Common use of Registrations, Licenses and Permits Clause in Contracts

Registrations, Licenses and Permits. 8.1.1 If and as required from time to time under the laws of the Territory, Nipro, at Nipro's expense, shall perform clinical trials and obtain all registrations, licenses, permits, import approvals, reimbursement approvals, and other legal or administrative items required to comply with the laws and regulations of the Territory for importation, sale and distribution of the FreeStyle Products, and gain reimbursement for such sales (collectively "Approvals"). Nipro shall provide to TheraSense, for *** Confidential treatment requested TheraSense's unrestricted use, complete copies of all clinical trials, protocols, data, analyses and other information, as well as applications, and all registrations, licenses, permits, and approval obtained therefrom relating to the FreeStyle Products. 8.1.2 TheraSense will provide Nipro with all information, data, materials and product samples in its possession necessary to obtain Approvals. In the event that disclosure of TheraSense trade secrets are required for the Approvals, TheraSense will provide such trade secret information directly to the Japan regulatory authorities. 8.1.3 All Approvals will be in Nipro's name unless otherwise agreed by the parties or required by law. Upon the expiration, cancellation, or termination of this Agreement, Nipro shall transfer such Approvals to TheraSense or TheraSense's agent so that TheraSense will be able to continue to sell FreeStyle Products and be reimbursed for FreeStyle Products in the Territory, subject to the following: (a) in the event this Agreement is terminated by Nipro due to TheraSense's material breach, or in the event TheraSense elects not to extend the term of this Agreement pursuant to Section 12.1.2, or in the event TheraSense terminates this Agreement for Nipro's failure to meet the Annual Minimum Purchase Obligations in any year, TheraSense shall pay Nipro *** to compensate Nipro for the direct expenses paid by Nipro to obtain and transfer such Approvals (the "Approval Compensation"); or (b) in the event this Agreement is terminated by TheraSense due to Nipro's material breach, or in the event Nipro elects not to extend the term of this Agreement pursuant to Section 12.1.2, TheraSense shall have no obligation to pay the Approval Compensation. *** Confidential treatment requested

Registrations, Licenses and Permits. 8.1.1 If and as required from time Licensor shall make available to time under the laws of the Territory, Nipro, at Nipro's expense, shall perform clinical trials and obtain Licensee all registrations, licenses, permitsgovernment approvals and permits in Licensor’s possession or control (“Permits”) required upon the Start Date to comply with the laws and regulations in the Territory for Licensed Exploitation, import approvalsdisplay and distribution of the Managed Assets, reimbursement approvals, including without limitation all Section 2257 and other legal or administrative items compliance documents, at Licensor’s expense. Licensor agrees to execute any documents and render any assistance as may be reasonably necessary to perfect Licensee’s rights in such Permits. To the extent such Permits are required during the Term, Licensee, at Licensee's expense but allocated as a cost of operations when calculating Net Profits, shall promptly obtain and/or renew all Permits required to comply with the laws and regulations of in the Territory for importationLicensed Exploitation, sale display and distribution of the FreeStyle ProductsManaged Assets, including without limitation all Section 2257 and gain reimbursement for other compliance documents (except to the extent any such sales (collectively "Approvals"Permits are required by Content provided by Licensor hereunder). Nipro shall provide In such case, Xxxxxxxx agrees to TheraSense, for *** Confidential treatment requested TheraSense's unrestricted use, complete copies of all clinical trials, protocols, data, analyses execute any documents and other information, render any assistance as well as applications, and all registrations, licenses, permits, and approval obtained therefrom relating may be reasonably required in order to the FreeStyle Products. 8.1.2 TheraSense will provide Nipro with all information, data, materials and product samples in its possession necessary assist Licensee to obtain Approvals. In the event that disclosure of TheraSense trade secrets are required for the Approvals, TheraSense will provide such trade secret information directly to the Japan regulatory authorities. 