Second Site Sample Clauses
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Second Site. Based on Forecasts for the Finished Excipients submitted from King to Durect, if Durect determines that it will need to either: (a) qualify an additional Manufacturing site to Manufacture Finished [ * * *] from [ * * *] Starter Material in addition to the Durect Facility (or any other facility which is then Manufacturing Finished [ * * *]) in order to ensure continuity of supply of Finished [ * * *] by Durect to King, or (b) qualify an additional Manufacturing site in addition to the [ * * *] Facility (or any other facility which is then Manufacturing Finished [ * * *]) for the Manufacture of Finished [ * * *] from [ * * *] Starter Material in order to ensure continuity of supply of Finished [ * * *] by Durect to King ((a) and (b) each individually, a “Second Site”), then Durect will prepare a written proposal to King for the qualification of such Second Site. [ * * *]. Durect shall provide King with information reasonably requested by King in connection with King’s evaluation. King’s approval of Durect’s proposal shall not be unreasonably withheld, delayed, or denied in view of the risk mitigation strategies which are reasonable and typical in the pharmaceutical industry for ensuring continuity of supply of excipients from a supply chain. Upon such approval, [ * * *]. If [ * * *]. If the Second Site is owned and operated by a Third Person, any Finished Excipient supplied by Durect to King from such Second Site will be pursuant to this Agreement and Durect shall contract directly with such Third Person for the supply thereof. Unless otherwise agreed to in writing by King, a Second Site shall produce no less than [ * * *] percent ([ * * *]%) of King’s annual requirements (based on King’s most recent Forecast at the time) of the applicable Finished Excipient. [ * * *]
