Common use of Conduct of Regulatory Activities Clause in Contracts

Conduct of Regulatory Activities. Terumo shall be solely responsible, in its expense (subject to IceCure’s obligation with respect to assistance as set in this Article 5.2(e) below), for preparing, filing, obtaining, and maintaining Regulatory Approvals, including Xxxxxx and Reimbursement Approvals for the Product in the Territory, including those improvements and post-marketing surveillance, and including the conduct of associated clinical trials or preclinical testing conducted in the Territory, all in accordance with the Regulatory Plan. Terumo shall be the holder of the Regulatory Approval and all Regulatory Filings for the Product in the Territory issued pursuant to this ‎Article 5 and the Regulatory Plan, and shall be responsible for all interactions with Regulatory Authorities with respect to the Product in the Territory. In the Limited Territory, IceCure shall be the holder of the Regulatory Approval and all Regulatory Filings for the Product and shall be responsible for all interactions with Regulatory Authorities with respect to the Product in the Limited Territory; without derogating from the above-mentioned, to the extent required by the Applicable Laws and/or with Terumo’s obligations as a distributor of the Product, Terumo shall be responsible for interactions with Regulatory Authorities with respect to the Product in the Limited Territory to such extent. Terumo shall ensure that IceCure is updated in advance of such activities and the decisions that may affect the progress of the Regulatory Plan, including allowing IceCure to participate in the discussions with Regulatory Authority (to the extent it is possible and permitted) and discussions regarding the labeling of, and post-marketing surveillance strategies with respect to the Product in Territory, but Terumo may make the final decision with respect to any of the foregoing activities, provided that, in the event such decision impose any substantial obligation on IceCure that are not set forth in this Agreement or Quality Agreement, such decision is feasible and can be exerted by Commercially Reasonable Efforts by IceCure, and that Terumo will bear expenses with respect to such decision as agreed by the Parties. Terumo shall consider in good faith all input provided by IceCure with respect to such regulatory activities. In connection with such activities, Terumo shall timely inform IceCure of scheduled meetings with Regulatory Authorities in the Territory with respect to the Product that may affect the progress of the Regulatory Plan in order to allow IceCure time to convey its opinion on the matter.

Conduct of Regulatory Activities. Terumo (i) Other than the allocation of costs as between the Parties as set forth in the Regulatory Plan, each Party shall be solely responsiblebear all of its internal costs, including indirect cost and direct labor cost for its employees and personnel, in its expense (subject to IceCure’s obligation with respect to assistance each case as set incurred in this Article 5.2(e) below), for preparing, filing, obtaining, and maintaining Regulatory Approvals, including Xxxxxx and Reimbursement Approvals for the Product in the Territory, including those improvements and post-marketing surveillance, and including the conduct of associated clinical trials or preclinical testing conducted in the Territory, all in accordance connection with the Regulatory Plan. Terumo shall be the holder of the Regulatory Approval and all Regulatory Filings for the Product in the Territory issued pursuant to Activities under this ‎Article 5 Agreement and the Regulatory Plan, and shall be responsible for all interactions with Regulatory Authorities including with respect to the Product payment terms as defined in the Territory. In Regulatory Plan and/or applicable Services Agreement(s); provided, however, that it is the Limited Territory, IceCure intention of the Parties that the Orchestra shall be primarily responsible for all of the holder costs related to Medtronic’s performance of clinical and regulatory responsibilities set forth in the Regulatory Plan, including all direct expenses and applicable submission fees to Regulatory Authorities, and provided, further, that allocation of costs related specifically to Regulatory Activities and pursuit of Regulatory Approval for the Products in [***] Country Groups shall be subject to the mutual written agreement of the Parties. The Parties shall enter into a separate Services Agreement (and a separate Quality Agreement, if applicable) that will specify the services to be provided by Medtronic (consistent with those outlined in the Regulatory Plan) and reimbursed by Orchestra in accordance with the terms as described in Exhibit H attached hereto. (ii) The sponsor of the Clinical Trial(s) (including the respective sponsors in case of joint Clinical Trials in two or more countries where such joint sponsorship is allowed by the applicable Regulatory Authority) shall be set forth in the Regulatory Plan. The Parties shall ensure that they update each other on progress of the Regulatory Approval and all Regulatory Filings for Activities, the Product and shall be responsible for all interactions with Regulatory Authorities with respect to the