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EXHIBIT 10.2 MANUFACTURING AND SUPPLY AGREEMENT

Manufacturing Agreement

EXHIBIT 10.2 MANUFACTURING AND SUPPLY AGREEMENT | Document Parties: FIRST HORIZON PHARMACEUTICAL CORP | Andrx Pharmaceuticals, Inc You are currently viewing:
This Manufacturing Agreement involves

FIRST HORIZON PHARMACEUTICAL CORP | Andrx Pharmaceuticals, Inc

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Title: EXHIBIT 10.2 MANUFACTURING AND SUPPLY AGREEMENT
Governing Law: New York     Date: 5/6/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

EXHIBIT 10.2 MANUFACTURING AND SUPPLY AGREEMENT, Parties: first horizon pharmaceutical corp , andrx pharmaceuticals  inc
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Exhibit 10.2


MANUFACTURING AND SUPPLY AGREEMENT

        This Manufacturing and Supply Agreement (this " Agreement ") is effective as of March 28, 2005 (the " Effective Date "), by and between First Horizon Pharmaceutical Corporation, a Delaware corporation with its principal place of business located at 6195 Shiloh Road, Alpharetta, Georgia 30005 (" Purchaser ") and Andrx Pharmaceuticals, Inc., a Florida corporation with its principal office located at 4955 Orange Drive, Davie, Florida 33314 (" Andrx ").

RECITALS

        WHEREAS, Andrx is engaged in the business of developing, manufacturing and selling pharmaceutical products;

        WHEREAS, Purchaser is engaged in the business of marketing and distributing pharmaceutical products; and

        WHEREAS, Purchaser, Andrx and certain Affiliates of Andrx have entered into an agreement to license and purchase dated as of March 2, 2005 (the " Agreement to License ") and the other agreements contemplated thereunder pursuant to which Purchaser has agreed to license from Andrx certain rights to the Products (as defined below).

        NOW, THEREFORE, in consideration of the premises and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:


Article I.
Definitions

        1.1     Definitions .    As used in this Agreement, the following capitalized terms shall have the following meanings:

        " Act " shall mean the Federal Food Drug and Cosmetics Act of the United States of America, United States Code Title 21, Chapter I, as amended.

        " Adverse Drug Experience Report " shall mean any oral, written or electronically transmitted report of any " Adverse Drug Experience " (as defined in the Act, including, but not limited to, 21 C.F.R. 314.80 or 312.32), associated with the use of the API (including the Products).

        " Affiliate " shall mean any Person that directly or indirectly controls, is controlled by or is under common control with Andrx or Purchaser, as the case may be, but only for so long as said control shall continue. As used herein, the term "control" means possession of the power to direct or cause the direction of the management and policies of a Person whether by ownership, contract or otherwise. Andrx and Purchaser shall not be considered to be Affiliates of one another.

        " Altoprev " shall have the meaning given on Exhibit A .

        " Alzheimer's Field of Use " shall mean the administration of lovastatin sodium for the treatment or prevention of Alzheimer's disease or related APP processing disorders.

        " Andrx Product Liability Claims " shall mean any Product Liability Claims (i) relating to Products sold by Andrx or its Affiliates prior to the Effective Date, or (ii) caused by Andrx's failure to supply Product that is in compliance with the Manufacturing Requirements.

        " API " shall mean active pharmaceutical ingredient; lovastatin for Altoprev, and metformin for Fortamet.

        " Certificate of Analysis " shall have the meaning ascribed to it in Section 2.4.2 .

        " Confidential Information " shall mean, with respect to any party (the " Disclosing Party "), any information relating to the Disclosing Party, the Products or the Disclosing Party's business (including,


 

but not limited, to the formulation or specifications for any Products and any other know-how relating to the manufacture or use of any Products, or to the manufacture of and the formulation and specifications for the active ingredients thereof and technical information, research, personnel, financial, marketing, strategic or other information) that is disclosed in writing to the other party (" Receiving Part y") in the course of the parties' negotiation of or performance under this Agreement (it being understood that if any information is disclosed verbally, in order for that information to be considered Confidential Information, the Disclosing Party must notify the Receiving Party in writing that the information is Confidential Information within thirty (30) days after disclosure), but shall not include information that: (a) the Receiving Party knew, owned or controlled prior to receipt from the Disclosing Party; (b) is or becomes public through no fault of the Receiving Party or any Affiliate thereof; (c) is developed by the Receiving Party independent of any disclosure from the Disclosing Party or (d) the Receiving Party obtains from a third party not under a confidentiality obligation to the Disclosing Party. The existence, terms and conditions of this Agreement do not constitute Confidential Information.

