[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Exhibit 10.36
Manufacturing and Supply
Agreement
By and Between
NOVA Biomedical
Corporation
AND
Cerus Corporation
September 24,
2008
Cerus/NOVA Biomedical Manufacturing
Agreement
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TABLE OF
CONTENTS
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Page
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Introduction
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1
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Recitals
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1
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Term
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2
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Definitions
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2
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Roles and Responsibilities
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3
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Product
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3
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Section 1/Product DMR
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4
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Section 2/Covenants; Representations and
Warranties
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4
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2.1/Covenants and Duties of
Cerus
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4
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2.2/Covenants and Duties of NOVA
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5
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Section 3/Distribution/Warehousing
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6
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Section 4/Production Engineering
Costs
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6
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4.1/Production Implementation
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6
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4.2/Non-Recoverable Engineering
Charges
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7
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4.3/Equipment; Tooling
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7
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4.4/Cerus-Supplied Components
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7
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Section 5/Pricing; Volume
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7
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5.1/Pricing Schedule
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7
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5.2/Purchase Orders
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8
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5.3/Cost Reduction Program
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9
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5.4/Changes’ Impact on
Costs
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9
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Section 6/Cost or Reword or
Scrap
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9
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Section 7/Manufacturing;
Engineering
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9
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Section 8/Product Changes
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9
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Section 9/Warranty
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10
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Section 10/Quality
Obligations
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11
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Section 11/Notices
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11
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Section 12/Governing Law;
Arbitration
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11
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Section 13/Liability;
Insurance
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12
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Section 14/Termination
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12
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Section 15/Terms of Payment
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13
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Cerus/NOVA Biomedical Manufacturing
Agreement
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Section 16/Indemnifications
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13
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16.1/Indemnification by Cerus
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13
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16.2/Indemnification by Nova
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14
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16.3/IP Infringement
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14
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16.4/Notification
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14
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16.5/Partial Indemnification
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15
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Section 17/Product Recall
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15
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Section 18/Disclosure of
Information
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15
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18.1/Confidentiality Obligation
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15
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18.2/Exclusions
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16
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18.3/Liability; Survival of
Obligations
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16
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Section 19/Compliance with
Law
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17
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Section 20/Ownership
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17
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Section 21/Miscellaneous
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17
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21.1/Status of Parties
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17
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21.2/Binding Effect; Assignment
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17
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21.3/Entire Agreement
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18
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21.4/Waivers
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18
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21.5/Force Majeure
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18
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21.6/Inventions
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18
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21.7/Independent Contractor
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19
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21.8/Specific Performance
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19
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21.9/Hiring of Other Party’s Employees
and Officers
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19
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Attachment 1: Quality
Obligations
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20
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Attachment 2: Nova Engineering
Rates
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28
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Attachment 3: Nova Pricing
Methodology
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29
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Manufacturing and Supply
Agreement
Introduction:
THIS MANUFACTURING AGREEMENT (the
“Manufacturing Agreement”) is effective this 24th day
of September, 2008 (“Effective Date”) between NOVA
Biomedical Corporation, a Massachusetts corporation with offices at
200 Prospect Street, Waltham, Massachusetts, (“NOVA”),
and Cerus Corporation, a Delaware corporation with offices at 2411
Stanwell Drive, Concord, CA, (“Cerus”, together with
NOVA, are collectively referred to as the
“Parties”).
Recitals:
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A.
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Cerus is
engaged in the business of developing, marketing and selling
products and technology for the inactivation of pathogens in blood
and blood components intended for transfusion (“the INTERCEPT
Blood System”). The INTERCEPT Blood System was developed by
Cerus and Baxter Healthcare Corporation
(“Baxter”).
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B.
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Nova develops
and manufactures medical devices and biomedical
instrumentation.
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C.
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NOVA and Baxter
entered into a Manufacturing Agreement, on December 18, 1998,
for the manufacture of UVA Illuminator devices (the
“Product(s)”), as part of the INTERCEPT Blood
System.
