EXHIBIT 10.7
FIRST AMENDMENT TO THE
U.S. PRODUCT AGREEMENT
THIS FIRST AMENDMENT to the U.S. Product Agreement, dated as of the 27th
day of February, 2006 ("First Amendment") is made and entered into by and
between Sanofi-Aventis U.S. LLC (formerly Hoechst Xxxxxx Xxxxxxx, Inc.), a U.S.
company ("Sanofi-Aventis US"), Sanofi-Aventis Deutschland GmbH (formerly Hoechst
Xxxxxx Xxxxxxx Deutschland GmbH), a German company ("SAD"), and King
Pharmaceuticals, Inc., a U.S. company ("King") (Sanofi-Aventis, SAD and King may
be referred to herein individually as a "Party" and collectively as the
"Parties"). Capitalized terms used in this First Amendment shall have the
meanings ascribed to them in the U.S. Product Agreement among the Parties dated
December 17, 1998, as supplemented by that certain Addendum dated June 30, 2000
(the "Product Agreement") unless otherwise expressly set forth herein.
RECITALS
WHEREAS, on December 17, 1998, Sanofi-Aventis, SAD and King entered into
the Product Agreement whereby Sanofi-Aventis and SAD granted certain rights to
Ramipril in the U.S. Territory to King; and
WHEREAS, the Parties wish to amend certain provisions of the Product
Agreement relating to its term and to improvements; and
WHEREAS, simultaneously with this First Amendment, SAD and King are
entering into an Amended and Restated U.S. Product Manufacturing Agreement, of
even date herewith, to effectuate certain additional modifications contemplated
by the Parties;
NOW, THEREFORE, pursuant to Section 11.2(b) of the Product Agreement,
Sanofi-Aventis, SAD and King agree to the terms and conditions of this First
Amendment as follows:
1. All references in the Product Agreement to "HMRI" or "Hoechst Xxxxxx
Xxxxxxx, Inc." shall be replaced with "Sanofi-Aventis US" or
"Sanofi-Aventis U.S. LLC," respectively; all references in the Product
Agreement to "HMR GmbH" or "Hoechst Xxxxxx Xxxxxxx Deutschland GmbH"
shall be replaced with "SAD" and "Sanofi-Aventis Deutschland GmbH",
respectively; and all references in the Product Agreement to "HMR" (by
which HMR and HMR GmbH are referred collectively in the Product
Agreement) shall be replaced with "Sanofi-Aventis".
2. Article I of the Product Agreement shall be amended by adding new
Sections 1.10(a), 1.12(a), 1.21(a), 1.21(b), 1.26(a) and 1.32(a) as
follows:
1.10(a) "Developed Data Agreement" shall mean that
certain agreement relating to a Ramipril/HCT combination product
being negotiated between SAD and King as of the date of execution
of the First Amendment to this Agreement.
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1.12(a) "Exclusivity Term" shall mean the term
beginning on December 17, 1998 and continuing until the later to
occur of (i) the Compound Patent Expiration Date or (ii) the
Pediatric Extension Expiration Date.
1.21(a) "Licensed Combination Product" shall mean a
Licensed Product that contains Ramipril as one of its active
ingredients and contains at least one additional active
ingredient.
1.21(b) "Licensed Mono-Product" shall mean a Licensed
Product that contains Ramipril as its sole active ingredient.
1.26(a) "Pediatric Extension Expiration Date" shall
mean the date of expiration of any pediatric exclusivity
extension that may be granted by the FDA to King for Licensed
Mono-Product, provided that in no event will such date extend
beyond April 30, 2009.
1.32(a) "Third Party" or "Third Parties" shall mean any
person other than Sanofi-Aventis US, SAD and King.
1.33 "U.S. Product Manufacturing Agreement" shall mean
the Amended and Restated U.S. Product Agreement entered into by
the parties of even date with the First Amendment to this
Agreement.
3. All references in the Product Agreement to "third party" or "third
parties" shall be replaced with "Third Party" or "Third Parties".
4. Section 2.1 of the Product Agreement shall be amended by deleting
Section 2.1 in its entirety and replacing in its stead the following:
2.1 Patent Rights and Schering Patent Rights.
(a) Patent Rights.
(i) During Exclusivity Term. Sanofi-Aventis hereby
grants to King an exclusive (including as to Sanofi-Aventis,
except as reserved in Section 2.3) license in the U.S. Territory
with the right to grant sublicenses in the U.S. Territory (upon
prior written approval of Sanofi-Aventis) under the Patent Rights
to make and have made Licensed Products from ramiprilat and, in
finished product form, from ramipril in Bulk Form supplied by
SAD, use (subject to Section 2.6), sell and have sold the
Licensed Product in the Field of Use until the end of the
Exclusivity Term.
