under or relating to, or any actual or potential violation of, any Environmental Laws, including for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes, pollutants or contaminants, and have no knowledge of any event or condition that would reasonably be expected to result in any such notice; (ii) there are no costs or liabilities associated with Environmental Laws of or relating to the Company or its subsidiary, except in the case of each of (i) and (ii) above, for any such matter as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and (iii) except as described in the Prospectus, (x) there is no proceeding that is pending, or that is known to be contemplated, against the Company or its subsidiary under any Environmental Laws in which a governmental entity is also a party, other than such proceeding regarding which it is reasonably believed no monetary sanctions of $100,000 or more will be imposed, (y) the Company and its subsidiary are not aware of any facts or issues regarding compliance with Environmental Laws, or liabilities or other obligations under Environmental Laws or concerning hazardous or toxic substances or wastes, pollutants or contaminants, that could reasonably be expected to have a material effect on the capital expenditures, earnings or competitive position of the Company and its subsidiary, and (z) none of the Company or its subsidiary anticipates material capital expenditures relating to any Environmental Laws.
(ff) 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). Except as otherwise disclosed in the Registration Statement and the Prospectus, 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 respect of any applicable law, including the FD&C Act, the PHSA or any similar state or local equivalents to any of the foregoing, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. “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 each Settlement Date.
(gg) Preclinical Studies and Clinical Trials. All studies, tests and clinical and non-clinical studies conducted by or, to the knowledge of the Company, on behalf of the Company or its affiliates have been and, if still pending, are being conducted in material compliance with research protocols and all applicable laws, including, but not limited to, the FD&C Act, its implementing regulations set forth at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and FDA guidance on the conduct of pre-clinical and clinical trials during the SARS-CoV-2 public health emergency. Except as otherwise disclosed in the Registration Statement and the Prospectus, neither the Company nor its affiliates has received any written notice that any regulatory authority, investigator, or any relevant institutional review board, independent ethics committee or any other similar body has (i) refused to approve any clinical study, or any substantial amendment to a protocol for any clinical study, conducted or proposed to be conducted by or on behalf of the Company or any of its affiliates, or (ii) initiated, or threatened to initiate, any action
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