and replacements thereto, that are developed and/or marketed by or on behalf of Beckman or its Affiliates.

 

1.3            “ Biosite Antibodies ” shall mean the [***] antibodies binding to BNP that are described more specifically in the Design Inputs and/or specified under the provisions of Section 3.1 (Biosite Materials).

 

1.4            “ Biosite/Scios Agreement ” shall mean the Semi-Exclusive BNP Diagnostic License Agreement between Biosite and Scios Inc. dated December 30, 1996 as amended or restated from time to time.

 

1.5            “ BNP ” shall mean the human protein known as B-type natriuretic peptide.

 

1.6            “ BNP Assay ” shall mean a diagnostic BNP assay for use in the diagnosis of cardiac diseases in humans [***] or [***] pursuant to this Agreement and the Design Inputs, which assay is designed for use on the Beckman Analyzers.

 

1.7            “ BNP Calibrator and Controls ” shall mean the BNP calibrator and controls [***] or on [***] or [***] pursuant to this Agreement and the Design Inputs, which calibrator and controls are for use with the BNP Assay.

 

1.8            “ Clinical Plan ” shall mean a plan and schedule for any external or internal evaluations to be carried out during validation and U.S. clinical trials for the purpose of regulatory approval.

 

1.9            “ Confidential Information ” shall mean, with respect to a party, all information of any kind whatsoever, and all tangible and intangible embodiments thereof of any kind whatsoever, that is disclosed by such party to the other party and is marked as confidential at the time of disclosure to the other party or if not marked as confidential at the time of the initial disclosure is so marked and disclosed again to the other party within thirty (30) days of the initial disclosure. Biosite’s Confidential Information includes, without limitation, all non-public information relating to the Biosite Antibodies. Notwithstanding the foregoing, Confidential Information of a party shall not include information which the other party can establish by written documentation (a) to have been publicly known prior to disclosure of such information by the disclosing party to the other party, (b) to have become publicly known, without fault on the part of the other party, subsequent to disclosure of such information by the disclosing party to the other party, (c) to have been received by the other party at any time from a source, other than the disclosing party, rightfully having possession of and the right to disclose such information, (d) to have been otherwise known by the other party prior to disclosure of such information by the disclosing party to the other party, or (e) to have been independently developed by employees or agents or Affiliates of the other party without access to or use of such information disclosed by the disclosing party to the other party.

 

1.10          “ Design Inputs ” shall mean the detailed product requirements, functional specifications and testing methodologies set forth in Exhibit A .

 

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1.11          “ FDA ” shall mean the United States Food and Drug Administration or the successor thereto.

 

1.12          “ First Commercial Sale ” shall mean the first sale anywhere in the world of a BNP Assay by Biosite or any Affiliate or authorized distributor of Biosite to customers who are not affiliates in any country after all applicable marketing and pricing approvals (if any) have been granted by the applicable governing health authority of such country. As used in this definition, “authorized distributor” includes [***] of Biosite in any country under the [***].

 

1.13          “ Foreign Purchase Price ” means the price equal to (a) for the first Pricing Period, [***] per [***] of the BNP Assays, and (b) for each subsequent Pricing Period, the price per [***] of the BNP Assays for the previous Pricing Period adjusted (in accordance with Section 6.1.7) by the [***] or [***] of the [***] for the applicable Measurement Period as compared to the [***] for the immediately preceding Measurement Period.

 

1.14          “ GMP ” shall mean current Good Manufacturing Practices as prescribed from time to time by the FDA.

 

1.15          “ Guidelines ” shall mean the guidelines and requirements for the parties’ obligations regarding the [***] of BNP Assay and BNP Calibrator and Controls attached hereto as Exhibit B (as modified from time to time by the Joint Committee in accordance with Section 5.7).

 

1.16          “ Joint Committee ” shall mean the joint committee described in Section 5.7.

 

1.17          “ Marker ” shall mean (a) [***], with or without the [***] sequence, or (b) any [***] thereof (however derived), including without limitation the [***] commonly known as [***] and the [***] commonly known as [***].

