Post-Market Reporting Obligations Sample Clauses
Post-Market Reporting Obligations. The Company is complying in all material respects with all applicable regulatory post-market reporting obligations, including, without limitation, the FDA’s adverse event reporting requirements at 21 CFR Parts 310, 314, 600, and 803, and, to the extent applicable, the respective counterparts thereof promulgated by governmental authorities in countries outside the United States.
Post-Market Reporting Obligations. Except as would not, individually or in the aggregate, result in a Material Adverse Effect, the Company is complying with all applicable regulatory post-market reporting obligations, including, without limitation, the FDA’s adverse event reporting requirements and, to the extent applicable, the respective counterparts thereof promulgated by governmental authorities in countries outside the United States.