REGULATORY / PRODUCT LIABILITY Sample Clauses

REGULATORY / PRODUCT LIABILITY. 22.1 All of the Relevant Products are and have been developed, manufactured, tested, packaged, labelled, held, stored, distributed, marketed, imported, exported, and sold, in all material respects in accordance with (i) the requirements, specifications and standards contained in the relevant Product Registration and (ii) all Applicable Laws. 22.2 The Seller has delivered to the Purchaser true and complete copies of all Product Registrations, Regulatory Information and any other data, documents, clinical studies, product dossiers, pre-clinical studies, or correspondence, in each case of a material nature, with Regulatory Agencies (including but not limited to all reports of inspection), complaints, and reports or notices of adverse events in the Seller's possession or control regarding or related to any of the Relevant Products or the Agila Business. The Seller or a Group Company has prepared, maintained and retained all Product Registrations that are required to be maintained or reported pursuant to and in accordance with Applicable Law, including but not limited to all Product Registrations required for the Relevant Products and all Product Registrations required for the conduct of the Agila Business, and all information contained in such Product Registrations is complete and accurate in all material respects. 22.3 (i) The Seller or a Group Company holds and has held all Product Registrations necessary for the Relevant Products and for the lawful operation of the Agila Business including all applicable authorisations, registrations and licences under any Applicable Regulatory Law, and any other authorisation required by any Regulatory Agency, and (ii) all such Product Registrations are and have been valid and in full force and effect. Since 31 December 2010, there has not occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to any third party any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Product Registration. The Seller is and has been in compliance in all material respects with the terms of all Product Registrations, and no event has occurred that, so far as the Seller is aware, would reasonably be expected to result in a material penalty under or the revocation, cancellation, non-renewal or adverse modification of any Product Registration. No proceeding is pending or, so far as the Seller is aware, threatened regarding the revoc...
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REGULATORY / PRODUCT LIABILITY. For the purposes of this Clause 11.1, Relevant Period shall mean the period commencing 4 years before the Closing Date and ending on the Closing Date. 11.1.1 The Seller shall indemnify, and hold harmless the US Purchaser's Group and the Group Companies (the "Indemnified Parties") from and against, any and all Losses (including, for the avoidance of doubt, the reasonable cost of recall or replacement of defective products or batches of products and the rectification of any related design errors or manufacturing systems) incurred by any Indemnified Party in respect of any personal injury or breach of product regulatory requirements alleged against any Indemnified Party by any third party arising out of or in connection with any products manufactured, supplied, sold or placed upon the market in the Relevant Period by any of the Group Companies provided that the Seller shall have no liability in respect of products manufactured but not sold as at Closing where any defect is identified following Closing as a result of failure occurring after Closing to follow normal procedures for the maintenance, care, protection, quality control or supply of the product. 11.1.2 Where the Seller is to indemnify the Indemnified Parties or any one of them under this Agreement, the Seller and the Indemnified Parties shall act in accordance with the provisions of Clause 10.4 and in addition, in respect of any such action or claim conducted by the Seller the Seller shall use all reasonable endeavours not to bring the name of the Indemnified Party into disrepute. 11.1.3 The Indemnified Party shall be free to pay or settle any claim on such terms as it thinks fit and without prejudice to its rights and remedies under this Agreement if the Seller: (i) fails to notify the Indemnified Party of its intention to take conduct of such claim within 20 Business Days of receipt of notice of such claim from the Indemnified Party or notifies the Indemnified Party that it does not intend to take over conduct of the claim; or (ii) fails to comply in any material respect with the provisions of Clause 11.1.2. 11.1.4 Any person taking any of the steps contemplated by Clause 11.1.2 shall comply with the requirements of any insurer who may have an obligation to provide an indemnity in respect of any liability referred to in this Clause 11.1.
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Related to REGULATORY / PRODUCT LIABILITY

  • Product Liability The Company has no Liability (and there is no basis for any present or future action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand against any of them giving rise to any Liability) arising out of any injury to individuals or property as a result of the ownership, possession, or use of any product manufactured, sold, leased, or delivered by the Company.

  • Product Warranty and Product Liability Schedule 3.20 contains true, correct and complete copies of each of Company's and the Subsidiaries' standard product warranty or warranties (as hereinafter defined) in effect as of the date of this Agreement. Schedule 3.20 sets forth a true, correct and complete list of customer complaints for each of the four (4) preceding fiscal years. Schedule 3.20 contains a description of all product liability claims and similar Litigation relating to products manufactured or sold, or services rendered, which are presently pending or which, to VENA's knowledge, are threatened (whether or not covered by insurance). There are no defects in design, construction or manufacture of Products manufactured since January 1, 2000 which would materially adversely affect performance or create an unusual risk of injury to persons or property. None of the Products manufactured since January 1, 2000 has been the subject of any replacement, field fix, retrofit, modification or recall campaign by Company or any of the Subsidiaries and, to VENA's knowledge, no facts or conditions exist which could reasonably be expected to result in such a recall campaign. The Products have been designed and manufactured so as to meet and comply with all publicly available governmental standards and specifications in effect when they were designed or manufactured. The Products manufactured since January 1, 2000 have received all governmental approvals necessary to allow their sale and use. None of the Products manufactured, installed, fabricated, sold, supplied, produced, distributed, released, marketed or disposed of within Mexico, in each case prior to the Closing Date, by Company or any of the Subsidiaries contains or has contained or includes or has included asbestos in any manner or respect; provided, however, that VENA makes no representation or warranty with respect to (i) any claims alleging exposure to Products that contain or include, or have contained or included, asbestos that are brought in any jurisdiction other than Mexico and (ii) the subsequent manufacture, installation, fabrication, sale, supply, production, distribution, release, marketing, disposal or other use of the Products, or any exposure in connection therewith, outside of Mexico by any third parties. As used in this Section 3.20, the term "

