Document:

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.

 

[**] = 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.

 

 

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;

 

[**] = 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.

 

2

 

(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.

 

[**] = 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.

 

3

 

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.

 

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

 

4

 

1.41        “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

 

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

 

5

 

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.

 

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

 

6

 

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

 

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

 

7

 

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.

 

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

 

8

 

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

 

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

 

9

 

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

 

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

 

10

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

(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

 

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

 

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

 

[**] = 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

 

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

 

[**] = 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

 

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.

 

[**] = 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

 

(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

 

[**] = 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

 

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

 

[**] = 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

 

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

 

[**] = 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

 

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.

 

[**] = 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

 

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).

 

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

 

27

 

(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

 

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

 

28

 

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

 

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

 

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

 

	
  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

 

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

 

(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

 

[**] = 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

 

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®/
LumizymeTM (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.Exhibit
10.10

 

LICENSE AGREEMENT

 

This
Agreement, effective as of the first day of January, 1995 (the “Effective Date”)
by and between:

 

GENZYME CORPORATION, a corporation organized
and existing under the laws of the Commonwealth of Massachusetts and having its
principal office at One Kendall Square, Cambridge, Massachusetts 02139
(hereinafter referred to as “GENZYME”) and

 

MOUNT SINAI SCHOOL OF MEDICINE OF THE CITY UNIVERSITY OF NEW YORK, a
not-for-profit corporation organized and existing under the laws of the State
of New York and having its principal office at One Gustave L.  Levy Place, New York, New York 10029
(hereinafter referred to as “MSSM”).

 

WITNESSETH

 

WHEREAS, MSSM  has certain
clinical and preclinical data, information and patent rights relating to the
production and use of recombinant x-galactosidase A for the treatment of Fabry
Disease;

 

WHEREAS, MSSM desires to have recombinant
x-galactosidase A developed and made available for general use to patients for
the treatment of Fabry Disease, and for these purposes is willing to grant an
exclusive license to GENZYME upon the terms and conditions set forth below;

 

WHEREAS, GENZYME has or has access to the
research and development capability, the manufacturing capacity and the
marketing ability needed to manufacture and sell recombinant a galactosidase A
therapeutic products in the United States and abroad;

 

WHEREAS, GENZYME desires to obtain an
exclusive, worldwide license under MSSM technology upon the terms and
conditions set forth below;

 

NOW, THEREFORE, in consideration of the
premises and the mutual covenants contained herein, the parties hereto agree as
follows:

 

ARTICLE I  - DEFINITIONS

 

For
the purposes of this Agreement, the following words and phrases shall have the
following meanings:

 

1.1          “Affiliate”
shall mean any corporation which directly or indirectly controls, is controlled
by or is under common control with GENZYME, control being the ownership of at
least 50% of the outstanding voting stock of such corporation.

 

1.2          “First
Commercial Sale” shall mean the first arms-length transaction pursuant to this
Agreement to one or more third party of any Product following receipt of
approval 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.

 

1

 

commence manufacturing and selling such
Product from the applicable regulatory agency in the applicable country.

 

1.3          “Licensed
Patents” shall mean the United States and foreign patents and patent
applications set forth in Schedule A attached hereto and owned or controlled by
MSSM, and the United States patents and foreign patents issuing from said
United States and foreign patent applications or later-filed foreign
applications based upon any of said United States patents and application and
any divisions, continuations, continuations-in-part, reissues or extensions of
any of the foregoing.

 

1.4          “Product” shall
mean an enzyme replacement product for the treatment of Fabry disease, which
includes recombinant x-galactosidase A.

 

1.5          “Net Sales”
shall mean GENZYME’s gross invoice price for Product less (a) normal cash
and quantity discounts and rebates actually allowed; (b) sales actually
made, but deemed uncollectible; (c) sales and excise taxes and duties
directly imposed, or other governmental charges; (d) outbound
transportation and insurance prepaid or allowed; (e) amounts actually
allowed or credited on account of returns; and (f) other contractual
allowances such as distribution fees.

