Reprocessing and Reworking. 5.3.1 Prior to any Product batch being reprocessed or reworked, SurModics must obtain approval of the GNE Quality Unit in advance. Reprocessing and reworking are considered Significant Deviations and shall be handled in accordance to Section 7.2. [*] 5.3.2 [*]
Appears in 2 contracts
Sources: Master Service Agreement (Surmodics Inc), License and Development Agreement (Surmodics Inc)