Confidential
treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality
request. Omissions are designated as [***]. A complete version of
this exhibit has been filed separately with the Securities and
Exchange Commission.
This Supply
Agreement (“Agreement”) is dated as of the 4th day of
September, 2003 by and between Andrx Pharmaceuticals, Inc., a
Florida Corporation (“hereinafter referred to as
“ANDRX”) with offices located at 4955 Orange Dr.,
Davie, FL, 33314 and Pfizer Inc., a Delaware corporation
(hereinafter referred to as “PFIZER”), with offices
located at 235 East 42 nd Street, New York, New York
l0017-5755.
WHEREAS, ANDRX,
and/or certain of its Affiliates, have filed with the FDA two
Abbreviated New Drug Applications, ANDA Nos. 76-159 and 76-621,
seeking approval to engage in the commercial manufacture, use,
offer for sale and sale of Glipizide Extended-release Tablets in 10
mg dosage strength (ANDA No. 76-159), and in 5 mg and 2.5 mg
dosage strengths (ANDA No. 76-621) (collectively, “ANDRX
ANDA Products”); and
WHEREAS, ANDRX and
certain of its Affiliates have entered into a Settlement Agreement
with PFIZER and ALZA CORPORATION pursuant to which PFIZER and ANDRX
are entering into this Agreement, which provides that ANDRX, for
the term stated herein, may market, sell, and distribute on a
non-exclusive basis (except as hereinafter provided) the Products
(as hereinafter defined) for PFIZER.
NOW, THEREFORE, in
consideration of the premises set forth and covenants exchanged
herein and other good and valuable consideration, the sufficiency
and receipt of which are hereby acknowledged, ANDRX and PFIZER
intending to be legally bound agree as follows:
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1.1
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“Affiliate(s)” shall
mean any corporation, association, company, organization or other
entity that directly or indirectly through one or more
intermediaries, controls, is controlled by, or is under common
control with ANDRX or PFIZER, as the case may be. For purposes of
this definition, control means the ability, directly or indirectly,
through ownership of securities, by agreement, or by any other
method, to direct more than fifty percent (50%) of the outstanding
equity votes of any entity, whether or not represented by
securities, or to otherwise control the management decisions of any
entity.
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1.2
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“Agreement” shall have
the meaning set forth in the first sentence hereof.
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1.3
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“Alza/Pfizer License
Agreement” shall mean the Development and U.S. License
Agreement dated November 5, 1993 between ALZA CORPORATION and
PFIZER INC.
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1.4
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“ANDRX” shall have the
meaning set forth in the first sentence hereof.
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1.5
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“ANDRX Activities” shall
have the meaning set forth in Section 8.1 hereof.
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1.6
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“ANDRX ANDA Products”
shall have the meaning specified in the first recital.
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1.7
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“cGMPs” shall mean
Current Good Manufacturing Practices as defined in 21 CFR §210
et seq., as amended from time to time.
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1.8
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“Calendar Quarter” shall
mean those three (3) month periods beginning on
January 1, April 1, July 1, and October
1.
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1.9
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“COA” shall have the
meaning set forth in Section 5.1 hereof.
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1.10
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“Commencement Date”
shall mean January 1, 2004 or such earlier date as ANDRX
receives FDA approval for a product described in either its ANDA
No. 76-159 or its ANDA No. 76-621; provided, however,
that in no event shall the Commencement Date be earlier than
November 25, 2003.
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1.11
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“Commercially Reasonable
Efforts” shall mean that degree of effort, expertise and
resources that a person of ordinary skill, ability and experience
in the matters addressed herein would utilize and otherwise apply
with respect to fulfilling the obligations assumed
hereunder.
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1.12
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“Confidential
Information” shall have the meaning set forth in
Section 9.1 hereof.
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1.13
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“FDA” shall mean the
Food and Drug Administration of the United States.
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1.14
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“FFDCA” shall mean the
Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C.
§301 et seq., and any related federal and/or state law or
regulation pertaining to the safety, effectiveness, adulteration,
misbranding, mishandling, packaging, labeling or storage of
pharmaceutical ingredients, finished pharmaceutical products,
and/or medical devices that may be applicable to the Product during
the term of this Agreement.
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1.15
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“Firm Order” shall mean
a firm, binding, written order for Product to be manufactured by
PFIZER, specifying quantities and delivery schedules for each
Product. Firm Orders must be in full lot size quantities as
described in Exhibit A.
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1.16
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“GAAP” means generally
accepted accounting principles in the United States of America,
consistently applied.
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1.17
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“Indemnified Party”
shall have the meaning set forth in Section 8.3
hereof.
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1.18
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“Indemnifying Party”
shall have the meaning set forth in Section 8.3
hereof.
