample does not contain a sufficient volume of DNA, you do not provide enough of a Sample, or the results from processing do not meet our standards for accuracy. If the initial processing fails for any of these reasons, Sun Genomics will reprocess the same Sample at no charge to the user. If the second attempt to process the same Sample fails, Sun Genomics will offer to send another kit to the user to collect a second Sample at no charge. If the user sends another Sample and Sun Genomics' attempts to process the second Sample are unsuccessful, (up to 0.35% of all Samples fail the second attempt at testing according to Sun Genomics data obtained in 2014 for all genotype testing), Sun Genomics will not send additional Sample collection kits and the user will be entitled solely and exclusively to a complete refund of the amount paid to Sun Genomics, less shipping and handling, provided the user shall not resubmit another sample through a future purchase of the Service.
You should not expect nor are you entitled to any financial benefit as a result of submission of your Sample. You understand that by providing any Sample, having your Sample processed, accessing your Sample, or providing any self-reported information that you have done so voluntarily and that you acquire no rights in any research or commercial products that may be developed by Sun Genomics or its collaborating partners. You specifically understand that you will not receive compensation for any research or commercial products that include or result from your Sample or information you provide to Sun Genomics.
Jurisdictional Statement
Sun Genomics does not represent that Materials are appropriate or made available for use outside of the United States of America. This website may contain links to other sites. If so, and if you choose to use the services provided by those third-party websites, you may be asked by those sites to provide certain personally identifiable information. Sun Genomics is not responsible for the privacy practices of those sites. Please be aware if or when you leave our site, read the privacy policies of each and every website that you visit. These Terms apply solely to this website. Sun Genomics is not responsible for the contents of any linked site or any link contained in a linked site.
Conditions of Use
When you register for an account you must (a) provide accurate and complete information, and (b) update such information from time to time as necessary to keep your registration information current and accurate. By establishing an account, you represent and warrant that you have the right to, and are authorized to, provide the information you provide when you register for the account. You are responsible for maintaining the confidentiality of your account information and password and for restricting access to such information and to your computer. All activities that occur under your account or password will be your responsibility. In using the Service, you agree not to engage in any of the following activities: (a) any resale or commercial (non-personal) use of the Service or the Materials therein; (b) the distribution, public performance or public display of any of the Materials; (c) any modification or derivative use of the Service or the Materials, or any portion thereof; (d) any use of automated means, including spiders, robots, crawlers, data mining tools, or the like to download data from the Service; (e) the download (other than page caching) of any portion of the Service, the Materials, or any information contained therein, except as expressly permitted; (f) any attempt to gain unauthorized access to Sun Genomics’ servers or computer systems or to engage in any activity that disrupts, diminishes the quality of, interferes with the performance of, or impairs the functionality of, any part of the Service; (g) the collection or harvesting of any personally identifiable information, including, but not limited to, company names, domain names or account names, from the Service, or the use of communication systems provided by the Service for any commercial solicitation purposes; (h) the use of any portion of the Service as a destination linked from any unsolicited bulk messages or unsolicited commercial messages; or (i) any use of the Service or the Materials other than for their intended purpose.
User Content
Some features of the Service may include functionality enabling you to post content, such as profiles, notes, messages, photos, and videos (“User Content”) that may be made available to Sun Genomics and/or other users of the Service. Sun Genomics has the right to refuse any User Content. You agree that Sun Genomics, at its sole discretion, has the right to screen, reject, or remove any User Content, or any portion thereof, posted using the Service that infringes Sun Genomics’ or any third party’s intellectual property or other rights, violates these Terms or our other policies, or is otherwise objectionable.