Product in the Limited Territory; without derogating from the above-mentioned, to the extent required by the Applicable Laws and/or with Terumo’s obligations as a distributor conduct of the ProductClinical Trial(s), Terumo shall be responsible for interactions with Regulatory Authorities with respect to the Product in the Limited Territory to such extent. Terumo shall ensure that IceCure is updated in advance of such activities and the decisions that may affect their impact on the progress of the Regulatory Plan, including allowing IceCure to participate in the without limitation discussions with applicable Regulatory Authority (to the extent it is possible Authorities and permitted) and discussions decisions regarding the labeling of, and post-marketing surveillance strategies with respect to to, the Product in the Territory, but Terumo the Party who is responsible pursuant to this Section 6.1(b)(iii), Section 5.1(b) and the Regulatory Plan may make the final decision with respect to any of the foregoing activities, provided that, in consultation with the JSC and with any independent advisory committee established to monitor the data and safety of subjects enrolled in the event such decision impose any substantial obligation on IceCure that are not set forth in this Agreement or Quality Agreement, such decision is feasible and can be exerted by Commercially Reasonable Efforts by IceCure, and that Terumo will bear expenses with respect to such decision as agreed by the PartiesClinical Trial(s). Terumo The Parties shall also consider in good faith all input provided by IceCure the other Party with respect to such regulatory activitiesRegulatory Activities. In connection with such activitiesRegulatory Activities, Terumo the Parties shall timely inform IceCure the other Party of scheduled meetings with Regulatory Authorities in the Territory with respect to the Product that may affect the progress of the Regulatory Plan in order to allow IceCure the other Party time to convey its opinion on the matter. (iii) The JSC shall discuss the Regulatory Activities described in this Section 6.1, including the design and implementation of any Clinical Trials, any updates on the progress, and results and publication thereof, in consultation with any independent advisory committee established to monitor the data and safety of subjects enrolled in such Clinical Trials. The Clinical Study sponsor shall not execute any related clinical study agreement, application, or Regulatory Submission that names the other Party as a co-party or indemnitee in any way without prior consultation with and consent of the other Party. The Parties shall maintain compliance with any and all applicable regulatory, ethical, privacy, and legal requirements relating to the conduct of human clinical studies in the Territory, including acquiring and maintaining any appropriate insurance related to product liability and study conduct.

Conduct of Regulatory Activities. Terumo All regulatory activities for obtaining Regulatory Approval of Products in the Field in the Territory shall be solely responsible, conducted by and on behalf of the Parties in its expense compliance with the provisions of this Agreement. Takeda shall: (subject i) be responsible for all activities relating to IceCure’s obligation with respect to assistance as set in this Article 5.2(e) below), for preparing, filingmaking submissions for, obtaining, owning and maintaining Regulatory Approvals, including Xxxxxx supplements and Reimbursement Approvals for amendments thereto, with respect to Products in the Product Field in the Territory; (ii) use Commercially Reasonable Efforts to obtain Regulatory Approval of the Products in the Field in the Territory; and (iii) lead discussions and meetings with all Regulatory Authorities regarding Licensed Compounds or Products in the Field in the Territory, including those improvements subject to the terms of this Section 4.1; provided, however, a representative of Amylin shall be entitled to participate in any such discussions and post-marketing surveillancemeetings with Regulatory Authorities, and including and, if an appropriate Amylin representative is requested by Takeda to attend a discussion or meeting with the conduct of associated clinical trials FDA regarding Licensed Compounds or preclinical testing conducted Products in the Field in the Territory, Amylin will use Commercially Reasonable Efforts to arrange for such individual to participate in such discussions or meetings. The ODC shall determine and set forth in the Development Plan the respective responsibilities of each of the Parties for all regulatory activities with respect to Products in the Field in the Territory other than the regulatory activities described in the immediately preceding sentence. Each Party shall conduct all regulatory activities for which it is the responsible Party in accordance with the Regulatory Development Plan, using Commercially Reasonable Efforts, and in compliance in all material respects with all Applicable Laws. Terumo shall be Upon request by the holder of the Regulatory Approval and all Regulatory Filings Party responsible for the Product in applicable regulatory activities, the Territory issued pursuant other Party shall provide reasonable assistance to such