Exhibit 10.1


 


Amended and Restated Purchase and Supply
Agreement


 


Between


 


Genzyme
Corporation & Invitrogen Corporation


 


Contract
# SPM-254-3


 


January
1, 2008 to December 31, 2011


 


1

















 


	
  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. Force Majeure

  
	
   

  	
   

  
	
   

  	
  20. Research Product Warranties

  
	
   

  	
   

  
	
   

  	
  21. Authorized use of Research Products

  
	
   

  	
   

  
	
   

  	
  22. [**]/Transmissible Spongiform Encephalopathy Compliance

  
	
   

  	
   

  
	
   

  	
  23. Export Control

  



 






[**] = 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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  24.
  Indemnification

  
	
   

  	
   

  
	
   

  	
  25.
  Compliance Laws

  
	
   

  	
   

  
	
   

  	
  26.
  Limitation of Liability

  
	
   

  	
   

  
	
   

  	
  27.
  Assignment

  
	
   

  	
   

  
	
   

  	
  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: Genzyme 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 and prices of Genetics Products

  
	
   

  	
   

  
	
   

  	
  Attachment
  C: Specifications, Certificates of Analysis,

  
	
   

  	
   

  
	
   

  	
  Attachment
  D: List of Account Managers

  
	
   

  	
   

  
	
   

  	
  Attachment
  E: Genzyme Accounts Payable Contacts

  
	
   

  	
   

  
	
   

  	
  Attachment
  F: Supplemental Product Amendment for Biosurgery
  Products

  



 






[**] = 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
  G: Genzyme Materials and Materials Specifications

  
	
   

  	
   

  
	
   

  	
  Attachment
  H: [**] Protocols

  
	
   

  	
   

  
	
   

  	
  Attachment
  I: Biosurgery Refrigeration & Transportation
  Requirements

  
	
   

  	
   

  
	
   

  	
  Attachment
  J: Supplemental Product Amendments

  
	
   

  	
   

  
	
   

  	
  Attachment
  K: Change or Discontinuation Notification Process

  
	
   

  	
   

  
	
   

  	
  Attachment
  L: Certification of Suitability of Monographs of the
  European Pharmacopoeia

  
	
   

  	
   

  
	
   

  	
  Attachment M:
  Reserve Requirements

  
	
   

  	
   

  
	
   

  	
  Attachment
  N: Disaster Recovery Plan

  
	
   

  	
   

  
	
   

  	
  Attachment
  O: Belgium Amendment No. 1 to Supply Agreement No
  SPM 254

  
	
   

  	
   

  
	
   

  	
  Attachment
  P: Genzyme On-Site Stockroom Programs

  



 


AMENDED AND RESTATED
PURCHASE AND SUPPLY AGREEMENT


 


This Purchase
and Supply Agreement (the “Agreement”)
effective December 31, 2007 (“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, 
a Massachusetts corporation with a principal place of business at 500
Kendall Street , Cambridge, MA 02142 and Genzyme Therapeutics Products Limited
Partnership, C/O Genzyme Center, 500 Kendall Street, Cambridge, MA 02142 (“Genzyme”)


 


Recitals:


 


A.    Genzyme
and Supplier previously entered into a purchase and supply agreement effective
January 1st, 2005 (the “Prior Agreement”).
For good and valuable consideration the receipt and sufficiency of which are
hereby acknowledged, the parties wish to amend and restate in its entirety
the  Purchase and Supply Agreement with
this Amended and Restated Purchase and Supply Agreement


 


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:


 






[**] = 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.


 


4

















 


1.             Definitions:


 


1.1.                  “Affected Product” shall mean Changed Products and discontinued
Products, as defined in Attachment K.


 


1.2.                  “Affected Product Effective Date” shall mean the date on which
the change or discontinuation giving rise to an Affected Product Notice is to
be implemented. In the case of multiple changes to a Changed Product, the
Affected Product Effective Date shall be the date of the first such change.


 


1.3.                  “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.


 


1.4.                  “Authorized Buying Entities” shall have the meaning set forth
in Section 2.2 hereof.


 


1.5.                  “BioProduction” means any materials that are procured to a
Genzyme part number and specification as contained in Attachment B1 and B2.


