EXHIBIT 10.29


 


TECHNOLOGY
TRANSFER AND SUPPLY AGREEMENT


 


THIS
TECHNOLOGY TRANSFER AND SUPPLY AGREEMENT (hereinafter referred to as the “Agreement”)
with an effective date of this 31st day of December 2009 (the “Effective
Date”) is made by and between Genzyme Corporation, a Massachusetts corporation
and Genzyme Therapeutics Products Limited Partnership, a Massachusetts Limited Partnership,
each having its headquarters at  500
Kendall Street, Cambridge, Massachusetts 02142 (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”).


 


WITNESSETH:


 


WHEREAS,
Genzyme owns rights to the compounds Cerezyme® (imiglucerase
for injection), Fabrazyme® (agalsidase beta for injection), Thyrogen® (thyrotropin alpha for injection) and Myozyme® (alglucosidase alfa for injection), and markets
each in a standard flip top vial;


 


WHEREAS,
Genzyme desires to use Hospira to perform fill and finish services with respect
to Genzyme’s Cerezyme® (imiglucerase for injection), Fabrazyme® (agalsidase beta for injection), Thyrogen® (thyrotropin alpha for injection) and certain
Myozyme® (alglucosidase
alfa for injection) pharmaceutical products; and


 


WHEREAS,
Hospira desires to perform such services for Genzyme with respect to Genzyme’s Cerezyme® (imiglucerase for injection), Fabrazyme® (agalsidase beta for injection), Thyrogen® (thyrotropin alpha for injection)  and certain Myozyme® (alglucosidase alfa for injection) pharmaceutical
products.


 


NOW,
THEREFORE, in consideration of the premises and the mutual promises and
agreements contained herein, Genzyme and Hospira agree as follows:


 


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.


 


1.2           “Affiliate” shall mean any
corporation or non-corporate business entity which controls, is controlled by,
or is under common control with a Party to this Agreement.  A corporation or non-corporate business
entity shall be regarded as in control of another


 






[**] = 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.


 

















 


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           “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.


 


1.4           “Bulk” or “Bulk Product(s)” shall mean the active ingredient of the
Products (as hereinafter defined) in bulk form that Genzyme shall deliver to
Hospira for incorporation into the Products (as hereinafter defined) and
meeting the applicable Bulk Specifications (as hereinafter defined).


 


1.5           “Bulk
Specifications” shall mean the detailed description and parameters
of the Bulk set forth on Exhibit 1.5.


 


1.6           “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.


 


1.7           “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;


 






[**] = 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;


 


(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; or


 


(e)           is required by law to be
disclosed by the recipient, provided that the recipient gives the other Party
hereto prompt notice of such legal requirement such that such other Party shall
have the opportunity to apply for confidential treatment of such Confidential
Information.


 


1.8           “Dedicated
Equipment” shall have the meaning set forth in Section 5.4.


 


1.9           “Development
Supplies”  shall have the meaning set
forth in Section 3.4.


 


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


 


1.11         “FDA” shall mean the
U.S. Food and Drug Administration.


 


1.12         “Firm
Order Period” shall have the meaning set forth in Section 6.2.


 


1.13         “Initial Term”
shall
have the meaning set forth in Section 10.1.


 


1.14         “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).


 


1.15         “MSDS” shall have the
meaning set forth in Section 5.6.


 


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


 


1.17         “Products” shall mean
Cerezyme® (imiglucerase for injection), Fabrazyme® (agalsidase beta for injection) and Thyrogen® (thyrotropin alpha for injection) and Myozyme® (alglucosidase alfa for injection) that is
filled on the [**], each in final dosage form, packaged in a flip top vial, filled and finished in
accordance with the Product Specifications (as hereinafter defined), and
each individually shall be a “Product”.


 


1.18         “Product
Supply Commitment” shall have the meaning set forth in Section 6.1.


 


1.19         “Product
Specifications” shall mean those product, labeling and performance
specifications for the Products filed with the FDA or other appropriate
Regulatory Authorities,


 






[**] = 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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including Product formula, labeling, and
materials required for the manufacture of the Product that is to be purchased
and supplied under this Agreement, as such are set forth on Exhibit 1.19,
which specifications may be amended from time to time by the written agreement
of the Parties.


 


1.20         “Project”  shall mean the technical transfer from Genzyme to
Hospira (as further detailed in Section 2.1 and Exhibit 2.1)
and development activities necessary for regulatory approval and commercial
manufacture of the Products.


 


1.21         “Project
Inventions” shall have the meaning set forth in Section 9.1.


 


1.22         “Regulatory
Authority” shall mean any federal, state or local or
international regulatory agency, department, bureau or other governmental
entity including 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 a regulatory jurisdiction.


 


1.23         “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.


 


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


 


1.25         “Technology
Transfer Fee” shall have the meaning set forth in Section 3.1
and further detailed in Exhibit 3.1.


 


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


 


1.27         “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.


