Common use of Compliance; Permits; Restrictions Clause in Contracts

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affected, except for conflicts, violations and defaults that (individually or in the aggregate) would not cause Parent to lose any material benefit or incur any material liability. No investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiaries, nor, to Parent's knowledge, has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiaries. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries which has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent, any acquisition of material property by Parent or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that are material to and required for the operation of the business of Parent as currently conducted (collectively, the "PARENT PERMITS"). Parent and its subsidiaries are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, Merger Sub is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Merger Sub or by which Parent it or any of its subsidiaries or any of their respective properties is are bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Merger Sub is a party or by which Parent or any of its subsidiaries Merger Sub or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesMerger Sub, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of Parent or any of its subsidiariesthe same. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Merger Sub which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or Merger Sub, any acquisition of material property by Parent or Merger Sub or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Merger Sub hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"“Parent Permits”). Parent and its subsidiaries Merger Sub are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, Xxxxxx Merger Sub is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Xxxxxx Merger Sub or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Xxxxxx Merger Sub is a party or by which Parent or any of its subsidiaries Xxxxxx Merger Sub or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesXxxxxx Merger Sub, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of the same, other than those which would not reasonably be expected to have a Parent or any of its subsidiariesMaterial Adverse Effect. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Xxxxxx Merger Sub which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or Xxxxxx Merger Sub, any acquisition of material property by Parent or Xxxxxx Merger Sub or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Xxxxxx Merger Sub hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"“Parent Permits”). Parent and its subsidiaries Xxxxxx Merger Sub are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, in conflict with, or in default or in violation of (i) to the knowledge of Parent, any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries or by which Parent or any of its subsidiaries or any of their respective businesses or properties is, or Parent believes is reasonably likely to be bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affected, except for conflicts, violations and defaults that (individually or in the aggregate) would not cause Parent to lose any material benefit or incur any material liability. No investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiaries, nor, to Parent's knowledge, has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiaries. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries which has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or any of its subsidiaries, any acquisition of material property by Parent or any of its subsidiaries or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, all permits, licenses, variances, exemptions, orders and approvals from governmental authorities Governmental Entities that are material to and required for the operation of the business of Parent as currently conducted (collectively, the "PARENT PERMITS"). Parent and its subsidiaries are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither The Parent nor any of its subsidiaries is, is not in any material respect, in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to the Parent or by which the Parent or any of its subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which the Parent or any of its subsidiaries is a party or by which the Parent or any of its subsidiaries or its or any of their respective properties is bound or affected, except for conflicts, violations and defaults that (individually or in the aggregate) would not cause Parent to lose any material benefit or incur any material liability. No investigation or review by any Governmental Entity is pending or, to the Parent's knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiariesthe Parent, nor, to Parent's knowledge, nor has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiariesthe same. There is no material agreement, judgment, injunction, order or decree binding upon the Parent or any of its subsidiaries which has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Parent, any acquisition of material property by the Parent or the conduct of business by the Parent as currently conducted. (b) . The Parent and its subsidiaries hold, to the extent legally required, holds all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that are material to and required for the operation of the business of the Parent as currently conducted (collectively, the "PARENT PERMITS"). The Parent and its subsidiaries are is in compliance in all material respects with the terms of the Parent Permits. Except as disclosed in the Parent Disclosure Letter, except where the failure to be Parent has no knowledge of any pending regulatory action of any sort against the Parent, or the Parent's products by any regulatory agency or any other duly authorized governmental authority which could have a Material Adverse Effect on the Parent or in compliance with any material way limit or restrict the terms ability of the Parent Permits would to market its existing products. Except as set forth in the Parent Disclosure Letter, the Parent, has not be material knowingly committed or permitted to Parentexist any violation of the rules and regulations of any regulatory agency or any other duly authorized governmental authority.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, Chelsea Merger Sub is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Chelsea Merger Sub or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Chelsea Merger Sub is a party or by which Parent or any of its subsidiaries Chelsea Merger Sub or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesChelsea Merger Sub, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of the same; other than those which would not reasonably be expected to have a Parent or any of its subsidiariesMaterial Adverse Effect. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Chelsea Merger Sub which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or Chelsea Merger Sub, any acquisition of material property by Parent or Chelsea Merger Sub or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Chelsea Merger Sub hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"“Parent Permits”). Parent and its subsidiaries Chelsea Merger Sub are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, MMMB is in conflict with, or in default or in violation of of: (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries MMMB or by which Parent it or any of its subsidiaries or any of their respective properties is are bound or affected, or ; or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries MMMB is a party or by which Parent or any of its subsidiaries MMMB or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liability. No Material Adverse Effect. (b) To Parent’s knowledge, no investigation or review by any Governmental Entity governmental entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesMMMB, nor, to Parent's knowledge, nor has any Governmental Entity governmental entity indicated in writing an intention to conduct an investigation of Parent or any of its subsidiariesthe same. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries MMMB which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or MMMB, any acquisition of material property by Parent or MMMB or the conduct of business by Parent as currently conducted. (bc) Parent and its subsidiaries hold, to the extent legally required, MMMB hold all permits, licenses, variances, exemptions, orders orders, and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"“Parent Permits”). Parent and its subsidiaries MMMB are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affected, except for conflicts, violations and defaults that (individually or in the aggregate) would not cause Parent to lose any material benefit or incur any material liability. No investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiaries, nor, to Parent's knowledge, has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiaries. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries which has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or any of its subsidiaries, any acquisition of material property by Parent or any of its subsidiaries or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, all permits, licenses, variances, exemptions, orders and approvals from governmental authorities Governmental Entities that are material to and required for the operation of the business of Parent as currently conducted (collectively, the "PARENT PERMITSParent Permits"). Parent and its subsidiaries are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, ; or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affected, except for conflicts, violations and defaults that (individually or in the aggregate) would not cause Parent to lose any material benefit or incur any material liability. No investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been threatened in a writing delivered to Parent against Parent or any of its 47 subsidiaries, nor, to Parent's knowledge, has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiaries. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries which has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or any of its subsidiaries, any acquisition of material property by Parent or any of its subsidiaries or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, all permits, licenses, variances, exemptions, orders and approvals from governmental authorities Governmental Entities that are material to and required for the operation of the business of Parent as currently conducted (collectively, the "PARENT PERMITS"). Parent and its subsidiaries are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, Merger Sub is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Merger Sub or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Merger Sub is a party or by which Parent or any of its subsidiaries Merger Sub or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesMerger Sub, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of the same; other than those which would not reasonably be expected to have a Parent or any of its subsidiariesMaterial Adverse Effect. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Merger Sub which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or Merger Sub, any acquisition of material property by Parent or Merger Sub or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Merger Sub hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"“Parent Permits”). Parent and its subsidiaries Merger Sub are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respectand since January 1, 2020 has been, in conflict withcompliance in all material respects with all applicable Laws, including the FDCA by the FDA, the PHSA and any other similar Law administered or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries or promulgated by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise the FDA or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affectedcomparable Drug Regulatory Agency, except for conflictsany noncompliance, violations and defaults that (either individually or in the aggregate) , which would not cause Parent be material to lose any material benefit the Parent. As of the date of this Agreement, no investigation, claim, suit, proceeding, audit or incur any material liability. No investigation or review other action by any Governmental Entity Body is pending or, to Parent's knowledge’s Knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiaries, nor, to Parent's knowledge, has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiaries. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent, any acquisition of material property by Parent or the conduct of business by Parent as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its subsidiaries hold, to the extent legally required, holds all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that required Governmental Authorizations which are material to and required for the operation of the business of Parent as currently conducted (collectivelythe “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each such Parent Permit is valid and in full force and effect, and Parent is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Parent as of the date of this Agreement and immediately prior to the Effective Time. (c) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent of the FDCA, the "PARENT PERMITS")PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds. (d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent, or in which Parent or its subsidiaries current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2020, Xxxxxx has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or in which Parent or any of its current products or product candidates have participated. (e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance 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, PHSA or other similar Laws. (f) Parent is not the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To Parent’s Knowledge, Parent has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. (g) None of Parent or any of its officers, employees or, to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent or any of its officers, employees or agents. (h) Parent has materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent has entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent is a party or otherwise bound. Parent, where required, has created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, Xxxxxx has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent or an agent or third party subject to a Business Associate Agreement with Parent. Parent is not currently submitting, receiving and handling transactions that are governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA. (i) The preclinical studies and clinical trials conducted by or on behalf of or sponsored by Parent or its Subsidiaries, or in which Parent or its Subsidiaries have participated, that are described in the Parent PermitsSEC Documents, or the results of which are referred to in the Parent SEC Documents, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by Parent and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”); (ii) the descriptions in the Parent SEC Documents of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived therefrom; (iii) to Parent’s Knowledge, there are no other studies or trials not described in the Parent SEC Documents, the results of which Parent believes are inconsistent with or reasonably call into question the results described or referred to in the Parent SEC Documents; (iv) Parent and its Subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not, individually or in the failure aggregate, have a Parent Material Adverse Effect; and (v) neither Parent nor any of its Subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Parent SEC Documents or the results of which are referred to be in the Parent SEC Documents, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. (j) Neither Parent nor any of its Subsidiaries has cultivated, produced, processed, imported or distributed, or has any current intention to cultivate, produce, process, import or distribute, any cannabis or cannabinoid product or has otherwise engaged, in any direct or indirect dealings or transactions in or to the United States of America, its territories and possessions, any state of the United States and the District of Columbia or any other federal, provincial, state, municipal, local or foreign jurisdiction where such activity is illegal. Neither the Parent nor any of its Subsidiaries has operated in or exported any cannabis or cannabinoid product to any jurisdiction outside of Canada where such activity is illegal. The Parent and its Subsidiaries have instituted and maintained policies and procedures reasonably designed to ensure that the Parent and its Subsidiaries do not carry on any activities in, or distribute any products to, any jurisdiction where such activities or products are not fully in compliance with the terms of all applicable federal, state or provincial Laws. (k) Neither the Parent Permits would not be material nor any of its Subsidiaries has engaged in (i) any direct or indirect dealings or transactions in violation of U.S. federal or state criminal laws, including, without limitation, the U.S. Controlled Substances Act, the U.S. Racketeering Influenced and Corrupt Practices Act or the U.S. Travel Act, or (ii) any “aiding and abetting” in any violation of U.S. federal or state criminal laws. No action, suit or proceeding by or before any U.S. court or governmental agency, authority or body or any arbitrator involving the Parent or any of its Subsidiaries with respect to ParentU.S. federal or state criminal Laws is pending or threatened.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, Merger Sub is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Merger Sub or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Merger Sub is a party or by which Parent or any of its subsidiaries Merger Sub or its or any of their respective properties is bound or affected, except with respect to clause (i) for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesMerger Sub, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of Parent or any of its subsidiariesthe same. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Merger Sub which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or Merger Sub, any acquisition of material property by Parent or Merger Sub or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Merger Sub hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"“Permits”). Parent and its subsidiaries Merger Sub are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respectand since January 1, 2020 has been, in conflict withcompliance in all material respects with all applicable Laws, including the FDCA by the FDA, the PHSA and any other similar Law administered or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries or promulgated by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise the FDA or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affectedcomparable Drug Regulatory Agency, except for conflictsany noncompliance, violations and defaults that (either individually or in the aggregate) , which would not cause Parent be material to lose any material benefit the Parent. As of the date of this Agreement, no investigation, claim, suit, proceeding, audit or incur any material liability. No investigation or review other action by any Governmental Entity Body is pending or, to Parent's knowledge’s Knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiaries, nor, to Parent's knowledge, has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiaries. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent, any acquisition of material property by Parent or the conduct of business by Parent as currently conducted. , (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its subsidiaries hold, to the extent legally required, holds all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that required Governmental Authorizations which are material to and required for the operation of the business of Parent as currently conducted (collectively, the "PARENT PERMITS"“Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each such Parent Permit is valid and its subsidiaries are in full force and effect, and Parent is in material compliance in all material respects with the terms of the Parent Permits. No Legal Proceeding is pending or, except where to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to the failure Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to be in compliance with those enjoyed by the terms Parent as of the Parent Permits would not be material date of this Agreement and immediately prior to Parentthe Effective Time.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, Merger Sub is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Merger Sub or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Merger Sub is a party or by which Parent or any of its subsidiaries Merger Sub or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesMerger Sub, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of the same; other than those which would not reasonably be expected to have a Parent or any of its subsidiariesMaterial Adverse Effect. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Merger Sub which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or Merger Sub, any acquisition of material property by Parent or Merger Sub or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Merger Sub hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"). Parent and its subsidiaries Merger Sub are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any and each of its subsidiaries Subsidiaries is, and since January 1, 2023, has been in any material respectcompliance with all applicable Laws. No investigation, in conflict withclaim, or in default or in violation of (i) any lawsuit, ruleproceeding, regulationaudit, order, judgment or decree applicable to Parent or any of its subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise Order or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affected, except for conflicts, violations and defaults that (individually or in the aggregate) would not cause Parent to lose any material benefit or incur any material liability. No investigation or review action by any Governmental Entity Authority is pending or, to the Knowledge of Parent's knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiaries, nor, to Parent's knowledge, has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiariesSubsidiaries. There is no material agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its subsidiaries Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Except for matters regarding the FDA or other Drug/Device Regulatory Agency, each of Parent and its subsidiaries hold, to the extent legally required, Subsidiaries holds all permits, licenses, variances, exemptions, orders and approvals from governmental authorities required Governmental Authorizations that are material to and required for the operation of the business of Parent and Merger Subs as currently conducted (collectively, the "PARENT PERMITS"“Parent Permits”). Section 4.14(b) of the Parent Disclosure Letter identifies each Parent Permit. Each of Parent and its subsidiaries Subsidiaries is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent, threatened, which seeks to revoke, substantially limit, suspend or materially modify any Parent Permit. The rights and benefits of each Parent Permit, if any, will be available to Parent and Surviving Entity immediately after the Second Effective Time on terms substantially identical to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the First Effective Time. (c) There are no Legal Proceedings pending or, to the Knowledge of Parent, threatened with respect to an alleged violation by Parent or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the Controlled Substances Act or any other similar Law promulgated by a Drug/Device Regulatory Agency. (d) Each of Parent and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Parent and Merger Subs as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Parent Product Candidates”) (the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Section 4.14(d) of the Parent Disclosure Letter identifies each Parent Regulatory Permit. Parent has timely maintained and is in compliance in all material respects with the terms Parent Regulatory Permits and neither Parent nor or any of its Subsidiaries has, since January 1, 2023, received any written notice or correspondence or, to the Knowledge of Parent, other communication from any Drug/Device Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Parent Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Parent Regulatory Permit. Parent has made available to the Company all information requested by the Company in Parent’s or its Subsidiaries’ possession or control relating to material Parent Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Parent PermitsProduct Candidates, except where including, but not limited to, complete copies of the failure following (to be the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information are accurate and complete in all material respects. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, in which Parent or its Subsidiaries or their respective product candidates, including the Parent Product Candidates, have participated were, since January 1, 2023, and, if still pending, are being conducted in accordance in all material respects with standard medical and scientific research procedures, and in compliance in all material respects with the terms applicable regulations of the Drug/Device Regulatory Agencies and other applicable Law, including 21 C.F.R. Parts 11, 50, 54, 56, 58, 312 and 812. Since January 1, 2023, neither Parent Permits nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug/Device Regulatory Agency requiring or, to the Knowledge of Parent, any action to place a clinical hold order on, or otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or its current product candidates, including the Parent Product Candidates, have participated. Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of Parent, on behalf of Parent or any of its Subsidiaries has been disqualified from participating in studies involving the Parent Product Candidates, and to the Knowledge of Parent, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending. (f) Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate is the subject of any pending or, to the Knowledge of Parent, threatened investigation in respect of its business or products by the FDA pursuant to its “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 or by any other Drug/Device Regulatory Agency under a comparable policy. Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer, nor their respective officers, employees or agents, with respect to any Parent Product Candidate has committed any acts, made any statement or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Parent, any of its Subsidiaries, and to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective officers, employees or agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in a material debarment or exclusion under (i) 21 U.S.C. Section 335a or (ii) any similar applicable Law. To the Knowledge of Parent, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Parent, any of its Subsidiaries, and to the Knowledge of the Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of its officers, employees or agents. (g) All manufacturing operations conducted by, or to the Knowledge of Parent, for the benefit of, Parent or its Subsidiaries in connection with any Parent Product Candidate, since January 1, 2023, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. (h) None of Parent, any of its Subsidiaries, and to the Knowledge of Parent, any manufacturing site of a contract manufacturer or laboratory, with respect to any Parent Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter or similar correspondence or notice from the FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not be material been complied with or closed to the satisfaction of the relevant Drug/Device Regulatory Agency, and, to the Knowledge of Parent, neither the FDA nor any other Drug/Device Regulatory Agency is considering such action.