Common use of Compliance with Applicable Laws; Permits Clause in Contracts

Compliance with Applicable Laws; Permits. (a) Except as set forth on SCHEDULE 5.16, the Company and its Subsidiaries have complied in all material respects with all laws, rules, regulations, writs, injunctions, decrees, and Orders applicable to it or to the operation of the Business (collectively, "Laws") and has not received any written notice of any alleged claim or threatened claim, violation of, liability or potential responsibility under, any such Law that has not heretofore been cured and for which there is no remaining liability other than those not having a Material Adverse Effect. (b) The Company and its Subsidiaries hold all licenses, permits and other governmental authorizations (the "Permits") the absence of any of which could have a Material Adverse Effect, and the Company has delivered to Clarant an accurate list and summary description (which is set forth on SCHEDULE 5.16) of all such Permits. To the Knowledge of the Company and the Stockholders, the Permits listed on SCHEDULES 5.16 are valid, and neither the Company nor any Subsidiary has received any written notice that any Governmental Authority intends to cancel, terminate or not renew any such Permit. The Company and its Subsidiaries have conducted and are conducting their Business in compliance with the requirements, standards, criteria and conditions set forth in the Permits listed on SCHEDULE 5.16 and are not in violation of any of the foregoing except where such non-compliance or violation would not have a Material Adverse Effect. Except as specifically provided in SCHEDULE 5.16, the transactions contemplated by this Agreement will not result in a default under or a breach or violation of, or adversely affect the rights and benefits afforded to the Company and its Subsidiaries by, any of the Permits listed on SCHEDULE 5.16.

Compliance with Applicable Laws; Permits. (a) Except as set forth The Company and the Subsidiaries are and have been in compliance with all Laws, regulations and orders of any Governmental Entity applicable to the Company or the Subsidiaries, except for such failures so to comply which, individually or in the aggregate, would not have a Material Adverse Effect on SCHEDULE 5.16, the Company. The business operations of the Company and its the Subsidiaries have complied not been conducted in all material respects with all laws, rules, regulations, writs, injunctions, decrees, and Orders applicable to it or to the operation of the Business (collectively, "Laws") and has not received any written notice violation of any alleged claim Law, ordinance or threatened claimregulation of any Governmental Entity, violation ofexcept for possible violations which, liability individually or potential responsibility underin the aggregate, any such Law that has would not heretofore been cured and for which there is no remaining liability other than those not having have a Material Adverse EffectEffect on the Company. (b) The Company and its Subsidiaries hold all licenses, permits and other governmental authorizations (the "Permits") the absence of any of which could have a Material Adverse Effect, and the Company has delivered to Clarant an accurate list and summary description (which is set forth on SCHEDULE 5.16) of all such Permits. To the Knowledge Each of the Company and the StockholdersSubsidiaries is in possession of all franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity, including, without limitation, the Permits listed on SCHEDULES 5.16 are validFDA, the United States Drug Enforcement Administration (the “DEA”), and similar authorities in any U.S. and non-U.S. jurisdictions, necessary for the Company or any Subsidiary to own, lease and operate its properties or to produce, store, distribute and market its products or otherwise to carry on its business as it is now being conducted (the “Company Permits”), and, as of the date of this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened, except, with regard to any Company Permits about which a representation and warranty is given by the Company in any other section in this Article IV and such other representation and warranty expressly includes a qualification as to Material Adverse Effect on the Company, where the failure to have, or the suspension or cancellation of, such Company Permits would not individually or in the aggregate have a Material Adverse Effect on the Company. Neither the Company nor any Subsidiary is in conflict with, or in default or violation of, (i) 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 except for such conflict, default or violation as would not individually or in the aggregate have a Material Adverse Effect on the Company or (ii) any Company Permits. As used in this Agreement, “Law” means any federal, state or local statute, law, ordinance, regulation, rule, code, order, other requirement or rule of law of the United States or any other U.S. or non-U.S. jurisdiction, including, without limitation, the Federal Food, Drug, and Cosmetic Act (the “FDCA”), the Controlled Substances Act, and any other similar act or law. (c) Except as would not, individually or in the aggregate, have a Material Adverse Effect on the Company: (i) all manufacturing operations of the Company and the Subsidiaries are being conducted in substantial compliance with applicable good manufacturing practices; (ii) all necessary clearances or approvals from governmental agencies for all drug and device products which are manufactured or sold by the Company and the Subsidiaries have been obtained, and the Company and the Subsidiaries are in substantial compliance with the most current form of each applicable clearance or approval with respect to the manufacture, storage, distribution, promotion and sale by the Company and the Subsidiaries of such products; (iii) to