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This excerpt taken from the ELN 6-K filed Aug 28, 2009. Other
matters
In January 2006, our subsidiary, Elan Pharmaceuticals, Inc.
(EPI) received a letter and subpoena from the
U.S. Department of Justice and the U.S. Department of
Health and Human Services asking for documents and materials
primarily related to marketing practices concerning our former
Zonegran product. In April 2004, we completed the sale of our
interests in Zonegran in North America and Europe to Eisai Co.
Ltd. We are cooperating with the government in its
investigation. The resolution of this Zonegran matter could
require Elan to pay substantial fines and to take other actions
that could have a material adverse effect on us. In April 2006,
Eisai delivered to us a notice making a contractual claim for
indemnification in connection with a similar subpoena received
by Eisai.
In June 2008, a jury ruled in the U.S. District Court for
the District of Delaware that Abraxis BioScience, Inc. (Abraxis)
had infringed a patent owned by us in relation to the
application of our NanoCrystal technology to Abraxane.
The jury awarded us $55.2 million, applying a royalty rate
of 6% to sales of Abraxane from January 2005 through
13 June 2008 (the date of the verdict). Abraxis has
announced its intention to appeal the ruling. Consequently,
pending final resolution of this matter, no settlement amount
has been recognised in our financial statements as at and for
the six months ended 30 June 2009.
We have related party relationships with our subsidiaries,
directors and executive officers. All transactions with
subsidiaries eliminate on consolidation and are not disclosed.
Table of Contents
There were no related party transactions that have taken place
in the six months ended 30 June 2009 that materially
affected the financial position or the performance of the
Company during that period, and there were no changes in the
related party transactions described in the 2008 Annual Report
that could have a material effect on the financial position or
performance of the Company in the same period.
This excerpt taken from the ELN 6-K filed Mar 30, 2009. Other
matters
In January 2006, our subsidiary, Elan Pharmaceuticals, Inc.
(EPI) received a letter and subpoena from the
U.S. Department of Justice and the U.S. Department of
Health and Human Services asking for documents and materials
primarily related to marketing practices concerning our former
Zonegran product. In April 2004, we completed the sale of our
interests in Zonegran in North America and Europe to Eisai Co.
Ltd. We are cooperating with the government in its
investigation. The resolution of this Zonegran matter could
require Elan to pay substantial fines and to take other actions
that could have a material adverse effect on us. In April 2006,
Eisai delivered to us a notice making a contractual claim for
indemnification in connection with a similar subpoena received
by Eisai.
In June 2008, a jury ruled in the U.S. District Court for
the District of Delaware that Abraxis BioScience, Inc. had
infringed a patent owned by us in relation to the application of
our NanoCrystal technology to Abraxane. The jury awarded
us $55.2 million, applying a royalty rate of 6% to sales of
Abraxane from January 2005 through 13 June 2008 (the date
of the verdict). Abraxis has announced its intention to appeal
the ruling. Consequently, pending final resolution of this
matter, no settlement amount has been recognised in our
financial statements as at and for the year ended
31 December 2008.
This excerpt taken from the ELN 20-F filed Feb 26, 2009. Other
matters
In January 2006, our subsidiary Elan Pharmaceuticals, Inc. (EPI)
received a letter and subpoena from the U.S. Department of
Justice and the U.S. Department of Health and Human
Services asking for documents and materials primarily related to
marketing practices concerning our former Zonegran product. In
April 2004, we completed the sale of our interests in Zonegran
in North America and Europe to Eisai. We are cooperating with
the government in its investigation. The resolution of this
Zonegran matter could require Elan to pay substantial fines and
to take other actions that could have a material adverse effect
on us. In April 2006, Eisai delivered to us a notice making a
contractual claim for indemnification in connection with a
similar subpoena received by Eisai.
