Enrollment Forms. CariCord.com

Transcription

1 Enrollment Forms CariCord.com

2 CariCord, Inc. Enrollment Packet Congratulations on your pregnancy. You have made a terrific decision to preserve your child s cord blood. This packet contains legal agreements between you and CariCord, Inc. Please read them carefully. Feel free to discuss this with your family, medical practitioner or an attorney of your choice. It is our goal that you be fully informed. When you are ready, please sign the following pages where indicated. It is our goal to provide accurate information in order to offer you a rewarding experience with the utmost care and respect. Please note: ClinImmune Labs- University of Colorado Cord Blood Bank- CariCord s activities for New York State residents are limited to collection, processing, and long-term storage of umbilical cord tissue. Possession of a New York State license for such collection, processing, and longterm storage does not indicate approval or endorsement of possible future uses or future suitability of umbilical cord tissue-derived cells. Instructions: Please complete all of the enclosed sections (1-4) and return them to CariCord, Inc. by either fax, Docusign, or mail. If faxed, please send the original via mail. If you have questions, please call us at: CariCord, Inc. Fax: (844) CariCord Customerservice@caricord.com CariCord, Inc. Corporate Address: CariCord, Inc Scientific Way Irvine, CA Attention: Enrollment (Must be returned immediately to ship kit to you, or returned with kit from hospital) page 2/8 8/10/2015

3 Yes No Medical Health Questionnaire Client ID: Reviewer: Date: To be completed by the Birth Parents or Surrogate Did you use a donor egg, donor sperm, surrogacy, or adoption for this pregnancy? If so, please list agency used: Have you had any serious diseases or infections during your pregnancy? Do you suffer from an autoimmune disease? 3. In the past 13 weeks, have you had smallpox, a smallpox vaccination or come in close contact with someone who had a smallpox vaccination? 4. In the past 8 weeks, have you had any vaccines/shots? 5. Are you now taking any prescription medications other than pre-natal vitamins? If yes, please list medications and reason for taking: 6. Have you ever had any acute respiratory disease, tuberculosis, had a positive test (PPD) for TB or been treated for tuberculosis? 7. Have you ever had head or brain surgery and received a dura mater transplant? 8. Have you ever had Kaposi s sarcoma, purple spots on your skin, or white spots in your mouth (fungal infection), or unexplained temperature higher than 100.5F (38.06C) for more than 10 days? 9. In the past 3 years, have you ever had or been treated for malaria? If yes, please describe and list date: 10. Have you ever had a parasitic blood disease such as Chagas disease or Babesiosis? 11. Have you ever had or tested positive for HIV, or ever had AIDS? 12. Have you ever had or tested positive for HTLV, Hepatitis B, Hepatitis C, or syphilis? 13. Have you ever had a transplant from or received organs, tissues, or cells from an animal or had intimate contact with someone who did? 14. Have you ever received human pituitary growth hormone or bovine insulin? page 3/8 8/10/2015

4 Yes No 15. In the past 12 months, have you received a blood transfusion? Client ID: Reviewer: Date: 16. In the past 12 months, have you had an organ, tissue transplant or graft? 17. In the past 12 months, have you had or tested positive for a sexually transmitted disease? If HPV or Herpes, list date of last outbreak or positive test: 18. In the past 12 months, have you had or tested positive for West Nile Virus (WNV)? 19. In the past 12 months, have you had a rabies vaccine or Immune Globulin (HBIG) for exposure? 20. In the past 3 years, have you traveled outside the United States (U.S.)? If yes, please list the City, State, Country and dates of travel: 21. In the past 3 years, have you lived outside the United States (U.S.)? If yes, please list the City, State, Country and dates of residency: 22. Between 1980 to 1996, did you spend 5 years or more all together in Europe? 23. From 1980 to 1996, did you spend 3 months or more all together in the United Kingdom (England, Northern Ireland, Scotland, Wales, Isle of Man, Channel Islands, Gibraltar, or Falkland Islands)? If yes, please list the countries and dates: 24. Since 1980, have you received a transfusion of blood or blood components in the United Kingdom or France? 25. From 1980 to 1996, did you spend time or live on a military base outside the U.S. for 6 months or more? If yes, please list countries and dates: 26. In the past 5 years, have you used a needle to take drugs not prescribed for you by a doctor? 27. In the past 5 years, have you received human clotting factor or platelet concentrates for a bleeding problem? If yes, please explain: 28. In the past 5 years, have you had sex in exchange for money, drugs, or other payment? 29. In the past 12 months, have you had sexual contact with anyone who used a needle to take drugs not prescribed for them by a doctor int he last 5 years? 30. In the past 12 months, have you had sexual contact with anyone who has an HIV infection (AIDS) or a positive test for HIV? page 4/8 8/10/2015

