Exhibit 10.9

 

MASTER SUPPLY AGREEMENT

 

THIS MASTER SUPPLY AGREEMENT (hereinafter referred to as the “Master Agreement”)
with an effective date of this 30th day of June 2010 (the “Effective Date”) is
made by and among Genzyme Corporation, a Massachusetts corporation having its
headquarters at 500 Kendall Street, Cambridge, Massachusetts 02142, U.S.A.,
Genzyme Ireland Limited, a wholly-owned subsidiary company of Genzyme
Corporation, organized under the laws of the Republic of Ireland with a
principal place of business in Waterford, Ireland, and its and their Affiliates
(collectively, hereinafter referred to as “Genzyme”), and Hospira
Worldwide, Inc., a Delaware corporation having its headquarters at 275 North
Field Drive, Lake Forest, Illinois 60045, U.S.A. (hereinafter referred to as
“Hospira”).

 

GENERAL PROVISIONS; AGREEMENT STRUCTURE

 

From time to time, Genzyme may request Hospira to provide Services (as defined
herein).  This Master Agreement contains general terms and conditions under
which Genzyme will engage Hospira to provide Services, and under which Hospira
will provide such Services.  Genzyme and Hospira shall complete and execute a
Project Statement of Work relative to each Product.

 

ARTICLE 1.        DEFINITIONS

 

The following words and phrases when used herein with capital letters shall have
the meanings set forth or referenced below:

 

1.1          “Act” shall mean the United States Federal Food, Drug and Cosmetic
Act (21 U.S.C. 301), as amended from time to time.

 

1.2          “Affiliate” shall mean any corporation or non-corporate business
entity which controls, is controlled by, or is under common control of a Party
to this Master Agreement.  A corporation or non-corporate business entity shall
be regarded as in control of another corporation or non-corporate business
entity if it owns, or directly or indirectly controls, in excess of fifty
percent (50%) of the voting stock of the other corporation, or (a) in the
absence of the ownership of in excess of fifty percent (50%) of the voting stock
of a corporation, or (b) in the case of a non-corporate business entity, if it
possesses, directly or indirectly, the power to direct or cause the direction of
the management and policies of such corporation or non-corporate business
entity, as applicable.

 

1.3          “Alliance Team” shall have the meaning set forth in Section 7.8.

 

1.4          “Applicable Law” shall mean all laws applicable to the
Manufacturing, processing, and distribution of the Products, including, without
limitation, the Act and the regulations promulgated thereunder; the Canadian
Food and Drugs Act (R.S., chapter F-27) and related regulations; European
Directive 2003/94/EC and 2001/83/EC, and related legislation; the Japanese
Pharmaceutical Affairs Law, 2003 (as amended); all applicable cGMP; and all
other corresponding laws, ordinances, rules and regulations of any other
applicable jurisdiction.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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1.5          “Bulk” or “Bulk Product(s)” shall mean the active ingredient of the
Products in bulk form that (i) meets the applicable Bulk Specifications, and
(ii) Genzyme delivers to Hospira for incorporation into the Products.

 

1.6          “Bulk Specifications” shall mean the detailed description and
parameters of the Bulk as specified in the relevant Project SOW.

 

1.7          “Business Day” shall mean any day on which banking institutions in
New York, New York, United States are open for business.

 

1.8          “Certificate of Analysis” shall mean a document, signed by an
authorized representative of Hospira and provided to Genzyme, that sets forth
the analytical test methods and the results thereof in relation to the Product
Specifications for a specified lot or batch of Product(s).

 

1.9          “Certificate of Compliance” shall mean a document, signed by an
authorized representative of Hospira and provided to Genzyme, that certifies,
warrants and reflects that a particular lot, batch, or run of Product(s) was
Manufactured in accordance with cGMP, Applicable Law, and the Product
Specifications.  The Certificate of Compliance may be included within the
Certificate of Analysis, or separately, as specified by Genzyme.

 

1.10        “cGMP” shall mean those principles and guidelines of good
manufacturing practices as set forth in 21 C.F.R. Parts 210 and Part 211; the
good manufacturing practices provisions contained in Part C, Division 2 of the
Canadian Food and Drugs Regulations; EU Directive 2003/94/EC - guidelines of
good manufacturing practices for medicinal products for human use (EudraLex Vol.
4); Japanese GMP regulations, ordinances and practice guidelines as contained in
the Pharmaceutical Affairs Law; the ICH Guideline on Good Manufacturing Practice
for Active Pharmaceutical Ingredients (ICH Q7A), adopted by EU Directive
2004/27; and the corresponding requirements of each other applicable
jurisdiction; and all other relevant rules, regulations or guidelines of global
good manufacturing practices adopted and in effect in any other regulatory
jurisdiction, as applicable.

 

1.11        “Commercial Product” shall mean a filled or finished Product as
Manufactured by Hospira for Genzyme’s commercial sale, pursuant to a given
Project SOW, in accordance with the requirements of the Product Specifications
incorporated therein.

 

1.12        “Confidential Information” shall mean all information disclosed
hereunder, except that which:

 

(a)           is lawfully known to the recipient at the time of the disclosure,
as evidenced by its written records or other competent evidence;

 

(b)           is disclosed to the recipient by a third person lawfully in
possession of such information and not under an obligation of nondisclosure;

 

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[**] = 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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(c)           is or becomes published or otherwise part of the public domain
through no fault of the recipient; or

 

(d)           is developed by or for the recipient independently of Confidential
Information disclosed hereunder as evidenced by the recipient’s written records
or other competent evidence.

 

1.13        “Consent” shall mean any consent, authorization, permit,
certificate, license, approval, or exemption by any Regulatory Authority or
other person.

 

1.14        “Dedicated Equipment” shall have the meaning set forth in
Section 7.2.

 

1.15        “Development Product” shall mean the pharmaceutical product, as
specified in the applicable Project SOW, Manufactured by Hospira for Genzyme’s
pre-clinical, clinical, and/or regulatory purposes.

 

1.16        “Development Project” shall mean Services necessary for regulatory
approval and Manufacture of the Products for clinical, non-commercial purposes.

 

1.17        “DMFs” shall mean Drug Master Files as set forth in Section 4.3.

 

1.18        “Exclusivity Period” shall have the meaning set forth in
Section 7.9(a).

 

1.19        “Facility” shall mean Hospira’s fill and finish Manufacturing
facility at McPherson, Kansas and/or Liscate, Italy, or such other fill and
finish manufacturing facility operated by Hospira, and approved by Genzyme.

 

1.20        “Force Majeure” shall have the meaning set forth in Section 15.1.

 

1.21        “Fill Slot Forecast” shall have the meaning set forth in
Section 8.1.

 

1.22        “FDA” shall mean the United States Food and Drug Administration, and
any successor agency thereto.

 

1.23        “Firm Order Period” shall have the meaning set forth in Section 8.3.

 

1.24        “Inability to Supply” shall have the meaning set forth in
Section 9.5.

 

1.25        “Letters of Authorization” shall mean documentation which shall be
prepared and delivered by Hospira to the appropriate Regulatory Authorities
permitting such Regulatory Authorities to consult Hospira’s DMFs in their review
of Genzyme’s Product marketing applications (as set forth in Section 4.3).

 

1.26        “Manufacture”, “Manufactured” or “Manufacturing” shall mean the
filling and/or finishing of Products, in each case as specified in the
applicable Project SOW.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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1.27        “Master Batch Record” shall mean the document that defines the
manufacturing methods, materials, and other procedures, directions and controls
associated with the Manufacture and testing of the Product, which may be amended
in writing from time to time by mutual agreement of the Parties.

 

1.28        “MSDS” shall have the meaning set forth in Section 7.4.

 

1.29        “Notice Period” shall have the meaning set forth in
Section 7.9(a)(ii).

 

1.30        “Occurrence” shall have the meaning set forth in Section 7.1(f)(i).

 

1.31        “Parties” shall mean Genzyme and Hospira together, with each
individual entity being a “Party”.

 

1.32        “Person(s)-in-the-Plant” shall have the meaning set forth in
Section 10.3(c)(e).

 

1.33        “Product” or “Products” shall mean any filled and finished drug
product comprised of Bulk and, where applicable, excipients and other raw
materials, in each case as specified in the applicable Project SOW.  A list of
Products covered under this Master Agreement is set forth on Exhibit 1.33
hereto.  The Parties may amend Exhibit 1.33 from time to time during the Term by
written agreement of the Parties.

 

1.34        “Product Fill Slot Commitment” shall have the meaning set forth in
Section 8.1.

 

1.35        “Product Specifications” shall mean the product, labeling and
performance specifications for a Product, approved by the FDA or other relevant
Regulatory Authorities, including Product formulae, labeling, and materials
required for the Manufacture of the specific Product that is to be purchased and
supplied under the relevant Project SOW.

 

1.36        “Project” shall mean the totality of the technology transfer,
development, Manufacturing and/or other Services that Hospira will perform under
a relevant Project SOW.

 

1.37        “Project Statement of Work” or “Project SOW” shall mean a written
order for the performance of Services by Hospira for each Product, substantially
in the form attached hereto as Exhibit 2.5, signed by duly authorized
representatives from both Parties and referencing this Master Agreement.

 

1.38        “Project Inventions” shall have the meaning set forth in
Section 12.3.

 

1.39        “Purchase Orders” shall have the meaning set forth in Section 8.4.

 

1.40        “Quality Technical Agreement” shall have the meaning as set forth in
Section 10.2.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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1.41        “Regulatory Authority” shall mean any federal, state or local or
international regulatory agency, department, bureau or other governmental entity
including, without limitation, the FDA, which is responsible for issuing
approvals, licenses, registrations or authorizations necessary for the
Manufacture, use, storage, import, transport or sale of Product in the
Territory.

 

1.42        “Relationship Managers” shall have the meaning set forth in
Section 14.4.

 

1.43        “Renewal Term” shall have the meaning set forth in Section 13.1.

 

1.44        “Service” or “Services” shall mean the technology transfer,
development and/or Manufacturing services and/or other services to be performed
by Hospira, as described in each Project SOW and initiated by Genzyme as
described in Article 2.

 

1.45        “Service Fees” shall have the meaning set forth in Section 3.1.

 

1.46        “Specially Regulated Waste” shall mean any hazardous waste, toxic
waste, medical waste, nuclear waste, mixed waste, or other waste materials or
by-products, including waste water, which may be subject to or require special
handling, treatment, storage, or disposal under any federal, state or local laws
or regulations intended to address such types of waste materials that arise from
the Manufacture of Product.

 

1.47        “Technical Contact” shall have the meaning set forth in Section 3.3.

 

1.48        “Term” shall have the meaning set forth in Section 13.1.

 

1.49        “Territory” shall mean those countries of the world where Genzyme
intends to market, promote, distribute and/or use the Product, as specified in
the relevant Project SOW.

 

1.50        “Third Party” shall mean a Party other than Hospira or Genzyme and
their respective Affiliates.

 

1.51        “Waste” shall mean all rejects, improper goods, garbage, refuse,
remainder, residue, waste water or other discarded material, including solid,
liquid, semisolid, or contained gaseous material that arises from the
Manufacture of the Products including, but not limited to, rejected or
unsuitable materials, Bulk or Products.  The term Waste shall not include any
Specially Regulated Waste.

 

1.52        “Yield Metrics” shall have the meaning set forth in
Section 7.1(g)(i).

 

ARTICLE 2.        PROJECT OVERVIEW

 

2.1          General.  During the Term, Hospira shall provide to Genzyme, or its
designee, Services pursuant to Purchase Orders delivered from time to time by
Genzyme to Hospira in accordance with Section 8.4.  Hospira shall perform the
Services in accordance with the terms of

 

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[**] = 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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this Master Agreement and any related Project SOW executed by the Parties. 
Prior to the execution of any Project SOW, Hospira will prepare a proposal which
clearly specifies the scope of work and costs associated with each Project. 
Thereafter, the Parties shall negotiate, in good faith, the terms and conditions
of the relevant Project SOW under which Hospira will perform the Services.  For
the avoidance of doubt, each Project will be governed by the terms and
conditions of this Master Agreement, the Quality Technical Agreement and the
relevant Project SOW.

