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 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:

Examples of Clinical Development Plan in a sentence

• If the JSC approves such proposed amendment in accordance with Section 2.1.4(c), the Clinical Development Plan or CMC Development Plan, as applicable, shall be deemed amended to reflect such amendment and such amended Clinical Development Plan or CMC Development Plan, as applicable, shall become effective and supersede the previous Clinical Development Plan or CMC Development Plan, as applicable, as of the date of such approval.

• From time to time during the Development Term, either Party may submit proposed amendments to the Clinical Development Plan to the JSC for review and approval, and either Party or the JMC may submit proposed amendments to the CMC Development Plan to the JSC for review and approval.

• The JSC shall also discuss whether any amendments to the Phase 2 Activities in the Clinical Development Plan should be made due to the results from the Phase 1 Activities and/or to address Material Safety Issues raised by either Party, and any such amendments shall be approved by the JSC in accordance with Section 3.2.2.

• The costs and expenses of the Phase 2 Activities shall be shared by the Parties in accordance with Section 7.2. Xxxxxxx shall use Diligent Efforts to conduct and complete the Phase 2 Activities in accordance with the Clinical Development Plan (including the timeline set forth therein).

• Once a determination is made by the PDC with respect to the appropriate actions to be taken, the PDC shall review and re-evaluate the relevant Clinical Development Plan and the Clinical Budget and make any changes necessary to implement such actions.

More Definitions of Clinical Development Plan

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

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, 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 means the plan which sets forth a detailed overview of the intended clinical development of each Licensed Product, including without limitation a summary of all material development activities to be conducted by or on behalf of ProNAi for the purposes of obtaining Regulatory Approval for Licensed Products in the Territory, together with associated timelines for such activities. An exemplary Clinical Development Plan has been prepared prior to the Effective Date and appended at Schedule 9. The Clinical Development Plan shall be updated at least annually by ProNAi and details of any material updates shall be set forth in the next applicable Progress Report and provided to CPF in accordance with Clause 4.4.1.

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, 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 shall have the meaning assigned thereto in Section 3.2.