Common use of FDA Regulatory Compliance Clause in Contracts

FDA Regulatory Compliance. (a) Each of the Credit Parties and their Subsidiaries have all Registrations from FDA or other Governmental Authority required to conduct their respective businesses as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, the FDA is not considering limiting, suspending, or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each Registration in all material respects, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their Subsidiaries. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Credit Parties and their Subsidiaries are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31, 2004, no product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their Subsidiaries.

FDA Regulatory Compliance. (a) Each of the Credit Parties and their Subsidiaries have all Registrations Registrations, or are pursuing such Registrations, from the FDA or other Governmental Authority required to conduct their respective businesses as currently conducted (other than the portion of such business conducted by distributors). With respect to jurisdictions in which Registrations are held by distributors, to the knowledge of the Credit Parties, each of the distributors has all Registrations, or is pursuing such Registrations, from the FDA or other Governmental Authority required to conduct its respective business as currently conducted. Each of the Registrations is is, in all material respects, valid and subsisting in full force and effect. To Except as set forth on Schedule 4.23 attached hereto, to the knowledge of the Credit Parties and their Subsidiaries, as of the Closing Date, the FDA is not considering limiting, suspending, or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each existing Registration in all material respects, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance in all material respects with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their Subsidiaries. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Except as could not reasonably be expected to result in a Material Adverse Effect, (i) the Credit Parties and their Subsidiaries are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority. The , and (ii) the Credit Parties and their Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31, 20042016, as of the Closing Date, no product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed set forth on Schedule 3.224.23 attached hereto, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could would, in each case of clauses (i) through (iii), reasonably be expected to result in a Material Adverse Effect. No Except as could not reasonably be expected to result in a Material Adverse Effect, no proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their Subsidiaries.

FDA Regulatory Compliance. (a) Each of the Credit Parties and their Subsidiaries have all Registrations from FDA or other Governmental Authority required to conduct their respective businesses as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, the FDA is not considering limiting, suspending, or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each Registration in all material respectsRegistration, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectRegistration. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for marketed or distributed by the Credit Parties and their Subsidiaries. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of Law, including, without limitation, pre-market notificationproduct approval, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Credit Parties and their Subsidiaries are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31, 2004, no No product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing manufacturing, except as disclosed set forth on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, cause (i) the seizure, denial, withdrawal, recall, detention, field correctionpublic health notification, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, or threatened against the Credit Parties and their Subsidiaries.

FDA Regulatory Compliance. (a) Each of BSC and the Credit Parties and their Subsidiaries Sellers have all material Registrations from FDA or the United States Food and Drug Administration (the “FDA”) and any other comparable Governmental Authority required to conduct their respective businesses the Business as currently conducted, and Section 3.17 of the Disclosure Schedule sets forth a true and complete list of such Registrations. Each of the Registrations such Registration is valid and subsisting in full force and effect. To the knowledge Knowledge of BSC, neither BSC nor the Credit Parties and their Subsidiaries, Sellers have received any written notice from the FDA or any comparable Governmental Authority that the FDA or such comparable Governmental Authority is not considering limiting, suspending, suspending or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiariesrelated Products. To the knowledge Knowledge of the Credit Parties and their SubsidiariesBSC, there is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable Governmental Authority. The Credit Parties BSC and their Subsidiaries have the Sellers have, in all material respects, fulfilled and performed their obligations under each Registration in all material respectssuch Registration, and no event has occurred or condition or state of facts exists which would constitute a material breach or material default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectRegistration. To the knowledge Knowledge of the Credit Parties and their SubsidiariesBSC, any third party that is a manufacturer or contractor for with respect to the Credit Parties and their Subsidiaries Products is in material compliance with all such Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product Products or components or products for the Credit Parties and their Subsidiaries. (b) All products developed, manufactured, tested, distributed Products for BSC or marketed by or on behalf of the Credit Parties and their Subsidiaries Sellers. Each Product that are is subject to the jurisdiction of the FDA or any comparable Governmental Authority have has been and are is being developed, tested, investigated, manufactured, distributed distributed, marketed, and marketed sold in material compliance with all applicable statutes, rules, regulations, standards, guidelines, policies and orders administered or issued by the FDA Laws or any comparable Governmental Authority and any other applicable Requirement requirement of Law, including, without limitationincluding those regarding clinical research, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, reporting and have been reporting of corrections and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effectremovals. (cb) The Credit Parties and their Subsidiaries are not Neither BSC nor any Seller has received, since January 1, 2008, any Form FDA-483, notice of adverse finding, Warning Letters, notice of violation or “untitled letters,” or notice of FDA action for import detentions or refusals for the FDA or other comparable Governmental Authority alleging or asserting noncompliance with any applicable Laws or Registrations with respect to the Business. Neither BSC nor any Seller is subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental AuthorityAuthority with respect to the Business. The Credit Parties BSC and their Subsidiaries the Sellers have made all notifications, submissions, submissions and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, complete and correct in all material respects as of the date of submission to the FDA or any comparable Governmental AuthorityAuthority with respect to the Business. (dc) Since December 31January 1, 20042008, no product Product has been seized, withdrawn, recalled, detained, detained or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22manufacturing, and and, to the Knowledge of BSC, there are no facts or circumstances reasonably likely to cause, cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any productsuch Product; (ii) a change in the labeling of any productsuch Product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effectsuch Product. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, detention or seizure of any product Product are pending or, to the knowledge Knowledge of the Credit Parties and their SubsidiariesBSC, threatened against the Credit Parties and their Subsidiariesthreatened.

FDA Regulatory Compliance. (a) Each Except as disclosed with respect to DESI Program Products or as disclosed in Schedule 4.26 or in public filings of the Credit Parties Parent with the SEC prior to the Closing Date and (2) as would not reasonably be expected to result in a Material Adverse Effect, (i) each Loan Party and each of their Subsidiaries have has, and it and its Products are in conformance with, all Registrations, (ii) all Registrations from FDA or other Governmental Authority required to conduct their respective businesses as currently conducted. Each of the Registrations is are valid and subsisting in full force and effect. To ; (iii) to the knowledge of the Credit Parties and their Subsidiarieseach Loan Party, neither the FDA nor any comparable Governmental Authority is not considering limiting, suspending, or revoking any such Registrations or changing Registration; (iv) the marketing classification or labeling of the products of the Credit Loan Parties and their Subsidiaries. To the knowledge each of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each Registration in all material respectsRegistration, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of of, any such Registration Registration; and (v) all reports, documents, claims, permits, adverse event reports, complaints, notices, registrations and applications required to be filed, maintained or furnished to the FDA or any other Regulatory Authority by a Loan Party or any of its Subsidiaries have been so filed, maintained or furnished. (b) Each Loan Party and each of their Subsidiaries are conducting their business and operations in compliance with all applicable Health Care Laws, except to the extent that any noncompliance, individually or in the aggregate, could not reasonably be expected to result in have a Material Adverse Effect. To the knowledge Except (1) with respect to DESI Program Products or as disclosed in Schedule 4.26 or in public filings of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for Parent with the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain SEC prior to the manufacture of product components or products for the Credit Parties Closing Date and their Subsidiaries. (b2) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could as would not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or (i) no Loan Party nor any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Credit Parties and their Subsidiaries are not is subject to any obligation arising under an administrative or regulatory action, proceeding, investigation or inspection by or on behalf of the FDA inspectionor any comparable Governmental Authority, FDA warning letter, FDA Form FDA-483, untitled letter, notice of violation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority. The Credit Parties , in each case, in respect of such Loan Party or its Subsidiary, and no such obligation has been threatened and (ii) no Loan Party has received written notice from a Governmental Authority that any Product designed, developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold or marketed by or on behalf of any Loan Party or any of their Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as that are subject to the jurisdiction of the date of submission to FDA or any comparable Governmental AuthorityAuthority are not being designed, developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance with the Health Care Laws. (dc) Since December 31, 2004, no product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except Except as disclosed on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could would not reasonably be expected to be result in a Material Adverse Effect. No proceedings in the United States , all pre-clinical and clinical investigations conducted or sponsored by or on behalf of any Loan Party or any other jurisdiction seeking of their Subsidiaries are being and have been conducted in compliance with all applicable Health Care Laws including (i) FDA standards for the withdrawaldesign, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312 and 314 of the Code of Federal Regulations, and (ii) federal and state Requirements of Law restricting the collection, use and disclosure of individually identifiable health information and personal information. (d) Except (i) as disclosed in public filings of the Parent with the SEC prior to the Closing Date or (ii) as would not reasonably be expected to be result in a Material Adverse Effect, neither any Loan Party nor any of their Subsidiaries has voluntarily or involuntarily initiated, conducted or issued, caused to be initiated, conducted or issued, or received written notice of any material recall, suspensionfield corrective action, import detentionmarket withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or seizure other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any product are pending orProduct or is currently considering initiating, to the knowledge conducting or issuing any recall of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their Subsidiariesany Product.

