Common use of Compliance with Law; Permits; Regulatory Matters Clause in Contracts

Compliance with Law; Permits; Regulatory Matters. (a) The Company Entities hold, and are operating in material compliance with, all Health Care Regulatory Authorizations required for the conduct of its business as currently conducted. The Company Entities have fulfilled and performed all of their material obligations with respect to the Health Care Regulatory Authorizations. The Company Entities have complied, and remain in compliance, in all material respects with all Laws applicable to the business, properties, assets and activities of the Company Entities. No Company Entity has received notice of or, to the Knowledge of the Company, been subject to or threatened with, any finding of deficiency or non-compliance; penalty, fine or sanction; request for corrective or remedial action; or pending or, to the Knowledge of the Company, threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action by the FDA or any other Governmental Body relating to any of (i) the Company Products, (ii) the ingredients in the Company Products or (iii) the facilities at which such Company Products are manufactured, packaged or initially distributed, whether issued by the FDA, the United States Federal Trade Commission (the “FTC”), the United States Drug Enforcement Administration (“DEA”), the United States Department of Agriculture (“USDA”) or by any other Governmental Body having responsibility for the regulation of such Company Products. To the Knowledge of the Company, there is no threatened suspension, revocation or withdrawal of any Health Care Regulatory Authorization. To the Knowledge of the Company, there is no condition that would preclude the renewal of a Health Care Regulatory Authorization upon its expiration. (b) All Company Products that are subject to the jurisdiction of the FDA, the FTC, the DEA, the USDA or other Governmental Bodies in other jurisdictions are being manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, detailed and distributed by or on behalf of the Company Entities in material compliance with all applicable requirements under any Permit or Law, including applicable statutes and implementing regulations administered or enforced by the FDA or other similar Governmental Body, including those relating to investigational use, premarket approval and applications or abbreviated applications to market a new pharmaceutical product. (c) No Company Entity has voluntarily recalled, suspended, or discontinued manufacturing or investigation of any of the Company Products or done so at the request of the FDA, the FTC, the DEA or any other Governmental Body having responsibility for the regulation of such Company Products, nor has any Company Entity received any notice from the FDA, the FTC, the DEA or any other Governmental Body having responsibility for the regulation of such Company Products that such Governmental Body has commenced or, to the Knowledge of the Company, threatened to initiate any action to withdraw any approval or application for investigation, sale or marketing of any Company Products, restrict sales or marketing of any Company Products, place any clinical investigation on clinical hold or request a recall of any Company Products, or that the FDA, the FTC, the DEA or such other Governmental Body having responsibility for the regulation of any Products has commenced or, to the Knowledge of the Company, threatened to initiate any action to enjoin or place restrictions on the production of any Company Products, other than those restrictions generally existing by Law or that may be specifically set forth in any Health Care Regulatory Authorizations, supplement thereto, or related supporting documentation, in each case. (d) To the Knowledge of the Company, all preclinical studies and clinical trials, and other studies and tests conducted by or on behalf of the Company Entities have been, and if still pending are being, conducted in material compliance with (i) the required experimental protocols, procedures and controls, (ii) all applicable Laws, and (iii) current good clinical practices. No clinical trial conducted by or on behalf of the Company Entities has been terminated, suspended or placed on clinical hold by the FDA, the FTC, the DEA or any other applicable Governmental Body, and none of the FDA, the FTC, the DEA or any other applicable Governmental Body has commenced or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company Entities. (e) None of the Company Products, or any other products previously manufactured, tested, distributed, held or marketed by the Company Entities, has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of (i) any Company Products, (ii) any other products previously manufactured, tested, distributed, held or marketed by the Company Entities, or (iii) any product candidate or pre-market approvals or marketing authorizations of the Company Entities, are pending or, to the Knowledge of the Company, threatened, against any Company Entity. The Company has, prior to the date hereof, made available to Purchaser all material information about adverse experiences relating to (i) the Company Products or (ii) any other products previously manufactured, tested, distributed, held or marketed by any Company Entity, obtained or otherwise received by any Company Entity from any source, in the United States or outside the United States, including material information relating to the Company Products derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, to the Knowledge of the Company, the Company Entities have