Exhibit 10.37
[*] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
AMENDED AND RESTATED
MANUFACTURING AND SUPPLY AGREEMENT
THIS AMENDED AND RESTATED
MANUFACTURING AND SUPPLY AGREEMENT (this “ Agreement ”) is
entered into by and between F ENWAL , I NC . , a
company organized under the laws of Delaware (“ Fenwal
”), and C ERUS C ORPORATION , a company organized under the laws of Delaware
(“ Cerus ”). Fenwal and Cerus, as corporations,
are sometimes referred to herein as a “ Party ”
and collectively as the “ Parties .” This
Agreement shall become effective as of the last date of signature
by the Parties (the “ Effective Date
”).
WHEREAS, Baxter Healthcare SA Switzerland and Baxter
Healthcare Corporation (collectively referred to herein as “
Baxter ”) and Cerus entered into a Manufacturing and
Supply Agreement, dated as of February 2, 2005 (the “
Original Supply Agreement ”) relating to the INTERCEPT
Blood System;
WHEREAS, Baxter and Cerus subsequently entered into a
Commercialization Transition Agreement (the “
Commercialization Agreement ”), effective
February 1, 2006, which amended certain provisions of the
Original Supply Agreement;
WHEREAS, Fenwal has advised Cerus that, as of
March 1, 2007, the Original Supply Agreement and the
Commercialization Agreement were assigned to Fenwal, and Fenwal
assumed all of Baxter’s obligations thereunder;
WHEREAS, Cerus desires to ensure continuity of supply and
achieve acceptable cost of goods regarding the supply of Platelet
Sets and Plasma Sets, as such terms are defined in this
Agreement;
WHEREAS, Fenwal desires to continue to supply Cerus with
its requirements for Platelet Sets and Plasma Sets and to
rationalize its production commitments;
WHEREAS, concurrently with this Agreement, the Parties
are entering into an Agreement Concerning INTERCEPT Product Supply,
relating to the supply of certain INTERCEPT products by Cerus to
BioOne Corporation (“ BioOne ”); and
WHEREAS, the Parties now wish to extend the Original
Supply Agreement and amend and restate its terms in the manner set
forth in this Agreement;
1
NOW, THEREFORE,
in consideration of the premises and
covenants set forth herein and other good and valuable
consideration, the receipt and sufficiency of which is hereby
acknowledged, Fenwal and Cerus agree as follows:
ARTICLE 1
D EFINITIONS
In this Agreement, the following
terms have the meanings specified or referred to in this
Article 1 and shall be equally applicable to both the singular
and plural forms. The words “including”,
“includes” and “include” shall be deemed to
be followed by the phrase “without limitation”, unless
the context clearly dictates otherwise. Any agreement, schedule,
attachment or exhibit referred to herein shall mean such agreement,
schedule, attachment or exhibit as amended, restated, supplemented
or modified from time to time to the extent permitted by the
applicable provisions of this Agreement. Reference to any statute
or regulation means such statute or regulation as amended at the
time and from time to time and includes any successor statute or
regulation. Unless otherwise stated, references to recitals,
articles, sections, paragraphs, schedules and exhibits shall be
references to recitals, articles, sections, paragraphs, schedules
and exhibits of this Agreement.
“ Affiliate ”
means, with respect to any Person, at the time in question, any
other Person controlling, controlled by or under common control
with such Person. For purposes of this definition,
“control” shall mean (a) in the case of corporate
entities, direct or indirect ownership of any of the stock or
shares having the right to vote for the election of a majority of
directors, (b) in the case of non-corporate entities, direct
or indirect ownership of any of the equity interest with the power
to direct the management and policies of such non-corporate
entities.
“ Components ”
means all raw materials and sub-assemblies, such as plastics,
containers (including without limitation “wet-filled”
containers), tubing, cannulas and compound adsorption devices for
the production of or use in connection with the Sets.
“ Cost of Goods ”
means Fenwal’s full cost of manufacturing or acquiring an
item, in accordance with accounting principles generally accepted
in the United States, consistently applied, (GAAP) and in
accordance with Fenwal’s normal accounting practices, all
consistently applied. Cost of Goods shall not, however, include
amortization of development expenditures, except as set forth in
Section 4.4(d) of this Agreement, or expenses falling under
the category designated by Fenwal “ other costs of
sales ” or similar category, however designated. It is
understood that Fenwal fixed overhead will include amortization of
Fenwal investments in additional assets to provide incremental
capacity, as required pursuant to Section 2.4 of this
Agreement.
