Clinical Development Plan definition

Clinical Development Plan shall have the meaning set forth in Section 5.2.

Clinical Development Plan means the outline and any and all amendments thereto made during the term of this Agreement, the initial copy of which has been tendered to MDI as part of the Conditions Precedent is attached hereto as Exhibit A and incorporated herein and made part of this Agreement along with all subsequent amendments.

Clinical Development Plan has the meaning set forth in Section 3.7.

Examples of Clinical Development Plan in a sentence

• Eucodis will keep adequate inventories of Product materials on hand or with suppliers according to the Clinical Development Plan and any quantities in inventory which comply with the requirements of the Act.

• The Steering Committee shall have the authority to generally guide, plan , monitor and, if needed, direct the Clinical Development Plan, settle disagreements between the Parties, monitoring the patent filing strategy in the Territory.

• Eucodis further covenants that a complete Clinical Development Plan will be delivered to MDI within ninety days of execution of this Agreement and Eucodis further covenants that updates of that Plan will be provided to MDI as the Clinical Development Plan is amended throughout the term of this Agreement.

• Each Local Study conducted in the Territory shall be conducted in accordance with the Clinical Development Plan, the study protocol approved by any relevant Regulatory Authority, and Applicable Laws in the Territory.

• As soon as practicable after the BLA Filing Date, and consistent with the transition plan adopted by the PDC and contained in the initial Clinical Development Plan, the Company shall transition such clinical and other studies ongoing with respect to the Products which have been identified in such Clinical Development Plan as being transferred to ERS in such transition plan from the Company's sole control to the control of the Party(ies) set forth in the initial Clinical Development Plan.

More Definitions of Clinical Development Plan

Clinical Development Plan means the definitive clinical development plan approved by the PDC pursuant to Section 4.3(b), and each subsequent definitive clinical development plan approved by the PDC pursuant to Section 4.3(e).

Clinical Development Plan means the Parties’ written plan for the clinical Development of the Initial Product during the Development Term, as amended from time to time pursuant to Section 3.2.2, including the budget and timelines described in Section 3.2.1(a). The initial Clinical Development Plan is attached hereto as Exhibit A.

Clinical Development Plan means, subject to Section 3, a plan for the Clinical Development activities to be performed by either Party under this Agreement that may be amended from time to time according to Section 6.

Clinical Development Plan means, with respect to the IVT Products, the clinical development plan set forth on Exhibit A for the Phase II Clinical Trial for the IVT Products and, with respect to the Oral DME Products, the activities leading up to a Phase II Clinical Trial design substantially similar to the plan for the IVT Products as set forth on Exhibit A.

Clinical Development Plan shall have the meaning assigned thereto in Section 3.2.

Clinical Development Plan means the JSC-reviewed written clinical development plan for a particular Product, setting forth the clinical development activities to be conducted by the Parties with the goal of achieving Marketing Authorizations in both the EU and the United States of America. Clinical Development Plans reviewed by the JSC pursuant to this Agreement shall be attached to and made a part of this Agreement and may be amended from time to time.

Clinical Development Plan means, for each Clinical Development Candidate, a detailed plan that sets forth the responsibilities of, and the activities to be conducted by, each of the Parties in advancing each such Clinical Development Candidate to Regulatory Approval for a Cardiovascular Indication (including a detailed budget corresponding to each such plan). Each such Clinical Development Plan shall include, without limitation, the following activities (or their equivalents), to the extent applicable: (a) conducting pre-clinical research, pre-clinical development and other pre-clinical studies that are intended to support clinical development of a Clinical Development Candidate for a Cardiovascular Indication; Table of Contents (b) preparation and filing of an IND for a Clinical Development Candidate for a Cardiovascular Indication; (c) conducting clinical trials of such Clinical Development Candidate for a Cardiovascular Indication, including clinical trials that are intended to support Regulatory Approvals for such Clinical Development Candidate for such Cardiovascular Indication; and (d) preparation and filing of documentation, applications (including, for example, an NDA/BLA) and related activities to enable the Parties to seek Regulatory Approval for such Clinical Development Candidate for such Cardiovascular Indication. Each Clinical Development Plan approved by the Parties shall be attached hereto as Schedule 1.14.