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D.
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In February
2006, Cerus gained worldwide rights (excluding certain Asian
countries) to manufacture and commercialize the INTERCEPT Blood
System, which rights had been previously held by Baxter.
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E.
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On May 16,
2007, NOVA and Cerus entered into a services agreement to ensure
proper calibration and maintenance of instruments used to calibrate
the Products (the “Services Agreement”).
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F.
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The Parties
additionally entered into a supply agreement on December 5,
2007, under which NOVA agreed to supply component parts to cover
repair contingencies and preventive maintenance operations for the
Products (the “Supply Agreement”).
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G.
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The Parties now
wish to enter into a Manufacturing and Supply Agreement for the
manufacture of the Products and the supply of critical component
parts used for future builds of the Product (the “Component
Parts”).
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Cerus/NOVA Biomedical Manufacturing
Agreement
Page
Term:
Unless terminated earlier as
provided in Section 14, this Manufacturing Agreement shall
have an initial term (“Initial Term”) which will expire
five (5) years from the Effective Date. Notwithstanding the
termination provisions of Section 14, the Initial Term shall
be automatically renewed, without further notice or action by
either party, for additional and successive terms of one year each
(“Renewal Terms” together with the Initial Term
collectively referred to as the “Term”) unless either
party gives written notice to the other of its intention not to
renew not less than 12 months prior to the end of the Initial Term
or any Renewal Term, as the case may be.
Definitions:
As used herein the following terms
have the meanings set forth below:
“Baxter” has the meaning
set forth in the Recitals.
“Bill of Materials”
means the structured list of materials required to assemble the
Product.
“Capital Equipment” has
the meaning set forth in Section 4.3.
“Cerus” has the meaning
set forth in the Introduction.
“Cerus Confidential
Information” has the meaning set forth in
Section 18.1.
“Change Control” has the
meaning set forth in Section 8.
“Device History Files”
has the meaning set forth in Section 20.
“DMR” has the meaning
set forth in Section 1.
“Effective Date” has the
meaning set forth in the Introduction.
“FDA QSR” means Food and
Drug Administration Quality Systems Regulation.
“FDA” means the Food and
Drug Administration and any successor agency.
“Initial Term” has the
meaning set forth in the Term section.
“INTERCEPT Blood System”
has the meaning set forth in the Recitals.
“Inventions” has the
meaning set forth in Section 21.6.
“Laws” has the meaning
set forth in Section 2.2(c).
“Losses” has the meaning
set forth in Section 16.1.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Cerus/NOVA Biomedical Manufacturing
Agreement
Page
“Non-Conforming Material
Requests (NCMRs)” means request to authorize use of Product
that does not meet specification.
“Manufacturing
Agreement” has the meaning set forth in the
Introduction.
“Manufacturing
Documentation” has the meaning set forth in
Section 20.
“NOVA” has the meaning
set forth in the Introduction.
“NOVA Confidential
Information” has the meaning set forth in
Section 18.1.
“Parties” has the
meaning set forth in the Introduction.
“Pricing Schedule” means
the pricing method as set forth in Attachment 3.
“Product Line Quality
Committee (PLQC)” has the meaning set forth in Attachment
1.
“Product” has the
meaning set forth in the Recitals.
“Purchase Order” means a
formal, binding request by Cerus to NOVA to procure materials
and/or services that Cerus deems necessary or desirable for the
procurement of Product, or the procurement of Product itself, at a
cost to be mutually agreed upon by Cerus and NOVA.
“Quality Plan” has the
meaning set forth in Section 3.1 in Attachment 1.
“Renewal Term” has the
meaning set forth in the Term section.
“Services Agreement” has
the meaning set forth in the Recitals.
“Specifications” means
the detailed plans, requirements, and instructions developed for
the production of Product provided by Cerus to NOVA pursuant to
Section 2.1(b) of this Agreement.
“Supply Agreement” has
the meaning set forth in the Recitals.
