Development Funding Responsibility Sample Clauses

Development Funding Responsibility. MYLAN shall reimburse THERAVANCE for all Development Expenses actually incurred, in accordance with the Development Budget contained in the Development Plan to Develop the Licensed Product in the Field for the U.S., from January 1, 2015 through first NDA approval for the Licensed Product in the Field in the U.S. MYLAN shall reimburse THERAVANCE on a quarterly basis in arrears for all such Development Expenses within thirty (30) days of receipt of THERAVANCE’s invoice therefor. After the approval of the first NDA for the Licensed Product in the Field in the U.S., all Development Expenses incurred by THERAVANCE for the U.S. and all costs actually incurred by MYLAN in connection with the Development of the Licensed Product in the Field for the U.S. in accordance with the Development Budget contained in the then-current Development Plan approved by the JSC (“Post-Approval Development Expenses”) will be Shared Expenses. For clarity, any Development Expense incurred by THERAVANCE after approval of the first NDA for the Licensed Product in the Field in the U.S. which is required or requested by FDA as a condition or in support of obtaining such NDA approval shall be Post-Approval Development Expenses.
Development Funding Responsibility. MYLAN shall pay all Development Expenses incurred or committed to and which are set forth in the Development Budget contained in the Development Plan for all ROW Development hereunder, unless otherwise agreed by the JSC as part of the Development Budget. For clarity, if THERAVANCE has responsibility to conduct any ROW Development activities under the ROW Development Plan, Section 4.02(d) shall apply with respect to ROW Development Expenses associated therewith. THERAVANCE shall reimburse MYLAN for [***] of the costs of any Licensed Product in the Field comprising Approval Batches for the ROW Countries that is not actually sold, within thirty (30) days of receipt of MYLAN’s invoice therefor.