Regulatory Costs. Each Party shall be responsible for all costs and expenses of preparing, maintaining, formatting, and submitting Regulatory Materials for Licensed Products in its respective territory and for all other costs and expenses in connection with seeking and maintaining Regulatory Approval and Pricing Approval for Licensed Products in its respective territory, except for those regulatory items (A) specifically set forth in the Global Product Development Plan and included in the Development Budget as to which the other Party explicitly agrees to share the costs or (B) conducted by the other Party through its Independent Activities.
Appears in 4 contracts
Samples: Collaboration Agreement (Takeda Pharmaceutical Co LTD), Collaboration Agreement (Seattle Genetics Inc /Wa), Collaboration Agreement (Takeda Pharmaceutical Co LTD)