Common use of National Registrations and IVD Registration Clause in Contracts

National Registrations and IVD Registration. The parties agree ------------------------------------------- and understand that (i) in December 2003, the IVD (98/79/EC) will become mandatory; (ii) until December 2003, National Registrations can be obtained and used; and (iii) Products already in the distribution chain in December 2003 can continue to be sold until December 2005. (a) Before CE-Marking according to IVD (98/79/EC). --------------------------------------------- (i) Disetronic, shall use its best efforts to obtain National Registrations in TheraSense's name (unless national regulations require the Registration to be in Disetronic's name) by December 31, 2000. It is understood and agreed by the parties that Disetronic's Affiliate, Disetronic Medical Systems AG, and/or Disetronic shall be the exclusive entity or entities responsible for obtaining such National Registrations; provided that if a National Registration must by -15- Initials: ____ ____ *** CONFIDENTIAL TREATMENT REQUESTED law be obtained by an entity other than Disetronic or Disetronic Medical Systems AG, then (i) Disetronic shall guarantee and hereby guarantees the performance of such other entity, and (ii) such other entity shall enter into a written agreement, binding such other party to terms and conditions substantially similar to the terms and conditions of this Agreement. If required by a regulatory agency to accomplish National Registration in a particular country in the European Territory, for each such country, TheraSense shall send to Disetronic within fourteen (14) days after Disetronic's request, those FreeStyle Products and copies of documents including but not limited to development files, production files, study protocols and results that are necessary to obtain such National Registration. It is understood and agreed by the parties that any such FreeStyle Products, documents, files, protocols and/or results are Confidential Information of TheraSense and subject to the terms of Article 11 herein. If and as required from time to time under the laws of any country or other jurisdiction within the European Territory, Disetronic, *** shall perform clinical trials and obtain all additional registrations, licenses and permits required to comply with the laws and regulations of each country in the European Territory for importation, sale and distribution of the FreeStyle Product; provided, however, that no activities in connection with obtaining such registrations, licenses or permits shall be initiated by Disetronic without TheraSense's prior written approval. Disetronic shall provide to TheraSense complete copies of all clinical trial protocols, data, analyses and other information, as well as applications, and all registrations, licenses and permits obtained therefrom relating to the FreeStyle Products. To the extent permitted by law, all registrations, approvals, and government authorizations obtained by Disetronic in the European Territory with respect to the FreeStyle Products shall be in the name of TheraSense. (ii) Upon (i) Disetronic obtaining a registration, approval, license, permit or authorization in the European Territory, and/or (ii) upon the expiration, cancellation, or termination of this Agreement, all registrations, approvals, and government authorizations shall be transferred and delivered to, and shall inure to the benefit of TheraSense or its designee, to the extent that this is permissible under applicable law, at no cost to TheraSense other than lawfully imposed transfer fees. Where any National Registration, registration, license, permit, approval and/or government authorization must by law be obtained in Disetronic, its Affiliate's, or Subdistributor's name, Disetronic shall (and shall ensure that its Affiliates and Subdistributors shall): (i) assign to TheraSense all right, title and interest to such National Registration, registration, license, permit, approval and/or government authorizations, and/or (ii) execute those documents, as requested by TheraSense, necessary to document and/or perfect the assignment of such National Registration, registration, license, approval and/or government authorization. TheraSense shall have the exclusive right to use all such National Registrations, registrations, licenses, permits, and/or governmental authorizations if this Agreement is terminated for any reason other than TheraSense's material breach of this Agreement. (iii) TheraSense warrants that the FreeStyle Meters are, at the time they are delivered to Disetronic, in Conformity with the provisions of the EMC Directive (89/336/EEC) and shall establish a corresponding Conformity declaration with the first shipment of such Meters. (iv) TheraSense shall sell and deliver to Disetronic by September 30, 2000 or as soon thereafter as reasonably possible approximately 100 FreeStyle Meters calibrated to a whole blood reference, for use by Disetronic in obtaining national registrations for the FreeStyle Products. Such Meters are not required to carry the Disetronic trademark specified in Section 4.7. (b) After CE-Marking according to IVD (98/79/EC). -------------------------------------------- -16- Initials _____ _____ *** CONFIDENTIAL TREATMENT REQUESTED (i) TheraSense shall appoint an Authorized Representative for FreeStyle Products. (ii) TheraSense shall be responsible for obtaining the IVD-CE Xxxx for the applicable FreeStyle Products. TheraSense shall use commercially reasonable efforts to obtain such CE xxxx by June 30, 2001. At TheraSense's request, Disetronic shall provide reasonable assistance to TheraSense in obtaining the CE xxxx. Disetronic will be considered as TheraSense's exclusive distributor of the FreeStyle Products in the Field of Use in the European Territory.

