Document:

Exhibit 10.20

 

***Text omitted and filed separately

Confidential Treatment Requested

Under 17 C.F.R.§§ 200.80 (b) (4)

And 240.24b-2

 

AMENDMENT NO. 2
TO SEMI-EXCLUSIVE BNP DIAGNOSTIC LICENSE AGREEMENT

 

THIS AMENDMENT NO. 2
TO SEMI-EXCLUSIVE BNP DIAGNOSTIC LICENSE AGREEMENT (this “Amendment”), dated as
of August 30, 2002 (the “Amendment Date”), is entered into between BIOSITE
INCORPORATED, a Delaware corporation (“Biosite”), having a place of business
located at 11030 Roselle Street, Suite D, San Diego, California 92121, and
SCIOS INC., a Delaware corporation (“Scios”), having a place of business at
2450 Bay Shore Parkway, Mountain View, California 94043.

 

W I T N E S S E T H:

 

WHEREAS, the parties
entered into a Semi-Exclusive BNP Diagnostic License effective as of December 30,
1996 (as amended, the “Agreement”).

 

WHEREAS, the parties
desire to amend the Agreement in certain respects as set forth below, in order
to clarify the parties mutual understanding regarding the calculation of
milestones and royalties payable to Scios under the Agreement.

 

NOW, THEREFORE, in
consideration of the foregoing premises and the mutual covenants set forth
below, the parties amend the Agreement and agree as follows:

 

1.                                       Amendments.

 

1.1                                 Section 3.2 of
the Agreement is amended to add the following sentence at the end thereof:

 

The parties acknowledge
and agree that the payments described in each of subsections (a), (b) and (c) above
shall be payable only once during the term of this Agreement, regardless of the
number of Licensed Products developed or sold by Biosite.

 

1.2                                 Section 3.4 of
the Agreement is restated in its entirety to read as follows:

 

Royalties. Within [***] following
the end of each calendar quarter during the term of this Agreement, Biosite
shall pay to Scios earned royalties based on [***] of Licensed Products during
the previous calendar quarter. If a Licensed Product [***] or [***] BNP and [***]
or more other analytes in the sample biological material tested, then Net
Sales, for purposes of royalty payments for such Licensed Product, shall be
adjusted by multiplying the Net Sales of such Licensed Product by the fraction
1/X, where X equals [***]. Royalties shall be paid at the following rate, [***]:

 

	
  (a) [***]

  	
   

  	
  [***]%

  
	
  (b) [***]

  	
   

  	
  [***]%

  
	
  (c) [***]

  	
   

  	
  [***]%

  

 

***Confidential Treatment
Requested

 

1

 

2.                                       Miscellaneous.

 

2.1                                 Defined Terms. All
terms used, but not defined, herein shall have the respective meanings set
forth in the Agreement.

 

2.2                                 Continuing Effect.
This Amendment shall be effective for all purposes as of the Amendment Date. Except
as otherwise expressly modified by this Amendment, the Agreement shall remain
in full force and effect in accordance with its terms.

 

2.3                                 Governing Laws.
This Amendment shall be governed by, interpreted and construed in accordance
with the laws of the State of California, without regard to conflicts of law
principles.

 

2.4                                 Counterparts. This
Amendment may be executed in two or more counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and the
same instrument.

 

IN WITNESS WHEREOF, the
parties have executed this Amendment effective as of the Amendment Date.

 

	
   

  	
  BIOSITE
  INCORPORATED

  
	
   

  	
   

  
	
   

  	
  By

  	
    /s/
  Chris R. Hibberd

  	
   

  
	
   

  	
   

  	
  Chris R. Hibberd

  	
   

  
	
   

  	
  Title

  	
    V.P.
  Business Development

  	
   

  
	
   

  	
   

  
	
   

  	
  SCIOS INC.

  
	
   

  	
   

  
	
   

  	
  By

  	
    /s/
  Matthew R. Hooper

  	
   

  
	
   

  	
   

  	
  Matthew R.
  Hooper

  	
   

  
	
   

  	
  Title

  	
    Vice
  President & General Counsel

  	
   

  
						

 

2Exhibit 10.21

 

*** Text omitted and filed separately

with the Securities and Exchange Commission

Confidential Treatment Requested

Under 17 C.F.R §§ 200.80 (b) (4)

And 240.24b-2

 

BNP ASSAY DEVELOPMENT, MANUFACTURE AND SUPPLY AGREEMENT

 

THIS
BNP ASSAY DEVELOPMENT, MANUFACTURE AND SUPPLY AGREEMENT (this “Agreement”)
effective as of June 24, 2003 (the “Effective Date”), is entered into by
and between BIOSITE INCORPORATED, a Delaware corporation (“Biosite”), having a
place of business at 11030 Roselle Street, Suite D, San Diego, California
92121, and BECKMAN COULTER, INC., a Delaware corporation (“Beckman”), having a
place of business at 4300 N. Harbor Boulevard, Fullerton, California
92834-3100.

 

WHEREAS,
Biosite owns or has rights relating to BNP (as defined below) and to reagents
and methods useful in assaying levels of BNP in human biological materials.

 

WHEREAS,
Beckman has expertise in the development and manufacture of automated
laboratory immunoassay instrumentation and tests, and owns or has rights relating
to a platform for the measurement of analytes in human biological materials.

 

WHEREAS,
Biosite desires to engage Beckman to develop and manufacture for the benefit of
Biosite, and to sell exclusively to Biosite (for resale by Biosite and Biosite’s
authorized distributors), a test for use in the diagnosis of cardiac diseases
in humans on the Beckman Analyzers (as defined below), on the terms and
conditions of this Agreement.

 

WHEREAS,
Beckman desires to accept such engagement on the terms and conditions of this
Agreement.

 

NOW,
THEREFORE, in consideration of the foregoing premises and the mutual covenants
set forth below, the parties hereby agree as follows:

 

1.             DEFINITIONS

 

For
purposes of this Agreement, the terms defined in this Section 1 shall have the
respective meanings set forth below:

 

1.1           “Affiliate”
shall mean, with respect to any Person, any other Person which directly or
indirectly controls, is controlled by, or is under common control with, such
Person. A Person shall be regarded as in control of another Person if it owns,
or directly or indirectly controls, at least fifty percent (50%) of the voting
stock or other ownership interest of the other Person, or if it directly or
indirectly possesses the power to direct or cause the direction of the management
and policies of the other Person by any means whatsoever.

