Common use of Licenses or Permits Clause in Contracts

Licenses or Permits. The Company possesses all licenses, certificates, permits and other authorizations required to be issued by all applicable authorities necessary to conduct its business, expect where the failure to possess such licenses, permits and other authorizations would not reasonably be expected to have a Material Adverse Effect, and the Company has not received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably expected to have a Material Adverse Effect, except as set forth in or contemplated in the General Disclosure Package, the Prospectus or Registration Statement (exclusive of any supplement thereto). The Company possesses all licenses, certificates, permits and other authorizations (collectively, “Permits”) issued by, and has made all declarations and filings with, the applicable federal, state, local or foreign governmental or regulatory authorities that are necessary for the ownership or lease of its properties or the conduct of its businesses as described in the Registration Statement, the General Disclosure Package and the Prospectus, or to permit all pre-clinical studies and clinical trials conducted by or on behalf of the Company, including, without limitation, all necessary U.S. Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”) and applicable foreign regulatory agency Permits, except as would not be expected to have a Material Adverse Effect; the Company is not in violation of, or in default under, any such Permit; and the Company has not received written notice of any revocation or modification of any such Permit and does not have any reason to believe that any such Permit will not be renewed in the ordinary course. The Company (i) is, and at all times has been, in compliance in all material respects with all Applicable Laws (as defined below) and (ii) has 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 or regulatory authority alleging or asserting non-compliance with (A) any Applicable Laws (as defined herein) or (B) any Permits required by any such Applicable Laws (as defined herein).

Licenses or Permits. The Company possesses all licenses, certificates, authorizations and permits and other authorizations required to be issued by all applicable authorities necessary to conduct its business, expect where the failure to possess such licenses, permits and other authorizations would not reasonably be expected to have a Material Adverse Effect, and the Company has not received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably expected to have a Material Adverse Effect, except as set forth in or contemplated in the General Disclosure Package, the Prospectus or Registration Statement (exclusive of any supplement thereto). The Company possesses all licenses, certificates, permits and other authorizations (collectively, “Permits”) issued by, and has have made all declarations and filings with, the applicable federalappropriate local, state, local federal or foreign governmental or regulatory authorities that are necessary for the ownership agencies or lease of its properties or the conduct of its businesses as described in the Registration Statement, the General Disclosure Package and the Prospectus, or to permit all pre-clinical studies and clinical trials conducted by or on behalf of the Company, bodies including, without limitation, all necessary U.S. those administered by the United States Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”) and applicable foreign or by any foreign, federal, state or local governmental or regulatory agency authority performing functions similar to those performed by the FDA) that are necessary for the ownership or lease of its properties or the conduct of its business as described in the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, except as would not be expected to singularly or in the aggregate, have a Material Adverse Effect; the Change. The Company is not in violation ofcompliance with all such Governmental Permits; all such Governmental Permits are valid and in full force and effect, except where the validity or failure to be in full force and effect would not, singularly or in the aggregate, have a Material Adverse Change. All such Governmental Permits are free and clear of any restriction or condition that are in addition to, or in default undermaterially different from those normally applicable to similar licenses, certificates, authorizations and permits. The Company has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Permit; Governmental Permit and no event has occurred that allows or results in, or after notice or lapse of time or both would allow or result in, revocation, modification, suspension, termination or invalidation (or proceedings related thereto ) of any such Governmental Permit and the Company has not received written notice of any revocation or modification of any such Permit and does not have any no reason to believe that any such Governmental Permit will not be renewed in the ordinary course. The Company (i) is, and at all times has been, in compliance in all material respects with all Applicable Laws (as defined below) and (ii) has 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 or regulatory authority alleging or asserting non-compliance with (A) any Applicable Laws (as defined herein) or (B) any Permits required by any such Applicable Laws (as defined herein)renewed.

