SETTLEMENT AGREEMENT
Exhibit
10.1
[*]
= Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
This
Settlement Agreement is made and entered into this 10th day of July, 2009,
by and between, on the one hand, Forest and Lundbeck, and on the other hand,
Caraco and Sun.
RECITALS
WHEREAS
Forest sells LEXAPRO® brand
escitalopram oxalate products in the Territory under New Drug Application 21-323
and those products are covered by multiple claims of the '712 Patent, the '941
Patent, and the '069 Patent;
WHEREAS
the '712 Patent, the '941 Patent, and the '069 Patent are owned by Lundbeck and
licensed exclusively to Forest in the Territory;
WHEREAS
Caraco has sought approval from the FDA to market proposed generic escitalopram
oxalate products in the Territory under ANDA 78-219;
WHEREAS
Forest and Lundbeck have maintained an action against Caraco and Sun for
infringement of the '712 Patent in connection with the proposed generic
escitalopram oxalate products defined by the Caraco ANDA in the United States
District Court for the Eastern District of Michigan, which action is captioned
Forest Laboratories, Inc. et
al. x. Xxxxxx Pharmaceutical Laboratories, Ltd. et al., Civil Action No.
06-13143 (E.D. Mich.);
WHEREAS
the '712 Patent was previously litigated in Forest Laboratories, Inc. et al. v.
Ivax Pharmaceuticals, Inc. et al., 438 F. Supp. 2d 479 (D. Del. 2006),
and Forest Laboratories, Inc.
et al. v. Ivax Pharmaceuticals, Inc. et al., 501 F.3d 1263 (Fed. Cir.
2007);
WHEREAS
Caraco and Sun stipulated that the Generic Products defined by the Caraco ANDA
infringe claims 1, 3, 5, 7, and 9 of the '712 Patent in the '712 Patent
Action, but contested the validity of those claims;
WHEREAS
Caraco has maintained two actions against Forest and Lundbeck seeking
declaratory judgments of non-infringement of the '941 Patent and the '069 Patent
in the Court, which actions are captioned Caraco Pharmaceutical Laboratories,
Ltd. v. Forest Laboratories, Inc. et al., Civil Action No. 07-10737 (E.D.
Mich.), and Caraco
Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. et al.,
Civil Action No. 09-10274 (E.D. Mich.), each regarding the Caraco ANDA and the
proposed generic escitalopram oxalate products that are the subject of that
ANDA;
WHEREAS,
subject to the terms and conditions herein, Forest and Lundbeck have agreed to
xxxxx Xxxxxx and Sun a non-exclusive license to make, have made, use, offer to
sell, sell or import the generic escitalopram oxalate products that are the
subject of the Caraco ANDA in the Territory as of the date, and upon the terms,
set forth in this Agreement; and
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WHEREAS
the Parties are willing to settle the Actions on the terms set forth
herein.
NOW
THEREFORE, in consideration of the promises and mutual covenants set forth
herein, the sufficiency of which are hereby acknowledged, the Parties hereby
agree as follows:
1. Definitions.
1.1. "'069
Patent" means U.S. Patent No. 7,420,069.
1.2. "'069
Patent Action" means the case captioned Caraco Pharmaceutical Laboratories,
Ltd. v. Forest Laboratories, Inc. et al., Civil Action No. 09-10274 (E.D.
Mich.).
1.3. "'712
Patent" means U.S. Patent No. Re.34,712.
1.4. "'712
Patent Action" means the case captioned Forest Laboratories, Inc. et al. x.
Xxxxxx Pharmaceutical Laboratories, Ltd. et al., Civil Action No.
06-13143 (E.D. Mich.).
1.5. "'941
Patent" means U.S. Patent No. 6,916,941.
1.6. "'941
Patent Action" means the case captioned Caraco Pharmaceutical Laboratories,
Ltd. v. Forest Laboratories, Inc. et al., Civil Action No. 07-10737 (E.D.
Mich.).
1.7. "Actions"
means the '712 Patent Action, the '941 Patent Action and the '069 Patent Action,
collectively.
1.8. "Affiliate"
means any person or legal entity controlling, controlled by or under common
control with the Party with respect to which such status is at issue and shall
include, without limitation, any corporation 50% or more of the voting power of
which (or other comparable ownership interest for an entity other than a
corporation) is owned, directly or indirectly, by a Party hereto or any
corporation, person or entity that owns 50% or more of such voting power of a
Party hereto.
1.9. "Agencies"
means the DOJ and the FTC, collectively.
1.10. "Agreement"
means this Settlement Agreement (including Exhibits A through F).
1.11. "Alphapharm"
means Alphapharm Pty Ltd. and its successors in interest and
Affiliates.
1.12. "ANDA"
means Abbreviated New Drug Application.
1.13. "Authorized
Generic" means Alphapharm, as defined above.
1.14. "Caraco"
means Caraco Pharmaceutical Laboratories, Ltd.
