Work Output. All reports specified in the Proposal and other applicable cGMP documentation (“Work Output”) will be prepared using KBI Biopharma’s standard format(s) unless otherwise specified in the Proposal or this Agreement. Client will be supplied with copies of Work Output generated as a result of the Services as set forth in the Proposal or Quality Agreement. All Work Output and any required Product samples will be at Client’s option, (a) delivered to Client at any address as Client may specify in such request, or (b) archived by KBI Biopharma for a period of five (5) years following completion of the Services unless otherwise provided in the Proposal or required by applicable U.S. laws or regulations. At such time after completion of the Services, Work Output and Product samples will be sent to Client and a reasonable return fee will be charged. If Client chooses to have KBI Biopharma dispose of Work Output and Product samples, a reasonable disposal fee will be charged. Not more than once annually, KBI Biopharma shall, during normal working hours, and with reasonable advance notice, permit Client or its authorized agents to inspect, audit and/or reproduce Records (i) to the extent necessary to adequately evaluate invoices submitted to Client by KBI Biopharma hereunder, (ii) as required by governmental authorities or (iii) as desired by Client for any other valid business purpose related to this Agreement.
Work Output. All reports specified in the Proposal and other applicable cGMP documentation (“Work Output”) will be prepared using KBI Biopharma’s standard format(s) (which shall be commercially reasonable) unless otherwise specified in the Proposal or this Agreement. Client will be supplied with copies of Work Output generated as a result of the Services as set forth in the Proposal or Quality Agreement Unless otherwise required by law, KBI Biopharma shall maintain records related to each Proposal, including, but not limited to the Services, accounting records, time sheets, written policies and procedures, test results, reports, correspondence, memoranda and any other documentation relating to the performance of its obligations under to this Agreement (“Records”). KBI Biopharma shall, during normal working hours, and with reasonable advance notice, permit Client or its authorized agents to inspect, audit and/or reproduce Records (i) to the extent necessary to adequately evaluate invoices submitted to Client by KBI Biopharma hereunder, (ii) as required by governmental authorities or (iii) as desired by Client for any other valid business purpose related to this Agreement. Vendor shall make appropriate personnel or other representatives available to Client and its agents to discuss Records and to resolve any questions or issues relating thereto. Such audits shall not be conducted more frequently than once per year. KBI Biopharma shall maintain all information and data generated by it in the course of providing the Services, including all Work Output, computerized records and files, in a secure area reasonably protected from fire, theft and destruction. To the extent not delivered prior to the expiration or termination of this Agreement, at the expiration or termination of this Agreement and upon the written request of Client, all Records, data, information and tangible property obtained or generated by KBI Biopharma in the course of providing the Services or arising out of the use of Client’s Confidential Information (collectively, “Results”) shall, at Client’s option, be (a) delivered to Client at any address as Client may specify in such request, or (b) retained by KBI Biopharma for a period of five (5) years from the completion of the Services or such longer period required by applicable laws and regulations. Client shall reimburse KBI Biopharma for the reasonable, documented cost of deliveries to Client under this Section 4. In no event shall KBI Biopharma dispose of...
Work Output a) All reports specified in the SoW and other cGMP documentation (“Work Output”) will be prepared using Fujifilm’s standard format(s) unless otherwise specified in the SoW.
Work Output. 6.1 All Work Output documents, reports or technical summaries and other cGMP documentation will be prepared using Diosynth’s standard format(s) unless otherwise specified in the Scope.
Work Output. 4.1 All reports specified in the Proposal and other applicable cGMP documentation (“Work Output”) will be prepared using KBI Biopharma’s standard format(s) unless otherwise specified in the Proposal, the Quality Agreement or this Agreement. Client will be supplied with copies of Work Output generated as a result of the Services as set forth in the Proposal or Quality Agreement. Furthermore, for all work segments, Client shall have access to all raw data for on-site review during a facility visit (pursuant to Section 5 of this Agreement) and have access to and be provided 3
Work Output a) All Information, data, documentation and reports produced by Diosynth in the conduct of the Program and/or all other cGMP documentation (“Work Output”) will be prepared by Diosynth using Diosynth’s standard format(s) unless otherwise specified in the Scope.
Work Output. All reports specified in each Proposal and other applicable Batch Documentation (collectively, the “Work Output”) will be prepared using KBI Biopharma’s standard format(s) unless otherwise specified in the applicable Proposal or this Agreement. Client will be supplied with copies of Work Output generated as a result of the Services as set forth in each Proposal or Quality Agreement. All Work Output and any required Client Product samples will be archived by KBI Biopharma in electronic and, as required, paper form for a period of [***] following completion of the Services unless otherwise provided in the corresponding Proposal or required by Applicable Laws. At such time after completion of the Services, Work Output and Client Product samples will be sent to Client and a reasonable return fee will be charged to Client. If Client chooses to have KBI Biopharma dispose of Work Output and Client Product samples, a reasonable disposal fee will be charged.
Work Output a) All reports specified in the Scope and other cGMP documentation, including the Batch Record, Certificate of Analysis, and the Batch Packet (“Work Output”) will be prepared using Fujifilm’s standard format(s) unless otherwise specified in the Scope.
Work Output a) All reports specified in each Scope and other cGMP documentation provided in the Quality Agreement, as well as records, accounts, notes, reports, and Batch data pertaining to a Program, the Product(s), and its and any third party subcontractor’s activities under this Agreement
Work Output. Boardroom’s work processes used, prepared or assembled by Boardroom during the Engagement, including Boardroom’s proprietary methodology, know-how and computer models (“Work Processes”) shall be the exclusive property of Boardroom. The Company shall not be entitled to the Work Processes. Boardroom shall retain copies of the Work Processes pursuant to its document retention policy as in effect from time to time. Upon the conclusion of the Engagement, Boardroom shall deliver to the Company any data, reports, or runs assembled or prepared by Boardroom for the Engagement specifically and for the benefit of the Company. The data, reports and runs shall be the property of the Company.
