Common use of Records Reports Clause in Contracts

Records Reports. Each Party shall prepare and maintain complete and accurate records of all work conducted by it under the Development Plan and all Information resulting from such work. Such records shall be complete and accurate and shall fully and properly reflect all work done and results achieved in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Each Party shall have the right to review such records maintained by the other Party at reasonable times. Each Party shall provide the JSC (or the other Party, if the JSC has been terminated) with regular reports summarizing in reasonable detail its work under the Development Plan and the results of such work. Unless the JSC establishes a different schedule, such Information shall be provided to the JSC reasonably in advance of any regularly scheduled JSC meeting (or to the other Party on semi-annual basis following termination of the JSC). Each Party shall promptly provide the JSC or the other Party with any additional Information regarding its Licensed Product development activities that is reasonably requested. Without limiting the forgoing, Licensee shall inform Company promptly following the occurrence of any significant development or regulatory event that occurs relating to Licensed Products (e.g., initiation or completion of a clinical trial, submission of a U.S. or international regulatory filing, receipt of a response to such U.S. or international regulatory filing, or clinical safety event for the Licensed Products).

Records Reports. Each Party shall prepare and maintain complete and accurate records of all work conducted by it under the Development Plan and all Information resulting from such work. Such records shall be complete and accurate and shall fully and properly reflect all work done and results achieved in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Each Party shall have the right to review such records maintained by the other Party at reasonable times. Each Party shall provide the JSC (or the other Party, if the JSC has been terminated) with regular reports summarizing in reasonable detail its work under the Development Plan and the results of such work. Unless the JSC establishes a different schedule, such Information shall be provided to the JSC reasonably in advance of any regularly scheduled JSC meeting (or to the other Party on semi-annual basis following termination of the JSC). Each Party shall promptly provide the JSC or the other Party with any additional Information regarding its Licensed Product development activities that is reasonably requested. Without limiting the forgoing, Licensee shall inform Company promptly following the occurrence of any significant development or regulatory event that occurs relating to Licensed Products (e.g., initiation or completion of a clinical trial, submission of a U.S. or international regulatory filing, receipt of a response to such U.S. or international regulatory filing, or clinical safety event for the Licensed Products). [*] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the SEC.