 

1.6          “Technical
Information” shall mean any and all proprietary technical data, know-how,
information and material relating to the Product, its manufacture or use, and
set forth in Schedule B attached hereto.

 

1.7          “Valid Claim”
means a claim of an issued patent within the Licensed Patents that has not
expired or been withdrawn, canceled, disclaimed or held invalid by a court or
governmental agency of competent jurisdiction in an unappealed or unappealable
decision.

 

ARTICLE II  - GRANT

 

2.1          MSSM hereby
grants to GENZYME an exclusive, worldwide right and license, and subject to
approval by MSSM, which shall not be unreasonably withheld, the right to
sublicense third parties, (a) to make, have made, use, and sell Product
under the Licensed Patents; and (b) to use the Technical Information
provided by MSSM.  MSSM agrees that
[**]other than GENZYME by or under [**] during the term of this Agreement.

 

2.2          GENZYME agrees
to forward to MSSM a copy of any and all sublicense agreements, and further
agrees to forward to MSSM annually a copy of royalty reports related to
royalties received by GENZYME from its sublicensees during the preceding twelve
(12) month period.

 

2.3          GENZYME agrees
to use its reasonable best efforts to substantially manufacture in the United
States that Product which is intended for sale in the United States.

 

[**] = 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.

 

2

 

ARTICLE III  - REPRESENTATIONS AND WARRANTIES

 

3.1          MSSM represents
and warrants that MSSM is the owner of the entire right, title and interest in
and to Licensed Patents, and has the right to grant the license as described
herein, and that the grant of such license will not result in a breach of any
agreement or other undertaking to which MSSM is a party.

 

3.2          MSSM represents
that the United States Government retains rights to the Licensed Patents and
Technical Information.  All rights
granted to GENZYME hereunder are subject to said retained rights as provided in
37 CFR 401 and 45 CFR 8.

 

ARTICLE IV  - CONSIDERATION

 

4.1          For the rights,
privileges and license granted hereunder, GENZYME shall pay or cause to be paid
to MSSM a royalty of [**] of the Net Sales of Product sold by GENZYME and its
Affiliates and [**] of the royalties payable to GENZYME by any sublicensees for
the longer of (i) the life of the Licensed Patents for Product covered by
Valid Claims in the country of sale, or (ii) [**] years after the First
Commercial Sale of Product.  The royalty
payable to MSSM shall be reduced to [**] of the Net Sales in any country in
which a recombinant x-galactosidase A product derived from mammalian cells is
commercially available from a third party.

 

4.2          No multiple
royalties shall be payable because Product, its manufacture, lease or sale, is
or shall be covered by more than one Valid Claim, patent application or patent
licensed under this Agreement.

 

4.3          Royalty
payments shall be paid to MSSM in United States dollars in New York, N.Y.  Any taxes which GENZYME or any Affiliate or
sublicensee shall be required by law to withhold or pay on remittance of the
royalty payments shall be deducted from royalty paid to MSSM.  GENZYME shall furnish MSSM upon request,
copies of all official receipts for such taxes. 
If any currency conversion shall be required in connection with the
payment of royalties hereunder, such conversion shall be made by using the
exchange rate as reported by the Wall Street Journal on the last business day
of the calendar quarterly reporting period to which such royalty payments
relate or when such conversion rate is next reported.

 

ARTICLE V  - REPORTS AND RECORDS

 

5.1          GENZYME shall
keep full, true and accurate accounts containing all particulars that may be
necessary for the purpose of showing the amount payable to MSSM.  Said books of account shall be kept at
GENZYME ‘s principal place of business or at such other location that is
reasonably accessible.  Said books and
the supporting data shall be open at all reasonable times, for three (3) years
following the end of the calendar year to which they pertain, to inspection no
more often than once a year by an independent certified public accountant
retained by MSSM, at its expense, solely for the purpose of verifying, under
suitable confidentiality obligations, GENZYME’s royalty statement to MSSM.  If GENZYME’s royalty statement is found to be
in error by [**] or more, such inspection expenses shall be paid by GENZYME.

