Common use of SANTARUS' REGULATORY RESPONSIBILITY Clause in Contracts

SANTARUS' REGULATORY RESPONSIBILITY. Santarus shall be responsible for obtaining and maintaining all regulatory filings and approvals (excluding the overall licensure and permitting of the Facility) for the manufacture and marketing of the Finished Product, including without limitation all INDA’s and NDA’s for the Finished Product. Santarus shall control and own all such filings and approvals. Patheon will supply to Santarus from time to time, all such data relating to the Finished Product, including release test results, complaint test results, all investigations (in manufacturing, testing and storage), and the like, that Santarus reasonably requires in order to complete any such filing or approval, including any annual product review report that Santarus is required to file with the FDA and as provided in the Quality Agreement. At Santarus’ request and subject to an additional fee to be agreed by the Parties, Patheon may prepare annual product review reports on behalf of Santarus and in accordance with Santarus’ instructions.

SANTARUS' REGULATORY RESPONSIBILITY. Santarus shall be responsible for obtaining and maintaining all regulatory filings and approvals (excluding the overall licensure and permitting of the Facility) for the manufacture and marketing of the Finished Product, including without limitation all INDA’s 's and NDA’s 's for the Finished Product. Santarus shall control and own all such filings and approvals. Patheon will supply to Santarus from time to time, all such data relating to the Finished Product, including release test results, complaint test results, all investigations (in manufacturing, testing and storage), and the like, that Santarus reasonably requires in order to complete any such filing or approval, including any annual product review report that Santarus is required to file with the FDA and as provided in the Quality Agreement. At Santarus’ ' request and subject to an additional fee to be agreed by the Parties, Patheon may prepare annual product review reports on behalf of Santarus and in accordance with Santarus’ ' instructions.

SANTARUS' REGULATORY RESPONSIBILITY. Santarus shall be responsible for obtaining and maintaining all regulatory filings and approvals (excluding the overall licensure and permitting of the Facility) for the manufacture and marketing of the Finished Product, including without limitation all INDA’s 's and NDA’s 's for the Finished Product. Santarus shall control and own all such filings and approvals. Patheon Manufacturer will supply to Santarus from time to time, all such data relating to the Finished Product, including release test results, complaint test results, all investigations (in manufacturing, testing and storage), and the like, that Santarus reasonably requires in order to complete any such filing or approval, including any annual product review report that Santarus is required to file with the FDA and as provided in the Quality Agreement. At Santarus’ request and subject to an additional fee to be agreed by the Parties' request, Patheon Manufacturer may prepare annual product review reports on behalf of Santarus and in accordance with Santarus’ ' instructions. Santarus will compensate Manufacturer for the preparation of annual product review reports based upon a mutually agreed upon (in writing) cost schedule.