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Exhibit 10.3
PURCHASE AND SUPPLY AGREEMENT
BETWEEN
GENZYME CORPORATION
&
INVITROGEN CORPORATION
CONTRACT # SPM-254
JANUARY 1, 2005 TO DECEMBER 31, 2007
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TABLE OF CONTENTS:
1. Definitions
2. Scope
3. Term
4. Payment Terms
5. Products and Pricing
6. Release of Orders
7. Forecasting, Purchase Orders and Supply Obligations
8. Biosurgery Products
9. Security of Supply
10. Acceptance; Rejection; Pre-shipment Samples
11. Certificate of Analysis; Other Documentation
12. Storage; Delivery
13. Manufacturing Obligations; Warranties
14. Other Obligations
15. Termination
16. SBA Socio-Economic Reporting
17. Confidentiality
18. Insurance
19. Work on Genzyme's Premises and Security
20. Research Product Warranties
21. Authorized use of Research Products
22. Regulatory
23. Export Control
24. Indemnification
25. Compliance Laws
26. Limitation of Liability
27. Assignment
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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28. Jurisdiction
29. Severability; Remedies; Waiver;
30. Notices
31. Advertising
32. Statutes and Executive Orders
33. Survival
34. Additional or Inconsistent Terms
35. Entire Agreement
36. General Provisions
The following Attachments are attached to this Purchase and Sale Agreement and
made a part hereof:
ATTACHMENT A: Global Buying Entities.
ATTACHMENT B1: Listing and prices of Custom Manufactured Products.
ATTACHMENT B2: Listings and prices of Biosurgery Products.
ATTACHMENT B3: Listing and prices of Research Products.
ATTACHMENT B4: Listing of Standard Custom Products
ATTACHMENT C: Specifications, Certificates of Analysis, [**] and Herd Management
ATTACHMENT D: List of Account Managers
ATTACHMENT E: Genzyme Accounts Payable Contacts
ATTACHMENT F: Supplemental Product Amendment for Biosurgery Products
ATTACHMENT G: GENZYME Materials and Materials Specifications
ATTACHMENT H: [**] Protocols
ATTACHMENT I: Biosurgery Refrigeration & Transportation Requirements
ATTACHMENT J: Supplemental Product Amendments
ATTACHMENT K: Change Notification Process
ATTACHMENT L: Certification of Suitability of Monographs of the European
Pharmacopoeia
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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PURCHASE AND SUPPLY AGREEMENT
This Purchase and Supply Agreement (the "AGREEMENT") effective January 1, 2005
("EFFECTIVE DATE") is between Invitrogen Corporation ("SUPPLIER"), a Delaware
corporation with a principal place of business at 1600 Faraday Avenue, Carlsbad,
CA 92008 and Genzyme Corporation ("GENZYME"), a Massachusetts corporation with a
principal place of business at One Kendall Square, Cambridge, MA 02139.
RECITALS:
A. GENZYME and Life Technologies, Inc. ("LIFE") were parties to a
Supply Agreement effective January 1, 1999 ("ORIGINAL AGREEMENT"),
whereby Life supplied certain products to GENZYME (GENZYME contract
number C-194). The Original Agreement expired on December 31, 2001.
B. SUPPLIER and GENZYME are parties to that certain Contract
Manufacture Agreement effective March 17, 1996 for the supply of
Biosurgery Products to GENZYME ("BIOSURGERY AGREEMENT").
C. On September 14, 2000, Life was acquired by and merged into
SUPPLIER. GENZYME desires to have SUPPLIER continue supplying
products similar to those supplied under the Original Agreement and
the Biosurgery Agreement. SUPPLIER is willing to supply such
products.
D. By entering into this new Agreement, GENZYME and SUPPLIER desire to
(i) renew and extend the supply relationship established by the
Original Agreement; and (ii) terminate the Biosurgery Agreement as
of the Effective Date, replacing such agreement with this
Agreement; provided, however, that the Supplemental Product
Amendments entered into under the Biosurgery Agreement shall not be
terminated, and shall be incorporated herein as described in
Section 8.2.
NOW THEREFORE, in consideration of the premises and the mutual covenants
and agreements contained herein and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties
intending to be legally bound agree as follows:
1. Definitions:
1.1 "AFFILIATE" shall mean any entity or person that, directly or
indirectly, controls, is controlled by, or is under common control
with another person. A person shall be deemed to control another
person if the controlling person possesses, directly or indirectly,
the power to direct or cause the direction of the management or
policies of the controlled person, whether through ownership of
stock, the power to elect or appoint the board of directors or
trustees, by contract, or otherwise.
1.2 "BIOPRODUCTION" means any materials that are procured to a GENZYME
part number and specification as contained in ATTACHMENT B1 and B2.
1.3 "FDA" means the U.S. Food and Drug Administration.
1.4 "PURCHASE ORDER" means any purchase order that GENZYME either
itself or through a Buying Entity completes and delivers to
SUPPLIER either directly or through one of its Affiliates listed in
ATTACHMENT D in accordance with Section 6.
1.5 "QSR" means regulations set forth in FDA's Quality System
Regulations at 21 C.F.R. Part 820.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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1.6 "SPECIFICATIONS" means the' procedures, test results, requirements,
criteria, specifications, standards and other data relating to the
manufacture and supply of Products, as more particularly set forth
on ATTACHMENT C.
1.7 "STERILE" means that any Product described as Sterile has been
manufactured in compliance with medical device QSR's through
aseptic processing to a sterility assurance level of 10-3.
1.8 "THIRD PARTY" means any person or entity other than GENZYME,
SUPPLIER, their respective Affiliates, and a Buying Entity.
2. SCOPE:
2.1 PRODUCTS. The products ("PRODUCTS"), individually or collectively,
to be bought and sold by GENZYME from SUPPLIER are any of the
following:
2.1.1 "CUSTOM MANUFACTURED PRODUCTS", as set forth more
particularly on ATTACHMENT B 1, and which are:
[**]
2.1.2 SUPPLIER's research products, as set forth in SUPPLIER's
then-current U.S. Catalog, and its Affiliates'
then-current written catalogs ("RESEARCH PRODUCTS"),
including research products supplied under on-site
stocking programs.
2.1.3 SUPPLIER's biosurgery products listed on ATTACHMENT B2
[**] (collectively, "BIOSURGERY PRODUCTS").
Products excludes services, custom products not listed above, and software
products.
2.2 Buying Entities. Only GENZYME and an entity listed on ATTACHMENT A
(each a "BUYING ENTITY") may place Purchase Orders for Products
under this Agreement.
2.2.1 An entity not listed on ATTACHMENT A may not place
Purchase Orders, either for itself or on behalf of any
other party, and is not entitled to the benefits of this
Agreement.
2.2.2 A GENZYME Affiliate or other entity may only become a
Buying Entity by a written amendment of ATTACHMENT A
signed by SUPPLIER and GENZYME. Removal of an entity
from ATTACHMENT A requires only written notice from
GENZYME to that Buying Entity and to SUPPLIER.
2.2.3 GENZYME warrants and represents to SUPPLIER that the
Buying Entities listed on ATTACHMENT A, are Affiliates
of GENZYME. If, at any time during this Agreement, any
entity listed on ATTACHMENT A ceases to be a GENZYME
Affiliate, then GENZYME shall so notify SUPPLIER, and
such entity shall be removed from ATTACHMENT A and shall
no longer be a Buying Entity.
2.2.4 Removal of a Buying Entity from ATTACHMENT A shall not,
alone, release such Buying Entity from its obligations
hereunder.
2.2.5 GENZYME and SUPPLIER each acknowledge and agree that the
terms and conditions of this Agreement shall apply to
all Purchase Orders submitted by GENZYME or any of the
Buying Entities during the Term of this Agreement. Where
the terms of this Agreement conflict with any such
Purchase Order, this Agreement shall govern.
2.2.6 The placement of a Purchase Order by a Buying Entity
constitutes such Buying Entity's acceptance that the
terms and conditions of this Agreement govern such
Purchase Order and agreement to abide by this Agreement.
2.2.7 SUPPLIER shall provide GENZYME with a list of all
SUPPLIER Affiliates who are selling Products subject to
this Agreement (together with SUPPLIER, "SELLING
ENTITIES"). The acceptance of a Purchase Order by a
Selling Entity constitutes
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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such Selling Entity's agreement (i) that the terms and
conditions of this Agreement govern such Purchase Order;
and (ii) to abide by the applicable terms and conditions
of Agreement. SUPPLIER shall also provide GENZYME with
written notice in due commercial course of any companies
acquired by SUPPLIER during the term of this Agreement,
any new product offerings, and new discounts or other
promotional offerings.
2.2.8 The only role of the Buying Entities and Selling
Entities under this Agreement is to facilitate the
ordering, delivery and payment process on a
multinational level. No Buying Entity or Selling Entity
shall be liable under this Agreement except as expressly
stated herein. GENZYME and SUPPLIER shall each be fully
liable and responsible for all supply, delivery,
quality, payment, warranty, security, insurance, use,
indemnity, and other commitments under this Agreement,
regardless of which Buying Entity or Selling Entity
(respectively) placed or accepted a Purchase Order, or
received or delivered Products.
3. TERM:
This Agreement shall be effective on the Effective Date and continue until
December 31, 2007 (the "INITIAL TERM"). Upon expiration of the Initial
term, this Agreement shall automatically renew for successive one year
terms unless it is terminated by either party pursuant to this Article 3 or
as otherwise provided herein. Each party may terminate this Agreement after
the Initial Term has expired by providing the other party with at least six
(6) months written notice.
4. PAYMENT TERMS:
4.1 NON-U.S. PURCHASES. Non-U.S. Buying Entities shall receive invoices
from, and payment on invoices shall be made to, the Selling Entity
corresponding to the territory in which such Buying Entity is
located. Such non-U.S. invoices shall be stated in the currency of
the invoicing Selling Entity or the Buying Entity, as such parties
may determine from time to time.
4.2 PAYMENT. Except as described in Section 4.3, invoices shall be paid
within thirty (30) days of receipt, provided that all invoices
shall include at least the following information: Buying Entity
account number, Purchase Order number, Product description,
quantity of Product desired, unit cost and extended cost of
Product, invoice number, and applicable Product part number.
4.3 CONSOLIDATED INVOICES. SUPPLIER shall provide upon GENZYME's
request consolidated monthly invoices for each U.S. Buying Entity.
All such consolidated invoices shall be paid in full within the
last date specified, provided that the parties agree on the amount
invoiced. Consolidated invoices shall be submitted in Excel format
and shall contain at least the following information: Buying Entity
account number; Purchase Order number; Product description;
quantity of Product; unit cost and extended cost of Product;
invoice number; and applicable Product part number.
4.4 INVOICE DISPUTES. In the event GENZYME disputes an invoice amount,
GENZYME shall notify SUPPLIER within fifteen (15) days of the date
of receipt of such invoice, may withhold payment of the disputed
amount, and shall pay the undisputed portion of such invoice by
such fifteenth (15th) days. The parties shall negotiate in good
faith how to address the disputed portion of the invoice.