the Company’s knowledge, all of the clinical studies which have been, or are being, conducted by or for the Company and the Subsidiaries are being conducted in substantial compliance with generally accepted good clinical practices and all applicable government regulatory requirements; (iv) as of the date of this Agreement, neither the Company nor any of the Subsidiaries has received written notice of any petition or other attempt by a brand name drug company to have the therapeutic equivalence rating of a product of the Company or a Subsidiary withheld or altered; (v) none of the Company, the Subsidiaries or, to the knowledge of the Company, any of their respective officers, employees or agents (during the term of such person’s employment by the Company or a Subsidiary or while acting as an agent of the Company or a Subsidiary) has made any untrue statement of a material fact or fraudulent statement to the FDA or any similar governmental agency (including, without limitation, non-U.S. regulatory agencies), failed to disclose a material fact required to be disclosed to the FDA or any similar governmental agency (including, without limitation, non-U.S. regulatory agencies), or committed an act, made a statement or failed to make a statement that could reasonably be expected to provide a basis for the FDA or any similar governmental agency (including, without limitation, non-U.S. regulatory agencies) to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or similar governmental policy or regulation (including, without limitation, non-U.S. policies or regulations), rule, regulation or law; (vi) neither the Company nor any of the Subsidiaries has received any written notice that the FDA or any Governmental Authority intends similar governmental agency (including, without limitation, non-U.S. regulatory agencies) has commenced, or threatened to cancelinitiate, terminate any action to withdraw its approval or request the recall of any product of the Company or any of the Subsidiaries, or commenced, or overtly threatened to initiate, any action to enjoin production at any facility of the Company or any of the Subsidiaries; (vii) as to each article of drug, device, cosmetic or vitamin manufactured and/or distributed by the Company or any of the Subsidiaries, such article is not renew adulterated or misbranded within the meaning of the FDCA or any similar governmental act or Law of any jurisdiction (including, without limitation, non-U.S. jurisdictions); and (viii) none of the Company, the Subsidiaries or, to the knowledge of the Company, any of their respective officers, employees or agents (during the term of such Permit. The person’s employment by the Company or a Subsidiary or while acting as an agent of the Company or a Subsidiary, subsidiaries or affiliates has been convicted of any crime or engaged in any conduct for which debarment or similar punishment is mandated or permitted by any applicable Law. (d) As to each product subject to FDA’s jurisdiction under the FDCA and its Subsidiaries have conducted the jurisdiction of the Drug Enforcement Agency under the Comprehensive Drug Abuse Prevention and are conducting their Business Control Act of 1970 (“CSA”) which is manufactured, tested, distributed, held, and/or marketed by the Company, such product is being manufactured, held and distributed in compliance with all applicable requirements under the requirementsFDCA and the CSA, standardsif applicable, criteria including, but not limited to, those relating to investigational use, premarket clearance, good manufacturing practices, labeling, advertising, record keeping, filing of reports, and conditions set forth in security. (e) None of the Permits listed on SCHEDULE 5.16 and are not in violation of Company, any of the foregoing except where such Subsidiaries or any product manufactured, tested, distributed, held, developed and/or marketed by the Company or any of the Subsidiaries is subject to the jurisdiction of the Health Protection Branch of the Ministry of Health Canada. (f) The Company will promptly provide Purchaser with copies of any document that is issued, prepared, or otherwise becomes available from the date of this Agreement until the Closing Date which bears on the regulatory status under the FDCA or the CSA of the Company, any Subsidiary or any product of the Company or any Subsidiary, including, but not limited to, any deficiency letter, warning letter, non-compliance approvable letter/order, and withdrawal letter/order, except for documents reflecting such matters which, individually or violation in the aggregate, would not have a Material Adverse Effect. Except as specifically provided in SCHEDULE 5.16, Effect on the transactions contemplated by this Agreement will not result in a default under or a breach or violation of, or adversely affect the rights and benefits afforded to Company. (g) Section 4.08(g) of the Company Disclosure Statement sets forth a complete and its Subsidiaries by, accurate list of (A) each investigational new drug filing made by the Company or any of the Permits listed on SCHEDULE 5.16Subsidiaries with the FDA or similar U.S. or non-U.S. governmental agency, (B) each clinical trial protocol submitted by the Company or any of the Subsidiaries to the FDA or similar U.S. or non-U.S. governmental agency, (C) each new drug application and abbreviated or supplemental new drug application filed by the Company or any of the Subsidiaries pursuant to the FDCA, or any non-U.S. equivalents, (D) each product license application filed by the Company or any of the Subsidiaries pursuant to the Public Health Service Act, as amended, or any non-U.S. equivalents and (E) each establishment license application filed with respect to any product of the Company or any of the Subsidiaries under the Public Health Service Act, as amended, or any non-U.S. equivalents.