filed all annual and periodic reports, amendments and safety reports required for any of the products or product candidates required to be made to the FDA, the FTC, the DEA or any other Governmental Body. (f) All batches and doses of any Company Product that is or was previously marketed, sold or distributed by any Company Entity have been manufactured in conformance with (i) specifications set forth in any Health Care Regulatory Authorization and/or applicable Contract Manufacturing Agreements and (ii) in material compliance with applicable Laws, including all Current Good Manufacturing Practices. (g) All labels and labeling for all Company Products, including all inventory of such Company Products, are and have been in material compliance with applicable Laws. All advertising and promotional materials, and the advertising and promotional practices, of the Company Entities are and have been in material compliance with all applicable Laws. (h) The Company Entities have complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPPA”) and (ii) any applicable state privacy Laws. No Company Entity has received written or, to the Knowledge of the Company, any non-written, notice of any claims (including any investigation or notice from any Governmental Body) that have been asserted or threatened against any Company Entity alleging any violation of any Person’s protected health information under HIPAA or any applicable state privacy Laws. (i) To the Knowledge of the Company, and in connection with the business of the Company Entities as currently conducted, no director, officer, employee or agent of any Company Entity has made any untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Body; failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body; or committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide the basis for the FDA or any other Governmental Body 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). (j) No Company Entity or any director or officer of a Company Entity is debarred or otherwise excluded from or restricted in any manner from participation in, any government program or, to the Knowledge of the Company, convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a, or convicted of any crime or engaged in any conduct for which such person could be excluded from participating in any federal health care programs. (k) The Company Entities have filed, maintained or furnished all material applications, reports, documents, claims, permits, notification and notices required to be filed, maintained or furnished to the FDA, FTC, the DEA or any other Governmental Body in connection with any active pharmaceutical ingredient, dietary ingredient, or Product developed, tested or manufactured or marketed by the Company Entities. All such applications, reports, documents, claims and notices were true, complete and accurate in all material respects on the date filed (or, to the extent not true, complete and accurate in all material respects, were corrected in or supplemented by a subsequent filing), and any necessary or required updates, changes, corrections or modifications to such applications, reports, documents, claims and notices, in each case, required to have been submitted to the FDA, the FTC, the DEA or other Governmental Body, have been so submitted. All information, claims, reports, statistics, and other data and conclusions, if any, submitted by the Company Entities to the FDA, the FTC, the DEA or other Governmental Body were true, complete and correct in all material respects as of the date of submission and no updates, changes, corrections, supplements, amendments or modifications has been submitted to the FDA outside the Ordinary Course of Business. (l) No Company Entity is, or has been since January 1, 2012, a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Governmental Body. (m) The Company has made available to Purchaser true and complete copies of (i) all warning letters, untitled letters, cyber letter, regulatory letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs) or other material written correspondences from any Governmental Body relating to the Company Entities’ manufacture or marketing of Company Products or compliance with Laws and all of the Company Entities’ responses thereto since January 1, 2012, and a complete list of the foregoing if set forth in Section 4.23(m) of the Disclosure Schedule; (ii) all correspondence, meeting minutes or related documents concerning material communications between any Governmental Body and the Company Entities, including requests for information and responses thereto; and (iii) all written audit reports pertaining to the assessment of compliance with Good Manufacturing Practice requirements by the Company Entities or any other Person as it relates to the manufacture of the Products. No Company Entity is currently subject to any outstanding observations or obligations arising under a criminal, civil or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation or “untitled” letter, or other obligation made in writing to or with the FDA or any other Governmental Body. (n) Section 4.23(n) of the Disclosure Schedule sets forth a complete and correct list of all Health Care Regulatory Authorizations from the FDA, the FTC, the DEA or any other Governmental Body that administers Health Care Laws held by the Company Entities and, to the Knowledge of the Company, there are no other Health Care Regulatory Authorizations required for the Company Entities or the Company Products in connection with the conduct of the business of the Company Entities as currently conducted.

