Common use of FDA Compliance Clause in Contracts

FDA Compliance. The Company and its subsidiary: (A) are and at all times have been in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all statutes, rules or regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the Company (“Applicable Laws”); (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental or regulatory authority alleging or asserting noncompliance with any Applicable Laws or any Licenses; (C) possess all Licenses and such Licenses are valid and in full force and effect and the Company and its subsidiary are not in violation of any term of any such Licenses; (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 or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Licenses and have no knowledge that the FDA or any governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) 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 Licenses 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).

FDA Compliance. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, each of the Company and its subsidiarysubsidiaries: (A) are and at all times have been is in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all material statutes, rules or regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities applicable to the ownership, business, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (“Applicable Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter, notice of violation letter or other correspondence or written notice from the FDA or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or Governmental Licenses and supplements or amendments thereto required by any Licensessuch Applicable Laws (“Authorizations”), which would, individually or in the aggregate, result in a Material Adverse Effect; (C) possess possesses all Licenses material Authorizations and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are is not in material violation of any term of any such LicensesAuthorizations; (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 other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Licenses and have no knowledge Authorizations; (E) has not received notice that the FDA or any other federal, state, local or foreign governmental authority or regulatory authority has initiated action to limit, suspend, modify or third party is considering revoke any such claim, litigation, arbitration, action, suit, investigation or proceedingmaterial Authorizations; and (EF) 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 Licenses 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 (G) 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, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation that is under development, manufactured or distributed by the Company.

FDA Compliance. The Company and its subsidiaryExcept as described in the Prospectuses, or would not, singly or in the aggregate, result in a Material Adverse Effect, the Company: (A) are is and at all times have has been in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all statutes, rules or regulations of the U.S. Food FDA and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities 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 or on behalf of 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 notice from the FDA or any governmental or regulatory authority Governmental Entity alleging or asserting material noncompliance with any Applicable Laws or any Licenseslicenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess possesses all Licenses material Authorizations and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are is not in material violation of any term of any such LicensesAuthorizations; (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 or regulatory authority Governmental Entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Licenses Authorizations and have has no knowledge that the FDA or any governmental or regulatory authority Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) have has not received 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) 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 Licenses 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).

FDA Compliance. The Company and its subsidiaryExcept as described in the Public Disclosure Record, or would not, singly or in the aggregate, result in a Material Adverse Effect, the Company: (A) are is and at all times have has been in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all statutes, rules or regulations of the U.S. Food FDA and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities 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 or on behalf of the Company (“Applicable Regulatory Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental or regulatory authority Governmental Entity alleging or asserting material noncompliance with any Applicable Regulatory Laws or any Licenseslicenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (C) possess possesses all Licenses material Authorizations and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are is not in material violation of any term of any such LicensesAuthorizations; (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 or regulatory authority Governmental Entity or third party alleging that any product operation or activity is in material violation of any Applicable Regulatory Laws or Licenses Authorizations and have has no knowledge that the FDA or any governmental or regulatory authority Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) have has not received 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) 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 Laws or Licenses 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).

FDA Compliance. The Company and its subsidiaryExcept in each case, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company: (A) are is, and at all times have been has since June 1, 2019 been, in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all applicable statutes, rules or regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities applicable FDA relating to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the 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 similar governmental or regulatory authority entity in each case alleging or asserting material noncompliance with any Applicable Laws or any Licenseslicenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess possesses all Licenses Authorizations required for the conduct of its business and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are is not in violation of any term of any such LicensesAuthorizations; (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 or regulatory authority entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Licenses Authorizations and have has no knowledge Knowledge that the FDA or any governmental or regulatory authority entity or third party is considering has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) have filedhas not received written notice that the FDA or any governmental entity has taken, obtainedis taking or intends to take action to limit, maintained suspend, modify or submitted all reports, documents, forms, notices, applications, records, claims, submissions revoke any material Authorizations and supplements has no Knowledge that the FDA or amendments as required by any Applicable Laws or Licenses and that all governmental entity is considering 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)action.