In June 2008, a jury ruled in the U.S. District Court for
the District of Delaware that Abraxis BioScience, Inc. had
infringed a patent owned by us in relation to the application of
our EDT’s NanoCrystal technology to Abraxane. The
jury awarded us $55 million, applying a royalty rate of 6%
to sales of Abraxane from January 2005 through June 13,
2008 (the date of the verdict). Abraxis has announced its
intention to appeal the ruling. Consequently,
Table of Contents
Elan
Corporation, plc
NOTES TO
THE CONSOLIDATED FINANCIAL
STATEMENTS — (Continued)
pending final resolution of this matter, no settlement amount
has been recognized in our financial statements as of and for
the year ended December 31, 2008.
This excerpt taken from the ELN 6-K filed Mar 31, 2008. Other
matters
In January 2006, our subsidiary, Elan Pharmaceuticals, Inc.
(EPI) received a letter and subpoena from the
U.S. Department of Justice and the U.S. Department of
Health and Human Services asking for documents and materials
primarily related to marketing practices concerning our former
Zonegran product. In April 2004, we completed the sale of our
interests in Zonegran in North America and Europe to Eisai. We
are cooperating with the government in its investigation. The
resolution of this Zonegran matter could require Elan to pay
substantial fines and to take other actions that could have a
material adverse effect on Elan. In April 2006, Eisai delivered
to Elan a notice making a contractual claim for indemnification
in connection with a similar subpoena received by Eisai.
We have a related party relationship with our subsidiaries (see
Note 34), directors and executive officers. All
transactions with subsidiaries eliminate on consolidation and
are not disclosed.
This excerpt taken from the ELN 20-F filed Feb 28, 2008. Other
matters
In January 2006, our subsidiary, Elan Pharmaceuticals, Inc.
(EPI) received a letter and subpoena from the
U.S. Department of Justice and the U.S. Department of
Health and Human Services asking for documents and materials
primarily related to marketing practices concerning our former
Zonegran product. In April 2004, we completed the sale of our
interests in Zonegran in North America and Europe to Eisai. We
are cooperating with the government in its investigation. The
resolution of this Zonegran matter could require Elan to pay
substantial fines and to take other actions that could have a
material adverse effect on Elan. In April 2006, Eisai delivered
to Elan a notice making a contractual claim for indemnification
in connection with a similar subpoena received by Eisai.
This excerpt taken from the ELN 6-K filed Mar 30, 2007. Other
matters
In January 2006, our subsidiary, Elan Pharmaceuticals, Inc.
(EPI) received a letter and subpoena from the US Department of
Justice and the US Department of Health and Human Services
asking for documents and materials primarily related to
marketing practices concerning our former Zonegran product. In
April 2004, we completed the sale of our interests in Zonegran
in North America and Europe to Eisai. We are cooperating with
the government in its investigation. The resolution of this
Zonegran matter could require Elan to pay substantial fines and
to take other actions that could have a material adverse effect
on Elan. In
126 Elan
Corporation, plc 2006 Annual Report
Table of Contents
Notes to the
Consolidated Financial Statements
April 2006, Eisai delivered to Elan
a notice making a contractual claim for indemnification in
connection with a similar subpoena received by Eisai.
This excerpt taken from the ELN 20-F filed Feb 28, 2007. Other
matters
In January 2006, our subsidiary, EPI received a letter and
subpoena from the US Department of Justice and the US Department
of Health and Human Services asking for documents and materials
primarily related to marketing practices concerning our former
Zonegran product. In April 2004, we completed the sale of our
interests in Zonegran in North America and Europe to Eisai. We
are cooperating with the government in its investigation. The
Table of Contents
Elan
Corporation, plc
NOTES TO
THE CONSOLIDATED
FINANCIAL STATEMENTS — (Continued)
resolution of this Zonegran matter could require Elan to pay
substantial fines and to take other actions that could have a
material adverse effect on Elan. In April 2006, Eisai delivered
to Elan a notice making a contractual claim for indemnification
in connection with a similar subpoena received by Eisai.
