Common use of Registration and Marketing of Products Clause in Contracts

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 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 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 (including but not limited to “Shonins” in Japan) 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 reasonable efforts --------------------------------------- best effort to investigate, obtain government approval for, promote and distribute the Products Products, at its own expense, in the Territory as soon as regulatory and reimbursement permits are obtained in it is feasible after the Territorydate of this Agreement, using generally the same channels and methods, exercising the same diligence and adhering to the same standards which it employs for with respect to the other coronary intervention 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: (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 nine (9) 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 agreement, Distributor must submit to Cardima a complete and accurate marketing plan, prepared by Distributor in good faith, which shall be subject to approval by Cardima, for the Products in each jurisdiction in the Territory as well as a financial statement acceptable to Cardima. If and as requested by Cardima, such plan shall be updated and delivered to Cardima annually and shall include, at minimum, information on competitive products; proposed labeling (including label, package insert, introductory folder and advertising); estimated sales volume; anticipated quantities of the Products to be purchased from Cardima; distribution and promotional plans; schedule for submission of applications for government registration and marketing approval; and marketing approval. All Product labels, package inserts and claims, which are prepared for or by Distributor, shall meet all legal requirements of the jurisdiction in which the Products are marketed and shall be subject to Cardima's prior review and approval. (iii) Commence marketing of the Products throughout the Territory immediately after receipt of government health registration approvals. Distributor shall be responsible deemed to have commenced the marketing of the Products only when it shall have offered the Products regularly for obtaining sale. (iv) Use its best efforts to distribute and sell the Products for use only by qualified individuals, as appropriate in the Territory, in compliance with local laws and regulations and good commercial practice and for uses and applications reasonably approved by Cardima for the Products. Distributor shall be subject to performance criteria applied to distributors of the Products generally and as governed by market opportunity, as communicated by Cardima from time to time after discussion and agreement with the Distributor. (v) Purchase or cause to be purchased from Cardima all import, regulatory quantities of the Products required by Distributor in order to meet demand by purchasers and reimbursement registrations and approvals that are necessary or advisable for sales potential purchasers of the Products in the Territory and for Territory. Distributor shall not distribute nor market products competitive with 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 Products in the Territory during the term of this Agreement without the prior written consent of Cardima. If Cardima does not approve the request for distribution of competitive products, the Distributor must withdraw the competitive products from its market place or this agreement is subject to termination in thirty (30) days at no chargeCardima's discretion. Distributor shall be responsible for paying all direct and Distributor’s indirect costs required for not make any changes, alterations, modifications 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 additions to the advance Products without prior 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 EnglishCardima.

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 Xxxx and FDA approvals with respect to the Products. All data necessary to obtain CE Mxxx Xxxx 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 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 (including but not limited to “Shonins” in Japan) and for the performance of its duties hereunder (collectively, “Regulatory Approvals”); provided, however, that Supplier shall be responsible for obtaining CE Mxxx Xxxx and FDA approvals with respect to the Products. All data necessary to obtain CE Mxxx Xxxx 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 reasonable efforts best effort to investigate, obtain government approval for, promote and distribute the Products Products, at its own expense, in the Territory as soon as regulatory and reimbursement permits are obtained in it is feasible after the Territorydate of this Agreement, using generally the same channels and methods, exercising the same diligence and adhering to the same standards which it employs for with respect to the other coronary intervention 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: (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 requited 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 nine (9) 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 agreement, Distributor must submit to Cardima a complete and accurate marketing plan, prepared by Distributor in good faith, which shall be subject to approval by Cardima, for the Products in each jurisdiction in the Territory as well as a financial statement acceptable to Cardima. If and as requested by Cardima, such plan shall be updated and delivered to Cardima annually and shall include, at minimum, information on competitive products; proposed labeling (including label, package insert, introductory folder and advertising); estimated sales volume; anticipated quantities of the Products to be purchased from Cardima; distribution and promotional plans; schedule for submission of applications for government registration and marketing approval; and marketing approval. All Product labels, package inserts and claims, which are prepared for or by Distributor, shall meet all legal requirements of the jurisdiction in which the products are marketed and shall be subject to Cardima's prior review and approval. (iii) Commence marketing of the Products throughout the Territory immediately after receipt of government health registration approvals. Distributor shall be responsible deemed to have commenced the marketing of the Products only when it shall have offered the Products regularly for obtaining sale. (iv) Use its best efforts to distribute and sell the products for use only by qualified individuals, as appropriate in the Territory, in compliance with local laws and regulations and good commercial practice and for uses and applications reasonably approved by Cardima for the Products. Distributor shall be subject to performance criteria applied to distributors of the Products generally and as governed by market opportunity, as communicated by Cardima from time to time after discussion and agreement with the Distributor. (v) Purchase or cause to be purchased from Cardima all import, regulatory quantities of the Products required by Distributor in order to meet demand by purchasers and reimbursement registrations and approvals that are necessary or advisable for sales potential purchasers of the Products in the Territory and for Territory. Distributor shall not distribute nor market products competitive with 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 Products in the Territory during the term of this Agreement without the prior written consent of Cardima. If Cardima does not approve the request for distribution of competitive products, the Distributor must withdraw the competitive products from its market place or this agreement is subject to termination in thirty (30) days at no chargeCardima's discretion. Distributor shall be responsible for paying all direct and Distributor’s indirect costs required for not make any changes, alterations, modifications 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 additions to the advance Products without prior 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 EnglishCardima.