Common use of PERMITS; COMPANY PRODUCTS; REGULATION Clause in Contracts

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of the Company and each Subsidiary are in possession of all franchises, grants, authorizations, clearances, licenses, registrations, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for the Company or each Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect. As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect. A list of the material Permits is set forth in Section 3.06(a) of the Company Disclosure Schedule. Neither the Company nor any Subsidiary is in conflict with, or in default or violation of, (i) the Foreign Corrupt Practices Act of 1977, as amended, (ii) any Law applicable to the Company or any Subsidiary or by which any property or asset of the Company or any Subsidiary is bound or affected, or (iii) any Permits, except for any such conflicts, defaults or violations that would not, individually or in the aggregate, have a Material Adverse Effect. (b) Except as would not have a Material Adverse Effect, since January 1, 1992, 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 (the "PRODUCTS") is defective or fails to meet any applicable standards promulgated by such Governmental Authority, and the Company does not know of any such defect or failure. Except as would not have a Material Adverse Effect, the Company has complied with the Law, policies, procedures and specifications applicable to the Company with respect to the design, manufacture, labelling, testing and inspection of Products in the United States and the operation of manufacturing facilities in the United States promulgated by the Food and Drug Administration ("FDA"), and has complied with the Law, policies, procedures and specifications applicable to the Company in any jurisdiction outside the United States with respect to the design, manufacture, labelling, testing and inspection of Products and the operation of manufacturing facilities outside of the United States. Since January 1, 1992, 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 Products that would, individually or in the aggregate, have a Material Adverse Effect, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notices from the FDA. (c) The Company has obtained, in all countries where the Company is marketing or has marketed its Products, all applicable Permits required to be obtained by it by Governmental Authorities (including the FDA) in such countries regulating the safety, effectiveness and market clearance of the Products that are currently marketed by the Company or its affiliates, except where the failure to obtain such Permits would not, individually or in the aggregate, have a Material Adverse Effect. Section 3.06(c)(i) of the Company Disclosure Schedule sets forth a list of all licenses, registrations, approvals, permits and device listings. Section 3.06(c)(ii) of the Company Disclosure Schedule sets forth a description of all Company inspections by regulatory authorities, recalls, product actions and audits since January 1, 1992 and a description of ongoing clinical studies.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of the Company and each Subsidiary are is in possession of all franchises, grants, authorizations, clearances, licenses, registrations, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for the Company or each Subsidiary that Subsidiary, to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSCompany Authorizations"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect. As of the date hereof, ) and no -11- 16 suspension or cancellation of any of the Permits Company Authorization is pending or, to the knowledge of the CompanyPrincipal Shareholders' knowledge, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits Company Authorization would not, individually or in the aggregate, not have a Material Adverse Effect. A list of Effect on the material Permits is set forth in Section 3.06(a) of the Company Disclosure ScheduleCompany. Neither the Company nor any Subsidiary is in conflict with, or in default or violation of, (i) the Foreign Corrupt Practices Act of 1977, as amended, (ii) any Law laws applicable to the Company or any Subsidiary or by which any property or asset of the Company or any Subsidiary is bound or affected, (ii) any Company Authorization or (iii) any Permitsnote, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which the Company or any Subsidiary is a party or by which the Company or any Subsidiary or any property or asset of the Company or any Subsidiary is bound or affected, except for any such conflictsconflict, defaults default or violations violation that would not, individually or in the aggregate, aggregate have a Material Adverse EffectEffect on the Company. (b) Except as would not have a Material Adverse Effect, since January 1, 1992Effect on the Company, there have been no written notices, citations or decisions by any Governmental Authority governmental or regulatory body that any product produced, manufactured manufactured, marketed or marketed distributed at any time by the Company or any Subsidiary (the "PRODUCTSProducts") is defective or fails to meet any applicable standards promulgated by such Governmental Authority, and the Company does not know of any such defect governmental or failureregulatory body. Except as would not have a Material Adverse EffectTo the knowledge of the Principal Shareholders, the Company has complied in all material respects with the