 

1.18          “ Measurement Period ” means, for the current Pricing Period, the most recent [***], prior to the date [***] before the start of the current Pricing Period, for which data (as determined by [***] or such other party mutually acceptable to the parties and agreed to in writing) is available for sales to [***] of assays [***] that measure or detect the presence or absence of the Marker. If the most recent such data provided by [***] (or such other party agreed to by the parties then providing such data) is only available for a period ending more than [***] prior to the start of the current Pricing Period, the parties shall agree upon a different, mutually acceptable party to provide such data or data substantially similar to that described in this Section.

 

1.19          “ Person ” shall mean an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint

 

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venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

 

1.20          “ Pricing Period ” means each [***] period ending on each [***] and [***] following the First Commercial Sale.

 

1.21          “ Product Risk Analysis ” shall mean a formal risk assessment of BNP Assay, using failure modes and effects analysis (FMEA), risk analysis, or other approved tool.

 

1.22          “ Project ” shall have the meaning as defined in Section 3.2.1.

 

1.23          “ Prototype Acceptance ” shall have the meaning as defined in Section 3.3.

 

1.24          “ Prototypes ” shall mean development prototypes of the BNP Assay and BNP Calibrator and Controls.

 

1.25          “ Release Specifications ” shall mean the detailed product requirements, functional specifications and testing methodologies for the final BNP Assay or BNP Calibrator and Control, as such requirements, specifications and methodologies shall be developed by the parties in accordance with Section 3.5 and as may be modified from time to time upon mutual written agreement of the parties.

 

1.26          “ Technical Validation Report ” shall mean a summary report for all testing conducted as part of the manufacturing validation plan, including pilot build results, demonstrating conformance of the Prototypes to the Design Inputs.

 

1.27          “ Technical Verification Report ” shall mean a summary of all testing results conducted as part of a verification plan, including Prototype build results and conformance of the Prototypes to the Design Inputs.

 

1.28          “ US Purchase Price ” means the price equal to (a) for the first Pricing Period, [***] [***] of the BNP Assays, and (b) for each subsequent Pricing Period, the price [***] [***] of the BNP Assays for the previous Pricing Period adjusted (in accordance with Section 6.1.7) by the [***] or [***] of the [***] for the applicable Measurement Period as compared to the [***] for the immediately preceding Measurement Period.

 

1.29          “ Validation Plan ” shall mean a description of all validation activities, including manufacturing and materials plan for product pilot lots (number and scale of test lots), identified suppliers, testing methods (protocols and procedures), shipping conditions and specifications to confirm conformance of the Prototypes to Design Inputs.

 

1.30          [***] shall mean, for any Measurement Period, and for [***] in [***] that measure or detect the presence or absence of

 

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the Marker sold during such Measurement Period to [***], the [***] (as determined by [***] or such other party mutually acceptable to the parties and agreed to in writing) of each such [***] by the [***] of such [***] to calculate a [***] [***] for all sales of [***].

 

1.31          “ Worldwide Purchase Price ” shall mean, for the current Pricing Period commencing after the first anniversary of the First Commercial Sale, the amount (calculated in accordance with Section 6.1.7) equal to the sum of (a) the product of (i)  the [***] during the applicable Measurement Period of [***] of BNP Assays sold to [***] located within the [***] ([***]), divided by the [***] during the applicable Measurement Period of [***] of BNP Assays sold to [***] ([***]), times (ii) the US Purchase Price for the current Pricing Period, plus (b) the product of (i) [***] minus [***] ([***]), divided by [***], times (ii) the Foreign Purchase Price for the current Pricing Period. The foregoing calculation is set forth as a formula as follows:

 

Worldwide Purchase Price =

[***] x US Purchase Price

+

[***] x Foreign Purchase Price

 

2.              REPRESENTATIONS AND WARRANTIES

 

Each party hereby represents and warrants to the other party as follows:

 

2.1            Corporate Existence . Such party is a corporation duly organized, validly existing and in good standing under the laws of the state in which it is incorporated.

 

2.2            Authorization and Enforcement of Obligations . Such party (a) has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (b) has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms.

 

2.3            Consents . All necessary consents, approvals and authorizations of all governmental authorities and other third parties required to be obtained by such party in connection with this Agreement have been obtained.

 

2.4            No Conflict . The execution and delivery of this Agreement and the performance of such party’s obligations hereunder (a) do not conflict with or violate any requirement of applicable laws or regulations, and (b) do not conflict with, or to its knowledge constitute a default under, any contractual obligation of such party.

