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Transcript
In addition:
•
certain of the Company’s products utilize radioactive material, and the Company is subject to federal, state, local and
non-U.S. regulations governing the management, storage, handling and disposal of these materials; and
•
some of the Company’s in vitro diagnostic drugs-of-abuse assays and reagents contain small amounts of controlled
substances, and as a result some of the Company’s facilities are inspected periodically by the United States Drug
Enforcement Administration to ensure that the Company properly handles, stores, and disposes of controlled
substances in the manufacture of those products.
For a discussion of risks related to the Company’s regulation by the FDA and comparable agencies of other countries, and the
other regulatory regimes referenced above, refer to “Item 1A. Risk Factors.”
Export/Import Compliance
The Company is required to comply with various U.S. export/import control and economic sanctions laws, including:
•
the International Traffic in Arms Regulations administered by the U.S. Department of State, Directorate of Defense
Trade Controls, which, among other things, imposes license requirements on the export from the United States of
defense articles and defense services (which are items specifically designed or adapted for a military application and/
or listed on the United States Munitions List);
•
the Export Administration Regulations administered by the U.S. Department of Commerce, Bureau of Industry and
Security, which, among other things, impose licensing requirements on the export or re-export of certain dual-use
goods, technology and software (which are items that potentially have both commercial and military applications);
•
the regulations administered by the U.S. Department of Treasury, Office of Foreign Assets Control, which implement
economic sanctions imposed against designated countries, governments and persons based on United States foreign
policy and national security considerations; and
•
the import regulatory activities of the U.S. Customs and Border Protection.
Other nations’ governments have implemented similar export and import control regulations, which may affect the Company’s
operations or transactions subject to their jurisdictions. For a discussion of risks related to export/import control and economic
sanctions laws, refer to “Item 1A. Risk Factors.”
International Operations
The Company’s products and services are available worldwide, and its principal markets outside the United States are in
Europe and Asia. The Company also has operations around the world, and this geographic diversity allows the Company to
draw on the skills of a worldwide workforce, provides greater stability to its operations, allows the Company to drive
economies of scale, provides revenue streams that may help offset economic trends that are specific to individual economies
and offers the Company an opportunity to access new markets for products. In addition, the Company believes that future
growth depends in part on its ability to continue developing products and sales models that successfully target emerging
markets (also referred to in this Annual Report as “high-growth markets”). The Company defines high-growth markets as
developing markets of the world experiencing rapid growth in gross domestic product and infrastructure which includes
Eastern Europe, the Middle East, Africa, Latin America and Asia (with the exception of Japan and Australia).
The table below describes annual revenue derived from customers outside the United States as a percentage of total annual
revenue for the years ended December 31, by segment and in the aggregate, based on geographic destination:
2016
Life Sciences
Diagnostics
Dental
Environmental & Applied Solutions
Total
2015
68%
63%
54%
61%
62%
11
2014
64%
63%
54%
60%
61%
67%
65%
54%
62%
63%