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. 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. Licensee shall make every reasonable effort to investigate and advise Licensor of all required permits or registrations of the Products with governmental authorities in the Territory; and, at Licensor’s request, apply for, obtain and maintain, on Licensor’s behalf, all such necessary product registrations and permits. Upon termination of this Agreement for any reason, Licensee shall take such action, execute such assignments or consents and otherwise do such things as may be reasonably necessary to transfer all product registrations and permits to Licensor or its designee(s), and/or to otherwise permit or facilitate the manufacture or importation and sale of the Products in the Territory by Licensor or any party Licensor may designate.
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. Section 3.23 of the Disclosure Schedule sets forth, as of the date hereof, a list of all material Governmental Licenses granted to IMS or IMA to market any of the Products (the "Product Registrations"). Except as set forth in Section 3.23 of the Disclosure Schedule, (i) all Products sold under the Product Registrations are manufactured and marketed in accordance with the specifications and standards contained in such Product Registrations, (ii) IMS or IMA is the sole and exclusive owner of the Product Registrations and has not granted any right of reference to any Person with respect thereto, and (iii) the Product Registrations do not include or require reference to any other Governmental Licenses or other filings with any Governmental Entity. The Product Registrations are all the registrations, approvals, licenses or authorizations required to market the Products currently marketed by the CD Business. IMS and IMA have made available to PGIO true, complete and accurate copies of all Product Registrations and all material correspondence, written notices or written communications received from or sent to the FDA or other Governmental Entities relating to the Products.
Product Registrations. Notwithstanding anything to the contrary herein, and, for clarity, without limiting the Transition Services Agreement, any obligations of Distributor with respect to obtaining, maintaining, renewing or modifying any product registration shall be set out in the Transition Services Agreement, except as expressly set forth in the next sentence. For clarity, except as set forth in the LSA or Transition Services Agreement, solely with respect to any product registration for the Products in the Territories hereunder which cannot be transferred from Distributor or a Distributor Affiliate to Supplier or a Supplier Affiliate and which Supplier or a Supplier Affiliate is not permitted under applicable Law to obtain, maintain or renew in its own name, Supplier shall perform all actions required to prepare such filings as are necessary to obtain, maintain or renew such product registration (as defined in the Transition Services Agreement) and Distributor shall make such filings in Distributor’s or a Distributor Affiliate’s name, in each case at Supplier’s sole cost and expense.
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.
