This Agreement is between you, the "Client," and Cbr Systems, Inc. ("Cord Blood Registry" or "CBR") for newborn stem cell preservation. You are electing to preserve cord blood and/or cord tissue. In this Agreement, cord blood and cord tissue are called "newborn stem cells" or "sample(s)."
1. Collection of the Newborn Stem Cells
CBR® will provide you with a CBR Newborn Stem Cell Collection Kit to collect and transport the newborn stem cells. You will need to request that the delivering healthcare provider collect the newborn stem cells. You agree to follow the instructions provided by CBR and the healthcare provider with respect to sample collection. CBR may provide the healthcare provider or other parties involved in the newborn stem cell preservation with information about your enrollment, education, consent, and collection.
Although infrequent, complications may occur during birth that preclude the collection of newborn stem cells or affect the quality of the sample. Therefore, collection of newborn stem cells cannot be guaranteed. The health of the person giving birth and the health of the baby are the healthcare provider's first priorities. You agree that the healthcare provider's judgment is absolute and final. You agree to not hold the healthcare providers, hospital/birthing center, or their affiliates, directors, officers, employees, or agents responsible for the collection or failure to collect cord blood or cord tissue for any reason or for the handling or mishandling of cord blood or cord tissue.
The healthcare provider does not act as an agent of CBR. Payment for the healthcare provider's services is solely your responsibility. Please be aware that CBR pays a fee for collection services to physicians and midwives who are enrolled in CBR's Healthcare Provider Network.
For pregnancy with multiples (twins, triplets, or other multiples), an individual collection kit is required for each baby. Collecting into a single collection receptacle (pooling) will impact the ability to store and use the newborn stem cells.
2. Transport of the Sample(s)
You will arrange for express shipment of the newborn stem cells to CBR's laboratory as soon as possible after collection. You may use One-Step ShippingSM which offers next-flight-out service, or another courier of your choice. One-Step Shipping is offered by CBR for your convenience and is performed by an independent company. No courier service can provide one hundred percent reliability, and on occasion, some samples may be delayed, lost, or damaged in transit. CBR has no responsibility or liability for third-party courier transport of the sample(s) to CBR's laboratory, including for One-Step Shipping.
3. Testing, Processing, and Storage of the Sample(s)
After CBR receives the Newborn Stem Cell Collection Kit, CBR will test, process, cryopreserve and store the newborn stem cells. In rare circumstances, it may not be possible to process or store the samples received. There is no way to know if a sample can be processed and subsequently stored until it arrives at CBR's laboratory. CBR will screen a blood sample of the individual giving birth for infectious disease markers (HIV, hepatitis, syphilis, and other transmissible diseases) as required by regulatory agencies. A Medical Health and History Profile (MHHP) is to be completed and submitted to CBR by the individual giving birth to the child.
You will be notified regarding reportable infectious disease screening results. If you are not the individual giving birth, authorization from the birthing individual is required to share infectious disease screening results with you. If there are reportable infectious disease screening results, any follow-up healthcare to clarify the clinical impact to the birthing individual or newborn(s) must be obtained from the birthing individual's and newborn's personal healthcare physician(s). You will be notified if the cord blood does not meet minimum cell count, viability, sterility or other parameters as determined by CBR. You will be notified if the cord tissue does not meet metabolic activity, sterility or other parameters as determined by CBR.
Incomplete enrollment contracts, newborn stem cells test results, infectious disease marker screening results, and MHHP forms may impact the ability to use the child's newborn stem cells for treatment.
Cord tissue use is still in early research stages. CBR stores segments of the whole, composite cord tissue to preserve options for future cell extraction. Should treatments using cord tissue become available in the future, cord tissue will require additional processing prior to use which may result in additional processing fees.
CBR retains the right to not process or store any newborn stem cell sample. In the event that CBR is not able to process or does not store the sample, you will be notified and CBR will refund all previously paid fees to you except for the shipping fee.
4. CBR's Commitment to Quality
CBR provides a $50,000 Quality Service Guarantee. In the event that the cord blood stem cells are used in hematopoietic reconstitution and fail to engraft, CBR will refund all service fees paid by you to CBR for the cord blood stem cells and will pay you, the Client, an additional $50,000. This Guarantee is subject to important terms and conditions, available at https://clients.cordblood.com/pdf/cbr_qualityserviceguarantee.pdf. Please note that this guarantee does not apply to cord blood or cord tissue use in regenerative medicine applications.
