DEVICE APPROVALS. Medtronic shall be responsible for filing, obtaining and maintaining all necessary regulatory approvals for the importation and sale of Developed Products. To the extent permitted by law, all foreign regulatory approvals shall be owned by Medtronic and shall be in the name of Medtronic.
DEVICE APPROVALS. MacroPore shall be responsible, on a timely basis and at its expense, for filing, obtaining and maintaining regulatory approvals in the Territory. To the extent permitted by law, all foreign regulatory approvals, including those processed by Medtronic, shall be owned by MacroPore and shall be in the name of MacroPore. Except as otherwise required by law or agreed by the parties, MacroPore will be responsible for the content of its own labeling. In connection with obtaining Device Approvals, MacroPore shall bear the expenses of meeting any applicable Product design and manufacturing facility requirements applicable to its then current manufacturing facility, and shall take all steps as are necessary to meet the EMD Directive.
DEVICE APPROVALS. Somnus shall be responsible, on a timely basis ---------------- and at its expense, for filing, obtaining and maintaining the CE Xxxx for Common Market approval. For countries requiring additional or an alternative regulatory approval, Medtronic may obtain any required regulatory approvals at its own expense. To the extent permitted by law, all foreign regulatory approvals, including those processed by Medtronic, shall be owned by Somnus and shall be in the name of Somnus. Medtronic will provide Somnus access to the copies of all government approval applications and other regulatory and governmental filings made by Medtronic with respect to each Product, together with the underlying data, promptly after submission to government authorities and shall provide to Somnus copies of all correspondence with government authorities with respect to Products promptly after receipt or [*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 9 submission thereof. Somnus may use, reference, and provide copies of regulatory and governmental filings and Product data made, developed, or acquired by Medtronic relating to its Products, to third parties as is reasonably necessary or useful for commercialization of any and all products or as required by law. Except as otherwise required by law or agreed by the parties, Somnus will be responsible for the content of its own labeling. In connection with obtaining Device Approvals, Somnus shall bear the expenses of meeting any applicable Product design and manufacturing facility requirements applicable to its then current manufacturing facility, and shall take all steps as are necessary to meet the EMD Directive.
DEVICE APPROVALS. MacroPore shall be responsible for filing, obtaining and maintaining any and all necessary regulatory approvals or clearances for the importation and/or commercialization of TS Surgical Film ("Device Approvals"). To the extent permitted by law, all foreign regulatory approvals, including those processed by Medtronic, shall be owned by MacroPore and shall be in the name of MacroPore. Except as otherwise required by law or agreed by the parties, MacroPore will be responsible for the content of its own labeling. In connection with obtaining Device Approvals, MacroPore shall bear the expenses of meeting any applicable TS Surgical Film design and manufacturing facility requirements applicable to its then current manufacturing facility, and shall take all steps as are necessary to meet the EMD Directive.