FDA Regulatory Compliance. (a) Each of the Credit Parties and their Subsidiaries have The Company has all Registrations from the FDA or and any other Governmental Authority Entity required to conduct their respective businesses business as currently conducted, including any applicable Governmental Entity that regulates the development, import, marketing, promotion, manufacture, sale or distribution of the Company Products or the conduct of the business of the business of the Company, including valid 510(k) clearances or exemptions therefrom (as set forth in 21 C.F.R. Part 807), and Section 2.23(a) of the Company Disclosure Schedules sets forth a true and complete list of such Registrations. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge Knowledge of the Credit Parties and their SubsidiariesCompany, neither the FDA nor any comparable Governmental Entity is not considering limiting, suspending, suspending or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their SubsidiariesCompany Products. To the knowledge of the Credit Parties and their Subsidiaries, there There is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable Governmental AuthorityEntity. The Credit Parties and their Subsidiaries have Company has fulfilled and performed their its obligations under each Registration in all material respectsrespects under each Registration, and and, to the Company’s Knowledge, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectRegistration. To the knowledge Knowledge of the Credit Parties and their SubsidiariesCompany, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries Company is in compliance in all material respects with all Registrations from the FDA or comparable Governmental Authority Entity insofar as they pertain to the manufacture of product components for or products of Company Products. No written notice of cancellation, default or any dispute concerning any Registration has been received by the Company. The Company is the sole and exclusive owner of the Registrations and the associated filings and applications with the FDA or any other applicable Governmental Entity, including any 510(k) submissions, comparable regulatory application or filing made or held by or issued to the Company, and holds all rights, title and interest in all such regulatory filings free and clear of any encumbrance. No consent from or notice to any Governmental Entity is necessary for the Credit Parties Registrations to continue in effect on and their Subsidiariesafter the Closing. The Company has not granted any third party any right or license to use, access, or reference any of the regulatory filings or Registrations. (b) All products developed, tested, investigated, manufactured, testeddistributed, distributed marketed, or marketed sold by or on behalf of the Credit Parties and their Subsidiaries Company that are subject to the jurisdiction of the FDA or comparable Governmental Authority Entity have been and are being developed, tested, investigated, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement requirement of Law, except where a failure including those regarding clinical research, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, adverse event reporting and reporting of corrections and removals. The Company has maintained or filed with FDA all material reports, documents, forms, notices, applications, records, claims, supplements or amendments that are necessary to be in compliance could not reasonably be expected to result in a Material Adverse Effectcomply with applicable Laws. (c) Except as set forth on Section 2.23(c) of the Company Disclosure Schedules, the Company has not received any Form FDA-483, notice of adverse finding, warning letters, notice of violation or “untitled letters,” or notice of FDA action for import detentions or refusals for the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or Registrations. The Credit Parties and their Subsidiaries are Company is not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental AuthorityEntity. The Credit Parties and their Subsidiaries have Company has made all notifications, submissions, submissions and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, complete and correct in all material respects as of the date of submission to the FDA or any comparable Governmental AuthorityEntity. (d) Since December 31There are no legal proceedings pending or threatened pertaining to any Company Product, 2004or to the Knowledge of the Company, no product against any Person that manufactures any component used in manufacturing the Company Products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company by the FDA, Department of Justice, Federal Trade Commission, the Securities and Exchange Commission, or any other applicable Governmental Entity. (e) No Company Product has been seized, withdrawn, recalled, detained, detained or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22manufacturing, and and, to the Company’s Knowledge, there are no facts or circumstances reasonably likely to cause, cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any productCompany Product; (ii) a change in the labeling of any productCompany Product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse EffectCompany Product. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, detention or seizure of any Company Products are pending or overtly threatened in writing against the Company. (f) The manufacture of the Company Products by the Company and, to the Knowledge of the Company, by third parties has been and is currently conducted in compliance in all material respects with the FDA’s Quality System Regulation as set forth at 21 C.F.R. Part 820. (g) The Company is and has been in compliance in all material respects with all applicable laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other applicable Governmental Entity, including, records and reports relating to product corrections and removals, including FDA requirements set forth at 21 C.F.R. Part 806, MDR Reportable Events, including FDA requirements set forth at 21 C.F.R. Part 802, serious injuries, incidents, or near-incidents and product malfunctions. (h) None of the Company or any of its officers, directors or employees or, to the Knowledge of the Company, agents or subcontractors (i) has been convicted of any crime or engaged in any conduct which has resulted or would reasonably be expected to result in debarment or disqualification by the FDA or any other applicable Governmental Entity, or (ii) has failed to disclose a material fact required to be disclosed to any applicable Governmental Entity, and there are no proceedings pending or, to the knowledge Knowledge of the Credit Parties and their SubsidiariesCompany, threatened against that would reasonably be expected to result in criminal or civil liability or debarment or disqualification by the Credit Parties FDA or any other applicable Governmental Entity. Neither the Company nor, to the Knowledge of the Company, any of its officers, directors, or employees has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and their SubsidiariesIllegal Gratuities” or for any other applicable Governmental Entity to invoke any similar policy.

FDA Regulatory Compliance. (a) Each of the Credit Parties and their Subsidiaries have all Registrations Registrations, or are pursuing such Registrations, from the FDA or other Governmental Authority required to conduct their respective businesses as currently conducted (other than the portion of such business conducted by distributors). With respect to jurisdictions in which Registrations are held by distributors, to the knowledge of the Credit Parties, each of the distributors has all Registrations, or is pursuing such Registrations, from the FDA or other Governmental Authority required to conduct its respective business as currently conducted. Each of the Registrations is is, in all material respects, valid and subsisting in full force and effect. To Except as set forth on Schedule 4.23 attached hereto, to the knowledge of the Credit Parties and their Subsidiaries, as of the Closing Date, the FDA is not considering limiting, suspending, or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each existing Registration in all material respects, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance in all material respects with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their Subsidiaries. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Except as could not reasonably be expected to result in a Material Adverse Effect, (i) the Credit Parties and their Subsidiaries are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority. The , and (ii) the Credit Parties and their Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31, 20042022, as of the Closing Date, no product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed set forth on Schedule 3.224.23 attached hereto, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could would, in each case of clauses (i) through (iii), reasonably be expected to result in a Material Adverse Effect. No Except as could not reasonably be expected to result in a Material Adverse Effect, no proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their Subsidiaries.