        " Conforming Products " shall have the meaning ascribed to it in Section 2.4.2 .

        " Dosage " shall mean the specific strength of a Product.

        " Facility " shall mean Andrx's existing manufacturing facilities in Davie, Florida or such other location that Andrx determines to manufacture or have manufactured the Product in accordance with applicable Law and Section 2.1.2 .

        " FDA " shall mean the United States Food and Drug Administration or any successor governmental agency performing similar functions.

        " Firm Order Period" shall have the meaning ascribed to it in Section 3.1.

        " Force Majeure " shall have the meaning ascribed to it in Section 11.13 .

        " Forecast " shall have the meaning ascribed to it in Section 3.1 .

        " Fortamet " shall have the meaning given on Exhibit A .

        " GMPs " and " GLPs " shall mean Good Manufacturing Practices and Good Laboratory Practices as defined in Parts 210 and 211 of Title 21 of the Code of Federal Regulations, as amended from time to time, or any successor thereto.

        " Governmental or Regulatory Authority " shall mean: (a) any domestic or foreign national, federal, provincial, state, municipal or other governmental body, (b) any international or multi-lateral body, (c) any subdivision, ministry, department, secretariat, bureau, agency, commission, board, instrumentality or authority of any of the foregoing governments or bodies, (d) any quasi-governmental or private body exercising any regulatory, expropriation or taxing authority under or for any of the foregoing governments or bodies, or (e) any domestic, foreign, international, multi-lateral, or multi-national judicial, quasi-judicial, arbitration or administrative court, grand jury, tribunal, commission, board or panel.

        " Laws " shall mean: (a) all constitutions, treaties, laws, statutes, codes, ordinances, orders, decrees, rules, regulations, and municipal by-laws, whether domestic, foreign or international, (b) all judgments, orders, writs, injunctions, decisions, rulings, decrees and awards of any Governmental or Regulatory Authority, and (c) all policies, practices and guidelines of any Governmental or Regulatory Authority.

        " License Agreement " means that certain License Agreement between the parties, contemplated by the Agreement to License.

        " Manufacturing Intellectual Property " means inventions or discoveries (whether or not patentable), Patent Rights, know-how, trade secrets, technical information and all other intellectual property rights

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owned by or licensed to Andrx and its Affiliates that relate to or are necessary to manufacture and distribute the Products, and all related documentation or other tangible expressions thereof, anywhere in the world, including without limitation, rights to the SCOT Technology.

        " Manufacturing Requirements " shall have the meaning ascribed to it in Section 2.4.1 .

        " Material Breach " shall have the meaning ascribed to it in Section 6.2.3 .

        " NDA " shall mean the New Drug Applications filed with the FDA for each of the Products, as defined in the Act and the regulations promulgated thereunder.

        " Opening Inventory Products " shall mean the supply of Products initially acquired by Purchaser pursuant to the Agreement to License.

        " Other Country Applications " shall mean applications similar to NDAs filed under the laws of other countries, including without limitation Marketing Authorization Applications filed in the United Kingdom.

        " Patent Right(s) " shall mean any and all patent applications, patents, and patentable subject matter, as well as any and all patent applications claiming priority to, or derived therefrom, both domestic and foreign, including all additions, divisions, continuations, continuations-in-part, divisions, improvements, reexaminations and substitutions, and any patents issuing therefrom including extensions, registrations and reissues thereof.

        " Per Unit Price " shall have the meaning ascribed to it in Section 4.1 .

        " Person " shall mean any natural person, corporation, partnership, limited liability company, joint venture, trust, proprietorship or other entity or organization.

        " Proceedings " shall mean claims, suits, actions, investigations or proceedings.

