- 1 -
SETTLEMENT AGREEMENT
THIS SETTLEMENT AGREEMENT (hereinafter "this Agreement") is entered
into as of the 11th day of August, 1997 (hereinafter "the Effective
Date"), by and among NeXstar Pharmaceuticals, Inc. (hereinafter
"NeXstar"), a Delaware corporation having a principal place of business
at 0000 Xxxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxxx 00000, Fujisawa U.S.A.,
Inc. (hereinafter "FUSA"), a Delaware corporation having a place of
business at Parkway North Center, 0 Xxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx
00000, and The Liposome Company, Inc. (hereinafter "TLC"), a Delaware
corporation having a principal place of business at Xxx Xxxxxxxx Xxx,
Xxxxxxxxx Xxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxx Xxxxxx 00000-0000.
SECTION I - BACKGROUND
1.1 On May 17, 1993, NeXstar sued TLC in the U.S. District Court
for the District of Delaware (Civil Action No. 93-232 (RRM)) seeking a
declaration that U.S. Patent No. 4,880,635 (hereinafter the "Xxxxxx I
Patent") was not infringed by NeXstar=s manufacture, use, and sale of
liposomal products and was invalid and/or unenforceable.
1.2 TLC thereafter requested that the U.S. Patent and Trademark
Office (hereinafter "USPTO") reexamine the Xxxxxx I Patent. The Court
stayed further proceedings upon NeXstar's declaratory judgment action
during the pendency of the reexamination proceeding.
1.3 On July 2, 1996, the USPTO issued a Reexamination Certificate
for the Xxxxxx I Patent, referred to as U.S. Patent No. B1 4,880,635
(hereinafter the "Reexamined Xxxxxx I Patent").
1.4 On July 29, 1996, NeXstar filed an Amended Complaint seeking a
declaration that the Reexamined Xxxxxx I Patent was not infringed by
NeXstar=s manufacture, use, and sale of liposomal products and was
invalid and/or unenforceable.
1.5 On August 16, 1996, TLC answered and counterclaimed, alleging
that NeXstar=s and FUSA=s manufacture, use, sale, and offer for sale of
certain liposomal products infringed the Reexamined Xxxxxx I Patent and
denying NeXstar's allegations.
1.6 On November 26, 1996, the USPTO issued U.S. Patent No.
5,578,320 (hereinafter the "Janoff II Patent").
1.7 On January 17, 1997, TLC filed a First Amended Counterclaim,
alleging that NeXstar=s and FUSA=s manufacture, use, sale, and offer
for sale of certain liposomal products infringed the Reexamined Xxxxxx
I Patent and the Janoff II Patent.
1.8 On February 25, 1997, NeXstar filed a Second Amended and
Supplemental Complaint (a) seeking a declaration that both the
Reexamined Xxxxxx I Patent and the Janoff II Patent were not infringed
by NeXstar=s and FUSA's manufacture, use, and sale of liposomal
products and were invalid and/or unenforceable, and (b) stating claims
under federal law for antitrust injury and under state law for tortious
injury based, inter alia, on TLC=s filing and maintenance of
infringement counterclaims based on the Reexamined Xxxxxx I Patent and
Janoff II Patent.
1.9 On March 18, 1997, TLC answered NeXstar's Second Amended and
Supplemental
Complaint and refiled its counterclaims against NeXstar and FUSA and
again denied NeXstar's allegations.
1.10 On October 27, 1993, European Patent No. 0190 315 B1
(hereinafter the "European Xxxxxx Dehydration Patent") was granted to
TLC. On July 8, 1994, NeXstar filed an opposition to the European
Xxxxxx Dehydration Patent. That opposition presently is pending.
1.11 On February 28, 1996, Japanese Patent No. 18973/1996
(hereinafter the "Japanese Xxxxxx Dehydration Patent") was granted to
TLC. On May 28, 1996, NeXstar filed an opposition to the Japanese
Xxxxxx Dehydration Patent. That opposition is presently pending.
