Common use of Permits and Compliance Clause in Contracts

Permits and Compliance. (a) The Company and its Subsidiaries are and at all times have been in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “Company Permits”), and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any of its Subsidiaries has been in violation of (i) any Company Permits, or (ii) any applicable law, ordinance, administrative, or governmental rule or regulation, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “SSA”)), except in the case of any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would not, individually or in the aggregate, have a Material Adverse Effect. (b) The Company is not subject to any consent decree from any Governmental Entity. The Company has not received any warning letter from the FDA during the last three years. The Company has received no communication from any regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under consideration. Without limiting the foregoing, the Company is in compliance, in all respects, with all current applicable statutes, rules, regulations, guidelines, policies or orders administered or issued by the FDA or comparable foreign Governmental Entity including FDA’s Quality System Regulation, 21 C.F.R. Part 820; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30, 1999, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s products, except set forth in Section 3.8 of the Company Letter. The Company’s products, where required, are being marketed under valid pre market notifications under Section 510 (k) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)’s”) or pre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(e) and 21 C.F.R. Part 814 (“PMA’s”). All 510(k)’s and PMA’s for the Company’s products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s or PMA’s or changing the marketing classification or labeling of any such products. To the knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the Company. Neither the Company nor any Subsidiary, nor the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to impair Buyer’s ability to conduct its businesses in any material respect.

Permits and Compliance. (a) The Company and Company, together with its Subsidiaries are and at all times have been Subsidiaries, is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, clearances (including appropriate security clearances), certificates, approvals and orders of any Governmental Entity necessary for the Company or any of Company, together with its Subsidiaries Subsidiaries, to own, lease and operate its properties or to carry on its business conduct the Business as it is now being conducted (the “Company Permits”), except where the failure to have any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company, and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the Company, threatened. Neither , except where the suspension or cancellation of any of the Company nor any of its Subsidiaries has been Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company. (b) To the Company’s Knowledge, it is not in violation of of: (i) any Company Permits, or (ii) any applicable law, ordinance, administrative, or governmental rule or regulationregulation of any Governmental Entity, including any consumer protection, kickback, procurement integrity, contingent fee, gratuities to government officials, environmental, equal opportunity, customs, export control, foreign trade, trade and foreign corrupt practices laws, securities laws, rules or regulations (including Cost Accounting Standards, the Foreign Corrupt Practices National Industrial Security Program Manual (including all rules and regulations relating to protection of classified information and retention of facility and personnel security clearances), the Federal Acquisition Regulations and any agency supplements thereto (e.g., FARS and NASA FAR regulations) and the Truth in Negotiation Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “SSA”)), except in the case of any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would notany order, individually decree or in judgment of any Governmental Entity having jurisdiction over the aggregateCompany, have a Material Adverse Effectincluding any Company Permit. (bc) The Company is not subject to any consent decree from any Governmental Entity. The Company Company, together with its Subsidiaries, has not received any warning letter from the FDA during the last three years. The Company has received no communication from any obtained all material regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under consideration. Without limiting the foregoingapprovals, the Company is in compliance, in all respects, with all current applicable statutes, rules, regulations, guidelines, policies or orders administered or issued by the FDA or comparable foreign Governmental Entity including FDA’s Quality System Regulation, 21 C.F.R. Part 820; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30, 1999, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s products, except set forth in Section 3.8 of the Company Letter. The Company’s products, where required, are being marketed under valid pre market notifications under Section 510 (k) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)’s”) or pre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(e) and 21 C.F.R. Part 814 (“PMA’s”). All 510(k)’s and PMA’s for the Company’s products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s or PMA’s or changing the marketing classification or labeling of any such products. To the knowledge Knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company Company, together with its Subsidiaries, has obtained all necessary material regulatory approvals from any foreign regulatory agencies agencies, related to the products distributed and or services sold by the Company. Neither Company or any Subsidiary. (d) Except as set forth in Section 3.11 of the Company nor Disclosure Schedule, the properties, assets and operations of the Company, together with its Subsidiaries, are in material compliance with all applicable federal, state, local and foreign laws, rules and regulations, orders, decrees, judgments, permits and licenses relating to public and worker health and safety (collectively, “Worker Safety Laws”). With respect to such properties, assets and operations, including any Subsidiarypreviously owned, nor leased or operated properties, assets or operations, to the officersKnowledge of the Company, directorsthere are no past or present conditions, managing employees circumstances, activities, practices, incidents, or agents (as those terms are defined in 42 C.F.R. §1001.1001) actions of the Company or any Subsidiary: (i) have engaged Subsidiary that may interfere with or prevent compliance or continued compliance with applicable Worker Safety Laws except as set forth in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There are no contracts or agreements 3.11 of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to impair Buyer’s ability to conduct its businesses in any material respectDisclosure Schedule.

