Filed by sedaredgar.com - Response Biomedical Corporation - Exhibit 4.6






ROCHE DIAGNOSTICS,
SALES AND DISTRIBUTION AGREEMENT
V.12 06_19_2008 
Certain
Information in this exhibit has been omitted as confidential, as indicated by
[***]. This information has been filed separately with the Commission.


SALES AND DISTRIBUTION AGREEMENT 

This Supply Agreement (the “Agreement”), effective as of
June 25th, 2008 (the “Effective Date”), is by and between Response
Biomedical Corporation, a Canadian corporation having its principal place of
business at 1781-75th Avenue W., Vancouver, BC V6P 6P2 Canada (the
“Supplier”), Roche Diagnostics Ltd, a Swiss corporation having its
registered office at Forrenstrasse, 6343 Rotkreuz, Switzerland (“RDR”) and Roche
Diagnostics Operations, Inc., a Delaware corporation having its principal place
of business at 9115 Hague Road, Indianapolis, Indiana 46250 (“RDO”). RDR,
RDO and Supplier are collectively referred to herein as the “Parties” and
each individually as a “Party.” 

R E C
I T A
L S: 


  
    WHEREAS, Supplier manufactures and
      sells certain cardiac marker products for in-vitro diagnostics, including
      instruments, reagents, controls, parts, accessories and service more particularly
      described on Exhibit A attached hereto (the “Products”);
      and

    WHEREAS, RDR and RDO desire to purchase
      the Products from Supplier, and Supplier is willing to sell and supply the
      Products to RDR and RDO (and/or certain designated Ordering Entities), all
      in accordance with the pricing and other terms and conditions set forth
      in this Agreement. 

  



NOW, THEREFORE,
in consideration of these premises, of the mutual covenants contained
herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties agree as follows: 

1.      
 DEFINITIONS 

For purposes of this Agreement, capitalized terms not otherwise
defined in this Agreement shall have the meanings set forth in this Article
1. 

	1.1 	
      “Affiliate” – with respect to a specified Party to
      this Agreement, any individual, association or other entity that directly
      or indirectly controls, is directly or indirectly controlled by, or is
      directly or indirectly under common control with such specified Party. For
      purposes of this definition, “control” (including
      “controlling,” “controlled by,” and “under common control
      with”) means owning fifty percent (50%) or more of the outstanding
      voting securities of an entity, or otherwise possessing, directly or
      indirectly, the power to direct or cause the direction of the management
      and policies of an individual, association, or other entity, whether
      through the ownership of voting securities, by contract or otherwise.
      Notwithstanding the foregoing, for purposes of this Agreement, Genentech,
      Inc., a Delaware corporation, 1 DNA Way, South San Francisco, California
      94080-4990, U.S.A. and Chugai Pharmaceutical Co., Ltd, 1-9, Kyobashi
      2-chome, Chuo-ku, Tokyo, 104-8301, Japan, shall not be considered
      Affiliates of RDO or RDR unless RDO or RDR opts for such inclusion of
      either of the foregoing entities by giving written notice to
    Supplier.

	 	 
	1.2 	
      “Applicable Laws” means all applicable common law,
      statutes, ordinances, rules, regulations, codes, requirements, laws or
      orders of any Governmental Authority, including Regulatory Laws.

	 	 
	1.3 	
      “Assay(s)” means those tests for cardiac markers
      set forth on Exhibit A.

	 	 
	1.4 	
      “Business Day” – any day other than (a) Saturday
      or Sunday or (b) a day on which banks in the United States, Germany,
      Switzerland or Canada are permitted or required to be
  closed.




	1.5 	
      “CLIA” means the Clinical Laboratory Improvement
      Amendments pursuant to which the Centers for Medicare & Medicaid
      Services regulate U.S. laboratories.




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1.6 		
“Competitive Product” means any assay for the detection of cardiovascular disease, including, but not limited to, NT-proBNP Assay, Troponin I Assay, CK-MB Assay, or Myoglobin Assay.

	
	 	 	 
	
1.7 		
“Confidential Information” – any and all information of a confidential and proprietary nature that may be hereafter disclosed in any form, whether in writing, orally, electronically, or otherwise made
available by observation, inspection or otherwise by or on the behalf of RDO, its Affiliates or any Ordering Entity on the one hand, and Supplier on the other hand (each a “Disclosing Party”) to the other Party or any Ordering Entity (each
a “Receiving Party”), including without limitation:

	
	 	 	 
		
(a) 		
all information that is a trade secret under applicable trade secret law or other legal requirement and any other information that the Disclosing Party treats as confidential or proprietary and that should reasonably be understood
to be confidential and proprietary to the Disclosing Party;

	
	 	 	 
		
(b) 		
all information concerning product specifications, data, know-how, formulae, compositions, processes, designs, sketches, photographs, graphs, drawings, samples, inventions and ideas, past, current and planned research and
development, current and planned manufacturing or distribution methods and processes, customer lists, current and anticipated customer requirements, price lists, market studies, business plans, computer hardware, computer software, database
technologies, systems, structures and architectures;

	
	 	 	 
		
(c) 		
all information concerning the business and affairs of the Disclosing Party, its Affiliates or any third party in the possession of the Disclosing Party under an obligation of confidentiality (which includes historical and current
financial statements, financial projections and budgets, historical, current and projected sales, capital spending budgets and plans, business plans, strategic plans, marketing and advertising plans, publications, client and customer lists and
files, contracts, the names and backgrounds of key personnel and personnel training techniques and materials, however documented), and all information obtained from review of the Disclosing Party’s documents or property or discussions with the
Disclosing Party regardless of the form of the communication, including any information regarding third party business partners of the Disclosing Party possessed by such Disclosing Party under an obligation of confidentiality; and

	
	 	 	 
		
(d) 		
all notes, analyses, compilations, studies, summaries and other material prepared by the Receiving Party to the extent containing or based, in whole or in part, upon any information included in the foregoing.

	
	 	 	 
			
For purposes of this Agreement, “RDR Confidential Information” shall mean Confidential Information that is disclosed by RDR (or its Affiliates or any Ordering Entity) to Supplier, “RDO Confidential
Information” shall mean Confidential Information that is disclosed by RDO (or its Affiliates or any Ordering Entity) to Supplier, and “Supplier Confidential Information” shall mean Confidential Information that is disclosed
by Supplier to RDR or RDO (or their Affiliates or any Ordering Entity).

	
	 	 	 
	
1.8 		
“EMT” means the Executive Management Team.

	
	 	 	 
	
1.9 		
“FDA” - the United States Food and Drug Administration or any successor agency having the administrative authority to regulate the sale or marketing of medical devices in the United States.

	
	 	 	 
	
1.10 		
“GMPs” - current good manufacturing practices as specified in the FDA’s Quality System Regulation at 21 CFR Part 820, or similar Regulatory Laws of any applicable Regulatory Authority, as such Regulatory Laws
are in effect at the time of design, manufacturing, and supply, and as such regulations and similar Regulatory Laws are interpreted at that time by the relevant Regulatory Authority.

	




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1.11 		
“Governmental Authority” - all agencies, commissions, officials, courts and other governmental and regulatory authorities and instrumentalities of the United States and any other countries in which the Products
are manufactured, marketed, sold, tested, investigated or regulated, and all states or other political subdivisions thereof and supranational bodies applicable thereto.

	
	 	 
	
1.12 		
“JPSC” means Joint Program Steering Committee.

	
	 	 
	
1.13 		
“Lifetime Buy” – a purchase option available to RDR or RDO under certain circumstances contemplated by this Agreement, covering whatever quantity of Product(s) RDR or RDO elects to purchase, in its sole
discretion, up to the equivalent of [***] of Product(s) from Supplier under this Agreement, but only for the purposes of Sections 8.3 and 8.4. The terms and conditions of this Agreement shall be applicable to all Product(s) purchased under such
option.

	
	 	 
	
1.14 		
“Manufacturing Processes” – the methods, processes, materials (including, without limitation, raw materials and manufacturing materials), controls and facilities (including, without limitation, the equipment
and equipment location) used in the manufacturing operations to produce the Product(s), including without limitation, the design, manufacture, packaging, labeling, handling, storage, distribution, installation and servicing of the Product(s), as
applicable, given the nature of the Product.

	
	 	 
	
1.15 		
“Ordering Entity” – RDR, RDO, an Affiliate of RDR or RDO or any other entity designated by RDR or RDO to purchase Product(s) pursuant to the terms of this Agreement. The initial Ordering Entities other than
RDR and RDO under this Agreement are identified on Exhibit B.

	
	 	 
	
1.16 		
“POL” - laboratories owned or operated for the purpose of testing specimens from patients seen by the physicians who own, operate, or are affiliated with that practice.

	
	 	 
	
1.17 		
“Product(s)” – the cardiac marker products identified on Exhibit A attached hereto and manufactured, packaged, and labeled for and provided to RDR and/or RDO in accordance with the Specifications,
Quality Requirements and other requirements of this Agreement.

	
	 	 
	
1.18 		
“Purchase Order” – the written orders for the manufacturing and delivery of the Product(s) submitted by Purchaser to Supplier in form and content complying with the terms and conditions of this Agreement.

	
	 	 
	
1.19 		
“Purchaser” – RDR and/or RDO and/or an Ordering Entity, as applicable.

	
	 	 
	
1.20 		
“Quality Requirements”- the quality standards, procedures, practices and requirements set forth on Exhibit E.

	
	 	 
	
1.21 		
“Recall” – any correction or removal of, field action, or customer notification or communication with respect to, a device manufactured, marketed, sold, or distributed by RDR, RDO or their Affiliates that is
initiated (a) at the direction of the FDA or other Regulatory Authority, or (b) voluntarily by RDR, RDO, its Affiliates or Supplier to reduce a risk to health posed by such device or to remedy a violation of the Federal Food, Drug and Cosmetic Act
(the “Act”) or other Regulatory Law caused by the device which may present a risk to health.

	
	 	 
	
1.22 		
“Regulatory Authority” - with respect to any country or jurisdiction, any Governmental Authority involved in granting approval of or regulating of the investigation, manufacture, distribution, marketing, sale,
pricing or reimbursement of the Products in that country or jurisdiction, including the FDA in the United States.

	
	 	 
	
1.23 		
“Regulatory Laws” - all Applicable Laws governing (i) marketing approval or clearance, import, export, testing, investigation, design, manufacture, packaging, labeling, handling, storage, distribution,
installation, servicing, marketing, or sale, (ii) recordkeeping and reporting obligations,

	




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      (iii) Recalls, or (iv) similar regulatory matters, with
      respect to the Products, including without limitation, GMPs.

	 	 
	1.24 	
      “Specifications” – the complete and accurate
      description of the shape, appearance, features, functionality and other
      characteristics of a Product and the Manufacturing Processes, standard
      procedures, formulae, specifications, tests (and testing protocols),
      labeling, packaging and other standards pertaining to such Products all as
      described in Exhibit C attached hereto, all or any of which may be
      modified from time-to-time in accordance with Exhibit E hereof. To
      clarify, Specifications may only be modified in accordance with Exhibit
      E. Any modification of the Specification pursuant to Exhibit E
      shall be incorporated into this Agreement.

	 	 
	1.25 	
      “Territory” means any and all jurisdictions
      world-wide, but excluding Japan with respect to the NT- proBNP Assay
      listed in Exhibit A. If during the term of this Agreement, Supplier
      acquires the right to extend the Territory to include such NT-proBNP Assay
      in Japan, it shall promptly notify Purchaser and at such time the
      Territory shall be deemed to include the NT-proBNP Assay in Japan without
      further action by the Parties. Supplier shall use commercially reasonable
      efforts to obtain for Purchaser in Japan non-exclusive rights to the
      NT-proBNP assay listed in Exhibit A.

	 	 
	2. 	
      SUPPLY OF PRODUCTS,
      PRODUCT PRICE AND PAYMENT
      TERMS

	 	 
	2.1 	
      Supply. Supplier agrees to manufacture and supply
      the Product(s) to Purchaser in accordance with the Specifications as set
      forth in Exhibit C, the Quality Requirements set forth in
      Exhibit E and the other requirements of this Agreement, and
      Purchaser agrees to purchase the Product(s) from Supplier, subject to the
      terms and conditions set forth herein.

	 	 
	
      2.2 
	
      Price. The prices for the Products ordered by
      Purchaser hereunder shall be as set forth in Exhibit D (the
      “Prices”). The Prices detailed in Exhibit D shall represent
      the maximum prices for the Products ordered by Purchaser during the
      Initial Term of this Agreement; provided, however, in the event of
      material cost savings to Supplier due to economies of scale resulting from
      increased orders of the Ramp 200 Test Module, the Ramp 200 Control Module,
      the Printer, the Bar Code Scanner, and controls, whether pursuant to this
      Agreement or other agreements, shall be automatically passed on to
      Purchaser and the Prices in Exhibit D revised accordingly. In the event of
      material cost increases to Supplier due to increases in the cost of
      materials, labor, regulatory requirements or subcontractor costs, a Party
      may submit to the JPSC for consideration in good faith whether the Prices
      should be adjusted, and if no agreement is reached, the discussion will be
      escalated to the EMT. Subsequent to the Initial Term, the Prices shall be
      established pursuant to good faith negotiations between the
  Parties.

	 	 
	2.3 	
      Payment Terms. Unless disputed by either Party,
      Purchaser shall pay Supplier for each shipment of Product(s) within [***]
      calendar days after the later of (a) Purchaser’s receipt of a complete
      invoice and (b) the shipment of Product(s) (such date, the “Receipt
      Date”). In consideration of Purchaser’s expedited payment to Supplier,
      Purchaser shall be entitled to a [***] cash discount on all payments made
      to Supplier within [***] calendar days of the Receipt Date.

	 	 
	2.4 	
      Taxes. To the extent that Products supplied
      hereunder are subject to any sales, use, value added or any other taxes,
      payment of said taxes, if any, is Purchaser’s responsibility and said
      taxes are included in the Prices. Supplier shall be liable for any and all
      taxes on any and all income resulting from payments by Purchaser under
      this Agreement.

	 	 
	2.5 	
      Tooling. To the extent that RDR, RDO or one of
      their Affiliates reimburses Supplier for tooling for the production of
      Products, Supplier agrees that it shall comply with RDO’s tooling
      requirements attached hereto as Exhibit G.

	 	 
	
      2.6 
	
      Closed System Requirement. Supplier agrees that
      instruments and/or systems identified on Exhibit A
      (including any subsequent versions or improvements) will only be able to
      read the cardiac tests





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      identified on Exhibit A (including subsequent versions,
      improvements and additional cardiac tests added to Exhibit A). In
      addition, Supplier agrees that the tests identified on Exhibit A
      and manufactured after the Effective Date (including any subsequent
      versions, improvements and additional cardiac tests added to Exhibit
      A) will not be capable of being read by any instrument and/or system
      manufactured by Supplier, other than the instruments/systems identified on
      Exhibit A.