 

1.2           “Beckman
Analyzers” shall mean any automated immunoassay (or combination
chemistry/immunoassay) laboratory instruments capable of performing the
measurement of analytes in human biological materials, together with all
improvements 

 

1

 

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.

 

***Confidential
Treatment Requested

 

2

 

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

 

***Confidential
Treatment Requested

 

3

 

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 

 

***Confidential
Treatment Requested

 

4

 

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.

 

***Confidential
Treatment Requested

 

5

 

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           [***]

 

***Confidential
Treatment Requested

 

6

 

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.

 

***Confidential
Treatment Requested

 

7

 

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 

 

***Confidential
Treatment Requested

 

8

 

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 

 

***Confidential
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9

 

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 the diagnosis of cardiac
diseases in humans that measures or detects the presence or absence of the
Marker (other than BNP Assays sold to Biosite hereunder) and (b) Beckman
shall not authorize or assist any third party (other than Biosite) to research
or develop any assay for use in the diagnosis of cardiac diseases in humans
that measures or detects the presence or absence of the Marker for use on an
analyzer developed and/or marketed by Beckman or its Affiliates. As a further
limitation, during the term of this Agreement (i) Beckman shall not
manufacture or sell, and shall cause its Affiliates not to manufacture or sell,
any assay for use in the diagnosis of cardiac diseases in humans that measures
or detects the presence or absence of the Marker (other than BNP Assays sold to
Biosite hereunder), and (ii) Beckman shall not authorize or assist any
third party (other than Biosite) to manufacture or sell any assay for use in
the diagnosis of cardiac diseases in humans that measures or detects the
presence or absence of the Marker for use on an analyzer developed and/or
marketed by Beckman or its Affiliates.

 

5.3           Forecasts
and Orders.

 

5.3.1        Development Forecast. Within [***] after the Effective Date, Biosite shall prepare and provide Beckman
with a written forecast of the estimated requirements for the BNP Assays and
BNP Calibrator and Controls for Biosite’s [***] of commercial sale thereof. The forecast shall not be binding on
either party and shall be used for creating plans and specifications during the
development phase.

 

5.3.2        Initial
Forecast. Upon Prototype
Acceptance, Biosite shall promptly prepare and provide Beckman with a written
forecast of the estimated requirements for the BNP Assays and BNP Calibrator
and Controls for each of the
subsequent [***] (the “Initial
Forecast”). The Initial Forecast shall specify Biosite’s good faith estimated
requirements of BNP Assays to be sold or otherwise transferred to end
user customers located within the U.S. or otherwise used or disposed of by Biosite, its Affiliates or
authorized distributors within the U.S. and the estimated requirements of BNP Assays to be sold or
otherwise transferred to end user customers located outside the U.S. or
otherwise used or disposed of by
Biosite, its Affiliates or authorized distributors outside the U.S.. The forecast
shall [***] on [***] and shall [***].

 

5.3.3        Revised Forecasts. Following delivery of the Initial Forecast
in accordance with Section 5.3.2 above, Biosite shall, within [***] after the
beginning of each [***] thereafter during the term of this Agreement, send Beckman a revised
[***]
forecast (a “Revised Forecast”) of
the estimated requirements for the BNP Assays and BNP Calibrator and Controls and
shall include Biosite’s good faith estimated requirements for the BNP Assays to
be sold or otherwise transferred to end user customers located within the U.S.
or otherwise used or disposed of by
Biosite, its Affiliates or authorized distributors within the U.S. and the estimated requirements of BNP Assays to
be sold or otherwise transferred to end user customers located outside the U.S.
or otherwise used or disposed of by
Biosite, its Affiliates or

 

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authorized distributors  outside the U.S.. The Revised Forecasts
shall [***] on [***] and shall [***].

 

5.3.4        Purchase Orders. Biosite shall make all purchases of
the BNP Assays and BNP Calibrator and Controls by submitting purchase orders to
Beckman. Each such purchase order shall be in writing and shall specify the
quantity of BNP Assays and BNP Calibrator and Controls ordered, for the
quantity of BNP Assays ordered Biosite’s estimate of the portion of such
quantity that will be sold or otherwise transferred to end user
customers located within the U.S. or otherwise used or disposed of by Biosite, its Affiliates or
authorized distributors within the U.S. and the remainder of such quantity shall be presumed as estimated to
be sold or otherwise transferred to end user customers located outside
the U.S. or otherwise used or disposed of by Biosite, its Affiliates or authorized distributors outside the
U.S., the place of delivery and the required delivery date thereof. Biosite
shall provide with the Initial Forecast a purchase order for the total
quantity, if any, of the BNP Assays and BNP Calibrator and Controls specified
for the first [***] of the
Initial Forecast, provided that all deliveries in such initial purchase order
are scheduled at least [***]
after the date of the initial purchase order. Biosite shall include with each
Revised Forecast a purchase order, if any, of BNP Assays and BNP Calibrators
and Controls specified in the [***] of such Revised Forecast. Beckman shall acknowledge each purchase
order in the form of a written order confirmation.

 

5.3.5        Adjustments. If, with
respect to any such forecast or purchase order, Biosite requests a quantity of
BNP Assays greater or less than the amount set forth therein, Beckman shall use
commercially reasonable efforts to increase or decrease production to
accommodate such request.

 

5.3.6        Acknowledgement. The parties acknowledge that neither party
knows what the market for the BNP Assays and BNP Calibrator and Controls will be and, subject to the binding purchase
orders under Section 5.3.4, Biosite makes no representations regarding the
quantities of BNP Assays and BNP Calibrator and Controls that Biosite will purchase hereunder.