This excerpt taken from the ELN 6-K filed Mar 31, 2006. Other matters
On 27 June 2002, BioPort filed suit against us in the Superior
Court of the State of California alleging breach of certain
collaboration and supply agreements relating to the development,
manufacture and supply of botulinum toxin. In addition to claims
for breach of contract, BioPort asserted claims for intentional
interference with contractual relations, unfair business
practices and unjust enrichment. The complaint sought a five
percent royalty on net sales of Myobloc, payments allegedly
owned under the collaboration agreement, a declaration that
BioPort has an ownership interest in Myobloc, and other relief,
including punitive damages. In June 2005 the parties settled
this matter. As part of the settlement we paid BioPort
$8.5 million in exchange for a full release.
On 11 December 2003, two of our subsidiaries, EPI and Neuralab,
commenced American Arbitration Association (AAA) arbitration
proceedings against Pfizer and Pharmacia and Upjohn Company
(Pharmacia) in connection with certain alleged breaches relating
to an Exclusive Mutual Beta Secretase Inhibitors Research,
Development and Marketing Collaboration Agreement, dated 28 July
2000, originally between Pharmacia and Neuralab. As a result of
these breaches and our subsequent termination of the
collaboration agreement, we believe that we hold an exclusive
worldwide licence to, among other things, all of Pfizer and
Pharmacia’s interest in regulatory approvals, patents and
know-how relating to the subject matter of the parties’
collaboration. On 23 December 2003, Pfizer and Pharmacia
asked the New York State Supreme Court to stay our arbitration
proceedings and the court subsequently issued a stay order on
14 January 2004. We appealed the stay order to the New York
Supreme Court Appellate Division. On 26 August 2004, the
New York Court Appellate Division reversed the lower
court’s decision and remanded the matter back to the lower
court for further proceedings relating to whether our
arbitration proceedings should be stayed.
On 13 September 2004, we commenced an action against Pfizer and
Pharmacia in the California Superior Court. The complaint in
this action asserts essentially the same breach of contract
claim asserted in the AAA arbitration demand and also alleges
claims for common-law monopolisation, unfair competition and
improper disclosure of trade secrets. In conjunction with the
filing of the California lawsuit, we withdrew our arbitration
demand. On 23 September 2004, Pfizer and Pharmacia
commenced a New York state action against us for injunctive
relief, declaratory relief and breach of contract. Immediately
upon filing this action, Pfizer and Pharmacia asked the New York
Supreme Court to stay our prosecution of the above-referenced
California lawsuit. The New York state court subsequently issued
an order temporarily staying us from taking any action in the
above-referenced California lawsuit. In addition, the Court
scheduled a 14 February 2005 evidentiary hearing on the
applicability of certain dispute resolution provisions contained
in the parties’ collaboration agreement. The
14 February hearing was temporarily taken off calendar to
allow the parties to conduct settlement discussions.
Elan Corporation, plc 2005 Annual Report 127
Table of Contents
This excerpt taken from the ELN 20-F filed Mar 30, 2006. Other
matters
On June 27, 2002, BioPort filed suit against us in the
Superior Court of the State of California alleging breach of
certain collaboration and supply agreements relating to the
development, manufacture and supply of botulinum toxin. In
addition to claims for breach of contract, BioPort asserted
claims for intentional interference with contractual relations,
unfair business practices and unjust enrichment. The complaint
sought a five percent royalty on net sales of Myobloc, payments
allegedly owned under the collaboration agreement, a declaration
that BioPort has an ownership interest in Myobloc, and other
relief, including punitive damages. In June 2005 the parties
settled this matter. As part of the settlement we paid BioPort
$8.5 million in exchange for a full release.
On December 11, 2003, two of our subsidiaries, EPI and
Neuralab, commenced American Arbitration Association (AAA)
arbitration proceedings against Pfizer and Pharmacia and Upjohn
Company (Pharmacia) in connection with certain alleged breaches
relating to an Exclusive Mutual Beta Secretase Inhibitors
Research, Development and Marketing Collaboration Agreement,
dated July 28, 2000, originally between Pharmacia and
Neuralab. As a result of these breaches and our subsequent
termination of the collaboration agreement, we believed that we
held an exclusive worldwide license to, among other things, all
of Pfizer and Pharmacia’s interest in regulatory approvals,
patents and know-how relating to the subject matter of the
parties’ collaboration. On December 23, 2003, Pfizer
and Pharmacia asked the New York State Supreme Court to stay our
arbitration proceedings and the court subsequently issued a stay
order on January 14, 2004. We appealed the stay order to
the New York Supreme Court Appellate Division. On
August 26, 2004, the New York Court Appellate Division
Table of Contents
Elan
Corporation, plc
NOTES TO
THE CONSOLIDATED FINANCIAL
STATEMENTS — (Continued)
reversed the lower court’s decision and remanded the matter
back to the lower court for further proceedings relating to
whether our arbitration proceedings should be stayed.