	 	 
	2.7 	
      Exclusivity. Supplier grants RDR and RDO the
      exclusive rights in the Territory, excluding [***] to market, sell and/or
      distribute the Products. Supplier shall not market, sell or distribute the
      Products itself, or through any other party and shall not develop, market
      or sell any Competitive Products in the Territory, [***] For the avoidance
      of doubt, the foregoing provisions of this Section 2.7 shall be
      subject to implementation of a plan to be established by the JPSC to
      address the intended phase- out of distributors which at the Effective
      Date are distributing Products. If Purchaser’s total purchases (by RDR,
      RDO and any Ordering Entity) fail to meet the Worldwide Minimum Purchase
      Quantities of a Product(s), as specified in Exhibit D, the Parties
      agree that Supplier will be released from its exclusivity obligations
      under this Section 2.7.

	 	 
	2.8 	
      CLIA Waiver. Promptly, but no longer than
      forty-five (45) days, following the Effective Date, Supplier shall propose
      to the JPSC for comment and approval a plan and budget pertaining to a
      CLIA waiver program. The budget shall cover direct and indirect costs of
      Supplier in performing the plan. While the budget to be agreed upon by the
      JPSC shall govern the amounts to be spent, it is currently anticipated
      that such budget will be approximately [***] per assay. The Parties agree
      to work jointly on the CLIA waiver development programs for the
      Product(s), but for the avoidance of doubt, such program shall be
      undertaken by Supplier. RDR will bear all of Supplier’s budgeted costs.
      Supplier shall not incur costs under such development programs without the
      approval of the JPSC. [*** Further, the Parties will explore obtaining
      equivalent waiver status in markets outside the U.S. If RDR wishes to
      obtain such status, RDR will also bear the expenses of any such programs
      and, if desired by RDR, Supplier will use its reasonable commercial
      efforts to complete such programs. The Parties recognize that in countries
      outside the U.S. and Canada, it may be beneficial for RDR to undertake
      such programs and Supplier agrees to cooperate fully with RDR with respect
      to these programs and to provide information and analysis and conduct such
      follow-up activities as reasonably requested by RDR. The Parties
      acknowledge that there is no assurance that any waiver will be obtained,
      and Supplier shall not be obligated to engage in non-budgeted
      activities.

	 	 
	2.9 	
      Production Requirements. Promptly, [***] following
      the Effective Date, Supplier shall propose to the JPSC for comment and
      approval a plan to achieve the following two (2) production requirements:
      [***]. Supplier is responsible for the plan and will bear all associated
      costs

	 	 
	2.10 	
      Additional Products.



(a)          
New Versions or Improvements/Enhancements. Minor improvements (including
minor software updates) and/or enhancements to the Products by Supplier shall
automatically be included as Products in Exhibit A at the prices set
forth in Exhibit D. Before the development or implementation of a new
version of a Product, that incorporates more than a minor improvement or
enhancement to the Product, the Parties shall discuss in good faith at the EMT
the development plan and an appropriate price therefore. 

(b)          
New Products Developed Independently by Supplier. During the term of this
Agreement, Supplier agrees to notify RDR and RDO in writing as soon as
commercially reasonable, of any new product developed by Supplier in the field
of assays for the detection of cardiovascular disease, including, but not
limited to, new test parameters. The Purchasers through their representatives on
the EMT shall have the first right of refusal to add such new products to this
Agreement and the Parties agree to negotiate in good faith the pricing and other
terms for these products and shall execute amended Exhibits A, C and D to
include the new products, specifications, terms and agreed-upon pricing. If the
Parties are unable to reach definitive agreement on such product, 



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specifications, terms and pricing
within sixty (60) days of notice RDR and RDO, shall have no further rights to
such product under this Section 2.10(b) and Supplier shall be free to deal in
respect of such product as it sees fit. 

(c)          
  New Products Developed by Supplier at RDR/RDO’s Request. In the
  event RDR and RDO desire improvements to the Products or new cardiac products,
  RDR or RDO shall notify the EMT. If Supplier, RDR and RDO agree to proceed,
  the Parties shall negotiate in good faith a separate development agreement covering
  the desired improvements/new products.

(d)          
Connectivity Solutions. In the event RDR and RDO desire a connectivity
solution to enable the Products to connect to a hospital or POL information
system, RDR or RDO shall notify the EMT. Supplier agrees to cooperate fully with
RDR, RDO and the third party software supplier selected by RDR and RDO, with
respect to the development of this solution and to provide information and
analysis and conduct such follow-up activities as reasonably requested by RDR,
RDO and the third party supplier. The JPSC shall in good faith establish a plan
and budget for the development of a connectivity solution. The Parties agree to
cooperate in good faith in the implementation of such plan. 

	3. 	
      PURCHASE ORDERS,
      FORECASTS, WARRANTY OF SUPPLY,
      AND FIRM
    LEAD-TIME

	 	 
	3.1 	
      Purchase Orders. During the Term of this
      Agreement, Purchaser may issue Purchase Orders containing instructions for
      performance under this Agreement, specifying the Specification number
      (i.e., change number) and quantities (and type, if applicable) of the
      Products desired. Supplier shall notify Purchaser promptly if the
      Specification number (change number) on the Purchase Order does not match
      the Specification number (change number) of the Product that Supplier has
      agreed to produce. Such Purchase Orders shall constitute the only
      authorization for Supplier to provide Products to Purchaser, and Purchaser
      shall accept only that performance that has been pre-authorized as
      evidenced by a Purchase Order. Supplier shall confirm its receipt and
      acceptance of each Purchase Order. Supplier shall not be entitled to
      reject an order which complies as a Purchase Order under this Agreement.
      For clarification, nothing in this Agreement requires Purchaser to submit
      any Purchase Orders or obligates Purchaser to purchase any quantity of
      Products other than as reflected in those portions of the Rolling Monthly
      Forecasts which are binding. Purchaser may make changes to the identity of
      Products, quantities, and/or delivery dates or delivery locations
      specified in issued Purchase Orders without penalty, additional cost, or
      the consent of the Supplier, provided that such changes are made
      outside of the Firm Lead-Time (as established in Section 3.4) and
      are otherwise in compliance with this Agreement. Supplier shall reference
      the Purchase Order number on all packing slips (and/or bills of lading)
      and invoices (including commercial invoices) for Product(s) delivered
      hereunder. Any term or condition of any Purchase Order, packing slip, bill
      of lading, or invoice that is different from or contrary to the terms and
      conditions of this Agreement shall be void and of no force and
    effect.

	 	 
	3.2 	
      Forecasts. In order to facilitate Supplier’s
      forward planning process for Products, and to assist Supplier in making
      certain decisions relative to inventory of long lead-time raw materials,
      by the first of each month during the Term of this Agreement, Purchaser
      shall provide Supplier with a written, rolling twelve-month forecast of
      its monthly estimated requirements for the Products (each a “Rolling
      Monthly Forecast”), of which only the first three (3) months will be
      binding. While the non- binding portion of each Rolling Monthly Forecast
      shall constitute the good faith beliefs of RDO and RDR, respectively, RDO
      and RDR may make such changes to the non-binding portion of each Rolling
      Monthly Forecast as it sees fit; provided, however, (i) the quantities
      forecasted for the sixth month of any Rolling Monthly Forecast shall not
      be increased by more than 25% prior to entering the Firm Order Period and
      (ii) the quantities forecasted for the ninth month of any Rolling Monthly
      Forecast shall not be increased by more than 50% prior to entering the
      Firm Order Period. In the event that RDO or RDR submit purchase orders in
      excess of those permitted pursuant to the forecasting mechanism set forth
      in this Section 3.2, Supplier shall not be obligated to accept that
      portion of the quantities set forth in such purchase orders that
      represents the overage (the “Excess Order Quantity”) .
      Nevertheless, to the extent Supplier accepts a purchase order reflecting
      an





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Excess Order Quantity, it shall use commercially reasonable efforts to fulfill the Excess Order Quantity.

	
	 	 
	
3.3 		
Warranty of Supply. Supplier hereby represents and warrants to RDR and RDO that it will use commercially reasonable efforts to have the capacity to manufacture and supply the Product(s) required by Purchaser pursuant to the
forecasting mechanism of Section 3.2 during the Term of the Agreement. Furthermore, Supplier hereby represents and warrants to RDR and RDO that (a) it will have the capacity to manufacture and supply the Product(s) (a) for any three (3) month
period during the Term in quantities equal to [***] of the quantity forecast for the three (3) month period prior thereto and [***] of the quantity forecast for the three (3) month period commencing six (6) months prior thereto, and (b) it will use
commercially reasonable efforts to have the capacity during the period specified in Section 8.3 for any Lifetime Buy. Purchaser may submit Purchase Orders for any quantity of Product(s), although Supplier shall not be obligated to accept any
Purchase Order that exceeds the quantity or other requirements of this Agreement. In the event Supplier’s manufacturing capacity is insufficient to meet the quantity of Products requested by Purchaser in a Purchase Order or the quantity set
forth in a Rolling Monthly Forecast, Supplier shall notify Purchaser of such circumstances as soon as possible, but in no event later than ten (10) Business Days from the date of receipt of such Purchase Order or Rolling Monthly Forecast, and RDR
and/or RDO shall be entitled to reduce the Worldwide Minimum Purchase Quantities specified in Exhibit D. Such reduction in the annual Minimum Purchase Quantity shall apply only to the year of such capacity shortage, and shall be a fraction
equal to the ratio of (i) the aggregate, cumulative Prices of Products covered by Purchase Orders or Rolling Monthly Forecasts as to which Supplier has notified Purchaser that it does not have capacity, over (ii) the aggregate, cumulative Prices of
all Products covered by Purchase Orders submitted by Purchaser to Supplier during such year. Such calculation shall not include Excess Order Quantities. If the capacity shortfall occurs during the first three years under Exhibit D, the annual
Minimum Purchase Quantity shall be deemed to be [***] units, but only for purposes of calculating the reduction. Supplier agrees that in the event Supplier’s manufacturing capacity is insufficient to meet the quantity of Products requested by
Purchaser in a Purchase Order, and not in excess of those permitted pursuant to the forecasting mechanism set forth in Section 3.2, or the quantity set forth in a Rolling Monthly Forecast, Supplier will equitably allocate its manufacturing capacity
based upon the quantities of products set forth in firm purchase orders received from its customers, until the shortfall issue is corrected.

	
	 	 
	
3.4 		
Firm Lead-Time. Firm lead-time for Products ordered hereunder shall be ninety (90) days (the “Firm Lead-Time”). Purchaser may not make changes to any Purchase Orders issued hereunder within the Firm
Lead-Time without the consent of Supplier.

	
	 	 
	
3.5 		
No Volume Guarantee. Supplier acknowledges that Purchaser is not guaranteeing that any volume of Assays will be ordered by Purchaser during any period during the Term of this Agreement.

	
	 	 
	
4. 		
DELIVERY

	
	 	 
	
4.1 		
Delivery. Supplier shall deliver the Product(s) Ex Works (ICC Incoterms 2000) Supplier facility in accordance with the Specifications, Quality Requirements, Purchaser’s shipping policies and Purchaser’s Purchase
Order on the dates specified in the delivery schedules attached to such Purchase Order. Purchaser shall select the designated freight carrier(s).

	
	 	 
	
4.2 		
On-Time Delivery. Supplier shall manufacture and deliver [***] of the Product covered by Purchase Orders in full compliance with the Specifications, the Quality Requirements and the other terms and conditions of this
Agreement; provided, however, in the event that Supplier delivers at least [***] of the Product ordered hereunder with respect to a given Purchase Order, it shall not be deemed to be in breach of this Agreement if it delivers any shortfall within
sixty (60) days of the initial delivery date. For purposes of this Agreement, “on-time” delivery shall be deemed to be five (5) calendar days before to zero (0) calendar days after the date of delivery to the facility specified in the
applicable Purchase Order.

	




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4.3 		
Remedies. In the event Supplier breaches Section 4.2, the sole remedies of RDO and RDR shall be replacement of defective Product or refund, at the option of Supplier together with the direct costs of (a)
Purchaser’s administration of the backorder situation caused by such breach and (b) Purchaser’s customers reimbursed by Purchaser to cover the incremental increased cost of cover that Purchaser is obligated to provide its customers as a
result of Supplier’s breach of Section 4.2. In the event of chronic breaches of Section 4.2, as set forth in Section 8.2 (b)(ii) or Section 8.2(b)(iii), Purchaser shall have the remedies set forth therein. Purchaser shall
have the obligation to maintain such inventories of Products as a reasonably prudent similarly situated company would maintain and to mitigate the amounts due from Supplier under this Section 4.2 in respect of its customers’ costs.
	
	 	 	 
	
5. 		
REPRESENTATIONS, WARRANTIES, AND COVENANTS
	
	 	 	 
	
5.1 		
Representations, Warranties, and Covenants of Supplier. In addition to all of the representations, warranties, and covenants of Supplier set forth herein, Supplier hereby represents, warrants, and covenants to Purchaser as
follows:
	
	 	 	 
		
(a) 		
Corporate Power and Authority. Supplier has all necessary power and authority to enter into and be bound by the terms and conditions of this Agreement, and that the execution, delivery, and performance of this Agreement by
Supplier have been duly authorized by all necessary corporate or company action on the part of Supplier. All persons executing this Agreement on Supplier’s behalf have been duly authorized to do so by all necessary corporate or company
action.
	
	 	 	 
		
(b) 		
Enforceability; No Conflict. This Agreement, when executed and delivered by Supplier in accordance with the provisions hereof, will be its legal, valid and binding obligation, enforceable against it in accordance with the
terms of this Agreement. This Agreement and Supplier’s performance hereunder does not and shall not violate any agreements that Supplier has with any third party.
	
	 	 	 
		
(c) 		
Product Specifications and Quality Requirements. All Products supplied by Supplier under this Agreement shall be manufactured and delivered in full compliance with the Quality Requirements, the Specifications, and the
Applicable Laws of the United States and of the place of manufacture, as well as Applicable Laws in those jurisdictions where Purchaser has given reasonable notice to Supplier of an intention to sell sufficient to enable Supplier to ascertain the
requirements of such Applicable Laws and to then comply therewith, and all other terms and conditions of this Agreement. Purchaser agrees to give Supplier reasonable notice of jurisdictions in which it plans to cease sales of the Products.
	
	 	 	 
		
(d) 		
Process Capability. Supplier will demonstrate, through reasonable documentation of validation, a process capability (CpK) of 1.33 or greater on any Purchaser-identified critical characteristics, dimensions or attributes, as
applicable and set forth in the Exhibits to this Agreement.
	
	 	 	 
		(e) 	
Intellectual Property. Supplier warrants that it has engaged in a thoughtful patent infringement clearance process, including conducting searches for third party patents and published applications relevant to products
it supplies under this Agreement. Based upon the infringement clearance process and thoughtful, well reasoned factual and legal analysis of the results of the patent searches, Supplier has cleared the products supplied under this Agreement for sale
from a patent infringement clearance perspective. Further, as of the Effective Date, no third party has raised any claim of patent infringement regarding products supplied under this Agreement.
	
	 	 	 
	
5.2 		
Representations, Warranties, and Covenants of RDR and RDO. In addition to all of the representations, warranties, and covenants of RDR and RDO set forth herein, RDR and RDO hereby represents, warrants, and covenants to
Supplier as follows:
	




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	 	(a) 	
      Corporate Power and Authority. RDR and RDO have
      all necessary power and authority to enter into and be bound by the terms
      and conditions of this Agreement, and that the execution, delivery, and
      performance of this Agreement by RDR and RDO have been duly authorized by
      all necessary corporate or company action on the part of RDR and RDO. All
      persons executing this Agreement on RDR and RDO’s behalf have been duly
      authorized to do so by all necessary corporate or company
action.