National Registrations and IVD Registration. The parties agree ------------------------------------------- and understand that (i) in December 2003, the IVD (98/79/EC) will become mandatory; (ii) until December 2003, National Registrations can be obtained and used; and (iii) Products already in the distribution chain in December 2003 can continue to be sold until December 2005. (a) Before CE-Marking according to IVD (98/79/EC). --------------------------------------------- (i) Disetronic, shall use its best efforts to obtain National Registrations in TheraSense's name (unless national regulations require the Registration to be in Disetronic's name) by December 31, 2000***. It is understood and agreed by the parties that Disetronic's Affiliate, Disetronic Medical Systems AG, and/or Disetronic shall be the exclusive entity or entities responsible for obtaining such National Registrations; provided that if a National Registration must by -15- Initials: ____ ____ *** CONFIDENTIAL TREATMENT REQUESTED law be obtained by an entity other than Disetronic or Disetronic Medical Systems AG, then (i) Disetronic shall guarantee and hereby guarantees the performance of such other entity, and (ii) such other entity shall enter into a written agreement, binding such other party to terms and conditions substantially similar to the terms and conditions of this Agreement. If required by a regulatory agency to accomplish National Registration in a particular country in the European Territory, for each such country, TheraSense shall send to Disetronic within fourteen (14) days after Disetronic's request, those FreeStyle Products and copies of documents including but not limited to development files, production files, study protocols and results that are necessary to obtain such National Registration. It is understood and agreed by the parties that any such FreeStyle Products, documents, files, protocols and/or results are Confidential Information of TheraSense and subject to the terms of Article 11 herein. If and as required from time to time under the laws of any country or other jurisdiction within the European Territory, Disetronic, *** shall perform clinical trials and obtain all additional registrations, licenses and permits required to comply with the laws and regulations of each country in the European Territory for importation, sale and distribution of the FreeStyle Product; provided, however, that no activities in connection with obtaining such registrations, licenses or permits shall be initiated by Disetronic without TheraSense's prior written approval. Disetronic shall provide to TheraSense complete copies of all clinical trial protocols, data, analyses and other information, as well as applications, and all registrations, licenses and permits obtained therefrom relating to the FreeStyle Products. To the extent permitted by law, all registrations, approvals, and government authorizations obtained by Disetronic in the European Territory with respect to the FreeStyle Products shall be in the name of TheraSense. (ii) Upon (i) Disetronic obtaining a registration, approval, license, permit or authorization in the European Territory, and/or (ii) upon the expiration, cancellation, or termination of this Agreement, all registrations, approvals, and government authorizations shall be transferred and delivered to, and shall inure to the benefit of TheraSense or its designee, to the extent that this is permissible under applicable law, at no cost to TheraSense other than lawfully imposed transfer fees. Where any National Registration, registration, license, permit, approval and/or government authorization must by law be obtained in Disetronic, its Affiliate's, or Subdistributor's name, Disetronic shall (and shall ensure that its Affiliates and Subdistributors shall): (i) assign to TheraSense all right, title and interest to such National Registration, registration, license, permit, approval and/or government authorizations, and/or (ii) execute those documents, as requested by TheraSense, necessary to document and/or perfect the assignment of such National Registration, registration, license, approval and/or government authorization. TheraSense shall have the exclusive right to use all such National Registrations, registrations, licenses, permits, and/or governmental authorizations if this Agreement is terminated for any reason other than TheraSense's material breach of this Agreement. (iii) TheraSense warrants that the FreeStyle Meters are, at the time they are delivered to Disetronic, in Conformity with the provisions of the EMC Directive (89/336/EEC) and shall establish a corresponding Conformity declaration with the first shipment of such Meters. (iv) TheraSense shall sell and deliver to Disetronic by September 30, 2000 *** or as soon thereafter as reasonably possible approximately 100 FreeStyle Meters calibrated to a whole blood reference, for use by Disetronic in obtaining national registrations for the FreeStyle Products. Such Meters are not required to carry the Disetronic trademark specified in Section 4.7. (b) After CE-Marking according to IVD (98/79/EC). -------------------------------------------- -16- Initials _____ _____ *** CONFIDENTIAL TREATMENT REQUESTED (i) TheraSense shall appoint an Authorized Representative for FreeStyle Products. (ii) TheraSense shall be responsible for obtaining the IVD-CE Xxxx for the applicable FreeStyle Products. TheraSense shall use commercially reasonable efforts to obtain such CE xxxx by June 30, 2001***. At TheraSense's request, Disetronic shall provide reasonable assistance to TheraSense in obtaining the CE xxxx. Disetronic will be considered as TheraSense's exclusive distributor of the FreeStyle Products in the Field of Use in the European Territory.