8.1.3 All Approvals will be in Nipro's name unless otherwise agreed by the parties or required by lawPermits. Upon the expiration, cancellation, expiration or termination of this Agreement, Nipro all Permits shall transfer be transferred and delivered to, and shall inure to the benefit of Licensor or its designee, to the extent permissible under applicable law, at Licensor’s expense; and Licensee and its Affiliates agree to execute any documents and render any assistance as may be reasonably necessary to perfect Licensor’s rights in such Approvals Permits. Licensee shall be responsible for obtaining the appropriate Permits required to TheraSense import or TheraSense's agent so that TheraSense will be able export any part of the Managed Assets into the Territory and for obtaining all documents required to continue to sell FreeStyle Products comply with the laws and be reimbursed regulations in the Territory for FreeStyle Products Licensed Exploitation, display, and distribution of the Managed Assets, including without limitation, all Section 2257 and other compliance documents, all at Licensee’s expense but allocated as a cost of operations when calculating Net Profits. Licensee shall implement Section 2257 compliance measures, as well as any other measures required by applicable law in the Territory. To the extent permitted by law within the Territory, subject to the following: (a) in the event this Agreement is terminated by Nipro due to TheraSense's material breach, upon expiration or in the event TheraSense elects not to extend the term termination of this Agreement pursuant to Section 12.1.2Agreement, or in the event TheraSense terminates this Agreement for Nipro's failure to meet the Annual Minimum Purchase Obligations in any year, TheraSense shall pay Nipro *** to compensate Nipro for the direct expenses paid by Nipro to obtain and transfer such Approvals (the "Approval Compensation"); or (b) in the event this Agreement is terminated by TheraSense due to Nipro's material breach, or in the event Nipro elects not to extend the term of this Agreement pursuant to Section 12.1.2, TheraSense Licensor shall have no obligation the exclusive rights to pay all Permits and all Section 2257 compliance documents, model releases, and other releases obtained during the Approval Compensation. *** Confidential treatment requestedTerm of the Agreement.

Registrations, Licenses and Permits. 8.1.1 If and as required from time to time under the laws of the Territory, Nipro, at Nipro's expense, shall perform clinical trials and obtain all registrations, licenses, permits, import approvals, reimbursement approvals, and other legal or administrative items required to comply with the laws and regulations of the Territory for importation, sale and distribution of the FreeStyle Products, and gain reimbursement for such sales (collectively "Approvals"). Nipro shall provide to TheraSense, for *** Confidential treatment requested TheraSense's unrestricted use, complete copies of all clinical trials, protocols, data, analyses and other information, as well as applications, and all registrations, licenses, permits, and approval obtained therefrom relating to the FreeStyle Products. 8.1.2 TheraSense will provide Nipro with all information, data, materials and product samples in its possession necessary to obtain Approvals. In the event that disclosure of TheraSense trade secrets are required for the Approvals, TheraSense will provide such trade secret information directly to the Japan regulatory authorities. 8.1.3 All Approvals will be in Nipro's name unless otherwise agreed by the parties or required by law. Upon the expiration, cancellation, or termination of this Agreement, Nipro shall transfer such Approvals to TheraSense or TheraSense's agent so that TheraSense will be able to continue to sell FreeStyle Products and be reimbursed for FreeStyle Products in the Territory, subject to the following: (a) in the event this Agreement is terminated by Nipro due to TheraSense's material breach, or in the event TheraSense elects not to extend the term of this Agreement pursuant to Section 12.1.2, or in the event TheraSense terminates this Agreement for Nipro's failure to meet the Annual Minimum Purchase Obligations in any year, TheraSense shall pay Nipro *** to compensate Nipro for the direct expenses paid by Nipro to obtain and transfer such Approvals (the "Approval Compensation")shall; or (b) in the event this Agreement is terminated by TheraSense due to Nipro's material breach, or in the event Nipro elects not to extend the term of this Agreement pursuant to Section 12.1.2, TheraSense shall have no obligation to pay the Approval Compensationshall. *** Confidential treatment requested

