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EXHIBIT 10.3
EXECUTION COPY
RAMIPRIL APPLICATION LICENSE AGREEMENT
This RAMIPRIL APPLICATION LICENSE AGREEMENT ("Agreement") is
entered
into as of the 12th day of February, 2006 (the "Effective Date")
among Arrow
International Limited, a corporation organized under the laws of
the Republic of
Malta with its principal place of business at 57 St. Christopher
Street,
Valletta VLT 08, Malta ("Arrow"), Robin Hood Holdings Limited, a
corporation
organized under the laws of Malta with its principal place of
business at 57 St.
Christopher Street, Valletta VLT 08, Malta ("Robin Hood"), King
Pharmaceuticals
Research and Development, Inc., a corporation organized under the
laws of
Delaware with its principal place of business at 4000 CentreGreen
Way, Suite
300, Cary, North Carolina USA ("King R&D"), and King
Pharmaceuticals, Inc., a
corporation organized under the laws of Tennessee with its
principal place of
business at 501 Fifth Avenue, Bristol, Tennessee 37620 USA
("King"). Arrow and
Robin Hood, 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, Arrow is the owner of Application Number [***] relating
to
[***] which was filed with the FDA ("Ramipril Application," as
further defined
in Appendix A); and
WHEREAS, Arrow owns or controls certain know-how relating to
[***]
("Ramipril Know-How," as further defined in Appendix A); and
WHEREAS, King wishes to license the Ramipril Application and
Ramipril
Know-How to use, Market, offer for sale, sell, import, distribute
and
manufacture [***] in the Territory, all on the terms and conditions
set forth
herein; and
WHEREAS, Arrow wishes to grant King such a license, as well as
an
exclusive option to acquire Arrow's entire right, title and
interest to the
Ramipril Application and any future filed Amended Ramipril
Application on the
terms and conditions set forth herein.
NOW THEREFORE, for good and valuable consideration, the
sufficiency
and receipt of which is hereby acknowledged:
1.
DEFINITIONS
All defined terms have the meaning set forth in Appendix A
hereto,
which is hereby incorporated by reference in its entirety.
2. LICENSE
GRANT
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.
<PAGE>
2.1
Application License. Subject to the terms and conditions of
this
Agreement, Arrow and its Affiliates hereby grant King and King's
Affiliates,
during the Term, an exclusive (even as to Arrow and its Affiliates,
except as
set forth in Section 2.3) right, with the right to sublicense the
Ramipril
Application and Amended Ramipril Application only (expressly
including any
Ramipril Know-How, to the extent embodied therein but not to the
extent any such
Ramipril Know-How is not embodied in such Ramipril Application or
Amended
Ramipril Application), under the Ramipril Application, the Amended
Ramipril
Application and the Ramipril Know-How, to use, offer for sale,
Market, sell,
import and distribute [***] in the Territory. Any sublicensees 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 grant King
the right to
manufacture, make or have made [***] anywhere in the world.
2.2
Grant of Manufacturing Rights. Arrow and its Affiliates hereby
grants
to King and its Affiliates, during the Term, an exclusive (except
as to Arrow
and its Affiliates) right, with the right to sublicense, under the
Ramipril
Application, the Amended Ramipril Application and the Ramipril
Know-How solely
to manufacture [***], 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 Arrow's material breach. At King's reasonable request, Arrow
and its
Affiliates shall cooperate with King in effecting a Tech Transfer
to King and
King's Affiliates with respect to [***]. Each Party shall bear its
own costs in
connection with any Tech Transfer.