 


1.6.                  “[**] Product” shall
mean any Product that contains, or is defined as being, a [**].


 


1.7.                  “Certificate of Suitability” shall have the meaning set forth
in European Pharmacopoeia Monograph 2001:1483, Products With Risk of
Transmitting Agents of Animal Spongiform Encephalopathies. A sample Certificate
of Suitability is set forth on Attachment A
hereto.


 


1.8.                  “Changed Product” shall mean any (i) Product, a component,
element or ingredient of which has changed, or (ii) Product for which the
process used for manufacturing such Product has changed.


 


1.9.                  “Consigned Inventory”
shall mean Products owned by Supplier and stored in a Stockroom as specified in
Attachment P hereof.


 


1.10.                “Core
Product” shall mean any franchised Product that Supplier maintains
in its catalog.


 


1.11.                [**].


 


1.12.                [**].


 


1.13.                “Custom-Manufactured
Products” shall mean non-catalog-based
Products manufactured according to Material Specifications provided by
Genzyme for Genzyme use only and not for sale to any other third party.


 






[**] = 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.


 


5

















 


1.14.                “Disaster”
shall mean any unplanned interruption of the operations of, or inaccessibility
to, Supplier’s manufacturing, shipping or storage facilities during which
Supplier requires relocation of any or all of its operations relating to
Products (the “Product Operations”) to an alternative facility or facilities
(each a “Recovery Location”).


 


1.15.                “Disaster Recovery Plan” shall mean a document defining the resources, actions, tasks and data
required for Supplier to continue its operations in the event of a business
interruption. [**]


 


1.16.                [**].


 


1.17.                “FDA” means the U.S. Food and Drug Administration.


 


1.18.                [**].


 


1.19.                “Lead
Time” shall mean the period of time between submission of an Order
by Genzyme and delivery to Genzyme of the Products included in such Order. A
description of Lead Times for each category of Product is set forth in Section
3.1 hereto.


 


1.20.                “List
Price” shall mean [**].


 


1.21.                “Manufacturer”
shall mean the manufacturer of a Product, but shall not include Supplier or any
Affiliate of Supplier.


 


1.22.                “Material Specifications” shall mean  specific
and detailed information regarding the composition, shipping, handling and
storage guidelines and other information necessary to properly manufacture,
ship and store a Product, including, without limitation, the identity of and
contact information for the Manufacturer, Part Number, sampling plan, safety
considerations, expiration date and retest instructions, Supplier certificate
requirements, Genzyme test requirements, and storage conditions.


 


1.23.                “Materials
of Animal Origin” shall mean material 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. Materials of Animal Origin shall not include material
derived from lower eukaryotic organisms (including without limitation higher
plants, fungi, protozoa and algae); nor does it include material derived from
prokaryotic organisms (including without limitation bacteria or blue-green
algae).


 


1.24.                [**].


 


1.25.                “On-Site
Personnel” shall mean employees, consultants, subcontractors or
other personnel employed or engaged by Supplier to perform services on its
behalf at a Genzyme facility.


 


1.26.                “Order”
shall mean an order provided by Genzyme or an Authorized Buying Entity to
Supplier for the purchase and delivery of Products to a location specified by
Genzyme or an Authorized Buying Entity pursuant to this Agreement. An Order may



 






[**] = 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.


 


6

















 


include, without limitation, (1) a purchase order, (2) a website order,
and/or (3) a procurement card order. All Orders shall be accompanied by a
corresponding control number and subject to the terms and conditions contained
herein, whether such Order references this Agreement or not.


 


1.27.                “PPL Schedule” – Product Price List – this is a
categorization in which related product lines are placed and managed. This list
carries detailed descriptions and packaging designations. The PPL also displays
list price for the products within.


 


1.28.                “Part Number” shall mean a unique, Genzyme-issued number identifying a particular
Product and the Manufacturing Specifications specific to such Product.


 


1.29.                “Person”
shall mean any individual, partnership, corporation, firm, association,
unincorporated organization, joint venture, trust or other entity.