1.12 On October 16, 1996, TLC filed suit in the Chancery
Division of the Patents Court in the United Kingdom charging NeXstar
and NeXstar Pharmaceuticals Ltd. with infringement of the European
Xxxxxx Dehydration Patent (hereinafter "TLC's British Legal Action").
On January 15, 1997, NeXstar answered and counterclaimed for a
declaration of invalidity of the European Xxxxxx Dehydration Patent.
1.13 On October 18, 1996, TLC filed suit in the Xxxxxxxx Xxxxx,
Xxxxxxxxxx , Xxxxxxx charging NeXstar Pharmaceuticals GmbH with
infringement of the European Xxxxxx Dehydration Patent (hereinafter
"TLC's German Legal Action"). On April 30, 1997, NeXstar
Pharmaceuticals GmbH filed an answer in TLC=s German Legal Action.
1.14 On or about November 4, 1996, TLC filed suit in the
Regional Court of The Hague, The Netherlands, charging NeXstar,
NeXstar Pharmaceuticals Ltd., NeXstar Pharmaceuticals B.V., and
Brocacef Intramuraal B.V. with infringement of the European Xxxxxx
Dehydration Patent (hereinafter "TLC's Dutch Legal Action").
1.15 On February 8, 1995, European Patent No. 0282 405 B1
(hereinafter "TLC's European High Drug Lipid Complex Patent") was
granted to TLC. On November 3, 1995, NeXstar filed an opposition to
TLC's European High Drug Lipid Complex Patent. That opposition
presently is pending.
1.16 Since at least November 14, 1989, subject to the
appropriate regulatory approvals, NeXstar has manufactured liposomal
products, including its AmBisome7 liposomal amphotericin B
(hereinafter defined in Section 2.8) in the United States, and
thereafter has made, used, sold, and/or offered such products for
sale in the United States and/or in numerous foreign countries.
NeXstar presently intends, subject to the appropriate regulatory
approvals, in the future to continue and/or to commence making,
using, selling, and/or offering for sale such products in the United
States and/or in foreign countries.
1.17 Subject to the appropriate regulatory approvals, FUSA
presently intends to commence using, selling, and offering for sale
AmBisome in the United States and Canada.
1.18 Subject to the appropriate regulatory approvals, TLC has
manufactured, used, sold, and/or offered for sale its Abelcet7 lipid-
associated amphotericin B (hereinafter defined in Section 2.12) in
the United States and in numerous foreign countries. TLC presently
intends, subject to the appropriate regulatory approvals, in the
future to continue and/or to commence making, using, selling, and/or
offering for sale such products in the United States and in foreign
countries.
1.19 Subject to the appropriate regulatory approvals, TLC has
manufactured and/or used in the United States and in foreign
countries a liposomal doxorubicin product presently known as D-99
(hereinafter defined in Section 2.13). TLC presently intends,
subject to the appropriate regulatory approvals, in the future to
continue and/or to commence making, using, selling, and/or offering
for sale such D-99 products, or products based thereon, in the United
States and in foreign countries.
SECTION II - DEFINITIONS
2.1 The "Xxxxxx Dehydration Patents" shall mean all United
States patents issuing from U.S. Patent Application Serial No.
638,809, filed August 8, 1984, and/or Serial No. 749,161, filed June
26, 1985, and/or Serial No. 749,419, filed July 26, 1985, and/or
issuing from any continuation, continuation-in-part, and/or
divisional applications thereof, and/or issuing from any reissue
and/or reexamination proceedings relating thereto (including but not
limited to U.S. Patents Nos. 4,880,635; B1 4,880,635; and 5,578,320),
and further shall mean any and all foreign patent applications and/or
foreign patents or similar rights claiming priority to any of the
applications, continuations, continuations-in-part, and/or divisional
applications identified above (including but not limited to European
Patent No. 0190 315 B1 and all corresponding national patents,
Japanese Patent No. 18973/1996, and Canadian Patent No. 1,270,197),
to the extent such patents claim dehydrated liposomes and/or methods
of dehydrating (including lyophilization) and/or rehydrating
liposomes, except that "Xxxxxx Dehydration Patents" shall not include
patents defined as "Gradient Loading Patents" in Section 2.5 below.