2.3
Reservation of Rights. Arrow and its Affiliates shall maintain
ownership of the Ramipril Application, the Amended Ramipril
Application and the
Ramipril Know-How, unless and until King elects to exercise its
option as set
forth in Section 2.4 hereof, and except as otherwise expressly set
forth herein,
King is not granted any assignment or rights and any and all
implied licenses
are hereby disclaimed. Arrow and its Affiliates shall, as and to
the extent
Arrow or its Affiliates remain the owner of the Ramipril
Application and/or
Amended Ramipril Application, comply with all Applicable Laws with
regard to
such applications. Arrow shall retain rights under the Ramipril
Application, the
Amended Ramipril Application and the Ramipril Know-How to the
extent necessary
to permit Arrow to perform its obligations to King and King's
Affiliates as set
forth in this Agreement and any other agreement entered into
between or among
Arrow or its Affiliates, on the one hand, and King or its
Affiliates, on the
other hand, relating to [***] provided, however, that with respect
to the
Ramipril Application and the Amended Ramipril Application, such
reservation of
rights shall automatically and immediately cease if and when King
exercises its
option pursuant to Section 2.4 hereof, and effective upon such
exercise by King,
King grants to Arrow a license under the Ramipril Application and
the Amended
Ramipril Application to the extent necessary to permit Arrow to
perform its
obligations to King and King's Affiliates as set forth in this
Agreement and any
other agreement entered into between or among Arrow or its
Affiliates, on the
one hand, and King or its Affiliates, on the other hand, relating
to [***].
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
<PAGE>
2.4
Option to Acquire. Subject to the terms and conditions of this
Agreement and Applicable Law, Arrow and its Affiliates hereby grant
King an
exclusive option exercisable upon Regulatory Approval of the
Ramipril
Application or any Amended Ramipril Application to acquire Arrow's
and Arrow's
Affiliates' entire right, title and interest to the Ramipril
Application and any
Amended Ramipril Application held by Arrow and its Affiliates, free
and clear of
all Encumbrances. Neither Arrow nor any Affiliate thereof shall
grant to any
Third Party any right, title, interest or option with respect to
the Ramipril
Application or the Amended Ramipril Application, and shall retain
all right,
title and interest in same. Arrow shall provide King with notice of
tentative
Regulatory Approval of the Ramipril Application or of the Amended
Ramipril
Application within [***] of receiving same. King may exercise its
option,
subject to Applicable Law, by providing, within [***] of receipt by
King of such
notice from Arrow, written notice to Arrow of its election to so
exercise the
option and payment to Arrow of U.S. Dollars ("USD") $[***]. After
exercising its
option, King as owner of the Ramipril Application and/or Amended
Ramipril
Application shall comply with all Applicable Laws with regard to
such
applications. Notwithstanding King's option right, as set forth in
this Section
2.4, King's acquisition of the Ramipril Application and the Amended
Ramipril
Application shall constitute a transfer of title of same, and of
all rights and
interests derived from any Regulatory Authority with respect to
same, but shall
not operate to transfer title to King with respect to any Ramipril
Know-How
contained in either of same, and King's rights to such Ramipril
Know-How shall
at all times be subject to and governed by Sections 2.1 and 2.2
hereof.
2.5
Delivery. Within [***] of the Effective Date, Arrow shall deliver
to
King one complete copy of the Ramipril Application and Arrow shall
promptly
provide King with copies of all submissions made by Arrow or any
Affiliate
thereof or received by Arrow or any Affiliate thereof from any
Regulatory
Authority or other Third Party in connection with the Ramipril
Application or
the Amended Ramipril Application during the Term of this Agreement.
At King's
reasonable request, Arrow and its Affiliates shall promptly provide
such
additional written or other tangible materials in Arrow's or its
Affiliates'
possession that may be necessary or helpful to enable King to make
use of the
Ramipril Application or the Amended Ramipril Application as
authorized
hereunder.
2.6
Understanding Regarding Third Parties.
(a) Relevant Third Party License. Arrow and/or its Affiliates
are
currently parties to one or more agreements with Third Parties
relating to
[***], as previously disclosed to King. Upon notification by King,
Arrow shall
approach such Third Party(ies), currently party(ies) to an
agreement with Arrow
or its Affiliates, identified by King, either orally or in writing,
who holds or
may hold intellectual property rights relevant to [***] in the
Territory
("Relevant Third Party") in order to negotiate in good faith to
secure a license
from any such Relevant Third Party, to the extent Arrow's
Pre-Existing Relevant
Third Party Agreements do not already provide King and King's
Affiliates with
such rights. Arrow shall, or shall cause its Affiliates, to use
commercially
reasonable efforts, at Arrow's expense, to secure a license from
any such
Relevant Third Party, in writing, to the extent Arrow's
Pre-Existing Relevant
Third Party Agreements do not already provide King and King's
Affiliates with
such rights, which license shall be effective to convey to King and
its
Affiliates any and all rights under such Relevant Third Party's
intellectual
property that may be necessary to enable King and its Affiliates
legally to use,
Market, sell, offer for sale, import, distribute and make
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
<PAGE>
[***] in the Territory in accordance with the terms and conditions
of this
Agreement, and any other agreement entered into between or among
Arrow or its
Affiliates, on the one hand, and King or its Affiliates, on the
other hand,
relating to [***] ("Relevant Third Party License"). In the event
Arrow fails to
use such commercially reasonable efforts, as set forth in the
immediately
preceding sentence, King's sole remedy hereunder shall be as
specified in
Section 5.3 below.