Licenses or Permits. The Company possesses all licenses, certificates, authorizations and permits and other authorizations required to be issued by all applicable authorities necessary to conduct its business, expect where the failure to possess such licenses, permits and other authorizations would not reasonably be expected to have a Material Adverse Effect, and the Company has not received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably expected to have a Material Adverse Effect, except as set forth in or contemplated in the General Disclosure Package, the Prospectus or Registration Statement (exclusive of any supplement thereto). The Company possesses all licenses, certificates, permits and other authorizations (collectively, “Permits”) issued by, and has have made all declarations and filings with, the applicable federalappropriate local, state, local federal or foreign governmental or regulatory authorities agencies or bodies including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) that are necessary for the ownership or lease of its properties or the conduct of its businesses business as described in the Registration Statement, the General Disclosure Package and the ProspectusProspectus (collectively, or to permit all pre-clinical studies and clinical trials conducted by or on behalf of the Company, including, without limitation, all necessary U.S. Food and Drug Administration of the U.S. Department of Health and Human Services (“FDAGovernmental Permits”) and applicable foreign regulatory agency Permitsexcept where any failures to possess or make the same would not, except as would not be expected to singularly or in the aggregate, have a Material Adverse Effect; the . The Company is not in violation ofcompliance with all such Governmental Permits; all such Governmental Permits are valid and in full force and effect, except where the validity or failure to be in full force and effect would not, singularly or in the aggregate, have a Material Adverse Effect. All such Governmental Permits are free and clear of any restriction or condition that are in addition to, or in default undermaterially different from those normally applicable to similar licenses, certificates, authorizations and permits. The Company has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Permit; Governmental Permit and no event has occurred that allows or results in, or after notice or lapse of time or both would allow or result in, revocation, modification, suspension, termination or invalidation (or proceedings related thereto ) of any such Governmental Permit and the Company has not received written notice of any revocation or modification of any such Permit and does not have any no reason to believe that any such Governmental Permit will not be renewed in the ordinary course. The Company (i) is, and at all times has been, in compliance in all material respects with all Applicable Laws (as defined below) and (ii) has 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 or regulatory authority alleging or asserting non-compliance with (A) any Applicable Laws (as defined herein) or (B) any Permits required by any such Applicable Laws (as defined herein)renewed.

Licenses or Permits. The Each of the Company possesses and the Subsidiaries has all necessary licenses, permits, certificates, permits authorizations, consents and other authorizations approvals and has made all necessary filings required to be issued by under any Law, and has obtained all applicable authorities necessary to conduct its business, expect where the failure to possess such licenses, permits permits, certificates, authorizations, consents and approvals from other authorizations would not reasonably be expected to have a Material Adverse Effectpersons, and the Company has not received any written notice of any proceedings relating to the revocation or modification of any such certificatethereof, authorization or permit which, singly or required in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably expected order to have a Material Adverse Effect, except as set forth in or contemplated in the General Disclosure Package, the Prospectus or Registration Statement (exclusive of any supplement thereto). The Company possesses all licenses, certificates, permits and other authorizations (collectively, “Permits”) issued by, and has made all declarations and filings with, the applicable federal, state, local or foreign governmental or regulatory authorities that are necessary for the ownership or lease of its properties or the conduct of its their respective businesses as described in the Registration Statement, each of the General Disclosure Package and the Prospectus, except to the extent that any failure to have any such licenses, permits, certificates, authorizations, consents or approvals, to make any such filings or to permit all pre-clinical studies and clinical trials conducted by obtain any such licenses, permits, certificates, authorizations, consents or on behalf of the Company, including, without limitation, all necessary U.S. Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”) and applicable foreign regulatory agency Permits, except as approvals would not reasonably be expected to have have, individually or in the aggregate, a Material Adverse Effect; other than as set forth in each of the General Disclosure Package and the Prospectus, neither the Company nor any of the Subsidiaries is required by any applicable Law to obtain accreditation or certification from any governmental agency or authority in order to provide the products and services that it currently provides or that it proposes to provide as set forth in each of the General Disclosure Package and the Prospectus, except to the extent such failure would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; neither the Company nor any of the Subsidiaries is in violation of, or in default under, or has received any such Permit; and the Company has not received written notice of any regarding a possible violation, default or revocation or modification of any such Permit and does not have license, permit, certificate, authorization, consent or approval or any reason Law applicable to believe that the Company or any such Permit will not of the Subsidiaries, the effect of which would reasonably be renewed expected to have, individually or in the ordinary course. The Company (i) isaggregate, a Material Adverse Effect; and at all times has beenno such license, permit, certificate, authorization, consent or approval contains a materially burdensome restriction that is not adequately disclosed in compliance in all material respects with all Applicable Laws (as defined below) each of the General Disclosure Package and (ii) has 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 or regulatory authority alleging or asserting non-compliance with (A) any Applicable Laws (as defined herein) or (B) any Permits required by any such Applicable Laws (as defined herein)the Prospectus.

