Stem Cell Transplantation Limited warrants that a batch of BCRO fetal precursor cell xenotransplants individually prepared for a specific patient have been manufactured in accordance, and in strict compliance, with GMP (‘Good Manufacturing Practice’), with regulations of the U. S. Food and Drug Administration, and of 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 cells in our fetal precursor cell xenotransplants are living beings, it is not possible to give any other warranty, but the one stated above.
Stem Cell Transplantation Limited, its affiliates, associates or partners are not liable for injuries resulting from the use of our fetal precursor cell xenotransplants 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 fetal precursor cell xenotransplant(s), breech 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 fetal precursor cell xenotransplant(s), as per our replacement policy stated herein below.
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 BCRO fetal precursor cell xenotransplant(s).
The ordering entity(ies) shall bear, indemnify, and hold Stem Cell Transplantation Limited, its affiliates, associates and/or partners, harmless from any and all actions, claims, judgments, costs, expenses, risks and liabilities, directly or indirectly, concerning any/all misuses and/or uses of the BCRO cell xenotransplant(s). The ordering entity(ies) is responsible for the ‘safe keeping’, and for assuring that the handling and/or use of said fetal precursor cell xenotransplant(s) will be done and/or carried out ONLY by a qualified and knowledgeable physician, and that the implantation of the BCRO fetal precursor cell xenotransplant(s) will be conducted and/or carried out IMMEDIATELY after their delivery by the currier or shipping agent.
REPLACEMENTS AND RETURNS (THE POLICY)
No returns will be accepted, nor will there be any replacement of BCRO cell xenotransplants(s) once they have been accepted at final destination, because BCRO cell xenotransplant(s) lose their effectiveness quickly (their viability is diminished unless stored properly in an incubator and handled only by a knowledgeable professional).
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 cell xenotransplant(s) prepared by us are kept in liquid nitrogen in our laboratory(ies), pursuant to U.S. FDA’s regulations.
However, BCRO fetal precursor cell xenotransplants(s) will be replaced free of charge in the following situation(s):
- In case of non-delivery or late delivery, caused by fault of our own, or those of our agent(s), shippers and/or curriers; or,
- In case of breech of warranty, as set forth applicably.