	 	 	 
	 	(b) 	
      Enforceability; No Conflict. This Agreement, when
      executed and delivered by RDR and RDO in accordance with the provisions
      hereof, will be its legal, valid and binding obligation, enforceable
      against it in accordance with the terms of this Agreement. This Agreement
      and RDR and RDO’s performance hereunder does not and shall not violate any
      agreements that RDR or RDO have with any third party.

	 	 	 
	 	(c) 	
      Compliance with Applicable Laws. RDR and RDO will
      store, handle, distribute, offer to sell, promote, advertise and sell the
      Products in full compliance with all Applicable
Laws.




	6. 	
      RECORDS AND
  AUDITS




	6.1 	
      Records. In compliance with Regulatory Laws and
      its own internal quality systems, Supplier shall maintain reproducible
      records of all information, data and documentation and retention samples
      relating to the Manufacturing Processes, Products, Quality Requirements,
      Specifications and its performance under this Agreement (the
      “Records”) until five (5) years after the later of the expiration
      or early termination of this Agreement and the period required by
      Applicable Laws. If Supplier is required to be registered with the FDA,
      Supplier shall comply with the requirements set forth in 21 C.F.R. Part 11
      regarding electronic records and signatures.

	 	 
	6.2 	
      Audit of Manufacturing Processes, Products and
      Records. Within ten (10) Business Days after a request is made by RDR
      or RDO, Supplier’s Manufacturing Processes, Products and Records shall be
      open to audit, inspection, examination and evaluation during normal
      working hours, but not more frequently than twice each year (other than by
      way of a follow-up audit to measure remedial measures to be taken
      following a finding of material deficiency during a regular audit), with
      the understanding that any audit(s) may be divided up into separate audits
      of specific business function, by RDR, RDO or their authorized
      representatives to the extent reasonably necessary to evaluate Supplier’s
      compliance with Applicable Laws and/or other requirements in connection
      with its performance under this Agreement. Without limiting the generality
      of the foregoing, Supplier shall permit RDR, RDO or their authorized
      representative, to enter the manufacturing, packaging, and quality control
      facilities to inspect and audit all the Manufacturing Processes (including
      without limitation equipment, facilities, operations and procedures),
      Products (including without limitation by sampling of such Products) and
      Records (including without limitation Records relating to quality
      assurance and regulatory compliance as they pertain to the Product(s) or
      to the system support and processes used to manufacture, process and/or
      package the Product(s)). For the purpose of such audits, inspections,
      examinations, and evaluations, RDR, RDO or their authorized
      representatives shall have access to such Manufacturing Processes,
      Products and Records beginning on the Effective Date and continuing until
      five (5) years after the later of (i) the termination or expiration of the
      Agreement or (ii) the satisfaction of Supplier’s obligations under this
      Agreement. In addition, Supplier shall provide adequate and appropriate
      workspace for RDO or its authorized representatives, which shall be
      reasonable in number, to conduct such audits, inspections, examinations
      and evaluations. Access to areas of Supplier’s facilities shall be subject
      to considerations of confidentiality pertaining to Supplier and its
      customers. Auditing personnel shall be subject to the standard facility
      procedures of Supplier and Purchaser shall be responsible for the conduct
      of its representatives while on the premises of Supplier.

	 	 
	6.3 	
      Ownership and Maintenance of Records. Supplier
      shall notify RDR and RDO in writing at the expiration of the time period
      specified for access to the Records set forth in Section 6.2 or at
      any time thereafter, if it does not intend to maintain the Records. RDR
      and RDO shall have sixty (60)





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      calendar days thereafter to respond to such notice. If
      RDR or RDO determines that it requires such Records, RDR or RDO shall
      notify Supplier and such Records pertaining to the Products shall be
      shipped to RDR or RDO, as specified, within a reasonable period of time,
      but in no event later than sixty (60) days after such notification from
      RDR or RDO. RDR and RDO agree to pay for reasonable retrieval and shipping
      costs associated with such Records.

	 	 	 	 
	7. 	
      PRODUCT RECALLS

	 	 	 	 
	7.1 	
      Recalls. If any Party, in good faith, determines
      that a Recall of one or more Products or its labeling may be warranted,
      such Party shall immediately notify the other Parties in writing and shall
      advise such other Parties of the reasons underlying its determination that
      a Recall may be warranted. The Parties shall consult with each other as to
      any action to be taken regarding such Recall. Notwithstanding the
      foregoing, RDR or RDO shall have the right to Recall one or more Products
      or its labeling at any time. Supplier agrees to reimburse RDR and RDO for
      the actual direct costs of a Recall, including but not limited to,
      freight, sorting, reworking or replacing Product, customer bulletins and
      direct administration of the Recall, but only with respect to and to the
      extent such Recall was a direct result of Supplier’s breach of this
      Agreement.

	 	 	 	 
	8. 	
      TERM AND
TERMINATION

	 	 	 	 
	8.1 	
      Initial Term. The “Initial Term” of this
      Agreement shall begin on the Effective Date and shall, unless earlier
      terminated pursuant to Section 8.2 below, continue in full force
      and effect for five (5) years thereafter. Subsequent to the Initial Term,
      this Agreement may be renewed in writing by the Parties. For purposes of
      this Agreement, the Initial Term and any renewal period thereafter shall
      be referred to herein as the “Term.” RDO and RDR shall notify
      Supplier, and Supplier shall notify RDO and RDR within [***] prior to the
      expiration of this Agreement of their intention whether or not to renew
      this Agreement.

	 	 	 	 
	8.2 	
      Termination.

	 	 	 	 
		(a) 	
      Termination for Cause.

	 	 	 	 
			(i) 	
      Any Party shall have the right to terminate this
      Agreement upon immediate written notice if the other Party is in material
      breach or default of any of its representations, warranties, covenants, or
      other obligations set forth in this Agreement and such Party fails to cure
      such breach or default within thirty (30) calendar days following receipt
      of written notice of such breach. In the event of such termination, the
      non-breaching Party shall be entitled to seek all available remedies at
      law or in equity in addition to exercising its right to terminate, unless
      such termination relates to Supplier’s failure to timely supply Product in
      accordance with this Agreement, in which case the remedies in Section 4.3
      are applicable.

	 	 	 	 
			(ii) 	
      Any Party may, at its sole option, immediately terminate
      this Agreement, or exercise the remedies set forth in Exhibit F,
      upon written notice, but without prior advance notice, to the other Party
      in the event that (A) the other Party is or becomes insolvent or is
      declared bankrupt by a court of competent jurisdiction; (B) a voluntary
      petition of bankruptcy is filed in any court of competent jurisdiction by
      such other Party; (C) an involuntary petition for bankruptcy is filed in
      any court of competent jurisdiction against such other Party; (D) a
      receiver or trustee is appointed for such other Party; or (E) this
      Agreement is assigned by such other Party for the benefit of creditors.
      For purposes of this Agreement, a Party shall be deemed to be
      “insolvent” when such Party has ceased to pay its debts in the
      ordinary course of business, cannot pay its debts as they become due, or
      is insolvent within the meaning of the federal bankruptcy law.

	 	 	 	 
		(b) 	
      Termination for Failure to Meet Certain
      Obligations.





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(i) Supplier shall have the right to
terminate this Agreement if Purchaser fails to meet the Worldwide Minimum
Purchase Quantities of the specified Product, as set forth in Exhibit D,
in years 4 or 5 of this Agreement. 

(ii) RDR or RDO shall have the right
to terminate this Agreement if Supplier fails to meet the quantity requirements
of any one Product, for any two (2) consecutive quarters (beginning in the first
year of the launch of the applicable Product launch with or without invocation
of the remedy set forth in Exhibit F. 

(iii) RDR or RDO shall have the right
to terminate this Agreement if Supplier fails to meet the Specifications set
forth in Exhibit C for a given Product for two (2) consecutive orders
and/or two (2) consecutive quarters with or without invocation of the remedy set
forth in Exhibit F. 

(iv) RDR or RDO shall have the right
to terminate this Agreement if Supplier fails to receive from FDA by the end of
Q3 2008 510(k) clearance on the NT-proBNP assay currently pending review.

	8.3 	
      Lifetime Buy. If either (a) Supplier provides
      notice of intent not to renew this Agreement after the Initial Term or any
      subsequent renewal period in accordance with Section 8.1, or (b)
      RDR or RDO terminates this Agreement pursuant to Section 8.2, then
      in addition to any other rights RDO or RDR may have hereunder, RDO or RDR
      shall be entitled to make a Lifetime Buy of Product(s). RDR or RDO shall
      have the option to submit a Purchase Order for prior to the expiration of
      this Agreement, and take delivery of, the Lifetime Buy of Products from
      Supplier for up to nine (9) months following the date of expiration or
      termination of this Agreement, as the case may be, but only for the
      purpose of covering outstanding tenders or purchase commitments and bona
      fide activities directed at the prompt, but orderly discontinuation of
      sales, marketing and distribution activities under this Agreement. RDR and
      RDO shall promptly discontinue all promotional and active sales and
      marketing activities related to Products. RDR’s or RDO’s Purchase Order
      for the Lifetime Buy shall constitute a binding obligation to purchase the
      quantities of Product referenced therein. Supplier shall update RDR or RDO
      periodically (but no less frequently than semi-weekly) regarding its
      status and progress on the Lifetime Buy build. RDR or RDO may, by written
      notice to Supplier, modify the specific Product(s) or quantities requested
      in the Lifetime Buy for any Product(s) or quantity for which manufacturing
      has not yet commenced by the time Supplier receives RDR’s or RDO’s notice.
      If RDR or RDO notifies Supplier of a reduction in the Lifetime Buy
      quantities for Products for which manufacture has not then commenced, RDR
      or RDO shall nonetheless be liable to Supplier for any Product-specific
      raw materials and/or components purchased by Supplier prior to such
      notification in furtherance of the Lifetime Buy build. Supplier shall
      provide to RDR or RDO or destroy such Product specific raw materials and
      components upon RDR’s or RDO’s request and RDR’s or RDO’s expense and in
      accordance with RDR’s or RDO’s written instructions.

	 	 
	8.4 	
      Post-Expiration/Termination Supply Obligations.
      Following expiration or termination of this Agreement, Supplier shall
      continue to sell to Purchaser, for those customers who have purchased a
      Hospital System or POL System in those jurisdictions where required by law
      or the sales terms by which RDR or RDO is obligated, reagents, parts,
      controls, disposables, accessories and service for [***] following the
      termination or expiration of this Agreement under the same terms and
      conditions set forth in this Agreement. The Parties agree that with
      respect to [***] such period will be [***] Neither RDR nor RDO shall
      institute any new promotion, advertisement or marketing of such items and
      shall use commercially reasonable efforts to cease existing promotion,
      advertisement and/or marketing of such items.

	 	 
	8.5 	
      Intellectual Property. If any Product or process
      used in the manufacture of Products by Supplier shall be held by a court
      of a competent jurisdiction in a final non-appealable judgment to infringe
      any patent, copyright or trademark or other intellectual property right,
      Supplier shall, or if Supplier, reasonable determines that there exists a
      material risk of infringement of a third party intellectual property
      right, whether or not a third party has made such a claim, Supplier may,
      at its expense use commercially reasonable efforts to (i) modify the
      Product or process in a manner reasonably





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acceptable to RDR and RDO to be
non-infringing (or acceptably reduce the material risk of infringement) or (ii)
obtain for RDR and RDO (without cost to RDR or RDO) a license to continue using
the Product or process or to reduce the material risk, as the case may be.
Supplier shall have thirty (30) calendar days following such a holding by a
court of competent jurisdiction to remedy said infringement. If Supplier is
unable to remedy said infringement to RDR’s and RDO’s satisfaction, or to
eliminate the material risk of infringement, this Agreement shall terminate with
respect to the affected Product without further cost or liability to either
Supplier, RDR or RDO; provided, however, Supplier shall (i) refund to RDR or
RDO, as the case may be, the price paid by them for any unsold inventory of
Products in their possession or under their control, and they shall promptly
return such Products to Supplier and (ii) reimburse to RDR and RDO any amounts
actually paid by them to their customers in satisfaction of claims made against
RDR or RDO by their customers due to the infringement of Products sold by RDR or
RDO to their customers, including, but not limited to, claims for breach of
contract due to failure to supply the Products. If one Party notifies the other
Party in writing, pursuant to Section 16.8, of a potential material risk of
infringement, and the Parties agree in writing that no license is required or to
be sought from a third party, the indemnity set forth in Section 9.1(a)(iii)
shall not apply after such agreement. 

8.6        Transfer of
Regulatory Filings. Upon expiration of this Agreement or termination by
Supplier pursuant to Section 8.1(a)(i), Section 8.1(a)(2) or Section 8.2(a)(1),
RDR and RDO shall promptly transfer to Supplier or its designee any regulatory
filings, approvals or authorizations pertaining to Products owned or controlled
by them, their Affiliates or any sublicensee.

	9. 	
      INDEMNIFICATION

	 	 	 
	9.1 	
      General Indemnification.

	 	 	 
		(a) 	
      Supplier’s Indemnification. Supplier shall
      protect, defend, indemnify, and hold harmless RDR, RDO, their Affiliates
      and each of their respective directors, officers, employees and agents and
      their respective permitted successors and assigns ( collectively, “RD
      Indemnitees”) from and against any and all claims, actions, and causes of
      action of third parties together with liabilities, losses, costs, expenses
      or damages resulting therefrom, including reasonable attorney’s fees
      (collectively, “Claims”) incurred by RD Indemnitees which directly or
      indirectly arise out of or relate to (i) the breach by Supplier of any of
      its representations, warranties, covenants, agreements, or obligations set
      forth in this Agreement, (ii) the negligence, recklessness, or willful
      misconduct of Supplier or its employees or agents in connection with its
      performance of its obligations set forth in this Agreement, or (iii)
      Claims (including treble damages for willful infringement) that any
      Product or any process utilized by Supplier to manufacture the Product
      infringes or misappropriates a copyright, patent or other intellectual
      property right of another person or entity.

	 	 	 
		(b) 	
      RDR/RDO’s Indemnification. RDR and/or RDO shall
      protect, defend, indemnify, and hold Supplier, its Affiliates and each of
      their respective directors, officers, employees, and agents, and their
      respective successors and permitted assigns (“Supplier Indemnitees”),
      harmless from and against any and all Claims incurred by Supplier which
      directly or indirectly arise out of or relate to (i) the breach by RDR or
      RDO of any of its representations, warranties, covenants, agreements, or
      obligations set forth in this Agreement, or (ii) the negligence,
      recklessness, or willful misconduct of RDR or RDO or its employees or
      agents in connection with its performance of its obligations set forth in
      this Agreement.

	 	 	 
		(c) 	
      Notice of Third-Party Claims. Any person or entity
      entitled to indemnification hereunder (each, an “Indemnified
      Person”) shall give to the party obligated to indemnify (the
      “Indemnifying Party”) (i) prompt written notice of any third-party
      claim(s) made against the Indemnified Person for which the Indemnified
      Person knows or reasonably should know that the Indemnifying Party may be
      liable hereunder, and (ii) the opportunity to defend, negotiate, and
      settle such third-party claim(s). The Indemnified Person shall provide the
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Party with all information in its
possession reasonably related to such third-party claim, all authority, and all
assistance necessary to enable the Indemnifying Party to carry on the defense of
such suit; provided, however, the Indemnified Person reserves the
right to retain its own counsel to defend itself in such suit. Notwithstanding
the foregoing, the Indemnified Person shall not be bound by any settlement made
without its prior written consent. 

