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. 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. 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. 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. 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. 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 Importation License for the Product in the Territory, including those improvements and post-marketing surveillance. Terumo shall be the holder of the Regulatory Approval for the Product in the Territory issued pursuant to this Article 5, and shall be responsible for all interactions with Regulatory Authorities with respect to the Product in the Territory. Terumo shall ensure that IceCure is updated in advance of such activities, 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 in order to allow IceCure time to convey its opinion on the matter.
Conduct of Regulatory Activities. (i) The applicable Lead Regulatory Party shall be responsible for (A) submitting all Regulatory Filings, including applications for Regulatory Approval, relating to the Collaboration Molecules and Collaboration Products, and (B) leading (1) scheduled face-to-face meetings, video conferences and any teleconferences, with the applicable Regulatory Authorities and (2) any preparatory meetings for such meetings with the applicable Regulatory Authorities. The other Party shall have the right to have up to two (2) senior, experienced employees reasonably acceptable to the applicable Lead Regulatory Party, participate (to the extent practicable) as observers in any such face-to-face meetings, video conferences, teleconferences and preparatory meetings. The applicable Lead Regulatory Party shall provide the other Party copies of (1) material documentation prepared for such meetings and (2) material submissions to the applicable Regulatory Authorities relating to Development of, or the process of obtaining Regulatory Approval for, the applicable Collaboration Products, in each case (to the extent practicable) sufficiently in advance of the applicable meeting or submission, as applicable, to allow such other Party a reasonable opportunity to review and provide comment on such materials, and such applicable Lead Regulatory Party shall consider in good faith such other Party’s comments with respect thereto.
(ii) The applicable Lead Regulatory Party may delegate to the other Party such responsibility(ies) for interfacing, corresponding and meeting with the applicable Regulatory Authorities with respect to a Collaboration Product as may be mutually agreed upon by the Parties.
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.
Conduct of Regulatory Activities outside the Territory and the XXXX Territory. Optimer agrees to keep Partner 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 outside the Territory (including any variation of, and update to, any Regulatory Approvals outside the Territory) and the XXXX Territory. In addition, Optimer shall promptly provide Partner with copies of all material documents, information and correspondence received from a Regulatory Authority and, upon reasonable request, with copies of any other documents, reports and communications from or to any Regulatory Authority relating to Compounds or Products outside the Territory and the XXXX Territory.