FDA Regulatory Compliance. (a) Each Buyer is in compliance with the FDA Laws and, to the Knowledge of Buyer, the Credit Parties and their Subsidiaries have FTC Laws. (b) Buyer has all Registrations material authorizations, approvals, licenses, permits, certificates, registrations, or exemptions from the FDA or other Governmental Authority Entities required to conduct their respective businesses and produce, market, sell and distribute their products, in each case as currently conductedconducted and as presently contemplated by Buyer to be conducted (“Buyer Registrations”). Each of the Buyer Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, Buyer has received no written or oral notice that the FDA or any other Governmental Entity is not considering or may consider limiting, suspending, or revoking such Buyer Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their SubsidiariesBuyer’s products. To the knowledge of the Credit Parties and their Subsidiaries, there There is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable Governmental AuthorityEntity. The Credit Parties and their Subsidiaries have Buyer has fulfilled and performed their all material obligations under each Registration in all material respectsBuyer Registration, and no event has occurred or condition or state of facts exists which that would reasonably be expected to constitute a breach violation or default or would to cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectBuyer Registration. To the knowledge Knowledge of the Credit Parties and their SubsidiariesBuyer, any all third party parties that is a manufacturer are manufacturers, contractors, or contractor suppliers for the Credit Parties and their Subsidiaries is Buyer are in compliance with all Registrations from the applicable FDA or comparable Governmental Authority Laws insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesBuyer. (bc) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries Buyer that are subject to the jurisdiction of the FDA or any comparable Governmental Authority Entity or the FTC have been and are being developed, investigated, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of LawLaws, including, without limitationwhere applicable, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, keeping and adverse event reporting, except where a failure and to be in compliance could not reasonably be expected to result in a Material Adverse Effectthe Knowledge of Buyer, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse EffectFTC Laws. (cd) The Credit Parties and their Subsidiaries are Buyer has not subject to received any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA written notice of violation letter, or other notice, response or commitment made to or with during the past three years from the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notificationsEntity, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of nor the date of submission to FDA FTC or any comparable Governmental AuthorityEntity that alleges that Buyer or a Subsidiary is not in compliance in any respect with FDA Laws or FTC Laws. Buyer and its Subsidiaries have responded to all observations made by the FDA during inspections and have not received any Warning Letters. (de) Since December 31, 2004, no No product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22manufacturing, and to Buyer’s Knowledge, there are no facts or circumstances reasonably likely to causecause the FDA, any comparable Governmental Entity or the FTC to require (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their SubsidiariesBuyer’s Knowledge, threatened against Buyer. (f) Neither Buyer nor any Subsidiary of Buyer nor, to the Credit Parties Knowledge of Buyer, any director, officer or employee, or other Person acting on behalf of any of them, has made any contribution, gift, bribe, rebate, payoff, influence payment, kickback, or other payment to any Person, private or public, regardless of form, whether in money, property, or services (i) to obtain favorable treatment in securing Buyer Registrations for Buyer or any of its Subsidiaries, (ii) to pay for favorable treatment by the FDA or any other comparable Governmental Entity or the FTC with regards to the manufacturing, labeling and marketing of their products, (iii) to obtain special concessions or for special concessions already obtained, for or in respect of Buyer or any of its Subsidiaries, or (iv) in violation of any FDA Laws or FTC Laws.

FDA Regulatory Compliance. (a) Each of 3.15.1. Except as set forth on Schedule 3.15.1, the Credit Parties and their Subsidiaries have Company has all Registrations from FDA or other Governmental Authority required to conduct their respective businesses as currently conductedbusiness, and Schedule 3.15.1 sets forth a true and complete list of such Registrations. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, Neither the FDA nor any comparable Governmental Authority has notified the Company that it is not considering limiting, suspending, suspending or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their SubsidiariesCompany. To the knowledge of the Credit Parties and their SubsidiariesCompany’s Knowledge, there is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have Company has fulfilled and performed their obligations under each Registration in all material respectsrequired to be performed as of or prior to the date hereof, and to the Company’s Knowledge, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectRegistration. To the knowledge of the Credit Parties and their SubsidiariesCompany’s Knowledge, any third party Third Party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries Company is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesCompany. (b) 3.15.2. All products developed, tested, investigated, manufactured, testedstored, distributed distributed, marketed, or marketed sold by or on behalf of the Credit Parties and their Subsidiaries Company that are subject to the jurisdiction of the FDA or any comparable Governmental Authority have been and are being developed, tested, investigated, manufactured, distributed stored, distributed, marketed, and marketed sold in compliance with the FDA Laws Legal Requirements or any other applicable Requirement of LawLegal Requirement, including, without limitationto Company’s Knowledge, those regarding non-clinical testing, clinical research, establishment registration, device listing, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reportingreporting and reporting of corrections and removals. 3.15.3. The Company has not received any Form FDA-483, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effectnotice of adverse finding, and have been and are being testedFDA warning letters, investigated, distributed, marketed, and sold in compliance in all material respects with notice of violation or “untitled letters,” or notice of FDA Laws action for import detentions or refusals or any other written correspondence from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) Legal Requirements or Registrations. The Credit Parties and their Subsidiaries are Company is not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental AuthorityAuthority with respect to a violation or FDA action, and, to the Company’s Knowledge, no such proceedings have been threatened. The Credit Parties and their Subsidiaries have Company has made all notifications, submissions, and reports required by any such obligation, and all such material notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to required by FDA or any comparable Governmental AuthorityLegal Requirements. (d) Since December 31, 20043.15.4. Except as set forth on Schedule 3.15.4, no product distributed or sold by or on behalf of the Company has been seized, withdrawn, recalled, detained, detained or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22manufacturing, and to the Company’s knowledge, there are no facts or circumstances reasonably likely to cause, cause (ia) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (iib) a change in the labeling of any such product; or (iiic) a termination, seizure or suspension of marketing of any such product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, detention or seizure of any such product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, or threatened against the Credit Parties Company, and their Subsidiariesno product sold by or on behalf of the Company is characterized by a design or other defect. 3.15.5. To the Company’s Knowledge, the Company has never been, and none of its employees or other persons engaged by the Company have ever been, (a) debarred (under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a (a) and (b)), (b) convicted of a crime for which a person can be debarred, (c) threatened to be debarred, (d) indicted for a crime or otherwise engaged in conduct for which a person can be debarred.

