Common use of Compliance with Legal Requirements; Regulatory Matters Clause in Contracts

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Alamo Corporations is, and has during the past two years been, in compliance in all material respects with all applicable Legal Requirements, including Environmental Laws and Legal Requirements relating to employment, privacy law matters, exportation of goods and services, securities law matters and Taxes, and all applicable Health Care Laws, which affect the business, properties, assets and activities of the Alamo Corporations. During the past five years, none of the Alamo Corporations has received any notice or other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect with, any Legal Requirement. (b) All Company Products subject to the jurisdiction of the FDA or Governmental Bodies which administer Health Care Laws in other jurisdictions are being marketed, sold, distributed, developed, manufactured, labeled, stored, tested and otherwise produced by or on behalf of the Alamo Corporations in compliance in all material respects with all applicable requirements under Health Care Laws. Part 2.12(b) of the Disclosure Schedule sets forth a complete and correct list of all Regulatory Authorizations from the FDA, or any other Governmental Body which administers Health Care Laws, held by the Alamo Corporations, and there are no other Regulatory Authorizations required for the Alamo Corporations or the Company Products in connection with the conduct of the business of the Alamo Corporations as currently conducted. (c) Neither any of the Alamo Corporations nor, to the knowledge of the Company, any officer, employee or agent of any of the Alamo Corporations, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body which administers Health Care Laws, 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 provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities" Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the "FDA Ethics Policy") or any similar policy. (d) All preclinical and clinical trials in respect of the activities of the Alamo Corporations being conducted by or on behalf of the Alamo Corporations are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including but not limited to, the FDA Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and all applicable laws of the relevant Governmental Bodies outside the United States. No clinical trial conducted by or on behalf of the Alamo Corporations has been terminated or suspended by the FDA or any other applicable Governmental Body, and neither the FDA nor any other applicable Governmental Body has commenced or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any of the Alamo Corporations. (e) No Company Product has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise) or has been the subject of any "dear doctor" notifications, investigator notices, safety alerts, or other notice of action related to an alleged lack of safety, efficacy, or regulatory compliance. No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product or product candidate or pre-market approvals or marketing authorizations are pending, or to the knowledge of the Company, threatened, against the Company or any of its affiliates, nor have any such proceedings been pending at any time. The Company has, prior to the execution of this Agreement, provided or Made Available to Parent accurate summaries of all significant adverse drug experiences relating to any Company Product and with respect to which information has been obtained or otherwise received by any of the Alamo Corporations prior to the date of this Agreement from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, the Company (and each of the Alamo Corporations, as applicable) has filed all annual and periodic reports, amendments and safety reports required for any Company Product required to be made to the FDA or any other Governmental Body. (f) All batches and doses of any Company Product that is or was previously marketed, sold, or distributed by any of the Alamo Corporations have been manufactured in conformance with cGMP and the product specifications set forth in any applicable Company Contract Manufacturing Agreements. To the extent any batches or doses of any drug product deviated from cGMP and the product specifications, all such batches or doses were destroyed in accordance with applicable industry standards and the terms of any applicable Company Contract Manufacturer Agreements, and the Company possesses written records documenting any such destruction. (g) No manufacturing site which assists in the manufacture of a Company Product has been subject to a Governmental Body (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Body notice of inspectional observations, "warning letters," "untitled letters" or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Health Care Laws or Regulatory Authorizations, and, to the knowledge of the Company, neither the FDA nor any Governmental Body is considering such action. (h) The Alamo Corporations are not the subject of any pending or, to the knowledge of the Company, threatened investigation in respect of any Alamo Corporation employee, officer or agent by the FDA pursuant to the FDA Ethics Policy. Neither any of the Alamo Corporations nor any of their respective officers, employees or agents, has been debarred, suspended or excluded under 21 U.S.C. Section 335a or has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in a debarment, suspension or exclusion under 21 U.S.C. Section 335a, or any similar laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions of any Governmental Body. (i) As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened against any of the Alamo Corporations or their officers, consultants, employees or agents. (j) The Alamo Corporations are not a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Body.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Alamo Abeline Corporations is, and has during the past two years been, in compliance in all material respects with all applicable Legal Requirements, including Environmental Laws and Legal Requirements relating to employment, privacy law matters, exportation of goods and services, securities law matters and Taxes, and all applicable Health Care Laws, which affect the business, properties, assets and activities of the Alamo Abeline Corporations. During the past five years, none of the Alamo Abeline Corporations has received any notice or other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect with, any Legal Requirement. (b) All Company Parent Products subject to the jurisdiction of the FDA or Governmental Bodies which administer Health Care Laws in other jurisdictions are being marketed, sold, distributed, developed, manufactured, labeled, stored, tested and otherwise produced by or on behalf of the Alamo Abeline Corporations in compliance in all material respects with all applicable requirements under Health Care Laws. Part 2.12(b3.12(b) of the Disclosure Schedule sets forth a complete and correct list of all Regulatory Authorizations from the FDA, or any other Governmental Body which administers Health Care Laws, held by the Alamo Abeline Corporations, and there are no other Regulatory Authorizations required for the Alamo Abeline Corporations or the Company Parent Products in connection with the conduct of the business of the Alamo Abeline Corporations as currently conducted. (c) Neither any of the Alamo Abeline Corporations