Common use of Regulatory Filings Clause in Contracts

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material filing, declaration, listing, registration, report or submission; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the The Company nor any of its subsidiaries has not failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submission; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submission; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission with respect to the Company’s product candidates that are described or referred to in the Registration Statement, the Prospectus and the Time of Sale Information; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies regarding compliance with applicable law have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries Subsidiaries has failed to file with the applicable Regulatory Authorities regulatory authorities (including, without limitation, the FDA or any material foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) any filing, declaration, listing, registration, report or submission; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; filed and no material deficiencies have been asserted by any applicable Regulatory Authority regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries Subsidiaries has failed to file with applicable regulatory authorities any statement, report, information or form required by any applicable law, regulation or order, except where the applicable Regulatory Authorities any material filingfailure to be so in compliance would not, declarationindividually or in the aggregate, listingreasonably be expected to have a Material Adverse Effect, registration, report or submission; all such filings, declarations, listings, registrations, reports filings or submissions were in material compliance with applicable laws when filed; filed and no material deficiencies have been asserted by any applicable Regulatory Authority regulatory commission, agency or authority with respect to any such filings, declarations, listings, registrations, reports filings or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with applicable regulatory authorities any statement, report, information or form required by any applicable law, regulation or order, except where the applicable Regulatory Authorities any material filingfailure to be so in compliance would not, declarationindividually or in the aggregate, listinghave a Material Adverse Effect, registration, report or submission; all such filings, declarations, listings, registrations, reports or submissions filings were in material compliance with applicable laws when filed; filed and no material deficiencies have been asserted by any applicable Regulatory Authority regulatory commission, agency or authority with respect to any such filings, declarations, listings, registrations, reports filings or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with applicable regulatory authorities any statement, report, information or form required by any applicable law, regulation or order, except where the applicable Regulatory Authorities any material filingfailure to be so in compliance would not, declarationindividually or in the aggregate, listinghave a Material Adverse Effect, registration, report or submission; and all such filings, declarations, listings, registrations, reports filings or submissions were in material compliance with applicable laws when filed; filed and no material deficiencies have been asserted by any applicable Regulatory Authority regulatory commission, agency or authority with respect to any such filings, declarations, listings, registrations, reports filings or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission with respect to the Company’s product candidates that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies regarding compliance with applicable law have been asserted by any applicable Regulatory Authority regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries Subsidiaries has failed to file with applicable regulatory authorities any statement, report, information or form required by any applicable law, regulation or order, except where the applicable Regulatory Authorities any material filingfailure to be so in compliance would not, declarationindividually or in the aggregate, listing, registration, report or submissionreasonably be expected to have a Material Adverse Effect; all such filings, declarations, listings, registrations, reports filings or submissions were in material compliance with applicable laws when filed; filed and no material deficiencies have been asserted by any applicable Regulatory Authority regulatory commission, agency or authority with respect to any such filings, declarations, listings, registrations, reports filings or submissions.

Regulatory Filings. Neither the The Company nor any of its subsidiaries has not failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submission; all such filings, declarations, listings, registrations, reports or submissions were in compliance, in all material compliance respects, with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissionssubmissions that have not been subsequently remedied.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission or failed to obtain any required approval or authorization with respect to the product candidates of the Company or its subsidiaries that are described or referred to in the SEC Reports; all such filings, declarations, listings, registrations, reports or submissions submissions, as applicable, were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission or failed to obtain any required approval with respect to the product candidates of the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; all such filings, declarations, listings, registrations, reports or submissions submissions, as applicable, were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries other Group Company has failed to file with the applicable Regulatory Authorities regulatory authorities any material required filing, declaration, listing, registration, report or submissionsubmission with respect to the product candidates of the Company or the other Group Companies that are described or referred to in the SEC Documents; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws Applicable Laws when filed; and no material deficiencies regarding compliance with Applicable Law have been asserted by any applicable Regulatory Authority regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries the LLC has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission with respect to the Company’s and the LLC’s product candidates that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies regarding compliance with applicable law have been asserted by any applicable Regulatory Authority regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the The Company nor any of its subsidiaries has not failed to file with the applicable Regulatory Authorities any material filing, declaration, listing, registration, report or submission; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; filed and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission or failed to obtain any required approval or authorization with respect to the product candidates of the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; all such filings, declarations, listings, registrations, reports or submissions submissions, as applicable, were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries or any of the Facilities operated by the Company or any of its subsidiaries has failed to file with the applicable Regulatory Authorities regulatory authorities any material filingstatement, declarationreport, listing, registration, report information or submission; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies have been asserted form required by any applicable Regulatory Authority with respect law, regulation or order, except where the failure to any such filingsso file would not, declarationssingly and in the aggregate, listings, registrations, reports or submissions.have a Material

