All Products developed, investigated, tested, manufactured, packaged, labeled, distributed or marketed by or on behalf of any Loan Party or any of its Subsidiaries that are subject to the jurisdiction of the FDA or other comparable Governmental Authority shall be developed, investigated, tested, manufactured, packaged, labeled, distributed and marketed in compliance with applicable Product Safety Laws and any other Requirements of Law, including Laws regarding registration and listing, product approval or premarket notification, good manufacturing practices, labeling, advertising, promotion, record-keeping, and adverse event reporting for dietary supplements, except, in each case, where the failure to so comply could not reasonably be expected to have a Material Adverse Effect.

Except as set forth on [Schedule 3.18]: # each Loan Party and its Subsidiaries are, and have been for the past five calendar years, in compliance in all material respects with, and each Product in current commercial distribution has been designed, developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, marketed, installed, and serviced in compliance in all material respects with Product Safety Law, including those regarding clinical and non-clinical testing, product approval or clearance, good manufacturing practices, labeling, advertising and promotion, record-keeping, establishment registration and listing; # each Loan Party and its Subsidiaries have no knowledge of any material non-compliance issues of contract manufacturers with Product Safety Laws; # each Loan Party and its Subsidiaries is in compliance in all material respects with the record-keeping and reporting requirements required by the FDA or any other Governmental Authority pertaining to the reporting of adverse events for dietary supplements and Class I recalls under the Reportable Foods Registry involving the Products; # all Products are and have been labeled, promoted, and advertised in material compliance with their regulatory clearance or approval or within the scope of an exemption from obtaining such clearance or approval; and # each Loan Party’s and its Subsidiaries’ establishments are registered with the FDA, as applicable.