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. (a) Zymeworks shall provide to Jazz (i) all material Regulatory Submissions prepared by or on behalf of Zymeworks with respect to the Zymeworks Ongoing Studies at least [***] prior to submission (or such shorter time period required for timely response to a Regulatory Authority) and shall incorporate reasonable comments received from Jazz with respect thereto, (ii) all material correspondence or communication between Zymeworks and a Regulatory Authority in the Territory with respect to the Zymeworks Ongoing Studies, as well as minutes of any material meetings, telephone conferences or discussions that Zymeworks has with such Regulatory Authority, in each case, with respect to a Licensed Product (and Zymeworks shall provide Jazz with material correspondence or communications from a Regulatory Authority, including, without limitation, any communications or correspondence relating to label requirements, within [***] of Zymeworks’ receipt of such correspondence or communications) and (iii) permission for [***] mutually acceptable representatives of Jazz, including representatives from the relevant functional areas, to attend and participate in any meetings and briefings with a Regulatory Authority in the Territory relating to the Zymeworks Ongoing Studies; provided that attendance and participation by a representative of Jazz is permitted by the applicable Regulatory Authority and the attendance of a representative of Jazz [***]. In addition, Zymeworks shall provide to Jazz all material Regulatory Submissions (including any certified English translations) prepared by or on behalf of the Ex-Territory Partner with respect to the Zymeworks Ongoing Studies or the Licensed Product in the Ex-Territory within [***] after receipt of such Regulatory Submission by Zymeworks, and to the extent that Zymeworks has access and the right to share with Jazz, all material correspondence or communication, as well as minutes of any material meetings, telephone conferences or discussions, between the Ex-Territory Partner and any Regulatory Authority in the Ex-Territory with respect to any Licensed Product and shall provide to the Ex-Territory Partner, for consideration, any reasonable comments received from Jazz with respect thereto.
Review of Regulatory Submissions. Zai shall provide to TPTX for review and comment drafts of all Regulatory Submissions in the Territory for the Products no later than [***] days prior to the planned submission. Zai shall incorporate any comments received from TPTX on such Regulatory Submissions where required under any Applicable Laws and shall consider in good faith any other comments received from TPTX on such Regulatory Submissions. In addition, Zai shall notify 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 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 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.
Review of Regulatory Submissions. Partner will provide to Kiniksa (through the JDC) for each of [***] (each a “Key Country”), and for each other country and region in the Territory upon Kiniksa’s request, in each case, for review and comment, drafts of all Regulatory Submissions for which Partner is responsible and all proposed Approved Labeling in the Territory for the Licensed Product, including all INDs and XXXx for the Licensed Product in each Indication in each Key Country and, to the extent requested by Kiniksa for each other country or region in the Territory, and Partner will incorporate any reasonable comments received from Kiniksa on such drafts. The JDC will review any changes in regulatory strategy and, to the extent requested by Kiniksa, will discuss any Regulatory Submission for which Partner is responsible and all proposed Approved Labeling for the Licensed Product in each Key Country and, to the extent requested by Kiniksa for each other country or region in the Territory. Partner will incorporate any reasonable comments received from Kiniksa on such proposed Approved Labeling. Notwithstanding the foregoing, if any regulatory activities are conducted, or any Regulatory Submissions filed, in each case, in Kiniksa’s name, then (a) Kiniksa will have final decision-making authority regarding all such regulatory activities, including the content of Regulatory Submissions for the Licensed Product in the Field in the Territory; provided that Kiniksa will reasonably consider any comments Partner may have regarding such regulatory activities; and (b) Partner will, and will ensure that its relevant Affiliates and Sublicensees will, conduct all regulatory activities in compliance with Kiniksa’s final decisions. In addition, each Party will notify the other Party of any substantive Regulatory Submissions in the U.S. or in any country or region the Territory and proposed Approved Labeling for the Licensed Product and any comments or other substantive correspondences related thereto submitted to or received from any Regulatory Authority in the U.S. or in any country or region in the Territory and will provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [***] days after submission or receipt thereof (or such longer time period as may be necessary to obtain translations thereof). If any such Regulatory Submission or proposed Approved Labeling, comment, or correspondence is not in English, then Kiniksa may obtain English translation th...
