<PAGE>
EXHIBIT 2.2
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
FINISHED PRODUCT SUPPLY AGREEMENT
THIS FINISHED PRODUCT SUPPLY AGREEMENT, dated as of March 5, 2004
and
effective as of the Effective Date, is made
and entered into by and between
Aventis Pharmaceuticals Inc., a company
organized and existing under the laws of
the State of Delaware, and its Affiliates
("AVENTIS"), and Aeropharm Technology,
Inc., a company organized and existing
under the laws of the State of Delaware
("PURCHASER"). Capitalized terms used in
this Agreement shall have the meanings
ascribed to them in Article 1 hereof or as
otherwise set forth herein.
RECITALS
WHEREAS, Aventis is engaged in the manufacture of a finished
product
form of the compound Triamcinolone
Acetonide in a chlorofluorocarbon ("CFC")
based propellant driven inhaler as sold in
the United States under the
registered trademark Azmacort(R);
WHEREAS, this Agreement is being entered into in connection
with
certain transactions in which Aventis and
its Affiliates are divesting and
licensing certain assets related to the
Product to Kos Life Sciences, Inc., an
Affiliate of Purchaser, pursuant to a
Product Acquisition Agreement dated as of
the date hereof (the "PRODUCT ACQUISITION
AGREEMENT");
WHEREAS, Purchaser desires to have Aventis manufacture and supply
it
with finished Product for sale and
distribution in the Territory during the Term
in accordance with this Agreement; and
WHEREAS, Aventis agrees to manufacture and supply to Purchaser
finished
Product for sale and distribution in the
Territory upon the terms and subject to
the conditions provided herein.
NOW, THEREFORE, in consideration of the mutual covenants and
agreements
set forth in this Agreement, and for other
good and valuable consideration, the
receipt of which are hereby acknowledged,
the parties hereto hereby agree as
follows:
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ARTICLE 1
DEFINITIONS
The following terms shall have the meanings set forth below. Unless
the
context indicates otherwise, the singular
shall include the plural and the
plural shall include the singular.
1.1 "4.5 DATE" has the meaning set forth in Section 7.10.
1.2 "ACT" means the United States Federal Food, Drug and Cosmetic
Act,
as amended.
1.3 "ACTUAL LOST SALES" means the product of (i) the number of
days
between the first day of a Canister
Shortage and the last day of the Payment
Term and (ii) the Average Daily Sales
Quantity.
1.4 "ADDITIONAL AGREEMENTS" has the meaning set forth in Section
7.1.
1.5 "ADJUSTED GROSS MARGIN PER UNIT" means ****.
1.6 "AFFILIATE" means a person or entity that, directly or
indirectly,
through one or more intermediates,
controls, is controlled by, or is under
common control with the person or entity
specified. For the purposes of this
definition, control shall mean the direct
or indirect ownership of (i) in the
case of corporate entities, securities
authorized to cast more than fifty
percent (50%) of the votes in any election
for directors, or (ii) in the case of
non-corporate entities, more than fifty
percent (50%) ownership interest with
the power to direct the management and
policies of such non-corporate entity.
1.7 "AGREEMENT " means this Finished Product Supply Agreement and
all
schedules and exhibits attached hereto.
1.8 "ALTERNATE SUPPLIER" has the meaning set forth in Section
2.10.
1.9 "AVENTIS FACILITY" has the meaning set forth in Section
2.4(b).
1.10 "AVERAGE DAILY SALES QUANTITY" means the quotient obtained
by
dividing (i) the total quantity of Product
sold in the twelve (12) month period
ending on the last day of the month
immediately preceding the month in which a
Canister Shortage occurs by (ii) three
hundred sixty-five (365).
1.11 "BUSINESS DAY" means a day other than Saturday, Sunday or any
day
on which a commercial bank in New York, New
York is authorized to close. Any
reference in this Agreement to "day"
whether or not capitalized shall refer to a
calendar day, not a Business Day.
2
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1.12 "CANISTER" means an Azmacort Unprinted Canister, Part
#CA-2742B
included in the Components sold to
Purchaser pursuant to Section 2.5 of the
Product Acquisition Agreement and as set
forth in SCHEDULE 4.5.
