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

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of Target and each Target Subsidiary is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals (including, without limitation, Food and Drug Administration ("FDA") approvals, --- licenses and permits, and any rights to use radio, television and other medium frequencies on a licensed or unlicensed basis) and orders necessary for Target or such Target Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "Target Authorizations"), and --------------------- no suspension, cancellation or substantial modification of any Target Authorization is pending or, to the knowledge of Target, threatened. Neither Target nor any Target Subsidiary is in conflict with, or in default or violation of, (i) any laws applicable to Target or any Target Subsidiary or by which any material property or asset of Target or any Target Subsidiary is bound or affected, (ii) any Target Authorization or (iii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Target or any Target Subsidiary is a party or by which Target or any Target Subsidiary or any property or asset of Target or any Target Subsidiary is bound or affected, except solely with respect to clauses (i) and (ii) to the extent that any such conflict, default or violation would not have a Material Adverse Effect on Target. (b) Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, Target has not received any written notices, citations or decisions by any governmental or regulatory body that any material product developed, produced, manufactured, marketed or distributed at any time by Target or any Target Subsidiary (the "Products") is defective or -------- fails to meet any applicable standards promulgated by any such governmental or regulatory body. Target and each Target Subsidiary has complied in all material respects with the laws, regulations, policies, procedures and specifications with respect to the development, design, manufacture, labeling, testing and inspection of the Products and the operation of manufacturing facilities promulgated by the FDA. Since January 1, 1998, there have been no recalls, field notifications or seizures ordered or, to the knowledge of Target, threatened by any such governmental or regulatory body with respect to any of the Products. Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, neither Target nor any Target Subsidiary has received a warning letter or Section 305 notice from the FDA. (c) Target has obtained, in all countries where either Target or a Target Subsidiary or any alliance partner thereof is manufacturing or marketing the Products, all applicable licenses, registrations, approvals, clearances and authorizations required by local, state or federal agencies (including the FDA) in such countries regulating the safety, effectiveness and market clearance of the Products currently manufactured or marketed by Target or any Target Subsidiary or any corporate partner or sublicensee thereof in such countries. Target has made available for examination by Acquiror all information relating to regulation of the Products, including licenses, registrations, approvals, permits, device listings, inspections, recalls and product actions, audits and ongoing field tests and clinical studies. (d) To the knowledge of Target, there have been no adverse events in any field tests or clinical trials conducted by or on behalf of Target, any Target Subsidiary or any alliance partner or sublicensee of any of them, of such a nature that would be required to be reported to any applicable regulatory authority that have not been so reported to such authority. (e) There is no judgment, injunction, pronouncement, order or decree which has or could reasonably be expected to have the effect of prohibiting or materially impairing any current or future business practice of Target or any Target Subsidiary, any acquisition of property by Target or any Target Subsidiary or the overall conduct of business by Target or any Target Subsidiary as currently conducted or as proposed to be conducted by Target or by any Target Subsidiary. Neither Target nor any Target Subsidiary has entered into any agreement under which Target or any Target Subsidiary is restricted from selling, licensing or otherwise distributing any of its products to any class of customers, in any geographic area, during any period of time or in any segment of the market. (f) Neither Target nor any Target Subsidiary has made any sales to customers that are contingent upon providing future enhancements of existing products, to add features not presently available on existing Products or to otherwise enhance the performance of its existing Products (other than beta or similar arrangements pursuant to which Target's customers from time to time test or evaluate products). The Products that Target and each Target Subsidiary have delivered to customers substantially comply with published specifications for such products and neither Target nor any Target Subsidiary has received material complaints from customers about its products that remain unresolved.