Review of Regulatory Submissions. Ionis may (but, for clarity, is not required to) provide drafts of any INDs or other Regulatory Submissions for the Licensed Products to Metagenomi prior to submission to the applicable Regulatory Authority for Metagenomi to review and provide comments. Metagenomi will use Commercially Reasonable Efforts to review and provide any such requested comments in a timely manner and the costs of such support will be reimbursed in accordance with Section 3.4.4 (Costs of Support). Article 8 Manufacturing
Review of Regulatory Submissions. Each Party shall provide to Deciphera for review and comment drafts of all Regulatory Submissions in the Territory for the Licensed Products no later than [***] prior to the planned submission. Each Party shall incorporate any comments received from the other Party on such Regulatory Submissions where required under any Applicable Law and shall consider in good faith any other comments received from the other Party on such Regulatory Submissions. In addition, each Party shall notify the other Party of any material Regulatory Submissions for the Licensed 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 such other Party with copies thereof as soon as reasonably practicable, but in all events within [***] after submission or receipt thereof. If any such Regulatory Submission, comment, or correspondence is not in English, then, at the other Party’s request and expense, the Party providing such copies shall also provide the other Party with a written English translation within the corresponding timelines as set forth in this ARTICLE 6.
Review of Regulatory Submissions. Zai shall provide to Karuna for review and comment drafts of all material Regulatory Submissions (including application for HGR Approvals) in Field in the Licensed Territory for the Licensed Product no later than [***] prior to the planned submission, provided that, [***]. Zai shall incorporate any comments received from Karuna on such Regulatory Submissions where required under any Applicable Laws and shall use good faith efforts to incorporate any other comments received from Karuna on such Regulatory Submissions; provided that in the event of any disagreement regarding incorporation of comments made by Karuna with respect to the contents of any substantive proposals or Regulatory Submission for the Licensed Product in the Licensed Territory or any written correspondence with any Regulatory Authority for the Licensed Product in the Licensed Territory, the Parties shall discuss, through the JSC, such disagreements in good faith. In addition, Xxx shall notify Karuna of any material Regulatory Submissions for the Licensed Product and any other material documents, comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Licensed Territory and shall provide Karuna with copies thereof as soon as reasonably practicable, but in all events within [***] after submission or receipt thereof [***].
Review of Regulatory Submissions. Tautomer shall provide to Skye for review and comment English language drafts of all Regulatory Materials in the Territory for the Licensed Products no later than fifteen (15) days prior to the planned submission. Tautomer shall consider in good faith any comments received from Skye on such Regulatory Materials. In addition, Xxxxxxxx shall notify Skye of any material Regulatory Materials for the Licensed Products filed with or received from any Regulatory Authority 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 Tautomer with copies thereof as soon as reasonably practicable, but in all events within five (5) Business Days after submission or receipt thereof.
Review of Regulatory Submissions. 4.12.2.1 Copies of all material submissions (including NDAs and applications for marketing approval) to the FDA, EMEA and other Regulatory Authorities in seeking Regulatory Approval of the Licensed Products for the Field and replies thereto, and, to the extent reasonably practicable, all other material correspondence with a Regulatory Authority, EMEA and other Governmental Authorities covering the Compound and the Licensed Products shall be provided by the submitting Party to the other Party promptly upon draft completion, but in no event less than *** (***) days before being submitted or sent, during which time such other Party shall have a reasonable opportunity to review such submissions or correspondence and consult with the submitting Party with respect thereto. Information provided under this provision shall include, but not be limited to: • Clinical reports of pivotal studies; • Overviews; • Pre-clinical and clinical summaries; • CMC Module 3 files of the NDA; • Quality overview Module 2 of the NDA; and • Draft labeling.
Review of Regulatory Submissions. (i) Avimex will provide Novavax with advance copies of any substantive Regulatory Submissions made by Avimex in the Territory reasonably in advance of submission to a Regulatory Authority (and in any event no less than 10 days in advance) and will provide Novavax a meaningful opportunity to comment or to make suggestions, and Avimex will not unreasonably reject comments or suggestions from Novavax. Avimex acknowledges that Novavax may share such Regulatory Submissions with Third Party Licensees and seek input from same. Avimex will not submit any Regulatory Submissions in any Territory unless Avimex has complied with this Section 4.1(b)(i) with respect to such Regulatory Submissions and has received written consent of Novavax to such Regulatory Submissions.