 


Article
2.                TECHNOLOGY
TRANSFER PROJECT


 


2.1           General.  Promptly following the Effective Date, the
Parties shall undertake a technical transfer consisting of the development
activities set forth in Exhibit 2.1 (the “Project”).  The objective of the Project shall be for
Hospira to assist in the technical transfer and fill finish of the Product
pursuant to Genzyme’s instructions and to assist Genzyme in obtaining an
approved regulatory filing
(and/or foreign equivalents) covering the Products.  Hospira then shall


 






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


 


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manufacture and deliver Products to Genzyme
for sale by Genzyme as a human pharmaceutical product, as herein provided.


 


2.2           Commercially
Reasonable Efforts.  Each Party
shall exercise good faith and use its commercially reasonable efforts to
successfully complete the Project. 
However, the Parties agree and understand that neither Party hereto
guarantees that the Project will be successful.


 


Article
3.                TECHNOLOGY
TRANSFER EFFORTS


 


3.1        Technology
Transfer Fee.  To
reimburse Hospira for its participation in the Project, Genzyme shall pay to
Hospira a nonrefundable technology transfer fee (the “Technology Transfer
Fee”).  The Technology Transfer Fee
shall be paid to Hospira in accordance with the payment terms and schedule set
forth in Exhibit 3.1.


 


3.2           Changes in
Project Scope.  If changes
occur in the Project or Product Specifications, or if technical difficulties
require that Hospira perform either additional work or repeat work, and such
additional work or repeat work is not required due to Hospira’s fault,
negligence or failure to comply with the terms and conditions of this
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 thirty (30) days of completion of such
work. Reimbursement for such additional work or repeat work shall be at the
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 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 thirty (30) 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 addressed to the Party’s relevant Technical Contact.


 


3.4           Technology
Transfer Supplies.  Based on
Genzyme’s final Product formulations, concentration, fill volumes, and the
Parties’ agreement to the final Product Specifications, Hospira will
manufacture the Products in engineering runs and for process validation
purposes (“Development Supplies”) at the prices set forth in the
Batch Pricing Table in Exhibit 5.8. 
Smaller batches will be quoted individually based on batch size.  Genzyme shall issue a purchase order for any
such Development Supplies 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 Supplies.


 


Article
4.                GENZYME’S
REGULATORY SUBMISSIONS


 


4.1           Hospira’s Right
to Review.  Hospira
shall have the right to review and consult on those portions of Genzyme’s
proposed regulatory submissions relating to Hospira’s packaging or


 






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


 


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manufacturing procedures before the
submissions are filed with the appropriate Regulatory Authorities.  Hospira shall 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. 
Hospira shall consult with and advise Genzyme in responding to questions
from Regulatory Authorities regarding Genzyme’s submission(s) for
Products.  Genzyme shall be the sole
owner of any regulatory submission filed pursuant to this Agreement. Genzyme
shall reimburse Hospira for Hospira’s review and consultation under this Section 4.1
at the rate of [**] per hour.  Genzyme shall provide to Hospira for its
files a final copy of the CMC section of any such regulatory submission(s).


 


4.2           Supplemental
International Regulatory Filings.  Hospira shall quote a price for supplemental
international regulatory, packaging and development work to support
international filings (excluding the U.S. and (European countries)) separately
and on a country-by-country basis.


 


4.3           Access to Drug
Master Files.  Hospira
shall grant Genzyme reference rights to all Drug Master Files (“DMFs”)
necessary to support Genzyme’s applications for marketing authorizations of
Products.  To affect 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 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.


 


4.4           User Fees.  Genzyme shall pay any FDA (or foreign
equivalent) user fees which may become payable for the Products.


 


Article
5.                MANUFACTURE AND
SUPPLY OF PRODUCTS


 


5.1           Purchase and
Sale of Products.  Pursuant to
the terms and conditions of this Agreement and for the duration of this
Agreement, Hospira shall manufacture, sell and deliver the Products to Genzyme,
and Genzyme shall purchase and take delivery of the Products from Hospira that
is ordered pursuant to a purchase order issued by Genzyme to Hospira.  Hospira shall manufacture the Products in
accordance with the Product Specifications. 
The Parties may alter from time to time the Product Specifications by
written agreement without amending this Agreement.


 


5.2           Government
Approvals. Notwithstanding any other provision of this
Agreement, Hospira shall have no obligation to manufacture, sell or deliver the
Products to Genzyme and Genzyme shall have no obligation to purchase and take
delivery of the Products until Genzyme has obtained all necessary Regulatory
Authorities’ approvals required to manufacture the Products.  However, Hospira agrees to [**] by Genzyme, and Genzyme shall be required to
[**].


 






[**] = 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           Bulk.