nor, to the knowledge of the CompanyParent, any officer, employee or agent of any of the Alamo Abeline Corporations, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body which administers Health Care Laws, 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 provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities" Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the "FDA Ethics Policy") Policy or any similar policy. (d) All preclinical and clinical trials in respect of the activities of the Alamo Abeline Corporations being conducted by or on behalf of the Alamo Abeline Corporations are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including but not limited to, the FDA Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and all applicable laws of the relevant Governmental Bodies outside the United States. No clinical trial conducted by or on behalf of the Alamo Abeline Corporations has been terminated or suspended by the FDA or any other applicable Governmental Body, and neither the FDA nor any other applicable Governmental Body has commenced or, to the knowledge of the CompanyParent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any of the Alamo Abeline Corporations. (e) No Company Parent Product has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise) or has been the subject of any "dear doctor" notifications, investigator notices, safety alerts, or other notice of action related to an alleged lack of safety, efficacy, or regulatory compliance. No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product or product candidate or pre-market approvals or marketing authorizations are pending, or to the knowledge of the CompanyParent, threatened, against the Company Parent or any of its affiliates, nor have any such proceedings been pending at any time. The Company Parent has, prior to the execution of this Agreement, provided or Made Available to Parent the Company accurate summaries of all significant adverse drug experiences relating to any Company Parent Product that have occurred and with respect to which information has been obtained or otherwise received by any of the Alamo Abeline Corporations prior to the date of this Agreement from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific paperspapers . In addition, the Company Parent (and each of the Alamo Abeline Corporations, as applicable) has filed all annual and periodic reports, amendments and safety reports required for any Company Parent Product required to be made to the FDA or any other Governmental Body. (f) All batches and doses of any Company Parent Product that is or was previously marketed, sold, or distributed by any of the Alamo Abeline Corporations have been manufactured in conformance with cGMP and the product specifications set forth in any applicable Company Parent Contract Manufacturing Agreements. To the extent any batches or doses of any drug product deviated from cGMP and the product specifications, all such batches or doses were destroyed in accordance with applicable industry standards and the terms of any applicable Company Parent Contract Manufacturer Agreements, and the Company Parent possesses written records documenting any such destruction. (g) No manufacturing site which assists in the manufacture of a Company Parent Product has been subject to a Governmental Body (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Body notice of inspectional observations, "warning letters," "untitled letters" or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Health Care Laws or Regulatory Authorizations, and, to the knowledge of the CompanyParent, neither the FDA nor any Governmental Body is considering such action. (h) The Alamo Abeline Corporations are not the subject of any pending or, to the knowledge of the CompanyParent, threatened investigation in respect of any Alamo Abeline Corporation employee, officer or agent by the FDA pursuant to the FDA Ethics Policy. Neither any of the Alamo Abeline Corporations nor any of their respective officers, employees or agents, has been debarred, suspended or excluded under 21 U.S.C. Section 335a or has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in a debarment, suspension or exclusion under 21 U.S.C. Section 335a, or any similar laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions of any Governmental Body. (i) As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the CompanyParent, threatened against any of the Alamo Abeline Corporations or their officers, consultants, employees or agents. (j) The Alamo Abeline Corporations are not a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Body.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Alamo Corporations The Company is, and since January 3, 2020 has during the past two years been, in compliance in all material respects with all applicable Legal RequirementsRequirements and Healthcare Laws. Since January 3, including Environmental Laws and Legal Requirements relating to employment2020, privacy law matters, exportation of goods and services, securities law matters and Taxes, and all applicable Health Care Laws, which affect the business, properties, assets and activities of the Alamo Corporations. During the past five years, none of the Alamo Corporations Company has received any not been given written notice or other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect been charged with, any material violation of any Legal RequirementRequirements and Healthcare Laws. (b) All Since January 3, 2020: (i) the Company Products subject has filed with the applicable Regulatory Authority all material required filings, applications, licenses, declarations, listings, registrations, reports or submissions, including but not limited to the jurisdiction adverse event reports and has otherwise complied with all requirements of the FDA applicable Regulatory Authority. All such filings, applications, licenses, declarations, listings, registrations, reports or Governmental Bodies which administer Health Care submissions were in material compliance with applicable Legal Requirements and Healthcare Laws when filed (or were corrected or supplemented in other jurisdictions are being marketeda subsequent filing), soldand no material deficiencies have been asserted in writing by any applicable Regulatory Authority with respect to any such filings, distributedapplication, developedlicenses, manufactureddeclarations, labeledlistings, storedregistrations, tested reports or submissions; (ii) the Company holds all Regulatory Permits required for the Company to conduct its business as currently conducted, and otherwise produced by or on behalf of the Alamo Corporations each such Regulatory Permit is valid and is in full force and effect. The Company is in compliance in all material respects with all the terms and requirements of such Regulatory Permits. No deficiencies have been asserted in writing or in any other communication by, or from, any applicable requirements under Health Care Laws. Part 2.12(b) Regulatory Authority with respect to any Regulatory Permits of the Disclosure Schedule sets forth a complete and correct list of all Regulatory Authorizations from Company that have not since been resolved; (iii) the FDACompany has not made any false, misleading, or any other Governmental Body which administers Health Care Laws, held by the Alamo Corporations, and there are no other Regulatory Authorizations required for the Alamo Corporations or the Company Products in connection with the conduct of