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, Ariston Merger Sub is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Ariston Merger Sub or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Ariston Merger Sub is a party or by which Parent or any of its subsidiaries Ariston Merger Sub or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesAriston Merger Sub, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of the same; other than those which would not reasonably be expected to have a Parent or any of its subsidiariesMaterial Adverse Effect. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Ariston Merger Sub which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or Ariston Merger Sub, any acquisition of material property by Parent or Ariston Merger Sub or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Ariston Merger Sub hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITSParent Permits"). Parent and its subsidiaries Ariston Merger Sub are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any and each of its subsidiaries Subsidiaries is, and since January 1, 2023, has been in any material respectcompliance with all applicable Laws. No investigation, in conflict withclaim, or in default or in violation of (i) any lawsuit, ruleproceeding, regulationaudit, order, judgment or decree applicable to Parent or any of its subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise Order or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affected, except for conflicts, violations and defaults that (individually or in the aggregate) would not cause Parent to lose any material benefit or incur any material liability. No investigation or review action by any Governmental Entity Authority is pending or, to the Knowledge of Parent's knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiaries, nor, to Parent's knowledge, has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiariesSubsidiaries. There is no material agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its subsidiaries Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Except for matters regarding the FDA or other Drug/Device Regulatory Agency, each of Parent and its subsidiaries hold, to the extent legally required, Subsidiaries holds all permits, licenses, variances, exemptions, orders and approvals from governmental authorities required Governmental Authorizations that are material to and required for the operation of the business of Parent and Merger Subs as currently conducted (collectively, the "PARENT PERMITS"“Parent Permits”). Section ‎4.14(b) of the Parent Disclosure Letter identifies each Parent Permit. Each of Parent and its subsidiaries Subsidiaries is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent, threatened, which seeks to revoke, substantially limit, suspend or materially modify any Parent Permit. The rights and benefits of each Parent Permit, if any, will be available to Parent and Surviving Entity immediately after the Second Effective Time on terms substantially identical to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the First Effective Time. (c) There are no Legal Proceedings pending or, to the Knowledge of Parent, threatened with respect to an alleged violation by Parent or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the Controlled Substances Act or any other similar Law promulgated by a Drug/Device Regulatory Agency. (d) Each of Parent and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Parent and Merger Subs as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Parent Product Candidates”) (the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Section ‎4.14(d) of the Parent Disclosure Letter identifies each Parent Regulatory Permit. Parent has timely maintained and is in compliance in all material respects with the terms Parent Regulatory Permits and neither Parent nor or any of its Subsidiaries has, since January 1, 2023, received any written notice or correspondence or, to the Knowledge of Parent, other communication from any Drug/Device Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Parent Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Parent Regulatory Permit. Parent has made available to the Company all information requested by the Company in Parent’s or its Subsidiaries’ possession or control relating to material Parent Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Parent PermitsProduct Candidates, except where including, but not limited to, complete copies of the failure following (to be the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information are accurate and complete in all material respects. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, in which Parent or its Subsidiaries or their respective product candidates, including the Parent Product Candidates, have participated were, since January 1, 2023, and, if still pending, are being conducted in accordance in all material respects with standard medical and scientific research procedures, and in compliance in all material respects with the terms applicable regulations of the Drug/Device Regulatory Agencies and other applicable Law, including 21 C.F.R. Parts 11, 50, 54, 56, 58, 312 and 812. Since January 1, 2023, neither Parent Permits nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug/Device Regulatory Agency requiring or, to the Knowledge of Parent, any action to place a clinical hold order on, or otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or its current product candidates, including the Parent Product Candidates, have participated. Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of Parent, on behalf of Parent or any of its Subsidiaries has been disqualified from participating in studies involving the Parent Product Candidates, and to the Knowledge of Parent, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending. (f) Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate is the subject of any pending or, to the Knowledge of Parent, threatened investigation in respect of its business or products by the FDA pursuant to its “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 or by any other Drug/Device Regulatory Agency under a comparable policy. Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer, nor their respective officers, employees or agents, with respect to any Parent Product Candidate has committed any acts, made any statement or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Parent, any of its Subsidiaries, and to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective officers, employees or agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in a material debarment or exclusion under (i) 21 U.S.C. Section 335a or (ii) any similar applicable Law. To the Knowledge of Parent, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Parent, any of its Subsidiaries, and to the Knowledge of the Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of its officers, employees or agents. (g) All manufacturing operations conducted by, or to the Knowledge of Parent, for the benefit of, Parent or its Subsidiaries in connection with any Parent Product Candidate, since January 1, 2023, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. (h) None of Parent, any of its Subsidiaries, and to the Knowledge of Parent, any manufacturing site of a contract manufacturer or laboratory, with respect to any Parent Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter or similar correspondence or notice from the FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not be material been complied with or closed to the satisfaction of the relevant Drug/Device Regulatory Agency, and, to the Knowledge of Parent, neither the FDA nor any other Drug/Device Regulatory Agency is considering such action.