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1.19
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“Initial Term” shall
have the meaning set forth in Section 7.1 hereof.
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1.20
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“Intellectual Property”
shall mean all intellectual property owned by, or licensed to a
Party including, without limitation, patents, patent applications,
continuations-in-part, divisionals, trade secrets, know-how,
copyrights, trade names, trademarks, and trade dress.
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1.21
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“Law” shall mean any
local, state or federal rule, regulation, statute or law relevant
to the manufacture, distribution and/or sale of the Product, and to
any other matters set forth herein.
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1.22
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“Losses” shall mean any
liabilities, damages, costs or expenses, including reasonable
attorneys’ fees, incurred by any Party that arise from any
claim, lawsuit or other action by a Third Party.
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1.23
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“Marketing Allowance”
shall mean [***] percent of gross sales, except that for sales made
by Anda, Inc., an Affiliate of ANDRX LLC, Anda Pharmaceuticals
Inc., an Affiliate of ANDRX LLC, and Valmed Pharmaceutical, Inc.,
an affiliate of ANDRX, doing business under the names Value in
Pharmaceuticals or V.I.P. (collectively, “ANDRX Distribution
Affiliate”), the Marketing Allowance shall be [***] percent
of gross sales. Notwithstanding the foregoing, the [***]% Marketing
Allowance on sales through an ANDRX Distribution Affiliate shall
not be applicable to any sales to large warehousing chains, managed
care organizations, wholesalers and distributors and shall apply
only to sales to independent pharmacies, buying
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groups, nonwarehousing chains and
physicians. Exhibit B to this Agreement provides a specific
(but not exclusive) list of accounts that shall not receive the
[***]% Marketing Allowance.
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1.24
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“MSDS” shall have the
meaning set forth in Section 5.1 hereof.
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1.25
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“NDA” shall mean the
PFIZER New Drug Application, and any supplements thereto, relating
to Glucotrol XL ® in 10 mg dosage strength, 5 mg
dosage strength or 2.5 mg dosage strength, as
applicable.
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1.26
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Net
Sales” shall mean the gross amount invoiced to Third Parties
for the Product for product received by Third Parties in the
Territory, less provisions for:
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(a)
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reasonable and customary trade
discounts, promotional allowances, cash discounts, customer refunds
and credits, returns, customer and government rebates and any other
similar allowances which effectively reduce the net selling
price;
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(b)
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actual chargebacks, retroactive
price or shelf stock adjustments and price equalizations;
and
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(c)
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the
Marketing Allowance.
Such amounts will be determined in accordance with GAAP, except for
the treatment of (b) above, which shall be treated on a cash
basis.
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1.27
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“Party” or
“Parties” shall mean ANDRX or PFIZER, or both of them,
depending upon the context in which such word may
appear.
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1.28
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“Person” means a natural
person, a corporation, a partnership, a trust, a joint venture, a
limited liability company, any governmental authority or any other
entity or organization.
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1.29
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“Pfizer” shall have the
meaning set forth in the first sentence hereof.
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1.30
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“PFIZER Activities”
shall have the meaning set forth in Section 8.2
hereof.
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1.31
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“Product” or
“Products” shall mean PFIZER’S NDA
extended-release glipizide pharmaceutical product, in 2.5 mg, 5mg
and 10 mg dosage strengths. Products shall not mean any product
sold by PFIZER under the trademark Glucotrol
®
or Glucotrol XL
®
or any ANDRX ANDA
products.
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1.32
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“Reporting Period” shall
mean a three-month period corresponding to a Calendar
Quarter.
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1.33
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“Settlement Agreement”
shall mean the Agreement dated as of September 4, 2003 by and
among PFIZER, ALZA CORPORATION, ANDRX CORPORATION, ANDRX
PHARMACEUTICALS, INC. and ANDRX PHARMACEUTICALS, LLC, which
provides that the Parties shall enter into this
Agreement.
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1.34
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“Specifications” shall
mean all product, regulatory, manufacturing, quality control, and
quality assurance procedures, processes, practices, standards,
instructions and specifications comprising PFIZER’s FFDCA
approval applicable to the manufacture and packaging of Products as
set forth in the NDA, and such other FDA and/or other regulatory
requirements as may be applicable.
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Confidential Treatment Requested.
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1.35
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“Territory” shall mean
the United States of America, together with its territories and
possessions.
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1.36
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“Third Party” shall mean
any Person that is neither a party to this Agreement nor an
Affiliate of a party to this Agreement.
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1.37
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“Transfer Price” shall
mean for each Product the price set forth in Exhibit A, as may be
modified by agreement of the Parties pursuant to Paragraph 4.1
hereof.