“ Device Master Record
” shall include device specifications, production process
specifications, quality assurance procedures and specifications
(including acceptance criteria and quality assurance equipment to
be used), and packaging and labeling specifications.
“ INTERCEPT Illuminator
” means a proprietary illumination device, including
operating software and data management system, including source
code for each, developed for use with Platelet Sets and Plasma
Sets.
“ License Agreement
” means the agreement entered between Baxter and Cerus,
effective February 2, 2005, whereby Baxter licensed to Cerus
certain patents, know-how and materials.
“ Manufactured Products
” means Platelet Sets, Plasma Sets, and
Components.
“ Person ” means
an individual, corporation, limited liability company, partnership,
sole proprietorship, joint venture, or other form of organization
or governmental agency or authority.
[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
2
“ Plasma Disks ” means
[*] disks designed for the pathogen inactivation system for
plasma.
“ Plasma Sets ”
means disposable processing sets for inactivation of pathogens in
plasma components of blood, containing [*].
“ Platelet Sets ”
means disposable processing sets for the inactivation of pathogens
in platelet components of blood, containing [*].
“ Platelet Wafers
” means [*] wafers designed for the pathogen
inactivation system for platelets.
“ Product
Specifications ” means the specifications for the
Platelet Sets and the Plasma Sets (as described in
Section 2.1(b)), and as modified from time to time pursuant to
Section 2.2. The Product Specifications for Components will be
the applicable specifications for Components included within the
Product Specifications mentioned above in this definition, or if
such do not exist for any Component, then specifications to be
developed by the Parties for such Component.
“ [*] ” means the
raw material [*] , a component of Platelet Sets and Plasma
Sets.
“ Sets ” means
the Platelet Sets and the Plasma Sets.
“ Work Order ”
means a written, signed order for the performance by Fenwal of
mutually-agreed services. A Work Order shall include a scope of
work, a project budget and a payment schedule. All Work Orders
shall be deemed to be incorporated into this Agreement and governed
by its terms and conditions.
ARTICLE 2
M ANUFACTURING AND S UPPLY
Section 2.1 Manufacturing
Services .
(a) General. Fenwal will, during the term of
this Agreement, manufacture Manufactured Products for Cerus on the
terms set forth below all in accordance with the Product
Specifications (collectively, the “ Manufacturing
Services ”) in a professional and efficient manner and in
accordance with the terms and conditions of this
Agreement.
(b) Product Specifications for
Platelet and Plasma Sets. As of the Effective Date, the Product
Specifications for the Platelet Sets and Plasma Sets are listed on
Exhibit A and Exhibit B, respectively, to this
Agreement.
Section 2.2 Change
Requests .
(a) Product Specifications;
Device Master Record. In
the event that Cerus requests any changes to such Product
Specifications (including, without limitation, the addition of new
product codes or changes made to comply with any requirement, order
or instructions by any regulatory authority), Fenwal will perform
and complete such requests in a timely fashion. Fenwal will not
unreasonably withhold its approval to any requests of Cerus to
change Product
[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
3
Specifications. Any changes to the Product
Specifications or Device Master Record must be reviewed and
approved under Fenwal and/or Cerus change control procedures.
Fenwal will make no changes to the Device Master Record for the
Manufactured Products without the prior written approval of Cerus.
In some cases, changes are caused by third-party suppliers (“
Third Party Changes ”) and are outside the scope of
Fenwal’s control. Fenwal shall give Cerus at least ninety
(90) days notice of any such Third Party Changes, provided
such third party gave sufficient notice to Fenwal. If, due to
circumstances beyond Fenwal’s control, Fenwal is required to
qualify a new third-party supplier, it will so notify Cerus and the
Parties will confer on the determination of and terms of agreement
with such new third-party supplier. Allocation of costs for such
changes is further described in Section 4.4(a).
(b) Product Improvements; Prototypes.
Periodically, Cerus may request that Fenwal manufacture prototype
development or clinical lots, or request additional validation or
qualification activities to obtain regulatory approvals. Fenwal
will manufacture and supply prototype lots of the Sets, as Cerus
may reasonably require in connection with any changes to Product
Specifications. Allocation of costs for such changes shall be
allocated in accordance with Section 4.4(b).
