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CLIENT CONSENT & SERVICE AGREEMENT:
CORD BLOOD AND CORD TISSUE STEM CELL COLLECTION, PROCESSING & STORAGE
Each undersigned Legal Guardian and/or Parent (hereinafter the "Client” or “You" or “Your”), on Your behalf and the behalf of Your unborn child ("Child"), requests under this Agreement that Alpha Cord, LLC. ("Alpha Cord" or “We” or “Our” or “Us”) arrange for the processing, storage and testing of newborn stem cells and other bio-matter from the placenta, umbilical cord blood and/or umbilical cord tissue (hereinafter referred to as the "Unit". A Unit means one or more than one Unit) subsequent to the birth of their Child. Each of the undersigned understands, acknowledges and agrees to the following legally-binding terms of this Agreement.
1. Nature of Services. These services include but are not limited to Your Healthcare Provider collecting Cord Blood and/or Cord Tissue or other bio-matter immediately following the birth of the Child. Subsequent to a successful collection, You consent to have these newborn stem cells shipped, tested and processed at Our contracted laboratory where they will be cryopreserved (placed into a long term frozen state) and stored for possible future use.
2. Purpose. Newborn stem cells are cryopreserved for possible therapeutic use in the event the Child's stem cells may be needed to treat the Child or other members of the Child's immediate or extended family. You understand and acknowledge stem cells from alternative sources, such as bone marrow, are currently used to treat various life-threatening conditions such as leukemia, other cancers and blood disorders. You understand cryopreservation of newborn stem cells is a relatively new procedure, and, while laboratory tests and studies thus far have indicated it is a successful method of preservation, no long-term assurances can be made about the effectiveness of preservation. You understand there are a limited number of therapies for which cord blood/cord tissue or your Unit can be used. You acknowledge successfully collecting and storing of stem cells from the Unit does not guarantee successful transplantation and/or treatment(s), and stem cells used in a clinical setting require the prescription and administration of a licensed physician. You understand the physician or regulations may require supplemental testing in order to allow a transplant to go forward. You understand the majority of potential therapies are new or experimental and there are no guarantees they will ever constitute approved uses by any regulatory or medical authority. Sanctioned clinical trials have certain standards to effectuate the safety of participants. If a use is currently approved, or may be approved in the future, there is no guarantee Your Unit processed and stored by Us will be suitable or usable in such therapies.
3. Collection of Your Unit. We will provide You with a Collection Kit prior to the birth of Your Child including instructional materials. You will be responsible for bringing the Collection Kit to the delivery area and giving it to Your Health Care Professional for the collection of the Unit. You must make sure the collection staff completes the Collection Worksheet accurately and fully prior to shipping. Failure to return a fully completed Collection Worksheet could result in your Unit being stored in such a way that it cannot be properly identified or located in the future if and when needed. Strict compliance with all directions including but not limited to collection, labeling and shipping of Your child’s cord blood or tissue is very important. Failure to properly follow the directions could cause Your Unit to be labeled as “not compliant with regulatory standards” and may adversely impact a doctor's ability or desire to use the Unit in the future. In addition, other issues such as a low volume of blood being collected may arise which could impact the quality, safety, potency and /or purity of Your Unit and cause Your Unit to be labeled “not compliant with regulatory standards.” By signing this Agreement, you acknowledge it is Your desire to have Your Unit processed and stored regardless of any potential issues or problems with regulatory or other compliance criteria and by Your signature, You expressly authorize and direct ACL and Our contracted lab to process and store Your Unit in a timely manner. If required, You have no objection to having Your Unit labeled “not compliant with regulatory standards” or other similar labeling.
4. Shipment of Your Unit. You or Your designee (family member or nursing staff, etc.) is responsible for packaging and shipping the Cord Blood and/or Cord Tissue to the Laboratory. AlphaCord representatives will be available by telephone if you need assistance.
5. Testing and Storage of Cord Blood and/or Cord Tissue. Upon receipt at Our contracted lab, Your Unit and any required maternal blood samples will undergo any tests required by the lab. It is possible re-testing for infectious diseases after the delivery of the Child may be required to comply with new regulations or new industry standards. If AlphaCord determines Your Unit is eligible, Our contracted lab will process and cryogenically store Your Unit. Approximately once per year, all newly processed Units are moved from our contracted lab’s temporary storage location to Our long term storage facility. By signing this agreement, You are consenting to this transfer of Your Unit. Although it is not anticipated, We reserve the right, in our sole discretion, to make additional transfers of Your Unit to another facility at Our expense. A notification attempt will be made to You of any additional transfers via our newsletters or Your current email address on file.
