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AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT

Requirements Supplier Agreement

AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT | Document Parties: Baxter Healthcare SA Switzerland and Baxter Healthcare Corporation | CERUS CORPORATION | FENWAL, INC | INTERCEPT Blood System You are currently viewing:
This Requirements Supplier Agreement involves

Baxter Healthcare SA Switzerland and Baxter Healthcare Corporation | CERUS CORPORATION | FENWAL, INC | INTERCEPT Blood System

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Title: AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT
Governing Law: Illinois     Date: 3/13/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT, Parties: baxter healthcare sa switzerland and baxter healthcare corporation , cerus corporation , fenwal  inc , intercept blood system
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Exhibit 10.37

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT

THIS AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT (this “ Agreement ”) is entered into by and between F ENWAL , I NC . , a company organized under the laws of Delaware (“ Fenwal ”), and C ERUS C ORPORATION , a company organized under the laws of Delaware (“ Cerus ”). Fenwal and Cerus, as corporations, are sometimes referred to herein as a “ Party ” and collectively as the “ Parties .” This Agreement shall become effective as of the last date of signature by the Parties (the “ Effective Date ”).

WHEREAS, Baxter Healthcare SA Switzerland and Baxter Healthcare Corporation (collectively referred to herein as “ Baxter ”) and Cerus entered into a Manufacturing and Supply Agreement, dated as of February 2, 2005 (the “ Original Supply Agreement ”) relating to the INTERCEPT Blood System;

WHEREAS, Baxter and Cerus subsequently entered into a Commercialization Transition Agreement (the “ Commercialization Agreement ”), effective February 1, 2006, which amended certain provisions of the Original Supply Agreement;

WHEREAS, Fenwal has advised Cerus that, as of March 1, 2007, the Original Supply Agreement and the Commercialization Agreement were assigned to Fenwal, and Fenwal assumed all of Baxter’s obligations thereunder;

WHEREAS, Cerus desires to ensure continuity of supply and achieve acceptable cost of goods regarding the supply of Platelet Sets and Plasma Sets, as such terms are defined in this Agreement;

WHEREAS, Fenwal desires to continue to supply Cerus with its requirements for Platelet Sets and Plasma Sets and to rationalize its production commitments;

WHEREAS, concurrently with this Agreement, the Parties are entering into an Agreement Concerning INTERCEPT Product Supply, relating to the supply of certain INTERCEPT products by Cerus to BioOne Corporation (“ BioOne ”); and

WHEREAS, the Parties now wish to extend the Original Supply Agreement and amend and restate its terms in the manner set forth in this Agreement;

 

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NOW, THEREFORE, in consideration of the premises and covenants set forth herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Fenwal and Cerus agree as follows:

ARTICLE 1

D EFINITIONS

In this Agreement, the following terms have the meanings specified or referred to in this Article 1 and shall be equally applicable to both the singular and plural forms. The words “including”, “includes” and “include” shall be deemed to be followed by the phrase “without limitation”, unless the context clearly dictates otherwise. Any agreement, schedule, attachment or exhibit referred to herein shall mean such agreement, schedule, attachment or exhibit as amended, restated, supplemented or modified from time to time to the extent permitted by the applicable provisions of this Agreement. Reference to any statute or regulation means such statute or regulation as amended at the time and from time to time and includes any successor statute or regulation. Unless otherwise stated, references to recitals, articles, sections, paragraphs, schedules and exhibits shall be references to recitals, articles, sections, paragraphs, schedules and exhibits of this Agreement.

Affiliate ” means, with respect to any Person, at the time in question, any other Person controlling, controlled by or under common control with such Person. For purposes of this definition, “control” shall mean (a) in the case of corporate entities, direct or indirect ownership of any of the stock or shares having the right to vote for the election of a majority of directors, (b) in the case of non-corporate entities, direct or indirect ownership of any of the equity interest with the power to direct the management and policies of such non-corporate entities.

Components ” means all raw materials and sub-assemblies, such as plastics, containers (including without limitation “wet-filled” containers), tubing, cannulas and compound adsorption devices for the production of or use in connection with the Sets.

