Common use of Review of Regulatory Submissions Clause in Contracts

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 therein) and at Jazz’s cost and expense as specified in Section 9.2, subject to successful completion of the applicable Zymeworks Ongoing Studies. Zymeworks will provide Jazz with each draft of the First BLA for Jazz’s review and comment, which drafts shall include, [***]. Zymeworks shall incorporate all comments from Jazz with respect to the First BLA, and upon Jazz’s final approval and instructions, submit the First BLA to the FDA. Zymeworks shall notify Jazz of any correspondence from and meetings with the FDA regarding the First BLA in accordance with the terms of this Section 6.2. Zymeworks shall provide Jazz with copies of proposed responses to such correspondence at least [***] prior to submission (or such shorter time period required for timely response to the FDA), Zymeworks shall incorporate all comments from Jazz with respect to such responses. Following Regulatory Approval of the First BLA or earlier upon ▇▇▇▇’s written request, Zymeworks will promptly transfer the First BLA to Jazz. The foregoing preparation and transfer of the First BLA shall be completed in accordance with the timeline set forth in the Zymeworks Development Plan. Jazz will cooperate in good faith with, and provide reasonable assistance to, Zymeworks in Zymeworks’ preparation of the First BLA, at Zymeworks’ request and ▇▇▇▇’s expense. Zymeworks will cooperate in good faith with, and provide reasonable assistance to, Jazz in Jazz’s preparation of any other applications for Regulatory Approval that are based on substantially similar Clinical Data as included in the First BLA, at Jazz’s request [***]. (c) In addition, (i) Jazz shall notify Zymeworks of any material correspondence regarding any Regulatory Submissions that are received by Jazz from any Regulatory Authority in the Territory, (ii) Zymeworks shall notify Jazz of any material correspondence regarding any Regulatory Submissions that are received by Zymeworks from a Regulatory Authority or the Ex-Territory Partner with respect to Clinical Trials conducted pursuant to the Zymeworks Development Plan or outside the Territory, and, in each case (i) and (ii) shall provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [***] of receipt. Each Party will provide [***] updates, at each JSC meeting, regarding its material activities and progress with respect to all Clinical Trials conducted or on behalf of the reporting Party or its Affiliates, (with respect to Zymeworks) the Ex-Territory Partner, or (with respect to Jazz) sublicensees. (d) 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 or outside the Territory, of which it becomes aware regarding any Licensed Product. (e) Jazz shall provide Zymeworks with notice no later than [***] after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field, such notice to include a summary of the topic of such meeting or discussion and relevant background. Jazz shall provide Zymeworks with a written summary of each such meeting or discussion (including the outcome and major actions) promptly following such meeting or discussion. Upon Jazz’s reasonable request and notice[***] Zymeworks will attend, or assist Jazz in its preparation for, any meeting or discussion that Jazz has with any Regulatory Authority in the Territory related to any Licensed Product in the Field. (f) Zymeworks will provide Jazz with reasonable advance notice [***] of all substantive meetings pertaining to each Licensed Product with a Regulatory Authority outside of the Territory of which Zymeworks becomes aware through use of reasonable efforts. Zymeworks will use reasonable efforts to obtain the right to permit Jazz to have[***] mutually acceptable representative of Jazz attend, solely as a non-participating observer, key substantive meetings pertaining to such Licensed Product with any Regulatory Authorities outside of the Territory.

Review of Regulatory Submissions. (a) Zymeworks Jazz shall provide to Jazz Zymeworks (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 Jazz 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 Jazz 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 representative of Jazz, including representatives from the relevant functional areas, Zymeworks 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 Zymeworks is permitted by the applicable Regulatory Authority and the attendance of a representative of Jazz Zymeworks [***]. 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 therein) and at Jazz’s cost and expense as specified and in Section 9.2accordance with a budget to be mutually agreed by the Parties [***] after the Amendment Effective Date (such agreement not to be unreasonably withheld, subject to successful completion of the applicable Zymeworks Ongoing Studies. Zymeworks will conditioned or delayed), and provide Jazz with each a complete first draft of the First BLA for Jazz’s review and comment, which drafts shall include, [***]. Zymeworks shall incorporate all comments from Jazz with respect to the First BLAsuch first draft of [***], and upon Jazz’s provide updated drafts to Jazz for further review and comment until Jazz provides final approval and instructions, submit the First BLA to the FDAof [***]. Zymeworks The Parties shall notify Jazz of any correspondence from and meetings with the FDA regarding the First BLA discuss in accordance with the terms of this Section 6.2. Zymeworks shall provide Jazz with copies of proposed responses to such correspondence at least good faith (i) earlier delivery [***] prior to submission of the first draft of [***] and (or such shorter time period required ii) the timing for timely response to the FDA)final draft of [***]. Upon Jazz’s request, and at Jazz’s cost and expense, Zymeworks shall prepare replies to FDA information requests relating to [***] and incorporate all comments from Jazz with respect to regarding such responses. Following Regulatory Approval of the First BLA or earlier upon ▇▇▇▇’s written request, Zymeworks will promptly transfer the First BLA to Jazz. The foregoing preparation and transfer of the First BLA shall be completed in accordance with the timeline set forth in the Zymeworks Development Plan. Jazz will cooperate in good faith with, and provide reasonable assistance to, Zymeworks in Zymeworks’ preparation of the First BLA, at Zymeworks’ request and ▇▇▇▇’s expensereplies. Zymeworks will cooperate in good faith with, and provide reasonable assistance to, Jazz in Jazz’s preparation of all other [***] and any other applications for Regulatory Approval that are based on substantially similar Clinical Data as included in the First BLA, at Jazz’s request [***]. (c) In addition, (i) Jazz shall notify Zymeworks of any material correspondence regarding any Regulatory Submissions that are received by Jazz from any Regulatory Authority in the Territory or outside the Territory, (ii) Zymeworks shall notify Jazz of any material correspondence regarding any Regulatory Submissions that are received by Zymeworks from a Regulatory Authority or the Ex-Territory Partner with respect to Clinical Trials conducted pursuant to the Zymeworks Development Plan or outside the Territory, and, in each case (i) and (ii) shall provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [***] of receipt. Each Party will provide [***] updates, at each JSC meeting, regarding its material activities and progress with respect to all Clinical Trials conducted by or on behalf of the reporting Party or its Affiliates, (with respect to Zymeworks) the Ex-Territory Partner, or (with respect to Jazz) sublicensees. (d) 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 or outside the Territory, of which it becomes aware regarding any Licensed Product. (e) Jazz shall provide Zymeworks with notice no later than [***] after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory or outside the Territory related to any Licensed Product in the Field, such notice to include a summary of the topic of such meeting or discussion and relevant background. Jazz shall provide Zymeworks with a written summary of each such meeting or discussion (including the outcome and major actions) promptly following such meeting or discussion. Upon Jazz’s reasonable request and noticenotice [***] ], Zymeworks will attend, or assist Jazz in its preparation for, any meeting or discussion that Jazz has with any Regulatory Authority in the Territory or outside the Territory related to any Licensed Product in the Field. (f) Zymeworks will provide Jazz with reasonable advance notice [***] of all substantive meetings pertaining to each Licensed Product with a Regulatory Authority outside of the Territory of which Zymeworks becomes aware through use of reasonable efforts. Zymeworks will use reasonable efforts to obtain the right to permit Jazz to havehave [***] mutually acceptable representative of Jazz attend, solely as a non-participating observer, key substantive meetings pertaining to such Licensed Product with any Regulatory Authorities outside of the Territory.