2.2 [
]
2.3 [
]
2.4 [
]
2.5 [
]
2.6 "TLC's European High Drug Lipid Complex Patent" shall mean
European Patent No. 0282 405 B1.
2.7 [
]
2.8 "AmBisome" shall mean liposomal amphotericin B products
made by NeXstar, or made by FUSA under license from NeXstar pursuant
to the FUSA Agreement as amended, that are lyophilized/dehydrated and
in which sugar is present in protective concentrations at the inside
and the outside of the bilayer membrane of the liposomes prior to
lyophilization/dehydration and rehydration.
2.9 "AmBisome SL" shall mean liposomal amphotericin B products
made by NeXstar that are lyophilized/dehydrated and in which sugar is
present in protective concentrations only at the outside of the
bilayer membrane of the liposomes prior to lyophilization/dehydration
and rehydration.
2.10 "Liquid AmBisome" shall mean liposomal amphotericin B
products made by NeXstar that have not been lyophilized or
dehydrated.
2.11 "AmBisome Product" shall mean any liposomal Amphotericin B
product made by NeXstar or made by FUSA under license by NeXstar
pursuant to the FUSA Agreement as amended.
2.12 "Abelcet" shall mean lipid-associated amphotericin products
made by TLC.
2.13 "D-99" shall mean liposomal doxorubicin products made by
TLC.
2.14 "Marketing Partner" shall mean and be limited to FUSA for
AmBisome sold in the United States and Canada and to Sumitomo
Pharmaceutical Co., Ltd. (hereinafter "Sumitomo") for AmBisome sold
in Japan.
2.15 [
]
2.16 [
]
2.17 "Controlling Interest" shall mean, with respect to a
patent, the ability to prevent the filing of a suit for patent
infringement whether by controlling the decision of whether to file
suit or by the ability to grant a license, sublicense, or immunity
from suit.
2.18 [
]
SECTION III - DISMISSALS
3.1 For and in consideration of the covenants, terms, and
conditions set forth herein, NeXstar, FUSA, and TLC, within three (3)
business days after the Effective Date of this Agreement, will cause
to be executed and TLC will file in the U.S. District Court for the
District of Delaware (Civil Action No. 93-232 (RRM)) a stipulated
dismissal with prejudice of TLC's Counterclaim against NeXstar and
FUSA.
3.2 For and in consideration of the covenants, terms, and
conditions set forth herein, NeXstar, FUSA, and TLC, within three (3)
business days after the Effective Date of this Agreement, will cause
to be executed and NeXstar will file in the U.S. District Court for
the District of Delaware (Civil Action No. 93-232 (RRM)) a stipulated
dismissal with prejudice of NeXstar's Second Amended and Supplemental
Complaint.
3.3 For and in consideration of the covenants, terms, and
conditions set forth herein, within ten (10) business days after the
Effective Date of this Agreement, NeXstar will file in the European
Patent Office a withdrawal of its opposition to the grant of TLC's
European Xxxxxx Dehydration Patent.
3.4 For and in consideration of the covenants, terms, and
conditions set forth herein, within ten (10) business days after the
Effective Date of this Agreement, NeXstar will file in the Japanese
Patent Office a withdrawal of its opposition to the grant of TLC's
Japanese Xxxxxx Dehydration Patent.
3.5 For and in consideration of the covenants, terms, and
conditions set forth herein, NeXstar and TLC, within ten (10)
business days after the Effective Date of this Agreement, will cause
to be executed and TLC will file a stipulated dismissal with
prejudice of TLC's British Legal Action in the Chancery Division of
the Patents Court, United Kingdom.
