STORAGE AGREEMENT Cord Blood Cord Blood+Cord Tissue
Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 STORAGE AGREEMENT Cord Blood or Cord Blood+Cord Tissue Cryosite Ltd 13a Ferndell Street South Granville NSW 2142 Phone: 1800 220 410 Fax: 1800 210 410 Email: [email protected] Web: www.cryosite.com TGA License number: MI-18072008-LI-00248-11 ISO 15189:2007 Accreditation No: 14598 NATA ABN: 86 090 919 476 ASX Code: CTE Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement Cryosite’s Family Cord Blood Bank is licensed by the Therapeutic Goods Administration (TGA) to collect and store cord blood described in this Storage Agreement (TGA lic no: MI-18072008-LI-002488-11). Please note that TGA DOES NOT currently license or regulate the collection or storage of cord tissue in Australia. Overview This Storage Agreement sets out the terms and conditions under which Cryosite will collect, process and store your baby’s Cord Blood or Cord Blood+Cord Tissue. Please read this information carefully as it is important that you understand exactly what is involved in the process of collection and storage of cord blood and cord tissue*. If after reading this document you have any questions, please do not hesitate to contact us on 1800 220 410. *Cord tissue refers to the cells of the umbilical cord or the cells derived from the processing of the umbilical cord. This Storage Agreement comprises a number of sections including: Client Details (Page 2): which collects your details and other important information about the birth. Client Declaration (Page 3-7): which describes the terms under which your baby’s cord blood and cord tissue (if applicable) will be collected and stored. Consent for Collection (Page 8): which you will need to complete and confirm with your doctor or midwife that they are willing to collect the cord blood, maternal blood and cord tissue (if applicable) at the time your baby is born. You and your collector must both sign the “Consent for Collection” section. If you require Cryosite to provide a collector, please call us to confirm collector availability and pricing (if applicable). Some hospitals may also ask you to sign a release document before they will permit the collection to proceed. Cryosite will provide this release document if required by your hospital. Medical and Social History (Page 9-11): which you must complete and which is similar to the form completed when a person donates blood. The medical and social history section must be completed by the birth mother (and if applicable, the surrogate/egg donor/sperm donor). If you require assistance to complete this section please contact Cryosite. If relevant medical information becomes known to you after you have returned this Storage Agreement you must let us know. Payment Options & Authorisation (Page 12-14): where you can elect to store your child’s Cord Blood or Cord Blood+Cord Tissue for an initial period of either 18 or 25 years*. There are a number of payment options and discounts available. You need to select your preferred payment plan and complete the payment authorisation (and if elected, the Direct Debit Request section). *Please note that while your payment options include initial storage for either 18 years or 25 years, the decision to extend storage beyond the initial storage period does not have to be made now. Just before the end of the initial period, all clients will have the option of extending storage by paying a nominal annual storage fee. You will be able to access the stored cord blood and cord tissue (if applicable) at any time during the initial storage period or extended storage period. What do I do when I have completed this Storage Agreement? Return your completed Storage Agreement to Cryosite: FAX to: 1800 210 410 Email to: [email protected] Mail to: 13a Ferndell Street, South Granville NSW 2142 (keep a copy for yourself) Cryosite will acknowledge receipt of your Storage Agreement and provide the contact number for our 24/7 Cord Blood Call Centre which you must call after the birth of your baby. Cryosite will also contact your hospital and your doctor/midwife (or the collector provided by Cryosite), to notify them of your intention to collect your baby’s cord blood and cord tissue (if applicable) and, if required, to provide training. Cryosite will prepare and send your unique Collection Kit to your nominated hospital. Occasionally it may be necessary to send the kit directly to your home address, if this is the case we will contact you to arrange a suitable time. Please allow 3 business days for standard (non-urgent) delivery. To enable the preparation and delivery of your Collection Kit in time for the birth it is preferable to send Cryosite this Storage Agreement at least 6 weeks prior to your estimated delivery date. If your due date is less than 4 weeks away, you should fax or email this Storage Agreement to Cryosite as soon as possible. While in most circumstances a Collection Kit can still be sent to you on the next working day, you will need to call Cryosite urgently if you need us to arrange this for you. Please note: Unlike some company’s Cryosite does NOT reuse, reassign or reassemble Collection Kits from failed collections, so we cannot refund the “Enrolment Fee” after your kit has been sent to you. All components of your Collection Kit are prepared and labelled specifically for your child and are maintained under Cryosite’s direct control until dispatch to prevent tampering, loss of traceability or contamination. What happens after my baby’s Cord Blood or Cord Blood+Cord Tissue are collected? After the collection of your baby’s cord blood and cord tissue (if applicable) and maternal blood samples for pathology testing, you or your birthing partner must contact our 24/7 Cord Blood Call Centre as soon as possible so that we can arrange for our medical courier to pick up the Collection Kit and transport it to our laboratory for processing and long-term storage. The courier will verify the contents of your Collection Kit in your presence before sealing for shipment. You (or a family member) will be asked to sign a packing slip and consignment note releasing the Collection Kit for shipment to Cryosite. Please note that cord blood and cord tissue have 36 hours from the time of collection to commencement of processing, so your Collection Kit may not be picked up immediately, especially for births that have taken place during the night. Please do not worry as our couriers are trained and aware of this timeframe and will arrange the pickup time accordingly. DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 1 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Client Details Please print clearly. All information is required. CONTRACT OWNER(S) DETAILS Mother’s Full Name: Contract is with