STEP #1 /11 - Consent and Agreement for the Collection and Storage of Stem Cells

Collection of a Specimen of Umbilical Cord and/or Umbilical Cord Blood

I/We, authorize the collection of a section of umbilical cord (perivascular stem cells) and/or umbilical cord blood (hereinafter collectively referred to as the “umbilical specimens”), from my/our child (hereinafter referred to as “The Child”), to be forwarded to the CReATe Cord Blood Bank (hereinafter referred to as “The Bank”) for the purpose of processing, testing, cryopreservation (freezing) and storage of my/our child’s umbilical cord blood stem cells and/or perivascular stem cells (hereinafter referred to as “Stem Cells”).

I/We understand that this agreement provides for the collection, processing, testing, cryopreservation and storage of Stem Cells from my/our child’s umbilical cord and/or umbilical cord blood. I/We understand that the umbilical cord and umbilical cord blood are normally discarded after delivery. However, I/we wish to collect a section of the umbilical cord and/or umbilical cord blood, in the event that any Stem Cells contained therein may be utilized as a possible future treatment for The Child, and possibly for other family members or other individuals.

I/We understand that while an attempt will be made to collect adequate umbilical specimens at the time of delivery, there is no guarantee that it will be technically feasible to collect adequate umbilical specimens. I/We understand that clinical circumstances and technical issues relating to the obtaining of the umbilical specimens may preclude such collection. If the umbilical specimens are of questionable quality or quantity, an attempt will be made to contact me/us in order to determine my/our instructions as to the further actions to be taken with the sample. The Bank maintains the right to reject any umbilical cord specimens due to insufficient volume/size, undue delays in having the specimens delivered to it, microbial contamination, positive/missing infectious disease test results, or other legal, regulatory or scientific reasons.

I/We will request that my/our healthcare provider, following the birth of The Child, collect umbilical specimens using the collection kit provided by The Bank. I/We understand that there is no guarantee or assurance of the success of the collection procedure.

I/We have been fully informed about the procedure for collecting the umbilical specimens. I/We consent to my/our healthcare provider collecting the umbilical specimens after the birth of The Child. I/We will forward the collected umbilical specimens, as well as the maternal blood samples and the documentation required in the collection kit, to The Bank, in the manner prescribed by it, as soon as possible and in any event within 24 hours of The Child’s birth.

I/We understand that The Bank is not responsible for The Child’s umbilical specimens until they have been received at its offices. I/We further understand that it is my/our responsibility to ensure that the umbilical specimens are taken to The Bank as soon as possible after they are collected.. I/We understand that the Stem Cells’ viability and yield may be poor in umbilical specimens that arrive at The Bank more than 24 hours following The Child’s delivery. I/We understand that it is best if all of the biological samples arrive at The Bank within 24 hours after The Child’s delivery, in order to ensure optimum extraction and survival of the Stem Cells. I/We understand that the quantity and quality of any Stem Cells isolated from the umbilical specimens can only be assessed and determined after the umbilical specimens have been processed by The Bank.

I/We understand that there is no guarantee that any Stem Cells obtained from The Child’s umbilical specimens will be suitable for future transplantation or other use. In this regard, I/we specifically understand that:

(a) microorganism (ie. bacteria, fungi, etc.) or maternal blood contamination inherent in the birth process may render any Stem Cells unsuitable for transplantation or other medical use;
(b) The Child’s umbilical cord section or umbilical cord blood specimen, even if they exceed the minimum sample size, may contain inadequate numbers of viable Stem Cells for transplantation or other medical use;
(c) there is no guarantee that The Child’s Stem Cells will survive the separation, cryopreservation and/or thawing processes;
(d) there is no guarantee that successful transplantation or other medical use will occur using The Child’s stored Stem Cells;
(e) if The Child’s birth mother suffers from, or has suffered from, certain transmissible diseases, it may not be possible to use the Stem Cells for future transplantation or other medical use; and
(f) there is a possibility that the collection and/or storage system may fail with consequent loss of the Stem Cells.

The safe use of blood and blood components is of paramount importance. As such, the decision as to who can or cannot use the Stem Cells will depend on the medical history of the biological parents (and the birth mother, if different) and screening blood test results. Use of the Stem Cells by any individual other than The Child may require additional screening and/or blood testing of the birth mother and/or The Child, and will be subject to compliance with Health Canada regulations, and any other regulatory or legal requirements that exist at the time of the proposed Stem Cell usage.

Birth Mother Screening
I/We understand that The Child’s parents (including the birth mother, if different from Partners 1 & 2) must complete a medical history form and that the completed form must be forwarded to The Bank. I/We further understand that if The Child’s parents (including birth mother) fail to complete this medical history form, it may not be possible to use The Child’s Stem Cells for future transplantation or other medical use.

