Common use of FDA Compliance Clause in Contracts

FDA Compliance. The Company and its subsidiaries: (A) are in compliance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCA”) except where failure to be so in compliance would not result in a Material Adverse Effect; (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA alleging or asserting material noncompliance with the FDCA or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse Effect; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of the FDCA or the terms of any Authorization and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company and its subsidiariesCompany: (A) are is in compliance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCA”) except where failure to be so in compliance would not result in a Material Adverse Effect; (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA alleging or asserting material noncompliance with the FDCA or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse Effect; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of the FDCA or the terms of any Authorization and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the Pricing Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in compliance with all statutes, rules or regulations of the Federal Food, Drug, U.S. Food and Cosmetic Act Drug Administration (21 U.S.C. § 301 et seq.“FDA”) and the regulations promulgated thereunder ( the other comparable federal, state, local or foreign governmental and regulatory authorities (“FDCAGovernmental Authority”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), except where failure such noncompliance would not, individually or in the aggregate, reasonably be expected to be so in compliance would not result in have a Material Adverse Effect; (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possesses all Authorizations, except where failure to possess all material Authorizations an Authorization would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with the terms of such Authorizations Authorizations, except where such noncompliance would not not, individually or in the aggregate, reasonably be expected to result in have a Material Adverse Effect; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product product, operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under by any Applicable Laws or Authorizations except where failure to do so would not, individually or in the FDCA or any Authorizations aggregate, reasonably be expected to have a Material Adverse Effect and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) except where failure to be so in compliance would not result in a Material Adverse Effect); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity other Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity other Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity other Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity other Governmental Entity is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect in the case of clauses (A), (C), (E) and its subsidiaries(F), the Company: (A) are is in compliance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCA”) except where failure to be so in compliance would not result in a Material Adverse Effectas currently enforced by the FDA taking into account the FDA’s application of enforcement discretion and with comparable applicable laws and regulations of other governmental entities (collectively “FDA Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any other material applicable governmental entity (each a “Regulatory Authority”) alleging or asserting material noncompliance with the FDCA FDA Laws or with any material licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under by the FDCA Regulatory Authorities to be obtained by the Company to conduct its business as currently conducted (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action Action from the FDA or any governmental entity or third party Regulatory Authorities alleging that any product product, operation or activity is in material violation of the FDCA any FDA Laws or the terms of any Authorization and has no knowledge that the FDA or any governmental entity or third party Regulatory Authority is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse EffectAction; (E) have has not received written notice that the FDA or any governmental entity a Regulatory Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and and, to the Company’s knowledge, no Regulatory Authority has no knowledge that the FDA or any governmental entity is considering threatened such action; and (F) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments thereto to the Regulatory Authorities as required under the FDCA FDA Laws or pursuant to any Authorizations Authorization and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the Pricing Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal Food, Drug, U.S. Food and Cosmetic Act Drug Administration (21 U.S.C. § 301 et seq.“FDA”) and the regulations promulgated thereunder ( the other comparable federal, state, local or foreign governmental or regulatory authority (“FDCAGovernmental Authority”) except where failure applicable to be so in compliance would not result in a Material Adverse Effectthe ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”), which would, individually or in the aggregate, result in a Material Adverse Effect; (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) except where failure to be so in compliance would not result in a Material Adverse Effect); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Entity alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Entity is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Except as described in the Time of Sale Disclosure Package and the Prospectus, the Company and its subsidiaries: (A) are and at all times have been in compliance with the Federal Foodall statutes, Drugrules, and Cosmetic Act regulations applicable to Company and its subsidiaries related to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and “Applicable Laws”), except as would not, individually or in the regulations promulgated thereunder ( the “FDCA”) except where failure aggregate, reasonably be expected to be so in compliance would not result in a Material Adverse Effect; (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is are not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has have no knowledge that the FDA or any governmental entity such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and the Company has no knowledge that the FDA or any governmental entity such Governmental Authority is considering such action; (F) have not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety, efficacy or regulatory compliance of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated or conducted any such notice or action and there are no facts which are reasonably likely to cause, and the Company has not received any written notice from the FDA or any other regulatory agency regarding, a material recall, market withdrawal or replacement of any Company product sold or intended to be sold by the Company, a material change in the marketing classification or a material adverse change in the labeling of any such Company products, or a termination or suspension of the manufacturing, marketing, or distribution of such Company products; and (FG) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company