5 Yes No Client ID: Reviewer: Date: In the past 12 months, have you had sexual contact with anyone who has Hepatitis B Infection, or symptomatic Hepatitis C (HCV)? In the past 12 months, have you had sexual contact with anyone who had sex in exchange for money or drugs in the past 5 years? 33. In the past 12 months, have you had sexual contact with anyone who received human clotting factor concentrates for a bleeding problem in the last 5 years? 34. In the past 12 months, have you had sexual contact with a man who had sexual contact with another man within the last 5 years? 35. In the past 12 months, have you been in jail or prison for more than 72 hours? Have you had sexual contact with someone that was incarcerated for more than 72 hours? 36. In the past 12 months, have you lived in the same house with someone who has Hepatitis B or symptomatic Hepatitis C infection? 37. In the past 12 months, have you had any piercings or tattoos? If yes, were shared or non-sterile inks, needles, instruments, or procedures used for the tattoo(s) or piercings(s)? In the past 12 months, have you come into contact with someone else s blood through a needle stick, mucous membrains (eye, mouth), or open wound? Have you or the baby s father been diagnosed with or had a relative diagnosed with Creutzfeldt-Jakob Disease (CJD), variant CJD, dementia, any degenerative or demyelinating disease, or other neurological disease of unknown cause? If yes, please describe diagnosis: 40. Have you, the baby s father, or sibling of the baby had cancer, leukemia, lymphoma or any other malignant disease? If yes, please list date and how treated: Have you, the baby s father, or sibling of the baby been diagnosed with Tuberculosis, platelet disorders, Thallassemia, anemia, hurler syndrome, Wiskott-aldrich syndrome, or genetic disorders? If yes, please list date and how treated: Have you had any significant exposure to a substance that may be transferred in toxic doses, such as lead, mercury, or gold (jewelry does not apply)? Please explain any answers that need further clarification: I agree that I have answered the above questions truthfully to the best of my ability. I agree to contact CariCord, Inc. with information in the event that my infant develops a serious illness at some time in the future or if there are any changes to the information I provided above. Print Mother s Name Signature of Mother Date Print Father s Name Signature of Father Date Please notify CariCord, Inc. in writing if there is any change concerning your health status up to the date of delivery of your baby page 5/8 8/10/2015

6 Service Agreement CariCord, Inc. Provides the Kit. CariCord, Inc. will provide a cord blood collection kit to you to be used following your delivery. We will also provide you with information to give to your Medical Professional who will be collecting the cord blood, whether that is a physician, midwife, or other person you authorize to do this for you ( Medical Professional ). It is essential that you arrange for collection of the cord blood with your Medical Professional. You are responsible to bring your CariCord, Inc. Collection Kit to where you are going to deliver, and to use the CariCord, Inc. Collection Kit. CariCord, Inc. Will Process, Preserve and Store the Cord Blood. We will process the cord blood by removing the plasma and red blood cells. If the collected blood volume is lower than 10g, we will process the cord blood. If the cord blood is suitable for storage, we will cryopreserve, and store the unit in liquid nitrogen vapor at -196 C (minus one hundred and ninety six) Celsius until such time that your Child needs it, or this Agreement terminates, whichever comes first. Completion of Forms. It is very important that you agree to read and complete all of the forms in this package. We hope you understand that CariCord, Inc. cannot provide our services to you until you do this, because we want you to be fully informed. Your Due Date. You will inform CariCord, Inc. of your due date. It is important that we know this so that we can prepare to give you the best service. Please enroll as early as possible. A small percentage of babies are born on their due dates. Use of a Medical Professional. You will choose your Medical Professional and inform them of your plan to collect your Child s cord blood. Your Medical Professional is not an agent or employee of CariCord, Inc., and is in no way affiliated with CariCord, Inc. or its parent company. CariCord, Inc. assumes no responsibility for assessing the qualifications of