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, at its expense, to use its best efforts to investigate, obtain government approval for, promote, and distribute the Products, in the Territory as soon as 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 for other medical application products sold by Distributor, as well as any of Distributor’s own products.
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.
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:
(i) Exercise due diligence to promptly obtain and maintain government approvals to import, register and market the Products in each jurisdiction in the Territory and to diligently proceed to secure and maintain, as may be required from time to time, government importing, registration and marketing approvals, import and export licenses, customs clearances and currency authorizations and any permits necessary in each jurisdiction in the Territory. Distributor shall keep Cardima generally informed of the regulatory requirements in each jurisdiction in the Territory and shall submit to the government health authorities in each jurisdiction in the Territory where the sale of the Products is planned a complete application for registration and marketing approval of the Products by the date set forth in any marketing plan required by Cardima below. Distributor shall file for regulatory approval by the date or dates set forth on Exhibit B attached hereto. If Cardima so requests, Distributor shall notify Cardima each time it submits an application for government approval for the Products and shall, at Cardima's request, supply with copies of or access to Distributor's filings and clinical data and shall keep Cardima fully informed of the progress of each such application. Cardima and Distributor agree to disclose promptly to the other all reports and any information which they have available or which become available to them relating to any deleterious physiological effects caused by or related to the Products. In the event that all necessary registrations, licenses and permits required to sell and distribute the Products in the Territory for clinical use (if applicable) are not obtained within twelve (12) months after the effective date of this Agreement, Manufacturer may, in its sole discretion, terminate this Agreement upon written notice to Distributor.
(ii) Prior to thirty (30) days after signing this a...
