Common use of FDA Regulatory Compliance Clause in Contracts

FDA Regulatory Compliance. 1 (i) Since January 1, 2019, CRH and all CRH products have been in material compliance with all applicable FDA Laws. (ii) Except as disclosed in Schedule 4.1(bb)(ii) to the CRH Disclosure Letter, since January 1, 2019, CRH has not received any written notice from any Governmental Authority asserting noncompliance with any FDA Law, including any warning or untitled letter, notice of violation, notice of inspectional observations, Form FDA-483, or similar letter or written notice. Since January 1, 2019, CRH has not been subject to any enforcement, regulatory or administrative proceedings initiated by any Governmental Authority and, to CRH’s knowledge, no such enforcement, regulatory or administrative proceeding has been threatened. 1 Subject to ongoing review by regulatory specialists. (iii) Except as disclosed in Schedule 4.1(bb)(iii) to the CRH Disclosure Letter, since January 1, 2019, no product distributed or sold by or on behalf of CRH has been seized, detained, withdrawn, voluntarily or involuntarily recalled, or subject to a suspension of manufacturing, and there are no facts or circumstances reasonably likely to cause a market withdrawal, recall, seizure, detention, or suspension of the manufacturing, marketing or distribution, of any such product. (iv) Since January 1, 2019, all preclinical and clinical investigations sponsored or conducted by or on behalf of CRH have been and are being conducted in material compliance with all applicable FDA Laws, applicable research protocols, institutional review board or other ethics committee requirements, and federal and state Laws relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. CRH has not received any written notice that any Governmental Authority or institutional review board or independent ethics committee has initiated, or threatened to initiate, any action to suspend, terminate, delay, or otherwise restrict any clinical trial sponsored or conducted by or on behalf of CRH. (v) Since January 1, 2019, neither CRH, nor to CRH’s knowledge, any officer, director employee or agent of CRH has (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submission to any Governmental Authority; or (ii) committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy. (vi) Since January 1, 2019, neither CRH, nor to CRH’s knowledge, any officer, director, employee, or agent of CRH, has been (i) debarred by the FDA under 21 U.S.C. § 335a, (ii) excluded from U.S. health care programs pursuant to 42 U.S.C. §1320(a)-7 and related regulations, or (iii) excluded or debarred under any applicable Laws by any Governmental Authority. Neither CRH, nor to the CRH’s knowledge, any officer, director, employee or agent of CRH, has engaged in any conduct that would reasonably be expected to result in such a debarment or exclusion.

FDA Regulatory Compliance. 1Except as otherwise set forth on the attached FDA Regulatory Schedule: (ia) Since January 1, 2019, CRH The Company and each of its Subsidiaries are in compliance in all CRH products have been in material compliance respects with all applicable FDA LawsLaws administered or issued by the FDA or any applicable, comparable Governmental Entity (such as the Drug Enforcement Administration (the “DEA”)), including requirements related to development, clinical and non-clinical evaluation, 510(k) premarket notification, investigational new drug applications, new drug applications, abbreviated new drug applications, establishment registration and product listing, medical device reporting, adverse drug experience reporting, field alert reporting, corrections and removals, recalls, quality system regulation, good manufacturing practices, product warranties (with respect to medical devices), distribution, importation, exportation, use, handling, quality, sale, labeling, promotion, or advertising and other premarket and postmarket requirements or commitments of any drug or medical device or controlled substance subject to regulation by the Drug Enforcement Administration under the Controlled Substances Act. (iib) Except as disclosed in Schedule 4.1(bb)(iiDuring the past three (3) years neither the Company nor any of its Subsidiaries nor, to the CRH Disclosure Letterknowledge of the Company, since January 1any of the directors, 2019officers, CRH or employees of the Company or any of its Subsidiaries has been