Lawlaws, regulations, policies, procedures and specifications applicable to the Company with respect to the design, manufacture, labellinglabeling, testing and inspection of Products the Products. Except as disclosed in the United States and the operation Section 4.11(b) of manufacturing facilities in the United States promulgated by the Food and Drug Administration ("FDA"), and has complied with the Law, policies, procedures and specifications applicable to the Company in any jurisdiction outside the United States with respect to the design, manufacture, labelling, testing and inspection of Products and the operation of manufacturing facilities outside of the United States. Since January 1, 1992Disclosure Schedule, there have been no recalls, field notifications or seizures ordered or, to the knowledge of the CompanyPrincipal Shareholders' knowledge, threatened by any Governmental Authority such governmental or regulatory body with respect to any of the Products that would, individually or in the aggregate, have a Material Adverse Effect, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notices from the FDAProducts. (c) The Company has obtained, in all countries where either the Company or a Subsidiary is marketing or has marketed its Products, all applicable Permits licenses, registrations, approvals, clearances and authorizations required to be obtained by it by Governmental Authorities (including the FDA) local, state or federal agencies in such countries regulating the safety, effectiveness and market clearance of the Products that are currently or previously marketed by the Company or its affiliatesany Subsidiary in such countries, except where the failure to obtain for any such Permits failures as would not, individually or in the aggregate, have a Material Adverse EffectEffect on the Company. Section 3.06(c)(i) The Principal Shareholders have identified and made available for examination by Offeror all information relating to regulation of the Company Disclosure Schedule sets forth a list of all its Products, including licenses, registrations, approvals, permits permits, device listing, inspections, the Company's recalls and device listingsproduct actions, audits and the Company's ongoing field tests. Section 3.06(c)(ii) of the Company Disclosure Schedule sets forth a description of The Principal Shareholders have identified in writing to Offeror all Company inspections by international locations where regulatory authorities, recalls, product actions information and audits since January 1, 1992 and a description of ongoing clinical studiesdocuments are kept.

PERMITS; COMPANY PRODUCTS; REGULATION. (ai) Each of the The Company and each Subsidiary are is in possession of all franchises, grants, authorizations, clearances, licenses, registrations, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for the Company or each Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect. As of the date hereof, “Company Authorizations”) and no suspension or cancellation of any of the Permits Company Authorization is pending or, to the knowledge of the Company’s knowledge, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits Company Authorization would not, individually or in the aggregate, not have a Material Adverse EffectEffect on the Company. A list of the material Permits The Company is set forth in Section 3.06(a) of the Company Disclosure Schedule. Neither the Company nor any Subsidiary is not in conflict with, or in default or violation of, (i) the Foreign Corrupt Practices Act of 1977, as amended, (ii) any Law laws applicable to the Company or any Subsidiary or by which any property or asset of the Company or any Subsidiary is bound or affected, (ii) any Company Authorization or (iii) any Permitsnote, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which the Company is a party or by which the Company or any property or asset of the Company is bound or affected, except for any such conflictsconflict, defaults default or violations violation that would not, individually or in the aggregate, aggregate have a Material Adverse EffectEffect on the Company. (bii) Except as would not have a Material Adverse EffectEffect on the Company, since January 131, 19922009, there have been no written notices, citations or decisions by any Governmental Authority governmental or regulatory body that any product produced, manufactured manufactured, marketed or marketed distributed at any time by the Company or by any agent on behalf of the Company (the "PRODUCTS"“Products”) is defective or fails to meet any applicable standards promulgated by such Governmental Authority, and the Company does not know of any such defect governmental or failureregulatory body. Except as would not have a Material Adverse EffectTo the knowledge of the Company, the Company has complied in all material respects with the Lawlaws, regulations, policies, procedures and specifications applicable to the Company with respect to the design, manufacture, labellinglabeling, testing and inspection of Products the Products. Except as disclosed in the United States and the operation Section 8(k)(ii) of manufacturing facilities in the United States promulgated by the Food and Drug Administration ("FDA"), and has complied with the Law, policies, procedures and specifications applicable to the Company in any jurisdiction outside the United States with respect to the designDisclosure Schedule, manufacturesince January 31, labelling, testing and inspection of