(b) Efforts Regarding Relevant Third Party License Exclusivity.
Upon
notification by King of a Relevant Third Party, Arrow shall
approach such
Relevant Third Party in order to negotiate in good faith to obtain
exclusive
intellectual property rights under a Relevant Third Party License.
Arrow shall,
in consultation with King, use commercially reasonable efforts to
secure for
King and King's Affiliates exclusive intellectual property rights
in the
Territory under any Relevant Third Party Licenses, to the extent
Arrow's
Pre-Existing Relevant Third Party Agreements do not already provide
King and
King's Affiliates with such exclusivity. In the event Arrow fails
to use such
commercially reasonable efforts, as set forth in the immediately
preceding
sentence, King's sole remedy hereunder shall be to launch, in the
Territory, a
[***] that is a [***].
(c) Fulfillment and Observance of Certain Obligations to
Relevant
Third Parties. Notwithstanding anything to the contrary herein,
King
acknowledges and agrees that Arrow and/or its Affiliates are
subject to certain
obligations under its pre-existing agreements with Relevant Third
Parties
("Pre-Existing Relevant Third Party Agreements"). Arrow shall not
amend,
terminate or cause to be terminated any Pre-Existing Relevant Third
Party
Agreements without the prior written consent of King, not to be
unreasonably
withheld, provided that Arrow shall have the right to amend its
Pre-Existing
Relevant Third Party Agreements without the consent of King if, and
only if,
such amendment does not in any way alter the rights or obligations
of King
hereunder or under any other agreement entered into between or
among Arrow or
its Affiliates, on the one hand, and King or its Affiliates, on the
other hand,
relating to [***]. Similarly, Arrow shall not exercise or fail to
exercise any
of Arrow's material rights or obligations under any Pre-Existing
Relevant Third
Party Agreements to the extent such exercise or failure to exercise
would alter
the rights or obligations of King under this Agreement, or any
other agreement
entered into between or among Arrow or its Affiliates, on the one
hand, and King
or its Affiliates, on the other hand, relating to [***], without
the prior
written consent of King, not to be unreasonably withheld. At the
reasonable
request of King, Arrow shall exercise such rights and make such
requests with
respect to [***] as are permitted under the Pre-Existing Relevant
Third Party
Agreements. Arrow will use commercially reasonable efforts to
comply with all
obligations and duties under the Pre-Existing Relevant Third Party
Agreements
including any provisions necessary to maintain in effect any rights
granted to
King or King Affiliates hereunder and, if applicable, the exclusive
nature of
such rights, including the preservation of King's rights hereunder
in the event
that Arrow shall breach or default on its obligations under the
Pre-Existing
Relevant Third Party Agreements. If Arrow should at any time breach
or default
on the Pre-Existing Relevant Third Party Agreements or become
unable to timely
perform its obligations thereunder, or receive notice that it may
be, is or is
deemed to be in breach or default of the Pre-Existing Relevant
Third Party
Agreements or has otherwise given rise to a right on the part of
the Relevant
Third Party to terminate Arrow's license in whole or in part, Arrow
shall
immediately notify King, and King shall be permitted to
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
<PAGE>
cure such breach or default, in accordance with the terms and
conditions of the
Pre-Existing Relevant Third Party Agreements or otherwise resolve
such breach or
default directly with the Relevant Third Party; provided that such
cure or
resolution shall not diminish the rights of Arrow under the
Pre-Existing
Relevant Third Party Agreements. Arrow agrees to use commercially
reasonable
efforts to amend any Pre-Existing Relevant Third Party Agreements
to provide
that if such Pre-Existing Relevant Third Party Agreements should
terminate or
expire for any reason other than termination as a consequence of
King's breach
or default of its obligations under this Agreement or any other
agreement
entered into between or among Arrow or its Affiliates, on the one
hand, and King
or its Affiliates, on the other hand, relating to [***], then
King's rights
thereunder shall continue in full force and effect provided that
King promptly
agrees in writing to be bound by the applicable terms and
conditions of the
Pre-Existing Relevant Third Party Agreements.
