Record Storage. Provider shall prepare and maintain records related to the Services and the manufacture, handling and storage of Product as required by the Specifications, Quality Agreement, applicable Work Order and/or Applicable Law, including batch and other records sufficient to trace the history of each batch of Product. In addition, Provider shall, as required by the Specifications, applicable Work Order, Quality Agreement and/or Applicable Law retain representative samples from each batch of Product, for record keeping, stability testing and other purposes. All records, materials, test results, data and documentation, including Documentation, obtained or generated by Provider in the course of providing the Services, including all computerized records and files (“Records”), will be maintained in a secure area in accordance with Applicable Laws, the Quality Agreement, and industry standards. The Records are the sole and exclusive property of Client and may be used by Client without any restriction. All Records will be kept in English. Upon Client’s request, Provider shall provide Client reasonable access to, and copies of, such Records and samples.
Record Storage. 14.1 During the term of this Agreement, PPD shall maintain all materials and all other data obtained or generated by PPD in the course of providing the Services hereunder, including all computerized records and files. During the term of this Agreement and for a period of two years after its expiration or termination, Sponsor may audit any records of PPD associated with this Agreement, including, but not limited to financial records, Study records, and patient records. Financial records may include invoice records, invoices from third parties, contracts with third parties and payments relating to this Agreement. PPD shall cooperate with any audit by Sponsor and make available to Sponsor for examination and duplication, during normal business hours and at the mutually agreeable times, all documentation, data and information relating to a Study.
14.2 Upon the expiration or termination of this Agreement all materials and all other data and information obtained or generated by PPD in the course of providing the Services hereunder shall, at Sponsor’s option, be (i) delivered to Sponsor at its expense and risk to its offices in Liberty Corner, New Jersey in such form as is then currently in the possession of PPD, (ii) retained by PPD for Sponsor for a period of two years, or (iii) disposed of as directed by written request of Sponsor, unless such materials are otherwise required to be stored or maintained by PPD under applicable law. If PPD is required or requested to maintain and/or store such material for a period beyond two years after the termination or expiration of this Agreement, the parties shall mutually agree on PPD’s compensation therefore. In no event shall PPD dispose of any materials or data or other information obtained or generated by PPD in the course of providing the Services hereunder without first giving Sponsor sixty (60) days prior written notice of its intent to dispose same. Notwithstanding the foregoing, PPD may retain copies of any such materials, data and information as is reasonably necessary for regulatory purposes or to demonstrate the satisfaction of its obligations hereunder, all subject to the confidentiality obligations set forth herein.
Record Storage. As consideration for the fees owing to PCAS under clause 6, PCAS shall retain the products produced in the context of the Tasks and the related data (raw data, components, products produced in bulk, packaged batches, reference substances, stabilised substances, correspondence, technical documents and all other documentation concerning the Tasks), in accordance with GMP Chapter 19/19.8 and 19.9, [***] from the date of expiry or termination of the corresponding Work Order. At the end of this period, PCAS shall immediately inform Xxxxxx and Xxxxxx shall decide whether the said data should be returned, destroyed or retained for a longer period. PCAS must not destroy any data without Xxxxxx’s prior consent.
Record Storage. Records shall be retained and stored in a manner which will preserve their integrity and admis- sibility as evidence in any audit or other proceeding. The burden of pro- duction and authentication of the records shall be on the custodian of the records.
Record Storage. (a) During the term of this Agreement, Novotech shall maintain all materials and all other data obtained or generated by Novotech in the course of providing the Services hereunder, including all computerized records and files, in a secure area reasonably protected from fire, theft and destruction. Novotech shall cooperate with any internal review or audit by Sponsor and make available to Sponsor for examination during normal business hours and at mutually agreeable times, documentation, data and information typically subject to regulatory inspection.
(b) At the expiration or termination of this Agreement and upon written instruction of Sponsor, all materials and all other data and information obtained or generated by Novotech in the course of providing the Services hereunder shall, at Sponsor’s option, be (i) delivered to Sponsor at its offices in such form as is then currently in the possession of Novotech, or (ii) disposed of, at the direction and written request of Sponsor, unless such materials are otherwise required to be stored or maintained by Novotech as a matter of law or regulation. In no event shall Novotech dispose of any materials or data or other information obtained or generated by Novotech in the course of providing the Services hereunder without first giving Sponsor sixty (60) days prior written notice of its intent to do so. Notwithstanding the foregoing, Novotech may retain copies of any of the materials referred to herein as are deemed reasonably necessary, in Novotech’s sole discretion, for regulatory or insurance purposes or to demonstrate the performance of its obligations hereunder, subject to its ongoing obligations to maintain the confidentiality of such materials.