 

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

 

3

 

5.2          Beginning with
the First Commercial Sale, GENZYME, within sixty (60) days after March 31,
June 30, September 30 and December 31, of each year, shall
deliver to MSSM true and accurate reports, giving such particulars of the
business conducted by GENZYME during the preceding quarter under this Agreement
as shall be pertinent to a royalty accounting hereunder.  Reports shall include: (a) total
billings for Product sold; (b) deductions applicable as provided in
Paragraph 1.5; and (c) total royalties due.

 

5.3          With each such
report submitted, GENZYME shall pay to MSSM the royalties then due and
payable.  If no royalties shall be due,
GENZYME shall so report.

 

ARTICLE VI  - TECHNICAL INFORMATION

 

6.1          Promptly after
the effective date of this Agreement and periodically during the term thereof,
MSSM, to the extent that it has all necessary legal and contractual rights to
do so, shall disclose and furnish to GENZYME all Technical Information which is
requested by GENZYME and which is known or possessed by MSSM.  To enable GENZYME to assist in protecting the
rights licensed to GENZYME hereunder, MSSM shall, provide to GENZYME a [**]
days prior right of review of MSSM publications relating to the Product.  GENZYME may then delay submission up to an
additional [**] days to allow filing of appropriate patent applications.  GENZYME agrees to review oral disclosures or
abstracts within [**] days of notification, and MSSM agrees to delete
proprietary information as requested by GENZYME.

 

6.2          Each of the
parties, for itself and its Affiliates, undertakes during the term of this
Agreement, to hold in confidence and not to disclose to any third party, the
Technical Information received from the other, provided that such undertaking
shall not apply to any portion of said Technical Information which:

 

(a)           was known to
the receiving party or any of its Affiliates prior to its receipt by the
receiving party or any of its Affiliates hereunder;

 

(b)           is received at
any time by the receiving party or any of its Affiliates in good faith from a
third party lawfully in possession of the same and having the right to disclose
the same;

 

(c)           is as of the
date of the receipt by the receiving party or any of its Affiliates in the
public domain or subsequently enters the public domain other than by reason of
acts or omissions of the employees or agents of the receiving party or any of
its Affiliates;

 

and
provided further that nothing contained herein shall prevent GENZYME or any of
its Affiliates from using and disclosing the Technical Information received
from MSSM in connection with applying for and securing governmental
authorizations for the marketing of licensed products or otherwise in the
performance of its obligations under 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.

 

4

 

ARTICLE VII  - PATENT SUPPORT AND PROSECUTION

 

7.1          GENZYME shall
[**] on a quarterly basis for [**] after the date of this Agreement in
connection with the filing, prosecution and maintenance of all Licensed Patents
filed, prosecuted or maintained at the request of GENZYME.  GENZYME shall not be required to [**].  If GENZYME elects not to [**], MSSM shall be
free to license such patent to any other party.

 

7.2          MSSM shall seek
prompt issuance of, and maintain, [**], the Licensed Patents, and shall keep
GENZYME informed of, and shall provide to GENZYME copies of, all official
documents received from and sent to governmental patent offices.  MSSM shall keep GENZYME apprised on a timely
basis of the progress of any patent prosecution, and shall provide GENZYME with
a reasonable opportunity to preview and comment upon prosecution
responses.  MSSM agrees to reasonably
consider any such comments provided by GENZYME.

 

7.3          If MSSM shall
decide to discontinue any such prosecution, or shall decide not to maintain any
patent, or not to file a patent application on an invention relating to the
Product, or not to file same in a particular country, it shall promptly notify
GENZYME in writing and in reasonably sufficient time for GENZYME to assume such
prosecution or maintenance, or file such patent application, and shall take the
necessary steps and execute the necessary documents to permit GENZYME to assume
the filing, prosecution, or maintenance of the same at GENZYME’s expense and
control, whereupon GENZYME shall possess a royalty-free, exclusive license to
same for the life of any such patent.