 

5.4           Delivery
and Acceptance.

 

5.4.1        Delivery.
Beckman shall ship the BNP Assays and BNP
Calibrator and Controls [***] to
[***] as designated by Biosite
in its purchase order and, subject to Section 5.3.4, in accordance with
the delivery schedule in such purchase order. Title and risk of loss and
damages to the BNP Assays and BNP Calibrator and Controls purchased by Biosite hereunder shall pass to
Biosite upon receipt by Biosite of the BNP Assays and BNP Calibrator and
Controls at Biosite’s designated receiving point.

 

5.4.2        Packaging, Labeling, Freight and Insurance. Beckman shall package the BNP Assays and BNP
Calibrator and Controls into kit configurations mutually acceptable to the
parties and in packaging [***] for assays, calibrators and controls for use
on the Beckman Analyzers.

 

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Beckman shall label the BNP Assays and BNP
Calibrator and Controls with
such labels and including such Biosite tradenames and trademarks as reasonably
determined by Biosite; provided, however, that Beckman may identify itself (as
mutually agreed by the parties) on the label as the authorized manufacturer of
the BNP Assays and BNP Calibrator and Controls. Beckman shall pay all freight, insurance charges, taxes, import and
export duties, inspection fees and other charges applicable to the sale and
transport of the BNP Assays and BNP Calibrator and Controls purchased by Biosite.

 

5.4.3        Rejection
and Cure. If a shipment of the BNP
Assays or BNP Calibrator and Controls or any portion thereof is damaged or does not conform to the Release
Specifications, then Biosite shall have the right to reject the portion of such
shipment of the BNP Assays or BNP Calibrator and Controls that is damaged or fails to so conform
within thirty (30) days after Biosite’s receipt of such shipment by providing
written notice to Beckman and specifying in such notice the grounds for such
rejection. Beckman shall, at its cost and expense, cure such rejection by
replacing such damaged or non-conforming shipment or portion thereof with
quantities of BNP Assays or BNP
Calibrator and Controls (a) in Beckman’s current inventory within ten (10)
business days after receipt of
notice of Biosite’s rejection thereof, and/or (b) if Beckman does not have
sufficient current inventory to replace such damaged or non-conforming shipment
or portion thereof, by increasing its next production run sufficient to satisfy
Biosite’s current orders and forecast and to replace such damaged or
non-conforming shipment or portion thereof that was not replaced under clause
(a) above. Beckman shall promptly investigate any such damaged or
non-conforming shipment to determine the cause of such damage or nonconformance
and shall provide Biosite with a reasonably detailed report of Beckman’s
investigations and its remedies therefor.

 

5.5           Warranty.
Beckman warrants that all the BNP Assays and BNP Calibrator and Controls
delivered to Biosite pursuant to this Agreement shall conform to the Release
Specifications, shall be free from defects in material and workmanship and
shall be manufactured in accordance with GMP and in compliance with applicable
laws and regulations. Subject to Section 10, Biosite’s sole and exclusive
remedy under this warranty is the rejection by Biosite and cure by Beckman
under Section 5.4.3 above.

 

5.6           [***] Beckman. The parties acknowledge that Beckman
is the manufacturer [***] of the BNP Assays and BNP Calibrator and Controls,
and the manufacturer and distributor of Beckman Analyzers. In such capacities,
Beckman shall [***] for [***] of the [***] and [***] and Beckman shall have the express
right to engage in the promotion of the Beckman Analyzer, all in accordance
with the Guidelines. Beckman shall not conduct any activities directly or
indirectly [***] [***] of the [***] and [***] except in accordance with the Guidelines.
Notwithstanding anything to the contrary in this Agreement or the Guidelines,
Biosite shall be solely responsible for the commercialization of the BNP Assays
and BNP Calibrator and Controls.

 

5.7           Joint Committee. The Joint Committee shall comprise an
equal number of representatives from Biosite and Beckman. Each party shall
appoint its

 

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representatives to the Joint Committee from time to time, and may substitute
one or more of its representatives, in its sole discretion, effective upon
written notice to the other party of such change. The purpose of the Joint
Committee is to oversee and implement the Guidelines. No modification of the
Guidelines, or implementation thereof, shall be effective unless and until
unanimously approved by the Joint Committee and set forth in a written document
evidencing such modification signed by a duly authorized signatory of each
party.

 

6.             PAYMENT
TERMS

 

6.1           Purchase
Price.

 

6.1.1        Subject
to the provisions of Section 5.2.2, for units of BNP Assays purchased by
Biosite from Beckman during a Pricing Period commencing prior to the first
anniversary of the First Commercial Sale, within [***] after receiving a
shipment of BNP Assays from Beckman, Biosite shall pay to Beckman a purchase
price equal to the US Purchase Price for the portion of the quantity of such
BNP Assays in such shipment that
corresponds to Biosite’s estimate in its purchase order that would be sold
or otherwise transferred to end user customers located within the U.S. or
otherwise used or disposed of by
Biosite, its Affiliates or authorized distributors within the U.S.. Biosite
is not responsible for royalty payments (if any) owed by Beckman for the sale
of such BNP Assays to Biosite or any subsequent resale.

 

6.1.2        Subject
to the provisions of Section 5.2.2, for units of BNP Assays purchased by
Biosite from Beckman during a Pricing Period commencing prior to the first
anniversary of the First Commercial Sale, within [***] after receiving a
shipment of BNP Assays from Beckman, Biosite shall pay to Beckman a purchase
price equal to the Foreign Purchase Price for the portion of the quantity of
such BNP Assays in such shipment
that corresponds to Biosite’s estimate in its purchase order that would be sold
or otherwise transferred to end user customers located outside the U.S. or
otherwise used or disposed of by
Biosite, its Affiliates or authorized distributors outside the U.S.. [***]
for [***] by Beckman [***] of such [***] to Biosite or any [***].

 

6.1.3        Subject
to the provisions of Section 5.2.2, for units of BNP Assays purchased by
Biosite from Beckman during a Pricing Period commencing after the first
anniversary of the First Commercial Sale, within [***] after receiving a
shipment of BNP Assays from Beckman, Biosite shall pay to Beckman a purchase
price equal to the Worldwide Purchase Price for the quantity of such BNP Assays
in such shipment. [***] for [***] by Beckman [***] of such [***] to Biosite or any [***].