 

2.2          Facilities, Equipment and Materials.  Other than as specifically
set forth herein, Hospira agrees to provide, at its own cost and expense, all
facilities, equipment, machinery, and materials in accordance with the Product
Specifications and the Project SOW, and the labor necessary for the performance
of the Services.

 

2.3          Responsibility.  Unless otherwise specified herein or expressly
consented to in writing by Genzyme, Hospira shall be solely responsible for
performance of all activities necessary to perform the Services contemplated
hereunder.  Neither Party shall amend or modify the Product Specifications, or
any protocols, processes or procedures used to perform the Services without the
express written approval of the other Party.  Unless otherwise expressly agreed
in writing in advance by Genzyme, Hospira may not sublicense or subcontract the
Services to be performed by Hospira under this Master Agreement to an Affiliate
or Third Party.

 

2.4          Exceptions; Governing Documents.  In the event of a conflict or
inconsistency between the terms and conditions of a Project SOW and those of
this Master Agreement, then except where expressly permitted under
Section 15.12, or where any provision of this Master Agreement is expressly
waived in a written agreement signed by both Parties, the terms and conditions
of this Master Agreement shall govern and control.

 

2.5          Project Statement of Work.

 

(a)           Each Project SOW will, to the extent possible: (a) describe the
Services to be provided by Hospira and the applicable Service Fees related
thereto, (b) describe the Product, including the Product Specifications for each
applicable Development Product and/or Commercial Product, (c) describe the
criteria for an acceptable Development Product or Commercial Product, (d) set
forth the Bulk Specifications and any special conditions for delivery and/or use
of the Bulk, (e) describe the information and analysis to be included in the
Bulk, (f) describe shipping and receiving requirements for Bulk and Product,
(g) if applicable, describe the costs and responsibilities for disposal of
Specially Regulated Waste and any Waste that shall become Specially Regulated
Waste during the term of the Project SOW, (h) include any other information
required to be provided pursuant to this Master Agreement or any additional
provision the Parties may mutually agree upon, and (i) be in the form similar to
the template set forth in Exhibit 2.5 attached hereto and incorporated herein.

 

(b)           Although the Parties intend to enter into good faith negotiations
to Manufacture the Development Product(s) contemplated hereunder, nothing herein
shall require Genzyme or Hospira to proceed with a Project SOW for the
Manufacture of such Development Products.

 

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[**] = 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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2.6          Commercially Reasonable Efforts.  Each Party shall negotiate in
good faith, and use commercially reasonable efforts to complete, each Project
SOW.

 

ARTICLE 3.        PROJECT STATEMENT OF WORK EFFORTS

 

3.1          Service Fees.  Genzyme shall pay to Hospira fees for the Services
Hospira provides under each Project SOW (“Service Fees”).  Genzyme will pay such
fees in accordance with the amounts, payment terms and schedules set forth in
each Project SOW.  Where appropriate, and to the extent commercially reasonable,
the Parties will seek to establish compatible pricing for Products that are
Manufactured in the same Facility and using the same Manufacturing processes.

 

3.2          Changes in Project Scope.  If (a) changes occur in a Project SOW or
the Product Specifications, or (b) technical difficulties arise during the
technology transfer process requiring that Hospira perform either additional
work or repeat work, and such additional work or repeat work is not as a result
of Hospira’s fault, negligence or failure to comply with the terms and
conditions of this Master Agreement, Hospira shall provide Genzyme with cost
estimates for such work.  If Genzyme approves such costs, Hospira shall perform
such work and Genzyme shall pay Hospira’s costs for such work within [**] days
of completion of such work.  Reimbursement for such additional work or repeat
work shall be at a rate of [**] per hour per person, plus [**].

 

3.3          Technical Contact.  Each Party will appoint a contact person having
primary responsibility for day-to-day interactions with the other Party for the
activities under the relevant Project (“Technical Contact”).  Any change to a
Technical Contact will be identified in writing to the other Party.  Each Party
will use reasonable efforts to provide the other Party with at least fifteen
(15) days prior written notice of any change in that Party’s Technical Contact. 
All communications between Hospira and Genzyme regarding the conduct of the
activities under the Project will be facilitated through the Party’s Technical
Contact identified in the Project SOW.

 

3.4          Development Product(s).  In any relevant Project SOW, based on
Genzyme’s final Product formulations, concentration, fill volumes, and the
Parties’ agreement to the final Product Specifications, Hospira will Manufacture
Development Products at the prices set forth in the relevant Project SOW. 
Genzyme shall issue a Purchase Order for any such Development Product(s) at
least [**] days before the requested delivery date.  Genzyme and Hospira shall
agree mutually to the formulation, concentration, fill volume and the components
for each lot of Development Product(s).

 

ARTICLE 4.        GENZYME’S REGULATORY SUBMISSIONS

 

4.1          Hospira’s Review.  For any relevant Project, at Genzyme’s request,
Hospira shall review and consult with Genzyme on those portions of Genzyme’s
proposed regulatory submissions relating to Hospira’s packaging or Manufacturing
procedures before the submissions are filed with the appropriate Regulatory
Authorities in the Territory.  Hospira shall

 

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[**] = 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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complete its review of the submissions within [**] days for submissions in
English, or within [**] days for submissions not in English, following receipt
of a proposed regulatory submission.  Genzyme shall be the sole owner of any
regulatory submission filed pursuant to this Master Agreement.  In the event
that a Regulatory Authority requires additional review and consultation from
Hospira (for example, for technical responses to a Regulatory Authority finding
of deficiency, should one arise), Hospira shall provide Genzyme with cost
estimates for any additional work to be done.  If Genzyme approves such costs in
writing, Genzyme shall reimburse Hospira for such additional work based on a
rate of [**] per hour.  Hospira shall provide Genzyme with an executed copy of
its comments.

 

4.2          Supplemental Regulatory Filings.  Hospira shall quote a price for
supplemental regulatory, packaging and development work to support regulatory
filings outside of the Territory specified in the initial Project SOW for the
relevant Product separately and on a country-by-country basis.

 

4.3          Access to Drug Master Files and Other Reports.  Hospira shall grant
Genzyme reference rights to all Drug Master Files (“DMFs”) and other regulatory
filings deemed necessary to support Genzyme’s applications for regulatory
approval of Products.  To effectuate this, Hospira shall execute Letters of
Authorization which shall be delivered to the appropriate Regulatory Authorities
permitting such Regulatory Authorities to consult Hospira’s DMFs and, as
applicable, other regulatory filings (as described in the Quality Technical
Agreement)  in their review of Genzyme’s Product marketing applications. 
Hospira shall send copies of such Letters of Authorization to Genzyme.  Hospira
shall update its DMFs annually and shall inform Genzyme prior to any
modifications thereto in order to permit Genzyme to amend or supplement any
affected regulatory applications and filings for the Products.

 

ARTICLE 5.        HOSPIRA’S OBLIGATIONS

 

5.1          Consents.  Hospira shall obtain all Consents for which it is
responsible for the Manufacture and supply of Product(s) under the terms of this
Master Agreement.  At all times, Hospira shall maintain and comply with all
Consents which may from time to time be required by any Regulatory Authority
having jurisdiction with respect to the Services and/or the Facility and
otherwise obtained by Hospira to permit the performance of its obligations under
this Master Agreement.  In the event any Consent held by Hospira relating to the
Facility or its ability to Manufacture Product(s) in accordance with this Master
Agreement is hereafter suspended or revoked, or Hospira has material
restrictions imposed upon it by any Regulatory Authority affecting Product(s) or
the Facility, Hospira shall promptly notify Genzyme and shall provide a schedule
of compliance and such other information related thereto as is reasonably
requested by Genzyme.

 

5.2          Notification of Adverse Effects on Fill and Finish Activities. 
Hospira shall advise Genzyme within one Business Day of any information arising
out of its Manufacturing activities that may have adverse regulatory, compliance
and/or reporting consequences concerning any Product(s) or the Facility.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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5.3          Regulatory Authorities.  Hospira shall notify Genzyme of any
requests from any relevant Regulatory Authority for information related to
Hospira’s provision of Services hereunder.  Hospira shall promptly advise
Genzyme of any requests by any Regulatory Authority for inspections of the
Facility.

 

5.4          Adverse Reaction Reporting.  As provided in the Quality Technical
Agreement, Hospira shall promptly forward to Genzyme any and all information
reported to Hospira relating to any adverse experience, whether expected or
unexpected, relating to the use of any Product(s).

 

5.5          Equipment.  Hospira agrees to provide sufficient resources in order
to meet Genzyme’s requirements for Products including, without limitation, the
provision of all equipment, machinery and labor.

 

5.6          Inventories.  Hospira shall maintain an inventory of the materials
that the Parties agree is necessary to provide the Services and to ensure the
fulfillment of its supply obligations herein, and shall respect the procedure of
“first in first out” to control and release the inventory.  Hospira further
agrees to maintain redundancies in the sourcing for all such materials so as to
mitigate any potential shortage of supply.  The Parties’ initial estimates of
the required levels of such materials inventories per Product are set forth in
Exhibit 5.6.  The Parties shall refine these estimates as the Services progress.

 

5.7          Validation.  Hospira will complete, or ensure the completion of,
validation of its equipment, facilities, cleaning processes, and Manufacturing
equipment as required by cGMPs and any other applicable regulatory requirements
as may be required from time to time.  Hospira will routinely assemble and
retain, or ensure the assembly and retention of, validation/qualification
documents and validation summary reports pertaining to the Manufacturing
activities for a period of time as agreed under the Quality Technical Agreement,
and will provide copies thereof to Genzyme.

 

5.8          Accident Reports.  Upon request, Hospira shall provide to Genzyme a
quarterly summary report on environmental, health and safety matters at the
Facility, which matters may include all material incidents related to Facility
operations, including:  (a) accidents resulting in significant personal injury
requiring more than first aid treatment, (b) accidents resulting in chronic
illness or loss of consciousness, (c) accidents resulting in material property
damage, (d) accidents resulting in material environmental release, and
(e) accidents that result in regulatory, safety, health or environmental
audits.  Hospira shall promptly provide Genzyme with a copy of any accident
report related to the Manufacture of the Products.  In the event that Genzyme
requires specific reporting on any non-material incidents directly related to
the Manufacture of any of the Products, Hospira will compile a report as soon as
reasonably practicable; provided, however, that Genzyme shall be required to pay
Hospira’s reasonable costs for the compilation work to be done.  The Genzyme
point of contact person for all such reporting will be Genzyme’s
Person-in-the-Plant.

 

5.9          Records, Retained Samples and Storage.  Hospira shall retain
samples and maintain records from each batch or lot of Product for a period of
time required by Applicable

 

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[**] = 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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Laws for record keeping, testing and regulatory purposes or as specified in the
Quality Technical Agreement.  When storing Bulk, nonconforming Bulk, Waste, or
Specially Regulated Waste, Hospira shall comply with and maintain all storage
facilities in compliance with Bulk Specifications and in accordance with cGMP
and Applicable Laws.

 

5.10        Maintenance of Facility.  During the Term, and specifically in
connection with the performance of the Services hereunder, Hospira shall
maintain the Facility, and all personal property, equipment, machinery, systems,
intangibles and contract rights in use at the Facility during the Term in the
ordinary course of business, in compliance with cGMPs and Applicable Laws.

 

ARTICLE 6.        MANUFACTURE OF PRODUCTS

 

6.1          Manufacture of Products.  Pursuant to the terms and conditions of
the relevant Project SOW and for the duration of the Project SOW, Hospira shall
Manufacture and deliver the Products to Genzyme, and Genzyme shall take delivery
of the Products from Hospira, pursuant to Purchase Orders issued by Genzyme to
Hospira.  Hospira shall Manufacture the Products in accordance with the Product
Specifications.  The Parties may alter the Product Specifications from time to
time by written agreement without amending the Project SOW.

