Product Registrations Sample Clauses
The Product Registrations clause establishes the requirements and responsibilities for registering products, typically with relevant authorities or regulatory bodies. It outlines which party is responsible for ensuring that products are properly registered before they are marketed or sold, and may specify the jurisdictions or types of registrations required, such as trademarks, patents, or regulatory approvals. This clause ensures that all necessary legal and regulatory steps are taken to allow lawful distribution and use of the products, thereby reducing the risk of non-compliance and potential legal disputes.
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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. ▇▇▇▇▇▇▇ shall obtain and maintain all site licenses and regulatory approvals which may be or become necessary to enable ▇▇▇▇▇▇▇ to manufacture and sell the Products to VisiJet. ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇, or the name of a VisiJet Affiliate and the name of ▇▇▇▇▇▇▇ all device registrations and regulatory filings for any other country VisiJet wants to market the products with ▇▇▇▇▇▇▇'▇ 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. The Product Registrations;
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. Except as otherwise mutually agreed by DURECT and Endo, DURECT shall own all Registrations for the Product in the Territory.
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) Except as set forth in Section 3.24 of the Disclosure Schedules, or as would not reasonably be expected to have a Business Material Adverse Effect:
(i) All Product Registrations are valid and are in full force and effect;
(ii) To the Knowledge of Chemtura, neither the Sellers nor the Transferred Entities are in default of any applicable requirement or obligation to provide data in support of the Product Registrations;
(iii) To the Knowledge of Chemtura, no Product Registration is subject to any third party claims for compensation;
(iv) Neither the Sellers nor the Transferred Entities have, in connection with the Business, manufactured, blended, compounded, formulated for resale, imported, exported, sold or used any product or compound without first obtaining a Product Registration, to the extent a Product Registration is required to do so;
(v) No Governmental Authority has taken, nor to the Knowledge of Chemtura, has any Governmental Authority threatened to take any action to suspend, cancel, or restrict the use of any Product Registration;
(vi) To the Knowledge of Chemtura, the information and data provided to Governmental Authorities in connection with applying for or obtaining the Product Registrations was at the time of its provision accurate and deemed acceptable by the Governmental Authorities; and
(vii) The Business or the Transferred Entities and after the Closing the Purchaser, Transferred Entities or Purchaser’s Affiliates will either own or have access to all information and data provided to Governmental Authorities in connection with obtaining the Product Registrations.
(b) As of the consummation of the Closing, Purchaser and its Affiliates, including the Transferred Entities, will hold Product Registration Rights for products from which, in the aggregate, the Business derived in 2013 at least 80% of the aggregate revenue of the Business in 2013, excluding any revenue derived from (x) the operations in India and (y) any Product Registration Right that is not held by Chemtura or any of its Affiliates as of immediately prior to Closing provided such excluded Product Registration Right is not included in the Business’s future revenues projections provided by Chemtura to Purchaser; provided further that any Product Registration issued by a U.S. state or Canadian provincial Governmental Authority shall be deemed to have been transferred to Purchaser or one or its Affiliates (including a Transferred Entity) if and when the corresponding Product R...
Product Registrations. 23 Section 3.24
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 Registrations issued by the USDA for the Products that use or incorporate the Purchased Assets shall remain in the name of Diamond, held by Diamond on behalf of Elanco, and, Diamond shall remain responsible for the maintenance of such Registrations and for fulfilling all obligations that such Registrations entail. In the case of Registrations outside the United States, where possible, and unless otherwise agreed by the Parties, such Registrations held by Diamond, if any, shall be transferred to and maintained in Elanco’s name at Elanco’s expense. Upon Notice of termination of this Agreement and request via Notice from Elanco, Diamond shall provide all reasonable support to Elanco in the prompt licensure of the Cattle Vaccine Products and Other Vaccine Products at an Elanco manufacturing facility or at another manufacturing facility designated by Elanco (as applicable) with the intent that such facility receives such license(s) prior to the expiration or termination of this Agreement. For the avoidance of doubt, Diamond shall retain its Registrations for Cattle Vaccine Products during and after the term of this Agreement. Such support by Diamond shall include, but not be limited to, providing Elanco with the following: - all related materials, including but not limited to Seeds, Cell Stocks, Reference materials and critical testing reagents; - all Registrations for Products; - collaboration in transferring these Registrations to the designated site - all correspondence with Regulatory Agencies related to Products - all reports related to the Products - all manufacturing and QC testing documentation that supports the manufacturing and testing of the biological products and it’s components Elanco shall reimburse Diamond for all reasonable out of pocket expenses incurred by Diamond and for reasonable labor efforts pertaining to the performance of such support.