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2.1
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Pursuant to the terms and conditions
of this Agreement, ANDRX shall purchase from PFIZER all of its
requirements of Products. PFIZER shall sell such Products to ANDRX
on a non-exclusive basis; provided, however, that PFIZER shall sell
and ANDRX shall be entitled to market, sell, promote and/or
distribute Products on an exclusive basis (except as to
PFIZER’s branded Glucotrol XL ® product) for a period beginning on
the Commencement Date and ending 180 days thereafter
(“Exclusivity Period”), which date shall be extended if
for any reason, including Force Majeure, PFIZER is unable to supply
quantities of the Products to ANDRX pursuant to a Firm Order by the
number of days that PFIZER is unable to supply pursuant to such
Firm Order. After the expiration of the Exclusivity Period, the
Agreement will continue on a non-exclusive basis for the remainder
of its term. Notwithstanding the foregoing, if ANDRX markets any
ANDRX ANDA Product prior to the end of the Exclusivity Period, the
Exclusivity Period shall immediately terminate with respect to such
ANDRX ANDA
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Product upon the first commercial
sale of such ANDRX ANDA Product to a Third Party (as evidenced by
invoices, transfer documents, shipping documents or the like to
such Third Party). It is the understanding of the Parties that
after the expiration of the Exclusivity Period, PFIZER shall have
the right to sell Products to Third Parties provided in any such
case, it does not adversely affect PFIZER’s ability to
manufacture or supply the Products to ANDRX as provided in this
Agreement.
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2.2
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ANDRX shall not promote or
distribute the Products outside the Territory or to any purchaser,
distributor or distributee that ANDRX knows or reasonably should
know, intends to utilize, resell or redistribute the Products
outside the Territory. ANDRX shall use Commercially Reasonable
Efforts to promote the Products, exercising substantially the same
diligence and adhering to substantially the same standards it
employs with respect to its other products, provided however, that
ANDRX shall not be deemed to have failed to abide by or have failed
to perform in accordance with the foregoing standard or promotional
effort if (1) ANDRX is prevented from performing or hindered
in its performance of such standard by any act or omission of
PFIZER; or (2) by virtue of ANDRX’s sale or marketing of the
ANDRX ANDA Products. The exercise of a right specifically conferred
by this Agreement shall not, by itself, constitute either a failure
by ANDRX to satisfy its obligation, pursuant to this section, to
use Commercially Reasonable Efforts to promote the Products, or an
act or omission by PFIZER that prevents or hinders ANDRX from
satisfying that obligation.
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2.3
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ANDRX will have the right in its
sole discretion to establish the price at which the Products will
be sold to Third Parties.
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III.
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FORECASTS AND SUPPLY
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3.1
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(a)
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ANDRX shall provide PFIZER with a
Firm Order for the period from the date hereof up to and including
March 31, 2004, which Firm Order shall be attached as
Schedule A. PFIZER shall supply the quantities set forth on
Schedule A for each Product in accordance with the delivery
schedule set forth therein, provided that the initial delivery date
is no less than [***] days following receipt by PFIZER of approved
label copy and tablet imprinting directions from ANDRX. PFIZER
shall use Commercially Reasonable Efforts to supply Products to
ANDRX as set forth in Schedule A no later than the
Commencement Date. To the extent such Firm Order is not sufficient
to meet ANDRX’s actual requirements for any Product for such
period, PFIZER shall use its Commercially Reasonable Efforts to
supply ANDRX with its requirements beyond the amounts set forth on
Schedule A. For periods after March 31, 2004, Firm Orders
shall be filled by PFIZER in accordance with the provisions of
Section 3.1(b) and (c).
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(b)
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Except as provided in
Section 3.1(a), within [***] after the beginning of each
Calendar Quarter (commencing with the first Calendar Quarter of
2004), ANDRX shall give to PFIZER a forecast of ANDRX’s
estimated quarterly requirements of the Products for the following
[***]. [***] forecast delivered to PFIZER pursuant to the preceding
sentence shall represent ANDRX’s reasonable estimates of the
quantity of the Products
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Confidential Treatment Requested.
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that ANDRX will require during [***]
to which such forecast applies, and the forecast of its
requirements of the Products during the first quarter of such [***]
period shall be reflected in a Firm Order accompanying such
forecast.
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(c)
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Notwithstanding the foregoing,
except as provided for below, any Firm Order (except for the first
Firm Order), for any Product placed for a Calendar Quarter in
accordance with Section 3.1(b) shall be between [***] of the
most recent forecast estimated quantity for such Product for such
Calendar Quarter provided by ANDRX to PFIZER in accordance with
this Section 3.1, except that Firm Orders shall not be
required to be between [***] of the most recent forecast in any
Calendar Quarter in which a new generic glipizide extended release
product enters the market. If requested by ANDRX, PFIZER shall use
its Commercially Reasonable Efforts to supply an amount exceeding
[***] of the most recent forecast estimated quantity for a
Product.
