Products; Product Liability. (a) Each of the Products (including all Finished Inventory): (i) is, and at all times up to and including the sale thereof has been processed, manufactured, packaged, labeled, stored, handled, distributed, shipped, marketed and promoted, and in all other respects has been, in compliance with all applicable laws, statutes, rules, regulations, ordinances or orders administered, issued or enforced by the FDA or any other governmental entity, and (ii) is, and at all relevant times has conformed in all material respects to all specifications and any promises, warranties or affirmations of fact made in all regulatory filings or set forth in any regulatory approvals, authorizations or clearances pertaining thereto or made on the container or label for such Product or in connection with its sale. There is no design or manufacturing defect with respect to the Products.
(b) Part 3.23(b) of the Seller Parties Disclosure Schedule sets forth the forms of the Company’s service or product warranties that are currently applicable to services or merchandise related to the Business (including, without limitation, the Products). Except as set forth on Part 3.23(b) of the Seller Parties Disclosure Schedule, there are no existing or, to Sellers’ Knowledge, Threatened, claims against the Company for services or merchandise related to the Business which are defective or fail to meet any service or product warranties other than in the Ordinary Course of Business consistent with past experience. The Company has not incurred liability arising out of any injury to individuals as a result of the ownership, possession, or use of any Product and, to Sellers’ Knowledge, there has been no inquiry or investigation made in respect thereof by any Governmental Body.
Products; Product Liability. (a) Each of the Products (including all Finished Inventory) is, and at all times up to and including the sale thereof has been processed, manufactured, packaged, labeled, stored, handled, distributed, shipped, marketed and promoted, and in all other respects has been, in compliance with all applicable laws, statutes, rules, regulations, ordinances or orders administered, issued or enforced by any Governmental Authority.
(b) Schedule 2.17(b) sets forth the forms of Seller’s service or product warranties that are currently applicable to services or merchandise related to the Business (including, without limitation, the Products). To Seller’s Knowledge, there is no design or manufacturing defect with respect to the Products. Except as set forth on Schedule 2.17(b), there is no pending or, to Seller’s Knowledge, threatened, claim or Action by any Person in which a product manufactured, sold, distributed or issued by the Seller in connection with the Business is alleged to have a defect and which is reasonably likely to result in a material claim. As used in this Section 2.17, the term “defect” shall mean a defect or impurity of any kind, whether in design, manufacture, processing, or otherwise, including, without limitation, any dangerous propensity associated with any reasonably foreseeable use of a Product, or the failure to warn of the existence of any defect, impurity, or dangerous propensity. Seller has not incurred any liability or obligation arising out of any injury to individuals as a result of the ownership, possession, or use of any Product and, to Seller’s Knowledge, there has been no inquiry or investigation made in respect thereof by any Governmental Authority.
(c) Except as shown on Schedule 2.17(c): (i) none of the Products has been recalled, withdrawn or suspended (other than (x) Products discontinued or suspended in the Ordinary Course of Business or by reason of business decisions made without regard to (1) concerns as to design or other inherent defect or risk to the safety of the users thereof or (2) concerns of any Governmental Authority and (y) isolated instances with respect to particular Product units which are not representative of an entire Product category) since January 1, 2011 and (ii) there are no Actions pending or, to the Seller’s Knowledge, threatened against Seller at any time since January 1, 2011 (whether such proceedings have since been resolved or remain pending) seeking the recall, withdrawal, suspension or seizure of an...
Products; Product Liability. (a) Set forth on Schedule 4.17(a) is a list of all of the Fat Grafting Products. Each of the Fat Grafting Products sold by Seller: (i) is, and at all times up to and including the sale thereof has been, in compliance in all material respects with all Requirements of Laws and (b) is, and at all relevant times has been, fit for the ordinary purposes for which it is intended to be used and conforms in all material respects to any promises or affirmations of fact made in all regulatory filings pertaining thereto and made on the container or label for such product or in connection with its sale. To Seller’s knowledge, there is no design or manufacturing defect with respect to any of the Fat Grafting Products.
(b) Set forth on Schedule 4.17(b) are the forms of Seller’s service or product warranties that are currently applicable to the Fat Grafting Products sold by Seller or in respect of which Seller is obligated. Except as set forth on Schedule 4.17(b), there are no existing or, to Seller’s knowledge, threatened, claims against Seller for Fat Grafting Products which are defective or fail to meet any service or product warranties other than in the ordinary course of business consistent with past experience.
Products; Product Liability. Set forth on Schedule 4.14(a) is a list of all of the Medical Device Products existing as of the Closing Date 4.15 Investment Representations
Products; Product Liability. (a) Each of the Products (including all Finished Inventory): (i) is, and at all times up to and including the sale thereof has been processed, manufactured, packaged, labeled, stored, handled, distributed, shipped, marketed and promoted, and in all other respects has been, in compliance with all applicable laws, statutes, rules, regulations, ordinances or orders administered, issued or enforced by the FDA or any other governmental entity, including, without limitation, current Good Tissue Practice regulations promulgated by the FDA, the PHSA and relevant sections of the FDCA, and the United States National Organ Transplant Act, Title 21 of the Code of Federal Regulations Part 1271, Human Cells, Tissues, and Cellular and Tissue Based Products and (b) is, and at all relevant times has conformed in all material respects to all specifications and any promises, warranties or affirmations of fact made in all regulatory filings or set forth in any regulatory approvals, authorizations or clearances pertaining thereto or made on the container or label for such Product or in connection with its sale. There is no design or manufacturing defect with respect to the Products.