1.13 "CANISTER SHORTAGE" means the cessation of supply of Product
by
Aventis hereunder due to an exhaustion of
the supply of Canisters and the
resulting complete depletion of all
inventories of Product held by Purchaser, as
demonstrated by reasonable documentary
evidence thereof provided by Purchaser to
Aventis; PROVIDED, HOWEVER, that a Canister
Shortage shall be deemed not to have
occurred in the event Purchaser takes any
action outside the ordinary course of
business to deplete its inventory of the
Product.
1.14 "CFC" has the meaning set forth in the first recital.
1.15 "CFC EVENT" has the meaning set forth in Section 7.19.
1.16 "CGMP" means current Good Manufacturing Practices as
promulgated
under the Act at 21 CFR (chapters 210 and
211), as the same may be amended or
re-enacted from time to time.
1.17 "COMPONENTS" shall mean the canisters, valves, actuators and
other
components used in connection with the
manufacture of the Product and as listed
on SCHEDULE 1.17 attached hereto.
1.18 "CONVERSION DATE" has the meaning set forth in Section
7.10
1.19 "DISCRETIONARY MANUFACTURING CHANGES" has the meaning set
forth in
Section 2.7(b).
1.20 "EFFECTIVE DATE" means the Closing Date as defined in the
Product
Acquisition Agreement.
1.21 "FDA" means the United States Food and Drug Administration or
any
successor agency thereof.
1.22 "FORCE MAJEURE" has the meaning set forth in Section 10.3.
1.23 "INDEMNITEE" has the meaning set forth in Section 9.3(a).
1.24 "INDEMNITOR" has the meaning set forth in Section 9.3(a).
1.25 "INITIAL PRODUCT COSTS" has the meaning set forth in Section
3.1.
1.26 "LAWS" means all laws, statutes, rules, regulations,
ordinances
and other pronouncements having the effect
of law of the United States, any
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foreign country, supranational entity or
any domestic or foreign state,
province, county, city or other political
subdivision of any Regulatory
Authority.
1.27 "LOSS THRESHOLD" means losses of Canisters equal to or
greater
than ****, calculated over the period
commencing on the Effective Date and
ending on the day immediately prior to a
Canister Shortage, such calculation to
be made solely by taking into account the
following factors: (i) normal process
loss, (ii) loss due to human error of
Aventis personnel or its subcontractor,
(iii) loss due to Product rejected for
failure to meet Specifications, (iv)
deemed losses pursuant to Section 6.1 in
the event, and solely to the extent,
that a recall results from any cause or
event as a result of the defective
manufacture, testing, storage or handling
of the Product by Aventis or its
Affiliates or its subcontactor and (v) any
loss or use of Canisters for
validation or other purposes pursuant to
any Discretionary Manufacturing Change
requested by Aventis, even if such
Discretionary Manufacturing Change is
consented to by Purchaser.
1.28 "METHOD TRANSFER" has the meaning set forth in Section
5.10.
1.29 "NDA" means a New Drug Application pursuant to Section 505 of
the
Act (21 U.S.C. Section 355) submitted to
the FDA or any successor application or
procedure or any foreign counterpart of a
U.S. New Drug Application for approval
to market, including, where applicable,
applications for pricing and
reimbursement approval.
1.30 "NEW COMPONENTS" means the new canisters and valves to be used
in
connection with the manufacture of the
Product and to be supplied by Purchaser
upon the exhaustion or expiration of, and
as a replacement for, the Old
Components purchased by Purchaser on the
Effective Date.
1.31 "OLD COMPONENTS" means Canisters and Valves DF10-50RC20
(OR
CEBIC), Part# VL-0456D, made with gaskets
compounded from Zeosil and perbunan
rubber and stockpiled by Aventis as
specified on SCHEDULE 4.5 hereof.
1.32 "PAYMENT TERM" means the period commencing on the Effective
Date
and ending on the two (2) year anniversary
thereof.
1.33 "PRIME RATE" has the meaning set forth in Section 3.2(a).