 

6.2          Regulatory Approvals.  Hospira agrees to Manufacture and supply
those quantities of Products requested in Purchase Orders by Genzyme that are
necessary to validate Hospira’s manufacturing facilities, obtain regulatory
approval(s) and build Genzyme’s inventory of the Products, and Genzyme shall be
required to [**].

 

ARTICLE 7.        SUPPLY OF PRODUCTS

 

7.1          Bulk.

 

(a)           Supply.

 

(i)            Hospira shall Manufacture Product for Genzyme from Bulk that
Genzyme shall supply to Hospira in quantities sufficient to satisfy Hospira’s
gross manufacturing requirements of Product.  Unless otherwise specified in the
relevant Project SOW, Genzyme shall deliver all required quantities of Bulk for
a particular Product no later than thirty (30) days prior to the date that
Manufacturing of such Product is scheduled to commence.  Hospira’s use of Bulk
received from Genzyme shall be limited to those purposes contemplated by this
Master Agreement and the Manufacture of Product for Genzyme.  Genzyme shall
deliver Bulk [**] Hospira’s Facility for all deliveries, pursuant to no-cost
Purchase Orders that Hospira issues to Genzyme.  Genzyme shall be responsible
for all costs of transport and carriage insurance.  In the event Genzyme fails
more than once to deliver the required quantities of Bulk for a particular
Product at least [**] days prior to the date that Manufacturing of such Product
is scheduled to commence, or as specified in the relevant Project SOW, the
Alliance Team leaders shall meet to establish a remediation plan to address the
failure.  If Genzyme fails more than twice to deliver the required quantities of
Bulk for a particular Product at least [**] days prior to the date that

 

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[**] = 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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Manufacturing of such Product is scheduled to commence, or as specified in the
relevant Project SOW, then a member of the senior management team from each
Party shall meet with one another to review the remediation plan established by
the Alliance Team and determine whether Genzyme is capable of delivering Bulk
within the specified delivery timeframe.  The Parties will at that time
determine whether Hospira will continue with the Manufacture the Product in
question or, alternatively, decide in the best interests of the Parties that
Hospira no longer manufacture such Product.

 

(ii)           With each delivery of Bulk, Genzyme will include a certificate of
analysis, signed by an authorized individual from Genzyme’s Quality Group (or
his/her designee) containing basic information regarding the Bulk, including: 
(A) the manufacturing date of the batch/lot delivered; (B) the batch/lot number;
(C) the quantity of Bulk in such batch/lot as shipped to Hospira; (D) an
indication of the expiry date of the batch/lot of Bulk by which Hospira must
begin filling operations; and (E) the testing (if any) to which the batch/lot of
Bulk has been subjected and the test results.

 

(iii)          Unless otherwise specified in the relevant Project SOW, within
[**] calendar days of Hospira’s receipt of any Bulk supplied by Genzyme
hereunder, Hospira shall:  (A) perform an identification test on the Bulk and
confirm the shipment quantity; and (B) notify Genzyme of any inaccuracies with
respect to quantity or of any claim that any portion of the shipment fails the
identification test.  In the event Hospira notifies Genzyme of any deficiency in
the quantity of Bulk received, Genzyme shall promptly investigate such
deficiency and provide Hospira with instructions on how to handle the Bulk. 
Genzyme may ship to Hospira, at Genzyme’s expense, the quantity of Bulk
necessary to complete the Bulk shipment.  In the event Hospira notifies Genzyme
that the Bulk shipment does not conform to the Bulk Specifications, as evidenced
by the results of the relevant identification test, Genzyme shall have the right
to confirm such findings at Hospira’s Facility.

 

(iv)          If Genzyme determines that such shipment of Bulk did, in fact,
conform to the Bulk Specifications, the Parties shall submit samples of such
shipment to a mutually acceptable independent expert for testing.  If such
independent expert determines that the shipment conformed to the Bulk
Specifications, Hospira shall bear all expenses of shipping and testing such
shipment samples.  If Genzyme or such independent expert confirms that such
shipment did not meet the Bulk Specifications, Genzyme shall use commercially
reasonable efforts to replace, at no cost to Hospira, the portion of the Bulk
shipment which does not conform to the Bulk Specifications and bear all expenses
of shipping and testing the shipment samples.  Notwithstanding the foregoing,
the independent expert may also determine that additional sample testing by an
independent laboratory is necessary.

 

(b)           Title.  Notwithstanding the [**] shipping terms set forth in
Section 7.1(a)(i), all Bulk supplied to Hospira by Genzyme is supplied as
consignment stock and shall be clearly identified as the property of Genzyme,
shall be kept segregated and maintained in the Facility, and Genzyme shall
retain title thereto.

 

(c)           Handling and Storage of Bulk.  Hospira represents, warrants and
covenants that unless otherwise agreed to by Genzyme in writing, it will
(i) store the Bulk at 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.

 

11

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Facility only; and (ii) store and maintain the Bulk, at its cost and expense, in
accordance with cGMP, the Quality Technical Agreement, the Bulk Specifications,
the relevant Project SOWs, and all Applicable Laws (including, without
limitation, the receipt and possession of all applicable Consents), as well as
Genzyme’s reasonable prior written instructions.

 

(d)           Inspection.  At no additional cost to Genzyme, Genzyme shall be
entitled to inspect the Bulk and its related records on a quarterly basis,
during normal business hours upon reasonable request and prior written notice,
and with the least reasonably possible interference with Hospira’s ordinary
course of business.  Genzyme’s Person-in-the-Plant shall be responsible for
carrying out any such inspections.

 

(e)           Risk of Loss.  Subject to the limitation in Section 7.1(f)(ii),
Hospira shall assume full responsibility and risk of loss associated with the
safekeeping, storage and handling of all Bulk in its possession and all
shipments of Bulk delivered hereunder and accepted by Hospira including, without
limitation, loss of Bulk due to casualty, spoilage, loss, theft, fire, damage or
destruction.

 

(f)            Replacement.

 

(i)            In the event of loss or damage of Bulk delivered hereunder
promptly upon receiving notice from Hospira of any such loss, damage or failure
(each, an “Occurrence”) Genzyme shall investigate the matter and provide Hospira
with direction on how to manage the Bulk and/or Products.  Genzyme may choose to
supply to Hospira replacement Bulk [**] in accordance with the terms set forth
in Section 7.1(a); provided, however, that if any loss or damage of such Bulk
results from a negligent act or omission by Hospira in the Manufacture, handling
or storage of the Bulk or the Products or due to casualty, spoilage, loss,
theft, fire, damage or destruction, Hospira shall reimburse Genzyme for [**] in
an amount equal to [**] within [**] days of Genzyme [**].

 

(ii)           Excluding Hospira’s contribution obligations pursuant to Sections
9.4 and 15.9 hereunder, in no event shall Hospira’s aggregate liability for
replacement of Bulk (on a Product by Product basis) exceed: (a) [**] per
Occurrence during the [**] Manufacturing of Commercial Products [**]; and
(b) [**] per Occurrence during Manufacturing of Products after the [**];
provided, however, in the event any Occurrence is due to the willful misconduct
or intentional act(s) of Hospira or its agent(s), Hospira shall [**], and the
limitations set forth in this Section 7.1(f)(ii) shall not apply.

 

(iii)          Hospira shall not be responsible for the inability to use any
batch/lot of Bulk in the event that Genzyme delivers such Bulk to Hospira with
an expiry date shorter than the minimum set forth in the relevant Project SOW.

 

(g)           Yield Metrics.

 

(i)            After Hospira has completed its initial validation runs of
Product and during the initial stages of Hospira’s Manufacture of Product, the
members of the Alliance

 

--------------------------------------------------------------------------------

[**] = 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

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Team shall consult with a view to developing a strategy for maximizing the
production yield of Product from the Bulk supplied by Genzyme.  Based upon such
consultations, the Parties will establish Manufacturing guidelines for each
Product, including Bulk yield minimums, maximum Bulk consumption factor targets,
and permitted variances of quantities of Products to be delivered according to
Genzyme’s Purchase Orders (“Yield Metrics”), and consequences of out-of-variance
performance.  It shall be Hospira’s goal to achieve production of consistent
batch quantities of Product in accordance with the Yield Metrics throughout the
term of each Project.  The Alliance Team may meet from time to time to discuss,
agree upon and implement measures for improving the Yield Metrics.

 

(ii)           In the event Hospira fails to meet the Yield Metrics for any
Product, the Alliance Team leaders shall meet to establish a remediation plan to
address the failure.  If Hospira fails to meet the Yield Metrics for any Product
more than once, then a member of the senior management team from each Party
shall meet with one another to review the remediation plan established by the
Alliance Team and determine whether Hospira is capable of meeting the Yield
Metrics.  The Parties will at that time determine whether Hospira will continue
with the Manufacture the Product in question or, alternatively, decide in the
best interests of the Parties that Genzyme should have the right to seek an
alternate source of supply for such Product.

 

7.2          Dedicated Equipment Costs.  If non-standard, specialized equipment
is required to perform the Services in connection with any Project (“Dedicated
Equipment”), Hospira shall pay the cost of such equipment, subject to Genzyme’s
prior approval of such costs, which approval shall not be unreasonably
withheld.  Prior to the execution of any Project SOW, Hospira shall advise
Genzyme of specialized equipment required and the estimated costs associated
with the purchase, installation and validation of such equipment for the related
Project.  After Genzyme approves such costs, Hospira shall install and validate
the equipment and bill Genzyme for the associated costs.  The costs and payment
terms for Dedicated Equipment shall be as set forth in the relevant Project
SOW.  Title to the Dedicated Equipment shall be in Genzyme’s name.  Hospira
shall cooperate with Genzyme in the completion of any and all document filings
required to secure Genzyme’s interest in the Dedicated Equipment.  Further, if
Hospira wishes to use the Dedicated Equipment for Manufacture of a product other
than the Products for Genzyme, Hospira and Genzyme shall meet and discuss the
technical and practical ramifications of such use and appropriate compensation
to Genzyme.

 

7.3          Product Labeling; Packaging.  The labeling and packaging
responsibilities of the Parties shall be as set forth in the relevant Project
SOW.  All such labeling and packaging shall be in accordance with the
Manufacturing Batch Record and applicable Product Specifications.

 

7.4          Off-Site Waste.  If necessary, Hospira shall hire, direct and pay
all costs for a waste contractor to remove all Product-related Waste from
Hospira’s Facility, consistent with each Product’s Material Safety Data Sheets
(“MSDS”).  The costs associated with the removal of Specially Regulated Waste,
as set forth in the relevant Project SOW, shall be borne by Genzyme.  Hospira
shall only dispose of Specially Regulated Waste at sites and through waste
management vendors that have been approved in writing by Genzyme, whose approval
shall not

 

--------------------------------------------------------------------------------

[**] = 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

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be unreasonably withheld.  Hospira shall document the destruction of any
Specially Regulated Waste in writing and provide copies of such written
documentation to an authorized representative of Genzyme.  Genzyme maintains the
right, but not the obligation, to witness the actual disposal of Specially
Regulated Waste.  Genzyme shall, upon request by Hospira, provide the MSDS for
the Bulk and the MSDS for each Product to Hospira.

 

7.5          Delivery.  Hospira shall deliver the Products, packed and ready for
shipment, to Genzyme [**].  Risk of loss shall pass to Genzyme [**].  Shipment
shall be via a carrier designated by Genzyme.  Hospira shall not ship any
Product until both Hospira and Genzyme have released such Product pursuant to
the Product Specifications and the Quality Technical Agreement.  All freight,
handling, insurance, duties, taxes and shipping expense will be borne by
Genzyme.  For any shipments outside the United States, Genzyme shall be the
exporter of record.

 

7.6          Price and Payment.

 

(a)           Price.  Hospira shall invoice Genzyme for the Products delivered
by Hospira at the prices set forth in the relevant Project SOW.  Unless
otherwise specified in the relevant Project SOW, Hospira shall provide Genzyme
with notice of any price increase by October 1 of each calendar year, and price
increases shall be effective for deliveries beginning January 1 of the following
calendar year.  Such increases shall not [**] of (i) the [**], or (ii) [**].

