Common use of Regulatory Authorities Clause in Contracts

Regulatory Authorities. Seller: (i) is and at all times has been in substantial compliance with all statutes, rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, development, manufacture, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, use (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 Seller (“Applicable Regulatory Laws”); (ii) has not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other Governmental 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) possesses all necessary Regulatory Authorizations, such Regulatory Authorizations are valid and in full force and effect and Seller is not in violation of any term of any such Regulatory Authorizations; (iv) 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 is in violation of any Applicable Regulatory Law or Regulatory Authorization and 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) 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 or reason to believe that any such Governmental Authority is considering such action; (vi) has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Law or Regulatory Authorization and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has 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 an alleged lack of safety or efficacy of any product, any alleged product defect, or violation of any Applicable Regulatory Law or Regulatory Authorization; Seller is not aware of any facts that would cause Seller to initiate any such notice or action; and Seller 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. Seller(a) Except as described in the Prospectus and the Registration Statement, the Company: (i) is and at all times has been in substantial full compliance with all statutes, rules, regulations, ordinances, orders, decrees and or guidances applicable to the ownership, testing, development, manufacture, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, use (including instructing and training users)use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by Seller the Company (“Applicable Regulatory Laws”); (ii) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA U.S. Food and Drug Administration or any other federal, state, local or foreign governmental authority having authority over the Company (“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) possesses all necessary Regulatory Authorizations, Authorizations and such Regulatory Authorizations are valid and in full force and effect and Seller is are not in violation of any term of any such Regulatory Authorizations; (iv) 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 product operation or activity is in violation of any Applicable Regulatory Law Laws or Regulatory Authorization Authorizations and has no Knowledge or reason to believe knowledge that any such Governmental Authority or third party is considering any such claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action; (v) 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 or reason to believe knowledge that any such Governmental Authority is considering such action; (vi) has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Law Laws or Regulatory Authorization Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has 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 an the alleged lack of safety or efficacy of any product, product or any alleged product defect, defect or violation of any Applicable Regulatory Law or Regulatory Authorization; Seller is not aware of any facts that would cause Seller to initiate any such notice or action; and Seller the Company does not have any Knowledge or reason to believe knowledge 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. SellerEach of the Company and its subsidiaries: (iA) is and at all times has been in substantial material compliance with all statutes, rules, regulations, ordinances, orders, decrees and guidances rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, use (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 Seller Company (“Applicable Regulatory Laws”); (iiB) has not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Canadian, U.S. federal or state or foreign governmental authority having authority over the FDA or any other Company (“Governmental Authority Authority”) alleging or asserting material 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”); (iiiC) possesses all necessary Regulatory Authorizations, Authorizations (except as would not reasonably be expected to have a Material Adverse Effect) and such Regulatory Authorizations are valid and in full force and effect and Seller is are not in material violation of any term of any such Regulatory AuthorizationsAuthorizations (except as would not reasonably be expected to have a Material Adverse Effect); (ivD) 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 company product, operation or activity is in violation of any Applicable Regulatory Law Laws or Regulatory Authorization Authorizations and has have no Knowledge or reason to believe knowledge 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) 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 or reason to believe knowledge that any such Governmental Authority is considering such action; and (viF) 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 Regulatory Law Laws or Regulatory Authorization 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); and (vii) has 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 an alleged lack of safety or efficacy of any product, any alleged product defect, or violation of any Applicable Regulatory Law or Regulatory Authorization; Seller is not aware of any facts that would cause Seller to initiate any such notice or action; and Seller 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. SellerExcept as described in the Prospectus, the General Disclosure Package and the Registration Statement, each of the Company and its subsidiaries: (ia) is and at all times has been in substantial material compliance with all statutes, rules, regulations, ordinances, orders, decrees and guidances rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, use (including instructing and training users)use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by Seller the Company (“Applicable Regulatory Laws”); (iib) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA U.S. Food and Drug Administration or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority Authority”) alleging or asserting material 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”); (iiic) possesses all necessary Regulatory Authorizations, Authorizations (except as would not reasonably be expected to have a Material Adverse Effect) and such Regulatory Authorizations are valid and in full force and effect and Seller is are not in material violation of any term of any such Regulatory AuthorizationsAuthorizations (except as would not reasonably be expected to have a Material Adverse Effect); (ivd) 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 company product, operation or activity is in violation of any Applicable Regulatory Law Laws or Regulatory Authorization Authorizations and has have no Knowledge or reason to believe knowledge 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) 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 or reason to believe knowledge that any such Governmental Authority is considering such action; and (vif) 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 Regulatory Law Laws or Regulatory Authorization 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). The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company and each of its subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws 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 (vii) has nottrials contained in the Prospectus, either voluntarily or involuntarilythe General Disclosure Package and the Registration Statement are accurate and complete in all material respects and fairly present the data derived from such studies, initiatedtests and trials; except to the extent disclosed in the Prospectus, conductedthe General Disclosure Package and the Registration Statement, 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 an alleged lack of safety or efficacy of any product, any alleged product defect, or violation of any Applicable Regulatory Law or Regulatory Authorization; Seller the Company is not aware of any facts that would cause Seller 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 initiate any in the Prospectus, the General Disclosure Package and the Registration Statement when viewed in the context in which such notice or actionresults are described and the clinical state of development; and Seller does not have neither the Company nor any Knowledge of its subsidiaries has received any notices or reason to believe that correspondence from any Governmental Authority requiring the termination, suspension or third party intends to initiate material modification of any such notice studies, tests or actionpreclinical or clinical trials after they were initiated and which were conducted by or on behalf of the Company or any of its subsidiaries.