        " Product(s) " shall mean Altoprev and Fortamet in various Dosages, including without limitation the Opening Inventory Products, and any modifications thereto and additional Dosages, in accordance with the terms of this Agreement.

        " Product Liability Claim " shall mean any third party Proceedings involving any actual or alleged death or bodily injury arising out of or resulting from the use of the Products.

        " Purchase Order " shall have the meaning ascribed to it in Section 3.2 .

        " Purchaser Product Liability Claims " shall mean all Product Liability Claims that do not constitute Andrx Product Liability Claims.

        " Quality Assurance Agreement " shall mean the Quality Assurance Agreement of even date herewith between Andrx and Purchaser, as in effect from time to time.

        " SCOT Technology " shall mean the know-how, applications, and patents relating to single composition osmotic table technology, including but not limited to the trade secrets and know-how required to manufacture the Products.

        " Second Quarter " shall have the meaning ascribed to it in Section 3.1.

        " Serious Adverse Drug Experience Report " shall mean any Adverse Drug Experience Report that involves an Adverse Drug Experience or any other event which would constitute a "serious" Adverse Drug Experience under the Act, including, without limitation, 21 C.F.R Parts 20, 310, 312, 314 and 600—Expedited Safety Reporting Requirement for Human Drug and Biological Products; Federal Register Vol. 62, No. 194, pp. 52237-52253; Tuesday, October 7, 1997.

        " Specifications " shall mean the internal control and regulatory specifications for the Products set forth on Exhibit A .

3


 

        " Standard Costs " shall be Andrx's standard manufacturing cost as of January 1, 2005 for the applicable Conforming Product, as modified and reflected in accordance with Exhibit B .

        " Supply Failure Notice " shall have the meaning set forth in Section 3.3 .

        " Takeda Arrangement " has the meaning set forth in the Agreement to License.

        " Term " has the meaning set forth in Section 6.1 .

        " Territory " shall mean the United States of America, United Kingdom and any other jurisdiction which approves an Other Country Application filed by Andrx for Products.

        " Trademark " shall mean any domestic or foreign registered or unregistered mark for Altoprev, including but not limited to U.S. Registration No. 2911749 as well as any domestic or foreign registered or unregistered mark for Fortamet, including but not limited to any registered or unregistered mark for Fortamet, including but not limited to U.S. Serial No. 78115656, together with any related marks, brands, logos, trade dress or designs, whether registered or unregistered.


Article II.
Manufacture and Supply of the Products

        2.1     Manufacturing and Supply .    

        2.1.1  Obligations of Purchaser .  During the Term, Purchaser shall purchase its entire requirement of the Products exclusively from Andrx, except as provided in Sections 5.2 and 11.13 .

        2.1.2  Obligations of Andrx .  During the Term, Andrx shall manufacture and sell to Purchaser all of Purchaser's requirements (subject to the provisions of Article III ) of the Products on an exclusive basis within the Territory, subject to the exceptions set forth in Article 9 of the Agreement to License. Andrx shall manufacture the Products in the Facility. Andrx shall obtain necessary regulatory approvals prior to manufacturing the Products in any other facility.

        2.2     Capacity .    Andrx represents and warrants that it has and will continue to have at all times during the Term the capacity to produce minimum annual volumes of Altoprev tablets of various Dosages and Fortamet tablets of various Dosages. If at any time Purchaser's volume requirements for either of the Products exceeds the foregoing amounts, Purchaser will promptly advise Andrx of same and Andrx will use its commercially reasonable efforts to increase its capacity as soon as practicable, to meet Purchaser's forecasted volume requirements; provided that Andrx will not be required to increase its manufacturing capacity in order to accommodate volumes in excess of the foregoing amounts unless Purchaser agrees to pay the incremental out-of-pocket costs required to increase such capacity, either through increases in the Standard Costs or in another mutually satisfactory manner. If Purchaser makes such request and Andrx refuses to increase capacity as so requested, Purchaser will have the right to use or make the Manufacturing Intellectual Property available to a third party manufacturer pursuant to Section 5.2 to satisfy any capacity shortfall, provided Andrx is paid for its time and costs involved in assisting in this initiative and further provided that Andrx shall have the right to select the third party manufacturer to satisfy the capacity shortfall and shall do so diligently and in good faith. Upon request of Purchaser and subject to good faith agreement on pricing, Andrx shall use commercially reasonable efforts to increase its manufacturing capacity so that it can manufacture and distribute the Products for sale outside the United States, to the extent required to sell Products outside the United States. Nothing in this Agreement will prohibit Purchaser from selling Products outside the United States.