3.6 For and in consideration of the covenants, terms, and
conditions set forth herein, NeXstar and TLC, within ten (10)
business days after the Effective Date of this Agreement, will cause
to be executed and NeXstar will file a stipulated dismissal with
prejudice of the Counterclaim of NeXstar and NeXstar Pharmaceuticals
Limited in the British Legal Action in the Chancery Division of the
Patents Court, United Kingdom.
3.7 For and in consideration of the covenants, terms, and
conditions set forth herein, NeXstar and TLC, within ten (10)
business days after the Effective Date of this Agreement, will cause
to be executed and TLC will file a stipulated dismissal with
prejudice of TLC's German Legal Action and NeXstar's counterclaims
therein, if any, in the Xxxxxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxx.
3.8 For and in consideration of the covenants, terms, and
conditions set forth herein, NeXstar and TLC, within ten (10)
business days after the Effective Date of this Agreement, will cause
to be executed and TLC will file a stipulated dismissal with
prejudice of TLC's Dutch Legal Action and NeXstar's counterclaims
therein, if any, in the Xxxxxxxx Xxxxx xx Xxx Xxxxx, Xxx Xxxxxxxxxxx.
3.9 For and in consideration of the covenants, terms, and
conditions set forth herein, within ten (10) business days after the
Effective Date of this Agreement, NeXstar will file in the European
Patent Office a withdrawal of its opposition to the grant of TLC's
European High Drug Lipid Complex Patent and shall not oppose foreign
counterparts in other jurisdictions.
SECTION IV - RELEASES
4.1 For and in consideration of the covenants, terms, and
conditions set forth herein, TLC and each of its subsidiaries and
affiliates hereby releases (a) NeXstar, its subsidiaries, and
NeXstar=s and its subsidiaries= affiliates, officers, employees,
agents, customers, distributors, and others in privity with NeXstar
(for purposes of Section 4.1 only, hereinafter collectively
"NeXstar"), and (b) FUSA, its subsidiaries, and FUSA=s and its
subsidiaries= affiliates, officers, employees, agents, customers,
distributors, and others in privity with FUSA (for purposes of
Section 4.1 only, hereinafter collectively "FUSA"), from any and all
liability, past, present or future, for infringement of the Xxxxxx
Dehydration Patents, including but not limited to all matters raised
or that could have been raised in TLC's First Amended Counterclaim,
TLC's British, German, and Dutch Legal Actions, and any and all other
proceedings and/or all other legal action(s) in any other
jurisdiction that could have been asserted against either NeXstar or
FUSA for past, present, or future infringement of the Xxxxxx
Dehydration Patents.
4.2 For and in consideration of the covenants, terms, and
conditions set forth herein, NeXstar and its subsidiaries and
affiliates (including but not limited to NeXstar Pharmaceuticals
Ltd., NeXstar Pharmaceuticals GmbH, and NeXstar Pharmaceuticals
B.V.), and FUSA and its subsidiaries hereby release TLC, its
subsidiaries, and TLC's and its subsidiaries' affiliates, officers,
employees, agents, customers, distributors, and others in privity
with TLC (for purposes of Section 4.2 only, hereinafter collectively
"TLC"), from any and all liability for all matters raised or that
could have been raised in NeXstar's Second Amended and Supplemental
Complaint (including, but not limited to the procurement and
enforcement of the Xxxxxx Dehydration Patents, and all statements and
other actions relating thereto), and NeXstar only further releases
TLC from any and all counterclaims raised or that could have been
raised against TLC in response to TLC=s British, German, and Dutch
Legal Actions, and any other proceeding or other legal action(s) in
any other jurisdiction that could have been asserted by NeXstar
against TLC based on TLC=s procurement and/or enforcement of the
Xxxxxx Dehydration Patents.
