Common use of Food and Drug Regulations Clause in Contracts

Food and Drug Regulations. As to each product subject to the jurisdiction of the FDA under the Federal Food, Drug and Cosmetic Act, and the regulations thereunder (the “FDCA”) and similar or comparable governmental authorities located in other countries and laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, including, without limitation in foreign jurisdictions including Health Canada (collectively, “Food and Drug Regulations”), that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Product”), such Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under applicable Food and Drug Regulations, except where the failure to be in compliance would not have or would reasonably be expected to have a Material Adverse Effect or as is disclosed in the Preliminary Prospectus or the Prospectus. Except as disclosed in the Preliminary Prospectus or the Prospectus, there is no pending, completed or, to the Company’s knowledge, threatened, Proceeding against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication arising from or relating to Food and Drug Regulations, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries (including Food and Drug Regulations), and which, either individually or in the aggregate, would have or would reasonably be expected to have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable Food and Drug Regulations. The Company has not been informed by the FDA or any other governmental authority that such governmental authority will prohibit the marketing, sale, license or use in the United States or in another jurisdiction of any product proposed to be developed, produced or marketed by the Company.