 


(a)           Supply.  Hospira shall manufacture the Products for
Genzyme from Bulk that Genzyme shall supply to Hospira at no cost.  Genzyme shall supply Bulk to Hospira in
quantities sufficient to satisfy Hospira’s gross manufacturing requirements of
the Products.  Hospira’s use of Bulk
received from Genzyme shall be limited to development contemplated by this
Agreement and the manufacture of the Products for Genzyme.  Genzyme shall ship all required quantities of
Bulk:  (i) [**] for deliveries originating
in the United States; or (ii) [**] for deliveries
originating outside the United States, to Hospira’s manufacturing plant in [**] (the “Facility”), pursuant to
no-cost purchase orders that Hospira issues to Genzyme.  Genzyme shall be responsible for all costs of
transport and carriage insurance.  Within
[**] days of Hospira’s receipt of
any Bulk, excluding [**]
Bulk in which case within [**]
days, supplied by Genzyme hereunder, Hospira shall:  (i) perform an identification test on
the Bulk and confirm the shipment quantity; and (ii) notify Genzyme of any
inaccuracies with respect to quantity, or of any claim that any portion of the
shipment fails the identification test. 
Hospira shall manufacture the Products from the Bulk in accordance with
the Product Specifications, generally within [**] days after receipt thereof; provided, however,
that Hospira will manufacture the [**]
Product(s) within [**]
days after receipt of [**]
Bulk or prior to Genzyme’s stated expiry date for such Bulk.  In the event Hospira notifies Genzyme of any
deficiency in the quantity of Bulk received, Genzyme shall promptly ship to
Hospira, [**], 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, Genzyme shall
have the right to confirm such findings at Hospira’s manufacturing
location.  If Genzyme determines that
such shipment of Bulk conformed to the Bulk Specifications, the Parties shall
submit samples of such shipment to a mutually acceptable independent laboratory
for testing.  If such independent
laboratory 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
laboratory confirms that such shipment did not meet the Bulk Specifications,
Genzyme shall 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.


 


(b)           Title.  Notwithstanding the [**] and [**] shipping terms set forth in Section 5.3(a),
Genzyme shall at all times retain title to and risk of loss of the Bulk;
provided, however, that subject to the limitation in Section 5.3(c);
provided, however, that Hospira shall assume full responsibility and risk for
the safekeeping, storage and handling for all Bulk in its possession and all
shipments of Bulk delivered hereunder and accepted by Hospira.


 


(c)           Replacement.


 


(i)            In the event of
any loss or damage of any Bulk delivered hereunder or the failure of a Product
or Products to meet Product Specifications, Genzyme shall supply to Hospira at
no cost replacement Bulk according to the terms set forth in Section 5.3(a).
If any loss, damage or replacement of such Bulk results from a negligent act or
omission by Hospira in the manufacture, handling or storage of the Bulk or the
Products, Hospira shall [**]. 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.


 


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consumption of Bulk for the manufacture of
the Products shall be in accordance with [**] that Hospira and Genzyme agree upon mutually in writing as promptly as
practicable, which [**].


 


(ii)           If, during any [**] month period, consumption of
Bulk to produce a given quantity of a Product exceeds [**] for such quantity of
Product, Hospira shall promptly [**]
as evidenced by [**].


 


(iii)          In no event
shall Hospira’s aggregate liability for replacement of Bulk exceed [**] per occurrence.  This section states [**]; provided, however, that the Parties hereby
agree to [**], as described
in Article 12 of this Agreement.


 


5.4           Dedicated
Equipment Costs.  If
non-standard, specialized equipment is required to manufacture the Products for
Genzyme (“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.  Hospira shall
advise Genzyme of specialized equipment required and the estimated costs
associated with the purchase, installation and validation of such
equipment.  After Genzyme approves such
costs, Hospira shall install and validate the equipment and bill Genzyme for
the associated costs.  Genzyme shall make
payment to Hospira no later than [**]
days after Genzyme receives an invoice from Hospira.  Title to the equipment shall be in Genzyme’s  name.  If Hospira
wishes to use the specialized 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.


 


5.5           Product
Labeling.  Except as
otherwise specified in Section 5.7, Genzyme shall be solely
responsible for the labeling and finished-form packaging of the Products.  All such labeling and packaging shall be in
accordance with the Product Specifications.


 


5.6           Off-Site Waste.  If necessary, Hospira shall hire, direct and
pay all costs for a waste contractor to remove all Waste from Hospira’s
manufacturing facility for the Products, consistent with each Product’s
Material Safety Data Sheets (“MSDS”). 
The costs associated with the removal of Specially Regulated Waste 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 be withheld unreasonably. 
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.


 


5.7           Delivery.  Hospira shall ship the Products to Genzyme, [**]. 
Title and risk of loss shall pass to Genzyme [**].  Shipment shall be via a
carrier designated by Genzyme.  Hospira
will label and package the Products in unmarked vials (“Brite Stock”)
for bulk shipment to Genzyme, as may be specified in further detail in the
Technical and Quality Agreement, attached hereto as Exhibit 7.2; provided, however, that Hospira shall not ship any Product
until both


 






[**] = 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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Hospira and Genzyme have released such
Product pursuant to the Product Specifications and/or the Technical and Quality
Agreement.  Genzyme will be responsible
for procuring carriage and insurance in an amount sufficient to cover the value
of the contents, for all shipments.  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.


 


5.8           Price and
Payment.


 


(a)           Price.  Hospira shall invoice Genzyme for the
Products delivered by Hospira at the prices set forth on Exhibit 5.8.  Prices are firm through [**]. 
Beginning [**] and on each
succeeding  [**] during the term hereof, prices may be increased by Hospira.  Price increases shall be effective for
deliveries beginning [**] of each
calendar year.  Notwithstanding the
foregoing, such increases shall not [**], and shall be subject to the prior written consent of
Genzyme.


