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[]SAFE HARBOR[] statement under the Private Securities Litigation Reform Act of
1995 and tender offer materials
Statements included in this communication that are not historical facts are
forward - looking statements. Such forward - looking statements involve a
number of risks and uncertainties and are subject to change at any time. In the
event such risks or uncertainties materialize, Shire's results could be
materially adversely affected. The risks and uncertainties include, but are not
limited to, that:
[] Shire's products may not be a commercial success;
[] revenues from ADDERALL XR and INTUNIV are subject to generic erosion;
[] the failure to obtain and maintain reimbursement, or an adequate level of
reimbursement, by third-party payors in a timely manner for Shire's products
may impact future revenues, financial condition and results of operations;
[] Shire conducts its own manufacturing operations for certain of its products
and is reliant on third party contract manufacturers to manufacture other
products and to provide goods and services. Some of Shire's products or
ingredients are only available from a single approved source for manufacture.
Any disruption to the supply chain for any of Shire's products may result in
Shire being unable to continue marketing or developing a product or may result
in Shire being unable to do so on a commercially viable basis for some period
of time;
[] the development, approval and manufacturing of Shire's products is
subject to extensive oversight by various regulatory agencies.
Submission of an application for regulatory approval of any of our product
candidates, such as our planned submission of a New Drug Application to the FDA
for Lifitegrast, may be delayed for any number of reasons and, once submitted,
may be subjected to lengthy review and ultimately rejected. Moreover,
regulatory approvals or interventions associated with changes to manufacturing
sites, ingredients or manufacturing processes could lead to significant delays,
increase in operating costs, lost product sales, an interruption of research
activities or the delay of new product launches;
[] the actions of certain customers could affect Shire's ability to sell or market products profitably.
Fluctuations in buying or distribution patterns by such customers can adversely
impact Shire's revenues, financial condition or results of operations;
[] investigations or enforcement action by regulatory authorities or law
enforcement agencies relating to Shire's activities in the highly regulated
markets in which it operates may result in significant legal costs and the
payment of substantial compensation or fines;
[] adverse outcomes in legal matters and other disputes, including Shire's ability to enforce and defend
patents and other intellectual property rights required for its business, could
have a material adverse effect on Shire's revenues, financial condition or
results of operations;
[] Shire faces intense competition for highly qualified personnel from other
companies, academic institutions, government entities and other organizations.
Shire is undergoing a corporate reorganization and the consequent uncertainty
could adversely impact Shire's ability to attract and/or retain the highly
skilled personnel needed for Shire to meet its strategic objectives;
[] failure to achieve Shire's strategic objectives with respect to the acquisition of
ViroPharma Incorporated may adversely affect Shire's financial condition and
results of operations;
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