	9.2 	
      LIMITATION OF LIABILITIES. NOTWITHSTANDING ANY
      OTHER PROVISION OF THIS AGREEMENT EXCEPT WITH RESPECT THIRD PARTY CLAIMS
      REQUIRED TO BE INDEMNIFIED PURSUANT TO SECTION 9.1 OR ANY CLAIM
      ARISING OUT OF A BREACH OF CONFIDENTIALITY, NEITHER PARTY SHALL BE LIABLE
      FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, INDIRECT OR PUNITIVE DAMAGES
      WHETHER ARISING OUT OF SAID PARTY’S PERFORMANCE OR NON- PERFORMANCE OF
      THIS AGREEMENT, TORT (INCLUDING NEGLIGENCE), WARRANTY, OR OTHERWISE, EVEN
      IF THE EXCLUSIVE REMEDIES PROVIDED HEREIN FAIL OF THEIR ESSENTIAL PURPOSE
      AND EVEN IF A PARTY IS ADVISED OF THE POSSIBILITY OF SUCH
  DAMAGES.

	 	 	 
	10. 	
      RISK MANAGEMENT

	 	 	 
	10.1 	
      Disaster Recovery Plan. In order to demonstrate
      supply risk management to RDR and RDO, Supplier shall establish within one
      hundred eighty (180) days of the Effective Dated and maintain a disaster
      recovery plan (the “Disaster Recovery Plan”), which Disaster
      Recovery Plan would be implemented in the event of on an insolvency of
      Supplier as defined in this Agreement or a significant or catastrophic
      event affecting the supply of Products. As a provision of the Disaster
      Recovery Plan, Supplier shall grant to RDR and/or RDO an exclusive license
      to manufacture the Products or to sublicense a third-party approved by RDR
      and/or RDO to do the same to prevent an interruption in supply of Products
      (the “License”). The License shall be subject to the applicable terms and
      conditions of any license under which Supplier is sublicensing Purchaser
      and to the terms and conditions set forth in a license agreement
      negotiated in good faith on commercially reasonable terms by the Parties.
      Upon such occurrence, Supplier shall immediately provide to RDR and/or RDO
      written detailed information and technical assistance sufficient for RDR
      and/or RDO or a third party to manufacture the Products (collectively, the
      “Detailed Manufacturing Instructions”). The Detailed Manufacturing
      Instructions shall include, without limitation and as applicable, the
      following:

	 	 	 
		(a) 	
      an approved raw material vendor list;

		(b) 	
      raw material specifications;

		(c) 	
      machine-readable materials (e.g. software);

		(d) 	
      operating manuals;

		(e) 	
      quality control procedures; and

		(f) 	
      detailed manufacturing instructions.

	 	 	 
		
      In the event the License to make or have made becomes
      effective as provided in this Section 10.1, or Section 8.2,
      the Parties will cooperate in the transition of manufacturing, including
      the transfer of Detailed Manufacturing Instructions to enable RDR and RDO
      or another supplier to manufacture the Products.

	 	 	 
		
      Supplier shall enter into an escrow agreement (“Escrow
      Agreement”) with a mutually agreeable escrow agent (“Escrow Agent”), such
      Escrow Agreement providing for the deposit of one complete copy of the
      Detailed Manufacturing Instructions. Once every year following the deposit
      of the Detailed Manufacturing Instructions, RDR and RDO shall have the
      right, but not the obligation, to audit such Detailed Manufacturing
      Instructions through an independent third party auditor reasonably
      agreeable to the Parties, upon prior written notice to Supplier. Any such
      auditor shall treat the escrowed information as Confidential Information
      of Supplier. The scope of such audit shall be limited to ensuring that the
      obligations of this Section 10.1 have been met. Any such
    audit





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shall take place at the premises of the Escrow Agent. Supplier shall be entitled to have at least one employee of its choosing present at all times during any said audit. If the Detailed Manufacturing Instructions are found to be
inaccurate or incomplete, Supplier shall supplement the Detailed Manufacturing Instructions within twenty (20) Business Days to restore accuracy and completeness, and Supplier shall bear the cost and expense of supplementing the Detailed
Manufacturing Instructions. Otherwise, RDR and RDO shall bear the expense of any such audit. Supplier represents and warrants to RDR and RDO that the Detailed Manufacturing Instructions shall be kept current and complete, and shall be updated by or
on behalf of Supplier from time to time and in no event more than sixty (60) days after Supplier has made one or more material modifications to any of the Detailed Manufacturing Instructions. In the event of implementation of the Disaster Recovery
Plan pursuant to Section 10.1 or upon termination of this Agreement by RDR or RDO pursuant to Section 8(a) or 8(b)(ii) or (iii) (the “Triggering Event”), Supplier agrees that (i) RDR, RDO or a designated
affiliate is entitled to possession of the Detailed Manufacturing Instructions unless Supplier is disputing the basis for the occurrence of the Triggering Event, and (ii) RDR or RDO may give written notice to both Supplier and the Escrow Agent
requesting release of the Detailed Manufacturing Instructions. The Escrow Agent shall release and make the Detailed Manufacturing Instructions available to RDR, RDO or the designated Affiliate on the earlier of (1) the Escrow Agent’s receipt of
written notice form Supplier agreeing to and authorizing the release or (2) the date that is thirty (30) days after the Escrow Agent’s receipt of the written notice from RDR or RDO under clause (ii) above, unless, during such 30-day period, the
Escrow Agent receives written notice from Supplier disputing the basis for the occurrence of the Triggering Event. If Supplier disputes that a Triggering Event has rightfully occurred, Supplier may initiate the Dispute Resolution procedures set
forth in Section 16.9 and Supplier shall give written notice to the Escrow Agent, RDR and RDO within thirty (30) days after RDR or RDO gives written notice under clause (ii) above. If the Escrow Agent receives such notice of dispute form
Supplier within such 30-day period, the Escrow Agent shall release and make the Detailed Manufacturing Instructions available to RDR and RDO on the date that is sixty (60) days after the Escrow Agent’s receipt of the written notice from RDR or
RDO under clause (ii) above; provided, however, that the Escrow Agent shall not release or make the Detailed Manufacturing Instructions available to RDR or RDO if, prior to the expiration of such 60-day period, all the Parties give written notice to
the Escrow Agent that the Detailed Manufacturing Instructions should not be released. If Supplier disputes the release of the Detailed Manufacturing Instructions and it is finally determined that the Detailed Manufacturing Instructions should not
have released to RDR or RDO hereunder, RDR’s and RDO’s sole responsibility shall be to cease any further use of the Detailed Manufacturing Instructions (and cause any third party to cease further use of the Detailed Manufacturing
Instructions) and to return all copies of the Detailed Manufacturing Instructions to the Escrow Agent. All Detailed Manufacturing Instructions shall be the Confidential Information of Supplier and use and disclosure of the Detailed Manufacturing
Instructions shall be subject to the provisions of Section 11. The agreement with the Escrow Agent shall provide that all Detailed Manufacturing Instructions shall be returned to Supplier and the Escrow Agreement shall be terminated within
thirty (30) days after termination of this Agreement for any reason other than a Triggering Event, as certified in writing by all the Parties. Except as otherwise stated herein, all costs and expenses associated with the escrow of the Detailed
Manufacturing Instructions, including the costs of the Escrow Agent, shall be paid by Supplier.

	
	 	 
		
If Supplier can resume supplying Product(s) to Purchaser(s) in the quantities as Purchaser requires, and in full compliance with all of the terms and conditions of this Agreement, RDR and RDO (or a third party, as applicable)
shall discontinue manufacturing the Product(s) following production restart, where Supplier warrants and provides reasonable and satisfactory assurances that Supplier has the capacity and capability of satisfying Purchaser’s full demand for
Products. In such case the manufacturing license with RDR and/or RDO and any sublicense with a third party shall terminate and all Detailed Manufacturing Instructions shall be promptly returned to Supplier. RDR, RDO and any sublicensee shall treat
all Detailed Manufacturing Instructions as Confidential Information of Supplier.

	
	 	 
	
10.2 		
Insurance Requirements:

	




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	 	(a) 	
      Amounts and Types. During the Term of this
      Agreement and at all times that Supplier performs work hereunder, the
      Supplier shall maintain in full force and effect, at Supplier’s own
      expense, insurance coverage by insurers acceptable to RDR and RDO
      including:

	 	 	 	 
	 		(i) 	
      Worker’s Compensation. Worker’s compensation
      insurance shall be provided as required by law or regulation. Where
      permitted by law, such policies shall contain waivers of the insurer’s
      subrogation rights against RDR and RDO.

	 	 	 	 
	 		(ii) 	
      Employer’s Liability Insurance. Employer’s
      liability insurance shall be provided in amounts not less than $100,000
      per accident for bodily injury by accident, $500,000 policy limit by
      disease, and $100,000 per employee for bodily injury by disease.

	 	 	 	 
	 		(iii) 	
      Commercial General Liability. Commercial General
      Liability insurance with minimum combined single limits for bodily injury
      and property damage of $1,000,000. Commercial General Liability coverage
      shall also include contractual liability with a minimum of $2,000,000. RDR
      and RDO are to be named as additional insureds on Supplier’s General
      Liability policy, with respect to all operations performed by or on behalf
      of Supplier.

	 	 	 	 
	 	(b) 	
      Liability. Nothing contained in this Section
      10.2 shall be deemed in any way to either limit or increase the
      liability of either Party or their insurers under this Agreement.
      Notwithstanding anything to the contrary contained herein, Supplier’s and
      its insurers’ liability and obligations to RDR and RDO shall be limited to
      coverage for claims for which Supplier is liable pursuant to this
      Agreement.




	10.3 	
      Security of Manufacturing Facility Located Outside the
      United States. Supplier represents and warrants that Supplier’s
      facility (or facilities) located outside of the United States that are
      utilized to manufacture the Product(s) are in compliance during the Term
      of the Agreement with the security guidelines set forth in Exhibit
      H. A copy of Supplier’s security compliance plan that is compliant
      with Exhibit H will be provided to RDO within one hundred eighty
      (180) days following the Effective Date. In addition, Supplier shall
      provide to RDO, upon request, any additional information that is necessary
      for RDO’s continued compliance with the guidelines set forth in the
      Customs-Trade Partnership Against Terrorism (“C-TPAT”) program
      established by U.S. Customs and Border Protection.

	 	 	 
	11. 	
      CONFIDENTIALITY

	 	 	 
	11.1 	
      Confidential Information.

	 	 	 
		(a) 	
      Confidentiality and Restricted Use. Each Receiving
      Party of Confidential Information hereunder acknowledges the confidential
      and proprietary nature of the Confidential Information of the Disclosing
      Party and agrees that during the Term and for the greater of: (a) five (5)
      years following its disclosure to the Receiving Party; or (b) the period
      of time that the Disclosing Party is entitled to claim a proprietary
      interest and/or trade secret protection in the Confidential Information,
      such Confidential Information (i) shall be kept confidential by the
      Receiving Party; (ii) shall not be used for any reason or purpose other
      than in furtherance of such Party’s performance of its obligations
      hereunder; and (c) without limiting the foregoing, shall not be disclosed
      by the Receiving Party to any person or entity, except in each case as
      otherwise expressly permitted by the terms of this Agreement or with the
      prior written consent of an authorized representative of the Disclosing
      Party.

	 	 	 
		(b) 	
      Exceptions. The restrictions set forth in
      Section 11.1(a) do not apply to that part of the Confidential
      Information of a Disclosing Party that the Receiving Party demonstrates
      (i) was, is or becomes generally available to the public other than as a
      result of a breach of this





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      Article 11 by the Receiving Party; (ii) was or is
      developed by the Receiving Party independently of and without reference to
      any Confidential Information of the Disclosing Party; or (iii) was, is or
      becomes available to the Receiving Party on a non-confidential basis from
      a third party not bound by a confidentiality agreement or any legal,
      fiduciary, or other obligation restricting disclosure.

	 	 	 
	 	(c) 	
      Legal Proceedings. If the Receiving Party becomes
      compelled in any legal proceeding or is requested by a Governmental
      Authority having the requisite legal or regulatory jurisdiction and
      authority to make any disclosure that is prohibited or otherwise
      constrained by this Article 11, the Receiving Party shall provide
      the applicable Disclosing Party with prompt notice of such compulsion or
      request so that it may seek an appropriate protective order or other
      appropriate remedy or waive compliance with the provisions of this
      Article 11. In the absence of a protective order or other remedy,
      the Receiving Party may disclose that portion (and only that portion) of
      the Confidential Information of the Disclosing Party that, based upon
      advice of the Receiving Party’s counsel, the Receiving Party is legally
      compelled to disclose or that has been requested by such governmental
      body; provided, however, that the Receiving Party shall use
      reasonable efforts to obtain reliable assurance that confidential
      treatment will be accorded by any person, entity or governmental body to
      whom any Confidential Information is so disclosed. The provisions of this
      Section 11.1(c) do not apply to any legal proceedings between the
      Parties to this Agreement.

	 	 	 
	 	(d) 	Public Document
Requirements. The Parties hereby agree to work together to review and agree
upon a redacted version of this Agreement for filing by Supplier with securities
authorities where required to do so by virtue of its status as a public company.
The Parties shall commence such activity in advance of the Effective Date in
acknowledgement that such filings must take place within ten (10) days
thereafter. This Section 11.1(d) shall not be construed to prevent Supplier from
making any such filing in a timely manner. To the extent Supplier is required to
file or disclose any additional information related to this Agreement by virtue
of its status as a public company, Supplier shall (i) seek, to the extent
permitted by law, confidential treatment for the financial and other business
terms hereof and (ii) give RDR and RDC at least ten (10) Business Days prior
written notice, or if that is not possible, as much prior written notice as
possible using commercially reasonable procedures and methods, so as to permit
RDR and RDC to take all possible action to protect and/or safeguard its rights
in the Confidential Information. 




	11.2 	
      Return or Destruction of Confidential Information.
      Upon expiration or earlier termination of this Agreement, the Receiving
      Party shall promptly deliver to the Disclosing Party all Confidential
      Information of the Disclosing Party, together with all copies thereof, in
      the possession, custody or control of the Receiving Party or,
      alternatively, with the written consent of the Disclosing Party, destroy
      all such Confidential Information and certify such destruction in writing
      to the Disclosing Party; provided, however, that the
      Receiving Party may retain one copy of the Confidential Information that
      it has returned or destroyed to facilitate the resolution of any
      controversies after the Disclosing Party’s Confidential Information is
      returned.

	 	 
	12. 	
      INTELLECTUAL
  PROPERTY

	 	 
	12.1 	
      Supplier Intellectual Property. Supplier hereby
      grants to RDR and RDO a non-exclusive, world- wide, perpetual and royalty
      free license to all pre-existing intellectual property of Supplier that is
      a component of, or may benefit RDR’s or RDO’s use of, the Products
      purchased hereunder. Said license shall inure to the benefit of RDR, RDO,
      their Affiliates, and the Ordering Entities and each of their successors
      and assigns, and the customers of each of the foregoing. For the avoidance
      of doubt, the foregoing grant of rights shall not be construed to convey
      any rights separate form those embodied in Products purchased by RDR or
      RDO pursuant to this Agreement.