Permits and Compliance. (a) The Each of the Company and its Subsidiaries are and at all times have been is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “"Company Permits”"), except where the failure to have any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company, and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the CompanyCompany (as hereinafter defined), threatened, except where the suspension or cancellation of any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company. Neither Except as set forth on Section 3.8 of the Company Letter, neither the Company nor any of its Subsidiaries has been is in violation of (iA) any Company Permitsits charter, by-laws or other organizational documents, (iiB) any applicable law, ordinance, administrative, or governmental rule or regulation, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “"SSA”")), except (C) any order, decree or judgment of any Governmental Entity having jurisdiction over the Company or any of its Subsidiaries or (D) any Company Permits, except, in the case of clauses (A), (B), (C) and (D) for any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would notthat, individually or in the aggregate, would not have a Material Adverse Effect. (b) The Company is not subject to any consent decree from any Governmental Entity. The Company has not received any warning letter from Effect on the FDA during the last three years. The Company has received no communication from any regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under considerationCompany. Without limiting the foregoing, the Company is in compliance, in all respects, with all current applicable not subject to statutes, rules, regulations, guidelines, policies regulations or orders administered or issued by the FDA or comparable foreign Governmental Entity including United States Food and Drug Administration (the "FDA’s Quality System Regulation, 21 C.F.R. Part 820; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30, 1999, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s products, except set forth in Section 3.8 of the Company Letter. The Company’s products, where required, are being marketed under valid pre market notifications under Section 510 (k") of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)’s”) or pre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(e) and 21 C.F.R. Part 814 (“PMA’s”). All 510(k)’s and PMA’s for the Company’s products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s or PMA’s or changing the marketing classification or labeling of any such products. To the knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the Company. Neither the Company nor any Subsidiary, nor the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §xx.xx. 1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § xx.xx. 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There . Except as disclosed in the Company SEC Documents filed prior to the date of this Agreement, there are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to materially impair Buyer’s Parent's ability to conduct its businesses in any material respectbusinesses. "Knowledge of the Company" means the actual knowledge of the directors and the following officers of the Company: Xxxx Xxxxx; Xxxxx X. Xxxxxxxx; Xxx Xxxxx; Xxxxxxxx Xxxxxxx; Xxxx Xxxxxxxxx; Xxxxx Xxxxxx; and Xxxxxxxx Xxxx.

