Common use of Licenses or Permits Clause in Contracts

Licenses or Permits. The Company possesses all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 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 their respective properties or the conduct of their respective businesses as described in the Pricing Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse Change. The Company is in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by 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. The Company has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 6 contracts

Samples: Underwriting Agreement (Tonix Pharmaceuticals Holding Corp.), Underwriting Agreement (Tonix Pharmaceuticals Holding Corp.), Underwriting Agreement (Tonix Pharmaceuticals Holding Corp.)

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Licenses or Permits. The Company possesses and each of its subsidiaries possess all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 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 their respective properties or the conduct of their respective businesses as described in the Pricing General Disclosure Package and the Prospectus Prospectus, including without limitation, such permits, licenses, approvals, consents and other authorizations required by the DOT, the FAA, EASA and the ITAR (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse ChangeEffect. The Company is and its subsidiaries are in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by 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 ChangeEffect. The Neither the Company nor any subsidiary has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 4 contracts

Samples: Underwriting Agreement (AerSale Corp), Underwriting Agreement (AerSale Corp), Underwriting Agreement (AerSale Corp)

Licenses or Permits. The Company possesses all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 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 their respective properties or the conduct of their respective businesses as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse Change. The Company is in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by 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. The Company has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 4 contracts

Samples: Underwriting Agreement (Synthetic Biologics, Inc.), Underwriting Agreement (Synthetic Biologics, Inc.), Underwriting Agreement (Synthetic Biologics, Inc.)

Licenses or Permits. The Company possesses all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA, but excluding Regulatory Authorizations (as defined below)) that are necessary for the ownership or lease of their respective its properties or the conduct of their respective businesses its business as described in the Pricing General Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, reasonably be expected to have a Material Adverse ChangeEffect. The Company is in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by such Governmental Permitsexcept where noncompliance would not have a Material Adverse Effect; all such Governmental Permits are valid and in full force and effect, except where the validity invalidity or failure to be in full force and effect would not, singularly or in the aggregate, not reasonably be expected to have a Material Adverse ChangeEffect. The Company has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed, except where any such non-renewal would not, singularly or in the aggregate, have a Material Adverse Effect.

Appears in 3 contracts

Samples: Underwriting Agreement (Nkarta, Inc.), Underwriting Agreement (Nkarta, Inc.), Underwriting Agreement (Nkarta, Inc.)

Licenses or Permits. The Company possesses and each of its subsidiaries possess all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 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 their respective properties or the conduct of their respective businesses as described in the Pricing Disclosure Package Registration Statement and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly singly or in the aggregate, reasonably be expected to have a Material Adverse ChangeEffect. The Company is and its subsidiaries are in compliance with all such Governmental Permits, including with all conditions except where noncompliance would not reasonably be expected to have a Material Adverse Effect, and limitations on the commercial rights granted by such Governmental Permits; all such Governmental Permits are valid and in full force and effect, except where the validity invalidity or failure to be in full force and effect would not, singularly singly or in the aggregate, reasonably be expected to have a Material Adverse ChangeEffect. The Neither the Company nor any subsidiary has not received written, and to the Company’s knowledge, oral, notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed, except for such revocations, modifications, suspensions, terminations or invalidations which would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Appears in 3 contracts

Samples: Common Stock Sales Agreement (Avidity Biosciences, Inc.), Sales Agreement (Avidity Biosciences, Inc.), Sales Agreement (Avidity Biosciences, Inc.)

Licenses or Permits. The Company possesses all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 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 their respective its properties or the conduct of their respective businesses its business as described in the Pricing General Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse ChangeEffect. The Company is in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by 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 ChangeEffect. All such Governmental Permits are free and clear of any restriction or condition that are in addition to, or materially 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 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 no reason to believe that any such Governmental Permit will not be renewed.

Appears in 3 contracts

Samples: Underwriting Agreement (G1 Therapeutics, Inc.), Underwriting Agreement (G1 Therapeutics, Inc.), Underwriting Agreement (G1 Therapeutics, Inc.)

Licenses or Permits. The Company possesses and each of its subsidiaries possess all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDAFDA or otherwise governing public health, consumer safety, and consumer products) that are necessary for the ownership or lease of their respective properties or the conduct of their respective businesses as described in the Pricing General Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, reasonably be expected to have a Material Adverse ChangeEffect. The Company is and its subsidiaries are in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by such Governmental Permits; all such Governmental Permits are valid and in full force and effect, except where the failure to be in compliance or the validity or failure to be in full force and effect would not, singularly or in the aggregate, reasonably be expected to have a Material Adverse ChangeEffect. The Neither the Company nor any subsidiary has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such material Governmental Permit and the Company has no reason to believe that any such material Governmental Permit will not be renewed.

Appears in 3 contracts

Samples: Underwriting Agreement (Greenlane Holdings, Inc.), Underwriting Agreement (Greenlane Holdings, Inc.), Underwriting Agreement

Licenses or Permits. The Company possesses and each of its subsidiaries possess all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 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 their respective properties or the conduct of their respective businesses as described in the Pricing General Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, reasonably be expected to have a Material Adverse ChangeEffect. The Company is and its subsidiaries are in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by such Governmental Permitsexcept where any noncompliance would not have a Material Adverse Effect; 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 notnot reasonably be expected to, singularly or in the aggregate, have a Material Adverse ChangeEffect. The Neither the Company nor any subsidiary has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 2 contracts

Samples: Underwriting Agreement (Atreca, Inc.), Underwriting Agreement (Atreca, Inc.)