your hospital(s), physician(s), or other Medical Professionals. And CariCord, Inc. is not responsible for reimbursing Client for fees that Client s Medical Professional may charge for the collection of the Child s cord blood. Notification upon Collection and Transport of Collected Cord Blood. The client is responsible for following the shipping procedures and instructions included in the collection kit. You, your Medical Professional, family, or friend will need to contact CariCord, Inc. as soon as possible once the procedures have been performed, at CariCord, Inc. employs its own Medical Courier who, once notified, will pick up your cord blood and deliver it directly to our lab. Alternatively, you may use a courier of your choice. Should you do so, you understand that CariCord, Inc. is not responsible for third party courier transport of your collection kit to CariCord, Inc. s facilities. The Client agrees that CariCord, Inc. is not liable for loss, destruction to, or deterioration of the cord blood due to improper handling or shipment of the cord blood prior to receipt at CariCord, Inc. s facilities should Client decide to use a third party courier transportation. It is recommended that you use our designated courier for this procedure. Change of Client Information. The client is responsible to inform CariCord, Inc. of all changes in address, contact information, payment information or changes to any other information provided to CariCord, Inc. throughout the term of this Agreement. Storage Fee. CariCord, Inc. agrees to honor the annual storage fee of $150 to you for the eighteen (18) years after signing this Agreement. Payment for Services. Client agrees to pay a $150 non refundable kit fee and all of CariCord, Inc. s fees for the services you request. If you fail to make a required payment, we will make attempts to contact you prior to Agreement termination and send you a written notice at the address you provided to us. Agreement Termination. You may terminate this Agreement for any reason and have the right to specify the disposition of your Child s cord blood to a designated location or physician which is authorized under applicable law to receive cord blood. Your Agreement with CariCord, Inc. will be deemed terminated if: 1. Your scheduled due date has passed by thirty (30) days and you have not contacted CariCord, Inc. to schedule the cord blood pickup; 2. Your account is overdue for more than sixty (60) days; 3. Your voluntary termination for any reason upon a written notice in advance. In the event of Agreement termination and no instructions are received 30 days after any event of the termination has occurred, CariCord, Inc. has the right to dispose of the cord blood for value or otherwise, without notice to you. You will not be entitled to any refund or compensation and CariCord, Inc. will retain all rights to the cord blood unit. You may also be charged for the incurred cost to process and store the blood unit. Refund of Unused Years of Storage. If you decide to retrieve your Child s cord blood/cord prior to the end of your prepaid storage years, then you will be issued a refund. Your refund will be the remaining amount of prepaid storage fees after deducting any discounts and used storage fees. What Happens When Your Child Needs the Cord Blood? Before your Child reaches the age of eighteen (18), you will have the right to request the use of the cord blood/cord. When your Child reaches the age of Eighteen (18), you will/may transfer the rights to the cord blood to the Child, and he or she will have the right to request the use of the cord blood. If your Child needs the cord blood, you agree to notify CariCord, Inc. in writing a minimum of two (2) weeks prior to prepare and ship the stored cord blood to a designated location or physician which is authorized under applicable law to receive cord blood. You will arrange for and be responsible for shipping and payment of all transport fees. Upon release of the cord blood to your designated courier, CariCord, Inc. will be released of any and all liabilities including any loss, destruction, or deterioration of the cord blood. If you request any future testing of the cord blood, or related tests, you or your Child agree to pay for it. CariCord, Inc. will then release the cord blood to your shipper and/or cause the test(s) to be performed. page 6/8 8/10/2015