Permits and Compliance. (a) The Company and its Subsidiaries are and at all times and, since January 1, 2003, have been in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “Company Permits”), and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither Since January 1, 2003, neither the Company nor any of its Subsidiaries has been in violation of (i) any Company Permits, or (ii) any applicable law, ordinance, administrative, or governmental rule or regulationLaw, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “SSA”)), except in the case of any violations of any law, ordinance, administrative, clauses (i) or governmental rule or regulation described in (ii) that as would not, individually or in the aggregate, have a Company Material Adverse Effect. (b) The None of the Company or any of its Subsidiaries is not subject to any consent decree from any Governmental Entity. The None of the Company or any of its Subsidiaries has not received any warning letter from the FDA United States Food and Drug Administration (the “FDA”) during the last three yearsyears except for the Warning Letter dated September 27, 2006 (the “Warning Letter”). The None of the Company or any of its Subsidiaries has received no any communication from any regulatory agency or been notified during the last three (3) years that any product approval is withdrawn or modified or that such an action is under consideration. Without limiting the foregoing, but except as described in any Form-FDA 483s and/or the Warning Letter, the Company and each of its Subsidiaries is in compliance, in all material respects, with all current applicable statutes, rules, regulations, guidelines, policies or orders administered or issued by the FDA or comparable foreign Governmental Entity including FDA’s Quality System Regulation, 21 C.F.R. Part 820; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 301, 19992002, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s or its Subsidiaries’ products, except set forth in Section 3.8 of the Company Letter. . (c) The Company’s and its Subsidiaries’ products, where required, are being marketed under valid pre market notifications under Section 510 (k) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)’s”) or pre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(eU.S.C. §360(e) and 21 C.F.R. Part 814 (“PMA’s”). All 510(k)’s and PMA’s for the Company’s and its Subsidiaries’ products are exclusively owned by the CompanyCompany or one of its Subsidiaries, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s or PMA’s or changing the marketing classification or labeling of any such products. To the knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has and its Subsidiaries have obtained all necessary regulatory approvals from any foreign regulatory agencies agency related to the products distributed and sold by the Company. Company or one of its Subsidiaries. (d) Neither the Company nor any Subsidiary, nor to the knowledge of the Company, the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (ce) There are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Company Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company or any of its Subsidiaries to conduct its business as currently conducted or would reasonably be expected to impair BuyerParent’s ability to conduct its businesses in any material respect.

Permits and Compliance. (a) The Each of the Company and its Subsidiaries are is and at all times have has been in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “"COMPANY PERMITS"), except where the failure to have any of the Company Permits”)Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company, and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the CompanyCompany (as hereinafter defined), threatened, except where the suspension or cancellation of any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company. Neither the Company nor any of its Subsidiaries is or has been in violation of (ia) any Company Permitsits charter, by-laws or other organizational documents, (iib) any applicable law, ordinance, administrative, or governmental rule or regulation, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “"SSA”")), except (c) any order, decree or judgment of any Governmental Entity having jurisdiction over the Company or any of its Subsidiaries or (d) any Company Permits, except, in the case of clauses (a), (b), (c) and (d) for any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would notthat, individually or in the aggregate, would not have a Material Adverse Effect. (b) The Company is not subject to any consent decree from any Governmental Entity. The Company has not received any warning letter from Effect on the FDA during the last three years. The Company has received no communication from any regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under considerationCompany. Without limiting the foregoing, the Company is in compliance, in all material respects, with all current applicable statutes, rules, regulations, standards, guidelines, policies or orders administered or issued by the FDA United States Food and Drug Administration (the "FDA") or comparable foreign Governmental Entity including Entity, including, but not limited to, FDA’s 's Quality System Regulation, 21 C.F.R. CFR Part 820; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30March 13, 19991997, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s 's products, except set forth in Section 3.8 of the Company Letter. The Company’s 's products, where required, are being marketed under valid pre 510(k) pre-market notifications cleared by FDA under Section 510 (k510(k) of the Federal Food, Drug Drug, and Cosmetic Act, 21 U.S.C. §ss. 360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)’s”"510(k)s") or pre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(e) U.S.C. ss. 360e and 21 C.F.R. Part 814 (“PMA’s”"PMAs"). All 510(k)’s and PMA’s 510(k)s and/or PMAs for the Company’s 's products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s 510(k)s or PMA’s PMAs or changing the marketing classification or labeling of any such products. To the knowledge Knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the Company. Neither the Company nor any Subsidiary, nor the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §1001.1001ss.1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to impair Buyer’s ability to conduct its businesses in any material respect.for

