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.
Examples of Clinical Development Plan in a sentence
Each Clinical Development Plan approved by the Parties shall be attached hereto as Schedule 1.14.
The Initial Development Plan includes and shall be integrated with those Phase 3 Clinical Trials that are currently being conducted by FibroGen or Astellas under the U.S. and EU plan for conducting Phase 3 Clinical Trials of the Product for the CKD Indications under the Astellas EU Agreement (the Transatlantic Clinical Development Plan or the TCDP).
MacroGenics shall be responsible for the manufacture of all Product required for the clinical trials described in the Phase I Clinical Development Plan, Phase II Clinical Development Plan and, if any, additional development plans, including any plan for a Phase III Clinical Trial, agreed upon in writing by the Parties for additional studies under this Agreement, either by itself or through one or more Third Parties, including all costs of such manufacture, as set forth in Section 3.4.
Either Party may subcontract any of its obligations under a Clinical Development Plan, provided that it furnishes the JSC and the other Party with advance written notice thereof specifying the work to be subcontracted, and with an opportunity to object to such subcontract for sound business reasons.
On no less than an annual basis, the JDC shall review the Phase I Clinical Development Plan and Phase II Clinical Development Plan, as appropriate, and recommend any amendment, and any changes to such plans shall be subject to the approval by the JDC and, subsequently, by the JSC.