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of Target and each Target Subsidiary is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals (including, without limitation, Food and Drug Administration ("FDA") approvals, --- licenses and permits, and any rights to use radio, television and other medium frequencies on a licensed or unlicensed basis) and orders necessary for Target or such Target Subsidiary that Subsidiary, to own, lease and operate its properties or to carry on its business as it is now being conducted (the "Target Authorizations"), ) and --------------------- no suspension, suspension or cancellation or substantial modification of any Target Authorization is pending or, to the knowledge best of Target's knowledge, threatened, except where the failure to have, or the suspension or cancellation of, any Target Authorization would not have a Material Adverse Effect on Target. Neither Target nor any Target Subsidiary is in conflict with, or in default or violation of, (i) any laws applicable to Target or any Target Subsidiary or by which any material property or asset of Target or any Target Subsidiary is bound or affected, (ii) any Target Authorization Authorization, or (iii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Target or any Target Subsidiary is a party or by which Target or any Target Subsidiary or any property or asset of Target or any Target Subsidiary is bound or affected, except solely with respect to clauses (i) and (ii) to the extent that for any such conflict, default or violation that would not, individually or in the aggregate, have a Material Adverse Effect on Target or any Subsidiary. (b) Except as would not have a Material Adverse Effect on Target. (b) Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, Target has not received any there have been no written notices, citations or decisions by any governmental or regulatory body that any material product developed, produced, manufactured, marketed or distributed at any time by Target or any Target Subsidiary (the "Products") is defective or -------- fails to meet any applicable standards promulgated by any such governmental or regulatory body. To the best knowledge of Target, Target and each Target Subsidiary has complied in all material respects with the laws, regulations, policies, procedures and specifications with respect to the development, design, manufacture, labeling, testing and inspection of the Products and Products. Except as disclosed in Section 2.11(b) of the operation of manufacturing facilities promulgated by the FDA. Since January 1, 1998Target Disclosure Schedule, there have been no recalls, field notifications or seizures ordered or, to the knowledge of Target's knowledge, threatened by any such governmental or regulatory body with respect to any of the Products. Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, neither Target nor any Target Subsidiary has received a warning letter or Section 305 notice from the FDA. (c) Target has obtained, in all countries where either Target or a Target Subsidiary is marketing or any alliance partner thereof is manufacturing or marketing the has marketed its Products, all applicable licenses, registrations, approvals, clearances and authorizations required by local, state or federal agencies (including the FDA) in such countries regulating the safety, effectiveness and market clearance of the Products currently manufactured or previously marketed by Target or any Target Subsidiary or any corporate partner or sublicensee thereof in such countries, except for any such failures as would not, individually or in the aggregate, have a Material Adverse Effect on Target. Target has identified and made available for examination by Acquiror all information relating to regulation of the its Products, including licenses, registrations, approvals, approvals and permits, device listings, inspections, recalls . Target has identified in writing to Acquiror all international locations where regulatory information and product actions, audits and ongoing field tests and clinical studiesdocuments are kept. (d) To the knowledge of Target, there have been no adverse events in any field tests or clinical trials conducted by or on behalf of Target, any Target Subsidiary or any alliance partner or sublicensee of any of them, of such a nature that would be required to be reported to any applicable regulatory authority that have not been so reported to such authority. (e) There is no judgment, injunction, pronouncement, order or decree which has or could reasonably be expected to have the effect of prohibiting or materially impairing any current or future business practice of Target or any Target Subsidiary, any acquisition of property by Target or any Target Subsidiary or the overall conduct of business by Target or any Target Subsidiary as currently conducted or as proposed to be conducted by Target or by any Target Subsidiary. Neither Target nor any Target Subsidiary has entered into any agreement under which Target or any Target Subsidiary is restricted from selling, licensing or otherwise distributing any of its products to any class of customers, in any geographic area, during any period of time or in any segment of the market. (f) Neither Target nor any Target Subsidiary has made any sales to customers that are contingent upon providing future enhancements of existing products, to add features not presently available on existing Products or to otherwise enhance the performance of its existing Products (other than beta or similar arrangements pursuant to which Target's customers from time to time test or evaluate products). The Products that Target and each Target Subsidiary have delivered to customers substantially comply with published specifications for such products and neither Target nor any Target Subsidiary has received material complaints from customers about its products that remain unresolved.