        2.3     Packaging .    If requested by Purchaser, and subject to Andrx's right to subcontract certain obligations pursuant to Section 11.5 , Andrx shall package the Products with labels, product inserts and other labeling as specified in Exhibit C . From time to time, Purchaser may, in its sole discretion, make changes to labels, product inserts and other labeling for the Products, which changes shall be prepared by Purchaser and provided to Andrx for review, approval and submission to any Governmental

4


 

Authority required to review or approve such change prior to or effective with the effectuation of such change. Andrx shall not be permitted to withhold approval for such change if such change is required by Law, unless such change does not comply with applicable Law. In connection with Opening Inventory Products and Products ordered by Purchaser during the six months immediately following the Effective Date, Andrx will be entitled to utilize supplies of packaging, labels and inserts on hand and on order as of the date hereof, including items reflecting brands and trademarks owned by Andrx. Purchaser will have the right to sell such Products in accordance with this Agreement. Except as described in the fourth sentence of this Section 2.3 , Andrx's brand shall not appear on the label nor anywhere else on the Products unless required by a governmental authority or applicable Laws or as it appears on the existing and in-transition inventory provided by Andrx to Purchaser at the Effective Date in accordance with the terms and conditions set forth in the Agreement to License. Subject to the foregoing, Purchaser shall provide all designs and artwork necessary to produce packaging, labeling and inserts for the Products which shall be implemented into Product production immediately unless otherwise specified by Purchaser. If the designs and artwork provided by Purchaser result in an increase in the packaging cost incurred by Andrx, then Andrx shall give prompt notice of such increase to Purchaser and the Per Unit Price shall increase by the amount of such additional cost. If Purchaser requests that Andrx subcontract its obligations under this Section 2.3 to a different third party, Andrx shall attempt in good faith to enter into an arrangement with such third party as soon as reasonably practicable.

        2.4     Quality Control and Assurance .    

        2.4.1  Manufacturing Requirements .  Andrx shall manufacture, package, label, store, test and ship the Products in accordance with: (a) all applicable Laws, (b) the Specifications, including requirements for Product dating, (c) the requirements of the approved NDAs and any Other Country Application and (d) the Quality Assurance Agreement. Andrx's responsibilities and obligations described in the foregoing sentence are hereinafter referred to as the " Manufacturing Requirements ". Andrx shall perform such quality control and quality assurance testing as is required (but in no event less than as generally practiced in the pharmaceutical manufacturing industry) to ensure that the Products comply with all of the Manufacturing Requirements. If the Products as manufactured by Andrx fail to meet the Manufacturing Requirements, Andrx shall, at its sole cost and expense, manufacture additional Products to replace such defective Products. Replacement of such non-conforming Products shall be Purchaser's sole remedy for such failure, except to the extent provided elsewhere in this Agreement. In such circumstances, Purchaser will have no obligation to purchase or pay for any rejected Products, but shall pay for the replacement product.

        2.4.2  Certificate of Analysis .  Each time Andrx ships the Products to or on behalf of Purchaser, it shall provide Purchaser with a " Certificate of Analysis " that sets out the actual test results for each lot of the Products, certifies that the Products shipped to Purchaser have been evaluated by Andrx and that the Products comply with the Manufacturing Requirements and describes the Products, Product numbers, lot numbers, expiration dates and test results for the Products, in each case as required by the NDA for such Product. Products that meet the foregoing are referred to as " Conforming Products ." Andrx shall not under any circumstances ship Non-Conforming Products (as defined in Section 2.4.3 ) to Purchaser. Andrx shall also provide Purchaser with Material Safety Data Sheets as required for the Products, and updates of same as necessary.