Products and the operation of manufacturing facilities outside of the United States. Since January 1, 19922009, there have been no recalls, field notifications or seizures ordered or, to the knowledge of the Company’s knowledge, threatened by any Governmental Authority such governmental or regulatory body with respect to any of the Products that would, individually or in the aggregate, have a Material Adverse Effect, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notices from the FDAProducts. (ciii) The Company has obtained, in all countries where either the Company or any agent of the Company is marketing or has marketed its the Company’s Products, all applicable Permits licenses, registrations, approvals, clearances and authorizations required to be obtained by it by Governmental Authorities (including the FDA) local, state or federal agencies in such countries regulating the safety, effectiveness and market clearance of the Products that are currently or previously marketed by the Company or its affiliatesagents in such countries, except where the failure to obtain for any such Permits failures as would not, individually or in the aggregate, have a Material Adverse EffectEffect on the Company. Section 3.06(c)(i) The Company has identified and made available for examination by Purchaser all information relating to regulation of the Company Disclosure Schedule sets forth a list of all its Products, including licenses, registrations, approvals, permits permits, device listing, inspections, the Company’s recalls and device listingsproduct actions, audits and the Company’s ongoing field tests. Section 3.06(c)(ii) of the The Company Disclosure Schedule sets forth a description of has identified in writing to Purchaser all Company inspections by international locations where regulatory authorities, recalls, product actions information and audits since January 1, 1992 and a description of ongoing clinical studiesdocuments are kept.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of the Company and each Subsidiary are is in possession of all franchises, grants, authorizations, clearances, licenses, registrations, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for the Company or each Subsidiary that Subsidiary, to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect. As of the date hereof, “Company Authorizations”) and no suspension or cancellation of any of the Permits Company Authorization is pending or, to the knowledge best of the Company’s and the Selling Stockholders’ knowledge, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits Company Authorization would not, individually or in the aggregate, not have a Material Adverse Effect. A list of Effect on the material Permits is set forth in Section 3.06(a) of the Company Disclosure ScheduleCompany. Neither the Company nor any Subsidiary is in conflict with, or in default or violation of, (i) the Foreign Corrupt Practices Act of 1977, as amended, (ii) any Law laws applicable to the Company or any Subsidiary or by which any property or asset of the Company or any Subsidiary is bound or affected, (ii) any Company Authorization, or (iii) any Permitsnote, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which the Company or any Subsidiary is a party or by which the Company or any Subsidiary or any property or asset of the Company or any Subsidiary is bound or affected, except for any such conflictsconflict, defaults default or violations violation that would not, individually or in the aggregate, have a Material Adverse EffectEffect on the Company or any Subsidiary. (b) Except as would not have a Material Adverse EffectEffect on the Company, since January 1, 1992, the inception of the Company there have been no written notices, citations or decisions by any Governmental Authority Entity that any product produced, manufactured manufactured, marketed or marketed distributed at any time by the Company or any Subsidiary (the "PRODUCTS"“Products”) is defective or fails to meet any applicable standards promulgated by any such Governmental Authority, Entity. To the best knowledge of the Company and the Company does not know of any such defect or failure. Except as would not have a Material Adverse EffectSelling Stockholders, the Company and each Subsidiary has complied in all material respects with the Lawlaws, regulations, policies, procedures and specifications applicable to the Company with respect to the design, manufacture, labellinglabeling, testing and inspection of Products the Products. Except as disclosed in the United States and the operation Section 2.11(b) of manufacturing facilities in the United States promulgated by the Food and Drug Administration ("FDA"), and has complied with the Law, policies, procedures and specifications applicable to the Company in any jurisdiction outside Disclosure Schedule, since the United States with respect to the design, manufacture, labelling, testing and inspection of Products and the operation of manufacturing facilities outside inception of the United States. Since January 1, 1992Company, there have been no recalls, field notifications or seizures ordered or, to the knowledge of Company’s and the CompanySelling Stockholders’ knowledge, threatened by any such Governmental Authority Entity with respect to any of the Products that would, individually or in the aggregate, have a Material Adverse Effect, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notices from the FDAProducts. (c) The Company has