 

6.1.4        In
consideration for the sale of the BNP Calibrator and Controls to Biosite under
Article 5, Biosite shall pay to Beckman an amount equal to the [***] to Beckman
[***] and [***] such BNP Calibrator and Controls to Biosite. [***] for [***] by
Beckman [***] of such [***] to Biosite or any [***].

 

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Beckman shall
invoice Biosite for such amount at the time of each delivery of such BNP
Calibrator and Controls, and Biosite shall pay to Beckman the amount of each
such invoice within [***] after receipt by Biosite of such invoice.

 

6.1.5        Prior to the first Pricing
Period commencing after the first anniversary of the First Commercial Sale,
within [***] after the end of each [***]
beginning with the first [***]
in which Biosite orders BNP Assays from Beckman hereunder, Biosite shall
furnish to Beckman a written report setting forth for the previous [***] (i) the [***] sold or
otherwise transferred to end user customers worldwide or otherwise used or
disposed of by Biosite, its
Affiliates or authorized distributors worldwide, (ii) whether each
such [***] was sold or otherwise transferred to end user customers [***] or
otherwise used or disposed of by
Biosite, its Affiliates or authorized distributors [***], or sold or
otherwise transferred to end user customers located [***] or otherwise used or
disposed of by Biosite, its
Affiliates or authorized distributors [***] (in each case to the extent such information is within
Biosite’s reasonable control, provided that any [***] for which Biosite can not
reasonably determine [***] such assay was sold or transferred or disposed of
shall be presumed to be sold or otherwise transferred to end user customers [***]
or otherwise used or disposed of by
Biosite, its Affiliates or authorized distributors [***]), (iii) the
portion of the quantities of [***] estimated in Biosite’s purchase
orders that would be sold or otherwise transferred to end user customers
located [***] or otherwise used or disposed of by Biosite, its Affiliates or authorized distributors [***] and the remainder presumed as
estimated to be sold or otherwise disposed of [***], and (iv) the difference between
what Biosite [***] Beckman
on [***] during such [***]
based on the estimated portions and what would otherwise [***] to Beckman based on portions during
such [***]. If the result of clause (iv) above is an [***] to Beckman, then Biosite shall [***] to Beckman such [***] concurrently with making the report. If
the result is an [***] to
Biosite, then Biosite shall have the right to [***] against [***] then currently [***] Beckman hereunder, or if there are no
such [***] currently [***] and/or after such [***] currently [***] have been fully [***] against [***] [***] Beckman hereunder until all such [***] Biosite are fully [***].

 

6.1.6        Prior
to the start of each Pricing Period following the First Commercial Sale,
Biosite shall provide Beckman with a written report in such detail and with
such supporting data that is reasonably satisfactory to Beckman setting forth
the [***] of the [***], [***], and, commencing after the first anniversary of
the First Commercial Sale, the [***] for such Pricing Period.

 

6.1.7        Biosite
shall calculate [***], [***] and [***] using such data and information as is
within Biosite’s reasonable control at the time of such calculation and which
is reasonably satisfactory to Beckman. Notwithstanding anything to the contrary
in this Agreement, (a) neither the [***] nor [***] shall be [***]

 

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15

 

for any Pricing
Period by more than [***] from the [***] or [***], as applicable, for the
immediately preceding Pricing Period; (b) the [***] shall never be less
than [***] of the BNP Assays; and (c) the [***] shall never be less than [***]
of the BNP Assays.

 

6.2           Taxes.
Biosite shall pay all federal, state, county or municipal sales or use tax,
excise or similar charge, or other tax assessment (other than that assessed
against income), assessed or charged on the sale of the BNP Assays sold to and
accepted by Biosite pursuant to this Agreement.

 

6.3           Payment
Method. All payments by a party to the other party under this Agreement
shall be paid in United States dollars and made by check or bank wire transfer
in immediately available funds to such account as the payee shall designate
before such payment is due.

 

6.4           BNP
Assay Audits.

 

6.4.1        Procedure.
Upon the written request of Beckman and not more than once in each calendar
year, Biosite shall permit an independent certified accounting firm of
nationally recognized standing, selected by Beckman and reasonably acceptable
to Biosite, at Beckman’s expense, to have access during normal business hours
to such of the records of Biosite as may be reasonably necessary to verify the
accuracy of the reports described in Section 6.1.5 for any year ending not
more than thirty-six (36) months prior to the date of such request. The
accounting firm shall disclose to Beckman only whether the reports are correct
or not and the specific details concerning any discrepancies. No other
information shall be shared.

 

6.4.2        Results
of Audit.

 

(a)           If such
accounting firm concludes that during a Pricing Period commencing prior to the
first anniversary of the First Commercial Sale, quantities of BNP Assays were
purchased at the Foreign Purchase Price but were sold or otherwise transferred
to end user customers located within the U.S. or otherwise used or disposed of by Biosite, its Affiliates or
authorized distributors within the U.S., or if such accounting firm is
unable to reasonably determine where BNP Assays purchased at the Foreign
Purchase Price were sold or transferred or disposed of, Biosite shall pay the
difference between the applicable U.S. Purchase Price and Foreign Purchase
Price for all such quantities [***] within[***] of the date Beckman delivers to
Biosite such accounting firm’s written report so concluding.

 

(b)           If such
accounting firm concludes that during a Pricing Period commencing prior to the
first anniversary of the First Commercial Sale, quantities of BNP Assays were
purchased at the U.S. Purchase Price but were sold or otherwise transferred to
end user customers located outside the U.S. or otherwise used or disposed of by Biosite, its Affiliates or
authorized distributors outside the U.S., following

 

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the date of such
accounting firm’s written report so concluding, Biosite shall have the right to offset
such amount against amounts then currently due Beckman hereunder, or if there
are no such amounts currently due and/or after such amounts currently due have
been fully offset, against future amounts due Beckman hereunder until all such
amounts described in such report are fully offset.