 

(b)           Payment.  Hospira shall invoice Genzyme upon delivery of the
Products.  Genzyme shall make payment net [**] days from the date of receipt of
Hospira’s invoice.  In the event Genzyme fails to pay any undisputed invoice
within [**] days of receipt of the invoice, Hospira may [**] (i) [**], or
(ii) [**].

 

(c)           Taxes.  Genzyme shall pay all federal, state, county or municipal
sales or use tax, excise, customs charges, duties or similar charge, or any
other tax assessment (other than that assessed against income), license, fee or
other charge lawfully assessed or charged on the Manufacture, delivery or
transportation of the Products sold pursuant to this Master Agreement.

 

(d)           User and Filing Fees.  Genzyme shall also be responsible for all
user and filing fees required by Regulatory Authorities in connection with the
Services, and Prescription Drug User (“PDUFA”) annual establishment fees with
respect to all of the Products.

 

(e)           Sub-lots.  Should Genzyme desire Hospira to split a Manufacturing
lot of the Products into several sub-lots during packaging, there will be a [**]
for each sub-lot packaged.

 

(f)            Cold Storage Fee.  A cold storage fee shall be due and payable to
Hospira if Hospira stores the Products at the Facility and such Products require
cold storage for more than [**] days after each individual Product’s final
release by Genzyme.  The fee shall be at the rate of [**] or any part thereof.

 

--------------------------------------------------------------------------------

[**] = 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

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7.7          Inspection and Replacement of Nonconforming Product.

 

(a)           Certificate of Analysis.  Hospira will include a Certificate of
Analysis with each batch of Products confirming that the Products have been
Manufactured in conformity with the Product Specifications and all Applicable
Laws.

 

(b)           Inspection; Rejection.  Upon completion of the Manufacture of each
batch of Products, Hospira will provide Genzyme with a copy of the Master Batch
Record and all other documents and records as required by the Quality Technical
Agreement for release of Products.  Genzyme will have [**] days from the date of
its receipt of all such documentation to inspect, and accept or reject, the
corresponding batch of Product as conforming or non-conforming with the Product
Specifications and cGMP.  If Genzyme rejects such batch, it shall promptly so
notify Hospira and, if applicable, provide to Hospira samples of Products
included in such batch for testing.  If Hospira tests such samples and
determines that it did conform to the Product Specifications, the Parties shall
submit samples of such Product to a mutually acceptable independent expert for
testing.

 

(c)           Testing.  If such independent expert determines that the Product
conformed to the Product Specifications, Genzyme shall bear all expenses of
shipping and testing such Product samples.  If such independent expert confirms
that such Product did not meet the Product Specifications, Hospira shall bear
all expenses of shipping and testing the shipment samples.  Notwithstanding the
foregoing, the independent expert may also determine that additional sample
testing by an independent laboratory is necessary.  Absent manifest error, the
test results of the independent expert (or those of the independent laboratory,
if so referred by the expert) shall be binding on the Parties.

 

(d)           Replacement; Disposition of Rejected Product.  Hospira shall use
its best efforts to replace, at no cost to Genzyme, that portion of the Product
which does not conform to the Product Specifications as soon as reasonably
practicable, as jointly determined by the Parties, given manufacturing
capacities and scheduling at the Facility; provided, however, that Genzyme
provides sufficient Bulk to Hospira [**] (subject to the limitations set forth
in Section 7.1(f)(ii) & (iii)).  Genzyme’s duty to pay all amounts otherwise
payable to Hospira in respect of the rejected Product shall be suspended until
Hospira replaces all nonconforming Product in accordance with this Section 7.7. 
Any nonconforming portion of any shipment shall be disposed of as directed by
Genzyme, at Hospira’s expense.  In lieu of receiving replacement Product,
Genzyme may [**].

 

(e)           Deemed Acceptance; Latent Defects.  Any Product that Genzyme does
not reject pursuant to this Section 7.7 shall be deemed accepted, and all claims
with respect to Product not conforming with Product Specifications shall be
deemed waived by Genzyme, except as to latent defects which are not reasonably
discoverable and render the Product not conforming to Product Specifications. 
Upon the conclusion of all appropriate internal investigations, should the
Parties disagree on the nature and cause of such latent defects, then the
Parties shall engage an independent expert to determine the cause of the latent
defect.  If it is confirmed that the cause of the defect is attributable to the
Manufacturing of the Product then,

 

--------------------------------------------------------------------------------

[**] = 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

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subject to the limitations set forth in Section 7.1(f)(ii), Hospira will replace
at no cost to Genzyme all such defective Products with Products that meet the
Product Specifications.

 

7.8          Alliance Team and Dedicated Personnel.  Hospira and Genzyme will
form a team (“Alliance Team”) comprised of at least three members from each
Party which will meet at least quarterly to review performance metrics, address
issues and oversee the relationship between Genzyme and Hospira.  The Alliance
Team will be a working committee that will have as its goal the quick and
mutually agreeable resolution of financial, technical and quality issues, thus
preserving throughout the term of each Project SOW the relationship established
by Genzyme and Hospira.  Either Party may change its representatives on the
Alliance Team at any time by written notice to the other.  Promptly following
the Effective Date, Hospira shall hire, at its own expense, two dedicated
personnel at the Facility to solely support the relationship between Genzyme and
Hospira.  These personnel, a contract manufacturing analyst, and a contract
manufacturing specialist, shall support the ordering, Manufacturing, release and
supply of the Products for Genzyme.

 

7.9          [**]; Risk Mitigation.

 

(a)           [**].

 

(i)            Subject to the terms of this Master Agreement, the execution of a
relevant Project SOW, the Quality Technical Agreement and any preexisting
contractual

 

obligation of Genzyme, Hospira shall have the [**] that Genzyme does not [**],
or any other [**], unless otherwise specified in this Agreement.

 

(ii)           Should Genzyme, in its discretion, decide to [**], then Genzyme
shall [**].  If Hospira [**].

 

(iii)          If Hospira accepts [**], the Parties shall mutually [**], it
being understood and agreed that Hospira will be [**].  Genzyme will be [**]. 
The Parties agree that all terms of this Master Agreement, including Product
prices, shall [**].

 

(iv)          The Parties shall [**].  In the event that Hospira [**], then
Genzyme shall [**].

 

(v)           For the avoidance of doubt, upon [**], Genzyme shall not [**];
provided however, that the foregoing shall not [**] as described elsewhere in
this Master Agreement.

 

(b)           Possible Acquisitions.  In the event that during the Term Hospira
acquires or is acquired by a Third Party with a company, business or
pharmaceutical production facility that manufactures products that treat the
disease states set forth on Exhibit 14.5, then Hospira will notify Genzyme as
soon as such information is able to be released and Hospira shall [**].

 

(c)           Risk Mitigation.  As soon as possible after the Effective Date,
members of the Alliance Team and/or senior management will meet and discuss the
ways of planning 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.

 

16

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implementing Manufacturing redundancies at Hospira’s McPherson, Kansas
Facility.  Such redundancies may include, without limitation, the qualification
of another filling line or lines, lyophilizers or other equipment for the
Manufacture of the Products.  Upon agreement on the qualification plan, the
Parties will undertake any necessary qualification procedures.  Hospira will be
responsible for its own costs in carrying out all of the necessary technical
qualification procedures and Genzyme will be responsible for all of its own
related qualification costs.  The Parties shall also consider implementing
additional Manufacturing redundancies at Hospira’s Liscate, Italy Facility to
Manufacture one of more of the Products

 

(d)     Notwithstanding the foregoing, nothing in this Section 7.9 shall
preclude Genzyme from qualifying an alternate contract manufacturer to provide
fill and/or finishing services related to the Products.  Further, the Parties
hereto agree that the [**].

 

ARTICLE 8.        ORDERS AND FORECASTS

 

8.1          [**] Year Product Supply Forecast.  For capacity planning purposes,
in connection with a Project SOW, by [**] of each calendar year Genzyme shall
provide Hospira with a non-binding, written [**]-year forecast of Genzyme’s
annual requirements for fill slots needed during the first three calendar years
of the relevant Project SOW (“Fill Slot Forecast”).  Within [**] days of
Hospira’s receipt of each Fill Slot Forecast, Hospira shall provide Genzyme with
either: (a) a written acceptance of the Fill Slot Forecast, and accordingly
allocate its annual capacity to Manufacture the Products for Genzyme, or (b) a
written rejection of the Fill Slot Forecast.  Any written acceptance shall
constitute Hospira’s fill slot commitment for each of the calendar years covered
by the Fill Slot Forecast (“Product Fill Slot Commitment”) but shall not be
binding on Genzyme.  When Genzyme submits, and Hospira accepts, a subsequent
Fill Slot Forecast covering one or more previously covered calendar years, such
subsequent Fill Slot Forecast shall constitute Hospira’s Product Fill Slot
Commitment for such calendar year(s).  In the event Hospira rejects a Fill Slot
Forecast, Hospira and Genzyme shall meet as soon as possible to discuss in good
faith the batch quantities of the Products that Hospira is willing and able to
provide during each of the three calendar years covered by the Fill Slot
Forecast.  Any such amount shall be agreed to in writing.  If the Parties
conclude that Hospira will be unable to supply Products to meet Genzyme’s
Manufacturing needs, then the exclusivity granted to Hospira pursuant to
Section 7.9 shall be waived for the affected Product(s) to enable Genzyme to
pursue other sources of supply to meet its demand.

 

8.2          Minimum Purchase Requirement.

 

(a)           During the term of each Project SOW, Genzyme agrees to purchase
from Hospira, and Hospira agrees to Manufacture and deliver to Genzyme, minimum
aggregate quantities of the Products set forth in the relevant Project SOW (the
“Minimum Purchase Requirement”) not to exceed its applicable Product Fill Slot
Commitment.  Subject to any differing terms contained in any Project SOW, during
the term of a Project SOW, Genzyme shall purchase not less than [**] of year one
in the Product Fill Slot Commitment accepted by Hospira in accordance with
Section 8.1.

 

--------------------------------------------------------------------------------

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

17

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(b)           In lieu of Genzyme taking delivery of each calendar year’s Minimum
Purchase Requirements of the Products, Genzyme shall have the option to pay for
its Minimum Purchase Requirement at the Product prices set forth in the relevant
Project SOW and waive Hospira’s Manufacture and delivery obligations for the
Products.  In the latter event, Hospira shall invoice Genzyme for the Service
Fees, less the applicable costs for vials, stoppers and crimps; provided that
Hospira is reasonably able to use such materials in future Genzyme product
orders.  Genzyme shall pay Hospira any amounts due hereunder within [**] days
after receipt of Hospira’s invoice in accordance with Section 7.6(b) hereof.

 

8.3          Rolling Forecast.  Concurrent with the execution of a Project SOW,
and on the [**] thereafter, Genzyme shall provide to Hospira a good faith,
estimated rolling forecast of the fill slots and Products that Genzyme expects
to order for the subsequent eighteen-month period of time (each, a “Rolling
Forecast”).  Notwithstanding the foregoing, and subject to the Minimum Purchase
Requirement, Genzyme shall provide Hospira with a binding, Product-specific
forecast for months one through four of each Rolling Forecast, and a binding
fill slot forecast for months one through seven of each Rolling Forecast
(individually and collectively, “Firm Order Period”).  For illustrative purposes
only, if the Rolling Forecast is submitted on [**], Genzyme shall provide
Hospira with a binding Product-specific forecast for [**], and a binding fill
slot forecast for [**].

 

8.4          Purchase Orders.  After execution of a Project SOW, Genzyme shall
submit a purchase order (“Purchase Order”) to Hospira at least [**] days prior
to the first requested fill date for a Product.  Thereafter, on or before the
[**], Genzyme shall submit a purchase order to Hospira in connection with said
Project SOW.  Hospira shall use its commercially reasonable efforts to meet the
delivery dates set forth in each Purchase Order.  Each Purchase Order shall
reference this Master Agreement or the relevant Project SOW and shall be
governed exclusively by the terms contained herein or therein.  Any terms or
conditions contained in a Purchase Order that are inconsistent or in conflict
with this Master Agreement or any relevant Project SOW shall be deemed not to be
a part of such Purchase Order.

