Right to Audit the Data. In accordance with the applicable privacy regulations, each Party shall have the right, throughout the term of this Agreement, to audit any and all preclinical and clinical trial work being performed, either directly or indirectly related to the Intellectual Property. The audit shall be at the expense of the auditing Party. Should the auditing Party learn, as a result of the audit, discrepancies or errors in data collection or compliance with regulations under the Act, then the auditing Party shall notify the other Party in writing of these discrepancies and or errors and the nonAuditing Party shall correct these discrepancies and errors at its own costs. Nothing herein shall be deemed a waiver of Eucodis obligation hereunder to supply data which is acceptable to the FDA and meets the requirements as set forth in the Act and the ensuing regulations. If MDI does not inform Eucodis on any discrepancies and/or errors, it is understood that data are acceptable and meet the requirements of FDA and Eucodis shall not be liable for any cost of eventual later action or studies required by FDA.
Appears in 3 contracts
Samples: Definitive Master Agreement (Global Clean Energy Holdings, Inc.), Definitive Master Agreement (Global Clean Energy Holdings, Inc.), Definitive Master Agreement (Global Clean Energy Holdings, Inc.)
Right to Audit the Data. In accordance with the applicable privacy regulations, each Party shall have the right, throughout the term of this Agreement, to audit any and all preclinical and clinical trial work being performed, either directly or indirectly related to the Intellectual Property. The audit shall be at the expense of the auditing Party. Should the auditing Party learn, as a result of the audit, discrepancies or errors in data collection or compliance with regulations under the Act, then the auditing Party shall notify the other Party in writing of these discrepancies and or errors and the nonAuditing Party shall correct these discrepancies and errors at its own costs. Nothing herein shall be deemed a waiver of Eucodis obligation hereunder to supply data which is acceptable to the FDA and meets the requirements as set forth in the Act *** Confidential Treatment Request and the ensuing regulations. If MDI does not inform Eucodis on any discrepancies and/or errors, it is understood that data are acceptable and meet the requirements of FDA and Eucodis shall not be liable for any cost of eventual later action or studies required by FDA.
Appears in 1 contract
Samples: Definitive Master Agreement (Medical Discoveries Inc)