(ii) After Exclusivity Term. Effective immediately
upon the expiration of the Exclusivity Term, Sanofi-Aventis
hereby grants to King the following:
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(A) Licensed Mono-Product. A license that is
exclusive with the right to grant sublicenses in the U.S.
Territory (upon prior written approval of Sanofi-Aventis) under
the Patent Rights to make, have made, use (subject to Section
2.6), sell and have sold the Licensed Mono-Products in the Field
of Use for the remaining term of this Agreement.
(B) Licensed Combination Products. A license
that is exclusive against Third Parties but non-exclusive as to
Sanofi-Aventis in the U.S. Territory with the right to grant
sublicenses in the U.S. Territory (upon prior written approval of
Sanofi-Aventis) under the Patent Rights to make, have made, use
(subject to Section 2.6), sell and have sold the Licensed
Combination Products in the Field of Use for the remaining term
of this Agreement. For the sake of clarity, Sanofi-Aventis shall
be entitled to make, have made, use, sell, have sold, develop or
have developed Licensed Combination Products in the U.S.
Territory after the end of the Exclusivity Term, subject to the
last sentence of Section 8.2(c). For the sake of further clarity,
in the event the Developed Data Agreement is executed,
Sanofi-Aventis' right to make, have made, use, sell, have sold,
develop or have developed "licensed products" (as such term is
defined in the Developed Data Agreement), will be subject to the
terms of the Developed Data Agreement, including without
limitation any exclusive rights granted to King thereunder.
(C) Development and Commercialization by
Sanofi-Aventis. For the sake of clarity, the parties acknowledge
and agree that, after the Exclusivity Term, Sanofi-Aventis shall
not grant an out-license except to Third Parties who are parties
to a collaboration agreement with Sanofi-Aventis to jointly
develop or jointly market Licensed Combination Products, and
shall not grant any such license or other right to any Third
Party to enable or permit such Third Party to commercialize any
Licensed Combination Product independent of Sanofi-Aventis.
(iii) The grant of rights to King under this
Section 2.1(a) is subject to the reservation of rights by
Sanofi-Aventis in Section 2.3.
(b) Schering Patent Rights.
(i) During Exclusivity Term. Sanofi-Aventis hereby
grants to King an exclusive (including as to Sanofi-Aventis,
except as reserved in Section 2.3) sublicense in the U.S.
Territory with the right to grant sublicenses in the U.S.
Territory (upon prior written approval of Sanofi-Aventis) under
the Schering Patent Rights with respect to Ramipril to make and
have made Licensed Products from ramiprilat and, in finished
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product form, from ramipril in Bulk Form supplied by SAD, use
(subject to Section 2.6), sell and have sold the Licensed Product
in the Field of Use until the earlier to occur of the end of the
Exclusivity Term or the termination of the Schering Agreement.
(ii) After Exclusivity Term. In the event the
Schering Agreement survives the end of the Exclusivity Term,
then, effective immediately upon the expiration of the
Exclusivity Term, Sanofi-Aventis hereby grants to King the
following:
(A) Licensed Mono-Products. A sublicense that
is exclusive in the U.S. Territory with the right to grant
sublicenses in the U.S. Territory (upon prior written approval of
Sanofi-Aventis) under the Schering Patent Rights with respect to
Ramipril to make, have made, use (subject to Section 2.6), sell
and have sold the Licensed Mono-Products in the Field of Use
until the earlier to occur of the termination of this Agreement
or the Schering Agreement; and
(B) Licensed Combination Products. A
sublicense that is exclusive against Third Parties but
non-exclusive as to Sanofi-Aventis, in the U.S. Territory with
the right to grant sublicenses in the U.S. Territory (upon prior
written approval of Sanofi-Aventis) under the Schering Patent
Rights with respect to Ramipril to make, have made, use (subject
to Section 2.6), sell and have sold the Licensed Combination
Products in the Field of Use until the earlier to occur of the
termination of this Agreement or the Schering Agreement. For the
sake of clarity, Sanofi-Aventis shall be entitled to make, have
made, use, sell, have sold, develop or have developed Licensed
Combination Products in the U.S. Territory after the end of the
Exclusivity Term, subject to the last sentence of Section 8.2(c).