1.15. "Caraco
ANDA" means ANDA 78-219, as supplemented and amended as of the Effective Date,
as defined below, and further including any Permitted Modification, as defined
below, after the Effective Date.
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1.16. "Control"
or "Controlled" means, with respect to any Licensed Patent, the ownership of
such Licensed Patent by a Party or the possession by a Party of rights
sufficient to grant licenses or sublicenses to such Licensed
Patent.
1.17. "Court"
means the United States District Court for the Eastern District of
Michigan.
1.18. "DOJ"
means the Antitrust Division of the Department of Justice.
1.19. "Effective
Date" means the date on which this document is fully executed, which is July 10,
2009.
1.20. "FDA"
means United States Food and Drug Administration.
1.21. "Forest"
means Forest Laboratories, Inc. and Forest Laboratories Holdings, Ltd.,
collectively.
1.22. "Forest
Product" means the escitalopram oxalate products manufactured or sold for use in
the Territory under NDA 21-323 as of the Effective Date under the trademark
LEXAPRO® (or
any replacement trademark).
1.23. "FTC"
means the Federal Trade Commission of the United States.
1.24. "Generic
Product" means the products described by the Caraco ANDA, as defined
above.
1.25. "Ivax"
means Ivax Pharmaceuticals and its successors in interest and
Affiliates.
1.26. "Launch
Date" means the date that any third party generic enters the market in the
Territory with a generic equivalent of the Forest Product that has received
final approval from the FDA, other than an authorized generic or first-filer
with Hatch Waxman related exclusivity. If and only if: [*] the License,
as defined below, shall be of no effect from the date [*] until [*].
1.27. "License"
means the license granted by Section 5.1.
1.28. "Licensed
Patents" means patents Controlled by Forest or Lundbeck, either now or in the
future, that, but for the License, would be infringed if Caraco and Sun make,
have made, use, sell, offer for sale, or import the Generic Product in or for
the Territory after the Launch Date. Any assignment or transfer of
any Licensed Patents by Forest or Lundbeck shall be subject to the
License. Licensed Patents includes, but is not limited to the '712
Patent, the '941 Patent and the '069 Patent.
1.29. "Lundbeck"
means X. Xxxxxxxx A/S.
1.30. "Parties"
means Forest, Lundbeck, Caraco and Sun.
1.31. "Party"
means any one of the Parties, as indicated.
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1.32. "Permitted
Modification" means any modification to ANDA 78-219 as supplemented and amended
as of the Effective Date, as defined above, that does not change the active
ingredient (i.e., use
an additional or different active ingredient), dosage form, indication(s),
reference listed drug or bioequivalence rating of the generic products defined
by said ANDA as of the Effective Date.
1.33. "Stipulations
and Orders" means the documents attached hereto as Exhibits A, B and C,
collectively.
1.34. "Sun"
means Sun Pharmaceutical Industries Ltd.
1.35. "Territory"
means the United States and all of its territories and possessions, including
Puerto Rico. For purposes of this Agreement, Territory also includes
the manufacture of some or all of the components or ingredients of the Licensed
Product outside the U.S. solely for purposes of importation into the U.S. for
use in the U.S. and its territories and possessions.
2. Stipulations
And Orders. In consideration
of the mutual benefits of entering into this Agreement, the Parties shall enter
into and cause to be filed with the Court, subject to Section 6
below:
(a) In the
'712 Patent Action, a stipulation and order dismissing, without prejudice, all
claims, defenses and counterclaims, substantially in the form annexed hereto as
Exhibit A. If the Court does not grant the Order substantially in the
form annexed hereto as Exhibit A, the Parties agree to confer in good faith and
revise that document consistent with its purpose and the requirements of the
Court.
(b) In the
'941 Patent Action, a stipulation and order dismissing, without prejudice, all
claims and defenses, substantially in the form annexed hereto as Exhibit
B. If the Court does not grant the Order substantially in the form
annexed hereto as Exhibit B, the Parties agree to confer in good faith and
revise that document consistent with its purpose and the requirements of the
Court.
(c) In the
'069 Patent Action, a stipulation and order dismissing, without prejudice, all
claims, defenses and counterclaims, substantially in the form annexed hereto as
Exhibit C. If the Court does not grant the Order substantially in the
form annexed hereto as Exhibit C, the Parties agree to confer in good faith and
revise that document consistent with its purpose and the requirements of the
court.
3. Other
Agreements.
Contemporaneously with the execution of this Agreement, Forest and Caraco
shall enter into the agreement attached hereto as Exhibit D (the "Inwood
Agreement"), and Lundbeck and Sun shall enter into the agreement attached hereto
as Exhibit E (the "Patent Assignment Agreement"). The Inwood
Agreement shall govern the terms and conditions related to the transfer of
Forest's Inwood products to Caraco. The Patent Assignment Agreement
shall govern the terms and conditions related to the assignment to Lundbeck of
certain patent applications owned by Sun related to
escitalopram.