this person Given names Surname Mother’s Date Mother’s Maiden of Birth: Name: Home Address: Address: Suburb: Telephone: State: Mobile: Postcode: Email: Partners Full Name (optional): Contract is also with this person if named Given names Surname Collection Kit Delivery Address: If different to Home Address Address: Suburb: State: Postcode: BIRTH MOTHER DETAILS Only complete this section if the Birth Mother’s details are different to Contract Owner Details (above) Birth Mother’s Date of Birth: Birth Mother’s Full Name: Given names Surname Complete this section only if the Birth Mother is booked into the hospital under a different name: Full Name: Given names Surname BIRTH DETAILS Estimated Due Date: Single Birth Elective Caesarean (please circle): YES ○ ○ Twins NO ○ Triplets ○ ○ Private Patient ○ Public Patient Date & Time (if known): Name of your Doctor / Midwife / Collector: If you require a Cryosite Collector write “Cryosite Collector” Doctor/Midwife’s contact details (if applicable) Address: Suburb: Telephone: Fax: State: Postcode: State: Postcode: Email: Hospital Name: Hospital Address: Address: Suburb: Refer a Friend bonus: If you were referred by an existing Cryosite Client, let us know and they will receive a $50 thank you voucher from us. Friend’s Name: Friend’s DOB: How did you hear about Cryosite? Cryosite Use Only Obstetrician www.cryosite.com Antenatal Class^ Baby Fair^ I am a repeat customer Pregnancy Magazine^ Internet Search Engine^ Hospital^ Personal referral^ Ultrasound Clinic^ TV/Radio^ Other^ Date Received: Initial: ^ Please give details: DCN: CB-F-014-16 Client ID: Date Implemented: 01 May 2015 Page 2 of 14 ○ Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Client Declaration I/We, _______________________________________________________________________________________(insert Contract Owner name(s)) agree to have our child’s Cord Blood or Cord Blood+Cord Tissue (please delete the option that does NOT apply) collected and stored with Cryosite. We have read the written information about cord blood and cord tissue storage provided to us by Cryosite. Our decision to enter into this Storage Agreement with Cryosite has been made after a full consideration of that information. We have had the opportunity to ask any further questions we may have about cord blood and cord tissue storage and those questions have been answered to our satisfaction by representatives of Cryosite. A. WE UNDERSTAND THAT: Introduction 1. In relation to cord blood, this is an autologous or directed allogeneic cord blood collection. This means that the cord blood can be used for the infant donor and may also be able to be used for a compatible Family member (i.e. “directed allogeneic use”) subject to clauses A22.i.c), A23, and A24. “Family” means a person genetically related to the infant donor and includes mother, father, children, siblings, grandparents, grandchildren and first cousins of the donor. 2. The birth mother has the right to refuse consent to the collection or storage of maternal blood, cord blood or cord tissue at any time without prejudice. 3. The medical records of the mother (birth and biological) and infant donor will be reviewed by Cryosite representatives. Acknowledgements 4. Cord blood and cord tissue collection and storage are relatively new and experimental techniques. Stem cells from our child’s cord blood or cord tissue may assist in the treatment of future diseases that our child, or compatible Family member may suffer. However, we acknowledge that this is not guaranteed. With regard to cord tissue (only), we further acknowledge that there is currently no medical or therapeutic use for cord tissue or cells derived from cord tissue and we understand that even where a therapy using cord tissue or cells derived from cord tissue may become available in the future, there is no guarantee that cord tissue collected and stored by Cryosite pursuant to this Storage Agreement under Cryosite’s current processes will be able to be released and/or used for the purposes of such therapy in the future. 5. There may be risks and complications associated with the collection, storage, release and future therapeutic use of our child’s cord blood and cord tissue (if collected), which are as yet unknown. Decisions about the benefits and risks of using our child’s cord blood or cord tissue (if collected) in future treatment will be made by us at that time. 6. No assurance has been given to us by Cryosite or its representatives about: i. ii. iii. iv. v. vi. The success or otherwise of long term storage of cord blood or cord tissue through cryopreservation; Whether our child’s cord blood or cord tissue collected, stored and released by Cryosite pursuant to this Storage Agreement under Cryosite’s current processes will be suitable for future therapeutic use; The availability of any future medical or therapeutic use(s) of the cells, including stem cells, derived from cord blood or cord tissue; The numbers of cells that will be collected to enable any particular medical or therapeutic use(s) of the cells derived from cord blood or cord tissue; Whether cord blood or cord tissue will be the best source of stem cells for treatment of any particular disease; or Whether any particular diseases or conditions suffered by our child or other Family member in the future will be able to be successfully treated with stem cells from the cord blood or cord tissue stored and released by Cryosite. Collection and Storage 7. On receipt of the completed documentation and payment of the Enrolment Fee (in accordance with the payment plan we have elected), Cryosite will: i. Provide us or our nominated hospital with a uniquely coded Collection Kit; ii. Inform our nominated hospital of our decision to collect our baby’s cord blood or cord blood+cord tissue; iii. Provide our nominated collector with cord blood and cord tissue collection guidelines and other training materials; and iv. Provide us with details of the pickup service. 8. The cord blood and cord tissue (if applicable) will only be collected if our doctor/midwife is confident that the collection will not pose a threat to the health of either mother or baby and that our doctor (or, in the absence of our doctor, our midwife) has an absolute discretion to decide whether or not to proceed with the collection of the cord blood and cord tissue (if applicable) at the time. 9. If a Cryosite collector is required, they are authorised to discuss the progress of the labor with my doctor/midwife to coordinate their attendance at the birth. 