FDA Regulatory Compliance. (a) Each Buyer is in compliance with the FDA Laws and, to the Knowledge of Buyer, the Credit Parties and their Subsidiaries have FTC Laws. (b) Buyer has all Registrations material authorizations, approvals, licenses, permits, certificates, registrations, or exemptions from the FDA or other Governmental Authority Entities required to conduct their respective businesses and produce, market, sell and distribute their products, in each case as currently conductedconducted and as presently contemplated by Buyer to be conducted ("Buyer Registrations"). Each of the Buyer Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, Buyer has received no written or oral notice that the FDA or any other Governmental Entity is not considering or may consider limiting, suspending, or revoking such Buyer Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their SubsidiariesBuyer's products. To the knowledge of the Credit Parties and their Subsidiaries, there There is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable Governmental AuthorityEntity. The Credit Parties and their Subsidiaries have Buyer has fulfilled and performed their all material obligations under each Registration in all material respectsBuyer Registration, and no event has occurred or condition or state of facts exists which that would reasonably be expected to constitute a breach violation or default or would to cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectBuyer Registration. To the knowledge Knowledge of the Credit Parties and their SubsidiariesBuyer, any all third party parties that is a manufacturer are manufacturers, contractors, or contractor suppliers for the Credit Parties and their Subsidiaries is Buyer are in compliance with all Registrations from the applicable FDA or comparable Governmental Authority Laws insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesBuyer. (bc) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries Buyer that are subject to the jurisdiction of the FDA or any comparable Governmental Authority Entity or the FTC have been and are being developed, investigated, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of LawLaws, including, without limitationwhere applicable, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, keeping and adverse event reporting, except where a failure and to be in compliance could not reasonably be expected to result in a Material Adverse Effectthe Knowledge of Buyer, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse EffectFTC Laws. (cd) The Credit Parties and their Subsidiaries are Buyer has not subject to received any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA written notice of violation letter, or other notice, response or commitment made to or with during the past three years from the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notificationsEntity, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of nor the date of submission to FDA FTC or any comparable Governmental AuthorityEntity that alleges that Buyer or a Subsidiary is not in compliance in any respect with FDA Laws or FTC Laws. Buyer and its Subsidiaries have responded to all observations made by the FDA during inspections and have not received any Warning Letters. (de) Since December 31, 2004, no No product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22manufacturing, and to Buyer's Knowledge, there are no facts or circumstances reasonably likely to causecause the FDA, any comparable Governmental Entity or the FTC to require (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their SubsidiariesBuyer's Knowledge, threatened against Buyer. (f) Neither Buyer nor any Subsidiary of Buyer nor, to the Credit Parties Knowledge of Buyer, any director, officer or employee, or other Person acting on behalf of any of them, has made any contribution, gift, bribe, rebate, payoff, influence payment, kickback, or other payment to any Person, private or public, regardless of form, whether in money, property, or services (i) to obtain favorable treatment in securing Buyer Registrations for Buyer or any of its Subsidiaries, (ii) to pay for favorable treatment by the FDA or any other comparable Governmental Entity or the FTC with regards to the manufacturing, labeling and marketing of their products, (iii) to obtain special concessions or for special concessions already obtained, for or in respect of Buyer or any of its Subsidiaries, or (iv) in violation of any FDA Laws or FTC Laws.

FDA Regulatory Compliance. (a) Each Loan Party and each of the Credit Parties and their Subsidiaries have has, and it and its products are in conformance with, all Registrations from registrations, listings, authorizations, approvals, licenses, permits, clearances, certificates and exemptions (including new drug applications, abbreviated new drug applications, biologics license applications, investigational new drug applications, over-the-counter drug monograph, device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits) issued or allowed by the FDA or other any comparable Governmental Authority (hereinafter “Registrations”) that are required to conduct their respective businesses its business as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiarieseach Loan Party, neither the FDA nor any comparable Governmental Authority is not considering limiting, suspending, or revoking any such Registrations or changing the marketing classification or labeling of the products of the Credit Registration. The Loan Parties and their Subsidiaries. To the knowledge each of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each Registration in all material respectsRegistration, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of of, any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesRegistration. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf Each Loan Party and each of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been conducting their business and are being developed, tested, manufactured, distributed and marketed operations in compliance with the FDA Laws or any other all applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reportingHealth Care Laws, except where a failure to be the extent that any noncompliance, individually or in compliance the aggregate, could not reasonably be expected to result in have a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or . No Loan Party nor any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Credit Parties and their Subsidiaries are not is subject to any obligation arising under an administrative or regulatory action, proceeding, investigation or inspection by or on behalf of the FDA inspectionor any comparable Governmental Authority, FDA warning letter, FDA Form FDA-483, untitled letter, notice of violation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority, and no such obligation has been threatened. The Credit Parties and All products designed, developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold or marketed by or on behalf of any Loan Party or any of their Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as that are subject to the jurisdiction of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31Authority have been and are being designed, 2004developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance with the Health Care Laws. As of the Closing Date, no product has been seized, withdrawn, recalled, detained, Loan Party nor any of their Subsidiaries is undergoing any inspection related to any activities or become products of the Loan Parties or any of their Subsidiaries that are subject to a suspension of manufacturing except as disclosed on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their SubsidiariesHealth Care Laws.

FDA Regulatory Compliance. (a) Each The Company is in compliance with all applicable Laws, rules, regulations and orders administered or issued by (i) the U.S. Food and Drug Administration ("FDA") or any comparable Governmental Entity ("FDA Laws") or (ii) to the Knowledge of the Credit Parties and their Subsidiaries have Company, the U.S. Federal Trade Commission ("FTC") ("FTC Laws"). (b) The Company has all Registrations material authorizations, approvals, licenses, permits, certificates, registrations, or exemptions from the FDA or other Governmental Authority Entities required to conduct their respective businesses and produce, market, sell and distribute their products, in each case as currently conductedconducted and as presently contemplated by the Company to be conducted ("Company Registrations"). Each of the Company Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, The Company has received no written or oral notice that the FDA or any other Governmental Entity is not considering or may consider limiting, suspending, or revoking such Company Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their SubsidiariesCompany's products. To the knowledge of the Credit Parties and their Subsidiaries, there There is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable Governmental AuthorityEntity. The Credit Parties and their Subsidiaries have Company has fulfilled and performed their all material obligations under each Registration in all material respectsCompany Registration, and no event has occurred or condition or state of facts exists which that would reasonably be expected to constitute a breach violation or default or would to cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectCompany Registration. To the knowledge Knowledge of the Credit Parties and their SubsidiariesCompany, any all third party parties that is a manufacturer are manufacturers, contractors, or contractor suppliers for the Credit Parties and their Subsidiaries is Company are in compliance with all Registrations from the applicable FDA or comparable Governmental Authority Laws insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesCompany. (bc) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries Company that are subject to the jurisdiction of the FDA or any comparable Governmental Authority Entity or the FTC have been and are being developed, investigated, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of LawLaws, including, without limitationwhere applicable, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, keeping and adverse event reporting, except where a failure and to be in compliance could not reasonably be expected to result in a Material Adverse Effectthe Knowledge of the Company, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse EffectFTC Laws. (cd) The Credit Parties and their Subsidiaries are Company has not subject to received any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA written notice of violation letter, or other notice, response or commitment made to or with during the past three years from the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notificationsEntity, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of or from the date of submission to FDA FTC or any comparable Governmental AuthorityEntity, that alleges that the Company or a Subsidiary is not in compliance in any material respect with FDA Laws or FTC Laws. The Company and its Subsidiaries have responded to all observations made by the FDA during inspections and have not received any Warning Letters. (de) Since December 31, 2004, no No product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22manufacturing, and to the Company's Knowledge there are no facts or circumstances reasonably likely to causecause the FDA, any comparable Governmental Entity or the FTC to require (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their SubsidiariesCompany's Knowledge, threatened against the Credit Parties Company. (f) Neither the Company nor any Subsidiary of the Company nor, to the Knowledge of the Company, any director, officer or employee, or other Person acting on behalf of any of them, has made any contribution, gift, bribe, rebate, payoff, influence payment, kickback, or other payment to any Person, private or public, regardless of form, whether in money, property, or services (i) to obtain favorable treatment in securing Company Registrations for the Company or any of its Subsidiaries, (ii) to pay for favorable treatment by the FDA or any other comparable Governmental Entity or the FTC with regards to the manufacturing, labeling and marketing of their products, (iii) to obtain special concessions or for special concessions already obtained, for or in respect of the Company or any of its Subsidiaries, or (iv) in violation of any FDA Laws or FTC Laws.