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4. Legal
Fees. Within ten (10)
days after the Effective Date, in partial consideration of Forest and Lundbeck's
saved legal fees associated with the Actions and Caraco's expended legal fees
associated with the Actions, Forest and Lundbeck shall reimburse [*] of Caraco's attorneys'
fees and costs up to a maximum total reimbursement of [*]. Caraco hereby
represents and warrants that its attorneys' fees to date have been in excess of
[*]. Thus,
[*] of legal fees shall
be paid from Forest and Lundbeck to Caraco. This payment shall be
non-refundable. Except for the foregoing, each Party will pay its own
legal fees and other costs incurred in the preparation, conduct and settlement
of the Actions.
5. License to Distribute
Generic Product.
5.1 Commercial
License. Subject to the terms, conditions, and limitations
hereof, Forest and Lundbeck hereby license and sublicense, as the case may be,
on a fully paid-up basis, the Licensed Patents to Caraco and Sun solely for them
to make, have made, use, sell, offer for sale, or import the Generic Product in
or for the Territory as of the Launch Date. The foregoing license
shall be non-exclusive. Except to the extent of the assignment
permitted under Section 11, neither Caraco nor Sun shall have the right to
sublicense or assign any of its rights under the License, except for a
sublicense to their respective Affiliates.
5.2 Foreign Patents and
Proceedings. The Parties acknowledge and agree that this
Agreement, and the fact that the Parties have entered into this Agreement and
consummated the transactions contemplated hereby, shall not have any effect
outside the Territory on the assertion of any foreign patents or patent
applications against any foreign counterparts to any Generic
Product. The Parties hereby agree that neither this Agreement nor
those facts may be proffered, or be referred to in any testimonial or other
evidence, by any Party or any of their respective Affiliates at any trial,
action or other proceedings outside the Territory regarding the assertion of any
foreign patents or patent applications against any foreign counterparts to any
Generic Product. Nothing herein shall be construed as an admission or
waiver as to any factual or legal matter by any Party or their respective
Affiliates with respect to any jurisdiction outside of the
Territory.
5.3 Regulatory
Matters.
(a) Forest
and Lundbeck (for themselves and their Affiliates) hereby grant to Caraco and
Sun and their Affiliates a fully paid-up license or waiver (as applicable) under
any regulatory exclusivities that would apply to the Generic Product from and
after the Launch Date (including any applicable pediatric
exclusivities). Such license or waiver shall be of the same scope and
duration as the License contained in Section 5.1.
(b) Forest
and Lundbeck shall execute such further documents or notices as Caraco may
reasonably request to further confirm the grant of the License contained in
Section 5.1 and/or the license or waiver contained in Section
5.3(a).
(c) Subject
to Caraco and Sun's compliance with the terms of this Agreement, Forest and
Lundbeck shall not initiate any activity directly or indirectly (such as by way
of Citizen's Petition) against Caraco or Sun related to the Generic Product to
interfere with Caraco's efforts to: (i) obtain FDA approval of the
Caraco ANDA; or (ii) launch the Generic Product from and after the Launch
Date. Nothing set forth in this Agreement shall be construed as a
representation by Forest or Lundbeck that the FDA or any other applicable
regulatory authority will or should approve of Caraco marketing a product
incorporating escitalopram oxalate in the Territory.
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(d) The
Generic Product shall be manufactured by or on behalf of Sun or Caraco in
substantial accordance with current Good Manufacturing Practices ("GMPs")
regulations promulgated by the FDA, as further defined by FDA guidance
documents.
(e) Forest
and Lundbeck shall take reasonable steps, including cooperating with any
necessary FDA submissions, to help ensure Caraco's market entry in the Territory
with the Generic Product on the Launch Date.
(f) Forest
and Lundbeck agree that, regardless of whether they continue to sell the Forest
Product, they will not request that the FDA rescind its approval of all of the
existing indications (as of the Effective Date) for the Forest Product unless
required by law to do so.
5.4 Covenants.
(a) Except
to the extent of the License, neither Caraco, Sun nor any of their respective
Affiliates shall under any circumstances: (a) offer to sell or sell
in the Territory any Generic Product prior to the Launch Date; or (b) knowingly
and voluntarily aid, abet, enable or contract with any third party regarding the
marketing in the Territory of any Generic Product prior to the Launch
Date.
(b) Neither
Forest, Lundbeck nor any of their respective Affiliates shall under any
circumstances enter into an agreement with Ivax to delay the lawful market entry
of a generic equivalent of the Forest Product. Nothing in this
Agreement, however, shall prevent Lundbeck, Forest or any of their respective
Affiliates from enforcing any of their patent rights against Ivax or entering
into any settlement agreements (which may have provisions related to Ivax's
generic entry), as necessary, to resolve disputes associated with such
enforcement.
