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 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 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 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 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 (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. (b) The Parent and each of its Subsidiaries is in compliance with all applicable FDA import and export requirements, including, but not limited to, import-for-export requirements, export notifications or authorizations and record keeping requirements except as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.

FDA Compliance. (a) The Company is and has been, operating its business (including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and distribution of the Company Product), in material compliance with, all applicable Legal Requirements, Company Permits and orders administered by the FDA, and other Governmental Entities for the Company Product. (b) During the three (3) year period prior to the Closing Date, neither the Company Product nor any manufacturing site of the Company Product has been subject to a Governmental Entity (including FDA) shutdown or import or export prohibition, nor has the Company received any FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters,” “untitled letters,” other written, or to the Knowledge of the Company, requests or requirements from any Governmental Entity to make changes to the Company Product that if not complied with would reasonably be expected to result in a material liability to the Company, or similar written notice from the FDA or other Governmental Entity in respect of the Company’s business alleging or asserting noncompliance with any applicable Legal Requirements, Company Permits or requests or requirements of a Governmental Entity. To the Knowledge of the Company, neither the FDA nor any other Governmental Entity is considering any such action. Except as set forth in Section 3.17(b) of the Company Disclosure Letter, no vigilance report or medical device report with respect to the Company Product has been reported as of the date of this Agreement, and, to the actual knowledge of the Company, there are no facts, circumstances, or conditions that would reasonably be expected to form the basis for a requirement that such a report should be filed. (c) All preclinical and clinical trials being conducted by or on behalf of the Company that have been submitted to any Governmental Entity, including the FDA and its subsidiaries: counterparts worldwide, in connection with any Company Permit, are being or have been conducted in compliance in all material respects with the experimental protocols, procedures and controls required pursuant to applicable Legal Requirements. To the Company’s Knowledge, none of the clinical investigators participating in Company trials has been or is disqualified, debarred or otherwise sanctioned by the FDA or any other Governmental Entity. (Ad) With respect to all manufacturing operations undertaken by the Company, such operations have been and are being conducted in all material respects in compliance with applicable Quality System Regulation at 21 C.F.R. Part 820 issued by the Federal FoodFDA and, Drugto the extent applicable, any similar applicable state or foreign regulations. (i) All design and development activities with respect to the Company Product have been, and Cosmetic continue to be conducted in compliance in all material respects with the applicable provisions of FDA’s Quality System Regulation at 21 C.F.R. Part 820, and (ii) all manufacturing operations conducted by the Company with respect to the Company Product are, have been, and continue to be conducted in compliance in all material respects with all applicable Legal Requirements. (f) The Company is not the subject of any pending or, to the Knowledge of the Company, threatened investigation in respect of the Company or the Company Product, 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, or similar policies of other Governmental Entities. (g) The Company has delivered or otherwise made available to Parent true and correct copies of each investigational device exemption application, premarket notification (510(k)), documentation for 510(k) exemption, all Substantially Equivalent or Not Substantially Equivalent Letters received from FDA, all written requests for additional information received from FDA regarding a 510(k) submission by the Company and written responses thereto, and where the Company Product has been changed, a modification analysis for not submitting a 510(k) relating to the Company Product. The Company has not received any written notice from any Governmental Entity (i) contesting the clearance of, the uses of or sale of the Company Product or (ii) otherwise alleging any violation of any laws by the Company with respect to the Company Product. The Company is in compliance in all material respects with all healthcare laws applicable to the operation of its business as currently conducted, including (i) any and all federal, state and local fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the civil False Claims Act (21 31 U.S.C. § 301 3729 et seq.) and the regulations promulgated thereunder ( pursuant to such statutes. The Company has delivered to Parent accurate and complete copies of (i) all data collection forms for all cases in humans performed with any version of the “FDCA”Company Product and (ii) except where failure all preclinical data relating to be so any version of the Company Product, in compliance would not result in a Material Adverse Effect; (B) have not received any FDA Form 483each case, 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 ’s inception through 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 Effectthis Agreement.