1.34
"PRODUCT" means the fully finished product forms (including
complete packaging of same) of the
pharmaceutical product (Triamcinolone
Acetonide) in a CFC based propellant driven
inhaler and more particularly
defined in NDA # 18-117.
1.35 "PRODUCT ACQUISITION AGREEMENT" has the meaning set forth in
the
Recitals.
1.36 "PURCHASED COMPONENTS" has the meaning set forth in Section
4.5.
1.37 "RESOURCE LIMIT" has the meaning set forth in Section
5.10.
1.38 "REGULATORY APPROVAL" means the technical, medical and
scientific
licenses, registrations, authorizations and
approvals, including, without
4
<PAGE>
limitation, approvals of NDA's, supplements
and amendments, pre- and post-
approvals, pricing and third party
reimbursement approvals, and labeling
approvals, of any Regulatory Authority
necessary for the development, including
the conduct of clinical trials,
manufacture, distribution, marketing, promotion,
offer for sale, use, import, export or sale
of a Product in a regulatory
jurisdiction.
1.39 "REGULATORY AUTHORITY" means the FDA and any other
national,
supra-national, regional, state or local
regulatory agency, department, bureau,
commission, council or other governmental
entity in each country in the
Territory.
1.40 "REPRESENTATIVES" has the meaning set forth in Section
8.1(b).
1.41 "REQUIRED MANUFACTURING CHANGES" has the meaning set forth
in
Section 2.7(a).
1.42 "SPECIFICATIONS " means the written specifications for the
Product
as set forth in applicable NDAs.
1.43 "SUPPLY COMMITTEE" has the meaning set forth in Section
7.13.
1.44 "TECHNICAL AGREEMENT " has the meaning set forth in Section
5.9
1.45 "TERM" has the meaning set forth in Section 4.1.
1.46 "TERRITORY" means worldwide.
1.47 "THIRD PARTY CLAIM" has the meaning set forth in Section
9.3(a).
1.48 "THIRD PARTY LIABILITIES" has the meaning set forth in
Section
9.1.
1.49 "VALVE DATE" has
the meaning set forth in Section 7.10.
Capitalized terms used but not defined
herein shall have the meanings ascribed
to such terms in the Product Acquisition
Agreement
ARTICLE 2
MANUFACTURE, PURCHASE AND SALE OF PRODUCT
2.1 SUPPLY. Pursuant to the terms and conditions of this
Agreement,
Aventis agrees to supply Product
exclusively to Purchaser in the Territory. So
long as Aventis or its permitted designee
is willing and able, or is not
otherwise in material breach of this
Agreement, Purchaser agrees to, and agrees
to cause its permitted designee to,
purchase exclusively from Aventis or its
permitted designee, Purchaser's requirement
of Product for purposes of
distribution by Purchaser in the Territory
during the Term hereof. Subject to
5
<PAGE>
its maximum monthly and annual
manufacturing capacity for the Product (as set
forth in SCHEDULE 2.6(A)), Aventis agrees
to provide manufacturing capacity
sufficient to fulfill Purchaser's
requirements for the Product, which
requirements shall be reflected by
Purchaser's forecasts as set out in this
Article 2.
2.2 FORECASTS.
(a) LONG-RANGE FORECASTS. Within ninety (90) days after the
Effective
Date, and by July 1 of each calendar year
thereafter during the Term, Purchaser
shall furnish Aventis with a quarterly
forecast of the quantities of each
Product that Purchaser intends to order for
the shorter of (i) the remaining
Term or (ii) three (3) years. Such
forecasts shall represent the most current
estimates for planning purposes, but shall
not be purchase commitments. Such
forecasts shall not exceed Aventis' maximum
monthly and annual capacity as set
forth in Section 2.6(a), unless a forecast
in excess of Aventis' maximum monthly
and annual capacity is mutually agreed to
in writing by the parties.
