Common use of Regulatory Filings Clause in Contracts

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority (including the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse EffectChange; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse EffectChange. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has have failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse EffectChange; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse EffectChange. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the ProspectusProspectuses, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any large, well-controlled clinical trial not described in the Prospectus the aggregate results of which reasonably call into question in any material respect the results of the clinical trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries Subsidiary has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, is in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not have a Material Adverse Effect.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the ProspectusProspectuses, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the ProspectusProspectuses, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, is in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority, except where the failure to be so in compliance would not reasonably be expected to have a Material Adverse Effect.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any failure to comply or deficiencies that, individually or in the aggregate, would not reasonably be expect to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority Authorities exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any failure to comply or deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in all material respects in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not be reasonably expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not be reasonably expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the ProspectusProspectuses, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and 15 currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has not failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any non-compliance or deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Except as disclosed in the Registration Statement and the Prospectus or as would not reasonably be expected to result in a Material Adverse Effect, the Company has operated and currently is, in all material respects, is in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and of other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its Subsidiaries has not failed to file with the applicable Governmental Authority (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any failure to comply or deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority.

Regulatory Filings. Except as disclosed set forth in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse EffectChange; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse EffectChange. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions related to the Company's ongoing clinical trials and approved products were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any failure to comply or deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority governmental authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental authority exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority (including the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any failures to comply or deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The To the Company’s knowledge, the Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in i n the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the ProspectusProspectuses, all such filings, declarations, listings, registrations, reports or submissions were in all material respects in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Entities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority Entity performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA FDA, and all applicable laws, rules, and regulations administered or enforced by other federal, state, local and foreign Governmental Authority Entity exercising comparable authorityauthority (including, without limitation, the EMA and Health Canada).

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have reasonably be expected to result in a Material Adverse EffectChange; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have reasonably be expected to result in a Material Adverse EffectChange. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any failure to comply or deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse EffectChange; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse EffectChange. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in all material respects in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not be reasonably expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not be reasonably expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority Authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has operated and currently is, in all material respects, is in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority, except for any noncompliance that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect.

Regulatory Filings. Except as disclosed in the Registration Statement, Statement and the Time of Sale Prospectus and the Prospectusas set forth in Schedule 6(s), neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any failure to comply or deficiencies that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Except as disclosed in the Registration Statement and the Prospectus, the Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any failure to comply or deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority.

Regulatory Filings. Except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority regulatory authorities (including including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Laws laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority governmental bodies exercising comparable authority.