Common use of Licenses and Other Rights; Compliance with Laws Clause in Contracts

Licenses and Other Rights; Compliance with Laws. The Company and its Subsidiaries possess such permits, licenses, approvals, consents, approvals, waivers, exemptions, franchises, certificates, orders, registrations and other authorizations (collectively, “Governmental Licenses”) issued by the appropriate Governmental Entities necessary to conduct the business now operated by them (including, without limitation, all such Governmental Licenses required by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency, or any other federal, state, local or foreign agencies or bodies engaged in the regulation of clinical or preclinical studies, pharmaceuticals, biologics or activities related to the business now operated by the Company and its Subsidiaries), except where the failure so to possess would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect. The Company and its Subsidiaries are in compliance with the terms and conditions of all Governmental Licenses, except where the failure so to comply would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect. All of the Governmental Licenses are valid and in full force and effect, except when the invalidity of such Governmental Licenses or the failure of such Governmental Licenses to be in full force and effect would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any notice of any Action relating to the revocation or modification of any Governmental Licenses which, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably be expected to result in a Material Adverse Effect. The Company and its Subsidiaries (i) are, and at all times have been, in compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product manufactured or distributed by the Company or its Subsidiaries (“Applicable Laws”), except where such noncompliance would not, individually or in the aggregate, result in a Material Adverse Effect; and (ii) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or Governmental Entity alleging or asserting noncompliance with (x) any Applicable Laws or (y) any Governmental License required by any such Applicable Laws, except where being in contravention of any of the foregoing representations or warranties, individually or in the aggregate, would not result in a Material Adverse Effect.

Licenses and Other Rights; Compliance with Laws. (a) The Company and its Subsidiaries possess such permits, each Subsidiary has all licenses, approvals, consents, approvals, waivers, exemptionspermits, franchises, certificatesConsents, ordersconcessions, registrations or similar rights and other authorizations of Governmental Entities (collectively, “Governmental Licenses”) issued "Permits"), required to own and lease its properties and assets and to conduct its business as now conducted, except for such Permits the failure of which to obtain would not reasonably be expected to result in a Company Material Adverse Effect. Section 4.27 of the Company Disclosure Schedule sets forth a list of each material Permit so required or used by the appropriate Governmental Entities necessary Company or any Subsidiaries in the operation or conduct of its business. No registrations, filings, applications, notices, transfers, Consents, audits, qualifications or other action of any kind is required by virtue of the execution and delivery of this Agreement or the Ancillary Agreements by the Company and the Sellers or of the consummation by the Company and the Sellers of the transactions contemplated hereby or thereby (i) to avoid the loss of any such Permit or any material asset, property or right pursuant to the terms thereof or (ii) to enable the Company or any Subsidiary to hold and enjoy such Permit after the Closing Date in the operation or conduct of its business as conducted prior to the business now operated by them Closing Date. To the Company's knowledge, no event has occurred which (i) is reasonably likely to result in the finding that the Company or any of the Subsidiaries is unqualified to hold any material Permit, (ii) permits, or after notice or lapse of time or both would permit, the revocation or termination of any of the material Permits or the denial of an application for the renewal thereof or (iii) would result in any impairment of the rights of the Company or any Subsidiary as holder of any such material Permit. (b) The Company and each Subsidiary has been and is in compliance with all material Applicable Laws including, without limitation, all such Governmental Licenses required by the U.S. Food rules, laws and Drug Administration (the “FDA”)regulations relating to fair employment practices. Since January 1, the European Medicines Agency2000, or any other federal, state, local or foreign agencies or bodies engaged in the regulation of clinical or preclinical studies, pharmaceuticals, biologics or activities related to the business now operated by neither the Company and its Subsidiaries), except where the failure so nor any Subsidiary has entered into or been subject to possess would not reasonably be expected to, individually any material Judgment or in the aggregate, result in a Material Adverse Effect. The Company and its Subsidiaries are in compliance Consent with the terms and conditions of all Governmental Licenses, except where the failure so respect to comply would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect. All any aspect of the business, affairs, properties or assets of the Company or such Subsidiary or received any request for information, notice, demand letter, administrative inquiry or formal or informal complaint or claim from any Governmental Licenses are valid and in full force and effectEntity with respect to any material aspect of the business, except when affairs, properties or assets of the invalidity of Company or such Governmental Licenses or the failure of such Governmental Licenses to be in full force and effect would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect. Subsidiary. (c) Neither the Company nor any Subsidiary: (i) has made any contributions, payments or gifts of its Subsidiaries has received any notice property to or for the private use of any Action relating to the revocation official, employee or modification agent of any Governmental Licenses whichEntity or educational institution where either the payment or the purpose of such contribution, individually payment or gift is illegal under any Applicable Law, (ii) has established or maintained any unrecorded fund or asset for any purpose other than promotional funds, or intentionally made any false or artificial entries on its books or records for any reason, (iii) has made any payments to any Person or Governmental Entity where the Company or such Subsidiary intended or understood that any part of such payment was to be used for any other purpose other than that described in the aggregatedocuments supporting the payment or (iv) has made any contribution, if or reimbursed any political gift or contribution made by any other Person, to candidates for public office, whether federal, state or local, where such contribution would be in violation of Applicable Law. (d) Sections 4.27(a) and 4.27(b) do not relate to Regulatory Agency (as defined in Section 12.15(a)) or Regulatory Law (as defined in Section 12.15(a)) matters, which are the subject of an unfavorable decision, ruling or finding, would reasonably be expected to result in a Material Adverse Effect. The Company and its Subsidiaries Section 4.28 (i) are, and at all times have been, in compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product manufactured or distributed by the Company or its Subsidiaries (“Applicable Laws”Regulatory Agency Matters), except where such noncompliance would not, individually or in the aggregate, result in a Material Adverse Effect; and (ii) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or Governmental Entity alleging or asserting noncompliance with (x) any Applicable Laws or (y) any Governmental License required by any such Applicable Laws, except where being in contravention of any of the foregoing representations or warranties, individually or in the aggregate, would not result in a Material Adverse Effect.