10. Cord blood samples collected in utero shall only be obtained from infant donors after at least 34 weeks gestation. If we have elected to store cord tissue, we understand that it may still be able to be collected after the birth of our child. DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 3 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Collection Consent 11. It is our responsibility to contact the Cryosite nominated courier to arrange for the cord blood and cord tissue (if applicable) to be picked up as soon as possible after collection. If there is a delay in our contacting the courier, this may affect the viability of the cord blood and cord tissue for storage. 12. Cord blood and cord tissue collection may be unsuccessful, or may be unable to be processed or stored for a number of reasons including, but not limited to: i. ii. iii. iv. v. vi. vii. That our doctor/midwife/collector is unable to perform the cord blood or cord tissue collection; That it is not possible to collect a sufficient quantity of cord blood for storage of a clinically useful number of stem cells; That a “low volume” of cord blood was collected, and we did not complete the “low volume authorisation” (clause B4); That after collection, the cord blood or cord tissue is found to be unsuitable for storage; Complications occurring at birth do not safely allow for cord blood or cord tissue collection. In such circumstances we understand that the doctor or midwife engaged to perform the delivery will in their complete discretion determine whether the cord blood or cord tissue will be collected; An equipment, material or other failure preventing the cord blood or cord tissue from being successfully processed: or That viability testing of cord tissue prior to storage identifies that the cord tissue MSCs were not viable. If cord blood or cord tissue is not collected or cannot be stored, we will pay no more than the stated “Maximum Charge for Unsuccessful Collections” (A35, A36). If cord blood or cord tissue is collected and cannot be stored it will be discarded and the Disposal Fee charged at clause A.26.iii will not apply. 13. If we elected to store cord tissue in addition to cord blood and the collection of only one of either cord blood or cord tissue is successful, Cryosite will proceed to process and store that one product and the payment plan will be amended as stated in “Maximum Charge for Unsuccessful Collections” (A35, A36). 14. Reference samples from the birth mother and samples of cord blood and cord tissue (if applicable) will be stored for future testing. 15. Upon notification that the sample(s) of cord blood and cord tissue (if applicable) have been collected: i. ii. Cryosite will arrange to have the sample(s) shipped to their own laboratory for processing; Cryosite will test the maternal (birth mother) blood sample for infections mandated by the TGA at the time of collection; including HIV-type 1, HIV type 2, Hepatitis B virus, Hepatitis C virus, HTLV type I, HTLV type II, Syphilis, CMV, NAT HCV and NAT HIV 1 and Malaria if indicated. The TGA does not permit cord blood to be stored if the maternal sample tests positive for HIV or HTLV type I, HTLV type II. We understand that the mandatory tests may be subject to regulatory change. We consent to these tests and acknowledge that it is our responsibility to inform our doctor and Cryosite of any information relevant to the infection status of either birth mother or child, or if the child develops a serious disease and we understand that while all results are confidential, we may be required by law to notify some positive test results to relevant health authorities. Cryosite will disclose any positive test results to our doctor whose name appears on this Storage Agreement, or if no such doctor, then directly to the birth mother. 16. Occasionally, abnormal or inconclusive test results are obtained from the maternal (birth mother) blood sample and further testing may be required before determining whether the cord blood and cord tissue (if applicable) can continue to be stored. If this occurs, then we may be liable for any additional costs incurred. Some medical conditions and risk factors may mean the collected cord blood is not suitable for storage or may be restricted to autologous use only. The Medical and Social History Questionnaire screens for risk factors and it is a regulatory requirement that it is completed. Cryosite will advise us of any additional maternal blood tests that may be required to exclude these conditions. We understand that if these tests are not performed, use of the collected cord blood and cord tissue may be restricted. Following review of our Medical and Social History Questionnaire, Cryosite may need to conduct a follow-up telephone interview to obtain additional information and advise us if any additional tests are required. 17. Subject to the test results described above, Cryosite will store our baby’s cord blood and cord tissue (if applicable) for an initial period of either 18 or 25 years from the date of collection as elected by us. Our baby’s cord blood and cord tissue (if applicable) will be cryopreserved and stored in vapour phase liquid nitrogen. Before the end of this initial period, we or our child can elect to continue storage by entering into an Extended Storage Agreement with Cryosite. The Extended Storage Agreement provides ongoing storage beyond the initial period through the payment of a nominal annual storage fee. 18. While our doctor/midwife/collector will take measures to minimise the risk of microbial contamination of cord blood and cord tissue (if applicable) during the collection process, there is still a possibility that contamination may occur. Australian regulatory standards require all cord blood samples to be tested for microbial contamination after processing has been completed. While cord blood testing positive for bacterial contamination can still be stored and released for autologous or directed allogeneic use in accordance with Australian regulatory standards, its clinical application may be restricted. A determination on the suitability of the cord blood and cord tissue (if applicable) will be made by the treating doctor at the time of release. If our cord blood sample is microbiologically contaminated, we will be advised in writing by Cryosite, and it will continue to be stored in accordance with this Storage Agreement. 19. Australian regulatory standards require that cord blood, cord tissue, maternal blood samples and associated collection records be appropriately labelled. If the doctor/midwife/collector does not appropriately label these items, the maternal blood sample, cord blood and/or cord tissue (if applicable) may have to be discarded. As this is out of Cryosite’s control we will be charged as if it was an “unsuccessful collection” (A35, A36). DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 4 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Collection Consent 20. Cryosite may dispose of maternal blood samples, cord blood and/or cord tissue (if applicable) that do not meet current regulatory requirements. Release 21. The decision to use the cord blood or cells derived from the cord blood or cord tissue (if applicable) in treating our child or Family member relative will be at our discretion (or our child’s discretion when he/she reaches 18 years of age) having regard to any advice from our medical practitioner(s). 