Registrations, Licenses and Permits. 8.1.1 If Distributor agrees to use its best efforts to investigate, obtain government approval for, promote and distribute the Products, (solely for research purposes) at its own expense, 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 with respect to other research 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 Manufacturer. 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, customs clearances and currency authorizations and any permits necessary in each jurisdiction in the Territory. Distributor shall keep Manufacturer 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 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 Manufacturer below. Distributor shall file for regulatory approval for the sale of Products in the Territory by Amersham K.K. If Manufacturer so requests, Distributor shall notify Manufacturer each time under it submits an application for government registration and marketing approval for the laws Products and shall, at Manufacturer's request, supply Manufacturer with copies of or access to Distributor's filings and clinical data and shall keep Manufacturer fully informed of the progress of each such application. Manufacturer 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 performance of, or any deleterious physiological effects caused by or related to, the Products. (ii) Within thirty (30) days after the date of this Agreement, submit to Manufacturer a complete marketing plan, prepared by Distributor in good faith, which shall be subject to approval by Manufacturer, for the Products in each jurisdiction in the Territory. Such plan shall be updated and delivered to Manufacturer annually and shall include, at a 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 Manufacturer; distribution and promotional plans; schedule for submission of applications for government registration and marketing approval; and marketing program. 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 Manufacturer's prior review and approval. (iii) Commence marketing of the Products throughout the Territory immediately after receipt of government health registration approvals, if applicable. Distributor shall be deemed to have commenced the marketing of the Products only when it shall have offered the Products regularly for sale. (iv) Use its best efforts to distribute and sell the Products for research purposes only and for use only by qualified individuals, as appropriate in the Territory, Nipro, at Nipro's expense, shall perform clinical trials and obtain all registrations, licenses, permits, import approvals, reimbursement approvals, and other legal or administrative items required to comply in compliance with the local laws and regulations of and good commercial practice and for uses and applications reasonably approved by Manufacturer for the Territory for importation, sale and distribution of the FreeStyle Products, and gain reimbursement for such sales (collectively "Approvals"). Nipro shall provide to TheraSense, for *** Confidential treatment requested TheraSense's unrestricted use, complete copies of all clinical trials, protocols, data, analyses and other information, as well as applications, and all registrations, licenses, permits, and approval obtained therefrom relating to the FreeStyle Products. 8.1.2 TheraSense will provide Nipro with all information, data, materials and product samples in its possession necessary to obtain Approvals. In the event that disclosure of TheraSense trade secrets all necessary registrations, licenses and permits required to sell and distribute the Products in the Territory for clinical use (if applicable) are required for not obtained within nine (9) months after the Approvals, TheraSense will provide such trade secret information directly to the Japan regulatory authorities. 8.1.3 All Approvals will be in Nipro's name unless otherwise agreed by the parties or required by law. Upon the expiration, cancellation, or termination effective date of this Agreement, Nipro shall transfer such Approvals to TheraSense or TheraSense's agent so that TheraSense will be able to continue to sell FreeStyle Products and be reimbursed for FreeStyle Products Manufacturer may, in the Territoryits sole discretion, subject to the following: (a) in the event terminate this Agreement is terminated by Nipro due upon written notice to TheraSense's material breach, or in the event TheraSense elects not to extend the term of this Agreement pursuant to Section 12.1.2, or in the event TheraSense terminates this Agreement for Nipro's failure to meet the Annual Minimum Purchase Obligations in any year, TheraSense shall pay Nipro *** to compensate Nipro for the direct expenses paid by Nipro to obtain and transfer such Approvals (the "Approval Compensation"); or (b) in the event this Agreement is terminated by TheraSense due to Nipro's material breach, or in the event Nipro elects not to extend the term of this Agreement pursuant to Section 12.1.2, TheraSense shall have no obligation to pay the Approval Compensation. *** Confidential treatment requestedDistributor.