Compliance of Products. (a) The Issuer and its Subsidiaries have obtained all required Regulatory Authorizations necessary for compliance with all Laws for its respective business as presently conducted and all such Regulatory Authorizations are in full force and effect except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development and Commercialization Activities concerning any Product. All Regulatory Authorizations held by the Credit Parties and their respective Subsidiaries are (i) legally and beneficially owned exclusively by Credit Parties or their respective Subsidiaries, free and clear of all Liens other than Permitted Liens, and (ii) validly registered and on file with the applicable Regulatory Agency, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Regulatory Agency except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development and Commercialization Activities concerning any Product. All required notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) and other required filings with respect to the Products for which Issuer or its Subsidiaries have such filing responsibility or control over have been filed with the FDA, the DEA, and all other applicable Regulatory Agencies when due, except where the failure to do so could not reasonably be expected to result in (x) a material adverse effect on any Product Development and Commercialization Activities or (y) a Material Adverse Effect. (b) Except where the failure to do so could not reasonably be expected to result in the termination or restriction of a Material Regulatory Authorization, all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests made by, on behalf of, or for the benefit of the Issuer or any of its Subsidiaries for a Regulatory Authorization from the FDA or other Regulatory Agency relating to the Issuer’s or any Subsidiary’s business operations and Products, when submitted to the FDA or other (c) Except as could not reasonably be expected to result in a material adverse effect on any Product Development and Commercialization Activities: (i) The Products, as well as the business of the Credit Parties and their respective Subsidiaries, comply in all material respects with (A) all applicable Laws, rules, regulations, orders, injunctions and decrees of the FDA, the DEA, and any other applicable Regulatory Agency, including, without limitation, all applicable requirements of the FDCA, the PHSA, the Controlled Substances Act, and similar state Laws, and (B) all applicable Product Authorizations, Regulatory Authorizations, and all other Permits; (ii) Except as set forth on Schedule 6.23(c) to the Disclosure Letter, none of the Credit Parties, their respective Subsidiaries nor, to the knowledge of the Issuer, their respective suppliers have received and do not otherwise have knowledge of: any inspection reports, “Warning Letters,” “Untitled Letters” or similar documents with respect to any Product or the manufacture, processing, packing, distribution, or holding thereof, as well as the business of the Credit Parties and their respective Subsidiaries, from any Regulatory Agency that assert lack of compliance with any applicable Laws, rules, regulations, orders, injunctions, or decrees; (iii) None of the Credit Parties, their respective Subsidiaries nor, to the knowledge of the Issuer, their respective suppliers have received any written notice of, and does not otherwise have knowledge of, any pending regulatory enforcement action, investigation or inquiry (other than non-material routine or periodic inspections or reviews) against the Credit Parties, any of their respective Subsidiaries or any of their respective suppliers with respect to the Products, and, to the knowledge of the Issuer, there is no basis for any adverse regulatory action against the Credit Parties or their respective Subsidiaries or, to the knowledge of the Issuer, their respective suppliers with respect to the Products; and (iv) Without limiting the foregoing, (A) to the knowledge of the Issuer, no supplier of any Credit Party or any Subsidiary has received, during the two (2) years prior to the Closing Date, any Form FDA 483 from the FDA asserting a lack of compliance with respect to any Product or Product Development and Commercialization Activities, (B) to the knowledge of the Credit Parties (1) there have been no Safety Notices conducted, undertaken or issued by any Person, whether or not at the request, demand or order of any Regulatory Agency or otherwise, with respect to any Product, (2) no Safety
Appears in 1 contract
Samples: Note Purchase Agreement (Revance Therapeutics, Inc.)
Compliance of Products. (a) The Issuer Borrower and its Subsidiaries have obtained all required Material Regulatory Authorizations necessary required for compliance with all Laws for its respective the conduct of their business as presently conducted currently conducted, and all such Material Regulatory Authorizations are in full force and effect except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development effect, without restriction, and Commercialization Activities concerning any Product. All all such Regulatory Authorizations held by the Credit Loan Parties and their respective Subsidiaries or their licensees are (i) legally and beneficially owned exclusively by Credit one of the Loan Parties or and their respective SubsidiariesSubsidiaries or licensees, free and clear of all Liens other than Permitted LiensLiens permitted pursuant to Section 8.01, and (ii) validly registered and on file with the applicable Regulatory Agency, in compliance in all material respects with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standingstanding (to the extent applicable), valid and enforceable with the applicable Regulatory Agency except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development and Commercialization Activities concerning any ProductAgency. All required notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) and other required filings with respect to the all material Products for which Issuer or its Subsidiaries have such filing responsibility or control over have been filed with the FDA, the DEA, and all other applicable Regulatory Agencies when due, except where the failure to do so could not reasonably be expected to result in (x) a material adverse effect on any Product Development and Commercialization Activities or (y) a Material Adverse EffectActivities.