 

ARTICLE VIII  - INFRINGEMENT

 

8.1          MSSM shall have
the first option to institute and prosecute [**] suits for infringement of
Licensed Patents.  Any recovery of
damages shall [**].

 

8.2          If MSSM elects
not to bring an action for infringement, GENZYME shall have the power, but not
the obligation, to institute and prosecute [**] suits for infringement of
Licensed Patents.  MSSM agrees to join as
party plaintiff in any such suits instituted by GENZYME, and shall fully
cooperate with GENZYME in the prosecution of such suits.  GENZYME may withhold up to [**] of royalties
due hereunder during the pendency of such suits and GENZYME may apply such
withheld amounts toward reimbursement of its expenses, including reasonable
attorney’s fees in connection therewith. 
Any recovery of damages by GENZYME shall be applied first in
satisfaction of any unreimbursed expenses and legal fees relating to the suit
or settlement thereof, and then toward reimbursement of MSSM for any royalties
withheld and applied pursuant to this Article VIII.  Any remaining recoveries shall be deemed Net
Sales for purposes of calculation of royalties hereunder.

 

8.3          If GENZYME does
not bring action, and MSSM chooses not to bring action, to halt infringement,
then the applicable royalty in such country shall be [**] of the rate otherwise
applicable, provided that GENZYME has suffered at least a [**] market share
loss due to such infringement.

 

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

 

5

 

ARTICLE IX  - TERM AND TERMINATION

 

9.1          This Agreement
shall be effective as of the date first written above and shall continue in
effect on a country-by-country basis until the later of (i) the expiration
of the last to expire of the Licensed Patents in a particular country, or (ii) ten
(10) years after the date of the First Commercial Sale.  Thereafter, Genzyme shall have a paid up
license to the Technical Information.

 

9.2          Should GENZYME
fail in its payment to MSSM of royalties due in accordance with the terms of
this Agreement, MSSM shall have the right to serve notice upon GENZYME by
certified mail at the address designated in Article XVI hereof, of its
intention to terminate this Agreement within [**] days after receipt of said
notice of termination unless GENZYME shall pay to MSSM within the [**] day
period, all such royalties due and payable, or institute arbitration
proceedings as provided herein.  Upon the
expiration of the [**] day period, if GENZYME shall not have paid all such
royalties due and payable, or implemented arbitration, the rights, privileges
and license granted hereunder shall thereupon immediately terminate.

 

9.3          Upon any
material breach or default of this Agreement by either party, other than those
occurrences set out in Paragraph 9.2 above, the other party shall have the
right to terminate this Agreement and the rights, privileges and license
granted hereunder by [**] days’ notice including a detailed explanation of the
reasons for termination, by certified mail to the defaulting party.  Such termination shall become effective
unless the defaulting party shall have cured any such breach or default prior
to the expiration of the other party’s notice of termination.

 

9.4          GENZYME shall
have the right, upon [**] days written notice, to terminate the license granted
herein, on a country-by-country basis or to fully terminate the license and
this Agreement.

 

9.5          Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either party from any obligation that matured prior to the effective
date of such termination.  GENZYME and its
Affiliates and sublicensees may, however, after the effective date of such
termination, sell all Product, and complete Product in the process of
manufacture at the time of such termination and sell the same, provided that
GENZYME shall pay to MSSM the royalties thereon as required by Article IV
of this Agreement and shall submit the reports required by Article V
hereof on the sales of Product.

 

9.6          The provisions
of Article VI shall survive termination of this Agreement for a period of
five (5) years.  The provisions of Article XII
shall survive termination of this Agreement.