FDA Compliance. The Company and its subsidiary: Subsidiaries and their respective directors, officers, employees, agents, affiliates and representatives (A) are and at all times have been in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all statutes, rules or regulations of the U.S. Food FDA and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities 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 or on behalf of the Company (“Applicable Laws”); (B) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written or, to the Company’s knowledge, oral notice from the FDA or any governmental or regulatory authority Governmental Entity alleging or asserting material noncompliance with any Applicable Laws or any Licenseslicenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess all Licenses material Authorizations and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are is not in material violation of any term of any such LicensesAuthorizations; (D) have not received written or, to the Company’s knowledge, oral notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental or regulatory authority Governmental Entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Licenses Authorizations and have has no knowledge that the FDA or any governmental or regulatory authority Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received written or, to the Company’s knowledge, oral 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 (EF) have 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 Licenses 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). Neither the Company nor its Subsidiaries nor any of its or their respective directors, officers, employees, agents or clinical investigators, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 42 U.S.C. § 1320a-7 or 21 U.S.C. § 335a. The Company has not failed to file with the FDA or any Governmental Entity any required filing, declaration, listing, registration, report or submission with respect to the Company’s product candidates that are described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed, or amended or supplemented in material compliance with applicable laws; and no material deficiencies regarding compliance with applicable law have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, or amendments or supplements thereof.

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiarythe Prospectus, the Company: (A) are is and at all times have has been in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all statutes, rules or rules, and regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the Company (“Applicable Laws”); (B) have has not received any FDA Form 483, written material notice of adverse finding, warning letter, untitled letter or other similar correspondence or written notice from the FDA U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting noncompliance with any Applicable Laws or any Licenseslicenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess possesses all Licenses required Authorizations and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are not in material violation of any term of any such LicensesAuthorizations; (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 other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Licenses Authorizations and have has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) have has not received written notice that the FDA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to suspend, revoke, or materially modify any Authorizations and has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (F) 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 Licenses 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 (G) 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 or other written notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the knowledge of the Company, there are no circumstances that would reasonably be expected to result in any such notice or action.

FDA Compliance. The Company Except as described in the Registration Statements, the Pricing Disclosure Package and its subsidiarythe Prospectuses, the Company: (A) are is and at all times have during the past three years has been in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all applicable statutes, rules or regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities applicable (“Governmental Authority”) relating 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, clinical development or manufactured or distributed by or on behalf of 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 notice from the FDA or any governmental or regulatory authority Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any Licenseslicenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess possesses all Licenses required material Authorizations and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are is not in material violation of any term of any such LicensesAuthorizations; (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 or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in material violation of any Applicable Laws or Licenses and have no knowledge Authorizations; (E) has not received notice that the FDA or any governmental Governmental Authority has taken, is taking or regulatory authority intends to take action to limit, suspend, modify or third party is considering revoke any such claim, litigation, arbitration, action, suit, investigation or proceedingmaterial Authorizations; and (EF) 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 Licenses 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). To the knowledge of the Company, all third parties that are collaborating with the Company with respect to the clinical development or manufacture of companion diagnostics medical devices are in material compliance with all Applicable Laws and possess all required material Authorizations relating to such companion medical devices being developed in collaboration with the Company.

FDA Compliance. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, each of the Company and its subsidiarythe Subsidiary: (A) are and at all times have been is in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all material statutes, rules or regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities applicable to the ownership, business, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (“Applicable Laws”); (B) have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter, notice of violation letter or other correspondence or written notice from the FDA or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or Governmental Licenses and supplements or amendments thereto required by any Licensessuch Applicable Laws (“Authorizations”), which would, individually or in the aggregate, result in a Material Adverse Effect; (C) possess possesses all Licenses material Authorizations and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are is not in material violation of any term of any such LicensesAuthorizations; (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 other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Licenses and have no knowledge Authorizations; (E) has not received notice that the FDA or any other federal, state, local or foreign governmental authority or regulatory authority has initiated action to limit, suspend, modify or third party is considering revoke any such claim, litigation, arbitration, action, suit, investigation or proceedingmaterial Authorizations; and (EF) 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 Licenses 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 (G) 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, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation that is under development, manufactured or distributed by the Company.