6. AlphaCord Quality Commitment. AlphaCord provides an $85,000 Quality Guarantee. In the event Your Unit is used in a stem cell transplant and they fail to engraft, We, in our sole discretion, may pay up to $85,000 towards the cost of procuring an alternate source of stem cells if written orders by the patient’s treating, licensed physician are issued to do so and it is approved by the appropriate hospital review board(s). See our current Quality Guarantee for additional terms, restrictions and conditions that shall apply.
7. Ownership of Cord Blood and/or Cord Tissue. You agree to be the custodian of the Unit until the Child reaches eighteen (18) years of age. When the Child becomes eighteen (18) he or she will become the custodian of the Unit. In the event of nonpayment by any current or future responsible party(s) to this agreement of any fees that are or become due under the terms of this Agreement (non-payment meaning any sums not paid in full within 60 days after such fees are due), this Agreement will automatically terminate, and all rights to, title to, and ownership of Your Unit will be relinquished to Us. We may, at sole Our discretion, utilize, donate, sell or dispose of Your Unit after this Agreement has been terminated for nonpayment. In the event of death or incapacity, We shall be entitled to rely on decisions or instructions or the like, of Your guardian, conservator, the administrator of Your Estate, or similar responsible person or successor in interest.
8. Retrieval of Unit for Use. A Unit must be requested by a licensed physician for treatment, the physician must provide written notification to Us at least 60 days in advance of the date needed. This notice shall include, but not be limited to, the name and address of the physician and hospital receiving the Unit and the date needed. You must adhere to all required AlphaCord, physician and hospital orders, paperwork and protocols regarding the release and shipping of the Unit. You shall be responsible for any and all preparation, shipping or transfer fees or costs incurred by Us for Unit(s) being shipped to or used inside or outside the United States. In addition, all fees due to Us must be paid in full prior to release and transfer of the Unit. If the Unit is to be used for a lifesaving treatment, We may, in our sole discretion, waive the cost and fees of preparation and shipping to the treatment facility.
9. Fees. You agree to pay Us the fees associated with the processing and storage of Your Unit pursuant to the processing and storage plan/option You have chosen and according to the method of payment and payment plan You have selected. If You cancel this agreement prior to shipping Your Unit to the processing facility, We will refund all amounts paid by You less a non-refundable $150 fee. You understand AlphaCord does not reimburse Doctors, healthcare professionals or facilities for any fees associated with Unit or sample collection. You understand any fees charged by them are your responsibility. After the initial term of this Agreement has expired, each year you will be charged an annual storage fee at the then current rate. The annual storage fee will be automatically drafted from the payment method selected by You on Your account profile. We reserve the right to change Your annual storage fee to reflect changes in market conditions or any reasonable cost increases We may incur.
10. Refunds. A refund may be granted for a low volume unit as defined by current standards and in our sole discretion. Refunds are only processed when We receive a written refund request, signed by You, no later than 60 days after the Child's birth. No refunds will be provided on or after the 61st day following the Child's birth. Any un-used portion of any storage plan (whether annual or long term) may or may not be refunded by Us, in our sole discretion.
11. Term of Agreement. This Agreement shall commence on the date you have signed it (or have otherwise legally consented to its terms) and shall remain in force for the length of time specified by the storage plan/option you have selected. Once that plan/option has expired, it shall thereafter renew automatically for additional one year periods unless either party notifies the other party in writing of their intent not to renew (or to terminate) this Agreement. A termination notice must be sent at least sixty (60) days prior to the anniversary date of this Agreement.
12. Termination of Agreement by Client. If You choose to terminate this Agreement, and You wish to transfer Your Unit to a different facility You must specify all details (including but not limited to the destination and desired timing of the transfer), in your termination notice. If you do not, then and all rights to, title to, and ownership of Your Unit will be relinquished to Us. We may, at sole Our discretion, utilize, donate, sell or dispose of Your Unit after this Agreement has been terminated regardless of the reason for termination. Any fees or expenses relating to a transfer of Your Unit as a result of the termination of this Agreement by anyone for any reason will be incurred by You. Except as provided in Section 8 of this Agreement, you will not be entitled to any refunds of any amounts previously paid. This includes but is not limited to any annual or pre-paid storage plans.