Permits and Compliance. (a) The Each of the Company and its ---------------------- Subsidiaries are and at all times have been is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “"Company Permits”"), except where the failure to have any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company, and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the CompanyCompany (as hereinafter defined), threatened, except where the suspension or cancellation of any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company. Neither the Company nor any of its Subsidiaries has been is in violation of (iA) any Company Permitsits charter, by-laws or other organizational documents, (iiB) any applicable law, ordinance, administrative, or governmental rule or regulation, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “"SSA”")), except or (C) any order, decree or judgment of any Governmental Entity having jurisdiction over the Company or any of its Subsidiaries, except, in the case of clauses (A), (B) and (C), for any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would notthat, individually or in the aggregate, would not have a Material Adverse Effect. (b) The Company is not subject to any consent decree from any Governmental Entity. The Company has not received any warning letter from Effect on the FDA during the last three years. The Company has received no communication from any regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under considerationCompany. Without limiting the foregoing, the Company is in compliance, in all material respects, with all current applicable statutes, rules, regulations, guidelines, policies regulations or orders administered or issued by the FDA United States Food and Drug Administration (the "FDA") or comparable foreign Governmental Entity including FDA’s Quality System Regulation, 21 C.F.R. Part 820Entity; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30, 19991997, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s 's products, except set forth in Section 3.8 of the Company Letter. The Company’s 's products, where required, are being marketed under valid pre market notifications under Section 510 (k) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)’s”) or prePre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(e) and 21 C.F.R. Part 814 (“PMA’s”). All 510(k)’s and PMA’s for the Company’s products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s or PMA’s or changing the marketing classification or labeling of any such productsMarket Approval Applications. To the knowledge Knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the Company. Neither the Company nor any Subsidiary, nor the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §1001.1001(S)1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § (S) 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to impair Buyer’s ability to conduct its businesses in any material respect.offenses

Permits and Compliance. (a) The Each of the Company and its Subsidiaries are and at all times have been is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “"COMPANY PERMITS"), except where the failure to have any of the Company Permits”)Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company, and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the CompanyCompany (as hereinafter defined), threatened, except where the suspension or cancellation of any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company. Neither Except as set forth on Section 3.8 of the Company Letter, neither the Company nor any of its Subsidiaries has been is in violation of (iA) any Company Permitsits charter, by-laws or other organizational documents, (iiB) any applicable law, ordinance, administrative, or governmental rule or regulation, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-third- party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “"SSA”")), except (C) any order, decree or judgment of any Governmental Entity having jurisdiction over the Company or any of its Subsidiaries or (D) any Company Permits, except, in the case of clauses (A), (B), (C) and (D) for any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would notthat, individually or in the aggregate, would not have a Material Adverse Effect. (b) The Company is not subject to any consent decree from any Governmental Entity. The Company has not received any warning letter from Effect on the FDA during the last three years. The Company has received no communication from any regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under considerationCompany. Without limiting the foregoing, the Company is in compliance, in all respects, with all current applicable not subject to statutes, rules, regulations, guidelines, policies regulations or orders administered or issued by the FDA or comparable foreign Governmental Entity including United States Food and Drug Administration (the "FDA’s Quality System Regulation, 21 C.F.R. Part 820; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30, 1999, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s products, except set forth in Section 3.8 of the Company Letter. The Company’s products, where required, are being marketed under valid pre market notifications under Section 510 (k") of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)’s”) or pre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(e) and 21 C.F.R. Part 814 (“PMA’s”). All 510(k)’s and PMA’s for the Company’s products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s or PMA’s or changing the marketing classification or labeling of any such products. To the knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the Company. Neither the Company nor any Subsidiary, nor the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §Section 1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to impair Buyer’s ability to conduct its businesses in any material respect.been

