Regulatory Strategy. The current plan is to have a pre-IND meeting with FDA in 4Q05 followed by filing of the full IND to FDA within one month of the meeting. This will enable start of the proposed Phase lb program in 1Q06 (estimated first patient in is January 7, 2006). Other meetings with FDA would occur after results from the Phase lb study are available (Pre-Phase 2 meeting) and after results from the Phase 2 study are available (End-of-Phase 2 or Pre-Phase 3 meeting).
Regulatory Strategy. The regulatory strategy and activities applicable to any New Collaboration Compound or Product in any stage of Development under this Agreement shall be set forth in the applicable Development Plan with respect to such stage, and approved in the same manner applicable to the other elements of such Development Plan(s). The regulatory strategy and activities applicable to any Joint Product after Regulatory Approval for such Joint Product has been obtained in a country shall be set forth in the applicable Commercialization Plan, and approved in the same manner applicable to the other elements of such Commercialization Plan(s). All regulatory activities for Joint Products shall be conducted by or on behalf of the Parties in accordance with such Commercialization Plan(s).
Regulatory Strategy. The Parties will work together through the Joint Development Committee and the Steering Committee to determine regulatory strategy in the Territory, including strategy for filings and label content other than as provided in this Agreement. All regulatory strategies shall be proposed by the Joint Development Committee and referred to the Steering Committee for final approval.
Regulatory Strategy. Upon completion of the development of the Project Vaccine, Barinthus Bio shall use [***] to obtain Regulatory Approval for such product in jurisdictions that would enable Equitable Access to such Project Vaccine. Barinthus Bio shall be responsible for developing the regulatory strategy for the Project Vaccine. Barinthus Bio shall use [***] to file for, obtain and maintain the appropriate licenses for the Project Vaccine with the relevant Regulatory Authorities.
Regulatory Strategy. As between the Parties, MINERALYS shall be solely responsible for developing a coordinated global regulatory strategy for interacting with Regulatory Authorities and, during the POC Period, MINERALYS shall consider in good faith all reasonable comments from MTPC. For clarity, MTPC shall have no obligation to conduct any of the regulatory activities and make additional Data.
Regulatory Strategy. The Parties will discuss and determine in the JDC the regulatory strategy for the Licensed Products in the Field in the Territory.
Regulatory Strategy. Within thirty (30) days after the Effective Date, E-Z-EM shall submit its Regulatory Strategy to Pharmacyclics for its review and comment.
Regulatory Strategy. 2.4.1 All detailed plans for coordination and preparation of Regulatory Filings and Regulatory Approval Applications for market approval for the Products that have been agreed to by Ionis Pharmaceuticals and Akcea pursuant to the Ionis Pharmaceuticals/Akcea License Agreements as of the Effective Date have been disclosed by Akcea to PTC in writing or via the electronic data room hosted in connection with the transactions contemplated hereunder (the “Ionis Pharmaceuticals/Akcea Product Regulatory Strategy”). After the Effective Date, except to the extent required by a Regulatory Authority in a country in the Akcea Territory or as set forth in Section 2.4.2, Akcea may not make any changes to the Ionis Pharmaceuticals/Akcea Product Regulatory Strategy that would have a material adverse effect on the timing or likelihood of obtaining Regulatory Approval in a country in the PTC Territory.
2.4.2 The Parties shall cooperate in good faith to develop a written regulatory strategy for each Product in the PTC Territory for review and approval by the JSC (each, a “Product Regulatory Strategy”). Each Product Regulatory Strategy shall address (a) the activities and the allocation between the Parties of the pre-launch activities to be undertaken by each Party in preparation for the commercial launch of a Product in any country within the PTC Territory; (b) the timeline for the transition of any regulatory responsibilities (including, subject to Section 3.4, pricing and reimbursement approval responsibilities) by Akcea and/or Ionis Pharmaceuticals and their applicable Affiliates to PTC; and (c) the timeline for the assignment and transfer of all Regulatory Approvals, Regulatory Filings and/or any pricing and reimbursement approvals, held by Akcea and/or Ionis Pharmaceuticals with respect to any country in the PTC Territory to PTC in accordance with Section 2.5. By [***] of each Calendar Year, the Parties shall submit an updated version of the Product Regulatory Strategy for such Calendar Year to the JSC for review and approval. Once the JSC has approved a Product Regulatory Strategy, each Party will use Commercially Reasonable Efforts to execute its respective tasks and responsibilities within the time frames set forth in such Product Regulatory Strategy. Each Party will bear its own costs and expenses associated with any activities that such Party performs in support of the implementation of such Product Regulatory Strategy. ActiveUS 169009360v.1
Regulatory Strategy. The Partners shall consult regularly with CEPI regarding the regulatory strategy for the Project Vaccine and each Project Clinical Trial or other clinical Sensitivity: Official Use 23 trial that utilises any Project Clinical Trial Materials and shall provide copies of the clinical trial authorisation and all material regulatory submissions with respect to such trial(s) to CEPI no later than [***] prior to their contemplated submission to a Regulatory Authority. For the avoidance of doubt the Partners shall have final editorial control of such submissions. If a final version is not available by [***] prior to submission, then a mature draft version may be electronically delivered to CEPI for review at that time. Additionally, the Partners shall promptly make available for review by CEPI or its designated Assessors at one of the Partner’s premises copies of the following to the extent reasonably required for CEPI to evaluate the progress of the conduct and completion of each Project Clinical Trial or other clinical trial that utilises any Project Clinical Trial Materials:
8.3.1 all submissions to Regulatory Authorities and regulatory filings for the Project Clinical Trial or other clinical trial that utilises any Project Clinical Trial Materials together with all data included or referenced therein (other than ministerial submissions that do not involve safety or efficacy issues); and
8.3.2 material documents and information exchanged between any Regulatory Authority and a Partner, including relating to the Project Clinical Trial or other clinical trial that utilises any Project Clinical Trial Materials including official meeting minutes.
Regulatory Strategy. The Parties shall work together through the JDC and the JMC to determine regulatory strategy in the Territory.
