Ownership and Maintenance of Governmental Approvals. 4.1.1 The Company will own all Marketing Authorizations for each country in the Territory for Licensed Products. Without limiting the generality of the foregoing, the Company shall prepare and submit in its own name and at its expense NDAs with the FDA in the U.S. and any other equivalent application with the Competent Authorities in other countries in the Territory.
Appears in 2 contracts
Samples: Contribution Agreement (CorMedix Inc.), Exclusive License Agreement (VioQuest Pharmaceuticals, Inc.)
Ownership and Maintenance of Governmental Approvals. 4.1.1 The Company will own all Marketing Authorizations for each country in the Territory for Licensed Products. Without limiting the generality of the foregoing, the Company shall prepare and submit in its own name and at its expense NDAs BLAs (or its equivalent) with the FDA appropriate Competent Authorities in the U.S. Territory’ and any other equivalent application with the Competent Authorities in other countries in the Territory.
Appears in 2 contracts
Samples: Exclusive License Agreement (Candel Therapeutics, Inc.), Exclusive License Agreement (Candel Therapeutics, Inc.)
Ownership and Maintenance of Governmental Approvals. 4.1.1 The Company will may obtain, in its own name, all Marketing Authorizations for each country in the Territory for Licensed Products. Without limiting the generality of the foregoing, the Company shall prepare and submit in its own name and at its expense NDAs PMAs with the FDA in the U.S. and any other equivalent application with the Competent Authorities in other countries in the Territory.
Appears in 2 contracts
Samples: License and Assignment Agreement (CorMedix Inc.), License and Assignment Agreement (CorMedix Inc.)
Ownership and Maintenance of Governmental Approvals. 4.1.1 The Company will own all Marketing Authorizations for each country in the Territory for Licensed ProductsProducts in the Field of Use. Without limiting the generality of the foregoing, the Company shall prepare and submit in its own name and at its expense NDAs with the FDA in the U.S. and any other equivalent application with the Competent Authorities in other countries in the Territory.
Appears in 1 contract
Samples: Migenix Cutanea Exclusive License Agreement (MIGENIX Inc.)
Ownership and Maintenance of Governmental Approvals. 4.1.1 The Company will own all Marketing Authorizations for each country in the Territory for Licensed ProductsProduct. Without limiting the generality of the foregoing, the Company shall prepare and submit in its own name and at its expense NDAs with the FDA in the U.S. and any other equivalent application with the Competent Regulatory Authorities in other countries in the Territory.
Appears in 1 contract
Samples: Exclusive License Agreement (CNS Pharmaceuticals, Inc.)