Recalls; Product Liability. (a) Since [***], there has not been any product recall, market withdrawal, replacement or “dear doctor” letter conducted by or on behalf of the Sellers or their respective Affiliates concerning the Products in the Territory or, to the Sellers’ knowledge, any jurisdiction outside of the Territory, or, to the knowledge of the Sellers, any product recall, market withdrawal, replacement or “dear doctor” letter conducted by or on behalf of any Third Party as a result of any alleged defect in any Product.
(b) To the Sellers’ knowledge, there are no (i) defects in design or Manufacture of any Products which would reasonably be expected to adversely affect performance or create an unusual risk of injury to persons or property, in each case, except as described in Product Labeling or (ii) citations, decisions, adjudications or statements by any Governmental Entity in the Territory or consent decrees stating that any Product is defective or unsafe or fails to meet any standards promulgated by any such Governmental Entity.
(c) Since [***], the Products have been Manufactured by Sellers or their respective Affiliates (to the extent applicable) in material compliance with cGMP and in compliance with the applicable Product Specifications and, to the knowledge of the Sellers, by any Third Party on behalf of any Seller or any of their respective Affiliates (to the extent applicable), in compliance in all material respects with cGMP and in compliance with the applicable Product Specifications.
Recalls; Product Liability. (a) There have been no product recalls (either compulsory pursuant to any order of any Governmental Entity, or made voluntarily in lieu of compulsion) involving any products of the Group Companies in the past two (2) years that, individually or in the aggregate, have been, or would reasonably be expected to be, material to the Business. Except as set forth in Section 3.25(a) of the Seller Disclosure Letter, no product manufactured, sold, assembled, leased, licensed or delivered by any of the Group Companies is, to the Knowledge of Seller, currently subject to a recall required by any Governmental Entity and none of the Group Companies has plans to initiate a voluntary product recall.
(b) There are, and for the past two (2) years have been, no existing or, to the Knowledge of Seller, threatened, product liability, warranty or other similar claims against any of the Group Companies, or otherwise alleging that any product manufactured, shipped, sold, assembled or delivered by any of the Group Companies is defective (in design, manufacture, materials or workmanship) or fails to meet any product or service warranties or guaranties, that, in any case, individually or in the aggregate, have been, or would reasonably be expected to be, material to the Business.
Recalls; Product Liability. Section 3.20 of the Disclosure Schedule sets forth a description of all (a) pending product recalls involving the Companies’ and the Subsidiaries’ products and (b) recall campaigns to which the Companies or the Subsidiaries have been subject in the past three years. Except as set forth on Section 3.20 of the Disclosure Schedule, for the past three years, none of the products manufactured, sold, marketed, processed or supplied by the Companies or the Subsidiaries have given rise to (i) any Legal Proceeding the primary purpose of which involves a claim for product liability or (ii) to the Knowledge of Sellers, any written threat of such Legal Proceeding, in each case that has resulted or would reasonably be expected to result, in material liability to the Companies and the Subsidiaries, taken as a whole.
Recalls; Product Liability. No event has occurred or circumstance exists within the Territory that (with or without notice or lapse of time) is reasonably likely to give rise to any actual, alleged, possible or potential (a) obligation on the part of Seller or any of its Subsidiaries to undertake, or to bear all or any portion of the costs of, any product recall of any nature with respect to the Business Products, (b) loss of or refusal to renew the Product Registrations relating to the Business Products, (c) renewal of the Product Registrations on terms less advantageous to Seller or any of its Subsidiaries than the terms of those Product Registrations currently in force, or (d) action to enjoin or suspend production of any Business Product. Since December 31, 2011, except as set forth on Schedule 3.21, no Business Product has been recalled, suspended, discontinued, or withdrawn from the market within the Territory, and no Business Product is currently involved in any ongoing, or to the Knowledge of Seller, threatened or potential, recall, discontinuance, withdrawal, or suspension from the market within the Territory.
Recalls; Product Liability. (a) Section 5.20(a) of the Disclosure Schedule sets forth a description of all (i) pending product recalls involving Companies’ products and (ii) recall campaigns to which the Companies have been subject in the past three (3) years.
(b) For the past two (2) years, none of the products manufactured or sold by the Companies have given rise to any Legal Proceeding involving product liability or, to the Knowledge of Holdings, any written threat of such Legal Proceeding that has resulted or would reasonably be expected to result, in material liability to the Companies.
Recalls; Product Liability. Section 2.24 of the Disclosure Letter identifies each product recall (whether voluntary or compulsory, other than recalls by any repackager of such product) and the circumstances surrounding each such recall, involving any product sold, leased, licensed, provided or delivered by a Target Company in the last three (3) years. No product sold, leased, licensed, provided or delivered by or on behalf of a Target Company is currently subject to a recall required by any Governmental Body, and the Target Companies do not have any plans to initiate a voluntary product recall relating to any product sold, leased, licensed, provided or delivered by a Target Company. There are no existing or, to the knowledge of Omega, threatened, product liability, warranty or other similar claims against the Target Companies alleging that any product sold by a Target Company is defective or fails to meet any product or service warranties or guaranties.
Recalls; Product Liability. (a) There have been no product recalls (either compulsory pursuant to any Order of any Governmental Entity, or made voluntarily in lieu of compulsion) involving any products of the Company or any of its Subsidiaries since January 1, 2017. No product manufactured, sold, leased, licensed or delivered by the Company or any of its Subsidiaries is currently subject to a recall required by any Governmental Entity and neither the Company nor any of its Subsidiaries has plans to initiate a voluntary product recall.
(b) There are no existing or, to the Knowledge of the Company, threatened, product Liability, warranty or other similar claims against the Company or any of its Subsidiaries, or otherwise alleging that any product of the Company or any of its Subsidiaries is defective or fails to meet any product or service warranties or guaranties, in each case except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Since January 1, 2017, there has been no Proceeding against or involving the Company or any of its Subsidiaries concerning any product of the Company or such Subsidiary manufactured, shipped, sold or delivered by or on behalf of the Company or such Subsidiary relating to or resulting from an alleged defect in design, manufacture, materials or workmanship of any such product, in each case except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
Recalls; Product Liability. (a) Schedule 5.27(a) identifies each product recall (whether voluntary or compulsory) and the circumstances surrounding each recall, involving any products of the Company in the past three years. No product manufactured, sold, leased, licensed or delivered by the Company is currently subject to a recall required by any Governmental Authority and the Company does not have any plans to initiate a voluntary product recall.
(b) Except as set forth on Schedule 5.27(b)(i), there are no existing or, to the Knowledge of the Company, threatened, product Liability, warranty or other similar claims against the Company or otherwise alleging that any product of the Company is defective or fails to meet any product or service warranties or guaranties. Schedule 5.27(b)(ii) lists all of the proceedings that the Company has settled in the past three years that is against or involving the Company concerning any product of such Company manufactured, shipped, sold or delivered by or on behalf of the Company relating to or resulting from an alleged defect in design, manufacture, materials or workmanship of any such product.
