Common use of Regulatory Data Clause in Contracts

Regulatory Data. (i) Licensee will obligate each and every Sublicensee to disclose and make available to Licensee in a timely fashion all Regulatory Data in such Sublicensee’s possession and allow Licensee to disclose such Regulatory Data to MTI and allow further disclosures to any Other Licensees. For clarity, the Sublicensee will be obligated to disclose to Licensee (A) any final study report containing Regulatory Data upon the completion of such final study report, and (B) the underlying raw data supporting such final study report, but only to the extent that such raw data or any sub-analysis of such data are reasonably deemed necessary or appropriate to be directly submitted to a Regulatory Authority. (ii) MTI will obligate each and every Other Licensee to disclose and make available to MTI in a timely fashion all Regulatory Data in such Other Licensee’s possession and allow MTI to disclose such Regulatory Data to Licensee and allow further disclosures to any Sublicensees. For clarity, the Other Licensee will be obligated to disclose to MTI (A) any final study report containing Regulatory Data upon the completion of such final study report and (B) the underlying raw data supporting such final study report, but only to the extent that such raw data or any sub-analysis of such data are reasonably deemed necessary or appropriate to be directly submitted to a Regulatory Authority. (iii) Each Party shall disclose and make available all relevant Regulatory Data to the other Party on a timely basis after the receipt of such Regulatory Data, upon the completion of a related final study report and the underlying raw data supporting such final study report, but only to the extent that such raw data or any sub-analysis of such data are reasonably deemed necessary or appropriate to be directly submitted to a Regulatory Authority. (iv) MTI may disclose and make available any and all Regulatory Data to any Other Licensee for use in the Development of the Product and Licensee may disclose and make available any and all Regulatory Data to any Sublicensee for use in the Development of the Product. The Regulatory Data of each Party will be considered such Party’s Confidential Information; however, the other Party may use and disclose such Regulatory Data (and allow the same rights to its Sublicensees and Other Licensees, as applicable) to the extent necessary in the Development of the Product consistent with the rights of such other Party.

Regulatory Data. (i) To the extent required by Licensee will obligate each to obtain or maintain any Regulatory Approval in or for the Territory and every Sublicensee to disclose and make available the extent otherwise reasonably requested by Licensee in connection therewith, Licensor shall, to the extent permitted by applicable Law, provide to Licensee copies of or access to all non-clinical data and clinical data, IND packages and other information, results, and analyses that are generated at any time, that pertain to any Development or Commercialization activities in respect of any Licensed Product, and that are controlled by Licensor or any of its Affiliates or its or their licensees or sublicensees or can be obtained by them with reasonable effort (collectively, “Licensor Regulatory Data”). All Licensor Regulatory Data in existence as of the Effective Date will be provided to Licensee within thirty (30) days of the Effective Date. To the extent required by Licensor to obtain or maintain any regulatory approval outside the Territory and to the extent otherwise reasonably requested by Licensor in connection therewith, Licensee shall, to the extent permitted by applicable Law, provide to Licensor copies of or access to all non-clinical data and clinical data, IND packages and other information, results, and analyses that are generated at any time, that pertain to any Development or Commercialization activities in respect of any Licensed Product, and that are controlled by Licensee or any of its Affiliates or its or their licensees or sublicensees or can be obtained by them with reasonable effort (collectively, “Licensee Regulatory Data”), provided that, if applicable, the Licensee Regulatory Data may be redacted of any regulatory data or other information if obtaining permission to export or otherwise remove such data or information from Mainland China would, in Licensee’s reasonable opinion, be unreasonably costly. Without limiting the foregoing, each Party shall, in a timely fashion all and responsive manner consistent with the requirements of applicable Regulatory Data Authorities, provide to the other Party, in such Sublicensee’s possession form and allow Licensee format as may be mutually agreed, (x) copies of all correspondence to disclose such or from any Regulatory Data Authority that relates to MTI and allow further disclosures to any Other Licensees. For clarity, the Sublicensee will be obligated to disclose to Licensee (A) any final study report containing Regulatory Data upon the completion of such final study reportLicensed Products, and (By) the underlying raw data supporting all Regulatory Documentation then in such final study reportParty’s possession or later received by it, but only its Affiliates or its or their licensees or sublicensees, provided that, if applicable, any such correspondence or Regulatory Documentation to the extent that such raw be provided by Licensee may be redacted of any regulatory data or any sub-analysis of other information if obtaining permission to export or otherwise remove such data are reasonably deemed necessary or appropriate to be directly submitted to a Regulatory Authority. (ii) MTI will obligate each and every Other Licensee to disclose and make available to MTI information from Mainland China would, in a timely fashion all Regulatory Data in such Other Licensee’s possession and allow MTI reasonable opinion, be unreasonably costly. Each Party agrees to disclose respond to all requests from Regulatory Authorities in respect of the Licensed Products by the required deadline, or if there is no required deadline, then within fifteen (15) days or within such Regulatory Data to Licensee and allow further disclosures to any Sublicenseesother timeframe as may be mutually agreed with the other Party. For claritythe avoidance of doubt, the Other Licensee will be obligated to disclose to MTI (A) any final study report containing Regulatory Data upon the completion of such final study report all information and (B) the underlying raw data supporting such final study report, but only to the extent that such raw data or any sub-analysis of such data are reasonably deemed necessary or appropriate to be directly submitted to documentation provided by a Regulatory Authority. (iii) Each Party shall disclose and make available all relevant Regulatory Data to the other Party on a timely basis after the receipt of pursuant to this Section 4.4(a) shall be treated by such Regulatory Data, upon the completion of a related final study report and the underlying raw data supporting such final study report, but only to the extent that such raw data or any sub-analysis of such data are reasonably deemed necessary or appropriate to be directly submitted to a Regulatory Authority. (iv) MTI may disclose and make available any and all Regulatory Data to any Other Licensee for use in the Development of the Product and Licensee may disclose and make available any and all Regulatory Data to any Sublicensee for use in the Development of the Product. The Regulatory Data of each other Party will be considered as such Party’s Confidential Information; however, the other Party may use and disclose such Regulatory Data (and allow the same rights to its Sublicensees and Other Licensees, as applicable) to the extent necessary in the Development of the Product consistent with the rights of such other Party.