Regulatory Filings. Neither (1) neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission with respect to the Company’s product candidates that are described in or incorporated by reference in the Registration Statement and the Prospectus; (2) all such filings, declarations, listings, registrations, reports or submissions were in compliance in all material compliance respects with applicable laws when filed; and (3) no material deficiencies regarding compliance with applicable law have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its --------------------------- subsidiaries has failed to file with applicable regulatory authorities any statement, report, information or form required by any applicable law, regulation or order, except where the applicable Regulatory Authorities any material filingfailure to be so in compliance would not, declarationindividually or in the aggregate, listinghave a Material Adverse Effect, registration, report or submission; all such filings, declarations, listings, registrations, reports filings or submissions were in material compliance with applicable laws when filed; filed and no material deficiencies have been asserted by any applicable Regulatory Authority regulatory commission, agency or authority with respect to any such filings, declarations, listings, registrations, reports filings or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submission; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission or failed to obtain any required approval with respect to the product candidates of the Company or its subsidiaries that are described or referred to in the Registration Statement, General Disclosure Package and the Prospectus; all such filings, declarations, listings, registrations, reports or submissions submissions, as applicable, were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries Subsidiaries has failed to file with the applicable Regulatory Authorities regulatory authorities any material filingstatement, declarationreport, listing, registration, report information or submission; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies have been asserted form required by any applicable Regulatory Authority with respect law, regulation or order, except where the failure to any such filingsbe so in compliance would not, declarationsindividually or in the aggregate, listings, registrations, reports or submissions.reasonably be expected to have a Material

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with applicable regulatory authorities any statement, report, information or form required by any applicable law, regulation or order, except where the applicable Regulatory Authorities any material filingfailure to be so in compliance would not, declarationindividually or in the aggregate, listinghave a Material Adverse Effect, registration, report or submission; all such filings, declarations, listings, registrations, reports filings or submissions were in material compliance with applicable laws when filed; filed and no material deficiencies have been asserted by any applicable Regulatory Authority regulatory commission, agency or authority with respect to any such filings, declarations, listings, registrations, reports filings or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission or failed to obtain any required approval with respect to the product candidates of the Company or its subsidiaries that are described or referred to in the Registration Statement and the Prospectus; all such filings, declarations, listings, registrations, reports or submissions submissions, as applicable, were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities any material required filing, declaration, listing, registration, report or submissionsubmission with respect to the Company’s product candidates that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and no material deficiencies regarding compliance with applicable law have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the applicable Regulatory Authorities regulatory authorities any material required filing, declaration, listing, registration, report or submissionsubmission or failed to obtain any required approval with respect to the product candidates of the Company or its subsidiaries that are described or referred to in the Registration Statement and the Prospectus; all such filings, declarations, listings, registrations, reports or submissions submissions, as applicable, were in material compliance with applicable laws when filed; and no material deficiencies have been asserted by any applicable Regulatory Authority regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Regulatory Filings. Neither the Company nor any of its ------------------ subsidiaries has failed to file with applicable regulatory authorities any statement, report, information or form required by any applicable law, regulation or order, except where the applicable Regulatory Authorities any material filingfailure to be so in compliance would not, declarationindividually or in the aggregate, listinghave a Material Adverse Effect, registration, report or submission; and all such filings, declarations, listings, registrations, reports filings or submissions were in material compliance with applicable laws when filed; filed and no material deficiencies have been asserted by any applicable Regulatory Authority regulatory commission, agency or authority with respect to any such filings, declarations, listings, registrations, reports filings or submissions.