Clinical Development Plan definition

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

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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

• The Clinical Development Plan shall include (a) an outline of Clinical Trials to be conducted by Zai in the Territory, including the Local Studies and Joint Global Studies; and (b) the material activities to be performed by the Parties to obtain the Regulatory Approvals for the Products in the Territory and to support the Joint Global Studies.

• Changes in the scope or direction of the Development work under this Agreement that would be a material deviation from the Clinical Development Plan must be approved by the JSC as set forth in Section 3.2(b); provided that any change with respect to Joint Global Studies shall be consistent with the Joint Global Studies as set forth in the Global Development Plan.

• 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.

• 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.

• 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.

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 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, 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 has the meaning set forth in Section 4.2(b).

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.