(c) Forest
and Lundbeck covenant not to xxx Xxxxxx and/or Sun for their use of the Licensed
Patents after the Launch Date in connection with the Generic
Product. Caraco and Sun covenant not to challenge any of the Licensed
Patents in connection with the Generic Product.
6. Legal
Compliance. The Parties shall
submit this Agreement to the appropriate personnel at the Agencies for review
under Section 1112 of the Medicare Prescription Drug Improvement and
Modernization Act of 2003, as soon as practicable after the Effective Date and
in no event later than three (3) days after the Effective Date.
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(a) If,
within forty (40) days of receipt of this Agreement by the Agencies, any Agency
objects to, responds to, or otherwise comments on such submission, the Parties
shall use commercially reasonable efforts to address or resolve such objection,
response or comment provided that there
shall be no material change to the rights and obligations of the Parties under
this Agreement, except as the Parties may mutually agree. These
efforts to address or resolve any such objection, response or comment shall
continue for a period of not more than thirty (30) days from when the objection,
response or comment is first raised, unless the Parties mutually agree to extend
that period. During that thirty (30) day period or agreed extension,
all obligations under this Agreement (except for the payment of legal fees under
Section 4 above), the Inwood Agreement, and the Patent Assignment Agreement
shall be temporarily suspended while the Parties engage in commercially
reasonable and good-faith efforts to address or resolve any such objection,
response or comment. If, despite such commercially reasonable
efforts, the Parties are unable to address or resolve any such objection,
response or comment during that thirty (30) day period or agreed extension, the
Parties shall promptly return to the Court and jointly seek the earliest
possible trial date for which lead counsel is available (but starting no later
than thirty (30) days from the date of the request, regardless of the trial
schedules of lead counsel, if the Court's schedule allows; if the Court's
schedule does not allow for a trial within thirty (30) days, then as quickly
thereafter as the Court is available, regardless of the trial schedules of lead
counsel). In that event, except for the legal fees paid pursuant to
Section 4 above, the Parties shall take all commercially reasonable steps to
return the Parties to the position they were in before signing this Agreement,
including without limitation the return by Sun of any payment by Lundbeck under
the Patent Assignment Agreement. Upon accomplishing this return, this
Agreement shall terminate.
(b) If
there is no objection from any Agency within forty (40) days of receipt of this
Agreement, or if an objection is received and the Parties address or resolve the
objection, all obligations in this Agreement shall be in
force. Within three (3) days of that date, or within three (3) days
of the closing of the transaction referenced in the Inwood Agreement, whichever
is later, the Parties shall file the Stipulations and Orders described in
Section 2 above.
(c) If,
after forty (40) days of receipt of this Agreement by the Agencies, any Agency
objects to, responds to, or otherwise comments on such submission, the Parties
shall use commercially reasonable efforts to address or resolve such objection,
response or comment, provided that there
shall be no material change to the rights and obligations of the Parties under
this Agreement, except as the Parties may mutually agree. If, despite
such commercially reasonable efforts, the Parties are unable to address or
resolve any such objection, response or comment, the Parties may mutually agree
to return the Parties to the position they were in before the signing of this
Agreement (except for the payment of legal fees under Section 4
above). If such a return is accomplished, this Agreement shall
terminate. If such mutual agreement to return is reached, any Party
shall have the right to reinitiate the '712 Action, the '941 Action, and/or the
'069 Action, and the Parties shall promptly return to Court in any such
reinitiated action and jointly seek the earliest possible scheduling conference
for each such action.
For
purposes of this Agreement, "commercially reasonable efforts" shall mean the
reasonable, diligent and good-faith efforts as such Party would normally use to
accomplish a similar objective under similar circumstances.