the business of the Alamo Corporations as currently conducted. (c) Neither any of the Alamo Corporations nor, to the knowledge of the Company, any officer, employee or agent of any of the Alamo Corporations, has made an untrue statement of a material fact fact, or fraudulent statement to the FDA or any other Governmental Body which administers Health Care Laws, failed to disclose a material fact required to be disclosed disclosed, to the FDA or any other Governmental Body which administers Health Care LawsRegulatory Authority, or nor committed an any act, made a any statement, or failed to make a any statement that, at the time such disclosure was made, that would reasonably be expected likely to provide a basis for the FDA or any other such Governmental Body U.S. Food and Drug Administration (the “FDA”) to invoke its policy respecting "with respect to “Fraud, Untrue Statements of Material Facts, Bribery, Bribery and Illegal Gratuities" Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and ,” or for any amendments thereto (the "FDA Ethics Policy") or other Regulatory Authority to invoke any similar policy.; (div) All all preclinical studies and clinical trials in respect of the activities of the Alamo Corporations being sponsored or conducted by or on behalf of the Alamo Corporations are being or Company have been conducted in material compliance in all material respects with applicable Legal Requirements and Healthcare Laws; (v) the required experimental protocolsCompany and its employees, procedures and controlsofficers, and all applicable Health Care Laws, including but directors have not limited to, the FDA Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and all applicable laws of the relevant Governmental Bodies outside the United States. No clinical trial conducted by or on behalf of the Alamo Corporations has been terminated or suspended by the FDA or any other applicable Governmental Body, and neither the FDA nor any other applicable Governmental Body has commenced or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any of the Alamo Corporations. (e) No Company Product has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise) or has been the subject of any "dear doctor" notifications, investigator notices, safety alerts, or other notice of action related to an alleged lack of safety, efficacy, or regulatory compliance. No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product or product candidate or pre-market approvals or marketing authorizations are pending, or to the knowledge of the Company, threatened, against the Company or any of its affiliates, nor have any such proceedings been pending at any time. The Company has, prior to the execution of this Agreement, provided or Made Available to Parent accurate summaries of all significant adverse drug experiences relating to any Company Product and with respect to which information has been obtained or otherwise received by any of the Alamo Corporations prior to the date of this Agreement from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, the Company (and each of the Alamo Corporations, as applicable) has filed all annual and periodic reports, amendments and safety reports required for any Company Product required to be made to the FDA or any other Governmental Body. (f) All batches and doses of any Company Product that is or was previously marketed, sold, or distributed by any of the Alamo Corporations have been manufactured in conformance with cGMP and the product specifications set forth in any applicable Company Contract Manufacturing Agreements. To the extent any batches or doses of any drug product deviated from cGMP and the product specifications, all such batches or doses were destroyed in accordance with applicable industry standards and the terms of any applicable Company Contract Manufacturer Agreements, and the Company possesses written records documenting any such destruction. (g) No manufacturing site which assists in the manufacture of a Company Product has been subject to a Governmental Body (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Body notice of inspectional observations, "warning letters," "untitled letters" or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Health Care Laws or Regulatory Authorizationsbeen, and, to the knowledge of the Company, neither no agent, contractor, or supplier acting on behalf of, or providing products or services to, the Company has been, (i) debarred (under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a(a) and (b) or any similar Legal Requirements and Healthcare Laws), (ii) excluded from participation in United States federal health care programs (under the provisions of 42 U.S.C. § 1320a-7 or any similar Legal Requirements and Healthcare Laws), (iii) convicted of a crime for which a Person can be debarred or excluded or (iv) threatened in writing to be debarred or excluded; (vi) the Company has not (i) received from the FDA nor any Governmental Body is considering such action. warning letter or untitled letter or (hii) The Alamo Corporations are not the subject of any pending or, to the knowledge of the Company, threatened investigation in respect been the subject of any Alamo Corporation employeeLegal Proceeding commenced by or on behalf of a Regulatory Authority, officer or agent by including the FDA pursuant to FDA, the FDA Ethics Policy. Neither any DEA, the DOJ, the United States Department of the Alamo Corporations nor any Health and Human Services Office of their respective officers, employees or agents, has been debarred, suspended or excluded under 21 U.S.C. Section 335a or has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in a debarment, suspension or exclusion under 21 U.S.C. Section 335aInspector General (“OIG”), or any similar laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions of any Governmental Body.foreign Regulatory Authority; (ivii) As of the date hereofCompany has not become, no claims, actions, proceedings or investigations that would reasonably continued to be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened against any of the Alamo Corporations or their officers, consultants, employees or agents. (j) The Alamo Corporations are not a party to, or been required to enter into any corporate integrity agreements, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, or other similar agreements written agreement, in each case, with or imposed by any Regulatory Authority, including the FDA, the DEA, the DOJ, the OIG, or any similar foreign Regulatory Authority; (viii) the Company is not authorized to bill, nor have they directly claimed or received reimbursement from, any Governmental BodyProgram or from any other Third-Party Payor Program for services reimbursable under such programs; and (ix) Prior to the date of this Agreement, the Company has delivered to Parent all material data and other material information known to the Company with respect to the products under development by the Company, including the quality, safety or efficacy thereof.