Document:

Exhibit 10.2

 

MANUFACTURING,
MARKETING AND SALES AGREEMENT

 

THIS MANUFACTURING,
MARKETING AND SALES AGREEMENT (this “Agreement”) is made effective as of the 1st
day of January, 2008 (the “Effective Date”),
by and among BioMarin Pharmaceutical Inc., a Delaware corporation having its
principal place of business at 105 Digital Drive, Novato, California 94949 (“BioMarin”); Genzyme Corporation, a
Massachusetts corporation having its principal place of business at 500 Kendall
Square, Cambridge, Massachusetts 02142 (“Genzyme”)
and BioMarin/Genzyme LLC, a Delaware limited liability company having its
principal place of business at 500 Kendall Street, Cambridge, Massachusetts
02142 (“BioMarin/Genzyme LLC”).

 

RECITALS

 

A.                                   BioMarin,
Genzyme and BioMarin/Genzyme LLC are parties to a Collaboration Agreement dated
as of September 4, 1998 (the “Original Collaboration
Agreement”) pursuant to which BioMarin and Genzyme through
BioMarin/Genzyme LLC develop, manufacture, market and sell Aldurazyme (as
defined herein).

 

B.                                     The
Parties no longer desire to develop, manufacture, market and sell Aldurazyme
through a joint venture and instead have agreed that: (1) BioMarin will
manufacture Aldurazyme and sell finished product to Genzyme; (2) Genzyme
will label and commercially distribute, market and sell Aldurazyme globally; (3) each
of Genzyme and BioMarin may conduct its own research and development of
Aldurazyme and other Collaboration Products (as defined herein) in accordance
with the terms of this Agreement and the Amended and Restated Collaboration
Agreement (as defined herein); and (4) BioMarin/Genzyme LLC will maintain
and provide intellectual property licenses and sublicenses to BioMarin and
Genzyme so that they may fulfill their respective obligations under this
Agreement, the Amended and Restated Collaboration Agreement and the Fill
Agreement (as defined herein).

 

C.                                     BioMarin
and Genzyme have amended and restated the Original Collaboration Agreement so
that hereafter BioMarin/Genzyme LLC will no longer engage in commercial activities
and will solely (1) hold the intellectual property relating to Aldurazyme
and license all such intellectual property on the terms set forth herein to
BioMarin and Genzyme on the terms set forth in the Amended and Restated
Collaboration Agreement (as defined below) and (2) and engage in research
and development activities that are mutually selected and funded by BioMarin
and Genzyme.

 

D.                                    To
effect the foregoing, the Parties are also entering into (1) a separate
Fill Agreement of even date herewith pursuant to which Genzyme will continue to
provide fill services for Aldurazyme to BioMarin (the “Fill
Agreement”); (2) the aforementioned amendment and restatement
of the Original Collaboration Agreement of even date herewith (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.

 

 

“Amended and Restated
Collaboration Agreement”); and (3) a Members Agreement
of even date herewith pursuant to which certain current assets and liabilities
of BioMarin/Genzyme LLC and its subsidiaries will be distributed to its Members
(the “Members Agreement”).

 

AGREEMENT

 

NOW, THEREFORE, in
consideration of the mutual promises set forth in this Agreement and other good
and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereto hereby agree as follows:

 

1.                                      DEFINITIONS.

 

1.1                               “Adverse Experience” shall mean any undesirable physical,
psychological or behavioral effect experienced by a human Patient or subject
that is associated with the use of Aldurazyme, whether or not considered
product-related, including an adverse experience occurring: in the course of
the use of Aldurazyme in professional practice; from an overdose of Aldurazyme
(whether accidental or intentional); from the abuse of Aldurazyme;  from
the withdrawal of Aldurazyme; or from any failure of Aldurazyme’s expected
pharmacological action.

 

1.2                               “Affiliate” shall mean any corporation, limited liability
company, firm, partnership, limited liability partnership or other entity,
whether de jure or de facto, which, at the time in question, is directly or
indirectly owned by or controlled by, or under common control with, BioMarin or
Genzyme, as the case may be.  For the
purposes of this definition, a Party shall be deemed to have “control” if such Party: (a) owns, directly or
indirectly, fifty percent (50%) or more (or such lesser percentage which is the
maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) of (i) the voting stock or shareholders’ equity of a
corporation, (ii) the partnership interests in a partnership, (iii) the
membership interests in a limited liability company, or (iv) in the case
of any other entity, the right to receive fifty percent (50%) or more of either
the profits or the assets upon dissolution; or (b) possesses, directly or
indirectly, the power to direct or cause the direction of the management and
policies of the corporation or other entity or the power to elect more than
fifty percent (50%) of the members of the governing body of the corporation,
limited liability company or other entity.

 

1.3                               “Agreement” shall have the meaning set forth
in the introductory paragraph hereof.

 

1.4                               “Aldurazyme” shall mean alpha-L-iduronidase meeting the Specifications.

 

1.5                               “alpha-L-iduronidase”
shall mean recombinant human alpha-L-iduronidase.

 

1.6                               “Amended
and Restated Collaboration Agreement” shall have the meaning set forth in
the recitals.

 

1.7                               “Annual Net Sales” shall have the meaning
set forth in Section 6.1(a).