“Term” has the meaning
set forth in the Term section.
“Unit” means a single
Product.
Roles and
Responsibilities:
Product:
The Product is the INTERCEPT UVA
Illuminator device.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Cerus/NOVA Biomedical Manufacturing
Agreement
Page
Section 1/Product DMR
The records containing the
procedures and Specifications for the Product constitute the device
master record (“DMR”). The Product DMR shall include,
without limitation, the following documentation:
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a.
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device
Specifications including appropriate drawings, composition,
formulation, component Specifications, and software
Specifications;
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b.
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production
process Specifications including the appropriate equipment
Specifications, production methods, production procedures, and
production environment Specifications;
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c.
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quality
assurance procedures and Specifications, including acceptance
criteria and quality assurance equipment to be used;
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d.
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packaging and
labeling Specifications, including methods and processes used;
and,
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e.
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installation,
maintenance, and servicing procedures and methods.
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Cerus shall own the Product DMR and
shall be responsible for Product performance to the extent Products
are manufactured in accordance with the Specifications. Cerus is
also responsible for obtaining all FDA and other agency approvals,
as needed, to manufacture and market the Product.
Section 2/Covenants;
Representations and Warranties
2.1/Covenants and Duties of
Cerus
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a.
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Cerus shall
render prompt technical support to NOVA as soon as practicable, but
no later than [ * ] , as needed, for the duration of the Term when
reasonably requested by NOVA.
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b.
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Cerus agrees to
provide to NOVA on a timely basis the design Specifications of the
Product, to the extent NOVA does not already possess such
Specifications, as well as all change notices with respect to the
Product.
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c.
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Cerus represents and warrants to
Nova that: (1) Cerus has the right to enter into this
Manufacturing Agreement; (2) all necessary actions, corporate
and otherwise, have been taken to authorize Cerus’s execution
and delivery of this Manufacturing Agreement and the same is the
valid and binding obligation of Cerus; (3) all licenses,
certifications, consents and approvals necessary for Cerus to carry
out all of the transactions contemplated in this Manufacturing
Agreement have been obtained by Cerus; (4) Cerus
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Cerus/NOVA Biomedical Manufacturing
Agreement
Page
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has the experience and technical
capacity to fulfill its obligations under this Manufacturing
Agreement; (5) the manufacture of the Product in accordance
with the Specifications pursuant to this Manufacturing Agreement
will not infringe any trade and product name, trademark service
mark, logo, copyright (including registrations and applications),
or any patents owned by any third party; and (6) no claim or
action is pending or threatened against Cerus or, to Cerus’s
knowledge, against any supplier or customer of Cerus that could
adversely affect the ability of Cerus to distibute the Product or
the right of Cerus or any customer of Cerus to use the Products for
their intended use.
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2.2/Covenants and Duties of
NOVA
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a.
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NOVA shall
manufacture the Product per Cerus’ written Specifications
provided pursuant to Section 2.1(b) and in accordance with
Cerus’ approved DMR.
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b.
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NOVA agrees to
inventory long lead-time items, as mutually agreed, at Cerus’
expense if so requested by Cerus in writing. NOVA will purchase
long lead-time items after receipt of an approved Cerus Purchase
Order that will include the quoted purchase price plus NOVA’s
then current material overhead. NOVA will invoice Cerus and require
payment in full upon quality acceptance of the items. NOVA will
store items in a suitable location to prevent damage or
deterioration. Cerus shall bear all costs associated with the [ * ]
. Cerus shall bear all costs related to [ * ]
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c.
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NOVA shall at
all times use commercially reasonable efforts, skill, and
experience to manufacture all Products in strict conformity with
all applicable Cerus Purchase Order requirements and
Specifications, as set forth in the DMR, and all applicable U.S.
and European Union laws and regulations (the “Laws”).
NOVA shall not make any change in or deviate in any way from such
Specifications, except pursuant to a change request issued by Cerus
pursuant to Section 8 of this Manufacturing Agreement and to
Non-Conforming Material Requests (NCMRs) that are evaluated and
approved by NOVA and Cerus.