(c) Changes in Manufacturing
Location. Fenwal will
provide Cerus with at least ninety (90) days advance written
notice of any change in its manufacturing location and, in any
event, will not change any location until the new location is
fully-qualified and licensed with each applicable Party’s
regulatory group for the manufacture of the Manufactured Products
for sale or clinical testing. Changes in manufacturing location
include changes in manufacturing location for raw materials,
components, subassemblies, or finished goods; changes in location
or subcontractor for sterilization processes; and, changes in
chemical and physical facilities. Cerus understands and
acknowledges that Fenwal intends to transfer and consolidate major
subassembly and final assembly equipment and processes to the
Fenwal plant in [*] . Allocation of costs for any such
changes is further described in Section 4.4(c).
(d) U.S. FDA Compliance. Upon Cerus’
written request, Fenwal agrees to review and modify, as may be
necessary, its existing manufacturing facilities and quality
systems to be compliant with FDA quality system requirements
(“ QSR’s ”) and cGMP within twelve
(12) months of such request. In the event of a modification to
meet QSR’s cGMP and standards applicable to the United
States, Europe or Asia, Fenwal will review and modify its existing
manufacturing facilities in agreement with Cerus. Allocation of
costs for such changes is further described in
Section 4.4(d).
(e) Plastics.
Cerus understands that Fenwal may
receive, from time-to-time, “Supplier Notice of Change”
notifications from Baxter for any of the formulations for the key
plastics used in the Platelet and Plasma Sets manufactured by
Baxter. No such changes, however, shall cause the Manufactured
Products to fail to meet any regulatory requirements. Additionally,
Cerus reserves any and all rights, and remedies it may have against
Baxter, for such plastics under the Original Supply Agreement.
Allocation of costs for such changes is further described in
Section 4.4(e).
[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
4
(f) Other.
In the event Cerus is interested in
conducting development, qualification and/or validation work for
substituting Fenwal plastics for Baxter plastics used in the
Platelet and Plasma Sets, the Parties shall agree on the work to be
performed by Fenwal and determine, in good faith, the terms of
supply, by Fenwal, of such Fenwal plastics to Cerus for inclusion
into the Sets.
(g) Work Order. In the event Cerus requires
Fenwal to perform any work pursuant to this Section 2.2, the
Parties shall enter into a Work Order for the performance by Fenwal
of such mutually-agreed services.
Section 2.3 Supply and
Purchase Commitments .
(a) Subject to Cerus’ supply of Platelet
Wafers, Plasma Disks and [*], during the Term of this Agreement,
Fenwal shall supply Cerus with purchase orders for Manufactured
Products within the delivery times required under Section 2.4.
Cerus shall purchase Manufactured Products from Fenwal as set forth
in Section 2.5.
(b) Cerus shall purchase its requirements of
Platelet Sets and Plasma Sets from Fenwal, subject to the
following:
(i) For the duration of this Agreement and in any
calendar year, Cerus shall purchase from Fenwal a number of Sets
equal to the greater of [*] . In any event, Cerus shall not
be required to purchase [*] in any given calendar year from
Fenwal absent a written mutual agreement between Cerus and Fenwal
stating such. Cerus is free to purchase [*] from a
third-party supplier or suppliers. Such purchases by Cerus at any
time from third-party supplier(s) will not alter Cerus’
purchase obligations under binding firm purchase orders to Fenwal
then in effect pursuant to Section 2.4 of this
Agreement.
(ii) In the event that Cerus provides [*]
written notice of termination pursuant to Section 6.2(g) of
this Agreement, then Cerus’ purchase requirements shall be
modified as follows (without altering Cerus’ purchase
obligations under binding firm purchase orders to Fenwal then in
effect pursuant to Section 2.4 of this Agreement):
(A) During the [*] months following such
notice, Cerus shall purchase Sets from Fenwal at a rate equal to
[*] of the [*] for Sets purchased by Cerus from
Fenwal during the [*] period preceding such
notice;
(B) During months [*] following such notice,
Cerus shall purchase Sets from Fenwal at a rate equal to [*]
of the [*] for Sets purchased by Cerus from Fenwal during
the [*] period preceding such notice; and
(C) During the [*] following such notice,
Cerus shall purchase Sets from Fenwal at a rate equal to [*]
of the [*] for Sets purchased by Cerus from Fenwal during
the [*] period preceding such notice.