obtained, in all countries where either the Company or a Subsidiary is marketing or has marketed its Products, all applicable Permits licenses, registrations, approvals, clearances and authorizations required to be obtained by it by Governmental Authorities (including the FDA) local, state or federal agencies in such countries regulating the safety, effectiveness and market clearance of the Products that are currently or previously marketed by the Company or its affiliatesany Subsidiary in such countries, except where the failure to obtain for any such Permits failures as would not, individually or in the aggregate, have a Material Adverse EffectEffect on the Company. Section 3.06(c)(i) The Company has identified and made available for examination by the Acquiror all material information relating to regulation of the Company Disclosure Schedule sets forth a list of all its Products, including licenses, registrations, approvals, permits and permits, device listings, inspections, the Company’s recalls and product actions, audits and the Company’s ongoing field tests. Section 3.06(c)(ii) of The Company has identified in writing to the Company Disclosure Schedule sets forth a description of Acquiror all Company inspections by international locations where regulatory authorities, recalls, product actions information and audits since January 1, 1992 and a description of ongoing clinical studiesdocuments are kept.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of the The Company and each Subsidiary are is in possession of all franchises, grants, authorizations, clearances, licenses, registrations, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for the Company or each Subsidiary Company, to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSCompany Authorizations"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect. As of the date hereof, ) and no suspension or cancellation of any of the Permits Company Authorization is pending or, to the knowledge of the Company's knowledge, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits Company Authorization would not, individually or in the aggregate, not have a Material Adverse EffectEffect on the Company. A list of the material Permits The Company is set forth in Section 3.06(a) of the Company Disclosure Schedule. Neither the Company nor any Subsidiary is not in conflict with, or in default or violation of, (i) the Foreign Corrupt Practices Act of 1977, as amended, (ii) any Law laws applicable to the Company or any Subsidiary or by which any property or asset of the Company or any Subsidiary is bound or affected, (ii) any Company Authorization or (iii) any Permitsnote, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which the Company is a party or by which the Company or any property or asset of the Company is bound or affected, except for any such conflictsconflict, defaults default or violations violation that would not, individually or in the aggregate, aggregate have a Material Adverse EffectEffect on the Company. (b) Except as would not have a Material Adverse EffectSince September 30, since January 1, 19921998, there have been no written notices, citations or decisions by any Governmental Authority governmental or regulatory body that any product produced, manufactured manufactured, marketed or marketed distributed at any time by the Company (the "PRODUCTS") is defective or fails to meet any applicable standards promulgated by such Governmental Authority, and the Company does not know of any such defect governmental or failureregulatory body. Except as would not have a Material Adverse EffectTo the knowledge of the Company, the Company has complied in all material respects with the Lawlaws, regulations, policies, procedures and specifications applicable to the Company with respect to the design, manufacture, labellinglabeling, testing and inspection of Products in the United States and the operation of manufacturing facilities in the United States promulgated by the Food and Drug Administration ("FDA"), and has complied with the Law, policies, procedures and specifications applicable to the Company in any jurisdiction outside the United States with respect to the design, manufacture, labelling, testing and inspection of Products and the operation of manufacturing facilities outside of the United StatesCompany's products. Since January 1, 1992, there There have been no recalls, field notifications or seizures ordered or, to the knowledge of the Company's knowledge, threatened by any Governmental Authority such governmental or regulatory body with respect to any of the Products that would, individually or in the aggregate, have a Material Adverse Effect, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notices from the FDAProducts. (c) The Company has obtained, in all countries where either the Company is marketing or has marketed its Products, all applicable Permits licenses, registrations, approvals, clearances and authorizations required to be obtained by it by Governmental Authorities (including the FDA) local, state or federal agencies in such countries regulating the safety, effectiveness and market clearance of the Products that are currently or previously marketed by the Company or its affiliatesin such countries, except where the failure to obtain for any such Permits failures as would not, individually or in the aggregate, have a Material Adverse EffectEffect on the Company. Section 3.06(c)(i) The Company has identified and made