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 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 Importation License 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 Plan5, 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 Planactivities, 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 Licensee (itself and through its Affiliates and Sublicensees, as applicable) shall be solely responsible, in its expense (subject to IceCure’s obligation responsible for the expenses and costs of all regulatory activities with respect to assistance as set the Products in this Article 5.2(e) below)the Field in the Licensee Territory. Under the oversight of the JSC, for preparingLicensee shall implement the regulatory strategy formulated and adopted by the JSC and prepare, filingfile, obtaining, obtain and maintaining maintain Regulatory Approvals, including Xxxxxx and Reimbursement Approvals for the Product Products in the Field in the Licensee 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 Approvals for the Product Products in the Territory issued pursuant to this ‎Article 5 and Field in the Regulatory PlanLicensee Territory, 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 have responsibility for interactions with Regulatory Authorities with respect to the Products in the Field in the Licensee Territory; provided however that if Applicable Laws in the Licensee Territory do not allow Licensee to hold Regulatory Approvals for any Product in the Limited Territory Licensee Territory, then during the Term Allogene shall hold such Regulatory Approval for Licensee’s benefit, shall appoint Licensee or one of its Affiliates as its exclusive agent to handle all regulatory activities for 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 Product in the discussions with Regulatory Authority (to the extent it is possible and permitted) and discussions regarding the labeling ofLicensee Territory, and post-marketing surveillance strategies with respect shall promptly transfer such Regulatory Approval to the Product in Territory, but Terumo may make the final decision with respect to any of the foregoing activities, Licensee or its designee when allowed by Applicable Laws; provided that, that in the event and during any period that Allogene holds such decision impose Regulatory Approval for Licensee’s benefit, (i) Allogene shall not be obligated to perform any substantial obligation on IceCure that are not activities, bear any obligations, or bear any costs, in each case, in addition to the activities set forth in this Agreement due to Allogene or Quality Agreementits Affiliate holding such Regulatory Approval; (ii) Allogene shall not assume any liability in connection with Allogene holding such Regulatory Approval; (iii) should Allogene incur any costs or expenses related to holding or transferring any such Regulatory Approval, Licensee shall reimburse Allogene or its Affiliates for any and all costs and expenses incurred by or on behalf of Allogene in holding or transferring such decision is feasible Regulatory Approval; and can be exerted by (iv) Licensee shall indemnify and hold Allogene Indemnitees (as defined herein) from and against all Losses to the extent arising from Allogene holding such Regulatory Approval in the Licensee Territory as set forth in Article 13. Notwithstanding anything in this Agreement to the contrary, Licensee may not modify the study protocol, use or indication of a Product without the JSC's prior written approval. The Parties acknowledge and agree that importation of final Products to the Licensee Territory would reduce cost and time to Regulatory Approvals. The Parties shall cooperate in good faith to explore importation of final Products to the Licensee Territory prior to Product approval. To fulfill the regulatory requirements for regulatory filings in the Licensee Territory, Allogene shall use Commercially Reasonable Efforts by IceCure, and that Terumo will bear expenses to provide the relevant certification documents or illustration statement 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 matternotarization and/or legalization within a reasonable timeline.

Conduct of Regulatory Activities. Terumo Pediatrix shall be solely responsible, in at its expense (subject to IceCure’s obligation with respect to assistance as set in this Article 5.2(e) below)own cost and expense, for formulating regulatory strategy and for preparing, filing, obtaining, obtaining and maintaining Regulatory ApprovalsApprovals for Products in the Field in the Pediatrix Territory. Pediatrix shall be the holder of all Regulatory Approvals for Products in the Field in the Pediatrix Territory, including Xxxxxx except if ARS is required by Applicable Laws to hold an Import Drug License or equivalent for any Product in the Pediatrix Territory, in which case ARS shall (a) hold such Regulatory Approval for Pediatrix’s benefit, (b) appoint Pediatrix (or an Affiliate or Sublicensee of Pediatrix) as its authorized exclusive legal agent of record to interact with NMPA and Reimbursement Approvals serve as its exclusive distributor for the Product in the Pediatrix Territory, including those improvements and post-marketing surveillancePediatrix shall reimburse ARS for all cost and expense incurred in connection therewith, (c) shall provide access to and copies of such Regulatory Filings, Regulatory Approvals and any Pricing and Reimbursement approvals to Pediatrix promptly upon Pediatrix’s request, and including the conduct of associated clinical trials (d) shall promptly transfer such Regulatory Approval to Pediatrix or preclinical testing conducted its designee when allowed by Applicable Laws. Pediatrix shall use Commercially Reasonable Efforts to file NDAs and, as applicable, seek Pricing and Reimbursement Approval for and seek and maintain Regulatory Approval for Products in the Field in all regions throughout the Pediatrix Territory. Pediatrix shall keep ARS regularly informed of, all in accordance the preparation, Regulatory Authority review and approval of substantive submissions and material communications with the Regulatory Plan. Terumo shall be the holder of the Regulatory Approval and all Regulatory Filings for the Product Authorities with respect to Products in the Territory issued pursuant Field in the Pediatrix Territory. ARS shall use Commercially Reasonable Efforts to this ‎Article 5 and the Regulatory Plan, and shall be responsible for all assist with Pediatrix with interactions with Regulatory Authorities with respect to the Product Products in the Territory. In Field in the Limited Pediatrix Territory, IceCure and Pediatrix shall be the holder of the Regulatory Approval and reimburse ARS for any third party costs incurred to provide such assistance that are agreed upon writing by both Parties. Parties shall conduct 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 accordance 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 matterApplicable Laws.

