Clinical Plan definition

Clinical Plan means a written clinical plan setting forth the protocol for the conduct of a Clinical Trial, preparation and filing of each Regulatory Package related to such Clinical Trial, and the activities to be conducted by each Person that is a party to conducting such Clinical Trial in support of such Clinical Trial, including the timelines for such Clinical Trial.

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Clinical Plan has the meaning set forth in Section 4.1 of the Amended and Restated Research and Development Agreement.

Clinical Plan shall have the meaning assigned to such term in Section 3.3(a).

Examples of Clinical Plan in a sentence

• The Parties, either separately or jointly, may submit written proposals for Clinical Development Plans for any Clinical Development Candidate (“Proposed Clinical Plans”) to the JSC for review (which review shall take place at the first JSC meeting following submission of a Proposed Clinical Plan to the JSC) and recommendation to the Parties; provided that each Party may submit no more than one Proposed Clinical Plan per calendar quarter during the Term.

• Angiotech and/or Athersys may prepare and submit a Proposed Clinical Plan to the JSC in accordance with Section 3.5(c) for any Clinical Development Candidate.

• Any Proposed Clinical Plan that is recommended by the JSC and approved in writing by the Parties will be deemed a Clinical Development Plan, and each such approved Clinical Development Plan shall be a part of, and subject to all of the provisions of, this Strategic Alliance Agreement and the other Transaction Agreements, as applicable.

• The Parties anticipate that the protocol for the Phase I/II Clinical Trial contemplated in the Clinical Plan Framework shall consist of two (2) parts; the first part [**] targeted at dose escalation and the second part focused on safety and efficacy of the ADC.

• Each Proposed Clinical Plan shall address the specific roles and responsibilities of each Party consistent with this Strategic Alliance Agreement, shall address and/or incorporate any JSC recommendations, and shall propose appropriate Clinical Development Programs for each stage of development set out in such Proposed Clinical Plan.

More Definitions of Clinical Plan

Clinical Plan means the plan governing the Ongoing Phase 1/2 Study, an initial version of which is attached hereto as Exhibit C and as amended from time to time as provided in Section 5.1.

Clinical Plan means the plan agreed upon by the parties for conducting the Clinical Program, as such plan may be amended from time to time by the TLC.

Clinical Plan shall have the meaning given to it in Section 3.6.

Clinical Plan means the plan that sets out the clinical goals of the Company in relation to the D5 Business, as agreed by ES1 and Nerano prior to the Completion of this Agreement, as set out at Schedule 14;

Clinical Plan means the written plan for the further clinical development of DepoCyt for seeking approval to sell DepoCyt in the Territory, including a budget for Clinical Trial Expenses. The initial Clinical Plan is attached hereto as EXHIBIT A, and shall be modified only by the CSC as provided in Article 4 below.

Clinical Plan means the clinical plan and budget for each Country as determined or varied in accordance with the provisions of Section 4.01.

Clinical Plan has the meaning given in the Transaction Agreement;