EXHIBIT 10.4
EXECUTION COPY
RAMIPRIL PATENT LICENSE AGREEMENT
This RAMIPRIL PATENT LICENSE AGREEMENT ("Agreement") is entered into
as of the 12th day of February, 2006 (the "Effective Date") among Selamine
Limited, a corporation organized under the laws of Ireland with its principal
place of business at Xxxx 0/0, Xxxxxxxxxxxx Xxxxxxx, Xxxxxxxxxx, Xxxxxx 00,
Xxxxxxx ("Selamine"), Xxxxx Xxxx Holdings Limited, a corporation organized under
the laws of Malta with its principal place of business at 00 Xx. Xxxxxxxxxxx
Xxxxxx, Xxxxxxxx VLT 08, Malta ("Xxxxx Xxxx"), Xxxx Pharmaceuticals Research and
Development, Inc. a corporation organized under the laws of Delaware with its
principal place of business at 0000 XxxxxxXxxxx Xxx, Xxxxx 000, Xxxx, Xxxxx
Xxxxxxxx XXX ("King R&D"), and King Pharmaceuticals, Inc., a corporation
organized under the laws of Tennessee with its principal place of business at
000 Xxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxx 00000 XXX ("King"). Selamine and Xxxxx
Xxxx, on the one hand, and King R&D and King, on the other hand, are sometimes
referred to individually as a "Party" and collectively as the "Parties."
WHEREAS, King is considering developing various pharmaceutical
formulations with Ramipril as the sole active ingredient; and
WHEREAS, Selamine is the owner of certain patent applications relating
to [***]; and
WHEREAS, King wishes to obtain, and Selamine wishes to grant, an
exclusive license to use, Market, offer for sale, sell, import and distribute
[***] and a co-exclusive license to make [***] in the Territory under such
patent applications, all on the terms and conditions set forth herein.
NOW THEREFORE, in consideration of the rights and obligations set
forth in this Agreement, the Parties agree as follows:
1. DEFINITIONS
All defined terms have the meaning set forth in Appendix A hereto,
which is hereby incorporated by reference in its entirety.
2. GRANT OF LICENSE
2.1 Patent License. Subject to the terms and conditions of this Agreement,
Selamine and its Affiliates hereby xxxxx Xxxx and its Affiliates, during the
Term, an exclusive (even as to Selamine except as set forth in Section 2.3)
license or sublicense, as the case may be, with the right to sublicense, under
the Ramipril Patents, to use, offer for sale, Market, sell, import and
distribute [***] in the Territory. Any sublicensee of King and its Affiliates
hereunder must agree to be bound by the terms and conditions of this Agreement
as they apply to King and its Affiliates. Except to the extent otherwise set
forth in this Agreement, or in Section 4.2 of the Product Supply Agreement, this
license shall in no way be construed to xxxxx Xxxx and its Affiliates the right
to manufacture, make or have made [***] under the Ramipril Patents anywhere in
the world.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
2.2 Grant of Manufacturing Rights. Selamine and its Affiliates hereby grant
to King and its Affiliates, during the Term, an exclusive (except as to
Selamine) license or sublicense, as the case may be, with the right to
sublicense under the Ramipril Patents to make [***], provided that such [***]
may be sold only in the Territory, and provided further that such license shall
be subject to the terms and conditions of this Agreement and shall be
exercisable only (a) on the occurrence of any of the events identified in
Section 4.2 of the Product Supply Agreement or (b) in the event the Product
Supply Agreement is terminated by King for Selamine's or its Affiliate's
material breach.
2.3 Reservation of Rights. Selamine and its Affiliates maintains ownership
of the Ramipril Patents and nothing in this Agreement shall be construed as
granting King or any Affiliate thereof any assignment or, except for the rights
expressly granted herein, other rights in or to the Ramipril Patents, and any
and all implied licenses are hereby disclaimed. Notwithstanding anything in this
Agreement to the contrary, Selamine has retained rights under the Ramipril
Patents to the extent necessary to permit Selamine and its Affiliates to perform
their obligations to King and King's Affiliates as set forth in this Agreement,
the Product Supply Agreement, and any other agreement entered into between or
among Selamine or its Affiliates, on the one hand, and King or its Affiliates,
on the other hand, relating to [***].
2.4 Other Ramipril Products. Selamine and its Affiliates shall be precluded
from granting rights to a Third Party under the Ramipril Patents with respect to
any formulation that is used in a [***], including without limitation any such
formulation to be labeled for the treatment or prevention of diabetes. Selamine
shall further be precluded from granting rights to any Third Party under the
Ramipril Patents with respect to any combination product that contains Ramipril
as an active ingredient for use in [***], including without limitation for
products labeled for the treatment or prevention of diabetes ("[***]") without
first offering such formulations to King and King's Affiliates on commercially
reasonably terms and negotiating in good faith with King, at King's election,
for such rights to [***].
2.5 Reimportation. Selamine and its Affiliates hereby acknowledge and agree
that each has granted to King and its Affiliates hereunder exclusive (except as
set forth in Section 2.3) rights in the Territory. Except as set forth in
Section 2.3, Selamine and its Affiliates acknowledge and agree that neither
Selamine nor any of its Affiliates has no right to and shall not grant any right
or license to any Affiliate or Third Party, directly or indirectly, under the
Ramipril Patents in the Territory, nor grant any such right to any Affiliate or
Third Party outside the Territory if Selamine or any of its Affiliates knows or
has a reasonable basis to believe that such Affiliate or Third Party intends to
undertake the manufacture, use, offer for sale, sale or importation of any [***]
in the Territory. Selamine and its Affiliates shall use commercially reasonable
efforts to prevent, in the Territory, the selling, distribution, offer for sale
and importation of [***], directly or indirectly, by Selamine or any of its
Affiliates, licensees, or sublicensees.
2.6 Assignment to Selamine. In order to effectuate the rights and licenses
granted to King and King's Affiliates hereunder, Selamine and Xxxxx Xxxx shall
cause each Affiliate of Selamine to, and each hereby does, either (a) transfer,
assign, and convey to Selamine, its successors and assigns, forever, all right,
title, and interest in and to, or (b) grant to Selamine an
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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exclusive license of all rights under, in each case, all Ramipril Patents
developed by each such Affiliate, jointly or solely, during the Term of this
Agreement, and any other agreement entered into between or among Selamine or its
Affiliates, on the one hand, and King or its Affiliates, on the other hand,
relating to [***], including all rights with respect to preparation, filing,
prosecution, maintenance, enforcement and defense of all intellectual property
rights associated therewith.
3. CONSIDERATION
3.1 Payments. In consideration of the rights and licenses granted herein,
King agrees to pay Selamine a total of U.S. Dollars ("USD") $10 million, to be
paid by wire transfer immediately upon execution of this Agreement.