FDA Regulatory Compliance. Except as would not reasonably be expected to have a Company Material Adverse Effect: (a) Each The Company and its Subsidiaries are in compliance with all Laws, including all applicable statutes, rules, regulations, standards, guidelines, policies and orders, administered or issued by the U.S. Food and Drug Administration (“FDA”) or any comparable Governmental Entity (“FDA Laws”). (b) Without limiting any representations or warranties of the Credit Parties Company made in Section 3.16, the Company and their its Subsidiaries have all Registrations authorizations, approvals, clearances, licenses, permits, certificates, registrations or exemptions (collectively, “Registrations”) from the FDA or other Governmental Authority Entities required to conduct their respective businesses as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, the FDA is not considering limiting, suspending, or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there There is no false or misleading information or significant omission in any product application or other submission made by the Company or its Subsidiaries to the FDA or any comparable Governmental AuthorityEntity. The Credit Parties Company and their its Subsidiaries have fulfilled and performed their respective obligations under each Registration in all material respectsRegistration, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectRegistration. To the knowledge Knowledge of the Credit Parties and their SubsidiariesCompany, any all third party parties that is a manufacturer are manufacturers, contractors, or contractor suppliers for the Credit Parties Company and their its Subsidiaries is are in compliance with all Registrations from the FDA or comparable Governmental Authority Entities insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesCompany. (bc) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties Company and their its Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority Entities have been and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of LawLaws, including, without limitation, pre-pre- market notification, good manufacturing practices, labeling, advertising, record-keeping, installation, service and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse EffectLaws. (cd) The Credit Parties Company and their its Subsidiaries are not subject to any obligation arising under an any pending administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental AuthorityEntity. The Credit Parties Company and their its Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to FDA or any comparable Governmental AuthorityEntity. (de) Since December 31January 1, 20042006, no product of the Company or any of its Subsidiaries has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22manufacturing, and to the Company's Knowledge there are no facts or circumstances reasonably likely to cause, cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any product; , (ii) a significant change in the labeling of any product; product required by FDA or comparable Governmental Entity, or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to product as a result in a Material Adverse Effectof the Company's noncompliance with applicable Law. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their SubsidiariesCompany’s Knowledge, threatened against the Credit Parties and their Company or its Subsidiaries.

FDA Regulatory Compliance. (a) Each of Trilogy Pharmacy Company has, and it and its products are in material conformance with, all registrations, listings, authorizations, approvals, licenses, permits, clearances, certificates and exemptions (including device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits) issued or allowed by the Credit Parties and their Subsidiaries have all Registrations from FDA or other any comparable Governmental Authority (hereinafter “Registrations”) that are required to conduct their respective businesses its business as currently conducted. Each of the Registrations is valid and subsisting in full force and effectClosing Date. To the knowledge of the Credit Parties and their Subsidiarieseach Borrower, neither the FDA nor any comparable Governmental Authority has stated in writing that it is not considering limiting, suspending, or revoking any such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their SubsidiariesRegistration. To the knowledge of the Credit Parties and their Subsidiarieseach Borrower’s knowledge, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have each Trilogy Pharmacy Company has fulfilled and performed their obligations under each Registration its obligations, in all material respects, under each Registration, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would reasonably be expected to cause revocation or termination of of, any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesRegistration. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties Each Trilogy Pharmacy Company is conducting its business and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and are being developed, tested, manufactured, distributed and marketed operations in compliance with the FDA Laws or any other all applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reportingPublic Health Laws, except where a failure to be the extent that any noncompliance, individually or in compliance the aggregate, could not reasonably be expected to result in have a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Credit Parties and their Subsidiaries are . Each Trilogy Pharmacy Company is not subject to any obligation arising under an administrative or regulatory action, proceeding, investigation or inspection by or on behalf of the FDA inspectionor any comparable Governmental Authority, FDA warning letter, FDA untitled letter, notice of violation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notifications, submissions, and reports required by any no such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31, 2004, no product obligation has been seizedthreatened in writing, withdrawnthat would reasonably be expected, recalled, detained, individually or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a terminationaggregate, seizure or suspension of marketing of any product, which could reasonably be expected to result in have a Material Adverse Effect. No proceedings All products prepared, assembled, packaged, labeled, distributed, sold or marketed by or on behalf of any Trilogy Pharmacy Company that are subject to the jurisdiction of the FDA have been and are being prepared, assembled, packaged, labeled, distributed, sold and marketed in compliance, in all material respects, with the Public Health Laws. As of the Closing Date, no Trilogy Pharmacy Company is undergoing any inspection related to any activities or products that are subject to Public Health Laws, other than routine inspections occurring in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure ordinary course of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their Subsidiaries.business. 112 US_Active\120558968\V-3 US_ACTIVE\122519032\V-4

FDA Regulatory Compliance. (aSection 3.15.1 The Company possesses all FDA 510(k) Each clearances and FDA premarket approvals and similar clearances and approvals of any other Governmental Entity required to market the Credit Parties Company Products and their Subsidiaries have all other material Registrations from any other non-FDA or other Governmental Authority Entity required to conduct their respective businesses its business as currently conducted, and Section 3.15.1 of the Company Disclosure Schedule sets forth a true and complete list of such FDA 510(k) clearances, FDA premarket approvals, similar clearances and approvals of any other Governmental Entity and Registrations. Each of the Registrations such Registration is valid and subsisting in full force and effect. To Without limiting the knowledge foregoing, as to each Company Product that requires approval of an investigational device exemption under FDA Laws prior to clinical investigations and as to each Company Product that requires clearance or approval from the Credit Parties and their SubsidiariesFDA prior to commercial marketing, including clearance or approval of modified versions of previously cleared or approved Company Products, the Company holds all required Registrations to conduct such clinical investigations and commercially market such Company Products, respectively. The Company has not received written notice from the FDA is not considering limitingor any comparable Governmental Entity proposing to limit, suspendingsuspend, revoke or revoking such Registrations or changing make an adverse change to the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authoritya Company Product. The Credit Parties and their Subsidiaries have Company has fulfilled and performed their (and continues to fulfill and perform) its obligations under each Registration in FDA 510(k) clearance, FDA premarket approval and similar clearances and approvals of any other Governmental Entity required to market the Company Products and all other material respectsRegistrations, and to the Knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge FDA 510(k) clearances, FDA premarket approvals, similar clearances and approvals of the Credit Parties and their Subsidiaries, any third party that is a manufacturer other Governmental Entity or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesRegistrations. (b) Section 3.15.2 All products developed, tested, investigated, manufactured, testeddistributed, distributed marketed or marketed sold by or on behalf of the Credit Parties and their Subsidiaries Company that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and Entity are being developed, tested, investigated, manufactured, distributed distributed, marketed and marketed sold in compliance with the FDA Laws or Laws, any other applicable Requirement requirement of Law, including, without limitationas applicable, the applicable Laws of the Federal Trade Commission and the Laws governing preclinical testing, human factors/usability testing, clinical research, pre-market notificationnotification or approval, good manufacturing practices, labeling, advertising, record-keeping, adverse event/medical device reporting and adverse event reportingreporting of corrections and removals. Section 3.15.3 Except as set forth on Section 3.15.3 of the Company Disclosure Schedule, except where a failure to be in compliance could for the past five (5) years, the Company has not reasonably be expected to result in a Material Adverse Effectreceived any Form FDA-483, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects FDA warning letters or “untitled letters,” Notice of FDA Action for import detentions or refusals from the FDA alleging or asserting noncompliance with any FDA Laws or Registrations, or any other applicable Requirement communication alleging actual or potential violations of LawFDA Law or similar Laws of any other Governmental Entity. The Company has made all material notifications, except where a failure submissions and reports to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Credit Parties and their Subsidiaries are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any and comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notifications, submissions, and reports Entities required by the FDA Laws and other similar laws of any such obligationother Governmental Entity, and all such notifications, submissions and reports were true, complete, complete and correct in all material respects as of the date of submission to the FDA or any comparable Governmental AuthorityEntity (or were corrected or supplemented by a subsequent notification, submission or report). The Company has not received notice of any pending, or to the Knowledge of the Company, threatened, investigation by the FDA or any other Governmental Entity alleging that any operation or activity of the Company is in violation of applicable Law. Section 3.15.4 Except as set forth on Section 3.15.4 of the Company Disclosure Schedule, for the past five (d5) Since December 31, 2004years, no product has been seized, withdrawn, recalled, detainedcorrected in the field, detained or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22by any Governmental Entity (or voluntarily by the Company in order to address violative product or protect the public health), and and, to the Knowledge of the Company, there are no facts or circumstances reasonably likely to cause, cause (ia) the such seizure, denial, withdrawal, recall, detention, field correction, safety alert detention or suspension of manufacturing relating to any productmanufacturing; (iib) a material change in the labeling of any product; or (iiic) a termination, seizure termination or suspension of marketing of any product. Section 3.15.5 Neither the Company nor any of its employees and to the Knowledge of the Company, which could any of its contractors, has been, or to the Knowledge of the Company, is in anticipation of being: (a) debarred pursuant to the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a(m)), as amended from time to time; (b) disqualified from participating in clinical trials pursuant to 21 C.F.R. § 812.119, as amended from time to time; or (c) disqualified as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended from time to time. Section 3.15.6 The Company has not made any untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Entity; failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority; or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to result provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in a Material Adverse Effect56 Fed. No proceedings in Reg. 46191 (September 10, 1991), or for the United States FDA or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of Governmental Entity to invoke any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their Subsidiariessimilar policy.