Compliance with Law; Permits; Regulatory Matters. (a) The Company Entities hold, and are operating in material compliance with, all Health Care Regulatory Authorizations required for the conduct of its business as currently conducted. The Company Entities have fulfilled and performed all of their material obligations with respect to the Health Care Regulatory Authorizations. The Company Entities have complied, and remain in compliance, in all material respects with all Laws applicable to the business, properties, assets and activities of the Company Entities. No Company Entity has received notice of or, to the Knowledge of the Company, been subject to or threatened with, any finding of deficiency or non-compliance; penalty, fine or sanction; request for corrective or remedial action; or pending or, to the Knowledge of the Company, threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action by the FDA or any other Governmental Body relating to any of (i) the Company Products, (ii) the ingredients in the Company Products or (iii) the facilities at which such Company Products are manufactured, packaged or initially distributed, whether issued by the FDA, the United States Federal Trade Commission (the “FTC”), the United States Drug Enforcement Administration (“DEA”), the United States Department of Agriculture (“USDA”) or by any other Governmental Body having responsibility for the regulation of such Company Products. To the Knowledge of the Company, there is no threatened suspension, revocation or withdrawal of any Health Care Regulatory Authorization. To the Knowledge of the Company, there is no condition that would preclude the renewal of a Health Care Regulatory Authorization upon its expiration. (b) All Company Products that are subject to the jurisdiction of the FDA, the FTC, the DEA, the USDA or other Governmental Bodies in other jurisdictions are being manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, detailed and distributed by or on behalf of the Company Entities in material compliance with all applicable requirements under any Permit or Law, including applicable statutes and implementing regulations administered or enforced by the FDA or other similar Governmental Body, including those relating to investigational use, premarket approval and applications or abbreviated applications to market a new pharmaceutical product. (c) No Company Entity has voluntarily recalled, suspended, or discontinued manufacturing or investigation of any of the Company Products or done so at the request of the FDA, the FTC, the DEA or any other Governmental Body having responsibility for the regulation of such Company Products, nor has any Company Entity received any notice from the FDA, the FTC, the DEA or any other Governmental Body having responsibility for the 44 regulation of such Company Products that such Governmental Body has commenced or, to the Knowledge of the Company, threatened to initiate any action to withdraw any approval or application for investigation, sale or marketing of any Company Products, restrict sales or marketing of any Company Products, place any clinical investigation on clinical hold or request a recall of any Company Products, or that the FDA, the FTC, the DEA or such other Governmental Body having responsibility for the regulation of any Products has commenced or, to the Knowledge of the Company, threatened to initiate any action to enjoin or place restrictions on the production of any Company Products, other than those restrictions generally existing by Law or that may be specifically set forth in any Health Care Regulatory Authorizations, supplement thereto, or related supporting documentation, in each case. (d) To the Knowledge of the Company, all preclinical studies and clinical trials, and other studies and tests conducted by or on behalf of the Company Entities have been, and if still pending are being, conducted in material compliance with (i) the required experimental protocols, procedures and controls, (ii) all applicable Laws, and (iii) current good clinical practices. No clinical trial conducted by or on behalf of the Company Entities has been terminated, suspended or placed on clinical hold by the FDA, the FTC, the DEA or any other applicable Governmental Body, and none of the FDA, the FTC, the DEA or any other applicable Governmental Body has commenced or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company Entities. (e) None of the Company Products, or any other products previously manufactured, tested, distributed, held or marketed by the Company Entities, has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of (i) any Company Products, (ii) any other products previously manufactured, tested, distributed, held or marketed by the Company Entities, or (iii) any product candidate or pre-market approvals or marketing authorizations of the Company Entities, are pending or, to the Knowledge of the Company, threatened, against any Company Entity. The Company has, prior to the date hereof, made available to Purchaser all material information about adverse experiences relating to (i) the Company Products or (ii) any other products previously manufactured, tested, distributed, held or marketed by any Company Entity, obtained or otherwise received by any Company Entity from any source, in the United States or outside the United States, including material information relating to the Company Products derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, to the Knowledge of the Company, the Company Entities have filed all annual and periodic reports, amendments and safety reports required for any of the products or product candidates required to be made to the FDA, the FTC, the DEA or any other Governmental Body. (f) All batches and doses of any Company Product that is or was previously marketed, sold or distributed by any Company Entity have been manufactured in conformance with (i) specifications set forth in any Health Care Regulatory Authorization and/or applicable Contract Manufacturing Agreements and (ii) in material compliance with applicable Laws, including all Current Good Manufacturing Practices. (g) All labels and labeling for all Company Products, including all inventory of such Company Products, are and have been in material compliance with applicable Laws. All advertising and promotional materials, and the advertising and promotional practices, of the Company Entities are and have been in material compliance with all applicable Laws. (h) The Company Entities have complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPPA”) and (ii) any applicable state privacy Laws. No Company Entity has received written or, to the Knowledge of the Company, any non-written, notice of any claims (including any investigation or notice from any Governmental Body) that have been asserted or threatened against any Company Entity alleging any violation of any Person’s protected health information under HIPAA or any applicable state privacy Laws. (i) To the Knowledge of the Company, and in connection with the business of the Company Entities as currently conducted, no director, officer, employee or agent of any Company Entity has made any untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Body; failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body; or committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide the basis for the FDA or any other Governmental Body 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). (j) No Company Entity or any director or officer of a