Terms & Conditions of the Laboratory Services

1. PROVISION OF SERVICES

1.1. Genetic Testing Services. Subject to the completion of an Order Form and Client’s compliance with the Terms and Conditions of the Laboratory Services (collectively, the “Agreement”), Baylor Genetics agrees to provide Client with the genetic testing services described in the applicable Order Form (the “Services”). Client and Baylor Genetics are referred to together herein as the “Parties” and each, individually, as a “Party”.

1.2. Performance Standards. Baylor Genetics shall perform the Services in a professional and timely manner in accordance with Baylor Genetics then-current standard operating procedures by duly qualified personnel.

1.3. Specimens. Client may send specimens to Baylor Genetics from the Client locations listed in the applicable Order Form (the “Client Locations”). Client shall be responsible for ensuring (i) all Client Locations follow proper protocols for specimen collection and shipment as described in this Agreement and (ii) Client has obtained and shall maintain any and all rights necessary to share the specimen with Baylor Genetics. Client will provide Baylor Genetics with certain specimens for genetic testing based on the specific specimen requirements that can be found on the Baylor Genetics’ website. Client agrees to follow the specimen requirements relevant to the specific genetic testing provided by Baylor Genetics. All costs associated with Client’s failure to follow the specimen requirements shall be Client’s responsibility.

1.4. Transport. All specimens should be shipped in the manner specified by the specimen requirements on the Baylor Genetics’ website to the following address:

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

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. Client acknowledges and agrees that the Testing Services are proprietary products of Baylor Genetics and its licensors, protected under trade secret laws, patents, copyright laws and international treaties.

Client further acknowledges and agrees that all right, 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. To the extent that Client has or obtains any right, title or interest in or to the Testing Services, Client hereby assigns, agrees to assign and to take such reasonable measures as may be necessary to assign such rights to Baylor Genetics. This Agreement and the rights granted hereunder do not convey to Client any interest in or to the Testing Services.

2. FEES AND PAYMENTS

2.1. Price. For the provision of such genetic testing services, Baylor Genetics will bill Client monthly, and Client shall pay Baylor Genetics at the rate set forth in the applicable Order Form as the current fees to be charged to Client for services rendered hereunder. No tests or services will be priced below the fair market value as required by law. Any amendments or changes to the scheduled fees set forth on the applicable Order Form shall be effective thirty (30) days following the date upon which Baylor Genetics has notified Client in writing, at which time the amended schedule will become part of this Agreement. The Parties agree that the compensation herein for testing of patient samples 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.

2.2. Invoices. Baylor Genetics will submit a detailed electronic invoice monthly to Client. Client shall pay such invoice within thirty (30) days after receipt thereof. Invoices shall be sent electronically to the email set forth on the Order Form. All questions regarding invoices should be directed to the Baylor Genetics’ Client Relations Division at (713) 798-6555 or by email at apayable@baylorgenetics.com, or such other person designated in writing by Baylor Genetics.

3. TERM AND TERMINATION

3.1. Term. The initial term of this Agreement shall commence as of the Effective Date and continue for the Term Length set forth in the applicable Order Form. Thereafter, this Agreement shall automatically renew for the Automatic Renewal Term Length set forth in the applicable Order Form unless either Party gives written notice of termination to the other Party. Such termination is effective forty-five (45) days after receipt of written notice sent by the terminating Party. Notwithstanding anything herein to the contrary:

  • 3.1.1. Baylor Genetics may terminate this Agreement immediately and without prior written notice upon Client’s failure to pay according to Section 2.2; and
  • 3.1.2. either Party may terminate this Agreement on thirty (30) days’ notice if the other Party breaches any covenant or other material obligation of such Party set forth in this Agreement and the Party fails to cure such breach in said thirty (30) day period.

4. CONFIDENTIALITY

4.1           Confidentiality. For the purposes of this Agreement, the term “Confidential Information” is that information or know-how communicated between the Parties which is identified as being confidential, or, given the circumstances surrounding disclosure, may be reasonably understood as confidential.  Confidential Information includes both oral and tangible communications, including the existence and terms of any negotiations between the Parties, and the terms and conditions of this Agreement. Confidential Information also includes but is not limited to information relating to pricing; inventory levels; product specifications; prototypes; marketing techniques and materials; marketing plans; timetables; strategic and development plans; organizational, technical, and financial data; personnel statistics; customer and patient information; trade secrets; organizational structure; business plans; and financial information.