Licenses or Permits. The Company possesses and each of its subsidiaries possess all required licenses, certificates, authorizations and permits issued by, and have made all declarations and filings with, the appropriate local, state, federal or foreign governmental or regulatory agencies or bodies (including, without limitation, those administered by the United States Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”), the Drug Enforcement Administration (“DEA”), the European Medicines Agency (“EMA”), the Medicines and Healthcare Products Regulatory Agency (“MHRA”) and any other authorizations required state, federal, national and foreign agencies or bodies performing similar functions to be issued by all applicable authorities the FDA, the DEA, the EMA and MHRA or engaged in the regulation of pharmaceuticals) that are necessary to for the ownership or lease of their respective properties or the conduct its businessof their respective businesses as described in the General Disclosure Package and the Prospectus (collectively, expect the “Governmental Permits”) except where the failure any failures to possess such licensesor make the same would not, permits and other authorizations would not singularly or in the aggregate, reasonably be expected to have a Material Adverse Effect. The Company and its subsidiaries are in compliance with the terms and conditions of all such Governmental Permits, except where the failure so to comply would not, singularly or in the aggregate, reasonably be expected to result in a Material Adverse Effect; all such Governmental Permits are valid and in full force and effect, except where the invalidity or failure to be in full force and effect would not, singularly or in the aggregate, reasonably be expected to have a Material Adverse Effect. Neither the Company nor any subsidiary has not received written notification of any notice of revocation, significant modification, suspension, termination or invalidation (or proceedings relating to the revocation or modification related thereto) of any such certificateGovernmental Permit, authorization or permit which, singly singularly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably be expected to have result in a Material Adverse Effect, except as set forth in or contemplated in the General Disclosure Package, the Prospectus or Registration Statement (exclusive of any supplement thereto). The Company possesses all licenses, certificates, permits and other authorizations (collectively, “Permits”) issued by, and has made all declarations and filings with, the applicable federal, state, local or foreign governmental or regulatory authorities that are necessary for the ownership or lease of its properties or the conduct of its businesses as described in the Registration Statement, the General Disclosure Package and the Prospectus, or to permit all pre-clinical studies and clinical trials conducted by or on behalf of the Company, including, without limitation, all necessary U.S. Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”) and applicable foreign regulatory agency Permits, except as would not be expected to have a Material Adverse Effect; the Company is not in violation of, or in default under, any such Permit; and the Company has not received written notice of any revocation or modification of any such Permit and does not have any no reason to believe that any such Governmental Permit will not be renewed renewed, except where the failure to renew would not, singularly or in the ordinary courseaggregate, reasonably be expected to result in a Material Adverse Effect. The Company (i) isand each of its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable laws or Governmental Permits, and at all times has beensuch reports, in compliance documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects with all Applicable Laws (as defined below) and (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence were corrected or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (A) any Applicable Laws (as defined herein) or (B) any Permits required supplemented by any such Applicable Laws (as defined hereina subsequent submission).

