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 00 Xx. Xxxxxxxxxxx Xxxxxx,
Xxxxxxxx VLT 08, Malta ("Arrow"), 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"), 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 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"). Arrow 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, 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 xxxxx Xxxx 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.
2.1 Application License. Subject to the terms and conditions of this
Agreement, Arrow and its Affiliates hereby xxxxx Xxxx and Xxxx'x 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 xxxxx Xxxx 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.
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2.4 Option to Acquire. Subject to the terms and conditions of this
Agreement and Applicable Law, Arrow and its Affiliates hereby xxxxx Xxxx 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
[***] 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
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 Xxxxx Xxxx 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
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
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
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 "Xxxx") 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 Xxxx to Xxxx for Xxxx'x review and approval. Arrow
and its Affiliates will comply with King's quality control standards, review
procedures and requirements regarding use of the Xxxx. 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
King's interest in the Xxxx, nor will Arrow or any Affiliate thereof adopt or
otherwise use any trademark, tradename, service xxxx, logo or symbol that is
confusingly similar to or likely to be confused with the Xxxx. Any goodwill
generated through the use by Arrow or its Affiliates of the Xxxx will inure to
the benefit of King. The foregoing license right shall not include the right to
use the Xxxx 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
Xxxx 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 Xxxx. Arrow and its
Affiliates hereby assign to King any and all rights it may acquire by operation
of law or otherwise in the Xxxx, 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 [***].
AMOUNT IN USD MILLIONS DUE DATE
---------------------- -----------------------------------
$25 Date of execution of this Agreement
$50 [***]
$25 See Section 5.3 hereof
(b) If the Parties do not receive Regulatory Approval of the Ramipril
Application or the Amended Ramipril Application in the Territory by [***].
AMOUNT IN USD MILLIONS DUE DATE
---------------------- -----------------------------------
$25 Date of execution of this Agreement
$25 [***]
$25 [***]
$25 See Section 5.3 hereof
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
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9
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 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
Arrow, or its Affiliates and all instruments and documents to be delivered by
Arrow or its Affiliates hereunder: (i) are within the corporate power of Arrow
or its Affiliates, respectively; (ii) have
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.
10
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 Arrow or its Affiliates, respectively; (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 Arrow or its Affiliates, respectively,
is a party or by which Arrow or its Affiliates, respectively, or any of the
property of either is bound, which violation would have a material adverse
effect on the financial condition of Arrow or its Affiliates, respectively, or
on the ability of Arrow or its Affiliates, respectively, 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 Arrow
constitutes a legal, valid and binding obligation of Arrow, enforceable against
Arrow 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 the knowledge of Arrow and its Affiliates, having made a
reasonable inquiry, there are no judicial, arbitral, regulatory or
administrative proceedings or investigations, claims, actions or suits related
to the Ramipril Application, Ramipril Know-How, or [***] pending against Arrow,
its Affiliates or any licensees of any of the same anywhere in the world, in any
court or by or before any government authority including, but not limited to,
product liability or compliance with cGMP or state or federal food and drug
laws.
(e) Arrow and its Affiliates are in compliance with all Applicable Law
in the Territory relating to the Ramipril Application, Ramipril Know-How and
[***], and neither Arrow nor any of its Affiliates has received any
communication from any Regulatory Authority indicating otherwise.
(f) Arrow owns all right, title and interest in and to the Ramipril
Application free and clear of all Encumbrances, and no person or entity other
than Arrow, including without limitation any current or former employee or
consultant of Arrow or its Affiliates, has any proprietary, commercial or other
interest in any of the Ramipril Application in the Territory. There are no
existing agreements, options, commitments, or rights with, of or to any person
or entity to acquire or obtain any rights to any of the Ramipril Application
entered into by Arrow or its Affiliates in the Territory. Arrow has the
unrestricted right to license to King all rights in the Ramipril Application in
the Territory granted herein, on the terms and conditions set forth herein, free
and clear of any rights or claims of any person or entity and, except as
disclosed to King with respect to Relevant Third Parties, without payment of any
royalty, licensee fee or other amount to any person or entity.