(d) King and its Affiliates will not amend or vary their
pre-existing
agreements with Aventis and/or its Affiliates or Wyeth and/or its
Affiliates, or
enter into new agreements with Aventis and/or its Affiliates or
Wyeth and/or its
Affiliates, in a manner that would cause Arrow and its Affiliates'
rights or
performance hereunder, or under the Product Supply Agreement, or
any other
agreement entered into between or among Arrow or its Affiliates, on
the one
hand, and King or its Affiliates, on the other hand, relating to
[***], to be
impaired or restricted by such amendment, variation, or new
agreement.
2.7
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 Arrow or
its Affiliates, on the one hand, and King or its Affiliates, on the
other hand,
relating to [***], 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. Arrow and
King agree that
they shall jointly own all right, title and interest in and to any
Technology
and Ramipril Know-How in any and all such inventions.
2.8
Assignment to Arrow. In order to effectuate the rights and
licenses
granted to King and King's Affiliates hereunder, Arrow and Robin
Hood shall
cause each Affiliate of Arrow to, and each hereby does, either (a)
transfer,
assign, and convey to Arrow, its successors and assigns, forever,
all right,
title, and interest in and to, or (b) grant to Arrow an exclusive
license of all
rights under, in each case, all Ramipril Know-How developed by each
such
Affiliate, jointly or solely, during the Term of this Agreement,
and any other
agreement entered into between or among Arrow or its Affiliates, on
the one
hand, and King or its Affiliates, on the other hand.
2.9
Third Party Know-How Misappropriation. If either Party or any
Affiliate
thereof becomes aware of actual or threatened misappropriation by a
Third Party
of any Ramipril Know-How 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, at its own expense, an
action against
any such Third Party ("Action"), and to use Arrow and its
Affiliate's name(s) as
required in connection therewith and Arrow and its Affiliates
hereby consents to
jurisdiction and venue if King names Arrow or any Affiliate thereof
as a party
thereto. King shall have full control over the conduct of any
Action, including
settlement thereof. Arrow shall have the right
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
<PAGE>
to provide comments to King with respect to any such Action, which
King shall
consider in good faith. King shall provide notice to Arrow 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
misappropriation, then Arrow, after notifying King in writing,
shall be entitled
to bring such Action at its own expense. Arrow shall have full
control over the
conduct of such Action. King shall have the right to provide
comments to Arrow
with respect to any such Action, which Arrow shall consider in good
faith. Arrow
may not settle any Action without prior written notice to King. In
any event,
King and Arrow and their Affiliates shall assist one another and
cooperate in
any such Action at the other's request without expense to 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 their respective, actual out-of-pocket
litigation
expenses, or equitable proportions thereof, 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
misappropriated sales of
[***], provided that King shall be obligated to pay to Arrow the
Arrow
Percentage 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 Arrow
receiving an amount equal to the Arrow Percentage of such remainder
and King
receiving the balance of such remainder.
3. REGULATORY
MATTERS
3.1
Scope of Arrow Obligations. Arrow and its Affiliates will use
commercially reasonable efforts to obtain Regulatory Approval of
the Ramipril
Application and the Amended Ramipril Application in the Territory,
including the
performance, outside the Territory, of all preclinical, clinical
and other
scientific studies necessary to obtain Regulatory Approval of the
Ramipril
Application and the Amended Ramipril Application. King will use
reasonable
efforts to assist and cooperate with Arrow and its Affiliates to
obtain such
Regulatory Approval in the Territory.
3.2
Expenses. King shall be responsible for [***] expenses associated
with
filing and obtaining Regulatory Approval in the Territory of the
Ramipril
Application and the Amended Ramipril Application, including all
expenses
relating to preclinical, clinical and other scientific studies
performed by
Arrow to obtain Regulatory Approval for [***] in the Territory.
