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. Primary regulatory responsibility under this Agreement shall be assigned to one of the Parties (such Party, the “Lead Regulatory Party”) as set forth in this Section 9.1.
Lead Regulatory Party. The lead regulatory Party, on a jurisdiction-by-jurisdiction basis, shall be responsible for preparing and filing all Regulatory Materials, including INDs, shall be the holder of all Regulatory Approvals in such jurisdiction and will have primary operational responsibility for interactions with Regulatory Authorities, including taking the lead role at all meetings with Regulatory Authorities, subject to the right of the other Party to attend such meetings, participate in such activities and provide input, which the lead regulatory Party will consider in good faith. Without limitation, this right of participation covers all regulatory activities, including development of regulatory strategy and review of regulatory submissions, attendance at all meetings with Regulatory Authorities that may potentially impact the Development of or registration package for a particular Product, and review of outcomes of such meetings.
Lead Regulatory Party. In general, XOMA shall be the lead Party for, and have the final say with respect to, subject to Section 2.9, regulatory activities regarding the Product in the Retained Territory for the Remaining Field and, if XOMA exercises the Cardiometabolic Indications Option, for the Cardiometabolic Indications. Servier (or its designee for the Retained Territory) shall be the lead Party for, and have the final say with respect to, subject to Section 2.9, all regulatory activities regarding the Product in the Licensed Territory for all indications and in the Retained Territory for the Cardiometabolic Indications if XOMA does not exercise the Cardiometabolic Indications Option before expiration thereof. Except for those clinical studies commenced prior to the Effective Date and unless otherwise agreed by the Parties, Servier shall be the sponsor of all clinical studies of the Product performed in the Licensed Territory, and XOMA (or its licensee) shall be the sponsor of all clinical studies performed in the Retained Territory; provided that if XOMA does not exercise the Cardiometabolic Indications Option before expiration thereof, Servier’s designee shall be the sponsor of all clinical studies performed in the Retained Territory for the Product in any Cardiometabolic Indication. To the extent a Party for a given clinical trial requires that the other Party conduct some part of such trial or interact with Regulatory Authorities in such other Party’s territory, such other Party will reasonably consider such request and should the latter accept it, it shall be the sponsor of such component of such trial in its territory.
Lead Regulatory Party. Except as otherwise set forth in this Article 4 with respect to INDs, the lead regulatory Party with respect to a Clinical Trial or other regulatory matter shall have operational responsibility for preparing and filing all Regulatory Materials with respect to such Clinical Trial or matter in the applicable jurisdiction(s), and will have primary operational responsibility for interactions with Regulatory Authorities, including taking the lead role at all meetings with Regulatory Authorities, subject to the right of the other Party to participate in such activities and provide input (or consent, as may be required pursuant to the other terms of this Agreement). With respect to regulatory activities conducted in any country in support of Regulatory Approvals for the Shared Territory, the EU, and Japan, the scope of this right of participation covers, without limitation, all regulatory activities, including development of regulatory strategy and advance review of regulatory submissions, attendance at all meetings with Regulatory Authorities that may potentially impact the Development Program or registration package for a particular Product, and review of outcomes of such meetings (including the rights set forth in Section 4.1(c)(ii)). With respect to regulatory activities conducted in any country in support of Regulatory Approvals for any country in the remainder of the Territory, this right of participation provides only the rights set forth in Section 4.1(c)(iii).
Lead Regulatory Party. The lead regulatory Party, on a jurisdiction-by-jurisdiction basis, shall be responsible for preparing and filing all Regulatory Materials, including INDs, shall be the holder of all Regulatory Approvals in such jurisdiction and
Lead Regulatory Party. The JSC shall agree on a strategy to allocate operational responsibility for regulatory activities relating to each Candidate or Product to one of the Parties (the “Lead Regulatory Party”) which shall, as a default initial allocation, be by reference to the country or region where such Party is the Lead Development Party. The JSC’s initial allocation shall be that Lead Regulatory Party for regulatory activities relating to each Candidate or Product in the EU shall be BioNTech, and the Lead Regulatory Party for regulatory activities relating to each Candidate or Product in the USA shall be Pfizer. Subject to the JSC’s mutual consent to seek Regulatory Approval in one or more countries or regions in the ROW, Pfizer shall be the Lead Regulatory Party for regulatory activities relating to each Candidate or Product in such country or region in the ROW. If the JSC cannot agree on whether Regulatory Approval shall be sought for any country or region in the ROW, the Party that wishes to seek Regulatory Approval in such country or region shall be entitled to be the Lead Regulatory Party for regulatory activities relating to each Candidate or Product in such country or region and seek such Regulatory Approval at its own cost. The JSC may vary from the foregoing allocations by mutual consent. The other Party shall cooperate with the Lead Regulatory Party, at its reasonable request, with respect to any regulatory matters for which the Regulatory Approval holder is responsible or to whom regulatory matters have been delegated. Notwithstanding the foregoing, for matters relating to any Vaccine Technical Committee, Price Approval or reimbursement approval in a country, such matters shall be handled by the Party in whose Commercialization Territory such country is located irrespective of whether they are the Lead Regulatory Party.
Lead Regulatory Party. Except as provided in Section 4.1(b)(ii), the lead regulatory Party, on a jurisdiction-by-jurisdiction basis, shall be responsible for preparing and filing all Regulatory Materials, shall be the holder of all Regulatory Approvals in such jurisdiction and will have primary operational responsibility for interactions with Regulatory Authorities, including taking the lead role at all meetings with Regulatory Authorities, subject to the right of the other Party to participate in such activities and provide input, which the lead regulatory Party will consider in good faith; provided, however, that any INDs or their foreign equivalents will be prepared, filed and held by the Party conducting the relevant Clinical Trial that is the subject thereof. Subject to Section 4.1(c)(ii), this right of participation covers all regulatory activities, including development of regulatory strategy and review of regulatory submissions, attendance at all meetings with Regulatory Authorities that may potentially impact the Development of the Collaboration Molecule or Product or registration package for a particular Product, and review of outcomes of such meetings.
Lead Regulatory Party. On a Target-by-Target basis, (a) prior to [**] for a given Target, LogicBio will be the “Lead Regulatory Party” with respect to all Products Directed to such Target and (b) thereafter, CANbridge will be the “Lead Regulatory Party” with respect to all Products Directed to such Target.
Lead Regulatory Party. The Joint Executive Committee shall identify the Party which shall own the INDs for each Joint DDC and the Regulatory Approvals for each Joint Product (the "Lead Regulatory Party") in the United States. Xxxxxx shall be the Lead Regulatory Party for the ROW. The Lead Regulatory Party shall license, transfer, provide a letter of reference with respect to, or take other action necessary to make available such INDs or Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. Regulatory Approvals to the other Party as may be reasonably necessary to enable such other Party to fulfill its obligations under the Development Plans with respect to the Development of such Joint DDC and under the Commercialization Plans with respect to the Commercialization of such Joint Product.
