Common use of Lead Regulatory Party Clause in Contracts

Lead Regulatory Party. The Parties intend that each Development Plan shall set forth the regulatory strategy approved by the JSC for the applicable Collaboration Product. The JSC shall select the Lead Regulatory Party for each Collaboration Product, provided that Trubion shall be the initial Lead Regulatory Party for TRU-016 in the United States and the JSC may change the Lead Regulatory Party for any Collaboration Product at any time. The Lead Regulatory Party shall be responsible for the implementation of such strategy in the applicable country. The Lead Regulatory Party shall comply with applicable Laws and other regulatory obligations related to the submission and maintenance of any Regulatory Materials for Regulatory Approval of a Collaboration Product, in the Field, in the applicable country(ies) of the Territory. The Party that is not the Lead Regulatory Party shall have a participatory role in all material regulatory activities that would have a potential impact on Collaboration Products in the relevant country, including all interactions with Regulatory Authorities. All material regulatory decisions (including the content of any regulatory filing or dossier, pharmacovigilance reports, patient risk management strategies and plans, Product Labeling and safety) will be made by the JSC and implemented by the Lead Regulatory Party. Notwithstanding any other provision of this Agreement, the decision to [ * ] any [ * ] for a [ * ] must be the result of consensus by the JSC or, in the event that the JSC is unable to reach consensus with respect to such a [ * ] decision [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. and the matter is submitted to the Parties’ Executive Officers pursuant to Section 2.7(b), the unanimous agreement of the Executive Officers pursuant to Section 2.7(c) to [ * ] such [ * ]. If the Executive Officers are unable to reach consensus on any such matter within the applicable [ * ] period, then the JSC will be deemed to have decided not to [ * ] such [ * ]. In no event will a dispute regarding whether to [ * ] a [ * ] for a [ * ] be resolved through arbitration under Article 15.

Lead Regulatory Party. The Parties intend that each Development Plan shall set forth the regulatory strategy approved by the JSC for the applicable Collaboration Product. The JSC shall select the Lead Regulatory Party for each Collaboration Product, provided that Trubion shall be the initial Lead Regulatory Party for TRU-016 in the United States and the JSC may change the Lead Regulatory Party for any Collaboration Product at any time. The Lead Regulatory Party shall be responsible for the implementation of such strategy in the applicable country. The Lead Regulatory Party shall comply with applicable Laws and other regulatory obligations related to the submission and maintenance of any Regulatory Materials for Regulatory Approval of a Collaboration Product, in the Field, in the applicable country(ies) of the Territory. The Party that is not the Lead Regulatory Party shall have a participatory role in all material regulatory activities that would have a potential impact on Collaboration Products in the relevant country, including all interactions with Regulatory Authorities. All material regulatory decisions (including the content of any regulatory filing or dossier, pharmacovigilance reports, patient risk management strategies and plans, Product Labeling and safety) will be made by the JSC and implemented by the Lead Regulatory Party. Notwithstanding any other provision of this Agreement, the decision to [ * ] any [ * ] for a [ * [*] must be the result of consensus by the JSC or, in the event that the JSC is unable to reach consensus with respect to such a [ * [*] decision [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. and the matter is submitted to the Parties’ Executive Officers pursuant to Section 2.7(b), the unanimous agreement of the Executive Officers pursuant to Section 2.7(c) to [ * ] such [ * [*]. If the Executive Officers are unable to reach consensus on any such matter within the applicable [ * [*] period, then the JSC will be deemed to have decided not to [ * ] such [ * [*]. In no event will a dispute regarding whether to [ * ] a [ * ] for a [ * [*] be resolved through arbitration under Article 15.