7. Released
Claims. In addition to
the dismissal of the Actions, as set forth in the Stipulations And Orders,
Forest and Lundbeck, and Caraco and Sun, make the following releases, which
shall be effective upon the grant of the last of the Stipulations And Orders by
the Court in the Actions:
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(a) Caraco
and Sun for themselves and their respective Affiliates hereby irrevocably
release and discharge Forest and Lundbeck and their respective Affiliates,
successors, assigns, directors, officers, employees, agents and customers from
all causes of action, demands, claims, damages and liabilities of any nature,
whether known or unknown, arising between Caraco, Sun and/or any of their
respective Affiliates, on the one hand, and Forest, Lundbeck and/or any of their
respective Affiliates, on the other hand, from or in connection with the Actions
or the Caraco ANDA, occurring prior to the Effective Date of this Agreement,
including, without limitation, all claims that Caraco and Sun have asserted or
could have asserted in the Actions or in any judicial proceeding that the '712
Patent, the '941 Patent and/or the '069 Patent are somehow invalid,
unenforceable or not infringed by the sale of the generic escitalopram oxalate
products that are the subject of the Caraco ANDA in the Territory (all of the
above collectively, the "Caraco Released Claims");
(b) Forest
and Lundbeck for themselves and their respective Affiliates hereby irrevocably
release and discharge Caraco and Sun and their respective Affiliates,
successors, assigns, directors, officers, employees, agents, distributors,
suppliers and customers from all causes of action, demands, claims, damages and
liabilities of any nature, whether known or unknown, arising between Forest,
Lundbeck and/or any of their respective Affiliates, on the one hand, and Caraco,
Sun and/or any of their respective Affiliates, on the other hand, from or in
connection with the Actions or the Caraco ANDA, occurring prior to the Effective
Date of this Agreement, including, without limitation, all claims that Forest
and Lundbeck have asserted or could have asserted in the Actions or in any
judicial proceeding that the '712 Patent, the '941 Patent and/or the '069 Patent
are infringed by the sale of the generic escitalopram oxalate products that are
the subject of the Caraco ANDA in the Territory (all of the above collectively,
the "Forest Released Claims");
(c) this
Agreement shall constitute a final settlement of the Actions by the Parties,
subject to the possibility the Actions are reinstituted under Section
6;
(d) Caraco
and Sun shall not release, to the extent there is a release provision or
control, any agent or consultant retained by Caraco and Sun (whether retained
for Caraco and Sun's benefit by Caraco and Sun or by any Caraco and Sun
attorney) to assist or cooperate with any litigant in any litigation against
Forest and Lundbeck with respect to the '712 Patent, the '941 Patent and/or the
'069 Patent regarding any Forest Product. Similarly, in any such
action Caraco and Sun shall not release any attorney who represented Caraco and
Sun in the Actions from maintaining the confidentiality of non-public
information to which such attorney had access in connection with the Actions or
grant any waivers with respect to such maintenance unless so ordered by the
Court or compelled by law. Nothing in this Agreement shall prohibit
Sun and Caraco from using agents, consultants or attorneys in any way should the
Actions be reinstituted under Section 6 or for attorneys to represent other
clients regarding the same patents;
(e) to
the extent necessary, Caraco and Sun shall permit and cooperate with Forest and
Lundbeck to enforce the obligations of such agents, consultants or attorneys
referred to under Section 7(d) herein; and
(f) nothing
in this Agreement shall prohibit any Party from challenging or enforcing any
patent (including any of the Licensed Patents) in connection with a product
other than the Generic Product.
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8. ACKNOWLEDGMENTS. Caraco and Sun,
and Forest and Lundbeck, acknowledge as follows:
(a) CARACO
AND SUN ACKNOWLEDGE THAT THEY MAY HEREAFTER DISCOVER CLAIMS OR FACTS IN ADDITION
TO OR DIFFERENT FROM THOSE WHICH THEY NOW KNOW OR BELIEVE TO EXIST WITH RESPECT
TO THE CARACO RELEASED CLAIMS, THE FACTS AND CIRCUMSTANCES ALLEGED IN THE
ACTIONS, AND/OR THE SUBJECT MATTER OF THIS AGREEMENT, WHICH, IF KNOWN OR
SUSPECTED AT THE TIME OF EXECUTING THIS AGREEMENT, MAY HAVE MATERIALLY AFFECTED
THIS AGREEMENT. NEVERTHELESS, UPON THE EFFECTIVENESS OF THE RELEASE
OF THE CARACO RELEASED CLAIMS AS SET FORTH IN SECTION 7 ABOVE, CARACO AND SUN
HEREBY ACKNOWLEDGE THAT THE CARACO RELEASED CLAIMS INCLUDE WAIVERS OF ANY
RIGHTS, CLAIMS OR CAUSES OF ACTION THAT MIGHT ARISE AS A RESULT OF SUCH
DIFFERENT OR ADDITIONAL CLAIMS OR FACTS. CARACO AND SUN ACKNOWLEDGE
THAT THEY UNDERSTAND THE SIGNIFICANCE AND POTENTIAL CONSEQUENCES OF SUCH A
RELEASE OF UNKNOWN UNITED STATES JURISDICTION CLAIMS AND OF SUCH A SPECIFIC
WAIVER OF RIGHTS. CARACO AND SUN INTEND THAT THE CLAIMS RELEASED BY
THEM UNDER THIS RELEASE BE CONSTRUED AS BROADLY AS POSSIBLE TO THE EXTENT THEY
RELATE TO UNITED STATES JURISDICTION CLAIMS. CARACO AND SUN ARE AWARE
OF CALIFORNIA CIVIL CODE SECTION 1542, WHICH PROVIDES AS FOLLOWS:
"A
general release does not extend to claims which the creditor does not know or
suspect to exist in his or her favor at the time of executing the release, which
if known by him or her, must have materially affected his or her settlement with
the debtor."
CARACO
AND SUN AGREE TO EXPRESSLY WAIVE ANY RIGHTS THEY MAY HAVE UNDER THIS CODE
SECTION OR UNDER FEDERAL, STATE OR COMMON LAW STATUTES OR JUDICIAL DECISIONS OF
A SIMILAR NATURE, AND KNOWINGLY AND VOLUNTARILY WAIVE SUCH UNKNOWN CARACO
RELEASED CLAIMS.
