Examples of CMC Data in a sentence
For clarity, CMC Data included in such submissions shall be subject to Section 7.3.b.
The Parties agree that Otsuka shall have no right to exercise its license right granted under Section 2.1 to use the Manufacturing GW Pharma Know-How or GW Pharma CMC Data to make and have made Licensed Products or BDS unless and until it is permitted to do so under the terms of the Manufacturing and Supply Agreement.
Under the Second Indication Development Plan and other future development plans for Additional Indications activities will primarily be managed and conducted by Otsuka at its own cost and expense save that GW Pharma shall be responsible for the generation of all relevant CMC Data at its own cost and expense.
The budget set forth in the First Indication Development Plan (the “Development Budget”) shall set out the Third Party costs projected to be incurred by GW Pharma in the performance of its obligations under such Development Plan (including the cost to GW Pharma of relevant clinical trial insurance) other than the costs to GW Pharma of generating the CMC Data (“Development Costs”).
All activities carried out in relation to any Development Plan (other than generation of the CMC Data) will be financed by Otsuka including all activities to be managed and conducted by GW Pharma in accordance with such Development Plan.