3.3
Other Ramipril Products. Arrow and King agree that neither Party
nor
any of its Affiliates shall engage, directly or indirectly, in
Development
relating to [***], including any existing and future developed
[***]
formulations, with any Third Party without the other of King or
Arrow, except to
the extent set forth in King's pre-existing agreements with
Aventis. Arrow
further agrees that neither it nor any Affiliate will engage in
Development of
any formulation that is used in a [***] with respect to a product
to be labeled
for the treatment or prevention of diabetes. Arrow further agrees
that neither
it nor any if its Affiliates shall engage in Development 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 on
commercially reasonably terms and negotiating in good faith with
King, at King's
election, for such rights to [***]. Notwithstanding anything to the
contrary in
this Agreement, or any other agreement
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
<PAGE>
entered into between or among Arrow or its Affiliates, on the one
hand, and
King or its Affiliates, on the other hand, relating to [***], King
and its
Affiliates shall have the unrestricted right to Develop and file
for Regulatory
Approval of any [***] that is a [***], provided that King and its
Affiliates
agree not to launch a [***] that is a [***] unless (a) on or before
the date on
which the first [***] that is not a [***] receives Regulatory
Approval, Arrow
and its Affiliates have not secured all Relevant Third Party
Licenses and King
does not otherwise have Assurance with respect to such [***] that
is not a [***]
or (b) at any time during the term of this Agreement, or any other
agreement
entered into between or among Arrow or its Affiliates, on the one
hand, and King
or its Affiliates, on the other hand, King or Arrow or any
Affiliate of either
is permanently enjoined from using, Marketing, offering for sale,
selling,
importing, distributing or making any [***] that is not a [***] in
the Territory
or (c) the Parties otherwise agree, taking into consideration all
financial and
legal factors relevant to using, Marketing, offering for sale,
selling,
importing, distributing or making any [***] that is not a [***] in
the
Territory.
4. TRANSFER OF
KING MATERIALS
4.1
Transfer of King Materials. As soon as practicable after the
Effective
Date, King agrees to deliver or have delivered to Arrow a sample of
each of the
King Materials in an amount sufficient, as mutually agreed upon by
the Parties,
for Arrow or its Affiliates to perform the Permitted Uses (as
defined below in
Section 4.7). If, during the conduct of the Permitted Uses,
additional amounts
of any of the King Materials are necessary, as determined by the
Parties, in
order to continue or complete the Permitted Uses, King shall
provide same to
Arrow, at King's sole expense and to the extent available. Arrow
and its
Affiliates shall treat the King Materials as Confidential
Information, in
accordance with Article 8 hereof.
4.2
Grant of Rights to Arrow. King hereby grants to Arrow and its
Affiliates during the Term a non-exclusive, nontransferable,
non-sublicensable,
fully paid-up, royalty free, personal right to use the King
Materials solely to
conduct Permitted Uses in accordance with the terms and conditions
of this
Agreement.
4.3
Use of King Materials. The Permitted Uses may be engaged in only
by
Arrow, its Affiliates, and their respective employees and
consultants, provided
that any such employee or consultant first agrees in writing to be
bound by the
provisions of this Agreement as they apply to Arrow or its
Affiliates, or is
already bound by a written agreement executed by both such employee
and Arrow or
its Affiliates that requires such employee or consultant (a) to
treat King's
Confidential Information as confidential according to provisions at
least as
stringent as those set forth herein and (b) to assign all right,
title and
interest in and to any Patents, Technology, and other intellectual
property
rights that may be developed hereunder by such employee or
consultant to Arrow
or its Affiliates. Arrow and its Affiliates agree to use the King
Materials
solely to engage in Permitted Uses. Arrow further agrees that the
King Materials
will not be made available, transferred, or provided to anyone
outside of Arrow
and its Affiliates without King's express prior written approval,
such consent
not to be unreasonably withheld.
4.4
Compliance with Applicable Laws. King will not knowingly supply
Arrow
or its Affiliates with King Materials pursuant to this Agreement
that are not
manufactured in compliance with all Applicable Laws and cGMP.