 


1.30.                “Products”
has the meaning set forth in Section 2.1 and may include (i) Custom-Manufactured Products; (ii) Capital
Equipment; (iii) items listed in a catalog (“Catalog
Products”); (iv) bulk catalog items (“Bulk
Products”); or (v) custom-packaged items listed in a catalog,
whether separately or in bulk (“Special Products”).
“Products” does not include services, custom products not listed in
Section 2.1 and software products.


 


1.31.                [**].


 


1.32.                “Product
Transition Period” shall mean the period beginning on the date of
Genzyme’s receipt of an Affected Product Notice and ending on (i) the
Affected Product Effective Date or (ii) the date which is nine (9) months
from such date, whichever is longer.


 


1.33.                “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 __ in accordance
with Section 6.


 


1.34.                “QSR” means regulations set forth in FDA’s Quality System
Regulations at 21 C.F.R. Part 820.


 


1.35.                “Quote”
shall mean a quotation provided by Supplier to Genzyme [**].


 


1.36.                “Reference Price”
shall mean, as of any particular date, the price  of
a Product in effect on  such date in
the previous year.


 


1.37.                “Special
Handling” shall mean increased freight and delivery charges required
to ship a Product (i) that has been classified as (a) hazardous material,
(b) oversized, or (c) a direct factory shipment and has been labeled as such in
any catalog, flyer or other promotional material of the Supplier; or
(ii) on an expedited basis at Genzyme’s request.


 


1.38.                “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.


 






[**] = 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.


 


7

















 


1.39.                “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.


 


1.40.                “Summary
Invoice” shall mean a monthly invoice in Microsoft Excel format sent
by Supplier to Genzyme that shall include all Orders (including, without
limitation, withdrawals of Consigned Inventory, Orders made using procurement
cards and Supplier website Orders) filled by Supplier during the relevant
monthly period.


 


1.41.                “Term”
shall mean the Initial Term and all Extended Terms, if any.


 


1.42.                “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, 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”).


 


2.1.4        [**].


 


Products does not
include 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.


 






[**] = 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.


 


8

















 


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. All
parties agree that Attachment O will specifically apply to Genzyme Belgium
purchases.


 


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 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,
2011  (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 


 






[**] = 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.


 


9

















 


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           Currency
Exchange. Prices for Custom Product purchases by non-U.S. Buying
Entities will be based on the List Price for such Custom Products as set
forth in this Agreement and adjusted to local currency using a
currency exchange rate determined as follows:  at the beginning of
each calendar year, the exchange rate for the applicable currency shall be
set for such calendar year as the previous year’s
average exchange rate for such currency as calculated from data published
at Oanda.com.  For clarity, the exchange rate for a given currency shall
be set at the beginning of the year and shall be applicable for the entire
calendar year.


 


4.3           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.


 


4.4           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.


 


4.5           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           [**].


 


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. [**].


 






[**] = 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.


 


10

















 


5.4           Price
and Payment Terms for [**]Batches.


 


The pricing
for the [**]is set forth in Attachment B 1. Delivery of the [**] will be
consistent with terms outlined in Section 10.1 of the Supply Agreement. [**].


 


5.5           Price
and Payment Terms for [**] Batches.


 


[**].


 


5.6           Pricing
for Research Products.


 


5.6.1        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. [**].


 


5.6.2        [**].


 


5.6.3        [**]


 


5.6.4        [**].


 


5.6.5        [**]


 


5.7           Contingency
Manufacturing Site and Disaster Recovery Plan. Will be reviewed annually
during a Quarterly Business Review Meeting where [**].


 


5.7.1 Raw
Material Safety Stock: [**]


 


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 


 






[**] = 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.


 


11

















 


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) [**] prior to the requested delivery date(s);
(ii) for [**],[**] prior to the requested delivery date(s); (iii) for
Biosurgery Products (excluding [**]),[**] 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
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 [**] shall be
[**] months from date of the Purchase Order.


 






[**] = 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.


 


 


12

















 


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 products
that is not subject to a SPA, Supplier and Genzyme shall review execute an SPA 


 






[**] = 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.


 


13

















 


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 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 there from.


 


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 upon [**] 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 or otherwise at Genzyme’s sole
discretion:


 


[**]


 


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 pre-shipment
sample was taken shall be 


 






[**] = 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.