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	12.2 	
      RDR/RDO Intellectual Property. Unless specifically
      granted otherwise, nothing contained in this Agreement shall be construed
      to grant Supplier a license or in any way give ownership to any RDR or
      RDO-owned intellectual property, except that Supplier shall have access to
      such RDR or RDO- owned intellectual property as required for Supplier to
      fulfill, and solely for the purpose of fulfilling, its contractual
      obligations herein.

	 	 	 
	13. 	
      PACKAGING AND
    TRADEMARKS

	 	 	 
		
      Product packaging, labeling and inserts, Product
      literature, and other advertising and promotional materials will be
      co-branded with RAMP® and Roche. Supplier will package the Products
      in accordance with the Specifications and shall be responsible for the
      content of all labels other than camera ready art pertaining to Purchaser
      trademarks and trade dress. Purchaser shall be responsible for all Product
      literature, advertising and promotional materials pertaining to Products.
      The Parties agree that in the event country-specific labeling is required
      by Applicable Laws, Supplier will package the Product(s) with the
      country-specific labeling. The Parties contemplate that there will be
      two (2) different packaging versions; one version for the United States
      and Canada, and a separate version for the rest of the world.
      Purchaser shall pay all direct and indirect costs associated with
      country specific labeling, preparing and translating Product packaging,
      labeling, inserts in languages other than English, Spanish, French,
      Chinese and German.

	 	 	 
	14. 	
      MANAGEMENT OF COOPERATION.
      The Parties agree that the success of their cooperation depends on
      trustful, regular exchanges of information and a fast decision making
      process. For such purposes, the Parties agree to establish two (2) working
      committees, each comprised of equal numbers of representatives of Supplier
      and Purchaser, being responsible for specific tasks in the management of
      the cooperation between the Parties, namely:

	 	 	 
		(a) 	
      An Executive Management Team (“EMT”) shall meet at
      least once per year or upon the request of one Party within two (2) months
      of the request. The EMT shall have the primary responsibility to
      facilitate and oversee the cooperation between the Parties, and act as an
      alternative decision maker for any matter unsettled by the JPSC or any
      other unsettled matter resulting out of this cooperation. Each Party,
      within thirty (30) days of the Effective Date, shall designate its
      respective members participating in the EMT meetings.

	 	 	 
		(b) 	
      A Joint Program Steering Committee (“JPSC”) shall
      meet at least four (4) times per year with the primary responsibility to
      address: supply chain topics, customer support topics, quality
      assurance/regulatory affairs topics including which Party shall be
      responsible for pursuing and which Party shall own regulatory filings in
      jurisdictions where they do not exist on the Effective Date, and otherwise
      perform a program management function. Each Party, within thirty (30) days
      of the Effective Date, shall designate its respective members
      participating in the JPSC meetings.

	 	 	 
		
      Every meeting shall be documented in minutes prepared by
      RDO/RDR and signed by all Parties. Decisions shall be made by consensus
      with Supplier having one vote and RDO and RDR collectively having one
      vote.

	 	 	 
	15. 	
      COMPLIANCE WITH
      LAWS

	 	 	 
	15.1 	
      Compliance with Laws. Supplier shall comply with,
      and give all notices required by, all Applicable Laws of any Governmental
      Authority bearing on the performance of this Agreement as existing on the
      Effective Date and/or as enacted or amended during the Term hereof,
      including, without limitation, all requirements relating to human health,
      safety, and the environment. Supplier shall notify RDR and RDO if it
      becomes aware of any non-compliance by it of any Applicable Laws and shall
      take all appropriate action necessary to comply with such Applicable
      Laws.





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	15.2 	
      Federal Contractor Status. RDO is a federal
      contractor with obligations from various federal laws, rules, regulations,
      and executive orders, including without limitation, Equal Employment
      Opportunity and the utilization of small, disadvantaged, woman-owned,
      veteran and HUB zone businesses. Supplier agrees to comply with such
      obligations contained in the Applicable Laws. Supplier agrees to provide,
      at RDO’s request, any and all documentation required to substantiate such
      compliance.

	 	 	 
	15.3 	
      Compliance with Import and Export Regulations. The
      Parties shall cooperate to comply with all export control regulations of
      the places of manufacture of the Products. In order for RDO and RDR to
      comply with U.S. and EU import and export regulations, Supplier
    shall:

	 	 	 
		(a) 	
      provide RDO with the proper Export Control Classification
      Number (“ECCN”) for Products (15 CFR 730-774);

		(b) 	
      notify RDO immediately of any change in its ECCN, whether
      such change was made voluntarily by Supplier or whether such change was
      made at the direction of a government authority;

		(c) 	
      notify RDO if any Product is listed or becomes listed on
      the U.S. Munitions List (22 CFR 121);

		(d) 	
      mark Products with the correct country of
  origin;

		(e) 	
      provide all relevant information required by RDO in order
      to obtain a license or classify the Product for import or export;
    and,

		(f) 	
      provide RDR with respective numbers/codes of the Products
      according to the EU Dual Use List and/or the US Commerce Control List or
      any other EU and US export control regulation, and, further, notify RDR of
      the percentage (%) of the US originated contents in the Products
      delivered.




	16. 	
      MISCELLANEOUS

	 	 
	16.1 	
      Assignability. Supplier shall not assign or
      otherwise transfer (including by operation of law or pursuant to a merger,
      consolidation or sale of all or substantially all of the assets relating
      to this Agreement) this Agreement or its obligations hereunder to any
      third party without prior written consent from RDR and RDO, which consent
      shall not be unreasonably withheld.

	 	 
	16.2 	
      Subcontractors. In the event Supplier determines
      that subcontractors are required to perform any of Supplier’s obligations
      pursuant to this Agreement, Supplier shall require such subcontractor to
      comply with all Applicable Laws and the requirements of this Agreement,
      including without limitation the FDA’s Quality System Regulation set forth
      at 21 C.F.R. Part 820, to the extent applicable and the Quality
      Requirements. Supplier shall hold RDR and RDO harmless from any loss or
      liability incurred by RDR and RDO as a result of Supplier’s failure to
      comply with this Section 14.2. Supplier shall be liable for any
      acts or omissions of any subcontractor to the same extent as if they were
      the acts or omissions of Supplier.

	 	 
	16.3 	
      Survivability. The rights and obligations of
      Section 2.5 (Tooling), Section 5 (Representations,
      Warranties and Covenants), Section 6 (Records and Audits),
      Section 7 (Product Recalls), Section 8.3 (Lifetime Buy),
      Section 9 (Indemnification), Section 11 (Confidentiality),
      Section 12 (Intellectual Property), Section 15 (Compliance
      with Laws), Section 16 (Miscellaneous), Exhibit E (Quality
      & Change Control Requirements) and Exhibit F (Additional
      Remedies for Delays and Non-Conforming Products) shall survive any
      termination of this Agreement and shall bind the Parties and their legal
      representatives, successors, and assigns.

	 	 
	16.4 	
      Entire Agreement. This Agreement embodies the
      entire understanding and agreement among the Parties and supersedes all
      previous negotiations, representations, writings and agreements, written,
      or oral, with respect to the subject matter herein. Any additional terms
      or conflicting terms or conditions contained in any other document
      pursuant to the subject matter herein are hereby superceded. Supplier, RDR
      and RDO agree that this Agreement shall not be altered, amended
  or





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      modified, except in writing that is signed by an
      authorized representative of both Parties. The Exhibits attached hereto
      are an integral part of this Agreement and all references to the term
      Agreement include all Exhibits attached hereto.

	 	 
	16.5 	
      Non-Waiver. No term or provision hereof shall be
      deemed waived and no breach excused unless such waiver or consent shall be
      in writing and signed by a duly authorized representative of the Party
      claimed to have waived or consented.

	 	 
	16.6 	
      Severability. If any provision of this Agreement
      is invalid or unenforceable under any Applicable Laws, the provision is to
      that extent to be deemed omitted, and the remaining provisions shall not
      be affected in any way. To the extent any provision is invalid or
      unenforceable in a particular Jurisdiction under Applicable Laws of that
      jurisdiction, the provisions is to that extent deemed omitted with respect
      to the affected jurisdiction, but remains in full force and effect in the
      remaining jurisdictions.

	 	 
	16.7 	
      Independent Relationship of the Parties. Supplier,
      RDR and RDO intend that an independent contractor relationship shall be
      created by this Agreement, and nothing herein shall be construed as
      creating an employer/employee relationship, partnership, joint venture, or
      concerted action. Personnel assigned by either Party to provide
      deliverables under this Agreement will be employees of said Party and will
      not for any purpose be considered employees or agents of the other Party.
      Each Party assumes full responsibility for the actions of such personnel
      while performing all its obligations hereunder, either at Supplier’s or
      Purchaser’s facility, and shall be solely responsible for their
      supervision, daily direction and control, payment of salary (including
      withholding of income taxes and social security), workmen’s compensation
      and occupational disease insurance as required by law, comprehensive
      public liability insurance, compensation, disability benefits and the
      like. Supplier agrees that, while its personnel are on Purchaser’s
      premises, they will conform to all Purchaser’s work rules, safety
      regulations and its standard practices governing behavior of its own
      employees. Also, Supplier agrees to require such personnel to work in a
      manner which will comply with all Applicable Laws governing said work
      practices.

	 	 
	16.8 	
      Notices. All notices, consents, waivers and other
      communications required or permitted by this Agreement shall be in writing
      and shall be deemed given to a Party when (a) delivered to the appropriate
      address by hand or by nationally recognized overnight courier service
      (costs prepaid); (b) sent by facsimile with confirmation of transmission
      by the transmitting equipment; or (c) received or rejected by the
      addressee, if sent by certified mail, return receipt requested, in each
      case to the following addresses, facsimile numbers and marked to the
      attention of the person (by name or title) designated below (or to such
      other address, facsimile number, e- mail address or person as a Party may
      designate by notice to the other Parties):




	 	if to RDO to: 	Roche Diagnostics Operations,
      Inc. 
	 	  	9115 Hague Road 
	 	  	Indianapolis, Indiana 46250

	 	  	Attn: Purchasing Manager 
	 	  	Fax No.: (317) 521-3080 
	 	  	  
	 	  	  
	 	with a copy to: 	Law Department 
	 	  	Roche Diagnostics Corporation
  
	 	  	9115 Hague Road 
	 	  	Indianapolis, Indiana 46250

	 	  	Fax No.: (317) 521-2840 
	 	  	  
	 	if to RDR to: 	Roche Diagnostics Ltd. 
	 	  	Forrenstrasse 
	 	  	6343 Rotkreuz 
	 	 	Switzerland
  




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	 	  	Attn: Joachim Doepper 
	 	  	Fax No.: +41 (41) 798-5215 
	 	  	  
	 	  	  
	 	with a copy to: 	Legal Department 
	 	  	Roche Diagnostics Ltd. 
	 	 	Forrenstrasse

	 	 	6343 Rotkreuz

	 	 	Switzerland 
	 	  	Fax No.:+ 41 (41) 798 5280 
	 	  	  
	 	  	  
	 	  	  
	 	if to Supplier to: 	Response Biomedical Corporation
    
	 	  	1781 – 75th Avenue W.
    
	 	  	Vancouver, British Columbia V6P
      6P2 
	 	  	Canada 
	 	  	Attn: Chief Executive Officer
  
	 	  	Fax No.: (604) 456-6066 
	 	  	  
	 	  	  
	 	with a copy to: 	Heller Ehrman LLP 
	 	  	701 Fifth Avenue, Suite 6100
  
	 	  	Seattle, Washington 98104 
	 	  	Attn: Alison Freeman-Gleason
  
	 	  	Fax No.: (206) 447-0849
  


16.9 Governing Law; Dispute Resolution. The Parties agree
  to use reasonable efforts in a good faith attempt to settle as promptly as possible
  any and all disputes arising from this Agreement or a transaction conducted
  pursuant to this Agreement, in the following order of preference: (a) good faith
  negotiation between executives of Purchaser and Supplier who have authority
  to fully and finally resolve the dispute; and then (b) non-binding mediation
  at a location acceptable to the Parties using a neutral mediator having experience
  with the industry (with the costs therefore shared equally). All negotiations
  pursuant to this clause shall be treated as Confidential Information in accordance
  with the provisions of Article 21 of this Agreement. Finally, as a last resort,
  either Party may commence litigation. Each Party consents to the New York courts'
  personal jurisdiction. Any questions, claims, disputes, remedies or procedural
  matters shall be governed exclusively by the laws of the State New York and
  of the United States of America, without regard to its principles of conflicts
  of law. The exclusive venue for any and all litigation relating to this Agreement
  shall be in the city of New York in the state or federal court having subject
  matter jurisdiction. The Parties hereby waive their right to a jury trial.

	16.10 	
      Use of Trademark and Name. Except as otherwise set
      forth in this Agreement, Supplier may not use RDR’s or RDO’s name or
      trademarks, or refer to or disclose the existence of this Agreement or the
      obligations performed hereunder, directly or indirectly, without the prior
      written consent of RDR’s or RDO’s Corporate Communications department.
      Except as otherwise set forth in this Agreement, RDR and/or RDO may not
      use Supplier’s name or trademarks, or refer to or disclose the existence
      of this Agreement or the obligations performed hereunder, directly or
      indirectly, without the prior written consent of Supplier.

	 	 
	16.11 	
      Cumulative Rights and Remedies. The rights and
      remedies provided in this Agreement and all other rights and remedies
      available to either Party at law or in equity are, to the extent permitted
      by law, cumulative and not exclusive of any other right or remedy now or
      hereafter available at law or in equity. Neither asserting a right nor
      employing a remedy shall preclude the
concurrent





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assertion of any other right or
employment of any other remedy, nor shall the failure to assert any right or
remedy constitute a waiver of that right or remedy. 

16.12 Force Majeure. Except as to payments
required under this Agreement, if any default or delay occurs which prevents or
materially impairs a Party’s performance and is due to a cause beyond the
Party’s reasonable control, and provided that the default or delay is not caused
by or the fault of such Party, including but not limited to an act of God,
flood, fire, explosion, earthquake, casualty, accident, war, revolution, civil
commotion, terrorism, blockade or embargo, injunction, law, proclamation, order,
regulation or governmental demand, the affected Party shall promptly notify the
other Party in writing of such cause and shall exercise diligent efforts to
resume performance under this Agreement as soon as possible. Neither Party will
be liable to the other Party for any loss or damage due to such cause and the
Term will not be extended thereby. No Party may terminate this Agreement because
of such default or delay except upon thirty (30) days prior written notice to
the other Party if the default or delay has existed for six (6) months and is
continuing at the end of the thirty (30) day notice period. 

[signature page follows] 



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IN WITNESS
WHEREOF, the Parties hereto have caused this Agreement
to be executed by their duly authorized representatives. 