4.3 NeXstar represents that Brocacef Intramuraal, B.V.
(Brocacef), a party to the Dutch Legal Actions, acts solely as an
independent distributor of AmBisome and is not an affiliate or
subsidiary of NeXstar; therefore in consideration of the covenants,
terms, and conditions set forth herein, NeXstar hereby agrees to use,
in good faith, commercially reasonable efforts to obtain from
Brocacef a release of TLC, its subsidiaries, and TLC's and its
subsidiaries' affiliates, officers, employees, agents, customers,
distributors, and others in privity with TLC (for purposes of Section
4.3 only, hereinafter collectively "TLC"), from any and all liability
for all matters raised or that could have been raised in the Dutch
Legal Actions and from any other claims or counterclaims that could
have been asserted by Brocacef against TLC relating to the subject
matter of the Dutch Legal Actions. Notwithstanding the provisions of
Section 3.8, above, TLC shall not be required to dismiss its action
against Brocacef only unless and until Brocacef provides to TLC the
release set forth in this Section.
SECTION V - IMMUNITIES FROM SUIT AND OPTIONS
5.1 Subject to Section 5.9, TLC grants to NeXstar, its
subsidiaries, and NeXstar=s and its subsidiaries= affiliates,
officers, employees, agents, customers, distributors, and others in
privity with NeXstar (including, but not limited to FUSA and Sumitomo
and their subsidiaries, affiliates, officers, employees, agents,
customers, distributors, and others in privity with them), a
worldwide immunity from suit for all NeXstar products, past, present,
and future, under any of the Xxxxxx Dehydration Patents, whether such
patents now are issued or shall issue in the future from the USPTO or
from any foreign patent office. The grant of immunity to Sumitomo
under this Section shall be in force and effect only so long as
Sumitomo remains a Marketing Partner, licensee, or is in privity with
NeXstar.
5.2 Subject to Sections 5.8 and 5.9, TLC grants to NeXstar, its
subsidiaries, and NeXstar=s and its subsidiaries= affiliates,
officers, employees, agents, customers, distributors, and others in
privity with NeXstar (including, but not limited to FUSA and Sumitomo
and their subsidiaries, affiliates, officers, employees, agents,
customers, distributors, and others in privity with them), a
worldwide immunity from suit for all AmBisome Products, including but
not limited to AmBisome, AmBisome SL, and Liquid AmBisome, under all
patents owned by TLC or in which TLC presently has or hereafter
acquires a Controlling Interest [
], whether such patents now are issued
from the USPTO or from any foreign patent office or shall issue in
the future from the USPTO or from any foreign patent office based on
applications with an effective filing date or priority date with
respect to the subject matter claimed therein on or prior to the
Effective Date of this Agreement. The grant of immunity to Sumitomo
under this Section shall be in force and effect only so long as
Sumitomo remains a Marketing Partner, licensee, or is in privity with
NeXstar.
5.3(a) Subject to Sections 5.8 and 5.9, NeXstar grants to
TLC, its subsidiaries, and TLC's and its subsidiaries' affiliates,
officers, employees, agents, customers, distributors, and others in
privity with TLC, a worldwide immunity from suit for D-99 and Abelcet
under all patents owned by NeXstar or in which NeXstar presently has
or hereafter acquires a Controlling Interest [
], whether such patents
now are issued from the USPTO or from any foreign patent office or
shall issue in the future based on applications with an effective
filing date or priority date with respect to the subject matter
claimed therein on or prior to the Effective Date of this Agreement.
5.3(b) Subject to Sections 5.8 and 5.9, FUSA grants to TLC,
its subsidiaries, and TLC's and its subsidiaries' affiliates,
officers, employees, agents, customers, distributors, and others in
privity with TLC, a worldwide immunity from suit for Abelcet in the
form presently approved for sale in the United States and Canada
under all patents owned by FUSA or in which FUSA presently has or
hereafter acquires a Controlling Interest, whether such patents now
are issued from the USPTO or from any foreign patent office or shall
issue in the future based on applications with an effective filing
date or priority date with respect to the subject matter claimed
therein on or prior to the Effective Date of this Agreement.