 


(b)           Payment.  Hospira shall invoice Genzyme upon shipment
of the Products.  Genzyme shall make
payment net [**] days from the
date of receipt of Hospira’s invoice.


 


(c)           Taxes.  Any 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, sale or transportation
of the Products sold pursuant to this Agreement, and all government license
filing fees and Prescription Drug User (“PDUFA”) annual establishment
fees with respect to all of the Products shall be paid by Genzyme.


 


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


 


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


 


5.9                           Replacement of
Nonconforming Shipment.


 


(a)  Genzyme shall have a period
of [**] days from the
date of its receipt of a shipment of any Product or Product samples to inspect
and reject such shipment for nonconformance with the Product
Specifications.  If Genzyme rejects such
shipment, it shall promptly so notify Hospira and if necessary provide to
Hospira samples of such shipment for testing. 
If Hospira tests such shipment and determines that it did conform to the
Product Specifications, the Parties shall submit samples of such shipment to a
mutually acceptable independent laboratory for testing.  If such independent laboratory determines
that the shipment 


 






[**] = 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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conformed to the Product Specifications,
Genzyme shall bear all expenses of shipping and testing such shipment samples.  If Hospira or such independent laboratory
confirms that such shipment did not meet the Product Specifications, Hospira
shall replace, at no cost to Genzyme, that portion of the Product shipment
which does not conform to the Product Specifications provided Genzyme provides
sufficient Bulk to Hospira, and shall bear all expenses of shipping and testing
the shipment samples. Genzyme’s duty to pay all amounts payable to Hospira in
respect of the rejected Product shall be suspended until Hospira replaces all
nonconforming Product in accordance with this Section 5.9.  Hospira shall reimburse Genzyme for Bulk in
an amount equal to [**]
per occurrence; provided, however, that the Parties hereby agree to [**], as described in Article 12 of this
Agreement.


 


(b)     Any nonconforming portion of
any shipment shall be disposed of as directed by Hospira, at Hospira’s
expense.  In lieu of receiving
replacement Product, Genzyme may request that Hospira provide a credit to Genzyme
for the amount, if any, previously paid by Genzyme to Hospira on account of the
Product in question.  Any Product that
Genzyme does not reject pursuant to this Section 5.9 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, render the Product not
conforming to Product Specifications, and are solely caused by Hospira.  The
Parties shall consult to confirm the cause of the latent defect.  If it is confirmed that the cause of the
defect is solely attributable to Hospira, then Hospira will replace at no cost
to Genzyme all such defective Products with Products that meet the Product
Specifications.


 


5.10     Alliance Team
and Dedicated Personnel. 
Hospira and Genzyme will form a team (“Alliance Team”) comprised
of at least two members from each Party which will meet at least twice annually
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 this Agreement 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.


 


5.11     [**].  Subject to the terms of this
Agreement, Hospira shall have the [**], unless there
is a failure by Hospira of its obligations under Sections 5.3(c), 5.9
or 7.1 of this Agreement.


 






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


 


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Article
6.                ORDERS AND
FORECASTS


 


6.1           [**] Year Product Supply Forecast.  For capacity planning purposes, by [**] Genzyme shall provide
Hospira with a non-binding written forecast of Genzyme’s annual batch
requirements of each Product for the first three calendar years of this
Agreement.  Thereafter, by [**] of each calendar year
Genzyme shall update such rolling non-binding [**]-year forecast of its batch requirements of the
Products for the period commencing on [**] of the next calendar year.  Upon receipt of each rolling three-year
non-binding estimate, Hospira shall within [**] days, provide Genzyme with a written acceptance of
the estimate and accordingly plan to allocate its annual capacity to
manufacture the Products for Genzyme, or a written rejection of the [**]-year forecast.  Any such written acceptance shall constitute
Hospira’s product supply commitment for each of the calendar years covered by
the forecast (“Product Supply Commitment”) but shall not be binding on
Genzyme.  If Genzyme issues, and Hospira
accepts, a subsequent [**]-year forecast
covering one or more previously covered calendar years, such subsequent
forecast shall constitute Hospira’s Product Supply Commitment for such calendar
year(s).  In the event Hospira rejects a [**]-year forecast, Hospira and Genzyme shall
meet as soon as possible to discuss in good faith the batch quantities of the
Products that Hospira could provide during each of the [**] calendar years covered by the forecast.  Any such amount shall be agreed to in
writing.


 


6.2           First Firm
Order.  Hospira and Genzyme shall
cooperate fully in estimating and scheduling production for the first
commercial order of the Products to be placed by Genzyme with Hospira in
anticipation of regulatory approval of the Facility.


 


6.3           Rolling
Forecast.  Concurrent with
the placing of its first commercial order, and on the [**] thereafter, Genzyme shall provide to Hospira
a good faith, estimated rolling forecast of the quantity of Products that
Genzyme expects to order for the coming [**] period of time (each, a “Rolling Forecast”).  The first [**] months of each Rolling Forecast shall be considered
a binding commitment upon Genzyme to purchase quantities described therein and
a binding commitment upon Hospira to produce and deliver such quantities on the
delivery dates described therein (“Firm Order Period”).  The last [**] months of each Rolling Forecast shall be non-binding
upon the parties.