[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
5
Section 2.4 Forecasts
.
In order to assist Fenwal in its
production planning of Manufactured Products for Cerus, Cerus will
provide to Fenwal during the Term of this Agreement a rolling
[*] forecast by product code, of which [*] will
constitute firm purchase orders for Platelet Sets and Plasma Sets,
and of which [*] will constitute firm purchase orders in the
case of Components ordered separately. Cerus agrees that these
forecasts will include consideration of obligations for supply of
products to meet the forecasts of any third party distributors or
other third parties, including BioOne. Additionally, during the
[*] of each [*] , Cerus shall provide to Fenwal an
“optimistic” volume forecast and a “base
case” volume forecast, for the following [*] .
“Optimistic” volume forecast shall be used for
manufacturing capacity assessment and discussion of manufacturing
capacity planning between the Parties based on such assessment.
Both Parties understand that investments in additional assets to
provide capacity above that required for base case volumes may
result in higher fixed overhead allocations. Monthly meetings with
Fenwal and Cerus representatives shall be held at a mutually
agreeable time to discuss production planning and inventory
management, including, but not limited to, volume forecasts
provided pursuant to this Section 2.4. It is understood that
standard costing will be based on the “base case”
volume forecast for following [*] terms, as further
described in Section 4.2.
Section 2.5 Purchase
Orders .
The firm purchase orders in each
rolling forecast described in Section 2.4 above will
constitute a binding obligation on the part of Cerus to purchase
such Manufactured Products regardless of whether Cerus has a need
for such Manufactured Products at the time of delivery and such
purchase obligation will not be relieved for longer than [*]
, except on account of any force majeure event, or the
unavailability of Cerus-supplied materials, that may arise
subsequent to the date the purchase order is placed. The terms and
conditions of this Agreement will be controlling over any terms and
conditions included in any purchase order form used in ordering
Manufactured Product. Any term or condition of any purchase order,
invoice, packing slip, quotation or other document delivered by
either Party incident to the purchases hereunder that is in
addition to, different from or contrary to the terms and conditions
of this Agreement will be void, unless the Parties otherwise agree
by a separate written agreement.
Section 2.6 Delivery;
Shipment; Invoices .
(a) All Manufactured Products supplied under this
Agreement will be delivered by Fenwal to Cerus’ designated
carrier at Fenwal’s facility in [*] INCOTERMS 2000).
Title and risk of loss passes to Cerus [*] Invoices issued
by Fenwal upon delivery shall be based on the standard costing
established in Section 4.2(a) and paid by Cerus within sixty
(60) days of invoice date. Disputed invoices are to be
resolved expeditiously and in good faith by the Parties. All
delivery costs, insurance, freight, import and export duties and
taxes will not be included as Cost of Goods. Fenwal shall cause to
be delivered all Manufactured Products according to [*]
purchase orders ( [*] firm purchase orders for Components,
if ordered separately) made by Cerus pursuant to Section 2.4
of this Agreement.
[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
6
(b) Fenwal shall include a packing list in each
shipment of the Manufactured Products providing the following
information: (1) Cerus purchase order number; (2) Fenwal
Components Code; and, (3) Quantity. Fenwal shall also mail a
copy of each packing list to Cerus for each shipment at the time of
shipment. Fenwal shall provide to Cerus a certificate of compliance
for each lot of Manufactured Goods shipped.
(c) Fenwal shall deliver each Manufactured Product
to Cerus within [*] of production.
(d) Within [*] of receipt of Product Release
Records (as defined in the Quality Agreement between the Parties)
for Manufactured Products, Cerus will complete a review to identify
any variations from the Product Specifications referenced on the
relevant Exhibit to this Agreement, which set forth quality
standards for the Manufactured Products. Cerus will work with
Fenwal to determine if the identified variations from Product
Specifications can be clarified or resolved. If evidence cannot be
provided by Fenwal that the Manufactured Products do meet the
Product Specifications then Cerus shall notify Fenwal of its
rejection of such Manufactured Products. Fenwal will invoice Cerus
for the Manufactured Products as described in Section 2.6
(a) of this Agreement. If Cerus delivers such notice of
variation from Product Specifications or rejection within such
[*] period, Cerus shall promptly make available to Fenwal
for examination and testing, at the expense of Fenwal, the
Manufactured Products in the rejected shipment and Fenwal shall, if
the Manufactured Products were properly rejected, at Fenwal’s
expense, either (i) credit Cerus for the amount of such
non-conforming Manufacturing Products for which Cerus has
previously paid Fenwal, or (ii) promptly provide replacement
Manufacturing Products that meet the Product
Specifications.