(b) Schedule 2.19(b) sets forth the forms of Seller’s service or product warranties that are currently applicable to services or merchandise related to the Business (including, without limitation, the Products). Except as set forth on Schedule 2.19(b), there are no existing or, to Seller’s Knowledge, threatened, claims against Seller for services or merchandise related to the Business which are defective or fail to meet any service or product warranties other than in the ordinary course of business consistent with past experience. Seller has not incurred liability arising out of any injury to individuals as a result of the ownership, possession, or use of any Product and, to Seller’s Knowledge, there has been no inquiry or investigation made in respect thereof by any governmental entity.
Products; Product Liability. To the best of the Acquired Companies’ Knowledge, all products manufactured or modified by the Acquired Companies are free from any defects in material and workmanship that could (1) allow a purchaser or user thereof to return any such product for refund or replacement other than in the ordinary course consistent with past practices, (2) result in a recall of any such product, or (3) give rise to a claim by any person for personal injury caused by any such product when used in the manner for which such product was designed and intended.
Products; Product Liability. (a) There are no outstanding Proceedings or, to the Individual Sellers’ Knowledge, threatened, against any of the Group Members in connection with any alleged defect in the design, manufacture, materials or workmanship of any products manufactured, licensed, distributed, shipped, sold or delivered by or on behalf of any Group Member or any alleged failure to warn, or any alleged breach of implied warranties or representations, other than to the extent such Proceedings would be immaterial.
(b) To the Sellers’ Knowledge, since January 1, 2015, there has not been any material Occurrence.
(c) There has not been any Recall conducted with respect to any product developed, shipped, sold or delivered by or on behalf of any Group Member (a “Company Product”), or, to the Sellers’ Knowledge, any investigation or consideration of or decision made by any Person or Governmental Authority concerning whether to undertake or not undertake any Recall.
(d) Each product manufactured, licensed, distributed, shipped, sold or delivered by or on behalf of any Group Member has been in conformity with all manufacturing standards applied, testing procedures used, and product specifications disclosed to customers by such Group Member and has complied in all material respects with all requirements established by any applicable Law or Order of any Governmental Authority.
Products; Product Liability. Except as set forth on Schedule 3.25, there are not presently pending, or, to the Knowledge of the Company, threatened, any civil, criminal or administrative actions, suits, demands, claims, hearings, notices of violation, investigations, proceedings or demand letters relating to any alleged hazard or alleged Defect or any failure to warn or alleged breach of express or implied warranty or representation, relating to any Product manufactured, distributed or sold by or on behalf of the Company or any Company Subsidiary. Since January 1, 2007, neither the Company nor any Company Subsidiary has sent or received any correspondence to or from any Governmental Authority with respect to a contemplated or ongoing actual recall, withdrawal, or suspension from the market of any Product. To the Knowledge of the Company, there are no Defects with respect to any Product sold or otherwise distributed by the Company or any of the Company Subsidiaries that may rise to a material Liability and all finished goods inventory held by the Company or any Company Subsidiary is free of any material Defect or other material deficiency, except to the extent that reasonable reserves in an amount not less than required in accordance with GAAP have been established therefor in the Financial Statements. Neither the Company nor any Company Subsidiary is currently investigating or considering a recall, withdrawal or suspension from the market of any Product.
Products; Product Liability. (a) Each of the products produced, developed or sold by the Company (excluding products developed by the Company but produced and sold by third parties under license or agreement or by third parties to which such products were sold, provided, that the Company has been fully indemnified by such third parties for any and all liabilities relating thereto, which indemnification rights will continue in full force and effect after the Effective Time) (the "Company Products") is, and at all times up to and including the sale thereof by the Company has been (a) in compliance in all material respects with all applicable federal, state, and local laws and regulations, and (b) conforms in all material respects to any promises or affirmations of fact made on the container or label for such product or in connection with its sale.
(b) To the knowledge of the Company, there is no design defect with respect to the Company Products. At the time of sale to the public, each Company Product contained adequate warnings, presented in a reasonably prominent manner, in accordance with applicable laws, rules and regulations and current industry practice with respect to its contents and use.
(c) The Company's External Analgesic Product, Benzocaine Canker Sore Product, Topical Antibiotic Product, Wound Wash Product, Wart Removal Product and BEMA-Dyclonine Canker Sore Disc (if such product is launched in the OTC market), as currently formulated, satisfy and conform and will satisfy and conform with (i) each OTC drug monograph applicable to such products and their intended uses, as promulgated by the Food and Drug Administration ("FDA"), (ii) the active ingredients allowed by the applicable OTC monographs both as to the specified concentration established for each ingredient and as to the specified
Products; Product Liability. Except as may be set forth in the Material Contracts, the Companies have not extended to any of its customers any written, non-uniform product warranties, indemnifications or guarantees. There are no Defects in the designs, specifications, or processes as currently in effect with respect to any Product sold or otherwise distributed by the Companies that would reasonably be expected to result in a material liability to the Companies. The Companies are not currently investigating or considering, and since January 1, 2020 the Companies have not investigated or considered, a recall, withdrawal or suspension from the market of any Product that resulted in, or is reasonably expected to result in, aggregate Liabilities in excess of $25,000.
