Thank you for considering banking of your stem cells. Personalized Stem Cells is committed to providing high-quality stem cell services, as well as excellent technical, clinical, and regulatory support to physicians, clinical investigators, and patients. We are also committed to expanding the conditions that stem cells can be used to treat and to improving quality of life.
Please review the information below and make your selection regarding cryo-banking, even if your choice is to Not have your stem cells banked.
CELL AND TISSUE BANKING SERVICE AGREEMENT
This agreement, together with any amendments, make up the contract for our optional tissue and cell banking services described herein between you, the customer, and Personalized Stem Cells, Inc. (PSC).
Your Stem Cells for Your Lifetime
- Your stored stem cells or tissues may be able to be used to grow a lifetime supply of stem cells
- Your own quality tested stem cells may be available for future approved treatments
- Stem Cells may be available for emergency medical conditions
- Your own stem cells may be used in FDA approved clinical trials
- Additional medical conditions are expected to be approved in coming years
Important Considerations:
- If you elect not to bank your cells, then no cells will be available for your future
- See below for “Additional Potential Fees”
Definitions
“Dose” means stem and regenerative cells sufficient for treatment.
“Retention Sample” or “Seed Vial” means cells stored for potential growth to produce doses of stem cells, but not sufficient for treatment.
“Account” means the relationship established between you (or your legal guardian / conservator / surrogate) and Personalized Stem Cells (PSC) in this Agreement for the purpose of banking your cells or tissues.
“Agreement” means the terms and conditions described in this document.
“Cell banking,” or “tissue banking” means maintaining one or more vials of your own cells or tissues for your possible use in the future, including processing for cryopreservation, performing quality testing, or multiplying the number of cells for use in approved clinical trials.
“Cell Product” means products resulting from your tissues or cells processed by PSC in accordance with FDA-compliant quality standards. Cell Products include cryopreserved cells produced from cells (culturing) or tissues from you and received from your physician.
“Tissue or Tissues” means your tissue(s) provided to us by your physician.
“FDA” means United States Food and Drug Administration.
“We,” “our” and “us” means Personalized Stem Cells, Inc., the provider of Services.
“You,” and “your” mean anyone who applied for an Account, uses the Account, or otherwise agrees to pay for the Account or to be obligated under this Agreement.
Our Services
Scope of Services. For each Account, we will receive and cryopreserve your cells or tissues sent to us from an approved doctor. We may manufacture and bank Cell Products through our proprietary processes. Tissue or Cell Banking will be carried out in accordance with FDA requirements, known as current Good Manufacturing Practices (cGMP). We may subcontract some of our services to third parties.
Release of Cell Product. We will only ship the Cell Product to the address of a PSC approved physician and only for your use.
Confidentiality. Information we collect from you will not be disclosed to anyone other than those you authorize or to your physician, subcontractors, or as required by state or federal agencies.
Using your account
Ownership of Tissues and Cell Product. The Tissues and Cell Product is your property. We hold your Tissues and Cell Product as a custodian of your property. Your ownership is subject to the terms of payments and other limitations described herein.
Authorized Use. You acknowledge that you understand and agree Cell Product can only be released by us to a physician who is approved by PSC and is compliant with all applicable regulations. Under no circumstances, are we obligated to release the Cell Product to you or anyone else in a manner not consistent with applicable rules and regulations.
Payment. We will require you to provide credit card information to collect the fee. All fees paid for the services are non-refundable, except in the case of loss of Cell Product solely due to our negligence.
Closing of Account. We will contact you regarding renewal of your account prior to the termination date of this agreement. Your account will be closed under the conditions below:
- Written notice: either you or we can close the Account by a written notice 60 days prior to the date of proposed closing.
- Abandonment: Upon expiration of the renewal term of your agreement, we will ask you to fill out our Cell and Tissue Banking renewal form on our website. We will make several attempts to receive the renewal within sixty days after we notify you. If you cannot be contacted, or we do not receive renewal authorization, your Account will be closed.
- Nonpayment: If we do not receive payment on time, we will make reasonable attempts to contact you. If we fail to receive payment within 60 days from the date of first nonpayment, your Account will be closed.