Cost of Goods ” means Fenwal’s full cost of manufacturing or acquiring an item, in accordance with accounting principles generally accepted in the United States, consistently applied, (GAAP) and in accordance with Fenwal’s normal accounting practices, all consistently applied. Cost of Goods shall not, however, include amortization of development expenditures, except as set forth in Section 4.4(d) of this Agreement, or expenses falling under the category designated by Fenwal “ other costs of sales ” or similar category, however designated. It is understood that Fenwal fixed overhead will include amortization of Fenwal investments in additional assets to provide incremental capacity, as required pursuant to Section 2.4 of this Agreement.

Device Master Record ” shall include device specifications, production process specifications, quality assurance procedures and specifications (including acceptance criteria and quality assurance equipment to be used), and packaging and labeling specifications.

INTERCEPT Illuminator ” means a proprietary illumination device, including operating software and data management system, including source code for each, developed for use with Platelet Sets and Plasma Sets.

License Agreement ” means the agreement entered between Baxter and Cerus, effective February 2, 2005, whereby Baxter licensed to Cerus certain patents, know-how and materials.

Manufactured Products ” means Platelet Sets, Plasma Sets, and Components.

Person ” means an individual, corporation, limited liability company, partnership, sole proprietorship, joint venture, or other form of organization or governmental agency or authority.

 

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

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Plasma Disks ” means [*] disks designed for the pathogen inactivation system for plasma.

Plasma Sets ” means disposable processing sets for inactivation of pathogens in plasma components of blood, containing [*].

Platelet Sets ” means disposable processing sets for the inactivation of pathogens in platelet components of blood, containing [*].

Platelet Wafers ” means [*] wafers designed for the pathogen inactivation system for platelets.

Product Specifications ” means the specifications for the Platelet Sets and the Plasma Sets (as described in Section 2.1(b)), and as modified from time to time pursuant to Section 2.2. The Product Specifications for Components will be the applicable specifications for Components included within the Product Specifications mentioned above in this definition, or if such do not exist for any Component, then specifications to be developed by the Parties for such Component.

[*] ” means the raw material [*] , a component of Platelet Sets and Plasma Sets.

Sets ” means the Platelet Sets and the Plasma Sets.

Work Order ” means a written, signed order for the performance by Fenwal of mutually-agreed services. A Work Order shall include a scope of work, a project budget and a payment schedule. All Work Orders shall be deemed to be incorporated into this Agreement and governed by its terms and conditions.

ARTICLE 2

M ANUFACTURING AND S UPPLY

Section 2.1 Manufacturing Services .

(a) General. Fenwal will, during the term of this Agreement, manufacture Manufactured Products for Cerus on the terms set forth below all in accordance with the Product Specifications (collectively, the “ Manufacturing Services ”) in a professional and efficient manner and in accordance with the terms and conditions of this Agreement.

(b) Product Specifications for Platelet and Plasma Sets. As of the Effective Date, the Product Specifications for the Platelet Sets and Plasma Sets are listed on Exhibit A and Exhibit B, respectively, to this Agreement.

Section 2.2 Change Requests .

(a) Product Specifications; Device Master Record. In the event that Cerus requests any changes to such Product Specifications (including, without limitation, the addition of new product codes or changes made to comply with any requirement, order or instructions by any regulatory authority), Fenwal will perform and complete such requests in a timely fashion. Fenwal will not unreasonably withhold its approval to any requests of Cerus to change Product

 

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

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Specifications. Any changes to the Product Specifications or Device Master Record must be reviewed and approved under Fenwal and/or Cerus change control procedures. Fenwal will make no changes to the Device Master Record for the Manufactured Products without the prior written approval of Cerus. In some cases, changes are caused by third-party suppliers (“ Third Party Changes ”) and are outside the scope of Fenwal’s control. Fenwal shall give Cerus at least ninety (90) days notice of any such Third Party Changes, provided such third party gave sufficient notice to Fenwal. If, due to circumstances beyond Fenwal’s control, Fenwal is required to qualify a new third-party supplier, it will so notify Cerus and the Parties will confer on the determination of and terms of agreement with such new third-party supplier. Allocation of costs for such changes is further described in Section 4.4(a).