Company Entity is debarred or otherwise excluded from or restricted in any manner from participation in, any government program or, to the Knowledge of the Company, convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a, or convicted of any crime or engaged in any conduct for which such person could be excluded from participating in any federal health care programs. (k) The Company Entities have filed, maintained or furnished all material applications, reports, documents, claims, permits, notification and notices required to be filed, maintained or furnished to the FDA, FTC, the DEA or any other Governmental Body in connection with any active pharmaceutical ingredient, dietary ingredient, or Product developed, tested or manufactured or marketed by the Company Entities. All such applications, reports, documents, claims and notices were true, complete and accurate in all material respects on the date filed (or, to the extent not true, complete and accurate in all material respects, were corrected in or supplemented by a subsequent filing), and any necessary or required updates, changes, corrections or modifications to such applications, reports, documents, claims and notices, in each case, required to have been submitted to the FDA, the FTC, the DEA or other Governmental Body, have been so submitted. All information, claims, reports, statistics, and other data and conclusions, if any, submitted by the Company Entities to the FDA, the FTC, the DEA or other Governmental Body were true, complete and correct in all material respects as of the date of submission and no updates, changes, corrections, supplements, amendments or modifications has been submitted to the FDA outside the Ordinary Course of Business. (l) No Company Entity is, or has been since January 1, 2012, a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Governmental Body. (m) The Company has made available to Purchaser true and complete copies of (i) all warning letters, untitled letters, cyber letter, regulatory letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs) or other material written correspondences from any Governmental Body relating to the Company Entities’ manufacture or marketing of Company Products or compliance with Laws and all of the Company Entities’ responses thereto since January 1, 2012, and a complete list of the foregoing if set forth in Section 4.23(m) of the Disclosure Schedule; (ii) all correspondence, meeting minutes or related documents concerning material communications between any Governmental Body and the Company Entities, including requests for information and responses thereto; and (iii) all written audit reports pertaining to the assessment of compliance with Good Manufacturing Practice requirements by the Company Entities or any other Person as it relates to the manufacture of the Products. No Company Entity is currently subject to any outstanding observations or obligations arising under a criminal, civil or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation or “untitled” letter, or other obligation made in writing to or with the FDA or any other Governmental Body. (n) Section 4.23(n) of the Disclosure Schedule sets forth a complete and correct list of all Health Care Regulatory Authorizations from the FDA, the FTC, the DEA or any other Governmental Body that administers Health Care Laws held by the Company Entities and, to the Knowledge of the Company, there are no other Health Care Regulatory Authorizations required for the Company Entities or the Company Products in connection with the conduct of the business of the Company Entities as currently conducted.

Compliance with Law; Permits; Regulatory Matters. (a) The Company Entities holdholds, and are is operating in material compliance with, all Health Care Regulatory Authorizations required for the conduct of its business as currently conducted. The Company Entities have has fulfilled and performed all of their its material obligations with respect to the Health Care Regulatory Authorizations. The Company Entities have has complied, and remain remains in compliance, in all material respects with all Laws applicable to the business, properties, assets and activities of the Company. The Company Entities. No Company Entity has not received notice of or, to the Knowledge of the Company, been subject to or threatened with, any finding of deficiency or non-compliance; penalty, fine or sanction; request for corrective or remedial actionRemedial Action; or pending or, to the Knowledge of the Company, threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action by the FDA or any other Governmental Body relating to any of (i) the Company Products, (ii) the ingredients in the Company Products or (iii) the facilities at which such Company Products are manufactured, packaged or initially distributed, whether issued by the FDA, the United States Federal Trade Commission (the “FTC”), the United States Drug Enforcement Administration (“DEA”), the United States Department of Agriculture (“USDA”) or by any other Governmental Body having responsibility for the regulation of such Company Products. To the Knowledge of the Company, there is no threatened suspension, revocation or withdrawal of any Health Care Regulatory Authorization. To the Knowledge of the Company, there is no condition that would preclude the renewal of a Health Care Regulatory Authorization upon its expiration. (b) All Company Products that are subject to the jurisdiction of the FDA, the FTC, the DEA, the USDA or other Governmental Bodies in other jurisdictions are being manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, detailed and distributed by or on behalf of the Company Entities in material compliance with all applicable requirements under any Permit or Law, including applicable statutes and implementing regulations administered or enforced by the FDA or other similar Governmental Body, including those relating to investigational use, premarket approval and applications or abbreviated applications to market a new pharmaceutical product. (c) No The Company Entity has not voluntarily recalled, suspended, or discontinued manufacturing or investigation of any of the Company Products or done so at the request of the FDA, the FTC, the DEA or any other Governmental Body having responsibility for the regulation of such Company Products, nor has any the Company Entity received any notice from the FDA, the FTC, the DEA or any other Governmental Body having responsibility for the regulation of such Company Products that such Governmental Body has commenced or, to the Knowledge of the Company, threatened to initiate any action to withdraw any approval or application for investigation, sale or marketing of any Company Products, restrict sales or marketing of any Company Products, place any clinical investigation on clinical hold or request a recall of any Company Products, or that the FDA, the FTC, the DEA or such other Governmental Body having responsibility for the regulation of any Products has commenced or, to the Knowledge of the Company, threatened to initiate any action to enjoin or place restrictions on the production of any Company Products, other than those restrictions generally existing by Law or that may be specifically set forth in any Health Care Regulatory Authorizations, supplement thereto, or related supporting documentation, in each case. (d) To the Knowledge of the Company, all preclinical studies and clinical trials, and other studies and tests conducted by or on behalf of the Company