 


14

















 


“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 therefore (“Security 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


 






[**] = 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.


 


15

















 


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 pre-shipment sample in accordance with Section 10.2.1.


 


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 Biosurgerv
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 


 






[**] = 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.


 


16

















 


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.


 


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 


 






[**] = 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.


 


17

















 


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.           Packaging, Storage
and Delivery:


 


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.
[**].


 






[**] = 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.


 


18

















 


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.


 


13.1.1      Manufacturing
Change or Discontinuance Notification: Refer to Attachment K.


 


13.1.2      Reliability
Analysis of Affected Products. Upon
Genzyme’s request, Supplier shall provide to Genzyme a sample of sufficient
quantity (as determined in Genzyme’s sole discretion), paid for by Genzyme for
Genzyme to perform a reliability analysis on such Affected Product. Supplier
acknowledges that such analysis may take up to nine (9) months to complete, and
agrees to provide an appropriate sample of the Affected Product as soon as
practical following a request from Genzyme.


 


13.1.3      Large Volume
Orders and Storage. Supplier will
continue to supply all of Genzyme’s requirements for any Affected Product
during the Product Transition Period as described in Attachment K


 


13.2         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.


 


13.3         Custom
Manufactured Products Warranty. Each Custom Manufactured Product 


 






[**] = 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.


 


19

















 


shipped
hereunder shall, at the time it is made delivered to Genzyme or any Buying
Entity:


 


13.3.1      Meet
such Custom Manufactured Product’s Specifications;


 


13.3.2      Be
manufactured in accordance with all applicable laws and regulations;


 


13.3.3      Be
conveyed to Genzyme or the Buying Entity with good title; and


 


13.3.4      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.


 


13.4         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):


 


13.4.1      Meet
the relevant Biosurgery Specifications attached hereto as Attachment B2,  and
Attachment G;


 


13.4.2      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;


 


13.4.3      Be
packaged and shipped to Genzyme in a manner consistent with the Biosurgery
Product Specifications attached hereto as Attachment B2  and G


 


13.4.4      Not
to be sold by Supplier over a Genzyme label to Third Parties for any purpose.


 


13.5         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.


 






[**] = 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.


 


20

















 


13.6         Genzyme
Acknowledgments.


 


13.6.1      Genzyme
acknowledges that Supplier has not qualified Biosurgery Products for any human
or animal diagnostic or therapeutic application.


 


13.6.2      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.


 


13.6.3      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.


 


13.7         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.


 


13.8         Genzyme Biosurgery
Product Warranties. Genzyme warrants that:


 


13.8.1      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;


 


13.8.2      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;


 


13.8.3      It
shall ship Biosurgery Products in furtherance of its provision of service to
its customers only under Genzyme’s label;


 


13.8.4      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;


 


13.8.5      It
shall perform diligently sufficient incoming inspection to satisfy its
obligations under this Agreement and under all applicable laws, rules and
regulations.


 


13.9         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.


 






[**] = 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.


 


21

















 


13.10         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.


 


13.11         Herd
Management. Supplier agrees to conduct its Herd Management in conformance
with the [**] Processing Protocols attached hereto as Attachment H to
this Agreement.


 


13.12        Traceability.
Supplier will ensure traceability to the original  manufacturer of each
raw material used in the manufacture of Custom Manufactured Products and
Biosurgery Products


 


13.13         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.


 


13.14         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 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 B 1, 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.


 






[**] = 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.


 


22

















 


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 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.


 






[**] = 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.


 


23

















 


15.2 Termination for Cause.
Either Party may terminate this Agreement in the event the other Party refuses,
declines or fails to perform or otherwise breaches its material obligations
under this Agreement and such breach is not cured within thirty (30) days after
receiving written notice from the non-breaching Party specifying the nature of
the failure to perform or breach. If more than thirty (30) days is reasonably
required to cure the failure to perform or breach, and the defaulting Party
diligently pursues the cure during such thirty (30)-day period, the period to
cure shall be extended a minimum of an additional thirty (30) days prior to the
termination being effective.


 


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 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, 


 






[**] = 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.