4. PATENT PROSECUTION, MAINTENANCE AND THIRD PARTY INFRINGEMENT
4.1 Ownership Of Inventions and Intellectual Property Rights Arising
Hereunder. In the event that Inventions are conceived and/or reduced to practice
hereunder or under any other agreement entered into between or among Selamine or
its Affiliates, on the one hand, and King or its Affiliates, on the other hand,
then the Party (or Affiliate thereof) making such Invention shall promptly
provide written notice of same to the other Party in sufficient detail to permit
evaluation of same by the receiving Party. Neither Party nor any Affiliate of
either shall disclose any such invention to any Third Party without the prior
written consent of the other Party. Selamine and King agree that they shall
jointly own all right, title and interest in and to any Patents, Technology,
Ramipril Patents and other intellectual property rights in any and all such
inventions.
4.2 Assignment. Each Party (the "Developing Party") agrees to, and hereby
does, and will cause each of its employees, consultants, Affiliates and
permitted Third Parties (collectively with the Developing Party, the
"Assignors") to, transfer, assign, and convey jointly to the other Party, its
successors and assigns, forever, a joint ownership right in all right, title,
and interest in and to all Inventions developed by each such Assignor, alone or
jointly with each other or the non-Developing Party, including all intellectual
property rights associated therewith. The Developing Party further agrees, and
will cause the other Assignors, (i) to promptly provide the non-Developing Party
with written notice, in sufficient detail, of any Inventions such Assignor makes
during the term hereof and (ii) to provide the non-Developing Party with such
additional information and to execute and deliver, and to cause the other
Assignors to execute and deliver, any documents or take any other actions or
otherwise cooperate with the non-Developing Party as may reasonably be
necessary, or as such Party may reasonably request, to document, enforce,
protect, or otherwise perfect such Party's joint ownership rights in any
Invention, including filing any applicable patent applications.
4.3 Employees. Each Party agrees to have each employee of itself or its
Affiliates involved in developing Inventions enter into a written agreement with
such Party that includes an assignment to such Party of all right, title and
interest in and to all work product and all inventions arising during the course
of his or her employment with such party in connection with such Inventions, and
all intellectual property rights attaching thereto.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
3
4.4 Prosecution and Maintenance. Selamine shall have the first right to
prepare, file, prosecute and maintain ("Prosecute") all Ramipril Patents in the
Territory, provided that King shall have the right to provide comments, which
Selamine shall consider in good faith incorporating to the extent not
inconsistent with the commercial or scientific interests of Selamine. King shall
reimburse Selamine for [***] costs and expenses incurred in connection with such
Prosecution of the Ramipril Patents in the Territory.
4.5 Third Party Infringement. If either Party or any Affiliate thereof
becomes aware of actual or threatened infringement by a Third Party of any
Ramipril Patent anywhere in the Territory, that Party or Affiliate shall
promptly notify the other Party in writing. King shall have the first right, but
not the obligation, to bring, [***], an infringement action against any such
Third Party ("Action"), and to use Selamine and its Affiliate's name(s) as
required in connection therewith and Selamine and its Affiliates hereby consents
to jurisdiction and venue if King names Selamine or any Affiliate thereof as a
party thereto. King shall have full control over the conduct of any Action,
including settlement thereof. Selamine shall have the right to provide comments
to King with respect to any such Action, which King shall consider in good
faith. King shall provide notice to Selamine prior to entering into any consent
to entry of judgment or any settlement of any Action. If King does not commence
a particular Action within [***] of receipt of the notice of infringement, then
Selamine, after notifying King in writing, shall be entitled to bring such
Action [***]. Selamine shall have full control over the conduct of such Action.
King shall have the right to provide comments to Selamine with respect to any
such Action, which Selamine shall consider in good faith. Selamine may not
settle any Action without prior written notice to King. In any event, King and
Selamine and their Affiliates shall assist one another and cooperate in any such
Action at the other's request [***] the requesting Party, and the Party who is
not in control of the Action, and its Affiliates, shall have the right to retain
separate counsel, at its own expense. The Parties shall each be entitled to
recover [***] expenses, [***], associated with any litigation or settlement
thereof from any recovery made by either Party. King shall thereafter be
entitled to recover its lost profits with respect to infringing sales of [***],
provided that King shall be obligated to pay to Selamine [***] with respect to
such recovery for such sales as if King had made such sales itself. The
remainder, if any, shall be shared by the parties, with Selamine receiving an
amount [***] of such remainder and King receiving [***] such remainder.
4.6 Defense of Third Party Claims. Selamine and King shall examine and
discuss in good faith the consequences of any actual or threatened suit, action
or proceeding against either or both Party or any Affiliate of either, alleging
infringement of the technology, patent rights or other intellectual property
rights of a Third Party with respect to the manufacture, use, Marketing,
distribution, offer for sale, sale or importation of any [***] in the Territory
("Third Party Claim"). King shall have the first right, but not the obligation,
to control the defense of any Third Party Claim [***] and to use Selamine and
its Affiliate's name(s) in connection therewith and Selamine and its Affiliates
hereby consents to jurisdiction and venue if King names Selamine or any
Affiliate thereof as a party thereto. King shall have full control over the
conduct of any Third Party Claim. Selamine shall have the right to provide
comments to King with respect to any such Third Party Claim, which King shall
consider in good faith. King shall provide notice to Selamine prior to entering
into any consent to entry of judgment or any settlement of any Third Party
Claim. If King does not assume control of the defense of any Third Party Claim
within [***] of the filing of the complaint in the relevant matter, then
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
4
Selamine, after notifying King in writing, shall be entitled to assume control
over the defense of such Third Party Claim [***]. Selamine shall have full
control over the conduct of such Third Party Claim. King shall have the right to
provide comments to Selamine with respect to any such Third Party Claim, which
Selamine shall consider in good faith. Selamine may not settle any Third Party
Claim without prior written notice to King. In any event, King and Selamine
shall assist one another and cooperate in any such Third Party Claim at the
other's request [***] the requesting Party, and the Party who is not in control
of the Third Party Claim, and its Affiliates, shall have the right to retain
separate counsel, [***]. In the event any Third Party Claim, or settlement
thereof, results in an obligation on King or Selamine or any Affiliate of either
to pay royalties, milestones, damages, costs, expenses or any other financial
consideration to any Third Party, whether by court order, consent decree,
settlement or license agreement or otherwise, the Parties shall share such
payment obligations [***].
5. REPRESENTATIONS AND WARRANTIES
5.1 Selamine's Representations and Warranties. Selamine hereby represents
and warrants the following to King as of the Effective Date:
(a) Selamine (i) is a corporation duly organized, validly existing,
and in good standing under the laws of Ireland, with its principal place of
business as indicated in the first paragraph of this Agreement; (ii) is duly
qualified as a corporation and in good standing under the laws of each
jurisdiction where its ownership or lease of property or the conduct of its
business requires such qualification; (iii) has the requisite corporate power
and authority and the legal right to conduct its business as now conducted and
hereafter contemplated to be conducted; (iv) has all necessary licenses,
permits, consents, or approvals from or by, and has made all necessary notices
to, all government authorities having jurisdiction, to the extent required for
such ownership and operation; and (v) is in compliance with its certificate of
incorporation and bylaws.
