Impax and Shire Settle Litigation Concerning Supply of Authorized Generic Adderall XR®

  Impax and Shire Settle Litigation Concerning Supply of Authorized Generic
  Adderall XR®

Business Wire

HAYWARD, Calif. -- February 8, 2013

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has settled
all pending litigation with Shire LLC and Shire Laboratories, Inc.
(collectively Shire) relating to supply of its authorized generic Adderall XR®
under the parties’ License and Distribution Agreement that was signed in
January 2006. As part of the settlement, the parties will submit a stipulation
of dismissal for entry by the Court. Shire has agreed to make a one-time cash
payment to Impax of $48 million upon the court’s order of dismissal.

Impax commenced sales of authorized generic Adderall XR in October 2009. On
November 1, 2010, Impax filed suit against Shire for breach of contract and
other related claims alleging that Shire failed to fill Impax’s orders for the
authorized generic Adderall XR. Shire filed a counterclaim against Impax
relating to its ordering practices under the agreement. Under the terms of the
settlement, Impax’s claims and Shire’s counterclaims will be dismissed.

The parties have entered into an amended License and Distribution Agreement
which will govern the future supply of authorized generic Adderall XR from
Shire to Impax. Following the end of the supply term on September 30, 2014,
Impax will continue to have the right to sell its products on hand or owed to
it under the agreement until depleted and will continue to pay a profit share
to Shire on sales of such products.

Impax will continue to pursue approval of its pending Abbreviated New Drug
Application for generic Adderall XR which was filed with the U.S. Food and
Drug Administration in September 2003.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) is a technology based specialty
pharmaceutical company applying its formulation expertise and drug delivery
technology to the development of controlled-release and specialty generics in
addition to the development of central nervous system disorder branded
products. Impax markets its generic products through its Global
Pharmaceuticals division and markets its branded products through the Impax
Pharmaceuticals division. Additionally, where strategically appropriate, Impax
develops marketing partnerships to fully leverage its technology platform and
pursues partnership opportunities that offer alternative dosage form
technologies, such as injectables, nasal sprays, inhalers, patches, creams and
ointments. Impax Laboratories is headquartered in Hayward, California, and has
a full range of capabilities in its Hayward, Philadelphia and Taiwan
facilities. For more information, please visit the Company's Web site at:
www.impaxlabs.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995:

To the extent any statements made in this news release contain information
that is not historical, these statements are forward-looking in nature and
express the beliefs and expectations of management. Such statements are based
on current expectations and involve a number of known and unknown risks and
uncertainties that could cause the Company’s future results, performance or
achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements. Such
risks and uncertainties include, but are not limited to, the effect of current
economic conditions on the Company’s industry, business, financial position
and results of operations, fluctuations in the Company’s revenues and
operating income, the Company’s ability to successfully develop and
commercialize pharmaceutical products, reductions or loss of business with any
significant customer, the impact of consolidation of the Company’s customer
base, the impact of competition, the Company’s ability to sustain
profitability and positive cash flows, any delays or unanticipated expenses in
connection with the operation of the Company’s Taiwan facility, the effect of
foreign economic, political, legal and other risks on the Company’s operations
abroad, the uncertainty of patent litigation, increased government scrutiny on
the Company’s agreements with brand pharmaceutical companies, consumer
acceptance and demand for new pharmaceutical products, the difficulty of
predicting Food and Drug Administration filings and approvals, the Company’s
inexperience in conducting clinical trials and submitting new drug
applications, the Company’s ability to successfully conduct clinical trials,
the Company’s reliance on third parties to conduct clinical trials and
testing, the availability of raw materials and impact of interruptions in the
Company’s supply chain, the use of controlled substances in the Company’s
products, disruptions or failures in the Company’s information technology
systems and network infrastructure, the Company’s reliance on alliance and
collaboration agreements, the Company’s dependence on certain employees, the
Company’s ability to comply with legal and regulatory requirements governing
the healthcare industry, the regulatory environment, the Company’s ability to
protect the Company’s intellectual property, exposure to product liability
claims, changes in tax regulations, the Company’s ability to manage the
Company’s growth, including through potential acquisitions, the restrictions
imposed by the Company’s credit facility, uncertainties involved in the
preparation of the Company’s financial statements, the Company’s ability to
maintain an effective system of internal control over financial reporting, any
manufacturing difficulties or delays, the effect of terrorist attacks on the
Company’s business, the location of the Company’s manufacturing and research
and development facilities near earthquake fault lines and other risks
described in the Company’s periodic reports filed with the Securities and
Exchange Commission.Forward-looking statements speak only as to the date on
which they are made, and Impax undertakes no obligation to update publicly or
revise any forward-looking statement, regardless of whether new information
becomes available, future developments occur or otherwise.

Contact:

Company:
Impax Laboratories, Inc.
Mark Donohue, 215-558-4526
Investor Relations and Corporate Communications
www.impaxlabs.com
 
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