For the sake of further clarity, in the event the Developed Data
Agreement is executed, Sanofi-Aventis' right to make, have made,
use, sell, have sold, develop or have developed "licensed
products" (as such term is defined in the Developed Data
Agreement) will be subject to the terms of the Developed Data
Agreement, including without limitation any exclusive rights
granted to King thereunder.
(iii) The grant of rights to King under this
Section 2.1(b) is subject to the reservation of rights by
Sanofi-Aventis in Section 2.3.
(c) Conversion to Non-Exclusive. In the event King
fails to make required payments consistent with the terms of
Sections 2.9(c) or 3.2(a) of the U.S. Product Manufacturing
Agreement (a "Payment Default"), and Sanofi-Aventis exercises its
right to liquidated damages pursuant to Section 3.2(c) of such
agreement, and terminates such agreement for such Payment Default
by King, pursuant to Section
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4.2(a) of such agreement, then (i) the rights and licenses
granted to King pursuant to this Agreement (including rights and
licenses to Improvements) shall, automatically, upon the
effective date of such termination become exclusive against Third
Parties but non-exclusive as to Sanofi-Aventis, with the right to
grant sublicenses in the U.S. Territory (upon prior written
approval of Sanofi-Aventis) to make, have made, use (subject to
Section 2.6), sell and have sold the Licensed Products in the
Field of Use for the remaining term of this Agreement, (ii) the
parties' rights to Improvements pursuant to Section 8.2 shall
terminate with respect to any Improvements discovered, made or
conceived after the effective date of such termination, and (iii)
the parties' rights to elect to acquire Improvements discovered,
made or conceived prior to the effective date of such termination
shall survive such termination on a non-exclusive basis as
described in Section 2.1(c)(i) hereof.
5. Section 2.2 of the Product Agreement is amended by deleting in its
entirety the first sentence and replacing in its stead the following:
Sanofi-Aventis hereby grants to King, and all
sublicensees hereunder, the non-exclusive right to use the
Ramipril Know-How disclosed by Sanofi-Aventis or its Affiliates
under this Agreement in the Field of Use for the term of this
Agreement in the U.S. Territory (a) during the Exclusivity Term,
to manufacture Licensed Products from ramiprilat (if any), and,
in finished product form, from ramipril in Bulk Form supplied by
Sanofi-Aventis, to use (subject to Section 2.6), sell and have
sold Licensed Product and (b) after the Exclusivity Term, to
manufacture, use (subject to Section 2.6), sell and have sold
Licensed Product.
6. Section 2.3 of the Product Agreement is amended by adding a sentence
at the end of subsection (d) as follows:
; and, subject to the provisions of Sections 2.1(a)(ii)
and 2.1(b)(ii) and the last sentence of 8.2(c), and further
subject to the terms and conditions of the Developed Data
Agreement, in the event such agreement is executed, with respect
to "licensed products" (as that term is defined in the Developed
Data Agreement) to make, have made, use, sell, have sold, develop
or have developed, whether inside or outside the U.S. Territory,
Licensed Combination Products after the Exclusivity Term.
7. Section 2.5 of the Product Agreement shall be amended by deleting
Section 2.5 in its entirety and replacing in its stead the following:
2.5 Sanofi-Aventis' Rights under Patent Rights and
Ramipril Know-How to Manufacture Ramipril. Sanofi-Aventis and its
Affiliates retain all rights under the Patent Rights and the
Ramipril Know-How to make and have made Product (as such term
defined in the U.S.
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Product Manufacturing Agreement). Pursuant to the U.S. Product
Manufacturing Agreement, SAD shall provide Product to King during
the Term (as such term is defined in the U.S. Product
Manufacturing Agreement) of the U.S. Product Manufacturing
Agreement, on the terms and conditions set forth in the U.S.
Product Manufacturing Agreement.
8. Article II of the Product Agreement shall be amended by adding a new
Section 2.10 as follows:
2.10 King's Rights Concerning Clinical Trials and
Development Work. King shall have the right to conduct Clinical
Trials and Experimental Uses in countries outside the U.S.
Territory in order to obtain and maintain regulatory approvals
for Licensed Product in the U.S. Territory; provided that the
right granted to King in this Section 2.10 shall be subject to
the requirements of Sections 2.6 and 3.1 of this Agreement and
provided further that King shall have no right to conduct such
activities in Canada for so long as Sanofi-Aventis continues to
own patents or have exclusive in-licensed rights to one or more
issued patents that claim the ramipril compound, which patents
have not been held invalid or unenforceable in a final,
unappealable decision.