and each of its subsidiaries: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal Food, Drug, U.S. Food and Cosmetic Act Drug Administration (21 U.S.C. § 301 et seq.the “FDA”) and other comparable governmental entities applicable to the regulations promulgated thereunder ( ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“FDCAApplicable Laws”) except where failure to be so in compliance would not result in a Material Adverse Effect); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from the FDA or any governmental entity alleging or asserting a material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any material term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering threatening any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering threatening such action, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under by any Applicable Laws or Authorizations and, to the FDCA or any Authorizations and knowledge of the Company, that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the Pricing Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is in material compliance with all statutes, rules or regulations of the Federal Food, Drug, U.S. Food and Cosmetic Act Drug Administration (21 U.S.C. § 301 et seq.“FDA”) and the regulations promulgated thereunder ( the other comparable federal, state, local or foreign governmental or regulatory authority (“FDCAGovernmental Authority”) except where failure applicable to be so in compliance would not result in a Material Adverse Effectthe ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”), which would, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (C) possess possesses all material Authorizations necessary for the operation of its business as described in the Pricing Disclosure Package and the Prospectus and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; and (D) have since January 1, 2011: (i) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (Eii) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (Fiii) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect in the case of clauses (A), (C), (E) and its subsidiaries(F), the Company: (A) are is in compliance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCA”) except where failure to be so in compliance would not result in a Material Adverse Effectas currently enforced by the FDA taking into account the FDA’s application of enforcement discretion and with comparable applicable laws and regulations of other governmental entities (collectively “FDA Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any other material applicable governmental entity (each a “Regulatory Authority”) alleging or asserting material noncompliance with the FDCA FDA Laws or with any material licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under by the FDCA Regulatory Authorities to be obtained by the Company to conduct its business as currently conducted (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action Action from the FDA or any governmental entity or third party Regulatory Authorities alleging that any product product, operation or activity is in material 11 violation of the FDCA any FDA Laws or the terms of any Authorization and has no knowledge that the FDA or any governmental entity or third party Regulatory Authority is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse EffectAction; (E) have has not received written notice that the FDA or any governmental entity a Regulatory Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and and, to the Company’s knowledge, no Regulatory Authority has no knowledge that the FDA or any governmental entity is considering threatened such action; and (F) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments thereto to the Regulatory Authorities as required under the FDCA FDA Laws or pursuant to any Authorizations Authorization and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The (a) All products currently being manufactured, tested, developed, processed, labeled, stored or distributed by or on behalf of the Company or any of its Subsidiaries, which are subject to the jurisdiction of the U.S. Food and Drug Administration (the "FDA"), are being manufactured, tested, developed, processed, labeled, stored, distributed, and marketed in compliance with all applicable Laws, guidances or orders administered or issued by the FDA or any other Governmental Entity, including without limitation, the FDA's current Good Manufacturing Practice regulations, except where any failure to so comply would not, individually or in the aggregate, have a Company Material Adverse Effect. All applicable operations of the Company and each of its subsidiaries: (A) Subsidiaries have achieved and maintained ISO 13485 Quality System certification, and there is no pending or, to the Company's Knowledge threatened, audit, repeal, failure to renew or challenge to any such certifications. All products being manufactured by the Company or any of its Subsidiaries are in compliance with applicable registration, licensing and notification requirements required by applicable Law for each site at which a product of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCA”) Company or any of its Subsidiaries is manufactured except where any failure to be so in compliance would not result in a Material Adverse Effect; (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA alleging or asserting material noncompliance with the FDCA or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations comply would not reasonably be expected to result have, individually or in the aggregate, a Company Material Adverse Effect; (D) have not received written notice . All pre-clinical and clinical trials being conducted by or on behalf of the Company or any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from of its Subsidiaries are being conducted in compliance with all applicable Laws and guidances of the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation other Governmental Entity, including without limitation, the FDA's current Good Clinical Practice regulations and federal and state Laws, regulations and guidances restricting the use and disclosure of the FDCA or the terms of any Authorization and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), individually identifiable health information except where instances of any failure to file, obtain, maintain or submit required documentation so comply would not reasonably be expected to result have, individually or in the aggregate, a Company Material Adverse Effect. Neither the Company nor any of its Subsidiaries is the subject, officially or otherwise, of any pending or threatened investigation by the FDA pursuant to its "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities" Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Neither the Company nor any of its Subsidiaries has committed any act, made any statement, or failed to make any statement that would provide a basis for the FDA to invoke its policy with respect to "Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities" and any amendments thereto. To the Company's Knowledge, each product distributed, sold or leased, or service rendered, by the Company or any of its Subsidiaries complies in all material respects with all applicable product safety standards of each applicable product safety agency, commission, board or other Governmental Entity.

