Obtaining and Maintaining Regulatory Approvals. Through its reports submitted to the JDC, Partner will keep Kiniksa informed of regulatory developments related to the Licensed Product in each country and region in the Territory and will promptly notify Kiniksa in writing of any decision by any Regulatory Authority in the Territory regarding the Licensed Product. Subject to this Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals), for each Indication that is included in the Territory Development Plan or Global Development Plan for the Licensed Product, Partner will be the marketing authorization holder and will be responsible for all regulatory activities leading up to and including obtaining, and thereafter maintaining, Regulatory Approvals and any Reimbursement Approvals in all countries and regions of the Territory, in its own name or in the name of its Affiliate, Sublicensee, or Third Party Distributor. If it is not feasible for Partner to own any such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals in its own name according to the relevant Applicable Laws in the Territory, then (a) Kiniksa will hold such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals in its own name for the benefit of and on behalf of Partner (in such case, Kiniksa will be the “Marketing Authorization Holder”, which means the Party in whose name the Regulatory Approvals and Reimbursement Approvals for the Licensed Product in the Territory are held) and will appoint Partner as its legal agent in the Territory; (b) without the prior written consent of Kiniksa, Partner will not conduct any activities or initiate any procedures that would affect the validity or change the information of such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals; (c) Kiniksa will reasonably cooperate with Partner and execute such documents and make such submissions on behalf of Partner as may be reasonably necessary or to the extent Kiniksa is required to do so as owner of such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals under Applicable Law in the Territory; provided that Kiniksa will assume no liability as a result of being the Marketing Authorization Holder or otherwise holding such Regulatory Submissions (unless Kiniksa is grossly negligent or willfully breaches its obligations as the Marketing Authorization Holder), Regulatory Approvals, or Reimbursement Approvals on behalf of Partner; (d) Partner will reimburse Kiniksa for Kiniksa’s costs and expenses incurred in its acting as Marketing Authorization Holder within [***] days after the date of any invoice from Kiniksa for any such costs or expenses; and (e) when feasible pursuant to Applicable Law, Kiniksa will conduct activities and execute documents that are necessary for transferring such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals to Partner upon Partner’s written request.
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Sources: Collaboration and License Agreement (Kiniksa Pharmaceuticals, Ltd.)
Obtaining and Maintaining Regulatory Approvals. Through its reports submitted to the JDC, Partner Each Party will keep Kiniksa the other Party informed of regulatory developments related to the Licensed Product Products in each country and region in the Territory and will promptly notify Kiniksa the other Party in writing of any decision by any Regulatory Authority in the Territory regarding the any Licensed Product.
(a) In the PRC. Subject Prior to this Section 6.2.1 (Obtaining [****], Zai or one of its Affiliates will be responsible for undertaking all regulatory activities and Maintaining interactions with Regulatory Approvals), Authorities in the PRC for each Indication that is included such Licensed Product in Blueprint’s name as the express and authorized regulatory agent of record for Blueprint in the Territory Development Plan or Global Development Plan and will take such actions on behalf of and for the benefit of Blueprint in the PRC in accordance with the applicable regulatory strategy approved by the JSC (including performing any and all regulatory activities assigned to Zai in this Agreement or by the JSC during the Term in connection with the Development or Commercialization of a Licensed Product, Partner will be Product in the marketing authorization holder and Territory). Following [****] Zai or one of its Affiliates will be responsible for all regulatory activities and interactions with Regulatory Authorities in the PRC leading up to and including obtaining, obtaining (to the extent not already obtained) and thereafter maintaining, Local Manufacturing Approvals, Regulatory Approvals Approvals, and any Reimbursement Approvals Approvals, as applicable, for such Licensed Product in all countries and regions of the Territory, PRC in Zai’s or its Affiliate’s own name or in accordance with the name of its Affiliate, Sublicensee, or Third Party Distributorapplicable regulatory strategy approved by the JSC. If it is not feasible for Partner Prior to own undertaking any such Regulatory Submissionsactivities and interactions relating to obtaining and maintaining Local Manufacturing Approvals, Regulatory Approvals, or Reimbursement Approvals for any Licensed Product in its own name according the PRC, whether prior to or after [****] for the applicable Licensed Product, ▇▇▇ will submit a [****] plan for undertaking the same to the relevant Applicable Laws JSC for review and discussion. Following [****] Zai or one of its Affiliates will continue to be responsible for all regulatory activities and interactions with Regulatory Authorities in the Territory, then (a) Kiniksa PRC with respect to any imported version of such Licensed Product as the express and authorized regulatory agent of record for Blueprint in the PRC and will hold continue to take such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals in its own name actions with respect to the imported Licensed Product on behalf of and for the benefit of and on behalf of Partner (in such case, Kiniksa will be the “Marketing Authorization Holder”, which means the Party in whose name the Regulatory Approvals and Reimbursement Approvals for the Licensed Product Blueprint in the Territory are held) and will appoint Partner as its legal agent PRC in accordance with the Territory; (b) without applicable regulatory strategy approved by the prior written consent of Kiniksa, Partner will not conduct any activities or initiate any procedures that would affect the validity or change the information of such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals; (c) Kiniksa will reasonably cooperate with Partner and execute such documents and make such submissions on behalf of Partner as may be reasonably necessary or to the extent Kiniksa is required to do so as owner of such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals under Applicable Law in the Territory; provided that Kiniksa will assume no liability as a result of being the Marketing Authorization Holder or otherwise holding such Regulatory Submissions (unless Kiniksa is grossly negligent or willfully breaches its obligations as the Marketing Authorization Holder), Regulatory Approvals, or Reimbursement Approvals on behalf of Partner; (d) Partner will reimburse Kiniksa for Kiniksa’s costs and expenses incurred in its acting as Marketing Authorization Holder within [***] days after the date of any invoice from Kiniksa for any such costs or expenses; and (e) when feasible pursuant to Applicable Law, Kiniksa will conduct activities and execute documents that are necessary for transferring such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals to Partner upon Partner’s written requestJSC.
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