Retain Samples. Fresenius will retain samples of the raw materials used in the manufacture of the PRODUCTS for a period of no less than three years following the labeled expiration date of that component. The amount of sample retained will be at least twice the amount necessary to carry out all of the tests required to determine if the material meets its specifications, with the exception of sterility and endotoxin testing. Fresenius will retain samples of the PRODUCTS for at least one year beyond the expiry period. The amount of sample retained will be twice the quantity required to carry out all of the tests required to determine if the material meets its specifications, with the exception of sterility and endotoxin testing. Fresenius will notify TransMedics prior to the destruction of any PRODUCT designated as Clinical Trial Material involved in clinical trials in which TransMedics was engaged.
Appears in 3 contracts
Sources: Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.)