definiens: means use of the Product to perform testing of hu man samples and specimens with Customer ’s own Laboratory Developed Tests in a clinical labora tory in the Territory where results are reported, d irectly or indirectly, to patient or health care practitioner, specifically excluding Excluded Uses . means the country or countries from which samples a nd specimens may be collected for testing by Purcha ser for Clinical Use . means Advantage Consumables and Temporary Consuma bles acquired hereunder . means individual boxes containing Advantage Consu mables . means, with respect to IA Consumables, any use that ( a ) is a use of the IA Consumables to perform NIPT, or ( b ) is a use of a IA Consumable as, or as a component o f, an IVD, as defined below . means a facility in the Territory that is owned by, leased by or otherw ise under the contractual control of, Purchaser . means a medical device that is used to diagnose or screen for a disease or other conditions and that may be used at any facility where its use is Approved by the appropria te regulatory authorities, or may otherwise be mark eted under applicable law, excluding Laboratory Developed Test s. means a diagnostic test developed by Purchaser or on behalf of Purchaser ( t o the extent permitted under applicable law in the Territory ) and performed and validated by Purchaser solely in its own laboratory Facility ( which if in the United States would be regulated under the Clinical Laboratory I m provements Act ( CLIA ) ), excluding an IVD . means non - invasive prenatal testing and includes without limitation all testing of nucleic acids of fetal or placental origin present in maternal tissue ( including matern al blood and blood components ) . are comprised of the Advantage Consumables referenced a t http://www.illumina.com/IAOTS that are generally commercialized in the Territory and subject to the maximum order quantities stated thereon . means Seller branded reagents and consumable item s that are ( i ) intended by Seller to be consumed through the use of Hardware, and ( ii ) not designated with the pre - fix in their catalogue number or product name and which [COMPANY] has authorized i n writing for Purchaser to purchase for use under t hese terms and conditions . means the country or countries in which Purchaser may use the IA Consumables