 

8.5          Purchase Order Acceptance.  Within [**] days after receipt of a
Purchase Order issued in accordance with Section 8.4, Hospira shall confirm to
Genzyme its acceptance of the Purchase Order, delivery date(s), the quantity of
Products ordered and the purchase price to be paid by Genzyme.  Hospira may
reject, in whole or in part, a Purchase Order only if it calls for the delivery
of Products:  (a) for which sufficient quantities of Bulk have not been
delivered by Genzyme or its designee in accordance with Section 7.1, or (b) less
than [**] days after the date of the Purchase Order.

 

8.6          Additional Quantities.  Should Genzyme order additional quantities
of the Products in excess of [**] over the latest Firm Order Period, Hospira
shall not be obligated to supply said additional quantities; provided, however,
that Hospira shall, until Genzyme’s orders in the aggregate reach the applicable
annual Product Supply Commitment, use reasonable commercial efforts to produce
and deliver to Genzyme said additional quantities within [**] days of issuance
of the Purchase Order for such additional quantities.

 

--------------------------------------------------------------------------------

[**] = 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

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8.7          Purchase Order Changes; Cancellations.

 

(a)           Changes.  If Genzyme requests that changes be made to any of its
Purchase Orders within the Firm Order Period, Hospira shall attempt to
accommodate such changes within reasonable Manufacturing capabilities and
efficiencies.  If Hospira can accommodate such changes, Hospira shall advise
Genzyme of any costs associated therewith.  If Genzyme indicates in writing to
Hospira that it should proceed to make the changes, Genzyme shall be deemed to
have accepted the obligation to pay Hospira for such costs.  If Hospira cannot
accommodate such change, Genzyme shall nonetheless be bound to its original
Purchase Orders.

 

(b)           Cancellations.  If Genzyme cancels any Purchase Order within the
Firm Order Period, Hospira shall be relieved of its Manufacturing obligations
relating to such order but Genzyme will not be relieved of its payment
obligation unless Hospira agrees to waive such obligation in writing. 
Furthermore, if Genzyme does not supply sufficient Bulk to allow Hospira to
fulfill any Purchase Order Genzyme shall remain liable for the full amount of
the Purchase Order, regardless of whether Hospira Manufactures the Product or
whether Genzyme takes delivery of the Product.

 

ARTICLE 9.        INABILITY TO SUPPLY

 

9.1          Notification.  Hospira will promptly notify Genzyme if it
anticipates a delay in any delivery of Products and the time of any delay in
delivery.  In the event that Hospira anticipates that it will otherwise be
unable to Manufacture and supply the Product in accordance with Genzyme’s firm
Purchase Orders, Hospira shall notify Genzyme promptly and shall use best
efforts to cure any Inability to Supply (as defined in Section 9.5) as soon as
possible.  In particular, Hospira shall promptly inform Genzyme of any notice,
written or oral, received from any of its materials suppliers regarding a
possible shortage.  If Hospira’s Inability to Supply is not attributable to
Genzyme’s breach of its obligations under this Agreement, then Hospira shall be
solely responsible for undertaking all commercially reasonable measures to
minimize any possible shortage of Product to Genzyme.  If such inability is
partial, Hospira shall fulfill Purchase Orders with such quantities of Product
as are available for supply to Genzyme hereunder.

 

9.2          Inability to Supply.

 

(a)           Delays in Production.  In the event that Hospira experiences, or
anticipates that it will experience, a delay in Manufacturing and supplying
Products to Genzyme for more than [**] days, the Parties will promptly meet to
discuss and formulate options to resolve the delay and to minimize the impact of
the delay on Genzyme and its customers.  Such options will include, without
limitation (i) plans to temporarily shift Manufacturing of one or more of the
Products from Hospira’s Facilities to one of Genzyme’s manufacturing facilities,
(ii) plans to shift Manufacture of one or more Products from dedicated filling
lines or other production equipment at the McPherson, Kansas Facility to other
qualified lines and equipment at such Facility, or (iii) plans to shift
Manufacture of one or more of the Products to the Liscate, Italy Facility.  Upon
notification of such actual or anticipated delay, all Purchase Orders accepted

 

--------------------------------------------------------------------------------

[**] = 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

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by Hospira and all outstanding Purchase Orders affected by such Inability to
Supply shall be tolled, pending resolution of the delay.

 

(b)           Minimums Reduced.  Genzyme’s Minimum Purchase Requirement for the
calendar year in which a delay in Manufacture and/or supply of Products has
occurred shall be reduced by the quantities of Product affected by the Inability
to Supply, whether Purchase Orders were partially filled, cancelled outright by
Genzyme as a result of the Inability to Supply, or Product is obtained from any
Third Party manufacturer as a result of such Inability to Supply.

 

9.3          Contract Manufacturer.  In the case of an Inability to Supply that
Hospira is unable to resolve in whole or in major part within [**] days, or if
Hospira notifies Genzyme that it will not be able to alleviate such Inability to
Supply within such [**] day period, Genzyme may, upon notice to Hospira,
terminate the relevant Project SOW, and Genzyme may contract with a Third Party
contract manufacturer to supply the Product.

 

9.4          Transfer Assistance.  In the event that Genzyme contracts with a
Third Party contract manufacturer, as contemplated in Section 9.3, Hospira shall
use commercially reasonable efforts for a reasonable period of time to assist
Genzyme in the transfer of the Project SOW information to the Third Party
contract manufacturer.  Hospira shall be responsible for [**], and shall [**] as
set forth on Exhibit 9.4; provided, however, that Hospira shall not [**] in the
event that an Inability to Supply has been caused by an event of Force Majeure. 
Notwithstanding the foregoing, nothing contained herein shall require Hospira to
disclose any Hospira intellectual property rights or Hospira Confidential
Information to such Third Party manufacturer, nor grant Genzyme any right to use
such rights or Hospira Confidential Information.

 

9.5          Definition.  For purposes of this Master Agreement, “Inability to
Supply” means:  (i) Hospira’s failure to supply at least [**] of Genzyme’s
requirements for Product meeting Product Specifications for any [**] for any
reason, or (ii) Genzyme reasonably concludes that Hospira, due to [**] of
Genzyme’s requirements for Product meeting Product Specifications for a period
which is expected to continue in excess of [**] days.  Inability to Supply shall
not include [**] this Master Agreement.

 

Article 10.            QUALITY

 

10.1        Quality Control.  Hospira shall apply its quality control procedures
and in-plant quality control checks to the Manufacture of the Products for
Genzyme in the same manner as Hospira applies such procedures and checks to
products of similar nature manufactured for sale by Hospira.  In addition,
Hospira will test and release the Products in accordance with the test methods
described in the relevant Project SOW to ensure that the Products conform to the
Product Specifications.  The Parties may change the test methods from time to
time by mutual written agreement.

 

10.2        Quality Technical Agreement.  The Parties have entered into a
Quality Technical Agreement as attached hereto as Exhibit 10.2.  Authorized
personnel of the Parties may amend

 

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[**] = 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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provisions of the Quality Technical Agreement by mutual agreement in writing,
without formal amendment to this Master Agreement.

 

10.3        Audit Rights.

 

(a)           General Audit.  Upon [**] days prior written notice to Hospira,
Genzyme shall have the right to visit the Facility during normal business hours
to review Hospira’s Manufacturing operations related to the Products, assess its
compliance with cGMP and quality assurance standards and discuss any related
issues with Hospira’s Manufacturing and management personnel.  Hospira shall
provide Genzyme with copies of Hospira’s Manufacturing records relating to the
Products for the purposes of assuring the quality of the Products and compliance
with agreed-upon Manufacturing procedures.  Such general audits shall:  (i) be
limited to not more than [**] auditors designated by or representing Genzyme;
(ii) last for not more than [**] days; and (iii) may be conducted not more than
[**] per calendar year.

 

(b)           For Cause Audits.  Genzyme shall also have the right to conduct
“for-cause” audits to address significant Product or safety concerns as
discovered through Product failures related to Hospira’s Manufacture of the
Products.  “Product failures” would include issues related to stability out of
specification, sterility, labeling, container integrity, or any other issues or
concerns related to Bulk.  Genzyme shall notify Hospira in writing in advance of
the audit and, thereafter, Genzyme and Hospira shall mutually determine the
timing of the audit.  Each for-cause audit shall be limited to [**] auditors for
no more than [**] days, except if the Parties mutually agree that a longer
for-cause audit period is necessary.

 

(c)           Regulatory Authority Audits.

 

(i)            Hospira shall allow audits conducted by Regulatory Authorities
related to the Manufacture of the Products, which may be required by such
Regulatory Authorities.  Hospira agrees to cooperate with the Regulatory
Authorities in connection with any such audit or inspection.  Hospira will
promptly (but in any event within [**] Business Day) notify Genzyme upon receipt
of a notice in connection with any such audit or inspection, and will, to the
extent permitted by Regulatory Authorities’ practices, allow Genzyme to be
present at the Facility during such audit or inspection.

 

(ii)           Hospira will notify Genzyme of all relevant portions of any
Regulatory Authority notice of observations or potential violations, to the
extent that such notice relates to the safety, efficacy or quality of the
Products, the Facility, or other issues that would adversely impact Hospira’s
performance hereunder, as well as a copy of Hospira’s response thereto.  In
addition, Hospira will provide Genzyme copies of any FDA 483(s) and
Establishment Inspection Reports (or their equivalents), which Hospira may
redact to protect its own Confidential Information or that of its other
customers.  Hospira shall use its commercially reasonable efforts to correct all
identified deficiencies in a timely manner and advise Genzyme periodically of
progress being made, as well as when all deficiencies have been corrected.

 

(iii)          In the event that inspections are requested or required by or for
any Regulatory Authority outside of the Territory identified in the initial
Project SOW for the

 

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[**] = 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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relevant Product, and such inspections are not general inspections of the
Facility but are directly related to the Manufacture of the Product(s), then
Hospira shall be entitled to an additional fee of [**] per each such Regulatory
Authority inspection; provided, however, that Hospira shall use reasonable
efforts to schedule any additional inspections concurrently so as to avoid any
additional fees.  In the event there is more than one such inspection occurring
at the same time, only one fee shall be assessed.

 

(d)           Confidential Information in Audits.  Audits by Genzyme or its
designees may involve the transfer of Confidential Information, and any such
Confidential Information shall be subject to the terms of Article 14 hereof. 
The results of such audits and inspections shall be considered Confidential
Information under Article 14 and shall not be disclosed to Third Parties,
excluding Regulatory Authorities, unless required by law and only then upon
prior written notice to Hospira.

 

(e)           Persons-in-the-Plant.  Notwithstanding the per person audit rights
under this Section 10.3, Hospira will permit up to two (2) employees of Genzyme
to have reasonable access to the Facility to observe and consult with Hospira
during active Manufacturing of the Products (the “Person(s)-in-the-Plant”). 
During such visits, Genzyme personnel will abide by all Hospira policies
regarding persons in the plant.  Genzyme will provide Hospira with sufficient
advance notice of any requests for such persons in the plant visits so that
Hospira may make appropriate arrangements for them.

 

10.4        Notification of Complaints.  Genzyme shall notify Hospira promptly
of any customer complaints involving Hospira’s Manufacturing or other Services
in sufficient time to allow Hospira to evaluate and investigate the complaints
and assist Genzyme in responding to such complaints.  Hospira shall be
responsible for all routine costs of such investigation.  In any case, Hospira
will use all reasonable commercial efforts to provide a written investigation
report to Genzyme within [**] days of notification.

