EXHIBIT 10.35
SETTLEMENT, RELEASE AND PATENT LICENSE
This Settlement, Release and Patent License Agreement (this "AGREEMENT") is
made as of February 9, 2007 ("EFFECTIVE DATE"), by and among Takeda
Pharmaceutical Company Limited, a Japanese corporation with its principal place
of business at ▇-▇ ▇▇▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇, ▇▇▇▇-▇▇, ▇▇▇▇▇, ▇▇▇▇▇ 540-8645
("TAKEDA"), Wako Pure Chemical Industries, Ltd., a Japanese corporation with its
principal place of business at ▇-▇ ▇▇▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇, ▇▇▇▇-▇▇, ▇▇▇▇▇, ▇▇▇▇▇
540-8605 ("WAKO"), TAP Pharmaceutical Products Inc., a Delaware corporation with
its principal place of business at ▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇
("TAP"), and ▇▇▇▇▇▇ Laboratories, Limited - Laboratories Abbott, Limitee, a
corporation organized and existing under the Canadian Business Corporations Act
and having its principal place of business at Montreal, Quebec
("▇▇▇▇▇▇-CANADA"), on the one hand, and QLT USA, Inc., a Delaware corporation
with its principal place of business at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("ATRIX") and Sanofi-Synthelabo, Inc., a Delaware corporation
with a principal place of business at ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇
▇▇▇▇▇ ("SANOFI"), on the other hand (collectively, the "PARTIES").
WHEREAS, the Parties deem it to be in their best interests and to their
mutual advantage to settle their disputes on the terms and conditions set forth
in this Agreement, without admitting liability, in order to achieve certainty in
their business dealings and avoid the expense of litigation.
NOW, THEREFORE, in view of the foregoing and for other good and valuable
consideration, receipt and sufficiency of which are hereby acknowledged, the
Parties agree as follows:
1. DEFINITIONS.
1.1. CERTAIN DEFINITIONS. For purposes of this Agreement, the following
terms shall have the following meanings:
(a) "AFFILIATE" shall mean any Person that controls, is controlled by,
or is under common control with a Party to this Agreement. For purposes of this
definition, "control" shall mean (i) in the case of a corporate entity, direct
or indirect ownership of more than fifty percent (50%) of the securities having
the right to vote for the election of directors, and (ii) in the case of a
non-corporate entity, direct or indirect ownership of a majority of the equity
interests with the power to direct the management and policies of such
non-corporate entity. Notwithstanding the foregoing, in no event shall ▇▇▇▇▇▇
Laboratories be considered an Affiliate of any of the Parties.
(b) "CLAIMS" shall mean any and all claims, actions, causes of action,
demands, suits, proceedings, administrative proceedings, losses, damages, costs,
expenses, liabilities, charges, interest, penalties, fines and charges of
whatever nature (including costs of collection, attorneys' fees and other costs
of defense, costs of enforcing indemnification provisions, and expenses of
investigation), whether known or unknown.
(c) "CONTROL" or "CONTROLLED," as to patent rights, shall mean
ownership of such patent right or the ability of a Person to grant a license, or
sublicense, or covenant not to ▇▇▇ under any such patent rights.
(d) "GOVERNMENTAL AUTHORITY" shall mean any nation, territory or
government (or union thereof), foreign, domestic or multinational, any state,
local or other political subdivision thereof, and any bureau, court, tribunal,
board, commission, department, agency or other Person exercising executive,
legislative, judicial, regulatory or administrative functions of government.
(e) "LICENSOR" or "LICENSORS" shall mean any and each of Takeda, Wako,
TAP, and ▇▇▇▇▇▇-Canada, collectively and individually.
(f) "LITIGATION" shall mean, collectively, that certain lawsuit
captioned "TAP Pharmaceutical Products Inc., Takeda Chemical Industries, Ltd.
and Wako Pure Chemical Industries, Ltd. v. Atrix Laboratories, Inc. and
Sanofi-Synthelabo Inc.," No. 03-C-7822, United States District Court for the
Northern District of Illinois and the appeal pending therefrom captioned "TAP
Pharmaceutical Products Inc., Takeda Chemical Industries, Ltd. and Wako Pure
Chemical Industries, Ltd. v. Atrix Laboratories, Inc. and Sanofi-Synthelabo
Inc.," ▇▇. ▇▇▇▇-▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇ Court of Appeals for the Federal Circuit.
(g) "LITIGATION PARTY" or "LITIGATION PARTIES" shall mean any and each
of Atrix, Sanofi, Takeda, Wako, and TAP, collectively and individually.
(h) "PARTY" shall mean any and each of Atrix, Sanofi, Takeda, Wako,
TAP, and ▇▇▇▇▇▇-Canada, collectively and individually.