 

ARTICLE X  - ARBITRATION

 

Except
as to issues relating to the validity, construction or effect of any patent
licensed hereunder, any and all claims, disputes or controversies arising
under, out of, or in connection with this Agreement, which have not been
resolved by good faith negotiations between the parties, shall be resolved by
final and binding arbitration in Boston, Massachusetts by three 

 

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

 

6

 

arbitrators, one selected by each party
within 30 days of receipt of notice to arbitrate, the remaining arbitrator to
be selected by the party- selected arbitrators. 
If a party fails to select an arbitrator within the thirty day period,
it shall forfeit its right to make such a selection.  The arbitration shall be under the rules of
the American Arbitration Association then obtaining.  The arbitrators shall have no power to modify
any of the terms or conditions of this Agreement.  Any award rendered in such arbitration may be
enforced by any of the parties in the United States District Court for
Massachusetts, to whose jurisdiction for such purposes MSSM and GENZYME each
hereby irrevocably consents and submits. 
Each party shall bear its own costs.

 

ARTICLE XI  - THIRD PARTY PATENTS

 

In
the event that a patent of a third party should exist during the term of this
Agreement, which such third party alleges is infringed by the manufacture, use
or sale of Product by GENZYME, or in the event that GENZYME shall undertake to
challenge the validity or infringement of such patent by litigation, GENZYME
may withhold up to [**] of the royalties otherwise due to MSSM towards the
reimbursement of its out-of-pocket costs and expenses incurred in such
litigation, and/or if GENZYME is required to pay to such other patentee a royalty
under such patent, GENZYME may deduct up to [**] of the royalties paid to such
third party.  In no event, however, shall
the deductions allowed in this Article XI cause the total royalty payable
to MSSM under Article 4.1 of this Agreement to be less than [**] of Net
Sales.

 

ARTICLE XII  - INSURANCE AND INDEMNIFICATION

 

12.1        GENZYME shall
at all times during the term of this Agreement and thereafter, defend,
indemnify and hold MSSM, its affiliates and their trustees, directors,
officers, employees, medical staff, agents, volunteers and students harmless
from any and all claims, demands, lawsuits, actions, settlements, judgments,
and expenses (including legal expenses and attorney’s fees), arising from or in
connection with the negligent acts or omissions or product liabilities of
GENZYME, its Affiliates, employees or other agents committed in connection with
this Agreement.  MSSM shall be required
to provide GENZYME with prompt notice of any such claims, as well as such
reasonable assistance and cooperation as GENZYME may request in the defense of
such claims.  GENZYME’S obligation to
protect, defend, indemnify and hold harmless hereunder shall Survive the
expiration and termination of this Agreement.

 

12.2        GENZYME shall
purchase and keep in force the following minimum insurance coverages, naming
MSSM as additional insured with such insurers as shall be acceptable to MSSM:

 

1)
Comprehensive General Liability, including:

 

(a)           Personal injury
and bodily injury and Broad form property damage liability with a combined
single limit of not less than $[**].

 

(b)           Coverage for
the contractual liability assumed by 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.

 

7

 

2)
Product liability insurance in an amount not less than [**] per occurrence,
with an aggregate yearly limit of [**]. 
Prior to any work being performed under this Agreement, GENZYME shall
deliver to MSSM certificates of insurance evidencing that the coverages
specified in these sections are in effect. 
Such certificates shall show that:

 

(a)           MSSM is an
additional named insured;

 

(b)           the insurer
shall give MSSM thirty (30) days written notice sent by registered mail of any
material change in, or cancellation of, such insurance.

 

ARTICLE XIII  - ASSIGNMENT

 

13.1        GENZYME shall
be entitled to assign its rights hereunder, with the written consent of MSSM,
which consent shall not be unreasonably withheld.  At GENZYME’s request, MSSM shall enter into a
separate counterpart agreement with any such assignee, it being expressly
agreed that GENZYME shall remain bound by the obligations hereof until such
separate counterpart agreement is signed. 
Such counterpart agreement shall be the same in form and substance
except for necessary changes to reflect the extent of the assignment.