ARTICLE 3
W ARRANTY
Section 3.1 Warranty.
Each Party represents and warrants
to the other as follows:
(a) As of the Effective Date, all corporate action
necessary for the authorization, execution and delivery of this
Agreement by such Party and the performance of its obligations
hereunder has been taken;
(b) As of the Effective Date, the execution,
delivery and anticipated performance of this Agreement do not
violate or conflict with any law applicable to it, any provision of
its charter or bylaws, any order or judgment of any court or other
agency of government applicable to it or any of its assets or any
contractual restriction or provision or agreement or instruction
binding on or affecting it or any of its assets;
(c) As of the Effective Date, its obligations
hereunder constitute its legal, valid and binding obligations,
enforceable in accordance with their respective terms (subject to
applicable bankruptcy, reorganization, insolvency, moratorium or
similar laws affecting creditors’ rights generally and
subject, as to enforceability, to equitable principles of general
application, regardless of whether enforcement is sought in a
proceeding in equity or at law); and
[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
7
(d) To the knowledge of the Parties as of the
Effective Date, no consents, waivers, approval or authorizations of
any third party, other than the regulatory authorities in other
countries in the Territory, are required for such Party to perform
any of its obligations under this Agreement.
(e) Fenwal represents and warrants that, upon
shipment and for a one-year period from the date of production of
each Manufactured Product (or for the shelf-life of the
Manufactured Product, if such period is longer) (the “
Warranty Period ”), Manufactured Products will meet
the then-current Product Specifications, and be free from defects
in material, workmanship and title, provided Manufactured Products
are stored according to label copy and are used according to label
instructions.
(f) Subject to Section 2.2(d), Fenwal
represents and warrants that its manufacturing facilities used to
provide Manufactured Products hereunder will meet the Good
Manufacturing Practices (cGMP) and standards applicable as required
to meet the Product Specifications.
Section 3.2
Disclaimer of Warranties
. With respect to the subject matter of this Agreement, the
warranties granted in Section 3.1 are exclusive and are
offered in LIEU OF ALL IMPLIED OR STATUTORY WARRANTIES (INCLUDING
WITHOUT LIMITATION, WARRANTIES AS TO MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE, OR ARISING FROM COURSE OF DEALING OR USAGE OF
TRADE) or any other express or implied warranties or
representations.
Section 3.3
Remedies . If any item
manufactured by Fenwal or its subcontractors shall prove defective
in material and/or workmanship within the Warranty Period, Cerus
shall notify Fenwal in writing of such defect or noncompliance
[*] of Cerus’ discovery of such defect or
noncompliance, and Fenwal shall replace said item. The Warranty
Period for such replaced item shall be as set forth in
Section 3.1(e) of this Agreement. Fenwal shall have no
responsibility if such item has been improperly stored by Cerus or
used outside of label instruction by Cerus, its agents or customers
or the defect or noncompliance is due to an act or omission by
Cerus or its third-party suppliers as relating to the Platelet
Wafers, Plasma Disks, [*] or INTERCEPT Illuminator devices or any
other component that Cerus decides to provide to Fenwal. The
foregoing shall be Fenwal’s sole and exclusive liability and
Cerus’ sole and exclusive remedy for any breach of contract
action arising out of any such defect, except with respect to each
Party’s indemnification obligations as set forth in Article
10, provided that Fenwal shall remain responsible to carry out its
obligations under the Quality Agreement (as defined
herein).
ARTICLE 4
P AYMENTS ; A UDIT
Section 4.1 Compensation for
Manufacturing Services .
(a) From the Effective Date to December 31,
2008, as compensation for the Manufacturing Services, Cerus will
pay to Fenwal an amount equal to (i) [*] Cost of Goods
of the Manufactured Products ordered and purchased by Cerus for
[*] , and (ii) [*] Cost of Goods of the
Manufactured Products ordered and purchased by Cerus for use in
[*] . (The Parties shall have previously entered into a Work
Order for Manufacturing Products ordered for use in [*] ).
Manufactured Products ordered and purchased under (i) and
(ii) of this Section 4.1(a) shall be invoiced
separately.