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
<PAGE>
4.5
Return of Unused King Materials. Upon the earlier of (a) completion
of
the Permitted Uses or (b) termination or expiration of this
Agreement, Arrow and
its Affiliates shall, at King's option, return to King or destroy
all unused
King Materials in Arrow's or its Affiliates' possession, including,
in the event
reasonably necessary to preserve King's rights or observe King's
obligations
with respect to any Third Party, any documents, materials, models,
exhibits, and
samples that incorporate same, provided that Arrow and its
Affiliates may retain
one copy of all such documents, materials, models, exhibits and
samples for
record-keeping purposes only.
4.6
Use In Accordance With Applicable Laws. Arrow and its Affiliates
agree
to engage in the Permitted Uses in accordance with Applicable Law,
including
without limitation any applicable provisions of the Federal Food,
Drug and
Cosmetic Act, as amended, and the regulations issued under such
Act.
4.7
Permitted Uses. Arrow and its Affiliates hereby agree to perform
the
following activities using the King Materials, and to do so in
accordance with
the terms and conditions of this Agreement (the "Permitted Uses"),
and not to
use the King Materials for any other purpose whatsoever.
(a) As set forth in Section 3.1, Arrow and its Affiliates will
use
commercially reasonable efforts to obtain Regulatory Approval of
the Amended
Ramipril Application in the Territory, including the performance,
outside the
Territory, of all preclinical, clinical and other scientific
studies necessary
to obtain Regulatory Approval of same, and may use the King
Materials as
necessary in connection therewith.
(b) King hereby grants to Arrow and its Affiliates the right to
reference King's New Drug Application Number [***] in the Ramipril
Application
and Amended Ramipril Application. Within [***] following the
Effective Date
hereof, King shall file with the FDA a letter granting Arrow the
foregoing right
of reference, substantially in the form attached as Schedule A.
(c) As soon as reasonably practicable after receiving the King
Materials from King, Arrow or its Affiliates shall re-formulate the
[***] using
the King Materials as the active ingredient and manufacture a
stability batch
and conduct necessary testing, in a manner and in a quantity
appropriate to
generate data adequate to file an Amended Ramipril Application with
the FDA for
purposes of obtaining Regulatory Approval of same.
4.8
Trademark License. King hereby grants to Arrow and its Affiliates
a
non-exclusive, royalty-free right and license to use the trademark
Altace(R)
(the "Mark") in the form set forth on Schedule B, solely for
purposes of
providing the FDA with sample labeling and a proposed product
insert for the
[***] as part of the Amended Ramipril Application, and to the
extent necessary
to enable Arrow, its Affiliates, or Third Parties qualified by
Arrow or any of
its Affiliates in accordance with Section 4.1 of the Product Supply
Agreement,
to manufacture [***] for King and King's Affiliates pursuant to the
terms and
conditions of the Product Supply Agreement. Arrow and its
Affiliates will submit
any materials containing the Mark to King for King's review and
approval. Arrow
and its Affiliates will comply with King's quality control
standards, review
procedures and requirements regarding use of the Mark. Neither
Arrow nor any
Affiliate thereof will take any action to register or otherwise
interfere with
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
<PAGE>
King's interest in the Mark, nor will Arrow or any Affiliate
thereof adopt or
otherwise use any trademark, tradename, service mark, logo or
symbol that is
confusingly similar to or likely to be confused with the Mark. Any
goodwill
generated through the use by Arrow or its Affiliates of the Mark
will inure to
the benefit of King. The foregoing license right shall not include
the right to
use the Mark for purposes of selling [***], except to the extent
necessary to
enable Arrow or its Affiliates to manufacture [***] for King and
King's
Affiliates pursuant to the terms and conditions of the Product
Supply Agreement,
or for any other purposes whatsoever not specifically enumerated in
this
Agreement. Arrow and its Affiliates acknowledge King's sole
ownership of the
Mark and all goodwill associated therewith. Nothing in this
Agreement or that
might otherwise be implied by law shall operate to grant Arrow or
any Affiliate
thereof any right, title, or interest in or to the Mark. Arrow and
its
Affiliates hereby assign to King any and all rights it may acquire
by operation
of law or otherwise in the Mark, including, without limitation, any
goodwill
associated therewith.