(b) Product Improvements; Prototypes. Periodically, Cerus may request that Fenwal manufacture prototype development or clinical lots, or request additional validation or qualification activities to obtain regulatory approvals. Fenwal will manufacture and supply prototype lots of the Sets, as Cerus may reasonably require in connection with any changes to Product Specifications. Allocation of costs for such changes shall be allocated in accordance with Section 4.4(b).

(c) Changes in Manufacturing Location. Fenwal will provide Cerus with at least ninety (90) days advance written notice of any change in its manufacturing location and, in any event, will not change any location until the new location is fully-qualified and licensed with each applicable Party’s regulatory group for the manufacture of the Manufactured Products for sale or clinical testing. Changes in manufacturing location include changes in manufacturing location for raw materials, components, subassemblies, or finished goods; changes in location or subcontractor for sterilization processes; and, changes in chemical and physical facilities. Cerus understands and acknowledges that Fenwal intends to transfer and consolidate major subassembly and final assembly equipment and processes to the Fenwal plant in [*] . Allocation of costs for any such changes is further described in Section 4.4(c).

(d) U.S. FDA Compliance. Upon Cerus’ written request, Fenwal agrees to review and modify, as may be necessary, its existing manufacturing facilities and quality systems to be compliant with FDA quality system requirements (“ QSR’s ”) and cGMP within twelve (12) months of such request. In the event of a modification to meet QSR’s cGMP and standards applicable to the United States, Europe or Asia, Fenwal will review and modify its existing manufacturing facilities in agreement with Cerus. Allocation of costs for such changes is further described in Section 4.4(d).

(e) Plastics. Cerus understands that Fenwal may receive, from time-to-time, “Supplier Notice of Change” notifications from Baxter for any of the formulations for the key plastics used in the Platelet and Plasma Sets manufactured by Baxter. No such changes, however, shall cause the Manufactured Products to fail to meet any regulatory requirements. Additionally, Cerus reserves any and all rights, and remedies it may have against Baxter, for such plastics under the Original Supply Agreement. Allocation of costs for such changes is further described in Section 4.4(e).

 

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

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(f) Other. In the event Cerus is interested in conducting development, qualification and/or validation work for substituting Fenwal plastics for Baxter plastics used in the Platelet and Plasma Sets, the Parties shall agree on the work to be performed by Fenwal and determine, in good faith, the terms of supply, by Fenwal, of such Fenwal plastics to Cerus for inclusion into the Sets.

(g) Work Order. In the event Cerus requires Fenwal to perform any work pursuant to this Section 2.2, the Parties shall enter into a Work Order for the performance by Fenwal of such mutually-agreed services.

Section 2.3 Supply and Purchase Commitments .

(a) Subject to Cerus’ supply of Platelet Wafers, Plasma Disks and [*], during the Term of this Agreement, Fenwal shall supply Cerus with purchase orders for Manufactured Products within the delivery times required under Section 2.4. Cerus shall purchase Manufactured Products from Fenwal as set forth in Section 2.5.

(b) Cerus shall purchase its requirements of Platelet Sets and Plasma Sets from Fenwal, subject to the following:

(i) For the duration of this Agreement and in any calendar year, Cerus shall purchase from Fenwal a number of Sets equal to the greater of [*] . In any event, Cerus shall not be required to purchase [*] in any given calendar year from Fenwal absent a written mutual agreement between Cerus and Fenwal stating such. Cerus is free to purchase [*] from a third-party supplier or suppliers. Such purchases by Cerus at any time from third-party supplier(s) will not alter Cerus’ purchase obligations under binding firm purchase orders to Fenwal then in effect pursuant to Section 2.4 of this Agreement.

(ii) In the event that Cerus provides [*] written notice of termination pursuant to Section 6.2(g) of this Agreement, then Cerus’ purchase requirements shall be modified as follows (without altering Cerus’ purchase obligations under binding firm purchase orders to Fenwal then in effect pursuant to Section 2.4 of this Agreement):

(A) During the [*] months following such notice, Cerus shall purchase Sets from Fenwal at a rate equal to [*] of the [*] for Sets purchased by Cerus from Fenwal during the [*] period preceding such notice;

(B) During months [*] following such notice, Cerus shall purchase Sets from Fenwal at a rate equal to [*] of the [*] for Sets purchased by Cerus from Fenwal during the [*] period preceding such notice; and

(C) During the [*] following such notice, Cerus shall purchase Sets from Fenwal at a rate equal to [*] of the [*] for Sets purchased by Cerus from Fenwal during the [*] period preceding such notice.