5. PRODUCTS AND PRICING:
5.1 GENZYME BIOPRODUCTION PRODUCTS AND PRICING.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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[**]
5.2 PROCESS DEVELOPMENT GENZYME & SUPPLIER SUPPORT.
SUPPLIER understands that GENZYME needs the freedom to operate
regarding the future development of mammalian cell base
technologies. Therefore GENZYME may elect to work with Vendors
whose skill set and know-how best suit GENZYME's timelines and or
other requirements. GENZYME may use a reasonable effort to provide
SUPPLIER an opportunity re: the above needs by using SUPPLIER's
catalogue products, custom products, and or optimized IP platforms
to address the cell culture needs of GENZYME during the course of
this Agreement, so long as SUPPLIER can meet GENZYME's timelines,
budgets and other requirements for the project. [**]
5.3 [**]
[**]
5.4 PRICE AND PAYMENT TERMS FOR [**] BATCHES.
The pricing for the [**] is set forth in ATTACHMENT B1. Delivery of
the [**] will be consistent with terms outlined in Section 10.1 of
the Supply Agreement. [**]
5.5 CURRENCY EXCHANGES.
For the purposes of calculating rebates as described in Sections
5.3 and 5.7, SUPPLIER shall convert sales to Buying Entities from
local currency to dollars using the methods it uses to convert all
of its other foreign revenues, provided only that such methods
comply with US generally accepted accounting principles. SUPPLIER
currently uses the exchange rates posted at www.oanda.com; if that
source changes SUPPLIER will report that source and the rate at the
close of the respective quarter.
5.6 PRICE AND PAYMENT TERMS FOR [**] BATCHES.
[**]
USDA Website-//www.ams.usda.gov/LSMNpubs/pdfmonthly/pharm.pdf
5.7 PRICING FOR RESEARCH PRODUCTS.
Current US prices for SUPPLIER Research Products are set forth in
SUPPLIER's current catalog ( "List Price"). Each Selling Entity has
a different catalog and the List Prices may vary by country. [**]
[**]
5.8 GENZYME/ SUPPLLER- [**] PROGRAM - RESEARCH PRODUCTS.
There are two levels of [**] status, with qualifications for each
detailed below. In exchange for each level of [**] status, SUPPLIER
will offer the stated price concessions.
5.8.1 [**] - LEVEL 1. Within 60 days of signing the contract,
GENZYME and authorized Buying Entities will provide SUPPLIER and
Selling Entities access to its end users for the purpose of
promoting SUPPLIER's products and services [**]
5.8.2 [**]
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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5.8.3 If SUPPLIER provides specific product, seminars and or
special product pricing information during the year, GENZYME may
list these in the Science and Research newsletter, as time and
space allow. SUPPLIER will be given an annual expected schedule of
newsletters.
GENZYME Science and Research Procurement may sponsor product shows
and technical meetings. Timing, content and location of these
product shows to be mutually agreed to and SUPPLIER must provide at
least a three (3) week advance notice request to GENZYME Science
and Research Procurement.
In exchange for its [**] status, Level 1, with respect to Research
Products, addition discounts on Research Products are provided as
listed in ATTACHMENT B3, Section A.
5.9 [**] - LEVEL II QUALIFICATION.
5.9.1 GENZYME will provide spend visibility on a quarterly basis
for selected life science reagents by product category which
SUPPLIER and GENZYME mutually agree too. GENZYME and SUPPLIER will
agree as to the form and format of this data and the method of
reporting.
5.9.2 [**]
5.10 GROWTH INCENTIVE ADJUSTMENTS.
5.10.1 If GENZYME purchases a company that has not done business
with SUPPLIER historically, the growth incentive charts will not
change and any new purchases from the acquired company can be
applied to the growth incentive tiers. If GENZYME purchases a
company that has done business with SUPPLIER historically, the
growth incentive tiers will be adjusted by adding the acquired
companies' historical volume to Tier 1. Each Tier will then be
adjusted upward by the same percent as current tiers.
5.10.2 Adjustments to the growth incentives for GENZYME resulting
from GENZYME's acquisition of a company that is presently procuring
products from SUPPLIER will be reviewed and approved by both
parties prior to any adjusts in the tiered rebates.
5.10.3 If SUPPLIER purchases any company that GENZYME has bought
from historically the growth incentive rebates will be reviewed by
both SUPPLIER and GENZYME and adjusted accordingly.
5.11 CONTINGENCY MANUFACTURING SITE AND DISASTER RECOVERY PLAN.
Outlined below is the current long-term manufacturing capacities
reflective both the US and Scotland Sites.
5.11.1 [**]
5.11.2 [**]
5.11.3 Contingency Manufacturing Site and Disaster Recovery Plan
Scotland Facility [Inchinnan]:
Plant capacity: currently staffed to run 5 days per week at two
shifts per day; 24/7 provides ample expansion capabilities
Based on above workweek, the current Inchinnan capacity
approximates:
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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[**]
6. RELEASE OF ORDERS:
6.1 PURCHASE ORDER PLACEMENT. GENZYME shall have no obligation to order
any Product by virtue of this Agreement alone. In the event that
GENZYME orders Products hereunder, GENZYME shall issue a Purchase
Order to SUPPLIER stating, at a minimum, the description and
quantity of the Product(s) being ordered and the required date(s)
for delivery of such Product(s). No Product shall be delivered
prior to receipt of an applicable Purchase Order (whether
electronically, by telephone, or fax). Purchase Orders for Custom
Manufactured Products and Biosurgery Products shall be sent by hard
copy or email only. In the event GENZYME does not receive a written
notice of acceptance or rejection of a Purchase Order within five
(5) business days of the Purchase Order date, acceptance of the
Purchase Order by SUPPLIER shall be conclusively presumed.
6.2 ELECTRONIC ORDERS. Purchase Orders placed and acknowledgments sent
under this Agreement may be sent in writing or by electronic means
in a mutually agreed upon platform. The parties agree that:
6.2.1 The electronically transmitted Purchase Orders shall be
deemed to satisfy any legal formalities requiring that agreements
be in writing.
6.2.2 Neither party shall contest the validity or enforceability of
any such electronic transmission under any applicable statute of
frauds.
6.2.3 Computer maintained records when produced in hard copy form
shall constitute business records and shall have the same validity
as any other generally recognized business records.
6.3 21 CFR PART 11 COMPLIANCE. SUPPLIER and GENZYME each represent and
warrant to the other that each is developing its electronic
transmission and computer maintained records/security to bring such
transmission, records, and security into compliance with the
requirements of 21 CFR Part 11.
7. FORECASTING. PURCHASE ORDERS AND SUPPLY OBLIGATIONS:
7.1 FORECASTS. [**]
7.2 PURCHASE ORDER REQUIREMENTS: SUPPLY OBLIGATIONS.
7.2.1 GENZYME shall issue Purchase Orders for Products as
follows: (i) for Custom Manufactured Products and [**]
(after [**] has been approved by GENZYME for use in its
bioproduction process) [**] months prior to the
requested delivery date(s); (ii) for [**] and [**], [**]
months prior to the requested delivery date(s); (iii)
for Biosurgery Products (excluding [**]), [**] weeks
prior to the requested delivery dates.
7.2.2 Each Purchase Order shall specify at a minimum the
amount of each Product required, the delivery dates and
location and any other ordering terms. Each Purchase
Order shall constitute a binding obligation on GENZYME
to take and pay for the Product specified therein
subject to the terms of this Agreement.
7.2.3 [**]
7.2.4 DELAY OF DELIVERY: GENZYME may delay deliveries under an
outstanding Purchase Order upon providing written notice
to SUPPLIER no less than (i) [**] days before the
scheduled delivery date for Custom Manufactured
Products, and (ii) [**] days before the scheduled
delivery date for Biosurgery Products. Such delays shall
be at no additional charge to GENZYME. The maximum
duration of any delay of [**] and Biosurgery Products
shall be [**] months from the date of
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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GENZYME's notification of acceptance of the pre-shipment
sample for the applicable Product (or, if no
pre-shipment sample is sent, then from the original date
of delivery of such Product); the maximum duration of
any delay of [**] or [**] shall be [**] months from date
of the Purchase Order.
8. BIOSURGERY PRODUCTS:
8.1 RAW MATERIALS FOR BIOSURGERY PRODUCTS. Prior to or on even date
with its submission of a Purchase Order for Biosurgery Products,
GENZYME shall deliver to SUPPLIER a sufficient amount of the
materials set forth in ATTACHMENT G ("MATERIALS") to enable
SUPPLIER to manufacture the amount of Biosurgery Products set forth
in such Purchase Order. In the event that Materials are lost or
destroyed due to SUPPLIER's negligence or misconduct, SUPPLIER will
reimburse GENZYME for its direct out-of-pocket costs of the
Materials and the associated shipping costs.
8.1.1 If GENZYME delays delivery of the necessary Materials,
the affected Purchase Order delivery date(s) may be
extended for the duration equal to such delay.
8.1.2 The parties acknowledge that SUPPLIER's manufacture of
Biosurgery Products manufactured using Materials is
conditional upon the Materials meeting certain
specifications ("MATERIALS SPECIFICATIONS") as set forth
on ATTACHMENT G. GENZYME shall accompany each delivery
of Materials with Certificates of Analysis confirming
that the delivered Materials meet the Materials
Specifications, along with instructions for proper
storage and handling of the Materials.
8.1.3 GENZYME acknowledges that if the Materials do not
conform to the Materials Specifications upon their
delivery to SUPPLIER, then SUPPLIER's manufacture of the
Biosurgery Products may be adversely affected. [**]
8.1.4 Upon the parties' agreement with respect to the amount
of Materials necessary to manufacture Biosurgery
Products, GENZYME has the right to instruct SUPPLIER
that excess Materials be disposed of by SUPPLIER, in
which case GENZYME will reimburse SUPPLIER a disposal
fee to cover SUPPLIER's expense in destroying such
Material and other reasonable costs associated with the
disposal of the materials.
8.1.5 SUPPLIER will provide reports to GENZYME prior to the
close of each month with respect to delivered Material
which will include: ending inventory, receipts, new
reserves, and usage details.
8.2 OTHER BIOSURGERY PRODUCTS. The parties may enter into future
agreements from time to time to add additional Biosurgery Products
to ATTACHMENT B2. Biosurgery Products may only be added to this
Agreement by execution of the Amendment form attached hereto as
ATTACHMENT F ("SUPPLEMENTAL PRODUCT AMENDMENT" or SPA), to which a
Certificate of Analysis and sample label for such product shall be
attached. Supplemental Product Amendments that are currently
effective between the parties as of the Effective Date are
identified on ATTACHMENT J, are incorporated by reference herein,
and the products described thereunder shall be Biosurgery Products
hereunder, provided that where the terms of this Agreement conflict
with the terms of any Supplemental Product Amendment, the terms of
this Agreement shall govern. Each Supplemental Product Amendment
entered into after the Effective Date shall be attached hereto as
ATTACHMENTS F1, F2, and so on.
8.3 PURCHASE ORDERS. Following receipt of a Purchase Order for a
biosurgery product that is not subject to a SPA, SUPPLIER and
GENZYME shall review execute an SPA in the form attached hereto as
ATTACHMENT F to incorporate such Biosurgery Product. SUPPLIER will
not manufacture and deliver to GENZYME any Biosurgery Product that
is not subject to an executed SPA. SUPPLIER shall use commercially
reasonable and good faith efforts to meet GENZYME's Purchase Orders
and delivery requirements for
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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Biosurgery Products. If SUPPLIER is unable for any reason to supply
any portion of the total demand for Biosurgery Products specified
in a Purchase Order that exceeds the then-applicable, accepted
GENZYME Forecast, SUPPLIER may allocate its available supply among
any or all customers on such basis as SUPPLIER may deem fair and
practical, without liability for any failure of performance that
may result therefrom.