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Alamo Corporations isExcept as has not had, and has during would not reasonably be expected to have, individually or in the past two years aggregate, a Material Adverse Effect, the Company and its Subsidiaries are, and since April 30, 2021 have been, in compliance in all material respects with all applicable Legal Requirements, including Environmental Laws and Healthcare Laws. To the knowledge of the Company, no Legal Proceeding is pending or threatened against the Company or its Subsidiaries alleging any material breach or violation of, material non-compliance with, or default under any such Legal Requirements relating to employment, privacy law matters, exportation in connection with the conduct of goods and services, securities law matters and Taxes, and all applicable Health Care Laws, which affect the business. Since April 30, properties2021, assets and activities neither the Company nor any of the Alamo Corporations. During the past five years, none its Subsidiaries have been given written notice of the Alamo Corporations has received any notice or other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect ofalleged violation, or failure to comply in been charged with, any material respect with, violation of any Legal Requirement. (b) All Since April 30, 2021, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect: (i) neither the Company Products subject to the jurisdiction nor any of the FDA or Governmental Bodies which administer Health Care Laws in other jurisdictions are being marketedits Subsidiaries has made any false, sold, distributed, developed, manufactured, labeled, stored, tested and otherwise produced by or on behalf of the Alamo Corporations in compliance in all material respects with all applicable requirements under Health Care Laws. Part 2.12(b) of the Disclosure Schedule sets forth a complete and correct list of all Regulatory Authorizations from the FDAmisleading, or any other Governmental Body which administers Health Care Laws, held by the Alamo Corporations, and there are no other Regulatory Authorizations required for the Alamo Corporations or the Company Products in connection with the conduct of the business of the Alamo Corporations as currently conducted. (c) Neither any of the Alamo Corporations nor, to the knowledge of the Company, any officer, employee or agent of any of the Alamo Corporations, has made an untrue statement of a material fact fact, or fraudulent statement to the FDA or any other Governmental Body which administers Health Care Laws, failed to disclose a material fact required to be disclosed disclosed, to the FDA or any other Governmental Body which administers Health Care LawsBody, or nor committed an any act, made a any statement, or failed to make a any statement that, at the time such disclosure was made, that would reasonably be expected likely to provide a basis for the FDA or any other such Governmental Body U.S. Food and Drug Administration (the “FDA”) to invoke its policy respecting "with respect to “Fraud, Untrue Statements of Material Facts, Bribery, Bribery and Illegal Gratuities" Final Policy set forth in 56 Fed. Reg. 46191 ,” or for any other Governmental Body to invoke any similar policy; (September 10ii) neither the Company nor any of its Subsidiaries has experienced a theft or significant loss of controlled substances or listed chemicals that would require reporting to any Governmental Body, 1991) and any amendments thereto including the U.S. Drug Enforcement Administration (the "FDA Ethics Policy"“DEA”) or any similar policy. (d) All preclinical and clinical trials in respect of the activities of the Alamo Corporations being conducted by or on behalf of the Alamo Corporations are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including but not limited to, the FDA Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and all applicable laws of the relevant Governmental Bodies outside the United States. No clinical trial conducted by or on behalf of the Alamo Corporations has been terminated or suspended by the FDA or any other applicable foreign Governmental Body, or experienced any diversion of controlled substances or listed chemicals or any breach of the security systems and neither procedures required under any applicable Legal Requirement governing the FDA nor Company’s and its Subsidiaries’ development, testing, investigation, manufacture, storage, handling, transportation, distribution, marketing, or sale of products; (iii) all products manufactured by the Company and its Subsidiaries have been developed, tested, sourced, manufactured, distributed, exported, imported, stored, handled, and sold in compliance with all Healthcare Laws; and no product manufactured, distributed, or sold by the Company or its Subsidiaries has been adulterated or misbranded by the Company, seized, withdrawn, recalled, detained, or subject to any other applicable Governmental Body has commenced orsuspension of manufacturing, to import hold or refusal, field notification, field correction, or safety alert. To the knowledge of the Company, threatened there has occurred no change reasonably likely to initiate, any action to place cause (a) a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any of change in the Alamo Corporations. (e) No Company Product has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise) or has been the subject of any "dear doctor" notifications, investigator notices, safety alerts, or other notice of action related to an alleged lack of safety, efficacy, or regulatory compliance. No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure manufacture of any such product or product candidate or pre-market approvals or marketing authorizations are pendingoutside the ordinary course of business, (b) a suspension of manufacturing, seizure, denial, withdrawal, recall, detention, import alert, field notification, field correction, or safety alert relating to the knowledge any such product, (c) a termination, seizure, or suspension of the Companymarketing of any such product, threatened, against or (d) a product to become adulterated or misbranded; (iv) neither the Company or nor any of its affiliates, Subsidiaries nor have any such proceedings been pending at any time. The Company has, prior to the execution of this Agreement, provided or Made Available to Parent accurate summaries of all significant adverse drug experiences relating to any Company Product and with respect to which information has been obtained or otherwise received by any of the Alamo Corporations prior to the date of this Agreement from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, the Company (and each of the Alamo Corporations, as applicable) has filed all annual and periodic reports, amendments and safety reports required for any Company Product required to be made to the FDA or any other Governmental Body. (f) All batches and doses of any Company Product that is or was previously marketed, sold, or distributed by any of the Alamo Corporations have been manufactured in conformance with cGMP and the product specifications set forth in any applicable Company Contract Manufacturing Agreements. To the extent any batches or doses of any drug product deviated from cGMP and the product specifications, all such batches or doses were destroyed in accordance with applicable industry standards and the terms of any applicable Company Contract Manufacturer Agreements, and the Company possesses written records documenting any such destruction. (g) No manufacturing site which assists in the manufacture of a Company Product has been subject to a Governmental Body (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Body notice of inspectional observations, "warning letters," "untitled letters" or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Health Care Laws or Regulatory AuthorizationsAssociate, and, to the knowledge of the Company, neither no agent, contractor, or