 

(c)           If such
accounting firm concludes that during a Pricing Period commencing after the
first anniversary of the First Commercial Sale, additional amounts were owed by
Biosite to Beckman due to the actual Worldwide Purchase Price being greater
than the Worldwide Purchase Price Biosite provided to Beckman under
Section 6.1.6 for such Pricing Period, Biosite shall pay such additional
amounts [***] within [***] of the date Beckman delivers to Biosite such
accounting firm’s written report so concluding.

 

(d)           If such
accounting firm concludes that during a Pricing Period commencing after the
first anniversary of the First Commercial Sale, Biosite paid to Beckman amounts
in excess of that owing to Beckman due to the actual Worldwide Purchase Price
being less than the Worldwide Purchase Price Biosite provided to Beckman under
Section 6.1.6 for such Pricing Period, following the date of such
accounting firm’s written report so concluding, Biosite shall have the right to offset such amount against amounts
then currently due Beckman hereunder, or if there are no such amounts currently
due and/or after such amounts currently due have been fully offset, against
future amounts due Beckman hereunder until all such amounts described in such
report are fully offset.

 

(e)           The fees
charged by such accounting firm shall be paid by Beckman; provided, however, if
the audit discloses that the aggregate amounts owing by Biosite to Beckman for
BNP Assays purchased during the applicable Pricing Period are more than [***]
of the aggregate invoiced amounts during such period, then Biosite shall pay
the reasonable fees and expenses charged by such accounting firm.

 

6.4.3        Information.
Beckman shall treat all information subject to review under this Section 6.4
as confidential, and shall cause its accounting firm to retain all such
information in confidence.

 

6.5           Audits
of Fully-Burdened Costs.

 

6.5.1        Procedure.
Upon the written request of a party (the “Payor”) and not more than once in
each calendar year, the other party (the “Payee”) shall permit an independent
certified accounting firm of nationally recognized standing, selected by the
Payor and reasonably acceptable to the Payee, at the Payor’s expense, to have
access during normal business hours to such of the records of the Payee as may
be reasonably necessary to verify the accuracy of (a) with respect to
Biosite as the Payee, the [***] of the Biosite Materials described in
Section 3.1, and (b) with respect to Beckman as Payee, the [***] of
the BNP Calibrator and Controls as described in Section 6.1.4 for any year
ending not more than

 

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thirty-six (36)
months prior to the date of such request. The accounting firm shall disclose to
the Payor only whether the amounts invoiced by the Payor for [***] are correct
or not and the specific details concerning any discrepancies. No other
information shall be shared.

 

6.5.2        Results
of Audit. If such accounting firm concludes that during the audited period
the Payee invoiced the Payor amounts greater than the applicable [***], the
Payee shall refund to the Payor the difference between the amounts actually
received by Payee and the applicable reasonable fully-burdened cost within [***]
of the date the Payor delivers to the Payee such accounting firm’s written
report so concluding. The fees charged by such accounting firm shall be paid by
the Payor; provided, however, if the audit discloses that such difference
payable by the Payee for such period are more than [***] of the amounts
actually paid by the Payor for such period, then the Payee shall pay the
reasonable fees and expenses charged by such accounting firm.

 

6.5.3        Information.
The Payor shall treat all financial information subject to review under this
Section 6.5.3 as confidential, and shall cause its accounting firm to
retain all such financial information in confidence.

 

7.             CONFIDENTIALITY

 

7.1           Confidential
Information.

 

7.1.1        Each
party shall maintain in confidence all Confidential Information disclosed by
the other party (including all Confidential Information disclosed prior to the
term of this Agreement pursuant to a written confidentiality agreement between
the parties), and shall not use, disclose or grant the use of the Confidential
Information except on a need-to-know basis to those directors, officers,
employees, consultants, distributors or permitted assignees, to the extent such
disclosure is reasonably necessary in connection with such party’s activities
as expressly authorized by this Agreement.

 

7.1.2        Without
limiting the generality of Section 7.1.1, and except to the extent
authorized hereunder, Beckman shall not use Biosite’s Confidential Information
for the purpose of researching, developing, manufacturing or commercializing an
assay that measures or detects the presence or absence of the Marker (other
than BNP Assays sold Biosite hereunder). For purposes of clarity, [***] [***]
and [***] information developed by Beckman in the course of the [***] the BNP
Assays and BNP Calibrator and Controls in accordance with the terms of this
Agreement and that [***] to [***] for [***] shall not be considered Biosite’s
Confidential Information after the expiration or termination of this Agreement.

 

7.1.3        To
the extent that disclosure is authorized by this Agreement, prior to
disclosure, each party hereto shall obtain agreement of any such third party to
hold in confidence and not make use of the Confidential Information of the
other

 

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party for any
purpose other than those permitted by this Agreement. Each party shall notify
the other promptly upon discovery of any unauthorized use or disclosure of the
other party’s Confidential Information.

 

7.2           Terms
of this Agreement. Except as otherwise provided in Section 7.1
(Confidential Information), during the term of this Agreement and for a period
of five (5) years thereafter, neither party shall disclose any terms or
conditions of this Agreement to any third party without the prior consent of
the other party. Notwithstanding the foregoing, prior to execution of this
Agreement, the parties have agreed in writing upon the substance of information
that can be used to describe the terms of this transaction, and each party may
disclose such information, as modified by mutual agreement from time to time,
without the other party’s consent.

 

7.3           Permitted
Disclosures. The confidentiality obligations contained in this
Section 7 shall not apply to the extent that such disclosure is reasonably
necessary in the following instances: (a) complying with an applicable
law, regulation of a governmental agency or a court of competent jurisdiction,
provided that the receiving party shall first give notice thereof to the disclosing
party such that the disclosing party shall have an opportunity to seek a
protective order limiting any such disclosure; and (b) disclosure to
investment bankers, investors and potential investors, each of whom prior to
disclosure must be bound by similar obligations of confidentiality and non-use
at least equivalent in scope to those set forth in this Section 7 and further
provided in each case that the disclosing party shall provide written notice
thereof to the other party and reasonable opportunity to object to any such
disclosure or to request confidential treatment thereof.