Licenses or Permits. The Company possesses and each of its subsidiaries possess all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 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 their respective properties or the conduct of their respective businesses as described in the Pricing General Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same any such Governmental Permits would not, singularly or in the aggregate, have a Material Adverse ChangeEffect. The Company is and its subsidiaries are in compliance with all such Governmental PermitsPermits except where any failures to comply would not, including with all conditions and limitations on singularly or in the commercial rights granted by such Governmental Permitsaggregate, have a Material Adverse Effect; 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 notnot reasonably be expected to, singularly or in the aggregate, have a Material Adverse ChangeEffect. The Neither the Company nor any subsidiary has not received written notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 2 contracts

Samples: Underwriting Agreement (Protara Therapeutics, Inc.), Underwriting Agreement (Protara Therapeutics, Inc.)

Licenses or Permits. The Company possesses all required licenses, certificates, registrations, authorizations and permits required by and has registered as a medical device establishment with the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 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 their respective properties or the conduct of their respective businesses as described in the Pricing Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse Change. The Company is and its subsidiaries are in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by such Governmental Permits; all such Governmental Permits are valid and in full force and effect, except where the validity invalidity or failure to be in full force and effect would not, singularly or in the aggregate, have a Material Adverse Change. The Neither the Company nor any subsidiary has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 2 contracts

Samples: Sales Agreement (Viveve Medical, Inc.), Viveve Medical, Inc.

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Licenses or Permits. The Company possesses all licenses, certificates, authorizations, approvals, registrations, authorizations clearances, exemptions, and permits required by the FDA issued by, and other governmental or regulatory authorities performing functions similar to those performed by the FDA and have has made all declarations and filings with, the appropriate local, state, federal or foreign governmental or regulatory agencies or bodies (bodies, including, without limitation, those administered or required by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) FDA that are necessary for the ownership or lease of their respective its properties or the conduct of their respective businesses its business as described in the Pricing Disclosure Package and Registration Statement or the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse Change. The Company is in compliance with all such Governmental Permits, including with all conditions and limitations on except where the commercial rights granted by such Governmental Permitsfailure to be in compliance would not, singularly or in the aggregate, have a Material Adverse Change; 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. The Company has not received written notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 1 contract

Samples: Open Market Sale Agreement (Spruce Biosciences, Inc.)

Licenses or Permits. The Company possesses and each of its subsidiaries possess all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA issued by, and have made all declarations and filings with, the appropriate localfederal, provincial, state, federal municipal, local or foreign governmental or regulatory agencies or bodies (including, without limitation, those administered by the FDA Health Canada or by any foreign, federal, state provincial, state, municipal, local or local foreign governmental or regulatory authority in Canada or any other country performing functions similar to those performed by the FDAHealth Canada) that are necessary for the ownership or lease of their respective properties or the conduct of their respective businesses as described in the Pricing Registration Statement, the General Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, reasonably be expected to have an adverse effect to the business taken as a Material Adverse Changewhole. The Company is and its subsidiaries have been and are in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by 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, reasonably be expected to have an adverse effect on the business taken as a Material Adverse Changewhole. The Neither the Company nor any subsidiary has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 1 contract

Samples: Underwriting Agreement (Tilray, Inc.)

Licenses or Permits. The Company possesses and each of its subsidiaries possess all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA issued by, and have made all declarations and filings with, the appropriate localfederal, provincial, state, federal municipal, local or foreign governmental or regulatory agencies or bodies (including, without limitation, those administered by the FDA Health Canada or by any foreign, federal, state provincial, state, municipal, local or local foreign governmental or regulatory authority in Canada or any other country performing functions similar to those performed by the FDAHealth Canada) that are necessary for the ownership or lease of their respective properties or the conduct of their respective businesses as described in the Pricing Disclosure Package Registration Statement and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, reasonably be expected to have an adverse effect to the business taken as a Material Adverse Changewhole. The Company is and its subsidiaries have been and are in compliance with all such Governmental Permits, including with all conditions and limitations on the commercial rights granted by 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, reasonably be expected to have an adverse effect on the business taken as a Material Adverse Changewhole. The Neither the Company nor any subsidiary has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 1 contract

Samples: Sales Agreement (Tilray, Inc.)

Licenses or Permits. The Company possesses and each of its subsidiaries possess all licenses, certificates, registrations, authorizations and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA 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 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 their respective properties or the conduct of their respective businesses as described now conducted or as proposed in the Pricing General Disclosure Package and the Prospectus to be conducted (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse ChangeEffect. The Company is and its subsidiaries are in compliance compliance, in all material respects, with all such Governmental Permits, including with all conditions ; and limitations on the commercial rights granted by 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 ChangeEffect. The Except as set forth in the General Disclosure Package, neither the Company nor any subsidiary has not received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 1 contract

Samples: Underwriting Agreement (Molecular Templates, Inc.)

Licenses or Permits. The Company possesses all licenses, certificates, authorizations, approvals, registrations, authorizations clearances, exemptions, and permits required by the FDA and other governmental or regulatory authorities performing functions similar to those performed by the FDA issued by, and have made all declarations and filings with, the appropriate local, state, federal or foreign governmental or regulatory agencies or bodies (bodies, including, without limitation, those administered or required by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) FDA that are necessary for the ownership or lease of their respective its properties or the conduct of their respective businesses its business as described in the Pricing General Disclosure Package and the Prospectus (collectively, the “Governmental Permits”) except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse ChangeEffect. The Company is in compliance with all such Governmental Permits, including with all conditions and limitations on except where the commercial rights granted by such Governmental Permitsfailure to be in compliance would not, singularly or in the aggregate, have a Material Adverse Effect; 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 ChangeEffect. The Company has not received written notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed.

Appears in 1 contract

Samples: Underwriting Agreement (Spruce Biosciences, Inc.)

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