Entities have has been, and if still pending are being, conducted in material compliance with (i) the required experimental protocols, procedures and controls, (ii) all applicable Laws, and (iii) current good clinical practices. No clinical trial conducted by or on behalf of the Company Entities has been terminated, suspended or placed on clinical hold by the FDA, the FTC, the DEA or any other applicable Governmental Body, and none of the FDA, the FTC, the DEA or any other applicable Governmental Body has commenced or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company EntitiesCompany. (e) None of the Company Products, or any other products previously manufactured, tested, distributed, held or marketed by the Company EntitiesCompany, has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of (i) any Company Products, (ii) any other products previously manufactured, tested, distributed, held or marketed by the Company EntitiesCompany, or (iii) any product candidate or pre-market approvals or marketing authorizations of the Company EntitiesCompany, are pending or, to the Knowledge of the Company, threatened, against any Company Entitythe Company. The Company has, prior to the date hereof, made available to Purchaser Parent all material information about adverse experiences relating to (i) the Company Products or (ii) any other products previously manufactured, tested, distributed, held or marketed by any Company Entitythe Company, obtained or otherwise received by any the Company Entity from any source, in the United States or outside the United States, including material information relating to the Company Products derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, to the Knowledge of the Company, the Company Entities have has filed all annual and periodic reports, amendments and safety reports required for any of the products or product candidates required to be made by the Company to the FDA, the FTC, the DEA or any other Governmental Body. (f) All batches and doses of any Company Product that is are or was were previously marketed, sold or distributed by any the Company Entity have been manufactured in conformance with (i) specifications set forth in any Health Care Regulatory Authorization and/or applicable Contract Manufacturing Agreements and (ii) in material compliance with applicable Laws, including all Current Good Manufacturing Practices. (g) All labels and labeling for all Company Products, including all inventory of such Company Products, are and have been in material compliance with applicable Laws. All advertising and promotional materials, and the advertising and promotional practices, of the Company Entities are and have been in material compliance with all applicable Laws. (h) The Company Entities have has complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPPA”) and (ii) any applicable state privacy Laws. No The Company Entity has not received written or, to the Knowledge of the Company, any non-written, notice of any claims (including any investigation or notice from any Governmental Body) that have been asserted or threatened against any the Company Entity alleging any violation of any Person’s protected health information under HIPAA or any applicable state privacy Laws. (i) To the Knowledge of the Company, and in connection with the business of the Company Entities as currently conducted, no director, officer, employee or agent of any the Company Entity has made any untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Body; failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body; or committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide the basis for the FDA or any other Governmental Body 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). (j) No Neither the Company Entity or nor any director or officer of a the Company Entity is debarred or otherwise excluded from or restricted in any manner from participation in, any government program or, to the Knowledge of the Company, convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a, or convicted of any crime or engaged in any conduct for which such person could be excluded from participating in any federal health care programs. (k) The Company Entities have has filed, maintained or furnished all material applications, reports, documents, claims, permits, notification and notices required to be filed, maintained or furnished to the FDA, FTC, the DEA or any other Governmental Body in connection with any active pharmaceutical ingredient, dietary ingredient, or Product product developed, tested or manufactured or marketed by the Company EntitiesCompany. All such applications, reports, documents, claims and notices were true, complete and accurate in all material respects on the date filed (or, to the extent not true, complete and accurate in all material respects, were corrected in or supplemented by a subsequent filing), and any necessary or required updates, changes, corrections or modifications to such applications, reports, documents, claims and notices, in each case, required to have been submitted to the FDA, the FTC, the DEA or other Governmental Body, have been so submitted. All information, claims, reports, statistics, and other data and conclusions, if any, submitted by the Company Entities to the FDA, the FTC, the DEA or other Governmental Body were true, complete and correct in all material respects as of the date of submission and no updates, changes, corrections, supplements, amendments or modifications has been submitted to the FDA outside the Ordinary Course of Business. (l) No The Company Entity isis not, or nor has it been since January 1, 2012, a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Governmental Body. (m) The Company has made available to Purchaser Parent true and complete copies of (i) all warning letters, untitled letters, cyber letter, regulatory letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs) or other material written correspondences from any Governmental Body relating to the Company Entities’ Company’s manufacture or marketing of Company Products or compliance with Laws and all of the Company Entities’ Company’s responses thereto since January 1, 2012, and a complete list of the foregoing if set forth in Section 4.23(m) of the Disclosure Schedule; (ii) all correspondence, meeting minutes or related documents concerning material communications between any Governmental Body and the Company EntitiesCompany, including requests for information and responses thereto; and (iii) all written audit reports pertaining to the assessment of compliance with Good Manufacturing Practice requirements by the Company Entities or any other Person as it relates to the manufacture of the Company Products. No The Company Entity is not currently subject to any outstanding observations or obligations arising under a criminal, civil or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation or “untitled” letter, or other obligation made in writing to or with the FDA or any other Governmental Body. (n) Section 4.23(n) of the Disclosure Schedule sets forth a complete and correct list of all Health Care Regulatory Authorizations from the FDA, the FTC, the DEA or any other Governmental Body that administers Health Care Laws held by the Company Entities and, to the Knowledge of the Company, there are no other Health Care Regulatory Authorizations required for the Company Entities or the Company Products in connection with the conduct of the business of the Company Entities as currently conducted.