	“RDO” 	 	“Supplier” 
	 	 	 	 	 
	ROCHE DIAGNOSTICS OPERATIONS, INC. 	 	RESPONSE BIOMEDICAL CORP 
	 	 	 	 	 
	By: 	/s/ Mary
      McCain 	 	By: 	/s/ S. Wayne Kay 
	  	Mary McCain 	 	  	S. Wayne Kay 
	 	 	 	 	 
	Title: 	Vice President, Supply Chain 	 	Title: 	Chief Executive Officer 
	Date: 	 
                       “June
      23, 2008” 	 	Date: 	                   “June
      24, 2008” 
	  		 	  	  
	 	 	 	 	 
	“RDR” 	 	  	  
	 	 	 	 	 
	ROCHE DIAGNOSTICS LTD. 	 	  	  
	 	 	 	 	 
	By: 	/s/ Verena
      Passauer 	 	  	  
	  	Verena Passauer 	 	  	  
	  	  	 	  	  
	 	 	 	 	 
	Title: 	Legal Counsel 	 	  	  
	Date: 	“June
      26, 2008” 	 	  	  
	 	 	 	 	 
	  	  	 	  	  
	By: 	/s/ Dirk
      Ehlers 	 	  	  
	  	Dirk Ehlers 	 	  	  
	 	 	 	 	 
	  	  	 	  	  
	Title: 	Head of Professional Diagnostics 	 	  	  
	Date: 	 
                       “26/6/08”
    	 	  	  




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EXHIBIT A 

Products 


  	Group 	Item 	Detail 	Qty 	Dexcription
	Roche Branded RAMP®
      200 CONTROL MODULE 	Control Module 	Top Assembly, Control Module 	1 	   
	  	Box
	Packaging, CM Box 	1 	 
	   	Box Insert 	Packaging, Korrvu Box Insert Set
    	1 	   
	  	Box
      Filler 	Packaging, CM Box Filler Insert 	1 	 
	   	USB Drive / Manual 	Partner branded 256MB USB Drive
      (containing English version of the manual, any other language versions of
      the manual, and the File Conversion Utility (FCU) 	1 	   
	   	Manual 	Printed copy of the US version
      manual 	1 	   
	   	Label 	Label, Serial & Model number
      label 	1 	   
	   	Power Supply 	Universal Power Supply 100-240
      VAC 50-60Hz) 	1 	   
	   	Cable 	Accessory, Cable, AC Line, NA
      (North American Plug and Cable) 	1 	   
	   	Box Label 	Label, Box Label (RCU) 	1 	   
	   	CD-ROM Label 	CD-ROM disk containing the Reader
      Configuration Utility Technical Service label 	1 	   
	   	DVD 	Training DVD (provided by Roche)
    	1 	   
	  	Card
    	Warranty card 	1 	 
	  	Label
    	Content label 	1 	 
	  	Label
    	Shipping/ storage conditions label 	1 	 





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Exhibit A 

Products 


  	Group 	Item 	Detail 	Qty. 	Description 
	Roche Branded RAMP® 200
      TEST MODULE 	Test Module 	Top Assembly, Test Module 	1 	   
	   	Label 	Label, Serial & Model number
      label 	1 	   
	  	Box
	Packaging, TM Box 	1 	 
    
	   	Box Insert 	Packaging, Korrvu Box Insert Set
    	1 	   
	   	Label 	Label, Serial & Model number
      label 	1 	   
	   	Cable 	Connection cable to RAMP®
      200 CONTROL MODULE 	1 	   
	   	Box Label 	Label, Box Label 	1 	   
	  	Label
    	Technical Service label 	1 	 
    
	  	Card
    	Warranty card 	1 	 
    
	  	Label
    	Content label 	1 	 
    
	   	Label 	Shipping/ storage conditions
      label 	1 	   





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Exhibit A 

Products 


  	Group 	Item 	Detail 	Qty. 	Description 
	PRINTER 	Printer 	Zebra
      Printer, TLP2824 	1 	 
    
	   	USB Cable 	Cable, USB, 6ft, A-Male to B-Male, Molded,
      24AWG, Beige with Ferrite, clip on 	1 	   
	   	Power Supply 	Universal switching power supply 	1 	   
	   	Labels 	Accessory, 500 Printer Labels, 2.5” x 3”, Zebra
      Technologies 	1 	   
	   
      	Ribbon
    	Accessory, Printer Ribbon, Wax 	1 	 
    
	   	Plug Sets 	Plug Sets for US/Canada, EU 	2 	1 US/Canada 1 EU 
	  	Box
	Packaging, TM Box 	1 	 
    
	  	Card
    	Warranty card 	1 	 
    
	  	Label
    	Content label 	1 	 
    
	  	Label
    	Shipping/ storage conditions label 	1 	 
    
	  	Box
      Label 	Label,
      Box Label 	1 	 
    
	  	Manual
    	Printed copy of the printer manual 	1 	 
    





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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

Exhibit A 

Products 


  	Group 	Item 	Detail 	Qty. 	Description 
	BAR CODE SCANNER 	Bar Code Scanner 	Symbol Tech. LS 9208 Bar Code
      Scanner 	1 	   
	   	USB Cable 	Cable, USB, Sym. Bar Code
      Scanner, 7ft with Ferrite, clip on 	1 	   
	   	Quick Start Card 	From Symbol 	   	   
	  	Manual
    	Symbol Manual 	1 	 
    
	  	Box
	  	1 	 
    
	   	Third party Warranty 	Symbol Warranty Card 	1 	   





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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

Exhibit A 

Products 


  	Group 	Item
      	Detail
      	Qty. 	Description 
	NT- proBNP ASSAY 	   	Each 	RAMP® NT-proBNP Assay
        kit contains all the reagents necessary for the quantification of NT-proBNP
        in EDTA whole blood using the RAMP 200 Control and Test Modules 
	   	Cartridges 	RAMP® NT- proBNP Test
        Cartridges 	25 	RAMP® NT-proBNP Test
        Cartridges contain nitrocellulose strips with antibodies, as well as sample
        and wicking pads 
	   	Tips 	RAMP® NT-BNP Assay Tips
        (pouched with Test cartridges) 	25 	RAMP® NT-proBNP Assay
        Tips contain fluorescent-dyed latex conjugated with antibodies. 
	   	Vials 	RAMP® NT- proBNP Sample
        Buffer Vials2 	25 	RAMP® NT-proBNP Sample
        Buffer contains phosphate buffer, animal protein, surfactant, and ProClin®
        300 / ProClin® 950 as preservatives (ProClin is a registered trademark
        of Rohm and Haas Company) 
	   	Drying agent 	Drying agent (pouched with Test cartridges) 	25 	Desiccant pack 
	   	Aluminum foil lined pouch 	Aluminum foil lined pouch for cartridge and tips
      	25 	   
	   	Transfer Device 	Assay Transfer Device (75μL minipipette)
      	1 	   
	   	Lot Card 	Lot Card in antistatic bag 	1 	Proprietary EPROM programmed with lot-specific
        calibration data. 
	   	Package insert 	Package Insert 	1 	   
	  	Box
      	Packaging, Box 	1 	  
	  	Box
        Insert 	Packaging 	1 	  
	   	Label 	Content / Lot / expiry label 	1 	   
	   	Label 	Shipping/ storage conditions label 	1 	   






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Exhibit A 

Products 


  	Group 	Item
      	Detail
      	Qty. 	Description 
	TROPONIN I ASSAY 	   	Each 	RAMP® Troponin I Assay
        kit contains all the reagents necessary for the quantification of Troponin
        I in EDTA whole blood using the RAMP 200 Control and Test Modules 
	   	Cartridges 	RAMP® Troponin I Test
        Cartridges 	25 	RAMP® Troponin I Test
        Cartridges contain nitrocellulose strips with antibodies, as well as sample
        and wicking pads 
	   	Tips 	RAMP® Troponin I Assay
        Tips (pouched with Test cartridges) 	25 	RAMP® Troponin I Assay
        Tips contain fluorescent-dyed latex conjugated with antibodies. 
	   	Vials 	RAMP® Troponin I Sample
        Buffer Vials 	25 	RAMP® Troponin I Sample
        Buffer contains phosphate buffer, animal protein, surfactant, and ProClin®
        300 / ProClin® 950 as preservatives (ProClin is a registered trademark
        of Rohm and Haas Company) 
	   	Drying agent 	Drying agent (pouched with Test cartridges) 	25 	Desiccant pack 
	   	Aluminum foil lined pouch 	Aluminum foil lined pouch for cartridge and tips
      	25 	   
	   	Transfer Device 	Assay Transfer Device (75μL minipipette)
      	1 	   
	   	Lot Card 	Lot Card in antistatic bag 	1 	Proprietary EPROM programmed with lot-specific
        calibration data. 
	   	Package insert 	Package Insert 	1 	   
	  	Box
      	Packaging, Box 	1 	  
	  	Box
        Insert 	Packaging 	1 	  
	   	Label 	Content / Lot / expiry label 	1 	   
	   	Label 	Shipping/ storage conditions label 	1 	   






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Exhibit A 

Products 


  	Group 	Item
      	Detail
      	Qty. 	Description 
	CK-MB ASSAY 	   	Each 	RAMP® CK-MB Assay kit
        contains all the reagents necessary for the quantification of NT-proBNP
        in EDTA whole blood using the RAMP 200 Control and Test Modules 
	   	Cartridges 	RAMP® CK-MB Test Cartridges
      	25 	RAMP® CK-MB Test Cartridges
        contain nitrocellulose strips with antibodies, as well as sample and wicking
        pads 
	   	Tips 	RAMP® CK-MB Assay Tips
        (pouched with Test cartridges) 	25 	RAMP® CK-MB Assay Tips
        contain fluorescent-dyed latex conjugated with antibodies. 
	   	Vials 	RAMP® CK-MB Sample Buffer
        Vials 	25 	RAMP® CK-MB Sample Buffer
        contains phosphate buffer, animal protein, surfactant, and ProClin®
        300 / ProClin® 950 as preservatives (ProClin is a registered trademark
        of Rohm and Haas Company) 
	   	Drying agent 	Drying agent (pouched with Test cartridges) 	25 	Desiccant pack 
	   	Aluminum foil lined pouch 	Aluminum foil lined pouch for cartridge and tips
      	25 	   
	   	Transfer Device 	Assay Transfer Device (75μL minipipette)
      	1 	   
	   	Lot Card 	Lot Card in antistatic bag 	1 	Proprietary EPROM programmed with lot-specific
        calibration data. 
	   	Package insert 	Package Insert 	1 	   
	  	Box
      	Packaging, Box 	1 	  
	  	Box
        Insert 	Packaging 	1 	  
	   	Label 	Content / Lot / expiry label 	1 	   
	   	Label 	Shipping/ storage conditions label 	1 	   






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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

Exhibit A 

Products 


  	Group 	Item
      	Detail
      	Qty. 	Description
      
	MYOGLOBIN ASSAY 	   	Each 	RAMP® Myoglobin Assay kit contains
        all the reagents necessary for the quantification of NT-proBNP in EDTA
        whole blood using the RAMP 200 Control and Test Modules 
	   	Cartridges 	RAMP® Myoglobin Test Cartridges
      	25 	RAMP® Myoglobin Test Cartridges
        contain nitrocellulose strips with antibodies, as well as sample and wicking
        pads 
	   	Tips 	RAMP® Myoglobin Assay
        Tips (pouched with Test cartridges) 	25 	RAMP® Myoglobin Assay
        Tips contain fluorescent-dyed latex conjugated with antibodies. 
	   	Vials 	RAMP® Myoglobin Sample
        Buffer Vials 	25 	RAMP® Myoglobin Sample
        Buffer contains phosphate buffer, animal protein, surfactant, and ProClin®
        300 / ProClin® 950 as preservatives (ProClin is a registered trademark
        of Rohm and Haas Company) 
	   	Drying agent 	Drying agent (pouched with Test cartridges) 	25 	Desiccant pack 
	   	Aluminum foil lined pouch 	Aluminum foil lined pouch for cartridge and tips
      	25 	   
	   	Transfer Device 	Assay Transfer Device (75μL minipipette)
      	1 	   
	   	Lot Card 	Lot Card in antistatic bag 	1 	Proprietary EPROM programmed with lot-specific
        calibration data. 
	   	Package insert 	Package Insert 	1 	   
	  	Box
      	Packaging, Box 	1 	  
	  	Box
        Insert 	Packaging 	1 	  
	   	Label 	Content / Lot / expiry label 	1 	   
	   	Label 	Shipping / storage conditions label 	1 	   






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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

Exhibit A 

Products 


  	Group 	Item 	Detail 	Qty. 	Description 
	Controls 	   	Each 	RAMP® Cardiac Controls are supplied
        in two levels, 2 x 1 mL each level per box. The Controls are supplied
        as a ready-to-use frozen liquid, requiring no reconstitution or dilution.
        They are prepared in a human EDTA plasma matrix fortified to target levels
        with human source materials at different concentrations for each level.
        Sodium Azide < 0.1% has been added as a preservative to inhibit microbial
        growth 
	   	Low Control 	Bottle 1 ml, TnI, CK-MB, Myoglobin and NT- proBNP
      	2 	   
	   	High Control 	Bottle 1 ml, TnI, CK-MB, Myoglobin and NT- proBNP
      	2 	   
	   	Package insert 	Package Insert 	1 	   
	   	Box 	Packaging, Box 	1 	   
	   	Box Insert 	Packaging, Box Insert 	1 	   
	   	Label 	Content / Lot / expiry label 	1 	   
	   	Label 	Shipping/ storage conditions label 	1 	   






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Exhibit A 

Products 


  	   
             Group 	Item
      	Detail
      	 Qty. 	Description 
	Calibration Verification Controls 	   	Each 	RAMP® Cardiac CalVer Controls are
        supplied as a four-level set, 2 x 1 mL each level per box. The Controls
        are supplied as a ready-to-use frozen liquid, requiring no reconstitution
        or dilution. They are prepared in a human EDTA plasma matrix fortified
        to target levels with human source materials at different concentrations
        for each level. Sodium Azide < 0.1% has been added as a preservative
        to inhibit microbial growth. 
	   	Level 1 	Bottle 1 ml, TnI, CK-MB, Myoglobin and NT-proBNP
      	2 	      
	   	Level 2 	Bottle 1 ml, TnI, CK-MB, Myoglobin and NT-proBNP
      	2 	   
	   	Level 3 	Bottle 1 ml, TnI, CK-MB, Myoglobin and NT-proBNP
      	2 	   
	   	Level 4 	Bottle 1 ml, TnI, CK-MB, Myoglobin and NT-proBNP
      	2 	   
	   	Package insert 	Package Insert 	1 	   
	   	Box 	Packaging, Box 	1 	   
	   	Box Insert 	Packaging, Box Insert 	1 	   
	   	Label 	Content / Lot / expiry label 	1 	   
	   	Label 	Shipping/ storage conditions label 	1 	   






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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

Exhibit A 

Products 


  	Configuration 	Group
      	Qty. 	Description
      
	Hospital
      System 	RAMP® 200 CONTROL MODULE 	•	  
	  	RAMP® 200 TEST MODULE 	•	  
	  	PRINTER 	•	  
	  	BAR CODE
        SCANNER 	•	  
	POL System
    	RAMP® 200 CONTROL MODULE 	•	  
	  	RAMP® 200 TEST MODULE 	•	  
	  	PRINTER 	•	  
	  	BAR CODE
        SCANNER 	•	  
	Cardiac Marker
      Tests 	TROPONIN I ASSAY 	•	  
	  	MYOGLOBIN ASSAY 	•	  
	  	CK-MB
        ASSAY 	•	  
	  	NT-proBNP ASSAY 	•	  



