New River Responsibilities. Except as otherwise set forth in Sections 3.3.3(a) and 3.3.3(c), New River will maintain all regulatory filings and Regulatory Approvals in the US Territory for each Collaboration Product Developed pursuant to this Agreement, including all INDs and Drug Approval Applications. As between the Parties, New River will be solely responsible for all activities in connection with maintaining Regulatory Approvals required for the Commercialization of Collaboration Product in the US Territory, including communicating and preparing and filing all reports with the applicable Governmental Authorities, as described in further detail in and subject to Section 3.3.3.
Appears in 2 contracts
Samples: Collaboration Agreement (Shire Pharmaceuticals Group PLC), Collaboration Agreement (New River Pharmaceuticals Inc)
New River Responsibilities. Except as otherwise set forth in Sections 3.3.3(a) and 3.3.3(c), New River will maintain all regulatory filings and Regulatory Approvals in the US Territory for each Collaboration Product Developed developed pursuant to this Agreement, including all INDs and Drug Approval Applications. As between the Parties, New River will be solely responsible for all activities in connection with maintaining Regulatory Approvals required for the Commercialization of Collaboration Product in the US Territory, including communicating and preparing and filing all reports with the applicable Governmental Authorities, as described in further detail in and subject to Section 3.3.3.
Appears in 1 contract
Samples: Collaboration Agreement (Shire Pharmaceuticals Group PLC)