Regulatory Authorities. Seller: (i) is and at all times has been in substantial material compliance with all statutes, rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, development, manufacture, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, use (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 Seller (“Applicable Regulatory Laws”); (ii) has not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other Governmental 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) possesses all necessary Regulatory Authorizations, such Regulatory Authorizations are valid and in full force and effect and Seller is not in material violation of any term of any such Regulatory Authorizations; (iv) 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 is in violation of any Applicable Regulatory Law or Regulatory Authorization and 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) 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 or reason to believe that any such Governmental Authority is considering such action; (vi) has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Law or Regulatory Authorization and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has 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 an alleged lack of safety or efficacy of any product, any alleged product defect, or violation of any Applicable Regulatory Law or Regulatory Authorization; Seller is not aware of any facts that would cause Seller to initiate any such notice or action; and Seller 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. SellerExcept as described in the Prospectus and the Registration Statement, the Company: (i) is and at all times has been in substantial full compliance with all statutes, rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, development, manufacture, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, use (including instructing and training users)use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by Seller the Company (“"Applicable Regulatory Laws”"); (ii) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA U.S. Food and Drug Administration, Nuclear Regulatory Commission or any other federal, state, local or foreign governmental authority having authority over the Company ("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) possesses all necessary Regulatory Authorizations, Authorizations and such Regulatory Authorizations are valid and in full force and effect and Seller is are not in violation of any term of any such Regulatory Authorizations; (iv) 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 is in violation of any Applicable Regulatory Law Laws or Regulatory Authorization Authorizations and 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) 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) has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Law Laws or Regulatory Authorization Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has 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 an alleged lack of safety or efficacy of any product, any alleged product defect, or violation of on any Applicable Regulatory Law Laws or Regulatory AuthorizationAuthorizations; Seller the Company is not aware of any facts that would cause Seller the Company to initiate any such notice or action; and Seller the Company 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. SellerExcept as described in the Prospectus and the Registration Statement, each of the Company and its subsidiaries: (ia) is and at all times has been in substantial material compliance with all statutes, rules, regulations, ordinances, orders, decrees and guidances rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, use (including instructing and training users)use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by Seller the Company (“Applicable Regulatory Laws”); (iib) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA U.S. Food and Drug Administration or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority Authority”) alleging or asserting material 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”); (iiic) possesses all necessary Regulatory Authorizations, Authorizations and such Regulatory Authorizations are valid and in full force and effect and Seller is are not in material violation of any term of any such Regulatory Authorizations; (ivd) 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 company product, operation or activity is in violation of any Applicable Regulatory Law Laws or Regulatory Authorization Authorizations and has have no Knowledge or reason to believe knowledge 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) 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 or reason to believe knowledge that any such Governmental Authority is considering such action; and (vif) 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 Regulatory Law Laws or Regulatory Authorization 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). The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company and each of its subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws 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 (vii) has nottrials 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, either voluntarily or involuntarilytests and trials; except to the extent disclosed in the Prospectus and the Registration Statement, 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 an alleged lack of safety or efficacy of any product, any alleged product defect, or violation of any Applicable Regulatory Law or Regulatory Authorization; Seller the Company is not aware of any facts that would cause Seller 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 initiate any in the Prospectus and the Registration Statement when viewed in the context in which such notice or actionresults are described and the clinical state of development; and Seller does not have neither the Company nor any Knowledge of its subsidiaries has received any notices or reason to believe that correspondence from any Governmental Authority requiring the termination, suspension or third party intends to initiate material modification of any such notice studies, tests or actionpreclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries.

Regulatory Authorities. SellerExcept as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company: (i) is and at in compliance in all times has been in substantial compliance material respects with all statutes, rules, regulations, ordinances, opinions, orders, decrees and guidances governmental agency guidance applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, inspecting, handling, installing, servicing, recordkeeping, use (including instructing and training users)use, distribution, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by Seller or for the Company (“Applicable Regulatory Laws”); (ii) has not received any FDA Form 483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice or untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other Governmental Authority alleging or asserting noncompliance with any Applicable Regulatory 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 Regulatory Laws (“Regulatory Authorizations”); (iii) possesses all necessary Regulatory AuthorizationsAuthorizations (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 Regulatory Authorizations are valid and in full force and effect effect) and Seller is are not in violation of any term of any such Regulatory Authorizations; (iv) 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 company operation of the Company’s operations or activity activities is in violation of any Applicable Regulatory Law Laws or Regulatory Authorization Authorizations and the Company has no Knowledge 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) 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 Regulatory Authorizations and the Company has no Knowledge knowledge or reason to believe that any such Governmental Authority is considering such action; (vi) 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 Regulatory Law Laws or Regulatory Authorization Authorizations, and that all such reports, documents, forms, notices, applications, records, claims, submissions submissions, registrations and supplements or amendments were materially complete and correct 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) has 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 recall, market withdrawal or replacement, safety alert, post sale 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 of any Applicable Regulatory Law or Regulatory Authorization; Seller accurate and complete in all material respects. The Company is not aware of any facts that would cause Seller studies, tests or trials the results of which reasonably call into question the clinical trial results described or referred to initiate in the Registration Statement, the General Disclosure Package or the Prospectus. The Company has not received any such notice written notices, correspondence or action; and Seller does not have other communication from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any Knowledge clinical trials conducted by, or reason to believe that any Governmental Authority on behalf of, the Company or third party intends to initiate any such notice or actionin which the Company has participated.