 

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

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Section 2.4 Forecasts .

In order to assist Fenwal in its production planning of Manufactured Products for Cerus, Cerus will provide to Fenwal during the Term of this Agreement a rolling [*] forecast by product code, of which [*] will constitute firm purchase orders for Platelet Sets and Plasma Sets, and of which [*] will constitute firm purchase orders in the case of Components ordered separately. Cerus agrees that these forecasts will include consideration of obligations for supply of products to meet the forecasts of any third party distributors or other third parties, including BioOne. Additionally, during the [*] of each [*] , Cerus shall provide to Fenwal an “optimistic” volume forecast and a “base case” volume forecast, for the following [*] . “Optimistic” volume forecast shall be used for manufacturing capacity assessment and discussion of manufacturing capacity planning between the Parties based on such assessment. Both Parties understand that investments in additional assets to provide capacity above that required for base case volumes may result in higher fixed overhead allocations. Monthly meetings with Fenwal and Cerus representatives shall be held at a mutually agreeable time to discuss production planning and inventory management, including, but not limited to, volume forecasts provided pursuant to this Section 2.4. It is understood that standard costing will be based on the “base case” volume forecast for following [*] terms, as further described in Section 4.2.

Section 2.5 Purchase Orders .

The firm purchase orders in each rolling forecast described in Section 2.4 above will constitute a binding obligation on the part of Cerus to purchase such Manufactured Products regardless of whether Cerus has a need for such Manufactured Products at the time of delivery and such purchase obligation will not be relieved for longer than [*] , except on account of any force majeure event, or the unavailability of Cerus-supplied materials, that may arise subsequent to the date the purchase order is placed. The terms and conditions of this Agreement will be controlling over any terms and conditions included in any purchase order form used in ordering Manufactured Product. Any term or condition of any purchase order, invoice, packing slip, quotation or other document delivered by either Party incident to the purchases hereunder that is in addition to, different from or contrary to the terms and conditions of this Agreement will be void, unless the Parties otherwise agree by a separate written agreement.

Section 2.6 Delivery; Shipment; Invoices .

(a) All Manufactured Products supplied under this Agreement will be delivered by Fenwal to Cerus’ designated carrier at Fenwal’s facility in [*] INCOTERMS 2000). Title and risk of loss passes to Cerus [*] Invoices issued by Fenwal upon delivery shall be based on the standard costing established in Section 4.2(a) and paid by Cerus within sixty (60) days of invoice date. Disputed invoices are to be resolved expeditiously and in good faith by the Parties. All delivery costs, insurance, freight, import and export duties and taxes will not be included as Cost of Goods. Fenwal shall cause to be delivered all Manufactured Products according to [*] purchase orders ( [*] firm purchase orders for Components, if ordered separately) made by Cerus pursuant to Section 2.4 of this Agreement.

 

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

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(b) Fenwal shall include a packing list in each shipment of the Manufactured Products providing the following information: (1) Cerus purchase order number; (2) Fenwal Components Code; and, (3) Quantity. Fenwal shall also mail a copy of each packing list to Cerus for each shipment at the time of shipment. Fenwal shall provide to Cerus a certificate of compliance for each lot of Manufactured Goods shipped.

(c) Fenwal shall deliver each Manufactured Product to Cerus within [*] of production.

(d) Within [*] of receipt of Product Release Records (as defined in the Quality Agreement between the Parties) for Manufactured Products, Cerus will complete a review to identify any variations from the Product Specifications referenced on the relevant Exhibit to this Agreement, which set forth quality standards for the Manufactured Products. Cerus will work with Fenwal to determine if the identified variations from Product Specifications can be clarified or resolved. If evidence cannot be provided by Fenwal that the Manufactured Products do meet the Product Specifications then Cerus shall notify Fenwal of its rejection of such Manufactured Products. Fenwal will invoice Cerus for the Manufactured Products as described in Section 2.6 (a) of this Agreement. If Cerus delivers such notice of variation from Product Specifications or rejection within such [*] period, Cerus shall promptly make available to Fenwal for examination and testing, at the expense of Fenwal, the Manufactured Products in the rejected shipment and Fenwal shall, if the Manufactured Products were properly rejected, at Fenwal’s expense, either (i) credit Cerus for the amount of such non-conforming Manufacturing Products for which Cerus has previously paid Fenwal, or (ii) promptly provide replacement Manufacturing Products that meet the Product Specifications.