 


24

















 


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 without [**])
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 Genzyme 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 is an
equal employment opportunity employer and is a federal contractor.
Consequently, the parties agree that, to the extent applicable, they will
comply with Executive Order 11246, the Vietnam Era Veterans Readjustment
Assistance Act of 1974 and Section 503 of the Vocational Rehabilitation Act of
1973 and also agree that these laws are incorporated herein by this
reference.  Supplier also agrees to comply with the provisions of
Executive Order 13201 Compliance (29 CFR Part 470), relating to the notice of
employee rights concerning payment of union dues.


 


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


 






[**] = 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.


 


25

















 


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.


 


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         Minimal Insurance Coverage Limits. 
Without limiting the scope of its aforementioned defense, hold harmless and
indemnity duties, Provider shall maintain at its sole cost and expense the
following insurance coverage:


 


[**]


 


 


18.2         Certificates of Insurance.  At the request of Genzyme, Supplier
will furnish Genzyme a true copy of a certificate of coverage issued by the
responsible insurance carrier.


 


18.3         [**].


 


18.4         [**].


 


 


18.5         [**].


 


 


18.6         [**].


 


19.           FORCE MAJEURE


 


19.1         General.  No
failure or omission by a Party (the “Incapacitated Party”) in the performance
of any obligation of this Agreement shall create any liability to the other
Party (the “Affected Party”) if such failure or omission arises from any
unforeseeable cause(s) beyond the reasonable control of the Incapacitated
Party, including without limitation the following: acts of God; fire; storm;
flood; earthquake; war; terrorism, sabotage; quarantine restrictions; labor
strike; and freight embargo (collectively, “Force Majeure”). In the event of
any delay or inability to perform arising pursuant to Force Majeure, the
Incapacitated Party shall notify the Affected Party within eight (8) business
hours following the occurrence of any qualifying event.


 






[**] = 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.


 


26

















 


19.2         Response by
Supplier. Upon the occurrence of a Force Majeure
where Supplier is the Incapacitated Party and such Force Majeure continues for
five (5) consecutive days following its initial occurrence, the Supplier shall
provide Genzyme with a proposal to remedy the situation (“Contingency Plan
Proposal”). Genzyme shall then have five (5) days to review and approve the
Contingency Plan Proposal or suggest changes to the Contingency Plan Proposal
which Supplier shall have one (1) day to review and approve or amend which the
above time frame will govern. If Supplier is unwilling or unable to make the
changes to the Contingency Plan Proposal suggested by Genzyme, Genzyme may
terminate this agreement on ten (10) days written notice.


 


19.3         Response by
Genzyme. Upon the occurrence of a Force Majeure
where Genzyme is the Incapacitated Party, Genzyme’s performance shall be
postponed by such length of time (the “Suspension Period”) as may be reasonably
necessary to compensate for the delay or inability to perform and Supplier’s
performance shall be postponed by a length of time equal to the Suspension
Period.


 


19.4         Contingency
Plan. Supplier shall put into place, with
Genzyme’s written approval, a contingency plan based on the Contingency Plan
Proposal and Genzyme instructions (“Contingency Plan”) to be used in the event
of Force Majeure conditions such as those described above. The purpose of the
Contingency Plan is to maintain, as consistently as possible and with complete
integrity in respect of quality and to Genzyme’s reasonable satisfaction,
Supplier’s supply of Products to Genzyme.


 


19.5         Disaster
Recovery. Supplier represents and warrants that
it has adopted and will maintain a complete integrity in respect of quality and
to Genzyme’s reasonable satisfaction, Supplier’s supply of Products to Genzyme
in the event of a Disaster. Supplier shall notify Genzyme immediately after
Supplier deems an event to be a Disaster. Immediately following a Disaster,
Supplier shall move the affected Product Operations to a Recovery Location as
expeditiously as possible to ensure the uninterrupted supply of Products to
Genzyme.


 


19.5.1      Communications.
Supplier shall work with Genzyme to establish a plan for alternative
communications in the event of a Disaster.


 


19.5.2      No
Warranty. Genzyme acknowledges that the Disaster
Recovery Plan is designed to minimize, but may not eliminate, risks associated
with a Disaster affecting Product Operations. Supplier does not warrant that
Product Operations will be uninterrupted in the event of a Disaster.