On September 13, 2004, we commenced an action against
Pfizer and Pharmacia in the California Superior Court. The
complaint in this action asserted essentially the same breach of
contract claim asserted in the AAA arbitration demand and also
alleged claims for common-law monopolization, unfair competition
and improper disclosure of trade secrets. In conjunction with
the filing of the California lawsuit, we withdrew our
arbitration demand. On September 23, 2004, Pfizer and
Pharmacia commenced a New York state action against us for
injunctive relief, declaratory relief and breach of contract.
Immediately upon filing this action, Pfizer and Pharmacia asked
the New York Supreme Court to stay our prosecution of the
above-referenced California lawsuit. The New York state court
subsequently issued an order temporarily staying us from taking
any action in the above-referenced California lawsuit. In
addition, the Court scheduled a February 14, 2005
evidentiary hearing on the applicability of certain dispute
resolution provisions contained in the parties’
collaboration agreement. The February 14th hearing was
temporarily taken off calendar to allow the parties to conduct
settlement discussions.
In November 2005 the parties settled this matter. The settlement
agreement provided, among other things, that Pfizer pay Elan
$7.0 million and includes provisions relating to
intellectual property rights and the development of target
compounds arising from the collaboration.
On August 26, 2005, Elan and its subsidiary, Elan Pharma
International Ltd., commenced mediation proceedings with the AAA
against King in connection with a dispute involving Elan’s
development of a modified release formulation of King’s
Sonata drug product. Elan is seeking lost milestone payments,
other direct damages and interest due in connection with the
development and reformulation of Sonata based upon the terms and
conditions set forth in a Reformulation Agreement entered into
by the parties on June 12, 2003 (the Reformulation
Agreement). The parties conducted a mediation on
January 11, 2006 but the matter was not resolved.
Accordingly, the dispute will proceed to binding arbitration
pursuant to the terms of the Reformulation Agreement. The
parties are currently in the process of selecting an arbitral
panel. We expect that evidentiary hearings in the arbitration
will be held this year and anticipate that a decision will be
issued by the arbitral panel sometime in late 2006. Given the
status of the proceedings, we are unable to predict the likely
outcome at this time.
In January 2006, EPI received a letter and subpoena from the
U.S. Department of Justice and the Department of Health and
Human Services asking for documents and materials primarily
related to marketing practices concerning our former Zonegran
product. We sold our interests in Zonegran to Eisai in April
2004 and, consequently, have not been marketing or selling the
product since the product’s divestiture. We intend to
respond to the government’s subpoena and cooperate with its
investigation.