        2.4.3  Rejection of the Products .  Purchaser shall inspect each lot of the Products manufactured by Andrx within thirty (30) days after the later of: (a) the date of Purchaser's receipt of such lot of the Products, or (b) the date of Purchaser's receipt of the Certificate of Analysis applicable to a Product, in order to determine whether a Product meets the Manufacturing Requirements. Purchaser shall provide Andrx with written notice (a " Deficiency Notice "), promptly, and, in no event later than ten (10) days, after determining that: (a) any of the Products do not conform to

5


 

the tests results as shown on the Certificate of Analysis or the Manufacturing Requirements (" Non-Conforming Products "), or (b) the amount of delivered Products in a lot is less than the amount ordered by Purchaser. Purchaser's failure to notify Andrx within the stipulated period will be deemed, for purposes of this Agreement, as Purchaser's acceptance of such lot of the Products, however, such acceptance will not limit Purchaser's right to reject such Product for latent defects discovered by Purchaser or Purchaser's customer(s) after such stipulated period has expired. If a Deficiency Notice relates to a shortage in the delivered Products, then the parties shall deal with such shortage in accordance with normal commercial practices. If a Deficiency Notice relates to Non-Conforming Products, then Purchaser shall return to Andrx, at Andrx's expense, all shipments of Non-Conforming Products. Andrx shall bear all cost and responsibility for disposing of any Non-Conforming Products returned by Purchaser to Andrx. Andrx will have no liability for any deviations or shortages for which it has not received notice within such thirty (30) day period, except with respect to (i) Product Recalls and Product Returns as provided in Sections 7.6 and 7.7 , respectively and (ii) indemnification obligations under Article X . Upon receipt of a Deficiency Notice relating to Non-Conforming Products, Andrx will have ten (10) days to notify Purchaser in writing that it either: (x) agrees that the subject Products are Non-Conforming Products or (y) disputes Purchaser's determination that the Products are Non-Conforming Products. If any dispute arises as to whether the subject Products are Non-Conforming Products, then the parties shall mutually select an independent laboratory to evaluate whether the Products are Non-Conforming Products. If the evaluation certifies that the subject Products are Non-Conforming Products or Andrx agrees that the subject Products are Non-Conforming Products, then Andrx shall, within thirty (30) days of such determination, replace such returned Non-Conforming Products at its expense or, if it is unable to make prompt replacement, either credit Purchaser's account or refund any payment made on the rejected Products, depending on Purchaser's account balance as Purchaser's sole remedy with respect to such Non-Conforming Products, except to the extent provided elsewhere in this Agreement.

        2.4.4  Stability Testing .  Andrx shall conduct stability testing on the Products as required by GMPs and in accordance with the protocols approved in the NDA and any applicable Other Country Application. Andrx shall comply with the Quality Assurance Agreement in making any changes to these testing procedures or specifications for stability testing. If any lot of Products fails stability testing, Andrx, after consulting with Purchaser, shall determine the Proceedings and methods to be undertaken to investigate the causes of such failure. Andrx shall bear the cost of such investigation. Andrx shall provide any and all data and results relating to the stability testing upon request by Purchaser, or as such results are generated.

        2.4.5  Product Line Extensions .  If requested by Purchaser, Andrx will reasonably consider developing and/or manufacturing an extension to Altoprev and/or Fortamet, including combination products other than the products expressly permitted by the Takeda Agreement or the Alzheimer's Field of Use.

        2.4.6  Performance Credit .  If (i) the aggregate quantity of Conforming Products shipped by Andrx to Purchaser in any calendar quarter, in the case of Fortamet and any calendar quarter following [xxxx]*, in the case of Altoprev, is less than [xxxx]* of the amount ordered by Purchaser for such calendar quarter, (ii) the amount ordered is in accordance with the Forecast for such quarter and not in excess of the maximum available capacity designated for the Product, and (iii) such deficiency continues (in whole or in part) for at least ten (10) days, then, in addition to any other right or remedy of Purchaser under this Agreement, Andrx will issue a credit, applicable against the current invoiced amount, in an amount equal to [xxxx]* of the aggregate price of the Products in such purchase order. [xxxx]*. The provisions of this Section 2.4.6 shall not be

6


 

applicable for any deficiency resulting from a Force Majeure event or an amount specified in a Purchase Order to the extent it exceeds the maximum amount specified in Section 3.2.4.