 


6.4           Minimum
Purchase Requirement.


 


(a)     During the term, Genzyme
agrees to purchase from Hospira and Hospira agrees to manufacture and supply to
Genzyme the following minimum aggregate quantities of the Products (the “Minimum
Purchase Requirement”) up to its Product Supply Commitment as follows: (a) in
calendar year 2010, not less than [**] of the year one annual forecast in
batches of the Products in the three-year Product supply forecast (“Annual
Forecast”) accepted by Hospira in accordance with Section 6.1; (b) in
calendar years 2011 and 2012, not less than [**] of the Annual Forecast for
each year respectively; and (c) in 2013 through 2015 (and in any calendar
year during


 






[**] = 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

















 


any Renewal Term, as defined herein) no less
than [**], in any
Product mix as determined by Genzyme; provided, however, that
in no case shall there be [**].  For purposes of illustration, Genzyme may
decide to have Hospira manufacture for [**].  If, however, Genzyme decides
to have Hospira manufacture [**].


 


(b)     In lieu of Genzyme taking
delivery of each year’s Minimum Purchase Requirements of the Products, Genzyme
shall have the option to [**].  In the
latter event, Hospira shall invoice Genzyme for the amount payable, and Genzyme
shall pay Hospira within [**] days after receipt of Hospira’s invoice.


 


6.5           Purchase Order
Acceptance.  Within [**] days after receipt of Genzyme’s firm
purchase orders for the Products ordered in accordance with Section 6.1
and 6.2, Hospira shall confirm to Genzyme its acceptance of the purchase
order, delivery date and quantity of the Products ordered by Genzyme.


 


6.6           Best Efforts to
Supply.  Should Genzyme order
additional quantities of the Products in excess of [**] over the previously forecasted amount, 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.


 


6.7           Firm Order
Changes or Cancellations.  If,
due to significant unforeseen circumstances, Genzyme requests changes to firm
purchase orders of the Products within the [**] month firm purchase order timeframe, Hospira shall attempt to
accommodate the changes within reasonable manufacturing capabilities and
efficiencies. If Hospira can accommodate such
change, Hospira shall advise Genzyme of the costs associated with making
any such change and Genzyme shall be deemed to have accepted the obligation to
pay Hospira for such costs if Genzyme indicates in writing to Hospira that
Hospira should proceed to make the change. 
If Hospira cannot accommodate such
change, Genzyme shall be bound to the
original firm purchase order.  If
Genzyme cancels a firm purchase order, Hospira shall be relieved of its
obligation relating to such order but Genzyme will not be relieved of its
obligation of payment unless Hospira agrees to such cancellation in writing. If
Genzyme does not supply sufficient Bulk to manufacture the Products requested
in such order which shall be deemed to be a breach of this Agreement, Genzyme
shall remain liable for the full amount of the firm purchase order regardless
of whether such Products are manufactured by Hospira or whether Genzyme takes
delivery of any such manufactured Products. 
Notwithstanding anything to the contrary contained herein, all Products
paid for by Genzyme shall count toward the Minimum Purchase Requirement of
Product including, without limitation, any payments made in the event of a
cancellation.


 


6.8           Purchase Order
Terms.  Each purchase order or any
acknowledgment thereof, whether printed, stamped, typed, or written shall be
governed by the terms of this Agreement 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.


 


12

















 


none of the provisions of such purchase order
or acknowledgment shall be applicable except those specifying the Products,
quantity ordered, delivery dates, special shipping instructions and invoice
information.


 


Article
7.                QUALITY


 


7.1           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 Exhibit 7.1
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.


 


7.2           Quality
Agreement.  The Parties
shall enter into a quality agreement substantially in the form of the agreement
attached hereto as Exhibit 7.2 within one-hundred and twenty (120)
days following the Effective Date.


 


7.3           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 and assess its compliance with cGMP and quality assurance standards
and to 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:  (a) be
limited to not more than [**] auditors designated by or representing Genzyme; (b) last
for not more than [**] days; and (c) 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.  Hospira also agrees to allow audits conducted
by the FDA which are related to the manufacture of the Products which may be
required by the FDA and Hospira agrees to reasonably cooperate with the FDA in
connection with such audit.  Hospira will
provide Genzyme with notice of any such FDA inspection as soon as
practicable.  However, if any additional
inspections are requested or required by or for any other Regulatory


 






[**] = 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

















 


Authority, 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 inspection occurring at the same time, 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 11 hereof.  The results of such audits and inspections
shall be considered Confidential Information under Article 11 and
shall not be disclosed to Third Parties, excluding the FDA, unless required by
law and only then upon prior written notice to Hospira.


 


7.4           Notification of
Complaints.  Genzyme
shall notify Hospira promptly of any complaints involving Hospira’s
manufacturing or packaging in sufficient time to allow Hospira to evaluate the
complaints and assist Genzyme in responding to such complaints.