FDA Compliance. The Company Except as described in the Registration Statement and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) except where failure to be so in compliance would not result in a Material Adverse Effect); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Entity alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Entity is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) except where failure to be so in compliance would not result in a Material Adverse Effect); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Entity alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Entity is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, each of the Company and its subsidiaries: (A) are is and at all times has been in compliance with all statutes, rules or regulations of the Federal Food, Drug, U.S. Food and Cosmetic Act Drug Administration (21 U.S.C. § 301 et seq.“FDA”) and the regulations promulgated thereunder ( the other comparable federal, state, local or foreign governmental and regulatory authorities (“FDCAGovernmental Authority”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product under development, manufactured or distributed by the Company or such subsidiary (“Applicable Laws”), except where failure such noncompliance would not, individually or in the aggregate, reasonably be expected to be so in compliance would not result in have a Material Adverse Effect; (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possesses all Authorizations, except where failure to possess all material Authorizations an Authorization would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and the Company or such subsidiary is not in material violation of any term of any such except where failure to possess or be so in compliance with the terms of such Authorizations Authorizations, except where such noncompliance would not not, individually or in the aggregate, reasonably be expected to result in have a Material Adverse Effect; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product product, operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under by any Applicable Laws or Authorizations except where failure to do so would not, individually or in the FDCA or any Authorizations aggregate, reasonably be expected to have a Material Adverse Effect and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, each of the Company and its subsidiaries: (A) are is and at all times has been in compliance with all statutes, rules or regulations of the Federal Food, Drug, U.S. Food and Cosmetic Act Drug Administration (21 U.S.C. § 301 et seq.“FDA”) and the regulations promulgated thereunder ( the other comparable federal, state, local or foreign governmental and regulatory authorities (“FDCAGovernmental Authority”) applicable to the ownership, testing, development, manufacture, packaging, labeling, processing, use, distribution, storage, quality, import, export or disposal of any product under development, manufactured or distributed by the Company or such subsidiary (“Applicable Laws”), except where failure such noncompliance would not, individually or in the aggregate, reasonably be expected to be so in compliance would not result in have a Material Adverse Effect; (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possesses all Authorizations, except where failure to possess all material Authorizations an Authorization would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and the Company or such subsidiary is not in material violation of any term of any such except where failure to possess or be so in compliance with the terms of such Authorizations Authorizations, except where such noncompliance would not not, individually or in the aggregate, reasonably be expected to result in have a Material Adverse Effect; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product product, operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under by any Applicable Laws or Authorizations except where failure to do so would not, individually or in the FDCA or any Authorizations aggregate, reasonably be expected to have a Material Adverse Effect and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its subsidiariesSubsidiaries: (A) are and at all times have been in full compliance with all statutes, rules, regulations, or guidances applicable to the Federal Food, Drug, Company and Cosmetic Act (21 U.S.C. § 301 et seq.) its Subsidiaries and the regulations promulgated thereunder ( ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“FDCAApplicable Laws”) ), except where failure to be so in such non-compliance would not result result, singly or in the aggregate, in a Material Adverse Effect; (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA any Governmental Entity alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptionsauthorizations, authorizationsregistrations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”)) which has not been remedied by the Company and its Subsidiaries or except where such noncompliance if not remedied would not, singly or in the aggregate, result in a Material Adverse Effect; (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has have no knowledge that the FDA or any governmental entity such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice that the FDA or any governmental entity Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and the Company has no knowledge that the FDA or any governmental entity such Governmental Entity is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of the failure to file, obtain, maintain or submit required documentation such documents would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company and each of its subsidiaries: (A) are is and at all times has been in compliance with all statutes, rules or regulations of the Federal Food, Drug, U.S. Food and Cosmetic Act Drug Administration (21 U.S.C. § 301 et seq.