*

filed under application for confidential treatment

        2.5     Sale of Inventory .    All Opening Inventory Products sold by Andrx to Purchaser pursuant to the Agreement to License shall be subject to the terms hereof.


Article III.
Forecasts, Purchase Orders and Delivery

        3.1     Forecasts .    Attached hereto as Exhibit D is an initial Forecast (as hereinafter defined) of Purchaser's expected requirements for Products for the periods set forth therein (including a break-down of commercial quantities, dosages, samples and safety stock). Not less than ninety (90) days prior to the beginning of each subsequent calendar quarter, Purchaser shall provide Andrx with a written, good faith, forecast (each, a " Forecast ") of the expected volume of each Product that Purchaser expects to require during the immediately following four (4) calendar quarters (including a break-down of commercial quantities, samples, and safety stock). Each Forecast shall set forth Purchaser's expected requirements on a month-by-month basis. Purchaser's sole obligations with respect to any Forecast will be (i) to purchase the volume of Products set forth in such Forecast for the first calendar quarter commencing at least ninety (90) days after such Forecast is delivered to Andrx (the " Firm Order Period "), as provided in Section 3.2.3 below, and (ii) to have its purchase requirements for the calendar quarter immediately following the Firm Order Period (the " Second Quarter ") be within the requirements set forth in Section 3.2.4 .

        3.2     Purchase Orders .    

        3.2.1  Delivery of Purchase Order .  Upon execution of this Agreement and at least thirty (30) days prior to the start of each calendar quarter, Purchaser shall provide a written " Purchase Order " to Andrx for such following quarter that sets forth the following information:

        (a)   the identity of each Product ordered (including a break-down of commercial quantities, safety stock (if any), dosages and samples);

        (b)   the quantity of each Product ordered;

        (c)   the Per Unit Price for each Product ordered and the total amount to be remitted by Purchaser;

        (d)   any special packaging, handling or labeling instructions;

        (e)   the delivery destination for each Product;

        (f)    the delivery date for each Product;

        (g)   any other special instructions regarding the Products not inconsistent with this Agreement; and

        (h)   a reference to this Agreement.

        3.2.2  Acceptance of Purchase Order .  Andrx shall accept any Purchase Order submitted by Purchaser that complies with the requirements of Section 3.2.1 and may, in its discretion, accept any Purchase Order that does not comply with Section 3.2.1 , and in either case shall deliver notice of its acceptance to Purchaser within five (5) days of its receipt of the Purchase Order; provided, that Andrx's failure to deliver such notice will not constitute non-acceptance of any Purchase Order that complies with Section 3.2.1 . Notwithstanding anything in this Agreement to the contrary, Andrx shall have no obligation to deliver Product with respect to any Purchase Order for

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a particular Dosage of Altoprev until it shall have met the Initial Trigger (as defined in the Agreement to License) with respect to such Dosage and shall have been paid by Purchaser the portion of the Holdback Amount (as defined in the Agreement to License) then payable with respect to such Dosage.

        3.2.3  Performance of Purchase Order .  If Purchaser submits a Purchase Order that complies with Sections 3.2.1 and 3.2.2 , or is otherwise accepted by Andrx, Andrx shall deliver the Products so ordered to Purchaser in accordance with the terms of the Purchase Order and this Agreement.

        3.2.4  Second Quarter.   Unless otherwise agreed by Andrx, the volumes set forth in any Purchase Order for the Second Quarter shall be at least eighty five percent (85%) of the volumes ordered pursuant to the Purchase Order for the preceding Firm Order Period, and shall not exceed one hundred fifteen percent (115%) of the volumes ordered pursuant to the Purchase Order for the preceding Firm Order Period.

        3.2.5  Transmission of Purchase Order; Governing Terms .  Purchaser may submit a Purchase Order to Andrx by facsimile transmission or e-mail, and Andrx shall confirm receipt of each Purchase Order by facsimile transmission or e-mail. The terms set forth on any of Purchaser's Purchaser Order forms shall be of no effect except as to quantities and delivery dates consistent with this Agreement.

