Common use of Permits and Regulatory Matters Clause in Contracts

Permits and Regulatory Matters. (a) Section 3.19 of the Company Disclosure Schedule sets forth a list of all Permits issued to or held by the Company or any Subsidiary. Each such Permit is in full force and effect; the Company or the applicable Subsidiary, as the case may be, is in compliance in all material respects with the terms of each such Permit; and, to the Knowledge of the Company, no suspension or cancellation of such Permit is threatened and there is no basis for believing that such Permit will not be renewable upon expiration. Each such Permit will continue in full force and effect immediately following the Closing. (b) The Company and the Subsidiaries have all material Permits required to conduct their businesses as currently conducted, including all such Permits required by the FDA, Health Canada, the European Medicines Agency (the “EMA”) or any other Governmental Entity exercising comparable authority. (c) All manufacturing, processing, distribution, labeling, storage, and testing of product candidates performed by or on behalf of Company are in compliance in all material respects with all applicable Laws administered or issued by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority. Neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA, the Health Canada, the EMA or any other Governmental Entity exercising comparable authority, and to the Knowledge of the Company, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any Subsidiary is not currently in compliance with any and all applicable Laws implemented by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority. (d) The studies, tests and preclinical and clinical trials of product candidates conducted by or on behalf of the Company and the Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards. Neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company and/or any of the Subsidiaries. (e) There is no pending, completed or, to the Knowledge of the Company, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint or investigation) against the Company, and the Company has not received any notice, warning letter or other communication from the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority, in each case which (a) imposes a clinical hold on any clinical investigation by the Company or (b) enters or proposes to enter into a consent decree of permanent injunction with the Company, which, either individually or in the aggregate, would result in the loss of a material benefit to, or in the creation of any material liability for, the Company. The operations of the Company have been and are being conducted in all material respects in accordance with all applicable Laws of the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority. The Company has not been informed by the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority that such Governmental Authority will prohibit the marketing, sale, license or use in any jurisdiction of any product proposed to be developed, produced or marketed by the Company.

Permits and Regulatory Matters. (a) Section 3.19 To the Knowledge of Parent, Parent or its Subsidiaries owns or holds all material Permits that are required for Parent and the Company Disclosure Schedule sets forth a list of all Permits issued Subsidiaries to conduct their business as presently conducted or held by the Company or any Subsidiary. Each as proposed to be conducted, and each such Permit is in full force and effect; the Company Parent or the applicable Subsidiary, as the case may be, is in material compliance in all material respects with the terms of each such Permit; and, to the Knowledge of the CompanyParent, no suspension or cancellation of such Permit is threatened and to the Knowledge of Parent there is no basis for believing that such Permit will not be renewable upon expiration. Each such Permit will continue in full force and effect immediately following the Closing. (b) The Company and the Subsidiaries have all material Permits required to conduct their businesses as currently conducted, including all such Permits required by the FDA, Health Canada, the European Medicines Agency (the “EMA”) or any other Governmental Entity exercising comparable authority. (c) All manufacturing, processing, distribution, labeling, storage, testing, specifications and testing sampling of product candidates products performed by or on behalf of Company Parent or any Subsidiary are in material compliance in all material respects with all applicable Laws administered or issued by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority. Neither the Company Since January 1, 2020, neither Parent nor any Subsidiary has received any written notices or correspondence from the FDA, the Health Canada, the EMA or any other Governmental Entity exercising comparable authority, and to the Knowledge of the Company, there is no action or proceeding pending or threatened in writing (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company Parent or any Subsidiary is not currently in compliance with any and all applicable Laws implemented by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority. (dc) The studiesTo Parent’s Knowledge, tests the nonclinical and preclinical and clinical trials of product candidates studies conducted by or on behalf of the Company Parent and the Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards. Neither the Company , including Good Laboratory Practices (GLPs); neither Parent nor any Subsidiary has received any written notices or correspondence from the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority Regulatory Authorities requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company Parent and/or any of the Subsidiaries. (e) There is no pending, completed or, . Parent has made available to the Knowledge Parent all written formal communications submitted by or on behalf of Parent or any of its Subsidiaries to any Regulatory Authority, as of the Companydate of this Agreement and each such communication, threatenedincluding all supplements and amendments thereto, action (including was true, complete and correct as of the applicable date thereof. Neither Parent nor any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint or investigation) against the Company, and the Company of its Subsidiaries has not received any notice, warning letter or other communication from the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority, in each case which (a) imposes a clinical hold on ever conducted any clinical investigation by the Company or (b) enters or proposes to enter into a consent decree of permanent injunction with the Company, which, either individually or in the aggregate, would result in the loss of a material benefit to, or in the creation of any material liability for, the Company. The operations of the Company have been and are being conducted in all material respects in accordance with all applicable Laws of the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority. The Company has not been informed by the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority that such Governmental Authority will prohibit the marketing, sale, license or use in any jurisdiction of any product proposed to be developed, produced or marketed by the Companytrials.