(b) SHORT TERM ROLLING FORECASTS. In addition to the non-binding,
long
range forecasts provided in Section 2.2(a),
commencing with the first (1st)
Business Day of the month immediately
succeeding the Effective Date, and on the
first (1st) Business Day of each month
thereafter, Purchaser shall furnish
Aventis with a rolling forecast of the
quantities of Product that Purchaser
intends to order by month during the twelve
(12) month period (or such shorter
period as remains in the Term) commencing
on the Effective Date. Such forecasts
shall be broken down into Product type,
quantities and shipping dates.
Notwithstanding the foregoing, the
Purchaser shall utilize Aventis' scheduled
firm orders for the first three (3) months
of this Agreement, as specified on
SCHEDULE 2.2(B), and such orders shall
constitute the first three (3) month
portion of Purchaser's initial twelve (12)
month forecast; PROVIDED, HOWEVER
that the Purchaser shall not be required to
purchase amounts for any one of
these first three (3) months that deviate
by more than twenty-five percent (25%)
from the quantities set forth on SCHEDULE
2.2(B) for such month. Such forecasts
shall not exceed Aventis' maximum monthly
and annual capacity limitations as set
forth in Section 2.6(a). Purchaser shall be
required to purchase one hundred
percent (100%) of the amount of Products
forecast for the first six (6) months
of each rolling forecast.
(c) If Aventis notifies Purchaser in writing within ten (10)
Business Days after Purchaser's delivery of
a rolling forecast, Aventis shall be
entitled to reject that portion of the
order in a rolling forecast, and require
Purchaser to submit a revised rolling
forecast, if such rolling forecast fails
to meet the following parameters:
<TABLE>
<CAPTION>
--------------------------------------
-------------------------------------------------------------
PERMISSIBLE INCREASE OR DECREASE OF PRODUCT
MONTH OF ANY GIVEN
COMPARED TO THE QUANTITY SPECIFIED IN THE
ROLLING FORECAST
ROLLING FORECAST DELIVERED THE PREVIOUS MONTH
--------------------------------------
-------------------------------------------------------------
<S>
<C>
--------------------------------------
-------------------------------------------------------------
Months 1 2, 3, 4 and 5
None
--------------------------------------
-------------------------------------------------------------
--------------------------------------
-------------------------------------------------------------
--------------------------------------
-------------------------------------------------------------
Months 6, 7 and 8
No less than 75% and no more than 125% of
Months 7, 8 and 9, collectively, of the previous
forecast.
--------------------------------------
-------------------------------------------------------------
--------------------------------------
-------------------------------------------------------------
Months 9, 10 and 11
No
less than 50% and no more than 150% of Months 10, 11 and
12, collectively, of the previous forecast.
--------------------------------------
-------------------------------------------------------------
--------------------------------------
-------------------------------------------------------------
</TABLE>
6
<PAGE>
(d) In no event shall Aventis be required to supply orders in
excess of the maximum monthly or annual
capacity as set forth in Section 2.6(a).
Aventis shall not be responsible or
otherwise required to accept any purchase
order to the extent of an insufficient
supply of New Components.
2.3 FIRM ORDERS.
(a) Purchaser shall place purchase orders with Aventis for
Products to be delivered for the first one
hundred eighty (180) days of each
Rolling Forecast. All purchase orders must
be received by Aventis at least six
(6) months prior to the delivery date
specified in each respective order.
Purchaser acknowledges that Products are
produced in full batch quantities. Such
orders shall be in full batch quantities
and when combined with all other
purchase orders for the applicable six (6)
month period are at least as great
and no greater than the amount required to
be purchased by Purchaser pursuant to
Section 2.2(c) for each Product. In
addition, the number of such purchase orders
shall not exceed one (1) per month for each
Product, unless they are a greater
monthly number is agreed to by Aventis,
and, to the extent possible, shall be
delivered to Aventis on or about the
fifteenth (15th) of such month. Each
purchase order shall specify the delivery
schedule within the month and Aventis
shall deliver against each such purchase
order in accordance with Section 2.4.
Purchaser shall be obligated to purchase
all such Products ordered and delivered
by the delivery date specified in
Purchaser's purchase order, PROVIDED that such
Products meet the Specifications. Unless
otherwise specified in writing by
Aventis, all orders placed by Purchaser
with Aventis hereunder shall be
addressed as follows:
Aventis Pharmaceuticals Inc.