 

8.             INTELLECTUAL
PROPERTY RIGHTS. Under no circumstances shall a party, as a result of this
Agreement, obtain any ownership interest or other right in any invention,
discovery, composition or other technology, or in any patent right or other
intellectual property right, of the other party (including without limitation
those owned, controlled or developed by the other party at any time pursuant to
this Agreement).

 

9.             TERM AND
TERMINATION

 

9.1           Term.
The term of this Agreement shall commence on the Effective Date, and unless
earlier terminated in accordance with its terms, shall terminate upon the
termination or expiration of the Biosite/Scios Agreement.

 

9.2           Termination.

 

9.2.1        A
party may terminate this Agreement by written notice to the other party upon or
after the breach of any material provision of this Agreement by the other
party, if the other party has not cured such breach within [***] after written
notice thereof from the non-breaching party.

 

9.2.2        A party may terminate this Agreement by written notice to the other
party if, after good faith negotiations in accordance with Section 3.5,
the parties 

 

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are unable to reach agreement upon a mutually acceptable set of
Release Specifications for a BNP Assay or BNP Calibrator and Control, and the
parties have not reached agreement upon a mutually acceptable set of Release
Specifications within [***] days after such written notice.

 

9.2.3        Biosite
may immediately terminate this Agreement by written notice to Beckman
(a) upon or after a breach by Beckman of Sections 5.2.3 or 7.1.2,
(b) if within [***] following the Effective Date, [***] is [***] to, or [***],
[***] the BNP Assays in accordance with the Design Inputs, or (c) if at
any time [***] of the BNP Assay in accordance with the Release Specifications
Beckman is unable to manufacture or have manufactured and sell to Biosite
quantities of the BNP Assay sufficient to meet the reasonably foreseeable
demand therefor.

 

9.2.4        The
parties acknowledge that neither party knows if additional third party
intellectual property rights must be obtained for the [***], [***] and [***] of
the BNP Assay or BNP Calibrator and Controls hereunder. Either party (the “Terminating
Party”) may terminate this Agreement by written notice to the other party if
(a) a [***] or [***] is [***] the Terminating Party [***] that the [***]
in accordance with, or [***] of, this Agreement [***] to any [***] in such [***],
(b) the Terminating Party [***] from a [***] [***] that the [***] in accordance
with, or [***] [***] of, this Agreement may [***] to any [***] or [***] and the
Terminating Party’s [***] has [***], [***], that in its [***] such [***]
appears to be [***] by such [***], or (c) whether or not there is a [***]
or [***] described in clause (a), or the Terminating Party has [***] described
in clause (b), the Terminating Party becomes aware of [***] that the
Terminating Party [***] in [***], and based on the [***] of [***], must be [***]
by [***] of the [***] for the [***] and [***] of the BNP Assay or BNP
Calibrator and Controls hereunder; provided however that any such written
notice shall not be given earlier than [***] after representatives of the
executive management of both parties meet in good faith to assess any such
event described in clauses (a) – (c) above and attempt in good faith to reach
an agreement relative to an appropriate response thereto, and any such meeting
shall be held not less than [***] after the Terminating Party’s request to the
other party for such meeting.

 

9.3           Effect
of Termination. All rights and obligations under this Agreement shall
terminate immediately upon any termination of this Agreement. Notwithstanding
the foregoing, the following sections shall survive any termination of this
Agreement:  Sections 5.4.3 (Rejection and
Cure), 5.5 (Warranty), 7 (Confidentiality), 8 (Intellectual Property
Rights), 9.3 (Effect of Termination), 10 (Indemnity), 11 (Limitation of
Liability) and 12 (Miscellaneous).

 

***Confidential
Treatment Requested

 

20

 

10.           INDEMNITY

 

10.1         Indemnity.

 

10.1.1      By
Biosite. Biosite shall defend, indemnify and hold Beckman harmless from and
against all losses, liabilities, damages and expenses (including reasonable
attorneys’ fees and costs) resulting from all claims, demands, actions and
other proceedings by any third party to the extent arising from (a) the breach of any representation, warranty or
covenant of Biosite under this Agreement, or (b) the gross negligence or
willful misconduct of Biosite in the performance of its obligations under this
Agreement.

 

10.1.2      By
Beckman. Beckman shall defend, indemnify and hold Biosite harmless from and
against all losses, liabilities, damages and expenses (including reasonable
attorneys’ fees and costs) resulting from all claims, demands, actions and
other proceedings by any third party to the extent arising from (a) the
breach of any representation, warranty or covenant of Beckman under this
Agreement, or (b) the gross negligence or willful misconduct of Beckman in
the performance of its obligations under this Agreement.

 

10.2         Procedure.
A party (the “Indemnitee”) that intends to claim indemnification under this
Section 10 shall promptly notify the other party (the “Indemnitor”) of any
claim, demand, action or other proceeding for which the Indemnitee intends to
claim such indemnification. The Indemnitor shall have the right to assume and
control the defense thereof with counsel selected by the Indemnitor; provided,
however, that the Indemnitee shall have the right to retain its own counsel to
participate in the defense, subject to Indemnitor’s right to control the
defense. The indemnity obligations under this Section 10 shall not apply
to amounts paid in settlement of any claim, demand, action or other proceeding
if such settlement is effected without the prior express written consent of the
Indemnitor, which consent shall not be unreasonably withheld or delayed. The
failure to deliver notice to the Indemnitor within a reasonable time after
notice of any such claim or demand, or the commencement of any such action or
other proceeding, if prejudicial to its ability to defend such claim, demand,
action or other proceeding, shall relieve such Indemnitor of any liability to
the Indemnitee under this Section 10 with respect thereto, but the
omission so to deliver notice to the Indemnitor shall not relieve it of any
liability that it may have to the Indemnitee otherwise than under this
Section 10. The Indemnitor may not settle or otherwise consent to an
adverse judgment in any such claim, demand, action or other proceeding, that
diminishes the rights or interests of the Indemnitee without the prior express
written consent of the Indemnitee, which consent shall not be unreasonably
withheld or delayed. The Indemnitee, its employees and agents, shall reasonably
cooperate with the Indemnitor and its legal representatives in the
investigation of any claim, demand, action or other proceeding covered by this
Section 10.