22. If we wish to retrieve our baby’s: i. Cord blood: a) We must make the request to Cryosite in writing and provide the name and consent of our treating physician who is requesting the cord blood. b) Cryosite will test the cord blood sample(s) for infections as mandated by the TGA at the time prior to release for supply. These tests currently include HIV-type 1, HIV-type 2, Hepatitis B virus, Hepatitis C virus, HTLV type I, HTLV type II and Syphilis. Mandatory testing requirements for release may be subject to regulatory change from time to time. c) Mandatory requirements for the release of both autologous and directed allogeneic cord blood are determined by the TGA and these may be amended by the TGA from time to time. Eligibility for release of cord blood will be assessed against the TGA’s mandatory requirements that are effective at the time of release. d) The infant donor’s haemoglobinopathy screening tests must be completed prior to the release of the cord blood for supply. e) Cryosite will not charge us to prepare and release the cord blood for use, or for transport within Australia, but we will be responsible for any other costs, including courier fees to ship the cord blood to an international destination. f) Cryosite will refund the pro-rata amount of any pre-paid storage fees. These will be calculated at the time the cord blood is released. g) Once released for transfusion, cord blood cannot be returned to storage. ii. Cord tissue (if applicable): a) b) c) d) 23. We must make the request to Cryosite in writing and provide the name and consent of our treating physician who is requesting the cord tissue. The release of cord tissue is currently not regulated by the TGA, but may become regulated by the TGA in the future. Eligibility for release of cord tissue will be assessed against the TGA’s mandatory requirements (if any) that are effective at the time of release. Cryosite will charge us to prepare and release the cord tissue for use. Cryosite will not charge us for transport within Australia. We will be responsible for any other costs, including courier fees to ship the cord tissue to an international destination. Cryosite will refund the pro-rata amount of any pre-paid storage fees. These will be calculated at the time the cord tissue is released. Cord blood cannot be released for directed allogeneic use: i. ii. iii. iv. v. If the maternal blood sample tests positive for HIV-type 1, HIV-type 2, Hepatitis B virus, Hepatitis C virus, HTLV type I, HTLV type II, Syphilis, NAT HCV or NAT HIV 1, Malaria PCR; If the cord blood sample(s) test positive for HIV-type 1, HIV-type 2, Hepatitis B virus, Hepatitis C virus, HTLV type I, HTLV type II and Syphilis; If HLA typing from the infant donor and the recipient are not compatible, or the cell dose is not sufficient for the degree of HLA incompatibility; If a clinically significant haemoglobinopathy was identified from the infant donor’s screening test; and If any additional maternal blood testing required after the birth of the child has not been performed. 24. The release or transfer of cord blood or cord tissue (if applicable) for any purpose not approved by the TGA or, for the purpose of continued storage, to a facility not appropriately licensed by the TGA, may mean that our baby’s cord blood or cord tissue (if applicable) does not comply with TGA requirements. This may affect Cryosite’s ability to release our baby’s cord blood or cord tissue (if applicable) to us. 25. Prior to release for supply, the treating physician may require additional information regarding the tests conducted, the history of the pregnancy and delivery details and maternal or child donor medical history and we hereby authorise Cryosite to provide this information to our treating physician at the time. Termination 26. We have the right to terminate this Storage Agreement at any time by giving Cryosite 90 days’ written notice. We will remain liable to Cryosite for all outstanding payments and costs for the period from the start of this Storage Agreement until the expiry of the notice period. Cryosite will provide us with a payout amount that will be based on our liability to pay for each cord blood and cord tissue (if applicable) collection; DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 5 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Collection Consent i. ii. iii. iv. For all cord blood only plans: The total amount that we are liable to pay is $2200, plus $175 for each year’s storage, to a maximum amount being the “Total Cost”, plus “Additional Charges” (where applicable) and less “Discounts” (where applicable). For all cord blood+cord tissue plans: The total amount that we are liable to pay is $3200, plus $300 for each year’s storage to a maximum amount being the “Total Cost”, plus “Additional Charges” (where applicable) and less “Discounts” (where applicable). We also agree to pay to Cryosite all costs associated with the transfer or disposal of the cord blood and/or cord tissue sample(s). The current Disposal Fee is $300 for each stored cord blood or cord tissue (if applicable) sample. If the sample(s) is to be transferred to another storage site, Cryosite will provide a cost for this transfer at the time the transfer is requested. 27. Immediately after we advise Cryosite of our intention to cancel this Storage Agreement, Cryosite will provide us with a Notice of Cancellation or Transfer Indemnity Form which we must sign and return to Cryosite before the transfer or destruction of our cord blood and cord tissue (if applicable) samples will be arranged. 