“FDA”) and the regulations promulgated thereunder ( the other comparable federal, state, local or foreign governmental and regulatory authorities (“FDCAGovernmental Authority”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product under development, manufactured or distributed by the Company or each such subsidiary (“Applicable Laws”), except where failure such noncompliance would not, individually or in the aggregate, reasonably be expected to be so in compliance would not result in have a Material Adverse Effect; (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possesses all Authorizations, except where failure to possess all material Authorizations an Authorization would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and the Company or such subsidiary is not in material violation of any term of any such except where failure to possess or be so in compliance with the terms of such Authorizations Authorizations, except where such noncompliance would not not, individually or in the aggregate, reasonably be expected to result in have a Material Adverse Effect; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product product, operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under by any Applicable Laws or Authorizations except where failure to do so would not, individually or in the FDCA or any Authorizations aggregate, reasonably be expected to have a Material Adverse Effect and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and each of its subsidiaries: subsidiaries (A) are is and at all times has been in full compliance with all statutes, rules, regulations, or guidances applicable to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) Company or any of its subsidiaries and the regulations promulgated thereunder ( ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the “FDCA”) Company or any of its subsidiaries ("Applicable Laws"), except where failure as could not reasonably be expected to be so in compliance would not result in a Material Adverse Effect; , (B) have has not received any FDA Form 483, written 483 notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under by any such Applicable Laws ("Authorizations"), except, in the FDCA (“Authorizations”); case of FDA Form 483 notices of adverse findings, singly or in the aggregate, as could not reasonably be expected to result in a Material Adverse Effect, (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse Effect; Authorizations, (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity such Governmental Entity is considering such action; action and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its subsidiaries: (A) are and at all times have been in full compliance with the Federal Foodall statutes, Drugrules, regulations, or guidances applicable to Company and Cosmetic Act (21 U.S.C. § 301 et seq.) its subsidiaries and the regulations promulgated thereunder ( ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“FDCAApplicable Laws”) ), except where failure to be so in such non-compliance would not result result, singly or in the aggregate, in a Material Adverse Effect; (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA any Governmental Entity alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptionsauthorizations, authorizationsregistrations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”)) which has not been remedied by the Company and its subsidiaries or except where such noncompliance if not remedied would not, singly or in the aggregate, result in a Material Adverse Effect; (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has have no knowledge that the FDA or any governmental entity such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice that the FDA or any governmental entity Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and the Company has no knowledge that the FDA or any governmental entity such Governmental Entity is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of the failure to file, obtain, maintain or submit required documentation such documents would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company and each of its subsidiaries: Subsidiaries (Ai) are and have at all times been in full compliance with all laws, statutes, rules, regulations or guidance applicable to the Federal Food, Drug, Company and Cosmetic Act (21 U.S.C. § 301 et seq.) its Subsidiaries and the regulations promulgated thereunder ( ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any pharmaceuticals or biohazardous substances, materials or any other products developed, manufactured or distributed by the Company (including, without limitation, from the FDA, EMA and any local or other governmental or regulatory authority performing functions similar to those performed by the FDA or EMA) (collectively, “FDCAApplicable Laws”) ), except where failure to as could not reasonably be so expected to, individually or in compliance would not the aggregate, result in a Material Adverse Effect; , (Bii) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company, any of its Subsidiaries or their activities alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under by any such Applicable Laws (collectively, the FDCA (“AuthorizationsGovernmental Permits”); , (Ciii) have made all filings with, the appropriate local, or other governmental or regulatory agencies or bodies that are necessary for the ownership or lease of their respective properties or the conduct of their respective businesses as described in the Registration Statement, the General Disclosure Package and the Prospectus, except where any failures to possess or make the same would not, singularly or in the aggregate, reasonably be expected to have a Material Adverse Effect, (iv) possess all material Authorizations Governmental Permits necessary to conduct their respective businesses as described in the Registration Statement, the General Disclosure Package and the Prospectus, and such Authorizations Governmental Permits are valid and in full force and effect and the Company is are not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse Effect; Governmental Permits, (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of the FDCA or the terms of any Authorization and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (Fv) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations Governmental Permits and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), and (vi) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any governmental authority. All Governmental Permits are valid and in full force and effect, except where instances of the validity or failure to filebe in full force and effect would not, obtainsingularly or in the aggregate, maintain or submit required documentation would not reasonably be expected to result in have a Material Adverse Effect. Neither the Company nor any Subsidiary has received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed. Neither the Company, any of its Subsidiaries nor, to the Company’s knowledge, any of their respective directors, officers, employees or agents has been convicted of any crime under any Applicable Laws or has been the subject of an FDA debarment proceeding. Neither the Company nor any of its Subsidiaries has been nor is now subject to the FDA’s Application Integrity Policy. To the Company’s knowledge, neither the Company, any of its Subsidiaries nor any of its directors, officers, employees or agents has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental authority.