 

13.2        MSSM shall be
entitled to assign its rights hereunder with the written consent of GENZYME, which
consent shall not be unreasonably withheld.

 

ARTICLE XIV  - NON-USE OF NAMES AND TRADEMARKS

 

14.1        Neither party
shall use the names or trademarks of the other party for any advertising,
promotional or sales literature without prior written consent which consent
shall not be unreasonably withheld, except that GENZYME may disclose that it is
exclusively licensed by MSSM hereunder. 
In all cases, GENZYME shall be permitted to make such disclosures as
required by state and federal law.

 

14.2        It is understood
that MSSM has selected the trademark [**] for use in connection with the
Product.  GENZYME agrees to reasonably
consider said trademark for use in connection with its commercialization of the
Product, and MSSM agrees to assign its rights to said trademark to GENZYME at
no cost, upon GENZYME’s request.

 

ARTICLE XV  - DUE DILIGENCE

 

GENZYME
shall use its reasonable efforts to develop the Product for
commercialization.  Such efforts shall
include the following:

 

(a)           within [**]
years of the Effective Date, to initiate [**] studies on the Product which is
intended for use in clinical trials;

 

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

 

8

 

 

(b)           within [**]
years of the Effective Date to initiate [**] for the Product; and

 

(c)           within [**]
years of the Effective Date to [**].

 

ARTICLE XVI  - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS

 

Any
payment, notice or other communication pursuant to this Agreement shall be
sufficiently made or given on the date of mailing if sent to such party by
certified first class mail, postage prepaid, addressed to it as its address
below or as it shall designate by written notice given to the other party:

 

In
the case of MSSM:

Office
of Science and Technology Development Mount Sinai School of Medicine

One
Gustave L.  Levy Place

New
York, NY 10029

Attention:
Dr.  Frank Landsberger

Fax.  No.  (212) 348-3116

 

In
the case of GENZYME:

Genzyme
Corporation One Kendall Square

Cambridge,
MA 02139

Attention:
Senior Vice President and General Counsel

Fax.  No.  (508) 872-5415

 

ARTICLE XVII  - MISCELLANEOUS PROVISIONS

 

17.1        This Agreement
shall be construed, governed, interpreted and applied in accordance with the
laws of the State of New York, except that questions affecting the construction
and effect of any patent shall be determined by the law of the country in which
the patent was granted.

 

17.2        The parties hereto
acknowledge that this Agreement and the Research Agreement dated of even date
sets forth the entire agreement and understanding of the parties hereto as to
the subject matter hereof, and shall not be subject to any change or
modification except by the execution of a written instrument subscribed to by
the parties hereto.

 

17.3        The provisions
of this Agreement are severable, and in the event that any provision of this
Agreement shall be determined to be invalid or unenforceable under any
controlling body of law, such invalidity or unenforceability shall not in any
way effect the validity or enforceability of the remaining provisions hereof.

 

17.4        The failure of
either party to assert a right hereunder or to insist upon compliance with any
term or condition of this Agreement shall not constitute a waiver of that right
or excuse a similar subsequent failure to perform any such term or condition by
the other party.

 

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

 

9

 

17.5        Neither party
shall, without the consent of the other, which consent shall not be
unreasonably withheld, originate any publicity, news release, or other public
announcement, written or oral, whether to the public press, to stockholders, or
otherwise, relating to this Agreement, any amendment hereto or performance
hereunder, save any such announcement as in the opinion of legal counsel to the
party making such announcement is required by law to be made.  Both parties acknowledge the likelihood that
GENZYME may be required to make a general announcement regarding the existence of
this Agreement as a material event.  The
party making such announcement will give the other party an opportunity to
review the form of the announcement before it is made.

 

17.6        Both parties
acknowledge and recognize the presence of risk regarding the development and
sale of the Product contemplated hereunder, that potential markets discussed
have only been estimated and are not being relied upon, and that the Product
may be unsuccessful in any such market.