Confidential Information disclosed to a Party (the “Recipient”) by any employee, agent, representative, or affiliate of the other Party (the “Discloser”) is subject to the following terms

a.         Confidential Information shall not include any information that: (i) is or subsequently becomes publicly available without a breach of any obligation of confidentiality owed to a Party under this Agreement or by any third party; (ii) was already known to a Party before the other Party’s disclosure of such information; (iii) became known to a Party from a source other than the other Party and other than by a breach of an obligation of confidentiality owed to the Party by such source; or (iv) is independently developed by a Party.

b.         Neither Party shall disclose any Confidential Information to third parties; provided, however, that a Party may disclose Confidential Information to its professional advisors on a need-to-know basis if such advisors are under an obligation to keep such information confidential in the same or a substantially similar manner as provided for in this Agreement. Neither Party shall use any Confidential Information except as expressly permitted by, or as required to achieve the purposes of, this Agreement.

c.         Notwithstanding any other provision of this Agreement, disclosure of Confidential Information shall not be prohibited to the extent required to comply with applicable laws or regulations, or with a valid court or administrative order, provided that Recipient (where possible and without violating an legal or regulatory requirements): (i) promptly notifies Discloser in writing of the existence, terms and circumstances of such required disclosure; (ii) consults with Discloser on the advisability of taking legally available steps to resist or narrow such disclosure; and (iii) takes all reasonable and lawful actions to obtain confidential treatment for such disclosure. Each Party shall take reasonable security precautions, at least as great as the precautions it takes to protect its own confidential information of a similar nature, to keep confidential the Confidential Information.

d.         At any time upon the request of the Discloser, Recipient shall promptly either return to the Discloser or destroy any Confidential Information that has been furnished hereunder, along with all hard or electronic copies thereof.  The Discloser may request the Recipient provide written certification as to the return or destruction, in accordance with this paragraph, and the Recipient will promptly provide such certification. Notwithstanding the foregoing, Recipient will be authorized to retain one (1) copy of any Confidential Information in its legal department for the purpose of determining any continuing obligation under this Agreement, and nothing herein shall require Recipient to delete electronic copies of Confidential Information (including emails) that have become embedded in Recipient’s electronic records system through normal back-up procedures; provided, however, that any retained copies of Confidential Information shall remain subject to the terms of this Agreement.

e.         Each Discloser warrants that it has the right to make the disclosures under this Agreement. EXCEPT AS DESCRIBED IN THIS AGREEMENT, NO OTHER WARRANTIES ARE MADE BY EITHER PARTY.  ANY INFORMATION EXCHANGED UNDER THIS AGREEMENT IS PROVIDED “AS IS.”

f.          The foregoing provisions regarding confidentiality shall survive the Agreement for a period of five (5) years after termination.  Furthermore,  the  foregoing  provisions  constitute  independent covenants and shall not be discharged by any breach or default of the Party seeking their enforcement.

4.2         Compliance with Laws. The terms of this Agreement are intended to be in compliance with all federal, state, and local statutes, regulations, and ordinances applicable on the date the Agreement takes effect, including but not limited to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Stark Law (42 U.S.C. § 1395nn), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) (18 U.S.C. § 220), and their implementing regulations (collectively, “Applicable Laws”). If applicable, both parties agree to enter into a Business Associate Agreement to preserve the confidentiality of Protected Health Information and any other patient information protected by federal and state privacy laws.

5. INDEMNIFICATION; LIMITATION OF LIABILITY

5.1. Indemnification. Each Party shall indemnify (the “Indemnifying Party”) and hold harmless the other Party (the “Indemnified Party”) from and against all damage, loss, liability and expense arising from a third party claim incurred as a result of or in connection with any breach or violation of any covenant or other obligation or duty of the Indemnifying Party under this Agreement, except to the extent such losses are determined to have resulted solely from negligence or intentional misconduct of the Indemnified Party. The Indemnified Party shall provide the Indemnifying Party with prompt notice of the claim, control over the defense or settlement of the claim and reasonable cooperation in the defense or settlement of the claim.

5.2. Limitation of Liability. NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT 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 THIS AGREEMENT, REGARDLESS OF WHETHER THE NONPERFORMING PARTY WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR NOT. FUR THER, IN NO EVENT SHALL BAYLOR GENETICS BE LIABLE FOR ANY DAMAGES IN EXCESS OF THE AMOUNT PAID BY CLIENT UNDER THIS AGREEMENT FOR THE SERVICES THAT CAUSED THE DAMAGE.

