Common use of Determination of Deficiency Clause in Contracts

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have ten days to advise Indivior by notice in writing that it disagrees with the contents of the Deficiency Notice. Patheon’s failure to issue such written notice to Indivior shall constitute Patheon’s agreement with Indivior’s Deficiency Notice If Indivior and Patheon fail to agree within ten days after Patheon's notice to Indivior as to whether any Product identified in the Deficiency Notice was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, the parties will proceed as follows: (i) if the issue is believed to be caused by a raw material deficiency, laboratory error or a suspect analytical method, representatives from both parties will jointly test the Product and/or materials side by side in the same laboratory to determine if a raw material or testing deficiency is the root cause and whether the Product and/or materials is acceptable; or (ii) if the issue is believed to be process related, representatives from both parties will jointly evaluate the Patheon deviation report to determine if any other investigation could identify the root cause and proceed as determined. If, after the joint testing or investigation has been performed, the parties still cannot agree on the root cause, executives from both parties will meet and use good faith efforts to resolve the deficiency and liability issues. If the parties’ executives are unable to resolve the dispute within 30 days, the dispute will be handled as a Technical Dispute under Section 12.2.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have ten [***] days to advise Indivior Client by notice in writing that it disagrees with the contents of the Deficiency Notice. Patheon’s failure to issue such written notice to Indivior shall constitute Patheon’s agreement with Indivior’s Deficiency Notice If Indivior Client and Patheon fail to agree within ten [***] days after Patheon's ’s notice to Indivior Client as to whether any Product identified in the Deficiency Notice was not manufactured in accordance with the Specifications, MAD or MBR, cGMPs, or Applicable Laws, the parties will proceed as follows: (i) if the issue is believed to be caused by a raw material deficiency, laboratory error or a suspect analytical method, representatives from both parties will jointly test the Product and/or materials side by side in the same laboratory to determine if a raw material or testing deficiency is the root cause and whether the Product and/or materials is acceptable; or (ii) if the issue is believed to be process related, representatives from both parties will jointly evaluate the Patheon deviation report to determine if any other investigation could identify the root cause and proceed as determined. If, after the joint testing or investigation has been performed, the parties still cannot agree on the root cause, the parties will engage an independent third party to perform testing and investigation to resolve the deficiency and liability issues and agree to accept the independent third party’s determination. If any aspect of the third party testing and investigation proves inconclusive, executives from both parties will meet and use good faith efforts to resolve the any remaining deficiency and liability issues. If the parties’ executives are unable to resolve the dispute within 30 [***] days, the dispute will be handled as a Technical Dispute under Section 12.2.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have ten days to advise Indivior Client by notice in writing that it disagrees with the contents of the Deficiency Notice. Patheon’s failure to issue such written notice to Indivior shall constitute Patheon’s agreement with Indivior’s Deficiency Notice If Indivior Client and Patheon fail to agree within ten days after Patheon's ’s notice to Indivior Client as to whether any Product identified in the Deficiency Notice was not manufactured Manufactured in accordance with the Specifications, the Quality Agreement, cGMPs, or Applicable Laws, Laws the parties will proceed as follows: (i) if the issue is believed to be caused by a raw material deficiency, laboratory error or a suspect analytical method, representatives from both parties will jointly test the Product and/or materials side by side in the same laboratory to determine if a raw material or testing deficiency is the root cause and whether the Product and/or materials is acceptable; or (ii) if the issue is believed to be process relatedrelated (including human error, equipment or facility malfunction), representatives from both parties will jointly evaluate the Patheon deviation report to determine if any other investigation could identify the root cause and proceed as determined. If, after the joint testing or investigation has been performed, the parties still cannot agree on the root cause, executives from both parties will meet and use good faith efforts to resolve the deficiency and liability issues. If the parties’ executives are unable to resolve the dispute within 30 days, the dispute will be handled as a Technical Dispute under Section 12.2.