604 San Jose Road Cotto Norte Industrial
Manati, Puerto Rico 00674
Attn: Dolores Fernandez, Supply Chain Leader
Mail: P.O. Box 345, Manati, P.R. 00674-0345
Fax: (787) 854-5715
Telephone: (787) 621-6000 / Ext. 1400
(b) Any purchase orders, purchase order releases,
confirmations, acceptances, advices and
similar documents submitted by either
party in conducting the activities
contemplated under this Agreement are for
administration purposes only and shall not
add to or modify the terms of this
7
<PAGE>
Agreement. To the extent of any conflict or
inconsistency between this Agreement
and any such document, the terms and
conditions of this Agreement shall control
as to a particular order unless otherwise
agreed to in writing by the parties.
2.4 DELIVERY.
(a) Aventis shall meet the delivery dates and order quantities
indicated in Purchaser's binding and
accepted firm orders for all Products. Any
shipment delivered that is within plus or
minus seven and one half percent
(7.5%) of the quantity ordered and/or plus
or minus seven (7) Business
Days of the delivery date specified on the
relevant firm order will be
considered as delivered on time.
(b) Delivery terms for Product shall be EXW (Incoterms 2000)
Aventis' manufacturing facility, warehouse
or such other facility mutually
agreed to by the parties (the "AVENTIS
FACILITY"). Title and risk of loss shall
pass to Purchaser once the Product is
placed on the loading dock of the Aventis
Facility. Purchaser shall be responsible
for all freight, insurance, handling,
fees, taxes and other costs associated with
the shipment of Product, as well as
all export licenses, import licenses and
customs formalities for the import and
export of goods.
2.5 REJECTED GOODS/SHORTAGES.
(a) NOTICE; REPLACEMENT. Purchaser shall notify Aventis in
writing of (i) any claim relating to
Product that fails to meet the
Specifications, or (ii) any shortage in
quantity of any shipment of Product as
soon as reasonably practical, but not later
than thirty (30) days (or sixty (60)
days in the event an outside testing
laboratory approved by Purchaser is used)
of receipt of such Product (unless such
failure to meet Specifications is due to
a latent or undetectable defect at such
time). Purchaser shall be deemed to have
accepted the Product if it does not provide
Aventis written notice of such
shortfall or failure to meet specification
within such thirty (30) day period
(or sixty (60) day period in the event an
outside testing laboratory approved by
Purchaser is used) (unless such failure to
meet Specifications is due to a
latent or undetectable defect at such
time). If the parties agree that such
Product is defective or that there is a
shortage, Aventis shall replace the
defective Product or use its commercially
reasonable efforts to make up the
shortage as soon as possible but in no
event later than the next practical
delivery date, at no additional cost to
Purchaser. Purchaser shall make
arrangements with Aventis for the return or
disposal of any rejected Product;
the costs of such return or disposal shall
be paid by Aventis. In the event that
only a limited supply of Product is
available to replace or supply such
rejection or shortage, then Aventis shall
ship to Purchaser such quantities of
Product as are available, supply the
remaining amount due as soon as possible
thereafter or, reimburse or credit
Purchaser against future orders, at
Purchaser's option, for amounts paid for
the remaining quantity of rejected
Product.
(b) DISPUTES. If Aventis disagrees with Purchaser's claim that
such Product fails to meet the applicable
Specifications, Aventis and Purchaser
representatives shall promptly attempt to
resolve such dispute. If the
representatives cannot resolve such dispute
within ten (10) Business Days of the
8
<PAGE>
date Purchaser notifies Aventis of its
determination that the Products failed to
meet the applicable Specification, a sample
of such Product shall be submitted
by Aventis and Purchaser to a mutually
agreed upon qualified laboratory for
testing against the Specifications and the
test results obtained by such
laboratory shall be final and controlling.