 

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

 

10

 

IN WITNESS WHEREOF, the parties
hereto have caused this License Agreement to be executed by their duly authorized
representatives as of the day and year first set forth above.

 

	
  MOUNT
  SINAI SCHOOL OF MEDICINE

  	
   

  	
  GENZYME
  CORPORATION

  
	
   

  	
   

  	
   

  
	
  BY:
  

  	
  /s/[illegible] Katz

  	
   

  	
  BY:

  	
  /s/
  Gregory D. Phelps

  
	
   

  	
   

  	
   

  	
   

  
	
  TITLE:

  	
  [illegible]

  	
   

  	
  TITLE:

  	
  Senior
  Vice President

  
	
   

  	
   

  	
   

  	
   

  
	
  DATE:

  	
  1-27-95

  	
   

  	
  DATE:

  	
  2-3-95

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ACCEPTED
  AND AGREED TO:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  NAME:

  	
  /s/
  Robert J. Desnick

  	
   

  	
   

  	
   

  
	
   

  	
  Robert J. Desnick, Ph.D., M.D.

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  DATE:

  	
  1-26-95

  	
   

  	
   

  	
   

  

 

[**] = 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

 

SCHEDULE A

 

	
  A.  United States Patents and Application

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  6923-005

  	
   

  	
  U.S. Patent No.  5,356,804

  
	
   

  	
   

  	
  Granted:  October 18, 1994

  
	
   

  	
   

  	
  To:

  	
  Desnick et al.

  
	
   

  	
   

  	
  For:

  	
  Cloning And Expression Of
  Biologically Active

  
	
   

  	
   

  	
  Alpha Galactosidase A

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  	
  Desnick
  et el.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  6923-030

  	
   

  	
  U.S. Serial No. 
  07/903,451 (allowed)

  
	
   

  	
   

  	
  Filed:  November 30, 1992

  
	
   

  	
   

  	
  For:

  	
  Cloning’ And Expression Of Biologically
  Active Alpha-Galactomidase A

  
	
   

  	
   

  	
  By:

  	
  Desnick et al.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  6923-042

  	
   

  	
  U.S. Serial No. 
  00/261,577 (pending)

  
	
   

  	
   

  	
  Filed: June 17, 1994 (as a
  division of Serial No. 07/983,451)

  
	
   

  	
   

  	
  For:

  	
  Cloning And Expression Of
  Biologically Active Alpha-Galactosidase A

  
	
   

  	
   

  	
  By:

  	
  Desnick et al.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  B.  Foreign Patents and Applications

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  6923-030-228

  	
   

  	
  International Application
  No.  PCT/US93/11539

  
	
   

  	
   

  	
  Filed: November 30, 1993

  
	
   

  	
   

  	
  For:

  	
  Cloning And Expression Of
  Biologically Active Alpha-Galactosidase A

  
	
   

  	
   

  	
  By:

  	
  Desnick et al.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  6923-030-158

  	
   

  	
  Israeli Application No. 
  107814

  
	
   

  	
   

  	
  Filed: November 30, 1993

  
	
   

  	
   

  	
  For:

  	
  Cloning And Expression Of
  Biologically Active Alpha-Galactooidaso A

  
	
   

  	
   

  	
  By

  	
  Desnick et al.

  

 

[**] = 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.

 

 

Schedule B

Technical Information

 

[**]

 

[**] = 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.

 

 

FIRST AMENDMENT TO LICENSE AGREEMENT

 

This
is the First Amendment to the January 1, 1995 License Agreement between
Genzyme Corporation (“GENZYME”) and Mount Sinai School of Medicine of the City
University of New York (“MSSM”).  This
Amendment shall be effective as of October 7, 2003.