(i) "PERSON" shall mean an individual, corporation, partnership,
limited partnership, limited liability company, unincorporated association,
trust, joint venture, union or other organization or entity, including a
Governmental Authority.
(j) "RELEASED PARTY" OR "RELEASED PARTIES" shall mean any and each of
Atrix and Sanofi, collectively and individually.
(k) "RELEASING PARTY" or "RELEASING PARTIES" shall mean any and each
of Takeda, Wako, TAP, and Abbott-Canada, collectively and individually.
(l) "SUBJECT PRODUCT" or "SUBJECT PRODUCTS" shall mean (i) the
following products marketed or sold on or prior to the Effective Date by Atrix
or licensed by Atrix and sold by its Affiliates or licensees in the Territory on
or prior to the Effective Date: the Eligard(R) products (which contain
leuprolide acetate in 7.5 mg, 22.5 mg, 30 mg, and 45 mg dosages) and dental
products called Atridox(TM), Atrisorb Free Flow(TM), Atrisorb-D(TM) and
Doxyrobe(TM); and (ii) products that are the same as or have only non-colorable
(i.e. insubstantial or immaterial) differences from any of the foregoing
products.
(m) "SUBJECT PRODUCT PATENT RIGHTS" shall mean any and all rights in
the following that are owned, licensed or Controlled by any of the Releasing
Parties, and that claim or cover the Subject Products (or the manufacture, use
or sale thereof), whether the following are existing as of the Effective Date or
thereafter: (i) patents in the Territory; (ii) patent applications in the
Territory, including provisional applications, and (iii) any patents issuing
therefrom and any divisionals, continuations, continuations-in-part, reissues,
re-examinations, extensions, and term extensions (under applicable patent law or
regulation or other law or regulation) in the Territory of any of the
above-described patents or patent applications.
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(n) "SUBLICENSEE" shall mean any Person, and their respective
sublicensees, to whom a sublicense is granted pursuant to Section 5.2.
(o) "TERRITORY" shall mean the United States of America, its
territories and possessions including the Commonwealth of Puerto Rico, and
Canada.
1.2. ADDITIONAL DEFINITIONS. Certain additional capitalized terms are
defined below in the body of this Agreement.
2. RELATIONSHIP OF AGREEMENT WITH MOTION TO DISMISS; STIPULATED ORDER OF
DISMISSAL.
Forthwith after execution of this Agreement, the Litigation Parties will
jointly file a motion to dismiss (the "MOTION TO DISMISS") the appeal in the
case entitled "TAP Pharmaceutical Products Inc., Takeda Chemical Industries,
Ltd. and Wako Pure Chemical Industries, Ltd. v. Atrix Laboratories, Inc. and
Sanofi-Synthelabo Inc.," No. 2006-1258 in the U.S. Court of Appeals for the
Federal Circuit (the "Appeals Court") in the form of Exhibit A attached to this
Agreement. If the Appeals Court grants the Motion to Dismiss prior to issuing
any opinions on the merits of the appeal (including a ruling pursuant to Federal
Rule of Appellate Procedure 36), then the Litigation Parties shall, within three
business days after the Appeals Court grants the Motion to Dismiss, file a
Stipulated Order of Dismissal in the case captioned "TAP Pharmaceutical Products
Inc., Takeda Chemical Industries, Ltd. and Wako Pure Chemical Industries, Ltd.
v. Atrix Laboratories, Inc. and Sanofi-Synthelabo Inc.," No. 03-C-7822 in the
United States District Court for the Northern District of Illinois (the
"District Court"), in the form of Exhibit B attached to this Agreement, and make
other appropriate filings requesting the District Court -- and take all other
actions reasonably required -- to dismiss with prejudice all claims for relief
asserted by any Party against any other Party in the Litigation. If the District
Court dismisses case no. 03-C-7822 in accordance with the Stipulated Order of
Dismissal, (a) Atrix shall and the Releasing Parties shall instruct Patterson,
Belknap, ▇▇▇▇ & ▇▇▇▇▇ to instruct the Escrow Agent (as that term is defined in
the Escrow Agreement dated June 8, 2006 between Atrix and JPMorgan Chase Bank,
N.V. (the "▇▇ ▇▇▇▇▇▇ Escrow Agreement")) to deliver the Escrow Funds (as that
term is defined in the ▇▇ ▇▇▇▇▇▇ Escrow Agreement) to Atrix in accordance the
terms of the ▇▇ ▇▇▇▇▇▇ Escrow Agreement; and (b) Atrix and Sanofi shall pay
their respective shares of the Settlement Amount in accordance with Section 3.1.
If the Appellate Court denies the Motion to Dismiss or issues an opinion on the
merits of the appeal prior to granting the Motion to Dismiss, then this
Agreement shall automatically and immediately terminate, cease to have any force
and effect, and shall be deemed null and void and of no effect on a retroactive
basis.