(g) To the knowledge of Arrow, the information contained in the
Ramipril Application, and any and all studies performed in connection therewith,
are in compliance with all Applicable Laws relating to the preparation and
filing of applications for Regulatory Approval to the FDA. All pre-clinical and
clinical work, studies, and trials conducted, supervised, or monitored by Arrow
with respect to the Ramipril Application have been
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SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
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11
conducted and performed in substantial compliance with Applicable Laws,
including Good Laboratory Practice, Good Clinical Practice, and cGMP
requirements and ICH Guidelines.
(h) To the knowledge of Arrow, the Ramipril Application includes all
of the sections, and is in the format, required by 21 C.F.R. Section 314.50.
6.2 Xxxxx Xxxx'x Representations and Warranties. Xxxxx Xxxx hereby
represents and warrants the following to King as of the Effective Date:
(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, respectively; (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 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 the knowledge of Xxxxx Xxxx, having made a reasonable inquiry,
there are no judicial, arbitral, regulatory or administrative proceedings or
investigations, claims, actions or suits related to the Ramipril Application,
Ramipril Know-How, or [***] pending against Xxxxx Xxxx anywhere in the world, in
any court or by or before any government authority, including but not limited
to, product liability or compliance with cGMP or state or federal food and drug
laws.
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.
12
(e) To the knowledge of Xxxxx Xxxx, the information contained in the
Ramipril Application, and any and all studies performed in connection therewith,
are in compliance with all Applicable Laws relating to the preparation and
filing of applications for Regulatory Approval to the FDA.
(f) To the knowledge of Xxxxx Xxxx, the Ramipril Application includes
all of the sections, and is in the format, required by 21 C.F.R. Section 314.50.
6.3 King's Representations and Warranties. King hereby represents and
warrants the following to Arrow 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 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) King is in compliance with the Applicable Laws in the Territory
relating to the King Materials and neither King nor any of its Affiliates has
received any correspondence from any Regulatory Authority in the Territory
indicating otherwise.
(e) Arrow and its Affiliates may exercise their rights and perform
their 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
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
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13
conditions of any other agreements 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 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.
(f) To King's knowledge, the use of the King Materials for the
Permitted Uses, in accordance with the terms and conditions of this Agreement
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 [***],
will not infringe or misappropriate the intellectual property rights of any
Third Party in the Territory as of the Effective Date, including any pending
patent applications, were same to be issued as patents.
(g) If Wyeth elects not to Participate or does not make any such
election, Wyeth shall not be entitled to any commercial benefit hereunder from
sales of [***] in the Territory. Except with respect to any additional payments
identified in Section 5.2 hereof or Section 2.12 of the Product Supply Agreement
as payable to Arrow or Arrow's Affiliates only in the event Wyeth elects to
Participate in [***], the pre-existing agreement between Wyeth and King does not
provide Wyeth with any right or other legal basis to materially alter the rights
or obligations of Arrow and its Affiliates hereunder, including in the event
Wyeth does not timely elect to Participate or elects not to Participate but
subsequently contends that it has retained such rights of election or
Participation.
6.4 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 APPLICATION, RAMIPRIL KNOW-HOW OR [***]. EACH PARTY EXPRESSLY DISCLAIMS
ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
NON-INFRINGEMENT. EXCEPT AS SET FORTH IN ARTICLE 7, IN NO EVENT SHALL ARROW,
XXXXX XXXX, XXXX OR THEIR AFFILIATES BE LIABLE FOR ANY INDIRECT, SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES.
7. INDEMNIFICATION
7.1 King Indemnification. King agrees to defend, indemnify and hold
harmless Arrow and its Affiliates and their respective directors, employees and
agents (the "Arrow Indemnitees") from and against [***] 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)
the willful misconduct or negligence of King or Aventis in the manufacture,
testing, storage and handling of the King Materials; (iv) Arrow's use of the
King Materials in accordance with the terms and conditions set forth herein,
including any product liability claims arising therefrom or relating thereto;
(v) 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 Arrow Indemnitee or to
the extent that Arrow is otherwise obligated to indemnify King under this
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.
