Common use of Compliance with FDA Regulations Clause in Contracts

Compliance with FDA Regulations. Except as set forth in the Prospectus, the Company and its subsidiaries, and, to the Company’s knowledge, its distributors, manufacturers and sublicensees, are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall notice, or other notice or commitment made to or with the FDA or any other governmental authority (including without limitation the Drug Enforcement Agency) regarding or impacting the Company’s approved products (the “Company Products”) or any product candidate of the Company, including without limitation any notice alleging a violation of any applicable law or required registration, except for any such obligation that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as described in the Prospectus, neither the Company nor its subsidiaries and, to the Company’s knowledge, neither its distributors, manufacturers nor sublicensees, have received any written or other notice from the FDA, the Drug Enforcement Agency or a comparable governmental authority alleging that the Company Products are the subject of any pending or threatened investigation in any jurisdiction that has not been fully remedied. Except as described in the Prospectus, the Company and its subsidiaries and, to the Company’s knowledge with respect to the Company Products, its distributors, manufacturers and sublicensees, are in compliance with all applicable laws administered or issued by the FDA or any other governmental authority, including, without limitation, those requirements relating to the testing, handling, distribution, regulatory approval, pricing approval, annual reporting, registration, good manufacturing practices, record-keeping, adverse event reporting, promotion, sales, packaging, labeling and advertising of drugs and controlled substances (where applicable) in each case in all material respects. The promotion, sale, manufacture, storage, packaging, labeling, handling, testing and distribution of the Company Products for which registrations have been obtained by the Company, its subsidiaries, distributors, manufacturers and sublicensees is being, and at all times following such registration has been, conducted in compliance in all material respects with the registrations, except for any failure that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; provided that the foregoing representation as it relates to the Company’s distributors, manufacturers and sublicensees shall be to the Company’s knowledge. All regulatory filings made by the Company or its subsidiaries, or, to the Company’s knowledge, by the Company’s distributors, manufacturers or sublicensees, to any governmental authority, in each case with respect to any of the Company Products, when submitted to the governmental authority were accurate in all material respects as of the date of submission, or as subsequently corrected or modified. Neither the Company nor its subsidiaries (including their officers or employees) nor, to the Company’s knowledge, any principal investigator or sub-investigator engaged in any clinical investigation conducted with respect to any Company Product (including their officers or employees) has been convicted of any crime under 21 U.S.C. Section 335a(a) or any similar state or foreign law or under 21 U.S.C. Section 335a(b) or any similar state or foreign law. To the Company’s knowledge, there are no facts which would reasonably be expected to cause (i) the withdrawal or recall of any Company Product sold by or on behalf of the Company, its subsidiaries, distributors or sublicensees, (ii) a termination or suspension of marketing of any such Company Product, or (iii) any adverse events or safety concerns not already publicly disclosed that would have a material impact on the ability to market any such Company Product.

Compliance with FDA Regulations. Except as set forth in the Prospectus, the Company and its subsidiaries, and, to the Company’s knowledge, its distributors, manufacturers and sublicensees, are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall notice, or other notice or commitment made to or with the FDA or any other governmental authority (including without limitation the U.S. Drug Enforcement AgencyAgency (the “DEA”)) regarding or impacting the Company’s approved products (the “Company Products”) or any product candidate of the Company), including without limitation any notice alleging a violation of any applicable law or required registration, except for any such obligation that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as described in the Prospectus, neither the Company nor its subsidiaries and, to the Company’s knowledge, neither its distributors, manufacturers nor sublicensees, have received any written or other notice from the FDA, the Drug Enforcement Agency DEA or a comparable governmental authority alleging that the Company Products are the subject of any pending or or, to the Company’s knowledge, threatened investigation in any jurisdiction that has not been fully remedied. Except as described in the Prospectus, the Company and its subsidiaries and, to the Company’s knowledge with respect to the Company Products, its distributors, manufacturers and sublicensees, are in compliance with all applicable laws administered or issued by the FDA or any other governmental authority, including, without limitation, those requirements relating to the testing, handling, distribution, regulatory approval, pricing approval, annual reporting, registration, good manufacturing practices, record-keeping, adverse event reporting, promotion, sales, packaging, labeling and advertising of drugs and controlled substances (where applicable) in each case in all material respects. The promotion, sale, manufacture, storage, packaging, labeling, handling, testing and distribution of the Company Products for which registrations have been obtained by the Company, Company and its subsidiaries, distributors, manufacturers and sublicensees subsidiaries is being, and at all times following such registration has been, conducted in compliance in all material respects with the registrations, except for any failure that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; provided that the foregoing representation as it relates to the Company’s distributors, manufacturers and sublicensees shall be to the Company’s knowledge. All regulatory filings made by the Company or its subsidiaries, or, to the Company’s knowledge, by the Company’s distributors, manufacturers or sublicensees, subsidiaries to any governmental authority, in each case authority with respect to any of the Company Products, when submitted to the governmental authority were accurate in all material respects as of the date of submission, or as subsequently corrected or modified. Neither the Company nor its subsidiaries (including their officers or employees) nor, to the Company’s knowledge, any principal investigator or sub-investigator engaged in any clinical investigation conducted with respect to any Company Product (including their officers or employees) has been convicted of any crime under 21 U.S.C. Section 335a(a) or any similar state or foreign law or under 21 U.S.C. Section 335a(b) or any similar state or foreign law. To the Company’s knowledge, there are no facts which would reasonably be expected to cause (i) the withdrawal or recall of any Company Product sold by or on behalf of the Company, its subsidiaries, distributors or sublicensees, or (ii) a termination or suspension of marketing of any such Company Product, or (iii) any adverse events or safety concerns not already publicly disclosed that would have a material impact on the ability to market any such Company Product.