Record Storage. 5.4.1 During the term of this Agreement, AAIPharma shall maintain all materials and all other data obtained or generated by AAIPharma in the course of providing the Services hereunder, including all computerized records and files, in a secure area reasonably protected from fire, theft and destruction. All computerized records and files shall be backed up in such a manner and frequency as to reasonably protect against loss of information from computer viruses or other equipment failure.
5.4.2 AAIPharma agrees to notify YMB USA no less than thirty (30) days prior to destruction or disposal of materials, records and data to enable YMB USA to determine whether it requires further archival time. In the event YMB USA requires storage of records and data beyond the minimum storage, AAIPharma agrees to continue to store the data until the Parties have agreed on storage or transfer of the data and reports to YMB USA. Time shall be of the essence in respect to coming to an agreement on further storage.
Record Storage. 17.1. During the Term, GTC shall maintain all materials and all other data obtained or generated by GTC in the course of providing the Services hereunder, including all computerized records and files. GTC shall cooperate with any internal review or audit requested by PharmAthene and make available to PharmAthene for examination and duplication, during normal business hours and at mutually agreeable times, all documentation, data and information relating to a Proposal.
17.2. Within thirty (30) days of the expiration or termination of this Agreement other than for PharmAthene's breach of Section 3, all materials and all other data and information obtained or generated by GTC in the course of providing the Services hereunder shall, at the election of PharmAthene and at PharmAthene's option and expense, be (i) delivered to PharmAthene at its offices in Annapolis, Maryland in such form as is then currently in the possession of GTC, (ii) retained by GTC for PharmAthene for a period of two years, or (iii) disposed of as directed by written request of PharmAthene, unless such materials are otherwise required to be stored or maintained by GTC under applicable law. If GTC is required or requested to maintain and/or store such material for a period beyond two years after the termination or expiration of this Agreement, the parties shall mutually agree on GTC's further compensation therefore. In no event shall GTC dispose of any materials or data or other information obtained or generated by GTC in the course of providing the Services hereunder without first giving PharmAthene sixty (60) days prior written notice of its intent to dispose same. Notwithstanding the foregoing, GTC may retain copies of any such materials, data and information as is reasonably necessary for regulatory purposes or to demonstrate the satisfaction of if its obligations hereunder, all subject to the confidentiality obligations set forth herein.
17.3. GTC shall employ all reasonable and appropriate measures and processes to ensure that all data collected and stored by GTC on its premises or offsite at any storage facility pursuant to this Agreement will be safeguarded against loss, damage and destruction arising from any cause including, but not limited to, theft, fire, flood, earthquake, lightening and electrical disruption. Such measures and processes shall include, but not be limited to, (a) storage of hard-copy documents and computer storage disks in locked, fireproof containers, and (b) ba...
Record Storage. 5.4.1 During the term of this Agreement, ALLPHASE shall maintain all materials and all other data obtained or generated by ALLPHASE in the course of providing the Services hereunder, including all computerized records and files, in a secure area reasonably protected from fire, theft and destruction. All computerized records and files shall be backed up in such a manner and frequency as to reasonably protect against loss of information from computer viruses or other equipment failure.
5.4.2 ALLPHASE agrees to notify YMB no less than thirty (30) days prior to destruction or disposal of materials, records and data to enable YMB to determine whether it requires further archival time. In the event YMB requires storage of records and data beyond the minimum storage, ALLPHASE agrees to continue to store the data until the Parties have agreed on storage or transfer of the data and reports to YMB. Time shall be of the essence in respect to coming to an agreement on further storage.
Record Storage. 13.1 During the term of this Agreement, PPD shall maintain all materials and all other data obtained or generated by PPD in the course of providing the Services hereunder, including all computerized records and files. PPD shall cooperate with any reasonable internal review or audit by Sponsor and/or any regulatory authority, and make available to Sponsor and/or any regulatory authority for examination and duplication, during normal business hours and at mutually agreeable times, all documentation, data and information relating to a Study.
Record Storage. The parties shall store and retain records and the Messages communicated under this Agreement as may he specified in the Technical Annex.