5. Understanding Your Rights to the Sample(s)
You agree that you, the Client, are the child's legal guardian, and you understand that CBR will treat you as the sole designated contact for all purposes relating to this Agreement, including but not limited to retrieval and use of the sample, access to your account, updating of contact information, payment of fees, and termination of this Agreement. In the event that you wish to assign your rights and/or obligations under this Agreement to a third party, both the third party and CBR must agree in writing.
Prior to the child's eighteenth birthday, you, as the child's legal guardian, may direct the release and use of the newborn stem cells. The rights to the newborn stem cells follow the child, so if you cease being the child's legal guardian, then you may not direct the release and use of the newborn stem cells, and the child's legal guardian obtains these rights to act on behalf of the child. CBR retains the right to require court documentation or a court order prior to releasing the sample.
Starting on the child's eighteenth birthday, only the child may direct the release and use of the newborn stem cells. You agree that on and after the child's eighteenth birthday, the retrieval and use of the newborn stem cells shall be at the sole direction of the child and that you have no further right or power to direct the release or use of the newborn stem cells.
Effective as of the child's eighteenth birthday, you hereby release and renounce in favor of the child any and all right, title or interest that you may have in or relating to the newborn stem cells. You may continue to pay the annual storage fees for the benefit of your child even after the child turns eighteen, but that does not give you the right, at that time, to direct the release or use of the sample(s).
6. Requests for Release of the Sample(s)
A client may instruct CBR in writing to release the newborn stem cells. CBR shall not be required to release, prepare, ship or dispose of any newborn stem cells unless and until any and all payments required to be made under this Agreement have been paid in full. A client (or the child, after the child turns eighteen) may request that CBR:
Send the newborn stem cells to a physician (or agent) appropriately qualified to perform a transplant or medical procedure;
Dispose of the newborn stem cells;
Release the newborn stem cells for scientific research.
CBR can send a sample only to an entity that can receive a sample in compliance with all applicable rules and regulations. CBR may charge an administrative fee for preparation of the sample and paperwork. You are responsible for any third-party costs, including shipping and services fees. CBR is required to maintain all records associated with the child's newborn stem cell sample, even after it has been released, so under limited circumstances, you may be charged a document maintenance fee. Any transfer or disposal will be performed in accordance with CBR's standard operating procedure in effect at the time of the request.
7. Genetic Testing Products
CBR, in partnership with genomic testing laboratory Fulgent Genetics, offers three options of Picture®* genetic testing.
CBR Snapshot™ genetic test provides pediatric testing of 250+ genes.
CBR Portrait™ genetic test provides pediatric testing of 600+ genes.
CBR Landscape™ genetic test provides pediatric testing of 1,500+ genes and pharmacogenetic testing.
If you choose one of the three genetic testing options, CBR will submit the order on your behalf after the birth of your child. You will receive a confirmation email and then be mailed a genetic testing kit (including collection instructions and a prepaid envelope for return shipping) and asked to register your genetic testing kit on the Picture Portal. In the registration process, you will be asked to sign an informed consent and provided additional terms and conditions for the genetic testing. After you provide a DNA sample from your child and send the sample to the laboratory, your test report will be available within approximately 3 to 5 weeks within the Picture Portal.
CBR will have access to these genetic testing results. Once you review your results, you may contact CBR to find out more about the general process and to obtain further information regarding consulting with a genetic counselor and/or speaking to your pediatrician. CBR may provide you with additional information on where you can obtain genetic counseling should you wish to do so. CBR will not be providing medical services or genetic counseling.
8. Payment of Fees
You are responsible for the payment of all fees that may apply hereunder. CBR will attempt to contact you if a payment is overdue. If a payment is not received within 180 days of its due date, your account may be forwarded to a collection agency for further action and your credit may be impacted. You consent to receive autodialed and/or pre-recorded calls from or on behalf of CBR for account collection purposes at the landline and/or mobile telephone numbers that you provide to CBR.
Except as set forth in Section 3, if you terminate this Agreement prior to CBR's storage of the sample(s), CBR will refund all amounts paid by you hereunder less an administrative fee of $150. Different fees may apply for international customers. If you terminate this Agreement after CBR's storage of the sample(s), you will not receive a refund.