Sun Genomics reserves the right to disclose any User Content as necessary to satisfy any applicable law, regulation, legal process or governmental request. Sun Genomics has the right to suspend or terminate the Service at any time without preserving your User Content. In using the Service, you agree not to post any User Content that (a) is false, deceptive, deceitful, misleading, unlawful, libelous, defamatory, obscene, pornographic, indecent, lewd, suggestive, harassing, threatening, invasive of privacy or publicity rights, abusive, inflammatory, harmful to minors, fraudulent or otherwise objectionable; (b) would constitute, encourage or provide instructions for a criminal offense, violate the rights of any party, or that would otherwise create liability or violate any local, state, national or international law; (c) may infringe any patent, trademark, trade secret, copyright or other intellectual or proprietary right of any party; (d) impersonates any person or entity or otherwise misrepresents your affiliation with a person or entity; (e) contains private or confidential information of any third party, including, without limitation, addresses, phone numbers, email addresses, Social Security numbers and credit card numbers; (f) contains viruses, spyware, malware, corrupted data or other harmful, disruptive or destructive files; (g) in the sole judgment of Sun Genomics, may expose Sun Genomics to any harm or liability of any type; or (h) harasses, degrades, intimidates or is hateful toward an individual or group of individuals for any reason and especially on the basis of religion, gender, sexual orientation, race, ethnicity, age or disability. By posting User Content, you grant Sun Genomics and its affiliates a perpetual, irrevocable, worldwide, royalty-free, freely transferable and sub-licensable (through unlimited levels of sublicense) non-exclusive right to use, reproduce, modify, transmit, publish, display, distribute, and create derivative works of such User Content for purposes of delivering the Service to you and other users of the Service. You represent and warrant that: (a) you own and control all of the rights to the User Content that you post or you otherwise have the right to post such User Content and to grant the rights granted herein; (b) the User Content is accurate and not misleading; and (c) distribution of the User Content you supply in accordance with your direction does not violate these Terms and will not violate any rights of or cause injury to any person or entity. You hereby waive any moral rights you may have in such User Content under the laws of any jurisdiction.
All rights are reserved to Sun Genomics. You may not modify, copy, reproduce, republish, upload, transmit, broadcast, sell or distribute in any way any material from this website or Products without express written permission from Sun Genomics. Other featured words or symbols, used to identify the source of goods and services, may be the trademarks of Sun Genomics. Pursuant to Title 17, United States Code, Section 512(c)(2), notifications of claimed copyright infringement should be sent to the service provider’s designated agent.
You agree that you will not, and will not assist or enable others to use the website: (a) to threaten, stalk, defraud, incite, harass, or advocate the harassment of another person or entity, or otherwise interfere with use of the website; (b) in violation of these Terms or any applicable law; (c) to modify, adapt, appropriate, reproduce, distribute, translate, create derivative works or adaptations of, publicly display, sell, trade, link to, or in any way exploit the website or website content except as expressly authorized by Sun Genomics; (d) to mine, record or gather information about other users.
Sun Genomics may terminate or suspend your account and/or ability to use the website, in whole or in part, at our sole discretion, for any or no reason, and without notice or liability of any kind.
Privacy Policy
The Sun Genomics' Privacy Policy describes how Sun Genomics collects, uses, discloses and protects your personally identifiable information, including any protected health information, in connection with the Service. The Privacy Policy is hereby incorporated by reference into these Terms and your acceptance of the Terms shall constitute your acceptance of the Privacy Policy.
Disclaimer and Liability
THE WEBSITE, ALL WEBSITE CONTENT, AND ALL SERVICES OFFERED BY SUN GENOMICS, INCLUDING, BUT NOT LIMITED TO FLORÉ, IS MADE AVAILABLE TO YOU ON AN "AS IS" BASIS. SUN GENOMICS MAKES NO WARRANTIES, REPRESENTATIONS, OR CONDITIONS OF ANY KIND, EXPRESS, STATUTORY OR IMPLIED AS TO (1) THE OPERATION AND FUNCTIONALITY OF THE WEBSITE OR PRODUCTS, (2) THE ACCURACY, INTEGRITY, COMPLETENESS, QUALITY, LEGALITY, USEFULNESS, SAFETY, AND INTELLECTUAL PROPERTY RIGHTS OF ANY OF THE SITE CONTENT, INCLUDING BUT NOT LIMITED TO THE ACCURACY OF INFORMATION LISTED ON THIS WEBSITE, AND (3) THE PRODUCTS AND SERVICES ASSOCIATED WITH AND/OR SOLD ON THE WEBSITE, AND (4) SUN GENOMICS FURTHER DISCLAIMS ALL WARRANTIES, EXPRESS, STATUTORY, OR IMPLIED WITH RESPECT THERETO, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY, MERCHANTABLE QUALITY, DURABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. IN NO CASE SHALL SUN GENOMICS, ITS DIRECTORS, OFFICERS, EMPLOYEES, AFFILIATES, AGENTS, CONTRACTORS, OR LICENSORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, PUNITIVE, SPECIAL, OR CONSEQUENTIAL DAMAGES ARISING FROM AND/OR RELATED TO YOUR USE OF THE WEBSITE AND/OR OF ANY OF PRODUCTS SOLD THEREON, INCLUDING, BUT NOT LIMITED TO, ANY ERRORS OR OMISSIONS IN ANY CONTENT, OR ANY LOSS OR DAMAGE OF ANY KIND INCURRED AS A RESULT OF THE USE OF ANY PRODUCT CONTENT (OR PRODUCT) POSTED, TRANSMITTED, OR OTHERWISE MADE AVAILABLE VIA THE SERVICE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. BECAUSE SOME STATES OR JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR THE LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, IN SUCH STATES OR JURISDICTIONS, SUN GENOMIC’S LIABILITY SHALL BE LIMITED TO THE EXTENT PERMITTED BY LAW.