available for examination by Purchaser all information relating to regulation of the Company Disclosure Schedule sets forth a list of all its Products, including licenses, registrations, approvals, permits permits, device listing, inspections, the Company's recalls and device listingsproduct actions, audits and the Company's ongoing clinical studies and trials. Section 3.06(c)(iiThe Company has identified in writing to Purchaser all international locations where regulatory information and documents are kept. (d) of To the Company's knowledge, the Company Disclosure Schedule sets forth has at all times conducted, and is presently conducting, its operations so as to comply with all laws, statutes, ordinances, rules and regulations applicable to the conduct or operation of its business or the ownership or use of its assets, except where failure to do so would not have a description of all Company inspections by regulatory authorities, recalls, product actions and audits since January 1, 1992 and a description of ongoing clinical studiesMaterial Adverse Effect.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of the The Company and each Subsidiary are is in possession of all franchises, grants, authorizations, clearances, licenses, registrations, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for the Company or each Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect. As of the date hereof, “Company Authorizations”) and no suspension or cancellation of any of the Permits Company Authorization is pending or, to the knowledge of the Company’s knowledge, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits Company Authorization would not, individually or in the aggregate, not have a Material Adverse EffectEffect on the Company. A list of the material Permits The Company is set forth in Section 3.06(a) of the Company Disclosure Schedule. Neither the Company nor any Subsidiary is not in conflict with, or in default or violation of, (i) the Foreign Corrupt Practices Act of 1977, as amended, (ii) any Law laws applicable to the Company or any Subsidiary or by which any property or asset of the Company or any Subsidiary is bound or affected, (ii) any Company Authorization or (iii) any Permitsnote, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which the Company is a party or by which the Company or any property or asset of the Company is bound or affected, except for any such conflictsconflict, defaults default or violations violation that would not, individually or in the aggregate, aggregate have a Material Adverse EffectEffect on the Company. (b) Except as would not have a Material Adverse EffectEffect on the Company, since January 131, 19922009, there have been no written notices, citations or decisions by any Governmental Authority governmental or regulatory body that any product produced, manufactured manufactured, marketed or marketed distributed at any time by the Company or by any agent on behalf of the Company (the "PRODUCTS"“Products”) is defective or fails to meet any applicable standards promulgated by such Governmental Authority, and the Company does not know of any such defect governmental or failureregulatory body. Except as would not have a Material Adverse EffectTo the knowledge of the Company, the Company has complied in all material respects with the Lawlaws, regulations, policies, procedures and specifications applicable to the Company with respect to the design, manufacture, labellinglabeling, testing and inspection of Products the Products. Except as disclosed in the United States and the operation Section 4.11 of manufacturing facilities in the United States promulgated by the Food and Drug Administration ("FDA"), and has complied with the Law, policies, procedures and specifications applicable to the Company in any jurisdiction outside the United States with respect to the designDisclosure Schedule, manufacturesince January 31, labelling, testing and inspection of Products and the operation of manufacturing facilities outside of the United States. Since January 1, 19922009, there have been no recalls, field notifications or seizures ordered or, to the knowledge of the Company’s knowledge, threatened by any Governmental Authority such governmental or regulatory body with respect to any of the Products that would, individually or in the aggregate, have a Material Adverse Effect, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notices from the FDAProducts. (c) The Company has obtained, in all countries where either the Company or any agent of the Company is marketing or has marketed its the Company’s Products, all applicable Permits licenses, registrations, approvals, clearances and authorizations required to be obtained by it by Governmental Authorities (including the FDA) local, state or federal agencies in such countries regulating the safety, effectiveness and market clearance of the Products that are currently or previously marketed by the Company or its affiliatesagents in such countries, except where the failure to obtain for any such Permits failures as would not, individually or in the aggregate, have a Material Adverse EffectEffect on the Company. Section 3.06(c)(i) The Company has identified and made available for examination by Purchaser all information relating to regulation of the Company Disclosure Schedule sets forth a list of all its Products, including licenses, registrations, approvals, permits permits, device listing, inspections, the Company’s recalls and device listingsproduct actions, audits and the Company’s ongoing field tests. Section 3.06(c)(ii) of the The Company Disclosure Schedule sets forth a description of has identified in writing to Purchaser all Company inspections by international locations where regulatory authorities, recalls, product actions information and audits since January 1, 1992 and a description of ongoing clinical studiesdocuments are kept.