Permits and Compliance. (a) The Each of the Company and its Subsidiaries are and at all times have been is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “"COMPANY Permits"), except where the failure to have any of the Company Permits”)Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company, and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the CompanyCompany (as hereinafter defined), threatened, except where the suspension or cancellation of any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company. Neither the Company nor any of its Subsidiaries has been is in violation of (iA) any Company Permitsits charter, by-laws or other organizational documents, (iiB) any applicable law, ordinance, administrative, or governmental rule or regulation, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “"SSA”")), except (C) any order, decree or judgment of any Governmental Entity having jurisdiction over the Company or any of its Subsidiaries or (D) any Company Permits, except, in the case of clauses (A), (B), (C) and (D) for any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would notthat, individually or in the aggregate, would not have a Material Adverse Effect. (b) The Company is not subject to any consent decree from any Governmental Entity. The Company has not received any warning letter from Effect on the FDA during the last three years. The Company has received no communication from any regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under considerationCompany. Without limiting the foregoing, the Company is in compliance, in all material respects, with all current applicable statutes, rules, regulations, guidelines, policies regulations or orders administered or issued by the FDA United States Food and Drug Administration (the "FDA") or comparable foreign Governmental Entity including FDA’s Quality System Regulation, 21 C.F.R. Part 820Entity; the Company does not have knowledge Knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30, 19991997, there have been no recalls, field notifications, alerts or seizures requested in writing, or to the Knowledge of the Company, either requested orally or threatened relating to the Company’s 's products, except as set forth in Section 3.8 of the Company Letter. The Company’s 's products, where required, are being marketed under valid pre market notifications under Section 510 (k) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)’s”) or prePre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(e) and 21 C.F.R. Part 814 (“PMA’s”). All 510(k)’s and PMA’s for the Company’s products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s or PMA’s or changing the marketing classification or labeling of any such productsMarket Approval Applications. To the knowledge Knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the Company. Neither the Company nor any Subsidiary, nor the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to impair Buyer’s ability to conduct its businesses in any material respect.comparable

Permits and Compliance. (a) The Each of the Company and its Subsidiaries are and at all times have been is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “"Company Permits”"), except where the failure to have any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company, and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the CompanyCompany (as hereinafter defined), threatened, except where the suspension or cancellation of any of the Company Permits would not, individually or in the aggregate, have a Material Adverse Effect on the Company. Neither the Company nor any of its Subsidiaries has been is in violation of (iA) any Company Permitsits charter, by-laws or other organizational documents, (iiB) any applicable law, ordinance, administrative, or governmental rule or regulation, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “"SSA”")), except or (C) any order, decree or judgment of any Governmental Entity having jurisdiction over the Company or any of its Subsidiaries, except, in the case of clauses (A), (B) and (C), for any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would notthat, individually or in the aggregate, would not have a Material Adverse Effect. (b) The Company is not subject to any consent decree from any Governmental Entity. The Company has not received any warning letter from Effect on the FDA during the last three years. The Company has received no communication from any regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under considerationCompany. Without limiting the foregoing, the Company is in compliance, in all material respects, with all current applicable statutes, rules, regulations, guidelines, policies regulations or orders administered or issued by the FDA United States Food and Drug Administration (the "FDA") or comparable foreign Governmental Entity including FDA’s Quality System Regulation, 21 C.F.R. Part 820Entity; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30December 31, 19991998, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s 's products, except set forth in Section 3.8 of the Company Letter. The Company’s 's products, where required, are being marketed under valid pre market notifications under Section 510 (k) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)’s”) or prePre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(e) and 21 C.F.R. Part 814 (“PMA’s”)Market Approval Applications. All 510(k)’s and PMA’s for the Company’s products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s or PMA’s or changing the marketing classification or labeling of any such products. To the knowledge of the Company, there There is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the CompanyCompany in those jurisdictions in which the Company products are sold, except to the extent that the failure to obtain such approvals would not, individually or in the aggregate, have a Material Adverse Effect. Neither the Company nor any Subsidiary, nor the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §1001.1001ss.1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § ss. 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to impair Buyer’s ability to conduct its businesses in any material respect.)