Indemnity
You agree to indemnify Sun Genomics and its agents and representatives from and against any and all liabilities, expenses (including attorneys' fees) and damages from any claim or demand made by any third-party due to or arising out of (i) your access or use of the website or of the Products sold thereon, (ii) your violation of these Terms, or (iii) the infringement by you, or any third-party using your account, of any intellectual property or other right of any person or entity.
Use of Website
You affirm that you are either more than 18 years of age, an emancipated minor, or possess legal parental or guardian consent, and are able and competent to enter into the terms and conditions set forth in these Terms. You must be at least thirteen (13) years of age to use this website. If you are under 13 years of age, then please do not use this website.
Charges and Billing
Sun Genomics charges a fee for certain Products. You must provide a valid credit card number when you order a Product. You represent and warrant that you are authorized to use such credit card, and you agree to pay all charges incurred using your account. You agree that we may pass your credit card information and related personally identifiable information to our designated service provider(s) for their use in charging you for the Product ordered by you. All charges are exclusive of sales and other taxes and you are responsible for payment of any applicable taxes (other than taxes on Sun Genomics income). We reserve the right to accept or reject orders for any reason. Price and availability of Products are subject to change without notice (unless you have purchased an ongoing subscription to a Sun Genomics Product, in which case the subscription price paid by you for such service shall apply during the term of such subscription). You agree that any payment submitted by you for Sun Genomics Products is submitted on behalf of yourself, without expectation of any reimbursement by third-party payers. Sun Genomics will not submit any information provided by you for reimbursement or payment from private insurance carriers, Medicare, Medicaid, or any other third-party payers. Sun Genomics may offer paid service plans which provide for ongoing Products over a specified period of time (for example, quarterly or annually). Any such plan shall automatically renew at the end of the stated service period (and again at the end of any subsequent renewal period) at the then-current renewal price until cancelled. Please note that Sun Genomics may provide refund(s) for current service plans or enrollments at its sole discretion regardless of when you cancel your account before the current service period expires. In addition, you may be responsible for paying any balance due on the account when you cancel. You agree that we may charge any unpaid fees to you through the payment method you provided during registration, and/or we may send you a bill for such unpaid fees. Sun Genomics will not provide a refund once a User’s Sample is sent for DNA sequencing and/or analysis.
Dispute Resolution
All disputes arising out of these Terms shall be submitted to mediation in accordance with the rules of Arts Arbitration and Mediation Services, a program of California Lawyers for the Arts. If mediation is not successful in resolving all disputes arising out of these Terms, those unresolved disputes shall be submitted to final and binding arbitration. The arbitrator shall be selected in accordance with the rules of Arts Arbitration and Mediation Services, a program of California Lawyers for the Arts. If such services are not available, the dispute shall be submitted to arbitration in accordance with the laws of the State of California. The arbitrator's award shall be final, and judgment may be entered upon it by any court having jurisdiction thereof. All disputes arising out of this these Terms shall be submitted to final and binding arbitration. The arbitrator shall be selected in accordance with the rules of Arts Arbitration and Mediation Services, a program of California Lawyers for the Arts. If such services are not available, the dispute shall be submitted to arbitration in accordance with the laws of the State of California. The arbitrator's award shall be final, and judgment may be entered upon it by any court having jurisdiction thereof. Testimony shall be permitted by telephone, video conference and other forms of real-time communications. If the arbitrator requires in-person hearings, the hearings shall be held in San Diego, California. The arbitral award will be final and binding and may be entered and enforced in any court of competent jurisdiction. In no event shall any claim, action or proceeding related in any way to the Service be instituted more than two (2) years after the cause of action arose.