(b) The execution, delivery and performance of this Agreement by
Selamine and all instruments and documents to be delivered by Selamine
hereunder: (i) are within the corporate power of Selamine; (ii) have been duly
authorized by all necessary or proper corporate action; (iii) are not in
contravention of any provision of the certificate of incorporation or bylaws of
Selamine; (iv) will not violate any law or regulation or any order or decree of
any court or government authority; (v) will not violate the terms of any
indenture, mortgage, deed of trust, lease, agreement, or other instrument to
which Selamine is a party or by which Selamine, or any of the property of
Selamine is bound, which violation would have a material adverse effect on the
financial condition of Selamine, or on the ability of Selamine to perform its
obligations hereunder; and (vi) do not require any filing or registration with
or the consent or approval of, any government authorities or any other person,
which has not been made or obtained previously.
(c) This Agreement has been duly executed and delivered by Selamine
and constitutes a legal, valid and binding obligation of Selamine enforceable
against Selamine in accordance with its terms, except as such enforceability may
be limited by applicable insolvency and other laws affecting creditors' rights
generally or by the availability of equitable remedies.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
5
(d) To Selamine's knowledge, having made a reasonable inquiry, there
are no judicial, arbitral, regulatory or administrative proceedings or
investigations, claims, actions or suits related to the Ramipril Patents pending
against Selamine or its Affiliates or its Affiliates' licensees thereof anywhere
in the world, in any court or by or before any government authority.
(e) Schedule A sets forth a complete and accurate list of all Ramipril
Patents owned or Controlled by Selamine and its Affiliates. Selamine and its
Affiliates own all right, title and interest in and to the Ramipril Patents set
forth on Schedule A, free and clear of all Encumbrances, and to Selamine and its
Affiliate's knowledge, no person or entity other than Selamine, including
without limitation any current or former employee or consultant of Selamine or
any Affiliate thereof, has any proprietary, commercial or other interest in any
of such Ramipril Patents in the Territory. Neither Selamine nor its Affiliates
have granted any agreements, options, commitments, or rights with, of or to any
person or entity to acquire or obtain any rights to any of the Ramipril Patents
in the Territory. Selamine and its Affiliates have the right to license to King
and its Affiliates rights in the Ramipril Patents in the Territory on the terms
and conditions set forth herein, free and clear of any rights or claims of any
person or entity and, without payment of any royalty, licensee fee or other
amount to any person or entity.
(f) To Selamine and its Affiliates' knowledge, the Ramipril Patents
have been duly prepared and prosecuted in accordance with all Applicable Laws,
including without limitation all duties of candor before the United States
Patent and Trademark Office. To Selamine and its Affiliate's knowledge, neither
Selamine nor any other Affiliate of Selamine, has received any notice of
interfering subject matter with respect to any of the Ramipril Patents, and to
Selamine's knowledge Selamine is unaware of any Third Party patents or patent
applications that contain any interfering subject matter with any of same.
(g) To Selamine and its Affiliates' knowledge, having made a
reasonable inquiry, the manufacture, use, offer for sale, sale, or importation
of [***] formulated as described or claimed in the Ramipril Patents will not
infringe or misappropriate the intellectual property rights of any Third Party.
To Selamine and its Affiliates' knowledge, having made a reasonable inquiry,
there are no pending patent applications that are reasonably likely to issue in
the Territory with claims that would be infringed or misappropriated by the
manufacture, use, offer for sale, sale or importation of any of the [***]
formulations described or claimed in such Ramipril Patents, except with respect
to pending patent applications that may be owned by Relevant Third Parties and
with respect to which Selamine or its Affiliates may be obligated, pursuant to
other agreements entered into between or among Selamine or its Affiliates, on
the one hand, and King or its Affiliates, on the other hand, relating to [***],
to obtain a Relevant Third Party License. To Selamine and its Affiliate's
knowledge, having made a reasonable inquiry, neither Selamine nor any Affiliate
thereof has misappropriated or infringed upon any intellectual proprietary
rights of any Third Party in any material respect in connection with the
development of any of the [***] formulations described or claimed in such
Ramipril Patents. To the knowledge of Selamine, having made a reasonable
inquiry, no Third Party has or is currently misappropriating or infringing upon
any of the Ramipril Patents in the Territory.
5.2 Xxxxx Xxxx'x Representations and Warranties. Xxxxx Xxxx hereby
represents and warrants the following to King as of the Effective Date:
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
6
(a) Xxxxx Xxxx (i) is a corporation duly organized, validly existing,
and in good standing under the laws of Malta, with its principal place of
business as indicated in the first paragraph of this Agreement; (ii) is duly
qualified as a corporation and in good standing under the laws of each
jurisdiction where its ownership or lease of property or the conduct of its
business requires such qualification; (iii) has the requisite corporate power
and authority and the legal right to conduct its business as now conducted and
hereafter contemplated to be conducted; (iv) has all necessary licenses,
permits, consents, or approvals from or by, and has made all necessary notices
to, all government authorities having jurisdiction, to the extent required for
such ownership and operation; and (v) is in compliance with its certificate of
incorporation and bylaws.
(b) The execution, delivery and performance of this Agreement by Xxxxx
Xxxx and all instruments and documents to be delivered by Xxxxx Xxxx hereunder:
(i) are within the corporate power of Xxxxx Xxxx; (ii) have been duly authorized
by all necessary or proper corporate action; (iii) are not in contravention of
any provision of the certificate of incorporation or bylaws of Xxxxx Xxxx; (iv)
will not violate any law or regulation or any order or decree of any court or
government authority; (v) will not violate the terms of any indenture, mortgage,
deed of trust, lease, agreement, or other instrument to which Xxxxx Xxxx is a
party or by which Xxxxx Xxxx, or any of the property of Xxxxx Xxxx is bound,
which violation would have a material adverse effect on the financial condition
of Xxxxx Xxxx, or on the ability of Xxxxx Xxxx to perform its obligations
hereunder; and (vi) do not require any filing or registration with or the
consent or approval of, any government authorities or any other person, which
has not been made or obtained previously.
(c) This Agreement has been duly executed and delivered by Xxxxx Xxxx
and constitutes a legal, valid and binding obligation of Xxxxx Xxxx enforceable
against Xxxxx Xxxx in accordance with its terms, except as such enforceability
may be limited by applicable insolvency and other laws affecting creditors'
rights generally or by the availability of equitable remedies.
(d) To Xxxxx Xxxx'x knowledge, having made a reasonable inquiry, there
are no judicial, arbitral, regulatory or administrative proceedings or
investigations, claims, actions or suits related to the Ramipril Patents pending
against Xxxxx Xxxx or its Affiliates or its Affiliates' licensees thereof
anywhere in the world, in any court or by or before any government authority.