 

21

 

11.           LIMITATION
OF LIABILITY. EXCEPT FOR A PARTY’S INDEMNITY OBLIGATIONS UNDER THIS AGREEMENT
AND EXCEPT FOR A BREACH OF SECTION 7 (CONFIDENTIALITY), IN NO EVENT SHALL
EITHER PARTY BE LIABLE OR OBLIGATED TO THE OTHER PARTY IN ANY MANNER FOR ANY
SPECIAL, NON-COMPENSATORY, CONSEQUENTIAL, INDIRECT, INCIDENTAL, STATUTORY OR
PUNITIVE DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, LOST PROFITS AND LOST
REVENUE, REGARDLESS OF THE FORM OF ACTION, WHETHER IN CONTRACT, TORT,
NEGLIGENCE, STRICT PRODUCT LIABILITY, OR OTHERWISE, EVEN IF INFORMED OF OR
AWARE OF THE POSSIBILITY OF ANY SUCH DAMAGES IN ADVANCE. THE LIMITATIONS SET
FORTH ABOVE SHALL BE DEEMED TO APPLY TO THE MAXIMUM EXTENT PERMITTED BY
APPLICABLE LAW AND NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE OF ANY
LIMITED REMEDIES. THE PARTIES ACKNOWLEDGE AND AGREE THAT THEY HAVE FULLY
CONSIDERED THE FOREGOING ALLOCATION OF RISK AND FIND IT REASONABLE, AND THAT
THE FOREGOING LIMITATIONS ARE AN ESSENTIAL BASIS OF THE BARGAIN BETWEEN THE
PARTIES.

 

12.           MISCELLANEOUS

 

12.1         Notices.
Any consent, notice or report required or permitted to be given or made under
this Agreement by one of the parties to the other shall be in writing and
addressed to such other party at its address indicated below, or to such other
address as the addressee shall have last furnished in writing to the addressor,
and shall be effective upon receipt by the addressee.

 

	
  If to Biosite:

  	
   

  	
  Biosite Incorporated

  
	
   

  	
   

  	
  11030 Roselle Street, Suite D

  
	
   

  	
   

  	
  San Diego, California 92121

  
	
   

  	
   

  	
  Attention: President

  
	
   

  	
   

  	
   

  
	
  with a copy to:

  	
   

  	
  Gray Cary Ware &
  Freidenrich LLP

  
	
   

  	
   

  	
  4365
  Executive Drive, Suite 1100

  
	
   

  	
   

  	
  San Diego,
  California 92121

  
	
   

  	
   

  	
  Attention: Mark R. Wicker, Esq.

  
	
   

  	
   

  	
   

  
	
  If to Beckman:

  	
   

  	
  Beckman Coulter,
  Inc.

  
	
   

  	
   

  	
  Clinical
  Diagnostics Division

  
	
   

  	
   

  	
  200 South
  Kraemer Boulevard

  
	
   

  	
   

  	
  Brea, California
  92821

  
	
   

  	
   

  	
  Attention:
  President

  

 

22

 

	
  with a copy to:

  	
   

  	
  Beckman Coulter, Inc.

  
	
   

  	
   

  	
  4300 N. Harbor Boulevard

  
	
   

  	
   

  	
  Fullerton, California 92834-3100

  
	
   

  	
   

  	
  Attention: General Counsel

  

 

 

12.2         Assignment.
Except as otherwise expressly provided under this Agreement, neither this
Agreement nor any right or obligation hereunder may be assigned or otherwise
transferred (whether voluntarily, by operation of law or otherwise), without
the prior express written consent of the other party; provided, however, that
either party may, without such consent, assign this Agreement and its rights
and obligations hereunder in connection with the transfer or sale of all or
substantially all of its business related to the subject matter of this
Agreement, or in the event of its merger, consolidation, change in control or
other similar transaction. Any permitted assignee shall assume all obligations
of its assignor under this Agreement. Any purported assignment or transfer in
violation of this Section 12.2 shall be void.

 

12.3         Applicable
Law. This Agreement shall be governed by and construed in accordance with
the laws of the State of California, without regard to the conflicts of law
principles thereof. The parties hereby submit to the exclusive jurisdiction of,
and venue in, the state and federal courts located in San Diego County,
California.

 

12.4         No Subcontracting.
Beckman shall not subcontract any portion of the manufacture of the BNP Assays
without the prior express written consent of Biosite.

 

12.5         Construction.
This Agreement will be fairly interpreted in accordance with its terms and
without any strict construction in favor of or against any party.

 

12.6         Severability.
Whenever possible, each provision of this Agreement, shall be interpreted in
such manner as to be effective and valid under applicable law, but if any
provision of this Agreement is held to be prohibited by or invalid under
applicable law, such provision shall be ineffective only to the extent of such
prohibition or invalidity, without invalidating the remainder of such
provisions or the remaining provisions of this Agreement.

 

12.7         Counterparts.
This Agreement may be executed in counterparts, all of which together shall
constitute one and the same instrument.

 

12.8         Headings.
The captions to the sections hereof are not a part of this Agreement, but are
merely guides or labels to assist in locating and reading the sections hereof.

 

12.9         Independent
Contractors. Each party hereby acknowledges that the parties shall be
independent contractors and that the relationship between the parties shall not
constitute a partnership, joint venture or agency. Neither party shall have the
authority to make any statements, representations or commitments of any kind,
or to take

 

23

 

any action, which shall be
binding on the other party, without the prior consent of the other party to do
so.

 

12.10       Waiver.
The waiver by a party of any right hereunder, or of any failure to perform or
breach by the other party hereunder, shall not be deemed a waiver of any other
right hereunder or of any other breach or failure by the other party hereunder
whether of a similar nature or otherwise.

 

12.11       Entire
Agreement. This Agreement contains the entire understanding of the parties
with respect to the subject matter hereof. All express or implied
representations, agreements and understandings with respect to the subject
matter hereof, either oral or written, heretofore made are expressly superseded
by this Agreement. This Agreement may be amended, or any term hereof modified,
only by a written instrument duly executed by both parties.

 

IN
WITNESS WHEREOF, the parties have executed this Agreement as of the Effective
Date.

