Common use of Zai’s Responsibilities Clause in Contracts

Zai’s Responsibilities. (a) Zai shall be responsible, at its sole cost and expense, for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by Five Prime during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that Five Prime is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) 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. Notwithstanding the foregoing, to the extent permitted under Applicable Law, Zai may file 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 submit a reasonably detailed plan for undertaking the same to the JSC for review and discussion. Each Party shall keep the other Party informed of regulatory developments related to 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 any Licensed Product.

Zai’s Responsibilities. Zai shall be responsible for (a) Zai shall be responsible, at its sole cost and expense, for all regulatory activities leading up to and including the obtaining of the Regulatory Approvals and any pricing or reimbursement approvals, as applicable, Approval for Licensed Products a Product from the Regulatory Authorities Authority on a Region-by-Region basis in the Territory, provided thatat 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 Xxxxxxxx. Subject to the terms and conditions of this Agreement, Xxxxxxxx shall appoint and hereby appoints Zai shall conduct such regulatory as its sole Authorized Regulatory Agent to handle all activities (with respect to filing for, obtaining and maintaining any and all regulatory activities delegated to Zai in this Agreement Regulatory Approval or by Five Prime during product registration for the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during 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 time activities in the Territory; provided that Five Prime is Xxxxxxxx shall promptly transfer all Regulatory Approvals and Regulatory Submissions to Zai or its designee when Applicable Laws in the holder of Territory allows Zai to hold such Regulatory Approvals and Regulatory Submissions for the Licensed Product in the TerritoryTerritory at Zai’s cost. During any period when Xxxxxxxx holds such Regulatory Approval and Regulatory Submissions for Zai’s benefit, (i) Xxxxxxxx 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 Xxxxxxxx or its Affiliate holding such Regulatory Approval and Regulatory Submissions; (ii) Xxxxxxxx shall not assume any liability in connection with Xxxxxxxx holding such Regulatory Approval and Regulatory Submissions; (iii) should Xxxxxxxx or its Affiliates incur any costs or expenses related to holding or transferring any such Regulatory Approval and Regulatory Submissions, Zai shall reimburse Xxxxxxxx or its Affiliates for any and all costs and expenses incurred by Xxxxxxxx or its Affiliates in holding or transferring such Regulatory Approval and Regulatory Submissions; and (iv) Zai shall indemnify and hold Xxxxxxxx Indemnitees (as the express defined herein) from 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. Notwithstanding the foregoing, against all Losses to the extent permitted under Applicable Law, Zai may file arising from Xxxxxxxx holding such Regulatory Approval and hold Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products Submissions in the Territory; provided that, Zai undertakes any such activities Territory as set forth 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, ARTICLE 12. Zai shall submit a reasonably detailed plan keep Xxxxxxxx promptly informed (and in any event within forty-eight (48) hours for undertaking the same to the JSC for review and discussion. Each Party shall keep the other Party informed any significant matter) of regulatory developments related to Licensed the Products in the Territory and shall promptly notify the other Party Xxxxxxxx in writing of any decision by any Regulatory Authority in the Territory regarding any Licensed a Product.