14
7.2 Arrow Indemnification. Arrow 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 [***]
Liabilities resulting from any claim by a Third Party, arising out of or
relating to (i) the willful misconduct or negligence of Arrow or Xxxxx Xxxx; or
(ii) any material misrepresentation or breach of warranty of Arrow or Xxxxx Xxxx
contained in this Agreement or in any schedule hereto; or (iii) the willful
misconduct or negligence of Arrow or any Affiliate thereof in the manufacture,
testing, storage and handling of [***] made using the King Materials; (iv) any
material breach of any covenant or obligation of Arrow or Xxxxx Xxxx contained
in this Agreement; (iv) trade secret misappropriation by Arrow relating to the
Ramipril Application or (v) any infringement or misappropriation by either Party
or any Affiliate of either Party of any intellectual property rights of any
Relevant Third Party with respect to the [***] by virtue of the acts of either
Party or Affiliate thereof in accordance with the terms and conditions 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
relating to [***] or by virtue of the acts of Arrow or any Affiliate thereof in
contravention of the terms and conditions of such agreements; 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 Arrow under this Agreement.
7.3 Indemnification Procedure. A party (the "indemnitee") that intends to
claim indemnification under this Article 7 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 [***] 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 [***]. If the indemnitor so
assumes such defense, the indemnitee may participate therein through counsel of
its choice, [***]. The party not assuming the defense of any such claim will
render all reasonable assistance to the party assuming such defense, and [***].
No such claim will be settled other than by 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.
7.4 Xxxxx Xxxx Guarantee. To the extent any of the obligations herein apply
to Affiliates of Arrow, Xxxxx Xxxx agrees (a) to abide by such obligations as an
Affiliate of Arrow and (b) to cause each other Affiliate of Arrow 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.
8. CONFIDENTIALITY
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.
15
8.1 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 Application, any Amended Ramipril Application and Ramipril
Know-How 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.
8.2 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 8.2, 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.
8.3 Period of Obligation. This Article shall survive expiration or
termination of this Agreement for a period of [***] from the Effective Date.
8.4 Equitable Relief. Arrow and King each acknowledges that a breach by it
of Article 8 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 8 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 8.
9. TERM AND TERMINATION
9.1 Term. This Agreement will expire upon the later of (a) ten (10) years
from Regulatory Approval of the last of the [***], including any terms of
marketing exclusivity associated with the [***], and (b) 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.
9.2 Termination for Breach. Either Party may terminate this Agreement by
giving sixty (60) days' notice to the other Party if the other Party is in
material breach of this Agreement and fails to cure that breach within such
sixty (60) day period.
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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9.3 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 9.3 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 9.3, 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.
9.4 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 4.5 and 4.9 and Articles 6, 7, 8, 9 and
10; 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.
10. MISCELLANEOUS
10.1 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.
10.2 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.
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.
17
10.3 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.
10.4 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 this
Agreement or a waiver of any other right or remedy or the later exercise of any
right or remedy.
10.5 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.
10.6 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, Arrow 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: Arrow shall pay for
the arbitrator it chooses, King shall pay for the arbitrator it chooses, Arrow
and King shall equally share the cost of a neutral arbitrator, and each shall
otherwise bear its own costs
10.7 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 Arrow 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,
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.
18
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.
10.8 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.
10.9 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 ARROW:
00 Xx. Xxxxxxxxxxx Xxxxxx
Xxxxxxxx XXX00,
Xxxxx
Fax: 000 00 000000
Attention: Xxxx Xxxxxxxxx and Xxxxxx Xxxxxx
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
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.
19
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
COPY TO:
Xxxxx Day
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, XX 00000
Attention: F. Xxxxxxx Cerrito, Esq.
