These Services Terms and Conditions (“Terms and Conditions”) govern the delivery of Services by Baby Genes, Inc., a Colorado corporation with a principal place of business at 15000 W 6th Ave, Suite 150, Golden, Colorado, USA 80401 (“BabyGenes”) pursuant to an order or request from a customer (the “Customer”) for such Services (the “Order”). The Order and the Terms and Conditions are collectively referred to as the “Agreement.
By submitting an Order for Service, Customer agrees to these Terms and Conditions, and provides consent for the delivery of the Services.
- Services. “Services” means the proprietary BabyGenes newborn screening and carrier testing services set forth on Exhibit A identified in the Order.
- Informed Consent for Genetic Testing. Customer authorizes BabyGenes to perform the genetic testing that was ordered. In doing so, and submitting the Order, Customer acknowledge and understands the potential outcomes, including the benefits, risks and limitations of the screening (as set forth in more detail below), and represents that they have had the opportunity to ask questions of a physician prior to giving this informed consent, and that the questions have been satisfactorily answered. Customer also acknowledges that it is Customer’s responsibility to contact their personal physician, medical provider or genetic counselor and discuss the reported results.
- Potential Test Results. Results are normally examined by a team of scientists and doctors, who determine if there are any pathogenic or likely pathogenic variants identified by the screening. In addition, variants of unknown significance (VUS) that are classified as non-synonymous (predicted to cause a pro- tein change) are identified. A written report that discusses each potentially disease-related variant will be issued. Possible results are as follows:
- No Findings – No reportable variants are identified.
- Findings – Pathogenic and/or Likely Pathogenic Variants with disease association are identified OR VUS that result in non-synonymous protein changes with no known clinical association. Customer understands that when Customer’s or Customer’s child’s panel sequence is compared to a reference sequence, many variations or differences are expected to be found. Based on currently available information in the medical literature and in scientific databases, Baby Genes determines whether any of these variations are predicted to be causative or related to a medical condition. The classification and interpretation of all variants identified in this testing reflects the current state of scientific understanding at the time the report is issued. In some instances, the classification and interpretation of variants may change as scientific information becomes available.
- Limitations of Testing. Customer understands that a “No Findings” result does not rule out all genetic causes of disease. It is still possible that Customer or Customer’s child may have a genetic condition that this technology is unable to detect or that are caused by one or more genes that are not included as part of the specific test ordered. Some results are of uncertain clinical significance meaning that while they may be related to disease, they may also be unrelated to disease and, therefore, likely harmless changes. A “Findings” result will not necessarily predict the prognosis or severity of disease. While identifying a variant of clinical significance may help direct management and treatment, it is also possible that identifying a variant of clinical significance will not affect management or treatment.
- DNA Sample and Results Disclosure. Customer understands that DNA samples will only be used for testing that is that is ordered. Any leftover DNA will be stored for 30 days. Customer understands that some samples may be maintained indefinitely after all testing has been completed for research purposes in an effort to advance scientific knowledge. I n such a case, all personal identifiers will first be removed, and Customer will not be informed of any results, as Baby Genes will have no means to determine the sample origin. Results may be released to any entity that, by statute or law, has the legal authority to request and receive genetic results. Baby Genes may discuss summaries of genetic test results in scientific presentations, publications, or marketing pieces. No names or personal identifiers will be revealed. Customer understands that Customer has the right to opt out of indefinite storage by notifying BabyGenes in writing.
- BabyGenes Limited Warranty and Limitation of Liability
- BabyGenes Warranties. BabyGenes warrants that it shall use reasonable efforts to perform the Services: (a) in accordance with the terms and subject to the conditions set out in this Agreement, and (b) in a workmanlike and professional manner in accordance with generally recognized industry standards for similar services.
- Remedy for Breach of Warranties. BabyGenes’ sole and exclusive liability and Customer’s sole and exclusive remedy for breach of the warranties in section 6.1 shall be for BabyGenes to use reasonable commercial efforts to promptly cure any such breach. The foregoing remedy shall not be available unless Customer provides written notice of such breach within ten (10) days after delivery of the Services giving rise to the claim.
- Disclaimer of Warranties. CLIENT ACKNOWLEDGES AND UNDERSTANDS THAT, EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, THE SERVICES ARE PROVIDED “AS IS” and “as available” AND otherwise WITHOUT WARRANTY BY BabyGenes OF ANY KIND AND, TO THE MAXIMUM EXTENT ALLOWED BY APPLICABLE LAW, BabyGenes EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY, title, AND FITNESS FOR A PARTICULAR PURPOSE OR ANY WARRANTY OF NON-INFRINGEMENT. CLIENT WILL NOT HOLD BabyGenes RESPONSIBLE FOR ANY DAMAGES THAT RESULT FROM CLIENT’S USE OF THE SERVICES. NO ORAL OR WRITTEN INFORMATION OR ADVICE GIVEN BY ANY PERSON SHALL CREATE A WARRANTY IN ANY WAY WHATSOEVER RELATING TO BabyGenes.