The fees and expenses of such
laboratory testing shall be borne entirely
by the party whose Product analysis
was in error. In the event the test results
indicate that the Product in
question does not conform to the
Specifications, Aventis shall replace such
Product at no additional cost to Purchaser
as soon as reasonably possible after
receipt of such results; PROVIDED, HOWEVER,
Aventis shall have no liability to
Purchaser if Product fails to meet the
Specifications if the Product: (i) has
been tampered with or otherwise altered
once title has passed to Purchaser; (ii)
has been subject to misuse, negligence or
accident once title has passed to
Purchaser, (iii) has been stored, handled
or used by others in a manner contrary
to applicable regulatory requirements once
title has been passed to Purchaser or
(iv) so fails, and such failure is
attributable to a New Component (excluding,
however, failure arising from the handling
or attachment of such New Component
by Aventis or its Affiliates).
(c) SOLE REMEDY. The provisions of (i) Sections 2.5(a) in the
case of shortage in quantity of any
shipment of Product, (ii) except as
otherwise provided in Section 9.2(a) herein
with respect to Third Party Claims,
Sections 2.5(a) and (b) in the case of
Product that fails to meet the
Specifications and (iii) Section 2.12 in
the case of a Canister Shortage, shall
be the sole remedies available to Purchaser
with respect to any shortage in
quantity of any shipment of Product,
Product that fails to meet the
Specifications, and/or Product lost in
production, as the case may be.
2.6 CAPACITY.
(a) CAPACITY. Aventis' maximum monthly and annual capacity to
manufacture Product is set forth on
SCHEDULE 2.6(A).
(b) AVENTIS NOTICE. In the event that Aventis, upon receiving
a forecast under Section 2.2(b) or a firm
order under Section 2.3, is, or
anticipates that it will be, unable to meet
such forecast or firm order, either
in whole or in part, due to any reason,
Aventis shall give written notice of
such inability to Purchaser within five (5)
Business Days of receipt of such
forecast or firm order (or upon Aventis'
reasonable belief that it cannot
fulfill the forecast or firm order, if such
date is after such five (5) Business
Day period). If such inability is partial,
Aventis shall fulfill firm orders
with such quantities of Product as are
available.
2.7 MANUFACTURING CHANGES.
(a) REQUIRED MANUFACTURING CHANGES. For changes to the
Specifications or manufacturing processes
that are required by changes in
applicable Laws (collectively, "REQUIRED
MANUFACTURING CHANGES"), Aventis and
Purchaser shall cooperate in making such
changes and use commercially reasonable
efforts to implement such changes
promptly.
(b) DISCRETIONARY MANUFACTURING CHANGES. For changes to the
Specifications or manufacturing process
that are not Required Manufacturing
Changes (collectively, "DISCRETIONARY
MANUFACTURING CHANGES"), Aventis and
Purchaser must each agree in writing to any
Discretionary Manufacturing Changes
9
<PAGE>
and shall, to the extent commercially
reasonable under the circumstances,
cooperate fully in making such changes, and
each agrees that it shall not
unreasonably withhold its consent to such
Discretionary Manufacturing Changes.
Notwithstanding the foregoing, Aventis'
standard change control procedures shall
be utilized in reviewing such changes.
(c) CANISTERS. Notwithstanding the provisions of this
subsection, Aventis shall not make any
Discretionary Manufacturing Changes that
require the utilization of the Canisters
without first obtaining Purchaser's
consent to such utilization.
(d) MANUFACTURING CHANGES. Notwithstanding the foregoing, all
internal and external costs, including,
without limitation, obsolete raw
materials, regulatory filings,
work-in-process, Product, packaging and labeling
materials (i) associated with Required
Manufacturing Changes relating solely to
Product in the Territory shall be borne by
Purchaser, and (ii) all costs
associated with Discretionary Manufacturing
Changes shall be borne by the party
initiating such changes.
****
2.8 LABELING AND PACKAGING. Purchaser shall be responsible for
all
costs of developing new packaging and
labeling for the Product for use by
Purchaser after the date hereof, including
without limitation obsolete inventory
of packaging and labeling materials
(including any Aventis labeling and
packaging materials specified on SCHEDULE
2.8 hereof that are no longer used by
Purchaser following the Effective Date),
and shall provide Aventis all art work
from vendors selected by Purchaser and
pharmacological information, usage
instructions and warnings to be applied to
each Product, which shall be
consistent with the FDA or Regulatory
Authority approved labeling for the
Product. Purchaser shall provide such
information pursuant to this Section 2.8
to Aventis in sufficient time in advance of
delivery requirements for the
Product set forth in this Agreement.
