Product Registrations Sample Clauses

Product Registrations. (a) Schering shall be responsible, at its cost and expense, and in its sole judgment, for determining the appropriate regulatory strategy, and for obtaining and maintaining all Regulatory Approvals for the sale of the Product in the Territory, except for costs and expenses to be borne by ICN with respect to its own Regulatory Approval in the EU as provided in this Agreement. Schering shall use its reasonable efforts to diligently obtain Regulatory Approvals with Minimum Labelling within the Territory and in any event shall file for such Regulatory Approvals in each country in the Major Market within nine months of the completion of clinical trials and studies required in each such country for Regulatory Approval, including any additional or supplemental clinical trials or studies subsequently required by a regulatory authority for such Regulatory Approval. For purposes of this Section 3.2, "completion of clinical trials" shall in no event be deemed to occur sooner than the time of availability of the integrated summary of safety reports and integrated summary of efficacy reports. Schering shall use reasonable efforts to complete such reports promptly after completion of treatment. With respect to countries in the Territory other than the Major Market, Schering's efforts shall be commensurate with those efforts used to pursue regulatory approval for its own products of similar potential, value and status in such country or a comparable country in the Territory, as the case may be, or, if Schering has no such similar products in a comparable country, Schering's efforts shall be commensurate with the efforts that other reputable pharmaceutical companies of comparable size and product portfolio would use with respect to a product of similar potential, value and status in such country. In connection with any health registration application of ICN relating to the Product pending as of the Effective Date with the CPMP or FDA or any successor to the CPMP or FDA, ICN shall, at Schering's request, provide to Schering in a prompt manner, but in no event later than December 31, 1995, responses to non-clinical questions which have been raised by the CPMP or FDA. In addition, at the request of Schering, ICN shall provide to Schering chemistry-pharmacy data and any other technical information which Schering may reasonably require in order to obtain any CPMP Opinion or Regulatory Approval for the Product in the Territory. At the request of Schering, ICN may agree to conti...

Product Registrations. The information in Appendix 4 was true and accurate in respects of the Product Registrations held by the Agila Business as at 31 December 2012.

Product Registrations. The Product Registrations;

Product Registrations. Xxxxxxx shall obtain and maintain all site licenses and regulatory approvals which may be or become necessary to enable Xxxxxxx to manufacture and sell the Products to VisiJet. Xxxxxxx shall maintain all device registrations for the European Union and other countries that are in existence at the time of signing of this agreement. VisiJet will be responsible for obtaining and maintaining in its own name and the name of Xxxxxxx, or the name of a VisiJet Affiliate and the name of Xxxxxxx all device registrations and regulatory filings for any other country VisiJet wants to market the products with Xxxxxxx'x reasonable assistance. Each party shall execute such documents and provide such information to assist the other in obtaining or transferring registrations in accordance with the terms of this Section 9.1 as may be reasonably requested by either party.

Product Registrations. 23 Section 3.24

Product Registrations. (a) Seller shall cause the Transferred Registrations to be transferred to Buyer in its or its designated Affiliates’ name(s) as soon as is reasonably practicable after the Closing. Any and all fees, expenses and other costs associated with effectuating such transfers shall be borne by Buyer and/or its Affiliates and none of Seller nor its Affiliates shall be responsible for the payment of such fees, expenses or costs. In furtherance of effectuating such transfers, Buyer shall, promptly after the Closing, commence the filing of all applications, documents, and supporting information with all applicable Governmental Bodies that are necessary or appropriate to effectuate such transfers and complete such filings within ninety (90) days after the Closing, and shall diligently prosecute the effectuation of such transfers. Upon receipt of approvals from the appropriate Governmental Bodies regarding a transfer of a Transferred Registration, Buyer and its Affiliates shall comply with all Legal Requirements for changeover of all Product packaging, labeling, and package inserts associated with the Products that are the subject of such Transferred Registration. Notwithstanding anything herein to the contrary and, subject to compliance with applicable Legal Requirements, except for such inventory of Products existing at the time the appropriate Governmental Body approves the transfer of a Transferred Registrations for a Product, (i) commencing with the first production run after the appropriate Governmental Body approves the transfer of a Transferred Registration for a Product, Buyer and its Affiliates shall use Buyer’s and its Affiliates’ approved packaging, labeling, and package inserts for such Product and cease using Seller’s or its Affiliates’ packaging, labeling, and package inserts for such Product and (ii) in any event, no later than six (6) months from the date the appropriate Governmental Body approves a transfer of a Transferred Registration for a Product, Buyer and its Affiliates shall change the labels on and package inserts included with all such Product produced after such approval to Buyer’s and its Affiliates’ approved labels and package inserts and in accordance with all Legal Requirements, and shall remove Seller’s name and telephone numbers from all labeling, package inserts, and other Product supporting materials and information associated with such Product including, but not limited to, material safety data sheets. Buyer and its Affiliates shall o...