8.4 TERMINATION OF SUPPLY OF BIOSURGERY PRODUCTS.
8.4.1 If GENZYME cannot offer its services as a result of
action by the FDA, and the FDA's requirements cannot be
satisfied within [**], GENZYME may terminate SUPPLIER's
supply of Biosurgery Products hereunder by providing
[**].
8.4.2 Each party may terminate the supply of Biosurgery
Products hereunder without cause [**] written notice to
the other party. Such termination shall not affect the
supply of Products other than Biosurgery Products.
9. SECURITY OF SUPPLY:
9.1 CUSTOM MANUFACTURED PRODUCTS. Upon GENZYME's request in a written
or electronic Purchase Order, SUPPLIER shall commence manufacture
of an inventory of Custom Manufactured Products (in the quantity
(ies) set forth below) that are Pre-Approved Finished Goods
(defined below), custom manufactured and stored in accordance with
the applicable Specifications, and held on reserve inventory for
the purpose of security of supply ("Security of Supply").
Submission of such initial Purchase Order obligates GENZYME to take
delivery of the Security of Supply. Upon completion of the
manufacture of the Security of Supply, SUPPLIER shall roll over
such Security of Supply into its delivery of Custom Manufactured
Products under the next-occurring Purchase Order on a
first-in-first out-basis. At all times during the term of this
Agreement, SUPPLIER shall maintain the inventory dedicated for
Security of Supply in the following quantities and at the following
locations:
(i) [**]
(ii) [**]
9.1.1 UNAPPROVED FINISHED GOODS. "UNAPPROVED FINISHED GOODS"
means a Custom Manufactured Product which is tested,
approved, packaged and labeled in accordance with the
applicable Specifications for delivery to GENZYME by
SUPPLIER, but which GENZYME has not tested to confirm
conformity to the applicable Specifications.
9.1.2 PRE-APPROVED FINISHED GOODS. For GENZYME to approve a
lot of [**] as Security of Supply, SUPPLIER shall send
GENZYME a sample of such lot within [**] of receiving
GENZYME's Purchase Order requesting such Security of
Supply. Upon receipt of GENZYME's notification of
acceptance of a pre-shipment sample of [**] as
conforming to the applicable Specifications, the lot
from which preshipment sample was taken shall be
"Pre-Approved Finished Goods" for purposes of this
Section 9.1.
9.1.3 FORM OF PACKAGING AND STORAGE CONDITIONS. The Security
of Supply of [**] shall be maintained in [**] unless
otherwise reasonably requested by GENZYME no less than
[**] in advance. The Security of Supply of [**] shall be
maintained in [**], unless otherwise reasonably
requested by GENZYME no less than [**] in advance.
9.1.4 ORDERING SECURITY OF SUPPLY. GENZYME may, at any time,
request delivery of all or part of the Security of
Supply by placing a Purchase Order therefor ("SECURITY
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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SUPPLY ORDER"). SUPPLIER shall deliver such Security of
Supply within[**] of receipt of such Security Supply
Order.
9.1.5 REPLENISHMENT OF SECURITY OF SUPPLY. If GENZYME takes
delivery of the entire inventory dedicated to Security
of Supply pursuant to this Section 9.1, SUPPLIER shall
use fully replenish the Security of Supply as follows:
[**]
9.2 BACK-UP MANUFACTURING FACILITY: SUPPLIER has two manufacturing
locations for [**]. In the event the primary manufacturing location
becomes or would become incapable of manufacturing Custom
Manufactured Products, SUPPLIER will use every available
opportunity to manufacture in the alternate location; provided
however, that manufacture in the Scotland facility must be approved
by GENZYME in advance.
9.3 [**]
10. ACCEPTANCE: REJECTION: PRE-SHIPMENT SAMPLES:
10.1 [**]. SUPPLIER will test a sample of each lot of [**] in accordance
with its Specifications prior to shipment of the full lot of [**].
SUPPLIER will provide GENZYME with a pre-shipment sample of [**]
within [**] of the Purchase Order date. Such pre-shipment sample
shall be [**] derived from one (1) lot of [**]. Upon receipt of
such sample, GENZYME will have [**] to retest the sample in
accordance with the [**] Specifications, and will notify SUPPLIER
within such time whether the sample complies with the [**]
Specifications. Within [**] of receipt of GENZYME's acceptance of
such pre-shipment sample, SUPPLIER shall ship the full order of
[**] from its New Zealand facility to its U.S. facility, and
SUPPLIER'S U.S. facility will then deliver such [**] to the GENZYME
location specified on the Purchase Order on or by the applicable
delivery date. GENZYME's failure to provide timely notice of
acceptance or rejection of the sample may result in a delay in
delivery, and if so, will relieve SUPPLIER of breach with respect
to a Purchase Order delivery late.
10.1.1 If GENZYME determines that the [**] sample does not
comply with the [**] Specifications, GENZYME shall
provide evidence to SUPPLIER supporting the claim. If
SUPPLIER agrees that the [**] sample does not comply
with the [**] Specifications, SUPPLIER shall provide a
sample from a replacement batch of [**] within [**]
after written notification of such rejection.
10.1.2 If SUPPLIER'S assays confirm that the [**] samples are
in compliance with the Specifications, but GENZYME's
assays determine that the samples are not in compliance
with the Specifications, SUPPLIER and GENZYME will
investigate the discrepancy and attempt to reach a
reasonable settlement.
10.1.3 Prior to the next-scheduled shipment of [**], SUPPLIER
will provide to GENZYME a Certificate of Analysis (COA)
with respect to such shipment to allow GENZYME to
determine the appropriate GENZYME location for the
shipment to be shipped.
10.2 [**] AS A BIOSURGERY PRODUCT.
10.2.1 PRE-SHIPMENT SAMPLES. Prior to delivering [**] as a
Biosurgery Product under a Purchase Order, SUPPLIER will
use commercially reasonable efforts to provide GENZYME
with a pre-qualification sample of [**] meeting the
Specifications derived from at least one (1) lot of
[**].
10.2.2 INVENTORY. In response to GENZYME's Purchase Order for
[**] as a Biosurgery Product, SUPPLIER will maintain an
inventory [**] equal to the amount set forth in such
Purchase Order, at no obligation to GENZYME, for [**]
from the date of delivery of the preshipment sample in
accordance with Section 10.2.1.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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10.2.3 ACCEPTANCE/REJECTION OF SAMPLE. If GENZYME rejects the
sample of [**] in such [**] period, then SUPPLIER will
provide a new sample of [**] from different lot; GENZYME
acknowledges that such rejection may affect the delivery
date of [**], notwithstanding any other provision
herein. If GENZYME does not notify SUPPLIER of
acceptance or rejection of the sample of [**] within
such time period, then SUPPLIER shall have no obligation
to fill the corresponding Purchase Order. If GENZYME
notifies SUPPLIER of acceptance of the sample within the
time period, then SUPPLIER shall ship the amount of [**]
set forth in the Purchase Order, at GENZYME's
instruction, either: (i) promptly in its entirety; or
(ii) in installments over a period not to exceed [**].
If such installments are instructed by GENZYME to be
delivered within [**] from notification of acceptance,
then the price for such [**] shall be as the price
existed on the date of the applicable Purchase Order;
and if such installments are instructed by GENZYME to be
delivered beyond [**] from notification of acceptance,
then the price for [**] shall be subject to change as
described in Section 5.6.
10.3 ALL BIOSURGERY PRODUCTS.
10.3.1 SHORTAGES: PATENT DEFECTS. Immediately upon receipt of a
Biosurgery Product, GENZYME shall inspect same, and
notify SUPPLIER of any claims for shortages, patent
defects or damages, and shall hold any such Biosurgery
Product pending receipt of SUPPLIER's written
instructions regarding disposition. The failure of
GENZYME to notify SUPPLIER within five (5) days after
receipt shall constitute confirmation that the
Biosurgery Product delivered was in the correct
quantity, and that there were no patent defects or
damages in the packaging containers. SUPPLIER will
notify GENZYME if the delivery reflects an overage in
excess of one hundred ten percent (110%) of the amount
requested in the Purchase Order within thirty (30) days
of the day of manufacture; and acceptance of such
overage will be at the sole discretion of GENZYME at the
original Purchase Order price.
10.3.2 COMPLIANCE WITH THE SPECIFICATIONS. GENZYME shall have
thirty (30) days from the date of receipt of Biosurgery
Products to confirm compliance of such Biosurgery
Products with the Biosurgery Product Specifications
(latent defects). The failure of GENZYME to notify
SUPPLIER in writing that any Biosurgery Product was not
in compliance with the Biosurgery Product Specifications
shall constitute GENZYME's final acceptance of the
Biosurgery Product.
10.3.3 CURE. If GENZYME rejects a Biosurgery Product as not
complying with the Biosurgery Product Specifications
subject to Section 8.1.3, then SUPPLIER will use
commercially reasonable efforts to deliver to GENZYME a
replacement lot of the Biosurgery Product. The
replacement lot( s) size will be the same size as the
rejected lot, unless otherwise agreed to by the parties,
and will be priced at the same unit price as the failed
lot. SUPPLIER will fully reimburse GENZYME for GENZYME's
out of pocket cost of any raw materials consumed in the
failed lot.
10.4 CUSTOM MANUFACTURED PRODUCT ACCEPTANCE
10.4.1 RECEIPT AND TESTING OF CUSTOM MANUFACTURED PRODUCT. All
Custom Manufactured Product shipped shall be accompanied
by quality control certificates of analysis (as set
forth in Section 11) signed by a duly authorized
official of SUPPLIER confirming that each batch of
Custom Manufactured Product covered by such certificate
meets the Specification's release requirements and shall
be deemed accepted by GENZYME unless GENZYME, acting
reasonably and in good faith, shall give written notice
of rejection (hereafter referred to as a "REJECTION
NOTICE") to SUPPLIER within sixty (60) days after
receipt of the Custom Manufactured Product by, on behalf
of, or for the account of GENZYME.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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10.4.2 REJECTION NOTICE. The Rejection Notice shall state in
reasonable detail (sufficient to enable) SUPPLIER to
identify the nature of the problem, the reason why the
Custom Manufactured Product is not acceptable. Any
Rejection Notice shall be accompanied by copies of all
written reports relating to tests, studies or
investigations performed to that date by or for GENZYME
on the Custom Manufactured Product rejected. GENZYME
shall have the right but not the obligation, to return
the rejected Custom Manufactured Product to SUPPLIER at
SUPPLIER's cost, and title to and risk of loss
associated with the rejected Custom Manufactured Product
shall transfer to SUPPLIER upon receipt by SUPPLIER of
the rejected Custom Manufactured Product.
10.4.3 RETURN OF CUSTOM MANUFACTURED PRODUCT. Upon receipt of
such Rejection Notice, SUPPLIER may require GENZYME to
return the rejected Custom Manufactured Product or
samples thereof (at SUPPLIER's cost) to SUPPLIER for
further testing, in which event such Custom Manufactured
Product or samples thereof as the case may be, shall be
returned by GENZYME to SUPPLIER. Upon receipt of the
rejected Custom Manufactured Product title to and risk
of loss associated with the rejected Custom Manufactured
Product shall transfer to SUPPLIER. If it is later
determined that GENZYME was not justified in rejecting
the Custom Manufactured Product, GENZYME shall reimburse
SUPPLIER for the costs of the return, as well as any
other costs or expenses incurred by SUPPLIER as a result
of the rejection or return and retest and title to and
risk of loss associated with such Custom Manufactured
Product shall transfer to GENZYME upon placement of the
Custom Manufactured Product on the designated carrier by
SUPPLIER.