7 When CariCord, Inc. s Service Cannot Continue. If, for any reason, CariCord, Inc. is unable to continue to provide storage services, your sample will be transferred at no cost to you to another facility (determined by CariCord) which is authorized under applicable law to receive and store cord blood/tissue. Confidentiality. CariCord, Inc. agrees to use reasonable efforts seeking to maintain confidentiality for information provided by you or your child. This provision shall be deemed not to restrict disclosure required by law, requested by any government agency or public authority, inadvertent disclosures due to unintentional release of information, disclosures resulting from media attention, disclosures made by individuals, whether or not employed by CariCord, Inc., disclosures of information resulting from computer hacking, or any other type of intruder acting without company authorization, release of information to your Medical Professional and any medical associations he or she may be affiliated with, such as the hospital where you will deliver, laboratory, or anyone for the claimed purpose of providing health or medical services to you or your Child, or disclosures to professional consultants or advisors to CariCord, Inc., or disclosures as part of a potential or actual sale, transfer or assignment of any or all rights or obligations of CariCord, Inc. under this Agreement. No Warranty. You acknowledge that neither CariCord, Inc., The University of Colorado, ClinImmune, its affiliates, successors, assignees, officers, directors, employees, agents, independent contractors, or subcontractors have made any representations, guarantees or warranties, express or implied, to you of any type or nature, including without limit, the generality of the foregoing, warranties or guarantees (except as stated in CariCord, Inc. s product guarantee, enclosed) with respect to (1) the therapeutic, or other value of cord blood/cord, either now or in the future, (2) that your child may ever need the cord blood, (3) the suitability of the cord blood for the use of another family member, (4) the guaranteed success of collecting the cord blood, (5) the suitability of the cord blood for storage, (6) the deterioration, loss, degradation, or spoilage of the cord blood, (7) the merchantability or fitness for a particular purpose or use of any product or service hereunder, (8) Or that CariCord, Inc. performs medical services or gives medical advice. Release, Limitation of Liability and Indemnification. You, on behalf of yourself and your child, release CariCord, Inc., The University of Colorado, ClinImmune, its affiliates, its shareholders, directors, officers, employees, agents, affiliates, insurers, professional advisors, service providers, successors, and assignees from any and all liability for any and all loss, harm, damage, or claim of any kind related to the collection, handling, processing, storage, and maintenance of the cord blood/cord or otherwise in connection with the storage services, except for CariCord, Inc. s gross negligence or willful misconduct, as well as any damages whatsoever arising or resulting from the action of others, including your Medical Professional, the hospital staff, and the shipper who transports your Child s cord blood. You, on behalf of yourself and your child, acknowledge that, by the releases in this Agreement, you give up for you and your child any right you or your child may have now or in the future to sue or otherwise seek money damages or other relief against Cari- Cord, Inc. for any reason related to the collection, handling, processing, storage, and maintenance of the cord blood/cord. You, on behalf of yourself and your child, acknowledge being aware of, or now learning, Section 1542 of the California Civil Code, which provides: A general release does not extend to claims which the creditor does not know or suspect to exist in his favor at the time of executing the release which, if known by him, would have materially affected his settlement with the debtor. You, on behalf of yourself and your child, waive all rights under Section 1542 of the California Civil Code or similar laws in any applicable jurisdiction, for any claim arising out of or relating to a matter released herein. CariCord, Inc. does not guarantee against any possible loss, degradation, spoilage, contamination, or the like of any portion or all of the cord blood/cord for any reason, including without limitation, as a result of CariCord, Inc. s negligence or as a result of circumstances beyond CariCord, Inc. s control such as, without limitation, war, fire, terrorist attacks, power outage, or natural disaster. CariCord, Inc. and its related parties are responsible only for exercising ordinary care in connection with providing its services herein and will not be liable for any damages other than as described in this paragraph. You, on behalf of yourself and your child, agree that if CariCord, Inc. is found liable for gross negligence or willful misconduct, the amount of damages you may incur shall be limited to the amount of money paid by you and your heirs, successors, and assignees pursuant to this Agreement. You understand and agree that CariCord, Inc. is not responsible for, and assumes no direct, indirect, punitive, incidental, special, or consequential damages. CariCord, Inc. expressly disclaims any express or implied warranties of