Compliance with Law; Permits; Regulatory Matters. (a) The Company Entities holdAcquired Regulatory Approvals are in full force and effect. All maintenance, fees under the Prescription Drug User Fee Act (as amended), and are operating in material compliance with, all Health Care Regulatory Authorizations required for the conduct of its business as currently conducted. The Company Entities have fulfilled and performed all of their material obligations with respect other fees related to the Health Care Acquired Regulatory AuthorizationsApprovals occurring or accruing prior to the Closing Date have been paid. All Acquired Regulatory Approvals and all related records have been maintained in accordance with all applicable Laws. (b) The Company Entities have compliedBusiness and the Seller’s use of the Purchased Assets is being, and remain has been, conducted in compliancecompliance with the Acquired Regulatory Approvals and all applicable Laws, except where the failure to be in all material respects with all Laws applicable to the business, properties, assets and activities of the Company Entitiescompliance would not have a Material Adverse Effect. No Company Entity has received notice loss, revocation, termination, suspension, material modification or expiration of orany Acquired Regulatory Approval is pending, reasonably foreseeable, or to the Knowledge of the CompanySeller, threatened, other than the expiration in accordance with the terms thereof. (c) The Existing Product is being and has been subject developed, tested, manufactured and stored, as applicable, in material compliance with applicable Law, including those requirements relating to good manufacturing practice, good laboratory practice and good clinical practice. Neither the Seller nor any of its Affiliates have received any (i) written notice from the FDA or threatened withany other Governmental Authority, including the Office of Inspector General, any finding United States Attorney, the Department of deficiency Justice, any attorney general of any jurisdiction, alleging that the Seller has been or non-compliance; penaltyis in violation of any healthcare or regulatory Law, fine the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims Act (42 U.S.C. § 1320a-7b(a)) or sanction; request for corrective false claims acts under comparable foreign, supranational, state or remedial action; local Law, or pending or, commencing or indicating an intention to the Knowledge of the Company, threatened claim, suit, proceeding, hearing, enforcementconduct an investigation, audit, investigationor review; (ii) written notice of inspectional observation (including those recorded on FDA Form 483), arbitration warning letter, penalty, fine, sanction, request for recall or other written request for remedial action in connection with the Purchased Assets; (iii) other written documents issued by the FDA or any other Governmental Body Authority alleging lack of compliance with any healthcare of regulatory Law by the Seller or any Person engaged by the Seller to provide any service with respect to the Existing Product or (iv) written notice from the FDA recommending or requiring the submission of a 505(b)(2) NDA with respect to the Existing Product. Solely with respect to the Existing Product, the Seller has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of the Existing Product or any of (i) the Company Productsalleged product defect or violation and, (ii) the ingredients in the Company Products or (iii) the facilities at which such Company Products are manufactured, packaged or initially distributed, whether issued by the FDA, the United States Federal Trade Commission (the “FTC”), the United States Drug Enforcement Administration (“DEA”), the United States Department of Agriculture (“USDA”) or by any other Governmental Body having responsibility for the regulation of such Company Products. To to the Knowledge of the CompanySeller, there is no threatened suspension, revocation Third Party has initiated or withdrawal of conducted any Health Care Regulatory Authorization. To the Knowledge of the Company, there is no condition that would preclude the renewal of a Health Care Regulatory Authorization upon its expirationsuch notice or action. (bd) All Company Products that are subject to the jurisdiction of the FDAThe Existing Product has not been sold, the FTC, the DEA, the USDA advertised for sale or other Governmental Bodies in other jurisdictions are being manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, detailed and distributed for commercial purposes by or on behalf of the Company Entities Seller or its Affiliates in material compliance with all applicable requirements under any Permit the Territory. (e) All reports, documents, claims and notices required to be filed, maintained, or Law, including applicable statutes and implementing regulations administered or enforced by furnished to the FDA or any other Regulatory Authority by the Seller with respect to the Existing Product have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). The Seller, with respect to the Purchased Assets, has delivered or made available to Purchaser all material correspondence and meeting minutes received from or sent to the FDA and any other similar foreign Governmental BodyAuthorities, with respect to the Purchased Assets, including those relating any and all notices of inspectional observations, establishment inspection reports, and any other material documents received by the Seller or Seller’s Affiliates from the FDA or similar foreign Governmental Authorities which relate to investigational usethe Seller’s compliance with regulatory requirements of the FDA or similar state, premarket approval and applications local or abbreviated applications to market a new pharmaceutical productforeign Governmental Authorities. (cf) No Company Entity has voluntarily recalled, suspended, or discontinued manufacturing or investigation