supplier acting on behalf of, or providing products or services to, the FDA nor any Governmental Body is considering such action. (h) The Alamo Corporations are not the subject of any pending or, to the knowledge of the Company, threatened investigation in respect of any Alamo Corporation employee, officer or agent by the FDA pursuant to the FDA Ethics Policy. Neither any of the Alamo Corporations nor any of their respective officers, employees or agents, Company and its Subsidiaries has been debarred, suspended or excluded under 21 U.S.C. Section 335a or has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in a debarmentbeing (a) debarred (under the provisions of the Generic Drug Enforcement Act of 1992, suspension or exclusion under 21 U.S.C. § 335a(a) and (b) or any similar Legal Requirement), (b) excluded from participation in United States federal health care programs (under the provisions of 42 U.S.C. § 1320a-7 or any similar Legal Requirement), (c) convicted of a crime for which a Person can be debarred or excluded, (d) threatened to be debarred or excluded, (e) prohibited from participating in any procurement program of or otherwise contracting with any Governmental Body; or (f) subject to any equivalent sanction described in this Section 335a2.13(b)(iv) in any foreign jurisdiction; (v) neither the Company nor any of its Subsidiaries has (a) received from the FDA any Form FDA-483, notice of adverse finding, warning letter or untitled letter, or any other written notice from the FDA or any other Governmental Body alleging or asserting noncompliance with any applicable Healthcare Laws or Governmental Authorizations, or (b) been the subject of any Legal Proceeding commenced by or on behalf of a Governmental Body, including the FDA, the DEA, the DOJ, the United States Department of Health and Human Services Office of the Inspector General of the (“OIG”), or any similar laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions of any foreign Governmental Body.; (ivi) As of neither the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened against Company nor any of the Alamo Corporations or their officersits Subsidiaries has become, consultants, employees or agents. (j) The Alamo Corporations are not continued to be a party to, or been requested to enter into any corporate integrity agreements, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, or other similar agreements written agreement, in each case, with or imposed by any Governmental Body, including the FDA, the DEA, the DOJ, the OIG, or any similar foreign Governmental Body; (vii) the Company and its Subsidiaries have been in compliance with all Legal Requirements regarding the retention and integrity of records and documents. All reports, data, documents, forms, claims, permits, submissions, filings, notices, applications, and records required to be filed with, maintained in connection with, or furnished to a Governmental Body by the Company and its Subsidiaries have been so filed, maintained, or furnished, and all such reports, data, documents, forms, claims, permits, submissions, filings, notices, applications, and records were true and complete on the date filed (or, to the extent required to be updated or corrected, were updated or corrected to be true, accurate and complete as of the date of such update); and (viii) the Company and its Subsidiaries have not been authorized to bill, nor have they directly claimed or received reimbursement from, any Governmental Program or from any other Third-Party Payor Program for services reimbursable under such programs.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Alamo Alaska Corporations is, and has during the past two years been, in compliance in all material respects with all applicable Legal Requirements, including Environmental Laws and Legal Requirements relating to employment, privacy law matters, exportation of goods and services, securities law matters and Taxes, and all applicable Health Care Laws, which affect the business, properties, assets and activities of the Alamo Alaska Corporations. During the past five years, none of the Alamo Alaska Corporations has received any notice or other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect with, any Legal Requirement. (b) All Company Products subject to the jurisdiction of the FDA or Governmental Bodies which administer Health Care Laws in other jurisdictions are being marketed, sold, distributed, developed, manufactured, labeled, stored, tested and otherwise produced by or on behalf of the Alamo Alaska Corporations in compliance in all material respects with all applicable requirements under Health Care Laws. Part 2.12(b3.12(b) of the Disclosure Schedule sets forth a complete and correct list of all Regulatory Authorizations from the FDA, or any other Governmental Body which administers Health Care Laws, held by the Alamo Alaska Corporations, and there are no other Regulatory Authorizations required for the Alamo Alaska Corporations or the Company Products in connection with the conduct of the business of the Alamo Alaska Corporations as currently conducted. (c) Neither any of the Alamo Alaska Corporations nor, to the knowledge of the Company, any officer, employee or agent of any of the Alamo Alaska Corporations, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body which administers Health Care Laws, 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 provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting "“Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities" Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the "FDA Ethics Policy") or any similar policy. (d) All preclinical and clinical trials in respect of the activities of the Alamo Corporations being conducted by or on behalf of the Alamo Corporations are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including but not limited to, the FDA Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and all applicable laws of the relevant Governmental Bodies outside the United States. No clinical trial conducted by or on behalf of the Alamo Corporations has been terminated or suspended by the FDA or any other applicable Governmental Body, and neither the FDA nor any other applicable Governmental Body has commenced or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any of the Alamo Corporations. (e) No Company Product has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise) or has been the subject of any "dear doctor" notifications, investigator notices, safety alerts, or other notice of action related to an alleged lack of safety, efficacy, or regulatory compliance. No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product or product candidate or pre-market approvals or marketing authorizations are pending, or to the knowledge of the Company, threatened, against the Company or any of its affiliates, nor have any such proceedings been pending at any time. The Company has, prior to the execution of this Agreement, provided or Made Available to Parent accurate summaries of all significant adverse drug experiences relating to any Company Product and with respect to which information has been obtained or otherwise received by any of the Alamo Corporations prior to the date of this Agreement from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, the Company (and each of the Alamo Corporations, as applicable) has filed all annual and periodic reports, amendments and safety reports required for any Company Product required to be made