9. Section 3.1(d)(iii) of the Product Agreement is amended to add the
following as its last sentence:
The parties acknowledge and agree that, pursuant to Sections
3.1(b) and 3.1(d), King has the right to request Requested
Meetings on an ad hoc basis, which meetings may be held by
teleconference, if so requested by either party, and shall be
held within thirty (30) days of King's request therefor. In
connection therewith, the parties agree to address issues
(Section 3.1(d)) in a timely manner and to cooperate in the
implementation of the process with respect to Requested Meetings
going forward.
10. Section 8.2 of the Product Agreement is amended by deleting the first
sentence of Section 8.2 in its entirety and replacing in its stead the
following:
8.2 Rights to Improvements. In the event that either party
discovers, makes or conceives of an Improvement (other than an
Excluded Combination Product) (a) during the term of this
Agreement, with respect to Licensed Mono-Products or (b) during
the Exclusivity Term with respect to Licensed Combination
Products, the following provisions apply:
11. Section 8.2(c) of the Product Agreement is amended by deleting Section
8.2(c) in its entirety and replacing in its stead the following:
(c) Procedure; Other Terms. The party discovering or
acquiring an Improvement shall give notice (the "Offer Notice")
to the other party of the discovery or acquisition of such
Improvement. The
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Offer Notice shall be given in a timely manner, and no later than
30 (thirty) days after receipt by the party discovering or
acquiring the Improvement of the final report of the study
results for the Phase IIB Clinical Trials of such Improvement.
Such Offer Notice shall include: (i) a description of the
Improvement; (ii) the Development Costs; and (iii) a form of the
license agreement containing such reasonable terms and conditions
as are customary in the pharmaceutical industry for products of a
similar commercial value. At any time within one hundred twenty
(120) days after receipt of an Offer Notice, the receiving party
may elect to acquire the Improvement on the terms and conditions
set forth in the Offer Notice, or on any such other terms and
conditions which the parties may negotiate in good faith.
Notwithstanding anything to the contrary in Section 2.1(a)(ii) or
2.1(b)(ii), any license granted to King pursuant to this Section
8.2(c) with respect to Improvements discovered, made or conceived
prior to the end of the Exclusivity Term on Licensed Combination
Products shall be and remain exclusive both during and after the
Exclusivity Term.
12. Article 8 of the Product Agreement shall be amended by adding new
Sections 8.3 and 8.4 as follows:
8.3 Rights to Improvements After the Compound Patent
Expiration Date. In the event that either party discovers, makes
or conceives an Improvement with respect to Licensed Combination
Products after the Exclusivity Term, such party shall have no
obligation to notify the other party of such Improvement or to
offer such other party any rights in such Improvement.
8.4 Notice of Improvements. Within thirty (30) days after
execution of the First Amendment to this Agreement, each party
shall provide to the other party the notice required under
Section 8.2(c) of any Improvements made by such party for which a
final report of the study results for such Phase IIB Clinical
Trials has been received by such party, or any Improvements which
exist in a later stage of development.
13. Section 11.1(a) of the Product Agreement is amended by deleting the
party names, addresses and facsimile numbers of the Sanofi-Aventis
notice parties and replacing them as follows:
If to Sanofi-Aventis to:
Sanofi-Aventis Deutschland GmbH
Attn: Legal Department
Xxxxxxxxxxxxxxx 00
00000 Xxxxxxxxx
0
Xxxxxxx
Fax: Legal Department No.: xx 00 00 000 00000
with a copy to:
Sanofi-Aventis
000 Xxxxxx xx Xxxxxx
00000 Xxxxx Xxxxxx
Attn: Head of Business Development
Facsimile: + 33 1 5377 4967
with a copy to:
Sanofi-Aventis
000 Xxxxxx xx Xxxxxx
00000 Xxxxx Xxxxxx
Attn: Head of Direction Juridique
Facsimile: x00-00-00-00-00-00
14. Except as modified by this First Amendment, all of the terms and
conditions of the Product Agreement shall remain in full force and
effect.
15. Articles X and XI of the Product Agreement are hereby incorporated
into this First Amendment.
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IN WITNESS WHEREOF, the Parties hereto have each caused this First
Amendment to the U.S. Product Agreement to be executed by their duly authorized
officers to be effective as of the date first written above.
KING PHARMACEUTICALS, INC. SANOFI-AVENTIS U. S. LLC
By: By:
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Name: Name:
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Title: Title:
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SANOFI-AVENTIS DEUTSCHLAND GMBH
By:
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Name:
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Title:
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SANOFI-AVENTIS DEUTSCHLAND GMBH
By:
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Name:
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Title:
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