- Limitation of Liability. EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, BABYGENES SHALL NOT BE LIABLE TO CLIENT (OR TO ANY PERSON CLAIMING RIGHTS DERIVED FROM CLIENT’S RIGHTS) FOR INCIDENTAL, INDIRECT, CONSEQUENTIAL, SPECIAL, PUNITIVE, OR EXEMPLARY DAMAGES OF ANY KIND — INCLUDING LOST REVENUES OR PROFITS, LOSS OF BUSINESS AND LOSS OF DATA — IN ANY WAY RELATED TO THIS AGREEMENT, INCLUDING WITHOUT LIMITATION AS A RESULT OF ANY BREACH OF ANY WARRANTY OR OTHER TERM OF THIS AGREEMENT OR AS A RESULT OF NEGLIGENCE OR BREACH OF STATUTORY DUTY, REGARDLESS OF WHETHER THE PARTY THAT IS LIABLE OR ALLEGEDLY LIABLE WAS ADVISED, HAD OTHER REASON TO KNOW, OR IN FACT KNEW OF THE POSSIBILITY THEREOF. IN NO EVENT SHALL BABYGENES’ LIABILITY FOR A CLAIM UNDER THIS AGREEMENT EXCEED THE TOTAL AMOUNT PAID TO OR RECEIVED BY BABYGENES UNDER THE APPLICABLE AGREEMENT FROM WHICH THE CLAIM AROSE.
- Customer Representations and Warranties. In addition to any other representations and warranties set forth in this Agreement, Customer represents, warrants and covenants that: (i) Customer has the full right, power and authority to enter into this Agreement; (ii) Customer is providing full informed consent for the Services to be provided, and (iii) Customer it has the right to provide samples and any other information requested by BabyGenes to BabyGenes to allow BabyGenes to perform the Services.
- Customer Indemnification. In addition to any other indemnification obligations under this Agreement, Customer shall defend, indemnify and hold harmless BabyGenes, and its officers, directors, employees, agents, Affiliates, successors and permitted assigns, and third party providers and licensors (collectively, “BabyGenes Indemnified Party”), from and against any and all claims and losses arising out of or resulting from any third-party Claim alleging or relating to: (i) breach by Customer of any representation, warranty, covenant or other obligations set forth in this Agreement; and (ii) negligence or other fault of Customer in connection with this Agreement; and (iii) Customer’s compliance with applicable law.
- Confidential Information. From time to time during the Term of this Agreement, either party (as the “Disclosing Party”) may disclose or make available to the other party (as the “Receiving Party”), non-public proprietary and confidential information of Disclosing Party (“Confidential Information”); provided, however, that Confidential Information does not include any information that: (a) is or becomes generally available to the public other than as a result of Receiving Party’s breach of this Section; (b) is or becomes available to the Receiving Party on a non-confidential basis from a third-party source, provided that such third party is not and was not prohibited from disclosing such Confidential Information; (c) was in Receiving Party’s possession prior to Disclosing Party’s disclosure hereunder; or (d) was or is independently developed by Receiving Party without using any Confidential Information.
- Non-Disclosure. The Receiving Party shall: (a) protect and safeguard the confidentiality of the Disclosing Party’s Confidential Information with at least the same degree of care as the Receiving Party would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care; (b) not use the Disclosing Party’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and (c) not disclose any such Confidential Information to any person or entity, except to the Receiving Party’s Representatives who need to know the Confidential Information to assist the Receiving Party, or act on its behalf, to exercise its rights or perform its obligations under this Agreement. If the Receiving Party is required by applicable law or legal process to disclose any Confidential Information, it shall, prior to making such disclosure, use commercially reasonable efforts to notify Disclosing Party of such requirements to afford Disclosing Party the opportunity to seek, at Disclosing Party’s sole cost and expense, a protective order or other remedy.
The parties shall maintain the confidentiality of medical records of individuals served under this Agreement. Neither party shall publish or otherwise disclose, except to the other party, and except matters of public record, any information or data obtained hereunder from private individuals, organizations, or public agencies, in a publication whereby the information or data furnished by or about any particular person or establishment can be identified, except with the informed consent of such person or establishment. BabyGenes shall not release any sensitive documents or information without the prior written approval of Customer. Neither party shall make any statement (whether oral or in writing) in any press release, external advertising, marketing or promotion materials regarding this Agreement or the other party or its business unless it has received the express written consent from the other party.
This provision shall survive termination of this Agreement.
- Entire Agreement. This Agreement, including and together with any related exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the parties with respect to the subject matter contained in the Agreement, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, regarding such subject matter.
- Notices. All notices, requests, consents, claims, demands, waivers and other communications under this Agreement (each, a “Notice”) must be in writing and addressed to the other party at its address set forth above or in the Order (or to such other address that the receiving party may designate from time to time in accordance with this Section). Unless otherwise agreed herein, all Notices must be delivered by personal delivery, nationally recognized overnight courier or certified or registered mail (in each case, return receipt requested, postage prepaid), or by email via a secure attachment and proof of receipt. Except as otherwise provided in this Agreement, a Notice is effective only (a) on receipt by the receiving Party; and (b) if the party giving the Notice has complied with the requirements of this Section.
