Common use of Compliance with Laws; No Defaults Clause in Contracts

Compliance with Laws; No Defaults. (a) The Company is not in material violation of any Applicable Laws except for violations which individually or in the aggregate would not have a Material Adverse Effect. (b) The Company is not in default under and no condition exists that with notice or lapse of time or both would constitute a default under, (i) any Material Contract, or (ii) any judgment, order or injunction of any court, arbitrator or governmental body, agency or authority. (c) The Company has all material governmental licenses, authorizations, permits, consents and approvals required to own, lease and operate its property and to carry on its business as now conducted. (d) Since the date of incorporation, the Company has not engaged in any conduct that is prohibited under, or fails to comply with the requirements of any U.S. or California Law or other Applicable Law that regulates either the manufacturing, promotion or distribution of pharmaceutical or medical device products, except for any such failures that, individually or in the aggregate, would not reasonably be likely to have a Material Adverse Effect. (e) The Company has not, and no officer, director, employee or agent of the Company, has made a fraudulent statement, including, but not limited to certification, to the FDA or any other governmental regulatory body or agent thereof, failed to disclose a material fact required to be disclosed to the FDA or any other governmental regulatory body or agent thereof, or committed an act, made a statement, or failed to make a statement that would reasonably be expected to require the FDA or any other governmental regulatory body or agent thereof, to cause the Company to withdraw any product from the marketplace, to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991), or to initiate any other legal action relating to fraud, false claims, or false statements. (f) Neither the Company nor any of its directors, officers, or employees are debarred by the FDA or other regulatory authority. (g) The Company has complied in all material respects with applicable security and privacy standards regarding protected health and employee information, or any Applicable Laws relating to privacy, except for any such failures to comply that, individually or in the aggregate, would not reasonably be likely to have a Material Adverse Effect.

Compliance with Laws; No Defaults. (a) RDI and its Subsidiaries holds all permits, licenses, variances, exemptions, orders and approvals of all Governmental Entities necessary for the lawful conduct of their businesses (the "RDI Permits"), except for failures to hold such RDI Permits which would not, in the aggregate, reasonably be expected to have a Material Adverse Effect of RDI and its Subsidiaries, taken as a whole. RDI and its Subsidiaries are in compliance with the terms of the RDI Permits, except where the failure so to comply would not reasonably be expected to have a Material Adverse Effect of RDI and its Subsidiaries, taken as a whole. The Company business of RDI and its Subsidiaries is not being conducted in material violation of any Applicable Laws applicable law, ordinance, rule, regulation, decree or order of any Governmental Entity, except for violations which individually or in the aggregate do not and would not reasonably be expected to have a Material Adverse EffectEffect of RDI and its Subsidiaries, taken as a whole. (b) The Company Except as set forth in Section 3.12 of the RDI Disclosure Schedule, neither RDI nor any Subsidiary is not in default under or violation (and no condition exists that event has occurred which with notice or the lapse of time or both would constitute a default underor violation) of any term, condition or provision of (i) any Material Contractnote, bond, mortgage, indenture, license, contract, agreement or other instrument or obligation to which RDI or any Subsidiary is a party or by which they or any material amount of their properties or assets is bound or (iiiii) any judgmentorder, order writ, injunction, decree, statute, rule or injunction of regulation applicable to RDI or any courtSubsidiary, arbitrator which defaults or governmental bodyviolations would, agency or authority. (c) The Company has all material governmental licenses, authorizations, permits, consents and approvals required to own, lease and operate its property and to carry on its business as now conducted. (d) Since the date of incorporation, the Company has not engaged in any conduct that is prohibited under, or fails to comply with the requirements of any U.S. or California Law or other Applicable Law that regulates either the manufacturing, promotion or distribution of pharmaceutical or medical device products, except for any such failures that, individually or in the aggregate, would not reasonably reasonable be likely expected to have a Material Adverse Effect. (e) The Company has notEffect of RDI and its Subsidiaries, and no officertaken as a whole, director, employee or agent which would materially delay the consummation of the Company, has made a fraudulent statement, including, but not limited to certification, to the FDA or any other governmental regulatory body or agent thereof, failed to disclose a material fact required to be disclosed to the FDA or any other governmental regulatory body or agent thereof, or committed an act, made a statement, or failed to make a statement that would reasonably be expected to require the FDA or any other governmental regulatory body or agent thereof, to cause the Company to withdraw any product from the marketplace, to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991), or to initiate any other legal action relating to fraud, false claims, or false statementstransactions contemplated hereby. (f) Neither the Company nor any of its directors, officers, or employees are debarred by the FDA or other regulatory authority. (g) The Company has complied in all material respects with applicable security and privacy standards regarding protected health and employee information, or any Applicable Laws relating to privacy, except for any such failures to comply that, individually or in the aggregate, would not reasonably be likely to have a Material Adverse Effect.

Compliance with Laws; No Defaults. (a) The Company is not in material violation of any Applicable Laws except for violations which individually or in the aggregate would not have a Material Adverse Effect. (b) The Company is not in default under and no condition exists that with notice or lapse of time or both would constitute a default under, (i) any Material Contract, or (ii) any judgment, order or injunction of any court, arbitrator or governmental body, agency or authority. (c) The Company has all material governmental licenses, authorizations, permits, consents and approvals required to own, lease and operate its property and to carry on its business as now conducted. (d) Since the date of incorporation, the Company has not engaged in any conduct that is prohibited under, or fails to comply with the requirements of any U.S. or California Law or 18 Confidential treatment has been requested for portions of this exhibit under 17 C.F.R. Sections §§ 200.80(b)(4) and 230.406. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. other Applicable Law that regulates either the manufacturing, promotion or distribution of pharmaceutical or medical device products, except for any such failures that, individually or in the aggregate, would not reasonably be likely to have a Material Adverse Effect. (e) The Company has not, and no officer, director, employee or agent of the Company, has made a fraudulent statement, including, but not limited to certification, to the FDA or any other governmental regulatory body or agent thereof, failed to disclose a material fact required to be disclosed to the FDA or any other governmental regulatory body or agent thereof, or committed an act, made a statement, or failed to make a statement that would reasonably be expected to require the FDA or any other governmental regulatory body or agent thereof, to cause the Company to withdraw any product from the marketplace, to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991), or to initiate any other legal action relating to fraud, false claims, or false statements. (f) Neither the Company nor any of its directors, officers, or employees are debarred by the FDA or other regulatory authority. (g) The Company has complied in all material respects with applicable security and privacy standards regarding protected health and employee information, or any Applicable Laws relating to privacy, except for any such failures to comply that, individually or in the aggregate, would not reasonably be likely to have a Material Adverse Effect.