charged with, nor received any notice or other communication from the FDA or any other Governmental Entity alleging, any material violation of any FDA Laws by the Company or any of its Subsidiaries relating to its business. To the Company’s knowledge, the Company and its Subsidiaries, and the directors, officers, or employees of the Company and its Subsidiaries, are not the subject of any investigation that is pending, proposed, or threatened by the FDA or any comparable Governmental Entity. Neither the Company nor any of its Subsidiaries is subject to any obligation arising under any civil or criminal judicial, administrative, or regulatory action, FDA inspection, FDA warning letter, FDA untitled letter, FDA notice of violation letter, or other communication from the FDA or a comparable Governmental Entity, including the DEA, or other notice, response or commitment made to or with the FDA or a comparable Governmental Entity, including the DEA. During the past three (3) years, the Company and its Subsidiaries have not received any written notice from information regarding, nor have knowledge of, any Governmental Authority asserting noncompliance with facts or circumstances that furnish any FDA Lawreasonable basis for any future civil or criminal judicial, including any warning administrative, or regulatory action, Form FDA-483 inspectional observations, untitled letter, notice of violationviolation letter, notice of inspectional observations, Form FDA-483warning letter, or similar letter communication from the FDA, or written noticeany comparable Governmental Entity, including the DEA. Since January 1, 2019, CRH has not been subject to any enforcement, regulatory or administrative proceedings initiated by any Governmental Authority and, to CRH’s knowledgeTo the knowledge of the Company, no such enforcementdirector, regulatory officer, or administrative proceeding employee of the Company or any of its Subsidiaries, or any consultant or agent of the Company or any of its Subsidiaries has been threatened. 1 Subject to ongoing review convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by regulatory specialists21 U.S.C. § 335a. (iiic) Except as disclosed in Schedule 4.1(bb)(iii) No seizure, denial, withdrawal, recall, detention, field notification, field correction, termination or suspension of manufacturing or marketing, import alert, or safety alert relating to any of the CRH Disclosure Letter, since January 1, 2019, no product distributed Company’s or sold by or on behalf of CRH its Subsidiaries’ products has been seizedinitiated, detainedproposed, withdrawn, voluntarily or involuntarily recalledrequested, or subject to threatened by FDA or a suspension of manufacturingcomparable Governmental Entity, including the DEA, within the past three (3) years. The Company and there are no its Subsidiaries have not received any information regarding, nor have knowledge of, any facts or circumstances reasonably likely to cause a market withdrawalany such action. (d) Each filing, recall, seizure, detentionsubmission, or suspension other communication to the FDA or any comparable Governmental Entity, including the DEA, in any other jurisdiction made by the Company or any of its Subsidiaries within the past three (3) years was true, accurate and complete in all material respects as of the manufacturingdate made. To the knowledge of the Company, marketing there is no false or distributionmisleading information or significant omission in any product application or other submission to the FDA or other comparable Governmental Entity, including the DEA, made by the Company or any of its Subsidiaries within the past three (3) years. The Company and each of its Subsidiaries have notified the FDA and all such Governmental Entities, including the DEA, of any changes to such productfilings or submissions as required by Law. (ive) Since January 1The Company and/or its Subsidiaries are the sole and exclusive owners of the pending, 2019cleared, all preclinical and clinical investigations sponsored approved abbreviated new drug applications, new investigational drug applications, and 510(k) premarket notifications set forth on the Drug/Device Applications Schedule, each of which is valid and existing in full force and effect, and may be assigned to, transferred to or conducted assumed by the Purchaser in accordance with this Agreement. To the Company’s knowledge, neither the FDA nor any