This excerpt taken from the ELN 6-K filed Apr 11, 2005. Other matters On 27 June 2002, BioPort filed suit against us in the Superior Court of the State of California alleging breach of certain collaboration and supply agreements relating to the development, manufacture and supply of botulinum toxin. In addition to claims for breach of contract, BioPort asserted claims for intentional interference with contractual relations (as to the Company), unfair business practices and unjust enrichment. The complaint seeks a five percent royalty on net sales of Myobloc, payments allegedly owned under the collaboration agreement, a declaration that BioPort has an ownership interest in Myobloc, and other relief, including punitive damages. A trial date for this matter has been scheduled for 15 July 2005. In addition, the parties intend to conduct an April 2005 mediation conference aimed at resolving some or all of the issues before trial. Discovery in this matter is continuing. On 11 December 2003, two of our subsidiaries, EPI and Neuralab, commenced AAA arbitration proceedings against Pfizer and Pharmacia and Upjohn Company (“Pharmacia”) in connection with certain alleged breaches relating to an Exclusive
Mutual Beta Secretase Inhibitors Research, Development and Marketing Collaboration Agreement, dated 28 July 2000, originally between Pharmacia and Neuralab. As a result of these breaches and our subsequent termination of the collaboration agreement, we believe that we hold an exclusive worldwide license of, among other things, all of Pfizer and Pharmacia’s interest in regulatory approvals, patents and know-how relating to the subject matter of the parties’ collaboration. On 23 December 2003, Pfizer and Pharmacia asked the New York State Supreme Court to stay our arbitration proceedings and the court subsequently issued a stay order on 14 January 2004. We appealed the stay order to the New York Supreme Court Appellate Division. On 26 August 2004, the New York Court Appellate Division reversed the lower court’s decision and remanded the matter back to the lower court for further proceedings relating to whether our arbitration proceedings should be stayed. On 13 September 2004, we commenced an action against Pfizer and Pharmacia in the California Superior Court. The complaint in this action asserts essentially the same breach of contract claim asserted in the AAA arbitration demand and also alleges claims for common-law monopolisation, unfair competition and improper disclosure of trade secrets. In conjunction with the filing of their California lawsuit, we withdrew our arbitration demand. On 23 September 2004, Pfizer and Pharmacia commenced a New York state action against us for injunctive relief, declaratory relief and breach of contract. Immediately upon filing this action, Pfizer and Pharmacia asked the New York Supreme Court to stay our prosecution of the above-referenced California lawsuit. The New York state court subsequently issued an order temporarily staying us from taking any action in the above-referenced California lawsuit. In addition, the Court scheduled a 14 February 2005 evidentiary hearing on the applicability of certain dispute resolution provisions contained in the parties’ collaboration agreement. The court has advised the parties that, after it conducts this evidentiary hearing,the court intends to lift its temporary stay order and permit us to proceed with our California litigation. The parties are currently engaged in discovery relating to the above-referenced evidentiary hearing. However, the hearing was temporarily taken off calendar to allow the parties to conduct settlement discussions.
From 1996 to mid-2001, we pursued collaborations with biotechnology, drug delivery and pharmaceutical companies in order to leverage our drug delivery technologies and our proprietary neurological and oncology research, and to access complementary or synergistic R&D programmes in our areas of expertise. This programme was referred to as the “business venture programme”. We have not entered into any new business ventures under the business venture programme since mid-2001. The business venture programme generally involved licensing drug delivery technologies and know-how, or pharmaceutical R&D assets, to a newly formed subsidiary (“the business venture”) of an emerging biotechnology, drug delivery or pharmaceutical company (“the business venture parent”) and the establishment of a joint development collaboration. Contemporaneously with the licensing and collaborative transaction, we typically made an investment in the business venture. In 2002, as part of the recovery plan, we completed a review of our business venture portfolio to conserve cash and reflect the reduced scope of our activities. As a result, we decided to restructure or terminate substantially all of our business ventures with the aim of substantially reducing or eliminating future cash outlays. There were approximately 55 business ventures in place prior to the announcement of the recovery plan on 31 July 2002. All business ventures have been terminated, restructured or are now inactive. As a consequence, we do not expect to provide any additional financing to the business ventures and business venture parents. We have received and recorded no initial revenue from the business ventures and made no initial investments in the business ventures or the business venture parents since 2001. The business ventures incurred R&D expenditures of approximately $Nil and $17.0 million in 2004 and 2003, respectively. While the business ventures and the business venture parents were generally responsible for ongoing R&D activities, they could request that we conduct R&D on their behalf. We received research revenue from the business ventures of $Nil and $3.7 million in 2004 and 2003, respectively. We do not expect to receive any future research revenues from the business ventures. We recognised charges in our profit and loss account to reflect impairments to our investment portfolio, including impairment charges relating to our investments in business ventures and business venture parent companies of $0.2 million and $4.0 million in 2004 and 2003, respectively, and $58.6 million and $106.0 million in 2004 and 2003, respectively.
Notes Relating to Financial Statements
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