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FINISHED PRODUCT SUPPLY AGREEMENT

Requirements Supplier Agreement

FINISHED PRODUCT SUPPLY AGREEMENT | Document Parties: KOS PHARMACEUTICALS INC | Aventis Pharmaceuticals Inc You are currently viewing:
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KOS PHARMACEUTICALS INC | Aventis Pharmaceuticals Inc

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Title: FINISHED PRODUCT SUPPLY AGREEMENT
Governing Law: New York     Date: 3/26/2004
Industry: Biotechnology and Drugs     Law Firm: Kos Pharmaceuticals, Inc.;     Sector: Healthcare

FINISHED PRODUCT SUPPLY AGREEMENT, Parties: kos pharmaceuticals inc , aventis pharmaceuticals inc
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<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:

 

 

                                       1

<PAGE>

 

                                    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

<PAGE>

 

         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

 

 

 

                                       3

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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

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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

 

 

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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

 

 

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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.

 

 

 

                                       12

<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.

 

 

 

 

                                       13

<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


 
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