FDA Compliance. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its subsidiaries: (A) are and at all times have been in full compliance with all statutes, rules, regulations, or guidance applicable to the Federal Food, Drug, Company and Cosmetic Act (21 U.S.C. § 301 et seq.) its subsidiaries and the regulations promulgated thereunder ( ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“FDCAApplicable Laws”) ), except where failure to be so in such non-compliance would not result result, singly or in the aggregate, in a Material Adverse Effect; (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA any Governmental Entity alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptionsauthorizations, authorizationsregistrations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”)) which has not been remedied by the Company and its subsidiaries or except where such noncompliance if not remedied would not, singly or in the aggregate, result in a Material Adverse Effect; (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has have no knowledge that the FDA or any governmental entity such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice that the FDA or any governmental entity Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and the Company has no knowledge that the FDA or any governmental entity such Governmental Entity is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of the failure to file, obtain, maintain or submit required documentation such documents would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company and its subsidiaries: (Ai) are in compliance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCA”) except where failure to be so in compliance would not result in a Material Adverse Effect; (Bii) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA alleging or asserting material noncompliance with the FDCA or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA (“Authorizations”); (Ciii) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse Effect; (Div) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of the FDCA or the terms of any Authorization and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (Ev) have not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (Fvi) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the Pricing Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is in material compliance with all statutes, rules or regulations of the Federal Food, Drug, U.S. Food and Cosmetic Act Drug Administration (21 U.S.C. § 301 et seq.“FDA”) and the regulations promulgated thereunder ( the other comparable federal, state, local or foreign governmental or regulatory authority (“FDCAGovernmental Authority”) except where failure applicable to be so in compliance would not result in a Material Adverse Effectthe ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”), which would, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (C) possess possesses all material Authorizations necessary for the operation of its business as described in the Pricing Disclosure Package and the Prospectus and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; and (D) have since January 1, 2008: (i) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (Eii) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (Fiii) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) except where failure to be so in compliance would not result in a Material Adverse Effect); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) except where failure to be so in compliance would not result in a Material Adverse Effect); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other similar action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company and its subsidiaries: (A) are Except as would not, individually or in compliance with the Federal Foodaggregate, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCA”) except where failure to be so in compliance would not result in a Material Adverse Effect, the Company: (A) is and at all times has been in compliance with all statutes, rules and regulations of the FDA and other comparable Governmental Entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product product, operation or activity is in material violation of any Applicable Laws or Authorizations and, to the FDCA or the terms of any Authorization and has no knowledge that Company’s knowledge, neither the FDA or nor any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that and, to the Company’s knowledge, neither the FDA or nor any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Each of the Company and its subsidiariesSubsidiaries: (A) are is and at all times has been in compliance with all statutes, rules and regulations applicable to the Federal Foodownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company or its Subsidiaries (21 U.S.C. § 301 et seq.) and “Applicable Laws”), except as would not, individually or in the regulations promulgated thereunder ( the “FDCA”) except where failure aggregate, reasonably be expected to be so in compliance would not result in a Material Adverse Effect; (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting noncompliance in any material noncompliance respect with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is are not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity such Governmental Entity is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (G) has not, except where instances either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear healthcare provider” letter, or other notice or action relating to the alleged lack of failure safety or efficacy of any product or any alleged product defect or violation and, to filethe Company’s knowledge, obtainno third party has initiated, maintain conducted or submit required documentation would not reasonably be expected intends to result in a Material Adverse Effectinitiate any such notice or action.