  • Product Liability Claims Notwithstanding the provisions of Section 9.2, any Losses arising out of any Third Party claim, suit, action, proceeding, liability or obligation involving any actual or alleged death or bodily injury arising out of or resulting from the development, manufacture or Commercialization of any Fibrocell Products or Improved Products for use or sale in the Field, to the extent that such Losses exceed the amount (if any) covered by the applicable Party’s product liability insurance (“Excess Product Liability Costs”), shall be paid by [*****], except to the extent such Losses arise out of any Third-Party Claim based on the gross negligence or willful misconduct of a Party, its Affiliates, or its Affiliates’ sublicensees, or any of the respective officers, directors, employees and agents of each of the foregoing entities, in the performance of obligations or exercise of rights under this Agreement.

  • Third Party Products 12.1 Third-party products provided to you by NCR Voyix for use with your subscription to the Service are subject to any terms provided by their supplier, including but not limited to those terms and conditions set forth in the exhibits attached hereto. Third-party terms and conditions are subject to change at any time by the supplier, and you agree that your use of such third-party products and services is governed by such supplier’s terms and conditions. You hereby release NCR Voyix from any and all liability associated with any damages or claims arising out of or related to third-party products. UNLESS NCR ▇▇▇▇▇ SPECIFICALLY AGREES OTHERWISE IN WRITING, YOU ACKNOWLEDGE AND AGREE THAT SUCH THIRD-PARTY PRODUCTS ARE PROVIDED “AS-IS” WITHOUT A WARRANTY FROM NCR Voyix. ACCORDINGLY, NCR Voyix EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY NATURE WITH RESPECT TO ANY SUCH THIRD-PARTY PRODUCTS, WHETHER ORAL OR WRITTEN, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF ANY THIRD-PARTY RIGHTS. 12.2 Third-party products and services may be advertised or made available to you for purchase directly from their supplier by email or other electronic communications, including notifications made through the Service or the Account Portal. Any representations or warranties that may be provided in connection with any such third-party products or services are provided solely by their supplier. NCR Voyix will not be responsible for any of your dealings or interactions with any of those third-party suppliers.

  • Third Party Patents If, after June 17, 2014, it was or is Necessary or Useful for Allogene (or Pfizer, to the extent identified by Pfizer prior to the Assignment) to license one or more Patent Rights from one or more Third Parties in order to Develop, Manufacture, Commercialize or use any Allogene Licensed Product, whether directly or through any Allogene Affiliate or Sublicensee, then Allogene may, in its sole discretion, negotiate and obtain a license under such Patent Right(s) (each such Third Party license, or any such Third Party license entered into as of the Effective Date by Allogene or by Pfizer and assigned to Allogene, referred to herein as an “Additional Third Party License”). Any royalty otherwise payable to Cellectis under this Agreement with respect to Net Sales of any Allogene Licensed Product by Allogene, its Affiliates or Sublicensees will be reduced by [***] of the amounts payable to Third Parties pursuant to any Additional Third Party Licenses, such reduction to continue until all such amounts have been expended, provided that in no event will the total royalty payable to Cellectis for any Allogene Licensed Product be less than [***] of the royalty amounts otherwise payable for such Allogene Licensed Product and in no event will the royalty payable to Cellectis for any Allogene Licensed Product be reduced below [***] (in each case, other than in the case of Cellectis’ breach of any representation, warranty or covenant hereunder). For purposes of this Section 5.2.2(b), (i) “Necessary” means that, without a license to use the Third Party’s Patent Right, the Development, Manufacture, Commercialization or use of any Allogene Licensed Product in the form such Allogene Licensed Product exists at the time that the Additional Third Party License is executed would, in Allogene’s opinion, infringe such Third Party’s Patent Right and (ii) “Useful” means that Allogene has determined in its discretion that use of such Third Party’s Patent Right would enhance the commercial potential of such Allogene Licensed Product. For the avoidance of doubt, the Parties agree and acknowledge that this Section 5.2.2(b) will not apply with respect to royalties payable by Allogene to any Third Party under any agreement in existence as of June 17, 2014. Neither Party will intentionally negotiate with a Third Party an exclusive license that excludes sublicense rights to the other Party, in the event such Third Party rights are necessary, as determined by the negotiating Party, to Develop and Commercialize Allogene Licensed Products and Cellectis Products in connection with this Agreement in the Field.