(b) FOREST
AND LUNDBECK ACKNOWLEDGE THAT THEY MAY HEREAFTER DISCOVER CLAIMS OR FACTS IN
ADDITION TO OR DIFFERENT FROM THOSE WHICH THEY NOW KNOW OR BELIEVE TO EXIST WITH
RESPECT TO THE FOREST RELEASED CLAIMS, THE FACTS AND CIRCUMSTANCES ALLEGED IN
THE ACTIONS, AND/OR THE SUBJECT MATTER OF THIS AGREEMENT, WHICH, IF KNOWN OR
SUSPECTED AT THE TIME OF EXECUTING THIS AGREEMENT, MAY HAVE MATERIALLY AFFECTED
THIS AGREEMENT. NEVERTHELESS, UPON THE EFFECTIVENESS OF THE RELEASE
OF THE FOREST RELEASED CLAIMS AS SET FORTH IN SECTION 7 ABOVE, FOREST AND
LUNDBECK HEREBY ACKNOWLEDGE THAT THE FOREST RELEASED CLAIMS INCLUDE WAIVERS OF
ANY RIGHTS, CLAIMS OR CAUSES OF ACTION THAT MIGHT ARISE AS A RESULT OF SUCH
DIFFERENT OR ADDITIONAL CLAIMS OR FACTS. FOREST AND LUNDBECK
ACKNOWLEDGE THAT THEY UNDERSTAND THE SIGNIFICANCE AND POTENTIAL CONSEQUENCES OF
SUCH A RELEASE OF UNKNOWN UNITED STATES JURISDICTION CLAIMS AND OF SUCH A
SPECIFIC WAIVER OF RIGHTS. FOREST AND LUNDBECK INTEND THAT THE CLAIMS
RELEASED BY THEM UNDER THIS RELEASE BE CONSTRUED AS BROADLY AS POSSIBLE TO THE
EXTENT THEY RELATE TO UNITED STATES JURISDICTION CLAIMS. FOREST AND
LUNDBECK ARE AWARE OF CALIFORNIA CIVIL CODE SECTION 1542, WHICH PROVIDES AS
FOLLOWS:
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"A
general release does not extend to claims which the creditor does not know or
suspect to exist in his or her favor at the time of executing the release, which
if known by him or her, must have materially affected his or her settlement with
the debtor."
FOREST
AND LUNDBECK AGREE TO EXPRESSLY WAIVE ANY RIGHTS THEY MAY HAVE UNDER THIS CODE
SECTION OR UNDER FEDERAL, STATE OR COMMON LAW STATUTES OR JUDICIAL DECISIONS OF
A SIMILAR NATURE, AND KNOWINGLY AND VOLUNTARILY WAIVE SUCH UNKNOWN FOREST
RELEASED CLAIMS.
9. Confidentiality. The terms of this
Agreement shall be maintained in confidence by all of the Parties except
that: (i) the press release to be issued by Forest in connection with
the Agreement is set forth on Part A of Exhibit F, the press release to be
issued by Lundbeck in connection with this Agreement is set forth on Part B of
Exhibit F, the press release to be issued by Caraco in connection with this
Agreement is set forth on Part C of Exhibit F, and the press release to be
issued by Sun in connection with this Agreement is set forth on Part D of
Exhibit F; (ii) Forest and Lundbeck may disclose such terms as may be necessary
or useful in connection with any anticipated, pending or actual patent
litigation or other legal proceeding with a third party in the Territory
relating to any of the Licensed Patents; and (iii) as otherwise required by law,
including without limitation United States Securities and Exchange Commission
reporting requirements, or by the rules or regulations of any stock exchange to
which any of the Parties are subject.
10. Term and
Termination. Unless terminated
earlier under Section 6, this Agreement shall continue from the Effective Date
until the expiration of the last to expire of the Licensed
Patents. The releases and discharges set forth in Section 7 of this
Agreement shall survive the expiration of this Agreement, but shall terminate in
connection with any earlier termination of this Agreement under Section
6. The confidentiality obligations set forth in Section 9 shall
survive and continue from the Effective Date until the expiration of the last to
expire of the Licensed Patents, notwithstanding any earlier expiration or
termination of this Agreement.
If any
Party believes that another Party has breached this Agreement, it shall specify
such breach in a written notice and the breaching Party shall have fourteen (14)
days to remedy any such breach prior to the initiation of arbitration or
litigation, except with respect to any sale or offer to sell the Generic Product
in the Territory prior to the Launch Date, which shall have no such notice or
cure period.