to the FDA or any other Governmental Body. (f) All batches and doses of any Company Product that is or was previously marketed, sold, or distributed by any of the Alamo Corporations have been manufactured in conformance with cGMP and the product specifications set forth in any applicable Company Contract Manufacturing Agreements. To the extent any batches or doses of any drug product deviated from cGMP and the product specifications, all such batches or doses were destroyed in accordance with applicable industry standards and the terms of any applicable Company Contract Manufacturer Agreements, and the Company possesses written records documenting any such destruction. (g) No manufacturing site which assists in the manufacture of a Company Product has been subject to a Governmental Body (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Body notice of inspectional observations, "warning letters," "untitled letters" or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Health Care Laws or Regulatory Authorizations, and, to the knowledge of the Company, neither the FDA nor any Governmental Body is considering such action. (h) The Alamo Corporations are not the subject of any pending or, to the knowledge of the Company, threatened investigation in respect of any Alamo Corporation employee, officer or agent by the FDA pursuant to the FDA Ethics Policy. Neither any of the Alamo Corporations nor any of their respective officers, employees or agents, has been debarred, suspended or excluded under 21 U.S.C. Section 335a or has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in a debarment, suspension or exclusion under 21 U.S.C. Section 335a, or any similar laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions of any Governmental Body. (i) As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened against any of the Alamo Corporations or their officers, consultants, employees or agents. (j) The Alamo Corporations are not a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Body.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Alamo Corporations is, and has during the past two years been, Deverra is not in compliance in all material respects with all applicable Legal Requirements, including Environmental Laws and Legal Requirements relating to employment, privacy law matters, exportation of goods and services, securities law matters and Taxes, and all applicable Health Care Laws, which affect the business, properties, assets and activities of the Alamo Corporations. During the past five years, none of the Alamo Corporations has received any notice or other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect ofof any Applicable Laws, including, without limitation, the rules, regulations, guidelines, guidance, or failure requirements of any Governmental Authority with respect to comply in research, development, manufacture, sale, labeling, storing, testing, distribution, record-keeping, reporting, import, export, advertising and promotion of or for the Products or otherwise relating to the Products or the Purchased Assets. Xxxxxxx has not received any material written notice of any asserted violation of Applicable Laws relating to the Purchased Assets or the Products. Xxxxxxx is not aware of any pending investigation of any Governmental Authority with respect with, any Legal Requirementto the Purchased Assets or the Products. (b) All Company Products subject of the activities of Deverra and its Affiliates relating to the jurisdiction of Products or the FDA or Governmental Bodies which administer Health Care Laws in other jurisdictions are being marketed, sold, distributed, developed, manufactured, labeled, stored, tested and otherwise produced by or on behalf of the Alamo Corporations Purchased Assets have been conducted in compliance in all material respects with all applicable requirements under Health Care all Applicable Laws. Part 2.12(b) Neither Deverra nor its Affiliates have received any written notice or other communication from any Governmental Authority alleging any violation of any Applicable Law relating to the Disclosure Schedule sets forth a complete and correct list of all Regulatory Authorizations from the FDA, or any other Governmental Body which administers Health Care Laws, held by the Alamo Corporations, and there are no other Regulatory Authorizations required for the Alamo Corporations Purchased Assets or the Company Products in connection with the conduct of the business of the Alamo Corporations as currently conductedProducts. (c) Neither any Xxxxxxx and its Affiliates possess all Registrations from Governmental Authorities, or required by Governmental Authorities to be obtained, in each case, necessary for the lawful conduct of the Alamo Corporations nor, their respective businesses as now conducted relating to the knowledge of Target IP or the CompanyProducts. All such Registrations are in full force and effect in all material respects and Deverra and its Affiliates have filed all reports, any officer, employee or agent of any of the Alamo Corporations, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body which administers Health Care Laws, 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 provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Briberynotifications and filings with, and Illegal Gratuities" Final Policy set forth have paid all regulatory fees to, the applicable Governmental Authority necessary to maintain all of such Registrations in 56 Fedfull force and effect. Reg. 46191 (September 10, 1991) Deverra and any amendments thereto (the "FDA Ethics Policy") or any similar policy. (d) All preclinical and clinical trials in respect of the activities of the Alamo Corporations being conducted by or on behalf of the Alamo Corporations its Affiliates are being or have been conducted in compliance in all material respects with the terms of all such Registrations. Neither Deverra nor its Affiliates have received written notice to the effect that a Governmental Authority was considering the amendment, termination, revocation or cancellation of any Registration. The consummation of the transactions contemplated under this Agreement, in and of itself, will not cause the revocation or cancellation of any Registration. (d) All Preclinical Studies performed by or on behalf of Deverra or any of its Affiliates with respect to or utilizing the Target IP or any Purchased Asset either (i) have been conducted in accordance, in all material respects, with applicable cGLP requirements, including those contained in 21 C.F.R. Part 58 or (ii) involved experimental research techniques that were not required experimental protocolsto be performed by a registered cGLP testing laboratory (with appropriate notice being given to FDA or the applicable Governmental Authority), but (in the case of this clause (ii)) employed the applicable procedures and controlscontrols generally used by qualified experts in the conduct of Preclinical Studies of products comparable to those being developed by Xxxxxxx. Neither Deverra nor its Affiliates have received any written notice from a Governmental Authority requiring the termination or suspension or material modification of any Preclinical Study with respect to the Products. (e) All human clinical trials to the extent conducted by or on behalf of Deverra or its Affiliates with respect to any Product have been and are being conducted, to the Knowledge of Deverra, in material compliance with all applicable regulatory requirements