 

10.5        Failed Batch.  In accordance with the Quality Technical Agreement,
Hospira shall investigate, and cooperate fully with Genzyme in investigating,
any batch of Product that fails to comply with cGMP or fails to meet the Product
Specifications or any Regulatory Authority requirements.  Hospira shall keep
Genzyme informed of the status of any investigation and, upon completion of the
investigation, shall provide Genzyme with a final written report describing the
cause of the failure and summarizing the results of the investigation, and the
corrective and preventative actions, with a schedule for completion of each
action.

 

10.6        Product Recalls.

 

(a)           Recall.  Genzyme shall direct and control responses to all Product
recalls, and Hospira shall provide reasonable cooperation to Genzyme in
connection with any such responses.  In the event: (i) any Regulatory Authority
or other national government authority issues a request, directive or order that
any Product be recalled; (ii) a court of competent jurisdiction orders a recall
of any Product; or (iii) Genzyme reasonably determines that any Product should
be recalled, the Parties shall take all appropriate corrective actions, and
shall cooperate in any governmental investigations surrounding the recall.

 

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[**] = 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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(b)           Administrative Expenses.  In the event that such recall results
from the breach of Hospira’s express warranties under Sections 11.2(a) or
11.2(b), or the gross negligence or willful misconduct of Hospira, Hospira shall
be responsible for promptly replacing the quantity of Products that were
recalled, at no cost to Genzyme, or reimbursing Genzyme for the cost of the
recalled Products, including the cost for Bulk and Manufacturing, subject to the
limitation in Section 7.1(f)(ii).  In addition, Hospira agrees that it shall be
responsible for the administrative expenses of any recall, provided, however,
that Hospira shall not pay more than [**] for the administrative expenses per
recall.  For purposes of this Agreement, administrative expenses of recall shall
include, but not be limited to, the expenses of notification and destruction or
return of the recalled Product, and any costs associated with the distribution
of the replacement Product, but shall not include lost profits of either Party. 
In the event that the recall does not result from the breach of Hospira’s
express warranties, gross negligence or willful misconduct, Genzyme shall be
responsible for all of the expenses of the recall.

 

ARTICLE 11.      WARRANTIES; COVENANTS AND INDEMNIFICATION

 

11.1        Genzyme’s Warranties.

 

(a)           Genzyme represents and warrants to Hospira that all Bulk delivered
to Hospira pursuant to this Master Agreement shall, at the time of delivery, not
be adulterated or misbranded within the meaning of the Act or within the meaning
of any Applicable Law in which the definitions of adulteration and misbranding
are substantially the same as those contained in the Act, as the Act and such
Applicable Laws are constituted and effective at the time of delivery, and will
not be an article which may not, under the provisions of Sections 404 and 505 of
the Act, be introduced into interstate commerce.

 

(b)           Genzyme further warrants to Hospira that Bulk supplied to Hospira
hereunder shall have been manufactured in accordance with all applicable cGMP
and shall meet the Bulk Specifications set forth in the relevant Project SOW.

 

(c)           Genzyme further warrants that all specifications including Bulk
Specifications and Product Specifications that Genzyme provides to Hospira shall
conform to the applicable regulatory filing Genzyme files with the appropriate
Regulatory Authorities.

 

(d)           Genzyme further represents and warrants to Hospira that Genzyme’s
performance of its obligations under this Master Agreement will not result in a
material violation or breach of any agreement, contract, commitment or
obligation to which Genzyme is a party or by which it is bound and will not
conflict with or constitute a default under its corporate charter or bylaws.

 

11.2        Hospira’s Warranties and Covenants.

 

(a)           Hospira represents and warrants to Genzyme that all Products
Hospira delivers to Genzyme pursuant to this Master Agreement shall, at the time
of delivery, not be

 

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[**] = 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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adulterated or misbranded within the meaning of the Act or within the meaning of
any Applicable Law in which the definitions of adulteration and misbranding are
substantially the same as those contained in the Act, as the Act and such
Applicable Laws are constituted and effective at the time of delivery, and will
be an article which may, under the provisions of Sections 404 and 505 of the
Act, be introduced into interstate commerce.

 

(b)           Hospira further represents and warrants to Genzyme that all
Products Hospira delivers to Genzyme pursuant to this Master Agreement shall, at
the time of delivery and through the expiration date of the Products, be free
from defects in material and workmanship and shall be Manufactured: (a) in
accordance and conformity with, and shall meet, the Product Specifications set
forth in the relevant Project SOW; and (b) in compliance with all Applicable
Laws including those relating to the environment, food or drugs and occupational
health and safety including, without limitation, those enforced or promulgated
by the FDA or any other applicable Regulatory Authority (including, without
limitation, compliance with cGMP).

 

(c)           Hospira further represents and warrants to Genzyme that Hospira’s
performance of its obligations under this Master Agreement will not result in a
material violation or breach of any agreement, contract, commitment or
obligation to which Hospira is a party or by which it is bound and will not
conflict with or constitute a default under its Certificate of Incorporation or
corporate bylaws.

 

(d)           The foregoing warranties shall not extend to any nonconformity or
defect which relates to or is caused by Bulk supplied by Genzyme to Hospira. 
Subject to Section 11.4, the replacement provisions of Sections 7.1(f) shall be
Genzyme’s sole and exclusive remedy for nonconforming or defective Products.

 

11.3        EACH PARTY MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH
RESPECT TO BULK OR PRODUCT.  ALL OTHER WARRANTIES, EXPRESS OR IMPLIED INCLUDING,
WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED.

 

11.4        Indemnification by Hospira.  Hospira shall indemnify and hold
harmless Genzyme, its Affiliates, officers, directors and employees from and
against all claims, causes of action, suits, costs and expenses (including
reasonable attorney’s fees), losses or liabilities of any kind related to this
Master Agreement or any relevant Project SOW and asserted by Third Parties to
the extent such arise out of or are attributable to (a) Hospira’s breach of this
Master Agreement, any relevant Project SOW, or any representation or warranty
set forth herein or therein, (b) any violation of any proprietary right of any
Third Party relating to Hospira’s processes used in the Manufacture of the
Products pursuant to this Master Agreement (excluding claims related to the Bulk
active ingredients or excipients), (c) any breach of Section 14.4 hereunder, or
(d) any negligent or wrongful act or omission on the part of Hospira, its
employees, agents or representatives and which relates to Hospira’s performance
hereunder; provided, however, that this indemnification shall not apply to the
extent that such claim results from Genzyme’s (or its agents’, employees’ or
representatives’) breach of this Master

 

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[**] = 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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Agreement, any relevant Project SOW or any warranty herein or therein, or
Genzyme’s (or its agents’, employees’ or representatives’) negligence or willful
misconduct.

 

11.5        Indemnification by Genzyme.  Genzyme shall indemnify and hold
harmless Hospira, its Affiliates, officers, directors and employees harmless
from and against all claims, causes of action, suits, costs and expenses
(including reasonable attorney’s fees), losses or liabilities of any kind
related to this Master Agreement or any relevant Project SOW and asserted by
Third Parties to the extent such arise out of or are attributable to
(a) Genzyme’s breach of this Master Agreement, any relevant Project SOW, or any
representation or warranty set forth herein or therein; (b) any violation of any
proprietary right of any Third Party relating to the Bulk and expressly
excluding all other Third Party proprietary rights, including those incorporated
in Hospira’s processes used in the Manufacture of the Products pursuant to this
Master Agreement; (c) any use of, or lack of safety or efficacy of Bulk or the
Products that is attributed to Genzyme’s actions or failure to act; or (d) any
negligent or wrongful act or omission on the part of Genzyme, its employees,
agents or representatives and which relate to Genzyme’s performance hereunder;
provided, however, that this indemnification shall not apply to the extent that
such claim results from Hospira’s (or its agents’, employees’ or
representatives’) breach of this Master Agreement, any relevant Project SOW or
breach of any warranty herein or therein, or Hospira’s (or its agents’,
employees’ or representatives’) negligence or willful misconduct.

 

11.6        Conditions of Indemnification.  If either Party seeks
indemnification from the other hereunder, it shall promptly give notice to the
other Party of any such claim or suit threatened, made or filed against it which
forms the basis for such claim of indemnification and shall cooperate fully with
the other Party in the investigation and defense of all such claims or suits. 
The indemnifying Party shall have the option to assume the other Party’s defense
in any such claim or suit with counsel reasonably satisfactory to the other
Party.  No settlement or compromise shall be binding on a Party hereto without
its prior written consent, such consent not to be unreasonably withheld.

 

11.7        No Consequential Damages.  NEITHER PARTY SHALL BE LIABLE TO THE
OTHER FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL
DAMAGES RESULTING FROM ANY BREACH OF THIS MASTER AGREEMENT EVEN IF THE PARTY HAS
BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.  THIS LIMITATION ON LIABILITY
SHALL NOT APPLY TO ANY DAMAGES OR CLAIMS ARISING FROM A VIOLATION OF ARTICLE 14
HEREOF, OR OUT OF ANY INDEMNITY PURSUANT TO THIS ARTICLE 11.

 

ARTICLE 12.      INTELLECTUAL PROPERTY RIGHTS

 

12.1        Hospira’s Proprietary Rights.  Except for the purposes of this
Master Agreement and/or relating to the Products and Services hereunder, Hospira
has granted no license, express or implied, to Genzyme to use Hospira’s
proprietary technology, know-how or other proprietary rights (i) existing as of
the Effective Date; or (ii) developed by or for Hospira on or after the
Effective Date.  It is understood and agreed by the Parties that Genzyme shall
owe no further fees, payments or royalties of any kind on any Product
Manufactured by Hospira (except as

 

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[**] = 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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expressly detailed in the applicable Project SOW), regardless of the technology,
know-how or other proprietary processes used by Hospira in the Manufacture of
Products or the performance of Services hereunder.

 

12.2        Genzyme’s Proprietary Rights.  Except for the purposes of this
Master Agreement and the Manufacture of Products or performance of Services
hereunder, Genzyme has granted no license, express or implied, to Hospira to use
Genzyme’s proprietary technology, know-how or other proprietary rights.

 

12.3        Project Inventions. Notwithstanding Hospira’s rights, the Parties
agree that Genzyme shall be the sole owner of any technology, know-how or other
proprietary rights developed by or for Hospira pursuant to any Project
undertaken by Hospira (the “Project Inventions”). Hospira shall promptly notify
Genzyme of all Project Inventions and shall use all reasonable efforts to
cooperate with Genzyme in any related patent filing and prosecution (each at
Genzyme’s expense) and shall assign all right, title and interest in any such
Project Inventions to Genzyme.

 

ARTICLE 13.      TERM AND TERMINATION

 

13.1        Term.  This Master Agreement shall commence on the Effective Date
and, unless earlier terminated as provided in this Section 13, shall expire on
the later of:  (a) five (5) years from the Effective Date or (b) the date of the
last to expire Project SOW (“Term”).  This Master Agreement shall be
automatically extended for additional and successive renewal terms of one
(1) year each (“Renewal Term”); provided, however, that this Master Agreement or
any Project SOW for a Commercial Product (in whole or in part) may be terminated
at the end of the Term or any Renewal Term upon either Party providing the other
with at least twenty-four (24) months prior written notice of termination.

 

13.2        Termination of a Development Project.  Either Party wishing to
terminate a Development Project (or any portion of it as it relates to any one
or more of the Products) shall request in writing a pre-termination consultation
with the other Party to review potential concerns and to make reasonable efforts
to continue with the Development Project. [**] days following said
consultation:  (i) Genzyme may terminate the Development Project upon [**] days
prior written notice to Hospira, or (ii) Hospira may terminate the Development
Project upon [**] months prior written notice to Genzyme in the event that the
terminating Party determines in good faith, and in its sole discretion, that the
successful performance of the Services is not technically, financially, or
commercially feasible using commercially reasonable efforts.  If the Development
Project is terminated in whole or in part, Hospira shall advise Genzyme of the
costs it has incurred in performing the Services (or the relevant portion
thereof) prior to such termination.  Genzyme shall pay Hospira for all
reasonable and documented costs for Services performed up to the date the
termination notice is received.  In the event of complete termination of the
Development Project, the Project SOW shall automatically terminate; provided,
however, that this Master Agreement shall remain in full force and effect.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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13.3        Termination.

