Common use of Company Products Clause in Contracts

Company Products. (a) Since January 1, 1991, there have been no written notices, citations, or decisions by any governmental authority that any product produced, manufactured, or marketed at any time by the Company or its Subsidiaries (collectively, the "COMPANY PRODUCTS") is defective or fails to meet any applicable standards promulgated by such governmental authority. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and its Subsidiaries are in compliance with the laws, regulations, policies, procedures, and specifications applicable to them with respect to the design, manufacture, labeling, testing, and inspection of the Company Products in the United States and the operation of manufacturing facilities in the United States promulgated by the Food and Drug Administration (the "FDA") or any other governmental authority that has jurisdiction over the design, manufacture, labeling, testing, and inspection of the Company Products and the operation of manufacturing facilities in the United States, and have complied with the laws, regulations, policies, procedures, and specifications applicable to the Company and its Subsidiaries in any jurisdiction outside the United States with respect to the design, manufacture, labeling, testing, and inspection of the Company Products and the operation of manufacturing facilities outside of the United States. Since January 1, 1991, there have been no recalls, field notifications, or seizures ordered or, to the knowledge of the Company, threatened by any governmental authority with respect to any of the Company Products, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notice from the FDA. (b) The Company or one of its Subsidiaries has obtained, in all countries where the Company or any of its Subsidiaries is marketing or has marketed Company Products, all applicable permits, licenses, orders, authorizations, notifications and approvals required to be obtained by it by governmental authorities (including the FDA) in such countries regulating the safety, effectiveness, and market clearance of the Company Products that are currently marketed by the Company or its Subsidiaries, except where the failure to obtain such permits, licenses, orders, authorizations, notifications or approvals would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company Disclosure Schedule sets forth a list of all of the Company's and its Subsidiaries' licenses, registrations, approvals, permits, and device listings regarding the Company Products. The Company Disclosure Schedule sets forth a description of all Company inspections by regulatory authorities, recalls, product actions, and audits from January 1, 1998 to the date of this Agreement, and a description of any ongoing clinical studies.

Company Products. (a) Since January 1, 1991, there have been no written notices, citations, or decisions by any governmental authority that any product producedAll products made, manufactured, distributed or marketed at any time sold by the Company or its Subsidiaries employees or agents (collectivelythe “Products” and each a “Product”) and, to the "COMPANY PRODUCTS") is defective or fails to meet any applicable standards promulgated by such governmental authority. Except as would not reasonably be expected to haveKnowledge of the Company, individually or all of the Company’s suppliers’ products used in the aggregatemanufacture of the Products (the “Supplier Products” and each a “Supplier Product”), a Company Material Adverse Effecthave been designed, the Company manufactured, sold, packaged, and its Subsidiaries are labeled in material compliance with all applicable Legal Requirements. (b) Since the lawsdate of the Balance Sheet, regulations, policies, procedures, and specifications applicable to them with respect to the designCompany’s Knowledge, manufacture, labeling, testing, and inspection there has been no pattern of the Company Products material defects in the United States and the operation design or manufacturing of manufacturing facilities in the United States promulgated by the Food and Drug Administration (the "FDA") any Product or any other governmental authority that has jurisdiction over the design, manufacture, labeling, testing, and inspection of the Company Products and the operation of manufacturing facilities in the United States, and have complied with the laws, regulations, policies, procedures, and specifications applicable to the Company and its Subsidiaries in any jurisdiction outside the United States with respect to the design, manufacture, labeling, testing, and inspection of the Company Products and the operation of manufacturing facilities outside of the United StatesSupplier Product. Since January 1, 19912016, there the Company has not received written notice of any alleged noncompliance with any applicable Legal Requirement or standard. Since January 1, 2016, neither the Company nor, to the Knowledge of the Company, any of its suppliers have filed or been no recallsrequired to file a notification, field notificationsnotice, announcement, report, or seizures ordered other similar action or filing with any Governmental Body or other organization concerning actual or potential hazards with respect to any Product or Supplier Product, by any other Governmental Body under any applicable Legal Requirement. (c) The Company has delivered or made available to Parent or Parent’s Representatives copies of all material correspondences to and from Governmental Bodies regarding the Products received since January 1, 2016. (d) Except to the extent reflected in the reserves for product warranties or product liabilities shown on the Balance Sheet, to the Company’s Knowledge, (A) all Products manufactured, sold, leased, or delivered by, and all services provided by, the Company (or, to the knowledge Knowledge of the Company, threatened by any governmental authority with respect to any Person acting on behalf of the Company ProductsCompany) have been in conformity with all applicable contractual commitments and all express and implied warranties, and the Company has not independently engaged no liability for replacement or repair thereof or other damages in such recalls or field notifications. The connection therewith and (B) to the Company’s Knowledge, the Company has not received no liability arising out of any warning letter injury to individuals or Section 305 notice from property as a result of the FDA. (b) The Company ownership, possession, or one use of its Subsidiaries has obtainedany Product manufactured, in all countries where sold, leased, or delivered by, or any service provided by, the Company or (or, to the Company’s Knowledge, any of its Subsidiaries is marketing or has marketed Company Products, all applicable permits, licenses, orders, authorizations, notifications and approvals required to be obtained by it by governmental authorities (including the FDA) in such countries regulating the safety, effectiveness, and market clearance of the Company Products that are currently marketed by the Company or its Subsidiaries, except where the failure to obtain such permits, licenses, orders, authorizations, notifications or approvals would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company Disclosure Schedule sets forth a list of all Person acting on behalf of the Company's and its Subsidiaries' licenses, registrations, approvals, permits, and device listings regarding the Company Products. The Company Disclosure Schedule sets forth a description of all Company inspections by regulatory authorities, recalls, product actions, and audits from January 1, 1998 to the date of this Agreement, and a description of any ongoing clinical studies).