3. MONETARY CONSIDERATION.
3.1. PAYMENT BY ATRIX AND SANOFI. Subject to the conditions set forth in
Section 2, which are for the benefit of and may be waived by Atrix and Sanofi
jointly, (a) Atrix shall pay to TAP the amount of $112.5 million, and (b) Sanofi
shall pay to TAP the amount of $45 million (the amounts in (a) and (b), in the
aggregate being the "SETTLEMENT AMOUNT"), in each case, within three business
days after both of the following events occur: the Appeals Court grants the
Motion to Dismiss and the District Court dismisses case no. 03-C-7822 in
accordance with the Stipulated Order of Dismissal. All payments shall be made in
United States Dollars. Atrix and Sanofi shall deposit their respective share of
the Settlement Amount with their respective legal counsel on the Effective Date
to be held in escrow on behalf of such Parties for payment to TAP in accordance
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with this Agreement. The Settlement Amount shall be paid to TAP by wire transfer
of immediately available funds to an account previously designated by TAP to
Atrix and Sanofi in writing and TAP shall apportion the Settlement Amount among
the other Releasing Parties, if any apportionment is to be made. Payment of the
Settlement Amount to TAP shall constitute full payment of any portion of the
Settlement Amount to the other Releasing Parties entitled thereto. TAP
represents that it will comply with any applicable United States federal, state
or local withholding tax obligations with respect to such payments, if any, that
TAP makes to the other Releasing Parties. TAP acknowledges that, as between TAP
on the one hand and Atrix and Sanofi on the other hand, TAP assumes full
responsibility to fulfill any withholding tax obligations with respect to the
Settlement Amount. The Settlement Amount, once paid, is not refundable.
3.2. NO OTHER FUNDS TRANSFER. The Settlement Amount represents full and
complete payment for all of the rights and releases granted to Atrix, Sanofi and
any Atrix and Sanofi Releasees (as defined in Section 4.1) under this Agreement,
and neither Atrix, Sanofi nor any Atrix and Sanofi Releasee shall be under any
obligation to pay any additional or further amounts to any Releasing Party under
this Agreement.
3.3. TAXES. If the United States Internal Revenue Service or any state or
local taxing authority within the United States imposes on Atrix or Sanofi any
withholding tax on any portion of the Settlement Amount under the Internal
Revenue Code of 1986, as amended or the Treasury regulations thereunder, TAP
shall indemnify and hold harmless Atrix and Sanofi for the amount of such
withholding tax, plus any interest, penalties or additions to tax related
thereto.
4. RELEASES, COVENANTS NOT TO ▇▇▇, AND DISMISSALS.
4.1. RELEASES BY EACH RELEASING PARTY. Upon full payment of the Settlement
Amount, each Releasing Party, each acting on behalf of itself and its respective
predecessors, successors, and assigns, does hereby now and shall forever release
and discharge Atrix and Sanofi, and their predecessors, successors, assigns and
Affiliates, and each of their respective current and former officers, directors,
employees, agents, attorneys, representatives, distributors, resellers,
licensees, direct or indirect customers and contract manufacturers (collectively
and individually, "ATRIX RELEASEES" and "SANOFI RELEASEES"), from and against
(a) any and all Claims arising under, related to, or connected with any Subject
Product Patent Rights in the Territory with respect to the period before the
Effective Date, (b) any and all Claims raised in the Litigation, including but
not limited to any requests in the Litigation to recover damages, fees or
expenses due for alleged infringement of the Subject Product Patent Rights, or
any requests to recover attorneys' fees or costs in connection with the
Litigation, (c) any and all Claims arising out of or related to actions taken or
statements made concerning or in connection with the Litigation in the
Territory, (d) any and all matters which could have been raised (whether or not
due to compulsory counterclaim requirements) in, or as a result of, the
Litigation in the Territory; and (e) any and all Claims, arising during the
period before the Effective Date, related to allegations that the Subject
Products (or any aspect thereof for use in the Subject Products) infringe any
Subject Product Patent Rights Controlled by a Releasing Party in the Territory.
Releasing Parties, acting jointly and severally, represent and warrant, as of
the Effective Date, to Atrix and Sanofi that they possess and Control (and have
always possessed and Controlled) the exclusive right to ▇▇▇ for infringement or
misappropriation of the Subject Product Patent Rights in the Territory and that
no other Person has ever had the right to recover damages for infringement or
misappropriation of any Subject Product Patent Rights in the Territory.
