CLIENT AGREEMENT. Copyright 2014 MiracleCord Inc. All rights reserved.

Transcription

1 CLIENT AGREEMENT MiracleCord, Inc. is a provider of services for the collecting, testing, processing, cryopreserving and storing of cells collected from a newbornʼs umbilical cord blood ( Cord Blood ) as well as certain umbilical cord tissue ( Cord Tissue ), (individually a Neonatal Specimen or collectively Neonatal Specimens ). This Client Agreement ( Agreement ) explains MiracleCordʼs obligations to you ( Client ) and your agreements with MiracleCord. MiracleCordʼs Obligations 1. MiracleCord shall provide to the Client a collection kit for the Client to bring to the hospital or other birth location for the collection of the Clientʼs newborn babyʼs Cord Blood and/or Cord Tissue, and a maternal blood sample (collectively Specimens ). MiracleCord shall include with the collection kit reasonable directions for the attending medical professional for the use of the kit and the collection of the Neonatal Specimens. 2. As soon as possible, after the Specimens have been collected, the Client will contact MiracleCordʼs medical courier partner ( Courier ). The Courier will pick up the Specimens at the birth location and deliver them to MiracleCordʼs laboratory partner ( Lab ). 3. Upon arrival at the Lab, certain tests will be conducted on the Specimens. 4. The Neonatal Specimens will be uniquely identified, stored, and maintained at a cryogenic storage facility, and shall remain in cryopreserved storage for the full period of the Agreement between MiracleCord and Client or until the Agreement is terminated as provided for in this Agreement. 5. MiracleCord reserves the right to transfer the Neonatal Specimens, at its cost, during the term of this Agreement. 6. Upon receipt by MiracleCord of a written request from the Client, MiracleCord shall arrange for some or all of the Neonatal Specimens (as requested by the Client) to be transported directly to a medical professional or medical care facility to be used in a medical procedure as determined by Client and Clientʼs medical professional. Except as otherwise provided in this Agreement, MiracleCord shall not transport the Neonatal Specimens from the storage facility to any party, including Client, other than to a medical professional or medical care facility for a medical procedure. The initial transportation within the United States of Cord Blood as provided herein shall be at MiracleCordʼs expense. A subsequent transportation of Cord Blood within the United States, the transportation of Cord Blood outside of the United States or any transportation of Cord Tissue shall be at Clientʼs expense. 7. Upon termination of this Agreement, for storage of the Neonatal Specimens between MiracleCord and the Client, MiracleCord will transport, at Clientʼs cost, the Neonatal Specimens to any medical professional, medical care facility, cryopreservation laboratory, storage facility or Client, as directed by Client. Alternatively, at Clientʼs direction, or if no direction is provided by Client within sixty (60) days after termination, MiracleCord or the Lab will dispose of the Specimens in an appropriate manner, including but not limited to transfer to a public cord blood bank or to a research facility. Clientʼs Obligations 1. The Client will carefully read and execute this Agreement and the Health History Profile provided by MiracleCord. The Client is encouraged to have the documentation related to the collection, testing, processing and storage of the Specimens reviewed by Clientʼs counsel and medical professional of Clientʼs choosing. 2. The Client will select the medical facility and medical professional that will conduct the collection of the Neonatal Specimens. The Client acknowledges the selection of the medical facility and the medical professional is solely the responsibility of the Client and that MiracleCord does not select or otherwise determine who shall perform these services. 3. Client agrees to notify the medical professional and the medical facility staff of the desire to collect the babyʼs Cord Blood and/or Cord Tissue. 4. As soon as possible after collection of the Cord Blood and/or Cord Tissue, the Client will call the Courier and arrange for the pick up of the Specimens for delivery to the Lab. 5. If the Client executing this Agreement is not the birth mother of the child whose Cord Blood and/or Cord Tissue is being collected, the Client will obtain the written consent of the birth mother to all of the terms and conditions in this Agreement. 6. The Client will make all payments in a timely manner. Fees and Plans 1. At the time of initial enrollment of the Client to receive MiracleCordʼs services, the Client will pay a non-refundable deposit of $ (in the event of a multiple births, the deposit will be $ per baby). Upon collection of the Specimens, Client shall be obligated for the payment of the balance of the fees for the plan as selected by the Client. By accepting this agreement, if the Client elects a financing arrangement for the fees, Client hereby accepts the Payment Plan Disclosure provided on the MiracleCord website. Other terms and conditions may apply. 2. Upon executing this Agreement the Client will select one of the storage and payment plans that is on MiracleCordʼs website for online enrollment. Storage plan options include an annual plan and/or a long-term plan. 3. The annual plan includes: (a) a separate fee for all initial testing and processing of the Specimens, the transport of Specimens by the Courier to the Lab, and the collection kit for the Specimens, and (b) the storage fee for the first twelve months. Thereafter, the Client will be invoiced for additional annual storage fees fourteen (14) days prior to each anniversary date of the commencement of the storage of the Neonatal Specimen(s). 4. The long-term plan includes: (a) a separate fee for all initial testing and processing of the Specimens, the transport of Specimens by the Courier to the Lab, and the collection kit for the Specimens, and (b) the applicable storage fee for the period set forth in the specific longterm plan selected by the Client.

