Registration and Marketing of Products. Distributor agrees to use its reasonable efforts to promote and distribute the Products in the Territory as soon as regulatory and reimbursement permits are obtained in the Territory, using generally the same channels and methods, exercising the same diligence and adhering to the same standards which it employs for other coronary intervention products sold by Distributor. Distributor shall be responsible for obtaining all import, regulatory and reimbursement registrations and approvals that are necessary or advisable for sales of the Products in the Territory and for the performance of its duties hereunder (collectively, “Regulatory Approvals”); provided, however, that Supplier shall be responsible for obtaining CE Mxxx and FDA approvals with respect to the Products. All data necessary to obtain CE Mxxx and FDA approvals will be the responsibility of Supplier and Supplier shall make such data available to Distributor for use in obtaining regulatory approvals in the Territory at no charge. Distributor shall be responsible for paying all direct and Distributor’s indirect costs required for or associated with obtaining Regulatory Approvals including clinical Products and the costs associated with clinical studies necessary for obtaining the Regulatory Approvals (collectively, the “Regulatory Costs”), except that Supplier will provide material and information in accordance with Section 4(b) at Supplier’s cost. Distributor shall keep Supplier apprised of the progress of all Regulatory Approvals. All clinical trial protocols and procedures required for or associated with obtaining Regulatory Approvals, and all data collection methods associated therewith, shall be subject to the advance written approval of Supplier, and all data obtained by or on behalf of Distributor under this Agreement shall be made available to Supplier in a timely manner at no charge for any and all purposes. Distributor shall have no duty to provide translation into English.
Registration and Marketing of Products. Distributor agrees to use its --------------------------------------- best effort to investigate, obtain government approval for, promote and distribute the Products, at its own expense, in the Territory as soon as it is feasible after the date of this Agreement, using generally the same channels and methods, exercising the same diligence and adhering to the same standards which it employs with respect to the other medical application products sold by Distributor, as well as Distributor's own products, if any. Unless prohibited by local law, all such registrations and approvals obtained by Distributor shall be in the name of Cardima. In particular, Distributor shall, at its own expense:
Registration and Marketing of Products. Distributor agrees to use -------------------------------------- its best effort to investigate, obtain government approval for, promote and distribute the Products, at its own expense, in the Territory as soon as it is feasible after the date of this Agreement, using generally the same channels and methods, exercising the same diligence and adhering to the same standards which it employs with respect to the other medical application products sold by Distributor, as well as Distributor's own products, if any. In particular, Distributor shall, at its own expense:
Registration and Marketing of Products. Distributor agrees, at its expense, to use its best efforts to investigate, obtain government approval for, promote, and distribute the Products, in the Territory upon execution of this Agreement, using generally the same channels and methods, exercising the same diligence and adhering to the same standards which it employs for other medical application products sold by Distributor, as well as any of Distributor’s own products. In addition, Distributor agrees to pursue regulatory approval and reimbursement for Supplier’s Products in the Territory in accordance with the local laws and regulations, provided that Supplier provides the required data and information to comply with the MHLW.