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4.2. RELEASES BY ATRIX AND SANOFI. Upon full payment of the Settlement
Amount, Atrix and Sanofi, each acting on behalf of itself and its respective
predecessors, successors and assigns, does hereby now and shall forever release
and discharge the Releasing Parties, and each of their respective predecessors,
successors, assigns and Affiliates, and each of their respective current and
former officers, directors, employees, agents, attorneys, representatives,
distributors, resellers, licensees, and direct or indirect customers
(collectively and individually, "COLLECTIVE TAP RELEASEES"), from and against
(a) any and all Claims raised in the Litigation, including but not limited to
any Claim that U.S. Patent No. 4,728,721 is invalid or unenforceable in the
Territory or should be reexamined or revoked, any Claim that any Releasing Party
wrongfully enforced or committed patent misuse with respect to U.S. Patent No.
4,728,721 in the Territory or any claim to recover attorneys' fees or costs in
connection with the Litigation, (b) any and all Claims arising out of or related
to actions taken or statements made concerning or in connection with the
Litigation in the Territory, (c) any and all matters which could have been
raised (whether or not due to compulsory counterclaim requirements) in, or as a
result of, the Litigation in the Territory, and (d) any and all Claims arising
during the period before the Effective Date that U.S. Patent No. 4,728,721 is
invalid or unenforceable or should be re-examined, opposed, or revoked in the
Territory and/or any and all Claims arising during the period before the
Effective Date that any Releasing Party wrongfully enforced or committed patent
misuse with respect to U.S. Patent No. 4,728,721 in the Territory.
4.3. COVENANTS NOT TO ▇▇▇. No Atrix Releasee or Sanofi Releasee shall now
or at any time in the future initiate any arbitration, lawsuit or other
proceeding asserting (or otherwise assert, directly or through any third party)
any Claim released pursuant to this Agreement. No Collective TAP Releasee shall
now or at any time in the future initiate any arbitration, lawsuit or other
proceeding asserting (or otherwise assert, directly or through any third party)
(a) any Claim released pursuant to this Agreement, or (b) that the Subject
Products infringe any Subject Product Patent Rights Controlled by any Collective
TAP Releasee in the Territory, provided that nothing shall be construed to
release Atrix and Sanofi from their respective obligations to pay their
respective share of the Settlement Amount in accordance with Section 3.1 hereof.
If any Collective TAP Releasee shall breach any obligation set forth in this
Section 4.3, the breaching Party (on behalf of itself and/or its respective
Collective TAP Releasee) shall indemnify each Atrix and Sanofi Releasee, and
defend and hold each such Atrix and Sanofi Releasee harmless, from and against
Claims arising out of or related to such breach. If any Atrix Releasee shall
breach any obligation set forth in this Section 4.3, Atrix shall indemnify each
such Collective TAP Releasee, and defend and hold each such Collective TAP
Releasee harmless, from and against any Claims arising out of or related to such
breach. If any Sanofi Releasee shall breach any obligation set forth in this
Section 4.3, Sanofi shall indemnify each such Collective TAP Releasee, and
defend and hold each such Collective TAP Releasee harmless, from and against any
Claims arising out of or related to such breach. This Section 4.3 will be fully
enforceable in every respect, at law or in equity, by any non-Party Collective
TAP Releasee or non-Party Atrix or Sanofi Releasee as an intended third party
beneficiary hereunder. For purposes of clarification, nothing in this Section 4
shall prohibit a Party in any way from bringing claims or counterclaims or
instituting judicial, administrative or other legal proceedings outside the
Territory, including but not limited to patent opposition or other proceedings
in patent offices outside of the Territory.
4.4. RETAINED RIGHTS. Notwithstanding anything to the contrary herein,
nothing in Sections 4.2 and 4.3 shall prohibit or restrict any Atrix Releasee or
Sanofi Releasee from (a)
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raising any defenses or counterclaims (including claims of invalidity or
non-enforceability) in connection with any action, suit or proceeding brought
against such Atrix or Sanofi Releasee for infringement of any Subject Product
Patent Rights (or any other patent rights), or (b) instituting judicial,
administrative or other legal proceedings within the Territory or outside the
Territory challenging the validity or enforceability of, or asserting the
noninfringement of, any Subject Product Patent Rights (or any other patent
rights) or otherwise claiming that any such patent rights should be re-examined,
opposed, or revoked in the Territory.