10.4.4 DISPUTE RESOLUTION. GENZYME's basis for rejection shall
be conclusive unless SUPPLIER notifies GENZYME, within
thirty-five (35) days of receipt of the Rejection Notice
that it disagrees with such rejection. In the event of
GENZYME's receipt of such a notice by SUPPLIER,
representative samples of the Custom Manufactured
Product in question shall be submitted to a mutually
acceptable independent laboratory or consultant for
analysis or review, the costs of which shall ultimately
be paid by the party that is determined by the
independent laboratory or consultant to have been
incorrect in its determination of whether the Product
should be rejected. Should the fees associated with the
work conducted by the independent laboratory or
consultant be due upfront, each of GENZYME and SUPPLIER
shall each pay fifty percent (50%) of such upfront fees,
and the party that is determined by the independent
laboratory or consultant to have been incorrect in its
determination shall then reimburse the other party.
10.4.5 PAYMENT OBLIGATIONS SUSPENDED FOR REJECTED CUSTOM
MANUFACTURED PRODUCT. If any order of Custom
Manufactured Products is rejected by GENZYME under
Section 10.4, GENZYME's duty to pay all amounts payable
to SUPPLIER in respect of the rejected Custom
Manufactured Product shall be suspended until such time
as it is determined by an independent laboratory or
consultant that the Custom Manufactured Products in
question should not have been rejected by GENZYME. If
only a portion of an order is rejected, only the duty to
pay the amount allocable to such portion shall be
suspended.
11. CERTIFICATE OF ANALYSIS: OTHER DOCUMENTATION:
A Certificate of Analysis will accompany Custom Manufactured Products and
Biosurgery Products. SUPPLIER will accompany a Research Product with a
Certificate of Analysis upon GENZYME's reasonable advanced written request.
[**] and [**] shipments will also be accompanied with a certificate of
country of origin, expiration date, and batch number.
12. STORAGE: DELIVERY:
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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12.1 PACKAGING. All Products shall be packaged, marked and otherwise
prepared for shipment by SUPPLIER in accordance with the
Specifications, or if there are no such specifications for a
particular Product, SUPPLIER will use reasonable commercial
packaging practices. SUPPLIER shall mark on containers all
necessary handling, loading and shipping instructions. An itemized
packing list setting forth all Products shipped shall be included
with each shipment. SUPPLIER shall store and transport Biosurgery
Products in accordance with the specification set forth on
ATTACHMENT I.
12.2 STORAGE. [**]
12.3 SHIPMENT. With respect to Custom Manufactured Products and
Biosurgery Products, SUPPLIER shall arrange and prepay for shipping
to GENZYME or the Buying Entity (as applicable), GENZYME or the
Buying Entity shall reimburse SUPPLIER for such shipping charges,
and title and risk of loss for such Custom Manufactured Products
and Biosurgery Products shall pass to GENZYME or the Buying Entity
(as applicable) upon delivery to GENZYME or Buying Entity (as
applicable). With respect to Research Products, SUPPLIER shall ship
such Research Products using the GENZYME Federal Express account
number specified by GENZYME, and title and risk of loss for such
Research Products shall pass to GENZYME or the Buying Entity (as
applicable) upon delivery to Federal Express.
12.4 DELIVERY DATES. Delivery of Custom Manufactured Products and
Biosurgery Products (subject to Section 8.3), shall be [**] late
and no more than [**] early from agreed upon delivery date. If
SUPPLIER is unable to deliver a Custom Manufactured Product or
Biosurgery Product within this agreed upon time frame, SUPPLIER
will, if requested by GENZYME or its Buying Entity, ship such
product the fastest commercial manner available, at SUPPLIER'S
expense. SUPPLIER will ship any Research Products not available at
time of receipt of a Purchase Order by next-day delivery.
13. MANUFACTURING OBLIGATIONS: WARRANTIES:
13.1 CUSTOM MANUFACTURED PRODUCTS. SUPPLIER shall manufacture each
Custom Manufactured Product in accordance with the Custom
Manufactured Product Specifications, as set forth on ATTACHMENT C1.
C2. C3 and ATTACHMENT C4.
13.2 SPECIFICATIONS: DISCONTINUATION. SUPPLIER shall not change any
Specifications for, or discontinue the manufacture of, Custom
Manufactured Products or Biosurgery Products without GENZYME's
prior written agreement, which shall not be unreasonably withheld,
except as may be required to comply with applicable laws and
regulations and regulatory authority requirements, in which case
SUPPLIER shall notify GENZYME and provide GENZYME with information
regarding such change in accordance with the Change Notification
Process set forth on attached ATTACHMENT K. Furthermore, SUPPLIER
may make changes to or discontinue manufacture of Custom
Manufactured Product and Biosurgery Product manufacturing process
only in accordance with the Change Notification Process set forth
on attached ATTACHMENT K.
13.3 BIOSURGERY PRODUCTS. Biosurgery Products supplied to GENZYME shall
be under a GENZYME label, as incorporated in the Specifications
and/or applicable Supplemental Product Amendment. GENZYME shall
have no rights to use any trademark or logo of SUPPLIER in the
promotion, sale or distribution of its products or services.
SUPPLIER does not warrant that Biosurgery Product labeling
designated by GENZYME meets any applicable regulatory requirement.
13.4 CUSTOM MANUFACTURED PRODUCTS WARRANTY. Each Custom Manufactured
Product shipped hereunder shall, at the time it is made delivered
to GENZYME or any Buying Entity:
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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13.4.1 Meet such Custom Manufactured Product's Specifications;
13.4.2 Be manufactured in accordance with all applicable laws
and regulations;
13.4.3 Be conveyed to GENZYME or the Buying Entity with good
title; and
13.4.4 Not be adulterated or misbranded.
EXCEPT AS OTHERWISE SET FORTH IN THIS AGREEMENT, INCLUDING IN
SECTIONS 24 (INDEMNIFICATION) AND 26 (LIMITATION OF LIABILITY)
HEREOF, GENZYME'S REMEDY FOR ANY BREACH OF THE FOREGOING WARRANTIES
SHALL BE, AT GENZYME'S DISCRETION, EITHER REPLACEMENT OF THE
NON-CONFORMING CUSTOM MANUFACTURED PRODUCT OR, IF SUPPLIER CANNOT
REPLACE SUCH CUSTOM MANUFACTURED PRODUCT, REFUND OF THE CUSTOM
MANUFACTURED PRODUCT PRICE.
13.5 SUPPLIER BIOSURGERY PRODUCT WARRANTY. SUPPLIER warrants to GENZYME
that each Biosurgery Product shall at the time it is made available
to GENZYME or a Buying Entity (as applicable):
13.5.1 Meet the relevant Biosurgery Specifications attached
hereto as ATTACHMENT B2, F and G;
13.5.2 Be manufactured in substantial compliance with QSR or
other similar requirements to the extent that such other
applicable requirements have been incorporated into the
Biosurgery Product Specifications at the time of
manufacture of the Biosurgery Product;
13.5.3 Be packaged and shipped to GENZYME in a manner
consistent with the Biosurgery Product Specifications
attached hereto as ATTACHMENT B2, F and G;
13.5.4 Not be sold by SUPPLIER over a GENZYME label to Third
Parties for any purpose.
13.6 STERILITY. The determination as to whether each batch of a
Biosurgery Product is Sterile by the procedures defined in the
Biosurgery Product Specifications provides a small, but non-zero
probability that each and every container of a Biosurgery Product
produced as part of a batch of a Biosurgery Product, which batch is
in compliance with the Biosurgery Product Specifications, is not
Sterile. Biosurgery Product packaging and aseptic filling process
has not been qualified by the SUPPLIER to achieve or maintain a
defined sterility assurance level.
SUPPLIER DISCLAIMS ANY WARRANTY THAT EACH AND EVERY CONTAINER OF
BIOSURGERY PRODUCT SHALL BE STERILE.
13.7 GENZYME ACKNOWLEDGEMENTS.
13.7.1 GENZYME acknowledges that SUPPLIER has not qualified
Biosurgery Products for any human or animal diagnostic
or therapeutic application.
13.7.2 GENZYME acknowledges that SUPPLIER has no responsibility
with respect to whether components in the end product of
any GENZYME therapeutic or diagnostic process are
suitable for GENZYME's intended use, or for use in any
other process using a Biosurgery Product which is
practiced by GENZYME or any other party and which
involves the health of a human.
13.7.3 EXCEPT AS OTHERWISE SET FORTH IN SECTION 24
(INDEMNIFICATION) HEREOF, GENZYME'S SOLE REMEDY FOR ANY
BREACH OF THE FOREGOING WARRANTIES REGARDING BIOSURGERY
PRODUCTS SHALL BE, AT GENZYME'S-DISCRETION, EITHER
REPLACEMENT OF THE NON-CONFORMING BIOSURGERY PRODUCT OR,
IF SUPPLIER CANNOT REPLACE SUCH BIOSURGERY PRODUCT,
REFUND OF THE BIOSURGERY PRODUCT PRICE PAID.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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13.8 BIOSURGERY PRODUCT ISSUES. SUPPLIER shall notify GENZYME or the
applicable Buying Entity in writing immediately upon learning: (i)
that a Biosurgery Product delivered hereunder fails to meet the
Biosurgery Product Specifications; or (ii) of a deviation of the
Biosurgery Product batch records which could impact product
quality; and in each case initiate an investigation and implement
corrective action where commercially reasonably appropriate.
13.9 GENZYME BIOSURGERY PRODUCT WARRANTIES. GENZYME warrants that:
13.9.1 It has now and will maintain the technical and other
requisite competencies to determine the suitability of
the Biosurgery Products for the uses to which GENZYME or
its customers will put such Biosurgery Products;
13.9.2 the Biosurgery Product Specifications have been
determined by GENZYME to be adequate to confirm the
suitability of the Biosurgery Product, its packaging and
labeling supplied hereunder for the uses to which such
Biosurgery Product will be put by GENZYME or its
customers;
13.9.3 it shall ship Biosurgery Products in furtherance of its
provision of service to its customers only under
GENZYME's label;
13.9.4 GENZYME's processes are structured and will be operated
only in a manner in which the use of any Biosurgery
Product which is not Sterile shall be detected by
GENZYME prior to any use of the Biosurgery Product;
13.9.5 It shall perform diligently sufficient incoming
inspection to satisfy its obligations under this
Agreement and under all applicable laws, rules and
regulations.
13.10 LIMITATION OF WARRANTIES. SUPPLIER's warranties herein are personal
to the purchaser of Biosurgery Products, and shall not be construed
as running to the benefit of any Buying Entity's distributors or
its or their customers.
13.11 WARRANTY DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH
HEREIN, SUPPLIER MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH
RESPECT TO ANY PRODUCT, AND SUPPLIER DISCLAIMS ALL OTHER
WARRANTIES, EXPRESS AND IMPLIED, INCLUDING WITHOUT LIMITATION THE
IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE. SUPPLIER PROVIDES NO REPRESENTATIONS OR WARRANTIES THAT
THE PRODUCTS ARE SUITABLE FOR USE IN ANY THERAPEUTIC OR DIAGNOSTIC
PROCESS FOR HUMANS AND ANIMALS.
13.12 HERD MANAGEMENT. SUPPLIER agrees to conduct its Herd Management in
conformance with the [**] Processing Protocols attached hereto as
ATTACHMENT H to this Agreement.
