Regulatory Obligations. Licensee will own and maintain all regulatory filings and Marketing Approvals in the Territory for POZEN Products, including all INDs and NDAs for the Initial POZEN Product. As between the Parties, but subject to [...***...], Licensee will be solely responsible for all activities in connection with maintaining Marketing Approvals required for the Commercialization and manufacture of POZEN Products in the Territory, including communicating and preparing and filing all reports (including Adverse Event reports) with the applicable Regulatory Authorities in the Territory.
Appears in 3 contracts
Samples: Collaboration and License Agreement, Collaboration and License Agreement (Horizon Pharma, Inc.), Collaboration and License Agreement (Horizon Pharma, Inc.)
Regulatory Obligations. On a country-by-country basis, Licensee will own and maintain all regulatory filings and Marketing Approvals in the Territory for POZEN Products, including all INDs and NDAs for the Initial POZEN ProductProduct in the Territory. As between the Parties, but subject to [...***...], Licensee will be solely responsible for all activities in connection with maintaining Marketing Approvals required for the Commercialization and manufacture of POZEN Products in the Territory, including communicating and preparing and filing all reports (including Adverse Event reports) with the applicable Regulatory Authorities in the Territory.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Pozen Inc /Nc), Collaboration and License Agreement (Pozen Inc /Nc)
Regulatory Obligations. Licensee will own and maintain all regulatory filings and Marketing Approvals in the Territory for POZEN Products, including all INDs and NDAs for the Initial POZEN Product. As between the Parties, but subject to [...***...], Licensee will be solely responsible for all activities in connection with maintaining Marketing Approvals required for the Commercialization and manufacture of POZEN Products in the Territory, including communicating and preparing and filing all reports (including Adverse Event reports) with the applicable Regulatory Authorities in the Territory.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Pozen Inc /Nc), Collaboration and License Agreement (Pozen Inc /Nc)