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, Subsidiaries is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Subsidiaries is a party or by which Parent or any of its subsidiaries Subsidiaries or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesSubsidiaries, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of the same; other than those which would not reasonably be expected to have a Parent or any of its subsidiariesMaterial Adverse Effect. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Subsidiaries which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Subsidiaries hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITSParent Permits"). Parent and its subsidiaries Subsidiaries are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, or Acquisition Sub is in conflict with, or in default or in violation of of: (i1) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Acquisition Sub or by which Parent it or any of its subsidiaries or any of their respective properties is are bound or affected, or ; or (ii2) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Acquisition Sub is a party or by which Parent or any of its subsidiaries Acquisition Sub or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit Material Adverse Effect. (b) To the knowledge of Parent or incur any material liability. No Acquisition Sub, no investigation or review by any Governmental Entity governmental entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesAcquisition Sub, nor, to Parent's knowledge, nor has any Governmental Entity governmental entity indicated in writing an intention to conduct an investigation of Parent or any of its subsidiariesthe same. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Acquisition Sub which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or Acquisition Sub, any acquisition of material property by Parent or Acquisition Sub or the conduct of business by Parent as currently conducted. (bc) Parent and its subsidiaries hold, to the extent legally required, Acquisition Sub hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"“Parent Permits”). Parent and its subsidiaries Acquisition Sub are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, Xxxxxxx Merger Sub is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Xxxxxxx Merger Sub or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Xxxxxxx Merger Sub is a party or by which Parent or any of its subsidiaries Xxxxxxx Merger Sub or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesXxxxxxx Merger Sub, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of the same, other than those which would not reasonably be expected to have a Parent or any of its subsidiariesMaterial Adverse Effect. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Xxxxxxx Merger Sub which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or Xxxxxxx Merger Sub, any acquisition of material property by Parent or Xxxxxxx Merger Sub or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Xxxxxxx Merger Sub hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"“Parent Permits”). Parent and its subsidiaries Xxxxxxx Merger Sub are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. Except as disclosed on Schedule 3.9, (a) Neither Parent nor any of its subsidiaries is, in any material respect, Subsidiaries is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries Subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries Subsidiaries is a party or by which Parent or any of its subsidiaries Subsidiaries or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent Material Adverse Effect. Except as disclosed on Schedule 3.9 to lose any material benefit or incur any material liability. No the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesSubsidiaries, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of the same; other than those which would not reasonably be expected to have a Parent or any of its subsidiariesMaterial Adverse Effect. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries Subsidiaries which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries hold, to the extent legally required, Subsidiaries hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITSParent Permits"). Parent and its subsidiaries Subsidiaries are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither The Parent nor any of its subsidiaries isis not, in any material respect, in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to the Parent or by which the Parent or any of its subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) except as set forth in Section 3.9 of the Parent Disclosure Letter, any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which the Parent or any of its subsidiaries is a party or by which the Parent or any of its subsidiaries or its or any of their respective properties is bound or affected, except for conflicts, violations and defaults that (individually or in the aggregate) would not cause Parent to lose any material benefit or incur any material liability. No investigation or review by any Governmental Entity is pending or, to the Parent's knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiariesthe Parent, nor, to Parent's knowledge, nor has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiariesthe same. There is no material agreement, judgment, injunction, order or decree binding upon the Parent or any of its subsidiaries which has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Parent, any acquisition of material property by the Parent or the conduct of business by the Parent as currently conducted. (b) The Parent and its subsidiaries hold, to the extent legally required, hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that which are material to and required for the operation of the business of the Parent as currently conducted (collectively, the "PARENT PERMITSParent Permits"). The Parent and its subsidiaries are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be . (c) Except as disclosed in compliance with the terms Section 3.9(c) of the Parent Permits would Disclosure Letter, the Parent has no knowledge of any pending regulatory action of any sort against the Parent by any regulatory agency or any other duly authorized governmental authority in any jurisdiction which could have a Material Adverse Effect on the Parent. Except as set forth on Section 3.9(c) of the Parent Disclosure Letter, the Parent has not be material knowingly committed or permitted to Parentexist any violation of the rules and regulations of any regulatory agency or any other duly authorized governmental authority.

