PART I
Item 1A Risk Factors
Laws and regulations governing international
business operations could adversely impact
our business.
The U.S. Department of the Treasury’s Office of Foreign Assets
Control (OFAC), and the Bureau of Industry and Security at the
U.S. Department of Commerce (BIS), administer certain laws and
regulations that restrict U.S. persons and, in some instances,
non-U.S. persons, in conducting activities, transacting business
with or making investments in certain countries, governments,
entities and individuals subject to U.S. economic sanctions. Our
international operations subject us to these laws and regulations,
which are complex, restrict our business dealings with certain
countries, governments, entities, and individuals, and are
constantly changing. Further restrictions may be enacted,
amended, enforced or interpreted in a manner that materially
impacts our operations.
From time to time, certain of our subsidiaries have limited
business dealings in countries subject to comprehensive
sanctions, including Iran, Sudan, Syria, Cuba and the region of
Crimea. Certain of our subsidiaries sell medical devices, and may
provide related services, to distributors and other purchasing
bodies in such countries. These business dealings represent an
insignificant amount of our consolidated revenues and income,
but expose us to a heightened risk of violating applicable
sanctions regulations. Violations of these regulations are
punishable by civil penalties, including fines, denial of export
privileges, injunctions, asset seizures, debarment from
government contracts and revocations or restrictions of
licenses, as well as criminal fines and imprisonment. We have
established policies and procedures designed to assist with our
compliance with such laws and regulations. However, there can
be no assurance that our policies and procedures will prevent us
from violating these regulations in every transaction in which we
may engage, and such a violation could adversely affect our
reputation, business, results of operations, financial condition,
and cash flows.
We are subject to environmental laws and
regulations and the risk of environmental
liabilities, violations and litigation.
We are subject to numerous U.S. federal, state, local and
non-U.S. environmental, health and safety laws and regulations
concerning, among other things, the health and safety of our
employees, the generation, storage, use and transportation of
hazardous materials, emissions or discharges of substances into
the environment, investigation and remediation of hazardous
substances or materials at various sites, chemical constituents in
medical products and end-of-life disposal and take-back
programs for medical devices. Our operations and those of
certain third-party suppliers involve the use of substances
subject to these laws and regulations, primarily those used in
manufacturing and sterilization processes. If we or our suppliers
violate these environmental laws and regulations, facilities could
be shut down and violators could be fined, criminally charged or
otherwise sanctioned. Furthermore, environmental laws outside
of the U.S. are becoming more stringent, resulting in increased
costs and compliance burdens.
In addition, certain environmental laws assess liability on current
or previous owners or operators of real property for the costs of
investigation, removal or remediation of hazardous substances
or materials at their properties or at properties which they have
disposed of hazardous substances. In addition to cleanup
actions brought by governmental authorities, private parties
could bring personal injury or other claims due to the presence
of, or exposure to, hazardous substances. The ultimate cost of
site cleanup and timing of future cash outflows is difficult to
predict, given the uncertainties regarding the extent of the
required cleanup, the interpretation of applicable laws and
regulations, and alternative cleanup methods.
The costs of complying with current or future environmental
protection and health and safety laws and regulations, or
liabilities arising from past or future releases of, or exposures to,
hazardous substances, may exceed our estimates, or have a
material adverse effect on our business, results of operations,
financial condition, and cash flows.
We rely on the proper function, security and
availability of our information technology
systems and data, as well as those of third
parties throughout our global supply chain, to
operate our business, and a breach, cyber-
attack or other disruption to these systems or
data could materially and adversely affect our
business, results of operations, financial
condition, cash flows, reputation or
competitive position.
We are increasingly dependent on sophisticated information
technology systems to operate our business. That technology
includes systems that could be used to process, transmit and
store sensitive data. Additionally, many of our products and
services include integrated software and information technology
that collects data regarding patients or connects to other
internal systems. Like all organizations, we routinely experience
attempted interference with the integrity of, and interruptions in,
our technology systems via events such as cyber-attacks,
malicious intrusions, or other breakdowns. The consequences
could mean data breaches, interference with the integrity of our
products and data, or other significant disruptions. Furthermore,
we rely on third-party vendors to supply and/or support certain
aspects of our information technology systems and resulting
products. As we have seen with recent “Supply Chain Attacks,”
these third-party systems could also become vulnerable to
cyber-attack, malicious intrusions, breakdowns, interference or
other significant disruptions, and may contain defects in design
or manufacture or other problems that could result in system
disruption or compromise the information security of our own
systems. Lastly, we continue to grow in part through new
business acquisitions and, as a result, may face risks associated
with defects and vulnerabilities in their systems, or difficulties or
other breakdowns or disruptions in connection with the
integration of the acquisitions into our information technology
systems.
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MEDTRONIC PLC 2021 Form 10-K