- Independent Contractor. BabyGenes shall be an independent contractor with respect to the performance of Services under this Agreement. BabyGenes and Customer agree that nothing in this Agreement shall be (i) construed as constituting BabyGenes as other than an independent contractor of Customer for any purpose whatsoever or (ii) deemed to create an employer-employee, partnership, franchise or joint venture relationship between BabyGenes and Customer.
- Severability. If any term or provision of this Agreement is found by a court of competent jurisdiction to be invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal or unenforceable, the parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
- Amendments. No amendment to or modification of this Agreement or any Agreement is effective unless it is in writing, identified as an amendment to this Agreement, and signed by an authorized representative of each Party.
- Waiver. No waiver by any party of any of the provisions of this Agreement shall be effective unless explicitly set forth in writing and signed by the party so waiving. Except as otherwise set forth in this Agreement, no failure to exercise, or delay in exercising, any right, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof, nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.
- Assignment. Customer shall not assign, transfer, delegate or subcontract any of its rights or delegate any of its obligations under this Agreement without the prior written consent of BabyGenes. Any purported assignment or delegation in violation of this section shall be null and void. No assignment or delegation shall relieve the Customer of any of its obligations under this Agreement.
- Successors and Assigns. This Agreement is binding on and inures to the benefit of the parties to this Agreement and their respective permitted successors and permitted assigns.
- No Third-Party Beneficiaries. This Agreement benefits solely the parties to this Agreement and their respective permitted successors and assigns and nothing in this Agreement, express or implied, confers on any other person any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.
- Choice of Law. This Agreement, including all exhibits attached to this Agreement, and all matters arising out of or relating to this Agreement, is governed by, and is to be construed in accordance with, the laws of the State of Colorado, without regard to the conflict of laws provisions thereof to the extent such principles or rules would require or permit the application of the laws of any jurisdiction other than those of the State of Colorado.
- Choice of Forum. Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other party in any way arising from or relating to this Agreement, in any forum other than the state or federal courts located in the City and County of Denver, Colorado, USA. Each party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts.
- Waiver of Jury Trial. Each party acknowledges that any controversy that may arise under this Agreement, including exhibits, schedules, attachments and appendices attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, attachments or appendices attached to this Agreement, or the transactions contemplated hereby.
- Force Majeure. BabyGenes shall not be liable or responsible to Customer, nor be deemed to have defaulted or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement when and to the extent such failure or delay is caused by or results from acts or circumstances beyond the reasonable control of BabyGenes including, without limitation, acts of God, flood, fire, earthquake, explosion, governmental actions, war, invasion or hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest, national emergency, revolution, insurrection, epidemic, lock-outs, strikes or other labor disputes (whether or not relating to either party’s workforce), or restraints or delays affecting carriers or inability or delay in obtaining supplies of adequate or suitable materials, materials or telecommunication breakdown or power outage.
- Testing Services. Upon submission of appropriate specimens and requests to BabyGenes, BabyGenes will perform the following carrier screening molecular tests using BabyGenes’ proprietary processes:
- BabyGenes™ Carrier Panel (Next-Generation Sequencing of genes associated with conditions that are linked to the most current validated panel; SNV and INDEL detection, annotation and associated reporting) test
- BabyGenes™ Supplemental Newborn Screening Panel (Next-Generation Sequencing of genes associated with conditions that are linked to the most current validated panel; SNV and INDEL detection, annotation and associated reporting) test
All testing shall be performed at a duly licensed clinical laboratory under applicable federal, state and municipal law.
- Submission of Samples. The following is required for any sample submitted to BabyGenes:
- Information required for proper sample accessioning, including (1) the name, gender, and ethnicity of the subject, (2) the reason for testing (newborn screening, carrier testing, diagnostic indication, etc.), (3) Clinical contact (to whom reports should be sent), and (4) if applicable, a completed BabyGenes consent form.
- The minimum required sample is three (3) dried blood spots, preferred full dried spot card on PerkinElmer 226, Whatman 903 or like cards or mouthwash/saliva collection tube kit. If multiple dried blood spot samples are to be shipped together, each must be separated by glassine or similar envelope and sealable plastic bag to ensure against sample cross contamination. Mouthwash/Saliva must be enclosed in collection tube and sealed.
- Specimen Test Report Delivery. BabyGenes will generally provide test results, in most cases, within 7-10 days (96 hours for newborn screening panel) of the time the specimen is received at the BabyGenes Lab. Results will be available via an encrypted PDF file.
- Consultation. BabyGenes staff shall be reasonably available to consult with Customer by telephone during normal BabyGenes working hours to discuss BabyGenes’ procedures and to explain test results.
- Unsatisfactory Specimens and Unsatisfactory Results. If BabyGenes cannot analyze a specimen because of improper collection or degradation in process, or is unable to obtain satisfactory test results, BabyGenes will notify Customer.