10.10 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 10.10(a) or 10.10(b), the Parties
will renegotiate the terms and conditions of this Agreement to resolve any
inequities.
10.11 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.
10.12 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.
** REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK **
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.
20
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.
ARROW INTERNATIONAL 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:
----------------------
CONFIDENTIAL TREATMENT REQUESTED
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.
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 "AMENDED RAMIPRIL APPLICATION" shall mean an amended Ramipril
Application seeking Regulatory Approval of a [***] made using the King
Materials as API, and all amendments and supplements thereto.
1.4 "API" shall mean active pharmaceutical ingredient.
1.5 "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.
1.6 "ARROW" shall mean Arrow International Limited, a corporation organized
under the laws of the Republic of Malta with its principal place of business at
00 Xx. Xxxxxxxxxxx Xxxxxx, Xxxxxxxx VLT 08, Malta.
1.7 "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.
1.8 "ARROW PERCENTAGE" shall mean, at a particular time, a percentage equal
to the percentage of Net Sales (as that term is defined in the Product Supply
Agreement) that Arrow's Affiliate is entitled to receive under the Product
Supply Agreement at such time.
1.9 "ASSURANCE" shall mean a determination, in the exercise of King's
business judgment, provided King will act reasonably and in good faith, and
taking into account any risks associated with unauthorized use of intellectual
property rights, that no Relevant Third Party possesses the ability to
materially impede King's right or ability legally to use, Market, offer for
sale, sell, import and distribute [***] in the Territory, except for any such
Relevant
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-1
Third Party who King determines, in its sole reasonable business judgment, has
no intention to exercise such ability.
1.10 "AVENTIS" shall mean Sanofi Aventis or any of its Affiliates.
1.11 "BANKRUPTCY CODE" shall mean the U.S. Bankruptcy Code, 11 U.S.C.
Sections 101 et seq.
1.12 "CGMP" shall mean the minimum standards for methods to be used in, and
the facilities or controls to be used for, the manufacture, processing, packing,
or holding of a drug to assure that such drug meets the requirements of the Act
as to safety, and has the identity and strength and meets the quality and purity
characteristics that it purports or is represented to possess. cGMP, or current
Good Manufacturing Practices, are established through FDA regulations (including
but not limited to 21 CFR Parts 210-211), FDA guidance and FDA current review
and inspection standards and current industry standards.
1.13 "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, Ramipril Application, Amended
Ramipril Application, Ramipril Know-How, [***], the Ramipril drug master file,
Technology, 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:
(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.
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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1.14 "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.
1.15 "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 Arrow 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.
1.16 "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.
1.17 "FDA" shall mean the United States Food and Drug Administration or any
successor organization and all agencies under their direct control.
1.18 "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 Arrow 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 permitted Third Parties. The term "Inventions" will
include the following: (i) any modification of, improvement to, or derivative
work of 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).
1.19 "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.
1.20 "KING MATERIALS" shall mean those certain active ingredients and/or
other proprietary materials owned and/or Controlled by King or King R&D and/or
Aventis and listed in Schedule C to this Agreement, which may be updated from
time to time only by mutual written agreement of the Parties.
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-3
1.21 "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.
1.22 "[***]" 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 Arrow or its Affiliates, on the one
hand, and King or its Affiliates, on the other hand, relating to [***].
1.23 "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).
1.24 "MARKET" shall mean promote, advertise, detail, sample and otherwise
market.
1.25 "PARTICIPATE(S)" shall mean that Wyeth has elected, under its
pre-existing agreement with King, to co-promote [***] in the Territory.
1.26 "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.
1.27 "PRE-EXISTING RELEVANT THIRD PARTY AGREEMENTS" shall have the meaning
set forth in Section 2.6(b) of this Agreement.
1.28 "PRODUCT SUPPLY AGREEMENT" shall mean that certain Product Supply
Agreement entered into among Arrow's Affiliate, Xxxxx Xxxx, Arrow Malta and King
on February 12, 2006.