Company Products. (a) Since January 1, 1991, there have been no written notices, citations, or decisions by any governmental authority that any product produced, manufactured, or marketed at any time by the Company or its Subsidiaries (collectively, the "COMPANY PRODUCTSCompany Products") is defective or fails to meet any applicable standards promulgated by such governmental authority. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and its Subsidiaries are in compliance with the laws, regulations, policies, procedures, and specifications applicable to them with respect to the design, manufacture, labeling, testing, and inspection of the Company Products in the United States and the operation of manufacturing facilities in the United States promulgated by the Food and Drug Administration (the "FDA") or any other governmental authority that has jurisdiction over the design, manufacture, labeling, testing, and inspection of the Company Products and the operation of manufacturing facilities in the United States, and have complied with the laws, regulations, policies, procedures, and specifications applicable to the Company and its Subsidiaries in any jurisdiction outside the United States with respect to the design, manufacture, labeling, testing, and inspection of the Company Products and the operation of manufacturing facilities outside of the United States. Since January 1, 1991, there have been no recalls, field notifications, or seizures ordered or, to the knowledge of the Company, threatened by any governmental authority with respect to any of the Company Products, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notice from the FDA. (b) The Company or one of its Subsidiaries has obtained, in all countries where the Company or any of its Subsidiaries is marketing or has marketed Company Products, all applicable permits, licenses, orders, authorizations, notifications and approvals required to be obtained by it by governmental authorities (including the FDA) in such countries regulating the safety, effectiveness, and market clearance of the Company Products that are currently marketed by the Company or its Subsidiaries, except where the failure to obtain such permits, licenses, orders, authorizations, notifications or approvals would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company Disclosure Schedule sets forth a list of all of the Company's and its Subsidiaries' licenses, registrations, approvals, permits, and device listings regarding the Company Products. The Company Disclosure Schedule sets forth a description of all Company inspections by regulatory authorities, recalls, product actions, and audits from January 1, 1998 to the date of this Agreement, and a description of any ongoing clinical studies.

Company Products. (a) Since January 1, 19912000, except as set forth in ss. 4(y) of the Disclosure Schedule: (i) there have not been no any written notices, citations, citations or published decisions by any governmental authority Governmental Authority that any product produced, manufactured, or marketed at any time by the Company or its Subsidiaries (collectively, the "COMPANY PRODUCTS") Product is defective or fails to meet any applicable regulations or standards promulgated by any such governmental authority. Except as would not reasonably be expected to haveGovernmental Authority; (ii) To the Company's Knowledge, individually or each of the Company's clinical investigators has complied in the aggregate, a Company Material Adverse Effect, the Company and its Subsidiaries are in compliance all material respects with the laws, regulations, policies, procedures, applicable laws and specifications applicable to them with respect to the design, manufacture, labeling, testing, testing and inspection of the each Company Products in Product promulgated by the United States and the operation of manufacturing facilities in the United States promulgated by the Food and Drug Administration (the "FDA") or any other governmental Governmental Authority having authority that has and jurisdiction over the designCompany and/or a Company Product ("Regulatory Requirements"). The Regulatory Requirements include quality system regulations (QSR), manufacturecurrent good manufacturing practices (cGMP) regulations, labelinggood clinical practices (GCP) regulations, testinggood laboratory practices (GLP) regulations, and inspection adverse event reporting requirements; (iii) The Company has made all submissions (of any kind and in any written, electronic, oral, or other forms) in connection with Company Products that are required by Regulatory Requirements. These submissions include adverse event reports to a Governmental Authority and communications with clinical investigators. All submissions and representations concerning Company Products which the Company Products and the operation of manufacturing facilities has made to any Governmental Authority or clinical investigator have been made in the United Statesgood faith, and have complied with the laws, regulations, policies, procedures, contained accurate and specifications applicable to the Company complete data and its Subsidiaries information in any jurisdiction outside the United States with respect to the design, manufacture, labeling, testing, and inspection of the Company Products and the operation of manufacturing facilities outside of the United States. Since January 1, 1991, all material respects; (iv) there have been no recalls, field notifications, notifications or seizures ordered or, to the knowledge Knowledge of the Company, threatened by any governmental authority Governmental Authority with respect to any of Company Product; (v) the Company Products, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notice from the FDA.; and (bvi) The Company or one of its Subsidiaries has obtained, in all countries where the Company has not received any written notice that there exist any reasonable grounds for a claim of defectiveness of any Company Product or for the recall of any of its Subsidiaries is marketing or Company Product. No Person has marketed Company Products, all applicable permits, licenses, orders, authorizations, notifications and approvals been required to be obtained by it by governmental authorities (including file any written notification or other written report with or provide information to any Governmental Authority or product safety standards organization or to disclose any information to any Person or the FDA) in such countries regulating the safetypublic at large with respect to actual or potential defects, effectiveness, and market clearance of the hazards or adverse events with respect to any Company Products that are currently marketed by the Company or its Subsidiaries, except where the failure to obtain such permits, licenses, orders, authorizations, notifications or approvals would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company Disclosure Schedule sets forth a list of all of the Company's and its Subsidiaries' licenses, registrations, approvals, permits, and device listings regarding the Company Products. The Company Disclosure Schedule sets forth a description of all Company inspections by regulatory authorities, recalls, product actions, and audits from January 1, 1998 to the date of this Agreement, and a description of any ongoing clinical studiesProduct.