Information Exchange / Regulatory Data. Gilead shall, upon reasonable request of JT, make available to JT as soon as practicable after such request, Gilead Know-How and Regulatory Information with respect to (i) the Quad7340, (ii) COBI as a Quad7340 Component, and (iii) COBI as a single agent or stand-alone product, which is Controlled by Gilead, and Gilead’s Affiliates or Sublicensees as a result of the performance of Gilead’s obligations under the EVG Agreement. For the avoidance of doubt, Regulatory Information about COBI as a single agent or stand-alone product shall include that about combination use and drug-drug interactions of such COBI single agent with other agents, provided that Gilead agrees that such information is required for Regulatory Approval of the Quad7340 for the Licensed Indication in the JT Territory (such agreement not to be unreasonably withheld or delayed). If the Regulatory Authority in the JT Territory request any material information, data (in final report form) or Know-How that is included in the Marketing Authorization Applications and INDs for the Quad7340 or COBI (including any combination products containing COBI) filed by Gilead or its Affiliates or licensees anywhere in the world for any indications (including those outside the Licensed Indication), and JT reasonably determines that the provision of such material information, data (in final report form) or Know-How is required for Regulatory Approval of the Quad7340 for the Licensed Indication in the JT Territory, then JT shall notify Gilead in writing of such determination. If Gilead agrees with JT’s determination (such agreement not to be unreasonably withheld or delayed), then Gilead shall provide JT with such additional material information, data (in final report form) and Know-How (subject to Gilead’s obligations under its agreements with Third Parties), together with all material subsequent correspondence and data submissions relating to the foregoing, as soon as practicable. If Gilead does not agree with JT’s determination, then Gilead shall have no obligation to provide JT with such additional material information, data (in final report form) or Know-How if Gilead has not unreasonably withheld the needed agreement as provided in the prior sentence.
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Information Exchange / Regulatory Data. Gilead shall, upon reasonable request of JT, make available to JT as soon as practicable after such request, Gilead Know-How and Regulatory Information with respect to (i) the Quad7340Quad, (ii) COBI GS-9350 as a Quad7340 Component, and (iii) COBI GS-9350 as a single agent or stand-alone product, which is Controlled by Gilead, and Gilead’s Affiliates or Sublicensees as a result of the performance of Gilead’s obligations under the EVG Agreement. For the avoidance of doubt, Regulatory Information about COBI GS-9350 as a single agent or stand-alone product shall include that about combination use and drug-drug interactions of such COBI GS-9350 single agent with other agents, provided that Gilead agrees that such information is required for Regulatory Approval of the Quad7340 Quad for the Licensed Indication in the JT Territory (such agreement not to be unreasonably withheld or delayed). If the Regulatory Authority in the JT Territory request any material information, data (in final report form) or Know-How that is included in the Marketing Authorization Applications and INDs for the Quad7340 Quad or COBI GS-9350 (including any combination products containing COBIGS-9350) filed by Gilead or its Affiliates or licensees anywhere in the world for any indications (including those outside the Licensed Indication), and JT reasonably determines that the provision of such material information, data (in final report form) or Know-How is required for Regulatory Approval of the Quad7340 Quad for the Licensed Indication in the JT Territory, then JT shall notify Gilead in writing of such determination. If Gilead agrees with JT’s determination (such agreement not to be unreasonably withheld or delayed), then Gilead shall provide JT with such additional material information, data (in final report form) and Know-How (subject to Gilead’s obligations under its agreements with Third Parties), together with all material subsequent correspondence and data submissions relating to the foregoing, as soon as practicable. If Gilead does not agree with JT’s determination, then Gilead shall have no obligation to provide JT with such additional material information, [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED data (in final report form) or Know-How if Gilead has not unreasonably withheld the needed agreement as provided in the prior sentence.
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