(e) To Xxxxx Xxxx'x knowledge, no person or entity other than Xxxxx
Xxxx and its Affiliates, including without limitation any current or former
employee or consultant of Xxxxx Xxxx or any Affiliate thereof, has any
proprietary, commercial or other interest in any the Ramipril Patents set forth
on Schedule A in the Territory. Neither Xxxxx Xxxx nor its Affiliates have
granted any agreements, options, commitments, or rights with, of or to any
person or entity to acquire or obtain any rights to any of the Ramipril Patents
in the Territory. Xxxxx Xxxx has not previously licensed the Ramipril Patents in
the Territory to any Third Party.
(f) To Xxxxx Xxxx'x knowledge, the Ramipril Patents have been duly
prepared and prosecuted in accordance with all Applicable Laws, including
without limitation all duties of candor before the United States Patent and
Trademark Office. To Xxxxx Xxxx'x knowledge, neither Xxxxx Xxxx nor any other
Affiliate of Xxxxx Xxxx, has received any notice
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
7
of interfering subject matter with respect to any of the Ramipril Patents, and
to Xxxxx Xxxx'x knowledge Xxxxx Xxxx is unaware of any Third Party patents or
patent applications that contain any interfering subject matter with any of
same.
(g) To Xxxxx Xxxx'x knowledge, having made a reasonable inquiry, the
manufacture, use, offer for sale, sale, or importation of [***] formulated as
described or claimed in the Ramipril Patents will not infringe or misappropriate
the intellectual property rights of any Third Party. To Xxxxx Xxxx'x knowledge,
having made a reasonable inquiry, there are no pending patent applications that
are reasonably likely to issue in the Territory with claims that would be
infringed or misappropriated by manufacture, use, offer for sale, sale or
importation of any of the [***] formulations described or claimed in such
Ramipril Patents, except with respect to pending patent applications that may be
owned by Relevant Third Parties and with respect to which Xxxxx Xxxx or its
Affiliates may be obligated, pursuant to other agreements entered into between
or among Selamine or its Affiliates, on the one hand, and King or its
Affiliates, on the other hand, relating to [***], to obtain a Relevant Third
Party License. To Xxxxx Xxxx'x knowledge, having made a reasonable inquiry,
neither Xxxxx Xxxx nor any Affiliate thereof has misappropriated or infringed
upon any intellectual proprietary rights of any Third Party in any material
respect in connection with the development of any of the [***] formulations
described or claimed in such Ramipril Patents. To Xxxxx Xxxx'x knowledge, having
made a reasonable inquiry, no Third Party has or is currently misappropriating
or infringing upon any of the Ramipril Patents in the Territory.
5.3 King's Representations and Warranties. King hereby represents and
warrants the following to Selamine as of the Effective Date:
(a) King (i) is a corporation duly organized, validly existing, and in
good standing under the laws of the State of Tennessee, with its principal place
of business as indicated in the first paragraph of this Agreement; (ii) is duly
qualified as a corporation and in good standing under the laws of each
jurisdiction where its ownership or lease of property or the conduct of its
business requires such qualification, where the failure to be so qualified would
have a material adverse effect on the financial condition of King or the ability
of King to perform its obligations hereunder; (iii) has the requisite corporate
power and authority and the legal right to conduct its business as now conducted
and hereafter contemplated to be conducted; (iv) has all necessary licenses,
permits, consents, or approvals from or by, and has made all necessary notices
to, all government authorities having jurisdiction, to the extent required for
such ownership and operation; and (v) is in compliance with its certificate of
incorporation and bylaws.
(b) The execution, delivery and performance of this Agreement by King
and all instruments and documents to be delivered by King hereunder: (i) are
within the corporate power of King; (ii) have been duly authorized by all
necessary or proper corporate action; (iii) are not in contravention of any
provision of the certificate of incorporation or bylaws of King; (iv) will not
violate any law or regulation or any order or decree of any court or government
authority; (v) will not violate the terms of any indenture, mortgage, deed of
trust, lease, agreement, or other instrument to which King is a party or by
which King or any of its property is bound, which violation would have a
material adverse effect on the financial condition of King or on the ability of
King to perform its obligations hereunder; and (vi) do not require any filing
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
8
or registration with or the consent or approval of, any government authority or
any other person, which has not been made or obtained previously.
(c) This Agreement has been duly executed and delivered by King and
constitutes a legal, valid and binding obligation of King, enforceable against
King in accordance with its terms, except as such enforceability may be limited
by applicable insolvency and other laws affecting creditors' rights generally or
by the availability of equitable remedies.
(d) Selamine may exercise its rights and perform its obligations
hereunder, in accordance with the terms and conditions of this Agreement or the
Product Supply Agreement (and, to the extent applicable to such performance, the
terms and conditions of any other agreements entered into between or among
Selamine or its Affiliates, on the one hand, and King or its Affiliates, on the
other hand, relating to [***]), without violating the terms of King's and/or its
Affiliates' pre-existing agreements with Aventis and/or its Affiliates or Wyeth
and/or its Affiliates and without infringing or misappropriating the
intellectual property of Aventis and/or its Affiliates that is licensed to King
and/or its Affiliates under its pre-existing agreements with Aventis and/or
Affiliates.
5.4 NO IMPLIED WARRANTY. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY OTHER WARRANTY, EXPRESS OR IMPLIED, WITH RESPECT TO THE
RAMIPRIL PATENTS OR [***]. EACH PARTY AND ITS AFFILIATES EXPRESSLY DISCLAIMS ANY
IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
NON-INFRINGEMENT. IN NO EVENT SHALL SELAMINE, XXXXX XXXX, XXXX OR ANY OF THEIR
AFFILIATES BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL
DAMAGES.
6. CONFIDENTIALITY
6.1 Confidentiality. All Confidential Information provided by the
Disclosing Party to the Receiving Party in connection with this Agreement is
proprietary to the Disclosing Party and shall be maintained in strict confidence
by the Receiving Party. Such Confidential Information shall remain the property
of the Disclosing Party, and the Receiving Party shall not use the same for or
on behalf of any entity other than the Disclosing Party. Both Parties agree to
maintain the Ramipril Patents, Patents and Technology in confidence pursuant to
the terms and conditions hereof. At the termination of this Agreement, the
Parties shall promptly return to the Disclosing Party any physical embodiments
(including copies) of any such Confidential Information or, at the Disclosing
Party's sole election, destroy the same under the Disclosing Party's
supervision.
6.2 Disclosure. Nothing in this Agreement shall be construed as preventing
or in any way inhibiting either Party from disclosing Confidential Information
necessary to comply with applicable laws. In the event a Party shall deem it
reasonably necessary to disclose Confidential Information belonging to the other
Party pursuant to this Section 6.2, the Disclosing Party shall to the extent
possible give reasonable advance notice of such disclosure to the other Party,
and shall consider in good faith the other Party's objections to such
disclosure, including suggestions to redact Confidential Information, and take
reasonable measures to ensure confidential treatment of such information.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
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6.3 Period of Obligation. This Article shall survive expiration or
termination of this Agreement for a period of [***] from the Effective Date.