[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
8
(b) Budgeted Standard Cost of Goods will be
[*] as further described in Section 4.2. From
January 1, 2009 and for the remainder of the Term of the
Agreement, the invoice price for each Manufactured Product shall be
equal to Fenwal’s Budgeted Standard Cost of Goods for such
Manufactured Product, and, additionally:
(i) for each of the aggregate number of Platelet
Sets and Plasma Sets invoiced by Fenwal in [*] up to and
including [*] , a charge of [*] shall be applied to
each Platelet Set and Plasma Set invoiced by Fenwal to Cerus for
[*] .
(ii) for each of the aggregate number of Platelet
Sets and Plasma Sets invoiced by Fenwal in [*] in excess of
[*] , a charge of [*] shall be applied to each
Platelet Set and Plasma Set invoiced by Fenwal to Cerus for
[*] .
The purchase price for Components
shall be negotiated in good faith and shall not exceed [*]
of Fenwal’s Cost of Goods of the Components.
(c) On [*] , Fenwal will provide to Cerus a
reconciliation report of Manufacturing Variances versus the
Budgeted standard Cost of Goods (“Manufacturing
Variances”). Manufacturing Variances will be calculated based
on (1) the variations in overhead absorption due to volume
variations of Cerus actual purchases from the “base
case” forecast and (2) raw materials cost changes of
more than [*] from any raw material supplier
(“Purchase Price Variances”), as described in 4.2 (c).
Labor and conversion loss shall be fixed at the budgeted levels and
not included in the Manufacturing Variance calculations, except as
may apply where described in Section 4.2 (d). Calculations
shall be performed such that a “positive variance”
would be in the favor of Cerus, while a “negative
variance” would be in the favor of Fenwal. Fenwal will
provide to Cerus [*] reconciliation reports of such
Manufacturing Variances as soon as practicable after the [*]
, and [*] reconciliation reports of such Manufacturing
Variances within [*] . Fenwal will provide to Cerus, within
[*] Manufacturing Variances reconciliation report. If
Manufacturing Variances are positive, Fenwal will pay a variance
adjustment rebate to Cerus within [*] . If Manufacturing
Variances are negative, Fenwal shall invoice Cerus a variance
adjustment fee, payable within thirty (30) days of receipt of
such variance invoice.
Section 4.2 Cost
Calculations
(a) Cost of Goods. Fenwal represents that the
2008 standard Cost of Goods for the Platelet Sets and Plasma Sets
is set forth on Exhibit C hereto. In the [*] , using the
“base case” production forecast for the following year
provided by Cerus to Fenwal (per Section 2.4), Fenwal will
provide a Budgeted Standard Cost of Goods for the following year
(the “Budgeted Standard Cost of Goods”). This Budgeted
Standard Cost of Goods will include labor, overhead and conversion
loss and a costed bill of materials. Determination of
Fenwal’s Budgeted Standard Cost of Goods shall be made
consistent with Fenwal’s current practice of computing cost
of goods, subject to the definition of “Cost of Goods”
in Article 1. Capital expenditures for
[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
9
facilities and/or equipment and capitalized
manufacturing start-up costs will be amortized on a straight-line
basis and included in Cost of Goods. The amortization basis for
facilities and equipment that were transferred by Baxter to Fenwal
shall not exceed Baxter’s depreciated book value of such
facilities and equipment immediately prior to their transfer to
Fenwal. Fenwal’s Cost of Goods and budget shall be determined
using [*] , consistent with the “base case”
volume forecast provided by Cerus. Fenwal’s cost of
inspection and storage of Platelet Wafers and Plasma Disks shall be
included as incremental variable overhead in determining the Cost
of Goods. In the event any item is acquired by Fenwal from an
Affiliate, “ cost of manufacturing or acquiring
” shall be deemed to mean such Affiliate’s cost of
manufacturing or acquiring. The Cost of Goods will be based upon
the local currency in the country in which the Manufactured
Products are manufactured. The Budgeted standard Cost of Goods may
change during [*] solely as required to reflect increases or
decreases in the Cost of Goods due to changes to the Product
Specifications based upon Cerus’ needs and legal
requirements.
(b) Long-Range Standard Cost of
Goods Estimates. In
addition to that described in Section 4.2 (a), following
receipt of Cerus’ [*] “optimistic” and
“base case” volume forecasts prepared to
Section 2.4, Fenwal shall, in the [*] of each
[*] , provide to Cerus [*] of product code cost for
the “optimistic” and “base” case volumes,
with details of material, labor, conversion loss factors, rework
allowance, overhead and depreciation for each finished kit code.