merchantability or fitness for a particular purpose. You, on behalf of yourself and your child, agree to indemnify, defend, and hold CariCord, Inc., The University of Colorado, Clin- Immune, the hospital, physicians, medical staff, your Medical Professional, and each of their respective shareholders, members, directors, officers, managers, employees, agents, affiliates, insurers, professional advisors, service providers, successors, and assignees harmless from any and all claims, liabilities, demands, and/or causes of action asserted by you or your child or other person(s) for whose benefit the cord blood is being collected and stored. In no event shall CariCord, Inc. or The University of Colorado/ClinImmune have any obligation to indemnify you or your child for any claims, damages, liabilities, costs, or expenses arising or resulting, directly or indirectly, out of childbirth or CariCord, Inc. s services to you. page 7/8 8/10/2015

8 Waiver. This is our Agreement on how we will address any issues that arise between us and, as such, you agree to waive any other legal claims you may have against us that are outside the scope of what we agree to in this Agreement. Governing Law, Jurisdiction, and Venue. In the event of a dispute arising from this Agreement or its interpretation, the laws of the State of California shall control. Jurisdiction and venue for any such dispute shall be in the Federal or State courts located in Orange County, California. Attorney Fees and Costs. In the event of a dispute arising from this Agreement or its interpretation, the prevailing party to such action shall be entitled to collect its reasonable attorney fees and costs incurred in such action from the other party. Future Laws. In the event the government passes new laws or changes existing ones, you acknowledge CariCord, Inc. s right to change or modify its procedures in order to comply with these new laws or changes to existing laws, and may pass on to, and/or require you to bear some or all of the costs associated with these changes. Arbitration. All disputes, which arise under this Agreement, shall be referred and resolved by a single arbitrator mutually acceptable to both parties. Arbitration shall be conducted in California. Sections 1280 to 1289 of the California Code of Civil Procedure shall govern. Your Representations and Warranties. In addition to the other representations and warranties you have made in this Agreement, you represent and warrant that you are the parent of the child, or the prospective legal guardian of the child, that you were advised to obtain medical and legal advice prior to signing this Agreement, and that your decision to enter this Agreement and abide by its terms was completely voluntary. In the event you do not become the legal guardian of the Child, this Agreement will terminate; CariCord, Inc. will have the right to dispose or use the cord blood/cord as set forth herein. Sole Agreement. This is the entire Agreement between you and CariCord, Inc. Any prior representations, statements, negotiations, omissions, or Agreements that precede this Agreement are integrated into and superseded by this Agreement and are null and void. Modification. Subject to the paragraph above regarding future laws, this Agreement cannot be modified without the written consent of both parties. Assignment. CariCord, Inc. may assign this Agreement to any individual, association, partnership, or corporation that is either providing a similar service or intends, subsequent to such assignment, to provide a similar service, whether or not as part of a sale, transfer, or assignment of all or part of CariCord, Inc. s business, or for other reasons or in other circumstances, and Cari- Cord, Inc. shall require that this Agreement remain in full force and effect. Death or Disability. In the event of your or your Child s death or disability, CariCord, Inc. shall be entitled to rely on the instructions of your or your Child s estate, guardian, conservator, trustee, administrator, or other similar responsible person or successor in interest. Data Collection and Study. You acknowledge and allow on behalf of yourself and your child that CariCord, Inc. shall have the right to aggregate data, provide aggregate data to others for any purpose, to use information obtained through services provided to you and/or your child, for purposes of research, development, marketing, applying for patents, licensing, and other development and use of intellectual property, or know how, whether or not any of these activities are intended to or actually benefit or generate revenue or profit to CariCord, Inc.. CariCord, Inc. s only obligation to you and your child is to use reasonable efforts to avoid disclosure of information that specifically identifies you or your child. Force Majeure. If the performance of this Agreement, or any obligations arising under this Agreement, is