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of Target and each Target Subsidiary is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals (including, without limitation, Food and Drug Administration ("FDA") approvals, --- licenses and permits, and any rights to use radio, television and other medium frequencies on a licensed or unlicensed basis) and orders necessary for Target or such Target Subsidiary any Subsidiary, to own, lease and operate its properties or to carry on its business as it is now being conducted (the "Target Authorizations"), ) and --------------------- no suspension, suspension or cancellation or substantial modification of any Target Authorization is pending or, to the knowledge best of Target's knowledge, threatened, except where the failure to have, or the suspension or cancellation of, any Target Authorization would not have a Material Adverse Effect on Target. Neither Target nor any Target Subsidiary is in conflict with, or in default or violation of, (i) any laws applicable to Target or any Target Subsidiary or by which any material property or asset of Target or any Target Subsidiary is bound or affected, (ii) any Target Authorization Authorization, or (iii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Target or any Target Subsidiary is a party or by which Target or any Target Subsidiary or any property or asset of Target or any Target Subsidiary is bound or affected, except solely with respect to clauses (i) and (ii) to the extent that for any such conflict, default or violation that would not, individually or in the aggregate, have a Material Adverse Effect on Target or any Subsidiary. (b) Except as would not have a Material Adverse Effect on Target. (b) Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, the inception of Target has not received any there have been no written notices, citations or decisions by any governmental or regulatory body that any material product developed, produced, manufactured, marketed or distributed at any time by Target or any Target Subsidiary (the "Products") is defective or -------- fails to meet any applicable standards promulgated by any such governmental or regulatory body. To the best knowledge of Target, Target and each Target Subsidiary has complied in all material respects with the laws, regulations, policies, procedures and specifications with respect to the development, design, manufacture, labeling, testing and inspection of the Products and Products. Except as disclosed in Section 2.11(b) of the operation Target Disclosure Schedule, since the inception of manufacturing facilities promulgated by the FDA. Since January 1, 1998Target, there have been no recalls, field notifications or seizures ordered or, to the knowledge of Target's knowledge, threatened by any such governmental or regulatory body with respect to any of the Products. Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, neither Target nor any Target Subsidiary has received a warning letter or Section 305 notice from the FDA. (c) Target has obtained, in all countries where either Target or a Target Subsidiary is marketing or any alliance partner thereof is manufacturing or marketing the has marketed its Products, all applicable licenses, registrations, approvals, clearances and authorizations required by local, state or federal agencies (including the FDA) in such countries regulating the safety, effectiveness and market clearance of the Products currently manufactured or previously marketed by Target or any Target Subsidiary or any corporate partner or sublicensee thereof in such countries, except for any such failures as would not, individually or in the aggregate, have a Material Adverse Effect on Target. Target has identified and made available for examination by Acquiror all material information relating to regulation of the its Products, including licenses, registrations, approvals, permits, device listings, inspections, Target's recalls and product actions, audits and Target's ongoing field tests tests. Target has identified in writing to Acquiror all international locations where regulatory information and clinical studiesdocuments are kept. (d) To the knowledge of Target, there have been no adverse events in any field tests or clinical trials conducted by or on behalf of Target, any Target Subsidiary or any alliance partner or sublicensee of any of them, of such a nature that would be required to be reported to any applicable regulatory authority that have not been so reported to such authority. (e) There is no judgment, injunction, pronouncement, order or decree which has or could reasonably be expected to have the effect of prohibiting or materially impairing any current or future business practice of Target or any Target Subsidiary, any acquisition of property by Target or any Target Subsidiary or the overall conduct of business by Target or any Target Subsidiary as currently conducted or as proposed to be conducted by Target or by any Target Subsidiary. Neither Target nor any Target Subsidiary has entered into any agreement under which Target or any Target Subsidiary is restricted from selling, licensing or otherwise distributing any of its products to any class of customers, in any geographic area, during any period of time or in any segment of the market. (f) Neither Target nor any Target Subsidiary has made any sales to customers that are contingent upon providing future enhancements of existing products, to add features not presently available on existing Products or to otherwise enhance the performance of its existing Products (other than beta or similar arrangements pursuant to which Target's customers from time to time test or evaluate products). The Products that Target and each Target Subsidiary have delivered to customers substantially comply with published specifications for such products and neither Target nor any Target Subsidiary has received material complaints from customers about its products that remain unresolved.