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 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 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 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 (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. (b) The Company and each of its Subsidiaries is in compliance with all applicable FDA import and export requirements, including, but not limited to, import-for-export requirements, export notifications or authorizations and record keeping requirements except as would not reasonably be expected to have, individually or in the aggregate, a Company 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 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. Except as set forth on the attached FDA Compliance Schedule, and without limiting in any way the generality of Section 3.8 above, to the Company’s knowledge: (a) The Company (including for purposes of this Section 3.10, its Subsidiaries, licensees, and its subsidiaries: any other persons or companies owning or holding the FDA approvals for the Company’s Products) is not in receipt of notice of, and is not subject to, any adverse inspection, finding of deficiency, finding of non-compliance, compelled or voluntary recall, investigation, penalty, fine, sanction, assessment, audit, request for corrective or remedial action, or other compliance or enforcement action, in each case relating to the products made, developed, licensed, under development, leased, sold, used or serviced by the Company (A“Products”) or to the Company’s facilities in which the Products are in manufactured, used or handled, by the United States Food and Drug Administration (“FDA”) or by any other federal, state, local or foreign authority having or asserting responsibility for the regulation of medical device products (“other authorities”); (b) The Company has obtained all necessary approvals, registrations and authorizations from, has made all necessary and appropriate applications and other submissions to, and has prepared and maintained all records, studies and other documentation needed to satisfy and demonstrate compliance with the Federal Foodrequirements of, Drugthe FDA and other authorities for its current and past business activities relating to the Products, including but not limited to any necessary Pre-Market Notifications (“510(k)s”), Pre-Market Approvals (“PMAs”), investigational device exemptions (“IDEs”), line extension letters relating individual Products to existing 510(k)s, requirements for custom medical devices, studies of safety and efficacy, claims relating to benefits or performance, design and engineering specifications and modifications, device history records, certificates of export, and Cosmetic Act Medical Device Reports (21 U.S.C. § 301 et seq“MDRs”). (c) and Neither 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 Company nor any FDA Form 483person acting on its behalf has made any material false statement in, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice material omission from the FDA alleging or asserting material noncompliance with the FDCA or any licenses, certificatesapplications, approvals, clearancesnotifications, exemptionsreports, authorizations, permits and supplements other submissions to the FDA and other authorities or amendments thereto required under in or from other records and documentation prepared or maintained to comply with 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 requirements 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 other authorities relating to the Products, including but not limited to any governmental entity 510(k)s, PMAs, IDEs, line extension letters, documentation of safety and efficacy, studies or documentation of equivalency, documentation of eligibility for treatment as a pre-1976 device, documentation of eligibility for treatment as a custom medical device, certificates of export, and MDRs; (d) No third party alleging (excluding the Purchaser), consultant, counsel, contractor, investigator, or researcher retained by the Company or otherwise acting on behalf of the Company has made any material false statement in, or material omission from, any report, study or other documentation prepared in conjunction with the applications, approvals, notifications, reports or records submitted to or prepared for the FDA or other authorities relating to the Products, nor has any such third party, consultant, counsel, contractor, investigator or researcher failed to comply with any testing requirements or study protocols in connection with work performed on behalf of the Company or work otherwise relied upon by the Company in submissions and documentation for the FDA or other authorities; (e) Neither the Company nor any third party or agent for the Company has made or offered any payment, gratuity or other thing of value that is prohibited by any product operation law or activity regulation to personnel of the FDA or other authorities in connection with the approval or regulatory status of the Products or the facilities in which the Products are manufactured, used or handled; (f) The Company is in compliance in all material violation respects with all applicable regulations and requirements of the FDCA FDA and other authorities relating to every Product, including but not limited to any applicable Good Manufacturing Practices, requirements for product approval, requirements for demonstrating and maintaining the safety and efficacy of the Products, export requirements, certificates of export, requirements for investigating customer complaints and inquiries, labeling requirements and protocols, shipping requirements, record-keeping and reporting requirements, monitoring requirements, packaging or the terms of any Authorization repackaging requirements, laboratory controls, sterility requirements, inventory controls, and has storage and warehousing procedures; and (g) There are no knowledge facts which would indicate that the FDA or other authorities have or will prohibit or materially restrict the marketing, sale, manufacture, license or use in the United States of any governmental entity Product or third party is considering the operation or use of any such claimfacility in which the Products are made. In addition, litigationthe Company has not received any notification, arbitration, action, suit, investigation written or proceedingverbal, which if resolved adversely to remains unresolved as of the Companydate of this Agreement, would reasonably be expected to have a Material Adverse Effect; (E) have not received written notice from the FDA, FDA personnel or other authorities, or any other information indicating that any Product is unsafe or ineffective for its intended use, and the Company knows of no product or process which the FDA has prohibited from being marketed or used in the United States which in function, composition or operation is substantially similar to 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 EffectProduct.