(b) Except where the failure to do so could not reasonably be expected expect to result in the termination or restriction of a Material Regulatory Authorization, all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted by any Loan Party or any of its Subsidiaries in connection with any and all requests made by, on behalf of, or for the benefit of the Issuer or any of its Subsidiaries for a Regulatory Authorization from the FDA or other Regulatory Agency relating to the Issuer’s Borrower or any Subsidiary’s , their business operations and to the Products, when submitted to the FDA or otherother Regulatory Agency were, to the knowledge of any Responsible Officer of any Loan Party, true, complete and correct in all material respects as of the date of submission (including any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data that have been submitted to the FDA or other Regulatory Agency). To the knowledge of any Responsible Officer of any Loan Party, the Material Regulatory Authorizations are valid and supported by proper research, design, testing, analysis and disclosure. To the knowledge of any Responsible Officer of any Loan Party, there has been no (i) material untrue statement of fact and/or no fraudulent statement made by the Loan Parties or their respective Subsidiaries, or any of their respective agents or representatives to the FDA or any other Governmental Authority, and (ii) none of the Loan Parties and their Subsidiaries has failed to disclose any fact required to be disclosed, committed an act, made a statement, or failed to make a statement to the FDA or any other Governmental Authority that could 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,” set forth in 56 Fed. Regulation 46191 (September 10, 1991).
(c) Except as could not reasonably be expected to result in a material adverse effect on any Product Development and Commercialization Activities:
(i) The the Products, as well as the business of the Credit Loan Parties and their respective Subsidiaries, comply in all material respects with (A) all applicable Laws, rules, regulations, orders, injunctions and decrees of the FDA, the DEA, and any other applicable Regulatory Agency, including, without limitation, all applicable requirements of the FDCA, the PHSA, the Controlled Substances Act, and similar state Laws, and (B) all applicable Product Authorizations, Regulatory Authorizations, and all other Permits; ;
(iii) Except as set forth on Schedule 6.23(c) to the Disclosure Letter, none of the Credit Parties, Loan Parties or their respective Subsidiaries norhave received, to the knowledge and no Responsible Officer of the Issuer, their respective suppliers have received and do not otherwise have any Loan Party has knowledge of: , any inspection reports, “Warning Letters,” “Untitled Letters” warning letters, untitled letters, Safety Notices or similar documents with respect to any Product or the manufacture, processing, packing, distribution, or holding thereof, as well as the business of the Credit Parties any Product Development and their respective SubsidiariesCommercialization Activities, from any Regulatory Agency that assert lack of compliance with any applicable Laws, rules, regulations, orders, injunctions, or decrees; ;
(iiiii) None none of the Credit Loan Parties, or their respective Subsidiaries nor, to the knowledge of the Issuer, their respective suppliers have received any written notice of, and does not otherwise have no Responsible Officer of any Loan Party has knowledge of, any pending regulatory enforcement action, investigation or inquiry (other than non-material routine or periodic inspections or reviews) against the Credit Parties, any of their respective Subsidiaries or any of their respective suppliers with respect to the Products, and, and to the knowledge of the Issuerany Responsible Officer of any Loan Party, there is no basis for any adverse regulatory action against the Credit Parties or their respective Subsidiaries or, to the knowledge of the Issuer, their respective suppliers with respect to the Products; and (iv) Without limiting the foregoing, (A) to the knowledge of the Issuer, no supplier of any Credit Party Products or any Subsidiary has received, during the two (2) years prior to the Closing Date, any Form FDA 483 from the FDA asserting a lack of compliance with respect to any Product or Product Development and Commercialization Activities; and
(A) there have been no Safety Notices, (B) to the knowledge of any Responsible Officer of any Loan Party, there are no facts that could reasonably result in issuance of a Safety Notice, (C) the Credit Loan Parties (1) there and/or their Subsidiaries have not received any written notice of, and no Responsible Officer of any Loan Party has knowledge of, any criminal, injunctive, seizure, detention or civil penalty actions that have at any time been no Safety Notices conducted, undertaken commenced or issued threatened in writing by any PersonRegulatory Agency with respect to or in connection with any Products, whether or any consent decrees (including plea agreements) which relate to any Products, and (D) to the knowledge of any Responsible Officer of any Loan Party, there is no basis for the commencement for any criminal injunctive, seizure, detention or civil penalty actions by any Regulatory Agency relating to the Products or for the issuance of any consent decrees. None of the Loan Parties or their respective Subsidiaries nor, to the knowledge of any Responsible Officer of any Loan Party, any of their respective suppliers is employing or utilizing the services of any individual who has been convicted of any crime or engaged in any conduct for which debarment or temporary suspension under any applicable Law, rule or regulation is warranted.
