Common use of Regulatory Authorities Clause in Contracts

Regulatory Authorities. Except as described in the Registration Statement and the Prospectus, the Company and its subsidiaries: (i) are and at all times has been in compliance in all material respects with all statutes, rules, regulations, ordinances, orders, decrees and guidance applicable to the ownership, testing, development, manufacture, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (ii) have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), Nuclear Regulatory Commission or any other federal, state, local or foreign governmental authority having authority over the Company or its subsidiaries (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations except for such violations as would not have a Material Adverse Effect; (iv) have not received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any operation or activity by the Company or its subsidiaries is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action; (v) have not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge or reason to believe that any such Governmental Authority is considering such action; (vi) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) have not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any Class I or Class II recall, market withdrawal or replacement, post sale warning or other notice or action relating to an alleged lack of safety or efficacy of any product, any alleged product defect, or violation on any Applicable Laws or Authorizations; the Company is not aware of any facts that would reasonably be expected to cause the Company or its subsidiaries to initiate any such notice or action; and the Company does not have any knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or action.

Regulatory Authorities. Except as described in the Registration Statement and the Prospectus, the Company and its subsidiariesSeller: (i) are is and at all times has been in substantial compliance in all material respects with all statutes, rules, regulations, ordinances, orders, decrees and guidance guidances applicable to the ownership, testing, development, manufacture, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, useuse (including instructing and training users), distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company Seller (“Applicable Regulatory Laws”); (ii) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), Nuclear Regulatory Commission FDA or any other federal, state, local or foreign governmental authority having authority over the Company or its subsidiaries (“Governmental Authority”) Authority alleging or asserting noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Regulatory Authorizations”); (iii) possess possesses all Authorizations and necessary Regulatory Authorizations, such Regulatory Authorizations are valid and in full force and effect and are Seller is not in violation of any term of any such Authorizations except for such violations as would not have a Material Adverse EffectRegulatory Authorizations; (iv) have has not received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any company operation or activity by the Company or its subsidiaries is in violation of any Applicable Laws Regulatory Law or Authorizations Regulatory Authorization and the Company has no knowledge Knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action; (v) have has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Regulatory Authorizations and has no knowledge Knowledge or reason to believe that any such Governmental Authority is considering such action; (vi) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws Regulatory Law or Authorizations Regulatory Authorization and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) have has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any Class I or Class II recall, market withdrawal or replacement, safety alert, post sale warning warning, “dear doctor” letter, or other notice or action relating to an alleged lack of safety or efficacy of any product, any alleged product defect, or violation on of any Applicable Laws Regulatory Law or AuthorizationsRegulatory Authorization; the Company Seller is not aware of any facts that would reasonably be expected to cause the Company or its subsidiaries Seller to initiate any such notice or action; and the Company Seller does not have any knowledge Knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or action.

Regulatory Authorities. Except as described in the Registration Statement Prospectus and the ProspectusRegistration Statement, each of the Company and its subsidiaries: (ia) are is and at all times has been in material compliance in all material respects with all statutes, rules, regulations, ordinances, orders, decrees and guidance rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (iib) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), Nuclear Regulatory Commission or any other federal, state, local state or foreign governmental authority having authority over the Company or its subsidiaries (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiic) possess possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations except for such violations as would not have a Material Adverse EffectAuthorizations; (ivd) have has not received notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity by the Company or its subsidiaries is in violation of any Applicable Laws or Authorizations and the Company has have no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, audit, investigation, arbitration or other action; (ve) have has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge or reason to believe that any such Governmental Authority is considering such action; and (vif) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or 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); . The studies, tests and (vii) have notpreclinical and clinical trials conducted by or on behalf of the Company and each of its subsidiaries were and, either voluntarily or involuntarilyif still pending, initiatedare being conducted in all material respects in accordance with experimental protocols, conducted, or issued or caused procedures and controls pursuant to be initiated, conducted or issued, any Class I or Class II recall, market withdrawal or replacement, post sale warning or other notice or action relating to an alleged lack of safety or efficacy of any product, any alleged product defect, or violation on any accepted professional scientific standards and all Applicable Laws or and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Prospectus and the Registration Statement are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Prospectus and the Registration Statement, the Company is not aware of any facts that would studies, tests or trials the results of which the Company believes reasonably be expected call into question the study, test, or trial results described or referred to cause in the Prospectus and the Registration Statement when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries to initiate any such notice or action; and the Company does not have any knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or actionsubsidiaries.