Once your Account is closed, your Tissues or Cell Product will be either disposed, kept for research purpose, or transferred to another FDA-compliant cell banking facility. They will NOT be used for treatment of anyone else. There will be no additional cost for disposal or keeping for research purpose. Should you choose to transfer the Tissues or Cell Product to another facility you designate, you will be billed for the costs associated with the transfer.
Transfer of Tissues or Cell Product. If we decide to transfer your Tissues or Cell Product to another facility due to a change in business circumstance, you will be notified, and, with your approval, your Tissues or Cell Product will be transferred at no additional cost to you.
Loss of Tissues or Cell Product. By opening an Account, you acknowledge that you understand that Tissues and Cell Product Banking is a biological process and the Tissues or Cell Product we hold for you is a living material. As such, despite handling tissues and cells according to the best practice available to date, tissues and cells can be lost or damaged due to reasons not yet explained by current understanding of biological processing. Should your tissues or cells be lost or damaged, we will only be responsible for the loss or damage, if such an event was a direct result of our negligence. In such an event, if you wish, you may have new tissues or cells submitted which we will process at no additional cost to you. If you do not wish to submit new tissues or cells, we will refund you the amount you paid for banking up to the point of the loss or damage. Otherwise, IN NO EVENT SHALL WE BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES, OR DAMAGES FOR LOST PROFITS OR LOSS OF OPPORTUNITY, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY, WHETHER BASED IN CONTRACT, TORT OR OTHER THEORY OF LIABILITY, REGARDLESS OF WHETHER WE WERE ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. IN NO EVENT SHALL OUR LIABILITY ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT EXCEED THE AMOUNT PAID BY YOU TO THE COMPANY UNDER THIS AGREEMENT FOR THE SERVICES, OR DELIVERABLES GIVING RISE TO SUCH LIABILITY.
Warranties of Merchantability or Fitness. Except as expressly set forth in this agreement, we make no warranties or representations of any kind, express or implied, including, but not limited to, warranties of fitness for a particular purpose or merchantability, with respect to any Tissues or Cell Product or any Tissue or Cell Banking services rendered hereunder, or any technology that may be used in such services or incorporated into such finished product.
Miscellaneous Provisions
Governing Law. This Agreement is governed by and construed in accordance with the laws of the State of California, without regard to principles of conflicts of law. You consent to the personal and exclusive jurisdiction of the state and federal courts located closest to Poway, California for any action or proceeding arising out of or related to this Agreement.
Arbitration. You agree that any dispute or controversy arising out of, relating to or in connection with the interpretation, validity, construction, performance, breach, or termination of this Agreement shall be settled by binding arbitration to be held in California, in accordance with the rules then in effect of the American Arbitration Association. The arbitrator may grant injunctions or other relief in such dispute or controversy. The decision of the arbitrator shall be final, conclusive and binding on the parties to the arbitration. Judgment may be entered on the arbitrator’s decision in any court of competent jurisdiction.
Entire Agreement. This Agreement constitutes the entire agreement between you and us with respect to the subject matter hereof, and supersedes all prior agreements, understandings, promises or undertakings with respect to the subject matter hereof, including any prior Services Agreement.
Amendments. This Agreement can be amended by a written instrument signed by both you and us.
Notices. Any notices, consents, waivers or other communications required or permitted to be given under the terms of this Agreement must be in writing and will be deemed to be effective upon delivery when delivered (a) personally; (b) by facsimile or email; or (c) express mail.
Attn: Michael Dale or President
Personalized Stem Cells, Inc.
12860 Danielson Court, Suite B
Poway, CA 92064
[email protected]
Fax: 858.218.8694
Successors and Assigns. If you are incapacitated, we will rely on instructions of your guardian, conservator, the administrator or executor of your estate. Upon notice of your death, the cells will be disposed of or used for research, but will NOT be used for any other person.
Severability. If any provision of this Agreement is determined to be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions will not in any way be affected or impaired thereby.
Force Majeure. Any delay or failure in the performance by you or us shall be excused if and to the extent caused by the occurrence of a Force Majeure.
Additional Potential Fees:
- Growth (culturing) of doses from banked tissues or cells as well as preparation and shipment of doses may incur an additional fee.
- A banked Retention Sample or Seed Vial may be used to grow doses but is not usable as a dose for treatment.
- Prices are subject to change. All charges for additional services will be communicated prior to accepting an order or performing the requested services