(d) Except as set forth on Schedule 6.24(d) to the Disclosure Letter, the Borrower and its Subsidiaries have not at received any written communication from any Regulatory Agency regarding, and, to the requestknowledge of any Responsible Officer of any Loan Party, demand there are no facts or order circumstances that are reasonably likely to give rise to (A) any material adverse change in any Material Regulatory Authorization, or any failure to materially comply with any applicable Laws or any term or requirement of any Regulatory Agency Authorization or otherwise(B) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material adverse modification of any Material Regulatory Authorization.
(e) Except as could not reasonably be expected, either alone or in the aggregate, to result in a Material Adverse Effect, all studies, tests, preclinical trials and clinical trials conducted by or on behalf of any Loan Party or any of its respective Subsidiaries with respect to any ProductProduct have been conducted in compliance with applicable Laws, including cGCPs. Except as set forth on Schedule 6.24(e) to the Disclosure Letter, none of the Loan Parties or their respective Subsidiaries has received from the FDA or other applicable Regulatory Agency any notices or correspondence alleging any material non-compliance with applicable Laws or requiring the termination, suspension, material adverse modification or clinical hold of any studies, tests or clinical trials in any material respect with respect to or in connection with the Products.
(f) With respect to Products, except as could not reasonably be expected, either alone or in the aggregate, to result in a Material Adverse Effect, (2i) no Safetyall activities by the Loan Parties and their respective Subsidiaries relating to the Products have been conducted, and are currently being conducted, in compliance with applicable Laws and the requirements of all applicable Regulatory Agencies, including, without limitation, cGMPs, adverse event reporting requirements, and state and federal requirements relating to the handling of controlled substances and (ii) none of the Loan Parties or their respective Subsidiaries has received written notice or are aware of a threat of commencement of action by any Governmental Authority to initiate any action against the Borrower or a Subsidiary, any action to enjoin the Borrower or a Subsidiary, its officers, directors, employees, or its agents and Affiliates, from conducting its business at any facility owned or used by the Borrower or a Subsidiary or for any civil penalty, injunction, seizure or criminal action. No Product in the inventory of the Loan Parties or their respective Subsidiaries is adulterated or
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Compliance of Products. (a) The Issuer Loan Parties and its Subsidiaries their Subsidiaries, either directly or through their Product Distributors, have obtained all required Regulatory Authorizations necessary for compliance with all Laws for its respective to conduct the business as presently conducted and all conducted, except where the lack of such Regulatory Authorizations are in full force and effect except to the extent the failure to do so could not reasonably be expected to have have, individually or in the aggregate, a material adverse effect on the Businesses or any Product Development and Commercialization Activities concerning any ProductActivities. All Regulatory Authorizations with respect to Material Products that are held by the Credit Loan Parties and their respective Subsidiaries and Product Distributors are (i) legally and beneficially owned exclusively by Credit one of the Loan Parties or their respective SubsidiariesSubsidiaries or Product Distributors, free and clear of all Liens other than Permitted Liens, and (ii) validly registered and on file with . All Regulatory Authorizations held by the applicable Regulatory Agency, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and Loan Parties are in good standing, valid and enforceable with the applicable Regulatory Agency except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development in full force and Commercialization Activities concerning any Product. All required notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) and other required filings with respect to the Products for which Issuer or its Subsidiaries have such filing responsibility or control over have been filed with the FDA, the DEA, and all other applicable Regulatory Agencies when dueeffect, except where the failure of any Regulatory Authorization to do so be valid or in full force and effect, individually or in the aggregate, could not be reasonably be expected to result in (x) have a material adverse effect on any Product Development and Commercialization Activities or (y) a Material Adverse EffectActivities.
(b) Except In the past three (3) years, except where the failure to do so could not reasonably be expected to result in the termination or restriction of a Material Regulatory Authorization, all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefromreports, utilized as the basis for amendments, modifications, supplements, or notices submitted in connection with any and all requests made by, on behalf of, or for the benefit of the Issuer or any of its Subsidiaries for a Regulatory Authorization from the FDA FDA, the EMA or other Regulatory Agency relating to the Issuer’s any Loan Party or any Subsidiary’s business operations and Subsidiary or any of their respective Products, when submitted to the FDA, the EMA or other Regulatory Agency were true, complete and correct in all material respects as of the date of submission (or were corrected in or supplemented by a subsequent submission). In the past three (3) years, to the knowledge of the Loan Parties, (i) there has been no material untrue statement of fact and/or no fraudulent statement made by the Loan Parties or their respective Subsidiaries or Product Distributors (as relating to Material Products), or any of their respective agents or representatives to the FDA, the DEA, the EMA or any other Regulatory Agency, and (ii) there has been no failure to disclose any material fact required to be disclosed, commission of an act, making of a statement, or failure to make a statement to the FDA, the DEA, the EMA or any other Regulatory Agency that could reasonably be expected to provide a basis for the FDA or otherto invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991).