Regulatory Authorities. Except as described in the Registration Statement Prospectus and the ProspectusRegistration Statement, the Company and its subsidiariesCompany: (i) are is and at all times has been in full compliance in all material respects with all statutes, rules, regulations, ordinances, orders, decrees and guidance guidances applicable to the ownership, testing, development, manufacture, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“"Applicable Laws”"); (ii) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration (the “FDA”)Administration, Nuclear Regulatory Commission or any other federal, state, local or foreign governmental authority having authority over the Company or its subsidiaries (“"Governmental Authority”") alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“"Authorizations”"); (iii) possess possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations except for such violations as would not have a Material Adverse EffectAuthorizations; (iv) have has not received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any company operation or activity by the Company or its subsidiaries is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action; (v) have has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge or reason to believe that any such Governmental Authority is considering such action; (vi) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) have has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any Class I or Class II recall, market withdrawal or replacement, safety alert, post sale warning warning, "dear doctor" letter, or other notice or action relating to an alleged lack of safety or efficacy of any product, any alleged product defect, or violation on any Applicable Laws or Authorizations; the Company is not aware of any facts that would reasonably be expected to cause the Company or its subsidiaries to initiate any such notice or action; and the Company does not have any knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or action.

Regulatory Authorities. Except as described in the Registration Statement Statement, the General Disclosure Package and the Prospectus, the Company and its subsidiariesCompany: (i) are and at all times has been is in compliance in all material respects with all statutes, rules, regulations, ordinances, opinions, orders, decrees and governmental agency guidance applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company (“Applicable Laws”); (ii) have has not received any FDA Form 483483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice or untitled letter or other correspondence or notice from the U.S. Food and Drug Administration FDA, any Institutional Review Board (the “FDA”as defined by federal regulation at 21 CFR Section 56.102(g), Nuclear Regulatory Commission ) or any other federal, state, local or foreign governmental authority having authority over the Company or its subsidiaries (“Governmental Authority”) Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits registrations, permits, franchises, privileges, variances, immunities, and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess possesses all Authorizations (including, without limitation, exemptions under any Investigational New Drug Application, as described at 21 CFR Sections 312 , and approvals of any Institutional Review Board), which are in full force and effect, required for the conduct of their respective businesses (and such Authorizations are valid and in full force and effect effect) and are not in violation of any term of any such Authorizations except for such violations as would not have a Material Adverse EffectAuthorizations; (iv) have has not received notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority alleging that any operation of the Company’s operations or activity by the Company or its subsidiaries activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such Governmental Authority Authority, or third party Institutional Review Board is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action; (v) have has not received written notice that any Governmental Authority or Institutional Review Board has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such Governmental Authority is considering such action; (vi) have has, or has had on its behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions submissions, registrations and supplements or amendments as are required by any Applicable Laws or Authorizations Authorizations, and that all such reports, documents, forms, notices, applications, records, claims, submissions submissions, registrations 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); . Any clinical trials conducted by or on behalf of the Company that are described in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are, to the knowledge of the Company, being conducted in compliance with experimental protocols, procedures and (vii) have notcontrols pursuant to accepted professional scientific standards and all applicable federal, either voluntarily state, local and foreign laws, rules and regulations, including, but not limited to, the Federal Food, Drug, and Cosmetic Act and implementing regulations at 21 CFR Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or involuntarilythe Prospectus are, initiatedand will be, conducted, or issued or caused to be initiated, conducted or issued, any Class I or Class II recall, market withdrawal or replacement, post sale warning or other notice or action relating to an alleged lack of safety or efficacy of any product, any alleged product defect, or violation on any Applicable Laws or Authorizations; the accurate and complete in all material respects. The Company is not aware of any facts that would studies, tests or trials the results of which reasonably be expected call into question the clinical trial results described or referred to cause in the Registration Statement, the General Disclosure Package or the Prospectus. The Company has not received any written notices, correspondence or other communication from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or its subsidiaries to initiate any such notice or action; and in which the Company does not have any knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or actionhas participated.

Regulatory Authorities. (a) Except as described in the Registration Statement Prospectus and the ProspectusRegistration Statement, the Company and its subsidiariesCompany: (i) are is and at all times has been in full compliance in all material respects with all statutes, rules, regulations, ordinances, orders, decrees and guidance or guidances applicable to the ownership, testing, development, manufacture, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (ii) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), Nuclear Regulatory Commission or any other federal, state, local or foreign governmental authority having authority over the Company or its subsidiaries (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations except for such violations as would not have a Material Adverse EffectAuthorizations; (iv) have has not received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product operation or activity by the Company or its subsidiaries is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action; (v) have has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge or reason to believe that any such Governmental Authority is considering such action; (vi) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) have has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any Class I or Class II recall, market withdrawal or replacement, safety alert, post sale warning warning, “dear doctor” letter, or other notice or action relating to an the alleged lack of safety or efficacy of any product, product or any alleged product defect, defect or violation on any Applicable Laws or Authorizations; the Company is not aware of any facts that would reasonably be expected to cause the Company or its subsidiaries to initiate any such notice or action; and the Company does not have any knowledge or reason to believe that any Governmental Authority or third party has initiated, conducted or intends to initiate any such notice or action. (b) The studies, tests and preclinical and clinical trials conducted or sponsored by or on behalf of the Company that are described or referred to in the Prospectus and the Registration Statement were and, if still pending, are being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations; the descriptions of the results of such studies, tests and trials contained in the Prospectus and the Registration Statement are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Prospectus and the Registration Statement, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Prospectus and the Registration Statement when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted or sponsored by or on behalf of the Company.