Permits and Regulatory Matters. (a) Section 3.19 3.20 of the Company Disclosure Schedule sets forth a list of all Permits issued to or held by the Company or any Subsidiary, including all governmental authorizations from the United States Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”) or any other Regulatory Authority. Such listed Permits are the only Permits that are required for the Company and the Subsidiaries to conduct their business as presently conducted. Each such Permit is in full force and effect; the Company or the applicable Subsidiary, as the case may be, is in material compliance in all material respects with the terms of each such Permit; and, to the Knowledge of the Company, no suspension or cancellation of such Permit is threatened and there is no basis for believing that such Permit will not be renewable upon expiration. Each To the Knowledge of the Company, each such Permit will continue in full force and effect immediately following the Closing. The Company has made available to the Buyer all such Permits. To the Knowledge of the Company: the Company Joint Venture holds all Permits required for the Company Joint Venture to conduct its business as presently conducted; each such Permit is in full force and effect; the Company Joint Venture is in material compliance with the terms of each such Permit; and each such Permit will continue in full force and effect immediately following the Closing. (b) The Company and the Subsidiaries have all material Permits required to conduct their businesses as currently conducted, including all such Permits required by the FDA, Health Canada, the European Medicines Agency (the “EMA”) or any other Governmental Entity exercising comparable authority. (c) All manufacturing, processing, distribution, labeling, storage, and testing testing, specifications or sampling of product candidates products performed by or on behalf of the Company or any Subsidiary are in material compliance in all material respects with all applicable Laws administered or issued by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority. Neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA, the Health Canada, the EMA or any other Governmental Entity exercising comparable authority, and there is no action or proceeding pending, or, to the Knowledge of the Company, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any Subsidiary is not currently in compliance with any and all applicable Laws implemented by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority. (dc) The studies, nonclinical studies and tests and preclinical and clinical trials of product candidates conducted by or on behalf of the Company and the Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards. Neither ; neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority Regulatory Authorities requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company and/or any of the Subsidiaries. Each submission to the Investigational New Drug applications submitted by or on behalf of the Company or any of its Subsidiaries to the FDA, including all supplements and amendments thereto was true, complete and correct as of the applicable date of submission. (d) The Company and its Subsidiaries have complied with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder and (ii) any applicable state privacy Laws. (e) There is no pending, completed or, to the Knowledge Section 3.20(e) of the CompanyCompany Disclosure Schedule sets forth a list of (i) all recalls, threatenedfield notifications, investigator notices, safety alerts, “serious adverse event” reports or other notices of action (including any lawsuit, arbitration, or legal or administrative relating to an alleged lack of safety or regulatory proceeding, charge, complaint or investigation) against the Company, and the Company has not received any notice, warning letter or other communication from the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority, in each case which (a) imposes a clinical hold on any clinical investigation compliance issued by the Company or any Subsidiary (b“Safety Notices”), (ii) enters the dates such Safety Notices, if any, were resolved or proposes closed, and (iii) to enter into a consent decree of permanent injunction with the Company’s Knowledge, which, either individually any complaints that are currently unresolved. (f) The Company has made available to the Buyer all material written formal communications submitted by or in the aggregate, would result in the loss of a material benefit to, or in the creation of any material liability for, the Company. The operations on behalf of the Company have been and are being conducted in all material respects in accordance with all applicable Laws of the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority. The Company has not been informed by the FDA, Health Canada, EMA or of its Subsidiaries to any other Governmental Entity exercising comparable authority that such Governmental Authority will prohibit the marketing, sale, license or use in any jurisdiction of any product proposed to be developed, produced or marketed by the CompanyRegulatory Authority.