10
<PAGE>
2.9 APPOINTMENT OF SUBLICENSEES OR SUBCONTRACTORS. Subject to
Section
2.7(e) and the provisions of the Technical
Agreement pertaining to change
control, Aventis may elect to appoint an
Affiliate or a third party as
sublicensee or subcontractor for the
purpose of manufacturing, testing and
supplying Product; PROVIDED, however, that
such Affiliate or third party is
subject to a written agreement that
subjects such Affiliate or third party to
all relevant restrictions and limitations
in this Agreement that pertain to
Aventis and Aventis remains responsible for
the performance by such Affiliate or
third party. Notwithstanding the foregoing,
Aventis shall not be permitted to
appoint a sublicensee or subcontractor
without the consent of Purchaser (which
consent shall not be unreasonably withheld
or delayed) if such appointment would
require Regulatory Approval.
****
2.11 SHELF-LIFE. Subject to any applicable Law or directive of
any
Regulatory Authority, the remaining shelf
life of the Products supplied by
Aventis to Purchaser shall be at least ****
months (based on the
currently-approved **** month dating
period) at the time of placement for pickup
by Purchaser on the loading dock of the
Aventis Facility. In the event that, for
legal, regulatory or other reasons, the
remaining shelf life of Products
supplied is less than **** months,
Purchaser may elect, in its discretion, to
accept such Products notwithstanding such
fact, and Purchaser hereby agrees to
discuss such situation with Aventis prior
to making (or not making) such
election.
****
11
<PAGE>
ARTICLE 3
PRICING AND PAYMENT
3.1 PRICING.
(a) The initial costs payable to Aventis by Purchaser for the
Product shall be as set forth on SCHEDULE
3.1 (together, the "INITIAL PRODUCT
COSTS"). The Initial Product Costs are
based upon an annual volume of supply of
Product hereunder equal to **** (the
"MINIMUM ANNUAL VOLUME"). On February 1,
2005, and on February 1 of each calendar
year thereafter, Aventis shall
determine the volume of Products sold under
this Agreement in the immediately
prior calendar year (which calculation
shall be annualized for the calendar year
2004) and, to the extent such amount is
less than the Minimum Annual Volume,
Aventis shall provide Purchaser a written
notice (the "PRICE ADJUSTMENT NOTICE")
indicating the increased fixed cost of the
Product as a result of not meeting
such Minimum Annual Volume. To the extent
that the volume of Products sold
hereunder is less than the Minimum Annual
Volume, Purchaser shall pay Aventis a
lump sum amount to compensate Aventis for
the increased fixed cost of supply of
the Product, as reasonably determined by
Aventis and as set forth in the Price
Adjustment Notice. Such payment shall be
due and payable no later than ten days
following delivery by Aventis of the Price
Adjustment Notice (unless Purchaser,
in good faith, is disputing such price
adjustment).
(b) The Initial Product Costs will remain firm until December
31, 2004. Beginning on January 1, 2005 and
on January 1 of each calendar year
thereafter, the Initial Product Cost shall
be increased to reflect increases in
the Producer Price Index as published by
the U.S. Department of Labor,
Pharmaceutical Preparations Series ID# 2834
(the "PPI") for the calendar year
prior to the year for which any such
adjustment is to take place. In the event
that the PPI is not available until after
January 1 of any given year, then upon
its availability the Initial Product Cost
shall be retroactively adjusted in
accordance therewith and Purchaser shall be
invoiced for the difference between
the amounts paid by the Purchaser for such
year prior to such adjustment and the
Initial Product Cost as so adjusted.
