Regulatory Activities. ZAI shall apply for (and maintain), at ZAI’s cost and expense, all Regulatory Approvals of Licensed Products in the ZAI Territory. ZAI shall be responsible for the preparation of all Regulatory Materials and all communications and interactions with Regulatory Authorities with respect to the Licensed Products in the ZAI Territory, both prior to and subsequent to Regulatory Approval. ZAI shall file all required regulatory dossiers to obtain (and maintain) Regulatory Approvals of the Licensed Products in the ZAI Territory, and will be the holder of such Regulatory Approvals.
Appears in 4 contracts
Samples: Collaboration, Development and License Agreement (Zai Lab LTD), Collaboration, Development and License Agreement (TESARO, Inc.), Collaboration, Development and License Agreement (TESARO, Inc.)