Waiver of Jury Trial and Class Action Suits
BY ENTERING INTO THESE TERMS, YOU AND SUN GENOMICS ACKNOWLEDGE AND AGREE TO WAIVE CERTAIN RIGHTS TO RECEIVE A JURY TRIAL OR TO PARTICIPATE AS A PLAINTIFF OR AS A CLASS MEMBER IN ANY CLAIM ON A CLASS OR CONSOLIDATED BASIS OR IN A REPRESENTATIVE CAPACITY.
Limitation of Claims
You agree that regardless of any statute or law to the contrary, any claim or cause of action arising out of, related to or connected with the use of this website or these Terms must be filed within one (1) year after such claim or cause of action arose or be forever banned. This provision only applies if you purchased Services from this website for resale to others (that is, it does not apply to consumer transactions).
Applicable Law
These Terms and the resolution of any dispute related to these Terms or the Service shall be governed by and construed in accordance with the laws of the State of California, United States of America, without giving effect to that state’s principles of conflicts of laws. The federal and state courts of the State of California shall have exclusive jurisdiction over all claims.
Severability
If any provision these Terms should be determined to be invalid, illegal or unenforceable for any reason by any court of competent jurisdiction then such provision shall be enforced only to the extent it is enforceable and the remaining provisions shall survive and remain in full force and effect and continue to be binding and enforceable.
Assignability
Neither party may assign these Terms without the written consent of the other and any attempt to do so shall be void, except that these Terms may be assigned as part of a merger or acquisition of substantially all of the assets or stock of the assigning party.
Relationship
You agree that no joint venture, partnership, employment, or agency relationship exists between you and Sun Genomics.
Waiver
No waiver of any term, provision or condition of these Terms, whether by conduct or otherwise, in any one or more instances, shall be deemed to be, or shall constitute, a waiver of any other term, provision or condition hereof, whether or not similar, nor shall such waiver constitute a continuing waiver of any such term, provision or condition hereof. No waiver shall be binding unless executed in writing by the party making the waiver.
Force Majeure
If the performance of any part of these Terms by either party is prevented, hindered, delayed or otherwise made impracticable by reason of any flood, riot, fire, judicial or governmental action, labor disputes, act of God or any other causes beyond the control of either party, that party shall be excused from such to the extent that it is prevented, hindered or delayed by such causes.
Entire Agreement
These Terms constitute the complete and exclusive statement of the agreement between the parties with respect to the use of the Service and any acts or omissions of Sun Genomics, and supersedes any and all prior or contemporaneous communications, representations, statements and understandings, whether oral or written, between the parties with respect to the subject matter thereof. You agree to abide by our Terms and not to use the Service or any part thereof in any manner not expressly permitted by these Terms. Except for the rights expressly granted to you in these Terms, Sun Genomics grants no right, title, or interest to you in the Service. Any Sun Genomics software applications of the Service are licensed, not sold, to you, and Sun Genomics and its licensors retain ownership of all copies of the Sun Genomics software applications even after installation on your personal computers, mobile handsets, tablets, and/or other relevant devices. Third party software (for example, open source software libraries) included in the Sun Genomics Service are licensed to you either under these Terms or under the relevant third party software library’s license terms as published in the help or settings section of the application and/or on our website.
Sun Genomics Online Privacy Policy
Effective Date: July 23, 2018
Information We Collect
When you use our website, customer portal or other Sun Genomic related platform, such as to purchase something from our online store, we collect certain personal information from you, such as your name, address and email address, as part of the buying and selling process. We also automatically receive your computer’s internet protocol (IP) address in order to provide us with information that helps us learn about your internet browser and operating system.
How We Share Personal Information
We may share some of your personal information with our business partners or entities that perform services on our behalf. In general, the third-party providers we use will only collect, use and disclose your personal information to the extent necessary to allow them to perform the services they provide to us.