(c) Except as could not reasonably be expected to result in a material adverse effect on any Product Development and Commercialization Activities:
(i) The Products, as well as the business of the Credit Loan Parties and their respective SubsidiariesSubsidiaries and, to the knowledge of the Borrower, Product Distributors (as relating to Material Products), comply in all material respects with (A) all applicable Laws, rules, regulations, orders, injunctions and decrees Laws of the FDA, the DEA, the EMA and any other applicable Regulatory Agency, including, without limitation, all applicable requirements of the FDCA, the PHSA, the Controlled Substances Act, and similar state Laws, and similar Laws of any country, jurisdiction or Governmental Authority other than the United States and (B) all applicable Product Authorizationsapplicable, Regulatory Authorizations, and all other Permits; ;
(ii) Except as set forth on Schedule 6.23(cDuring the past three (3) to the Disclosure Letteryears, none of the Credit no Loan Parties, their respective Subsidiaries nor, to the knowledge of the IssuerBorrower, their respective suppliers Product Distributors (as relating to Material Products) have received and do not otherwise have knowledge ofreceived: any inspection reportsFDA Form 483, “Warning Letters,” “Untitled Letters” warning letter, untitled letter or similar documents written correspondence or notice with respect to any Product or the manufacture, processing, packing, distribution, or holding thereof, as well as the business of the Credit Loan Parties and their respective SubsidiariesSubsidiaries or relevant Product Distributors (as relating to Material Products), from any Regulatory Agency that assert lack of compliance with any applicable Laws, rules, regulations, orders, injunctions, or decrees; ;
(iii) None of During the Credit Partiespast three (3) years, no Loan Parties nor their respective Subsidiaries nor, to the knowledge of the IssuerBorrower, their respective Product Distributors or suppliers (as relating to Material Products) have received any written notice of, and does not otherwise have knowledge of, any pending regulatory enforcement action, investigation or inquiry from any Regulatory Agencies (other than non-material routine or periodic inspections or reviews) against the Credit Parties, Loan Parties or any of their respective Subsidiaries or any of their respective Product Distributors or suppliers (as relating to Material Products) alleging or asserting noncompliance with the FDCA, Controlled Substances Act, or similar Laws related to the Product Development and Commercialization Activities; and
(iv) During the past three (3) years, (A) no Loan Party or Subsidiary or to the knowledge of the Loan Parties with respect to Material Products, no Product Distributor or supplier of any Loan Party has issued any Safety Notices and (B) to the Loan Parties’ knowledge, there are no facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Products, andor (2) a termination or suspension of marketing of any of the Products.
(d) In the past three (3) years, except as could not reasonably be expected, individually or in the aggregate to result in a material adverse effect on any Product Development and Commercialization Activities, none of the Loan Parties or their respective Subsidiaries nor, to the knowledge of the IssuerLoan Parties, there any Product Distributors (as relating to Material Products) has received any written notice of proceedings from any Regulatory Agency with respect to (i) any material adverse change in any applicable Regulatory Authorization, or any failure to materially comply with any term or requirement of any applicable Regulatory Authorization or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or modification of any applicable Regulatory Authorization.
(e) In the past three (3) years, except as could not reasonably be expected, either individually or in the aggregate, to result in a material adverse effect on any Product Development and Commercialization Activities: (i) all studies, tests, preclinical trials and clinical trials conducted by or on behalf of or for the benefit of any Loan Party or any of its respective Subsidiaries with respect to any Product have been conducted in material compliance with applicable Laws, including applicable cGCPs, (ii) no Loan Party nor any of their respective Subsidiaries has received any notice from the FDA, the EMA or any other Regulatory Agency alleging any material non-compliance with applicable Laws, including applicable cGCPs or otherwise terminating or suspending any clinical trial conducted by or on behalf of or for the benefit of such Loan Party or Subsidiary with respect to any Product and (iii) none of the Loan Parties nor their respective Subsidiaries, or, to the knowledge of the Loan Parties with respect to Material Products, any of their respective Product Distributors, licensees, licensors or third party services providers or consultants, has received from the FDA, the EMA or other applicable Regulatory Agency any notices or correspondence requiring the termination, suspension or material modification of any studies, tests or clinical trials in which the Products have participated.
(f) In the past three (3) years, neither the Borrower nor any Subsidiary nor, to the knowledge of any Loan Party, any Product Distributor has experienced any failures in the manufacturing of any Material Product for commercial sale that could reasonably be expected, individually or in the aggregate, to result in a material adverse effect on any Product Development and Commercialization Activities.
(g) None of the Products is currently, and have not for the past six (6) years been, the subject of any claim or allegation, formal or informal, that any Product, or its use, is defective or has resulted in or proximately caused any material injury to any Person or property.