other comparable Governmental Entity, including the DEA, has notified the Company that it is considering limiting, suspending or on behalf revoking any such Regulatory Permit and Exemption or changing the regulatory classification or labeling of CRH have any Product. To the Company’s knowledge, no third party that is a supplier, manufacturer or contractor for the Company or any of its Subsidiaries has been and are being conducted in subject to civil or criminal judicial, administrative, or regulatory action during the past three (3) years alleging material compliance with all applicable violation of FDA Laws, applicable research protocolsincluding receipt of an FDA warning letter, institutional review board FDA untitled letter, FDA notice of violation letter, FDA-483 inspectional observations, or other ethics committee requirementscommunications from the FDA or comparable Governmental Entities, and federal and state Laws including the DEA, relating to patient privacy requirements the manufacture of the Products or restricting the use and disclosure of individually identifiable health information. CRH has not received any written notice that any Governmental Authority or institutional review board or independent ethics committee has initiated, or threatened to initiate, any action to suspend, terminate, delay, or otherwise restrict any clinical trial sponsored or conducted by or on behalf of CRH. (v) Since January 1, 2019, neither CRH, nor to CRH’s knowledge, any officer, director employee or agent of CRH has (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submission to any Governmental Authority; or (ii) committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide a basis product components for the FDA to invoke Company or its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policySubsidiaries. (vi) Since January 1, 2019, neither CRH, nor to CRH’s knowledge, any officer, director, employee, or agent of CRH, has been (i) debarred by the FDA under 21 U.S.C. § 335a, (ii) excluded from U.S. health care programs pursuant to 42 U.S.C. §1320(a)-7 and related regulations, or (iii) excluded or debarred under any applicable Laws by any Governmental Authority. Neither CRH, nor to the CRH’s knowledge, any officer, director, employee or agent of CRH, has engaged in any conduct that would reasonably be expected to result in such a debarment or exclusion.

FDA Regulatory Compliance. 1 (i) Since January 1, 2019, CRH and all CRH products have been in material compliance with all applicable FDA Laws. (iia) Except as disclosed in Schedule 4.1(bb)(ii4.25 or in public filings of the Borrower with the SEC prior to the Closing Date and (2) as would not reasonably be expected to result in a Material Adverse Effect, (i) each Loan Party and each of their Subsidiaries has, and it and its Products are in conformance with, all Registrations, (ii) all Registrations are valid and in full force and effect; (iii) to the CRH Disclosure Letterknowledge of each Loan Party, since January 1, 2019, CRH has not received neither the FDA nor any written notice from any comparable Governmental Authority asserting noncompliance is considering limiting, suspending, or revoking any such Registration; (iv) the Loan Parties and each of their Subsidiaries have fulfilled and performed their obligations under each Registration, and, to the knowledge of each Loan Party, no event has occurred or condition exists which would constitute a breach or default under, or would cause revocation or termination of, any such Registration; and (v) to the knowledge of each Loan Party, all reports, documents, claims, permits, adverse event reports, complaints, notices, registrations and applications required to be filed, maintained or furnished to the FDA or any other Regulatory Authority by a Loan Party or any of its Subsidiaries have been so filed, maintained or furnished. (b) Each Loan Party and each of their Subsidiaries are conducting their business and operations in compliance with all applicable Health Care Laws, except to the extent that any noncompliance, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect. Except as disclosed in Schedule 4.25 or in public filings of the Borrower with the SEC prior to the Closing Date and (2) as would not reasonably be expected to result in a Material Adverse Effect, (i) no Loan Party nor any of their Subsidiaries is subject to any obligation arising under an