5.3(c) [
]
5.4 [
]
5.5 [
]
5.6 [
]
5.7 [
]
5.8 [
]
5.9 The immunities from suit granted in Sections 5.1 through
5.3 of this Agreement shall not extend to transactions with third
parties in which the party that has been granted the immunity is so
peripherally involved that an extension of the immunity would be
tantamount to a transfer of the immunity to said third party. Any
dispute regarding the degree of involvement of the party that has
been granted the immunity in such transaction shall be resolved by
arbitration under Section 9.10.
5.10 [
]
SECTION VI - PAYMENTS
6.1 NeXstar will pay to TLC $1,750,000 within five (5) days of
the Effective Date of this Agreement.
6.2 [
]
6.3 [
]
6.4 [
]
6.5 [
]
6.6 [
]
6.7 [
]
6.8 [
]
6.9 NeXstar, FUSA, and TLC (if applicable) shall keep good and
accurate books of account sufficient to permit determination of any
payments due hereunder and shall make such books of account available
for inspection by an independent accountant not otherwise rendering
services to the party to which the payment is due and mutually
agreeable to all parties. Such inspections shall be no more frequent
than once each calendar year during which a payment is due and once
within six months after cessation of any obligation to make payments
under this Agreement. The designated accountant shall retain in
confidence the information in the books of account and shall report
to the party to which the payment is due only the accuracy or
inaccuracy in the calculation of such payment. Such inspections will
be at the expense of the party requesting the inspection unless the
designated accountant identifies an underpayment of the payment due
by five percent (5%) or more, in which event the party obligated to
make the payment shall pay for such inspection. Any party=s failure
to inspect shall not constitute a waiver of its right to object to
the accuracy of the calculations or payments made under this
Agreement. Notwithstanding the foregoing, no inspection shall occur
for any calendar year in which the maximum payment pursuant to
Section 6.4 has been made.
6.10 If TLC desires to have conducted an inspection of the
Sumitomo books of account, NeXstar hereby agrees to request such an
inspection in accordance with all of the provisions, and subject to
all of the limitations, of Paragraph 7 of the Sumitomo Agreement,
provided that TLC agrees to reimburse NeXstar within 30 days of the
completion of such inspection for the entire cost associated
therewith.
6.11 All payments made under this Agreement shall be in U.S.
dollars and shall be paid by check or by wire to a bank in the United
States that shall be designated in writing by the party to which such
payment is due.
SECTION VII - WARRANTIES AND REPRESENTATIONS
7.1 Nothing in this Agreement shall be construed as (a) a
warranty or representation by either TLC or NeXstar as to the valid
ity, enforceability or scope of any of the patents described herein,
or (b) granting by implication, estoppel, or otherwise, any license
or rights under any patents, trade secrets, knowhow, copyrights,
trademarks, or other intangible rights of either TLC or NeXstar other
than those specifically granted under this Agreement.
7.2 No party to this Agreement makes any representations,
extends any warranty of any kind, either express or implied, or
assumes any responsibility whatever with respect to manufacture, use,
sale or other disposition by any other party or its customers or
transferees or their customers of products or methods incorporating
or made by use of any inventions claimed in any patent described
herein.
7.3 NeXstar, FUSA, and TLC hereby warrant that they have all
necessary authority to enter into this Agreement and to convey the
rights granted hereunder.
7.4 [
]
7.5 [
]
SECTION VIII - ASSIGNMENT
8.1 All rights granted under this Agreement shall be assignable
only upon (1) written consent of the grantor, or (2) the sale or
transfer (including by merger or spin-off) of all or substantially
all of the assets of that portion of the business involved in making,
marketing, selling, or distributing AmBisome, Abelcet, and/or D-99,
as the case may be, or (3) a corporate reorganization for tax or
similar corporate restructuring purposes.