(h) During the past three (3) years, no basis for Loan Party, any adverse regulatory action against the Credit Parties or of their respective Subsidiaries or, to the knowledge of the IssuerLoan Parties, any relevant Product Distributor (as related to Products) has received any written notice from the United States Department of Justice, any U.S. Attorney, any State Attorney General, or other similar federal, state, or foreign Governmental Authority alleging any material violation of the Federal Anti-kickback Statute (42 U.S.C. Section 1320a-7b), the Federal False Claims Act (31 U.S.C. Section 3729-3733), the Foreign Corrupt Practices Act of 1977 (15 U.S.C. Section 78dd–1, et seq.), any federal Law, or state or foreign Law. No Loan Party nor any of their respective suppliers Subsidiaries is aware of a material violation of any such Law.
(i) The transactions contemplated by the Loan Documents and the exercise by the Administrative Agent or the Secured Parties of any right or protection set forth in the Loan Documents will not (i) constitute a breach or violation of, or otherwise materially affect, the enforceability or approval of any Regulatory Authorization with respect to the Products; and Material Products or (ivii) Without limiting impair the foregoingLoan Parties’ ownership of or rights under (or the license or other right to use, as the case may be) any Regulatory Authorizations with respect to the Material Products in any material manner.
(j) No Loan Party nor any of their respective Subsidiaries or any Product Distributor on behalf of any Loan Party or Subsidiary is enrolled in or currently receives payments from any federal or state government or private healthcare reimbursement program or has ever been terminated from any federal or state government or private healthcare reimbursement program (including Medicare or Medicaid) or otherwise had its rights to receive payments from any government or private healthcare reimbursement program adversely affected as a result of any investigation or enforcement action, whether by any Governmental Authority or other Third Party.
(k) During the past three (3) years, no information security or privacy breach event has occurred (including with respect to the Systems of the Loan Parties or their Subsidiaries) that would require notification to any Person by the Loan Parties or their Subsidiaries under any applicable Privacy Laws.
(l) During the past three (3) years, no Loan Party nor any of their respective Subsidiaries nor, to the Loan Parties’ knowledge, any individual who is an officer, director, manager, employee, shareholder, agent or managing agent of any Loan Party or any of their respective Subsidiaries, has been convicted of: (i) any federal or state health program-related offense or any other offense related to healthcare or been terminated, excluded or suspended from participation in any such program, or (ii) any crime that has resulted or would reasonably be expected to result in a debarment or exclusion (A) to the knowledge under 21 U.S.C. Section 335a, or (B) any similar applicable Law. No debarment proceedings or investigations in respect of the Issuer, no supplier business of any Credit Loan Party or any Subsidiary has receivedof their respective Subsidiaries are pending or, during to the two Loan Parties’ knowledge, threatened against any Loan Party or any of their respective Subsidiaries or any individual who is an officer, director, manager, employee, shareholder, agent or managing agent of any Loan Party or any of their respective Subsidiaries.
(2m) years As of the Closing Date, all Products of the Borrower and its Subsidiaries are listed on Schedule 1.01 and the Loan Parties have delivered to the Administrative Agent on or prior to the Closing Date, any Form FDA 483 from the FDA asserting a lack Date copies of compliance with respect all material Regulatory Authorizations relating to any Product such Products issued or Product Development and Commercialization Activities, (B) to the knowledge outstanding as of the Credit Parties (1) there have been no Safety Notices conducted, undertaken or issued by any Person, whether or not at the request, demand or order of any Regulatory Agency or otherwise, with respect to any Product, (2) no SafetyClosing Date.
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Compliance of Products. (a) The Issuer Super Holdings and its Subsidiaries have obtained all required Regulatory Authorizations necessary for compliance with all Laws for its respective business as presently conducted and all such Regulatory Authorizations are in full force and effect except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development and Commercialization Activities concerning any Producteffect. All Regulatory Authorizations held by the Credit Parties and their respective Subsidiaries are (i) legally and beneficially owned exclusively the by Credit Parties or their respective Subsidiaries, free and clear of all Liens other than Permitted Liens, and (ii) validly registered and on file with the applicable Regulatory Agency, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Regulatory Agency except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development and Commercialization Activities concerning any ProductAgency. All required notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) and other required filings with respect to the Products for which Issuer or its Subsidiaries have such filing responsibility or control over have been filed with the FDA, the DEA, and all other applicable Regulatory Agencies when due, except where the failure to do so could not reasonably be expected to result in (x) a material adverse effect on any Product Development and Commercialization Activities or (y) a Material Adverse Effect.