11. No
Assignment. This Agreement
may not be assigned or transferred to a third party without the express prior
written consent of the other Parties hereto, except to a successor to all or
substantially all of the business of the assigning or transferring Party to
which this Agreement pertains (whether by sale of stock, merger, consolidation
or otherwise), in which case the Party shall assign this Agreement to such
successor, provided that a Party may in the ordinary course of its business
assign its rights under this Agreement to an Affiliate or may transfer the
rights under this Agreement from one Affiliate to another without the prior
consent of the other Party. The covenants, rights and obligations of
a Party under this Agreement shall remain binding upon the assigning or
transferring Party and shall inure to the benefit of and be binding upon any
successor or permitted assignee of the Party.
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12. Notice. Any notice
required or permitted to be given or sent under this Agreement shall be hand
delivered or sent by express delivery service or certified or registered mail,
postage prepaid, to the Parties at the addresses indicated below.
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If
to Forest, to:
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Xxxxxxx
X. Xxxx
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|
|
Vice
President, Chief Intellectual Property Counsel
|
||
|
Forest
Research Institute, Inc.
|
||
|
000
Xxxxx Xxxxxx
|
||
|
Xxx
Xxxx, XX 00000
|
||
|
with
copies to:
|
Xxxxx
X. Xxxxxxx
|
|
|
Xxxxxxxx &
Xxxxx LLP
|
||
|
000
Xxxxxxxxx Xxxxxx
|
||
|
Xxx
Xxxx, Xxx Xxxx 00000
|
||
|
If
to Lundbeck, to:
|
Xxxx
Xxxxxxx Xxxxxxxx
|
|
|
Director,
Corporate Patents
|
||
|
X.
Xxxxxxxx A/S
|
||
|
Xxxxxxxxxx
0
|
||
|
XX-0000
Xxxxx
|
||
|
Xxxxxxxxxx,
Xxxxxxx
|
||
|
with
copies to:
|
Xxxxx
X. Xxxxxxx
|
|
|
Xxxxxxxx &
Xxxxx LLP
|
||
|
000
Xxxxxxxxx Xxxxxx
|
||
|
Xxx
Xxxx, Xxx Xxxx 00000
|
||
|
If
to Caraco, to:
|
Xxxxxx
Xxxxxx
|
|
|
Chief
Executive Officer
|
||
|
Caraco
Pharmaceutical Laboratories Ltd.
|
||
|
0000
Xxxxxx XxXxx Xxxxx
|
||
|
Xxxxxxx,
Xxxxxxxx 00000
|
||
|
with
copies to:
|
Xxxxx
X. Xxxxxx
|
|
|
Xxxxxxx &
Xxxxxx LLP
|
||
|
00
Xxxx Xxxxxx Xxxxx
|
||
|
Xxxxxxx,
Xxxxxxxx 00000
|
||
|
If
to Sun, to:
|
Xxxxxx
Xxxxx
|
|
|
General
Counsel
|
||
|
Sun
Pharmaceutical Industries Ltd.
|
||
|
Acme
Plaza
|
||
|
Andheri
- Kurla Rd, Andheri (E)
|
||
|
Mumbai
- 400 059
|
||
|
with
copies to:
|
Xxxxx
X. Xxxxxx
|
|
|
Xxxxxxx &
Xxxxxx LLP
|
||
|
00
Xxxx Xxxxxx Xxxxx
|
||
|
Xxxxxxx,
Xxxxxxxx 00000
|
11
Any such
notice shall be deemed to have been received on the date actually
received. Any Party may change its address by giving the other Party
written notice, delivered in accordance with this Section.
13. Entire
Agreement. This Agreement,
as defined herein to include Exhibits A through F, constitutes the complete,
final and exclusive agreement between the Parties with respect to the subject
matter hereof and supersedes and terminates any prior or contemporaneous
agreements and/or understandings between the Parties, whether oral or in
writing, relating to such subject matter. There are no covenants,
promises, agreements, warranties, representations, conditions or understandings,
either oral or written, between the Parties other than as are set forth in this
Agreement. No subsequent alteration, amendment, change, waiver or
addition to this Agreement shall be binding upon the Parties unless reduced to
writing and signed by an authorized officer of each Party. Each Party
in deciding to execute this Agreement has retained counsel and has not relied on
any understanding, agreement, representation or promise by the other Party that
is not explicitly set forth herein.