4.9
Ownership Rights. Except as otherwise expressly provided in
this
Agreement, King and/or Aventis, as applicable, shall retain all
right, title,
and interest in and to the King Materials, including but not
limited to all
right, title, and interest in Patents, Technology, and other
intellectual
property rights covering the King Materials. Except as set forth in
Sections 4.2
and 4.7, no right or interest in or to any Technology, Patents or
other
intellectual property rights of King is granted or implied
hereunder.
5. PAYMENTS
5.1
Payment. As consideration for the rights granted herein, King shall
pay
Arrow as set forth below:
(a) If the Parties receive Regulatory Approval of the Ramipril
Application or the Amended Ramipril Application in the Territory by
[***].
<TABLE>
<CAPTION>
AMOUNT IN USD MILLIONS
DUE DATE
----------------------
-----------------------------------
<S>
<C>
$25
Date of execution of this Agreement
$50
[***]
$25
See Section 5.3 hereof
</TABLE>
(b) If the Parties do not receive Regulatory Approval of the
Ramipril
Application or the Amended Ramipril Application in the Territory by
[***].
<TABLE>
<CAPTION>
AMOUNT IN USD MILLIONS
DUE DATE
----------------------
-----------------------------------
<S>
<C>
$25
Date of execution of this Agreement
$25
[***]
$25
[***]
$25
See Section 5.3 hereof
</TABLE>
5.2
Wyeth Participation. Within [***] after the Effective Date hereof,
King
shall notify Wyeth in writing of the existence of this Agreement
solely to
determine whether Wyeth will Participate with respect to the [***].
Within [***]
after the Effective Date, King
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.
9
<PAGE>
agrees to use commercially reasonable efforts to determine whether
Wyeth will
Participate with respect to the [***] and to notify Arrow in
writing thereof. If
Wyeth elects to Participate, King shall immediately notify Arrow in
writing
thereof and, within [***] of Wyeth's election to Participate, King
shall pay
Arrow an amount equal to the sum of all payments due prior to the
date of
Wyeth's election to Participate under Section 5.1. Following the
date of Wyeth's
election to Participate, King's payments to Arrow shall be equal to
[***] the
remaining payments set forth under Section 5.1. Notwithstanding the
foregoing,
the payments to Arrow described in this Section 5.2 are intended to
be paid by
Wyeth to King, and then by King to Arrow, and King's obligation to
make the
payments to Arrow described in this Section 5.2 as a result of
Wyeth's
Participation is subject to Wyeth making such payments, in full, to
King. To the
extent Wyeth does not make the payments, in full, to King, then
either (a) King
shall cause Wyeth to cure such failure to make such payments within
[***], in
which case Wyeth's election to Participate shall continue in full
force and
effect or (a) effective upon the expiration of such [***] period,
Wyeth shall no
longer be entitled to any commercial benefit hereunder from sales
of [***] in
the Territory despite its election to Participate, and,
notwithstanding Wyeth's
election to Participate, shall be deemed not to have so elected
through its
default in payments to King. For illustrative purposes, [***], King
shall pay
Arrow a total of USD $100 million if Wyeth does not Participate and
[***].
5.3
Relevant Third Party Adjustment. Notwithstanding anything to
the
contrary in Sections 5.1 or 5.2 hereof, the Parties acknowledge and
agree that
the obligation to make the last milestone payment, whether [***]
("Last
Milestone"), shall be subject to the following conditions. In the
event, by June
1, 2007 (a) [***] or (ii) [***], or (b) [***], then the Last
Milestone shall be
payable on [***]. If any one of the conditions of subsections
(a)(i) or (ii) or
(b) of this Section 5.3 is first met between [***], then the Last
Milestone
shall be payable within [***] of such condition being met. If none
of such
conditions are met by [***], then Arrow shall not be entitled to
receive, and
King shall have no obligation to pay, the Last Milestone.
6.
REPRESENTATIONS AND WARRANTIES
6.1
Arrow's Representations and Warranties. Arrow hereby represents
and
warrants the following to King as of the Effective Date:
(a) Arrow (i) is a corporation duly organized, validly existing,
and
in good standing under the laws of the Republic 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
