This is an agreement between OOTHY LLC, and the individual, parents or legal guardian of the individual (“Client”) who wishes OOTHY to provide processing, freezing, cryogenic storage and related services for the cells collected from teeth, Dental Pulp Stem Cells (“Dental Pulp”), after the tooth has fallen out or has been extracted.
OOTHY is responsible for providing a complete Dental Pulp kit for tooth collection at home or a dentist’s office. After successful collection of the tooth/teeth, Client will arrange for FedEx to transport the tooth/teeth to OOTHY’s processing laboratory using OOTHY’s prepaid envelope and label included with the Dental Pulp collection kit. OOTHY’s lab will process, cryopreserve and store the Dental Pulp stem cells at its laboratory and cryogenic storage facility.
OOTHY’s lab may choose not to process and/or store the Dental Pulp unit if it does not meet certain requirements including, but not limited to, a tooth containing fillings, dental caries, unhealthy pulp tissue, lack of pulp tissue, the Dental Pulp is not collected properly, not handled or shipped according to OOTHY’s procedures, or if the unit tests positive for certain microbial contamination. In the event a tissue sample is not a viable source of stem cell or does not meet the requirements, OOTHY will notify the client immediately. All information obtained by OOTHY may be used where confidentiality is maintained as required by federal or state law.
If the Dental Pulp stem cells are requested for a cellular therapy application, OOTHY’s lab may conduct appropriate testing and ship the Dental Pulp unit to the appropriate facility upon written request from a qualified physician. OOTHY will culture (expand) the cell sample to meet the specifications of the physician’s request. Client is responsible for all associated expenses.
Client is responsible for completing the health profile form prior to us processing the tooth, as well as payment of all required fees. Client is responsible for notifying OOTHY of any changes to their contact information and payment information while this agreement is in effect.
The legal guardian may cancel this agreement at any time while the child is still a minor. At the age of 18 years old, your child has ownership claims to the Dental Pulp unit and only he or she may cancel this agreement. If at any time you elect to terminate this agreement, you must notify OOTHY in writing. OOTHY may terminate this agreement upon written notice to you if for any reason you fail to pay any required fees within thirty (30) days of the payment due date. OOTHY will retain all rights to the Dental Pulp unit, and neither you nor OOTHY will have any continuing obligations to the other. Any changes to this agreement must be in writing and agreed upon by ALL parties in order to be enforceable. This agreement will be governed by and construed in accordance with the laws of the State of Florida, without giving effect to conflict of laws, rules or principles. This agreement has been prepared in the English language and the English language shall control its interpretation.
I/We, the Client, Parent(s)/Legal Guardian(s) of the individual, on behalf of myself/ourselves and my/our/child (“Child”), hereby grant permission to OOTHY’s Lab to process, test, and store the Dental Pulp Stem Cells (“Dental Pulp”) after extraction of my/our/the Child’s tooth/teeth. This document constitutes a legally binding Agreement between OOTHY and the Parent(s) or Legal Guardian(s), the (“Client”). This Agreement outlines the rights and obligations of the parties as set forth in this document.
I/We, the Client, agree and acknowledge understanding of the following:
1) The term Dental Pulp also indicates the Stem Cells in the tooth/teeth that are extracted, processed, cryopreserved, and stored for future use.
2) The Client understands that the Client is the custodian of the Dental Pulp Stem Cells until the Child reaches (18) years of age. At that time, OOTHY shall recognize any claims made by the Child for the Dental Pulp Stem Cells.
3) The Client understands that Dental Pulp cellular therapy is relatively new and many of the possible future benefits to the donor and other potential beneficiaries in regenerative/personalized medicine. The Client understands that Dental Pulp offers a rich source of stem cells. The Client understands that cryopreservation is a successful method of preservation of Dental Pulp; however, no assurance or guarantee can be made about the effectiveness of preservation nor the benefits or utility derived there from. The Client also understands that the individual who banked these cells may never need to use the Dental Pulp stem cells. In addition, these cells are for autologous use only, no other individual can use/benefit from the use of the Dental Stem cells other than the donor.
4) We advise the Client to discuss stem cell storage with a qualified health and dental professional. OOTHY is in no way providing health or dental advice, care or treatment to you.
5) The Client understands that he/she should request a qualified dentist to extract the tooth/teeth and place it in the collection kit provided by OOTHY. The Client acknowledges that the Dental Pulp will be sent to an independent laboratory ("Laboratory") for testing during the term of this contract. OOTHY’s duties are limited to providing educational materials and the collection kit, and OOTHY is not responsible for any dental procedure or advice.
6) The Client understands that there are risks with any dental procedure, that there may be additional considerations or unforeseeable circumstances during the period of a tooth extraction and that the safety and care of the client is of primary concern. Therefore, in the event the tooth/teeth cannot be extracted or collected, Client releases from liability and waives all claims against the Dentist, Dental Facility, Facility Staff, OOTHY, its shareholders, directors, officers, owners, employees, representatives, agents, affiliates and consultants, and the Client enters into this agreement with this understanding.
7) The Client understands that the tooth/teeth are normally discarded after extraction and that the decision to collect, process, and store the Dental Pulp stem cells is a voluntary act on the part of the Client that may allow them to protect their personal rights to the Dental Pulp unit.
