Autologous Precursor Stem Cells - Warranty

WARRANTY

FCTI, Inc. warrants its production of stem cell transplants that are individually prepared for a specific patient have been manufactured in accordance and in strict compliance with GMP (Good Manufacturing Practice), regulations of the U. S. Food and Drug Administration and the respective regulatory agencies of the European Union, by a specific request made in writing by an ordering individual and physician's prescription. Except as stated in the proceeding sentence, there are no warranties, expressed or implied, including, without any limitations, any implied warranty of merchantability, or of fitness for a particular purpose. Because our stem cell transplants are living beings, it is not possible to give any other warranty, but the one stated above. FCTI, Inc. its affiliates, associates or partners are not liable for injuries resulting from the use of our stem cell transplants in clinical practice, whether the handling or use was, or was not, improper, inappropriate, unintended, wrongful or negligent, in any manner whatsoever. Ordering entity(ies)' exclusive remedy for any losses resulting from the use of our stem cell transplant(s), breach of warranty, or, any other cause, including but not limited to, direct or indirect negligence or strict liability, shall be limited to the suitable replacement of the stem cell transplant(s), as per our replacement policy stated hereinbelow. Any further liability besides those applicable hereto, including consequential damage(s), is thereby excluded and is, in every case, limited to the price of the stem cell transplant(s). The ordering entity(ies) shall bear, indemnify, and hold FCTI, Inc. its affiliates, associates and/or partners, harmless from any and all actions, claims, judgements, costs, expenses, risks and liabilities, directly or indirectly, concerning any/all misuses and/or uses of the stem cell transplant(s). The ordering entity(ies) is responsible for the 'safe keeping', and for assuring that the handling and/or use of said stem cell transplant(s) will be done and/or carried out ONLY by a qualified and knowledgeable physician, and that the implantation of the stem cell transplant(s) will be conducted and/or carried out IMMEDIATELY after their delivery by the courier or shipping agent.



Returned Goods Policy

All individualised prescription ordered are FINAL. No returns, replacements, cancellations, exchanges or credits allowed except if non-delivery or late delivery due to our part. No returns will be accepted, nor will there be any replacement of stem cell transplants(s) once they have been accepted at final destination, because stem cell transplant(s) lose their effectiveness quickly. As previously stated, all steps recommended by U.S. FDA, and by the respective regulatory agencies of the European Union, have been put into practice to aid and assure "top quality" preparations. Besides many other specimens, samples of each stem cell transplant(s) prepared by us are kept in liquid nitrogen in our laboratory, pursuant to U.S. FDA's regulations.