 


7.5           Product Recalls.  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:  (a) any
Regulatory Authority or other national government authority issues a request,
directive or order that any Product be recalled; (b) a court of competent
jurisdiction orders a recall of any Product; or (c) 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. 
In the event that such recall results from Hospira’s breach of this
Agreement; or Hospira’s negligence or willful misconduct, Hospira shall be
responsible for the expenses of the recall up to a maximum of [**]; provided, however, that the Parties agree
to negotiate an alternative liability provision as part of the Master Services
Agreement, as described in Article 12 of this Agreement.  For purposes of this Agreement, the expenses
of the 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, nor the cost to replace Product and Bulk
as per Section 5.9.


 


Article
8.                WARRANTIES;
COVENANTS AND INDEMNIFICATION


 


8.1           Genzyme’s
Warranties.


 


(a)           Genzyme represents and
warrants to Hospira that all Bulk delivered to Hospira pursuant to this
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 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.


 






[**] = 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

















 


(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 on Exhibit 1.5.


 


(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 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.


 


(e)           Genzyme further represents
and warrants that it will not sell the Products into any jurisdiction unless
and until it receives the necessary Regulatory Authority approvals.


 


8.2           Hospira’s
Warranties and Covenants.


 


(a)           Hospira represents and
warrants to Genzyme that all Products Hospira delivers to Genzyme pursuant to
this 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 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)           Hospira further represents
and warrants to Genzyme that all Products Hospira delivers to Genzyme pursuant
to this Agreement shall, at the time of delivery and for the shelf life of the
Products, be free from defects in material and workmanship and shall be
manufactured: (a) in accordance and conformity with the Product
Specifications; 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
(including, without limitation, compliance with cGMPs).


 


(c)           Hospira further represents
and warrants to Genzyme that Hospira’s performance of its obligations under
this 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 8.3, the
replacement provisions of Sections 5.3(c) shall be Genzyme’s sole
and exclusive remedy for nonconforming or defective Products.


 






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


 


15

















 


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


 


8.3           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 Agreement and asserted by Third Parties to the extent such
arise out of or are attributable to:  (a) Hospira’s
breach of this Agreement or any representation or warranty set forth herein; (b) any
violation of any proprietary right of any Third Party relating to Hospira’s
manufacturing processes used in the manufacture of the Products pursuant to this
Agreement (excluding the Bulk Specifications, Product Specifications, Bulk or
Products); (c) any breach of Section 11.4 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 that, this indemnification shall not apply to the extent that such
claim results from Genzyme’s breach of this Agreement or any warranty herein or
its negligence or willful misconduct.


 


8.4           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 Agreement and asserted by Third Parties to the
extent such arise out of or are attributable to (a) Genzyme’s breach of
this Agreement or any representation or warranty set forth in Section 8.1;
(b) any violation of any proprietary right of any Third Party relating to
the those portions of the Bulk Specifications or Product Specifications
provided to Hospira by Genzyme, and expressly excluding all other Third Party
proprietary rights, including those incorporated in Hospira’s manufacturing
processes used in the manufacture of the Products pursuant to this 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; and (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
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 Agreement or breach of any warranty herein or Hospira’s (or its agents’,
employees’ or representatives’) negligence or willful misconduct.


 


8.5           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


 






[**] = 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














 


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.


 


8.6           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 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 11
HEREOF, OR OUT OF ANY INDEMNITY PURSUANT TO THIS SECTION 8, PROVIDED, HOWEVER, THAT SUCH DAMAGES OR
CLAIMS DO NOT ARISE AS A RESULT OF A BREACH OF ANY WARRANTY HEREIN, OR
NEGLIGENCE OR WILLFUL MISCONDUCT BY THE PARTY SEEKING INDEMNIFICATION.


 


Article
9.                INTELLECTUAL
PROPERTY RIGHTS


 


9.1           Hospira’s
Proprietary Rights. 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 other than for
the purposes of this Agreement; or (ii) developed by or for Hospira on or
after the Effective Date other than for the purposes of this Agreement. Genzyme
has granted no license, express or implied, to Hospira to use Genzyme’s
proprietary technology, know-how or other proprietary rights other than for the
purposes of this Agreement. Notwithstanding Hospira’s rights, the Parties agree
that Genzyme shall be the sole owner of any proprietary technology, know-how or
other proprietary rights developed by or for Hospira pursuant to any Project
undertaken by Hospira (the “Project Inventions”). Hospira shall 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
10.              TERM AND
TERMINATION


 


10.1         Term. This
Agreement shall commence on the Effective Date and, unless earlier terminated
as provided below, shall expire on December 31, 2015 (the “Initial Term”).
Unless otherwise terminated in accordance with this Article 10,
this Agreement shall be automatically extended for additional terms of two
years and (each, a “Renewal Term”) and may be terminated anytime after
the Initial Term by either Party providing the other with at least [**] months prior written notice
of termination.


 


10.2         Termination of
the Project. Either Party wishing to terminate the 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 this
Agreement. Upon [**] days following
said consultation,


 






[**] = 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

















 


either Party may terminate the Project upon [**] days prior written notice to
the other Party if the terminating Party determines in good faith that the
technical transfer of the Product(s) is at issue is not technically
feasible using commercially reasonable efforts. If the Project is terminated in
whole or in part, Hospira shall advise Genzyme of Hospira’s actual technology
transfer costs on the Project (or the relevant portion thereof) incurred prior
to such termination. Genzyme shall pay Hospira for all reasonable and
documented technology transfer costs incurred to the date the termination
notice is received. In the event of complete termination of the Project, this
Agreement shall automatically terminate.


