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 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. 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). Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission.
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. 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. The Parties will discuss and determine in the JDC the regulatory strategy for the Licensed Products in the Field in the Territory.
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.
Regulatory Strategy. The JDC will discuss and develop a regulatory strategy for the Licensed Product in each country or region in the Territory (which, strategy will include the estimated timeline for submission of XXXx for the Licensed Product in each country and region in the Territory) to be included in the Territory Development Plan and will submit the same to the JSC to review, discuss, and determine whether to approve. From time to time the JDC may update the regulatory strategy for the Licensed Product and submit the same to the JSC to review, discuss, and determine whether to approve. Once approved by the JSC, each update to a regulatory strategy for such the Licensed Product will become effective and supersede the then-current regulatory strategy for the Licensed Product.
Regulatory Strategy. Exhibit C sets forth Cadence’s Regulatory Strategy associated with development of the Product. Cadence shall be solely responsible for the Regulatory Strategy, which must be finalized prior to commencement by Baxter of Product stability batch production; provided, Cadence will discuss with Baxter any elements of its Regulatory Strategy which may reasonably be expected to have an impact on Bxxxxx’x obligations under this Agreement.
Regulatory Strategy. With respect to each Product, except for any interaction or communication with a Regulatory Authority that Xxxxx is required to conduct under Applicable Law in connection with Xxxxx’x conduct of the Existing Clinical Studies in accordance with the terms of this Agreement, Licensee and its Related Parties are solely responsible for all interactions and communications with Regulatory Authorities including, without limitation, in relation to INDs, BLAs, label development, advisory committee meetings or their equivalent (if applicable) and negotiation with Regulatory Authorities regarding post-approval requirements/commitments.