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d.
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Products shall
be packaged and labeled in accordance with Specifications as set
forth in the DMR. NOVA’s name shall not appear on the
Products or in any documentation except as required by law.
Notwithstanding the foregoing, NOVA’s name may appear on
serial number labels , provided such labels are not visible
to Cerus’ customers , and in documents relating to
obtaining regulatory approval of the Product. Nothing in this
Manufacturing Agreement shall be deemed to grant either Party any
right to use the other Party’s name for any purpose other
than as expressly provided herein.
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e.
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NOVA shall
report to Cerus, as soon as possible, all anticipated delays of
greater than [ * ] related to the manufacturing and/or shipping of
Product to Cerus. Cerus shall have the right to cancel (without
penalty) any order within [ * ] , or the delay is a result of a
change request issued by Cerus, or NOVA has taken steps
satisfactory to Cerus to resolve delays.
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Cerus/NOVA Biomedical Manufacturing
Agreement
Page
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f.
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NOVA represents
and warrants to Cerus that: (1) NOVA has the right to enter
into this Manufacturing Agreement; (2) all necessary actions,
corporate and otherwise, have been taken to authorize NOVA’s
execution and delivery of this Manufacturing Agreement and the same
is the valid and binding obligation of NOVA; (3) all licenses,
certifications, consents and approvals necessary for NOVA to carry
out all of the transactions contemplated in this Manufacturing
Agreement have been obtained by NOVA; (4) NOVA has the
experience and technical capacity to fulfill its obligations under
this Manufacturing Agreement; (5) NOVA has and shall pass to
Cerus good title to the Products free and clear of all liens and
encumbrances; and (6) no claim or action is pending or, to
NOVA’s knowledge, threatened against NOVA or, to NOVA’s
knowledge, against any supplier of NOVA that could adversely affect
the ability of NOVA to manufacture the Product or the right of
Cerus or any customer of Cerus to use the Products for their
intended use.
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Section 3/Distribution/Warehousing
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a.
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All Products
will be shipped [ * ] . NOVA agrees to ship the Products via
mutually agreed upon carriers to Cerus or other locations
designated by Cerus, [ * ] .
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b.
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Cerus shall be
responsible for payment of all export and import duties, local
sales taxes and all other charges with respect to shipment of the
Products.
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c.
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Title,
ownership and risk of loss to the Products and Component Parts
shall pass to Cerus FOB upon pickup at NOVA Biomedical facility in
Waltham, Massachusetts or, if sooner, at the time payment for such
Products and/or Component Parts is made by Cerus. All Products and
Component Parts held by NOVA pursuant to a written request from
Cerus to hold completed and invoiced goods at NOVA for future
shipment shall be stored in accordance with Section 4.0 of the
Quality Obligations, attached hereto as Attachment 1 , and
Cerus shall reimburse NOVA for any reasonable storage costs
incurred by NOVA.
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d.
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NOVA will
temporarily store a maximum of [ * ] completed and invoiced Units
if requested by Cerus. Title, ownership and risk of loss to such
stored Products and Component Parts shall pass to Cerus [ * ]
Pickup of all completed and invoiced Units must be completed by
mid-month of each fiscal month (as defined by NOVA’s annual
fiscal calendar and to be provided by NOVA to Cerus) following
completion of the manufacturing for such Units or invoicing,
whichever is later.
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Section 4/Production
Engineering Costs
4.1/Production
Implementation
Prior to Commencement of production
of Product, NOVA will complete all tasks related to implementing
production such as updating the product structure, assembly
procedures and testing approaches; and designing and fabricating
test fixtures and assembly jigs. Following
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Cerus/NOVA Biomedical Manufacturing
Agreement
Page
Commencement of production, NOVA will provide
all manufacturing engineering, drafting and documentation required
to manufacture the Product and to conform to FDA regulations and
ISO 13485 standards. NOVA and Cerus will identify materials that
are acquired solely for the purpose of testing the Product, and
Cerus will supply such materials to Nova at [ * ]
4.2/Non-Recoverable Engineering
Charges
Certain non-recoverable engineering
may be required by Cerus, which involves the development of [ * ]
Specifications and design or product design to enhance the
manufacturing of the product. A written estimate of non-recoverable
engineering charges shall be submitted to Cerus for prior approval.