Fenwal’s product standard costing for the following
[*] will be provided by Fenwal in the form of a costed bill
of materials and with the details of material, labor, conversion
loss factors, rework allowance, fixed and variable overhead
elements. Such product standard costing shall be based on the
“base case” production forecast for [*] and
shall be net of the costs for Cerus-supplied materials, as provided
under Section 5.1. Any estimates used by Fenwal in calculating
standard Cost of Goods shall be made reasonably and in good faith.
Such costing is intended for use with long-range planning efforts
of both parties, and shall not be binding for future
years.
(c) Raw Material Cost
Changes. Cerus
additionally understands and acknowledges that Fenwal has supply
agreements for key plastics used in the Platelet and Plasma Sets,
and that such agreements may result in raw materials cost changes,
such cost changes to be passed through to Cerus as Purchase Price
Variances to the extent provided in Section 4.1(c) of this
Agreement.
(d) Conversion Loss. Fenwal shall use
commercially reasonable efforts to continually reduce conversion
loss and rework for Manufactured Products and Cerus-supplied
materials. For the purpose of this Agreement, “ conversion
loss ” shall include losses due to quality control
testing and scrap of excess or non-conforming Manufactured
Products. Any process or activity undertaken by Fenwal to bring a
defective or non-conforming product into compliance with the
Specifications shall be considered “ rework ”
under this Agreement. Prior to the beginning of each calendar year,
the Parties shall agree on a reasonable conversion loss factor and
rework allowance to be included within the standard cost for each
Manufactured Product, based on an assessment of the actual costs of
conversion loss and rework incurred in prior years. The conversion
loss factor and rework allowance will be fixed for that calendar
year. Any excess conversion loss or rework will not be included in
the Cost of Goods. Cerus and Fenwal agree to review and negotiate
in good faith for payment for conversion losses and rework
[*] of
[*] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24b-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
10
the budgeted amounts for such activities if such
costs are incurred as a result of circumstances which could not
have been predicted or avoided by Fenwal or Cerus. Cerus agrees to
pay [*] arising from changes in Manufactured Products
Specifications. Fenwal will promptly notify Cerus of the nature and
amount of such [*] accordingly. Prior to the beginning of
each calendar year, the Parties shall agree on a reasonable level
of conversion loss for Cerus-supplied materials; the conversion
loss factor is expected to remain flat or decrease during each year
of this contract. If the conversion loss for any Cerus-supplied
materials exceeds the agreed-upon amount, Fenwal shall reimburse
Cerus the amount of Cerus’ cost of goods corresponding to
such excess conversion loss.
(e) Meetings.
Cerus and Fenwal agree to meet at
least twice per calendar year as part of the planned semi-annual
management meetings to review and prioritize cost reduction
initiatives. At such time, Cerus and Fenwal shall identify projects
for implementation (if any), and estimate and allocate related
costs (including, but not limited to, engineering time, operating
and capital expenses), and risks and benefits.
(f) Request for
Documentation. Upon
request by Cerus, Fenwal will supply Cerus with a full accounting
of Fenwal’s Cost of Goods, including a costed bill of
materials.
Section 4.3
Audit . Cerus shall
have the right, through an independent third-party auditor approved
by Fenwal (which approval shall not be unreasonably withheld), to
perform a full audit, on an annual basis and after thirty
(30) days prior notice, on Fenwal records directly associated
with or related to the Manufacturing Services and Fenwal’s
calculation of Cost of Goods. Any audit shall be conducted during
Fenwal’s normal business hours. Prior to commencing any
audit, such third-party auditor shall enter into a confidentiality
agreement in a form acceptable to Fenwal. Any undisputed
overpayment or underpayment determined by this Section 4.3
shall be due and payable to the other Party by the Party owing such
amount within thirty (30) days after notice of such audit
finding. Cerus shall bear the full costs of such audit, except that
in the event that any audit performed hereunder results in a
decrease of [*] or more in the case of Platelet Sets and
Plasma Sets, or [*] or more in the case of Components, in
any purchase price due to Fenwal hereunder, then Fenwal shall be
obligated to reimburse Cerus for such audit costs, but will not be
required to reimburse more than [*] Dollars ($ [*] )
for any audit e