Product Registrations. Notwithstanding anything to the contrary herein, and, for clarity, without limiting the Transition Services Agreement, any obligations of Service Provider with respect to obtaining, maintaining, renewing or modifying product registrations shall be set out in the Transition Services Agreement.

Product Registrations. Manufacturer shall use its commercially reasonable efforts to obtain and to maintain and, to the extent lawful, in Manufacturer's name any product registrations, market authorizations, licenses or other government approvals required from time to time for the importation, distribution and sale of the Products in the Territory.

Product Registrations. A-S shall have the exclusive right to file, prosecute, seek and obtain all applicable Registrations for Products in the Territory. Strides shall prepare all information required to allow A-S to file, prosecute, seek and obtain all applicable Registrations for each Product in the Territory, including, but not limited to an ANDA, in A-S’ name, within the time frame mutually agreed by A-S and Strides. Strides shall provide all required information and documentation, including, but not limited to, a Chemistry Manufacturing Controls (CMC) section in a format acceptable to the FDA, and otherwise cooperate as requested by A-S in support of any regulatory application related to a Product, as part of Strides’ obligations pursuant to the receipt of Registration Costs paid by A-S. Any such application related to the Product shall be the sole and exclusive property of A-S. If requested by A-S and at the sole cost and expense of A-S, Strides shall file any required amendments to such application to allow manufacturing of the Product in its facility. Any such applicable Registration related to the Product in the Territory shall be the sole and exclusive property of A-S. A-S shall file any required amendments to such application to allow manufacturing of the Product in the Approved Facility. Each Party shall reasonably cooperate with the other Party (including without limitation, providing all reasonably necessary information in its possession, taking all reasonably necessary actions and executing all reasonably necessary instruments) in connection with the preparation, filing, prosecution, seeking and obtaining the Registrations.

Product Registrations. Sano shall own all Product Registrations in each country in the Territory, except that the Product Registration shall be in the name of BMS (or its designated Affiliate or Sub-Distributor) in any country in the Territory where: (i) it is necessary for BMS's name (or that of its designated Affiliate or Sub-Distributor) to be the principal name on the label for the Product in such country; or (ii) to do otherwise would be inconsistent with the Parties, respective duties under applicable laws and regulations, such as vigilance obligations or related continuing regulatory responsibilities. In addition, a Product Registration shall be in the name of BMS (or its designated Affiliate or Sub-Distributor) in any country in the Territory: (x) where BMS provides Sano with valid business reasons, acceptable to Sano, that it is advantageous or necessary for BMS (or its designated Affiliate or Sub-Distributor) to own such Product Registration; or (y) where the Parties mutually agree. In any country where the Product Registration is to be in BMS's name (or that of its Affiliate or Sub-Distributor), then subject to and upon the terms and conditions contained in this Agreement, in connection with and in furtherance of BMS's grant of distribution rights as set forth in Section 2, Sano shall transfer and assign to, or give BMS the right to file in the name of, BMS (or its designated Affiliate or Sub-Distributor), and BMS (or its designated Affiliate or Sub-Distributor) shall acquire from Sano, all of Sano's right, title and interest in and to, or the right to file in such name, such Product Registration for the Product in such country in the Territory. In connection with any transfers, Sano shall execute an Assignment of Product Registrations in such form as BMS shall reasonably require. Sano shall use all reasonable efforts and shall execute, acknowledge and deliver such further instruments, and shall do all such other acts, all as promptly as possible, which may be necessary or appropriate to effectuate the transfer of the Product Registrations in each such country in the Territory.