Non-recoverable engineering charges shall be billed to Cerus at the
rates outlined in Attachment 2 and subject to the conditions
indicated in Section 5.1, plus material and NOVA’s then
current and auditable material overhead costs. [ * ]
4.3/Capital Equipment;
Tooling
Cerus will reimburse NOVA for [ * ]
Such capital equipment/tooling may include, but is not limited to,
test fixtures, tooling specifically related to the INTERCEPT Blood
System, molds unique to the Product, computers, and automatic test
equipment(all collectively referred to herein as the “Capital
Equipment”). Cerus shall be the sole owner of the external
radiometer calibration station and all such Capital Equipment. No
reimbursement or payment shall be due by Cerus to Nova in relation
to the external radiometer calibration station.
4.4/Cerus-Supplied
Components
Cerus will provide NOVA with [ * ]
(“Cerus-Supplied Components), at no-cost, for use in the
production of Products to be manufactured by NOVA for
Cerus.
Section 5/Pricing;
Volume
5.1/Pricing
Schedule
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a.
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Products will
be priced according to the Pricing Schedule shown in Attachment 3.
Component Parts shall be [ * ] NOVA will develop the [ * ] Pricing
Schedule and will provide Cerus with [ * ] Bill of Materials and [
* ] at the [ * ] used to calculate price if so requested by Cerus.
NOVA will sell the Products to Cerus at a price, which depends on
actual Purchase Order volume as set forth in Attachment 3. The
formula utilizes NOVA [ * ]
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b.
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The transfer price to Cerus will
fluctuate based on [ * ] and may be adjusted [ * ] as described
below. The actual Purchase Order volume will include Units shipped
in [ * ] periods commencing with the first passed and accepted
commercial Units, excluding units in a previous [ * ] Purchase
Order. The margin percentage for the intial Purchase Order volume
will be fixed upon written acceptance of the Purchase Order by Nova
as set
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Cerus/NOVA Biomedical Manufacturing
Agreement
Page
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forth in Attachment 3. A new
margin percentage may be established for subsequent Purchase Orders
for additional Units should these incremental units result in an
improved pricing tier margin percentage per Attachment 3 when
included with the initial purchase order volume for determination
of the total volume for the [ * ] The new margin percentage will
apply only to the incremental units shipped or scheduled for a
shipment within that [ * ] and will be fixed upon written
acceptance of the subsequent Purchase Orders by Nova as set forth
in Attachment 3.
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c.
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Except as set
forth in Sections 4.2, 8 and 9, the transfer price includes the
costs of all manufacturing engineering necessary to implement and
support production of the Products and, except as noted in
Section 3, all packaging and handling charges. The transfer
price shall exclude the material costs for Cerus-Supplied
Components incorporated in the Products. Additionally, the transfer
price shall [ * ] under Section 2.2(e).
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d.
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Pricing may be
adjusted annually from the base year pricing described in
Attachment 3, and/or if a new Purchase Order is issued by Cerus,
but it may not increase or decrease by more than [ * ] from the
preceding year’s pricing for any given year. The price will
be adjusted according to the Pricing Schedule shown in Attachment 3
at the [ * ]
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5.2/Purchase
Orders
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a.
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Cerus will
provide NOVA with a firm Purchase Order a minimum of [ * ] days in
advance of the first day of the month in which the start of
manufacture is to take place, for delivery of the Product at a
mutually agreed upon date, not to exceed [ * ] Firm Purchase Orders
are not subject to change. Except for any order modifications
agreed to by Cerus and Nova, all terms and conditions in this
Manufacturing Agreement shall prevail over the terms and conditions
contained in any Purchase Order.