 


10.3         Termination.


 


(a)           Special
Termination Rights. Either Party shall have the right to terminate
this Agreement as it relates to the Products or any individual Product by
giving the other Party no less than [**] days prior written notice if the Facility has not
received regulatory approval from the FDA in connection with any Product by July 1,
2011.


 


(b)           For Cause Termination Rights.


 


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


 


(ii)   Hospira may terminate this
Agreement by giving Genzyme [**]
days’ prior written notice upon Genzyme’s breach of any warranty or any
other material provision of this Agreement if the breach is not cured within [**] days after written notice
thereof to Genzyme.


 


(c)           Termination for Convenience.
Genzyme may terminate this Agreement, without cause, 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 expiration of the [**] day notice period (or any agreed extension thereof), such termination
shall not be effective.


 


10.4         Accrued Payment
Obligations. Upon termination pursuant to this Article 10,
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 firm purchase orders or Genzyme’s estimates of its requirements of the
Products, and such supplies cannot be reasonably


 






[**] = 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

















 


used by Hospira for other purposes. Hospira
shall invoice Genzyme for all amounts due hereunder. Payment shall be made
pursuant to Section 5.8.


 


10.5         Return of
Inventory, Dedicated Equipment and Product. In the event of any
termination, Hospira shall 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 this Agreement by
Hospira, in which case such inventory, Dedicated Equipment and any Product
shall be returned at Hospira’s expense.


 


10.6         Survival. Expiration or
early termination of this 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 this Agreement, 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 Agreement.


 


Article 11.              CONFIDENTIAL INFORMATION


 


11.1         Nondisclosure. It is
contemplated that in the course of the performance of this 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. 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.


 


11.2         Exceptions to
Duty of Nondisclosure. Notwithstanding the above, nothing
contained in this 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 pursuant Article 9; or (b) either
Party from (i) obtaining governmental marketing approvals, (ii) manufacturing
the Products pursuant to the terms and conditions of this 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 as information included in any Project
Invention patent applications), or (iv) corresponding with any Regulatory
Authority in connection with this 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 Agreement.


 


11.3         Public
Announcements. Neither Party shall make any public announcement
concerning the transactions contemplated herein, or make any public statement
which includes 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 may be required by law or judicial
order, without the written consent of the other Party, which consent shall not
be


 






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


 


19

















 


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.


 


11.4         Pricing
Information. Any information [**] provided by Genzyme to Hospira shall be provided on a need to know
basis, as determined by Genzyme, and in any case only disclosed to the Hospira
Vice President and General Manager of Contract Manufacturing Services, Director
of Business Development, and Manager of Business Development (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, 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
any loss pursuant to Section 10.3(b)(iii) hereof.


 


11.5         Injunctive
Relief. The Parties acknowledge that either Party’s breach of this Article 11
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.


 


Article
12.    [**]


 


12.1         [**]. Within [**] days following the Effective Date of this Agreement,
the Parties shall [**].


 


Article 13.              MISCELLANEOUS


 


13.1         Force Majeure
and Failure of Suppliers.


 


(a)           Excusable Delay. Any delay in
the performance of any of the duties or obligations of either Party hereto
(except the payment of money) shall not be considered a breach of this
Agreement and the time required for performance shall be extended for a period
equal to the period of such delay, provided that such delay has been caused by
or is the result of any acts of God, acts of the public enemy, 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. The affected Party shall give prompt notice to the other
Party of such cause, and shall take promptly whatever reasonable steps are
necessary to relieve the effect of such cause.


 


(b)           Transfer of Production. If Hospira
becomes subject to an event of force majeure which interferes with production
of the Products at the Facility, the Parties shall mutually agree on
implementation of an agreed-upon action plan to transfer production of the
Products to another Hospira facility, or to a Genzyme facility. The Parties
shall, after the execution of this Agreement and at the request of either
Party, meet to discuss and define such an action plan.


 






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


 


20

















 


(c)           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 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.


 


13.2         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:

  	
   

  	
  If to
  Hospira:

  
	
   

  	
   

  	
   

  
	
  Genzyme
  Corporation

  	
   

  	
  Hospira, Inc.

  
	
  200 Crossing
  Boulevard

  	
   

  	
  275
  North Field Drive

  
	
  Framingham, MA
  01701-9322

  	
   

  	
  Lake
  Forest, Illinois 60045

  
	
  Attention:

  	
   

  	
  Attention:

  
	
  Senior
  Vice President, Materials Management

  	
   

  	
  Vice
  President and General Manager, Contract

  
	
  Facsimile:
  (508) 661-8538

  	
   

  	
  Manufacturing

  
	
   

  	
   

  	
  Facsimile:
  (224) 212-3210

  
	
  Genzyme
  Therapeutics Products, L.P.

  	
   

  	
   

  
	
  500 Kendall
  Street

  	
   

  	
   

  
	
  Cambridge, MA 02139

  	
   

  	
  With
  copy to:

  
	
  Attention:

  	
   

  	
   

  
	
   

  	
   

  	
  Hospira, Inc.

