Common use of Review of Regulatory Submissions Clause in Contracts

Review of Regulatory Submissions. Zai shall provide to Xxxxxxxx for review and comment drafts of all material Regulatory Submissions in the Territory for the Products no later than fifteen (15) days prior to the planned submission. Zai shall incorporate any comments received from Xxxxxxxx on such Regulatory Submissions where required under any Applicable Laws and shall consider in good faith any other comments received from Xxxxxxxx on such Regulatory Submissions. In addition, Zai shall notify Xxxxxxxx of any material Regulatory Submissions for the Products and any other material documents, comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide Xxxxxxxx with copies thereof as soon as reasonably practicable, but in all events within [***] days after submission or receipt thereof. If any such Regulatory Submission, comment, or correspondence is not in English, then, in addition to a copy thereof in its original language, Zai shall also provide Xxxxxxxx with an English summary thereof within the corresponding timelines as set forth in this ARTICLE 6 at Zai’s cost.

Review of Regulatory Submissions. Zai shall provide to Xxxxxxxx TPTX for review and comment drafts of all material Regulatory Submissions in the Territory for the Products no later than fifteen (15) […***…] days prior to the planned submission. Zai shall incorporate any comments received from Xxxxxxxx TPTX on such Regulatory Submissions where required under any Applicable Laws and shall consider in good faith any other comments received from Xxxxxxxx TPTX on such Regulatory Submissions. In addition, Zai shall notify Xxxxxxxx TPTX of any material Regulatory Submissions for the Products and any other material documents, comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide Xxxxxxxx TPTX with copies thereof as soon as reasonably practicable, but in all events within […***…] days after submission or receipt thereof. If any such Regulatory Submission, comment, or correspondence is not in English, then, in addition to a copy thereof in its original language, (a) Zai shall also provide Xxxxxxxx TPTX with an English summary thereof within the corresponding timelines as set forth in this ARTICLE 6 at Zai’s cost; and (b) upon TPTX’s reasonable request, provide TPTX with an English translation thereof at TPTX’s cost.