 


19.5.3      Reporting
Obligations. A current and
complete copy of the Disaster Recovery Plan in effect on the Effective Date is
set forth on Attachment N hereto. On June 30
and December 31 of each year during the Term, Supplier shall deliver to Genzyme
a copy of the then-current Disaster Recovery Plan with a statement describing
any changes made to the Disaster Recovery Plan during the previous six month
period.


 


20.           Research Product
Warranties:


 


The Supplier
warrants to Genzyme that each Research Product shall conform substantially to
the 


 






[**] = 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.


 


27

















 


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:


 


21.1         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.


 


21.2         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.


 


21.3         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.


 


21.4         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.


 


21.5         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 involved in Genzyme’s use or handling of the Research Products. Genzyme
agrees to comply with instructions 


 






[**] = 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.


 


28

















 


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 HAZMA T 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 [**].


 






[**] = 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.


 


29

















 


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, 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 


 






[**] = 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.


 


30

















 


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.


 


For notices to
Supplier regarding forecasts or operation of this Agreement:


 


To Supplier
(Custom Manufactured Products):


 


Invitrogen
Corporation 3175 Staley Road Grand Island, NY 14072 


Attention:
Beth Webb Tel: 617-630-0242


Fax:
617-630-0243


 


To Genzvme:


Emily Nault


Supply
Management Genzyme Corporation


PO Box 9322


Framingham, MA
01701-9322


 


To Supplier
(Biosurgery Products):


Invitrogen
Corporation 3175 Staley Road


Grand Island,
NY 14072 Attention: Rick McAvoy Tel: 716-774-6959


Fax:
716-774-6811


 


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 Genzvme:


Emily Nault


Supply
Management Genzyme Corporation


PO Box 9322.


Framingham, MA
01701-9322


 


With a Copy
to:


Legal
Department of Genzyme


500 Kendall Street


Cambridge, MA 02142


 


Notices to
Buying Entities under this Agreement shall be delivered to those entities at
the locations and addresses identified on Attachment A.


 






[**] = 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.


 


31

















 


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.


 


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 Refer to section 19.


 


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 


 






[**] = 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.


 


32

















 


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)


 


By:


 


Name:
Bernd Brust


 


Title:  Sr.
VP. Worldwide Sales


 


 


GENZYME
CORPORATION (GENZYME)


 


By:


 


Name: Mark
Bamforth


 


Title:  Sr.
VP. Corporate Operations and Pharmaceuticals


 






[**] = 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.


 


 


33

















 


Attachment
A


 


Genzyme Global Buying Entities


 


Corporations


Genzyme
Corporation * (Headquarters)


500
Kendall Street

Cambridge, MA 02142

Telephone: 617-252-7500

Fax: 617-252-7600


 


Authorized
Buying Entities


Genzyme
Corporation

80 New York Avenue

Framingham, MA  01701-9322

Telephone:  508-424-4300

Fax:  508-424-4066


 


Genzyme
Corporation

74 New York Avenue

Framingham, MA  01701-9322

Telephone:  508-424-4300

Fax:  508-424-4066


 


Genzyme
Corporation

31 New York Avenue

Framingham, MA  01701-9322

Telephone:  508-424-4300

Fax:  508-872-4091


 


Genzyme
Corporation

11 Pleasant Street Connector

PO Box 9322

Framingham, MA  01701-9322

Telephone:  508-872-8400

Fax:  508-872-9080


 


Genzyme
Corporation

78 New York Avenue

Framingham, MA  01701-9322

Telephone:  508-424-4300

Fax:  508-872-4091


 


Genzyme
Corporation

51 New York Avenue

Framingham, MA  01701-9322

Telephone:  508-424-4300

Fax:  508-872-4091


 


Genzyme
Corporation

One Mountain Road

Framingham, MA  01701-9322

Telephone:  508-872-8400

Fax:  508-872-9080


 


Genzyme
Corporation

15 Pleasant Street Connector

PO Box 9322

Framingham, MA  01701-9322

Telephone:  508-872-8400

Fax:  508-872-9080


 