Permits and Regulatory Matters. (a) Section 3.19 of The Company owns or holds all material Permits that are required for the Company Disclosure Schedule sets forth a list of all Permits issued to or held by the Company or any Subsidiaryconduct its business as presently conducted. Each such Permit is in full force and effect; the Company or the applicable Subsidiary, as the case may be, is in compliance in all material respects with the terms of each such PermitPermit in all material respects; and, to the Knowledge of the Company, no suspension suspension, revocation, withdrawal, termination, material modification or cancellation of such Permit is threatened and there is no basis for believing that such Permit will not be renewable upon expirationhas been threatened. Each such Permit will continue in full force and effect immediately following the Closing. No legal proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, limit, suspend, or materially modify any Permit. The Company has made available to Parent all such Permits. (b) The As to each of the product candidates of the Company, including compounds currently under research and/or development by the Company and subject to the Subsidiaries have all material Permits required to conduct their businesses as currently conductedjurisdiction of the Food and Drug Administration (“FDA”), including all such Permits required by the FDA, Health Canada, the European Medicines Agency (the “EMA”) or any equivalent Regulatory Authority in any legal jurisdiction other Governmental Entity exercising comparable authority. than the U.S. and the European Union (c) All manufacturingeach such product, processinga “Company Regulated Product”), distributionif any, labelingsuch Company Regulated Product is being researched, storageinvestigated, developed, manufactured, packaged, labeled, stored, distributed, imported and exported, and testing of product candidates performed by or on behalf of Company are tested in compliance in all material respects with all applicable Laws administered or issued by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authorityLaws. Neither the The Company nor any Subsidiary has not received any written notices or correspondence from the FDA, the Health Canada, the EMA or any other Governmental Entity Regulatory Authority exercising comparable authority, and to the Knowledge of the Company, there is no action or proceeding pending or or, to the Company’s Knowledge, threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any Subsidiary is not currently in compliance with any and all applicable Laws implemented by the FDA, Health Canada, the EMA or any other Governmental Entity Regulatory Authority exercising comparable authority. (dc) The studies, tests and All preclinical studies and clinical trials trials, and other studies and tests of product candidates any Company Regulated Product conducted by or on behalf of the Company have been, and if still pending are being, conducted in material compliance and to the extent applicable with, the applicable protocol for such study or trial, good laboratory practices, good clinical practices and all applicable Laws, including the FDCA and its implementing regulations governing good laboratory practices and good clinical practices (e.g., 21 C.F.R. Parts 50, 54, 56, and 312 of the U.S. Code of Federal Regulations) and the Subsidiaries were and, if still pending, are being conducted respective counterparts in all material respects in accordance with experimental protocols, procedures the European Union and controls pursuant to, where applicable, accepted professional and scientific standards. Neither other jurisdictions outside the Company nor any Subsidiary has received any written notices or correspondence from the FDA, Health Canada, the EMA or any other Governmental Entity United States exercising comparable authority requiring the terminationover any Company Regulated Product. Since January 11, suspension or material modification of any studies2024, tests or preclinical or no clinical trials trial conducted by or on behalf of the Company and/or has been terminated or placed on full or partial clinical hold by the FDA, EMA or by the applicable Institutional Review Board (“IRB”) for safety reasons or otherwise prior to scheduled completion, and neither the FDA, EMA, an IRB nor any other applicable Regulatory Authority that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the SubsidiariesCompany has initiated, or, to the Company’s Knowledge, threatened to initiate, any action to place a full or partial clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation of the Company Regulated Products conducted or proposed to be conducted by or on behalf of the Company. (d) All manufacturing operations conducted by or for the benefit of the Company have been, and are being conducted in material compliance with applicable Laws, including provisions of the FDA’s current good manufacturing practice regulations and comparable regulatory requirements of the EMA and foreign Regulatory Authorities exercising comparable authority. The Company’s facilities are registered, as required, and the Company has established and maintains a quality agreement with each of the third party vendors that manufacture, process, package, or supply ingredients and packaging materials for or distribute the Company Regulated Products. Since January 11, 2024, the Company and, to the Company’s Knowledge, its third party vendors have filed all required notices, registration applications, order forms, reports, supplemental applications and annual or other reports or documents, including adverse experience reports, that are material to the continued development, handling, manufacture, sale, and distribution of the Company Regulated Products. Since January 11, 2024, no supplier or manufacturing site for any Company Regulated Product (whether owned by the Company or that of a contract manufacturer) has been subject to an FDA, EMA or other Regulatory Authority shutdown or import or export prohibition, nor received and not closed out any FDA Form 483 or any other Regulatory Authority notice of inspectional observations, “warning