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Quality Commitment/Quality Report

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Xytex guarantees that insemination materials will arrive on or before the requested date. The semen samples will either be unwashed (for ICI), washed (for IUI) or vials prepared for ART procedures, as specified by your clinic. Xytex agrees to waive all or a portion of the shipping fees for a shipment not received by the time requested by the physician.

Xytex makes a "Quality Commitment" of providing a minimum of 25 million motile sperm per thawed milliliter in the thawed material, whether washed or unwashed. Xytex provides a minimum of 10 million motile sperm per milliliter in the thawed ART vials and a minimum of 4 million motile sperm per milliliter in the thawed ICSI vials. This is a commitment rather than a guarantee because there are numerous accepted methods of counting sperm and each yields different results. The "Quality Commitment" is limited to 120 days after shipment of the units from the Xytex warehouse, including transit time. Any procedure applied to semen other than insemination after shipment from Xytex voids Xytex "Quality Commitment." Semen is intended for insemination immediately after the required thawing time per Xytex thawing instructions which can be found in the packing slip. Xytex will consider providing replacement vials for semen that, upon thawing, is found by the physician to have fewer than acceptable minimum concentrations of motile sperm. Consideration will only be given for replacements if our Quality Report is completed and submitted within 30 days of the date of thaw. Xytex may acquire further details about the situation through a phone call to the professional. The report will be reviewed with the understanding that because labs are evaluating samples using several different counting chambers, we allow for up to a 20% variance from the total motile sperm cells listed on the packing slip. Example: The guarantee is 12.5 million motile per vial. With a 20% variance, 10.0 million motile per vial is acceptable

As a clinical laboratory, Xytex undergoes proficiency testing several times annually by an independent credentialing agency. Xytex performs its counts using a manual counting chamber (Makler or comparable chamber) in accordance with the procedures in the World Health Organization (WHO) manual for the examination of human semen and sperm-cervical mucus interaction, 3rd edition.

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