13.13 TRACEABILITY. SUPPLIER will ensure traceability to the original
manufacturer of each raw material used in the manufacture of Custom
Manufactured Products and Biosurgery Products
13.14 SITE AUDIT. SUPPLIER will, within sixty (60) days of GENZYME's
reasonable written request, allow GENZYME to inspect that portion
of SUPPLIER's manufacturing facilities in which SUPPLIER
manufactures Products, provided that GENZYME signs SUPPLIER'S
standard site visit confidentiality agreement. SUPPLIER will work
with GENZYME's audit team to secure a mutually agreeable date for
such audit, respond to any reasonable questions, and take any
compliance issues that may arise into consideration.
13.15 REGULATORY INSPECTION. SUPPLIER shall provide written notification
of all inspections from any regulatory agencies that specifically
apply to Custom Manufactured Products and Biosurgery Products
within thirty (30) days of SUPPLIER's receipt of notice of such
inspections. These inspections include: ISO, FDA, EC, HPB, and MCA.
SUPPLIER shall
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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inform GENZYME within twenty-four (24) hours should any regulatory
or ISO approval be withdrawn for Custom Manufactured Products and
Biosurgery Products, if there are any recalls of items provided to
GENZYME, or if any regulatory agency initiates any enforcement
action against the SUPPLIER with respect to Custom Manufactured
Products and Biosurgery Products.
14. OTHER OBLIGATIONS:
14.1 TECHNICAL SEMINARS. SUPPLIER and GENZYME's Science and Research
Corporate Purchasing group will, from time to time, discuss the
provision of technical seminars by SUPPLIER at a central GENZYME
location.
14.2 QUARTERLY BUSINESS REVIEWS. SUPPLIER will conduct quarterly
business reviews coordinated with designated GENZYME personnel, to
monitor GENZYME's forecasts, business progress, on-time delivery
(of product listed in ATTACHMENTS B1, B2 and B4) and cost savings.
Such business reviews will review all areas of SUPPLIER'S business
that is directly related to GENZYME. SUPPLIER will supply such
business reviews to GENZYME no later than forty-five (45) days
after the close of the previous business quarter for international,
and thirty (30) days after the close of the previous business
quarter for domestic, and the parties will meet to discuss such
business reviews at a GENZYME location no later than sixty (60)
days after the close of each calendar quarter.
14.3 ACCOUNT ADMINISTRATION: GENZYME and SUPPLIER will assign a primary
individual to manage such party's account established by this
Agreement. Each party may request a change of the other party's
account manager upon written notice of at least ninety (90) days to
the other party, at which point the parties shall attempt to
resolve the issue.
14.4 GOVERNMENT APPLICATIONS.
14.4.1 SUPPLIER will cooperate with GENZYME by supporting any
FDA applications with appropriate technical information
available at that time to SUPPLIER.
14.4.2 GENZYME shall have the sole responsibility to obtain any
government authorizations necessary to test, distribute
or sell materials that use or incorporate the Biosurgery
Products.
14.4.3 To the extent that GENZYME determines that applications
to and approval from the FDA or other governmental
authority are necessary for a Biosurgery Product,
SUPPLIER will cooperate fully with GENZYME by providing
available technical information about the Biosurgery
Product to GENZYME for incorporation in GENZYME's
application
14.4.4 Should GENZYME request SUPPLIER to provide proof of
manufacture of a Biosurgery Product to a regulatory
authority, SUPPLIER shall cooperate and supply
information in response to such request. GENZYME shall
reimburse any reasonable out of pocket expenses incurred
by SUPPLIER in complying with GENZYME's request.
14.4.5 With respect to supply of Biosurgery Products for use in
a European or other non-U.S. country, all of the
provisions of this Section 14.4 and of Section 13.5
shall be construed to encompass the various equivalent
(or most nearly equivalent) regulatory agencies and
regulations applicable, to the extent that any
requirements of such other authorities which are
different than those of the U.S. government have been
incorporated by mutual written agreement in amended
Biosurgery Product Specifications. The parties shall
negotiate in good faith using reasonable efforts any
modifications to the provisions hereof occasioned by
virtue of the supply of Biosurgery Products to a
European country. The parties acknowledge and agree that
because Biosurgery Products to be supplied to European
countries pursuant to this Agreement is to be under a
GENZYME label, the primary responsibility lies with
GENZYME to identify the requirements
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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of the laws and regulations of each such country, and to
communicate such requirements to SUPPLIER in order to
amend the Biosurgery Product Specifications
appropriately.
15. TERMINATION:
15.1 TERM. The term of this Agreement is set forth in Section 3.
15.2 TERMINATION FOR BREACH. If one party defaults in the performance,
or fails to perform any of its material obligations under this
Agreement, and such default is not remedied, or significant
progress is not made towards resolving such default, within sixty
(60) days written notice from the non-defaulting party, then the
nondefaulting party shall have the right to terminate this
Agreement and avail itself of any and all rights and remedies to
which it may be entitled by law or in equity.
15.3 TERMINATION FOR BANKRUPTCY. Each party may terminate this Agreement
effective immediately without liability upon written notice to the
other if anyone of the following events occurs:
15.3.1 the other files a voluntary petition in bankruptcy or an
involuntary petition is filed against it;
15.3.2 the other is adjudged bankrupt;
15.3.3 a court assumes jurisdiction of the assets of the other
under federal reorganization act;
15.3.4 a trustee or receiver is appointed by a court for all or
a substantial portion of the assets of the other;
15.3.5 the other becomes insolvent or suspends business; or
15.3.6 the other makes an assignment of its assets for the
benefit of its creditors.
15.4 TERMINATION FOR INFRINGEMENT OR VIOLATION OF LAW. Each party may
terminate this Agreement, or may terminate supply of a particular
Product under this Agreement, upon sixty (60) days written notice
to the other party if it would constitute a violation of law for
the terminating party or its relevant Affiliate (i.e., a Buying
Entity or Selling Entity, as applicable) to fulfill its obligations
hereunder without (i) infringing the intellectual property of a
Third Party, breaching federal or other governmental regulations,
including but not limited to FDA requirements; or (ii) violating
any law.
15.5 EFFECT OF TERMINATION OR EXPIRATION.
15.5.1 PURCHASE ORDERS. Upon termination or expiration of this
Agreement, GENZYME either itself or through its Buying
Entities shall (i) take delivery of and pay for all
Products under any Purchase Order outstanding as of the
date of termination; (ii) take delivery of and pay for
all Biosurgery Products manufactured in reliance upon
the binding portion of the relevant forecast; (iii) each
Buying Entity shall not be relieved of the obligation to
purchase all Products for which it has placed Purchase
Orders; (iv) purchase all Products held in inventory as
of the date of termination by or for SUPPLIER pursuant
to the security of supply provision in Sections 9.1 or
10.2; and (v) SUPPLIER either itself or through its
Selling Entity will fulfill all Purchase Orders
submitted to SUPPLIER either itself or through its
Selling Entity prior to the effective date of
termination. In the event of any termination of this
Agreement, GENZYME shall be responsible for taking
delivery of Custom Manufactured Products and Biosurgery
Products under any outstanding Purchase Order only if
such Custom Manufactured Product or
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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Biosurgery Product has entered the manufacturing process
at the time of termination.
15.5.2 SUPPLY STOCK AND RAW MATERIALS. If this Agreement is
terminated by GENZYME for any reason, or if the
Agreement is terminated by SUPPLIER on account of breach
by GENZYME, GENZYME will purchase (i) all Custom
Manufactured Products and Biosurgery Products that may
reside in SUPPLIER inventory under outstanding Purchase
Orders and as set forth in Sections 9.1 or 10.2; and
(ii) any raw material (including [**]) purchased by or
for SUPPLIER specifically for manufacture of any Custom
Manufactured Product or Biosurgery Product in accordance
with an outstanding Purchase Order and/or, in the case
of Biosurgery Products, in accordance with the
the-binding portion of GENZYME's forecast. GENZYME may
request that SUPPLIER provide cost justification to
support such reimbursement. No termination shall relieve
GENZYME of its obligation to purchase all Products for
which it has placed Purchase Orders.
15.5.3 BIOSURGERY PRODUCTS. In the event of GENZYME's
termination of this Agreement for reason other than
SUPPLIER's breach or bankruptcy, and unless otherwise
agreed to by the parties, GENZYME shall accept delivery
and pay for all Biosurgery Products for which SUPPLIER
has commenced manufacture under the then-current GENZYME
Forecast, and GENZYMES shall reimburse SUPPLIER for its
direct, out-of-pocket costs of raw materials purchased
to manufacture such Biosurgery Products to the extent
such costs were authorized in writing by GENZYME and
SUPPLIER cannot reasonably use raw materials.
16. SBA SOCIO-ECONOMIC REPORTING:
GENZYME encourages SUPPLIER to use the following subcontractors and
suppliers among its sources of supply, as defined by the Fair Labor
Standards Act: Small Business, Small Disadvantaged, Service Disabled
Veteran Owned, Woman Owned, HubZoned Small Business, and Veteran Owned.
SUPPLIER shall supply GENZYME with SUPPLIER's Vendor Diversification Plan
upon GENZYME's written request.
17. CONFIDENTIALITY:
17.1 NONUSE AND NONDISCLOSURE OBLIGATIONS. Each party shall maintain as
confidential and shall not disclose, copy nor use for purposes
other than the performance of this Agreement, any information which
relates to the other party's business affairs, trade secrets,
technology, research and development, pricing, or the terms of this
Agreement ("CONFIDENTIAL INFORMATION") and each agrees to protect
that Confidential Information of the other with the same degree of
care it exercises to protect its own confidential information.
17.2 Exceptions. "Confidential Information" shall not include any
information that:
17.2.1 is within the public domain prior to the time of the
disclosure hereunder or thereafter becomes within the
public domain other than as a result of disclosure by
the receiving party in violation of this Agreement;
17.2.2 was in the possession of the receiving party on or
before the date of disclosure hereunder, as evidenced by
records, however maintained;
17.2.3 is acquired by a party hereto from a Third Party not
under an obligation of confidentiality;
17.2.4 the receiving Party must disclose by law, order,
subpoena, or regulation of a governmental agency or a
court of competent jurisdiction, provided the other
party receives prior written notice of such disclosure;
or
17.2.5 is hereafter independently developed by a party without
reference to or reliance upon the other party's
Confidential Information, as evidenced by records,
however maintained.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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17.3 INJUNCTIVE RELIEF. Breach of this Section 17 by one party may cause
irreparable damage to the other party and, therefore, the injured
party shall have the right to seek equitable and injunctive relief,
and to recover the amount of damages (including reasonable
attorney's fees and expense) incurred in connection with such
disclosure and/or unauthorized use.
17.4 EFFECT UPON TERMINATION OR EXPIRATION. Upon expiration or
termination of this Agreement, each party agrees to return to the
other or destroy all Confidential Information of the other, as the
other party may request. The obligations of confidentiality and
nonuse set forth in this Section 17 shall survive expiration or
termination of this Agreement.
18. INSURANCE:
18.1 INSURANCE COVERAGE. SUPPLIER, as its own expense, shall procure and
maintain during the Initial Term, insurance policies with the
following minimum coverages ("INSURANCE").