Compliance with Applicable Laws; Permits. (a) Except as set forth on SCHEDULE 5.16, the Company and its Subsidiaries have complied in all material respects with all laws, rules, regulations, writs, injunctions, decrees, and Orders applicable to it or to the operation of the Business (collectively, "Laws") and has not received any written notice of any alleged claim or threatened claim, violation of, liability or potential responsibility under, any such Law that has not heretofore been cured and for which there is no remaining liability other than those not having a Material Adverse Effect. (b) The Company and its Subsidiaries hold all licenses, permits and other governmental authorizations (the "Permits") the absence of any of which could have a Material Adverse Effect, and the Company has delivered to Clarant an accurate list and summary description (which is set forth on SCHEDULE 5.16) of all such Permits. To the Knowledge of the Company and the StockholdersMembers, the Permits listed on SCHEDULES 5.16 are valid, and neither the Company nor any Subsidiary has received any written notice that any Governmental Authority intends to cancel, terminate or not renew any such Permit. The Company and its Subsidiaries have conducted and are conducting their Business in compliance with the requirements, standards, criteria and conditions set forth in the Permits listed on SCHEDULE 5.16 and are not in violation of any of the foregoing except where such non-compliance or violation would not have a Material Adverse Effect. Except as specifically provided in SCHEDULE 5.16, the transactions contemplated by this Agreement will not result in a default under or a breach or violation of, or adversely affect the rights and benefits afforded to the Company and its Subsidiaries by, any of the Permits listed on SCHEDULE 5.16.

Compliance with Applicable Laws; Permits. (a) The Companies and Cawse are in compliance with all applicable Laws, except for instances of noncompliance that, individually or in the aggregate, have not had and would not reasonably be expected to have an Adverse Impact. Except as set forth on Schedule 4.13(a), neither of the Companies nor Cawse has received any written notice since June 30, 2004 from a Governmental Entity that alleges that either of the Companies or Cawse is not in compliance in any material respect with any applicable Law. Neither of the Companies nor Cawse is subject to or in default under any Judgment, except for matters that have been resolved or are no longer outstanding or as would not reasonably be expected to have an Adverse Impact. (b) Except as set forth on SCHEDULE 5.16Schedule 4.13(b), the Company Companies and its Subsidiaries Cawse have complied in all material respects with all lawsgovernmental permits, ruleslicenses, regulationscertificates, writswarrants, injunctionsconfirmations, decreesfranchises, variances, exemptions, exceptions, orders and Orders applicable other governmental authorizations, consents, clearances and approvals necessary to it or to the operation of the Business conduct their business as presently conducted (collectively, "Laws") the “Permits”), except those Permits the failure of which to possess would not reasonably be expected to have, individually or in the aggregate, an Adverse Impact. There are no violations of the terms and conditions of any Permit required under applicable Laws by the Companies and Cawse that would reasonably be expected to have, individually or in the aggregate, an Adverse Impact. The Companies and Cawse have filed or caused to be filed all reports, notifications and filings with, and have paid all regulatory fees to, the applicable Governmental Entity necessary to maintain all of the Permits in full force and effect, except in each case for any Permits the failure of which to be in full force and effect would not reasonably be expected to have, individually or in the aggregate, an Adverse Impact. Except as set forth on Schedule 4.13(b), neither of the Companies nor Cawse has not received any written notice since June 30, 2004 of a Proceeding relating