28. Cryosite has the right to terminate this Storage Agreement: i. ii. iii. iv. Immediately by giving written notice of termination if we fail to pay any fees within 30 days of their due date in accordance with our elected payment plan. In this circumstance, Cryosite is authorised to dispose of the cord blood and cord tissue (if applicable); At any time by giving not less than six months’ written notice so that we have time to make alternative arrangements for the storage of cord blood and cord tissue (if applicable). Cryosite will use its best endeavours to assist us to arrange alternative storage; If we do not make alternative arrangements for storage of our child’s cord blood and cord tissue (if applicable) within 90 days of written notification of our termination of this Storage Agreement. In this circumstance, Cryosite is authorised to dispose of the cord blood and cord tissue (if applicable); or If it comes to Cryosite’s knowledge that any information provided by us in this Storage Agreement is false or we have intentionally withheld material information. In this case there will be no refund of fees paid by us. If we do not make alternative arrangements for storage of our child’s cord blood and cord tissue (if applicable) within 90 days of written notification of termination from Cryosite, Cryosite is authorised to dispose of our child’s cord blood and cord tissue (if applicable) samples in its possession. Privacy 29. The information that we provide about us and our family is of a personal and highly sensitive nature. We understand that Cryosite will use best endeavours to protect the privacy and confidentiality of the information we provide in accordance with all applicable Commonwealth, State and Territory laws. 30. Cryosite will not disclose our personal information to anyone except to the extent it is needed to facilitate the collection, processing, storage or release of the cord blood or cord tissue or if Cryosite is required by law to do so. We have read and understood Cryosite’s Privacy Policy and understand that the personal information that we provide to Cryosite will be collected, stored and used in accordance with that Privacy Policy and that we will be able to access, correct and delete our personal information at any time. Dispute Resolution 31. In the unlikely event of a dispute arising between ourselves and Cryosite, we agree to refer the dispute for mediation by the Australian Commercial Dispute Centre Limited (ACDC), if not satisfactorily resolved between us and Cryosite within 60 days, in accordance with the Commercial Mediation Guidelines of the ACDC in Sydney, New South Wales, Australia. Limitation of Liability 32. Cryosite will only be liable to us for any loss we directly suffer as a result of any failure by it to carry out its obligations under this Storage Agreement to the extent that the circumstances of the loss are within its direct control. In this circumstance, Cryosite will only be liable up to the amount of fees we have already paid to Cryosite. 33. Notwithstanding clause 32 above, Cryosite will not be liable for any claim, liability, loss or cost, whether direct or indirect, associated with this Storage Agreement or any use of (or inability to use) the cord blood or cord tissue (if applicable) in the future. Governing Law 34. This Storage Agreement is governed by the law in force in the state of New South Wales and the parties agree to submit to the exclusive jurisdiction of the courts of that state. DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 6 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Collection Consent Maximum charge for unsuccessful collections 35. For all Plans: If, after sending your Collection Kit, the collection of your baby’s cord blood and cord tissue does not occur, is unsuccessful, or cannot be processed and stored (refer to clause A12) the maximum amount you will be charged will be $500 and any additional charges, if applicable, for urgent dispatch or provision of a Cryosite collector. 36. For Cord Blood + Cord Tissue Plans: If, either your baby’s cord blood or cord tissue cannot be processed and stored in accordance with clause A12i-vi you will receive a reduction in the "Total Cost" of your plan by $1400 for 18 year plans and $1650 for 25 year plans. For Prepayment Plans the "Storage Fee" will be reduced by this amount. For Monthly and Annual Plans repayment amounts will be reduced and the repayment period will remain unchanged. If your baby’s cord tissue cannot be stored in accordance with clause A12vii your Total Cost will be as per the equivalent Cord Blood only plan. 37. NONPAYMENT OF FEES: In the event that payment is not received and the Company refers any overdue amount to a mercantile collection agency for recovery, you will be liable for any debt collection fees in addition to any amounts outstanding including interest on the overdue amount calculated using the official published Reserve Bank interest rate. B. WE ACKNOWLEDGE THAT: 1. We as parents and guardians of our child are responsible for the storage of our child’s cord blood and cord tissue (if applicable) until the expiry of the initial period being either 18 or 25 years as elected by us. 2. We will pay the fees in accordance with our chosen payment plan and payment method specified in the Payment Options & Authorisation section of this Storage Agreement. 3. We must notify Cryosite of any changes to our contact details including changes of name, address, telephone number, email address, banking details (if applicable) and emergency contacts. If we fail to do this and Cryosite is unable to make contact with us, then Cryosite reserves the right to dispose of the cord blood and cord tissue (if applicable) at the end of the period for which the fees have been paid. 4. We agree to undertake, if required, additional maternal blood tests advised by Cryosite before or after the birth of our child. We acknowledge that if these tests are not performed the use of our cord blood and cord tissue may be restricted. 5. The minimum cord blood collection required to store sufficient viable stem cells to be clinically useful is approx. 25mL. Cryosite performs an exact count of the number of stem cells present in cord blood on receipt. If insufficient stem cells are present, the collection will be discarded and we will NOT be charged a Processing or Storage Fee for the cord blood. While still acceptable for storage, a cord blood collection of approx. 25-45mL is considered to be “low volume” and can only be stored if the following “low volume” authorisation is completed. Please contact Cryosite if you require more information. We authorise Cryosite to proceed with the storage of our child’s cord blood even if a “low volume” of cells is collected 6. ○ Yes ○ No If we have elected to also store cord tissue in addition to cord blood, the cord tissue can be stored irrespective of the volume or cell count of the accompanying cord blood sample. If the collection of only cord tissue is successful, as stated in clause A.13, Cryosite will process and store the cord tissue and the payment plan will be amended as stated in “Maximum Charge for Unsuccessful Collections” (A35, A36). We have read and fully understood the information about cord blood and cord tissue (if applicable) storage provided to us by Cryosite. Our decision to enter into this Storage Agreement with Cryosite has been made after a full consideration of that information. We have had the opportunity to ask any further questions we may have about cord blood and cord tissue (if applicable) collection