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of Target and each Target Subsidiary is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals (including, without limitation, Food and Drug Administration ("FDA") approvals, --- licenses and permits, and any rights to use radio, television and other medium frequencies on a licensed or unlicensed basis) and orders necessary for Target or such Target Subsidiary any Subsidiary, to own, lease and operate its properties or to carry on its business as it is now being conducted (the "Target Authorizations"), ) and --------------------- no suspension, suspension or cancellation or substantial modification of any Target Authorization is pending or, to the knowledge best of Target's knowledge, threatened, except where the failure to have, or the suspension or cancellation of, any Target Authorization would not have or would not reasonably be expected to have Material Adverse Effect on Target. Neither Target nor any Target Subsidiary is in conflict with, or in default or violation of, (i) any laws applicable to Target or any Target Subsidiary or by which any material property or asset of Target or any Target Subsidiary is bound or affected, (ii) any Target Authorization Authorization, or (iii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Target or any Target Subsidiary is a party or by which Target or any Target Subsidiary or any property or asset of Target or any Target Subsidiary is bound or affected, except solely with respect to clauses (i) and (ii) to the extent that for any such conflict, default or violation that would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Effect on Target or any Subsidiary. (b) Except as would not have or reasonably be expected to have a Material Adverse Effect on Target. (b) Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, the inception of Target has not received any there have been no written notices, citations or decisions by any governmental or regulatory body that any material product developed, produced, manufactured, marketed or distributed at any time by Target or any Target Subsidiary (the "Products") is defective or -------- fails to meet any applicable standards promulgated by any such governmental or regulatory body. To the best knowledge of Target, Target and each Target Subsidiary has complied in all material respects with the laws, regulations, policies, procedures and specifications with respect to the development, design, manufacture, labeling, testing and inspection of the Products and the operation of manufacturing facilities promulgated by the FDAProducts. Since January 1, 1998the inception of the Target, there have been no recalls, field notifications or seizures ordered or, to the knowledge of Target's knowledge, threatened by any such governmental or regulatory body with respect to any of the Products. Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, neither Target nor any Target Subsidiary has received a warning letter or Section 305 notice from the FDA. (c) Target has obtained, in all countries where either Target or a Target Subsidiary is marketing or any alliance partner thereof is manufacturing or marketing the has marketed its Products, all applicable licenses, registrations, approvals, clearances and authorizations required by local, state or federal agencies (including the FDA) in such countries regulating the safety, effectiveness and market clearance of the Products currently manufactured or previously marketed by Target or any Target Subsidiary or any corporate partner or sublicensee thereof in such countries, except for any such failures as would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Effect on Target. Target has identified and made available for examination by Acquiror all information relating to regulation of the its Products, including licenses, registrations, approvals, permits, device listings, inspections, Target's recalls and product actions, audits and Target's ongoing field tests tests. Target has identified in writing to Acquiror all international locations where regulatory information and clinical studiesdocuments are kept. (d) To the knowledge of Target, there have been no adverse events in any field tests or clinical trials conducted by or on behalf of Target, any Target Subsidiary or any alliance partner or sublicensee of any of them, of such a nature that would be required to be reported to any applicable regulatory authority that have not been so reported to such authority. (e) There is no judgment, injunction, pronouncement, order or decree which has or could reasonably be expected to have the effect of prohibiting or materially impairing any current or future business practice of Target or any Target Subsidiary, any acquisition of property by Target or any Target Subsidiary or the overall conduct of business by Target or any Target Subsidiary as currently conducted or as proposed to be conducted by Target or by any Target Subsidiary. Neither Target nor any Target Subsidiary has entered into any agreement under which Target or any Target Subsidiary is restricted from selling, licensing or otherwise distributing any of its products to any class of customers, in any geographic area, during any period of time or in any segment of the market. (f) Neither Target nor any Target Subsidiary has made any sales to customers that are contingent upon providing future enhancements of existing products, to add features not presently available on existing Products or to otherwise enhance the performance of its existing Products (other than beta or similar arrangements pursuant to which Target's customers from time to time test or evaluate products). The Products that Target and each Target Subsidiary have delivered to customers substantially comply with published specifications for such products and neither Target nor any Target Subsidiary has received material complaints from customers about its products that remain unresolved.