Compliance; Permits; Restrictions. (a) a. Neither Parent nor any of its subsidiaries is, in any material respect, BA is in conflict with, or in default or in violation of (i) of: i. any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries BA or by which Parent it or any of its subsidiaries or any of their respective properties is are bound or affected, or (; or ii) . any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries BA is a party or by which Parent or any of its subsidiaries BA or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liability. No Material Adverse Effect. b. To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiariesBA, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of Parent or any of its subsidiariesthe same. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries BA which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or BA, any acquisition of material property by Parent or BA or the conduct of business by Parent as currently conducted. (b) c. Parent and its subsidiaries hold, to the extent legally required, BA hold all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of the business of Parent as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the "PARENT PERMITS"“Parent Permits”). Parent and its subsidiaries BA are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries is, in any material respect, is in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries such subsidiary or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affected, affected except for those conflicts, defaults or violations and defaults that (individually or in the aggregate) which would not cause be reasonably expected to have a Parent to lose any material benefit or incur any material liabilityMaterial Adverse Effect. No To the knowledge of Parent, no investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been or threatened in a writing delivered to Parent against Parent or any of its subsidiaries, nor, to Parent's knowledge, nor has any Governmental Entity indicated in writing an intention to conduct an investigation of the same; other than those which would not reasonably be expected to have a Parent or any of its subsidiariesMaterial Adverse Effect. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries which has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of ParentParent or any of its subsidiaries, any acquisition of material property by Parent or any of its subsidiaries or the conduct of business by Parent or any of its subsidiaries as currently conducted. (b) Parent and each of its subsidiaries hold, to the extent legally required, holds all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that Governmental Entities which are material necessary to and required for the operation conduct of its business except those the business absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent as currently conducted Material Adverse Effect, (collectively, the "PARENT PERMITS"“Parent Permits”). Parent and each of its subsidiaries are in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.

Compliance; Permits; Restrictions. (a) Neither Parent nor any of its subsidiaries isis not, in any material respect, in conflict with, or in default or in violation of (i) any law, rule, regulation, order, judgment or decree applicable to Parent or any of its subsidiaries or by which Parent or any of its subsidiaries or any of their respective properties is bound or affected, or (ii) any material note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its subsidiaries is a party or by which Parent or any of its subsidiaries or its or any of their respective properties is bound or affectedbound, except for conflicts, violations and defaults that (individually or in the aggregate) would not cause Parent to lose any material benefit or incur any material liability. No investigation or review by any Governmental Entity is pending or, to Parent's knowledge, has been threatened in a writing delivered to Parent against Parent or any of its subsidiariesParent, nor, to Parent's knowledge, has any Governmental Entity indicated an intention to conduct an investigation of Parent or any of its subsidiariesParent. There is no material agreement, judgment, injunction, order or decree binding upon Parent or any of its subsidiaries which has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent, any acquisition of material property by Parent or the conduct of business by Parent as currently conducted. (b) Parent and its subsidiaries holdholds, to the extent legally required, all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that are material to and required for the operation of the business of Parent as currently conducted (collectively, the "PARENT PERMITSParent Permits"). Parent and its subsidiaries are is in compliance in all material respects with the terms of the Parent Permits, except where the failure to be in compliance with the terms of the Parent Permits would not be material to Parent.