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: 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; (Bi) have 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 U.S. Food and Drug Administration (the “FDA”), European Medicines Agency (“EMA”) or any other similar federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with the FDCA any Health Care Laws (defined below) or any licenses, certificates, approvals, clearancesauthorizations, registrations, certifications, exemptions, authorizations, permits and supplements or amendments thereto required under by any Health Care Laws to conduct the FDCA Company’s business as described in the Prospectus (“Authorizations”); (Cii) possess all material applicable Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor its subsidiaries 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 violation would not reasonably be expected to result to, singly or in the aggregate, have a Material Adverse EffectChange; (Diii) have not received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA FDA, EMA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any product operation candidate, operation, or activity is in material violation of any Health Care Laws or Authorizations and the FDCA or the terms of any Authorization and Company has no knowledge that the FDA FDA, EMA 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 Companyhearing, would reasonably be expected to have a Material Adverse Effectenforcement, investigation, arbitration or other action; (Eiv) have not received written notice that the FDA FDA, EMA 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, materially modify or revoke any material Authorizations and has no knowledge that the FDA FDA, EMA or any other federal, state, local or foreign governmental entity or regulatory authority 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 Health Care Laws or any Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially true, 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 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 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 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 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.

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 Company and its subsidiaries: (Aa) are in compliance with As to each product subject to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) FDCA and the regulations of the FDA promulgated thereunder ( the or any comparable foreign laws, rules and regulations (such laws and regulations, “FDCAMedical Regulations”) except where that has been developed, manufactured, tested, distributed and/or marketed by or on behalf of the Company or any of its Subsidiaries (each such product, a “Medical Device”), each such Medical Device has been developed, manufactured, tested, distributed and marketed in compliance in all material respects with all applicable requirements under the Medical Regulations, including those relating to registration and listing, good manufacturing practice requirements, quality systems regulations, labeling, advertising, record keeping and filing of required reports and security. Each Medical Device in commercial distribution is a Class I device under 21 U.S.C.360c(a)(1)(A), and applicable rules and regulations thereunder. (b) The Company has not received any notice or written communication with respect to the Company’s business from any Governmental Entity regarding, and, there are no facts or circumstances that are likely to give rise to, (i) any material violation of applicable Legal Requirements or material adverse change in any Permit, or any failure to materially comply with any applicable Legal Requirement or any term or requirement of any Permits or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or modification of any Permits. No Permit will be so terminated or impaired, or will become terminable, in compliance would whole or in part, as a result of the consummation of the transactions contemplated by this Agreement. (c) There is no actual or, to the knowledge of the Company, threatened material action or investigation in respect of the Company’s business by the FDA or any other Governmental Entity which has jurisdiction over the operations, properties, products or processes of the Company, or, to the knowledge of the Company, by any third parties acting on their behalf. The Company has no knowledge that any Governmental Entity is considering such action or of any facts or circumstances that are likely to give rise to any such action or investigation. (d) During the three (3) year period ending on the Closing Date, the Company has not result in had any product or manufacturing site subject to a Material Adverse Effect; Governmental Entity (Bincluding FDA) have not shutdown or import or export prohibition, nor received any FDA Form 483, written 483 or other Governmental Entity notice of adverse findinginspectional observations, “warning letterletters,” “untitled letters” or, untitled letter to the knowledge of the Company, requests or other requirements to make changes to the operations of the Company’s business or the Company Products that if not complied with would reasonably be expected to materially affect the operations of the Company’s business, or similar correspondence or written notice from the FDA or other Governmental Entity in respect of the Company’s business and alleging or asserting material noncompliance with any applicable Legal Requirements, Permits or such requests or requirements of a Governmental Entity, and, to 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 knowledge 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 neither the FDA or nor 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 Governmental Entity is considering such action; . No medical device or other safety report with respect to the Company or the Company Products has been reported by the Company, and to the knowledge of the Company, no medical device or other safety report is under investigation by any Governmental Entity with respect to the Company Products or Company’s business. (Fe) have filedThe manufacture of Company Products by, obtainedor on behalf of, maintained the Company is being conducted in compliance in all material respects with all applicable Legal Requirements including the FDA’s Quality System Regulation at 21 C.F.R. Part 820 for products sold in the United States. The Company, and, to the knowledge of the Company, any third party assembler, sterilizer or submitted manufacturer of Company Products, is in material compliance with all reportsapplicable Legal Requirements and certifications currently held by the Company governing quality systems and manufacturing processes and registration and listing requirements governing those third parties’ activities, documents, forms, notices, applications, records, claims, submissions including those set forth in 21 C.F.R. Part 807 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 Effect21 C.F.R. Part 820.

