Terms & Conditions of the Laboratory Services

1. PROVISION OF SERVICES

If you have a current Laboratory Services Agreement (LSA) with Baylor Genetics, these terms do not apply, and your order will be subject to the terms of your LSA as of the date that your order is received. In the absence of a current LSA, you agree to be subject to these Terms and Conditions when ordering genetic testing services (“Lab Services”) from Baylor Genetics from within the United States. You also agree to abide by the terms of Baylor Genetics’ Annual Provider Notice.

1.1. Parties

Baylor Genetics is a CLIA certified laboratory which provides clinical Lab Services pursuant to a written order submitted by or on behalf of a licensed provider authorized under state law to order genetic tests. Baylor Genetics only provides genetic testing for purpose of diagnosis and/or treatment of a medical condition and therefore functions as a Covered Entity subject to HIPAA. Baylor Genetics does not provide direct-to-consumer genetic testing and will not accept requests for testing from non-healthcare providers. As a Covered Entity subject to HIPAA, Baylor Genetics will manage the data derived from Lab Services in accordance with HIPAA and applicable state medical records and privacy laws.

The person ordering Lab Services under these Terms & Conditions is referred to as (“You/Your”) and represents that they are a licensed provider authorized to order genetic testing in accordance with their state licensing laws.

You and Baylor Genetics are referred to together herein as the “Parties” and each, individually, as a “Party.”

1.2. Genetic Testing Services. Subject to the completion of a laboratory requisition form (Order Form), Baylor Genetics agrees to provide Lab Services as ordered by an authorized provider. Baylor Genetics’ Order Forms are available on Baylor Genetics website at https://www.baylorgenetics.com or you may set up an account and order through our on-line Provider Portal to submit the Order Form. If You are requesting Lab Services pursuant to a court order, please contact our Baylor Genetics Client Services team at 1-800-411-4363 before submitting the Order Form.

1.3. Performance Standards. Baylor Genetics shall perform the Lab Services in a professional and timely manner in accordance with Baylor Genetics’ then-current standard operating procedures.

1.4. Specimen: Collection and Transport.

a. Test Kit. Test Kit(s) can be ordered from Baylor Genetics website (baylorgenetics.com) or you may contact Baylor Genetics’ logistics team at [email protected].

b. Collection. You agree to provide Baylor Genetics with specimen(s) for Lab Services based on the specific specimen requirements found on Baylor Genetics’ website at https://www.baylorgenetics.com. You agree to follow the specimen requirements relevant to the specific genetic testing ordered and to be provided by Baylor Genetics. You assume all costs associated with your failure to follow the specimen requirements. You are responsible for obtaining all appropriate consents for the Lab Services required under applicable laws in your jurisdiction.

c. Transport. All specimen(s) must be shipped in the manner specified by the specimen requirements on Baylor Genetics website (baylorgenetics.com) to the following address:

    • Baylor Miraca Genetics Laboratories,
    • 2450 Holcombe, Grand Blvd. – Receiving Dock
    • Houston, Texas 77021-2024.

The risk of loss or damage to the specimen(s) remains with You until the specimen(s) is received by Baylor Genetics.

d. Receipt. Upon receipt of the specimen(s), Baylor Genetics will use commercially reasonable efforts to meet our published turnaround times. Baylor Genetics will notify you if the specimen(s) are missing required information or received in damaged, contaminated, or improperly preserved condition. The following information must be included with the specimen(s): 1) Patient’s Name and date of birth, and 2) date of collection for each specimen. Baylor Genetics will not process the sample if any of this information is missing.

1.5. Raw Data. Raw data (including FastQ, BAM, VCF) and all curatorial content resulting from review and curation of variants shall be owned by Baylor Genetics, and Baylor Genetics will have the right to store and distribute this content, subject to applicable privacy and data protection laws, including without limitation, HIPAA, and HITECH.

1.6. Proprietary Rights. Any and all of Baylor Genetics’ test procedures, materials, methods, and reports (collectively the “Testing Services”) provided in connection with this Agreement are the proprietary products of Baylor Genetics and its licensors. You acknowledge and agree that the Testing Services are propriety products of Baylor Genetics and its licensors, protected under trade secret laws, patents, copyright laws and international treaties.