14. Governing
Law. This Agreement
shall be governed, interpreted and construed in accordance with the laws of the
State of Illinois, without giving effect to choice of law
principles. The Parties hereto agree that any disputes arising with
respect to the interpretation or enforcement of any provision hereof shall be
submitted to arbitration in Chicago, Illinois, or such other location as may be
mutually agreed by the Parties, in accordance with the then existing Commercial
Arbitration Rules of the American Arbitration Association. Such
arbitration shall be conducted before a panel of three arbitrators, one chosen
by Forest and Lundbeck, one chosen by Caraco and Sun, and the third chosen by
such other two arbitrators. The award or decision of a majority of
the arbitrators pursuant to this Section 14 shall be binding and conclusive on
the Parties, provided that the enforcement of such award or decision may be
obtained in any court having jurisdiction over the Party against whom such
enforcement is sought. The losing party shall pay all reasonable
attorneys fees and costs associated with such
arbitration. Notwithstanding the preceding, nothing set forth herein
shall be deemed to preclude either Party from seeking appropriate judicial
injunctive relief in any Court of competent jurisdiction with respect to the
provisions of Section 9 hereof or the enforcement of any other provision
hereunder the breach of which would cause irreparable harm to the other Party
and which would not have an adequate remedy at law. If there is any
dispute that is not subject to arbitration and for which the United States
District Court for the Northern District of Illinois does not have subject
matter jurisdiction, the state courts in Illinois shall have
jurisdiction. In connection with any dispute arising out of or in
connection with this Agreement that is not subject to arbitration, each Party
hereby expressly consents and submits to the personal jurisdiction of the
federal and state courts in the State of Illinois.
15. Severability. Subject to the
provisions and the mechanisms of Section 6 above, if any provision of this
Agreement is declared illegal, invalid or unenforceable by a court having
competent jurisdiction, it is mutually agreed that this Agreement shall endure
except for the part declared invalid or unenforceable by order of such court;
provided, however, that in the event that the terms and conditions of this
Agreement are materially altered, the Parties will, in good faith, renegotiate
the terms and conditions of this Agreement in an effort to reasonably replace
such invalid or unenforceable provisions in light of the intent of this
Agreement.
12
16. Waiver. Any delay or
failure in enforcing a Party's rights under this Agreement, or any acquiescence
as to a particular default or other matter, shall not constitute a waiver of
such Party's rights to the enforcement of such rights, nor operate to bar the
exercise or enforcement thereof at any time or times thereafter, except as to an
express written and signed waiver as to a particular matter for a particular
period of time.
17. Counterparts. This Agreement
shall become binding when any one or more counterparts hereof, individually or
taken together, bears the signatures of each of the Parties
hereto. This Agreement may be executed in any number of counterparts
(including facsimile or electronic counterparts), each of which shall be an
original as against a Party whose signature appears thereon, but all of which
taken together shall constitute one and the same instrument.
18. Representations
and Warranties.
The Parties hereby represent and warrant that: (a) they have
approved the execution of this Agreement and have authorized and directed the
signatory officers below to execute and deliver this Agreement; (b) they each
have the full right and power to enter into this Agreement, and there are no
other persons or entities whose consent or joinder in this Agreement is
necessary to make fully effective those provisions of this Agreement that
obligate, burden or bind either of them; (c) when so executed by each Party,
this Agreement shall constitute a valid and binding obligation of such Party,
enforceable in accordance with its terms; and (d) they have not transferred or
assigned or pledged to any third party, whether or not Affiliated, the right to
bring, pursue or settle any of the claims, counterclaims or demands made in the
Actions. Forest and Lundbeck further represent that they are not
aware of any pending claim by a third party of incorrect ownership, invalidity
or unenforceability asserted against the Licensed Patents. Sun and
Caraco further represent that they are not aware of any pending claim by a third
party of patent infringement asserted against the Generic Product.
19. Costs. Except as
otherwise stated in this Agreement, each Party shall bear its own costs,
expenses and taxes in the performance of this Agreement.
20. Construction. This Agreement has been
jointly negotiated and drafted by the Parties through their respective counsel
and no provision shall be construed or interpreted for or against any of the
Parties on the basis that such provision, or any other provision, or this
Agreement as a whole, was purportedly drafted by the particular
Party. All references to periods of days for taking certain actions
in this Agreement shall be construed in the same manner they are construed in
the Federal Rules of Civil Procedure.
* * * * *
13
IN WITNESS WHEREOF, this
Agreement has been executed by the duly authorized representatives of the
Parties.
|
FOREST
LABORATORIES, INC.
|
FOREST
LABORATORIES HOLDINGS,
LTD.
|
|
By: /s/ Xxxxxx
Xxxxxxx
Name: Xxxxxx
Xxxxxxx
Title: Chief
Executive Officer
|
By: /s/ Xxxxxx
Xxxxxxx
Name: Xxxxxx
Xxxxxxx
Title: Chief
Executive Officer
|
|
X.
XXXXXXXX A/S
|
|
|
By: /s/ Xxx
Xxxxxxxx
Name: Xxx
Xxxxxxxx
Title: Chief
Executive Officer
|
|
|
CARACO
PHARMACEUTICAL
LABORATORIES,
LTD.
|
SUN
PHARMACEUTICAL
INDUSTRIES
LTD.
|
|
By: /s/ Xxxxxx X.
Xxxxxx
Name: Xxxxxx
X. Xxxxxx
Title: Chief
Executive Officer
|
By: /s/ Xxxxx
Xxxxxxxx
Name: Xxxxx
Xxxxxxxx
Title: Chairman
and Managing Director
|