Permits and Compliance. (a) The Company and its Subsidiaries are and at all times have been in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “"Company Permits”"), and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any of its Subsidiaries has been in violation of (i) any Company Permits, or (ii) any applicable law, ordinance, administrative, or governmental rule or regulation, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “"SSA”")), except in the case of any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would not, individually or in the aggregate, have a Material Adverse Effect. (b) The Company is not subject to any consent decree from any Governmental Entity. The Company has not received any warning letter from the FDA during the last three years. The Company has received no communication from any regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under consideration. Without limiting the foregoing, the Company is in compliance, in all respects, with all current applicable statutes, rules, regulations, guidelines, policies or orders administered or issued by the FDA or comparable foreign Governmental Entity including FDA’s 's Quality System Regulation, 21 C.F.R. Part 820; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30, 1999, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s 's products, except set forth in Section 3.8 of the Company Letter. The Company’s 's products, where required, are being marketed under valid pre market notifications under Section 510 (k) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(kss.360(k), and 21 C.F.R. Part 807, Subpart E (“"510(k)’s”'s") or pre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(eU.S.C.ss.360(e) and 21 C.F.R. Part 814 (“"PMA’s”'s"). All 510(k)’s 's and PMA’s 's for the Company’s 's products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s 's or PMA’s 's or changing the marketing classification or labeling of any such products. To the knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the Company. Neither the Company nor any Subsidiary, nor the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §1001.1001ss.1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § ss. 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to impair Buyer’s 's ability to conduct its businesses in any material respect.

Permits and Compliance. (a) The Each of the Company and its Subsidiaries are is and at all times have has been in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “"Company Permits”"), and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the CompanyCompany or the Company Subs, threatened. Neither the Company nor any of its Subsidiaries is nor has been in violation in any material respect of (i) any Company Permits, or (ii) any applicable law, ordinance, administrative, or governmental rule or regulationother Applicable Law, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “"SSA”")), except in the case of any violations of any law, ordinance, administrative, or governmental rule or regulation described in (ii) that would not, individually or in the aggregate, have a Material Adverse Effect. (b) The Neither the Company nor any of its Subsidiaries is not subject to any consent decree from any Governmental Entity. The Neither the Company nor any of its Subsidiaries has not received any warning letter from the FDA during the last three years. The Neither the Company nor any of its Subsidiaries has received no a communication from any regulatory agency or been notified during the last three years that any product approval is withdrawn or modified or that such an action is under consideration. Without limiting the foregoing, the Company is and its Subsidiaries are in compliance, in all material respects, with all current applicable statutes, rules, regulations, guidelines, policies or orders administered or issued by the FDA or comparable foreign Governmental Entity including FDA’s 's Quality System Regulation, 21 C.F.R. CFR Part 820; the Company does not have knowledge has no Knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30, 1999, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s productsCompany Products, except set forth in Section 3.8 of the Company Letter. The Company’s productsCompany Products, where required, are being marketed under valid pre market notifications under Section 510 (k) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360(kss.360(k), and 21 C.F.R. Part 807, Subpart E (“"510(k)’s”'s") or pre-market approval applications approved by the FDA in accordance with 21 U.S.C.§360(e) and 21 C.F.R. Part 814 (“PMA’s”)'s. All 510(k)’s 's and PMA’s 's for the Company’s products Company Products are exclusively owned by the CompanyCompany Subs, and to the Knowledge of the Company there is no reason to believe that FDA is considering limiting, suspending, or revoking any such 510(k)’s 's or PMA’s 's or changing the marketing classification or labeling of any such products. To the knowledge Knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has Subs have obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the CompanyCompany Subs. Neither the Company Company, nor its Subsidiaries, nor any Subsidiary, nor the of their respective officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §1001.1001) of the Company or any Subsidiary: ss.1001.1001): (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Program; or (iv) have been convicted (as defined in 42 C.F.R. § ss. 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There Except as set forth in Section 3.8(c) of the Company Letter, there are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company Subs or having covenants not to compete that materially impair the ability of the Company or its Subsidiaries to conduct its the business of the Company Subs as currently conducted or would reasonably be expected to impair Buyer’s 's ability to conduct its businesses in any material respectthe business of the Company Subs as it is currently being conducted (other than as a result of facts or circumstances related solely to Buyer).