FDA Compliance. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and each of its subsidiary: subsidiaries (A) are is and at all times have has been in material full compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all statutes, rules rules, regulations, or regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities guidances applicable to Company or any of its subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the Company or any of its subsidiaries (“Applicable Laws”); , except as could not, individually or in the aggregate, reasonably be expected to 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 notice from the FDA or any governmental or regulatory authority other Governmental Entity alleging or asserting noncompliance with any Applicable Laws or any Licenses; licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), (C) possess possesses all Licenses material Authorizations and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are is not in violation of any term of any such Licenses; 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 or regulatory authority Governmental Entity or third party alleging that any product operation or activity is in violation of any Applicable Laws or Licenses Authorizations and have has no knowledge that the FDA or any governmental or regulatory authority such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and , (E) have has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Entity is considering such action and (F) 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 Licenses 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).

FDA Compliance. The Company and its subsidiaryExcept in each case, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company: (A) are is, and at all times have been has since February 1, 2020 been, in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all applicable statutes, rules or regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities applicable FDA relating to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the 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 similar governmental or regulatory authority entity in each case alleging or asserting material noncompliance with any Applicable Laws or any Licenseslicenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess possesses all Licenses Authorizations required for the conduct of its business and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are is not in violation of any term of any such LicensesAuthorizations; (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 or regulatory authority entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Licenses Authorizations and have has no knowledge that the FDA or any governmental or regulatory authority entity or third party is considering has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) have filedhas not received written notice that the FDA or any governmental entity has taken, obtainedis taking or intends to take action to limit, maintained suspend, modify or submitted all reports, documents, forms, notices, applications, records, claims, submissions revoke any material Authorizations and supplements has no knowledge that the FDA or amendments as required by any Applicable Laws or Licenses and that all governmental entity is considering 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)action.

FDA Compliance. The Company Seller and its subsidiarythe Seller Subsidiaries: (Aa) are and at all times have been in material compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all statutes, rules or regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities Laws applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the Company (“Applicable Laws”)Seller Compounds; (Bb) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental or regulatory authority other Government Entity alleging or asserting material noncompliance with any Applicable Laws or any LicensesAuthorizations thereto required by any such Laws in connection with the Program; (Cc) possess all Licenses material Authorizations necessary for their conduct of the Program and such Licenses are valid and in full force and effect Seller and the Company and its subsidiary Seller Subsidiaries are not in material violation of any term of any such LicensesAuthorizations; (Dd) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action Proceeding from the FDA or any governmental or regulatory authority other Government Entity or third party alleging that any product Seller Compound, or operation or activity related to any Seller Compound, is in violation of any Applicable Laws or Licenses Authorizations and have has no knowledge that the FDA or any governmental or regulatory authority other Government Entity or third party is considering any such claimProceeding; (e) have not received notice that the FDA or any other Government Entity has taken, litigationis taking or intends to take action to limit, arbitrationsuspend, action, suit, investigation modify or proceedingrevoke any Authorizations related to the Program; and (Ef) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments with respect to the Program as required by any Applicable Laws or Licenses 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).

FDA Compliance. The Company Except as described in the Registration Statement, the General Disclosure Package and its subsidiarythe Prospectus, the Company: (A) are is and at all times have has been in material full compliance with the Federal Food, Drug and Cosmetic Act (“FDCA”), and all statutes, rules rules, regulations, or regulations of the U.S. Food and Drug Administration (“FDA”) and of other comparable governmental or regulatory authorities guidances applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the 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 notice from the FDA U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting noncompliance with any Applicable Laws or any Licenseslicenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess possesses all Licenses Authorizations and such Licenses Authorizations are valid and in full force and effect and the Company and its subsidiary are not in violation of any term of any such LicensesAuthorizations; (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 other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Licenses Authorizations and have has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) have has not received notice that the FDA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (F) 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 Licenses 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 (G) 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 the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate any such notice or action.