Facility Qualification definition
Examples of Facility Qualification in a sentence
At such times as are set forth in the Clinical Facility Qualification Plan, I3 shall prepare and submit to NeoRx a report (the "Clinical Facility Qualification Report") summarizing the activities performed pursuant to the Clinical Facility Qualification Plan, including but not limited to facility qualifications that are needed to begin producing Product for Phase III Clinical Trials.
VII-6 5.6 Unbundled Loop Facility Qualification..........................................................................................................
I3 shall also prepare and submit to NeoRx a final Clinical Facility Qualification Report, as described in Section 2.1(b), at such time as the Clinical Manufacturing Facility and Process are Qualified, but no later than thirty (30) days after the Primary Completion Date.
All payments due to Nordion under this Section 2.5 shall be paid by Coul▇▇▇ ▇▇▇hin thirty (30) days of Coul▇▇▇'▇ ▇▇▇eipt of invoice therefor, except that the final payment due to Nordion for performance of the Primary Facility Qualification Plan shall be made by the later of (i) fifteen (15) days after Coul▇▇▇'▇ ▇▇▇eptance of the Primary Facility Qualification Report or (ii) thirty (30) days after Coul▇▇▇'▇ ▇▇▇eipt of an invoice therefor.
I3 will prepare and NeoRx will approve a qualification plan for the Clinical Manufacturing Facility and Process (the "Clinical Facility Qualification Plan"), which will set forth the steps to be followed by I3 in causing the Clinical Manufacturing Facility and Process to be qualified for use in clinical trials.
If, at any time during the Term of this Agreement after the Clinical Manufacturing Facility and Process are Validated, the parties determine that modifications to the Clinical Manufacturing Facility or Process are required as a result of errors committed by I3 in carrying out the Clinical Facility Qualification Plan, then I3 shall make such modifications and bear all costs and expenses associated therewith.
I3 acknowledges that any or all data included in the final Clinical Facility Qualification Report may be used by NeoRx for purposes of completing the CMC section of the IND.
I3 shall prepare and execute, and deliver to NeoRx no later than thirty (30) days after the Primary Completion Date, a final Clinical Facility Qualification Report indicating that the construction of the Clinical Manufacturing Facility and the Process are complete and qualified and that I3 has satisfied all aspects of the Clinical Facility Qualification Plan.
All other Excess Expenses related to performance under the Primary Facility Qualification Plan shall be borne by Coul▇▇▇, ▇▇bject to Coul▇▇▇'▇ ▇▇▇or written authorization.
VII-7 5.6 Unbundled Loop Facility Qualification..........................................