 

	
   

  	
  BIOSITE INCORPORATED

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
       /s/ Chris
  Twomey          

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Title

  	
         V.P
  Finance, CFO       

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  BECKMAN COULTER, INC.

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
        G. R.
  Bell               

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Title

  	
     V.P. Strategy & Business

  	
   

  
	
   

  	
   

  	
  Development

  	
   

  
					

 

24

 

EXHIBIT A

 

Design Inputs

 

Design Characteristic                                                                      Clinical
Utility

 

Requirement                            [***]

 

	
  Design Category,

  Attribute or

  	
   

  	
  Customer Inputs

  (Note customer

  	
   

  	
  Other Considerations

  	
   

  	
   

  	
   

  	
  Design Input Goals

  
	
  Characteristic

  	
   

  	
  type & sources)

  	
   

  	
  (Note sources)

  	
   

  	
  Verification Methods

  	
   

  	
  Min. Essential

  	
   

  	
  Target

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  

 

Design Characteristic                                                                      Antibodies

 

Requirement                            [***]

 

Design Characteristic                                                                      Standards
and Regulatory Requirements

 

Requirement                            [***]

 

	
  Design Category,

  Attribute or

  	
   

  	
  Customer Inputs

  (Note customer

  	
   

  	
  Other Considerations

  	
   

  	
   

  	
   

  	
  Design Input Goals

  
	
  Characteristic

  	
   

  	
  type & sources)

  	
   

  	
  (Note sources)

  	
   

  	
  Verification Methods

  	
   

  	
  Min. Essential

  	
   

  	
  Target

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  •       [***]

  	
   

  	
  •       [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  •       [***]
  

  	
   

  	
  •       [***]
  

  	
   

  	
   

  

 

***Confidential
Treatment Requested

 

25

 

Design Characteristic                                                                      Assay
Attributes

 

Validation Method               [***]

 

	
  Design Category,

  Attribute or

  	
   

  	
  Customer Inputs

  (Note customer

  	
   

  	
  Other Considerations

  	
   

  	
   

  	
   

  	
  Design Input Goals

  
	
  Characteristic

  	
   

  	
  type & sources)

  	
   

  	
  (Note sources)

  	
   

  	
  Verification Methods

  	
   

  	
  Min. Essential

  	
   

  	
  Target

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  •      [***]

  	
   

  	
  •      [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
  •      [***]

  	
   

  	
  •      [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  •     [***]

  
	
   

  	
   

  	
  •      [***]

  	
   

  	
  •      [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  •     [***]

  

 

***Confidential
Treatment Requested

 

26

 

 

Design Characteristic                                                                      Calibration

 

Requirement                            [***]

 

	
  Design Category,

  Attribute or

  	
   

  	
  Customer Inputs

  (Note customer

  	
   

  	
  Other Considerations

  	
   

  	
   

  	
   

  	
  Design Input Goals

  
	
  Characteristic

  	
   

  	
  type & sources)

  	
   

  	
  (Note sources)

  	
   

  	
  Verification Methods

  	
   

  	
  Min. Essential

  	
   

  	
  Target

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  N/A

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  N/A

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  TBD

  	
   

  	
  TBD

  

 

***Confidential
Treatment Requested

 

27

 

 

Design Characteristic                                                                      Assay
Performance

 

Validation Method               [***]

 

	
  Design Category,

  Attribute or

  	
   

  	
  Customer Inputs

  (Note customer

  	
   

  	
  Other Considerations

  	
   

  	
   

  	
   

  	
  Design Input Goals

  
	
  Characteristic

  	
   

  	
  type & sources)

  	
   

  	
  (Note sources)

  	
   

  	
  Verification Methods

  	
   

  	
  Min. Essential

  	
   

  	
  Target

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  •      [***]

  	
   

  	
  •      [***]

  	
   

  	
  [***]

  	
   

  	
  •      [***]

  	
   

  	
  •      [***]

  
	
   

  	
   

  	
  •      [***]

  	
   

  	
  •      [***]

  	
   

  	
   

  	
   

  	
  •      [***]

  	
   

  	
  •      [***]

  
	
   

  	
   

  	
   

  	
   

  	
  •      [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  •      [***]

  	
   

  	
  [***]

  	
   

  	
  •      [***]

  	
   

  	
  •      [***]

  
	
   

  	
   

  	
   

  	
   

  	
  •      [***]

  	
   

  	
   

  	
   

  	
  •      [***]

  	
   

  	
  •      [***]

  

 

***Confidential
Treatment Requested

 

28

 

Design Characteristic                                                                      Component
Stability

 

Validation Method               [***]

 

	
  Design Category,

  Attribute or

  	
   

  	
  Customer Inputs

  (Note customer

  	
   

  	
  Other Considerations

  	
   

  	
   

  	
   

  	
  Design Input Goals

  
	
  Characteristic

  	
   

  	
  type & sources)

  	
   

  	
  (Note sources)

  	
   

  	
  Verification Methods

  	
   

  	
  Min. Essential

  	
   

  	
  Target

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  N/A

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  •      [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
  •      [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  •      [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
  •      [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  •      [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
  •      [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

***Confidential
Treatment Requested

 

29

 

EXHIBIT B

 

Guidelines

 

1.             [***]

 

1.1           [***]

 

1.2           [***]

 

1.3           [***]

 

2.             [***]

 

2.1           [***]

 

2.2           [***]

 

3.             [***]

 

3.1           [***]

 

***Confidential
Treatment Requested

 

30

 

3.2           [***]

 

3.3           [***]

 

3.4           [***]

 

3.5           [***]

 

4.             [***]

 

4.1           [***]

 

4.2           [***]

 

4.3           [***]

 

4.4           [***]

 

4.5           [***]

 

4.6           [***]

 

4.7           [***]

 

4.8           [***]

 

4.9           [***]

 

***Confidential
Treatment Requested

 

31

 

4.10         [***]

 

5.             [***]

 

5.1           [***]

 

5.2           [***]

 

5.3           [***]

 

5.4           [***]

 

***Confidential
Treatment Requested

 

32

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