and storage and those questions have been answered to our satisfaction by representatives of Cryosite. We hereby certify that we have answered all questions in this Storage Agreement truthfully and to the best of our knowledge. ________________________________________ _____________________________________ Signature of Mother (Contract Owner) Signature of Witness ________________________________________ _____________________________________ Mother’s name (Contract Owner) Name of Witness ________________________________________ _____________________________________ Signature of Partner (optional) Signature of Witness (optional) ________________________________________ _____________________________________ Name of Partner (optional) Name of Witness (optional) Note: Partners and other family members can witness signatures. DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 7 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Collection Consent Birth Mother’s Consent to collect cord blood, cord tissue and maternal blood samples I, .................................................................................................................... (insert full name of Birth Mother), authorise my doctor, midwife or authorised collector (as applicable) to collect a sample of: Umbilical Cord Blood only Umbilical Cord Blood AND Umbilical Cord Tissue following the birth of my baby to enable the cord blood and cord tissue (if applicable) to be stored with Cryosite. I have decided to request the collection of cord blood and cord tissue (if applicable) after considering and understanding the information about cord blood and cord tissue storage provided to me by Cryosite. I have had an opportunity to contact Cryosite to discuss cord blood and cord tissue storage and to ask any further questions I may have. All my questions have been answered to my satisfaction by Cryosite. I understand that at the time the cord blood and cord tissue (if applicable) is collected, my doctor, midwife or authorised collector (as applicable) will also take a blood sample from me which will be sent to Cryosite and tested for various infections as required by the then current law, including HIV, HTLV, Hepatitis B and C, Syphilis, and Malaria (if required). I consent to the taking of this blood sample and to the tests as required by law. If I have opted to use an authorised Cryosite collector, I agree that if the collector is not present at the time of the delivery of my baby, another authorised collector may collect my blood sample, the cord blood and cord tissue (if applicable). I understand that my medical records and that of my baby will be reviewed by representatives of Cryosite and that I may be contacted by Cryosite at any time before or after collection of the cord blood and cord tissue (if applicable) regarding the collection. I understand the possible risks and benefits to myself and my baby in the collection of my blood sample, cord blood and cord tissue (if applicable) and that I am free to withdraw my consent to such collection at any time for any reason. ________________________________________ ______________________________________ Signature of Birth Mother Signature of Witness ______________________________________________ __________________________________________ Date Name of Witness Doctor’s/Collector’s Consent to collect NOTE: This section needs to be completed by your Doctor or Midwife if they are performing the collection for you. If Cryosite has agreed to provide a collector for you, please write “Cryosite Collector” below. I hereby certify that I have read and understood all the cord blood, cord tissue and maternal blood sample collection guidelines and protocols provided by Cryosite and I agree to collect the: Umbilical Cord Blood {notes:…………………………………………………….……………………………………………………………………………} Umbilical Cord Tissue {notes:…………………………………………………….……………………………………………………………………………} Maternal Blood {notes:…………………………………………………….……………………………………………………………………………} following the delivery of ...........................................................................................’s (insert full name of Birth Mother) baby in accordance with those guidelines and protocols. ________________________________________ _________________________________________ Name of Doctor/Midwife/Collector DCN: CB-F-014-16 Signature of Doctor/Midwife/Collector Date Implemented: 01 May 2015 ____________ Date Page 8 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Medical & Social History Questionnaire This medical and social history questionnaire allows Cryosite to have a comprehensive medical history on file for your baby’s cord blood / tissue sample. A positive response to any question does not necessarily exclude you from collection. All personal information is held in accordance with the relevant Commonwealth, State and Territory privacy legislation. Please answer these questions honestly and to the best of your knowledge. Please print clearly and provide all requested information in the space provided at the end of the questionnaire. In some circumstances, we may need further clarification of your answers, or may need to perform additional blood tests prior to or after the cord blood collection. If you require assistance to complete this section please contact Cryosite. 1: Questions About This Pregnancy (Birth Mother to complete) 1 Ethnic Background of Biological Mother 2 Was this pregnancy a result of assisted reproductive technology (e.g. IVF.)? If yes, was the child conceived using: Ethnic Background of Biological Father (optional) Yes No 2a: General health questions Yes No 3 If yes, please describe (page 11) 2b: Specific health questions Yes No 2c: Malaria Yes No 12 If yes, please state how long you have been asymptomatic and/or off treatment (page 11) Have you ever had an undiagnosed febrile illness that is consistent with malaria, during or within 6 months of a visit to a malarial endemic country? ○ Birth Mother’s Egg or ○ Donor Egg ○ Partner’s Sperm or ○ Donor Sperm (For Donor Egg or Donor Sperm, a separate medical history may be required. Please contact us for assistance in completing this section) 2: Maternal Health Questions (Birth Mother to complete) Are you in good general health? If no, please describe (page 11) 4 Do you currently have an unexplained fever or infectious illness? If yes, please describe (page 11) 5 Are you currently taking any prescription medications? If yes, please describe (page 11) 6 Have you had any medical problems with this pregnancy? If yes, please describe (page 11) 7 8 Have you ever had a serious illness? Have you: Spent a cumulative period of 6 months or more in the United Kingdom, Channel Islands, Isle of Mann, or Ireland between 1 January 1980 and 31 December 1996? and/or; Received a blood