Genzyme
Corporation

76 New York Avenue

Framingham, MA  01701-9322

Telephone:  508-424-4300

Fax:  508-424-4066


 


Genzyme
Corporation

45 New York Avenue

Framingham, MA  01701-9322

Telephone:  508-424-4300

Fax:  508-872-4091


 


Genzyme
Corporation

5 Mountain Road

Framingham, MA  01701-9322

Telephone:  508-872-8400

Fax:  508-872-9080


 


Genzyme
Corporation

(Diagnostics Business
Unit Headquarters)

One Kendall Square

Cambridge, MA  02139

Telephone:  617-252-7500

Fax:  617-252-7600


 


Genzyme
Corporation

(Diagnostics Business Unit Location)

6659 Top Gun

San Diego, CA 92121

Telephone:   858-452-3198

Fax:  858-452-3258


 


Genzyme
Corporation

(Pharmaceuticals
Business Unit Headquarters)

500 Kendall Street

Cambridge, MA 02142

Telephone: 617-252-7500

Fax: 617-252-7600


 






[**] = 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.


 


34

















 


Genzyme
Corporation

(Molecular Oncology
Division Headquarters)

MetroWest Place

15 Pleasant Street Connector

PO Box 9322

Framingham, MA  01701-0322

Telephone:  505-271-2627

Fax:  508-271-2604


 


Genzyme
Corporation

(Therapeutics Business
Unit Headquarters)

500 Kendall Street

Cambridge, MA 02142

Telephone: 617-252-7500
 Fax: 617-252-7600


 


Genzyme
Corporation

(Biosurgery Division
Headquarters)

500 Kendall Street

Cambridge, MA 02142

Telephone: 617-252-7500

Fax: 617-252-7600


 


Genzyme
Corporation

(Biosurgery Division Location)

64 Sidney Street

Cambridge, MA  02139

Telephone:  617-494-8484

Fax:  617-494-6561


 


Genzyme
Corporation

(Biosurgery Division Location)

65 Railroad Avenue

Ridgefield, NJ  07657


 


Genzyme
Corporation

(Genetics Business
Unit Headquarters)

MetroWest Place

15 Pleasant Street Connector

PO Box 9322

Framingham, MA  01701-9322

Telephone:  508-872-8400

Fax:  508-872-5663


 


Genzyme
Corporation

(Genetics Business Unit Location)

6991 E. Camelback Road

Suite B295

Scottsdale, AZ  85251

Telephone:  602-675-0250

Fax:  602-675-0210


 


Genzyme
Corporation

(Genetics-Pasadena)

11 West Del Mar

Pasadena, CA 91105

Telephone: 800-255-1616


 


Genzyme
Corporation

(Genetics Business Unit Location)

2000 Vivigen Way

Santa Fe, NM  87505

Telephone:  505-438-1111

Fax:  505-438-1120


 


(Genetics
Business Unit Location)

10421 University Center Drive #100

Tampa, FL  33612-6422

Telephone:  813-979-9442

Fax:  813-972-4632


 


Diagnostic
Testing

4310 E. Cotton Center Blvd

Suite 120

Phoenix, AZ 85040

Tel: 602-254-6620

Fax: 602-254-7340

Toll free: 800-645-6626


 


Diagnostic
Testing

655 East Huntington Drive

Monrovia, CA 91016

Tel: 626-471-9922

Fax: 626-471-7510

Toll free: 800-255-1616


 


(Genetics
Business Unit Location)

1054 Town & Country Road

Orange, CA  92868

Telephone:  714-245-9259

Fax:  714-245-9259


 


Genzyme
Genetics | Impath

521 West 57th St.

New York NY 10019


 


Genzyme
Genetics | Impath

Receiving Location

625 West 55th St.

5th Floor

New York, NY 10019


 


Genzyme
Genetics | Impath

Receiving Location

5340 Alla Rd.

Los Angeles CA 90066


 


Genzyme
Genetics | Impath

Receiving Location

518 West 58th St.

5th Floor

New York, NY 10019


 


Genzyme
Genetics | Impath

Receiving Location

5300 McConnell Ave.

Los Angeles, CA 90066


 


Genzyme
Genetics | Impath

Receiving Location

810 East Hammond Ln.

Phoenix, AZ 85034


 


Genzyme
Drug Discovery and Development

153 Second Avenue

Waltham, MA  01254


Telephone:  781-290-5890

Fax:  781-290-5890


 






[**] = 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.


