Manufacturing Processes. 6.1.1 Human dermal tissues from which GRAFTJACKET® is produced shall be procured in accordance with FDA regulations and AATB guidelines. 6.1.2 Dermal and epidermal cells shall be removed and the product freeze-dried by LifeCell Corporation per their patented processes. 6.1.3 GRAFTJACKET® shall be certified to conform to the appropriate WMT material specification upon receipt.
Appears in 2 contracts
Sources: Supply and Development Agreement (Wright Medical Group Inc), Supply and Development Agreement (Wright Medical Group Inc)