letters,” “untitled letters” or similar correspondence or notice from the FDA, EMA or other Regulatory Authority. (e) There The Company has made available to Parent all material written formal communications submitted by or on behalf of the Company to any Regulatory Authority, and each such communication, including all supplements and amendments thereto, was true, complete and correct as of the applicable date thereof. The Company has made available to Parent all of the material raw preclinical, nonclinical and other data associated with the Company Regulated Products. All material summaries of preclinical, nonclinical and other data and studies provided by the Company to Parent are consistent with the raw preclinical, nonclinical and other data associated with the Company’s Regulated Products, in all material respects, and are true, complete and accurate descriptions of the subject matter thereof, in all material respects. The Company has not made any untrue statement of a material fact or fraudulent statement to the FDA, EMA or any Regulatory Authority or otherwise failed to disclose a material fact required to be disclosed to the FDA, EMA or any Regulatory Authority. The Company is no pending, completed not the subject of any pending or, to the Knowledge of the Company, threatenedthreatened investigation in respect of any Company Regulated Product pursuant to the FDA’s “Fraud, action (including Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy or the FDA’s Application Integrity Policy. All documents and information filed by the Company with the FDA, EMA or any lawsuit, arbitrationother Regulatory Authority with respect to the Company Regulated Products, or legal the manufacturing, handling, storage or administrative or regulatory proceedingshipment of the Company Regulated Products were, chargeat the time of filing, complaint or investigationtrue, complete and accurate in all material respects. (f) against There are no proceedings pending or, to the Knowledge of the Company, threatened against the Company with respect to an alleged material violation of the FDCA or any similar Law administered or promulgated by the EMA or any Regulatory Authority. Neither the Company nor any of its officers and employees has been or is subject to any enforcement proceedings by the FDA or other Regulatory Authority and, to the Knowledge of the Company, no such proceedings have been threatened. There is not any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against the Company or any of its officers and employees, and to the Company’s Knowledge, the Company has no liability for failure to comply with the FDCA or other similar Laws. There is no act, omission, event, or circumstance of which the Company has Knowledge that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA or other similar Laws. The Company has not received any notice, warning letter or other communication from written notice that the FDA, Health Canada, EMA FDA or any other Governmental Entity Regulatory Authority exercising comparable authority has commenced, or, to the Company’s Knowledge, threatened in writing to initiate, any action to enjoin the manufacture and production of the Company Regulated Products or any component thereof at any of its or its suppliers’ facilities. (g) Neither the Company nor any of its officers, directors, or employees has been, is, or is in anticipation of being (based on a conviction by the courts or a finding of fault by a regulatory authority, in each case which ): (a) imposes a clinical hold on any clinical investigation by debarred pursuant to the Company or Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a), as amended from time to time; (b) enters disqualified from participating in clinical trials pursuant to 21 C.F.R. §312.70, as amended from time to time; (c) disqualified as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended from time to time; (d) excluded, debarred or proposes suspended from or otherwise ineligible to enter into participate in a consent decree “Federal Health Care Program” as that term is defined in 42 U.S.C. 1320a-7b(f), including under 42 U.S.C. § 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (e) assessed any civil money penalties pursuant to 42 C.F.R. Part 1003; or (f) included on the HHS/OIG List of permanent injunction with Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. Neither the Company nor, to the Knowledge of the Company, whichany of its officers, either individually directors or employees has engaged in any activities that are prohibited, or are cause for civil penalties, or grounds for mandatory or permissive exclusion, debarment, or suspension pursuant to any of these authorities. Since January 11, 2024, the aggregateCompany has not used, would result and is currently not using, in any capacity related to any Company Regulated Product, any person that has ever been, or to the loss Knowledge of the Company, is the subject of a material benefit toproceeding that could lead to the persons becoming debarred, excluded, disqualified, restricted or in the creation suspended pursuant to any of any material liability for, the Company. these authorities. (h) The operations of the Company have been and are being conducted in all material respects in accordance has materially complied with all applicable Laws relating to patient, medical or individual health information, including the Health Insurance Portability and Accountability Act and the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time. To the Knowledge of the FDACompany, Health Canadathere has been no breach of unsecured protected health information, EMA unpermitted disclosure of personal health information, or any other breach of personally identifiable information with respect to information maintained or transmitted to the Company that would require notice to a Governmental Entity exercising comparable authority. The Company has not been informed by the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority that such Governmental Authority will prohibit the marketing, sale, license or use in any jurisdiction of any product proposed to be developed, produced or marketed by the CompanyEntity.