FDA Compliance. The Company Except as described in the Registration Statement, the Pricing Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is in material compliance with all statutes, rules or regulations of the Federal Food, Drug, U.S. Food and Cosmetic Act Drug Administration (21 U.S.C. § 301 et seq.“FDA”) and the regulations promulgated thereunder ( the other comparable federal, state, local or foreign governmental or regulatory authority (“FDCAGovernmental Authority”) except where failure applicable to be so in compliance would not result in a Material Adverse Effectthe ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”), which would, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (C) possess possesses all material Authorizations necessary for the operation of its business as described in the Pricing Disclosure Package and the Prospectus and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; and (D) have since January 1, 2009: (i) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (Eii) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (Fiii) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) except where failure to be so in compliance would not result in a Material Adverse Effect); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or 9 amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.. (xxvii)

FDA Compliance. The Company Except as described in the Registration Statement, the Pricing Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in material compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) except where failure to be so in compliance would not result in a Material Adverse Effect); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company and its subsidiaries: (A) are Except as could not, individually or in compliance with the Federal Foodaggregate, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCA”) except where failure reasonably be expected to be so in compliance would not result in have a Material Adverse EffectEffect or as otherwise disclosed in each of the Time of Sale Information and the Offering Memorandum, the Issuers, the Guarantors and their respective subsidiaries (i) are and at all times have been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the Issuers, the Guarantors and their respective subsidiaries (“Industry Laws”); (Bii) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with the FDCA any Industry Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits permits, registrations and supplements or amendments thereto required under the FDCA by any such Industry Laws (“AuthorizationsHealthcare Permits”)) that have not been resolved to the satisfaction of the FDA or other relevant authority; (Ciii) possess all material Authorizations and such Authorizations Healthcare Permits, which are valid and in full force and effect effect, and the Company is are not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectHealthcare Permit; (Div) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any product product, operation or activity of the Issuers, the Guarantors or any of their respective subsidiaries is in material violation of any Industry Laws or Healthcare Permits that have not been resolved to the FDCA satisfaction of the FDA or the terms of any Authorization other relevant authority, and has have no knowledge that the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (Ev) have not received written notice that the FDA or any other federal, state, local or foreign governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations Healthcare Permit, and has have no knowledge that the FDA or any other federal, state, local or foreign governmental entity or regulatory authority is considering such action; and (Fvi) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Industry Laws or any Authorizations Healthcare Permits, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) to their knowledge, except where instances have not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, correction, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of failure safety or efficacy of any product of the Issuers, the Guarantors any of their respective subsidiaries or any alleged defect or violation of any such product and, to filethe knowledge of the Issuers or any of the Guarantors, obtainno third party has initiated, maintain conducted or submit required documentation would not reasonably be expected intends to result in a Material Adverse Effectinitiate any such notice or action.