FDA Regulatory Compliance. (a) Each Loan Party and each of the Credit Parties and their Subsidiaries have has, and it and its products are in conformance with, all Registrations from registrations, listings, authorizations, approvals, licenses, permits, clearances, certificates and exemptions (including new drug applications, abbreviated new drug applications, biologics license applications, investigational new drug applications, over-the-counter drug monograph, device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits) issued or allowed by the FDA or other any comparable Governmental Authority Authority, including but not limited to Health Canada (hereinafter “Registrations”) that are required to conduct their respective businesses its business as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiarieseach Loan Party, neither the FDA nor any comparable Governmental Authority, including but not limited to Health Canada, is not considering limiting, suspending, or revoking any such Registrations or changing the marketing classification or labeling of the products of the Credit Registration. The Loan Parties and their Subsidiaries. To the knowledge each of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each Registration in all material respectsRegistration, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of of, any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesRegistration. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf Each Loan Party and each of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been conducting their business and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold operations in compliance in all material respects with FDA Laws or all applicable Public Health Laws. No Loan Party nor any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Credit Parties and their Subsidiaries are not is subject to any obligation arising under an administrative or regulatory action, proceeding, investigation or inspection by or on behalf of the FDA inspectionor any comparable Governmental Authority, FDA including but not limited to Health Canada, warning letter, FDA Form FDA-483, untitled letter, notice of violation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority, and no such obligation has been threatened. The Credit Parties and All products designed, developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold or marketed by or on behalf of any Loan Party or any of their Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as that are subject to the jurisdiction of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31Health Canada have been and are being designed, 2004developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance with the Public Health Laws. As of the Closing Date, no product has been seized, withdrawn, recalled, detained, Loan Party nor any of their Subsidiaries is undergoing any inspection related to any activities or become products of the Loan Parties or any of their Subsidiaries that are subject to a suspension of manufacturing except as disclosed on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their SubsidiariesPublic Health Laws.

FDA Regulatory Compliance. (a) Each The Company is in compliance with all applicable Laws, rules, regulations and orders administered or issued by (i) the U.S. Food and Drug Administration (“FDA”) or any comparable Governmental Entity (“FDA Laws”) or (ii) to the Knowledge of the Credit Parties and their Subsidiaries have Company, the U.S. Federal Trade Commission (“FTC”) (“FTC Laws”). (b) The Company has all Registrations material authorizations, approvals, licenses, permits, certificates, registrations, or exemptions from the FDA or other Governmental Authority Entities required to conduct their respective businesses and produce, market, sell and distribute their products, in each case as currently conductedconducted and as presently contemplated by the Company to be conducted (“Company Registrations”). Each of the Company Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, The Company has received no written or oral notice that the FDA or any other Governmental Entity is not considering or may consider limiting, suspending, or revoking such Company Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their SubsidiariesCompany’s products. To the knowledge of the Credit Parties and their Subsidiaries, there There is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable Governmental AuthorityEntity. The Credit Parties and their Subsidiaries have Company has fulfilled and performed their all material obligations under each Registration in all material respectsCompany Registration, and no event has occurred or condition or state of facts exists which that would reasonably be expected to constitute a breach violation or default or would to cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectCompany Registration. To the knowledge Knowledge of the Credit Parties and their SubsidiariesCompany, any all third party parties that is a manufacturer are manufacturers, contractors, or contractor suppliers for the Credit Parties and their Subsidiaries is Company are in compliance with all Registrations from the applicable FDA or comparable Governmental Authority Laws insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesCompany. (bc) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries Company that are subject to the jurisdiction of the FDA or any comparable Governmental Authority Entity or the FTC have been and are being developed, investigated, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of LawLaws, including, without limitationwhere applicable, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, keeping and adverse event reporting, except where a failure and to be in compliance could not reasonably be expected to result in a Material Adverse Effectthe Knowledge of the Company, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse EffectFTC Laws. (cd) The Credit Parties and their Subsidiaries are Company has not subject to received any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA written notice of violation letter, or other notice, response or commitment made to or with during the past three years from the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notificationsEntity, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of or from the date of submission to FDA FTC or any comparable Governmental AuthorityEntity, that alleges that the Company or a Subsidiary is not in compliance in any material respect with FDA Laws or FTC Laws. The Company and its Subsidiaries have responded to all observations made by the FDA during inspections and have not received any Warning Letters. (de) Since December 31, 2004, no No product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22manufacturing, and to the Company’s Knowledge there are no facts or circumstances reasonably likely to causecause the FDA, any comparable Governmental Entity or the FTC to require (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their SubsidiariesCompany’s Knowledge, threatened against the Credit Parties Company. (f) Neither the Company nor any Subsidiary of the Company nor, to the Knowledge of the Company, any director, officer or employee, or other Person acting on behalf of any of them, has made any contribution, gift, bribe, rebate, payoff, influence payment, kickback, or other payment to any Person, private or public, regardless of form, whether in money, property, or services (i) to obtain favorable treatment in securing Company Registrations for the Company or any of its Subsidiaries, (ii) to pay for favorable treatment by the FDA or any other comparable Governmental Entity or the FTC with regards to the manufacturing, labeling and marketing of their products, (iii) to obtain special concessions or for special concessions already obtained, for or in respect of the Company or any of its Subsidiaries, or (iv) in violation of any FDA Laws or FTC Laws.