Licenses and Other Rights; Compliance with Laws. The Company and its Subsidiaries possess such Homology has all franchises, permits, licenses, approvals, consents, approvals, waivers, exemptions, franchises, certificates, orders, registrations licenses and other authorizations rights and privileges (collectively, “Governmental LicensesPermits”) issued by the appropriate Governmental Entities necessary to permit it to own its properties and to conduct its business as presently conducted and is in compliance thereunder, except where the business now operated by them (includingfailure to be in compliance would not reasonably be expected to have a Material Adverse Effect on Homology. To Homology’s knowledge, without limitation, Homology has not taken any action that would interfere with its ability to renew all such Governmental Licenses Permit(s) when required, except where the failure to renew such Permit(s) would not reasonably be expected to have a Material Adverse Effect on Homology. Homology is and has been in compliance with all laws applicable to its business, properties and assets, and to the products and services sold by it, except where the failure to be in compliance has not had and would not reasonably be expected to have a Material Adverse Effect on Homology. Homology has made all material filings and obtained all such material approvals as may be required by the U.S. United States Food and Drug Administration (the “FDA”)) or any committee thereof or from any other U.S. or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the European Medicines Agency, or any other federal, state, local or foreign agencies or bodies engaged in “Regulatory Agencies”) to conduct the regulation of clinical or preclinical studies, pharmaceuticals, biologics or trials and manufacturing activities related to such clinical trials currently being conducted by Homology, and Homology has operated and currently is in compliance in all material respects with all applicable rules, regulations and policies of the business now operated by the Company and its Subsidiaries)Regulatory Agencies, except where the failure so to possess would make such filings, obtain such approval or comply with such rules, regulations and policies could not reasonably be expected to, individually or in the aggregate, result in to have a Material Adverse EffectEffect on Homology. The Company and its Subsidiaries are in compliance with the terms and conditions of all Governmental Licenses, except where the failure so to comply would Homology has not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect. All of the Governmental Licenses are valid and in full force and effect, except when the invalidity of such Governmental Licenses or the failure of such Governmental Licenses to be in full force and effect would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any notice written notification of any pending or threatened Action relating to the revocation or modification of from any Governmental Licenses whichAuthority, individually or in the aggregateincluding any Regulatory Agency, if the subject of an unfavorable decision, ruling or finding, would that could reasonably be expected to result in have a Material Adverse Effect. The Company and its Subsidiaries (i) are, and at all times have been, in compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product manufactured or distributed by the Company or its Subsidiaries (“Applicable Laws”), except where such noncompliance would not, individually or in the aggregate, result in a Material Adverse Effect; and (ii) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or Governmental Entity alleging or asserting noncompliance with (x) any Applicable Laws or (y) any Governmental License required by any such Applicable Laws, except where being in contravention of any of the foregoing representations or warranties, individually or in the aggregate, would not result in a Material Adverse EffectEffect on Homology.