(b) Except where the failure to do so could not reasonably be expected to result in the termination or restriction of a Material Regulatory Authorization, all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests made by, on behalf of, or for the benefit of the Issuer or any of its Subsidiaries for a Regulatory Authorization from the FDA or other Regulatory Agency relating to the Issuer’s Super Holdings or any Subsidiary’s , their business operations and Products, when submitted to the FDA or otherother Regulatory Agency were true, complete and correct in all material respects as of the date of submission (including any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data that have been submitted to the FDA or other Regulatory Agency). The Regulatory Authorizations issued by the FDA and other Regulatory Agencies for the Products are valid and supported by proper research, design, testing, analysis and disclosure. There has been no material untrue statement of fact and/or no fraudulent statement made by the Credit Parties or their respective Subsidiaries, or any of their respective agents or representatives to the FDA, the DEA, or any other Regulatory Agency, and there has been no failure to disclose any material fact required to be disclosed, commission of an act, making of a statement, or failure to make a statement to the FDA, the DEA, or any other Regulatory Agency that could 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,” set forth in 56 Fed. Regulation 46191 (September 10, 1991).
(c) Except as could not reasonably be expected to result in have a material adverse effect on any Product Development and Commercialization ActivitiesMaterial Adverse Effect:
(i) The Products, as well as the business of the Credit Parties and their respective Subsidiaries, materially comply in all material respects with (A) all applicable Laws, rules, regulations, orders, injunctions and decrees of the FDA, the DEA, and any other applicable Regulatory Agency, including, without limitation, all applicable requirements of the FDCA, the PHSA, the Controlled Substances Act, and similar state Laws, and (B) all applicable Product Authorizations, Regulatory Authorizations, and all other Permits; ;
(ii) Except as set forth on Schedule 6.23(c) to the Disclosure Letter, none None of the Credit Parties, their respective Subsidiaries nor, to the knowledge of the Issuer, their respective suppliers have received and do not otherwise have knowledge of: any inspection reports, “Warning Letters,” “Untitled Letters” warning letters, untitled letters or similar documents with respect to any Product or the manufacture, processing, packing, distribution, or holding thereof, as well as the business of the Credit Parties and their respective Subsidiaries, from any Regulatory Agency that assert lack of compliance with any applicable Laws, rules, regulations, orders, injunctions, or decrees;
(iii) None of the Credit Parties, their respective Subsidiaries nor, to the knowledge of the Issuer, their respective suppliers have received any written notice of, and does not otherwise have knowledge of, any pending regulatory enforcement action, investigation or inquiry (other than non-material routine or periodic inspections or reviews) against the Credit Parties, any of their respective Subsidiaries or any of their respective suppliers with respect to the Products, and, to the knowledge of the Issuer, there is no basis for any adverse regulatory action against the Credit Parties or their respective Subsidiaries or, to the knowledge of the Issuer, their respective suppliers with respect to the Products; and and
(iv) Without limiting the foregoing, (A) to the knowledge of the Issuer, no supplier of any Credit Party or any Subsidiary has received, during the two (2) years prior to the Closing Date, any Form FDA 483 from the FDA asserting a lack of compliance with respect to any Product or Product Development and Commercialization Activities, (B) to the knowledge of the Credit Parties (1) there have been no Safety Notices conducted, undertaken or issued by any Person, whether or not at the request, demand or order of any Regulatory Agency or otherwise, with respect to any Product, (2) no SafetySafety Notice has been requested, demanded or ordered by any Regulatory Agency, and, to the knowledge of the Issuer, there is no basis for the issuance of any Safety Notice by any Person with respect to any Products, and (C) none of the Credit Parties or their respective Subsidiaries have received any written notice of, or otherwise have knowledge of, any criminal, injunctive, seizure, detention or civil penalty actions that have at any time been commenced or threatened in writing by any Regulatory Agency with respect to or in connection with any Products, or any consent decrees (including plea agreements) which relate to any Products, and, to the knowledge of the Issuer, there is no basis for the commencement for any criminal injunctive, seizure, detention or civil penalty actions by any Regulatory Agency relating to the Products or for the issuance of any consent decrees. None of the Credit Parties or their respective Subsidiaries nor, to the knowledge of the Issuer, any of their respective suppliers is employing or utilizing the services of any individual who has been convicted of any crime or engaged in any conduct for which debarment or temporary suspension under any applicable Law, rule or regulation is warranted.
(d) Except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, neither Super Holdings nor any Subsidiary has received any communication from any Regulatory Agency regarding, and there are no facts or circumstances that are likely to give rise to (i) any material adverse change in any applicable Regulatory Authorization, or any failure to materially comply with any Laws or any term or requirement of any applicable Regulatory Authorization or (ii) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any applicable Regulatory Authorization.