Certain third-party service providers, such as payment gateways and other payment transaction processors, have their own privacy policies for the information we are required to provide to them for your online transactions. For these providers, we recommend that you read their privacy policies so you can understand the manner in which your personal information will be handled. In particular, remember that certain providers may be located in, or have facilities that are located in, a different jurisdiction than either you or us. If you elect to proceed with a transaction that involves the services of a third-party service provider, your personal information may become subject to the laws of the jurisdiction(s) in which that service provider or its facilities are located. For example, if you are located in Canada and your transaction is processed by a payment gateway located in the United States, your personal information used in completing that transaction may be subject to disclosure under United States laws and regulations, including the USA PATRIOT Act.
We may disclose your personal information where we believe necessary to comply with legal or regulatory obligations, or if you violate our Terms of Service.
Once you leave our website or are redirected to a third-party website or application, you are no longer governed by this online privacy policy or our website’s Terms of Service.
Our online store uses Google Analytics to help us learn about your store visits and the pages being viewed.
Email marketing (if applicable): We may send you emails about our online store, new products and other updates.
Our Relationship with Shopify, Inc.
Our online store is hosted on Shopify Inc. Shopify provides us with an online e-commerce platform that allows us to sell our products and services to you. In providing information in our online store, you may be also providing that information to Shopify. Information collected by Shopify is subject to their Terms of Service and Privacy Policy. We may also share information with Shopify for the purpose of providing you with our products and services.
Revising Your Personal Information
You may revise your personal information by going to the User Profile on our website. You may login, view and revise your personal information.
Links
When you click on links on our online store, they may direct you away from our site. We are not responsible for the privacy practices of other sites and encourage you to read their privacy statements.
Protection of Personal Information
To protect your personal information, we take reasonable precautions and follow industry best practices to ensure it is not lost, misused, accessed, disclosed, altered or destroyed.
If you provide us with your credit card information, the information is encrypted using secure socket layer technology (SSL) and stored with AES-256 encryption. Although no method of transmission over the Internet or electronic storage is 100% secure, we follow all PCI-DSS requirements and implement additional generally accepted industry standards.
Our Use of Cookies and Similar Tools
Our website uses cookies to provide you with a better online shopping experience. The types of cookies we use include the following:
- session_id, unique token, sessional -Allows Shopify to store information about your session (referrer, landing page, etc).
- shopify_visit, no data held, persistent for 30 minutes from the last visit - Used by our website provider’s internal statistics tracker to record the number of visits.
- shopify_uniq, no data held, expires at midnight (relative to the visitor) of the next day - Counts the number of visits to a store by a single customer.
- cart, unique token, persistent for 2 weeks - Stores information about the contents of your cart.
- secure_session_id, unique token - Sessional
- storefront_digest, unique token, indefinite - If the website’s online storefront has a password, this is used to determine if the current visitor has access.
- PREF, persistent for a very short period of time - Set by Google and tracks who visits the store and from where
Your browser may permit you to disable some or all of these cookies, but doing so may affect your experience on our website.
Our website does not respond differently or limit our practices set forth under this online privacy policy when you access the website with a browser that uses a “do not track” signal or similar mechanism.
Use of Our Site by Minors
By using this website, you represent that you are at least the age of majority in your state or province of residence, or that you are the age of majority in your state or province of residence and that you have given us your consent to allow any of your minor dependents to use this site.
We do not intend to invite children to visit our website and we do not knowingly collect or retain personal information from children under the age of thirteen (13). For more information on the Children’s Online Privacy Protection Act (COPPA), please visit the Federal Trade Commission website at www.ftc.gov.
Updates to this Online Privacy Policy
We reserve the right to modify this online privacy policy at any time, so please review it frequently. Any revised version will be posted on the website with the revised effective date and changes and clarifications will take effect immediately on the posting of the revised version. If we make material changes to this policy, we will notify you here that it has been updated, so that you are aware of what information we collect, how we use it, and under what circumstances, if any, we use and/or disclose it.
If all or a portion of our business is acquired by another entity, your personal information may be transferred to one or more other entities.