  
	
  With
  a copy to:

  	
   

  	
  275 North Field Drive

  
	
   

  	
   

  	
  Lake Forest, Illinois
  60045

  
	
  Genzyme
  Corporation

  	
   

  	
  Attention: General
  Counsel, Building H1;

  
	
  500 Kendall
  Street

  	
   

  	
  Department NLEG

  
	
  Cambridge, MA
  02139

  	
   

  	
  Facsimile:
  (224) 212-2086

  
	
  Attention:
  General Counsel

  	
   

  	
   

  
	
  Facsimile: (617)
  252-7553

  	
   

  	
   

  



 


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 or delivery to the overnight courier. A Party may
change its address listed above by written notice to the other Party.


 


13.3         Choice of Law. This
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.


 






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


 


21

















 


13.4         Assignment. Neither Party
shall assign this Agreement nor any part thereof without the prior written
consent of the other Party; provided, however: (a) either Party may assign
this Agreement to one of its wholly-owned subsidiaries or its parent
corporation without such consent; and (b) either Party, without such
consent, may assign this Agreement in connection with the transfer, sale or
divestiture of substantially all of its business to which this Agreement
pertains or in the event of its merger or consolidation with another entity. Any
permitted assignee shall assume all obligations of its assignor under this
Agreement. No assignment shall relieve any Party of responsibility for the
performance of any accrued obligation which such Party then has hereunder.


 


13.5         Entire
Agreement. This Agreement, together with the Exhibits
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 with respect thereto.


 


13.6         Severability. This
Agreement is subject to the restrictions, limitations, terms and conditions of
all applicable governmental regulations, approvals and clearances. If any term
or provision of this Agreement 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 Agreement 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.


 


13.7         Waiver-Modification
of Agreement. No waiver or modification of any of the terms of
this Agreement 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 Agreement 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.


 


13.8         Insurance. Each Party will
procure and maintain, at its own expense, for the duration of the 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


 






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


 


22

















 


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 and shall remain in effect for 2 years after the expiration of said
Agreement;


 


(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.


 


(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. Prior to commencement of
services, 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.


 


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


 


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


 






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


 


23

















 


IN
WITNESS WHEREOF, the Parties intending to be bound by the terms and conditions
hereof have caused this 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 THERAPEUTIC PRODUCTS LIMITED PARTNERSHIP

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  By: 
  Genzyme Therapeutic Products Corporation, its General Partner

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  By: 

  	
  /s/ Henri A. Termeer

  
	
   

  	
   

  	
   

  	
  Name:

  	
  Henri
  A. Termeer

  
	
   

  	
   

  	
   

  	
  Title: 

  	
  President

  










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


 


24






 










 


Exhibit 1.5


 


Bulk Specifications


 


Genzyme
shall use all reasonable efforts to prepare and submit to Hospira the Bulk
Specifications no later than ninety (90) days after the Effective Date.  Upon submission, the Bulk Specifications
shall be attached to this Exhibit 1.5 and shall be made an integral
part of this Agreement.


 


Exhibit 1.19


 


Product Specifications


 


Genzyme
and Hospira will consult and use all reasonable efforts to prepare and complete
the Product Specifications no later than ninety (90) days after the Effective
Date.  Upon completion, the Product
Specifications shall be attached to this Exhibit 1.19 and shall be
made an integral part of this Agreement.


 


Exhibit 2.1


 


Project Activities


 


Project
Activities


 


Milestone
I: Project Initiation and Tech Transfer


 


[**]


 


Milestone
II: Conformance Batch Production


 


[**]


 


Milestone
III: REGULATORY FILINGS


 


[**]


 






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


 


25

















 


Exhibit 3.1


 


Payment Schedule


 


Payment
of the Technology Transfer Fee shall be in accordance with the following
schedule:


 


(a)           [**] upon
execution of this Amendment and receipt of Hospira’s invoice for the amount
due;


 


(b)           [**] (i) within
[**] days after Hospira completes the final Product Specifications and receipt
of Hospira’s invoice for the amount due, or (ii) [**], whichever is later;
and


 


(c)           [**] within
[**] days after completion of all identified validation protocols and the
invoice for the amount due from Hospira.


 


Exhibit 5.8


 


Product Prices


 


[**]


 


Exhibit 7.1


 


Product Test Methods


 


In
consultation with Genzyme, no later than forty-five (45) days after the Effective
Date, Hospira will use all reasonable efforts to prepare and complete
documentation describing the procedures, methods and protocols by which the
Products will be tested and released, as specified in Section 7.1
of the Agreement.  Upon completion, such
documentation shall be attached to this Exhibit 7.1 and shall be
made an integral part of this Agreement.


 


Exhibit 7.2


 


Form of Quality Agreement


 


Genzyme
and Hospira agree to consult and use all reasonable efforts to prepare and
complete the Quality Agreement no later than one hundred and twenty (120) days
after the Effective Date.  Upon
completion, the Quality Agreement shall be attached to this Exhibit 7.2
and shall be made an integral part of this Agreement.


 






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


 


26