5. LICENSES.
5.1. LICENSE GRANT TO ATRIX AND SANOFI. Upon full payment of the Settlement
Amount, each Licensor hereby grants to Atrix and its Affiliates and Sanofi and
its Affiliates a non-exclusive, perpetual, irrevocable, fully paid-up,
royalty-free license under the Subject Product Patent Rights to use, make, have
made, sell, have sold, offer for sale, import and export, the Subject Products
in the Territory, and such license shall be effective retroactive to the
Effective Date. Such license shall be sublicensable by Atrix, Sanofi, or their
Affiliates and their respective Sublicensees in accordance with Section 5.2. For
the avoidance of doubt, the foregoing license includes the right in the
Territory to make, have made, import and use components or ingredients of the
Subject Products for inclusion in the Subject Products. By way of clarification,
Licensors do not grant any express or implied licenses or other rights to Atrix
and its Affiliates or Sanofi and its Affiliates outside of the Territory;
provided, however, that, for the avoidance of doubt, the manufacture, use,
import and/or sale of any Subject Products (or any aspect thereof for use in the
Subject Products) by or for Atrix, Sanofi or any of their Affiliates outside the
Territory would not constitute a breach or violation of this Agreement (even
though such activity is not authorized or licensed by this Agreement either),
and therefore, for example, the act of exporting Subject Products from the
Territory is not restricted by this Agreement (even though corresponding import,
use and/or sale of such products in countries outside the Territory following
such export is not licensed or otherwise authorized hereunder), and the
Releasing Parties are not waiving any rights they may have, if any, to assert
their rights (including but not limited to any patent rights outside the
Territory) against import, use and/or sale of such products in countries outside
the Territory.
5.2. SUBLICENSES. Each Licensor hereby grants to Atrix, Sanofi, their
Affiliates and Sublicensees, the right to sublicense, through multiple levels,
in whole or in part, the rights set forth in Section 5.1 to any licensee of the
Subject Products in the Territory. Each such sublicense shall be subject to
Atrix's and Sanofi's rights and obligations under the terms of this Agreement.
Each Licensor acknowledges and agrees that Sanofi is acting as authorized
Sublicensee of Atrix under the license granted pursuant to this Section 5.2 and
is entitled to all the benefits of such license.
6. COMPROMISE AGREEMENT. This Agreement is a compromise and settlement of
disputed Claims and is not intended to be, nor shall it be construed as, an
admission of liability or wrongdoing by any Party, or of the validity or
invalidity, enforceability or unenforceability, or infringement or
non-infringement, of any Subject Product Patent Rights in the Territory.
Accordingly, neither this Agreement, nor anything contained in this Agreement,
or done or omitted in connection with this Agreement (whether or not this
Agreement expires or is terminated), is intended as, or shall be construed as,
or may be offered or used, either within the Territory or outside the Territory,
by any Collective TAP Releasee, Atrix Releasee or Sanofi
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Releasee as, an admission, acknowledgement, implication or evidence of
infringement or the need for a license by any Party or its Affiliates, or an
admission, acknowledgement, implication or evidence of fault, liability or
wrongdoing by any Party or its Affiliates or an admission, acknowledgement,
implication or evidence, directly or indirectly, against any Party or its
Affiliates in any way or for any purpose in any judicial, administrative or
other legal proceedings, except solely for the purpose of enforcing this
Agreement.
7. PRESS RELEASE/PUBLIC FILINGS.
7.1. PRESS RELEASE. One or more of the Parties may issue press releases
regarding this Agreement in the form attached as Exhibit C. Each Party agrees
that it will not make public statements regarding this Agreement that are
inconsistent with its press release.
7.2. REQUIRED BY LAW. The Parties acknowledge that the terms of this
Agreement may be disclosed as required by law, including but not limited to the
Securities and Exchange Commission, listing requirements of any securities
exchange, or other such regulatory authorities.
8. MATTERS CONCERNING THE LICENSE AND THE AGREEMENT.
8.1. TERM OF LICENSE GRANT. Upon the District Court signing and entering
the Stipulated Order of Dismissal and upon full payment of the Settlement
Amount, the rights granted in Section 5 shall take effect as of the Effective
Date and shall continue until the last to expire of the Subject Product Patent
Rights.
8.2. SECTION 365(n). All licenses and rights granted under or pursuant to
this Agreement by Licensors to Atrix, its Affiliates, Sanofi, its Affiliates,
and their Sublicensees are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of Title 11, U.S. Code (the "BANKRUPTCY CODE"), licenses of
rights to "intellectual property" as defined in the Bankruptcy Code. The Parties
agree that Atrix and its Affiliates, Sanofi and its Affiliates, and their
Sublicensees shall retain and may fully exercise all of their rights and
elections under the Bankruptcy Code. Licensors agree during the term of this
Agreement to create and maintain current copies or, if not amenable to copying,
detailed descriptions or other appropriate embodiments, of all such intellectual
property. All rights, powers and remedies of Atrix and Sanofi provided under
this Section 8.2 are in addition to and not in substitution for any and all
other rights, powers and remedies now or hereafter existing at law or in equity
in the event of any such commencement of a bankruptcy proceeding by or against
any of the Licensors.