 

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3.              DEVELOPMENT

 

3.1            Biosite Materials . From time to time during the development and manufacture of the BNP Assay and the BNP Calibrator and Controls, Biosite shall deliver to Beckman such quantity of [***] as may be reasonably required by Beckman and ordered by Beckman under this Section, and any other materials the parties agree to in writing, if any, (the [***] and such other materials individually and collectively the “Biosite Materials”) solely for use by Beckman to [***]. Biosite shall acknowledge each such order in the form of a written order confirmation. Prior to delivery of any such Biosite Materials, the parties shall agree in good faith upon mutually acceptable terms regarding specifications and delivery schedules for such Biosite Materials. Biosite shall use commercially reasonable efforts to deliver to Beckman Biosite Materials that conform to such specifications and in accordance with such schedules. If Beckman determines in good faith that the Biosite Materials do not materially conform to such specifications, Beckman shall so notify Biosite in writing and include with such notification a reasonable description of such non-conformance. Subject to Section 10, as Beckman’s sole and exclusive remedy hereunder, Biosite shall use commercially reasonable efforts to promptly replace any such non-conforming Biosite Materials. Beckman shall use the Biosite Materials delivered by Biosite solely for purposes of [***] pursuant to the terms of this Agreement. In consideration for the sale of the Biosite Materials to Beckman under this Section 3.1, Beckman shall pay to Biosite an amount equal to [***] to [***] such [***]. Biosite shall invoice Beckman for such amount at the time of each delivery of such Biosite Materials, and Beckman shall pay to Biosite the amount of each such invoice within [***] after receipt by Beckman of such invoice. If Beckman’s obligation to perform under this Agreement is substantially prevented or materially hindered by Biosite’s failure to supply conforming Biosite Materials according to the delivery schedule for such Biosite Materials, Beckman shall have the right to provide written notice thereof to Biosite. Beckman’s future [***] to perform under this Agreement, and any other related obligations (including related indemnity obligations) affected by such failure, shall be suspended, relieved and/or discharged solely to the extent that and for so long as Beckman’s performance is or was substantially prevented or materially hindered by such failure. Except as required by Beckman quality systems, Beckman shall destroy all unused quantities of the Biosite Materials immediately upon the expiration or termination of this Agreement. [***] for [***] by Biosite [***] the Biosite Materials or any [***] of the [***] or the [***].

 

3.2            [ ***]

 

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3.2.1         Beckman shall use its reasonable commercial efforts to [***] the [***] and [***] in accordance with the Design Inputs (the “Project”) all under and according to Beckman’s [***] and [***] for other projects of similar scientific and commercial [***].

 

3.2.2         Beckman shall perform the Project under the Beckman quality system as applied to other projects of similar scientific and commercial [***]. Beckman shall maintain its quality system such that the quality system meets and maintains regulatory approval and conformity assessment requirements. Beckman shall comply with all FDA regulatory and quality system requirements and all other U.S. and international regulatory and quality system requirements regarding [***] and [***], including but not limited to 21 CFR 820 and be certified as conforming to ISO 13485 and to the requirements of the In Vitro Diagnostic Directive or equivalent international standard.

 

3.2.3         Other than as provided in Section 3.3, Beckman shall provide Project personnel, materials, equipment and other resources required under the Project at its own expense, without contribution or offset from Biosite.

 

3.3            Biosite Assistance .

 

3.3.1         Biosite shall provide reasonable assistance to Beckman in connection with the Project.

 

3.3.2         Biosite shall provide to Beckman [***] for Beckman’s use during the Project, all at no cost to Beckman. Beckman shall use the [***] solely to conduct the Project and not for any other purpose. Beckman hereby acknowledges that, as between the parties, Biosite is the sole owner or licensee of the [***] and the transfer of physical possession thereof by Biosite to Beckman shall not be (nor construed as) a sale, lease, offer to sell or lease, or other transfer of title. The [***] are, and shall remain at all times, the personal property of Biosite, regardless of how they are or may become attached or installed. Beckman shall not transfer the [***] to any third party without the prior express written consent of Biosite. Beckman shall not damage or destroy the [***]. Upon the earlier of the expiration or termination of the Project or this Agreement, Beckman shall promptly return the [***] to Biosite. Beckman shall use [***] provided by Biosite, if any, solely in accordance with the [***] accompanying such [***]. If Beckman’s obligation to perform under this Agreement is substantially prevented or materially hindered by Biosite’s failure to supply [***], Beckman shall have the right to provide written notice thereof to Biosite. Beckman’s future [***] obligations to perform under this Agreement, and any other related obligations (including related indemnity obligations) affected by such failure, shall be suspended, relieved and/or discharged solely to the extent that and for so long as Beckman’s performance is or was substantially prevented or materially hindered by such failure.

