Common use of Zai’s Responsibilities Clause in Contracts

Zai’s Responsibilities. Zai shall be responsible for (a) all regulatory activities leading up to and including the obtaining of the Regulatory Approval for a Product from the Regulatory Authority on a Region-by-Region basis in the Territory, at its sole cost and expense, except as set forth in the Global Development Plan and Development Plan; and (b) hold and maintain all Regulatory Approvals for a Product in the Territory, in each case, in the name of ▇▇▇▇▇▇▇▇. Subject to the terms and conditions of this Agreement, ▇▇▇▇▇▇▇▇ shall appoint and hereby appoints Zai as its sole Authorized Regulatory Agent to handle all activities with respect to filing for, obtaining and maintaining any Regulatory Approval or product registration for the Product in the Territory and Zai shall use Commercially Reasonable Efforts to obtain Regulatory Approvals and pricing and reimbursement approvals (if applicable) for Products in the Territory in accordance with the Development Plan and Zai shall be solely responsible for all costs and expenses incurred in connection with performing such activities in the Territory; provided that ▇▇▇▇▇▇▇▇ shall promptly transfer all Regulatory Approvals and Regulatory Submissions to Zai or its designee when Applicable Laws in the Territory allows Zai to hold such Regulatory Approvals and Regulatory Submissions for the Product in the Territory at Zai’s cost. During any period when ▇▇▇▇▇▇▇▇ holds such Regulatory Approval and Regulatory Submissions for Zai’s benefit, (i) ▇▇▇▇▇▇▇▇ shall not be obligated to perform any activities, bear any obligations, or bear any costs, in each case, in addition to the activities set forth in this Agreement due to ▇▇▇▇▇▇▇▇ or its Affiliate holding such Regulatory Approval and Regulatory Submissions; (ii) ▇▇▇▇▇▇▇▇ shall not assume any liability in connection with ▇▇▇▇▇▇▇▇ holding such Regulatory Approval and Regulatory Submissions; (iii) should ▇▇▇▇▇▇▇▇ or its Affiliates incur any costs or expenses related to holding or transferring any such Regulatory Approval and Regulatory Submissions, Zai shall reimburse ▇▇▇▇▇▇▇▇ or its Affiliates for any and all costs and expenses incurred by ▇▇▇▇▇▇▇▇ or its Affiliates in holding or transferring such Regulatory Approval and Regulatory Submissions; and (iv) Zai shall indemnify and hold ▇▇▇▇▇▇▇▇ Indemnitees (as defined herein) from and against all Losses to the extent arising from ▇▇▇▇▇▇▇▇ holding such Regulatory Approval and Regulatory Submissions in the Territory as set forth in ARTICLE 12. Zai shall keep ▇▇▇▇▇▇▇▇ promptly informed (and in any event within forty-eight (48) hours for any significant matter) of regulatory developments related to the Products in the Territory and shall promptly notify ▇▇▇▇▇▇▇▇ in writing of any decision by any Regulatory Authority in the Territory regarding a Product.

Zai’s Responsibilities. (a) Zai shall be responsible responsible, at its sole cost and expense, for (a) all regulatory activities leading up to and including the obtaining of the Regulatory Approval Approvals and any pricing or reimbursement approvals, as applicable, for a Product Licensed Products from the Regulatory Authority on a Region-by-Region basis Authorities in the Territory, at its sole cost provided that, Zai shall conduct such regulatory activities (and expense, except as set forth any and all regulatory activities delegated to Zai in this Agreement or by Five Prime during the Global Term in connection with the Development Plan and Development Plan; and (b) hold and maintain all Regulatory Approvals for a Product in Commercialization of the Territory, in each case, in the name of ▇▇▇▇▇▇▇▇. Subject to the terms and conditions of this Agreement, ▇▇▇▇▇▇▇▇ shall appoint and hereby appoints Zai as its sole Authorized Regulatory Agent to handle all activities with respect to filing for, obtaining and maintaining any Regulatory Approval or product registration for the Licensed Product in the Territory and Zai shall use Commercially Reasonable Efforts to obtain Regulatory Approvals and pricing and reimbursement approvals (if applicable) for Products in during such time that Five Prime is the Territory in accordance with the Development Plan and Zai shall be solely responsible for all costs and expenses incurred in connection with performing such activities in the Territory; provided that ▇▇▇▇▇▇▇▇ shall promptly transfer all Regulatory Approvals and Regulatory Submissions to Zai or its designee when Applicable Laws in the Territory allows Zai to hold such holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory at Zai’s costTerritory) as the express and authorized regulatory agent of record for Five Prime in the Territory, and provided further, that such actions shall be taken on behalf of Five Prime and for the benefit of Zai in the Territory. During any period when ▇▇▇▇▇▇▇▇ holds such Regulatory Approval and Regulatory Submissions for Zai’s benefitNotwithstanding the foregoing, (i) ▇▇▇▇▇▇▇▇ shall not be obligated to perform any activities, bear any obligations, or bear any costs, in each case, in addition to the activities set forth in this Agreement due to ▇▇▇▇▇▇▇▇ or its Affiliate holding such Regulatory Approval extent permitted under Applicable Law, Zai may file and Regulatory Submissions; (ii) ▇▇▇▇▇▇▇▇ shall not assume any liability in connection with ▇▇▇▇▇▇▇▇ holding such Regulatory Approval and Regulatory Submissions; (iii) should ▇▇▇▇▇▇▇▇ or its Affiliates incur any costs or expenses related to holding or transferring any such Regulatory Approval and hold Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory; provided that, Zai undertakes any such activities in compliance with this Agreement to the same extent as if Zai were acting as Five Prime’s authorized regulatory agent under this Agreement and, prior to taking any such activities, Zai shall reimburse ▇▇▇▇▇▇▇▇ or its Affiliates submit a reasonably detailed plan for any and all costs and expenses incurred by ▇▇▇▇▇▇▇▇ or its Affiliates in holding or transferring such Regulatory Approval and Regulatory Submissions; and (iv) Zai shall indemnify and hold ▇▇▇▇▇▇▇▇ Indemnitees (as defined herein) from and against all Losses undertaking the same to the extent arising from ▇▇▇▇▇▇▇▇ holding such Regulatory Approval JSC for review and Regulatory Submissions in the Territory as set forth in ARTICLE 12discussion. Zai Each Party shall keep ▇▇▇▇▇▇▇▇ promptly the other Party informed (and in any event within forty-eight (48) hours for any significant matter) of regulatory developments related to the Licensed Products in the Territory and shall promptly notify ▇▇▇▇▇▇▇▇ the other Party in writing of any decision by any Regulatory Authority in the Territory regarding a any Licensed Product. (b) Zai shall provide to Five Prime for review and comment drafts of all Regulatory Submissions, including certified English translations thereof if requested by Five Prime, [***] and shall consider in good faith any comments received from Five Prime and incorporate such comments where required by Applicable Law. In addition, each Party shall notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [***] after submission or receipt. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also provide Five Prime with a certified English translation [***]; provided, that Zai shall provide Five Prime with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission [***]. Five Prime shall have the right to review and comment on such Regulatory Submissions and Zai shall take such comments into consideration and incorporate such comments where appropriate. (c) Each Party shall provide the other Party 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. Zai shall lead any such meeting or discussion, provided, however, that Five Prime or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If Five Prime elects not to attend such meeting or discussion, Zai shall provide Five Prime with a written summary thereof in English promptly following such meeting or discussion.