SECTION IX - MISCELLANEOUS
9.1 Each party hereto agrees to execute, acknowledge, and
deliver all such further instruments, and to do all such further
acts, as may be necessary or appropriate to carry out the intent and
purposes of this Agreement. This Agreement shall be binding upon all
successors in interest to, and upon all assignees of, each of the
parties hereto.
9.2 Nothing herein shall be deemed to create an agency, joint
venture or partnership relation between any of the parties hereto.
9.3 This Agreement and the attachments thereto constitute the
entire agreement and understanding of the parties with regard to the
subject matter hereof and merges and supersedes all prior
discussions, negotiations, understandings and agreements between the
parties concerning the subject matter hereof. No party shall be
bound by any definition, condition, warranty, right, duty or covenant
other than as expressly stated in this Agreement or as subsequently
set forth in a written document signed by all parties.
9.4 This Agreement shall be interpreted and construed, and the
legal relations created herein shall be determined, in accordance
with the laws of the State of Delaware (excluding conflicts of laws)
and the United States.
9.5 This Agreement may be amended only by a written document
signed by authorized representatives of all parties.
9.6 The headings contained in this Agreement are for reference
purposes only and shall not affect in any way the meaning or
interpretation of this Agreement.
9.7 The parties shall prepare and issue a joint press release,
to be approved by all parties to this Agreement prior to its
issuance, stating the fact of the settlement and the dismissal and/or
withdrawal of the various actions and proceedings described in
Section III, above. Although the joint press release may state that,
under this Agreement, NeXstar will make certain payments to TLC, the
amount, terms, and conditions of such payments shall remain
confidential, except to the extent that certain disclosures may be
required by law, compelled by judicial or administrative order, or
are believed in good faith by the disclosing party to be necessary to
comply with any applicable federal, state, or foreign law regarding
the sale or regulation of securities. In the case of such a
disclosure, the disclosing party shall make all reasonable efforts to
limit such disclosure and to maintain the confidentiality of the
terms and conditions of this settlement.
9.8 Except to the extent disclosed by Section 9.7, all other
information concerning this Agreement and/or the terms thereof and
all financial and sales information disclosed by each party shall be
maintained as confidential by the receiving party on an ongoing
basis. If a receiving party desires to disclose such confidential
financial and sales information to another party to this Agreement or
to a third party, the receiving party must notify the owner of the
confidential information in writing at least ten days prior to such
disclosure. An agreement to disclose such information must be
reached in writing prior to any such disclosure. If the receiving
party is legally obligated by Court Order or by any applicable
federal, state, or foreign law regarding the sale or regulation of
securities to disclose the confidential financial information, the
receiving party will immediately notify the owner of such
confidential information. If possible, the receiving party will
notify the owner of such confidential information as soon as it is
aware of the possibility of legally obligated disclosure in a timely
manner so that the owner of the confidential information can object
to such disclosure. If an agreement cannot be reached between the
parties as to whether confidential information can be disclosed, the
parties will make all reasonable efforts to resolve such disagreement
(e.g., the independent accountants will discuss the issues).
9.9 Any and all notices or other communications required or
permitted by this Agreement or by law to be served on or given to
either party hereto by the other party shall be in writing and
delivered or sent to the addresses set forth below:
To NeXstar:
NeXstar Pharmaceuticals, Inc.
0000 Xxxxxxxxxx Xxxxx
Xxxxxxx, Xxxxxxxx 00000
Attn: Xxxx Xxxxxxx, Esq.
To TLC:
The Liposome Company, Inc.
Xxx Xxxxxxxx Xxx
Xxxxxxxxx Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
Attn: General Counsel
To FUSA:
Fujisawa U.S.A., Inc.