If you prepay all or a portion of the storage fees, and you terminate this Agreement, you will not receive a refund of the pre-paid fees.
9. Term and Termination
This Agreement is effective upon your acceptance of terms, which shall be the earliest date that you signed the agreement, attached your electronic signature, clicked a box accepting this Agreement's terms, or broke the seal on CBR's Newborn Stem Cell Collection Kit. If you are not the individual giving birth to the child, that person must also agree to an Informed Consent and Authorization, Authorization to Release Personal Health Information, and must complete the Medical Health and History Profile. Failure to complete these forms can limit the clinical utility of the child's cord blood and/or cord tissue samples.
This Agreement may be terminated by:
You.
All payments required under this Agreement must be paid in full, and CBR's procedures in effect at the time of such termination must be followed.
If you are no longer the child's legal guardian, or if the child is eighteen years old or older, the child's legal guardian, or the child eighteen years old or older (as applicable) will have the option to agree to take on all the rights and obligations under this Agreement prior to closure of the applicable CBR account. If the legal guardian or the child (as applicable) does not accept the terms of this Agreement prior to termination of the account, then the Agreement will expire. If the legal guardian or the child (as applicable) does not accept the terms of the Agreement prior to the account expiration date, then the Agreement shall continue in the name of the legal guardian or the child (as applicable) and succeeding to all of your rights and obligations under this Agreement.
The child, starting on the child's eighteenth birthday.
All payments required under this Agreement must be paid in full, and CBR's procedures in effect at the time of such termination must be followed.
CBR.
If you fail to make any payment required within 180 days of its due date, following written notice to your last available address, CBR may send your account to a collections agency and terminate your account anytime thereafter.
Release of all samples from storage.
If all the samples have been released from storage by the child or the child's legal guardian, this Agreement shall terminate.
Legal or regulatory requirement.
If you move to a country where CBR is prohibited from providing newborn stem cell preservation services, CBR may cease to maintain the newborn stem cells absent authorization from the U.S. Treasury Department.
Any expiration or termination of this Agreement is without prejudice to any rights, claims or causes of action that may have accrued prior to such expiration or termination.
In the event of your death, incapacity, or other failure to serve as legal guardian for the child, the child's successor legal guardian will have the right to become CBR's client under this Agreement.
If this Agreement terminates and the newborn stem cells remain in the custody of CBR, the samples become the property of CBR and may be used at CBR's sole discretion for any purpose – with no further obligations to you or the child -- including, but not limited to use for training new staff, quality control and equipment calibration and testing, developing and testing new procedures and processes, research, and future product development. Once this Agreement terminates, the sample(s) may not be available for use by your family.
10. Notification of Account Changes
At all times while this Agreement remains in effect, you shall promptly notify CBR of changes to your and the child's contact information and your payment method. CBR is entitled to rely on the contact information contained in your online client account. Any changes of the child's legal guardian must be promptly disclosed to CBR.
To update your contact information, call CBR at 1.888.932.6568 or edit your information by logging into your Client Account at https://clients.cordblood.com/. You can also contact us by postal mail at Cord Blood Registry, 6550 South Bay Colony Drive, Suite 160, Tucson, AZ 85756, Attn: Customer Service.
11. Third Party Beneficiary
The child is an intended third-party beneficiary of this Agreement with the right to enforce it without the need to join you.
12. Warranty Disclaimer
You acknowledge and agree that neither CBR nor its parent company, or any of their shareholders, directors, officers, agents, employees or affiliates have made any representation, guaranty or warranty, express or implied, to you of any kind. You acknowledge and agree to the following specific disclaimers:
There is no guarantee or assurance regarding success in collecting newborn stem cells. Complications may occur during birth that preclude the collection of the newborn stem cells. You acknowledge that the delivering healthcare provider makes the final determination whether or not to collect the newborn stem cells and neither CBR nor the healthcare provider shall be held liable for the failure, for any reason, to collect sample(s). Eligibility for processing and storage cannot be fully assessed until the arrival and evaluation of a sample at CBR's laboratory. CBR maintains the right to reject or discard any samples in accordance with our standard operating procedures.
There is no guarantee that the newborn stem cells will not deteriorate or suffer another form of loss. There is no guarantee that the newborn stem cells will be of therapeutic value. You acknowledge that the newborn stem cells may never be used.