 

(a)           Project Termination Rights.

 

(i)            Either Party shall have the right to terminate an individual
Project SOW by giving the other Party no less than [**] days prior written
notice upon the non-terminating Party’s breach of any warranty or any other
material provision of the relevant Project SOW if the breach is not cured within
[**] days after written notice thereof to the non-terminating Party.  In the
event that the material breach is curable and the Party in breach anticipates
that it may not be able to cure such material breach within the prescribed [**]
day period despite its continuing diligent efforts to do so, it shall provide
the other Party with notice of all relevant issues.  The Parties may thereafter
agree to extend the period to cure for an additional [**] day period.

 

(ii)           Either Party shall have the right to terminate an individual
Development Project SOW by giving the other Party no less than [**] days prior
written notice if a Development Product has not received regulatory approval
from the FDA (or any other relevant Regulatory Authority) by the date specified
in the relevant Project SOW.

 

(iii)          Either Party shall have the right to terminate an individual
Project SOW upon written notice to the other Party, should the non-terminating
Party be unable to perform its obligations under any Project SOW for a period in
excess of [**] days by reason of force majeure, in accordance with
Section 15.1(a).

 

(iv)          Genzyme may terminate an individual Project SOW upon [**] days
prior notice following the loss or damage to Bulk and/or Product(s) with an
aggregate Bulk value of more than $[**] within any [**] month period, while such
Bulk Product(s) and/or Product(s) are in Hospira’s custody; provided, however,
that during such [**] day notice period the Parties shall meet to discuss
whether there is any ability to implement procedures which would avoid future
losses; and further provided that, in the event the Parties reach a written
agreement on such procedures prior to the expiry of the [**] day notice period
(or any agreed extension thereof), such termination shall not be effective.

 

(v)           Genzyme shall have the right to terminate an individual Project
SOW upon notice in the event that Hospira fails to provide Genzyme with
reasonable assurances acceptable to Genzyme of its ability to resume the
Manufacture and supply of Products as set forth in Article 9.

 

(vi)          Hospira shall have the right to terminate an individual Project
SOW for Commercial Product upon notice if in any [**] consecutive calendar
years, Genzyme fails to purchase its Minimum Purchase Requirement, irrespective
of whether Genzyme waives Hospira’s Manufacturing and delivery obligations
pursuant to Section 8.2(b).

 

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[**] = 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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(b)           Master Agreement Termination Rights.

 

(i)            Either Party may immediately terminate this Master Agreement by
providing written notice upon the bankruptcy or the insolvency of the other
Party.

 

(ii)           Either Party may terminate this Master Agreement by giving the
other Party ninety (90) days prior written notice upon the other Party’s
material breach of any provision of this Master Agreement, if the breach is not
cured within [**] days after written notice thereof to the Party in breach.  In
the event that the material breach is curable and the Party in breach
anticipates that it may not be able to cure such material breach within the
prescribed [**] day period despite its continuing diligent efforts to do so, it
shall provide the other Party with notice of all relevant issues.  The Parties
may thereafter extend the period to cure for whatever time they agree is
reasonable under the circumstances.

 

(iii)          Either Party may terminate this Master Agreement by giving the
other Party written notice should the non-terminating Party be unable to perform
its obligations under any Project SOWs for a period in excess of [**] days by
reason of force majeure, in accordance with Section 15.1(a).

 

(iv)          Genzyme may terminate this Master Agreement, upon [**] days prior
notice following the loss or damage to Bulk Product(s) and/or Product(s) with an
aggregate value of more than $[**] within any [**] month period, while such Bulk
Product(s) and/or Product(s) are in Hospira’s custody; provided, however, that
during such [**] day notice period the Parties shall meet to discuss whether
there is any ability to implement procedures which would avoid future losses;
and further provided that, in the event the Parties reach a written agreement on
such procedures prior to the expiry of the [**] day notice period (or any agreed
extension thereof), such termination shall not be effective.

 

(v)           Genzyme may terminate this Master Agreement if there is an
Inability to Supply affecting more than [**] Products that continues for more
than [**] days.

 

(vi)          Hospira may terminate this Master Agreement upon [**] days prior
notice if in any [**] consecutive calendar years Genzyme fails to purchase its
Minimum Purchase Requirements for [**] or more Project SOWs, irrespective of
whether Genzyme waives Hospira’s manufacturing and delivery obligations pursuant
to Section 8.2(b).

 

13.4        Accrued Payment Obligations.  Upon termination of any Project SOW or
this Master Agreement pursuant to Sections 13.3(a)(ii), 13.3(a)(iv), or
13.3(b)(iv), as applicable, Genzyme shall reimburse Hospira for Hospira’s cost
of all supplies purchased and on hand or on order, to the extent such supplies
were ordered by Hospira based on Purchase Orders and such supplies cannot be
reasonably used by Hospira for other purposes.  Hospira shall invoice Genzyme
for all amounts due hereunder.  Payment shall be made pursuant to
Section 7.6(b).

 

13.5        Return of Inventory, Dedicated Equipment and Product.  In the event
of any termination, Hospira shall promptly return any remaining inventory of
Bulk, all Dedicated Equipment, and any Product to Genzyme at Genzyme’s expense,
unless such termination shall have been as a result of a breach of any relevant
Project SOW or this Master Agreement by Hospira, or if Hospira terminates under
Section 13.3(a)(ii) or Genzyme terminates under Section

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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13.3(a)(iv), or Section 13.3(b)(iv), in which case such inventory, Dedicated
Equipment and any Product shall be returned at Hospira’s expense.

 

13.6        Exclusive Rights and Remedies.  Termination of any Project SOW or
this Master Agreement under Sections 13.3(a)(v), 13.3(a)(vi), 13.3(b)(v), or
13.3(b)(vi), respectively, is an election of remedies.  With regard to such
provisions, except in instances of willful misconduct or gross negligence, all
rights and remedies of the Parties provided under Sections 9.4 or 8.2(b) of this
Master Agreement, as applicable, are exclusive.

 

13.7        Survival.  Expiry or early termination of any relevant Project SOW
or this Master Agreement shall not relieve either Party of any obligations that
it may have incurred prior to expiration or early termination and all covenants
and agreements contained in any relevant Project SOW or this Master Agreement
including, but not limited to, Sections 10.3, 10.6 and 13.7, and Articles 11, 12
and 14, which by their terms or context are intended to survive and will
continue in full force and effect for a period of five (5) years unless a
different time period is indicated in this Master Agreement.

 

ARTICLE 14.      CONFIDENTIAL INFORMATION AND NON-COMPETE

 

14.1        Nondisclosure.  It is contemplated that in the course of the
performance of this Master Agreement each Party may, from time to time, disclose
Confidential Information to the other.  Hospira agrees that, except as expressly
provided herein, it shall not disclose Confidential Information received from
Genzyme, and shall not use Confidential Information disclosed to it by Genzyme,
for any purpose other than to fulfill Hospira’s obligations hereunder.  Hospira
further agrees that it will limit the permitted disclosures of Genzyme’s
Confidential Information only to those persons within Hospira’s One 2 One® group
and the Facilities who have a “need to know” such Confidential Information and
as further set forth in Section 14.4.  Genzyme agrees that, except as expressly
provided herein, it shall not disclose Confidential Information received from
Hospira, and shall not use Confidential Information disclosed to it by Hospira,
for any purpose other than to fulfill Genzyme’s obligations hereunder.

 

14.2        Exceptions to Duty of Nondisclosure.  Notwithstanding the above,
nothing contained in this Master Agreement shall preclude: (a) Genzyme from
utilizing Confidential Information as may be necessary in prosecuting patent
rights related to Project Inventions as set forth in Article 12, or (b) either
Party from (i) obtaining governmental marketing approvals, (ii) Manufacturing
the Products pursuant to the terms and conditions of this Master Agreement,
(iii) complying with other Applicable Laws (provided that the Party disclosing
such Confidential Information uses reasonable efforts to seek confidential
treatment of such Confidential Information, except for information included in
any Project Invention patent applications), or (iv) corresponding with any
Regulatory Authority in connection with this Master Agreement, or on any
relevant matter.  The obligations of the Parties relating to Confidential
Information shall expire ten (10) years after the termination of this Master
Agreement.

 

14.3        Public Announcements.  Neither Party shall make any public
announcement concerning the transactions contemplated herein, or make any public
statement which includes

 

--------------------------------------------------------------------------------

[**] = 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

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the name of the other Party or any of its Affiliates, or otherwise use the name
of the other Party or any of its Affiliates in any public statement or document,
except as (i) may be required by Applicable Laws (including U.S. federal
securities regulations) or judicial order, or (ii) is made to a Regulatory
Authority, without the written consent of the other Party, which consent shall
not be unreasonably withheld.  Subject to any legal or judicial disclosure
obligation, any such public announcement proposed by a Party that names the
other Party shall first be provided in draft to the other Party for the other
Party’s review and approval.

 

14.4        [**] Cost Information.  Any information related to the cost of [**]
provided by Genzyme to Hospira shall only be provided on a need to know basis,
as determined by Genzyme, and in any case only disclosed to the following
individuals within the Hospira One2One® group  (i) the Hospira Vice President
and General Manager of Contract Manufacturing Services, (ii) the Director of
Business Development, and (iii) the Manager of Business Development
(collectively, the “Relationship Managers”).  Any disclosure by Hospira to
individuals other than to the Relationship Managers, must be approved in writing
by the Genzyme Senior Vice President of Materials Management (or his/her
designee), and is otherwise expressly prohibited.  Notwithstanding the
foregoing, any such disclosure to the Relationship Managers, or any other
authorized individual, shall be used exclusively for the purpose of calculating
the costs for any [**] under this Master Agreement.  Any information related to
the cost of [**] shall be in writing and marked as “highly confidential” along
with a notice that significant penalties may attach in the event of unauthorized
use or disclosure.

 

14.5        [**].  Notwithstanding the Minimum Purchase Requirements of
Section 8.2, in consideration of Genzyme’s ordering and purchasing in each
calendar year, the minimum number of batches of Products as set forth in
Exhibit 14.5, the Hospira [**], as may be amended from time to time by the
Parties.  Should Genzyme fail to meet the minimum batch requirements set forth
in Exhibit 14.5, then the [**].  Notwithstanding the foregoing, if Genzyme
decides not to renew this Master Agreement and so notifies Hospira, then Hospira
may provide development services for products that treat the disease states set
forth in Exhibit 14.5 within one (1) year prior to the expiration of this Master
Agreement, which development services shall not include any manufacturing
services including, without limitation, product verification runs, engineering
runs, or any other technology transfer manufacturing services.  In addition, in
lieu of Genzyme taking delivery of the batch requirements set forth in
Exhibit 14.5, Genzyme shall have the option to pay for the batch requirements at
the Product prices set forth in the relevant Project SOW and waive Hospira’s
Manufacture and delivery obligations for the Products.  In the latter event,
Hospira shall invoice Genzyme for [**], and Genzyme shall pay Hospira within
[**] days after receipt of Hospira’s invoice, in accordance with Section 7.6(b).

 

14.6        Injunctive Relief. The Parties acknowledge that either Party’s
breach of this Article 14 may cause the other Party irreparable injury for which
it would not have an adequate remedy at law.  In the event of such breach, the
non-breaching Party may be entitled to seek injunctive relief in addition to any
other remedies it may have at law or in equity.