to the revocation, cancellation, modification or termination of any alleged claim or threatened claimPermit, violation of, liability or potential responsibility under, any such Law that has not heretofore been cured and for which there is no remaining liability other than those not having a Material Adverse Effect. (b) The Company and its Subsidiaries hold all licenses, permits and other governmental authorizations (the "Permits") the absence of any loss of which could have a Material would reasonably be expected to have, individually or in the aggregate, an Adverse Effect, and the Company has delivered to Clarant an accurate list and summary description (which is set forth on SCHEDULE 5.16) of all such PermitsImpact. To the Knowledge of the Company and the StockholdersSellers, the Permits listed on SCHEDULES 5.16 there are valid, and neither the Company nor any Subsidiary has received any written notice that any Governmental Authority intends no circumstances which could reasonably be expected to cancel, terminate or not renew any such Permit. The Company and its Subsidiaries have conducted and are conducting their Business in compliance with the requirements, standards, criteria and conditions set forth result in the Permits listed on SCHEDULE 5.16 and are not in violation suspension, cancellation, modification or termination of any of Permit which could reasonably be expected to have, individually or in the foregoing except where such non-compliance or violation would aggregate, an Adverse Impact. This Section 4.13(b) does not have a Material Adverse Effect. Except as specifically provided in SCHEDULE 5.16, the transactions contemplated by this Agreement will not result in a default under or a breach or violation of, or adversely affect the rights and benefits afforded relate to matters with respect to the Company and its Subsidiaries bytitle to those Permits which constitute Tenements, any of the Permits listed on SCHEDULE 5.16such items being exclusively governed by Section 4.06(a).

Compliance with Applicable Laws; Permits. (a) Except as set forth on SCHEDULE 5.16, the Company and its Subsidiaries have Contributor has complied in all material respects with all laws, rules, regulations, writs, injunctions, decrees, and Orders applicable to it or to the operation of the Business (collectively, "Laws") applicable to the operation of the Business and the Acquired Assets and has not received any written notice of any alleged claim or threatened Threatened claim, violation of, liability or potential responsibility under, any such Law that which has not heretofore been cured and for which there is no remaining liability other than those not having a Material Adverse Effect. (b) The Company and its Subsidiaries hold Contributor holds all licenses, permits and other governmental authorizations (the "Permits") necessary to the conduct of the Business the absence of any of which could would have a Material Adverse Effect, and the Company Contributor has delivered to Clarant an accurate list and summary description (which is set forth on SCHEDULE 5.16) of all such Permits. To the Knowledge of the Company and the StockholdersContributor, the Permits listed on SCHEDULES 5.16 are valid, and neither the Company nor any Subsidiary Contributor has not received any written notice that any Governmental Authority intends to cancel, terminate or not renew any such Permit. The Company and its Subsidiaries have Contributor conducted and are is conducting their the Business in compliance with the requirements, standards, criteria and conditions set forth in the Permits listed on SCHEDULE 5.16 and are is not in violation of any of the foregoing except where such non-non- compliance or violation would not have a Material Adverse Effect. Except as specifically provided in SCHEDULE 5.16, the transactions contemplated by this Agreement will not result in a default under or a breach or violation of, or adversely affect the rights and benefits afforded to the Company and its Subsidiaries Contributor by, any of the Permits listed on SCHEDULE 5.16Permits.