FDA Regulatory Compliance. (a) Each of Trilogy Pharmacy Company has, and it and its products are in material conformance with, all registrations, listings, authorizations, approvals, licenses, permits, clearances, certificates and exemptions (including device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits) issued or allowed by the Credit Parties and their Subsidiaries have all Registrations from FDA or other any comparable Governmental Authority (hereinafter “Registrations”) that are required to conduct their respective businesses its business as currently conducted. Each of the Registrations is valid and subsisting in full force and effectClosing Date. To the knowledge of the Credit Parties and their Subsidiarieseach Borrower, neither the FDA nor any comparable Governmental Authority has stated in writing that it is not considering limiting, suspending, or revoking any such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their SubsidiariesRegistration. To the knowledge of the Credit Parties and their Subsidiarieseach Borrower’s knowledge, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have each Trilogy Pharmacy Company has fulfilled and performed their obligations under each Registration its obligations, in all material respects, under each Registration, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would reasonably be expected to cause revocation or termination of of, any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesRegistration. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties Each Trilogy Pharmacy Company is conducting its business and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and are being developed, tested, manufactured, distributed and marketed operations in compliance with the FDA Laws or any other all applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reportingPublic Health Laws, except where a failure to be the extent that any noncompliance, individually or in compliance the aggregate, could not reasonably be expected to result in have a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Credit Parties and their Subsidiaries are . Each Trilogy Pharmacy Company is not subject to any obligation arising under an administrative or regulatory action, proceeding, investigation or inspection by or on behalf of the FDA inspectionor any comparable Governmental Authority, FDA warning letter, FDA untitled letter, notice of violation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notifications, submissions, and reports required by any no such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31, 2004, no product obligation has been seizedthreatened in writing, withdrawnthat would reasonably be expected, recalled, detained, individually or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a terminationaggregate, seizure or suspension of marketing of any product, which could reasonably be expected to result in have a Material Adverse Effect. No proceedings All products prepared, assembled, packaged, labeled, distributed, sold or marketed by or on behalf of any Trilogy Pharmacy Company that are subject to the jurisdiction of the FDA have been and are being prepared, assembled, packaged, labeled, distributed, sold and marketed in compliance, in all material respects, with the Public Health Laws. As of the Closing Date, no Trilogy Pharmacy Company is undergoing any inspection related to any activities or products that are subject to Public Health Laws, other than routine inspections occurring in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure ordinary course of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their Subsidiariesbusiness.

FDA Regulatory Compliance. (a) Each of the Credit Parties and their Subsidiaries have all Registrations from FDA or other Governmental Authority required to conduct their respective businesses as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To Except as set forth in Schedule 3.22, to the knowledge of the Credit Parties and their Subsidiaries, the FDA is not considering limiting, suspending, or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each Registration in all material respects, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their Subsidiaries. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Except as set forth in Schedule 3.22, the Credit Parties and their Subsidiaries are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31, 20042010, no product has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their Subsidiaries.

FDA Regulatory Compliance. Except as would not reasonably be expected to have a Company Material Adverse Effect: (a) Each The Company and its Subsidiaries are in compliance with all Laws, including all applicable statutes, rules, regulations, standards, guidelines, policies and orders, administered or issued by the U.S. Food and Drug Administration (“FDA”) or any comparable Governmental Entity (“FDA Laws”). (b) Without limiting any representations or warranties of the Credit Parties Company made in Section 3.16, the Company and their its Subsidiaries have all Registrations authorizations, approvals, clearances, licenses, permits, certificates, registrations or exemptions (collectively, “Registrations”) from the FDA or other Governmental Authority Entities required to conduct their respective businesses as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, the FDA is not considering limiting, suspending, or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there There is no false or misleading information or significant omission in any product application or other submission made by the Company or its Subsidiaries to the FDA or any comparable Governmental AuthorityEntity. The Credit Parties Company and their its Subsidiaries have fulfilled and performed their respective obligations under each Registration in all material respectsRegistration, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectRegistration. To the knowledge Knowledge of the Credit Parties and their SubsidiariesCompany, any all third party parties that is a manufacturer are manufacturers, contractors, or contractor suppliers for the Credit Parties Company and their its Subsidiaries is are in compliance with all Registrations from the FDA or comparable Governmental Authority Entities insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesCompany. (bc) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties Company and their its Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority Entities have been and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of LawLaws, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, installation, service and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse EffectLaws. (cd) The Credit Parties Company and their its Subsidiaries are not subject to any obligation arising under an any pending administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental AuthorityEntity. The Credit Parties Company and their its Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as of the date of submission to FDA or any comparable Governmental AuthorityEntity. (de) Since December 31January 1, 20042006, no product of the Company or any of its Subsidiaries has been seized, withdrawn, recalled, detained, or become subject to a suspension of manufacturing except as disclosed on Schedule 3.22manufacturing, and to the Company’s Knowledge there are no facts or circumstances reasonably likely to cause, cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any product; , (ii) a significant change in the labeling of any product; product required by FDA or comparable Governmental Entity, or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to product as a result in a Material Adverse Effectof the Company’s noncompliance with applicable Law. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their SubsidiariesCompany’s Knowledge, threatened against the Credit Parties and their Company or its Subsidiaries.

FDA Regulatory Compliance. (a) Each Loan Party and each of the Credit Parties and their Subsidiaries have has, and it and its products are in conformance with, all Registrations from registrations, listings, authorizations, approvals, licenses, permits, clearances, certificates and exemptions (including new drug applications, abbreviated new drug applications, biologics license applications, investigational new drug applications, over-the-counter drug monograph, device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits) issued or allowed by the FDA or other any comparable Governmental Authority Authority, including but not limited to Health Canada (hereinafter “Registrations”) that are required to conduct their respective businesses its business as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiarieseach Loan Party, neither the FDA nor any comparable Governmental Authority, including but not limited to Health Canada, is not considering limiting, suspending, or revoking any such Registrations or changing the marketing classification or labeling of the products of the Credit Registration. The Loan Parties and their Subsidiaries. To the knowledge each of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each Registration in all material respectsRegistration, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of of, any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their SubsidiariesRegistration. (b) All products developed, manufactured, tested, distributed or marketed by or on behalf Each Loan Party and each of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been conducting their business and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold operations in compliance in all material respects with FDA Laws or all applicable Public Health Laws. No Loan Party nor any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect. (c) The Credit Parties and their Subsidiaries are not is subject to any obligation arising under an administrative or regulatory action, proceeding, investigation or inspection by or on behalf of the FDA inspectionor any comparable Governmental Authority, FDA including but not limited to Health Canada, warning letter, FDA Form FDA-483, untitled letter, notice of violation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority, and no such obligation has been threatened. The Credit Parties and All products designed, developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold or marketed by or on behalf of any Loan Party or any of their Subsidiaries have made all notifications, submissions, and reports required by any such obligation, and all such notifications, submissions and reports were true, complete, and correct in all material respects as that are subject to the jurisdiction of the date of submission to FDA or any comparable Governmental Authority. (d) Since December 31Health Canada have been and are being designed, 2004developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance with the Public Health Laws. As of the Effective Date, no product has been seized, withdrawn, recalled, detained, Loan Party nor any of their Subsidiaries is undergoing any inspection related to any activities or become products of the Loan Parties or any of their Subsidiaries that are subject to a suspension of manufacturing except as disclosed on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could reasonably be expected to result in a Material Adverse Effect. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any product are pending or, to the knowledge of the Credit Parties and their Subsidiaries, threatened against the Credit Parties and their SubsidiariesPublic Health Laws.

