AMENDED AND RESTATED STRATEGIC ALLIANCE AGREEMENTStrategic Alliance Agreement |
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<PAGE>
Exhibit 10.1
EXECUTION COPY
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
AMENDMENT AGREEMENT
This
amendment (this "2007 Amendment") to the Amended and Restated
Strategic Alliance Agreement dated as of April 2, 2002 (the "2002
Agreement") by
and between PENWEST PHARMACEUTICALS CO., a corporation organized
and existing
under the laws of the State of Washington, with its principal place
of business
at 39 Old Ridgebury Road, Danbury, Connecticut 06810 ("Penwest"),
and ENDO
PHARMACEUTICALS INC., a corporation organized and existing under
the laws of the
State of Delaware, with its principal place of business at 100
Painters Drive,
Chadds Ford, Pennsylvania 19317 ("Endo"), is entered into by and
between Penwest
and Endo this 7th day of January, 2007.
WHEREAS, pursuant to the 2002 Agreement, Penwest and Endo have
developed
and commercialized the Product, (as defined in the 2002
Agreement);
WHEREAS, under the terms of the 2002 Agreement, Endo is required to
pay
Royalties (as defined in the 2002 Agreement) to Penwest with
respect to the
Product based on Net Realization (as defined in the 2002 Agreement)
and other
factors set forth in the 2002 Agreement;
WHEREAS, certain disagreements have arisen between Penwest and
Endo
regarding the calculation of Royalties and other matters relating
to the
parties' respective rights and obligations under the 2002
Agreement; and
WHEREAS, in order to resolve their differences and for other
reasons, the
parties desire to modify the 2002 Agreement to provide that
Royalties be
calculated based on net sales of the Product in the United States
and to change
certain related provisions of the 2002 Agreement;
NOW,
THEREFORE, in consideration of the foregoing and the mutual
covenants
and conditions herein set forth, the receipt and sufficiency of
which
consideration are hereby acknowledged, the parties agree as
follows:
1.
DEFINITIONS
Capitalized terms used in this 2007 Amendment and not defined in
this 2007
Amendment shall have the meanings ascribed to them in the 2002
Agreement.
2. NET SALES
DEFINITION
The
Definitions Exhibit to the 2002 Agreement is hereby amended by
inserting immediately following Section 1.44 of the Definitions
Exhibit to the
2002 Agreement the following:
"1.45 "U.S. Product Net Sales" shall mean the gross amount invoiced
by Endo
and its Affiliates and sublicensees for the sale or other
disposition
of the Product to independent third parties in the United States
less
the following amounts, in each
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case determined in accordance with generally accepted
accounting
principles as consistently applied to all products of Endo: (i)
discounts, including cash discounts, discounts to managed care
or
similar organizations or government organizations, rebates
paid,
credited, accrued or actually taken, including government rebates
such
as Medicaid chargebacks or rebates, and retroactive price
reductions
or allowances actually allowed or granted from the invoiced
amount,
and commercially reasonable and customary fees paid to
distributors;
(ii) credits or allowances actually granted upon claims, rejections
or
returns of such sales of Product, including recalls, regardless of
the
party requesting the claim, rejection, or return; and (iii)
provisions
for actual uncollectible accounts.
1.46
"2007 Amendment" shall mean that certain Amendment Agreement dated
as
of January 7, 2007 by and between Penwest and Endo.
1.47
"2007 Amendment Effective Date" shall mean January 7, 2007."
3. CERTIFICATION
EXCESS
3.1
The 2002 Agreement is hereby amended by deleting Section 3.5.3 of
the
2002 Agreement in its entirety and inserting the following new
Section 3.5.3 in
its place:
"3.5.3 In view of Penwest having elected, as of March 18, 2003, not
to
participate further in the U.S. Certification Period, Section
6.7
shall apply and the other provisions of this Agreement shall remain
in
effect in accordance with their terms and the terms of Section
6.7;
provided, however, that, as the U.S. Certification Period ended
prior
to the 2007 Amendment Effective Date and the parties have agreed
that
the Certification Excess arising from the U.S. Certification
Period
shall be deemed to be $28,000,000 and shall not be subject to
further
adjustment, audit or dispute between the parties, and Endo shall
have
the right to recoup such Certification Excess solely through
the
Royalty reduction mechanism set forth in the immediately
following
sentence. Commencing at such time as cumulative Royalties
otherwise
(i.e., without giving effect to Section 4.5.2) payable to
Penwest
pursuant to Section 4.5.1 exceed $41,000,000, Endo shall pay
Penwest
fifty percent (50%) of the Royalties otherwise due under Section
4.5.1
until Endo has thereby recouped the $28,000,000 total
Certification
Excess."