Compliance with Applicable Laws; Permits. (a) Except as set forth on SCHEDULE 5.16, the Company and its any Subsidiaries have complied in all material respects with all laws, rules, regulations, writs, injunctions, decrees, and Orders applicable to it or to the operation of the Business (collectively, "Laws") and has not received any written notice of any alleged claim or threatened claim, violation of, liability or potential responsibility under, any such Law that has not heretofore been cured and for which there is no remaining liability other than those not having a Material Adverse Effect. (b) The Company and its any Subsidiaries hold all licenses, permits and other governmental authorizations (the "Permits") the absence of any of which could have a Material Adverse Effect, and the Company has delivered to Clarant an accurate list and summary description (which is set forth on SCHEDULE 5.16) of all such Permits. To the Knowledge of the Company and the StockholdersMembers, the Permits listed on SCHEDULES 5.16 are valid, and neither the Company nor any Subsidiary has received any written notice that any Governmental Authority intends to cancel, terminate or not renew any such Permit. The Company and its any Subsidiaries have conducted and are conducting their Business in compliance with the requirements, standards, criteria and conditions set forth in the Permits listed on SCHEDULE 5.16 and are not in violation of any of the foregoing except where such non-compliance or violation would not have a Material Adverse Effect. Except as specifically provided in SCHEDULE 5.16, the transactions contemplated by this Agreement will not result in a default under or a breach or violation of, or adversely affect the rights and benefits afforded to the Company and its any Subsidiaries by, any of the Permits listed on SCHEDULE 5.16.

Compliance with Applicable Laws; Permits. (a) Except as set forth on SCHEDULE 5.16, the Company and its Subsidiaries the Subsidiary have complied in all material respects with all laws, rules, regulations, writs, injunctions, decrees, and Orders applicable to it or to the operation of the Business (collectively, "Laws") and has not received any written notice of any alleged claim or threatened claim, violation of, liability or potential responsibility under, any such Law that which has not heretofore been cured and for which there is no remaining liability other than those not having a Material Adverse Effect. (b) The Company and its Subsidiaries the Subsidiary hold all licenses, permits and other governmental authorizations (the "Permits") the absence of any of which could have a Material Adverse Effect, and the Company has delivered to Clarant an accurate list and summary description (which is set forth on SCHEDULE 5.16) of all such Permits. To the Knowledge of the Company Company, the Subsidiary and the Stockholders, the Permits listed on SCHEDULES 5.16 are valid, and neither the Company nor any the Subsidiary has received any written notice that any Governmental Authority intends to cancel, terminate or not renew any such Permit. The Company and its Subsidiaries the Subsidiary have conducted and are conducting their Business in compliance with the requirements, standards, criteria and conditions set forth in the Permits listed on SCHEDULE 5.16 and are not in violation of any of the foregoing except where such non-compliance or violation would not have a Material Adverse Effect. Except as specifically provided in SCHEDULE 5.16, the transactions contemplated by this Agreement will not result in a default under or a breach or violation of, or adversely affect the rights and benefits afforded to the Company and its Subsidiaries the Subsidiary by, any of the Permits listed on SCHEDULE 5.16.

Compliance with Applicable Laws; Permits. (a) Except as set forth on SCHEDULE 5.16, the Company and its any Subsidiaries have complied in all material respects with all laws, rules, regulations, writs, injunctions, decrees, and Orders applicable to it or to the operation of the Business (collectively, "Laws") and has not received any written notice of any alleged claim or threatened claim, violation of, liability or potential responsibility under, any such Law that has not heretofore been cured and for which there is no remaining liability other than those not having a Material Adverse Effect. (b) The Company and its any Subsidiaries hold all licenses, permits and other governmental authorizations (the "Permits") the absence of any of which could have a Material Adverse Effect, and the Company has delivered to Clarant an accurate list and summary description (which is set forth on SCHEDULE 5.16) of all such Permits. To the Knowledge of the Company and the Stockholders, the Permits listed on SCHEDULES 5.16 are valid, and neither the Company nor any Subsidiary has received any written notice that any Governmental Authority intends to cancel, terminate or not renew any such Permit. The Company and its any Subsidiaries have conducted and are conducting their Business in compliance with the requirements, standards, criteria and conditions set forth in the Permits listed on SCHEDULE 5.16 and are not in violation of any of the foregoing except where such non-compliance or violation would not have a Material Adverse Effect. Except as specifically provided in SCHEDULE 5.16, the transactions contemplated by this Agreement will not result in a default under or a breach or violation of, or adversely affect the rights and benefits afforded to the Company and its any Subsidiaries by, any of the Permits listed on SCHEDULE 5.16.