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of Target and each Target Subsidiary is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals (including, without limitation, Food and Drug Administration ("FDA") approvals, --- licenses and permits, and any rights to use radio, television and other medium frequencies on a licensed or unlicensed basis) and orders necessary for Target or such Target Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "Target Authorizations"), and --------------------- no suspension, cancellation or substantial modification of any Target Authorization is pending or, to the knowledge of Target, threatened. Neither Target nor any Target Subsidiary is in conflict with, or in default or violation of, (i) any laws applicable to Target or any Target Subsidiary or by which any material property or asset of Target or any Target Subsidiary is bound or affected, (ii) any Target Authorization or (iii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Target or any Target Subsidiary is a party or by which Target or any Target Subsidiary or any property or asset of Target or any Target Subsidiary is bound or affected, except solely with respect to clauses (i) and (ii) to the extent that any such conflict, default or violation would not have a Material Adverse Effect on Target. (b) Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, Target has not received any written notices, citations or decisions by any governmental or regulatory body that any material product developed, produced, manufactured, marketed or distributed at any time by Target or any Target Subsidiary (the "Products") is defective or -------- fails to meet any applicable standards promulgated by any such governmental or regulatory body. Target and each Target Subsidiary has complied in all material respects with the laws, regulations, policies, procedures and specifications with respect to the development, design, manufacture, labeling, testing and inspection of the Products and the operation of manufacturing facilities promulgated by the FDA. Since January 1, 1998, there have been no recalls, field notifications or seizures ordered or, to the knowledge of Target, threatened by any such governmental or regulatory body with respect to any of the Products. Except as disclosed in the Target SEC Reports filed prior to February 8, 2001, since January 1, 1998, neither Target nor any Target Subsidiary has received a warning letter or Section 305 notice from the FDA. (c) Target has obtained, in all countries where either Target or a Target Subsidiary or any alliance partner thereof is manufacturing or marketing the Products, all applicable licenses, registrations, approvals, clearances and authorizations required by local, state or federal agencies (including the FDA) in such countries regulating the safety, effectiveness and market clearance of the Products currently manufactured or marketed by Target or any Target Subsidiary or any corporate partner or sublicensee thereof in such countries. Target has made available for examination by Acquiror all information relating to regulation of the Products, including licenses, registrations, approvals, permits, device listings, inspections, recalls and product actions, audits and ongoing field tests and clinical studies. (d) To the knowledge of Target, there have been no adverse events in any field tests or clinical trials conducted by or on behalf of Target, any Target Subsidiary or any alliance partner or sublicensee of any of them, of such a nature that would be required to be reported to any applicable regulatory authority that have not been so reported to such authority. (e) There is no judgment, injunction, pronouncement, order or decree which has or could reasonably be expected to have the effect of prohibiting or materially impairing any current or future business practice of Target or any Target Subsidiary, any acquisition of property by Target or any Target Subsidiary or the overall conduct of business by Target or any Target Subsidiary as currently conducted or as proposed to be conducted by Target or by any Target Subsidiary. Neither Target nor any Target Subsidiary has entered into any agreement under which Target or any Target Subsidiary is restricted from selling, licensing or otherwise distributing any of its products to any class of customers, in any geographic area, during any period of time or in any segment of the market. (f) Neither Target nor any Target Subsidiary has made any sales to customers that are contingent upon providing future enhancements of existing products, to add features not presently available on existing Products or to otherwise enhance the performance of its existing Products (other than beta or similar arrangements pursuant to which Target's customers from time to time test or evaluate products). The Products that Target and each Target Subsidiary have delivered to customers substantially comply with published specifications for such products and neither Target nor any Target Subsidiary has received material complaints from customers about its products that remain unresolved.