6. INSURANCE

6.1. Insurance. Client shall, at its sole cost and expense at all times during the term of this Agreement, procure and maintain comprehensive general and professional liability insurance or self-insurance (including personal injury, property damage, products liability, and completed operations liability), in a minimum amount of one million dollars ($1,000,000). Upon Baylor Genetics’ request, Client shall cause to be issued to Baylor Genetics proper certificates of insurance or self-insurance evidencing the foregoing provisions of this Agreement have been complied with. Prior to any cancellation without replacement or material adverse change in the underlying insurance during the policy period, Client will use reasonable efforts to first give thirty (30) calendar days’ written notice to Baylor Genetics.

6.2. Baylor Genetics shall, at its sole cost and expense and at all times during the term of the Agreement, procure and maintain professional liability self-insurance (including personal injury, property damage, products liability) in a minimum amount of ten million dollars ($10,000,000). Upon Client’s request, Baylor Genetics shall issue to Client proper certificates of self-insurance evidencing the foregoing provisions of this Agreement have been complied with. Prior to any cancellation without replacement or material adverse change in the underlying insurance during the policy period, Baylor Genetics will use reasonable efforts to first give thirty (30) calendar days’ written notice to Client.

7. GENERAL PROVISIONS

7.1. Assignment and No Third Party Rights. This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld and any purported assignment without such consent shall be null and void. No Party may delegate any performance of its obligations under this Agreement without notifying the other Party via telephone or electronic means. Notwithstanding the foregoing, Baylor Genetics may assign or transfer this Agreement as party of a sale, merger or other business reorganization.

7.2. Amendments. This Agreement may not be amended, supplemented or otherwise modified except in a written document signed by each Party to be bound by the amendment and that identifies itself as an amendment to this Agreement.

7.3. 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 under this Agreement 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.

7.4. Entire Agreement. This Agreement (including any exhibits hereto and the Business Associate Agreement (if applicable)) constitutes the entire agreement between Baylor Genetics and Client and supersedes any prior negotiations, correspondence, understandings, agreements or representations by or among the Parties, or any of them, written or oral, with respect to the subject matter of this Agreement.

7.5. Independent Contractors. Baylor Genetics and Client are independent contractors, and nothing in this Agreement shall be deemed or construed to create an employment or agency relationship between Baylor Genetics and Client.

7.6. Non-Waiver. None of the terms, covenants and conditions of this Agreement may be waived by a Party except by its written consent. Any enumeration of a Party’s rights and remedies in this Agreement is not intended to be exclusive, and a Party’s rights and remedies are intended to be cumulative to the extent permitted by law and include any rights and remedies authorized in law or in equity.

7.7. Severability. If any provision of this Agreement is held void, invalid, illegal or unenforceable, the remaining provisions of this Agreement will remain in full force and effect, if the essential terms and conditions of this Agreement for each Party remain valid, binding and enforceable.

7.8. 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 this Agreement, and its respective exhibits, 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 the Agreement will be adjudicated in the state and/or federal courts of the United States located in Harris County, Texas.

7.9. Waiver of Jury. EACH OF THE PARTIES KNOWINGLY, VOLUNTARILY, AND IRREVOCABLY WAIVE, TO THE FULLEST EXTENT PERMITTED BY LAW, ALL RIGHTS TO TRIAL BY JURY IN ANY PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT, OR OTHERWISE) ARISING OUT OF OR RELATED TO THIS AGREEMENT.

7.10. Non-Solicitation. During the term of this Agreement and for twelve (12) months after any termination of this Agreement, neither Party will, without the prior written consent of the other Party, either directly or indirectly solicit or attempt to solicit, divert or hire away any person from either Party.

7.11. Notices. All notices and other communications under this Agreement must be in writing and are deemed duly delivered when (a) delivered, if delivered personally or by nationally recognized overnight courier service (costs prepaid), or (b) received or rejected by the addressee, if sent by U.S. certified or registered mail, return receipt requested; in each case to the following physical addresses marked to the attention of the individual (by name or title) designated below (or to such other physical address or individual as a Party may designate by notice to the other Party). Telephone numbers are provided below for courtesy communications, and any information received by telephone or left on a voicemail shall not constitute notice.

If to Baylor Genetics:

  • Attn: Chief Executive Officer
    Baylor Miraca Genetics Laboratories
    2450 Holcombe Blvd, Suite O104
    Houston, TX 77021
  • CC: legal@baylorgenetics.com
  • If to Client: To the email and address in the applicable Order Form.

7.12. Counterparts. This Agreement may be executed in counterparts, each of which constitutes an original as against the Party that signed it, and all of which together constitute one agreement. This Agreement is effective upon delivery of one executed counterpart from each Party to the other Party. The signatures of all Parties need not appear on the same counterpart. The delivery of signed counterparts by.pdf in an email transmission that includes a copy of the sending Party’s signature(s) is as effective as signing and delivering the counterpart in person.

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