Compliance with FDA Regulations. Except as set forth in the Prospectus, the Company and its subsidiaries, and, to the Company’s knowledge, its distributors, manufacturers and sublicensees, are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall notice, or other notice or commitment made to or with the FDA or any other governmental authority (including without limitation the U.S. Drug Enforcement AgencyAgency (the “DEA”)) regarding or impacting the Company’s approved products (the “Company Products”) or any product candidate Product Candidate of the Company, including without limitation any notice alleging a violation of any applicable law or required registration, except for any such obligation that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as described in the Prospectus, neither the Company nor its subsidiaries and, to the Company’s knowledge, neither its distributors, manufacturers nor sublicensees, have received any written or other notice from the FDA, the Drug Enforcement Agency DEA or a comparable governmental authority alleging that the Company Products are the subject of any pending or or, to the Company’s knowledge, threatened investigation in any jurisdiction that has not been fully remedied. Except as described in the Prospectus, the Company and its subsidiaries and, to the Company’s knowledge with respect to the Company Products, its distributors, manufacturers and sublicensees, are in compliance with all applicable laws administered or issued by the FDA or any other governmental authority, including, without limitation, those requirements relating to the testing, handling, distribution, regulatory approval, pricing approval, annual reporting, registration, good manufacturing practices, record-keeping, adverse event reporting, promotion, sales, packaging, labeling and advertising of drugs and controlled substances (where applicable) in each case in all material respects. The promotion, sale, manufacture, storage, packaging, labeling, handling, testing and distribution of the Company Products for which registrations have been obtained by the Company, Company and its subsidiaries, distributors, manufacturers and sublicensees subsidiaries is being, and at all times following such registration has been, conducted in compliance in all material respects with the registrations, except for any failure that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; provided that the foregoing representation as it relates to the Company’s distributors, manufacturers and sublicensees shall be to the Company’s knowledge. All regulatory filings made by the Company or its subsidiaries, or, to the Company’s knowledge, by the Company’s distributors, manufacturers or sublicensees, subsidiaries to any governmental authority, in each case authority with respect to any of the Company Products, when submitted to the governmental authority were accurate in all material respects as of the date of submission, or as subsequently corrected or modified. Neither the Company nor its subsidiaries (including their officers or employees) nor, to the Company’s knowledge, any principal investigator or sub-investigator engaged in any clinical investigation conducted with respect to any Company Product (including their officers or employees) has been convicted of any crime under 21 U.S.C. Section 335a(a) or any similar state or foreign law or under 21 U.S.C. Section 335a(b) or any similar state or foreign law. To the Company’s knowledge, there are no facts which would reasonably be expected to cause (i) the withdrawal or recall of any Company Product sold by or on behalf of the Company, its subsidiaries, distributors or sublicensees, or (ii) a termination or suspension of marketing of any such Company Product, or (iii) any adverse events or safety concerns not already publicly disclosed that would have a material impact on the ability to market any such Company Product.