3.2
The parties hereby agree that the Certification Excess with respect
to
the Product and the Certification Period for the Product in the
United States
shall equal $28,000,000; that such amount shall not be subject to
further
adjustment, audit or dispute between the parties; that neither of
the parties
shall have any obligation under Section 3.7 of the 2002 Agreement,
including
without limitation, no obligation on the part of Endo to issue
invoices under
Section 3.7; and that Penwest's sole and exclusive liability with
respect to the
Certification Excess with respect to the U.S. Certification Period
and the
expenditures, costs and other resources devoted by the parties to
U.S.
Certification Tasks during the Certification Period is the
reduction in
Royalties payable by Endo to Penwest set forth in Section 3.5.3 of
the 2002
Agreement, as
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<PAGE>
amended by this 2007 Amendment; provided, however, that, for the
sake of
clarity, the parties further acknowledge and agree that all amounts
previously
borne or paid by Penwest with respect to the U.S. Certification
Period shall not
be remitted to or otherwise recoupable by Penwest.
4. ROYALTIES AND
OTHER PAYMENTS
4.1
The 2002 Agreement is hereby amended by deleting Section 4.5 in
its
entirety and inserting the following new Section 4.5 in its
place:
"4.5
Royalties; Recoupment of Certification Excess.
4.5.1 U.S. Product Net Sales. With respect to Product sold or
otherwise disposed of in the United States in a calendar year,
Endo hereby agrees to pay to Penwest Royalties equal to the
following percentages of such calendar year U.S. Product Net
Sales:
<TABLE>
<CAPTION>
Calendar Year
Royalty Rate (as a percentage
U.S. Product Net Sales
of U.S. Product Net Sales)
----------------------
-----------------------------
<S>
<C>
Amounts less than $150,000,000
22%
Amounts greater than or equal to
25%
$150,000,000 and less than $[**]
Amounts greater than or equal to $[**] [**]%
and less than $[**]
Amounts greater than or equal to $[**] [**]%
and less than $[**]
Amounts greater than or equal to $[**] [**]%
and less than $1,000,000,000
Amounts greater than or equal to
30%
$1,000,000,000
</TABLE>
4.5.2 Notwithstanding Section 4.5.1, the first $41,000,000 in
cumulative Royalties otherwise payable by Endo to Penwest
pursuant to Section 4.5.1 (including, for purposes of clarity,
Royalties on all U.S. Product Net Sales commencing with the
commercial launch of the Product in 2006) shall not be payable
and the corresponding U.S. Product Net Sales shall be excluded
from Endo's Royalty obligations under Section 4.5.1; provided,
however, that such corresponding U.S. Product Net Sales shall
not
be excluded from the calculation of Calendar Year U.S. Product
Net Sales for purposes of calculating the Royalty rate under
Section 4.5.1 or of Calendar Year U.S. Product Net Sales for
purposes of Section 4.10. Any
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<PAGE>
exclusion pursuant to this Section 4.5.2 shall be reflected in
the statements provided for in Section 4.7.
4.5.3 With respect to Product sold or otherwise disposed of in
the
Territory outside the United States, Endo hereby agrees to pay
to
Penwest Royalties equal to the Applicable Percentage of the
relevant Net Realization from all units of the Product sold by
Endo and its distributors and licensees in the Territory
outside
the United States; provided that unless otherwise agreed by the
parties, development and commercialization of the Product in
the
Territory outside the United States shall be subject to Section
5.1(c) of the 2007 Amendment.
4.5.4 Bundling; Certain Other Sales. Endo, its Affiliates and
sublicensees shall be permitted to bundle the Product together
with any other product(s) in any sale or transfer of the
Product;
provided however that the revenues from such product bundles
shall be equitably allocated and none of Endo, its Affiliates
or
sublicensees shall disproportionately discount the Product
compared to the other product(s) in the bundle. None of Endo,
its
Affiliates or sublicensees shall make commercial sales of the
Product to independent third parties except in arm's-length
transactions for monetary consideration.
4.2
The 2002 Agreement is hereby amended by deleti