•    [***]



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 ROCHE DIAGNOSTICS, SALES
  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

EXHIBIT B 

Ordering Entities 

Roche Diagnostics GmbH, Sandhofer Strass 116, 68305
Mannheim, Federal Republic of Germany 

Roche Diagnostics Ltd. Forrenstrasse 6343 Rotkreuz,
Switzerland 

Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis,
  Indiana 46250 



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 ROCHE DIAGNOSTICS, SALES
  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

EXHIBIT C 

Specifications 

RAMP® 200 CONTROL MODULE 

The RAMP® 200 CONTROL Module and
RAMP® 200 TEST Module are specified as in 

RAMP® 200 product description version
1.0
RAMP® 200 Software Requirement document version 1.0


Reference Instrument

Control Module 
Model: RAMP®200 CM 
Hardware Revision:
1.1 

Test Module 
Model: RAMP®200 TM 
Hardware Revision: 1.1


 

TROPONIN I ASSAY 

The TROPONIN I ASSAY is specified as in: 

Product claims from package insert #50117 rev8 
Fullfills
the quality release criteria: 

Troponin I 


	QC Release Criteria 	Specification 
	Barcode / Lot Card
      recognition 	•
	Accuracy – “Spike”
      Std* 	•
	Precision –
      “Spike” Std 	•
	Standard Curve parameters 
-    
      RAMP® Ratio increases with [TnI] 
-    
      R2 
-     Slope linear fit 	

        •

	External
      Controls** 	•
	Blood Samples 	•
	Correlation to
      RAMP® QC Ref. 	•



* the internal “Spike” standard is at a concentration of [***]
and is in a proprietary matrix. 
** expected values for external controls
are vendor-lot specific 

•    [***] 



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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

MYOGLOBIN ASSAY 

The MYOGLOBIN ASSAY is specified as in: 

Product claims from package insert #50066 rev14 
Fullfills
the quality release criteria: 

Myoglobin


	QC Release Criteria 	Specification 
	Barcode / Lot Card
      recognition 	•
	Accuracy – 0 ng/mL
      Std* 	•
	Accuracy – “Spike”
      Std* 	•
	Precision –
      “Spike” Std 	•
	Standard Curve parameters 
-    
      RAMP® Ratio increases with [Myo] 
-     Mean
      conversion factor (200 ng/mL) 
-     R2
    	

        •

        

	External
      Controls** 	•
	Blood Samples 	•
	Correlation to
      RAMP® QC Ref. 	•



* The internal “0” standard is in a proprietary matrix. The
internal “Spike” standard is at a concentration of [***] and is in a proprietary
matrix. 
** Expected values for external controls are vendor-lot specific


•    [***] 

CK-MB ASSAY 

The CK-MB ASSAY is specified as in: 

Product claims from package insert #50067 rev14 
Fullfills
the quality release criteria: 

CK-MB


  	QC Release Criteria 	Specification 
	Barcode / Lot Card
      recognition 	•
	Accuracy – 0 ng/mL
      Std* 	•
	Accuracy – “Spike”
      Std* 	•
	Precision –
      “Spike” Std 	•
	Standard Curve parameters 
-    
      RAMP® Ratio increases with [CK-MB] 
-     Mean
      conversion factor (5/10/20 ng/mL) 
-    
      R2 	

        •

        

	External
      Controls** 	•
	Blood Samples 	•
	Correlation to
      RAMP® QC Ref. 	•



* The internal “0” standard is in a proprietary matrix.
  The internal “Spike” standard is at a concentration of [***] and is
  in a proprietary matrix. 



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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

** Expected values for external controls are vendor-lot
specific 

•    [***] 

NT proBNP ASSAY 

The NT proBNP ASSAY is specified as in: 

Product claims from package insert #50174 rev3 
Fullfills
the quality release criteria: 

NT-proBNP


	QC Release Criteria 	Specification 
	Barcode / Lot Card
      recognition 	•
	Accuracy – 0 ng/mL
      Std* 	•
	Accuracy – “Spike”
      Std* 	•
	Precision –
      “Spike” Std 	•
	Standard Curve parameters 
-    
      RAMP® Ratio increases with [NT- 
      
      proBNP] 
-     Mean conversion factor
      
-     R2 	


        •

        

	External
      Controls** 	•
	Blood Samples 	•
	Correlation to
      RAMP® QC Ref. 	•



* the value of the internal “Spike” standard is currently
  under revision but is expected to be at a concentration approximately [***]
  and is in a proprietary matrix. 

  ** Expected values for external controls are vendor-lot specific 

  •    [***] 

TROPONIN I CONTROL 

The TROPONIN I CONTROL is specified as in 

Product claims from package inserts #50256 rev1 / 50257 rev1

Fulfills the quality release criteria (see below): 

MYOGLOBIN CONTROL 

The MYOGLOBIN CONTROL is specified as in 

Product claims from package inserts #50256 rev1 / 50257 rev1

Fulfills the quality release criteria (see below): 

CK-MB CONTROL 

The CK-MB CONTROL is specified as in 



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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

Product claims from package inserts #50256 rev1 / 50257 rev1

Fulfills the quality release criteria (see below): 

NT proBNP CONTROL 

The NT proBNP CONTROL is specified as in 

Product claims from package inserts #50256 rev1 / 50257 rev1

Fulfills the quality release criteria (see below): 


  	 	 	 	 	 
	  	 CalVer Controls 
	  	  	
        Controls 	  
	  	Level 0 	Level I 	Level 2 	Level 3 
	CK-MB 	  	  	  	  
	Troponin I 	  	  	  	  
	Myoglobin 	•	•	•	•
	NT- 	  	  	  	  
	proBNP 	  	  	  	  
	Reported ranges for each analyte / level are not to
        exceed [***] of the mean value. 




•    [***] 

The minimum shelf lives for cardiac tests reaching RDO in
Indianapolis are: 

Troponin          
[***] 

CK-MB             
[***] 

Myoglobin        [***] 

NT-proBNP       [***] 

The minimum shelf life for the cardiac tests reaching other
Ordering Entities will be defined later in good faith by the JPSC. 

The minimum shelf life will be revised in good faith by the
JPSC with the availability of additional stability data. 

The minimum shelf life for Cardiac and Cal/Ver controls will be
  [***] upon receipt in Indianapolis under 

  specified storage conditions of [***]



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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

EXHIBIT D 

1) Prices for Hospital & POL System Configuration



  	Configuration 	Group 	Price per 

        Unit 
(USD) 	Qty. 	Total Price 

        (USD) 	Total 

        Configuration 
Price
      
(USD) 
	Hospital System 	RAMP 200 CONTROL MODULE
      1) 	•	•	•	  
	  	RAMP 200 TEST MODULE 1) 	•	•	•	  
	  	PRINTER 1) 	•	•	•	  
	  	BAR CODE SCANNER 1) 	•	•	•	  
	  	  	•	•	•	•
	POL System
    	RAMP 200 CONTROL MODULE 1) 	•	•	•	  
	  	RAMP 200 TEST MODULE 1) 	•	•	•	  
	  	PRINTER 1) 	•	•	•	  
	  	BAR CODE SCANNER 1) 	•	•	•	  
	  	  	  	  	  	•



•    [***] 

  1)for details see Exhibit A – Products 



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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

2) Prices for Assay Kits (volume dependent) 


  	  	 Purchasing
        Prices (USD) 
	Assay Kit
        	•Single Tests p.a. 4)	•Single Tests p.a. 4)	•Single Tests p.a. 4)	•Single Tests p.a. 4)
	NT-proBNP 5)
        	•
      	•	•	•
      
	Troponin I 5),
        6) 	•
      	•
      	•
      	•
      
	CK-MB 5), 6)
      	•
      	•
      	•
      	•
	Myoglobin 5),
        6) 	•
      	•
      	•	•
      




•    [***] 

4) Volumes to depend on single assay quantities 

  5) for details see Exhibit A – Products 

  6) Troponin I, CK-MB, and Myoglobin volumes to be cumulative



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  AND DISTRIBUTION AGREEMENT V.12 06_19_2008
  

3) Prices for Spare Parts


  	Reference Group 7)	Item 	Qty. 	Total Price 

        (USD) 
	NT-proBNP, Troponin I, CK-MB, Myoglobine Assay Kits 	Assay Transfer Device (75μL
      minipipette) 	•	•
	Ramp
      200 Control Module 	USB Drive, preloaded and
      branded 	•	•
	Ramp
      200 Control Module 	Power Supply 	•	•
	Ramp
      200 Test Module 	Cord from Test Module to Control
      Module 	•	•
	Printer 	Printer Ribbon Roll, Zebra
      Technologies 	•	• 8) 
	Printer 	Accessory, 500 Printer Labels,
      2.5” x 3”, Zebra Technologies 	•	• 8) 



•    [***] 

7) for details see Exhibit A – Products 

  8) not to be sold/stocked by RBC, third party price 



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4) Prices for Controls 


  	Kit 	Purchasing 

        Prices
      (USD) 

	RAMP® Cardiac 
Controls 	•

	RAMP® Cardiac 
CalVer Controls 	•




•    [***] 

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5) Worldwide Minimum Purchase Quantities 

TABLE 1: Hospital System 


  	
	 Worldwide
        Minimum Purchase Quantities 

        [***] 
	Configuration
      	•
      	•	•	•	•
      
	Hospital 	•	•	•
      	•
      	•
      




•    [***] 

TABLE 2: POL System 


  	 	Worldwide Minimum Purchase
        Quantities 

        [***] 
	Configuration
      	•	•	•
      	•
      	•
      
	POL 	•
      	•	•
      	•
      	•
      




•    [***] 

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EXHIBIT E 

QUALITY & CHANGE CONTROL

	1. 	
      Roles. Supplier is the manufacturer of the
      Product(s), as defined in 21 CFR 820.3(o). Supplier shall comply with all
      Regulatory Laws applicable to a manufacturer of finished medical devices,
      including without limitation, pre-market notification and quality system
      requirements, if applicable.

	 	 
	2. 	
      Changes to Products or Specifications Requested by RDR
      or RDO. RDR and RDO reserve the right to request changes to the
      Product or Specifications upon written notice delivered to Supplier. Upon
      receiving such written request from RDR or RDO, Supplier shall deliver to
      RDR or RDO within a reasonable time, but in no event more than fifteen
      (15) business days following receipt of the request, a report setting
      forth Supplier’s best judgment as to the probable effect on the proposed
      changes (the “Change Report”). Depending on the extent of the
      impact of the proposed changes to the Products or Specifications, RDR, RDO
      and Supplier agree to cooperate and negotiate, in good faith, an amendment
      to this Agreement, if required, to address the terms and conditions in
      this Agreement that are affected by the requested change. Notwithstanding
      anything to the contrary in this Agreement, no change shall be implemented
      by Supplier until an amendment is negotiated or until final written
      approval by RDR and RDO is provided regarding such change. If such written
      approval is provided by RDR and RDO or an amendment is negotiated,
      Supplier shall maintain control records that demonstrate appropriate
      validation of all engineering and process changes in accordance with the
      standards set forth in Paragraph 5 of this Exhibit E. Supplier
      shall, in addition, maintain control records that document the effective
      dates, lot numbers, and/or serial numbers of all engineering and process
      changes in accordance with the standards set forth in Paragraph 5 of
      this Exhibit E. The document control system must ensure that obsolete
      drawings and Specifications are removed from all areas of use.

	 	 
	3. 	
      Changes to Manufacturing Processes, Product or
      Specifications Requested by Supplier. Supplier must have written
      authorization from RDR or RDO prior to incorporating any change into the
      Manufacturing Processes or Product(s) that affects the Specifications, or
      the Specifications themselves (including without limitation, changes
      incorporated by Supplier’s vendors, manufacturers, and/or subcontractors).
      No Products shall be manufactured with such changes and no shipments shall
      be delivered incorporating such changes until written authorization is
      received from RDR’s or RDO’s Source Development Group. All requested
      changes by Suppler shall be provided to RDR or RDO in a form reasonably
      acceptable to RDR or RDO. RDR or RDO shall respond to the change request
      in writing within 60 days. Supplier shall maintain control records that
      demonstrate appropriate validation of all engineering and process changes
      in accordance with the standards set forth in Paragraph 5 of this
      Exhibit E. Supplier shall, in addition, maintain control records that
      document the effective dates, lot numbers, and/or serial numbers of all
      engineering and process changes in accordance with the standards set forth
      in Paragraph 5 of this Exhibit E. The document control system must
      ensure that obsolete drawings and specifications are removed from all
      areas of use.

	 	 
	4. 	
      Product Quality. Supplier expressly covenants and
      warrants that all Products furnished under this Agreement shall conform to
      all Specifications, will be new, will be free from defects in materials
      and workmanship, will be merchantable, will be fit for their intended
      purposes, and will be properly packaged and labeled. This warranty shall
      apply for a period of five years following receipt of Products by
      Purchaser, for Product(s) that are instruments manufactured by Supplier,
      unless otherwise expressly provided for herein. This warranty shall apply
      for a period of fifteen (15) months for the following Product(s): printer,
      bar code scanner and USB devices. Supplier shall promptly correct, repair
      or replace defective Products to RDR’s and RDO’s satisfaction. At RDR’s or
      RDO’s sole discretion, RDR, RDO or a third party at their direction, may
      make corrections, repairs or replacements necessary to cure Supplier’s
      breach of this warranty, whenever time or other market conditions prevent
      RDR or RDO from waiting for Supplier to cure such breach or in the event
      Supplier fails to satisfactorily make such corrections, repairs
  or





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      replacement within a commercially reasonable time or
      provide adequate assurances that it will do so. In the event of a breach
      of this warranty, Supplier agrees to reimburse RDR and RDO for any and all
      damages associated with such breach including any and all costs incurred
      for freight, sorting, reworking, replacement product, customer bulletins
      and Product Recalls.

	 	 
	5. 	
      Compliance with Quality Assurance and Quality System
      Regulations. Supplier represents and warrants as follows: (a) the
      Manufacturing Processes used to produce the Products comply with all
      Applicable Laws, including GMPs, and have been validated in compliance
      with the FDA’s Quality System Regulations at 21 C.F.R. Part 820, (b) the
      Manufacturing Processes comply with ISO 900x or ISO 13485 series standard
      in the most current version, including all future changes and
      substitutions, and (c) the Manufacturing Processes comply with the
      requirements of European IVD directive (98/79/EC). Supplier further
      represents and warrants that Supplier shall maintain purchasing controls
      in accordance with all Applicable Laws, including but not limited to 21
      C.F.R. Part 820.50, and shall establish and maintain procedures to ensure
      that Supplier’s subcontractors, vendors and manufacturers comply with all
      such Applicable Laws. Supplier shall provide RDR and RDO with any
      applicable validation certificates upon request. Supplier represents and
      warrants that an installation qualification, operational qualification,
      and performance qualification has been performed on all applicable aspects
      of the Manufacturing Processes. Without limiting the warranty in this
      Paragraph, Supplier guarantees that none of the Products, at the
      time of delivery, are adulterated or misbranded within the meaning of the
      Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 321-394) (the
      “Act”), or similar law of any other jurisdiction. All warranties
      and commitments set forth in this Paragraph shall be deemed to be
      made and given by Supplier on a continuing basis throughout the Term of
      this Agreement and until all of Supplier’s obligations have been
      satisfied.