ARTICLE 3

W ARRANTY

Section 3.1 Warranty. Each Party represents and warrants to the other as follows:

(a) As of the Effective Date, all corporate action necessary for the authorization, execution and delivery of this Agreement by such Party and the performance of its obligations hereunder has been taken;

(b) As of the Effective Date, the execution, delivery and anticipated performance of this Agreement do not violate or conflict with any law applicable to it, any provision of its charter or bylaws, any order or judgment of any court or other agency of government applicable to it or any of its assets or any contractual restriction or provision or agreement or instruction binding on or affecting it or any of its assets;

(c) As of the Effective Date, its obligations hereunder constitute its legal, valid and binding obligations, enforceable in accordance with their respective terms (subject to applicable bankruptcy, reorganization, insolvency, moratorium or similar laws affecting creditors’ rights generally and subject, as to enforceability, to equitable principles of general application, regardless of whether enforcement is sought in a proceeding in equity or at law); and

 

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

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(d) To the knowledge of the Parties as of the Effective Date, no consents, waivers, approval or authorizations of any third party, other than the regulatory authorities in other countries in the Territory, are required for such Party to perform any of its obligations under this Agreement.

(e) Fenwal represents and warrants that, upon shipment and for a one-year period from the date of production of each Manufactured Product (or for the shelf-life of the Manufactured Product, if such period is longer) (the “ Warranty Period ”), Manufactured Products will meet the then-current Product Specifications, and be free from defects in material, workmanship and title, provided Manufactured Products are stored according to label copy and are used according to label instructions.

(f) Subject to Section 2.2(d), Fenwal represents and warrants that its manufacturing facilities used to provide Manufactured Products hereunder will meet the Good Manufacturing Practices (cGMP) and standards applicable as required to meet the Product Specifications.

Section 3.2 Disclaimer of Warranties . With respect to the subject matter of this Agreement, the warranties granted in Section 3.1 are exclusive and are offered in LIEU OF ALL IMPLIED OR STATUTORY WARRANTIES (INCLUDING WITHOUT LIMITATION, WARRANTIES AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM COURSE OF DEALING OR USAGE OF TRADE) or any other express or implied warranties or representations.

Section 3.3 Remedies . If any item manufactured by Fenwal or its subcontractors shall prove defective in material and/or workmanship within the Warranty Period, Cerus shall notify Fenwal in writing of such defect or noncompliance [*] of Cerus’ discovery of such defect or noncompliance, and Fenwal shall replace said item. The Warranty Period for such replaced item shall be as set forth in Section 3.1(e) of this Agreement. Fenwal shall have no responsibility if such item has been improperly stored by Cerus or used outside of label instruction by Cerus, its agents or customers or the defect or noncompliance is due to an act or omission by Cerus or its third-party suppliers as relating to the Platelet Wafers, Plasma Disks, [*] or INTERCEPT Illuminator devices or any other component that Cerus decides to provide to Fenwal. The foregoing shall be Fenwal’s sole and exclusive liability and Cerus’ sole and exclusive remedy for any breach of contract action arising out of any such defect, except with respect to each Party’s indemnification obligations as set forth in Article 10, provided that Fenwal shall remain responsible to carry out its obligations under the Quality Agreement (as defined herein).

ARTICLE 4

P AYMENTS ; A UDIT

Section 4.1 Compensation for Manufacturing Services .

(a) From the Effective Date to December 31, 2008, as compensation for the Manufacturing Services, Cerus will pay to Fenwal an amount equal to (i)  [*] Cost of Goods of the Manufactured Products ordered and purchased by Cerus for [*] , and (ii)  [*] Cost of Goods of the Manufactured Products ordered and purchased by Cerus for use in [*] . (The Parties shall have previously entered into a Work Order for Manufacturing Products ordered for use in [*] ). Manufactured Products ordered and purchased under (i) and (ii) of this Section 4.1(a) shall be invoiced separately.