of any of Neither the Company Products or done so at the request of the FDA, the FTC, the DEA or any other Governmental Body having responsibility for the regulation of such Company Products, nor has any Company Entity received any notice from the FDA, the FTC, the DEA or any other Governmental Body having responsibility for the regulation of such Company Products that such Governmental Body has commenced orSeller nor, to the Knowledge of the Company, threatened to initiate any action to withdraw any approval or application for investigation, sale or marketing of any Company Products, restrict sales or marketing of any Company Products, place any clinical investigation on clinical hold or request a recall of any Company Products, or that the FDA, the FTC, the DEA or such other Governmental Body having responsibility for the regulation of any Products has commenced or, to the Knowledge of the Company, threatened to initiate any action to enjoin or place restrictions on the production of any Company Products, other than those restrictions generally existing by Law or that may be specifically set forth in any Health Care Regulatory Authorizations, supplement thereto, or related supporting documentation, in each case. (d) To the Knowledge of the Company, all preclinical studies and clinical trials, and other studies and tests conducted by or on behalf of the Company Entities have been, and if still pending are being, conducted in material compliance with (i) the required experimental protocols, procedures and controls, (ii) all applicable Laws, and (iii) current good clinical practices. No clinical trial conducted by or on behalf of the Company Entities has been terminated, suspended or placed on clinical hold by the FDA, the FTC, the DEA or any other applicable Governmental Body, and none of the FDA, the FTC, the DEA or any other applicable Governmental Body has commenced or, to the Knowledge of the Company, threatened to initiateSeller, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company Entities. (e) None of the Company Products, or any other products previously manufactured, tested, distributed, held or marketed by the Company Entities, has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of (i) any Company Products, (ii) any other products previously manufactured, tested, distributed, held or marketed by the Company Entities, or (iii) any product candidate or pre-market approvals or marketing authorizations of the Company Entities, are pending or, to the Knowledge of the Company, threatened, against any Company Entity. The Company has, prior to the date hereof, made available to Purchaser all material information about adverse experiences relating to (i) the Company Products or (ii) any other products previously manufactured, tested, distributed, held or marketed by any Company Entity, obtained or otherwise received by any Company Entity from any source, in the United States or outside the United States, including material information relating to the Company Products derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, to the Knowledge of the Company, the Company Entities have filed all annual and periodic reports, amendments and safety reports required for any of the products or product candidates required to be made to the FDA, the FTC, the DEA or any other Governmental Body. (f) All batches and doses of any Company Product that is or was previously marketed, sold or distributed by any Company Entity have been manufactured in conformance with (i) specifications set forth in any Health Care Regulatory Authorization and/or applicable Contract Manufacturing Agreements and (ii) in material compliance with applicable Laws, including all Current Good Manufacturing Practices. (g) All labels and labeling for all Company Products, including all inventory of such Company Products, are and have been in material compliance with applicable Laws. All advertising and promotional materials, and the advertising and promotional practices, of the Company Entities are and have been in material compliance with all applicable Laws. (h) The Company Entities have complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPPA”) and (ii) any applicable state privacy Laws. No Company Entity has received written or, to the Knowledge of the Company, any non-written, notice of any claims (including any investigation or notice from any Governmental Body) that have been asserted or threatened against any Company Entity alleging any violation of any Person’s protected health information under HIPAA or any applicable state privacy Laws. (i) To the Knowledge of the Company, and in connection with the business of the Company Entities as currently conducted, no director, officer, employee or agent of the Seller (including, without limitation, any Company Entity Person engaged by the Seller to provide any service with respect to the Existing Product) has made any an untrue statement or fraudulent statement of material fact or fraudulent statement to the FDA or any other Governmental Body; Authority or to any physician or customer, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body; Authority or to any physician or customer, or committed an any material act, made a any material statement, or failed to make a statement any material statement, that would reasonably be expected to provide the a basis for the FDA or any other Governmental Body to invoke its policy respecting “Fraud, Untrue Statements of Material FactsFact, Bribery, and Illegal Gratuities,” as ”, set forth in 56 FedFDA’s Compliance Policy Guide Sec. Reg120.100 (CPG 7150.09). 