Compliance with FDA Regulations. Except as set forth in the ProspectusTime of Sale Information and the Offering Memorandum, the Company and its subsidiaries, and, to the Company’s knowledge, its distributors, manufacturers and sublicensees, are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall notice, or other notice or commitment made to or with the FDA or any other governmental authority (including without limitation the U.S. Drug Enforcement AgencyAgency (the “DEA”)) regarding or impacting the Company’s approved FDA cleared products (the “Company Products”) or any product candidate of the Company), including without limitation any notice alleging a violation of any applicable law or required registration, except for any such obligation that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as described in the ProspectusTime of Sale Information and the Offering Memorandum, neither the Company nor its subsidiaries and, to the Company’s knowledge, neither its distributors, manufacturers nor sublicensees, have received any written or other notice from the FDA, the Drug Enforcement Agency DEA or a comparable governmental authority alleging that the Company Products are the subject of any pending or or, to the Company’s knowledge, threatened investigation in any jurisdiction that has not been fully remedied. Except as described in the ProspectusTime of Sale Information and the Offering Memorandum, the Company and its subsidiaries and, to the Company’s knowledge with respect to the Company Products, its distributors, manufacturers and sublicensees, are in compliance with all applicable laws administered or issued by the FDA or any other governmental authority, including, without limitation, those requirements relating to the testing, handling, distribution, regulatory approval, pricing approval, annual reporting, registration, good manufacturing practices, record-keeping, adverse event reporting, promotion, sales, packaging, labeling and advertising of drugs and controlled substances (where applicable) in each case in all material respects. The promotion, sale, manufacture, storage, packaging, labeling, handling, testing and distribution of the Company Products for which registrations have been obtained by the Company, Company and its subsidiaries, distributors, manufacturers and sublicensees subsidiaries is being, and at all times following such registration has been, conducted in compliance in all material respects with the registrations, except for any failure that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; provided that the foregoing representation as it relates to the Company’s distributors, manufacturers and sublicensees shall be to the Company’s knowledge. All regulatory filings made by the Company or its subsidiaries, or, to the Company’s knowledge, by the Company’s distributors, manufacturers or sublicensees, subsidiaries to any governmental authority, in each case authority with respect to any of the Company Products, when submitted to the governmental authority were accurate in all material respects as of the date of submission, or as subsequently corrected or modified. Neither the Company nor its subsidiaries (including their officers or employees) nor, to the Company’s knowledge, any principal investigator or sub-investigator engaged in any clinical investigation conducted with respect to any Company Product (including their officers or employees) has been convicted of any crime under 21 U.S.C. Section 335a(a) or any similar state or foreign law or under 21 U.S.C. Section 335a(b) or any similar state or foreign law. To the Company’s knowledge, there are no facts which would reasonably be expected to cause (i) the withdrawal or recall of any Company Product sold by or on behalf of the Company, its subsidiaries, distributors or sublicensees, or (ii) a termination or suspension of marketing of any such Company Product, or (iii) any adverse events or safety concerns not already publicly disclosed that would have a material impact on the ability to market any such Company Product.

Compliance with FDA Regulations. Except as set forth in the Prospectus, the Company and its subsidiaries, and, to the Company’s knowledge, its distributors, manufacturers and sublicensees, are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall notice, or other notice or commitment made to or with the FDA or any other governmental authority (including without limitation the Drug Enforcement Agency) regarding or impacting the Company’s approved products (the “Company Products”) or any product candidate of the Company, including without limitation any notice alleging a violation of any applicable law or required registration, except for any such obligation that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as described in the Prospectus, neither the Company nor its subsidiaries and, to the Company’s knowledge, neither its distributors, manufacturers nor sublicensees, have received any written or other notice from the FDA, the Drug Enforcement Agency or a comparable governmental authority alleging that the Company Products are the subject of any pending or threatened investigation in any jurisdiction that has not been fully remedied. Except as described in Registration Statement and the Prospectus, the Company Company: (A) is and its subsidiaries and, to the Company’s knowledge with respect to the Company Products, its distributors, manufacturers and sublicensees, are at all times has been in material compliance with all statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) and other comparable governmental authorities applicable laws administered to the ownership, testing (including clinical trials and pre-clinical studies), development, manufacture, packaging, processing, use, labeling, storage, import, export or issued disposal of any product under development, manufactured by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or other formal notice from the FDA or any other governmental authorityauthority alleging or asserting material noncompliance with any Applicable Laws or any licenses, includingcertificates, without limitation, those requirements relating to the testing, handling, distribution, regulatory approval, pricing approval, annual reporting, registration, good manufacturing practices, record-keeping, adverse event reporting, promotion, sales, packaging, labeling permits and advertising of drugs and controlled substances supplements or amendments thereto required by any such Applicable Laws (where applicable“Authorizations”); (C) in each case in possesses all material respects. The