(a) [**]
(b) [**]
(c) [**]
18.2 PREMIUMS: PRIMARY COVERAGE. GENZYME shall not be liable for the
payment of any premium or assessments with respect to any of the
Insurance. GENZYME and each Buying Entity and their successors and
assigns (and their officers, directors, employees, agents, and
designees) shall be named as additional insured relative to
SUPPLIER'S performance of services and other activities on or about
the premises of each GENZYME or its Buying Entity. The Insurance
shall be primary for all purposes to other insurance coverage,
whether such other insurance is stated to be primary, contributory,
excess, contingent or otherwise, as respects any and all liability,
loss, claims, damages or expense arising out of the negligence or
alleged negligence of SUPPLIER or a Selling Entity.
19. WORK ON GENZYME'S PREMISES AND SECURITY:
19.1 PREMISES RULES. SUPPLIER'S employees shall, when on GENZYME'S
premises, conduct themselves in such a manner that the work does
not interfere with the operation of GENZYME'S business, and
strictly comply with all of GENZYME'S written rules for on-premises
work.
19.2 VEHICLE SEARCH. For security purposes, all vehicles, persons and
materials of or from SUPPLIER and its subcontractors, employees,
agents, representatives or invitees entering or exiting the
premises of GENZYME are subject to search upon request of any
representative of the Corporate Security Department of GENZYME.
19.3 LOSS OR THEFT. Any instances of theft or loss under this Agreement
involving SUPPLIER or any of its personnel, employees, agents,
representatives, subcontractors or invitees of which SUPPLIER
becomes aware shall be immediately reported to GENZYME.
20. RESEARCH PRODUCT WARRANTIES:
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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The SUPPLIER warrants to GENZYME that each Research Product shall conform
substantially to the description of such Research Product as provided in
the applicable catalog as referenced in Section 2.1.2 above and literature
accompanying the Research Products until their respective expiration dates
or, if no expiration date is provided, for six (6) months from the date of
the Buying Entity's receipt of the Research Products. SUPPLIER warrants
that all Research Products delivered hereunder will be new, of the grade
and quality specified by SUPPLIER, free from material defects in design,
material and workmanship, will conform to delivered samples and written
descriptions, and will be free of liens and encumbrances. The warranties
shall survive any delivery, inspection, payment or acceptance of the
Products. At its expense, SUPPLIER shall replace Research Products not
conforming to the foregoing warranties. GENZYME'S SOLE REMEDY FOR ANY
BREACH OF THE FOREGOING WARRANTIES SHALL BE REPLACEMENT OF THE
NON-CONFORMING RESEARCH PRODUCT OR, IF SUPPLIER CANNOT REPLACE SUCH
RESEARCH PRODUCT, REFUND OF THE RESEARCH PRODUCT PRICE PAID.
21. AUTHORIZED USES OF RESEARCH PRODUCTS:
Except as otherwise agreed in writing by an authorized representative of
SUPPLIER, the purchase and sale of Research Products hereunder only conveys
to GENZYME the non-transferable right for only GENZYME to use the purchased
quantity of Research Products in compliance with the applicable intended
use statement, limited use statement or limited label license, if any, in
SUPPLIER's written catalogs or more recent Research Product literature or
on the label or other documentation accompanying the Research Products (all
such statements or licenses being incorporated herein by reference as if
set forth herein in their entirety). Unless otherwise expressly indicated
in SUPPLIER's written catalogs or more recent Research Product literature,
or on the label or other documentation accompanying the Research Products,
GENZYME may use the Research Products for research use only and not for any
other purpose including, but not limited to, commercial purposes, in vitro
diagnostic purposes, ex vivo or in vivo therapeutic purposes,
investigational use, in foods, drugs, devices or cosmetics of any kind, or
for consumption by or use in connection with or administration or
application to humans or animals.
GENZYME acknowledges that the Research Products have not been tested by or
for SUPPLIER for safety or efficacy except as expressly stated in
SUPPLIER'S written catalogs or more recent product literature, or on the
label or other documentation accompanying the Research Products. Without
limiting the foregoing restrictions, GENZYME warrants to SUPPLIER that
should GENZYME use the goods for any use other than research, GENZYME shall
conduct all necessary tests, comply with all applicable regulatory
requirements, issue all appropriate warnings and information to subsequent
purchasers and/or users and be responsible for obtaining any required
intellectual property rights.
GENZYME agrees to comply with instructions for use of the Research
Products, if any, and not to misuse the Research Products. GENZYME also
agrees to inform its employees of the risks, if any, involved in using or
handling the Research Products and to train and equip them to handle the
Research Products safely. SUPPLIER will label all hazardous shipments in
accordance with HAZMA T standards.
GENZYME realizes that because SUPPLIER'S goods are intended primarily for
research purposes, they may not be on the Toxic Substances Control Act
(TSCA) inventory. GENZYME assumes responsibility to ensure that purchased
Research Products are approved for use under TSCA, if applicable.
GENZYME has the responsibility to conduct any research necessary to learn
the hazards involved for any of GENZYME'S uses of Research Products and to
warn GENZYME'S customers, employees and any auxiliary personnel (such as
freight handlers, etc.) of any risks
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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involved in GENZYME's use or handling of the Research Products. GENZYME
agrees to comply with instructions for use of the Research Products, if
any, and not to misuse the Research Products. If GENZYME is to repackage,
re-label or use a Research Product as a starting material or component of
other products, GENZYME will make commercially reasonable efforts to
qualify the Research Products for such applications, and comply with all
applicable laws and regulations relating to labeling or providing other
communications to customers. GENZYME also agrees to make commercially
reasonable efforts to inform its employees of the risks, if any, involved
in using or handling the Research Products and to train and equip them to
handle the Research Products safely. SUPPLIER will label all hazardous
shipments in accordance with HAZMAT standards.
22. [**] TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY COMPLIANCE. SUPPLIER warrants
that in the event that any Product that contains or is defined as being a
ruminant derived material(s) and/or material(s) derived from animals which
are susceptible to infection with transmissible spongiform encephalopathy
through the oral route, it shall provide GENZYME with a current Certificate
of Suitability (as defined in European Pharmacopoeia Monograph 2001: 1483,
Products With Risk of Transmitting Agents of Animal Spongiform
Encephalopathies - a sample of which is contained in ATTACHMENT L).
SUPPLIER shall be responsible for advising GENZYME of any changes to the
Certificate of Suitability in writing, and shall also provide an updated
copy of the Certificate of Suitability as soon as it becomes available.
SUPPLIER shall be responsible for identifying the Certificate of
Suitability 10 number and its expiration date on any Certificate of
Analysis for materials of Animal Origin (defined below). Within a
commercially reasonable time after receipt of GENZYME's written request,
SUPPLIER shall provide GENZYME with a Letter of Origin stating whether raw
materials used in the manufacture of a Product are synthetic or plant
derived, or if Animal Origin, whether the raw materials meet the
Certificate of Suitability requirements. Material shall be deemed of
"Animal Origin" if it is derived from animal tissues, cells, or body
fluids; an "animal" is defined as a higher eukaryotic organism, including
mammals (to include humans), fish, birds, reptiles, amphibians, insects,
mollusks, etc. Animal Origin does not include lower eukaryotic organisms
(including without limitation higher plants, fungi, protozoa and algae);
nor does it include prokaryotic organisms (including without limitation
bacteria or blue-green algae).
23. EXPORT CONTROL:
Neither SUPPLIER nor GENZYME shall export or re-export, either directly or
indirectly, any technical data relating to Products, incorporating the
other party's Confidential Information or any Product in contravention of
any laws or regulations of the United States, including but not limited to
the United States Export Administration Act of 1979 as amended, the Trading
With the Enemy Act, and the regulations of the U.S. Departments of
Commerce, Defense, State, Energy and Treasury, pursuant thereto.
24. INDEMNIFICATION:
24.1 [**]
24.2 [**]
24.3 [**]
24.4 [**]
25. COMPLIANCE WITH LAWS:
Each party represents and warrants that in the performance of this
Agreement, it and its relevant Affiliates (i.e., Selling Entities and
Buying Entities) shall comply with all applicable federal, state and local
laws, ordinances, rules, and regulations (including without limitation, and
if applicable,
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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40 CFR 720.3(ee)). Each party agrees to indemnify and hold harmless the
other from any and all liabilities, claims, demands, losses, costs, damages
or expenses regardless of the nature of same to the extent they arise from
any Third Party claim against such party for its or its relevant
Affiliate's failure to comply with such laws, ordinances, rules or
regulations.
26. LIMITATION OF LIABILITY:
Except for claims arising under Sections 17 (Confidentiality), neither
party shall be liable to the other for any indirect, incidental, special or
consequential damages (including, without limitation, any damages arising
from loss of use or lost business revenue, profits or goodwill) arising in
connection with this Agreement, whether in an action in contract, tort,
strict liability, warranty, or negligence even if advised of the
possibility of such damages. [**]
27. ASSIGNMENT:
The terms and provisions of this Agreement shall inure to the benefit of,
and be binding upon, GENZYME, SUPPLIER, and their respective successor and
assigns, including pursuant to a merger or consolidation; further, each
party may, without the consent of the other, assign its rights and
interests, and delegate its obligations hereunder, effective upon written
notice thereof to the other party: (a) to an Affiliate if such Affiliate
assumes all of the obligations of the assigning party hereunder and this
Agreement remains binding upon the assignor, or (b) to any entity that
acquires all or substantially all of the assets of a party to which this
Agreement pertains, or which is the surviving entity in a merger or
consolidation, if such entity assumes in writing all of the obligations of
a party hereunder. Any attempt to assign or delegate any portion of this
Agreement in violation of this Section 27 shall be null and void. Subject
to the foregoing, any reference to GENZYME or SUPPLIER hereunder shall be
deemed to include the successors thereto and assigns thereof.
28. JURISDICTION:
This Agreement is deemed to be made under and shall be interpreted in
accordance with the laws of the Commonwealth of Massachusetts.
29. SEVERABILITY: REMEDIES: WAIVER:
In the event that anyone or more provisions contained in this Agreement
shall be held by a court of competent jurisdiction to be invalid, illegal
or unenforceable in any respect, the validity, legality and enforceability
of the remaining provisions contained herein shall not in any way be
affected or impaired thereby.
The remedies contained herein are cumulative and in addition to, any other
remedies at law or equity. A failure to enforce, or waiver of a breach of,
any provision of this Agreement shall not constitute a waiver of any other
breach or of such provisions.
30. NOTICES:
All notices under this Agreement shall be in writing, properly addressed
and shall be deemed to have been duly given or received upon the earlier of
(i) if by personal service, when actually received, (ii) five business days
after sending by registered or certified mail, return receipt requested,
(iii) one business day after sending via a next business day commercial
delivery service, and such service obtains the signature of a
representative of the recipient; or (iv) one (1) day after transmission by
facsimile. Any notices not addressed as follows shall be deemed not to have
been give or received.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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For notices to SUPPLIER regarding forecasts or operation of this Agreement:
TO SUPPLIER (CUSTOM MANUFACTURED PRODUCTS): TO SUPPLIER (BIOSURGERY PRODUCTS):
Invitrogen Corporation Invitrogen Corporation
3175 Staley Road 3175 Staley Road
Grand Island, NY 14072 Grand Island, NY 14072
Attention: Arun Singhal Attention: Rick McAvoy
Tel: 716-774-6769 Tel: 716-774-6959
Fax: 716-774-6811 Fax: 716-774-6811
TO GENZYME: WITH A COPY TO:
Patti Nardi Douglas Hunt
Director, Supply Management Associate Director, CQS
Genzyme Corporation Genzyme Corporation
PO Box 9322 PO Box 9322
Framingham, MA 01701-9322 Framingham, MA 01701-9322
WITH A COPY TO:
Legal Department of Genzyme
One Kendall Square
Cambridge, MA 02139
For notices to SUPPLIER regarding interpretation, terms, termination, or breach
of this Agreement, all notices shall be sent via mail or commercial delivery
service:
TO INVITROGEN: WITH A COPY TO:
Invitrogen Corporation Invitrogen Corporation
1600 Faraday Avenue 1600 Faraday Avenue
Carlsbad, CA 92008 Carlsbad, CA 92008
Attention: Contracts Department Attention: General Counsel
Tel: 760-603-7200 Tel: 760-603-7200
Fax: 760-476-6326 Fax: 760-476-6326
TO GENZYME: WITH A COPY TO:
Patti Nardi Douglas Hunt
Director, Supply Management Associate Director
Genzyme Corporation Genzyme Corporation
PO Box 9322. PO Box 9322
Framingham, MA 01701-9322 Framingham, MA 01701-9322
WITH A COPY TO:
Legal Department of Genzyme
15 Pleasant Street Connector
Framingham, MA 10701
Notices to Buying Entities under this Agreement shall be delivered to those
entities at the locations and addresses identified on ATTACHMENT A.