 

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3.3.3         BECKMAN ACKNOWLEDGES THAT THE [***] ARE PROVIDED “AS IS,” AND WITHOUT WARRANTY OF ANY KIND. BIOSITE MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE [***] OR THE USE THEREOF. BIOSITE DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT. BECKMAN’S USE OF THE [***] SHALL BE AT ITS OWN RISK.

 

3.4            Prototypes . Upon completion of the verification phase of the Project, Beckman shall deliver Prototypes and a Technical Verification Report, a Validation Plan, Technical Validation Report, and a Product Risk Analysis for the Project to Biosite for Biosite’s testing, evaluation, and acceptance or rejection. If Biosite rejects any such Prototype for failure to meet the Design Inputs, Biosite shall provide to Beckman a written report of the reasons for such rejection and Beckman shall have [***] to cure such non-conformance and redeliver to Biosite a replacement Prototype (BNP Assay and/or BNP Calibrator and Controls, as applicable). If Biosite rejects any resubmitted Prototype, Biosite shall again provide to Beckman a written report outlining the reasons for such rejection and Biosite may at its option, and as its sole and exclusive remedy under this Agreement, either (a) request that Beckman resubmit conforming Prototype (BNP Assay and/or BNP Calibrator and Controls, as applicable) at Beckman’s expense, or (b) terminate this Agreement in accordance with Section 9.2.2 below. For purposes of clarity, the parties acknowledge and agree that Biosite may reject a Prototype on the basis of (i) a non-conformance of the Prototype (BNP Assay and/or BNP Calibrator and Controls, as applicable) to a key Design Input (as reasonably designated by Biosite), or (ii) a material non-conformance of the Prototype (BNP Assay and/or BNP Calibrator and Controls, as applicable) to any other Design Input. Biosite shall indicate its acceptance of the Prototype (both BNP Assay and BNP Calibrator and Controls) and the Technical Validation Report (collectively “Prototype Acceptance”) by delivering to Beckman a written acceptance under this Section 3.4 (Prototypes).

 

3.5            Release Specifications . With respect to each production lot of BNP Assay and BNP Calibrator and Control, upon Prototype Acceptance for such BNP Assay or BNP Calibrator and Control in accordance with Section 3.4 above, the parties shall agree in good faith upon a set of mutually acceptable Release Specifications for such BNP Assay or BNP Calibrator and Control.

 

3.6            Clinical Plan . Promptly following the Effective Date, [***] shall [***] a Clinical Plan on [***].

 

3.7            Clinical Testing; Regulatory Approval . Upon Prototype Acceptance, Biosite and Beckman shall conduct clinical testing in accordance to roles and responsibilities listed in the Clinical Plan, and each shall perform its respective obligations under the Clinical Plan at its own expense. Each party shall provide reasonable assistance to the other party at no cost to the other party in connection with the performance of the clinical testing. Biosite shall seek and use reasonable efforts to obtain

 

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regulatory approval as necessary to sell the BNP Assays and the BNP Calibrator and Controls in the United States and such other countries as Biosite reasonably determines. Biosite is responsible for paying all regulatory filing costs worldwide incurred by Biosite in connection with obtaining such regulatory approval. Biosite and Beckman shall provide the personnel, materials, equipment and other resources required to perform the clinical testing at their respective own expense. Biosite and Beckman shall perform such activities in accordance with their commercially reasonable efforts and standards, and in compliance in all material respects within the requirements of applicable laws and regulations.

 

3.8            Design Input Changes . The Design Inputs may not be modified other than by a mutually acceptable written agreement executed by the parties.

 

4.              MANUFACTURE

 

4.1            Release Specifications . Upon Prototype Acceptance and once Biosite has obtained regulatory approval from the FDA or its foreign equivalent to sell the BNP Assay in the United States or other country, respectively, Beckman shall begin commercial manufacture of the BNP Assays and the BNP Calibrator and Controls on behalf of Biosite. Beckman shall manufacture the BNP Assays and the BNP Calibrator and Controls in strict conformance with the Release Specifications.