transfusion whilst in the United Kingdom, Channel Islands, Isle of Mann, or Ireland since 1 January 1980? If yes, please describe (page 11) 9 Have you ever been exposed to a situation where a disease was endemic, or a situation involving a disease outbreak (e.g. Hepatitis A outbreak)? If yes, please describe the disease and when it occurred (page 11) 10 11 Have you received injections of human growth hormone for short stature, or human-derived pituitary hormone for infertility? If yes, please describe what you received and when (page 11) Do you have an active infection of your blood cells or tissues? If yes, please describe (page 11) 13 Have you ever had Malaria? If yes, please describe and state how long you have been asymptomatic and/or off treatment (p11) 14 Have you ever lived for longer than 6 months in a country where malaria is endemic? (Malaria endemic countries are listed on the “World Health Organisation” website: www.who.int/malaria/publications/country-profiles/en/) If yes, please state which country, the duration of your residence and date of last visit (page 11) 15 Have you ever visited a country where malaria is endemic? (Malaria endemic countries are listed on the “World Health Organisation” website www.who.int/malaria/publications/country-profiles/en/) If yes, please state which country, the duration of your visit and date of your last visit (page 11) DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 9 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Medical & Social History (continued) 2d: Vaccinations 16 Have you received any of the following vaccinations in the last 12 months: Live attenuated bacteria or virus except small pox? Small pox? Sera of animal origin or other unknown vaccine? Yes No Yes No Yes No If yes, please describe the vaccination you received and when you received it (page 11) 2e: Transmissible diseases 17 Ever had a test which showed you were infected with: HIV (AIDS), HTLV-1 / HTLV-2? If yes, please describe (page 11) 18 Ever had a test which showed you were infected with: Hepatitis C? If yes, please describe (page 11) 19 Ever suspected you could be infected with: HIV (AIDS), Hepatitis C, HTLV-1 / HTLV-2? If yes, please describe what you thought you were infected with and when (page 11) 20 Ever had a test which showed you were infected with Hepatitis B, or have you ever suspected you had been infected with Hepatitis B? If yes, please describe what test you had and when it was performed (page 11) 2f: Transmissible disease risks 21 Have you ever received: A blood transfusion, Blood components, Human clotting factors, Had a cell/tissue or organ transplant/graft of human origin (including, cornea, dura mater, bone etc.)? If yes, please describe what you received, when received it, and where you received the treatment (p11) 22 Ever injected or been injected with drugs for a non-medical reason in the last 5 years? If yes, please describe what was injected and when it was injected (page 11) 23 Ever been refused as a blood donor? If yes, please describe the reason (page 11) 24 Had any of the following in the last 6 months: A blood or body fluid splash to eyes, mouth, nose or to broken skin, A tattoo, A needle stick injury, Body piercing, Acupuncture (exempt if performed using sterile single use needles) If yes, please describe the incident / event and when it occurred (page 11) 25 Been imprisoned for a consecutive period of 72 hours or more in the last 12 months? If yes, please state when you were released (page 11) 26 Ever received viable (living) non-human animal cells or tissues? For example, any procedure that involves the transplantation, implantation, or infusion of live cells, tissues, or organs from a nonhuman animal source (e.g. pig heart valve replacement). If yes, please state when you were released (page 11) 27 Ever engaged in the following activities: Engaged in sexual activity with someone, whose sexual practices or medical history might put you are risk of acquiring an infectious disease? Had sexual activity with a sex worker, or with someone who may have had sexual activity with a sex worker? Had sexual activity with someone who may have had male-to-male sex? Received money, gifts or drugs in exchange for sex? Engaged in sexual activity with a new partner who currently lives or has previously lived in a HIV high risk country? (Contact Cryosite if unsure about HIV high risk countries) If yes, please state the date of the last activity / contact (page 11) 28 Have you or your partner ever engaged in sexual activity with someone you might think would answer YES to question 27 above. If yes, please describe (page 11) DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 10 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Medical & Social History (continued) 3: Family History - Has anyone in the Biological Mothers’ or Biological Father’s Family: Including parents, Yes No grandparents, siblings and parent’s siblings - (Biological mother to complete^) 29 Had a blood or bleeding disorder? Had any serious diseases? Had a congenital or genetic disease? Had or have Creutzfeldt Jacob Disease (CJD)? Had or have Gerstmann Straussler-Scheinker Syndrome (GSS) or Fatal Familial Insomnia (FFI)? Had any immune deficiency, platelet or metabolic diseases? Had any cancers or other malignancies? If yes, please describe (page 11) ^ If the Birth mother is not the biological mother (i.e. the child was conceived using an egg donor as per question 1, please contact Cryosite for assistance in completing this section If you answered “yes” to any question (or “no” to number 3) please specify which question and provide the requested information in the table below. If you require assistance to complete this section please contact Cryosite. I certify that I have answered all questions truthfully and to the best of my knowledge. __________________________________ ___________________________________ Signature of Birth Mother Signature of Witness __________________________________ ___________________________________ Name of Birth Mother Name of Witness DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 11 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Storage and Payment Options How much does Family Cord Blood and Tissue Stem Cell Banking cost? We appreciate that having a baby can sometimes be financially challenging but we also believe in the importance of storing your baby’s cord blood and cord tissue and offer a range of payment plans to help make cord blood and cord tissue banking as financially accessible to parents as possible. You have the option of 18 year or 25 year initial storage periods Your child’s cord blood and cord tissue (if applicable) will be initially stored for either 18 or 25 years, unless released for use before this time. After this initial