8) The Client agrees to be responsible for delivery of the tooth/teeth to the Laboratory within 72 hours of extraction. Upon request of Client, OOTHY may, at its sole discretion, facilitate the delivery of the tooth/teeth on the Client’s behalf.
9) The Client understands that tooth/teeth collection is voluntary and that the Client has the right to stop the collection at any time. In the event the decision to stop the tooth/teeth collection is made prior to the processing of the Dental Pulp, OOTHY will close the client's account and no further fees are due to OOTHY.
10) Fees - Client agrees to pay to OOTHY the fees set forth on their payment agreement. Client accepts full responsibility for the contractual balance due to OOTHY LLC. All charges made to the selected payment method will be processed in United States US dollars.
11) Term - The Client understands the initial term of this Agreement shall commence on the Client’s date of enrollment. The “storage term” will begin on the date the tooth/teeth are processed and will continue for the Client’s selected storage period, unless either party provides written notice to the other of its intent not to renew at least sixty (60) days prior to the anniversary date of the Storage Date.
12) Termination and Release - This Agreement shall terminate upon the occurrence of any one of the following:
A. With Cancellation Penalty
B. Without Cancellation Penalty
Upon termination of this Contract, Client agrees to release all rights and waive all claims against OOTHY, and its shareholders, directors, officers, owners, employees, agents, affiliates, representatives and consultants with regard to this Contract, the services hereunder and the Dental Pulp, and agrees that OOTHY shall have no further liability to the Client or with regard to the Dental Pulp after termination.
13) No Warranty or Guarantee; Limitation of Liability -The Client acknowledges that neither OOTHY nor any of its officers, directors, shareholders, executives, employees, agents, or consultants have made any representations, guarantees or warranties, express or implied, to the Client of any kind or nature, including, without limiting the generality of the foregoing, nor have there been any representations, warranties or guarantees with respect to (i) suitability of Dental Pulp for the future treatment of diseases; (ii) successful treatment of diseases through Dental Pulp cellular therapy; (iii) advantages of Dental Pulp transplantation over other types of treatment using stem cells; (iv) the merchantability or fitness for a particular purpose or use of any product or service hereunder; (v) client agrees that should he or she make any claim against OOTHY, such claim shall be limited in total to the amount of Fees paid by the Client to OOTHY under this Contract; (vi) client acknowledges that any results of test performed by the independent laboratory are not guaranteed. The elimination of some errors is not possible due to the nature of the tests. The independent laboratory does not guarantee or warranty the services. The Independent laboratory is not responsible for any losses or damages arising out of the services provided, unless and only to the extent caused by the independent laboratory’s negligence or misconduct.
14) Withdraw (Preparation, Transfer, and Shipment) – In the event that these cells are needed for treatment, the Client shall provide written order from the physician to OOTHY. The notice shall include the name and address of the physician and facility receiving the Dental Pulp. The decision of how many stem cells quantity are required will be made by the Client’s physician. The Client shall bear all costs related to the preparation and shipment of the Dental Pulp.
15) Indemnify and Hold Harmless - The Client agrees to indemnify, defend and hold harmless OOTHY, the processing laboratory, and any of its agents, affiliates, shareholders, directors, officers, owners, employees, consultants and other representatives from and against any and all liability, loss, expense, attorney’s fees, or claims from injury or damages, arising out of the services provided under this agreement. The Client further acknowledges that OOTHY is not responsible for the actions of others including but not limited to the Client’s dentist or provider, the dental facility or its staff, laboratory staff, and transporters of the tooth/teeth.
16) Assignment - This Agreement is assignable by OOTHY to any individual, association, partnership, or other corporation, which is either providing a similar service or intends subsequent to such assignment to provide similar service. This agreement is not assignable by the Client without the written notification to and written consent by OOTHY.
17) Miscellaneous - This Agreement represents the entire Agreement between the parties concerning the subject matter hereof and there are no understandings, agreements, representations other than as herein set forth. This Agreement shall be binding upon the parties and their respective heirs, spouses, executors, administrators, agents, representatives, successors, and assigns. The Agreement shall be construed in accordance with the laws of the State of Florida, and any dispute or controversy hereunder shall be resolved in the local courts sitting in Florida. If any provision of this Agreement is deemed unenforceable, the remaining provisions hereof shall nevertheless be fully enforceable in accordance with their terms.
18) Change in Fees - Any fees set forth in this Contract, including the Storage Option Form, is subject to changes or adjustment such as those that may reflect industry standards and governmental regulations. OOTHY will provide Client with written notice of any change in fees at least thirty (30) days prior to the date the payment is due. The fees stated in the Storage Option Form are fixed for a period 20, 40 and 60 years, while under this agreement. OOTHY reserves the right to increase fees due to Consumer Price Index (CPI), inflation or increase in cost of materials. Client is subject to new pricing when contract has reached its term or in the event a new storage plans change is requested by client.
19) Client Consent to Release of Information - Client hereby agrees to the release of any and all information with regard to the Client, or the Child, or anything related to the services performed hereunder, to the dentist, laboratory, and any physician, provider, dental facility staff, hospital staff or representative, nurse, or other provider of services to the Client. Client’s right to privacy and confidence is protected by current regulations. Client information will not be distributed or sold to any third party.
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