definiens: as defined in the Private Securities Litigati on Reform Act of 1995, regarding a new license and collaborat ion agreement and the development, manufacture and commercialization of a new drug candidate . The read er is cautioned not to rely on these forward - lookin g statements . These statements are based on current e xpectations of future events . If underlying assumpt ions prove inaccurate or known or unknown risks or uncertainti es materialize, actual results could vary materiall y from the expectations and projections of [COMPANY] Biotech, In c., [COMPANY] Research & Development, LLC, Johnson & Johnson Innovation — JJDC, Inc. and/or Johnson & Jo hnson . Risks and uncertainties include, but are not limited to : the potential that the expected benefit s and opportunities related to the collaboration ma y not be realized or may take longer to realize than expecte d ; challenges and uncertainties inherent in product research and development, including the uncertainty of clini cal success and of obtaining regulatory approvals ; uncertainty of commercial success for new products ; competition, including technological advances, new products and patents attained by competitors ; chall enges to patents ; manufacturing difficulties or del ays ; product efficacy or safety concerns resulting in pr oduct recalls or regulatory action ; changes to appl icable laws and regulations, including global health care refor ms ; and trends toward health care cost containment