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of the Company Target, Pilot and each Subsidiary are in possession of all franchises, grants, authorizations, clearances, licenses, registrations, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for Target, Pilot and the Company or each Subsidiary Subsidiaries to own, lease and operate its their respective properties or and to carry on its business their respective businesses as it is they are now being conducted (the "PERMITSTarget Authorizations"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect. As of the date hereof, and no suspension or cancellation of any of the Permits Target Authorization is pending or, to the knowledge of the Company, or threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits Target Authorization would not, individually or in the aggregate, not have a Material Adverse EffectEffect on Target, Pilot and the Subsidiaries, taken as a whole, or prevent Target or Pilot from performing their respective obligations under this Agreement. A list None of the material Permits is set forth in Section 3.06(a) of the Company Disclosure Schedule. Neither the Company nor Target, Pilot or any Subsidiary is in conflict with, or in default or violation of, (i) the Foreign Corrupt Practices Act of 1977any Target Authorization, as amended, or (ii) any Law applicable note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to the Company or any Subsidiary which it is a party or by which it or any its property or asset of the Company or any Subsidiary assets is bound or affected, or (iii) any Permits, except for any such conflictsconflict, defaults default or violations violation that would not, individually or in the aggregate, have a Material Adverse EffectEffect on Target, Pilot and the Subsidiaries, taken as a whole, or prevent Target or Pilot from performing their respective obligations under this Agreement. (b) Except as would not have a Material Adverse EffectEffect on Target, since January 1Pilot and the Subsidiaries, 1992taken as a whole, there have been no written notices, citations or decisions by any Governmental Authority governmental or regulatory body that any product produced, manufactured manufactured, marketed or marketed distributed at any time by the Company Target, Pilot or any Subsidiary (the "PRODUCTSProducts") is defective or fails to meet any applicable standards promulgated by such Governmental Authority, and the Company does not know of any such defect governmental or failureregulatory body. Except as would not have a To the knowledge of Platinum, Target and Pilot, Target, Pilot and each Material Adverse Effect, the Company Subsidiary has complied in all material respects with the Lawlaws, regulations, policies, procedures and specifications applicable to the Company with respect to the design, manufacture, labellinglabeling, testing and inspection of Products in the United States and the operation of manufacturing facilities in the United States promulgated by the Food and Drug Administration ("FDA"), and has complied with the Law, policies, procedures and specifications applicable to the Company in any jurisdiction outside the United States with respect to the design, manufacture, labelling, testing and inspection of Products and the operation of manufacturing facilities outside of the United StatesProducts. Since January 1, 1992, there There have been no recalls, field notifications or seizures ordered or, to the knowledge of the Company, or threatened by any Governmental Authority such governmental or regulatory body with respect to any of the Products that would, individually or in the aggregate, have a Material Adverse Effect, and the Company has not independently engaged in such recalls or field notifications. The Company has not received any warning letter or Section 305 notices from the FDAProducts. (c) The Company Target, Pilot or a Material Subsidiary has obtained, in all countries where the Company any of them is marketing or has marketed its any Products, all applicable Permits licenses, registrations, approvals, clearances and authorizations required to be obtained by it by Governmental Authorities (including the FDA) local, state or federal agencies in such countries regulating the safety, effectiveness and market clearance of the Products that are currently or previously marketed by the Company or its affiliatesin such countries, except where the failure to obtain for any such Permits failures as would not, individually or in the aggregate, have a Material Adverse Effect. Section 3.06(c)(i) of Effect on Target, Pilot and the Company Disclosure Schedule sets forth Subsidiaries, taken as a list of all licenseswhole, registrations, approvals, permits and device listings. Section 3.06(c)(ii) of the Company Disclosure Schedule sets forth a description of all Company inspections by regulatory authorities, recalls, product actions and audits since January 1, 1992 and a description of ongoing clinical studiesor prevent Target or Pilot from performing their respective obligations under this Agreement.