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b.
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Cerus shall be
permitted to cancel a Purchase Order if authorization to market a
Product is suspended or revoked by a regulatory agency or
prohibited by applicable Laws, or in the event NOVA is unable to
deliver Products after having taken all reasonable steps to resolve
potential delays under Section 2.2(e). In the event Cerus
cancels a Purchase Order in accordance with this Section, Cerus
agrees to pay all charges incurred by NOVA as a result of the
cancellation of such Purchase Order. At Cerus’ request, NOVA
agrees to use reasonable commercial efforts to return any unused
materials and to negotiate reduction or elimination of cancellation
or rescheduling fees where possible.
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c.
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Usable excess
raw material inventory at the end of the Manufacturing Agreement
Term, purchased by NOVA pursuant to Cerus Purchase Orders, [ *
]
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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5.3/Cost Reduction Program
A cost reduction program may be
established which will define the estimated reduction in cost
resulting from changes in production techniques. Savings as a
result of capital investment and engineering by NOVA and Cerus may
result in a price reduction equivalent to the direct costs saved.
In the event savings are realized by joint NOVA/Cerus investment,
the savings will be negotiated and shared based on the contribution
of each party. Any savings will be passed on to Cerus through an
adjustment in price for subsequent purchases.
5.4/Changes’ Impact on
Costs
The Parties agree to review each
change to the Specifications made by either party (as set forth in
the DMR) and determine if such change is feasible and directly
affects [ * ] If such change impacts [ * ] the price of the Product
shall be adjusted accordingly. Prior to the implementation of any
Product Specification change both Parties will agree on who is
responsible for costs arising out of failures of the Product due to
the Product change.
Section 6/Cost of Rework or
Scrap
NOVA will absorb all costs related
to scrap or rework resulting from manufacturing errors or defects.
Cerus will be charged all costs related to rework and scrapping of
inventory as a result of design changes initiated by Cerus or to
scrapping product which meet the design Specifications set forth in
the DMR, but are found to be unacceptable by Cerus.
Section 7/Manufacturing;
Engineering
Following the Commencement of
production, NOVA will provide manufacturing engineering services
which are required: (i) to ensure that the Product conforms
with NOVA’s quality standards; and (ii) to support
continuing cost and reliability improvements. NOVA will estimate
the costs associated with non-routine manufacturing engineering
services and process validations. Cerus will be charged all costs
related to non-routine manufacturing engineering services and
validations requested by Cerus. NOVA shall manufacture the Product
in accordance with the [ * ] NOVA shall also provide Cerus with
documentation necessary to establish the Product’s compliance
with [ * ]
Section 8/Product
Changes
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a.
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Cerus and NOVA
anticipate that during the Term, modifications to the Product
design will occur. Change requests shall be made in accordance with
Section 5.0 et seq. of the Quality Obligations
(“Change Control”), attached hereto as Attachment
1.
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b.
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NOVA will make
no design changes without written authorization by
Cerus.
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c.
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Cerus may from time to time
request NOVA to incorporate an engineering change into a Product.
Within [ * ] from receipt of such request, NOVA will inform Cerus
in writing of the earliest possible implementation date for the
proposed engineering change, any
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Cerus/NOVA Biomedical Manufacturing
Agreement
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increase or decrease in the price
of the Product, and any scrap or rework costs as a result of such
change, and any effect on production scheduling or QA test
coverage. NOVA agrees to accept and implement all reasonable
engineering changes to the Products subject to price
adjustments.
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d.
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NOVA will
maintain the DMR according to its document control procedures, [ *
]
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e.
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Any changes to
the DMR require Cerus’ approval in writing prior to change.
NOVA will estimate the cost to implement changes to the DMR and
will obtain written authorization by Cerus prior to implementation
of proposed changes. Non-recoverable engineering costs incurred to
implement changes to the DMR will be invoiced to Ce
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