responsible Party with regard to such regulatory activities under this ‎Article 5 and Agreement. The Party responsible for the Regulatory Planapplicable regulatory activities agrees to consult with the other Party regarding, and shall be responsible for all interactions keep the other Party regularly and fully informed of, the preparation, and Regulatory Authority review and approval, of submissions and communications with Regulatory Authorities with respect to the Product Products in the Territory. In the Limited Territory, IceCure shall be the holder of the Regulatory Approval and all Regulatory Filings for the Product and shall be responsible for all interactions with Regulatory Authorities with respect to the Product Field in the Limited Territory; without derogating from the above-mentioned, Territory for which such Party is responsible. Each Party agrees to the extent required consider in good faith any comments or suggestions made by the Applicable Laws and/or with Terumo’s obligations as a distributor of the Product, Terumo shall be responsible for interactions with Regulatory Authorities with respect to the Product in the Limited Territory to such extent. Terumo shall ensure that IceCure is updated in advance of such activities and the decisions that may affect the progress of the Regulatory Plan, including allowing IceCure to participate in the discussions with Regulatory Authority (to the extent it is possible and permitted) and discussions regarding the labeling of, and post-marketing surveillance strategies with respect to the Product in Territory, but Terumo may make the final decision with respect to any of the foregoing activities, provided that, in the event such decision impose any substantial obligation on IceCure that are not set forth in this Agreement or Quality Agreement, such decision is feasible and can be exerted by Commercially Reasonable Efforts by IceCure, and that Terumo will bear expenses other Party with respect to such decision as agreed by the Parties. Terumo shall consider in good faith all input provided by IceCure with respect to such regulatory activitiesmatters. In connection with such activitiesaddition to the information required to be provided to the other Party in other provisions of this Agreement, Terumo each Party shall timely inform IceCure provide the other Party with summaries of scheduled meetings its communications and correspondence with the Regulatory Authorities in the Territory Territory, including with respect to Product safety and manufacturing issues. Amylin shall transfer to Takeda responsibility for regulatory activities with respect to each Product at the next specified phase of development (for example, upon advancement of a Product from Phase 2 Clinical Trials to Phase 3 Clinical Trials). In addition, Amylin shall either: (a) transfer to Takeda its current INDs related to Amylin Licensed Compounds that may affect are not contained in an Excluded Product; or (b) permit Takeda to reference Amylin’s INDs related to Amylin Licensed Compounds that are contained in an Excluded Product, in each case pursuant to a mutually agreed upon timeline set forth in the progress Development Plan, which shall be not later than [***] in advance of the Regulatory Plan in order first to allow IceCure time to convey its opinion on occur of (1) the matterstart of the next Clinical Trial for such Amylin Licensed Compound; and (2) a significant meeting with the FDA regarding such Amylin Licensed Compound.

Conduct of Regulatory Activities. Terumo (a) Each Development Plan shall set forth the regulatory strategy for seeking Regulatory Approval of the Product for the applicable Indication in the Major Market Countries and in other countries in the Territory, in each case as determined by the JSC. The Parties intend to and will collaborate to maximize any Regulatory Exclusivity for the Product in and outside the Territory to the extent permitted by Applicable Law. (b) As set forth in the Development Plan for the Initial Indication, prior to the filing of an MAA for the Product for the Initial Indication in the EU, ChemoCentryx shall be solely responsible, in at its own expense (subject except for any Development Funding Payments by VIT under Section 4.4), for all regulatory activities related to IceCure’s obligation Development of the Product in the Field in the Territory, including all Regulatory Filings for the Development and all communications with respect Regulatory Authorities (e.g., IND submissions). In addition, ChemoCentryx shall be solely responsible for preparing, filing with the EMA, obtaining from the EMA and maintaining all Conditional Marketing Authorisations for the Product in the Field in the Territory in accordance with the regulatory strategy set forth in the applicable Development Plan and under coordination of the JSC. Promptly after obtaining any such Conditional Marketing Authorisation, ChemoCentryx shall assign it to assistance VIT, and the Parties shall take all actions reasonably necessary to effect such assignment and transfer. VIT shall reimburse all reasonable and documented external expenses incurred by ChemoCentryx in connection with such Conditional Marketing Authorisations. For the purpose of this Agreement, “Conditional Marketing Authorisation” has the