The use of newborn stem cells is determined by the treating physician and is influenced by many factors, including the patient's medical condition, the characteristics of the sample, and whether the newborn stem cells should come from the patient or an appropriately matched donor. Cord blood has established uses in transplant medicine; however, its use in regenerative medicine is still being researched. There is no guarantee that treatments being studied in the laboratory, clinical trials, or other experimental treatments will be available in the future.
Cord tissue use is still in the early research stages, and there is no guarantee that treatments using cord tissue will be available in the future. Cord tissue is stored whole. Additional processing prior to use will be required to extract and prepare any of the multiple cell types from cryopreserved cord tissue. CBR's activities for New York State residents are limited to collection of umbilical cord tissue and long-term storage of umbilical cord– derived stem cells. CBR's possession of a New York State license for such collection and long-term storage does not indicate approval or endorsement of possible future uses or future suitability of these cells.
13. Limitation of Liability
CBR HAS NO LIABILITY OF ANY KIND IN RESPECT OF CBR'S PERFORMANCE OR FAILURE TO PERFORM UNDER THIS AGREEMENT EXCEPT TO THE EXTENT ATTRIBUTABLE TO CBR'S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT. IN NO EVENT SHALL CBR'S LIABILITY EXCEED THE TOTAL AMOUNT PAID BY CLIENT TO CBR UNDER THIS AGREEMENT. CBR SHALL NOT BE LIABLE FOR ANY SPECIAL, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES IN RESPECT OF BREACH OF CONTRACT, WARRANTY, STRICT LIABILITY OR TORT), WHETHER OR NOT CBR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE LIMITATIONS SET FORTH IN THIS PARAGRAPH SHALL APPLY NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. THE LIMITATIONS SET FORTH IN THIS PARAGRAPH SHALL NOT APPLY TO THE $50,000 QUALITY SERVICE
GUARANTEE APPLICABLE TO STORED CORD BLOOD. (Please see important terms and conditions on the Certificate of Guarantee.)
CBR shall not be responsible for procedures or services performed by third parties, including, but not limited to, sample collection, lab testing, courier transport (including any One-Step Shipping courier), improper handling, or use during transplantation or other medical procedure.
14. Assignment and Delegation
CBR may assign its rights and delegate its obligations under this Agreement without further consent to any successor by merger or consolidation, to any purchaser of all or substantially all of CBR's assets relevant to the performance of the services to be provided by CBR hereunder, or to any entity that provides services similar to those that are to be provided by CBR hereunder or that intends to provide such services following any such assignment or delegation. CBR may perform services to be provided by it hereunder through subcontractors.
This Agreement is not assignable by you without the prior written consent of CBR and any attempted assignment in breach of the foregoing restriction shall be void.
15. Governing Law
This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware without reference to its conflicts of laws provisions. Any dispute or controversy arising between or among you, the child, and CBR shall be finally and conclusively resolved by mandatory binding arbitration following the rules provided by the American Arbitration Association for commercial disputes. In the event of arbitration, or any court proceedings, the court or arbitrator may award reasonable attorneys' fees and costs to the prevailing party in addition to any other relief to which the party is entitled.
16. Entire Agreement
This Agreement, together with the Informed Consent, Payment Agreement, and the Authorization to Release Personal Health Information, constitute the entire Agreement between the parties and supersede all previous agreements or representations by CBR, oral or written, relating to the subject matter of this Agreement.
17. Force Majeure
If CBR's performance of this Agreement is prevented, restricted, or interfered with by reason of fire, earthquake, or other casualty or accident, strikes or labor disputes, war or other violence, any law, order, proclamation, ordinance, demand, or requirement of any government agency, or any other act or condition beyond the control of CBR, then CBR shall be excused from such performance.
18. Severability
If any provision of this Agreement is held by a court of competent jurisdiction to be invalid, void, or unenforceable, the remaining provisions shall nevertheless continue in full force without being impaired or invalidated in any way.
19. General
This Agreement shall be binding on you and CBR and your and its heirs, personal representatives, successors and permitted assigns.
This Agreement may only be modified or amended by a writing signed by you and an authorized CBR attorney or officer of the company.
Please note: The delivering hospital may require a copy of this form (Sections 1 and 2) upon admission.
* Picture is a registered trademark of Fulgent Genetics.
CBR Snapshot, CBR Portrait and CBR Landscape are trademarks of Cbr Systems, Inc.
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