FDA Regulatory Compliance. (a) Each of the Credit Parties The Company and their its Subsidiaries have all Registrations from FDA or other Governmental Authority required to conduct their respective businesses as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, the FDA is not considering limiting, suspending, or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each Registration in all material respects, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is operated in compliance with all Registrations from applicable Laws including, without limitation, FDA Laws, and other requirements related to any of the FDA products or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their Subsidiaries. (b) All products services developed, manufactureddesigned, tested, produced, marketed, licensed, sold, distributed or marketed performed by or on behalf of the Credit Parties Company or any of its Subsidiaries (the "Company Products"), whether contractual, statutory, regulatory, or imposed by company policies, customers, or third-party certification bodies. Each Company Product has been and their Subsidiaries that are subject to the jurisdiction currently is compliant with all applicable Laws and has been and currently is in material conformity with all applicable Contracts of the FDA or comparable Governmental Authority have been Company. (b) The Company's employees and are being developedagents hold all approvals, testedclearances, manufacturedpermits, distributed licenses, variances, registrations, exemptions, Orders, consents, certifications, authorizations and marketed in compliance with approvals from the FDA Laws or U.S. Food and Drug Administration (the "FDA") and any other applicable Requirement Governmental Entity with jurisdiction over Company Products (any such Governmental Entity, a "Company Regulatory Agency") necessary for the lawful operating of Lawthe businesses of the Company and each of its Subsidiaries as currently conducted (the "Company Regulatory Permits"), including, without limitationbut not limited to, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, all authorizations required under FDA Laws. Each of the Company and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold each of its Subsidiaries is in compliance in all material respects with FDA Laws the requirements associated with all Company Regulatory Permits. Except as disclosed in Schedule 3.23(b), each Company Regulatory Permit is held by the Companies or one of their Subsidiaries, as applicable, and is valid and in full force and effect and will not be terminated or impaired (or become terminated or impaired) as a result of the transactions contemplated by this Agreement. Neither the Companies nor any of their Subsidiaries is in default under and no condition exists that with notice or lapse of time or both would constitute a default or violation under, any Company Regulatory Permit held by the Companies or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effecttheir Subsidiaries. (c) The Credit Parties and their Except as set forth on Schedule 3.23(c), neither Company nor any of its Subsidiaries are not subject to have received any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA written notice of violation letter, or other notice, response or commitment made to or with that the FDA or any comparable Governmental Authority. The Credit Parties other applicable Regulatory Authority has commenced or initiated, or to the Knowledge of the Company threatened to commence or initiate, any action to withdraw any Company Regulatory Permit, requested a recall (whether by correction or removal) of any Products, or commenced or initiated or to the Knowledge of the Company threatened to commence or initiate, any Action to enjoin any Product Development and their Subsidiaries have made all notificationsCommercialization Activities. (d) All applications, submissions, information and reports required data utilized by the Company or any such obligationof its Subsidiaries as the basis for, or submitted by or on behalf of the Company or any of its Subsidiaries in connection with any and all such notificationsrequests for a Company Regulatory Permit relating to the Company or any of its Subsidiaries, submissions and reports when submitted to the FDA or any other Company Regulatory Agency, were true, complete, correct and correct complete in all material respects as of the date of submission submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or any comparable Governmental Authority. (d) Since December 31other Company Regulatory Agency. None of the Company or its Subsidiaries nor, 2004to the Company's Knowledge, no product any director, officer, employee, agent or representative thereof, has been seizedcommitted any act, withdrawn, recalled, detained, made any statement or become subject failed to a suspension of manufacturing except as disclosed on Schedule 3.22, and there are no facts or circumstances reasonably likely to cause, (i) the seizure, denial, withdrawal, recall, detention, field correction, safety alert or suspension of manufacturing relating to make any product; (ii) a change in the labeling of any product; or (iii) a termination, seizure or suspension of marketing of any product, which could statement that would reasonably be expected to result provide a basis for the FDA to invoke its policy with respect to "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities," as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto, or a Material Adverse Effect. No proceedings in the United States or similar policy enforced by any other jurisdiction seeking Company Regulatory Agency. (e) None of the withdrawal, recall, suspension, import detention, Company or seizure of any product are pending orits Subsidiaries nor, to the knowledge of the Credit Parties and their SubsidiariesCompany, any representatives thereof, has engaged in any activity that would result in a material violation under applicable U.S. federal or state criminal or civil health care Laws (including without limitation the FDA Laws). There is no civil, criminal, administrative or other proceeding, notice or demand pending, received or, to the Company's Knowledge, threatened against the Credit Parties Company or any of its Subsidiaries or any Seller that relates to an alleged violation of any FDA Laws. There are no orders or similar actions to which the Company or any of its Subsidiaries or, to the Company's Knowledge, any director, officer, employee, agent or representative thereof, are bound or which relate to Company Products, or alleged violation of any FDA Laws. (f) All preclinical, nonclinical, and clinical trials that are or have been sponsored or conducted by or behalf of the Companies and their Subsidiaries are listed in Schedule 3.23(f). The Company and its Subsidiaries have complied with all applicable FDA Laws, in carrying out any testing and clinical studies conducted by or on behalf of the Company and its Subsidiaries. Each of the Company and its Subsidiaries has filed all required notices (and made available to Buyer copies thereof) of design defects, product problems, adverse events, injuries and deaths arising from clinical trials conducted by or on behalf of the Company or any of its Subsidiaries with respect to such Company Products. None of the Company or its Subsidiaries nor, to the Company's Knowledge, any of the representatives, licensors, licensees, assignors or assignees thereof has received any notice that the FDA or any other Company Regulatory Agency has initiated, or threatened to initiate, any action to suspend or place restrictions on any clinical trial, suspend or terminate any Investigational Device Exemption or comparable clinical trial application sponsored by the Company or any of its Subsidiaries or otherwise restrict the pre-clinical research related to or clinical study of any Company Product or any medical device or component being developed by any licensee or assignee of the Company's intellectual property based on such intellectual property, or to recall, suspend or otherwise restrict the development or manufacture of any Company Product. (g) Except as set forth in Schedule 3.23(g), the Company and its Subsidiaries have not received written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, FDA Form 483 observation, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, penalty, untitled letter, warning letter, seizure, injunction, prosecution, or other compliance or enforcement action relating to any Company Products or to the business of the Company. To the Knowledge of the Company, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such action. All deficiencies and non-conformities discovered during internal audits, customer audits, and government or certifying body inspections have been corrected and resolved. (h) The Company and its Subsidiaries have made available to Buyer true, correct and complete copies of any and all material applications, approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or any other Company Regulatory Agency, including documents that indicate or suggest lack of compliance with the regulatory requirements of the FDA or any other Company Regulatory Agency. The Company and its Subsidiaries have made available to Buyer for review all material correspondence to or from the FDA or any other Company Regulatory Agency, minutes of meetings, written reports of phone conversations, visits or other contact with the FDA or any other Company Regulatory Agency, and all other documents concerning communications to or from the FDA or any other Company Regulatory Agency, or prepared by the FDA or any other Company Regulatory Agency or which bear in any way on the Company's or any of its Subsidiaries' compliance with regulatory requirements of the FDA or any other Company Regulatory Agency, or on the likelihood or timing of approval of any Company Products.