31. ADVERTISING:
Without the prior written consent of each party's representative as
designated in Section 30, and except as permitted under Section 17, neither
GENZYME nor SUPPLIER shall in any manner advertise, publish, or disclose to
any Third Party the terms of this Agreement.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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32. STATUTES AND EXECUTIVE ORDERS:
The following statutes and Executive Orders ("EO's") together with
Regulations issued hereunder are made a part of this Agreement:
- Equal Opportunity (41 C.R.R. 60-14, EO 11246),
- Employment of Disabled Veterans, and Veterans of Vietnam
ERA (Sec. 60-250.4 of Title 41 C.F.R.)
- Employment of the handicapped (sec. 60-741.4 of title 41
C.F.R., EO 11758)
33. SURVIVAL:
All rights and obligations of the parties set forth herein that expressly
or by their nature survive the expiration or termination of this Agreement
(including, without limitation, rights and obligations under outstanding
Purchase Orders) shall continue in full force and effect subsequent to and
notwithstanding the expiration or termination of this Agreement until they
are satisfied or by their nature expire and shall bind the parties and
their legal representatives, successors, and permitted assigns. Without
limiting the foregoing, any of the provisions of this Agreement and/or its
Attachments dealing with Delivery, Payment, Warranty, Authorized Use,
Confidential Information and Advertising, Intellectual Property Indemnity,
Compliance with Laws, and Sections 2.2.8, 26, 28, 30, 34, 35, 36.4, 36.5
and 36.6=shall survive termination of this Agreement.
34. ADDITIONAL OR INCONSISTENT TERMS:
Any terms or conditions set forth in any invoice provided to GENZYME by
SUPPLIER or in any order provided to SUPPLIER by GENZYME (including,
without limitation, Purchase Orders) which is in any way different from,
inconsistent with or in addition to the terms and conditions set forth
herein will not become a part of this Agreement or be binding upon GENZYME
or SUPPLIER.
35. ENTIRE AGREEMENT:
This Agreement and its Attachments constitute the entire agreement between
the parties relating to the subject matter hereof, and supersedes and
replaces all prior agreements, written or oral; between the parties
regarding Products (including, without limitation, the Biosurgery
Agreement). Any modification or waiver of any provision must be made in
writing and signed by authorized representatives of each party.
36. GENERAL PROVISIONS.
36.1 NON-EXCLUSIVITY. SUPPLIER is not, and nothing in this Agreement
shall imply that SUPPLIER or Selling Entities are GENZYME's or
Buying Entities' exclusive manufacturer or supplier of Products.
GENZYME and Buying Entities are not, and nothing in this Agreement
shall imply that GENZYME or Buying Entities are, SUPPLIER's
exclusive purchaser of Products.
36.2 FORCE MAJEURE. Notwithstanding anything contained in this Agreement
to the contrary, and except for the obligation to make payment in
any event other than war or civil disturbance, neither GENZYME nor
SUPPLIER shall be liable for or considered to be in breach of this
Agreement as a result of failure or delay in fulfilling its
obligations under this Agreement where such failure or delay is due
either in whole or in part to any act of God, war, civil
disturbance, strike, labor dispute, fire, storm, earthquake,
shortage of power, labor, materials, or transport or act of any
government or other competent authority or any other circumstance
beyond the reasonable control of GENZYME or SUPPLIER (as the case
may be). This Agreement shall be deemed suspended as long as and to
the extent that any such cause prevents or delays its performance.
After sixty (60) cumulative days of such suspension on the part of
one party, the other party may, at
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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its sole discretion, terminate its obligations under this Agreement
with respect to the particular Product delayed by such force
majeure, without further liability.
36.3 INDEPENDENT CONTRACTOR. SUPPLIER shall furnish Products to GENZYME
as an independent contractor and not as an employee or agent of
GENZYME. Except as expressly stated herein, SUPPLIER may not act
for, bind, or represent GENZYME in any manner.
36.4 HEADINGS. Headings used herein are for descriptive purposes only
and shall not control or alter the meaning of this Agreement as set
forth in the text.
36.5 SEVERABILITY. Should one or more of the provisions contained in
this Agreement be held invalid, illegal or unenforceable by a court
or tribunal with jurisdiction to do so, then the validity, legality
and enforceability of the remaining provisions contained herein
shall not be affected or impaired thereby, unless the absence of
the invalidated provision(s) adversely affect the parties'
substantive rights. In such instance, the parties shall use their
best efforts to replace the invalid, illegal or unenforceable
provision(s) with valid, legal and enforceable provision(s) which,
insofar as practical, implement the purposes of this Agreement.
36.6 NO AMENDMENT: WAIVER. This Agreement shall not be amended except by
an instrument in writing executed by both parties. Failure of
either party at any time to enforce any of the provisions of this
Agreement shall not be deemed to be a waiver of such or any other
provision hereof.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized representatives.
Invitrogen Corporation (SUPPLIER) GENZYME CORPORATION (GENZYME)
By: By:
----------------------------------- ------------------------------
Name: Mark Bamforth Date
---------------------------------
Title: Title: SVP, Corporate Operations
--------------------------------
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
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ATTACHMENT A
GENZYME AUTHORIZED BUYING ENTITIES
<Table>
GENZYME Genzyme Genzyme Genzyme
CORPORATION * Corporation Corporation Corporation
(Headquarters) 31 New York 51 New York 76 New York
500 Kendall Street Avenue Avenue Avenue
Cambridge, MA Framingham, MA Framingham, MA Framingham, MA
02142 01701-9322 01701-9322 01701-9322
Telephone: 617- Telephone: 508- Telephone: 508- Telephone: 508-
252-7500 424-4300 424-4300 424-4300
Fax: 617-252-7600 Fax: 508-872-4091 Fax: 508-872-4091 Fax: 508-424-4066
Genzyme Genzyme Genzyme Genzyme
Corporation Corporation Corporation Corporation
80 New York 11 Pleasant Street One Mountain Road 45 New York
Avenue Connector Framingham, MA Avenue
Framingham, MA PO Box 9322 01701-9322 Framingham, MA
01701-9322 Framingham, MA Telephone: 508- 01701-9322
Telephone: 508- 01701-9322 872-8400 Telephone: 508-
424-4300 Telephone: 508- Fax: 508-872-9080 424-4300
Fax: 508-424-4066 872-8400 Fax: 508-872-4091
Fax: 508-872-9080
Genzyme Genzyme Genzyme Genzyme
Corporation Corporation Corporation Corporation
74 New York 78 New York 15 Pleasant Street 5 Mountain Road
Avenue Avenue Connector Framingham, MA
Framingham, MA Framingham, MA PO Box 9322 01701-9322
01701-9322 01701-9322 Framingham, MA Telephone: 508-
Telephone: 508- Telephone: 508- 01701-9322 872-8400
424-4300 424-4300 Telephone: 508- Fax: 508-872-9080
Fax: 508-424-4066 Fax: 508-872-4091 872-8400
Fax: 508-872-9080
GENZYME Genzyme
CORPORATION Corporation
(Diagnostics (Diagnostics
Business Unit Business Unit
Headquarters) Location)
One Kendall Square 6659 Top Gun
Cambridge, MA San Diego, CA
02139 92121
Telephone: 617- Telephone: 858-
252-7500 452-3198
Fax: 617-252-7600 Fax: 858-452-3258
</Table>
<Page>
<Table>
GENZYME GENZYME
CORPORATION PHARMACEUTICALS
(Pharmaceuticals Sygena Facility
Business Unit Eichenweg 1
Headquarters) CH 4410 Liestal
500 Kendall Street SWITZERLAND
Cambridge, MA Telephone: 011-41-
02142 061-906-5959
Telephone: 617- Fax: 011-41-061-
252-7500 906-5958
Fax: 617-252-7600
GENZYME Genzyme Genzyme
CORPORATION Corporation Corporation
(Biosurgery Division (Biosurgery Division (Biosurgery Division
Headquarters) Location) Location)
500 Kendall Street 64 Sidney Street 65 Railroad Avenue
Cambridge, MA Cambridge, MA Ridgefield, NJ
02142 02139 07657
Telephone: 617- Telephone: 617-
252-7500 494-8484
Fax: 617-252-7600 Fax: 617-494-6561
GENZYME Genzyme Genzyme Genzyme
CORPORATION Corporation Corporation Corporation
(Genetics Business (Genetics Business (Genetics Business (Genetics Business
Unit Headquarters) Unit Location) Unit Location) Unit Location)
Metro West Place 2000 Vivigen Way One Corporate 6991 E. Camelback
15 Pleasant Street Santa Fe, NM Drive Road
Connector 87505 Yonkers, NY Suite B295
PO Box 9322 Telephone: 505- 10701-6807 Scottsdale, AZ
Framingham, MA 438-1111 Telephone: 914- 85251
01701-9322 Fax: 505.A38-1120 969-3399 Telephone: 602-
Telephone: 508- Fax: 914-969-2019 675-0250
872-8400 Fax: 602-675-0210
Fax: 508-872-5663
Genzyme Genzyme Genzyme
Corporation Corporation Corporation
(Genetics Business (Genetics Business (Genetics-
Unit Location) Unit Location) Pasadena)
10421 University 1054 Town & 11 West Del Mar
Center Drive #100 Country Road Pasadena, CA
Tampa, FL 33612- Orange, CA 92868 91105
6422 Telephone: 714- Telephone: 800-
Telephone: 813- 245-9259 255-1616
979-9442 Fax: 714-245-9259
Fax: 813-972-4632
</Table>
<Page>
<Table>
Genzyme Genetics Genzyme Genetics Genzyme Genetics Genzyme Genetics
I m path Impath Impath Impath
521 West 5ih St. Receiving Location Receiving Location Receiving Location
New York NY 10019 5340 Alia Rd. 5300 McConnell 625 West 55th St.
Los Angeles CA Ave. 5th Floor
90066 Los Angeles, CA New York, NY
90066 10019
Genzyme Genetics Genzyme Genetics
I m path I m path
Receiving Location Receiving Location
518 West 58th St. 810 East Hammond
5th Floor In.
