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) 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. 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. Elevance has obtained necessary chemical inventory or other registrations or authorizations for Elevance Products for the countries and regions designated under “Registrations Obtained” in Exhibit E for the corresponding volumes set forth therein. Elevance shall use commercially reasonable efforts to obtain necessary chemical inventory or other registrations or authorizations for Elevance Products for such countries and regions designated under “Registrations to be Obtained” in Exhibit E for the corresponding volumes set forth therein. Notwithstanding anything to the contrary in this Agreement, Elevance shall not be required to supply Elevance Products to any countries or regions not specified in Exhibit E. If Clariant identifies additional countries or regions not included in Exhibit E to which Clariant would like Elevance to ship Elevance Products, Clariant may provide notice thereof to Elevance, and the Parties will reasonably cooperate and coordinate to seek registrations or authorizations in Elevance’s name as necessary for Elevance to ship Elevance Products to the applicable country or region. Clariant shall obtain, at its expense, all other necessary chemical inventory or other registrations or authorizations to sell, export, import, process, or use for commercial purposes the Clariant Products in all countries or regions into which Clariant sells the Clariant Products. The Parties shall coordinate and cooperate with respect to regulatory filings for registrations and authorizations for their respective products to minimize overlap and duplication of fees and efforts and to seek registrations and authorizations in the name of the Party best-positioned to utilize the applicable registrations and authorizations under this Agreement and across its business generally. In order to assist Elevance in its regulatory compliance program and without limiting anything in the foregoing, Clariant shall promptly notice Elevance of each country or jurisdiction into which Clariant exports, sells, or distributes any Elevance Product or Clariant Product.
Product Registrations. Except as otherwise mutually agreed by DURECT and Endo, DURECT shall own all Registrations for the Product in the Territory.
Product Registrations. Except as otherwise mutually agreed by the Company and BMS, the Company shall own all Registrations in each country in the Territory.