46191 (September 10, 1991). (j) No Company Entity or any director or officer of a Company Entity is debarred or otherwise excluded from or restricted in any manner from participation in, any government program orNeither the Seller nor, to the Knowledge of the CompanySeller, any director, officer, employee or agent of the Seller (including, without limitation, any Person engaged by the Seller to provide any service with respect to the Existing Product) has (i) been excluded, suspended, debarred or disqualified by any Governmental Authority, (ii) been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335athat would reasonably be expected to result in, or convicted that has resulted in, debarment or disqualification by any Governmental Authority, or (iii) any knowledge of facts that would lead to a false claim, or debarment, and there are no proceedings pending or threatened that would result in criminal liability or debarment or disqualification by any crime or engaged in any conduct for which such person could be excluded from participating in any federal health care programsGovernmental Authority. (kg) Neither the Seller, nor, to the Knowledge of the Seller, any Affiliate, director, manager, officer, equityholder, employee, agent or subcontractor of the Seller has (i) used any funds for contributions, gifts, entertainment or other expenses in violation in any material respect of applicable Law, (ii) paid any bribe, kickback or other similar payment, directly or indirectly, to any foreign government official or employee in violation of the Foreign Corrupt Practices Act of 1977 or other applicable Law, (iii) made any other payment of any kind in violation of any Law, to secure any improper advantage for the Purchased Assets or the Seller, or (iv) knowingly incorrectly recorded any transactions in any of the foregoing categories on the books and records of the Seller. (h) The Company Entities have filedSeller and its applicable Affiliate(s), maintained or furnished all material applicationsif any, reportshave, documents, claims, permits, notification and notices required to be filed, maintained or furnished with respect to the FDAExisting Product, FTC, the DEA or any other Governmental Body in connection with any active pharmaceutical ingredient, dietary ingredient, or Product developed, tested or manufactured or marketed by the Company Entities. All such applications, reports, documents, claims and notices were true, complete and accurate complied in all material respects with all applicable marketing codes of conduct, including federal, state, local and foreign Laws and marketing codes of conduct and the PhRMA Code on Interactions with Health Care Professionals in the date filed [***] prior to the Closing. (i) Seller has all applicable Permits necessary for the ownership of the Existing Product and the operation of the Business, as currently conducted, except where the failure to possess any such Permit, individually or in the aggregate, would not have a Material Adverse Effect. No proceeding is pending or, to the extent not true, complete and accurate in all material respects, were corrected in or supplemented by a subsequent filing), and any necessary or required updates, changes, corrections or modifications to such applications, reports, documents, claims and notices, in each case, required to have been submitted to the FDA, the FTC, the DEA or other Governmental Body, have been so submitted. All information, claims, reports, statistics, and other data and conclusions, if any, submitted by the Company Entities to the FDA, the FTC, the DEA or other Governmental Body were true, complete and correct in all material respects as Knowledge of the date Seller, (i) threatened regarding the withdrawal, material modification or revocation of submission and no updatesany such Permit. And (ii) Seller has not received any written communication from any Governmental Authority threatening to withdraw, changes, corrections, supplements, amendments materially modify or modifications has been submitted to suspend any Permit. Seller is not in violation of the FDA outside the Ordinary Course terms of Businessany Permit in any material respect. (lj) No Company Entity is, or has been since January 1, 2012, a Seller is not party to any corporate integrity agreementagreements, monitoring agreementagreements, consent decreedecrees, settlement order, orders or similar agreement agreements with or imposed by any Governmental Body. (m) The Company has made available to Purchaser true and complete copies of (i) all warning letters, untitled letters, cyber letter, regulatory letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs) or other material written correspondences from any Governmental Body Authority relating specifically to the Company Entities’ manufacture or marketing of Company Products or compliance with Laws and all of the Company Entities’ responses thereto since January 1, 2012, and a complete list of the foregoing if set forth in Section 4.23(m) of the Disclosure Schedule; (ii) all correspondence, meeting minutes or related documents concerning material communications between any Governmental Body and the Company Entities, including requests for information and responses thereto; and (iii) all written audit reports pertaining to the assessment of compliance with Good Manufacturing Practice requirements by the Company Entities or any other Person as it relates to the manufacture of the Products. No Company Entity is currently subject to any outstanding observations or obligations arising under a criminal, civil or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation or “untitled” letter, or other obligation made in writing to or with the FDA or any other Governmental BodyExisting Product. (n) Section 4.23(n) of the Disclosure Schedule sets forth a complete and correct list of all Health Care Regulatory Authorizations from the FDA, the FTC, the DEA or any other Governmental Body that administers Health Care Laws held by the Company Entities and, to the Knowledge of the Company, there are no other Health Care Regulatory Authorizations required for the Company Entities or the Company Products in connection with the conduct of the business of the Company Entities as currently conducted.