prevented, restricted, or interfered with by reason of fire, earthquake, flood, or other casualty or accident, strikes, labor disputes, war or other violence, any law, order, proclamation, ordinance, demand, or requirement of any government agency, or any other act or condition beyond the control of CariCord, Inc., CariCord, Inc. shall not be liable to you or your child. Method of Execution. This Agreement will be fully enforceable and binding upon CariCord, Inc. s receipt by online submission, , or facsimile of your manual signature executing this Agreement and, where required, in its related documents. Survival. All covenants and Agreements made in this Agreement that, by their terms, require performance after termination of this Agreement, shall survive the termination of this Agreement. Severability. If any provision of this Agreement is held by a court of competent jurisdiction to be invalid, void, or unenforceable, the remaining provisions shall, nevertheless, continue in full force and effect without being impaired or invalidated in any way. Binding. All of the obligations, terms, provisions, and releases set forth in this Agreement shall be binding upon and inure to the benefit of CariCord, Inc. and you, as well as to each party s respective heirs, personal representatives, successors, and assignees. page 8/8 8/10/2015

9 Informed Consent Let it be CMYK: known 6/100/26/24 to participate in the CariCord, Inc. Private/Family Umbilical Cord Blood/Tissue Banking CMYK: 3/50/13/12 Service is entirely voluntary. To participate in the Service, you will have to agree to have your baby s Cord Blood/Tissue CMYK: and 100/85/5/22 a sample of your (blood collected at the time of birth) tested for certain diseases to determine if the Cord Blood/Tissue is appropriate for storage. Cord Blood/Tissue will not be collected if your healthcare professional believes that the Collection might pose any potential harm to you or your child after delivery. CariCord, Inc., will defer to the recommenda - tion of your healthcare professional, and does not participate in any medical decision-making related to the Cord Blood/ Tissue collection. I, the undersigned have reviewed and understand the above information regarding possible risks of having a sample of my blood collected and tested for certain diseases. I wish to participate in the Service provid - ed by CariCord, Inc. and hereby consent to the following procedures: I agree to complete a risk assessment questionnaire (Enrollment Form). I agree to allow my Healthcare Provider to collect my baby s cord blood and/or tissue at the time of the birth of my child, and to draw a 30ml sample of my blood in 5 tubes within 48 hours of the my baby s bir th. I consent to have my blood sample tested for certain infectious diseases (AIDS/HIV, hepatitis, Human T-cell lymphotropic viruses, West Nile Virus, Chagas and Syphilis). In order to determine whether the Cord Blood/Tissue is suitable for storage. I consent to have my baby s cord blood tested for the red blood cell type (ABO/Rh), cell viability, total nucleated cells, sterility (bacterial/fungal contamination), and other selected tests in order to evaluate the suitability of the cord blood for storage and/or transplantation. Any additional tests needed at the time of transplant. I consent to have my baby s umbilical cord tissue, if collected, tested for sterility. I consent to have my baby s cord blood tested for HLA, if ordered. I understand that my physician/i may be notified in the event of a positive test. The $150 collection kit fee is a non-refundable payment, once I enter this agreement I understand that this consent is for the private collection and storage of cord blood and/or tissue, for potential use in the future. I also understand that there are public banks that may be available (if I choose to donate this cord blood) at no cost to me. I further understand that if I do choose to donate publicly, I will not have any rights to the cord blood in the future. I understand that government agencies in my state may require CariCord, Inc. to report positive test results for infectious diseases, including HIV, hepatitis B, hepatitis C, syphilis and West Nile Virus. Please note: ClinImmune Labs- University of Colorado Cord Blood Bank- CariCord s activities for New York State residents are limited to collection, processing, and long-term storage of umbilical cord tissue. Possession of a New York State license for such collection, processing, and long-term storage does not indicate approval or endorsement of possible future uses or future suitability of umbilical cord tissue-derived cells. Check this box if you choose to Privately Bank with CariCord Check one box only: Cord Blood and Tissue Cord Blood Only Tissue Only Signature of Birth Mother Date Printed Name of Birth Mother (If Surrogate or Adoption) Printed Name of Custodial Parent E /10/2015