Common use of Records; Disclosure of Data and Results Clause in Contracts

Records; Disclosure of Data and Results. In conformity with standard pharmaceutical industry practices and the terms and conditions of this Agreement, each Party shall prepare and maintain, or shall cause to be prepared and maintained, complete and accurate written records, accounts, notes, reports and data with respect to activities conducted pursuant to the [***] Development Plans for a minimum of three (3) years following the end of the Calendar Year to which they pertain (or such longer period as may be required by Applicable Laws) and, upon the other Party’s reasonable written request, shall send legible copies (in English and in electronic format) of the aforesaid to the other Party, to the extent not already provided, throughout the Term and for a minimum of twelve (12) months following the Term. Upon reasonable advance notice, at the request of the JSC, each Party agrees to make its employees and consultants reasonably available at their respective places of employment to consult with the other Party on issues arising in connection with the [***] Development Plans. In accordance with the reporting format and schedule approved by the JSC, each Party shall promptly and fully disclose to the other Party in writing all data, including preclinical data, Clinical Trial data, formulation data and manufacturing data, generated by or on behalf of such Party with respect to the Products in the Licensed Field. Without limiting the foregoing: (a) Ultragenyx shall keep Takeda regularly and fully informed by reporting to the JSC on a quarterly basis regarding the Development of Licensed Products in the Ultragenyx Field in the Territory by Ultragenyx, its Affiliates and sublicensees, including information regarding the status of Clinical Trials, filing of Regulatory Materials and receipt of Regulatory Approval with respect to the Products in the Ultragenyx Field in the Territory; (b) on at least an annual basis (but in any event, no later than December 1 of each Calendar Year), each Party, as applicable, shall submit to the JSC proposed updates and amendments, as appropriate, to the [***] Development Plans; and (c) Takeda shall keep Ultragenyx regularly informed by reporting to the JSC on a quarterly basis regarding the Development of Licensed Products in the Takeda Field by Takeda, its Affiliates and sublicensees, including information regarding the status of any Clinical Trials, filing of Regulatory Materials and receipt of Regulatory Approval with respect to the Products in the Takeda Field in the Territory.