Parkway Xxxxx Xxxxxx
0 Xxxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attn: Xxxxx Xxxxxxxx, Esq.
Any party to this Agreement may change its address for purposes
of this Agreement by written notice to the other party. All notices
or other communications shall be deemed duly served and given on the
date when personally delivered to the party to whom it is directed,
when transmitted electronically by telex or facsimile, provided that
a confirming copy is sent by United States mail as set forth
hereafter, or when deposited in the United States mail, first class,
postage prepaid, and addressed to the party at the address on the
first page hereof.
9.10 Any controversy or claim arising out of or relating to this
Agreement, or any alleged breach thereof, shall be settled by binding
arbitration, before a panel of three (3) arbitrators, administered by
the American Arbitration Association under its Commercial Arbitration
Rules, or by such other procedures as to which the parties may agree,
and judgment on the award rendered by the arbitrators may be entered
in any court having jurisdiction thereof. If an arbitration is
commenced pursuant to this Section, the losing party will be
obligated to pay all arbitration costs (but not attorney fees)
incurred by each of the parties to such arbitration.
9.11 (a) FUSA hereby agrees to indemnify and hold TLC harmless
for any liability associated with the manufacture, use, or sale by
FUSA of any products with respect to which an immunity from suit,
option to license, license, or sublicense is granted by TLC under
this Agreement.
(b) NeXstar hereby agrees to indemnify and hold TLC
harmless for any liability associated with the manufacture, use, or
sale by NeXstar of any products with respect to which an immunity
from suit, option to license, license, or sublicense is granted by
TLC under this Agreement.
9.12 TLC hereby agrees to indemnify and hold FUSA and/or NeXstar
harmless for any liability associated with the manufacture, use, or
sale by TLC of any products with respect to which an immunity from
suit, option to license, license, or sublicense is granted by FUSA
and/or NeXstar under this Agreement.
9.13 Neither FUSA nor NeXstar guarantees that TLC will have the
ability to make, use, sell, or offer to sell free from liability for
infringement of third party patents any product with respect to which
an immunity from suit, option to license, license, or sublicense is
granted by FUSA and/or NeXstar under this Agreement.
9.14 TLC does not guarantee that FUSA and/or NeXstar will have
the ability to make, use, sell, or offer to sell free from liability
for infringement of third party patents any product with respect to
which an immunity from suit, option to license, license, or
sublicense is granted by TLC under this Agreement.
9.15 NeXstar, TLC, and FUSA mutually covenant that they neither
will instigate nor encourage legal action against the other by third
parties with respect to products for which an immunity from suit is
granted under Section 5.1, 5.2, or 5.3 of this Agreement. NeXstar
and FUSA further agree not to oppose, seek to invalidate, or to have
revoked, or to have held or rendered unenforceable any of the U.S. or
foreign Xxxxxx Dehydration Patents.
9.16 None of the parties shall be responsible or liable to
another party for nonperformance or delay in performance of any terms
or conditions of this Agreement due to acts or occurrences beyond the
control of the nonperforming or delayed party, including but not
limited to, acts of God, acts of government, wars, riots, strikes or
other labor disputes, shortages of labor or materials, fires and
floods, provided the nonperforming or delayed party provides to the
other party written notice of the existence and the reason for such
nonperformance or delay.
9.17 This Agreement shall be executed by each party in
triplicate originals, each of which shall be deemed an original, but
the three originals together shall constitute only one and the same
instrument.
IN WITNESS WHEREOF, the parties have executed this
Agreement in triplicate on the signature page hereof.
The Liposome Company, Inc. NeXstar Pharmaceuticals, Inc.
By By
Typed Name Xxxxxxx X. Xxxxx Typed Name Xxxxxxx Xxxxxxx
Title Chairman and CEO Title President and CEO
Date 8/13/97 Date 8/11/97
Fujisawa USA, Inc.
By
Typed Name B. Xxxxxxx Xxxx
Title Vice President, Business Development
Date 08/11/97