 

WHEREAS,
in the License Agreement, MSSM has granted to GENZYME an exclusive license
under certain Technical Information and Licensed Patents rights, including
U.S.  patent No.  5,356,804 (“the ‘804
patent”), in connection with the commercialization of recombinant "-galactosidase
A for the treatment of Fabry Disease; and

 

WHEREAS,
MSSM and Genzyme are co-plaintiffs and appellants in a suit against
Transkaryotic Therapies, Inc.  (“TKT”)
alleging infringement of the ‘804 patent (the “Infringement Suit”), which
Infringement Suit was originally brought in the United States District Court
for the District of Delaware (Civil Action No.  00-677 GMS) and is now on
appeal to the Court of Appeals for Federal Circuit (Appeal No.  02-1312);

 

NOW,
THEREFORE, in consideration of the premises and the mutual covenants contained
herein and for other good and valuable consideration, the receipt and sufficiency
of which each party acknowledges, MSSM and GENZYME hereby agree as follows:

 

1.             Definitions.  Capitalized terms not defined in this First
Amendment shall have the meaning given them in the License Agreement.

 

2.             Restatement
of Section 2.1.  Section 2.1 of the License Agreement
shall be amended and restated to read as follows:

 

“2.1        Except as provided in Article XVIII,
MSMM hereby grants to GENZYME an exclusive, worldwide right and license, and
subject to approval by MSMM, which shall not be unreasonably withheld, the
right to sublicense third parties, (a) to make, have made, use, and sell
Product under the Licensed Patents; and (b) to use the Technical
Information provided by MSSM.  MSSM
agrees that [**] other than GENZYME [**] by or under [**] during the term of
this Agreement.”

 

3.             Addition
of Article XVIII.  New Article XVIII
shall be added to the License Agreement, which Article shall read as
follows:

 

“ARTICLE XVIII
— INFRINGEMENT SUIT AGAINST TKT

 

18.1.1  In the event
that GENZYME withdraws as plaintiff-appellant from the Infringement Suit, MSSM
shall have the right (i) to continue the proceedings and maintain the
Infringement Suit as the sole plaintiff [**] and (ii) to solely bring,
defend or maintain any other proceeding relating to the Licensed Patents or
Technical Information in which TKT is a party or has an interest [**].  Notwithstanding the foregoing, GENZYME shall
[**] from any [**] for which [**] to the extent arising out of or related to (i) [**]
or (ii) any agreement between

 

[**] = 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.

 

 

[**].  In addition, only to the extent permitted by
any Settlement Agreement, GENZYME [**] shall reasonably cooperate with MSSM’s
prosecution of the Infringement Suit or any other action related to the
Licensed Patents or Technical Information. 
Such cooperation includes making available to MSSM any documents,
witnesses, or other information in GENZYME’s control.

 

18.2        Any [**] in the Infringement
Suit or any other proceeding between [**].

 

18.3        Notwithstanding the
provisions of Section 2.1, MSSM shall have [**].”

 

4.             Acknowledgements.  GENZYME and MSSM acknowledge that, if GENZYME
withdraws from the Infringement Suit:

 

a.             Effective as of
the date GENZYME withdraws, GENZYME confirms that, [**].  For the avoidance of doubt, amounts
previously [**].

 

b.             Section 8.3
of the License Agreement shall not apply to [**], or their respective successors,
assigns or licensees.

 

Except
as provided herein, the License Agreement shall remain in full force and
effect.  Any capitalized terms used
herein but not otherwise defined shall have the meanings ascribed to them in
the License 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.

 

 

IN
WITNESS WHEREOF, the Parties hereto have caused this Amendment to
be executed and delivered as of the effective day and year set forth above.

 

 

	
  MOUNT SINAI SCHOOL OF MEDICINE

  	
   

  	
  GENZYME
  CORPORATION

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/
  Kenneth L. Davis

  	
   

  	
  By:

  	
  /s/
  Thomas DesRosier

  
	
   

  	
  Kenneth L. Davis, M.D.

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Dean

  	
   

  	
  Title:

  	
  Senior
  Vice President

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date:

  	
  10-7-2003

  	
   

  	
  Date:

  	
  10-7-2003

  

 

[**] = 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.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00177-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00177-of-00352.parquet"}]]