        3.2.6  Introduction of Generic Products .  Notwithstanding anything set forth in this Section 3.2 and subject to the final sentence of this Section 3.2.6 , if any third-party introduces a generic form of a Product, in the same Dosage, Purchaser will not be obligated to issue a Purchase Order for or purchase the forecasted volume for such Product or comply with its obligations set forth in Section 3.2.4 in respect of such Product. In such event, Purchaser and Andrx shall negotiate in good faith a revision to the forecast to reflect the effect of such introduction. Purchaser shall honor all Purchase Orders that have been accepted by Andrx and shall reimburse Andrx for all unused raw materials and packaging purchased in accordance with outstanding forecasts for the succeeding two calendar quarters; provided, however, that Andrx shall use commercially reasonable efforts to utilize any such unused raw materials and packaging materials in an effort to mitigate Purchaser's obligation set forth in this sentence.

        3.3     Delivery .    Andrx shall deliver to Purchaser the amount of Products ordered by Purchaser in accordance with the delivery terms set forth in the Purchase Order. Notwithstanding anything to the contrary contained herein, Andrx shall not be required to deliver Products to Purchaser less than one hundred twenty (120) days after its receipt of the applicable Forecast; provided, that Andrx shall use commercially reasonable efforts to reduce its cycle time for the manufacture of the Products but shall have no liability solely as a result of its failure to achieve any level of cycle time reduction. Unless otherwise provided in a Purchase Order, title to the Products and the risk of loss shall pass from Andrx to Purchaser F.O.B. at Andrx's Facility, and Purchaser shall be responsible for shipping costs related thereto. The parties may mutually agree to modify the date of delivery. Andrx shall promptly notify Purchaser in writing if for any reason Andrx has reason to believe that it will be unable to supply on a timely basis the quantities of Product ordered by Purchaser (a " Supply Failure Notice "), but notification shall not relieve Andrx from any obligation hereunder or limit any right or remedy of Purchaser in respect of Andrx's failure.

        3.4     Purchase of Products .    All purchases of the Products shall be made solely pursuant to this Agreement and the terms required by Section 3.2 in each Purchase Order submitted by Purchaser to Andrx hereunder. This Agreement, the Agreement to License and the Purchase Orders constitute the entire and exclusive statement by the parties of the terms of their agreement regarding the manufacture and sale of the Products, notwithstanding any additional or different terms (including, without limitation, preprinted terms and conditions) contained in any Purchase Order, acknowledgment, invoice or other form furnished by either party. All such additional and different terms are hereby specifically

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rejected by the parties. All prior and contemporaneous proposals, negotiations, representations and agreements are merged into this Agreement.

        3.5     Monthly Reports .    Andrx shall provide Purchaser, on a monthly basis, manufacturing and supply reports containing reasonable and customary information on the status of outstanding Purchase Orders, including: (i) a schedule of all work in progress, (ii) shipping information, expiration dating, lot numbers and release data, and the sufficiency of raw materials on hand to cover open purchase orders, (iii) third party packaging information for all packagers of Purchaser's product, including status of all outstanding Purchase Orders and inventory on hand at each such packager, and (iv) such other information as Purchaser may, from time to time, reasonably request from Andrx.


Article IV.
Price and Payment

        4.1     Prices .    The " Per Unit Price " for each Product (other than samples) shall be equal to the [xxxx]* The Per Unit Price for samples shall be equal to [xxxx]*


*

filed under application for confidential treatment

        4.2     Payment .    Purchaser shall pay to Andrx the amount properly invoiced by Andrx for delivered, Conforming Products within thirty (30) days after Purchaser's receipt of such invoice. If Purchaser disputes in good faith the amount of any invoice, Purchaser shall pay Andrx the undisputed portion of such invoice pending resolution of such dispute. Andrx shall not invoice Purchaser for Opening Inventory Products of Fortamet, payment for which is included as part of the Fortamet Amount under the Agreement to License.

        4.2.1  Payment Credits .  Purchaser shall receive a payment credit of [xxxx]* per month towards the Products purchased under its Purchase Orders for the [xxxx]* of this Agreement and a payment credit of [xxxx]* per month to


 
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