6.4 Equitable Relief. Selamine and King each acknowledges that a breach by
it of Article 6 cannot reasonably or adequately be compensated in damages in an
action at law and that such a breach may cause the other Party irreparable
injury and damage. By reason thereof, each Party agrees that the other Party may
be entitled, in addition to any other remedies it may have under this Agreement
or otherwise, to preliminary and permanent injunctive and other equitable relief
to prevent or curtail any breach of Article 6 by the other Party; provided,
however, that no specification in this Agreement of a specific legal or
equitable remedy shall be construed as a waiver or prohibition against the
pursuing of other legal or equitable remedies in the event of such a breach.
Each Party agrees that the existence of any claim, demand, or cause of action of
it against the other Party, whether predicated upon this Agreement, or
otherwise, shall not constitute a defense to the enforcement by the other Party,
or its successors or assigns, of the covenants contained in Article 6.
7. TERM AND TERMINATION
7.1 Term. This Agreement shall remain in effect until the expiration of the
last to expire of the Ramipril Patents, including any patent term extensions or
restorations, unless previously terminated as provided in this Agreement.
7.2 Termination. This Agreement may only be terminated upon mutual written
agreement of the Parties or upon sixty (60) days' prior written notice if one
Party is in material breach of this Agreement and fails to cure that breach
within such sixty (60) day period. In the event the Product Supply Agreement is
terminated by Selamine for King's material breach, this Agreement shall
automatically terminate upon the effective date of such termination of the
Product Supply Agreement.
7.3 Termination for Bankruptcy. This Agreement may be terminated upon
fifteen (15) days prior written notice by either Party at any time during this
Agreement if: (a) the other Party shall file in any court, pursuant to any
statute of any government in any country, a petition in bankruptcy or insolvency
or for reorganization, or for an arrangement or for the appointment of a
receiver or trustee of the Party or of its assets, (b) any other Party proposes
a written agreement of composition for extension of its debts, (c) the other
Party shall be served with an involuntary petition against it, filed in any
insolvency proceeding, and such petition shall not be dismissed within sixty
(60) days after filing thereof, (d) the other Party shall be a Party to any
dissolution or liquidation, (e) the other Party shall make a general assignment
for the benefit of its creditors; or (f) the other Party is subject to any final
order of debarment which can be expected to have a material adverse effect on
the Development or commercialization of [***]. A termination pursuant to this
Section 7.3 shall constitute a termination for material breach, and the
non-breaching party shall be entitled to seek damages or equitable relief for
such material breach. Notwithstanding the occurrence of any of the event
specified in subsections (a) through (f) of this Section 7.3, the Parties
acknowledge and agree that, to the extent Section 365(n) of the Bankruptcy Code
applies to this Agreement, the non-insolvent party may elect to retain and
exercise the rights granted to it hereunder with respect to the intellectual
property owned or Controlled by the insolvent party.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
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7.4 Survival. The terms and conditions of the following provisions shall
survive termination or expiration of this Agreement for as long as necessary to
permit their full discharge: Sections 2.3, 4.1, 4.2 and 4.3, and Articles 5, 6,
7, 8 and 9; and, upon expiration (but not termination) of this Agreement, the
licenses granted to King in Article 2 will survive and continue as fully
paid-up, royalty-free non-exclusive licenses.
8. INDEMNIFICATION AND GUARANTEE
8.1 King Indemnification. King agrees to defend, indemnify and hold
harmless Selamine and its Affiliates and their respective directors, employees
and agents (the "Selamine Indemnitees") from and against any and all Liabilities
resulting from any claims by a Third Party, arising out of or relating to (i)
the willful misconduct or negligence of King; (ii) any material
misrepresentation or breach of warranty of King contained in this Agreement or
in any schedule hereto; (iii) any material breach of any covenant or obligation
of King contained in this Agreement, except, in each case, to the extent such
claims are due to the negligent acts, willful misconduct or omissions of any
Selamine Indemnitee or to the extent that Selamine or Xxxxx Xxxx is otherwise
obligated to indemnify King under this Agreement; and (iv) any infringement,
misappropriation or other violation by Selamine and its Affiliates of the
intellectual property of Aventis and/or its Affiliates that is licensed to King
and/or its Affiliates under their pre-existing agreements with Aventis and/or
its Affiliates or of which King and/or its Affiliates is aware.
8.2 Selamine Indemnification. Selamine and Xxxxx Xxxx each agree to defend,
indemnify and hold harmless King and its Affiliates and their respective
directors, employees and agents (the "King Indemnitees") from and against any
Liabilities resulting from any claim by a Third Party, arising out of or
relating to (i) the willful misconduct or negligence of Selamine or any
Affiliate thereof; or (ii) any material misrepresentation or breach of warranty
of Selamine or any Affiliate thereof contained in this Agreement or in any
schedule hereto; or (iii) any material breach of any covenant or obligation of
Selamine or any Affiliate thereof contained in this Agreement; except, in each
case, to the extent such claims are due to the negligent acts, willful
misconduct or omissions of any King Indemnitee or to the extent that King is
otherwise obligated to indemnify Selamine or any Affiliate thereof under this
Agreement.
8.3 Indemnification Procedure. A party (the "indemnitee") that intends to
claim indemnification under this Article 8 will notify the indemnifying party
(the "indemnitor") within a reasonable time in writing of any action, claim, or
liability in respect of which the indemnitee believes it is entitled to claim
indemnification; provided that the failure to give timely notice to the
indemnitor will not release the indemnitor from any liability to the indemnitee
except to the extent the indemnitor is actually prejudiced thereby. The
indemnitor will have the right, by notice to the indemnitee, to assume the
defense of any such action or claim within the fifteen (15)-day period after the
indemnitor's receipt of notice of any action or claim with counsel of the
indemnitor's choice and at the sole cost of the indemnitor. If the indemnitor
does not so assume the defense of such Third Party claim, the indemnitee may
assume such defense with counsel of its choice and at the sole cost of the
indemnitor. If the indemnitor so assumes such defense, the indemnitee may
participate therein through counsel of its choice, but at the sole cost of the
indemnitee. The party not assuming the defense of any such claim will render all
reasonable assistance to the party assuming such defense, and all reasonable
out-of-pocket costs of such assistance will be for the account of the
indemnitor. No such claim will be settled other than by
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the party defending the same, and then only with the consent of the other party,
which will not be unreasonably withheld; provided that the indemnitee will have
no obligation to consent to any settlement of any such action or claim that
imposes on the indemnitee any liability or obligation that cannot be assumed and
performed in full by the indemnitor, and the indemnitee will have no right to
withhold its consent to any settlement of any such action or claim if the
settlement involves only the payment of money by the indemnitor or its insurer.
8.4 Xxxxx Xxxx Guarantee. To the extent any of the obligations herein apply
to Affiliates of Selamine, Xxxxx Xxxx agrees (a) to abide by such obligations as
an Affiliate of Selamine and (b) to cause each other Affiliate of Selamine to
abide by such obligations, including through the exercise of all of Xxxxx Xxxx'x
corporate power and authority to cause such Affiliates to perform their
obligations hereunder.