 


35

















 


Genzyme
Glycobiology Research Institute

800 Research Parkway,
Suite 200

Oklahoma City, OK  73104

Telephone:  405-271-8144

Fax:  405-271-1030


 


GBL West
Malling

50 Gibson Drive

Kings Hill, West Malling

Kent  ME19 4AF

UNITED KINGDOM

Telephone:  011-44-1732-22-0022

Fax:  011-44-1732-22-0024


 


Genzyme
Flanders NV

Cipalstraat 8

B-2440 Geel

BELGIUM

Telephone:  011-32-1456-4911

Fax:  011-32-1456-4916


 


Genzyme
Pharmaceuticals

Sygena Facility

Eichenweg 1

CH 4410 Liestal

SWITZERLAND

Telephone:  011-41-061-906-5959

Fax:  011-41-061-906-5958


 


Genzyme
Ltd

37 Hollands Road

Haverhill

Suffolk CB9 8PU

UNITED KINGDOM

Telephone:  011-44-1440-703-522

Fax:  011-44-1440-707-783


 


Genzyme
(formerly Sangstat)

58, Avenue Debourg

B.P. 7055

F-69348 Lyon Cedex 07

FRANCE

Telephone: +33 (0)4 37 28 16 88

Fax: +33 (0)4 37 28 16 95


 


Genzyme
Virotech GmbH

Lowenplatz 5

D-65428 Ruesselsheim

GERMANY

Telephone:  011-49-6142-69-0963

Fax:  011-49-6142-82-621


 


Genzyme
Waterford

IDA Business Park

Kilmeadan Road

Waterford

IRELAND

Telephone:  011-353-51-594-100

Fax:  011-353-51-594-105


 


Genzyme (formerly Sangstat)

1541, Avenue Marcel Mérieux

69280 Marcy L’Etoile

FRANCE

Telephone: +33 (0)4 37 22 58 10

Fax +33 (0)4 37 22 58 98


 






[**] = 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.


 


36

















 


Attachment
B-1


 


Bioproduction
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.


 


37

















 


Attachment
B2


 


Biosurgery
Products


 


[**]


 






[**] = 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.


 


38

















 


Attachment
B3


 


Research
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.


 


39

















 


Attachment
B4


 


GENETICS
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.


 


40

















 


Attachment
C


 


SPECIFICATIONS


 


[**]


 






[**] = 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
D


 


LIST OF
ACCOUNT MANAGERS FOR INVITROGEN


 


WILL BE
PROVIDED AT THE YEARLY BUSINESS REVIEW


 






[**] = 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.


 


42

















 


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.


 






[**] = 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.


 


43

















 


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:

  	
   

  	
   

  
										



 






[**] = 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.


 


44

















 


ATTACHMENT
G


 


GENZYME
MATERIALS

AND MATERIALS SPECIFICATIONS


 


[**]


 






[**] = 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.


 


45

















 


ATTACHMENT
H


 


[**] PROTOCOLS


 


[**]


 






[**] = 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.


 


46

















 


ATTACHMENT
I


 


Biosurgery
Refrigeration and Transportation 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.


 


47

















 


ATTACHMENT
J


 


SUPPLEMENTAL
PRODUCT AMENDMENTS


[**]


 


ATTACHMENT
K


 


Change
or Discontinuation 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.


 


48

















 


ATTACHMENT
M


 


RESERVE
REQUIREMENTS


 


[**]


 


ATTACHMENT
N


 


DISASTER
RECOVERY PLAN


 


[**]


 






[**] = 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.


 


49

















 


ATTACHMENT
O


 


SPECIAL
REQUIREMENTS for GENZYME’S BELGIUM FACILITY


 


[**]


 






[**] = 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.


 


50

















 


ATTACHMENT
P


 


GENZYME
ON-SITE STOCKROOM PROGRAMS


 


[**]


 






[**] = 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.


 


51