FDA Compliance. The Company (a) All products currently being manufactured, tested, developed, processed, labeled, stored or distributed by or on behalf of Parent or any of its Subsidiaries, which are subject to the jurisdiction of the FDA, are being manufactured, tested, developed, processed, labeled, stored, distributed, and its subsidiaries: (A) are marketed in compliance with all applicable Laws, guidances or orders administered or issued by the Federal FoodFDA or any other Governmental Entity, Drugincluding without limitation, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCA”) FDA's current Good Manufacturing Practice regulations, except where any failure to be so in compliance would not result in a Material Adverse Effect; (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA alleging or asserting material noncompliance with the FDCA or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations comply would not reasonably be expected to result have, individually or in the aggregate, a Parent Material Adverse Effect; (D) . All applicable operations of Parent and each of its Subsidiaries have not received written notice of achieved and maintained ISO 13485 Quality System certification, and there is no pending or, to Parent's Knowledge threatened, audit, repeal, failure to renew or challenge to any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA such certifications. All products being manufactured by Parent or any governmental entity or third party alleging that any of its Subsidiaries are in compliance with applicable registration, licensing and notification requirements required by applicable Law for each site at which a product operation or activity is in material violation of the FDCA or the terms of any Authorization and has no knowledge that the FDA Parent or any governmental entity or third party of its Subsidiaries is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), manufactured except where instances of any failure to file, obtain, maintain or submit required documentation so comply would not reasonably be expected to result have, individually or in the aggregate, a Parent Material Adverse Effect. All pre-clinical and clinical trials being conducted by or on behalf of Parent or any of its Subsidiaries are being conducted in compliance with all applicable Laws and guidances of the FDA or any other Governmental Entity, including without limitation, the FDA's current Good Clinical Practice regulations and federal and state Laws, regulations and guidances restricting the use and disclosure of individually identifiable health information except where any failure to so comply would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Neither Parent nor any of its Subsidiaries is not the subject, officially or otherwise, of any pending or threatened investigation by the FDA pursuant to its "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities" Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Neither Parent nor any of its Subsidiaries has committed any act, made any statement, or failed to make any statement that would provide a basis for the FDA to invoke its policy with respect to "Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities" and any amendments thereto. To Parent's Knowledge, each product distributed, sold or leased, or service rendered, by Parent or any of its Subsidiaries complies in all material respects with all applicable product safety standards of each applicable product safety agency, commission, board or other Governmental Entity.

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) ), except where the failure so to be so comply would not, singly or in compliance would not the aggregate, result in a Material Adverse Effect; (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or Governmental Licenses amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”), and to the knowledge of the Company, neither the FDA nor any other Governmental Entity is considering such action; (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, hearing, enforcement, audit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Company and its subsidiariesCompany: (A) are is in compliance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( (the “FDCA”) except where failure to be so in compliance would not result in a Material Adverse EffectChange; (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA alleging or asserting material noncompliance with the FDCA or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectChange; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of the FDCA or the terms of any Authorization and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse EffectChange; (E) have has not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse EffectChange.

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiariesthe Prospectus, the Company: (A) are is and at all times has been in compliance with all statutes, rules or regulations of the Federal FoodFDA and other comparable Governmental Entities applicable to the ownership, Drugtesting, and Cosmetic Act development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder ( the “FDCAApplicable Laws”) ), except where the failure so to comply would not, singly or in the aggregate, be so in compliance would not reasonably likely to result in a Material Adverse Effect; (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of failure to file, obtain, maintain or submit required documentation would not reasonably be expected to result in a Material Adverse Effect.

FDA Compliance. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its subsidiaries: (A) are and at all times have been in full compliance with all statutes, rules, regulations, or guidances applicable to the Federal Food, Drug, Company and Cosmetic Act (21 U.S.C. § 301 et seq.) its subsidiaries and the regulations promulgated thereunder ( ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“FDCAApplicable Laws”) ), except where failure to be so in such non-compliance would not result result, singly or in the aggregate, in a Material Adverse Effect; (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA any Governmental Entity alleging or asserting material noncompliance with the FDCA any Applicable Laws or any licenses, certificates, approvals, clearances, exemptionsauthorizations, authorizationsregistrations, permits and supplements or amendments thereto required under the FDCA by any such Applicable Laws (“Authorizations”)) which has not been remedied by the Company and its subsidiaries or except where such noncompliance if not remedied would not, singly or in the aggregate, result in a Material Adverse Effect; (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such except where failure to possess or be so in compliance with such Authorizations would not reasonably be expected to result in a Material Adverse EffectAuthorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Entity or third party alleging that any product operation or activity is in material violation of the FDCA any Applicable Laws or the terms of any Authorization Authorizations and has have no knowledge that the FDA or any governmental entity such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, which if resolved adversely to the Company, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice that the FDA or any governmental entity Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and the Company has no knowledge that the FDA or any governmental entity such Governmental Entity is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required under the FDCA by any Applicable Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), except where instances of the failure to file, obtain, maintain or submit required documentation such documents would not reasonably be expected to result in a Material Adverse Effect.