administrative or regulatory action, proceeding, investigation or inspection by or on behalf of the FDA Lawor any comparable Governmental Authority, including any warning or letter, Form FDA-483, untitled letter, notice of violationviolation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority, in each case, in respect of such Loan Party or its Subsidiary, and no such obligation has been threatened and (ii) no Loan Party has received written notice of inspectional observations, Form FDA-483, or similar letter or written notice. Since January 1, 2019, CRH has not been subject to any enforcement, regulatory or administrative proceedings initiated by any from a Governmental Authority andthat any Product designed, to CRH’s knowledgedeveloped, no such enforcementinvestigated, regulatory manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold or administrative proceeding has been threatened. 1 Subject to ongoing review by regulatory specialists. (iii) Except as disclosed in Schedule 4.1(bb)(iii) to the CRH Disclosure Letter, since January 1, 2019, no product distributed or sold marketed by or on behalf of CRH has been seized, detained, withdrawn, voluntarily any Loan Party or involuntarily recalled, or any of their Subsidiaries that are subject to a suspension of manufacturing, and there are no facts or circumstances reasonably likely to cause a market withdrawal, recall, seizure, detention, or suspension the jurisdiction of the manufacturingFDA or any comparable Governmental Authority are not being designed, marketing or distributiondeveloped, of any such productinvestigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance with the Health Care Laws. (ivc) Since January 1, 2019Except as would not reasonably be expected to be result in a Material Adverse Effect, all preclinical pre-clinical and clinical investigations conducted or sponsored or conducted by or on behalf of CRH any Loan Party or any of their Subsidiaries are being and have been and are being conducted in material compliance with all applicable Health Care Laws including (i) FDA Lawsstandards for the design, applicable research protocolsconduct, institutional review board or other ethics committee requirementsperformance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312 and 314 of the Code of Federal Regulations, and (ii) federal and state Laws relating to patient privacy requirements or Requirements of Law restricting the collection, use and disclosure of individually identifiable health information and personal information. CRH has not received any written notice that any Governmental Authority or institutional review board or independent ethics committee has initiated, or threatened to initiate, any action to suspend, terminate, delay, or otherwise restrict any clinical trial sponsored or conducted by or on behalf of CRH. (vd) Since January 1, 2019, neither CRH, nor to CRH’s knowledge, any officer, director employee or agent of CRH has Except (i) made any materially false statement on, as disclosed in Schedule 4.25 or material omission from, any notifications, applications, approvals, reports and other submission in public filings of the Borrower with the SEC prior to any Governmental Authority; the Closing Date or (ii) committed an act, made a statement, or failed to make a statement that as would not reasonably be expected to provide be result in a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy. (vi) Since January 1, 2019Adverse Effect, neither CRHany Loan Party nor any of their Subsidiaries has voluntarily or involuntarily initiated, nor conducted or issued, caused to CRH’s knowledgebe initiated, any officer, director, employeeconducted or issued, or agent received written notice of CRHany material recall, has been (i) debarred by the FDA under 21 U.S.C. § 335afield corrective action, (ii) excluded from U.S. health care programs pursuant to 42 U.S.C. §1320(a)-7 and related regulationsmarket withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or (iii) excluded other notice or debarred under action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any applicable Laws by Product or is currently considering initiating, conducting or issuing any Governmental Authority. Neither CRH, nor to the CRH’s knowledge, recall of any officer, director, employee or agent of CRH, has engaged in any conduct that would reasonably be expected to result in such a debarment or exclusionProduct.