storage period, your child can elect to continue storage by entering into an Extended Storage Agreement with Cryosite. The Extended Storage Agreement provides ongoing storage on a year by year basis and payment is via the annual storage fee effective at that time. Your Payment Plan Options The cost of storing your baby’s cord blood and cord tissue (if applicable) has two components – the Enrolment Fee, and the Processing & Storage Fee. There are no additional charges to release and transport your child’s cord blood within Australia when they are needed. There will an additional charge to prepare and transport cord tissue cells when they are needed (if approved for release for therapeutic use). This will be able to be determined at the time of release. Choose from Cryosite’s flexible payment options: Pay in full on a prepaid plan, pay monthly on a 12 or 24 month plan or pay per year on an annual plan over the duration of your storage. You can store your child’s Cord Blood + Tissue for either 18 or 25 years and extend at that time. Fees are applicable to each child. Prepaid Plans and Annual Plans: Storage payment is invoiced approx. 2 weeks after birth. Monthly Plans: Monthly payments commence one month after your child’s birth. Annual Plans: Annual payments commence the year after your child’s birth. Annual payments are subject to yearly CPI increases each year and is subject to review. Changes will be advised with 30 days written notice. An early repayment option is available for Annual Plans. At any time during the contract period the remaining storage fees may be paid in full. If exercised, any remaining storage fees will be discounted by 30%. Storage fees may be paid in full. If exercised, any remaining storage fees will be discounted by 30%. DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 12 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 Storage Agreement – Storage and Payment Options NOTES Discounts: The single highest value discount applies per contract. Discounts are applied to the processing & storage fee (via a reduction in the initial monthly payments equal to the value of the discount given for monthly repayment plans) or as a reduction to the fee paid on storage for Upfront Payment Plans. Additional charges: Cryosite collector or “same day” courier fees, if applicable, will be added to the Enrolment Fee are payable at the time of enrolment. Annual payments: Annual payments for Annual Plans are subject to CPI increases each year. The annual storage fee is subject to review and any change will be advised with 30 days prior written notice. Contact us for special pricing on triplets. DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 13 of 14 Cryosite Family Cord Blood Bank Cryosite Ltd ABN 86 090 919 476 STORAGE AGREEMENT – PAYMENT OPTIONS STORAGE AGREEMENT – DIRECT DEBIT REQUEST FORM To: Cryosite CRYOSITE PAYMENT PLAN – DIRECT DEBIT SERVICE AGREEMENT I/we ………………………..…………………………………………………………………………………. Our commitment to you, drawing arrangements: The Cryosite Payment Plan drawing arrangements will commence on the last business day of the month in which your Storage Agreement is received. authorise Cryosite Limited APCA User ID Number 216886 to arrange for funds to be debited from my/our account at the Financial Institution identified below and as prescribed below through the Bulk Electronic Clearing System (BECS). This authorisation is to remain in force in accordance with the terms described in the Cryosite Payment Plan – Direct Debit Service Agreement. (Signature 1) ………………………………………………………………………………………………. (Signature 2) ……………………………………………………………………………………………… Date: …………………………………………………………………………………………………………. Details of Account to be debited Name of Financial Institution: ………………………………………………….………………. Branch: ................………………………………………………………………...………………. BSB: ..…………….…………………………………………………………………....………………… Account No: ..…………………………………………………………………………...……………… Account Name: ………………………………………………………………………………………… I/we request that you debit my/our account in accordance with the Cryosite Storage Agreement. I/we authorise the following: 1. The Debit user to verify the details of the abovementioned account with my/our Financial Institution. 2. The Financial Institution to release information allowing the Debit User to verify the abovementioned account details. (Signature 1) ………………………………………………………………………………………………. (Signature 2) ………………………………………………………………………………………………. Our commitment to you, drawing arrangements (Continued): We will give 14 days advance notice of any change to the amount or frequency of direct debit arrangements. We reserve the right to cancel the Cryosite Payment Plan drawing arrangements if three or more drawings are returned unpaid by your nominated financial institution, and to arrange with you, an alternate payment method. We will keep all information pertaining to your nominated account at the financial institution, private and confidential. Your Rights: You may terminate the Cryosite Payment Plan drawing arrangements at any time by giving written notice directly to Cryosite, or through your nominated financial institution. Such notice should be received by us at least 5 business days prior to the due date. You may stop payment of a drawing under the Cryosite Payment Plan by giving written notice directly to Cryosite, or through your nominated financial institution. Such notice should be received by us at least 5 business days prior to the due date. You may request change to the drawing amount or frequency of Cryosite Payment Plan drawings by giving written notice directly to Cryosite. Such notice should be received by us at least 5 business days prior to the due date. If you consider that a drawing has been initiated incorrectly (outside the Cryosite Payment Plan arrangements), you should contact Cryosite or your nominated financial institution. Your commitment to us, Your responsibilities: It is your responsibility to ensure the following: That direct debit through BECS is available on the nominated account and that you have checked with the Financial Institution the account details prior to completing the Direct Debit Request Form. Sufficient funds are available in the nominated account to meet a drawing on its due date. The authorization to draw on the nominated account is identical to the account signing instruction held by the Financial Institution where the account is based. Advise us if the account nominated by you to receive the Cryosite Limited Payment Plan drawings is transferred or closed. Arrange for a suitable alternate payment method if you wish to cancel the Cryosite Payment Plan drawing. Date:………………………………………………………………………………………………………….. DCN: CB-F-014-16 Date Implemented: 01 May 2015 Page 14 of 14
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