8.3. FINAL AND BINDING AGREEMENT. This Agreement constitutes the entire
agreement among the Parties to this Agreement with respect to the subject matter
of this Agreement and supersedes all prior agreements and understandings,
whether written or oral, between or among the Parties, or any of the Parties, in
connection with such subject matter. Each Party agrees that it is not relying in
any manner on any statement, promise, representation or omission, whether oral
or written, express or implied, made by any Person, not specifically set forth
in this Agreement. Each Party agrees that it has made such investigation of all
matters pertaining to this Agreement that such Party deems necessary, including
but not limited to the Subject Products and any other products made, sold,
offered for sale, used, exported or imported by Atrix and Sanofi and their
Affiliates. Each Party acknowledges that, after execution of this Agreement,
such Party may discover facts different from or in addition to those which it
now knows or believes to be true.
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Nevertheless, each Party agrees that this Agreement shall be and remain in full
force and effect in all respects, notwithstanding such different or additional
facts.
9. REPRESENTATIONS AND WARRANTIES OF THE PARTIES. The Parties make the
representations and warranties set forth in this Section 9. In making the
representations and warranties that apply to any or all Parties, each Party is
making such representations and warranties as to itself and is not making such
representations and warranties jointly with any other Party.
9.1. CORPORATE POWER. Each Party represents and warrants that (a) it has
the full legal right and power to enter into and perform the transactions
contemplated by this Agreement, without need for any consent, approval,
authorization, license or order of, or notice to or filing with, any
Governmental Authority or other Person; (b) the execution, delivery and
performance by such Party of this Agreement and the consummation by such Party
of the transactions contemplated hereby have been duly and validly authorized
and approved by all necessary corporate action of such Party, including approval
of this Agreement by the board of directors and stockholders of such Party, if
required; (c) this Agreement evidences the legal, valid and binding obligations
of such Party, enforceable against such Party in accordance with its terms; and
(d) this Agreement has been duly executed and delivered by such Party.
9.2. DUE ORGANIZATION. Each Party represents and warrants that it is a
corporation duly organized, validly existing and in good standing under the laws
of the jurisdiction in which it is incorporated and that it has corporate power
to own its properties, to conduct its business as currently owned and conducted,
and to carry out the transactions contemplated by this Agreement.
9.3. NO ASSIGNMENT OF CLAIMS. Each Party represents and warrants that (a)
it has not sold, assigned, conveyed, pledged, encumbered, or otherwise in any
way transferred to any Person any Claim released by such Party pursuant to this
Agreement and (b) it has not agreed to do any of the foregoing.
9.4. NO OTHER LAWSUITS. Each Releasing Party represents and warrants that
as of the Effective Date it has not filed (or caused to be filed through a third
party), any legal or administrative proceeding of any kind or nature in the
Territory against Atrix, Sanofi or any other Atrix and Sanofi Releasee relating
to any Subject Product Patent Rights, except for the Litigation. Atrix and
Sanofi each represents and warrants that as of the Effective Date it has not
filed (or caused to be filed through a third party), any legal or administrative
proceeding of any kind or nature in the Territory against any Collective TAP
Releasee relating to any Subject Product Patent Rights, except for the
Litigation.
9.5. RIGHT TO GRANT LICENSES. Each Licensor represents, warrants and
covenants to Atrix and Sanofi that (a) the Subject Product Patent Rights include
any and all rights of any kind in any and all issued or pending patents and/or
patent applications that are Controlled, as of the Effective Date, by the
Releasing Parties, their Affiliates, or any of them, in the Territory that claim
or cover any Subject Product (or any aspect thereof for use in the Subject
Products), or the manufacture, use or sale thereof; (b) Licensors own the
Subject Product Patent Rights that exist as of the Effective Date and have the
right to grant the rights, licenses and covenants set forth in this Agreement,
without the need for any licenses, releases, consents, approvals or immunities
not yet granted or obtained; and (c) Licensor has not previously granted and
shall not grant any rights in the Subject Product Patent Rights that are
inconsistent with the rights, licenses and covenants
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granted to Atrix and Sanofi in this Agreement. Each of TAP and ▇▇▇▇▇▇-Canada
represent, warrant and covenant to Atrix and Sanofi that ▇▇▇▇▇▇ Laboratories and
its affiliates (excluding ▇▇▇▇▇▇-Canada) do not Control as of the Effective Date
any rights of any kind in any issued or pending patents and/or patent
applications in the Territory that claim or cover any aspect of the Subject
Products or for use in the Subject Products.
9.6. INDEPENDENT ADVICE. Each Party represents and warrants that it has
received or had the opportunity to obtain independent legal advice from such
Party's attorney with respect to the rights and obligations arising from, and
the advisability of executing, this Agreement.
9.7. SURVIVAL OF REPRESENTATIONS AND WARRANTIES. All representations,
warranties and covenants set forth in this Agreement shall survive the execution
and delivery of this Agreement indefinitely.