13. Assignment. AlphaCord may assign this Agreement to any partnership, association, individual, corporation or other entity that provides similar services or intends, after such assignment, to provide such services. In order to provide the best possible services to You, AlphaCord may delegate responsibilities hereunder to one or more subcontractors who perform similar services as part of their regular business activities. You acknowledge and understand that We currently contract Our processing and storage activities to third party laboratories. This Agreement is not assignable by You without written notification to and the written consent of AlphaCord. You are responsible for any costs or fees associated with or arising out of Your Assignment.
14. No Warranty or Guarantee; Limitation of Liability. You acknowledge that neither Alpha Cord nor any of its respective officers, directors, shareholders, executives or employees (the Vendor Parties) have ever made any representations, guarantees or warranties, express or implied, to You of any type or nature, including without limiting the generality of the foregoing, with respect to (i) suitability of Cord Blood and/or Cord Tissue for future management or treatment of diseases; (ii) successful treatment of diseases by Cord Blood and/or Cord Tissue; (iii) any advantage(s) of Cord Blood and/or Cord Tissue transplantation over other treatments using other stem cells or other therapies; and (iv) the merchantability or fitness for a particular purpose or use of any product or service hereunder. You agree that any claim against the Vendor Parties or their assignees, including any claim for loss, injury, damage or destruction directly caused by the Vendor Parties’ failure to exercise reasonable care in its services, including but not limited to, the transportation, processing or, storage of Your Unit shall be limited to the total amount of fees paid by You to Alpha Cord.
15. Client Consent and Understanding. The undersigned hereby consents to and understands the following:
- I consent to have my healthcare provider collect the cord blood and/or cord tissue after the birth of my child.
- I understand there are potential benefits to the collection of cord blood and/or cord tissue, including the procurement of stem cells to treat certain diseases, such as certain cancers and blood disorders. However, I understand treatments based on stem cells may not the best treatment for all diseases, and stem cell treatment for any particular disease may not be effective. I also understand it is possible better treatment alternatives may be developed in the future.
- I understand there are alternatives to obtaining stem cells from cord blood and/or cord tissue, such as from bone marrow, and stem cells harvested from alternative sources have proven effective in treating the same diseases as stem cells harvested from cord blood and/or cord tissue.
- I understand my child or my family may never need to use the Unit.
- I understand the decision to collect the Unit will be made by my healthcare provider at the time of the delivery of my child. I further understand the primary consideration during childbirth will be the health of my child and the birth mother, and circumstances may exist in which the healthcare provider determines it is in the best interests of the child or the birth mother that the Unit not be collected.
- If the collection volume is low by current standards, We reserve the right, in Our sole discretion, to not process or store Your Unit, but We will use our best efforts to notify You before We do so.
- I consent to have the Unit undergo various tests including but not limited to red blood cell type (ABO/Rh), total nucleated cells, cell viability, sterility (bacterial and fungal testing) to determine transplant suitability, and HLA testing if ordered. The testing may indicate the Unit should not be stored, or may only be stored, in a fashion that quarantines it from other Units. I understand other tests may need to be performed as a condition of and at the time of use or transplant.
- I understand the Unit will be stored at cryogenic temperatures pursuant to procedures normal for the industry. I understand it is not known at this time how long cord blood and/or cord tissue can safely and effectively be stored using this process.
- I understand either I or my designee will be responsible for shipping the collected Unit to the contracted lab along with a fully completed "Collection Worksheet" and all other information reasonably required. I also understand it may not be possible to process and store the Unit if it is not accompanied by the fully completed "Collection Worksheet" and all other identifying documentation, and if it is not shipped and delivered in accordance with the procedures outlined by Alpha Cord.
- If instructed by Us, I consent to and shall have samples of my blood (or I shall obtain the consent and compliance of birth mother, if different) drawn within 24 hours after the delivery of my child. These samples shall accompany the shipped Unit. It will be tested for certain infectious diseases to determine if the Unit is suitable for storage and transplant. These tests may include but are not limited to Hepatitis B, Hepatitis C, HTLV, cytomegalovirus and syphilis. We may elect, in our sole discretion, not to store the Unit if any of the blood tests are positive.