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 *** Confidential Treatment Requested ***Text Omitted and Filed Separately with the progress Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2 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 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 shall JW (itself and through its Affiliates and Sublicensees, as applicable) will be solely responsible, in at its expense (subject to IceCure’s obligation own expense, for all regulatory activities with respect to assistance as set the Products in this Article 5.2(e) below)the Field in the JW Territory, for including formulating regulatory strategy and preparing, filing, obtaining, obtaining and maintaining Regulatory Approvals, including Xxxxxx and Reimbursement Approvals for the Product Products in the Field in the JW 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 will be the holder of the Regulatory Approval and all Regulatory Filings Approvals for the Product Products in the Territory issued pursuant to this ‎Article 5 and Field in the Regulatory PlanJW Territory, 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 will have responsibility for interactions with Regulatory Authorities with respect to the Product Products 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 Field in the discussions with Regulatory Authority (JW Territory; provided that TSVT may elect, in its sole discretion, to submit CMC Information directly to the extent it is possible and permitted) and discussions regarding concerned Regulatory Authority. Notwithstanding 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 thatforegoing, in the event that JW, its Affiliates or Sublicensees are unable to become the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory in order to exercise its rights and perform its obligations under this Agreement, (a) TSVT will be the legal and beneficial owner of the Regulatory Documents for in the JW Territory and such decision impose any substantial obligation on IceCure that are not set forth Regulatory Documents will be included in TSVT Know-How, (b) TSVT hereby designates JW, its Affiliates or Sublicensees as TSVT’s regulatory agent and exclusive general distributor for the Products in the JW Territory, and (c) to the extent later permitted by Applicable Laws, TSVT will cooperate with JW to allow JW, its Affiliates or Sublicensees to be the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory. XX will conduct the regulatory activities in the JW Territory under this Agreement (i) in its own name, if JW (or Quality Agreementits Affiliates or Sublicensees) is the legal and beneficial owner of the Regulatory Approvals for the Products in the JW Territory or (ii) as the express and authorized regulatory agent of record for TSVT in the JW Territory, if TSVT is the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory, under which situation such decision is feasible actions will be taken on behalf of TSVT and can be exerted by Commercially Reasonable Efforts by IceCurefor the benefit of JW in the JW Territory. If any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT will have final decision-making authority regarding all such regulatory activities, including the content of regulatory submissions for Products in the JW Territory and JW will, and will ensure that Terumo will bear expenses its relevant Affiliates and Sublicensees will, conduct all regulatory activities in compliance with respect to such decision as agreed by TSVT’s final decisions. Notwithstanding the Parties. Terumo foregoing, in the event any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT shall consult with and reasonably consider all suggestions from JW in good faith all input provided by IceCure with respect prior to such regulatory activities. In connection with such activities, Terumo shall timely inform IceCure of scheduled meetings with Regulatory Authorities in exercising 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 matteraforementioned final decision rights.

Conduct of Regulatory Activities. Terumo ALFRESA 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), responsible for formulating regulatory strategy and for preparing, filing, obtaining, obtaining and maintaining Regulatory Approvals, including Xxxxxx and Reimbursement Approvals for the Product Products in the Territory, including those improvements and post-marketing surveillance, and including the conduct of associated clinical trials or preclinical testing conducted Field in the ALFRESA Territory, all in accordance with . If the Regulatory PlanAuthority in the ALFRESA Territory requires reanalysis of any Product used in a clinical trial, ARS shall assist with such reanalysis subject to reimbursement by ALFRESA of costs incurred by ARS for such reanalysis. Terumo ALFRESA shall be the holder of the Regulatory Approval and all Regulatory Filings Approvals for the Product Products in the Field in the ALFRESA 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 have responsibility for interactions with Regulatory Authorities with respect to the Product Products in the Limited Territory Field in the ALFRESA Territory. ALFRESA shall use Commercially Reasonable Efforts to such extentfile XXXx and, as applicable, seek Pricing and Reimbursement Approval for and seek and maintain Regulatory Approval for Products in the Field throughout the ALFRESA Territory. Terumo ALFRESA shall ensure that IceCure is updated in advance of conduct all such activities in accordance with Applicable Laws. ALFRESA shall consult with ARS either directly or through the JDC regarding, and keep ARS regularly informed of, the decisions that may affect the progress preparation, Regulatory Authority review and approval of the Regulatory Plan, including allowing IceCure to participate in the discussions submissions and communications with Regulatory Authority (to the extent it is possible and permitted) and discussions regarding the labeling of, and post-marketing surveillance strategies Authorities with respect to Products in the Product Field in the ALFRESA Territory. In addition, but Terumo may make the final decision ALFRESA shall promptly provide ARS with respect copies of any material documents, information and correspondence received from a Regulatory Authority with an English translation thereof and, upon reasonable request by ARS, with copies of any other documents, reports and communications from or to any of Regulatory Authority relating to Compositions, Products or activities under this Agreement. Except as agreed otherwise by the foregoing activitiesParties under Section 4.3, provided that, ALFRESA shall bear all expenses it incurs to conduct all regulatory activities in the event such decision impose any substantial obligation on IceCure that are not set forth in ALFRESA Territory under 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.