promotion, sale, manufacture, storage, packaging, labeling, handling, testing Authorizations and distribution of such Authorizations are valid and in full force and effect and the Company Products for which registrations have been obtained by the Company, its subsidiaries, distributors, manufacturers and sublicensees is being, and at all times following such registration has been, conducted not in compliance in all material respects with the registrations, except for any failure that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; provided that the foregoing representation as it relates to the Company’s distributors, manufacturers and sublicensees shall be to the Company’s knowledge. All regulatory filings made by the Company or its subsidiaries, or, to the Company’s knowledge, by the Company’s distributors, manufacturers or sublicensees, to any governmental authority, in each case with respect to any of the Company Products, when submitted to the governmental authority were accurate in all material respects as of the date of submission, or as subsequently corrected or modified. Neither the Company nor its subsidiaries (including their officers or employees) nor, to the Company’s knowledge, any principal investigator or sub-investigator engaged in any clinical investigation conducted with respect to any Company Product (including their officers or employees) has been convicted violation of any crime under 21 U.S.C. Section 335a(a) or any similar state or foreign law or under 21 U.S.C. Section 335a(b) or any similar state or foreign law. To the Company’s knowledge, there are no facts which would reasonably be expected to cause (i) the withdrawal or recall of any Company Product sold by or on behalf of the Company, its subsidiaries, distributors or sublicensees, (ii) a termination or suspension of marketing term of any such Company ProductAuthorizations; (D) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, Health Canada or any governmental authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (iiiE) has not received any adverse events formal notice that the FDA, Health Canada or safety concerns not already publicly disclosed any governmental authority has taken, is taking or intends to take action to materially limit, suspend, modify or revoke any material Authorizations and has no knowledge that would have a the FDA, Health Canada or any governmental authority is considering such action; and (F) has filed, obtained, maintained or submitted all material impact 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 on the ability to market any such Company Productdate filed (or were corrected or supplemented by a subsequent submission).

Compliance with FDA Regulations. Except as set forth disclosed in the Registration Statement and the Prospectus, the Company and its subsidiaries, and, to the Company’s knowledge, its distributors, manufacturers and sublicensees, are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall notice, or other notice or commitment made to or with the FDA or any other governmental authority (including without limitation the Drug Enforcement AgencyDEA) regarding or impacting the Company’s approved products (the “Company Products”) or any product candidate of the Company), including without limitation any notice alleging a violation of any applicable law or required registration, except for any such obligation that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as described in the Prospectus, neither the Company nor its subsidiaries and, to the Company’s knowledge, neither its distributors, manufacturers nor sublicensees, have received any written or other notice from the FDA, the Drug Enforcement Agency DEA or a comparable governmental authority alleging that the Company Products are the subject of any pending or or, to the Company’s knowledge, threatened investigation in any jurisdiction that has not been fully remedied. Except as described in the Prospectus, the Company and its subsidiaries and, to the Company’s knowledge with respect to the Company Products, its distributors, manufacturers and sublicensees, are in compliance with all applicable laws administered or issued by the FDA or any other governmental authority, including, without limitation, those requirements relating to the testing, handling, distribution, regulatory approval, pricing approval, annual reporting, registration, good manufacturing practices, record-keeping, adverse event reporting, promotion, sales, packaging, labeling and advertising of drugs and controlled substances (where applicable) in each case in all material respects. The promotion, sale, manufacture, storage, packaging, labeling, handling, testing and distribution of the Company Products for which registrations have been obtained by the Company, Company and its subsidiaries, distributors, manufacturers and sublicensees subsidiaries is being, and at all times following such registration has been, conducted in compliance in all material respects with the registrations, except for any failure that has not, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; provided that the foregoing representation as it relates to the Company’s distributors, manufacturers and sublicensees shall be to the Company’s knowledge. All regulatory filings made by the Company or its subsidiaries, or, to the Company’s knowledge, by the Company’s distributors, manufacturers or sublicensees, subsidiaries to any governmental authority, in each case authority with respect to any of the Company Products, when submitted to the governmental authority were accurate in all material respects as of the date of submission, or as subsequently corrected or modified. Neither the Company nor its subsidiaries (including their officers or employees) nor, to the Company’s knowledge, any principal investigator or sub-investigator engaged in any clinical investigation conducted with respect to any Company Product (including their officers or employees) has been convicted of any crime under 21 U.S.C. Section 335a(a) or any similar state or foreign law or under 21 U.S.C. Section 335a(b) or any similar state or foreign law. To the Company’s knowledge, there are no facts which would reasonably be expected to cause (i) the withdrawal or recall of any Company Product sold by or on behalf of the Company, its subsidiaries, distributors or sublicensees, or (ii) a termination or suspension of marketing of any such Company Product, or (iii) any adverse events or safety concerns not already publicly disclosed that would have a material impact on the ability to market any such Company Product.