FDA Regulatory Compliance. 1 (a) Except as disclosed with respect to DESI Program Products or as disclosed in Annex IV or in Holdings’ SEC Filings and (2) as would not reasonably be expected to result in a Material Adverse Effect, (i) Since January 1each Credit Party and each of their Subsidiaries has, 2019and it and its Products are in conformance with, CRH all Registrations, (ii) all Registrations are valid and in full force and effect; (iii) to the knowledge of each Credit Party, neither the FDA nor any comparable Governmental Authority is considering limiting, suspending, or revoking any such Registration; (iv) the Credit Parties and each of their Subsidiaries have fulfilled and performed their obligations under each Registration, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of, any such Registration; and (v) all CRH products reports, documents, claims, permits, adverse event reports, complaints, notices, registrations and applications required to be filed, maintained or furnished to the FDA or any other Regulatory Authority by a Credit Party or any of its Subsidiaries have been so filed, maintained or furnished. (b) Each Credit Party and each of their Subsidiaries are conducting their business and operations in material compliance with all applicable FDA Health Care Laws. , except to the extent that any noncompliance, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect. Except (ii1) Except with respect to DESI Program Products or as disclosed in Schedule 4.1(bb)(iiAnnex IV or in Holdings’ SEC Filings and (2) as would not reasonably be expected to result in a Material Adverse Effect, (i) no Credit Party nor any of their Subsidiaries is subject to any obligation arising under an administrative or regulatory action, proceeding, investigation or inspection by or on behalf of the CRH Disclosure LetterFDA or any comparable Governmental Authority, since January 1warning letter, 2019Form FDA-483, CRH has not received any written notice from any Governmental Authority asserting noncompliance with any FDA Law, including any warning or untitled letter, notice of violationviolation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority, in each case, in respect of such Credit Party or its Subsidiary, and no such obligation has been threatened and (ii) no Credit Party has received written notice of inspectional observations, Form FDA-483, or similar letter or written notice. Since January 1, 2019, CRH has not been subject to any enforcement, regulatory or administrative proceedings initiated by any from a Governmental Authority andthat any Product designed, to CRH’s knowledgedeveloped, no such enforcementinvestigated, regulatory manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold or administrative proceeding has been threatened. 1 Subject to ongoing review by regulatory specialists. (iii) Except as disclosed in Schedule 4.1(bb)(iii) to the CRH Disclosure Letter, since January 1, 2019, no product distributed or sold marketed by or on behalf of CRH has been seized, detained, withdrawn, voluntarily any Credit Party or involuntarily recalled, or any of their Subsidiaries that are subject to a suspension of manufacturing, and there are no facts or circumstances reasonably likely to cause a market withdrawal, recall, seizure, detention, or suspension the jurisdiction of the manufacturingFDA or any comparable Governmental Authority are not being designed, marketing or distributiondeveloped, of any such productinvestigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance with the Health Care Laws. (ivc) Since January 1, 2019Except as would not reasonably be expected to be result in a Material Adverse Effect, all preclinical pre-clinical and clinical investigations conducted or sponsored or conducted by or on behalf of CRH any Credit Party or any of their Subsidiaries are being and have been and are being conducted in material compliance with all applicable Health Care Laws including (i) FDA Lawsstandards for the design, applicable research protocolsconduct, institutional review board or other ethics committee requirementsperformance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312 and 314 of the Code of Federal Regulations, and (ii) federal and state Laws relating to patient privacy requirements or Requirements of Law restricting the collection, use and disclosure of individually identifiable health information and personal information. CRH has not received any written notice that any Governmental Authority or institutional review board or independent ethics committee has initiated, or threatened to initiate, any action to suspend, terminate, delay, or otherwise restrict any clinical trial sponsored or conducted by or on behalf of CRH. (vd) Since January 1, 2019, neither CRH, nor to CRH’s knowledge, any officer, director employee or agent of CRH has Except (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submission to any Governmental Authority; as disclosed in Holdings’ SEC Filings or (ii) committed an act, made a statement, or failed to make a statement that as would not reasonably be expected to provide be result in a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy. (vi) Since January 1, 2019Adverse Effect, neither CRHany Credit Party nor any of their Subsidiaries has voluntarily or involuntarily initiated, nor conducted or issued, caused to CRH’s knowledgebe initiated, any officer, director, employeeconducted or issued, or agent received written notice of CRHany material recall, has been (i) debarred by the FDA under 21 U.S.C. § 335afield corrective action, (ii) excluded from U.S. health care programs pursuant to 42 U.S.C. §1320(a)-7 and related regulationsmarket withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or (iii) excluded other notice or debarred under action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any applicable Laws by Product or is currently considering initiating, conducting or issuing any Governmental Authority. Neither CRH, nor to the CRH’s knowledge, recall of any officer, director, employee or agent of CRH, has engaged in any conduct that would reasonably be expected to result in such a debarment or exclusionProduct.