 

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

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(b) Budgeted Standard Cost of Goods will be [*] as further described in Section 4.2. From January 1, 2009 and for the remainder of the Term of the Agreement, the invoice price for each Manufactured Product shall be equal to Fenwal’s Budgeted Standard Cost of Goods for such Manufactured Product, and, additionally:

(i) for each of the aggregate number of Platelet Sets and Plasma Sets invoiced by Fenwal in [*] up to and including [*] , a charge of [*] shall be applied to each Platelet Set and Plasma Set invoiced by Fenwal to Cerus for [*] .

(ii) for each of the aggregate number of Platelet Sets and Plasma Sets invoiced by Fenwal in [*] in excess of [*] , a charge of [*] shall be applied to each Platelet Set and Plasma Set invoiced by Fenwal to Cerus for [*] .

The purchase price for Components shall be negotiated in good faith and shall not exceed [*] of Fenwal’s Cost of Goods of the Components.

(c) On [*] , Fenwal will provide to Cerus a reconciliation report of Manufacturing Variances versus the Budgeted standard Cost of Goods (“Manufacturing Variances”). Manufacturing Variances will be calculated based on (1) the variations in overhead absorption due to volume variations of Cerus actual purchases from the “base case” forecast and (2) raw materials cost changes of more than [*] from any raw material supplier (“Purchase Price Variances”), as described in 4.2 (c). Labor and conversion loss shall be fixed at the budgeted levels and not included in the Manufacturing Variance calculations, except as may apply where described in Section 4.2 (d). Calculations shall be performed such that a “positive variance” would be in the favor of Cerus, while a “negative variance” would be in the favor of Fenwal. Fenwal will provide to Cerus [*] reconciliation reports of such Manufacturing Variances as soon as practicable after the [*] , and [*] reconciliation reports of such Manufacturing Variances within [*] . Fenwal will provide to Cerus, within [*] Manufacturing Variances reconciliation report. If Manufacturing Variances are positive, Fenwal will pay a variance adjustment rebate to Cerus within [*] . If Manufacturing Variances are negative, Fenwal shall invoice Cerus a variance adjustment fee, payable within thirty (30) days of receipt of such variance invoice.

Section 4.2 Cost Calculations

(a) Cost of Goods. Fenwal represents that the 2008 standard Cost of Goods for the Platelet Sets and Plasma Sets is set forth on Exhibit C hereto. In the [*] , using the “base case” production forecast for the following year provided by Cerus to Fenwal (per Section 2.4), Fenwal will provide a Budgeted Standard Cost of Goods for the following year (the “Budgeted Standard Cost of Goods”). This Budgeted Standard Cost of Goods will include labor, overhead and conversion loss and a costed bill of materials. Determination of Fenwal’s Budgeted Standard Cost of Goods shall be made consistent with Fenwal’s current practice of computing cost of goods, subject to the definition of “Cost of Goods” in Article 1. Capital expenditures for

 

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

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facilities and/or equipment and capitalized manufacturing start-up costs will be amortized on a straight-line basis and included in Cost of Goods. The amortization basis for facilities and equipment that were transferred by Baxter to Fenwal shall not exceed Baxter’s depreciated book value of such facilities and equipment immediately prior to their transfer to Fenwal. Fenwal’s Cost of Goods and budget shall be determined using [*] , consistent with the “base case” volume forecast provided by Cerus. Fenwal’s cost of inspection and storage of Platelet Wafers and Plasma Disks shall be included as incremental variable overhead in determining the Cost of Goods. In the event any item is acquired by Fenwal from an Affiliate, “ cost of manufacturing or acquiring ” shall be deemed to mean such Affiliate’s cost of manufacturing or acquiring. The Cost of Goods will be based upon the local currency in the country in which the Manufactured Products are manufactured. The Budgeted standard Cost of Goods may change during [*] solely as required to reflect increases or decreases in the Cost of Goods due to changes to the Product Specifications based upon Cerus’ needs and legal requirements.