(e) Except as could not reasonably be expected, either individually or in the aggregate, to have Material Adverse Effect, all studies, tests, preclinical trials and clinical trials conducted by or on behalf of any Credit Party or any of its respective Subsidiaries with respect to any Product have been conducted in material compliance with applicable Laws, including cGCPs. No Credit Party nor any of their respective Subsidiaries has received any notice from the FDA or any other Regulatory Agency alleging any material non-compliance with applicable Laws, including cGCPs or otherwise terminating or suspending any clinical trial conducted by or on behalf of such Credit Party or Subsidiary with respect to any Product. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Administrative Agent. The summaries and descriptions of any of the foregoing provided to the Administrative Agent are accurate and contain no material omissions. None of the Credit Parties, their respective Subsidiaries, or, to the knowledge of the Issuer, any of their respective licensees, licensors or third party services providers or consultants, has received from the FDA or other applicable Regulatory Agency any notices or correspondence requiring the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials in any material respect with respect to or in connection with the Products.
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Compliance of Products. (a) The Issuer Loan Parties represent and warrant:
(i) that RedHill Parent and its Subsidiaries have obtained possess all required Permits, including Regulatory Authorizations necessary for compliance with all Laws for its respective business as presently conducted and all such Regulatory Authorizations are in full force and effect except to Approvals from the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development and Commercialization Activities concerning any Product. All Regulatory Authorizations held by the Credit Parties and their respective Subsidiaries are (i) legally and beneficially owned exclusively by Credit Parties or their respective Subsidiaries, free and clear of all Liens other than Permitted Liens, and (ii) validly registered and on file with the applicable Regulatory Agency, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Regulatory Agency except to the extent the failure to do so could not reasonably be expected to have a material adverse effect on the Businesses or Product Development and Commercialization Activities concerning any Product. All required notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) FDA and other Governmental Authorities required filings with respect to for the Products for which Issuer or its Subsidiaries have such filing responsibility or control over have been filed with Exploitation of the FDA, the DEA, and all other applicable Regulatory Agencies when dueTalicia Assets, except where the failure to do so possess could not reasonably be expected to result in (x) a material adverse effect on any Product Development and Commercialization Activities or (y) a Material Adverse Effect.
(b) Except , and all such Permits are in full force and effect, except where the failure to do so be in full force and effect could not reasonably be expected to result in a Material Adverse Effect;
(ii) that (A) RedHill Parent and its Subsidiaries have not received any written communication from any Governmental Authority regarding any failure to materially comply with any Laws, including any terms or requirements of any Regulatory Approval and (B) to the Knowledge of RedHill Parent and its Subsidiaries, there are no facts or circumstances that are reasonably likely to give rise to any revocation, withdrawal, suspension, cancellation, material limitation, termination or restriction adverse modification of any Regulatory Approval, in each case as they relate to the Talicia Assets;
(iii) that none of the officers, directors, employees, shareholders, agents, or Affiliates of RedHill Parent or any Subsidiary or any agent or consultant involved in any Drug Application, has been alleged to have committed or convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a;
(iv) that none of the officers, directors, employees, or, to the Loan Parties’ Knowledge, Affiliates of RedHill Parent or any Subsidiary or any agent or consultant has (A) made an untrue statement of material fact or fraudulent statement to any Governmental Authority or failed to disclose a material fact required to be disclosed to a Governmental Authority; or (B) committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Regulatory AuthorizationFacts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991);
(v) that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests made by, on behalf of, or for the benefit of the Issuer or any of its Subsidiaries for a Regulatory Authorization Approval from the FDA or other Regulatory Agency Governmental Authority relating to the Issuer’s RedHill Parent or any Subsidiary’s , their business operations and Productswith respect to the Talicia Assets, when submitted to the FDA or otherother Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority;
(cvi) Except that all preclinical and clinical trials conducted by or on behalf of RedHill Parent and its Subsidiaries that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any request for a Regulatory Approval, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to and applicable Laws;
(vii) that all of the Talicia Assets have since January 1, 2018 been manufactured, transported, stored and handled in all material respects in accordance with current good manufacturing practices applicable from time to time and applicable Laws;
(viii) that neither RedHill Parent nor any Subsidiary has received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS or the United States Department of Justice has commenced or threatened to initiate any action against RedHill Parent or a Subsidiary, any action to enjoin RedHill Parent or a Subsidiary, its officers, directors, employees, agents and Affiliates, from conducting its business at any facility owned or used by it or for any material civil penalty, injunction, seizure or criminal action that could reasonably be expected to have a Material Adverse Effect;
(ix) neither RedHill Parent nor any Subsidiary has received from the FDA, at any time since January 1, 2018, a Warning Letter, unresolved Form FDA-483, “Untitled Letter,” or similar written correspondence or notice alleging violations of laws and regulations enforced by the FDA, or any comparable correspondence from any other Governmental Authority with regard to the Talicia Assets or the manufacture, processing, packaging or holding thereof, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to the Talicia Assets or the testing, manufacture, processing, packing, or holding thereof, that could reasonably be expected to have a Material Adverse Effect; and
(x) that, since January 1, 2018, (A) there have been no Safety Notices, (B) to the Loan Parties’ Knowledge, there are no unresolved material product complaints with respect to the Talicia Assets which could reasonably be expected to have a Material Adverse Effect, and (C) to the Loan Parties’ Knowledge, there are no facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Talicia Assets, (2) a material change in the labeling of any of the Talicia Assets, or (3) a termination or suspension of the Exploitation of the Talicia Assets.