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(d)
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PFIZER shall promptly notify ANDRX
in writing if at any time PFIZER has reason to believe that PFIZER
will not be able to fill at [***] of a Firm Order for any Product
in accordance with the delivery schedule specified therein by ANDRX
and pursuant to the terms and conditions of this Agreement. PFIZER
shall deliver Product to ANDRX pursuant to each Firm Order no more
than [***] after ANDRX’s requested delivery date, provided
that such Firm Orders are delivered to PFIZER at [***] to
ANDRX’s requested delivery date.
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Confidential Treatment Requested.
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(e)
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During any period in which PFIZER
does not or cannot for any reason supply all of ANDRX’s
requirements of the Products pursuant to a Firm Order, then PFIZER
will supply ANDRX on a [***] before producing Products for any
Third Party or for its own branded Glucotrol XL
®
product or generic
Product. [***]
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(f)
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In
the event ANDRX intends to manufacture and/or market any of the
ANDRX ANDA Products, it shall have the right to do so without
terminating this Agreement. In such event, ANDRX shall give PFIZER
[***] prior written notice of its intention to do so. Upon the
effective date of such written notice, PFIZER shall be relieved of
its obligations to manufacture and supply Products for ANDRX, other
than the fulfillment of Firm Orders. ANDRX will remain obligated to
purchase previously provided Firm Orders. If ANDRX ceases providing
Firm Orders to PFIZER and then later wishes to resume purchase of
any of the Products pursuant to this Agreement, PFIZER and ANDRX
will discuss in good faith the feasibility of such request. If
PFIZER determines, in its sole discretion, that it has the
resources and capacity to accommodate ANDRX’s request, then
ANDRX shall provide PFIZER with a new Firm Order for such Products
with a delivery date [***] from receipt by PFIZER of the Firm
Order.
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(g)
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All
forecasts to be provided or delivered by ANDRX to PFIZER pursuant
to this Section 3.1 shall be in writing.
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Confidential Treatment Requested.
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3.2
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PFIZER agrees to accept all Firm
Orders submitted in accordance with and on the terms set forth in
this Agreement. No terms and conditions contained in any Firm
Order, acknowledgment, invoice, bill of lading, acceptance or other
preprinted form issued by either Party shall be effective to the
extent they are inconsistent with or modify the terms and
conditions contained herein.
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3.3
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All
Products sold pursuant to this Agreement shall be delivered FCA
(INCOTERMS 2000) [***]. ANDRX shall bear the cost of shipping and
insurance.
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3.4
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PFIZER will manufacture, package,
label, store, and ship the Products in accordance with
Specifications set forth in the NDA for such Product as such NDA
may be amended from time to time, and, as to tablet printing
designation and label copy, in accordance with ANDRX’s
reasonable instructions to PFIZER. ANDRX shall be promptly and
fully advised of any new instructions or specifications required by
the FDA or the FFDCA. In the event that PFIZER cannot reasonably
manufacture Products in accordance with ANDRX’s instructions
and Specifications, PFIZER shall promptly so advise
ANDRX.
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4.1
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(a)
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ANDRX shall remit payment for
shipments of Products sent by PFIZER to ANDRX in U.S. dollars
[***]. The invoice shall reflect the Transfer Price on date of
shipment by PFIZER for each Product. The Transfer Price for the
first twelve (12) month period for each Product is set forth on
Exhibit A attached hereto. [***] prior to the end of the
initial twelve (12)
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month period and each twelve
(12) month period thereafter, ANDRX and PFIZER agree to
discuss in good faith the establishment of a new Transfer Price.
Additionally, either party may request a new Transfer Price from
time to time for good cause or, in any case, if the Reconciliation
Statement (defined in 4.2(a) below) reflects a discrepancy of [***]
or greater, then the Parties shall adjust the Transfer Price in an
amount which the Parties determine in good faith reflects an
appropriate Transfer Price based upon then existing market
conditions.
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(b)
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If,
in any Reporting Period, the Net Sales price per bottle, multiplied
by [***], is less than the amounts set forth below, the parties
will discuss in good faith any amendments to the Agreement
necessary to make the Agreement economically viable for both
parties
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10 mg Product
— price per bottle (100) [***]
5 mg Product
— price per bottle (100) [***]
2.5 mg Product
— price per bottle (30) [***]
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4.2
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(a)
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Within [***] of the end of each
Reporting Period, ANDRX will determine the quantity of each Product
sold by ANDRX during the Reporting Period, and the corresponding
Net Sales and aggregate Transfer Price associated with the units of
Products sold by ANDRX during the Reporting Period and provide such
information to PFIZER (“Reconciliation Statement”).
Additionally
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