regarding which it is reasonably believed no monetary sanctions of $100,000 or more will be imposed, (y) the Company and its subsidiaries 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 subsidiaries, and (z) none of the Company or its subsidiaries 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 to suspend any clinical study conducted by or on behalf of the Company or any of its affiliates, or suspend or terminate any investigational new drug sponsored by the Company or any of its
affiliates.
(hh) Health Care Products Manufacturing. Except as otherwise disclosed in the Registration Statement and the
Prospectus, (i) neither the Company nor its affiliates have received any warning letter or untitled letter, report of inspectional observations, including FDA Form 483s, establishment inspection reports, notices of violation, clinical holds,
enforcement notices or other documents or written notifications from any regulatory authority or other governmental authority, or any institutional review board, independent ethics committee or similar body, alleging a material
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