2 5. The Client will be charged a late fee equal to 10% of the amount due if any required fee is not paid when due. Additionally, any amount not paid within thirty (30) days of the date due shall accrue interest at the rate of 1.5% per month until paid. 6. As set forth above, there is no MiracleCord fee for an initial transfer of the Cord Blood that is retrieved by the Client to be used in an engrafting or transplant procedure within the United States. MiracleCord shall be responsible for any shipping or courier costs for transfer of the Cord Blood for use in such medical procedures within the United States. The Client shall be responsible for any shipping or courier costs for any subsequent transfer of Cord Blood, any transfer to any location outside of the United States, or for transfer of Cord Tissue. The fee to transfer (a) the Cord Blood that is retrieved for any reason other than an engrafting or transplant procedure within the United States or (b) the Cord Tissue for any reason, will be made available to Client by MiracleCord or can be determined by calling MiracleCord prior to requesting retrieval of the Neonatal Specimens. Limitations of the Program 1. MiracleCord shall have no liability in the event of: a. Failure of the medical professional to correctly collect, label or assemble the Specimens inside the collection kit; b. Failure of the medical professional to attend to any medical issue that arises during the delivery of the newborn, even if such failure was due to such medical professionalʼs attention to collecting the Specimens; c. Failure of the Courier to deliver the Specimens, due to loss or destruction of the Specimens while in the Courierʼs possession; d. Any contamination of the Specimens at the time of collection and up until the Specimens are delivered to the laboratory for further processing and testing; e. Any event that harms or contaminates the Specimens that was beyond the reasonable control of MiracleCord, such as, fire, explosions, power outages, storms, floods, terrorism, wars, labor disputes, governmental action, imposition of statutes, laws or regulations that materially alter the program for collection, processing, testing and storage of the Specimens; f. Any failure of an engrafting procedure or transplant of the Neonatal Specimens, except as provided in MiracleCordʼs Quality Guarantee with respect to Cord Blood. 2. MiracleCordʼs liability to the Client for any claims, loss, harm, damages, expenses, costs (including attorneysʼ fees) shall be limited to a return of the fees paid by Client for MiracleCordʼs services under this Agreement. 3. In the unlikely event a Neonatal Specimen is reasonably determined to be inappropriate for the program, MiracleCord will return to Client any storage fees paid by Client in advance, whether under any annual or long-term plan. 4. MiracleCord shall have no liability for, and Client hereby releases and discharges MiracleCord from any obligations with respect to, any disclosure of information in accordance with the Privacy Policy that is on an attachment to this Agreement and/or provided on MiracleCordʼs website. Quality Guarantee As a MiracleCord client, the viability of your babyʼs umbilical cord blood stem cells is guaranteed by MiracleCord with respect to the initial stem cell transplant procedure. If, in an initial stem cell transplant procedure, your childʼs Cord Blood stem cells fail to engraft, MiracleCord will pay up to fifty thousand dollars ($50,000) toward the cost of procurement of an alternative stem cell source, if medically indicated. Cord Tissue is specifically excluded from the terms of this quality guarantee. 1. Definition of Engraftment - Stem cell engraftment is defined as three consecutive days in which the patientʼs absolute neutrophil count is at least 500 per microliter, with the first of the three measurements occurring within 100 days of transplantation. 2. Quality Guarantee Medical Requirements: a. The Cord Blood must have been collected with a MiracleCord collection kit and processed and cryogenically stored by the Lab, and cannot subsequently have been transferred to a storage facility other than a MiracleCord Lab; b. The results of the testing by the Lab of the Cord Blood and maternal blood must show no evidence of infection or contamination; c. The cells must be used in a stem cell transplant for hematopoietic reconstitution either by the donor (autologous) or by the donorʼs biological parents or biological siblings; d. The donor cells must be at least a 4 out of 6 HLA match to the recipient; e. The Cord Blood unit must contain at least 2 x 10 7 total nucleated cells (TNC) per kilogram weight of recipient; f. The Cord Blood unit must contain at least 1 x 10 5 CD34+ cells per kilogram weight of recipient; g. The transplant facility must use a validated cord blood thawing procedure, and the cord blood stem cells must be administered immediately upon thawing; h. The stem cells must be administered to the transplant recipient by a transplant physician, in a medical facility qualified by an Institutional Review Board (IRB) for stem cell transplantation; i. The cells must not be subjected to manipulation, cell expansion, positive or negative cell selection, or gene therapy; j. The patient must be given sufficient time (post-transplant) for engraftment to occur; k. The stem cells must not be used in combination with supplemental stem cell sources, including, but not limited to, additional cord blood, peripheral blood, or bone marrow; l. The stem cells must not be used in experimental procedures, including, but not limited to, mini-transplants, or other types of extensive and/or experimental laboratory cultures; m. The stem cells and/or transplant recipient must not be subjected to an investigational drug within 100 days of transplantation. 3. Quality Guarantee Documentation Requirements:

