Reports. Institution and Investigator shall, within three (3) days of a Trial subject visit, submit to Sponsor complete and accurate case report forms (“CRFs”) and any other records, reports, and data that may be required to be delivered to Sponsor pursuant to the Protocol or this Agreement (collectively “Trial Data”) in accordance with the schedules set forth therein. All other information and data collected or prepared in connection with the Protocol other than Trial Data, such as medical records, source worksheets, x-rays, CT scans, MRIs, other diagnostic images, and all other primary data sources underlying data recorded on the case report forms (collectively “Source Records”) shall remain at the Institution and shall be available for inspection by Sponsor or their representatives. In addition, Institution and Investigator agree, and shall ensure that Trial Personnel agree, to provide any additional data, access or assistance reasonably requested by Sponsor in connection with Sponsor’s submission for approval or clearance of the Trial Drug.
Reports. Upon written request from PTC, Customer agrees to provide to PTC an installation and/or usage report with respect to the Licensed Products (and in the case of Registered User Products, as specified in the Licensing Basis Document, such report shall include a list of all individuals for whom Customer has issued a password or other unique identifier to enable such individual to use the Registered User Product). Each such report shall be certified by an authorized representative of Customer as to its accuracy within ten (10) business days after receipt of PTC’s written request. For any period in which Customer’s use of the Licensed Products exceeds the number and/or the scope of the Licenses in effect during such period for such Licensed Products, Customer agrees to pay for any such excess usage, including applicable license and Support Services fees, and without limiting any other rights or remedies to which it is entitled, failure to pay shall be grounds for termination in accordance with Section 9.1 hereof. PTC and its licensors are the sole owners of the Licensed Products and of any copies of the Licensed Products, and of all copyright, trade secret, patent, trademark and other intellectual or industrial property rights in and to the Licensed Products. All copies of the Licensed Products, in whatever form provided by PTC or made by Customer, shall remain the property of PTC, and such copies shall be deemed to be on loan to Customer during the License Term. Customer acknowledges that the License granted hereunder does not provide Customer with title to or ownership of the Licensed Products or any copies thereof, but only a right of limited use consistent with the exp ress terms and conditions of this Agreement. Customer shall have no rights to the source code for the Licensed Products and Customer agrees that only PTC shall have the right to maintain, enhance, or otherwise modify the Licensed Products.
Reports. The reports to be submitted are set forth in Schedule 5A hereto, including the financial reporting requirements established by EIT (current requirements set forth in Schedule 5B hereto).
Reports. Provider and Investigator shall timely submit to Sponsor complete and accurate case report forms (“CRFs”) and any other records, reports, and data that may be required to be delivered to Sponsor pursuant to the Protocol or this Agreement (collectively “Trial Data”) in accordance with the schedules set forth therein. Notwithstanding any longer time period set forth in the Protocol, all CRFs must be completed by Provider and Investigator within two weeks of any Trial subject’s visit. All other information and data collected or prepared in connection with the Protocol other than Trial Data, such as medical records, source worksheets, x-rays, CT scans, MRIs, other diagnostic images, and all other primary data sources underlying data recorded on the case report forms (collectively “Source Records”) shall remain at the Provider and shall be available for inspection by Sponsor or their representatives. In addition, Provider and Investigator agree, and shall ensure that Trial Personnel agree, to provide any additional data, access or assistance reasonably requested by Sponsor in connection with Sponsor’s submission for approval or clearance of the Trial Drug. získání povolení.
Reports. The Investigator shall, within three (3) days of a Trial subject visit, submit to Sponsor complete and accurate case report forms (“CRFs”) and any other records, reports, and data that may be required to be delivered to Sponsor pursuant to the Protocol or this Agreement (collectively “Trial Data”) in accordance with the schedules set forth therein. All other information and data collected or prepared in connection with the Protocol other than Trial Data, such as medical records, source worksheets, x-rays, CT scans, MRIs, other diagnostic images, and all other primary data sources underlying data recorded on the case report forms (collectively “Source Records”) shall remain at the Institution and shall be available for inspection by Sponsor or their representatives. In addition, Institution and Investigator agree, and shall ensure that Trial Personnel agree, to provide any additional data, access or assistance reasonably requested by Sponsor in connection with Sponsor’s s předložením Hodnoceného Léčiva ke schválení nebo získání povolení.