(b) With respect to the Talicia Assets, the Loan Parties represent and warrant that:
(i) all such Products are listed on Schedule 1.01(c) and RedHill Parent has delivered to the Administrative Agent on or prior to the Closing Date copies of all Regulatory Approvals relating to such Products issued or outstanding as of the Closing Date; provided, that, if RedHill Parent and/or any Subsidiary shall at any time obtain any new or additional Regulatory Approvals from the FDA, or parallel state or local authorities, or foreign counterparts of the FDA, or parallel state or local authorities, with respect to any such Product which has previously been disclosed to Administrative Agent, RedHill Parent shall promptly give written notice to Administrative Agent of such new or additional Regulatory Approvals, along with a copy thereof);
(ii) the operation of the business of RedHill Parent and its Subsidiaries with respect to the Talicia Assets, including the manufacture, import, marketing, promotion, sale, labeling, and distribution of such Products, has been in compliance with all Permits and applicable Laws, except where a failure to so comply could not reasonably be expected to have a Material Adverse Effect;
(iii) without limiting the generality of Section 6.23(a)(i) and (ii) above, with respect to the Talicia Assets being tested or manufactured by RedHill Parent and its Subsidiaries, as of the Closing Date, to the Loan Parties’ Knowledge, neither RedHill Parent nor any Subsidiary has received any written notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) RedHill Parent and its Subsidiaries’ (or any third party contractors therefor) manufacturing facilities and processes for manufacturing such Product or the marketing and sales of such Product, in each case which have identified any material deficiencies or violations of Laws or the Permits related to the manufacture, marketing and/or sales of such Product that could reasonably be expected to result in a material adverse effect on any Product Development and Commercialization Activities:
(i) The ProductsMaterial Adverse Effect, as well as the business of the Credit Parties and their respective Subsidiaries, comply in all material respects with (A) all applicable Laws, rules, regulations, orders, injunctions and decrees of the FDA, the DEA, and any other applicable Regulatory Agency, including, without limitation, all applicable requirements of the FDCA, the PHSA, the Controlled Substances Act, and similar state Laws, and or (B) all applicable any such Regulatory Approval that could be reasonably expected to result in a revocation or withdrawal of such Regulatory Approval, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing, manufacturing, marketing or sales of such Product Authorizations, Regulatory Authorizations, by RedHill Parent and all other Permits; (ii) Except as set forth on Schedule 6.23(c) to its Subsidiaries should cease or that such Product should be withdrawn from the Disclosure Letter, none of the Credit Parties, their respective Subsidiaries nor, to the knowledge of the Issuer, their respective suppliers have received and do not otherwise have knowledge of: any inspection reports, “Warning Letters,” “Untitled Letters” or similar documents with respect to any Product or the manufacture, processing, packing, distribution, or holding thereof, as well as the business of the Credit Parties and their respective Subsidiaries, from any Regulatory Agency that assert lack of compliance with any applicable Laws, rules, regulations, orders, injunctions, or decrees; (iii) None of the Credit Parties, their respective Subsidiaries nor, to the knowledge of the Issuer, their respective suppliers have received any written notice of, and does not otherwise have knowledge of, any pending regulatory enforcement action, investigation or inquiry (other than non-material routine or periodic inspections or reviews) against the Credit Parties, any of their respective Subsidiaries or any of their respective suppliers with respect to the Products, and, to the knowledge of the Issuer, there is no basis for any adverse regulatory action against the Credit Parties or their respective Subsidiaries or, to the knowledge of the Issuer, their respective suppliers with respect to the Products; and marketplace;
(iv) Without limiting the foregoing, (A) to the knowledge of the Issuer, no supplier of any Credit Party or neither RedHill Parent nor any Subsidiary has received, during experienced any significant failures in the two (2) years prior to the Closing Date, any Form FDA 483 from the FDA asserting a lack of compliance with respect to any Product or Product Development and Commercialization Activities, (B) to the knowledge of the Credit Parties (1) there have been no Safety Notices conducted, undertaken or issued by any Person, whether or not at the request, demand or order manufacturing of any Regulatory Agency such Product for commercial sale that has had or otherwisecould reasonably be expected to have, with respect to any Productif such failure occurred again, (2) no Safetya Material Adverse Effect.
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