3 a. Signed statement from the transplant physician attesting that engraftment did not occur; b. Medical records documenting proof of non-engraftment; c. Proof that all third-party payers responsible for payment of any fees associated with the collection, storage, or transplant of the cord blood have been notified of the existence of MiracleCordʼs Quality Guarantee and the amount to be paid. 4. This Quality Guarantee is not available to: a. Clients that reside in areas where this guarantee is prohibited by law, or in the event the transplant procedure is performed outside of the United States; b. Clients whose cord blood banking fees or transplant fees are paid in full or in part by Medicare or Medicaid; c. Clients whose cord blood banking fees are paid in part or whole by third-party payers in Massachusetts and Michigan; d. Clients who have an unpaid balance due to MiracleCord for services rendered; e. Clients enrolled in MiracleCordʼs Select Transplant Program. 5. Your babyʼs Cord Blood is not guaranteed to be a match for a family member, and an umbilical cord blood transplant may not provide the best course of treatment for any particular disease. Ultimately, the use of your childʼs cord blood stem cells will depend on the physicianʼs determination of disease type and the HLA matching for donor and recipient. Informed Consent 1. To confirm that the Client (a) understands the services to be provided by MiracleCord, and (b) has been informed of the processes and procedures that will be performed by MiracleCord or the Lab, the following provisions regarding the Clientʼs informed consent for such engagement and receipt of services is incorporated into this Agreement. The term I, as used in this informed consent provision, is a reference to the Client and, where different from the Client, the birth mother: I acknowledge that I have decided and consented to have my childʼs Cord Blood and/or Cord Tissue (as applicable) collected after the birth of my baby and to have such Neonatal Specimens tested, processed, cryopreserved and stored. I also agree to provide samples of my own blood for testing. Although infrequent, I understand that at the time of childbirth complications may occur and attending to my health or the health of my newborn is the priority; therefore, it may not be possible to collect my babyʼs Neonatal Specimens. I acknowledge that it is my decision to select the medical professional that will attend to the birth of my baby and conduct related medical procedures, including the collection of my childʼs Neonatal Specimens. I understand that MiracleCord may contact the medical professional for the purposes of discussing MiracleCordʼs services, and in certain cases, such medical professional may receive payment from MiracleCord for performing services related to the collection of my Specimens. In order to ensure and enhance the communications for my benefit between the hospital, medical professional and MiracleCord, I hereby authorize the hospital and medical professional to disclose my protected health information related to the collection of my Specimens with MiracleCord. MiracleCord may provide the hospital and medical professional with a copy of this authorization. I understand that I am entitled to be provided a copy of any disclosed information and that this authorization can be revoked at any time. I understand that MiracleCord will not use my protected health information for marketing or promotional purposes. I understand that the Lab will perform tests on the Cord Blood, including cell viability, total cell number, stem cell concentration, blood typing, and bacteria and fungus, to determine the nature and quality of the Cord Blood, and the Lab will perform tests on the Cord Tissue (if collected), including cell viability and sterility, to determine the nature and quality of the Cord Tissue, and that my blood will be tested for certain infectious diseases including human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, human T-lymphotrophic virus (HTLV), cytomegalovirus (CMV), and syphilis. I understand that if applicable law, regulations, certification requirements or industry standards are modified or amended, then alternative, additional or substitute tests may be performed. I acknowledge and consent to MiracleCord and the Lab making such reports of the results of these tests as required by applicable law. I understand that MiracleCord may elect not to retain the collected Neonatal Specimens if, in MiracleCordʼs reasonable judgment such Neonatal Specimen is not appropriate for storage. Such reasons may include, but are not limited to, if