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 Regu...
Conduct of Regulatory Activities. Before the Effective Date of this Agreement, AcelRx has obtained clearance from the EMA that the Licensed Product can (but need not) be submitted through a Centralized Procedure and has submitted a respective letter of intent to the EMA and has requested a corresponding pre-submission meeting with the EMA and Grünenthal has received a copy of such documentation. Furthermore, AcelRx has initiated the clearance procedure(s) regarding the AcelRx Trademarks to be used for the commercialization of the Licensed Product under the EMA in accordance with the Centralized Procedure. Each Party shall conduct all of those regulatory activities for which it is the responsible Party as set forth in Section 4.4 or Section 4.5 as the case may be, and shall fund all regulatory activities for obtaining Marketing Approval in the Territory in accordance with Section 4.4 above. Each Party shall conduct such regulatory activities for which it is the responsible Party in compliance with this Agreement and in accordance with the Development Plan (including the Budget set forth therein) and shall use Commercially Reasonable Efforts to obtain Marketing Approval in the Field in the Territory.
Conduct of Regulatory Activities. Pediatrix shall be solely responsible, at its own cost and expense, for formulating regulatory strategy and for preparing, filing, obtaining and maintaining Regulatory Approvals 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, 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 serve as its exclusive distributor for the Product in the Pediatrix Territory, and Pediatrix 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 (d) shall promptly transfer such Regulatory Approval to Pediatrix or 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, the preparation, Regulatory Authority review and approval of substantive submissions and material communications with Regulatory Authorities with respect to Products in the Field in the Pediatrix Territory. ARS shall use Commercially Reasonable Efforts to assist with Pediatrix with interactions with Regulatory Authorities with respect to Products in the Field in the Pediatrix Territory, and Pediatrix shall reimburse ARS for any third party costs incurred to provide such assistance that are agreed upon writing by both Parties. Parties shall conduct all such activities in accordance with Applicable Laws.
Conduct of Regulatory Activities. (i) Other than the allocation of costs as between the Parties as set forth in the Regulatory Plan, each Party shall bear all of its internal costs, including indirect cost and direct labor cost for its employees and personnel, in each case as incurred in connection with the Regulatory Activities under this Agreement and the Regulatory Plan, including with respect to the payment terms as defined in the Regulatory Plan and/or applicable Services Agreement(s); provided, however, that it is the intention of the Parties that the Orchestra shall be primarily responsible for all of the 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.
Conduct of Regulatory Activities. All regulatory activities with respect to Product in the Field in the Territory will be conducted by or on behalf of Sanofi in accordance with the provisions of this Agreement and the regulatory strategy developed by Sanofi and approved by the JAC; provided, however, that MannKind reserves the exclusive right, as manufacturer of Product, to submit, obtain and maintain Master Files in MannKind’s name in the Territory, provided, further, that, solely to the extent and for so long as the licenses granted by the Licensors to Sanofi under Sections 2.1 and 2.2 remain in full force and effect, Sanofi shall have the irrevocable right to refer to the Master Files with respect to the Product in the Territory solely for the purposes of (i) Developing Product in the Field in accordance with this Agreement, (ii) Manufacturing and having Manufactured Product in the Field in the Territory, subject to the terms of and as permitted by the Supply Agreement, and (iii) using, Commercializing and having Commercialized Product in the Field in the Territory. For the avoidance of doubt, and notwithstanding the foregoing or any other provision of this Agreement to the contrary, Sanofi
Conduct of Regulatory Activities. MTPC shall be solely responsible for formulating regulatory strategy and for preparing, filing, obtaining and maintaining Regulatory Approvals for Products in the Field in the MTPC Territory. MTPC, its Affiliate or Sublicensee shall be the holder of all Regulatory Approvals for Products in the Field in the MTPC Territory and shall have responsibility for interactions with Regulatory Authorities with respect to Products in the Field in the MTPC Territory. MTPC shall consult with Neurocrine through the JDC regarding, and keep Neurocrine regularly informed of, the preparation, Regulatory Authority review and approval of submissions and communications with Regulatory Authorities with respect to Products in the Field in the MTPC Territory. In addition, MTPC shall promptly provide Neurocrine with copies of any material documents, information and correspondence received from a Regulatory Authority with an English summary thereof and, upon reasonable request by Neurocrine, with copies of any other documents, reports and communications from or to any Regulatory Authority relating to Compounds, Products or activities under this Agreement, with an English summary thereof. Except as agreed otherwise by the Parties under Section 4.3, MTPC shall bear all expenses it incurs to conduct all regulatory activities in the MTPC Territory under this Agreement.
Conduct of Regulatory Activities. Teva shall conduct its regulatory activities in compliance with this Agreement and Applicable Laws. Teva may request, and Alexza shall reasonably consider, providing regulatory support as a subcontractor of Teva from time to time during the Term, provided that any such subcontractor obligations shall be pursuant to a separate agreement and financial terms to be negotiated in good faith between the Parties on terms that are commercially reasonable and customary in the industry.
Conduct of Regulatory Activities. Licensee (itself and through its Affiliates) shall be solely responsible, at its own expense, for all regulatory activities with respect to the Licensed Product(s) in the Field in the Territory, including preparing, filing, obtaining and maintaining Regulatory Approvals for the Licensed Product(s) in the Field in the Territory. [***]. Inventiva shall use Commercially Reasonable Efforts to assist Licensee’s regulatory activities, including by responding in a timely manner to Licensee’s reasonable request(s) and questions regarding Regulatory Approvals.
Conduct of Regulatory Activities. Licensee (itself and through its Affiliates and Sublicensees, as applicable) shall be solely responsible for the expenses and costs of all regulatory activities with respect to the Products in the Field in the Licensee Territory. Under the oversight of the JSC, Licensee shall implement the regulatory strategy formulated and adopted by the JSC and prepare, file, obtain and maintain Regulatory Approvals for the Products in the Field in the Licensee Territory, shall be the holder of all Regulatory Approvals for the Products in the Field in the Licensee Territory, and shall 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 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 Product in the Licensee Territory, and shall promptly transfer such Regulatory Approval to Licensee or its designee when allowed by Applicable Laws; provided that in the event and during any period that Allogene holds such Regulatory Approval for Licensee’s benefit, (i) Allogene shall not be obligated to perform any 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 its 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 Regulatory Approval; and (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 ...
Conduct of Regulatory Activities. Ideaya shall be solely responsible, at its own expense, for (a) all regulatory activities related to Licensed Products in the Field in the Territory, including all Regulatory Filings and all communications with Regulatory Authorities, and (b) preparing, filing, obtaining, and maintaining Regulatory Approvals for Licensed Products in the Field in the Territory. Subject to Applicable Laws, Ideaya (or its Affiliate or other Sublicensee) shall be the holder of all Regulatory Approvals for Licensed Products in the Field in the Territory.
