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. 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. (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. 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. 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. 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. All regulatory activities for obtaining Marketing Approval of Product in the Field in the Territory shall be conducted by and on behalf of the Parties in compliance with the provisions of this Agreement. Each Party shall conduct all of those regulatory activities for which it is the Responsible Party, and BLS shall conduct all of those regulatory 24. ***Confidential Treatment Requested activities for obtaining Marketing Approval of Product in the Field in Canada, in compliance in all material respects with all Applicable Laws of the country in which such activities are conducted. ACADIA may not conduct any development (including regulatory) activities with respect to any Product in the Field in the Territory without BLS’s prior written consent, which consent shall not be unreasonably withheld, except pursuant to a Development Plan. Upon request by the Responsible Party, the other Party shall provide reasonable assistance to the Responsible Party in relation to the performance by the Responsible Party of such regulatory activities under this Agreement.
Conduct of Regulatory Activities. (i) OBIO shall, in furtherance of Terumo’s ownership of the Regulatory Approval described in this Section 5.1(b)(i), be responsible for carrying out the Regulatory Activities relating to clinical trials in the United States with regard to the PMA approval for the Milestone Indication in accordance with the Regulatory Plan, at its cost, including those for post- marketing surveillance if required as a condition to the PMA (it being understood that this shall not include post-PMA approval clinical registries).
Conduct of Regulatory Activities. Partner shall be solely responsible for formulating regulatory strategy and for preparing, filing, obtaining and maintaining Regulatory Approvals, including all regulatory authorizations, for Products in the Field in the Territory. Partner shall be the holder of all Regulatory Approvals for Products in the Field in the Territory and shall have responsibility for interactions with Regulatory Authorities with respect to Products in the Field in the Territory. Partner agrees to consult with Optimer regarding, and keep Optimer regularly and fully 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 Territory. In addition, Partner shall promptly provide Optimer with copies of all material documents, information and correspondence received from a Regulatory Authority with an English summary thereof and, upon reasonable request, with copies of any other documents, reports and communications from or to any Regulatory Authority relating to Compounds, Products and/or activities under this Agreement with an English summary thereof. Partner shall bear all costs and expenses incurred in connection with regulatory activities with respect to Products in the Field in the Territory pursuant to this Agreement.