there is any condition that may affect the viability of the future use of such Neonatal Specimen. The final decision as to whether such Neonatal Specimen is appropriate for storage shall be that of MiracleCord and the Lab. I understand that I will be notified in writing of a decision that such Neonatal Specimen is not appropriate for either testing or storage. I understand that there are potential benefits of Cord Blood and Cord Tissue for use in the treatment of certain diseases and conditions. I also understand that the limits of the longevity of storing Neonatal Specimens are not completely known. I acknowledge that it is not possible to know if transplanting Cord Blood or Cord Tissue stem cells will be effective in the treatment of any particular diseases or conditions. I understand that the Neonatal Specimens are a perfect match for my baby, and have been informed that, unless and until further testing is completed, it is not possible to know whether the Neonatal Specimens will be a match for any other particular individual. I understand that the collection of Specimens, and transplantation of Neonatal Specimens are medical procedures, and that there are inherent risks in any medical procedure. I acknowledge that MiracleCord does not and will not, perform, advise or participate in any way in such medical procedures and will not have any liability for such medical procedures, and I release and discharge MiracleCord from any such liabilities. Miscellaneous 1. Confidentiality - MiracleCord acknowledges the confidential nature of the Clientʼs information provided to MiracleCord (and the information about the Clientʼs child) and will use its reasonable best efforts to maintain the confidentiality of such information, except as may be required by applicable law. The Client agrees to the release of information by MiracleCord to any medical facility, hospital, laboratory or medical professional providing services to the Client that are related to the Specimens, including the provision of any engrafting or transplant procedures.

4 2. Termination by Client - This Agreement may be terminated by the Client (a) at any time prior to collection of the Specimens, or (b) after giving MiracleCord at least sixty (60) days prior written notice at any time after storage of the Neonatal Specimens. All fees paid through the date of termination are non-refundable. 3. Termination by MiracleCord - This Agreement may be terminated by MiracleCord (a) if MiracleCord has determined any such Neonatal Specimen is not appropriate for storage, in which case MiracleCord will return to Client any storage fees paid by Client in advance for such Neonatal Specimen, whether under any annual or long-term plan, (b) if Client does not timely pay any fee when due, or (c) at any time after giving Client at least sixty (60) days prior written notice of such termination, in which case MiracleCord will return to Client a pro rata portion of any storage fees paid in advance under any annual or long-term plan. 4. Upon termination of this Agreement by Client in accordance with Section 2 above, or by MiracleCord in accordance with Sections 3(a) or 3(c) above, and after storage has commenced, Client may request to retrieve the Neonatal Specimen and shall pay the applicable retrieval fee at such time. If either (a) pursuant to the preceding sentence, Client does not request retrieval of the Neonatal Specimen or (b) MiracleCord has terminated the Agreement in accordance with Section 3(b) above, MiracleCord, without liability, shall be free to use or dispose of such Neonatal Specimen in an appropriate manner, including but not limited to transfer to a public cord blood or tissue bank or to a research facility. Client hereby releases and discharges MiracleCord from any and all claims, liabilities, costs or actions that may arise out of or result from MiracleCordʼs activity or handling of the Specimens after termination. 5. Notices - Any notice either required or permitted under this Agreement may be given (a) personally to the other party, (b) by private delivery services (e.g., Federal Express or United Parcel Service) with a return receipt requested, or (c) by United States registered or certified mail return receipt requested. Notice shall be sent to the other party at their last known address. 6. Dispute Resolution - In the event of any dispute between the Client and MiracleCord with respect to this Agreement or related in any way to the collection, testing, processing and storage of the Specimens, or a dispute over any payments or fees, such dispute will be submitted to binding arbitration under the rules of the American Arbitration Association (the AAA Rules ). The arbitration will be held in Chicago, Illinois before a single arbitrator. The fees of the arbitrator will be shared equally by the parties. Other than such arbitrator fees, the prevailing party in such arbitration, as determined by the arbitrator will be entitled to recover its costs and expenses of the arbitration. The arbitrator will issue a written opinion of his/her decision and such decision will be binding, final and enforceable in any court of competent jurisdiction. 