9. MISCELLANEOUS
9.1 Public Announcements. Neither Party nor any Affiliate thereof shall
make any publicity releases, interviews, or other dissemination of information
concerning this Agreement or its terms, or either Party's or any Affiliate's
performance hereunder, to communication media, financial analysts, or others
without the approval of the other Party, which approval shall not unreasonably
be withheld. Either Party and any Affiliate thereof may upon notice to the other
Party make any disclosure in filings with regulatory agencies as required by law
or applicable court order; provided that the other Party and its Affiliates
shall have the opportunity to consult in advance on such disclosures and
filings.
9.2 Force Majeure. Neither Party nor any Affiliate thereof shall be liable
for any default or delay in such Party's or any Affiliate's performance if such
default or delay is caused by an event beyond the reasonable control of such
Party or Affiliate, including, but not limited to: act of God; war or
insurrection; civil commotion; destruction of essential facilities or materials
by earthquake, fire, flood or storm; labor disturbance; epidemic; or other
similar event; provided, however, that the Party or Affiliate so affected will
give prompt notice of such event, and shall use its commercially reasonable
efforts to avoid, remove or alleviate such causes of nonperformance and shall
continue performance hereunder with the utmost dispatch whenever such causes are
removed.
9.3 Entire Agreement. This Agreement and the documents referred to herein,
including without limitation all Schedules and Appendices hereto (which are
hereby incorporated by reference), constitute the entire agreement between the
Parties and the Affiliates of each pertaining to the subject matter hereof, and
this Agreement supersedes, on its Effective Date, any other agreements,
understandings, promises and representation, whether written or oral, between
the Parties and such Affiliates relating to the same subject matter save for
where otherwise expressed in this Agreement. No agent of either Party or any
Affiliate of either is authorized to make any representation, promise, or
warranty not contained in this Agreement.
9.4 Amendment and Waiver. This Agreement may only be amended by the Parties
in writing, making specific reference to this Agreement, provided that the same
is signed by all Parties. No course of dealing between the Parties any their
Affiliates or failure by either Party or any Affiliates thereof to exercise any
right or remedy hereunder shall constitute an amendment to
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12
this Agreement or a waiver of any other right or remedy or the later exercise of
any right or remedy.
9.5 Governing Law. This Agreement shall be construed in accordance with the
laws of the State of New York, without regard to any choice of law provisions.
Each Party and each Affiliate of each Party hereby submits itself for the sole
purpose of this Agreement and any controversy arising hereunder to the
jurisdiction of the courts located in the Southern District of New York and any
courts of appeal therefrom, and waives any objection on the grounds of lack of
jurisdiction (forum non conveniens or otherwise) to the exercise of such
jurisdiction over it by any such courts.
9.6 Dispute Resolution. Any controversy, claim, or dispute arising out of
or relating to this Agreement (collectively "Dispute") shall be attempted to be
settled by the Parties and their Affiliates, in good faith. In the event that
there is no resolution of such Dispute, it shall further be submitted to
appropriate senior management representatives of each Party in a good faith
effort to effect a mutually acceptable resolution thereof. Only if such efforts
are not successful shall such Dispute be resolved by binding arbitration. Such
arbitration shall take place in New York, New York and it shall proceed in
accordance with the Commercial Arbitration Rules of the American Arbitration
Association. Within [***] from the filing of the demand or submission, or longer
if the Parties mutually agree, Selamine and King shall each select one
arbitrator; the two arbitrators so appointed shall select and appoint a third
neutral arbitrator. Judgment upon the award rendered by arbitration shall be
binding and may be entered in any court having jurisdiction thereof. Costs of
arbitration are to be divided by the Parties in the following manner: Selamine
shall pay [***], King shall pay [***], Selamine and King shall [***], and each
shall [***]
9.7 Assignment. No Party nor any Affiliate thereof may assign any right or
obligation hereunder without the written consent of the other Parties, such
consent not to be unreasonably withheld, provided that each Party may assign
this Agreement and the rights, obligations, and interests of such Party, in
whole or in part, only to any of its Affiliates (for so long as they remain
Affiliates) or to any Third Party that succeeds to all or substantially all of a
Party's business or assets relating to this Agreement, the Product Supply
Agreement and any other agreement entered into between or among Selamine or its
Affiliates, on the one hand, and King or its Affiliates, on the other hand,
relating to [***], whether by sale, merger, operation of law, or otherwise, or
to one or more financial institutions providing financing to such Party,
pursuant to the terms of the relevant security agreement, and, upon the
occurrence of any such succession, shall make such assignment; provided that
such assignee or transferee shall also promptly agree in writing to be bound by
the terms and conditions of this Agreement. This Agreement shall be binding upon
and inure to the benefit of the Parties hereto and their respective successors
and assigns. Any attempted assignment in violation of this provision shall be
void and of no effect.
9.8 Nature of Agreement. In operating under the Agreement, each Party shall
act independently and this Agreement shall not be construed as creating any
partnership, joint venture or incorporated business entity. No Party shall have
any authority to incur any liability or obligation whatsoever on behalf of any
other Party.
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9.9 Notice. Any notice, demand, waiver, consent, approval or other
communication which is required or permitted to be given to any Party under this
Agreement shall be in writing, shall specifically refer to this Agreement, and
shall be effective on receipt, as evidenced in writing, when given by registered
airmail or certified mail, postage prepaid, or overnight courier, and addressed,
unless otherwise specified in writing, to the addresses of the Parties described
below, and effective upon sending if sent by facsimile confirmed by a written
transmission report:
IF SELAMINE:
Xxxx 0/0, Xxxxxxxxxxxx Xxxxxxx,
Xxxxxxxxxx, Xxxxxx 00, Xxxxxxx
Fax: 000 0 000 0000
Attention: Xxxx Power and Xxxx Xxxxxxxx
COPY TO:
Weil, Gotshal & Xxxxxx LLP
000 Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxx Xxxxxxxxx, Esq.
IF XXXXX XXXX:
00 Xx. Xxxxxxxxxxx Xxxxxx
Xxxxxxxx XXX00,
Xxxxx
Fax: 000 0000 0000
Attention: Xxxxxxx Xxxxxx
copy to:
Weil, Gotshal & Xxxxxx LLP
000 Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxx Xxxxxxxxx, Esq.
IF KING OR KING R&D:
000 Xxxxx Xxxxxx
Xxxxxxx, XX 00000
Fax: 000 000 0000
Attention: General Counsel
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SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
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14
COPY TO:
Xxxxx Day
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, XX 00000
Attention: F. Xxxxxxx Cerrito, Esq.
9.10 Separability.
(a) In the event any portion of this Agreement shall be held illegal,
void or ineffective, the remaining portions hereof shall remain in full force
and effect.
