Regulatory Support. 5.3.1 TEKMIRA will be responsible for (a) designing and implementing stability study protocols for the testing of Investigational Medicinal Product and reporting out-of-specification results, if any, to OXFORD during the duration of the Clinical Trial; and (b) updating TEKMIRA’s regulatory filings for the Investigational Medicinal Product with all results generated in the performance of the stability studies. Parameters for the stability study design are set forth in Exhibit 5.3.1 attached hereto.
Appears in 2 contracts
Sources: Manufacturing and Clinical Trial Agreement (TEKMIRA PHARMACEUTICALS Corp), Manufacturing and Clinical Trial Agreement (TEKMIRA PHARMACEUTICALS Corp)