Regulatory Authorities. Except as described in the Registration Statement and the Prospectus, the Company and its subsidiariesSeller: (i) are is and at all times has been in material compliance in all material respects with all statutes, rules, regulations, ordinances, orders, decrees and guidance guidances applicable to the ownership, testing, development, manufacture, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, useuse (including instructing and training users), distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company Seller (“Applicable Regulatory Laws”); (ii) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), Nuclear Regulatory Commission FDA or any other federal, state, local or foreign governmental authority having authority over the Company or its subsidiaries (“Governmental Authority”) Authority alleging or asserting noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Regulatory Authorizations”); (iii) possess possesses all Authorizations and necessary Regulatory Authorizations, such Regulatory Authorizations are valid and in full force and effect and are Seller is not in material violation of any term of any such Authorizations except for such violations as would not have a Material Adverse EffectRegulatory Authorizations; (iv) have has not received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any company operation or activity by the Company or its subsidiaries is in violation of any Applicable Laws Regulatory Law or Authorizations Regulatory Authorization and the Company has no knowledge Knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action; (v) have has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Regulatory Authorizations and has no knowledge Knowledge or reason to believe that any such Governmental Authority is considering such action; (vi) have has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws Regulatory Law or Authorizations Regulatory Authorization and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) have has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any Class I or Class II recall, market withdrawal or replacement, safety alert, post sale warning warning, “dear doctor” letter, or other notice or action relating to an alleged lack of safety or efficacy of any product, any alleged product defect, or violation on of any Applicable Laws Regulatory Law or AuthorizationsRegulatory Authorization; the Company Seller is not aware of any facts that would reasonably be expected to cause the Company or its subsidiaries Seller to initiate any such notice or action; and the Company Seller does not have any knowledge Knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or action.

Regulatory Authorities. Except as described in the Registration Statement and the Prospectus, Each of the Company and its subsidiaries: (iA) are is and at all times has been in material compliance in all material respects with all statutes, rules, regulations, ordinances, orders, decrees and guidance rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (iiB) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the any Canadian, U.S. Food and Drug Administration (the “FDA”), Nuclear Regulatory Commission federal or any other federal, state, local state or foreign governmental authority having authority over the Company or its subsidiaries (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess possesses all Authorizations (except as would not reasonably be expected to have a Material Adverse Effect) and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations (except for such violations as would not reasonably be expected to have a Material Adverse Effect); (ivD) have has not received notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity by the Company or its subsidiaries is in violation of any Applicable Laws or Authorizations and the Company has have no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, audit, investigation, arbitration or other action; (vE) have has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge or reason to believe that any such Governmental Authority is considering such action; and (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) have not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any Class I or Class II recall, market withdrawal or replacement, post sale warning or other notice or action relating to an alleged lack of safety or efficacy of any product, any alleged product defect, or violation on any Applicable Laws or Authorizations; the Company is not aware of any facts that would reasonably be expected to cause the Company or its subsidiaries to initiate any such notice or action; and the Company does not have any knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or action.

Regulatory Authorities. Except as described in the Registration Statement Prospectus, the General Disclosure Package and the ProspectusRegistration Statement, each of the Company and its subsidiaries: (ia) are is and at all times has been in material compliance in all material respects with all statutes, rules, regulations, ordinances, orders, decrees and guidance rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (iib) have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), Nuclear Regulatory Commission or any other federal, state, local state or foreign governmental authority having authority over the Company or its subsidiaries (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiic) possess possesses all Authorizations (except as would not reasonably be expected to have a Material Adverse Effect) and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations (except for such violations as would not reasonably be expected to have a Material Adverse Effect); (ivd) have has not received notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity by the Company or its subsidiaries is in violation of any Applicable Laws or Authorizations and the Company has have no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, audit, investigation, arbitration or other action; (ve) have has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge or reason to believe that any such Governmental Authority is considering such action; and (vif) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or 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); . The studies, tests and (vii) have notpreclinical and clinical trials conducted by or on behalf of the Company and each of its subsidiaries were and, either voluntarily or involuntarilyif still pending, initiatedare being conducted in all material respects in accordance with experimental protocols, conducted, or issued or caused procedures and controls pursuant to be initiated, conducted or issued, any Class I or Class II recall, market withdrawal or replacement, post sale warning or other notice or action relating to an alleged lack of safety or efficacy of any product, any alleged product defect, or violation on any accepted professional scientific standards and all Applicable Laws or and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Prospectus, the General Disclosure Package and the Registration Statement are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Prospectus, the General Disclosure Package and the Registration Statement, the Company is not aware of any facts that would studies, tests or trials the results of which the Company believes reasonably be expected call into question the study, test, or trial results described or referred to cause in the Prospectus, the General Disclosure Package and the Registration Statement when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials after they were initiated and which were conducted by or on behalf of the Company or any of its subsidiaries to initiate any such notice or action; and the Company does not have any knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or actionsubsidiaries.