Common use of Regulatory Approvals and Regulatory Reporting Clause in Contracts

Regulatory Approvals and Regulatory Reporting. AntriaBio will be solely responsible for the preparation and filing of the Regulatory Approvals for the Licensed Products with the applicable Regulatory Authorities in the Territory. AntriaBio shall prepare and file the Regulatory Approval Applications for the Products with the Regulatory Authorities in its name and at its cost. AntriaBio shall file, in its own name and at its own expense, all other applications for any approvals required for any clinical study or other study or action necessary or desirable to obtain such Regulatory Approval. AntriaBio shall have the sole responsibility for communicating with any Regulatory Authority regarding any MAA or any Regulatory Approval for the Licensed Products once granted or any such other applications. AntriaBio shall be responsible for filing, at its own expense, all reports required to be filed in order to maintain any Regulatory Approvals granted for the Licensed Products.