I/We understand that The Child’s birth mother must be tested for transmissible diseases by using a blood specimen that is obtained from her either during labour or shortly after delivery. This blood specimen will be collected in the tubes provided in the collection kit and forwarded to The Bank along with The Child’s umbilical specimens. If the maternal blood sample is not collected at the time of birth, I/we understand it is my/our responsibility to notify The Bank immediately and to make arrangements to have the maternal blood sample collected within 7 days of The Child’s birth. I/We further understand that if The Child’s birth mother fails to have these blood samples obtained, it may not be possible to use The Child’s Stem Cells for future transplantation or other medical use.

Fees
I/We understand that I/we am/are responsible for the costs of the collection, transportation, processing, cryopreservation and storage of The Child’s Stem Cells.

I/We have reviewed and understand the fee schedule and terms of payment. I/we agree to pay the fees in accordance with the schedule.
The initial fee is due and payable to The Bank as per the current fee schedule.

The annual storage fees are due and payable at the beginning of each annual storage interval thereafter. I/We understand that the annual storage fees are non-refundable and are not subject to any pro-rated adjustments for partial storage intervals.

I/We understand that some hospitals, physicians and other healthcare providers may independently charge fees for collecting umbilical specimens following birth. Any such fees are specific to those individuals and institutions. They are not fees levied by or on behalf of CReATe Cord Blood Bank. Any such fees are the sole responsibility of the individual(s) who requested the collection of the umbilical specimens. CReATe Cord Blood Bank is not responsible for any additional fees incurred, or charges levied by hospitals, physicians or other healthcare providers, arising in any manner whatsoever out of the collection of umbilical specimens.

I/We understand that before the one year anniversary date of the cryopreservation of The Child’s Stem Cells, an invoice for the annual storage fees for the cryopreserved Stem Cells will be forwarded to me/us, by regular lettermail, to the most recent address that I/we have provided to The Bank. I/We understand and agree that full payment of that invoice is due on or before the anniversary date of the cryopreservation of The Child’s Stem Cells.
I/We understand and agree that if I/we have not provided payment in full of The Bank’s invoice for the annual storage fees for The Child’s Stem Cells within ninety (90) days of the anniversary date of their cryopreservation, The Bank will notify me/us of the outstanding balance. If I/we have not paid the outstanding balance in full, within 30 days of that notification, I/we authorize The Bank to donate The Child’s Stem Cells for use in research projects, public banking, or to discard them, as The Bank shall decide in its sole discretion and in accordance with any governing legislation at the material time.

Contact Information
I/We agree and undertake to provide The Bank with my/our current address, email address and telephone numbers, as long as The Bank is maintaining The Child’s Stem Cells in storage. I/We understand and agree that it is my/our responsibility to advise The Bank immediately of any change in my/our name, address, email address and telephone numbers. I/We consent to The Bank contacting us by means of telephone, letter mail, email and facsimile transmission, using the contact information that I/we have provided, as The Bank shall decide in its sole discretion.

Transfer, Release or Disposition of the Stem Cells
I/We agree and understand that in order for The Bank to release or transfer The Child’s Stem Cells, The Child’s parents or legal guardians must provide written consent for the release or transfer. I/We agree and understand that The Child’s cryopreserved Stem Cells will not be released or transferred by The Bank until it has been provided with an “Authorization and Consent to Release/Transfer Frozen Stem Cells” properly executed by The Child’s parents or legal guardians, and that any outstanding storage fees have been paid in full.

I/We further agree and understand that The Bank (in its sole discretion) may refuse to dispose of, release or transfer The Child’s Stem Cells unless it has been provided with an Order from an Ontario Court specifically directing and authorizing their disposition, release or transfer, if it has concerns about the legal validity of the disposition, release or transfer instructions that have been provided to it. In the event that The Bank requires an Order from an Ontario Court, the costs of obtaining that Order will be borne solely by the party seeking to dispose of, transfer, or release the Stem Cells, and not by The Bank.
In the event of a legal separation or divorce of The Child’s parents, or a disagreement between them (or between The Child’s legal guardians, if applicable), as to the disposition and/or use of The Child’s Stem Cells, The Bank shall continue to store the cryopreserved Stem Cells, as long as the annual storage fees are paid in full, until either:
(a) The Child’s parents (or legal guardians, if applicable) agree to the disposition and/or use of The Child’s Stem Cells and they both execute the “Authorization and Consent to Release/Transfer Frozen Stem Cells” form in a manner that is acceptable to The Bank in its sole discretion; or
(b) The disposition and/or use of the Stem Cells is determined and directed through a legal process and The Bank is in receipt of an Order from an Ontario Court authorizing and directing the disposition and/or use of the Stem Cells.

