The health care industry is highly regulated and subject to complex and increasing regulations. U.S. federal and state
regulators, including the FDA and comparable ex-U.S. regulators directly regulate our most critical business activities,
including those related to research, development, manufacturing, and commercialization, as described in Item 1, “Business –
Government Regulation.”
The process for obtaining regulatory approvals to market a product is costly and time consuming, and approvals may not
be granted for future products, or additional indications of existing products, on a timely basis or at all. In addition, we cannot
guarantee that we will remain compliant with applicable regulatory requirements once approval has been obtained. These
requirements govern, among other things, our manufacturing practices, communications regarding our products, and
reporting of safety events. Maintaining compliance with these extensive regulations is complex, expensive, and time
consuming, and failure to comply may result in additional regulatory actions, including recalls, withdrawal or suspension of
product approvals, civil and criminal charges, reputational harm, and fines, penalties, or other monetary or non-monetary
remedies, including exclusion from receipt of payment from U.S. federal and state healthcare programs like Medicare and
Medicaid. Compliance with the regulatory requirements for biologics and cell and gene therapies can be more burdensome,
expensive and time-consuming than for other, better known or more extensively studied types of medicines, such as small
molecules. Regulatory requirements governing cell and genetic therapy products have changed frequently and may continue
to change in the future. Furthermore, risks relating to compliance with laws and regulations may be heightened as we
continue to expand our global operations and enter new therapeutic areas with different patient populations, which may
require different commercialization activities from those we currently utilize.
We expect that regulation of the healthcare industry will continue to evolve through political and legal action, as future
proposals to reform healthcare systems are considered by U.S. and foreign governments and regulatory authorities. We
cannot predict when additional changes in the healthcare industry in general, or the pharmaceutical industry in particular, will
occur, or what the impact of such changes may be. For example, new proposals or requirements regarding local
manufacturing of pharmaceutical products, enhanced data security and privacy measures, sustainability, importation
restrictions, embargoes, or trade sanctions may negatively impact our business. In addition, our development and
commercialization activities could be harmed or delayed by a shutdown of the U.S. government or events that affect the
manner in which the FDA operates.