1.29 "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.
1.30 "RAMIPRIL APPLICATION" shall mean Application Number [***], prepared,
owned and filed by Arrow and its Affiliates with the FDA, and all amendments and
supplements thereto.
1.31 "RAMIPRIL KNOW-HOW" shall mean all Technology relating to the
manufacture, finishing, formulation, or packaging of [***] that is owned or
Controlled by Arrow or any Affiliate thereof at any time 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,
relating to [***] including, without limitation, methods of production or use
of, and structural and functional information pertaining to or disclosed in,
Ramipril, the Ramipril Application and the Amended Ramipril Application.
1.32 "RAMIPRIL PATENTS" shall mean any and all of the following owned or
Controlled by Arrow or any of its Affiliates at any time during the Term of this
Agreement or any other
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
agreements entered into between or among Arrow 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 the other agreements entered into between or among Arrow or its Affiliates,
on the one hand, and King or its Affiliates, on the other hand, relating to
[***], as such agreements may be amended by the parties 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, and any and all continuations,
continuations-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
Arrow 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 Arrow or any Affiliate thereof, jointly or solely, in connection
with performance under 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 [***], including without limitation
performance of the Permitted Uses, or otherwise in connection with the [***] or
with generating or obtaining Regulatory Approval of the [***].
1.33 "[***]" 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.
1.34 "REGULATORY APPROVAL" shall mean final approval by the FDA or other
applicable Regulatory Authority to market a product in the Territory.
1.35 "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 [***].
1.36 "RELEVANT THIRD PARTY" shall have the meaning set forth in Section
2.6(a) of this Agreement.
1.37 "RELEVANT THIRD PARTY LICENSE" shall have the meaning set forth in
Section 2.6(a) of this Agreement.
1.38 "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-5
1.39 "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.
1.40 "TECH TRANSFER" shall mean cooperation between the Arrow and its
Affiliates, on the one hand, and King and its Affiliates, on the other hand, in
effecting an orderly transition of manufacturing matters with respect to [***],
including transferring copies of reasonably necessary information and files,
disclosing all reasonably necessary Ramipril Know-How and granting all necessary
rights of reference with respect to the FDA to King. To the extent Applicable
Law requires King or any of its Affiliates to control original documents, such
original documents will be provided to King or its Affiliates as part of the
Tech Transfer.
1.41 "TERRITORY" shall mean the United States.
1.42 "THIRD PARTY" shall mean any person other than a Party or an Affiliate
of a Party.
1.43 "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-6
SCHEDULE A
RIGHT OF REFERENCE LETTER FROM KING
February 15, 2006
Xxxxxx Xxxxxxxxxxx, M.D., Ph.D., Acting Director
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Cardiovascular and Renal Drug Products, Room 4160
0000-X Xxxxxxxxx Xxxx
Xxxxxxxxxx, XX 00000-0000
RE: ALTACE(R) (RAMIPRIL) CAPSULES
AUTHORIZATION TO REFERENCE NDA 19-901
Dear Xx. Xxxxxxxxxxx :
King Pharmaceuticals, Inc. hereby authorizes
Cobalt Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxx
Xxxxxxxxxxx, Xxxxxxx
Xxxxxx,
X0X 0X0
to reference its NDA [***] for Altace(R) (ramipril) Capsules in so far as it
supports the approval of Selamine's NDA for [***]. This authorization
also provides FDA access to the underlying raw data that provide the basis for
the reports of the investigations submitted within NDA [***].
Sincerely,
KING PHARMACEUTICALS, INC.
Xxxxxx X. Xxxxxx, III
EVP and Corporate Head, Regulatory Affairs
CC: Xx. Xxxxxx Xxxxx, Cobalt Pharmaceuticals, Inc.
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.
SCHEDULE B
LICENSED XXXX
ALTACE(R)
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.
SCHEDULE C
KING MATERIALS
[***]
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.