In the event of the death of The Child’s parents (or legal guardians, if applicable) before The Child reaches the age at which s/he is legally capable of authorizing and directing the use and/or disposition of the Stem Cells, I/we hereby appoint: as the sole decision maker(s) regarding the use and/or disposition of The Child’s Stem Cells.

I/We understand that any future use of The Child’s Stem Cells by an individual other than The Child may require additional screening and/or blood testing of The Child’s birth mother and/or The Child, and will be subject to compliance with any governing legislation in force at the time of the proposed usage.

I/We acknowledge and understand that although The Bank has no present intention to move from or change the location of its business premises, such relocation may become necessary at some point in the future. I/We acknowledge and accept that The Bank reserves the right to change the location of its business premises. In the event that The Bank does change the location of its premises, it will provide me/us with written notification (using the contact information I/we have provided) of the new storage location.

Termination of this Agreement
Unless earlier terminated as provided below, the term of this Agreement shall be for eighteen (18) years from the date of birth of The Child. The Bank will notify me/us of the expiration of this Agreement (using the contact information I/we have provided).

I/We understand that in the event that I/we no longer wish to have The Bank maintain The Child’s Stem Cells in storage, I/we may terminate this agreement by providing written notice, including any transfer or disposition instructions, signed by me/us to The Bank. I/We understand that our options for disposition include: donation of the Stem Cells for research or public banking; and/or discarding them. I/We understand and agree that if I/we do not provide specific disposition instructions when we terminate the cryopreservation of The Child’s Stem Cells, The Bank shall be entitled to donate them anonymously for use in research projects or public banking, or to discard them, as The Bank shall decide in its sole discretion and in accordance with any governing legislation at the material time.

Limitation of Liability
The Bank does not provide any guarantee against deterioration or loss of the Stem Cells due to natural disasters or equipment failure.

I/We agree that it would be impractical and extremely difficult to determine actual damages for the loss, injury, damage or destruction of the Stem Cells collected, processed, cryopreserved and stored under this agreement by The Bank.

I/We acknowledge and agree that any claim against CReATe Cord Blood Bank, its officers, directors, owners, employees, agents, successors and permitted assigns including, without limitation, any claim for loss, injury, death, damage or destruction in connection with performance, non-performance or purported performance of the collection, processing, cryopreservation and storage of The Child’s Stem Cells, shall be limited to an amount not to exceed those fees actually paid by me/us for the collection, processing, cryopreservation and storage of The Child’s Stem Cells. I/We hereby waive and release CReATe Cord Blood Bank, its officers, directors, owners, employees, agents, successors and permitted assigns from any and all liability for any and all loss, harm, damage or claim of any kind in connection with the collection, processing, cryopreservation and storage of The Child’s Stem Cells in excess of the above quantum. I/We understand that by this waiver and release I/we are giving up any right I/we might otherwise have, now or in the future, to sue or otherwise seek money damages or other relief against CReATe Cord Blood Bank for any reason relating to the collection, processing, cryopreservation and storage of The Child’s Stem Cells, with the sole exception of seeking recovery of the monetary amount specified earlier in this paragraph.

Consent
I/We confirm and acknowledge that the procedure, material risks, complications and potential outcomes of obtaining a section of umbilical cord and umbilical cord blood, and the separation, cryopreservation and storage of Stem Cells, have been explained to me/us and I/we have been afforded the opportunity to ask questions and that all of my/our questions have been fully answered to my/our satisfaction.

By executing this agreement, I/we request, authorize and provide my/our consent to The Bank, its physicians, agents, delegates and employees, to process, separate, cryopreserve and store The Child’s Stem Cells. I/We understand that my/our acceptance of, and agreement to participate in, this program is completely voluntary.

The terms of this agreement will be binding on me/us, my/our heirs, executors, administrators, assigns, guardians, lawyers and trustees.

I/We have read and fully accept the terms of this agreement. I/We certify that I/we have not relied upon any inducements or promises not set out in this document.
I/We am/are signing this agreement voluntarily and of my/our own free will.


I agree to the Agreement and Waiver By entering my name below, I assert that I have reviewed and agree to all the waivers and agreements I selected above Electronic signature

*Version Code:  FRM-017-004-002 REGISTRATION COLLECTION AND STORAGE AGREEMENT (2012-03-29) I agree to the CReATe Terms of Service Agreement.
 
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