meaning provided under the then current EMA and EU regulations and directives. (c) Except as set provided below and in this Article 5.2(eSection 5.1(b) below)above, VIT shall be solely responsible, at its own expense, for preparing, filing, obtaining, and maintaining Regulatory Approvals, including Xxxxxx and Reimbursement Approvals for the Product in the TerritoryField in the Territory in accordance with the regulatory strategy set forth in the applicable Development Plan and under coordination of the JSC. ChemoCentryx shall provide content and subject matter expertise as reasonably requested by VIT in connection with the preparation, including those improvements filing and post-marketing surveillance, and including obtaining of regulatory Approvals for the conduct of associated clinical trials or preclinical testing conducted Product in the Field in the Territory, all in accordance including but not limited to providing VIT with a copy of the regulatory dossier to be filed with the Regulatory Plan. Terumo FDA in the U.S. Each Party shall be responsible for all costs it incurs to conduct such activities under this Section 5.1(c), except as provided in Section 5.1(f). (d) Subject to Applicable Laws and to Section 5.1(b), VIT (or its Affiliate or Sublicensee) shall be the holder of the Regulatory Approval and all Regulatory Filings Approvals for the Product in the Field in the Territory issued pursuant to this ‎Article 5 and the Regulatory Plan, and shall be responsible for all interactions with Regulatory Authorities with respect to the Product in the Field in the Territory. In ChemoCentryx will cooperate to provide subject-matter expertise to support VIT, VIT’s Affiliates and any Sublicensee in such interactions. (e) VIT shall consult with ChemoCentryx through the Limited TerritoryJSC regarding, IceCure shall be and keep ChemoCentryx regularly and fully informed of, the holder preparation, Regulatory Authority review and approval of the Regulatory Approval Filings, and all Regulatory Filings for the Product and shall be responsible for all interactions communications with Regulatory Authorities with respect to the Product in the Limited Field in the Territory; without derogating . In addition, VIT shall promptly provide ChemoCentryx with copies, translated into English (to the extent that VIT obtains English translations in the ordinary course of business), of all material documents, information, and correspondence received from a Regulatory Authority and, upon reasonable request, with copies, translated into English (to the above-mentionedextent that VIT obtains English translations in the ordinary course of business), of any other documents, reports, and communications from or to any Regulatory Authority relating to the Compound, the Product, or activities under this Agreement. Upon VIT’s reasonable request, ChemoCentryx shall use Commercially Reasonable Efforts to assist VIT, VIT’s Affiliates and any Sublicensees in maintaining Regulatory Approvals for the Product in the Field in the Territory. (f) VIT will reimburse all reasonable and documented external expenses incurred by ChemoCentryx to Third Parties in connection with any assistance or provision of content and subject matter expertise under Sections 5.1(c), (d) and (e). ChemoCentryx will reimburse all reasonable and documented external expenses incurred by VIT to Third Parties in connection with any assistance or provision of content and subject matter expertise as requested by ChemoCentryx in connection with ChemoCentryx’s regulatory activities for outside the Territory. (g) ChemoCentryx shall keep VIT reasonably updated, through the JSC, of its material Regulatory Filings and communications with Regulatory Authorities in major countries outside the Territory, to the extent required by the Applicable Laws and/or with Terumo’s possible without breaching confidentiality obligations as to a distributor of the Product, Terumo shall be responsible for interactions with Regulatory Authorities with respect to the Product in the Limited Territory to such extent. Terumo shall ensure that IceCure is updated in advance of such activities and the decisions that may affect the progress of the Regulatory Plan, including allowing IceCure to participate in the discussions with Regulatory Authority (to the extent it is possible and permitted) and discussions regarding the labeling of, and post-marketing surveillance strategies with respect to the Product in Territory, but Terumo may make the final decision with respect to any of the foregoing activities, provided that, in the event such decision impose any substantial obligation on IceCure that are not set forth in this Agreement or Quality Agreement, such decision is feasible and can be exerted by Commercially Reasonable Efforts by IceCure, and that Terumo will bear expenses with respect to such decision as agreed by the Parties. Terumo shall consider in good faith all input provided by IceCure with respect to such regulatory activities. In connection with such activities, Terumo shall timely inform IceCure of scheduled meetings with Regulatory Authorities in the Territory with respect to the Product that may affect the progress of the Regulatory Plan in order to allow IceCure time to convey its opinion on the matterThird Party.