You further acknowledge and agree that all rights, title and interest in and to the Testing Services including associated intellectual property rights and all improvements, modifications, revisions, derivative works, and customization are and shall remain the sole and exclusive property of Baylor Genetics and its licensors.

2. FEES AND PAYMENTS

2.1. Price. For the provision of the Lab Services ordered by You, Baylor Genetics will charge its usual and customary price for the Lab Services. If Lab Services are to be billed to the patient’s insurer, it is Your responsibility to provide all information necessary to allow Baylor Genetics to submit a sufficient third-party payor claim, including but not limited to patient demographics, insurance information, assignment of benefits, letter of medical necessity, authorization obtained, and clinical notes. If you agree for Baylor Genetics to invoice the pertinent third-party payor, such information shall be provided at the time Baylor Genetics receives the associated specimen(s). If You fail to provide that information, then Baylor Genetics will bill the patient directly for the cost of the Lab Services at the self-pay cost.

NOTE: If the Lab Services are for a Medicare patient, you must provide a valid, signed Advance Beneficiary Notice (ABN) for any service that our Medicare Contractor, Novitas, deems as not medically necessary. Failure to provide the necessary ABN may delay testing.

No Lab Services will be priced below the fair market value as required by law. The Parties agree that the compensation herein for the Lab Services is commercially reasonable and has not been determined in a manner that takes into account the volume or value of any referrals or other business generated between the Parties.

All questions regarding payment should be directed to the Baylor Genetics at 1.800.411.4363, Option 2, or by email at [email protected].

3. TERMINATION

3.1. You may cancel the Lab Services as outlined on the Baylor Genetics website at: https://www.baylorgenetics.com/%20cancel-test and agree to be subject to the terms as outlined therein.

4. CONFIDENTIALITY

4.1 Confidentiality. Each Party agrees to comply with HIPAA privacy and security standards as well as any applicable state privacy laws.

5. OTHER PROVISIONS

5.1. LIMITATION OF LIABILITY. NOTWITHSTANDING ANY OTHER PROVISION HEREIN TO THE CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS) IN CONNECTION WITH ANY CLAIMS ARISING OUT OF OR RELATED TO THESE TERMS & CONDITIONS, REGARDLESS OF WHETHER THE NONPERFORMING PARTY WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR NOT. FURTHERMORE, IN NO EVENT SHALL BAYLOR GENETICS BE LIABLE FOR AN AMOUNT EXCEEDING THE AMOUNT PAID FOR THE LAB SERVICES.

5.2. Force Majeure. In the event that either Party is delayed in or prevented from performing its obligations under this Agreement, in whole or in part, due to a cause beyond its reasonable control and without its fault or gross negligence, including an act of God, fire, flood, explosion, epidemic, civil disorder, strike, lockout or other labor trouble, material shortages of utilities, delay in transportation, breakdown or accident, any law, judgment, demand or requirement of any governmental authority, riot, war, or other cause beyond the reasonable control of the Parties (each a “Force Majeure Event”), then upon written notice to the other Party, (a) the affected obligations hereunder will be suspended to the extent reasonably necessary during the period of the Force Majeure Event, (b) neither Party will have any liability to the other Party or any other person in connection with such suspended obligation and, (c) the Parties will resume performance as soon as practicable after the Force Majeure Event has ended.

5.3. Independent Contractors. The Parties are independent contractors, and nothing in herein shall be deemed or construed to create an employment or agency relationship between the Parties.

5.4. Governing Law and Jurisdiction. The internal laws of the State of Texas (without giving effect to any choice or conflict of law provision or rule that would cause the application of laws of any other jurisdiction) shall govern all matters arising out of or relating to these Terms & Conditions, and all actions contemplated thereby, including its validity, interpretation, construction, performance and enforcement and any disputes or controversies arising therefrom or related thereto. The Parties agree and acknowledge that any dispute about or involving these Terms & Conditions will be adjudicated in the state and/or federal courts of the United States located in Harris County, Texas.