Permits and Regulatory Matters. (a) Section 3.19 To the Knowledge of the Company, each of the Company Disclosure Schedule sets forth a list of and its Subsidiaries owns or holds all material Permits issued to or held by that are required for the Company and its Subsidiaries, respectively, to conduct their business as presently conducted or any Subsidiaryas proposed to be conducted. Each such Permit is in full force and effect; the Company or the applicable Subsidiary, as the case may be, is in compliance in all material respects with the terms of each such Permit; and, to the Knowledge of the Company, no suspension or cancellation of such Permit is threatened and and, to the Knowledge of the Company, there is no basis for believing that such Permit will not be renewable upon expiration. Each such Permit will continue in full force and effect immediately following the Closing. The Company has made available to the Parent all such Permits as of the date of this Agreement. (b) The Company and the Subsidiaries have all material Permits required to conduct their businesses as currently conducted, including all such Permits required by the FDA, Health Canada, the European Medicines Agency (the “EMA”) or any other Governmental Entity exercising comparable authority. (c) All manufacturing, processing, distribution, labeling, storage, testing, specifications and testing sampling of product candidates products performed by or on behalf of the Company or any Subsidiary are in material compliance in all material respects with all applicable Laws administered or issued by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority. Neither Since January 1, 2020, neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA, the Health Canada, the EMA or any other Governmental Entity exercising comparable authority, and to the Knowledge of the Company, there is no action or proceeding pending or threatened in writing (including any prosecution, injunction, seizure, civil fine, suspension or recall)) or, to the Company’s Knowledge, orally, in each case alleging that the Company or any Subsidiary is not currently in compliance with any and all applicable Laws implemented by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority. (dc) The studies, tests nonclinical and preclinical and clinical trials of product candidates studies conducted by or on behalf of the Company and the its Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards. Neither , including Good Laboratory Practices (GLPs); neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority Regulatory Authorities requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company and/or any of the Subsidiaries. (e) There is no pending, completed or, to the Knowledge of the Company, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint or investigation) against the Company, and the Company has not received any notice, warning letter or other communication from the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority, in each case which (a) imposes a clinical hold on any clinical investigation by the Company or (b) enters or proposes to enter into a consent decree of permanent injunction with the Company, which, either individually or in the aggregate, would result in the loss of a material benefit to, or in the creation of any material liability for, the Company. The operations of the Company have been and are being conducted in all material respects in accordance with all applicable Laws of the FDA, Health Canada, EMA or any other Governmental Entity exercising comparable authority. The Company has not been informed made available to the Parent all written formal communications submitted by or on behalf of the Company or any of its Subsidiaries to any Regulatory Authority, as of the date of this Agreement and each such communication, including all supplements and amendments thereto, was true, complete and correct as of the applicable date thereof. Neither the Company nor any of its Subsidiaries has ever conducted any clinical trials. (d) The Company has made available to the Parent all of the raw preclinical, nonclinical and other data associated with the Company’s Customer Offerings as of the date of this Agreement. All summaries of preclinical, nonclinical and other data and studies provided by the FDACompany to the Parent are consistent with the raw preclinical, Health Canada, EMA or any nonclinical and other Governmental Entity exercising comparable authority that such Governmental Authority will prohibit the marketing, sale, license or use in any jurisdiction of any product proposed to be developed, produced or marketed by data associated with the Company’s Customer Offerings and are true, complete and accurate descriptions of the subject matter thereof.