Questions and Contact Information
If you would like to view, correct, amend or delete any personal information we have about you, register a complaint, or simply want more information about our privacy policy, please contact our Privacy Compliance Officer at privacy@sungenomics.com or by mail at
Sun Genomics
[Re: Privacy Compliance Officer]
2801 B Street San Diego California US 92102
INFORMED CONSENT FORM.
Project Title: Internal testing and quality assessment of extracting DNA from stool samples and suitability for use for sequencing, genotyping, and/or in an assay for microbiome profiling including detection of commercial supplier probiotic strains, human genetic variants, or microbial taxa in the sample of individuals.
PURPOSE OF THIS RESEARCH STUDY You are being asked to participate in a training and quality assessment project designed (i) to test the quality of a process and third party commercial product for obtaining and quantifying microbes from stool samples, (ii) to prove that the process works by sequencing (determining the primary structure of the DNA) the DNA (iii) further prove the viability of our supplier probiotics within our formulations. This Research Study is sponsored by and occurs within the facilities of Sun Genomics and its contractors. Most of the study will take place at the Sun Genomics facility located at 10210 Campus Point Dr. Suite 150, San Diego, CA 92121.
PROCEDURES You will be asked to provide a stool sample, to be taken at home or on-site. We will assign a unique coded identification number to your consent form and your stool sample; the coded number will be used to identify the stool sample. The consent form will be held by an individual not associated with the conduct of the study; the de-identified stool sample will be delivered to qualified personnel that shall be designated from time to time, who will provide your sample to Sun Genomics laboratory personnel. The laboratory personnel will perform the DNA extraction process on your sample and attempt to sequence your sample with the extracted DNA. Any results generated from sequencing your sample will be de-identified, so no one will know it is your sample, as explained below. Laboratory personnel may repeat the DNA extraction process and or assay one or more times on any of the stool sample that remains. Sun Genomics will retain your sample for a minimum of 1 year for follow up or confirmation of research results. The expected duration of the project is six months. The de-identified results of the Research Study will be used solely to evaluate the performance of the DNA extraction process, the quality of results obtained with the extracted DNA, and our ability to perform the procedures such as sequencing and microbiome profiling. De-identified information regarding the amount of DNA obtained from a sample may be provided to regulatory agencies in the course of CLIA Laboratory certification. This type of information does not allow the sample to be traced back to you. DNA sequence information will not be provided to a regulatory agency. Other than as stated in this paragraph, the de-identified results of the study will not be provided to anyone outside of Sun Genomics without your authorization. The de-identified results of the Research Study, including any genotyping and/or sequencing data will not be provided to you. You may receive summary information for the purpose of collecting feedback and improving the product. This Research Study is not intended to treat or diagnose, and is for quality and testing purposes only in order to evaluate a DNA extraction process for use in future, applications and our ability to use the DNA, and metagenomics analysis. Sun Genomics will not perform any monitoring of you during or after the Research Study, but you may be asked to provide follow up samples to examine changes to your microbiome profile over time.
CONFIDENTIALITY Your identity in this Research Study will be treated as confidential and we will protect this confidentiality in several ways. Your signed consent form will be maintained by a Sun Genomics team member not associated with the conduct of the Research Study and nobody else within Sun Genomics will have access to such consent form. The identification number assigned to your stool sample and to your consent form will be stored in a secure location. Only one designated person at Sun Genomics will have the link between your name and the identification number that labels your sample. The sex and race associated with your sample may be provided to the laboratory personnel for purposes of analyzing the data generated from your sample, however, this information will not allow the laboratory personnel to trace the sample back to you. If you choose to tell others about your participation in this Research Study, then Sun Genomics will still protect the confidentiality of your sample and its associated identification number. Sun Genomics will not provide or return samples or any extracts, aliquots, or derivatives to you or to any other external individuals.