	 	 
	6. 	
      Incoming Quality Control Tests/Inspections.
      Supplier shall perform appropriate incoming quality control tests and/or
      inspections to determine that the quality of the component parts and/or
      raw materials used in the manufacture of the Product(s) meets Supplier’s
      requirements. Supplier shall keep complete, accurate, and reproducible
      records of all data relating to such component parts and/or raw materials.
      Supplier shall maintain an appropriate system for auditing its
      subcontractors, vendors or manufacturers (if any).

	 	 
	7. 	
      Compliance with European IVD Directives. For the
      Product(s) supplied under this Agreement, Supplier shall maintain
      comprehensive technical documentation (including complete production
      process documents and testing documentation and a listing of associated
      operating procedures and drawings for the manufacture of the Product(s) to
      support the Product(s) submission for IVDD compliance) as required by the
      European IVD Directive. Supplier and Supplier’s Affiliates shall maintain
      reproducible records of all such technical information and shall make such
      information available to RDR and RDO within 48 hours of its requests to
      assure compliance with the European IVD Directive. Supplier warrants the
      correctness and completeness of this technical documentation and is aware
      that RDR and RDO may rely on it.

	 	 
	8. 	
      Final Inspection of Lots. Supplier shall use a
      statistically valid sampling plan to test and/or inspect every lot of
      Product(s) to be delivered to Purchaser for compliance with the
      Specifications and the other terms and conditions of this Agreement prior
      to shipment, and shall issue a certificate of analysis in a form
      reasonably satisfactory to RDR and RDO in respect thereof.

	 	 
	9. 	
      Reports, Complaints and Inquiries from Governmental
      Authority.



(a) Adverse Event Reports. RDR
or RDO shall report any adverse device events, malfunctions, incidents, near
incidents and other reportable events for the Product to the Supplier within 48
hours of the occurrence of the event. Supplier shall be responsible for
reporting adverse device events, malfunctions, incidents, near incidents and
other reportable events for the Product to relevant Regulatory Authorities
pursuant to the Regulatory Laws of any jurisdiction in which the Product is
marketed or sold, including the FDA’s medical device reporting requirements set
forth in 21 C.F.R. Part 803. RDR and RDO shall provide such assistance and
information as Supplier reasonably 



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requests to fulfill its reporting
obligations for the Product. Supplier shall deliver to RDR and RDO a copy of any
such report within two (2) business days after submitting the report to a
Regulatory Authority. Supplier shall maintain files and records as required by
21 C.F.R. § 803.18 (or similar provisions of other Regulatory Laws, as
applicable). 

(b) Complaints. Each Party shall
  cooperate fully with the other Party in dealing with customer complaints concerning
  the Product(s) and shall take reasonable action to promptly resolve and follow
  up with regard to such complaints. Without limiting the generality of the foregoing,
  Supplier shall: (1) keep and maintain records of all customer complaints received
  by Supplier relating to the Product(s) as required by 21 C.F.R. § 820.198
  (or similar provisions of other Regulatory Laws); (2) notify RDR and RDO of
  all such complaints; and (3) otherwise cooperatively undertake investigations,
  provide information and analysis, and conduct such follow-up activities as reasonably
  requested by RDR and RDO, including providing to RDR and RDO an explanation
  or summary of each response to a complaint within fifteen (15) days. RDR and
  RDO shall: 1) keep and maintain records of all customer complaints received
  by RDR and RDO relating to the Product(s) as required by RDR and RDO; 2) notify
  Supplier upon receipt of any information that indicates a potentially significant
  effect on the safety or efficacy of the Product(s); and (3) otherwise cooperatively
  undertake investigations, provide information and analysis, and conduct such
  follow-up activities as reasonably requested by Supplier. 

(c) Inquiries from Governmental
Authority. If either Supplier, RDR or RDO receives notice of an inspection,
audit, or inquiry by a Governmental or Regulatory Authority relating to the
Product(s), arising from the any activities under this Agreement, or concerning
either Party's compliance with Regulatory Laws in connection with its activities
under this Agreement, the Party receiving such notice of inspection, audit, or
inquiry will notify the other Party as soon as possible, but in no event later
than 48 hours after receipt of such notice or notification, and provide to the
other Party, within 72 hours, copies of any documents received from or supplied
to the Governmental Authority or Regulatory Authority that are relevant to the
inspection or inquiry. Supplier, RDR and RDO agree to cooperate with each other
during any inspection, investigation or other inquiry, including providing
information and/or documentation as requested by the Regulatory Authority. 

(d) Right to Participate in
Regulatory Inspections or Audits. Supplier shall permit RDR or RDO or any
representative designated by them to be present during any inspection or audit
by a Governmental or Regulatory Authority of Supplier’s facilities or records if
the inspection or audit is reasonably expected to relate to the Product(s) or
the manufacture thereof or otherwise arise from or relate to any activities
under this Agreement. RDR and RDO shall have the right to review and participate
in drafting any response to any such inspection or audit, or any other request
for information from a Regulatory Authority pertaining to the Product(s) or any
activities under this Agreement, prior to Supplier’s submission of such response
to the Regulatory Authority. Supplier shall provide to RDR and RDO copies of all
information furnished to or received from any Regulatory Authority prior to,
during, or following any audit or inspection of Supplier’s facilities, within
the time frames set forth in Paragraph 9(c). 

	10. 	
      Regulatory Approval. Supplier represents and
      warrants to RDR and RDO that Supplier has obtained any marketing approvals
      or clearances for the Products required by applicable Regulatory
      Authorities in the United States and other applicable jurisdictions.
      Supplier hereby grants to RDR and RDO the fully paid-up right during the
      Term of this Agreement to use any and all regulatory approvals and
      clearances related to the Products owned by or licensed to Supplier. RDR
      and RDO shall have a right of reference to any and all technical,
      scientific and clinical data in any application for marketing approval or
      clearance for the Product.

	 	 
		
      The decision to seek regulatory or marketing approvals in
      any jurisdictions not in place on the effective date and the
      responsibility to obtain such approvals and clearances will be addressed
      by the joint Executive Management Team.





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11. 		
Supplier Corrective Action Request. If, during the Term of this Agreement, RDR or RDO reasonably identifies an issue that may affect the quality of a Product(s), its components or raw materials, Supplier’s
Manufacturing Processes or quality control processes or procedures, RDR or RDO may at its sole discretion, issue to Supplier a Supplier Correction Action Request (each a “SCAR”). Within fifteen (15) Business Days after the issue
date of the SCAR, Supplier shall deliver to RDR and RDO a detailed response to the SCAR (a “SCAR Response”). If final closure and verification on the issue or issues identified in the SCAR cannot be achieved within fifteen (15)
Business Days of Supplier’s receipt of the SCAR, as part of the SCAR Response, Supplier shall submit to RDR and RDO an action plan detailing its proposed plan to correct the issues identified in the SCAR. RDR and RDO shall have the right to
review and propose revisions to any such action plans, and all such action plans are subject to RDR’s and RDO’s written approval. Following RDR’s and RDO’s approval and Supplier’s initial implementation of the corrective
action plan, Supplier shall provide bi-weekly status reports, upon request, to RDR and RDO until final verification of the corrective action is accomplished and RDR and RDO accept the corrective action by written notice to Supplier.

	
	 	 
	
12. 		
Regulatory Documentation. Supplier shall accurately prepare and maintain all necessary and customary records related to the Manufacturing Processes undertaken by Supplier pursuant to this Agreement in compliance with all
Applicable Laws, including, but not limited to, 21 C.F.R. Part 820, Subpart M (or similar provisions of other Regulatory Laws, as applicable). RDR and RDO shall have access to and the right to reference, copy, retain copies of, and use for any
purpose all such records, upon request and without charge.

	
	 	 
	
13. 		
Violations. Supplier shall notify RDR and RDO promptly after becoming aware of any violation of any Applicable Laws or Quality Requirements, relating to the Product(s), the Manufacturing Processes, or otherwise relating to
or arising out of Supplier’s activities pursuant to this Agreement.

	




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EXHIBIT F 
ADDITIONAL
REMEDIES FOR DELAYS, AND
NON-CONFORMING PRODUCTS 

Technology Transfer: 

In the event that this Agreement is terminated by RDR or RDO
pursuant to Section 8(a) or 8(b)(ii) or (iii), Supplier shall grant to RDR and
RDO the license required as part of the Disaster Recovery Plan set forth in
Section 10.1 of the Agreement for the unexpired portion of the Initial Term, and
shall provide all assistance and other obligations therein as if a significant
or catastrophic event occurred affecting the supply of Products.

Supplier further agrees to use commercially reasonable efforts
  to assist in a transition of supply chain requirements, including the continuation
  of manufacturing until either RDR or RDO are capable of manufacturing demanded
  volumes. RDR and RDO will pay all reasonable costs incurred by Supplier in the
  one-time transfer of manufacturing technology and ongoing support for a reasonable
  time, not longer than six (6) months. If RDR or RDO requests additional assistance
  in connection with the transferred manufacturing technology beyond that set
  forth above, RDR and RDO will request the assistance in writing and pay Supplier
  for all such assistance. 

  

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EXHIBIT G 

Tooling Requirements 

The Parties agree that all tooling, including but not limited
to equipment, fixtures, molds, dies, knifestacks, print cylinders, inspection
cameras, etc. that are provided by RDO to Supplier (hereinafter
“Tooling”) will be used exclusively by Supplier to produce Products for
RDO and title to such Tooling shall, during the Term of the Agreement remain
with RDO. In addition, Supplier agrees, at its sole cost and expense, to the
following:

	1. 	
      To keep the Tooling fully insured at replacement value
      against loss arising from fire, theft, damage and extended coverage as
      appropriate.

	 	 	 
	2. 	
      To provide a Certificate of Insurance evidencing the
      coverage set forth herein.

	 	 	 
	3. 	
      To store the Tooling at Supplier’s facility, as specified
      in the quarterly report described to Section 12 of this
      Exhibit, in a safe and secure condition consistent with Supplier’s
      current policy or industry standards. Should transportation of the Tooling
      to another facility be necessary, Supplier must obtain RDO’s prior
      approval. Tooling shall not be transported to another facility or
      location without RDO approval. When such approval is granted, Supplier
      shall pack and ship per RDO’s approved standards.

	 	 	 
	4. 	
      To maintain the Tooling in a state of repair, which will
      render parts, manufactured from the tooling, fit for their intended
      purpose and meets all applicable RDO specifications. Notwithstanding the
      foregoing, Supplier shall provide RDO immediate notice in the event the
      Tooling is required to be repaired, altered or modified.

	 	 	 
	5. 	
      To keep the Tooling free of all liens and encumbrances.
      To the extent required by RDO, Customer shall also consent to RDO filing a
      UCC Financing Statement for the Tooling and shall cooperate and complete
      all documentation required to evidence RDO’s ownership in the
    Tooling.

	 	 	 
	6. 	
      To allow RDO the right, at all reasonable times, upon
      reasonable notification to enter Supplier’s premises to inspect any and
      all Tooling.

	 	 	 
	7. 	
      To surrender or return the Tooling upon receipt of RDO’s
      written notice, at which time RDO agrees to pay only for the packing,
      transportation costs and insurance costs to the specified destination.
      Supplier agrees to return the Tooling in as good condition as when
      Supplier received it except for ordinary wear and tear.

	 	 	 
	8. 	
      To indemnify and hold RDO harmless from any personal
      injury or property damage, including attorney’s fees and cost of defense
      that results from Supplier’s use or custody of the Tooling.

	 	 	 
	9. 	
      To clearly mark all Tooling “Property of Roche
      Diagnostics Operations, Inc.” and clearly identify by the appropriate RDO
      part number.

	 	 	 
	10. 	
      To provide RDO nine (9) month prior written notice in the
      event the Tooling is required to be scrapped or destroyed.

	 	 	 
	11. 	
      To provide the following information to RDO’s Source
      Development Department in writing upon execution of the Agreement and
      thereafter on a quarterly basis, after the Tooling has been approved for
      production:

	 	 	 
		 •
	
      Tooling description.

		 •
	
      Specific location of Tooling.

		 •
	
      RDO part number.

		 •
	
      Estimated life of Tooling from date approved.

		 •
	
      The maintenance and repairs performed while the Tooling
      is in the Supplier’s possession.

		 •
	
      Remaining life of Tooling.

		 •
	
      Estimated maintenance cost for the next 24 month period
      divided into annual increments.

		 •
	
      Estimated replacement cost of the Tooling.

	 	 	 
	13. 	
      If the Tooling is used to produce a Product that is
      imported into the United States, Supplier shall document the Tooling as a
      separate line item in the first invoice in order to document the value for
      purposes of entry for U.S. Customs.





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EXHIBIT H 

Security Guidelines for Manufacturing Facilities Located
Outside of the United States 

RDO has been accepted as a Customs-Trade Partnership Against
Terrorism (“C-TPAT”) supplier with U.S. Customs & Border Protection.
As a C-TPAT importer, RDO is required to maintain effective security processes
in its supply chain. Therefore, RDO requires each Supplier with manufacturing
facilities located outside the United States to provide RDO with a comprehensive
written security plan that includes the following items:

Physical Security: All buildings should be constructed
of materials, which resist unlawful entry and protect against outside intrusion.
Physical security should include: adequate locking devices for external and
internal doors, windows, gates and fences, segregation and marking of
international, domestic, high-value and dangerous goods cargo within the
facility by a safe, caged or otherwise fenced-in area, adequate lighting
provided inside and outside the facility to include parking areas, separate
parking area for private vehicles separate from the shipping/loading dock and
cargo areas, and internal/external communications systems in place to contact
internal security personnel or local law enforcement. 

Access Controls: Unauthorized access to the shipping,
loading dock and cargo areas should be prohibited. Controls should include: the
positive identification, recording and tracking of all employees, visitors and
vendors, and procedures for challenging unauthorized/unidentified persons. 

Procedural Security: Measures for the handling of
incoming and outgoing goods should include the protection against the
introduction, exchange, or loss of any legal or illegal material. Security
controls should include: properly marked, weighed, counted and documented
products, procedures for affixing, replacing, recording, tracking and verifying
seals on containers, trailers and railcars, procedures for detecting and
reporting shortages and overages, procedures for tracking the timely movement of
incoming and outgoing goods, proper storage of empty and full
containers/trailers/railcars to prevent unauthorized access, and procedures to
notify Customs and Border Protection in cases where anomalies or illegal
activities are detected or suspected by the company. 

Personnel Security: Companies should conduct employment
screening and interviewing of prospective employees to include periodic
background checks and application verifications in accordance with
applicable statutes and regulations.

Education and Training Awareness: A security awareness
program shall be provided to employees and include instruction on how to
recognize internal conspiracies, maintaining product integrity, and determining
and addressing unauthorized access. Provide details in the security plan
regarding this education and training awareness program.

Threat Awareness: A threat awareness program shall be
  established and maintained by security personnel to recognize and foster an
  awareness of the threat posed by terrorists and contraband smugglers at each
  point in the foreign-based logistical chain. Provide details in the security
  plan regarding this threat awareness program. 



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