9.8. NO OTHER REPRESENTATIONS. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN
THIS AGREEMENT, NONE OF THE PARTIES, EITHER INDIVIDUALLY OR COLLECTIVELY, MAKES
ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR
IMPLIED, TO ANY OTHER PARTY, AND EACH PARTY HEREBY DISCLAIMS ALL IMPLIED
WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, WITH RESPECT TO ANY AND ALL OF THE FOREGOING.
10. GENERAL PROVISIONS.
10.1. AMENDMENTS. This Agreement may be amended, modified or supplemented
only by a written instrument executed by all of the Parties to this Agreement.
10.2. SEVERABILITY. If any provision of this Agreement is found invalid or
unenforceable by a court of competent jurisdiction, the invalid or unenforceable
provision shall either be modified to make it legal and enforceable while
retaining as far as possible the original intent of the provision or, if that is
not possible, it shall be stricken. In either case, the remainder of the
Agreement shall continue in full force and effect.
10.3. RELATIONSHIP OF THE PARTIES. This Agreement shall not constitute any
Releasing Party as the agent or legal representative of any Released Party for
any purpose whatsoever, and vice versa, and no Releasing Party shall hold itself
out as an agent of any Released Party, and vice versa. Except as provided in
Section 3.1, this Agreement creates no relationship of joint venturers,
partners, associates, employment or principal and agent between or among any
Parties, and all Parties are acting as independent contractors. Except as
provided in Section 3.1, neither any Releasing Party nor any Released Party is
granted herein any right or authority to, and no Party shall attempt to assume
or create any obligation or responsibility for or on behalf of any other Party.
Neither any Releasing Party nor any Released Party shall have any authority to
bind any other Party to any contract, whether of employment or otherwise.
10.4. NO ELECTION OF REMEDIES. Except as otherwise specifically provided
herein, the rights and remedies accorded herein to Releasing Parties and Atrix
and Sanofi are cumulative and in addition to those provided by law, and may be
exercised separately, concurrently, or successively.
-9-
10.5. NOTICES. Any notice, request, demand or other communication required
or permitted hereunder shall be in writing, shall reference this Agreement and
shall be: (a) delivered personally; (b) sent by facsimile, with written
confirmation of receipt; (c) sent by registered or certified mail, return
receipt requested, postage prepaid; or (d) sent by a private industry express
courier, with written confirmation of receipt. No notice shall be effective
until actually received. In each case notices shall be addressed to the intended
recipient as set forth below:
(a) if to Releasing Parties, to:
TAP Pharmaceutical Products Inc.
▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: Vice President and Chief Legal Counsel
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
And with a required copy to:
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ & ▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, ▇▇.
Telephone No: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Takeda Pharmaceutical Company Limited
▇-▇ ▇▇▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇, ▇▇▇▇-▇▇
▇▇▇▇▇, ▇▇▇▇▇, 540-8645
Attention: General Manager, Legal Department
With a required copy to:
▇▇▇▇▇ & ▇▇▇▇▇▇▇
▇▇▇▇ ▇ ▇▇▇▇▇▇, ▇▇
▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇.▇. ▇▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Telephone No.: ▇▇▇.▇▇▇.▇▇▇▇
Facsimile No.: 202.672.5399
Wako Pure Chemical Industries, Ltd.
▇-▇ ▇▇▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇, ▇▇▇▇-▇▇
▇▇▇▇▇, ▇▇▇▇▇, 540-8605
Attention: General Manager, Legal Department
-10-
With a required copy to:
▇▇▇▇▇ & ▇▇▇▇▇▇▇
▇▇▇▇ ▇ ▇▇▇▇▇▇, ▇▇
▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇.▇. ▇▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Telephone No.: ▇▇▇.▇▇▇.▇▇▇▇
Facsimile No.: 202.672.5399
▇▇▇▇▇▇ Laboratories Ltd.
▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇. ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇ ▇▇▇ ▇▇▇
Attention: President
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
(b) if to Atrix, to:
QLT USA, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: President
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
With a required copy to:
▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇ LLP
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, Esq.
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
(c) if to Sanofi:
sanofi-aventis
▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇ ▇▇▇▇▇▇▇▇
Vice President and General Counsel
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
-11-
with a required copy to:
Proskauer Rose LLP
▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇ ▇. ▇▇▇▇▇, Esq.
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
or at such other address for a Party as shall be specified by
like notice.
10.6. GOVERNING LAW AND VENUE. This Agreement shall be governed by and
construed in accordance with the internal laws of the State of New York without
giving effect to any choice or conflict of law provision or rule (whether of the
State of New York or any other jurisdiction) that would result in the
application of laws of any jurisdiction other than those of the State of New
York. All claims or disputes arising under or with respect to this Agreement, or
with respect to the interpretation, performance, enforcement, or breach of this
Agreement, shall be resolved exclusively in the courts of the State of New York,
the courts of the United States in the Southern District of New York, and
appellate courts from any thereof and the Parties agree that the exclusive
jurisdiction and venue for resolving such claims and disputes shall reside in
such courts. Each Party consents that any such action or proceeding may be
brought in, and hereby submits to the jurisdiction of, such courts and waives
any objection or defense (including, without limitation any defense of
inconvenient forum or absence of jurisdiction) that it may now or hereafter have
to the venue of any such action or proceeding in any such court.
