HAYWARD, Calif.--(BUSINESS WIRE)--
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.
Source: Impax Laboratories, Inc.