COLLECTING:
HOPE shall not extract tissue/blood from the Newborn. HOPE will provide You with placenta and/or cord blood collection instructions and necessary collection supplies for collection of the placenta and/or cord blood of the Newborn (the “Sample”). Upon the birth of the Newborn, You will notify HOPE for the pickup of the Sample by HOPE, and will provide HOPE with the legal name of the Newborn. At such time, HOPE will pick up and transport, in accordance with applicable rules and regulations, the Sample to HOPE’s storage facility, currently located at 16700 Creek Bend Drive, Sugar Land, Texas, but which may be changed at HOPE’s sole discretion. HOPE is not responsible for any type of compromise, damage or loss of the Sample during transportation which is beyond its control or is a result of “Force Majeure”. For purposes of this Agreement, “Force Majeure” shall mean any delays or results due to strikes, riots, acts of God, inclement weather, shortages of labor or material, war, governmental laws, regulations, or restrictions, pandemic or epidemic, or any other cause that is out of the control of HOPE. You may also transfer an existing Sample stored at another facility to HOPE at Your sole expense. HOPE will only accept a Sample from another storage facility that is an FDA-registered storage facility, and that includes all paperwork regarding the bloodwork, quality testing, and other testing performed by the other storage facility on the Sample. HOPE reserves the right to reject a Sample from another storage facility, in its sole discretion, for any reason it deems worthy. Any costs associated with the need to obtain another Sample because of loss, damage, or destruction to a Sample in transport are Your responsibility.
SCREENING/TESTING:
You agree to have the mother of the Newborn be tested prior to Banking for Hepatitis B, Hepatitis C, Syphilis and HIV at a facility designated by HOPE. A positive test for any of these screening tests will preclude the Banking of the Newborn’s Sample. In such event, the mother of the Newborn (and You, if the mother of the Newborn so authorizes) will be notified of such results by a licensed medical provider, as HOPE is unable to discuss any results directly with You. Additionally, HOPE may terminate this Agreement immediately upon written notice to You. HOPE shall screen and test the Newborn’s Sample prior to Banking for quality testing as required by the U.S. Food and Drug Administration (the “FDA”). HOPE reserves the right to reject a Sample if the Sample produces a positive result for a negative attribute in any of the quality testing (mycoplasma, endotoxin, sterility, and others) and/or if there are contaminated tissues or cells in the Sample. In such event, You will be notified of such positive results by a licensed medical provider, as HOPE is not able to discuss any results directly with You. HOPE also reserves the right to reject and return the Sample, at Your expense, if it determines, in its sole discretion, that the Newborn’s Sample presents a hazard or an unreasonable risk to HOPE or its storage facility. HOPE will not accept any Samples with microbes.
PROCESS/QUALITY:
Upon a successful screening and testing, HOPE shall separate the cells and fat in the Sample, if applicable, to multiply the stem cells to insure a viable Sample prior to extended storage. This process usually requires 5–6 weeks of development time. If the Sample is viable, the stem cells will be Banked as described below, and a portion of the multiplied stem cells acquired from the Newborn may be used for validation and/or quality testing that may be required by any regulatory agency. You waive any rights or claims to any results from the validation or research on the excess stem cells from the Newborn’s Sample. If the Newborn’s Sample is not viable (meaning the Sample is not capable of multiplying additional cells), You may elect either (i) another extraction and test for viability to produce additional stem cells, to be arranged by HOPE at no additional charge, or (ii) a refund of one-half of the Initial Fee paid by You to that point. The foregoing remedy is Your sole remedy for a Sample that is not viable. If the second Sample cannot produce viable stem cells, this Agreement shall be automatically canceled with no refunds to You.
BANKING:
Once, and if, the Sample is determined to have produced viable and active stem cells, the Newborn’s Sample shall be cryogenically stored by HOPE at its storage facility pursuant to the terms and conditions of this Agreement. HOPE is specifically authorized by You to move the Newborn’s Sample to an alternate storage location controlled by HOPE, with written notice to Your last known address. Once the cells are Banked, there are no refunds of the Initial Fee, any Annual Banking Fees, or any other fees paid by You. You understand and acknowledge that there may be a loss of cells as a result of the cryopreservation process or prolonged storage, and HOPE is not responsible for any loss or damage to the stored cells because of Force Majeure.
RELEASE OF CELLS:
HOPE will only release the stored cells under U.S. FDA regulations such as a clinical trial, your treating physician via Right to Try (RTT), (i) with an FDA clearance letter or approval, (ii) with written approval from the FDA for compassionate use, or (iii) if You desire to move the stored cells to another FDA-registered storage facility. HOPE shall comply with all regulatory rules, laws and regulations on the use of stem cells upon Your request for release. In such event, You will take possession of the stored cells at HOPE’s storage facility and will be solely responsible for the cost and logistics of the transportation of the cells to Your desired location, and HOPE’s responsibility ceases when the cells are sent for shipment.