New York, NY Phoenix, AZ 85034
10019
GENZYME DRUG GENZYME
DISCOVERY AND GLYCOBIOLOGY
DEVELOPMENT RESEARCH INSTITUTE
153 Second Avenue 800 Research
Waltham, MA Parkway, Suite 200
01254 Oklahoma City, OK
Telephone: 781- 73104
290-5890 Telephone: 405-
Fax: 781-290-5890 271-8144
Fax: 405-271-1030
GBL WEST MAILING GENZYME LTD GENZYME GENZYME FLANDERS
50 Gibson Drive 37 Hollands Road WATERFORD NV
Kings Hill, West Haverhill IDA Business Park Cipalstraat 8
Mailing Suffolk CB9 8PU Kilmeadan Road B-2440 Geel
Kent ME194AF UNITED KINGDOM Waterford BELGIUM
UNITED KINGDOM Telephone: 011-44- IRELAND Telephone: 011-32-
Telephone: 011-44- 1440-703-522 Telephone: 011- 1456-4911
1732-22-0022 Fax: 011-44-1440- 353-51-594-100 Fax: 011-32-1456-
Fax: 011-44-1732- 707-783 Fax: 011-353-51- 4916
22-0024 594-105
GENZYME (FORMERLY GENZYME (FORMERLY
SANGSTAT) SANGSTAT)
58,Avenue 1541, Avenue
Debourg Marcel Merieux
B.P. 7055 69280 Marcy
F-69348 Lyon L'Etoile
Cedex 07 FRANCE
FRANCE Telephone: +33 (0)4
Telephone: +33 (0)4 37 22 58 1 0
37 28 16 88 Fax +33 (0)4 37 22
Fax: +33 (0)4 37 28 5898
1695
</Table>
<Page>
ATTACHMENT B1
CUSTOM MANUFACTURED PRODUCTS
ATTACHED TO THE AGREEMENT
[ ** ]
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
<Page>
ATTACHMENT B2
BIOSURGERY PRODUCTS
ATTACHED TO THE AGREEMENT
[ ** ]
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
<Page>
ATTACHMENT B3
RESEARCH PRODUCTS
ATTACHED TO THE AGREEMENT
[ ** ]
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
<Page>
ATTACHMENT D
LIST OF ACCOUNT MANAGERS FOR INVITROGEN
<Table>
UNITED STATES BELGIUM
Invitrogen Corporation 1600 Pieters, Stefan Telephone vert commandes:
Faraday Avenue Sr Account Manager 0800 23 20 79
PO Box 6482 Hoogwegel71 B-8470 Fax vert commandes:
Carlsbad, California 92008 Gistel Gistel, Belgium 0800 13 58 13
Phone: (760) 603-7200 FAX: +32 59 27 39 76 Order Enquiries:
(760) 602-6500 Email: serviceclients@invitroqen.com
Rich Allred Gielen, Kurt Euro Tech-LinesM - 0800 91 83 92
(800) 955-6288 x61423 Technical Sales Representative Graaf Email: eurotech@invitroqen.com
de Theuxlaan 25 Heusden-Zolder
Andrews, Rick Belgium 3550 General Web Enquiries:
BioProduction Specialist +3247531 0397 Email: eurowebinfo@invitroqen.com
972-396-5396
GERMANY
.V. Invitrogen SA
Customer Service Darlene Hundelgemsesteenweg 284 9820 Miebach, Anton
Adams Merelbeke Senior Account Manager Westfeldgasse 19
716) 774-6642 Phone: 09 272 5599 Koeln 0-5 1143
Grand Island, New York FAX: 09 272 5598 Germany
Email: euroinfo@)invitroqen.com +49 2203 982245
U.S. Electronic (Web) Orders Hours of FREE PHONE ORDERS: Invitrogen GmbH
operation: 8:00 AM - 8:00 PM EST 0800 14894 Technologiepark Karlsruhe Emmy-
Phone: (800) 955- 6288, Option 3, ORDERING ENQUIRIES: Noether Strasse 10
x46029 Email: ordersbel@invitroqen.com 76131 Karlsruhe
FAX: (800) 331-2286 Email: euroinfo@invitrogen.com
Email: catalog@invitrogen.com Technical Information:
Euro Tech-LinesM - 0800 16369 Email: Gebi.ihrenfreie Bestellungen:
U.S. Supply Center Orders Hours of eurotech@)invitroqen.com Tel: 0800 083 09 02
operation: 8:00 AM - 8:00 PM EST General Web Enquiries: Fax: 0800 083 34 35
Phone: (800) 955-6288, Option 3, x45430 Email: eurowebinfo@invitroqen.co ill Order Enquiries:
FAX: (800) 331-2286 Email: orders germanv@invitrogen.co ill
Email: suppycenters@invitrogen.
com Technical Enquiries:
Euro Tech-LinesM - 0800 181 54 50
U.S. Custom Primer Orders Hours of CANADA Email: eurotech@invitrogen.com
operation: 8:00 AM - 8:00 PM EST
Phone: (800) 955-6288, Option 3, Invitrogen Canada Inc. 2270 General Web Enquiries:
x46636 Industrial St Burlington, Ontario Email: eurowebinfo@invitrogen.com
FAX: (800) 331-2286 L7P 1A1
Email: primers@invitrogen.com Phone: 1-800-263-6236 FAX: UNITED KINGDOM
1-00-387-1007
Invitrogen Ltd
3 Fountain Drive
Inchinnan Business Park Paisley
UK
PA4 9RF
Phone: 0141 8146100
FAX: 0141 814 6260
Email: euroinfo@invitrogen.com
</Table>
<Page>
<Table>
U.S. TECHNICAL SERVICES FRANCE
Hours of operation: 9:00 AM - 8:00 Invitrogen SARL Free Phone Orders:
PM EST BP 96 0800 269 210
FAO/ASK US 95613 Cergy Pontoise Cedex Free Fax Orders:
Phone: (800) 955-6288 Phone: 01 34 32 31 00
FAX: (800) 352-1468 FAX: 01 30 37 50 07
Email: tech service@invitrogen.com Email: euroinfo@invitrogen.com
</Table>
<Page>
ATTACHMENT E
GENZYME ACCOUNTS PAYABLE CONTACTS
US Invoices. Unless otherwise specified, all US invoices (with the exception of
EDI invoices as referenced below) shall be sent by mail to the following
address:
GENZYME Corporation
P.O. Box 9322
Framingham, MA 01701-9322 USA
International Invoices. Unless otherwise specified, all non-US (International)
Invoices shall be sent to applicable GENZYME locations at the appropriate
address specified in Attachment A.
<Page>
ATTACHMENT F
SUPPLEMENTAL PRODUCT AMENDMENT FOR BIOSURGERY PRODUCTS
Pursuant to Section 8.2 of that certain PURCHASE AND SUPPLY AGREEMENT entered
into by and between Genzyme Corporation ("GENZYME") and Invitrogen Corporation
("Invitrogen") dated December -' 2003.
SUPPLIER agrees to manufacture for the Biosurgery Division of GENZYME the
following Biosurgery product (referred to herein as the "Biosurgery Product," ,
subject to the warranties and limitations set forth herein. The Biosurgery
Product formulation and packaging components are attached.
SUPPLIER will manufacture the Biosurgery Product in accordance with
specifications attached here (the "Specifications"). SUPPLIER's warranty's for
the Biosurgery Products are as set forth in the Purchase and Supply Agreement. A
copy of the Certificate of Analysis that defines the Specifications is attached.
In witness whereof each of the parties has caused its authorized representative
to execute this Supplemental Product Amendment on the date specified below.
Invitrogen Corporation Genzyme Corporation
Name: Name:
-------------------------------- -----------------------------------
Signature: Signature:
--------------------------- -----------------------------
Title: Title:
------------------------------- ---------------------------------
Date: Date:
-------------------------------- ----------------------------------
<Page>
ATTACHMENT G
GENZYME MATERIALS
AND MATERIALS SPECIFICATIONS
ATTACHED TO THE AGREEMENT
[ ** ]
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
<Page>
ATTACHMENT J
SUPPLEMENTAL PRODUCT AMENDMENTS ATTACHED TO THE AGREEMENT
[ ** ]
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
<Page>
ATTACHMENT L
CERTIFICATION OF SUITABILITY OF MONOGRAPHS OF THE EUROPEAN PHARMACOPOEIA
ATTACHED TO THE AGREEMENT
[ ** ]
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.
<Page>
COUNCIL OF EUROPE
EUROPEAN DIRECTORATE FOR
THE QUALITY OF MEDICINES
CERTIFICATION OF SUITABILITY OF MONOGRAPHS
OF THE EUROPEAN PHARMACOPOEIA
CERTIFICATION NO. RO-CEP 2000-171-REV. 03
Name of the substance:
DONOR BOVINE SERUM
(New Zealand Origin)
Name of Holder:
INVITROGEN CORPORATION
3175 Staley Road
USA - 14072 Grand Island, New York
Sites of production:
Main Site:
INVITROGEN NEW ZEALAND LIMITED
18-24 Botha Road
NZ-Penrose, Auckland
Backup or overflow sites:
INVITROGEN CORPORATION INVITROGEN LIMITED
3175 Staley Road 3 Fountain Drive, Inchinnan Business Park
USA - 14072 Grand Island, New York GB - Paisley PA4 9RF Scotland
THIS CERTIFICATE SUPERSEDES THE PREVIOUS CERTIFICATE
R0-CEP 2000-171-REV 02
After examination of the information provided on the origin of raw material(s)
and type of tissue(s) used an d on the manufacturing process for this substance
on the sites of production mentioned above, NZ - Penrose, Auckland, USA - 14072
Grand Island, New York and GB-Paisley PA4 9RF Scotland, we certify that the
substance DONOR BOVINE SERUM meets the criteria described in the monograph
Products with risk of transmitting agents of animal spongiform encephalopathies
(no. 1483, Ph. Eur. 4th Ed. And any subsequently revised version).
- - country of origin of source materials: New Zealand
- - nature of animal tissues used in manufacture: Bovine blood
The submitted dossier must be updated every five years or after any significant
modification of the manufacturing method, the country(ies) or origin or the
nature of the tissues used that may alter the risk of transmitting animal
spongiform encephalopathy agents or require changing the specifications of the
monograph.
Manufacture of the substance shall take place in accordance with a suitable
quality assurance system such as GMP and ISO 9001, and in accordance with the
dossier submitted.
Failure to comply with these provisions will render this certificate void.
The certificate is valid provided that there has been no deterioration in the
TSE status of the country(ies) of origin of the source material.
<Page>
This certificate is granted within the framework of the procedure established by
the European Pharmacopoeia Commission [Resolution AP-CSP (93) 5 as amended] for
a period of five years starting from 15 December 2000. Moreover, it is granted
according to the provisions of Directive 2001/83/EC and Directive 2001/82/EC and
any subsequent amendment, and the related guidelines.
THIS CERTIFICATE HAS 41 LINES ONLY.
/s/ Dr. A. Artiges
-----------------------------------
Dr. A. Artiges
Director of Quality of Medicines
Strasbourg, 26 February 2003
Declaration of access (TO BE FILLED IN MY THE CERTIFICATE HOLDER UNDER THEIR OWN
RESPONSIBILITY)
INVITROGEN CORPORATION, as holder of the certificate of suitability
RO-CEP 2000-171-Rev 03 for DONOR BOVINE SERUM
Hereby authorizes
--------------------------------------------------------------
(name of the pharmaceutical company)
to use the above-mentioned certificate of suitability in support of their
application(s) for the following Marketing Authorisation(s): (name of product(s)
and marketing number(s), if known)
Date and signature (of the CEP holder):