(b) Long-Range Standard Cost of Goods Estimates. In addition to that described in Section 4.2 (a), following receipt of Cerus’ [*] “optimistic” and “base case” volume forecasts prepared to Section 2.4, Fenwal shall, in the [*] of each [*] , provide to Cerus [*] of product code cost for the “optimistic” and “base” case volumes, with details of material, labor, conversion loss factors, rework allowance, overhead and depreciation for each finished kit code. Fenwal’s product standard costing for the following [*] will be provided by Fenwal in the form of a costed bill of materials and with the details of material, labor, conversion loss factors, rework allowance, fixed and variable overhead elements. Such product standard costing shall be based on the “base case” production forecast for [*] and shall be net of the costs for Cerus-supplied materials, as provided under Section 5.1. Any estimates used by Fenwal in calculating standard Cost of Goods shall be made reasonably and in good faith. Such costing is intended for use with long-range planning efforts of both parties, and shall not be binding for future years.

(c) Raw Material Cost Changes. Cerus additionally understands and acknowledges that Fenwal has supply agreements for key plastics used in the Platelet and Plasma Sets, and that such agreements may result in raw materials cost changes, such cost changes to be passed through to Cerus as Purchase Price Variances to the extent provided in Section 4.1(c) of this Agreement.

(d) Conversion Loss. Fenwal shall use commercially reasonable efforts to continually reduce conversion loss and rework for Manufactured Products and Cerus-supplied materials. For the purpose of this Agreement, “ conversion loss ” shall include losses due to quality control testing and scrap of excess or non-conforming Manufactured Products. Any process or activity undertaken by Fenwal to bring a defective or non-conforming product into compliance with the Specifications shall be considered “ rework ” under this Agreement. Prior to the beginning of each calendar year, the Parties shall agree on a reasonable conversion loss factor and rework allowance to be included within the standard cost for each Manufactured Product, based on an assessment of the actual costs of conversion loss and rework incurred in prior years. The conversion loss factor and rework allowance will be fixed for that calendar year. Any excess conversion loss or rework will not be included in the Cost of Goods. Cerus and Fenwal agree to review and negotiate in good faith for payment for conversion losses and rework [*] of

 

[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

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the budgeted amounts for such activities if such costs are incurred as a result of circumstances which could not have been predicted or avoided by Fenwal or Cerus. Cerus agrees to pay [*] arising from changes in Manufactured Products Specifications. Fenwal will promptly notify Cerus of the nature and amount of such [*] accordingly. Prior to the beginning of each calendar year, the Parties shall agree on a reasonable level of conversion loss for Cerus-supplied materials; the conversion loss factor is expected to remain flat or decrease during each year of this contract. If the conversion loss for any Cerus-supplied materials exceeds the agreed-upon amount, Fenwal shall reimburse Cerus the amount of Cerus’ cost of goods corresponding to such excess conversion loss.

(e) Meetings. Cerus and Fenwal agree to meet at least twice per calendar year as part of the planned semi-annual management meetings to review and prioritize cost reduction initiatives. At such time, Cerus and Fenwal shall identify projects for implementation (if any), and estimate and allocate related costs (including, but not limited to, engineering time, operating and capital expenses), and risks and benefits.

(f) Request for Documentation. Upon request by Cerus, Fenwal will supply Cerus with a full accounting of Fenwal’s Cost of Goods, including a costed bill of materials.

Section 4.3 Audit . Cerus shall have the right, through an independent third-party auditor approved by Fenwal (which approval shall not be unreasonably withheld), to perform a full audit, on an annual basis and after thirty (30) days prior notice, on Fenwal records directly associated with or related to the Manufacturing Services and Fenwal’s calculation of Cost of Goods. Any audit shall be conducted during Fenwal’s normal business hours. Prior to commencing any audit, such third-party auditor shall enter into a confidentiality agreement in a form acceptable to Fenwal. Any undisputed overpayment or underpayment determined by this Section 4.3 shall be due and payable to the other Party by the Party owing such amount within thirty (30) days after notice of such audit finding. Cerus shall bear the full costs of such audit, except that in the event that any audit performed hereunder results in a decrease of [*] or more in the case of Platelet Sets and Plasma Sets, or [*] or more in the case of Components, in any purchase price due to Fenwal hereunder, then Fenwal shall be obligated to reimburse Cerus for such audit costs, but will not be required to reimburse more than [*] Dollars ($ [*] ) for any audit e


 
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