(b) If any of the terms or provisions of this Agreement are in
conflict with any applicable statute or rule of law, then such terms or
provisions shall be deemed inoperative to the extent that they may conflict
therewith and shall be deemed to be modified to conform with such statute or
rule of law, and the remaining portions hereof shall remain in full force and
effect.
(c) In the event that the terms and conditions of this Agreement are
materially altered as a result of Sections 9.10(a) or 9.10(b), the Parties will
renegotiate the terms and conditions of this Agreement to resolve any
inequities.
9.11 Execution in Counterparts. This Agreement may be executed in two or
more counterparts, each of which shall be an original and all of which shall
constitute together the same instrument.
9.12 Recording. Either Party shall have the right, at any time, to record,
register, or otherwise notify this Agreement in appropriate governmental or
regulatory offices anywhere within the Territory, and the other Parties shall
provide reasonable assistance to the recording, registering or notifying Party
in effecting such recording, registering or notifying and provided that the
other Parties shall have the opportunity to consult in advance on such
disclosures and filings.
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15
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to
be executed on the date first written above by their respective duly authorized
officers, on the date first written above.
SELAMINE LIMITED
By: (signature)
-------------------------
Name:
----------------------------------
Title:
---------------------------------
XXXXX XXXX HOLDINGS LIMITED
By: (signature)
-------------------------
Name:
----------------------------------
Title:
---------------------------------
KING PHARMACEUTICALS RESEARCH AND
DEVELOPMENT, INC.
By: (signature)
-------------------------
Name:
----------------------------------
Title:
---------------------------------
KING PHARMACEUTICALS, INC.
By: (signature)
-------------------------
Name:
----------------------------------
Title:
---------------------------------
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SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
APPENDIX A
DEFINITIONS
1.1 "ACT" shall mean the United States Federal Food, Drug and Cosmetic Act,
as amended.
1.2 "AFFILIATE" shall mean any corporation, firm, partnership or other
entity that directly or indirectly controls or is controlled by or is under
common control with a Party to an agreement. For purposes of this definition,
"control" means ownership, directly or through one or more Affiliates, of (a)
fifty percent (50%) or more of the shares or voting rights in case of a
corporation or limited company, (b) fifty percent (50%) or more of the shares of
stock entitled to vote for the election of directors, in the case of a
corporation, (c) fifty percent (50%) or more of the equity or controlling
interests in the case of any other type of legal entity (including, without
limitation, joint ventures) or status as a general partner in any partnership,
or (d) any other arrangement whereby a Party controls or has the right to
control the Board of Directors or equivalent governing body of an entity.
1.3 "APPLICABLE LAW" shall mean applicable U.S. and foreign laws, rules,
regulations, guidelines and standards, including but not limited to those of the
FDA and comparable foreign governmental and Regulatory Authorities, including
without limitation the Act.
1.4 "ARROW MALTA" shall mean Arrow Pharm Malta Limited, a corporation
organized under the laws of Malta with its principal place of business at 00 Xx.
Xxxxxxxxxxx Xxxxxx, Xxxxxxxx VLT 08, Malta.
1.5 "AVENTIS" shall mean Sanofi Aventis or any of its Affiliates.
1.6 "BANKRUPTCY CODE" shall mean the U.S. Bankruptcy Code, 11 U.S.C.
Sections 101 et seq.
1.7 "CONFIDENTIAL INFORMATION" shall mean the existence and contents of
this Agreement and any information, in whatever form, disclosed by a Party or
its Affiliates (the "Disclosing Party"), to the other Party or its Affiliates
(the "Receiving Party"), in connection with the performance or implementation of
this Agreement including, but not limited to, any Technology and Patents, [***],
the Ramipril drug master file, Ramipril Patents, including without limitation
any pending patent applications, patent office correspondence, FDA applications
and submissions, FDA correspondence, technical or clinical data, trade secrets,
and know-how, including, but not limited to research, product plans, products,
services, suppliers, customer lists and customers, prices and costs, markets,
software, developments, ideas, techniques, business methods, photographs,
sound-recordings, algorithms, inventions, laboratory notebooks, processes,
formulas, technology, specifications, test results, designs, drawings,
engineering, hardware configuration information, marketing, licenses, finances,
budgets and other actual or anticipated business, research or development
information which is disclosed by the Disclosing Party to the Receiving Party
whether or not specifically designated as confidential. Confidential Information
shall not include:
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EXCHANGE ACT OF 1934.
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(a) information which at the time of disclosure is publicly known;
(b) information which, after the time of disclosure, becomes part of
the public domain, except by breach of an agreement between the Disclosing Party
or any Affiliate thereof and the Receiving Party or any Affiliate thereof;
(c) information which is or was in the possession of the Receiving
Party or any Affiliate thereof at the time of disclosure by the Disclosing Party
and was not acquired directly or indirectly from the Disclosing Party or any
Affiliate thereof or from any other party under an agreement of confidentiality
to the Disclosing Party or any Affiliate thereof; and
(d) information which the Receiving Party can show through written
documentation is or was developed by the Receiving Party or its Affiliates
independently of receipt hereunder.
1.8 "CONTROL" OR "CONTROLLED" shall mean, with respect to patents, know-how
or other intellectual property rights of any kind, the possession by a Party of
the ability to grant a license or sublicense of such rights as provided herein
without the payment of additional consideration and without violating the terms
of any agreement or arrangement between such Party and any Third Party.
1.9 "DEVELOPMENT" or "DEVELOP" shall mean, with respect to [***], the
conduct of research, preclinical, clinical and other development activities,
including but not limited to such activities undertaken prior to Regulatory
Approval of such products in order to obtain Regulatory Approval of such
products in accordance with this Agreement, and any other agreement entered into
between or among Selamine or its Affiliates, on the one hand, and King or its
Affiliates, on the other hand, relating to [***]. These activities may include
clinical drug development and stability testing, statistical analysis and report
writing, clinical trial design and performance prior to obtaining Regulatory
Approvals, and regulatory affairs related to the foregoing.
1.10 "ENCUMBRANCE" shall mean any mortgage, pledge, assessment, security
interest, deed of trust, lease, lien, levy, license, restriction on
transferability, defect in title, charge or other encumbrance on any kind or any
conditional sale or title retention agreement or other agreement to give any of
the foregoing in the future.
1.11 "FDA" shall mean the United States Food and Drug Administration or any
successor organization and all agencies under their direct control.
1.12 "INVENTION(S)" shall mean any inventions, discoveries, improvements,
trade secrets, know-how, and proprietary methods and materials that are
conceived, made, or developed in connection with the performance by the Parties
or any Affiliates of either under this Agreement or any other agreement entered
into between or among Selamine or its Affiliates, on the one hand, and King or
its Affiliates, on the other hand, relating to [***], including without
limitation performance of the Permitted Uses, or otherwise in connection with
the [***] or with generating or obtaining Regulatory Approval of the [***], in
each case (a) whether or not patentable and (b) whether developed or conceived
by employees of, or consultants to, either Party or any Affiliate of either,
alone or jointly with each other or with
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permitted Third Parties. The term "Inventions" will include the following: (i)
any modification of, improvement to, or derivative work of a the [***] or
then-existing patent rights or technology, (ii) any information, materials,
records, or reports developed in connection with, or related to, the items in
clause (i), and (iii) any trade secrets, know-how, or intellectual property
rights with respect to the items in clauses (i) and (ii).