Permits and Compliance. (a) The Except as set forth in Section 3.8(a) of the Company Letter, the Company and its Subsidiaries are and at all times have been in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity necessary for the Company or any of its Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the “"Company Permits”"), and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither Except as set forth in Section 3.8(a) of the Company Letter, neither the Company nor any of its Subsidiaries has been in violation of (i) any Company Permits, or (ii) any applicable law, ordinance, administrative, or governmental rule or regulationApplicable Law, including any consumer protection, equal opportunity, customs, export control, foreign trade, foreign corrupt practices (including the Foreign Corrupt Practices Act), patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program health care program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “"SSA”")), except in the case of any violations of any law, ordinance, administrative, clauses (i) or governmental rule or regulation described in (ii) that as would not, individually or in the aggregate, have a Material Adverse EffectEffect on the Company. (b) The Company is not subject to any consent decree from any Governmental Entity. The Company has not received any warning letter from the FDA United States Food and Drug Administration (the "FDA") during the last three years. The Company has received no communication from the FDA or any comparable state or foreign regulatory agency or been notified during the last three years that any product approval or clearance is withdrawn or modified or that such an action is under consideration. Without limiting the foregoing, the Company is in compliance, in all material respects, with all current applicable statutes, rules, regulations, guidelines, policies or orders administered or issued by the FDA or comparable foreign Governmental Entity including FDA’s 's Quality System Regulation, 21 C.F.R. Part 820; the Company does not have knowledge of any facts which furnish any reasonable basis for any Form FDA-483 observations or regulatory or warning letters from the FDA, Section 305 notices, or other similar communications from the FDA or comparable foreign entity; and since April 30, 1999, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Company’s 's products, except as set forth in Section 3.8 of the Company Letter. The Company’s 's products, where required, are being marketed under valid pre market premarket notifications under Section 510 (k) of the Federal Food, Drug Drug, and Cosmetic Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E (“"510(k)’s”'s") or pre-market premarket approval applications approved by the FDA in accordance with 21 U.S.C.§360(eU.S.C. §360(e) and 21 C.F.R. Part 814 (“"PMA’s”'s"). All 510(k)’s 's and PMA’s 's for the Company’s 's products are exclusively owned by the Company, and there is no reason to believe that FDA is considering limiting, suspending, or revoking withdrawing any such 510(k)’s 's or PMA’s 's or changing the marketing classification or labeling of any such products. To the knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the Company. Neither the Company nor any Subsidiary, nor the officers, directors, managing employees or agents (as those terms are defined in 42 C.F.R. §1001.1001) of the Company or any Subsidiary: (i) have engaged in any activities which are prohibited under, or are cause for civil penalties or mandatory or permissive exclusion from, any Federal Health Care Program health care program under Sections 1128, 1128A, 1128B, or 1877 of SSA or related state or local statutes, including knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any such program; (ii) have had a civil monetary penalty assessed against them under Section 1128A of SSA; (iii) have been excluded from participation under any Federal Health Care Programhealth care program; or (iv) have been convicted (as defined in 42 C.F.R. § 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (b)(3) of SSA. (c) There are no contracts or agreements of the Company or its Subsidiaries having terms or conditions which would have a Material Adverse Effect on the Company or having covenants not to compete that materially impair the ability of the Company to conduct its business as currently conducted or would reasonably be expected to impair Buyer’s ability to conduct its businesses in any material respect.