7. Governing Law - This Agreement and the relationship between the Client and MiracleCord shall be governed by and interpreted in accordance with the laws of the State of Illinois without regard to its choice of laws rules. 8. Assignment - Upon the attainment of the age of majority by the child from whom the Neonatal Specimens were collected (the age of majority as determined in the state of the domicile of the child, but in no event earlier than the age of majority in the State of Illinois), the Agreement between the Client and MiracleCord shall be assigned to such child who shall then be the Client hereunder. Additionally, if different from the initial Client, this Agreement shall be assigned to any guardian of the child from whom the Neonatal Specimens were collected. MiracleCord may assign its rights and obligations under this Agreement (i) to any acquirer of the majority of the stock of MiracleCord or substantially all of the assets of MiracleCord or (ii) in the unlikely event that, for any reason, MiracleCord ceases to be an ongoing concern, to ensure the uninterrupted provision of services, MiracleCord may assign its rights and obligations under this Agreement to the Lab. Except for the foregoing circumstances, neither the Client nor MiracleCord shall assign its rights and obligations under this Agreement without the prior written consent of the other party. All of the terms and conditions shall be binding on any successor or assign of a party. 9. Severability - If any of these terms and conditions are held to be invalid or unenforceable, such invalidity or unenforceability will not affect the other terms and conditions, which will remain in full force and effect. 10. Entire Agreement - This Agreement, and the attachments to this Agreement, represent the entire agreement between the Client and MiracleCord and supersede any oral or written prior agreements, representations or understandings. The Client (and the birth mother, if different than the client) has indicated acceptance of this Agreement as of the date set forth below. Client Birth Mother (If different than Client) Printed Name Printed Name Signature Date Signature Date

5 CLIENT RIGHTS Medical care for the birth mother and baby are of the highest priority to MiracleCord. If the medical condition of the mother or baby becomes a concern, the collection process should be withdrawn. Under no circumstances should the collection process be completed if any medical care would be sacrificed to the mother or baby. The Clientʼs healthcare professional is responsible for identifying any circumstances that would put the mother or baby at risk. The Client also has the right to deny consent of the collection at any time without affecting access to medical care. Also, the Client has the right to have any and all questions answered concerning any part of the process, completion of the forms, testing for infectious diseases, and storage (this list is not all-inclusive). PRIVACY POLICY MiracleCord takes seriously its obligation to keep all personal and health information strictly confidential and to limit the disclosure of such information. The Information As a result of enrollment with MiracleCord, the Client will provide MiracleCord with various types of information. The Client will provide MiracleCord with personal identification information such as names, addresses and credit card numbers. The Client will also provide MiracleCord with a health history profile that contains information about the birth mother and family. Included in information that is subject to this policy is any additional information voluntarily provided to MiracleCord. MiracleCordʼs Obligations of Confidentiality With respect to the personal identification information provided to us, MiracleCord will only disclose such information to its employees, agents, representatives and its service partners providing collection, testing and storage services related to the Specimens, and only where such individuals or entities have demonstrated a need to know for the purposes of completing the process of storing the Specimens as part of the program in which the Client has enrolled, and maintaining adequate records related to such storage. Without the Clientʼs consent, MiracleCord will not transfer the Clientʼs information to any vendor, marketing or promotion firm or any other third party. One exception to this general commitment is that MiracleCord will comply with all applicable governmental orders or requirements as well as any judicial or other regulatory agency subpoenas. MiracleCord will notify the Client in the event it receives such order, requirement or subpoena. With respect to the medical information provided to MiracleCord, including responses on the Health History Profile and the results of any tests on the Specimens, MiracleCord will only disclose such information as required by applicable federal or state law. Additionally, MiracleCord may disclose such information to a third party for whom you have granted consent for such disclosure, including any medical professional providing healthcare services to the Client, the birth child or any third party. Any information related to the Specimens maintained by either MiracleCord or its service partners will be treated the same as medical information as described under this policy.