10.7. COUNTERPARTS AND FACSIMILE SIGNATURES. This Agreement may be executed
and delivered in any number of counterparts. When each Party has signed and
delivered at least one counterpart to all other Parties, all counterparts, taken
together, shall constitute one and the same agreement, which shall be binding
and effective on the Parties to this Agreement. Each counterpart shall be deemed
an original. Facsimile execution and delivery of this Agreement and any Exhibits
by any of the Parties shall be legal, valid and binding execution and delivery
of such document for all purposes.
10.8. ASSIGNMENT. Without the consent of Atrix or Sanofi, Releasing Parties
may assign this Agreement to an Affiliate or in connection with any merger,
acquisition, reorganization, sale or transfer of substantially all of the assets
to which this Agreement relates. Notwithstanding the foregoing, any assignment
of this Agreement shall not relieve the Releasing Parties from the performance
of their obligations under this Agreement and for the avoidance of doubt, any
Subject Product Patent Rights that are assigned shall remain subject to the
applicable terms of this Agreement. Without the consent of Releasing Parties,
Atrix or Sanofi may assign this Agreement to an Affiliate or in connection with
any merger, acquisition, reorganization, sale or transfer of substantially all
of the assets to which this Agreement relates. Notwithstanding the foregoing,
any assignment of this Agreement shall not relieve Atrix or Sanofi from the
performance of their obligations under this Agreement. Subject to the foregoing,
this Agreement will be binding upon, inure to the benefit of and be enforceable
by the Parties and their respective successors and permitted assigns.
-12-
10.9. INTERPRETATION. The recitals to this Agreement constitute an integral
part of this Agreement. The headings contained in this Agreement are for
convenience of reference only and shall not affect in any way the meaning or
interpretation of this Agreement. Because all Parties have participated in
drafting, reviewing, and editing the language of this Agreement, no presumption
for or against any Party arising out of drafting all or any part of this
contract shall be applied in any action whatsoever. Whenever the context may
require, any pronouns used in this Agreement shall include the corresponding
masculine, feminine or neuter forms, and the singular form of nouns and pronouns
shall include the plural, and vice versa.
10.10. LICENSE REGISTRATION AND RECORDAL. Atrix and Sanofi shall have the
right, at their sole cost and expense, to register, record and otherwise
document the license granted under this Agreement in any country in the
Territory. Licensors agree to take, at Atrix's or Sanofi's sole cost and
expense, all steps reasonably requested by Atrix or Sanofi, respectively,
including but not limited to executing a "short form" license, to effect the
foregoing registration, recordal or other documentation in any such country in
the Territory, and may record such short form license, but no short form license
shall in any way alter or otherwise affect the rights and obligations of the
Parties hereunder.
10.11. COSTS. Each Party shall bear its own costs and expenses incurred in
connection with the Litigation and the negotiation and preparation of this
Agreement.
10.12. WAIVER OF JURY TRIAL. The Parties each hereby irrevocably and
unconditionally waives all rights to trial by jury in any legal action,
proceeding or counterclaim with respect to any matter whatsoever arising out of
or in connection with or related to this Agreement or the enforcement thereof.
IN WITNESS WHEREOF, the Parties have executed, or caused their duly
authorized representatives to execute, this Agreement under seal as of the date
first written above.
TAKEDA PHARMACEUTICAL COMPANY LIMITED
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
----------------------------------
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, Ph. D.
Title: Managing Director, Member of
the Board
WAKO PURE CHEMICAL INDUSTRIES, LTD.
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
----------------------------------
Title: Director, Member of the Board
General Manager, Licensing and
I.P. Dept.
-13-
TAP PHARMACEUTICAL PRODUCTS INC.
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
----------------------------------
▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Title: President
▇▇▇▇▇▇ LABORATORIES, LIMITED -
LABORATORIES ABBOTT, LIMITEE
By: /s/ [ILLEGIBLE]
----------------------------------
Title: President, General Manager
QLT USA, INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
----------------------------------
▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, President
SANOFI-SYNTHELABO INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
----------------------------------
▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Title: Vice President & General Counsel
-14-
EXHIBIT A
FORM OF JOINT MOTION TO DISMISS
EXHIBIT B
FORM OF STIPULATED ORDER OF DISMISSAL AND OTHER FILING
EXHIBIT C
Form of Press Releases
