Regulatory Activities. (a) Except as detailed in Section 5.1(b), Licensee shall be responsible for conducting all Development activities related to Regulatory Materials and Regulatory Approvals in the Field and in the Territory. Licensee shall be responsible for preparing and submitting the NDAs in the Territory and in the Field for all indications for the Product. Licensee shall file and own all right, title and interest in all regulatory filings designed to obtain or support Regulatory Approval in the Territory.
Appears in 4 contracts
Samples: License and Collaboration Agreement (Menlo Therapeutics, Inc.), License and Collaboration Agreement (Menlo Therapeutics, Inc.), License and Collaboration Agreement (Menlo Therapeutics, Inc.)
