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. (a) BeiGene shall provide to AssemblyBio all Regulatory Submissions (including certified English translations thereof) prepared by or on behalf of BeiGene at least [* * *] prior to submission and shall consider in good faith any reasonable comments received from AssemblyBio with respect thereto. AssemblyBio shall provide BeiGene with copies of all Clinical Trial Applications for the Licensed ABI-H0731 Products in the Territory (including certified English translations thereof) prepared by or on behalf of AssemblyBio.
(b) In addition, each Party shall notify the other Party of any comments or other material correspondence regarding any Regulatory Submissions that are received from any Regulatory Authority in the Territory or, with respect to Clinical Trials conducted pursuant to the Global Development Plan, outside the Territory, and shall provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [* * *] of receipt (or such longer time period as may be necessary to obtain translations thereof). Each Party will provide quarterly updates, at each JDC meeting, regarding its activities and progress with respect to all Clinical Trials conducted pursuant to the Global Development Plan or the Territory Development Plan.
(c) Each Party shall keep the other Party reasonably informed of regulatory developments related to Licensed Products in the Field in the Territory and outside the Territory of which it becomes aware and shall promptly notify the other Party in writing of any material decision by any Regulatory Authority in the Field, in the Territory and outside the Territory, of which it becomes aware regarding any Licensed Product.
(d) Each Party shall provide the other Party with notice no later than [* * *] after receiving notice of any material meeting or substantive communication with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Each Party shall provide the other Party with a written summary of each such meeting or substantive communication in English promptly following such meeting or discussion. AssemblyBio or its designee will have the right, but not the obligation, to attend and observe any such meeting or discussion with Regulatory Authorities in the Territory unless prohibited or restricted by Applicable Law or the Regulatory Authorities; provided that BeiGene shall not be obligated to schedule such meetings to specifically enable AssemblyBio’s or its designee’s at...
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.
(b) Zymeworks shall prepare the first Biologics License Application for Regulatory Approval for the Licensed Product for submission to the FDA (the “First BLA”), in accordance with the Zymeworks Development Plan (including the budget identified therei...
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
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 ther...
Review of Regulatory Submissions. CStone will provide to Blueprint for review and comment drafts of all Regulatory Submissions in the Territory for the Collaboration Products, other than the pre-IND meeting request referred to in Section 5.1.4(a) (BLU-554 Monotherapy Clinical Trials). CStone will incorporate any comments received from Blueprint on such Regulatory Submissions where required under Applicable Law and will consider [***] and incorporate [***] any other comments received from Blueprint on such Regulatory Submissions. In addition, each Party will notify the other Party of any Regulatory Submissions for the Collaboration Products and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and will provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [***] after submission or receipt thereof (or such longer time period as may be necessary to obtain translations thereof). If any such Regulatory Submission, comment, or correspondence is not in English, then CStone will also provide Blueprint with a certified English translation as soon as practicable after receipt of such Regulatory Submission, comment, or correspondence[***]. Blueprint will have the right to review and comment on all such Regulatory Submissions, and CStone will [***] and incorporate such comments [***].
Review of Regulatory Submissions. Except to the extent prohibited by Applicable Law, each Party will provide to the other Party for review and comment drafts of all Regulatory Submissions in its respective territory (i.e. the TPTX Territory or the LaNova Territory, as applicable) for the Product no later than [***] days prior to the planned submission. Such Party will respond to the other Party within [***] days and shall incorporate any comments received from the other Party on such Regulatory Submissions and will consider in good faith any comments received from such other Party on such Regulatory Submissions. In addition, each Party will notify the other Party of any material Regulatory Submissions for the Product related thereto submitted to or received from any Regulatory Authority in its respective territory (i.e. the TPTX Territory or the LaNova Territory, as applicable) and will provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment, or correspondence is not in English, then, in addition to a copy thereof in its original language, (a) each Party will also provide the other Party with an English summary thereof within the corresponding timelines as set forth in this Article 6 at its cost; and (b) upon the other Party’s reasonable request, provide such other Party with an English translation thereof at its cost.
Review of Regulatory Submissions. Partner will provide to ImmunoGen (through the JDC) for review and comment, drafts of all INDs and XXXx for which Partner is responsible and all proposed Approved Labeling in each country or region in the Territory for each Licensed Product in each Indication, and Partner will incorporate [***]. The JDC will review any changes in regulatory strategy and, to the extent requested by ImmunoGen, will discuss any Regulatory Submission for which Partner is responsible and all proposed Approved Labeling in each country or region in the Territory for each Licensed Product. Partner will incorporate [***]. All INDs, XXXx, Approved Labeling, and other Regulatory Submissions for the Licensed Products in the Territory will be consistent with the then-current regulatory strategy. In addition, each Party will notify the other Party of any substantive Regulatory Submissions in the U.S. or in any country or region in the Territory and proposed Approved Labeling for each 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 [***] in all events within [***] after submission or receipt thereof (or such longer time period as may be necessary to obtain translations thereof).
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.
(ii) Novavax will keep Avimex reasonably informed as to the clinical development of the Influenza Vaccine outside of the Territory. In the event that any clinical trial results are not satisfactory and therefore would not support Regulatory Approval in the Territory, then Avimex and Novavax will discuss and agree whether clinical development should continue in the Territory and/or whether any clinical development plans should be amended or terminated.
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 [***].
