Common use of Regulatory Permits and Compliance Clause in Contracts

Regulatory Permits and Compliance. The Company holds, and is operating in material compliance with, such Permits of the FDA and any other Regulatory Agency required for the conduct of its business as currently conducted (collectively, the “FDA Permits”), and all such FDA Permits are in full force and effect. The Company has fulfilled and performed all of its material obligations with respect to the FDA Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any FDA Permit. The Company has operated and currently is in compliance with applicable statutes and implementing regulations administered or enforced by the FDA or other Regulatory Agency, except where the failure to so comply would not result in a Material Adverse Effect. The Company has not received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA or comparable foreign regulatory agency alleging that any operation or activity of the Company is in violation of any applicable law, rule or regulation.

Regulatory Permits and Compliance. The Company holds, and is operating in material compliance with, such Permits of the FDA and any other Regulatory Agency required for the conduct of its business as currently conducted (collectively, the “FDA Permits”), and all such FDA Permits are in full force and effect. The Company has fulfilled and performed all of its material obligations with respect to the FDA Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any FDA Permit. The Company has operated and currently is in compliance with applicable statutes and implementing regulations administered or enforced by the FDA or other Regulatory Agency, including the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and applicable regulations promulgated thereunder, except where the failure to so comply would not result in a Material Adverse Effect. The Company has not received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA or comparable foreign regulatory agency Regulatory Agency alleging that any operation or activity of the Company is in violation of any applicable law, rule or regulation.