relating to cGCP, “Informed Consent” and “Institutional Review Boards”, as those terms are defined by FDA and in all applicable Drug Laws relating to clinical trials or the protection of human subjects, including those contained in the International Conference on Harmonization (“ICH”) E6: Good Clinical Practices Consolidated Guideline, and all applicable Health Care Laws, including but not limited to, the FDA Act and its applicable implementing regulations at in 21 C.F.R. Parts 50, 54, 56, 58 and 312, and all applicable laws the provisions governing the privacy of patient medical records under the Health Insurance Portability and Accountability Act of 1996 and the implementing regulations of the relevant Governmental Bodies outside United States Department of Health and Human Services, and all comparable foreign Drug Laws. Neither Deverra, nor to the United States. No clinical trial conducted by or Knowledge of Deverra anyone acting on behalf of the Alamo Corporations Xxxxxxx, has been terminated received any written notice that any Governmental Authority or suspended by the FDA Institutional Review Board has initiated, required, or any other applicable Governmental Body, and neither the FDA nor any other applicable Governmental Body has commenced or, to the knowledge of the Company, threatened to initiateinitiate or require, any action to place a the termination or suspension, including clinical hold order onholds, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf material modification of any of the Alamo Corporations. (e) No Company Product has been recalled, withdrawn, suspended clinical trials or discontinued (whether voluntarily or otherwise) or has been the subject of any "dear doctor" notifications, investigator notices, safety alerts, or other notice of action related to an alleged lack of safety, efficacy, or regulatory compliance. No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product or product candidate or prenon-market approvals or marketing authorizations are pending, or to the knowledge of the Company, threatened, against the Company or any of its affiliates, nor have any such proceedings been pending at any time. The Company has, prior to the execution of this Agreement, provided or Made Available to Parent accurate summaries of all significant adverse drug experiences relating to any Company Product and clinical research with respect to which information has been obtained any Product sponsored by Deverra or otherwise received by any of the Alamo Corporations prior to the date of this Agreement from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, the Company (and each of the Alamo Corporations, as applicable) has filed all annual and periodic reports, amendments and safety reports required for any Company Product required to be made to the FDA or any other Governmental Bodyits Affiliate. (f) All batches and doses manufacturing operations with respect to the Products conducted by or, to the Knowledge of any Company Product that is or was previously marketedDeverra for the benefit of, sold, or distributed by any of the Alamo Corporations Deverra have been manufactured and are being conducted in conformance with cGMP and the product specifications set forth accordance, in any applicable Company Contract Manufacturing Agreements. To the extent any batches or doses of any drug product deviated from cGMP and the product specificationsall material respects, all such batches or doses were destroyed in accordance with applicable industry standards cGMPs as that term is defined by FDA and the terms of any in all applicable Company Contract Manufacturer Agreements, and the Company possesses written records documenting any such destructionDrug Laws. (g) No manufacturing site which assists in the manufacture of a Company Product has been subject to a Governmental Body (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Body notice of inspectional observations, "warning letters," "untitled letters" or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Health Care Laws or Regulatory Authorizations, and, to the knowledge of the Company, neither the FDA nor any Governmental Body is considering such action. (h) The Alamo Corporations are not the subject of any pending or, to the knowledge of the Company, threatened investigation in respect of any Alamo Corporation employee, officer or agent by the FDA pursuant to the FDA Ethics Policy. Neither any of the Alamo Corporations Deverra nor any of their respective its current officers, employees or agents, nor to the Knowledge of Deverra any of its Affiliates, have ever been, are currently, or are the subject of a proceeding that could lead to it or such employees or agents becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual. For purposes of this provision, the following definitions shall apply: (i) a “Debarred Individual” is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a(a) or barred from providing services in any capacity to a person that has an approved or pending drug or injectable product application; (ii) a “Debarred Entity” is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a(a) or barred from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity; (iii) an “Excluded Individual” or “Excluded Entity” is (A) an individual or entity, as applicable, who has been excluded, debarred, suspended or excluded under 21 U.S.C. Section 335a is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, or (B) is an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA); and (iv) a “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. §335a(a) or 42 U.S.C. §1320a - 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible, and in each case any crime foreign equivalents thereof, as applicable. (h) To Xxxxxxx’s Knowledge, the Third Party contractors manufacturing Product have all of the material registrations necessary for the manufacture of such Product and are not in material breach of or engaged default in any conduct material respect under any such material registrations and are conducting manufacturing in accordance with all Applicable Laws. (i) All personal data collected, processed and disclosed by Deverra or any of its Affiliates, including any information or data collected during any clinical trials conducted during the development, Preclinical Studies and clinical testing, manufacture, storage, distribution, supply and administration of the Products, have been, and are being, collected, processed, transferred, stored, used and disclosed in material compliance with (A) all Applicable Laws and industry standards, including the Health Insurance Portability and Accountability Act of 1996 and the implementing regulations of the U.S. Department of Health and Human Services, Directive 95/46/EC of 24 October 1995 and the implementing laws of the individual European Union countries and (B) Xxxxxxx’s privacy, data protection and information security policies and practices (collectively “Privacy Practices”). Neither Deverra nor any of its Affiliates have received any: (i) written notice or complaint alleging non-compliance with any Applicable Laws or the Privacy Practices relating to the collection, processing and disclosure of information or data; (ii) written claim for compensation for loss or unauthorized collection, processing or disclosure of data; or (iii) written notification of an application for rectification, erasure or destruction of information or data that is still outstanding. (j) Xxxxxxx has made available to Coeptis (i) complete and correct copies of the Registrations, including all supplements and amendments thereto, (ii) all correspondence sent to and received from any Governmental Authority or any Institutional Review Board that concerns or would reasonably be expected to result in a debarment, suspension or exclusion under 21 U.S.C. Section 335a, impact the Target IP or any similar lawsProduct, rules and regulations, ordinances, judgments, decrees, orders, writs (iii) all existing written records relating to all discussions and injunctions of meetings between or involving Deverra and any Governmental BodyAuthority or other Persons relating to any Product. (ik) As Deverra has made available, or has caused its Affiliates to make available, to Coeptis all Technical Information, Regulatory Documentation, Manufacturing Documentation, and any other data, clinical studies and Preclinical Studies in Xxxxxxx’s or Xxxxxxx’s Affiliates’ Control regarding or related to the Products, and all such Technical Information, Regulatory Documentation and Manufacturing Documentation were and are true, complete and correct at such time and as of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened against any of the Alamo Corporations or their officers, consultants, employees or agents. (j) The Alamo Corporations are not a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Body.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Alamo Alaska Corporations is, and has during the past two years been, in compliance in all material respects with all applicable Legal Requirements, including Environmental Laws and Legal Requirements relating to employment, privacy law matters, exportation of goods and services, securities law matters and Taxes, and all applicable Health Care Laws, which affect the business, properties, assets and activities of the Alamo Alaska Corporations. During the past five years, none of the Alamo Alaska Corporations has received any notice or other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect with, any Legal Requirement. (b) All Company Products subject to the jurisdiction of the FDA or Governmental Bodies which administer Health Care Laws in other jurisdictions are being marketed, sold, distributed, developed, manufactured, labeled, stored, tested and otherwise produced by or on behalf of the Alamo Alaska Corporations in compliance in all material respects with all applicable requirements under Health Care Laws. Part 2.12(b3.12(b) of the Disclosure Schedule sets forth a complete and correct list of all Regulatory Authorizations from the FDA, or any other Governmental Body which administers Health Care Laws, held by the Alamo Alaska Corporations, and there are no other Regulatory Authorizations required for the Alamo Alaska Corporations or the Company Products in connection with the conduct of the business of the Alamo Alaska Corporations as currently conducted. (c) Neither any of the Alamo Alaska Corporations nor, to the knowledge of the Company, any officer, employee or agent of any of the Alamo Alaska Corporations, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body which administers Health Care Laws, 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 provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting "“Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities" ” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the "“FDA Ethics Policy"”) or any similar policy. (d) All preclinical and clinical trials in respect of the activities of the Alamo Alaska Corporations being conducted by or on behalf of the Alamo Alaska Corporations are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including but not limited to, the FDA Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and all applicable laws of the relevant Governmental Bodies outside the United States. No clinical trial conducted by or on behalf of the Alamo Alaska Corporations has been terminated or suspended by the FDA or any other applicable Governmental Body, and neither the FDA nor any other applicable Governmental Body has commenced or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any of the Alamo Alaska Corporations. (e) No Company Product has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise) or has been the subject of any "“dear doctor" ” notifications, investigator notices, safety alerts, or other notice of action related to an alleged lack of safety, efficacy, or regulatory compliance. No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product or product candidate or pre-market approvals or marketing authorizations are pending, or to the knowledge of the Company, threatened, against the Company or any of its affiliates, nor have any such proceedings been pending at any time. The Company has, prior to the execution of this Agreement, provided or Made Available to Parent accurate summaries of all significant adverse drug experiences relating to any Company Product and with respect to which information has been obtained or otherwise received by any of the Alamo Alaska Corporations prior to the date of this Agreement from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers. In addition, the Company (and each of the Alamo Alaska Corporations, as applicable) has filed all annual and periodic reports, amendments and safety reports required for any Company Product required to be made to the FDA or any other Governmental Body. (f) All batches and doses of any Company Product that is or was previously marketed, sold, or distributed by any of the Alamo Alaska Corporations have been manufactured in conformance with cGMP and the product specifications set forth in any applicable Company Contract Manufacturing Agreements. To the extent any batches or doses of any drug product deviated from cGMP and the product specifications, all such batches or doses were destroyed in accordance with applicable industry standards and the terms of any applicable Company Contract Manufacturer Agreements, and the Company possesses written records documenting any such destruction. (g) No manufacturing site which assists in the manufacture of a Company Product has been subject to a Governmental Body (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Body notice of inspectional observations, "“warning letters," "” “untitled letters" ” or similar correspondence or notice from the FDA or other Governmental Authority Body alleging or asserting noncompliance with any applicable Health Care Laws or Regulatory Authorizations, and, to the knowledge of the Company, neither the FDA nor any Governmental Body is considering such action. (h) The Alamo Alaska Corporations are not the subject of any pending or, to the knowledge of the Company, threatened investigation in respect of any Alamo Alaska Corporation employee, officer or agent by the FDA pursuant to the FDA Ethics Policy. Neither any of the Alamo Alaska Corporations nor any of their respective officers, employees or agents, has been debarred, suspended or excluded under 21 U.S.C. Section 335a or has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in a debarment, suspension or exclusion under 21 U.S.C. Section 335a, or any similar laws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions of any Governmental Body. (i) As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened against any of the Alamo Alaska Corporations or their officers, consultants, employees or agents. (j) The Alamo Alaska Corporations are not a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Body.