(c) In addition to the foregoing adjustments, if Aventis'
documented aggregate material costs
increase at any time in excess of the PPI
increase described in clause (b) above,
then Aventis shall increase the Initial
Product Cost by an amount equal to such
excess; PROVIDED, HOWEVER, that if the
Initial Product Cost is scheduled to
increase by more than an aggregate **** for
any calendar year, Aventis shall notify
Purchaser, and Aventis and Purchaser
shall consult with each other and take such
actions as may be mutually agreed to
(including attempting to renegotiate the
price increase of any individual raw
material item or component).
Notwithstanding the foregoing, Aventis shall not be
responsible for any delay or other
production or manufacturing issues as a
result of any actions requested, or
suggestions made, by Purchaser.
(d) Notwithstanding anything to the contrary contained herein,
the sum of ****, once paid by Purchaser
under the Product Acquisition Agreement
for the purchase of the Components shall be
credited against the first **** to
otherwise be paid by Purchaser for the
acquisition of Product hereunder.
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<PAGE>
3.2 PAYMENT.
(a) TERMS. All payments required by this Agreement shall be
made in United States Dollars by wire
transfer to an account designated in
writing by Aventis. All invoices are to be
paid in full without any setoff or
deduction except as permitted in this
Agreement and payment must be received
within thirty (30) days from the date of
receipt of invoice. The date of each
invoice shall be the date the Products are
available for shipment pursuant to
Section 2.4. Payment shall be made without
deduction, deferment, set-off, lien
or counterclaim of any nature, other than
for rejected or returned goods for
which a credit acknowledgment has been
issued by Aventis. Time for payment shall
be of the essence. Interest shall accrue on
any amount overdue at the lesser of
(i) the annual prime rate as reported by
the WALL STREET JOURNAL, New York
Edition, or any other reputable publication
mutually agreed to in writing by the
parties (the "PRIME RATE") on the date such
payment is due, plus an additional
**** or (ii) the maximum rate permitted by
Law, such interest to begin accruing
on a daily basis from the date of invoice,
and shall accrue both before and
after judgment; PROVIDED, HOWEVER, in the
case of a good faith dispute regarding
payment resolved to be due and not paid
within three (3) Business Days after
such resolution, such interest shall begin
accruing on a daily basis from the
date such payment becomes overdue, and
shall accrue both before and after
judgment; PROVIDED, FURTHER, in the case of
a good faith dispute regarding
payment, Purchaser may in its discretion
determine to pay such amounts disputed
to be overdue and in the event amounts are
finally determined not to be due by
Purchaser, Aventis shall repay such excess
amounts to Purchaser determined not
be due. The foregoing interest shall begin
to accrue and be payable to Aventis
without notice.
(b) DEFAULT. With respect to defaults of payment not cured
within thirty (30) Business Days after
receipt of written notice from Aventis to
Purchaser, Aventis shall, in its sole
discretion, and without prejudice to any
other of its accrued rights, be entitled to
suspend the provision of the Product
or to terminate this Agreement by notice in
writing to Purchaser exercised at
any time thereafter until such default is
cured; PROVIDED, HOWEVER, that a good
faith bona fide dispute by Purchaser
regarding a payment pursuant to this
Agreement shall not be considered a default
of payment so long as Purchaser
notifies Aventis in writing of such dispute
within the later of five (5)
Business Days from the date of receipt of
invoice or the date of payment.
Purchaser acknowledges it will notify
Aventis promptly upon a determination that
a dispute exists regarding a payment.
ARTICLE 4
TERM AND TERMINATION
4.1 TERM; SUPPLY OF PRODUCT. The Term will commence upon the
Effective
Date and will continue for a five (5) year
period thereafter, unless terminated
earlier in accordance with the provisions
of Section 4.2 (the "TERM").
Notwithstanding the foregoing, this
Agreement may be renewable upon the mutual
agreement of the parties, on mutually
acceptable terms, which shall be
comparable to those contained herein.
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<PAGE>
4.2 EARLY TERMINATION. Either Purchaser or Aventis (or one of them
as
may be indicated in the applicable
provision) may terminate this Agreement by
notice in writing to the other party upon
the occurrence of any of the following
events (and subject to such prior notice
periods as may be indicated in the
applicable provision):
(a) if the other party commits a material breach of this
A