Lead Regulatory Party. (a) The Parties intend that each regulatory strategy for the Licensed Product in the Territory shall be governed by the applicable portion of the Development Plan related to regulatory matters (the “Regulatory Plan”). The Regulatory Plan shall set forth the regulatory strategy approved only be amended upon approval by the JSC JSC. The Lead Regulatory Party with respect to a given country in the Territory shall be responsible for, and shall use Commercially Reasonable Efforts to, conduct the activities pursuant to the Regulatory Plan for the applicable Collaboration Product. Licensed Product in such country, which shall include the Parties’ plan for filing XXXx for the applicable Licensed Product in such country, including any supplements and amendments thereto. (b) The JSC shall select the Lead Regulatory Party for each Collaboration Product, provided that Trubion shall be the initial Lead Regulatory Party for TRU-016 in the United States and the JSC may change the Lead Regulatory Party for any Collaboration Product at any time. The applicable Lead Regulatory Party shall be responsible for taking the implementation lead with all interactions with Regulatory Authorities (meetings, telephone, etc.) in a given country in the Territory and for other regulatory matters related to the Licensed Product in such country in the Territory [ * ]. To the extent permitted by the applicable Regulatory Authority and Applicable Law, the non-Lead Regulatory Party shall be entitled to have [ * ] to the [ * ] with [ * ] in the [ * ] for the Licensed Product and (ii)] to the extent [ * ] for the [ * ] (and in each case, [ * ], the Lead Regulatory Party shall provide notice to the other Party sufficiently in advance of any such meeting or interaction unless such advance notice is not possible due to the urgency of the situation, in which case the Lead Regulatory Party shall inform the other Party of the content of such strategy a meeting as soon as reasonably possible after the meeting has taken place). (c) Subject to Section 5.5.1(b) with respect to the Core Data Sheet, the Lead Regulatory Party for a country shall also be responsible for preparing all Regulatory Documentation for the applicable Licensed Product in such country in the Territory [ * ]. The non- Lead Regulatory Party shall have the right to review and comment upon (which comments shall be made in a timely manner and shall be considered in good faith by the Lead Regulatory Party) all material Regulatory Documentation for the Licensed Product in the Territory (which material Regulatory Documentation shall be provided by the Lead Regulatory Party to the other Party -68- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED (d) The Lead Regulatory Party for a country in the Territory shall also be responsible, in accordance with this Agreement, for submitting and thereafter maintaining (including all routine maintenance) all (subject to Section 5.5.3) investigational study applications (including INDs) and all registration dossiers (including XXXx) and all Marketing Authorizations related to the applicable Licensed Product in such country in the Territory (including with respect to Pricing Approvals and health technology assessments for the Licensed Product, as applicable), and all such INDs, XXXx and Marketing Authorizations (including with respect to Pricing Approvals and health technology assessments for the Licensed Product, as applicable) shall be in the name of the Lead Regulatory Party (or its Affiliate or sublicensee, or if required under Applicable Law in a given country, a local Distributor). The Lead Regulatory Party shall comply not withdraw (and shall cause its Affiliates not to withdraw) any Marketing Authorization for the Licensed Product in the Territory without the prior consent of the JSC. (e) The Lead Regulatory Party for a country in the Territory shall also be responsible, in accordance with applicable Laws this Agreement, for activities to support the registration of the Licensed Product, including post-marketing surveillance programs, in accordance with the Development Plan. (f) With respect to Pricing Approvals and other regulatory obligations related health technology assessments for the Licensed Product, the following shall apply to the submission extent permitted by Applicable Law and maintenance of any Regulatory Materials for Regulatory Approval of a Collaboration Product, in the Field, in the applicable country(iesRegulatory Authority: (i) of the Territory. The Party that is not the Lead Regulatory Party shall have a participatory role in all material regulatory activities that would have a potential impact on Collaboration Products in seek to obtain Pricing Approvals for the relevant country, including all interactions with Licensed Product from the applicable Regulatory Authorities. All material regulatory decisions (including the content of any regulatory filing or dossier, pharmacovigilance reports[ * ]; provided, patient risk management strategies and planshowever, Product Labeling and safety) will be made by the JSC and implemented by the Lead Regulatory Party. Notwithstanding any other provision of this Agreement, the decision to that [ * ] any [ * ] for a [ * ] must be the result of consensus by the JSC or, in the event that the JSC is unable to reach consensus with respect to such a [ * ] decision then, before doing so[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. and the matter is submitted to the Parties’ Executive Officers pursuant to Section 2.7(b), the unanimous agreement of the Executive Officers pursuant to Section 2.7(c) to shall [ * ] such and shall [ * ] with respect thereto, however, [ * ]. If the Executive Officers are unable to reach consensus on any such matter within the applicable [ * ] period, then the JSC will be deemed to have decided not to [ * ] such [ * ]. In no event will a dispute regarding whether to [ * ] a [ * ] for a [ * ] be resolved through arbitration under Article 15.

Lead Regulatory Party. The Parties intend that each Development Plan shall set forth the regulatory strategy approved by the JSC for the applicable Collaboration Product. The JSC shall select the Lead Regulatory Party for each Collaboration Product, provided that Trubion shall be the initial Lead Regulatory Party for TRU-016 in the United States and the JSC may change the Lead Regulatory Party for any Collaboration Product at any time. The Lead Regulatory Party shall be responsible for the implementation of such strategy in the applicable country. The Lead Regulatory Party shall comply with applicable Laws and other regulatory obligations related to the submission and maintenance of any Regulatory Materials for Regulatory Approval of a Collaboration Product, in the Field, in the applicable country(ies) of the Territory. The Party that is not the Lead Regulatory Party shall have a participatory role in all material regulatory activities that would have a potential impact on Collaboration Products in the relevant country, including all interactions with Regulatory Authorities. All material regulatory decisions (including the content of any regulatory filing or dossier, pharmacovigilance reports, patient risk management strategies and plans, Product Labeling and safety) will be made by the JSC and implemented by the Lead Regulatory Party. Notwithstanding any other provision of this Agreement, the decision to [ * ] any [ * ] for a [ * ] must be the result of consensus by the JSC or, in the event that the JSC is unable to reach consensus with respect to such a [ * ] decision [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. and the matter is submitted to the Parties’ Executive Officers pursuant to Section 2.7(b), the unanimous agreement of the Executive Officers pursuant to Section 2.7(c) to [ * ] such [ * ]. If the Executive Officers are unable to reach consensus on any such matter within the applicable [ * ] period, then the JSC will be deemed to have decided not to [ * ] such [ * ]. In no event will a dispute regarding whether to [ * ] a [ * ] for a [ * ] be resolved through arbitration under Article 15.