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 Te...
Records; Disclosure of Data and Results. 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 its activities conducted pursuant to a Research Plan in conformity with Applicable Law and standard pharmaceutical industry practices; provided that in no case shall such records be maintained for less than three (3) years following the Calendar Year to which such records pertain (or such longer period as may be required by Applicable Laws). Upon the other Party’s written request, the Party receiving such written request shall send legible copies of the aforesaid to the other Party throughout the Term with respect to such Research Product and for a minimum of twelve (12) months following such Term. Upon reasonable advance notice, at the request of the JRC, 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 each Research Plan. In accordance with the reporting format and schedule approved by the JRC, each Party shall promptly disclose to the other Party in writing all data, including preclinical data, clinical trial data (if any), formulation data and Manufacturing data, generated by or on behalf of such Party with respect to a Research Product in the Licensed Field in the Territory.
Records; Disclosure of Data and Results. In conformity with standard pharmaceutical industry practices and the terms and conditions of this Agreement, Licensee will prepare and maintain, or will cause to be prepared and maintained, complete and accurate written records, accounts, notes, reports, and data with respect to activities conducted pursuant to the TAK-385 Development Plan for a minimum of [***] years following the end of the Calendar Year to which such plan pertains and, upon Takeda’s written request, will send legible copies of the aforesaid to Takeda throughout the Term and for a minimum of [***] months following the Term. [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Records; Disclosure of Data and Results. In conformity with Applicable Law, 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 Development activities conducted pursuant to this Agreement; provided, that, in no instance shall such records be maintained for less than two (2) years following the end of the Calendar Year to which the records pertain.
Records; Disclosure of Data and Results. In conformity with standard pharmaceutical industry practices and the terms and conditions of this Agreement, Licensee shall prepare and maintain, or shall cause to be prepared and maintained, complete and accurate written records of its Development of the Products, for a minimum of [***] Licensee shall provide to Takeda a reasonably detailed report consisting of (a) an update on the progress of Licensee’s Development and Commercialization activities, including (i) key achievements or milestones to date in the reporting period, and (ii) studies that were run or are in process and (b) [***]
Records; Disclosure of Data and Results. (a) 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 of its Development of the Products, for a minimum of [***], Licensee shall provide to Takeda a reasonably detailed report consisting of (a) an update on the progress of Licensee’s Development and Commercialization activities, including (i) key achievements or milestones to date in the reporting period, and (ii) studies that were run or are in process and (b) a summary of the planned Development and Commercialization activities for the upcoming [***], such as anticipated commercial launches in various countries and other commercial milestones. At least [***] prior to the start of each [***], commencing with the first [***], and ending with the [***] in which Regulatory Approval has been obtained for a Product in Japan, Takeda shall provide to Licensee a reasonably detailed report consisting of (x) an update on the progress of Takeda’s Development and Commercialization activities, including (i) key achievements or milestones to date in the reporting period, and (ii) studies that were run or are in process and (y) [***].
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 Plan for a minimum of [*] following the end of the Calendar Year to which they pertain and, upon the other Party’s written request, shall send legible copies of the aforesaid to the other Party throughout the Term and for a minimum of [*] following the Term. Upon reasonable advance notice, at the request of the CGB, 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 Plan. In accordance with the reporting format and schedule approved by the CGB, 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 Field (as well as with respect to Takeda, safety data outside the Field, as necessary).
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 Program for a minimum of [***] following the end of the calendar year to which they pertain and, upon the other Party’s written request, shall send legible copies of the aforesaid to the other Party throughout the Term and for a minimum of [***] following the Term. Upon reasonable advance notice, at the request of the ODC, 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 Program. In accordance with the reporting format and schedule approved by the ODC, 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 Products in the Field in the Territory. Without limiting the foregoing, Takeda shall keep Amylin regularly and fully informed regarding the Development of Products in the Field in the Territory by Takeda and its Affiliates and sublicensees, including information regarding the status of Clinical Trials, filing of regulatory filings and receipt of Regulatory Approval with respect to Products in the Field in the Territory.
Records; Disclosure of Data and Results. 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 its activities conducted pursuant to the Pre-Option Development Plan in conformity with Applicable Law and standard pharmaceutical industry practices; provided that in no case shall such records be maintained for less than two (2) years following the Calendar Year to which such records pertain. Upon the other Party’s written request, the Party receiving such written request shall send legible copies of the aforesaid to the other Party 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 Pre-Option Development Plan. In accordance with the reporting format and schedule approved by the JSC, each Party shall promptly 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 a Compound or a Product in the Field in the Territory.
Records; Disclosure of Data and Results. In conformity with standard pharmaceutical industry practices and the terms and conditions of this Agreement, Licensee will prepare and maintain, or will cause to be prepared and maintained, complete and accurate written records, accounts, notes, reports, and data with respect to activities conducted pursuant to the TAK-385 Development Plan for a minimum of [***] years following the end of the Calendar Year to which such plan pertains and, upon Takeda’s written request, will send legible copies of the aforesaid to Takeda throughout the Term and for a minimum of [***] months following the Term.