POSSIBLE RISKS AND BENEFITS This Research Study involves very minimal physical risk. The likelihood of harm associated with providing a stool sample is very low and may include slight pain or discomfort, possible risk of contamination exposure, and a minimal risk of infection at the site of stool draw. The risks associated with any inadvertent disclosure of your genetic information, assay information, or sample are also low because Sun Genomics has in place procedures to protect your confidentiality, as described above, and your sample will be securely stored in the Sun Genomics repository for a minimum of 1 year. Except as stated above, you will not receive any results generated from your sample. This non-invasive procedure should have no adverse effects, but we cannot account for any existing conditions that may impact your ability to collect a sample for Sun Genomics. If, after your stool collection, you experience persistent (2+ hours) swelling and inflammation at the site, please contact your health care provider and then Stella Kramer, or equivalently qualified personnel that shall be designated from time to time, at Sun Genomics to record the issue. The study of your sample may, one day, result in a DNA extraction, analysis, or interpretation process that may be used in association with Sun Genomics product and service offerings, which may in turn benefit Sun Genomics, the scientific community and the public health. To the fullest extent permitted by applicable law, you hereby irrevocably waive all legal and equitable rights relating to all liabilities, claims, demands, actions, suits, damages, and expenses of whatever kind or nature, now known or hereafter known in any jurisdiction throughout the world (collectively, “Claims”) arising directly or indirectly from Sun Genomics, its affiliates, suppliers, vendors, contractors, subcontracts, agents, directors, officers, employees, representatives, licensees and assigns (“Released Parties”) that may result from (i) the exercise of the Released Parties’ rights under this consent, (ii) any probiotics or other materials used in connection with this project, whether provided by a Released Party or provided by any other third party, or (iii) the production, use, exhibition, exploitation, promotion, or other use of the DNA extraction process, your stool sample or results associated with your stool sample, and whether resulting in whole or in part by the negligence of a Released Party or any other person, and forever release and discharge the Released Parties from liability under such Claims. You further agree and acknowledge that you shall have no rights to any profits, royalties or any other type of compensation relating to or arising from any Sun Genomics or third party product or service offerings that may result in connection with this project and/or this consent. As a volunteer, you hereby expressly assume the risk of injury or harm from these activities and release the Released Parties from all liability for injury, illness, death or property damage resulting from the services you provide as a volunteer or occurring while you are providing services hereunder.
FINANCIAL CONSIDERATIONS You will not be compensated for your participation in this Research Study.
TERMINATION OF RESEARCH STUDY Taking part in this Research Study is voluntary and you may choose to not participate or to withdraw at any time. There will be no penalty or loss of benefits to which you are otherwise entitled if you choose not to participate or to withdraw at any time. In the event you decide to discontinue your participation in the study, please notify customer service at 661-888-4799 or via email at customerservice@sungenomics.com.
AVAILABLE SOURCES OF INFORMATION If you have any questions about this Research Study, or if you have any complaint about the conduct of this study, or about your treatment, please contact customer service at 661-888-4799 or via email at customerservice@sungenomics.com.
MISCELLANEOUS This consent constitutes the sole and entire agreement between you and Sun Genomics with respect to the subject matter contained herein and supersedes all prior and contemporaneous understandings, agreements, representations, and warranties, both written and oral, with respect to such subject matter. You acknowledge and agree that you have not relied on any statement, representation, warranty, or agreement of Sun Genomics or of any other person on Sun Genomics’ behalf, except for the representations, warranties, or agreements expressly contained in this consent. If any term or provision of this consent is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability will not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Sun Genomics may assign this Agreement and its rights hereunder, in whole or in part, to any party. This consent is binding on and inures to your benefit and the benefit of Sun Genomics and our respective heirs, executors, administrators, legal representatives, successors, and permitted assigns. All matters arising out of or relating to this consent shall be governed by and construed in accordance with the internal laws of the State of California without giving effect to any choice or conflict of law provision or rule. Any claim or cause of action arising under this consent may be brought only in the federal and state courts located in State of California, and you hereby irrevocably consents to the exclusive jurisdiction of such courts.
AUTHORIZATION I have read and understand this consent form, and I volunteer to participate in this Research Study. I understand that I will receive a copy of this form. I have had a chance to ask questions and have them answered to my satisfaction. I understand that nothing in this consent form is intended to replace or amend any Federal, state, or local laws that may apply. I represent and warrant that I am authorized to provide the informed consent set forth herein, on behalf of myself or as legal representative of the participant in this Research Study (as applicable), and hereby agree to indemnify, defend and hold harmless the Released Parties from and against any and all Claims that may arise from the failure of such representation and warranty to be, and remain during such participation in this Research Study, true.