- I hereby consent to have my blood (or obtain the consent of birth mother, if different) tested for the Human Immunodeficiency Virus (HIV). I understand a final positive test result indicates I have been exposed to the Virus and am infected, but it does not mean I have AIDS or I will become sick with AIDS in the near future. I understand a negative test result indicates I am probably not infected with the Virus, although I understand I should be retested if I think I have been recently exposed to the Virus. I hereby consent and authorize Alpha Cord or any other entity providing services to me pursuant to this Agreement to release any medical records or test results on file to any other provider as may be requested or required from time to time. I understand that not timely submitting a maternal blood sample to AlphaCord or not successfully completing maternal infectious disease testing within certain time parameters could impede, restrict or halt the future release/use of my Unit.
- I understand there are risks to having my blood drawn, such as fainting, bruising, discomfort, redness or inflammation around the needle site, and I will be tested for diseases that may discover an infection I otherwise did not know about. All test results are confidential and will only be disclosed in writing to You or Your authorized designee or as required by any industry standards, laws, statutes, rules or regulations. State or Federal agencies may require Us to report positive infectious disease results to them and/or your primary care or treating physician.
- I understand and agree Alpha Cord’s liability for any breach of its obligations or other acts or omissions in connection with the services described in this Agreement is limited to the total amount I have paid to AlphaCord under this Agreement. I hereby release AlphaCord, my healthcare provider, the hospital or birthing center and their officers, directors, employees, agents, affiliates, successors and assigns (collectively referred to as the Released Parties) from any and all other liability for any and all loss, harm, damage or claim of any kind arising out of or related in any way to the services provided under this agreement. I understand by this release I am giving up any right I might otherwise have, now or in the future, to sue or otherwise seek money damages or other relief against AlphaCord or any of the Released Parties for any reason relating to the services, with the sole exception of seeking a return of any money paid under this Agreement.
16. Arbitration. This Agreement shall be governed by and construed in accordance with the laws of the State of Georgia without regard to its principles of conflicts of laws. Any claim arising out of this Agreement shall be submitted to binding arbitration with the American Arbitration Association in Atlanta, Georgia and shall be finally and conclusively determined by the decision of a board of arbitration consisting of one (1) member. Any decision made by the arbitrator shall be final, binding and conclusive on the parties to the dispute and entitled to be enforced to the fullest extent permitted by law and entered as a judgment in any court of competent jurisdiction. The prevailing party shall be awarded its costs of litigation, including reasonable attorney fees, incurred in enforcing this Agreement.
17. Notices. Any and all notices that may be given in connection with this Agreement shall be in writing. Any notice(s) shall be deemed to have been duly given on the date of service if served personally on the party to whom notice is to be given, or within 72 hours after mailing, if mailed to the party to whom notice is to be given, by certified mail, postage prepaid, or by a priority delivery service such as FedEx, UPS or USPS overnight services, with a signature from the notified party evidencing receipt. Notices shall be properly addressed to Us at our current address listed on our web site www.AlphaCord.com and to You at the most current address We have in our client database or any other address a party has designated by written notice to the other party. The Client agrees to promptly notify Alpha Cord in the event of a change in Client's current mailing address or payment methods at any time during the term of this Agreement or any renewals thereof.
18. Miscellaneous. This Agreement represents the entire Agreement between the parties concerning the subject matter hereof, and there are no understandings, agreements, or representations other than as set forth herein. This Agreement is binding upon the parties, their heirs, spouses, executors, administrators, successors and assigns. No modification, amendment or waiver of any provision of this Agreement, nor any consent to any departure by any party from the terms hereof, shall be effective unless the same be in writing and signed by all parties hereto. If any provision of this Agreement is held invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions shall in no way be affected or impaired thereby. AlphaCord shall not be liable for any delay or failure to perform per the terms of this Agreement caused by Acts of God or other causes beyond the parties’ control and without fault or negligence. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
I have read and understand the above agreements, consents, limitation of liability and releases, and know the services described above are totally voluntary and elective on my part. I have discussed the services with my healthcare provider, and I have signed this Agreement freely and voluntarily. By signing this Agreement, I hereby acknowledge that I am giving up legal rights I might otherwise have had.
By clicking the "I Agree" button, I hereby affix my signature in accordance with Georgia's Uniform Electronic Transactions Act, O.C.G.A. § 10-12-1, et. seq.,, signifying my consent and fully binding me to this agreement.
Form B.1-2 Rev 07-28-2017