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 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 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 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 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 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 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 Company (a) Except as set forth in Section 4.16(a) of the NIMS Disclosure Letter, the operation of the NIMS Business, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and its subsidiaries: distribution of NIMS Products, is and, during the three (A3) are year period ending on the date hereof has been, in material compliance with all applicable Legal Requirements and NIMS Permits. (b) Except as set forth in Section 4.16(b) of the Federal FoodNIMS Disclosure Letter, Drugduring the three (3) year period ending on the date hereof, and Cosmetic Act NIMS has not had any product or manufacturing site subject to a Governmental Entity (21 U.S.C. § 301 et seq.including FDA) 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 shutdown or import or export prohibition, nor received any FDA Form 483, written 483 or other Governmental Entity notice of adverse findinginspectional observations, “warning letterletters,” “untitled letters” or, untitled letter to the Knowledge of NIMS, requests or other requirements to make changes to NIMS Products that if not complied with would reasonably be expected to result in a material liability to NIMS, or similar correspondence or written notice from the FDA or other Governmental Entity in respect of the NIMS Business and alleging or asserting material noncompliance with any applicable Legal Requirements, NIMS Permits or such requests or requirements of a Governmental Entity, and, to the FDCA Knowledge of NIMS, neither the FDA nor any Governmental Entity is considering such action. (c) Each of NIMS and its Subsidiaries has all Permits necessary to conduct its business as presently conducted, including all such Permits required by the FDA or any licensesother Governmental Entity, certificatesexcept those Permits the absence of which, approvalsindividually or in the aggregate, clearancesis not material to NIMS and its Subsidiaries, exemptionstaken as a whole (collectively, authorizations, permits and supplements or amendments thereto required under the FDCA (“AuthorizationsNIMS Permits”); (C) possess all material Authorizations and . All such Authorizations Permits are valid and in full force effect, and effect and the Company is not in material violation of any term no suspension, revocation or termination of any such Permit is pending or, to the knowledge of NIMS, threatened, except where failure for such noncompliance, suspensions or cancellations with respect to possess such Permits that, individually or be so in compliance with such Authorizations the aggregate, are not material to NIMS and its Subsidiaries, taken as a whole. (d) To the Knowledge of NIMS, neither NIMS nor any Subsidiaries is the subject of any pending or threatened investigation in respect of NIMS or NIMS Products, 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. (e) Neither the NIMS, nor to the knowledge of the NIMS, any officer, employee, consultants, contractors, clinical investigators or agent of NIMS or its Subsidiaries has been (i) debarred, or convicted of any crime that would not reasonably be expected to result in a Material Adverse Effect; debarment, under 21 U.S.C. Section 335a or any similar state or foreign Legal Requirement or (Dii) have not received written notice excluded, or convicted of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging crime 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 exclusion under 42 U.S.C. Section 1320a–7, or in each case any similar state or foreign applicable Legal Requirement. (f) Neither NIMS nor any of its Subsidiaries, nor, to the knowledge of the NIMS, any of their respective managers, directors, officers, agents, or employees acting on behalf of or in the name of NIMS or any of its Subsidiaries have, in any way: (i) offered or used any corporate funds for any unlawful contribution to any political campaign or activity; (ii) violated any provision of the U.S. Foreign Corrupt Practices Act of 1977 or any other applicable equivalent Legal Requirements concerning bribing a Material Adverse Effectforeign public official and the accuracy of books and records; or (iii) offered or given any bribe, kickback or other payment or remuneration to any healthcare professional in violation of applicable Legal Requirements.

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: (i) 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”); (Bii) 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”); (Ciii) 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; (Div) 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 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 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 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 and, to the Company’s knowledge, neither the FDA or nor any governmental entity Governmental Entity is considering such action; and (Fvi) 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 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 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 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.