 

--------------------------------------------------------------------------------

[**] = 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

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ARTICLE 15.      MISCELLANEOUS

 

15.1        Force Majeure and Failure of Suppliers.

 

(a)           Excusable Delay.  Neither Party shall be considered to be in
breach of any relevant Project SOW or this Master Agreement if a delay in the
performance of any of its duties or obligations hereunder (except the payment of
money) has been caused by or is the result of an act of God, acts of a public
enemy, acts of terrorism, insurrections, riots, embargoes, labor disputes,
including strikes, lockouts, job actions, boycotts, fires, explosions, floods,
shortages of material or energy, or other unforeseeable causes beyond the
control and without the fault or negligence of the Party so affected (each an
event of  “Force Majeure”).  The performance of the affected Party shall be
extended for a period equal to the period of such delay; provided, however, that
affected Party shall give prompt notice to the other Party of such cause, and
shall promptly take whatever reasonable steps are necessary to relieve the
effect of such force majeure and resume compliance with the relevant Project SOW
or this Master Agreement as soon as possible.  Should the event of Force Majeure
continue for a period longer than ninety (90) days, then the Party not so
affected may terminate the relevant Project SOW in accordance with
Section 13.3(a)(iii).  Should the event of Force Majeure continue for a period
longer than one hundred and eighty (180) days, then the Party not so affected
may terminate this Master Agreement in accordance with Section 13.3(b)(iii).

 

(b)           Failure of Suppliers.  The Parties understand and agree that
Genzyme has chosen the excipient and primary container packaging component
suppliers listed in the Product Specifications.  Under no circumstances shall
Hospira have any liability to Genzyme, nor shall Hospira be deemed to be in
breach of this Master Agreement, if Hospira is unable to supply the Products or
any Product to Genzyme due to a failure of such suppliers to provide such
excipients and/or primary container packaging components to Hospira (provided
that such failure is due in no part to Hospira’s negligence).

 

15.2        Notices.  All notices hereunder shall be delivered as follows:
(a) personally; (b) by facsimile and confirmed by first class mail (postage
prepaid); (c) by registered or certified mail (postage prepaid); or (d) by
overnight courier service, to the following addresses of the respective Parties:

 

If to Genzyme:

 

With a copy to:

 

 

 

Genzyme Corporation

 

Genzyme Corporation

200 Crossing Boulevard

 

500 Kendall Street

Framingham, MA 01701-9322

 

Cambridge, MA 02139

Attention: Senior Vice President, Materials Management

 

Attention: General Counsel

 

 

 

Facsimile: (508) 661-8538

 

Facsimile: (617) 252-7553

 

 

 

Genzyme Ireland Limited

 

 

IDA Industrial Park

 

 

 

--------------------------------------------------------------------------------

[**] = 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

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Old Kilmeaden Road

 

 

Cork Road

 

 

Waterford

 

 

Attn: Director

 

 

 

If to Hospira:

 

With copy to:

 

 

 

Hospira, Inc.

 

Hospira, Inc.

275 North Field Drive

 

Building H1; Department NLEG

Lake Forest, IL 60045

 

275 N. Field Drive

Attention: Vice President, Contract Manufacturing

 

Lake Forest, IL 60045

 

 

Attention: General Counsel

 

 

 

Facsimile: (224) 212-3210

 

Facsimile: (224) 212-2086

 

Notices shall be effective upon receipt if personally delivered or delivered by
facsimile and confirmed by first class mail, on the third business day following
the date of registered or certified mailing, or on the first business day
following the date of delivery to the overnight courier. A Party may change its
address listed above by written notice to the other Party.

 

15.3        Choice of Law.  This Master Agreement shall be construed,
interpreted and governed by the laws of the State of Delaware, excluding its
choice of law provisions.  The United Nations Convention on the International
Sale of Goods is hereby expressly excluded.

 

15.4        Assignment.  Neither Party shall assign any Project SOW or this
Master Agreement nor any part thereof without the prior written consent of the
other Party; provided, however, that either Party, without such consent, may
assign a Project SOW and/or this Master Agreement in connection with the
transfer, sale or divestiture of substantially all of its business to which the
Project SOW or this Master Agreement pertains or in the event of its merger or
consolidation with another entity unless, in the case of Hospira, such
assignment would be to a competitor of Genzyme, in which case Hospira shall
obtain Genzyme’s prior written consent to such assignment which consent shall
not be unreasonably withheld.  Any permitted assignee shall assume all
obligations of its assignor under the relevant Project SOW or this Master
Agreement.  No assignment shall relieve any Party of responsibility for the
performance of any accrued obligation which such Party then has hereunder.

 

15.5        Entire Agreement.  This Master Agreement, together with the Quality
Technical Agreement, the Exhibits and Project Statements of Work referenced and
incorporated herein, constitute the entire agreement between the Parties
concerning the subject matter hereof and supersede all written or oral prior
agreements or understandings between the Parties with respect thereto.

 

--------------------------------------------------------------------------------

[**] = 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

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15.6        Severability.  This Master Agreement and any associated Project SOW
is subject to the restrictions, limitations, terms and conditions of all
applicable governmental regulations, approvals and clearances.  If any term or
provision of this Master Agreement any associated Project SOW shall for any
reason be held invalid, illegal or unenforceable in any respect, such
invalidity, illegality or unenforceability shall not affect any other term or
provision hereof, and this Master Agreement any associated Project SOW shall be
interpreted and construed as if such term or provision, to the extent the same
shall have been held to be invalid, illegal or unenforceable, had never been
contained herein.

 

15.7        Waiver Modification of Agreement.  No waiver or modification of any
of the terms of this Master Agreement any associated Project SOW shall be valid
unless in writing and signed by authorized representatives of both Parties. 
Failure by either Party to enforce any such rights under this Master Agreement
any associated Project SOW shall not be construed as a waiver of such rights,
nor shall a waiver by either Party in one or more instances be construed as
constituting a continuing waiver or as a waiver in other instances.

 

15.8        Insurance.  Each Party will procure and maintain, at its own
expense, for the duration of this Master Agreement, and for five (5) years
thereafter if written on a claims made or occurrence reported form, the types of
insurance specified below with carriers rated A-VII or better with A.M. Best or
like rating agencies:

 

(a)           Workers’ Compensation accordance with applicable statutory
requirements and shall provide a waiver of subrogation in favor of the other
Party;

 

(b)           Employer’s Liability with a limit of liability in an amount of not
less than $[**];

 

(c)           Commercial General Liability including premises operations,
products & completed operations, blanket contractual liability, personal injury
and advertising injury including fire legal liability for bodily injury and
property damage in an amount not less than $[**]per occurrence and $[**] in the
aggregate;

 

(d)           Commercial Automobile Liability for owned, hired and non-owned
motor vehicles with a combined single limit in an amount not less than $[**]
each occurrence;

 

(e)           Excess Liability including products liability with a combined
single limit in an amount of not less than $[**] per occurrence and in the
aggregate;

 

(f)            Professional Liability with a limit of liability in an amount of
not less than $[**] per claim and in the aggregate;

 

(g)           Commercial Crime or Fidelity Bond in an amount of not less than
$[**] per occurrence and in the aggregate including an endorsement for Third
Party liability without the requirement of a conviction; 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.

 

33

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(h)           Marine Insurance covering all shipments from warehouse to
warehouse as described on the bill of lading at a full replacement cost.

 

Each Party shall include the other Party and its Affiliates, directors,
officers, employees and agents as additional insureds with respect to Commercial
General Liability, Commercial Automobile Liability and Excess Liability but only
as their interest may appear by written contract.  Promptly after the Effective
Date, and annually thereafter, each Party shall furnish to the other Party
certificates of insurance evidencing the insurance coverages stated above and
shall require at least thirty (30) days written notice to the other Party prior
to any cancellation, non-renewal or material change in said coverage.  In the
case of cancellation, non-renewal or material change in said coverage, each
Party shall promptly provide the other Party with a new certificate of insurance
evidencing that the coverage meets the requirements in this Section.  Each Party
agrees that its insurance shall act as primary and noncontributory from any
other valid and collectible insurance maintained by the other Party.  Each Party
may, at its option, satisfy, in whole or in part, its obligation under this
Section through its self-insurance program.

 

15.9        Supplemental Insurance.  Notwithstanding the foregoing, Genzyme may
obtain supplemental insurance coverage for operational or manufacturing risk of
loss of Bulk and/or Product in excess of, or in addition to, any other insurance
coverage Hospira and/or Genzyme may have in force.  In consideration of
Genzyme’s Minimum Purchase Requirements set forth in Section 8.2 of this
Agreement, Hospira shall [**] (up to [**] during the [**], and shall [**],
except as otherwise set forth in [**].  In the event the [**], then Hospira
shall [**].

 

15.10      Exhibits.  All Exhibits referred to herein are hereby incorporated by
reference.

 

15.11      Debarment Warranty.  Hospira and Genzyme represent and warrant that
neither Party uses nor will use in the future in any capacity the services of
any person debarred under Section (a) or (b) of 21 U.S.C. Section 335a.

 

15.12      Different Provisions for Specific Compounds. Both Parties accept that
certain terms herein including, but not limited to, those respecting
confidentiality and inventions, may need to be modified for a specific Project
SOW.  Provided that any such modified terms are set forth in a Project SOW,
those terms shall control over any terms herein (solely for that Project SOW)
notwithstanding anything to the contrary in this Master Agreement.

 

REMAINDER OF PAGE INTENTIONALLY LEFT BLANK

SIGNATURE PAGE FOLLOWS

 

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[**] = 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

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IN WITNESS WHEREOF, the Parties, intending to be bound by the terms and
conditions hereof, have caused this Master Agreement to be signed by their duly
authorized representatives as of the date first above written.

 

HOSPIRA WORLDWIDE, INC.

 

GENZYME CORPORATION

 

 

 

 

 

 

By:

/s/ Anthony Cacich

 

By:

/s/ Henri A. Termeer

Name:

Anthony Cacich

 

Name:

Henri A. Termeer

Title:

Vice President & General Manager of Contract Manufacturing

 

Title:

President & Chief Executive Officer

 

 

 

 

 

 

 

By:

/s/ Michael S. Wyzga

 

 

Name:

Michael S. Wyzga

 

 

Title:

Executive Vice President

 

 

 

Chief Financial Officer

 

 

 

 

 

GENZYME IRELAND LIMITED

 

 

 

 

 

 

 

 

By:

/s/ Michael S. Wyzga

 

 

Name:

Michael S. Wyzga

 

 

Title:

Director

 

 

 

 

 

 

 

 

By:

/s/ Dominic Carolan

 

 

Name:

Dominic Carolan

 

 

Title:

Director

 

--------------------------------------------------------------------------------

[**] = 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.

 

--------------------------------------------------------------------------------

 

Exhibit 1.33

Initial Product List

 

·      Cerezyme® (imiglucerase for injection) 400 mg

·      Fabrazyme® (agalsidase beta for injection) 5 mg

·      Fabrazyme® (agalsidase beta for injection) 35 mg

·      Thyrogen® (thyrotropin alpha for injection)

·      Myozyme®/ Lumizyme™ (alglucosidase alfa for injection)

·      Thymoglobulin® (rabbit-anti-human thymocyte immune globulin)

·      [**]

·      Campath® (alemtuzumab)

·      [**]

 

Exhibit 2.5

Form of Project Statement of Work

 

[final to be attached]

 

Exhibit 5.6

Estimates of Required Materials Inventories

 

Component

 

Product

 

Hospira Inventory Number

 

Proposed Safety
Stock(1)

 

[**]

 

[**]

 

[**]

 

[**]

 

 

--------------------------------------------------------------------------------

(1)Amount is the sum required for all products using the same component with a 3
– 5% overage

 

Exhibit 5.6

Estimates of Required Materials Inventories (cont’d)

 

Product

 

Component

 

Hospira Inventory
Number

 

Description

 

Qty/Batch(1)

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

 

--------------------------------------------------------------------------------

(1)Based on current clinical or commercial batch sizes

 

Exhibit 9.4

Transfer Assistance

 

[**]

 

--------------------------------------------------------------------------------

[**] = 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.

 

--------------------------------------------------------------------------------

 

Exhibit 10.2

Quality Technical Agreement

 

[to be entered into by the parties]

 

Exhibit 14.5

[**]

 

Minimum Batch Requirements (per calendar year)

 

[**]

 

Products

 

[**]

 

*The minimums specified herein shall be pro rated for any partial calendar year.

 

--------------------------------------------------------------------------------

[**] = 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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