 

4.2            GMP . Beckman shall manufacture all BNP Assays in accordance with GMP and all applicable laws and regulations. Biosite shall have the right, at its sole expense, to audit Beckman for compliance with GMP under the provisions of Section 4.5 (Facility Audits) below.

 

4.3            Certificates of Analysis . Beckman shall provide certificates of analysis to Biosite for all BNP Assays manufactured and supplied hereunder based upon a reference standard established by Beckman and reasonably acceptable to Biosite.

 

4.4            Quality Control Information . Upon the reasonable request of Biosite, Beckman shall provide Biosite with such information, including analytical and manufacturing documentation, requested by Biosite regarding quality control of the BNP Assays supplied under this Agreement. Biosite shall treat all such information disclosed pursuant to this Section 4.4 as confidential information of Beckman subject to the provisions of Section 7 (Confidentiality).

 

4.5            Facility Audits . Biosite shall have the right, during normal business hours and upon reasonable notice, and not more than [***] per calendar year unless required or mandated by a governmental or regulatory authority, to audit the facilities of Beckman at which the BNP Assays are [***] (a) for compliance with GMP, (b) for compliance with all laws and regulations reasonably applicable to the [***] of the BNP Assay or BNP Calibrator and Controls, and/or (c) for compliance with the Release Specifications. To the extent reasonably possible to do so, Beckman shall give Biosite prior written notice of any FDA inspection of the facilities of Beckman at which the BNP Assays or BNP Calibrator and

 

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Controls are [***] but only to the extent that such inspection is related to the [***] of BNP Assays or BNP Calibrator and Controls. Beckman promptly shall provide Biosite with copies of all notices, correspondence, findings, responses, resolutions and other materials delivered to or received from the FDA regarding the BNP Assays or BNP Calibrator and Controls.

 

5.              SUPPLY OF BNP ASSAYS, CALIBRATORS AND CONTROLS

 

5.1            Requirements . Upon Prototype Acceptance and once Biosite has obtained regulatory approval from the FDA or its foreign equivalent to sell the BNP Assay in the United States or other country, respectively, Biosite shall purchase from Beckman, and Beckman shall physically transfer and sell to Biosite, [***] of the BNP Assays and the BNP Calibrator and Controls for sale and/or use directly by Biosite or indirectly by Biosite’s authorized distributors throughout the world.

 

5.2            Exclusivity .

 

5.2.1         Beckman shall manufacture, offer for sale, and sell the BNP Assays exclusively to Biosite, and shall not [***]. Beckman and Biosite acknowledge and agree that Beckman is not [***] of the BNP Assays and [***]. Biosite and Beckman acknowledge and agree that Biosite is not, by reason of this Agreement or otherwise, [***] of the Beckman Analyzers or any Beckman labeled assay, component, supply or spare part for use in the Beckman Analyzers or any other Beckman labeled product (other than BNP Assays or BNP Calibrator and Controls that the parties agree may bear a [***]).

 

5.2.2         Prior to the date [***] following First Commercial Sale, Biosite shall not engage more than [***] unaffiliated third party (in addition to Beckman) to have manufactured for Biosite a diagnostic BNP assay for use in the diagnosis of cardiac diseases in humans developed by such third party designed for use on such third party’s automated immunoassay laboratory instrument. During such [***] period (a) if, and for so long as, Biosite purchases such BNP assays for resale in the U.S. from such unaffiliated third party at a purchase price [***] that is greater than [***] U.S. Purchase Price, then the purchase price [***] under Section 6.1.1 shall be increased to [***] for such BNP assay for resale in the U.S. from such unaffiliated third party, (b) if, and for so long as, Biosite purchases such BNP assays for resale outside the U.S. from such unaffiliated third party at a purchase price [***] that is greater than [***] Foreign Purchase Price, then the purchase price [***] under Section 6.1.2 shall be increased to such greater purchase price for such BNP assay for resale outside the U.S. from such unaffiliated third party, and (c) Biosite shall use commercially reasonable efforts to promote the BNP Assay.

 

5.2.3         For a period commencing on the Effective Date and expiring [***] before the termination or expiration of the Biosite/Scios

 

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Agreement, (a) Beckman shall not research or develop, and shall cause its Affiliates not to research or develop, any assay for use in th