Archived Data. Client agrees to compensate Cardno for all costs associated with archiving the Project data files accumulated as a part of this Agreement. These expenses shall be billed as a reimbursable expense as a part of the final invoice for the Project. Cardno agrees to store and maintain this data for a period of five (5) years. Client agrees to compensate Cardno for any future requests for retrieval or distribution of Archived Data.
Archived Data. The Guidelines describe the process of approval of such a proposed collaboration and the rules governing an approved collaboration. The letter of intent for collaboration of the listed collaborator has been approved by the Principal Investigator, Xxxx X.
Archived Data. From the Closing Date and until the earlier of (i) two (2) years following FDA approval of a marketing application or two (2) years following application approval in any ICH region related to any clinical trial for which the Parent’s CT/Alpha Platform was used and (ii) the date on which the Parent has given to the Acquirer (A) all ECG Data (as defined below) related to studies in which the Parent’s CT/Alpha Platform was used and (B) a means to query and display such ECG Data such that the Acquirer and the Company can readily comply in all respects with any applicable laws, the needs of any regulatory audit and the demands of any customer, the Covance Parties shall, after any request by the Acquirer, promptly (as required by the applicable regulatory agency or customer) supply to the Acquirer and the Company, in electronic format suitable for human review and reasonably necessary for the Acquirer’s or the Company’s customer archival needs or compliance with any applicable law or regulatory audit, any ECG Data and customer and regulatory information, for any electrocardiogram study in which the Company provided services or otherwise participated in any respect and that is residing on the Parent’s CT/Alpha Platform or is otherwise in the Parent’s control. “ECG Data” means all digital and numerical electrocardiogram data and corresponding audit trails, including, without limitation, electrocardiogram source files and annotations, electrocardiogram results, interval duration measurements and morphology results, study setup parameters, study files (e.g., correspondence, protocol, setup forms, PM files, contracts, equipment logs, site certifications, etc.) including demography and visit information, FDA XML files, summary reports provided to clients and sites, data transfer specifications/documentation of delivery, QC/QA records and documentation on database lock. The Parent shall accompany all ECG Data with all iterations of such ECG Data including a comprehensive audit trail with old values, new values, reason for change, date/time change and name of person making any such changes.