Licenses or Permits. The Company possesses and each of its subsidiaries possess all licenses, certificates, authorizations and permits and other authorizations required to be issued by all applicable authorities necessary to conduct its business, expect where the failure to possess such licenses, permits and other authorizations would not reasonably be expected to have a Material Adverse Effect, and the Company has not received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably expected to have a Material Adverse Effect, except as set forth in or contemplated in the General Disclosure Package, the Prospectus or Registration Statement (exclusive of any supplement thereto). The Company possesses all licenses, certificates, permits and other authorizations (collectively, “Permits”) issued by, and has have made all declarations and filings with, the applicable federalappropriate local, state, local federal or foreign governmental or regulatory authorities agencies or bodies (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) that are necessary for the ownership or lease of its their respective properties or the conduct of its their respective businesses as described in the Registration Statement, the General Disclosure Package and the ProspectusProspectus (collectively, or to permit all pre-clinical studies and clinical trials conducted by or on behalf of the Company, including, without limitation, all necessary U.S. Food and Drug Administration of the U.S. Department of Health and Human Services (“FDAGovernmental Permits”) and applicable foreign regulatory agency Permitsexcept where any failures to possess or make the same would not, except as would not singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; . The Company and its subsidiaries are in compliance with all such Governmental Permits, except where noncompliance would not reasonably be expected to have a Material Adverse Effect, and all such Governmental Permits are valid and in full force and effect, except where the invalidity or failure to be in full force and effect would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect. Neither the Company is not in violation ofnor any subsidiary has received written, and to the Company’s knowledge, oral, notification of any revocation, modification, suspension, termination or in default under, invalidation (or proceedings related thereto) of any such Permit; Governmental Permit and the Company has not received written notice of any revocation or modification of any such Permit and does not have any no reason to believe that any such Governmental Permit will not be renewed renewed, except for such revocations, modifications, suspensions, terminations or invalidations which would not, singly or in the ordinary course. The Company (i) isaggregate, and at all times has been, in compliance in all material respects with all Applicable Laws (as defined below) and (ii) has 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 or regulatory authority alleging or asserting non-compliance with (A) any Applicable Laws (as defined herein) or (B) any Permits required by any such Applicable Laws (as defined herein)reasonably be expected to have a Material Adverse Effect.

Licenses or Permits. The Company possesses all and each subsidiary possess such valid and current certificates, approvals, licenses, certificatesclearances, consents, grants, exemptions, marks, notifications, orders, authorizations or permits and other authorizations required to be issued by all applicable the appropriate state, federal or foreign regulatory agencies or bodies (including, without limitation, the United States Food and Drug Administration (the “FDA”), to the extent applicable, the United States Drug Enforcement Administration, or any other foreign, federal, state, provincial, court or local government or regulatory authorities including self-regulatory organizations engaged in the regulation of clinical trials, pharmaceuticals, biologics or biohazardous substances or materials) necessary for the ownership or lease of their respective properties or to conduct its businessbusinesses as described in the General Disclosure Package and the Prospectus (collectively, expect where “Permits”), except for such Permits the failure of which to possess such licensespossess, permits and other authorizations obtain or make the same would not reasonably be expected to have a Material Adverse Effect, and Change; the Company and its subsidiaries are in compliance with the terms and conditions of all such Permits, except where the failure to be in compliance would not reasonably be expected to have a Material Adverse Change; all of the Permits are valid and in full force and effect, except where any invalidity, individually or in the aggregate, would not be reasonably expected to have a Material Adverse Change; and neither the Company nor any of its subsidiaries has not received any written notice of proceedings relating to the revocation limitation, revocation, cancellation, suspension, modification or modification non-renewal of any such certificate, authorization or permit Permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably expected to have a Material Adverse Effect, except as set forth in or contemplated in the General Disclosure Package, the Prospectus or Registration Statement (exclusive of any supplement thereto). The Company possesses all licenses, certificates, permits and other authorizations (collectively, “Permits”) issued byChange, and has made all declarations and filings with, the applicable federal, state, local or foreign governmental or regulatory authorities that are necessary for the ownership or lease of its properties or the conduct of its businesses as described in the Registration Statement, the General Disclosure Package and the Prospectus, or to permit all pre-clinical studies and clinical trials conducted by or on behalf of the Company, including, without limitation, all necessary U.S. Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”) and applicable foreign regulatory agency Permits, except as would not be expected to have a Material Adverse Effect; the Company is not in violation of, or in default under, any such Permit; and the Company has not received written notice of any revocation or modification of any such Permit and does not have any reason to believe that any such Permit license, certificate, permit or authorization will not be renewed in the ordinary course. The To the extent required by applicable laws and regulations of the FDA, the Company (i) is, and at or the applicable subsidiary has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all times has been, such submissions were in compliance in all material respects with all Applicable Laws (as defined below) and (ii) has 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 or regulatory authority alleging or asserting non-compliance with (A) any Applicable Laws (as defined herein) or (B) any Permits required applicable laws and rules and regulations when submitted and no material deficiencies have been asserted by the FDA with respect to any such Applicable Laws (as defined herein)submissions.