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. Starkey, at Xxxxxxx'x ----------------------------------- expense, shall obtain all registrations, licenses, and permits required to comply with the laws and regulations within the Territory for sale and distribution of the Products.
Registrations, Licenses and Permits. Except as expressly provided in Section 7.1 above, if and as required from time to time under the laws of any jurisdiction within the Territory, JVC, at JVC's expense, shall obtain all registrations, licenses, and permits required to comply with the laws and regulations within the Territory for marketing, sale and distribution of the Products. JVC shall provide to CBI complete copies of all applications, and all registrations, licenses and permits obtained therefrom relating to the Products. To the extent permitted by law, all registrations, approvals, and government authorizations obtained by JVC in the Territory with respect to the Products shall be in the name of CBI. 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 CBI or its designee, to the extent that this is permissible under applicable law, at no cost to CBI other than lawfully imposed transfer fees.
Registrations, Licenses and Permits. (a) ArthroCare shall maintain all regulatory approvals in ArthroCare’s name for the marketing of the Licensed Products for the Term of this Agreement.
(b) ArthroCare will maintain the “Technical File” required by MDD 93/42 EEC (Medical Device Directives), design history records, device master records, and history records, and the quality system records for the Licensed Products for the period of time required by the directives of its Notified Body and other regulatory agencies requirements.
(c) ArthroCare will maintain for the period of this Agreement and its extensions a certified quality system in compliance with and maintain certifications with its Notified Body for valid standing to CE conformity of its manufacturing facility and the Licensed Products. ArthroCare shall use best efforts to supply to Collagen the information necessary to fulfill any request by the EC Competent Authority or Notified Body to Collagen for information contained in the records within the requested time period. Changes in Specifications, manufacturing, including change of sterilization process or provider, labeling, or packaging agreed to by Collagen and ArthroCare may result in amendments to the Technical File. ArthroCare will provide to Collagen a copy of any FDA or other regulatory agency correspondence within seven (7) days of receipt that is directly relating to the Licensed Products which are reasonably necessary to Collagen’s performance under this Agreement or which could adversely affect Collagen or its Customers.
(d) ArthroCare understands that Collagen or any government regulatory agency or third party observers may send representatives to ArthroCare’s facility to observe, inspect and audit the production facilities related to the Licensed Products. ArthroCare will allow such representatives reasonable access to all manufacturing facilities and records for the Licensed Products so as to ensure applicable regulations are in compliance. Collagen will provide at least ten (10) days advance notice of such observation and provide the names, meeting agenda and provide proper identification of such representatives. ArthroCare will use reasonable commercial efforts to correct any material non-compliance brought to its attention as a result of such inspections and audits. ArthroCare also agrees, during the Term of this Agreement, to allow Collagen access to all clinical and pre-clinical data involving the Licensed Products for use in the Field. Collagen understands that Arth...
Registrations, Licenses and Permits. (a) Except as set forth in Sections 7.1, VTAL, at VTAL ‘s expense, shall obtain all registrations, licenses, and permits (“Permits”) required to comply with the laws and regulations for the countries within the Territory where VTAL, in its sole discretion, imports and distributes the R2 Product; provided, however, that VTAL shall promptly notify R2 upon the initiation of any applications for Permits. VTAL shall provide to R2 complete copies of all applications for and issued Permits relating to the R2 Product. To the extent permitted by law, all Permits obtained by VTAL in the Territory with respect to the R2 Product shall be in the name of R2. Each party agrees to execute such instruments, documents and agreements and to give such further written assurances, as may be reasonably necessary to better realize the intent and understanding of the parties set forth in this Section 7.2.
(b) Upon the expiration or termination of this Agreement, at R2’s requests, all Permits relating to the R2 Product shall be transferred and delivered to, and shall inure to the benefit of R2 or its designee, to the extent that this is permissible under applicable law, at no cost to R2 other than legitimate fees and charges imposed by local governmental authorities; and VTAL agrees to execute any documents and render any assistance, at R2’s request and expense, as may be necessary to perfect R2 rights in such Permits. The parties will split equally (50%) any other customary and routine fees which are agreed and approved in advance by both parties.
Registrations, Licenses and Permits. Amersham shall comply in all material respects with all laws, rules and regulations applicable to the marketing, promotion, distribution and sale of Products within the Territory. If and as required from time to time under the laws of any country within the Territory, Amersham shall apply for and use its commercially reasonable efforts to obtain all registrations, licenses and permits that are necessary to market, distribute and sell the Products within such country. Epoch shall reasonably cooperate with Amersham in connection with Amersham's efforts to obtain such registrations, licenses and permits.
Registrations, Licenses and Permits. Distributor shall be responsible, at ----------------------------------- its expense, for obtaining any registrations, licenses and permits required to comply with the laws and regulations of each county in the Territory for sale and distribution of the Products and the conduct of its business operations in accordance with this Agreement; provided, however, that such activities shall be conducted in VidaMed's name and on VidaMed's behalf, and no activities in connection with obtaining such registrations, licenses or permits shall be initiated by Distributor without VidaMed's prior written approval. In particular, the Distributor shall register the Product and its approvals with the Distributor's national regulatory body in VidaMed's name, and provide VidaMed evidence of such registration. In the event that all necessary registrations, licenses and permits required to sell and distribute the Products in the Territory are not obtained within six (6) months after the Effective Date of this Agreement, Distributor and VidaMed jointly shall review all actions taken and determine what further actions, if any, should be undertaken. VidaMed shall have the exclusive right to use all such registrations, licenses or permits if this Agreement is terminated for any reason.
Registrations, Licenses and Permits. Except as expressly ----------------------------------- provided in Section 9.3 below, if and as required from time to time under the laws of any country or other jurisdiction within the Territory, SST, at SST's expense, shall obtain all registrations, licenses and permits required to comply with the laws and regulations of each country in the Territory for sale and distribution of the Products; provided, however, that no activities in connection with obtaining such registrations, licenses or permits shall be initiated by SST without FMT's prior written approval. SST shall provide to FMT complete copies of all applications, and all registrations, licenses and permits obtained therefrom relating to the Products. To the extent permitted by law, all registrations, approvals, and government authorizations obtained by SST in the Territory with respect to the Products shall be in the name of FMT. 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 FMT or its designee, to the extent that this is permissible under applicable law, at no cost to FMT other than lawfully imposed transfer fees. In the event that all necessary registrations, licenses and permits required to sell and distribute the Products in the Territory are not obtained within twelve (12) months after the Effective Date of this Agreement, SST and FMT jointly shall review all actions taken and determine what further actions, if any, should be undertaken. FMT shall have the exclusive right to use all such registrations, licenses or permits if this Agreement is terminated for any reason.
Registrations, Licenses and Permits. Representative shall be responsible, at its expense, for obtaining any registrations, licenses and permits required to comply with the laws and regulations of each country in the Territory for sale and distribution of the Network.
Registrations, Licenses and Permits. Sunrise shall obtain, at its own expense, and shall own and maintain, pre-market approval ("PMA") from the United States Food and Drug Administration for the Product, and shall make the PMA available to Distributor for its use in the Territory.
