Common use of Manufacturing Operations Clause in Contracts

Manufacturing Operations. To the knowledge of the Company, the Company Products are being and at all times have been manufactured, imported, processed, developed, distributed, packaged, labeled, and stored in material compliance with all applicable laws, including the Federal Food, Drug, and Cosmetic Act (“FD&C Act”); the Public Health Service Act (“PHSA”); and any regulations adopted by regulatory authorities thereunder (including, as applicable, those requirements relating to good laboratory practice, good clinical practice, investigational use, and pre-market approval, as applicable). As of the date hereof, neither the Company nor, to the knowledge of the Company, any of its affiliates, has received notice of any pending or threatened investigation or action from the U.S. Food and Drug Administration (the “FDA”), the U.S. Department of Justice, or any other federal, state, local, or foreign governmental authority alleging that the Company or any of its affiliates is in violation in any material respect of any applicable law, including the FD&C Act, the PHSA or any similar state or local equivalents to any of the foregoing. “Company Products” means any drug product that the Company is developing under its FGFR2, PI3Kα, and SHP2 development programs on or before the date of this Agreement or at any time thereafter prior to the Closing Date.