1.13 "KING" shall mean King Pharmaceuticals, Inc., a corporation organized
under the laws of Tennessee with its principal place of business at 000 Xxxxx
Xxxxxx, Xxxxxxx, Xxxxxxxxx 00000 XXX.
1.14 "KING R&D" shall mean King Pharmaceuticals Research and Development,
Inc., a corporation organized under the laws of Delaware with its principal
place of business at 0000 XxxxxxXxxxx Xxx, Xxxxx 000, Xxxx, Xxxxx Xxxxxxxx.
1.15 "[***]" shall mean [***] that is owned or Controlled by King or any
Affiliate thereof at any time during the term of this Agreement or any other
agreement entered into between or among Selamine or its Affiliates, on the one
hand, and King or its Affiliates, on the other hand, relating to [***].
1.16 "LIABILITIES" shall mean claims, liabilities, damages, costs or
expenses (including any liability arising out of the injury or death of any
person or damage to any property and including reasonable attorney's fees).
1.17 "MARKET" shall mean promote, advertise, detail, sample and otherwise
market.
1.18 "PATENT(S)" shall mean and collectively include United States and
foreign patent applications, including any provisional applications, and any
patents issued from such patent applications, reissues, re-examinations,
extensions, substitutions, divisionals, continuations and continuations-in-part
thereof.
1.19 "PRE-EXISTING RELEVANT THIRD PARTY AGREEMENT" shall mean any
pre-existing agreement(s) between Selamine and/or its Affiliates and any
Relevant Third Parties.
1.20 "PRODUCT SUPPLY AGREEMENT" shall mean that certain Product Supply
Agreement entered into among Selamine, Xxxxx Xxxx, Arrow Malta and King on
February 12, 2006.
1.21 "RAMIPRIL" shall mean the compound (2S,3aS,6aS)-1[(S)-N-[(S)-1
-Carboxy-3-phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid,
1-ethyl ester.
1.22 "RAMIPRIL PATENTS" shall mean any and all of the following owned or
Controlled by Selamine or any of its Affiliates at any time during the Term of
this Agreement or any other agreements entered into between or among Selamine or
its Affiliates, on the one hand, and King or its Affiliates, on the other hand,
relating to [***], whether protected, created or arising under the Laws of the
United States or the Laws of any other jurisdiction: patents, patent
applications (along with all patents issuing thereon), statutory invention
registrations, in each case as specified in Schedule A of this Agreement, and
any and all continuations, continuations-
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in-part, and divisions of the foregoing, along with any and all reissues,
reexaminations, and extensions of the foregoing, and all rights therein provided
by international treaties or conventions owned or Controlled by Selamine or any
of its Affiliates. Ramipril Patents shall include, without limitation, any and
all patent applications and issued patents generated by or on behalf of Selamine
or any Affiliate thereof, jointly or solely, in connection with performance
under this Agreement and any other agreement entered into between or among
Selamine or its Affiliates, on the one hand, and King or its Affiliates, on the
other hand, relating to [***], including without limitation performance of the
Permitted Uses, or otherwise in connection with the [***] or with generating or
obtaining Regulatory Approval of the [***]. The Parties to this Agreement may
update Schedule A thereto from time to time by mutual agreement to reflect newly
issued patents that claim [***] or uses or indications of or methods of making
Ramipril or products with Ramipril as the sole active ingredient.
1.23 "[***]" shall mean [***], including, but not limited to, all articles
claimed in the Ramipril Patents and the [***], but expressly excluding any
combinations of Ramipril together with any other active ingredient(s) or any
Ramipril formulation indicated for the treatment or prevention of diabetes.
1.24 "REGULATORY APPROVAL" shall mean final approval by the FDA or other
applicable Regulatory Authority to market a product in the Territory.
1.25 "REGULATORY AUTHORITY" shall mean the FDA or any counterpart of the
FDA outside the United States, or other national, supra-national, regional,
state or local regulatory agency, department, bureau, commission, council or
other governmental entity with authority over the distribution, importation,
exportation, manufacture, production, use, storage, transport or clinical
testing, pricing and/or sale of a product, including without limitation any
device incorporating the [***].
1.26 "RELEVANT THIRD PARTY" shall mean Third Party(ies), currently
party(ies) to an agreement with Selamine or its Affiliates, identified by King,
either orally or in writing, who holds or may hold intellectual property rights
relevant to [***] in the Territory.
1.27 "RELEVANT THIRD PARTY LICENSE" shall mean a license from any Relevant
Third Party, in writing, which license shall be effective to convey to King and
its Affiliates any and all rights under such Relevant Third Party's intellectual
property, to the extent Selamine or its Affiliate's Pre-Existing Relevant Third
Party Agreements do not already provide King and King's Affiliates with such
rights, that may be necessary to enable King and its Affiliates legally to use,
Market, sell, offer for sale, import, distribute and make [***] in
the Territory in accordance with the terms and conditions of this Agreement, and
any other agreement entered into between or among Selamine or its Affiliates, on
the one hand, and King or its Affiliates, on the other hand, relating to
[***].
1.28 "XXXXX XXXX" shall mean Xxxxx Xxxx Holdings Limited, a corporation
organized under the laws of Malta with its principal place of business at 00 Xx.
Xxxxxxxxxxx Xxxxxx, Xxxxxxxx VLT 08, Malta.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
A-4
1.29 "SELAMINE" shall mean Selamine Limited, a corporation organized under
the laws of Ireland with its principal place of business at Xxxx 0/0,
Xxxxxxxxxxxx Xxxxxxx, Xxxxxxxxxx, Xxxxxx 00, Xxxxxxx.
1.30 "SELAMINE PERCENTAGE" shall mean, at a particular time, the percentage
of Net Sales (as that term is defined in the Product Supply Agreement) that
Selamine is entitled to receive under the Product Supply Agreement at such time.
1.31 "TECHNOLOGY" shall mean non-patented, proprietary know-how, trade
secrets, inventions, discoveries, improvements, methods, materials and
information, including, without limitation, basic research data, clinical and
pre-clinical data, designs, formulas, materials, compounds, formulations,
pre-formulation experiments, and process information.
1.32 "TERRITORY" shall mean the United States.
1.33 "THIRD PARTY" shall mean any person other than a Party or an Affiliate
of a Party.
1.34 "WYETH" shall mean Wyeth, acting through its Wyeth Pharmaceuticals
Division (formerly American Home Products Corporation, acting through its
Wyeth-Ayerst Laboratories Division) or any of its Affiliates.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
A-5
SCHEDULE A
[***]
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