 

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

 

2

 

1.8                               “Batch” or “Lot” shall mean each separate and distinct quantity of
Aldurazyme processed under continuous conditions and designated by BioMarin
with a batch or lot number.

 

1.9                               “BioMarin Companies” shall mean BioMarin and BioMarin
Genetics.

 

1.10                        “BioMarin Genetics” shall mean BioMarin Genetics, Inc.,
a Delaware corporation and wholly-owned subsidiary of BioMarin.

 

1.11                        “BLA” shall mean a Biologics License Application or similar
application as approved by the FDA on April 30, 2003, that provides for
marketing approval for Aldurazyme in the United States, as the same may be
updated or amended from time to time.

 

1.12                        “cGMP Regulations” means the applicable
current Good Manufacturing Practices as promulgated under ICH Q7A-Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients, U.S. Federal Food, Drug and Cosmetic Act at 21 CFR
and the EEC Guide to Good Manufacturing Practices for Medical Products (Vol. IV
— rules governing medical products in the European Community 1989) in the
most recent version.

 

1.13                        “Certificate
of Analysis” or “COA”
shall mean a document in the form attached as Exhibit B
executed by BioMarin to certify that a Batch or Lot of Aldurazyme meets the
Specifications.

 

1.14                        “Certificate of Compliance”
or “COC” shall mean a document certifying a
Batch or Lot of Aldurazyme meets Genzyme’s product release criteria and was
produced in compliance with cGMP requirements.

 

1.15                        “Collaboration Product” shall mean Aldurazyme and any other
pharmaceutical compositions of alpha-L-iduronidase,
including without limitation any and all improvements, derivatives, analogs,
combination products, delivery systems and dosage forms related thereto.

 

1.16                        “commercially reasonable and diligent efforts” will mean that
level of effort which, consistent with the exercise of prudent scientific and
business judgment, is applied by the Party in question to its other therapeutic
products at a similar stage of development and with similar commercial
potential.

 

1.17                        “Control” shall mean possession of the ability to grant a
license or sublicense as provided for herein without violating the terms of an
agreement with a Third Party.

 

1.18                        “Effective Date” shall mean January 1, 2008.

 

1.19                        “EMEA” shall mean the European Agency for
the Evaluation of Medical Products or any successor agency.

 

1.20                        “European Commission” shall mean that body of the European
Union that grants Marketing Application Approvals.

 

[**] = 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

 

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

 

1.22                        “Field” shall mean any and all therapeutic applications of
alpha-L-iduronidase for MPS I
and other alpha-L-iduronidase
deficiencies.  Notwithstanding the
foregoing, the Field shall not include Gene Therapy for MPS I or other alpha-L-iduronidase deficiencies.  For purposes of this Agreement, “Gene Therapy” shall mean treatment or prevention of MPS I or
other alpha-L-iduronidase
deficiencies by means of ex vivo or in vivo introduction (via viral or nonviral gene transfer
systems) of nucleotide sequences (including without limitation, DNA, RNA and
complementary and reverse complementary nucleotide sequences thereto, whether
coding or non-coding).

 

1.23                        “Fill
Agreement” shall have the meaning set forth in the recitals.

 

1.24                        “GAAP” shall mean the then-current United States generally
accepted accounting principles, consistently applied.

 

1.25                        “Insolvency Event”
shall mean, with respect to a Party, that the Party (i) applies for
or consents to the appointment of a receiver, trustee, liquidator or custodian
for itself or of all or a substantial part of its property; (ii) becomes
unable, or admits in writing its inability, to pay its debts generally as they
mature; (iii) makes a general assignment for the benefit of its or any of
its creditors; (iv) is dissolved or liquidated in full or in part; (v) commences
a voluntary case or other proceeding seeking liquidation, reorganization or
other relief with respect to itself or its debts under any bankruptcy,
insolvency or other similar law now or hereafter in effect or consents to any
such relief or to the appointment of or taking possession of its property by
any official in an involuntary case or other proceeding commenced against it;
or (vi) takes any action for the purpose of effecting any of the
foregoing; or (vii) the Party has commenced against it proceedings for the
appointment of a receiver, trustee, liquidator or custodian, or an involuntary
case or other proceedings seeking liquidation, reorganization or other relief
under any bankruptcy, insolvency or other similar law now or hereafter in
effect and such proceeding is not dismissed or discharged within sixty (60)
calendar days of commencement.

 

1.26                        “Labeling Materials” shall have the meaning
set forth in Section 3.1.

 

1.27                        “MAA” shall mean the Marketing Application
as approved by the EMEA on June 10, 2003 that provides for marketing
approval for Aldurazyme in the European Union, as the same may be updated or
amended from time to time.

 

1.28                        “Manufacturing Know-How” shall mean all information,
techniques, inventions, discoveries, improvements, practices, methods,
knowledge, skill, experience and other technology, whether or not patentable or
copyrightable, and any copyrights based thereon, relating to or necessary or
useful for the production, purification, packaging, storage and transportation
of Collaboration Products, including without limitation specifications,
acceptance criteria, manufacturing batch records, standard operating
procedures, engineering plans, installation, operation and process qualification

 

[**] = 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

 

protocols for equipment, validation records, master
files submitted to the FDA, process validation reports, environmental
monitoring processes, test data including pharmacological, toxicological and
clinical test data, cost data and employee training materials.

 

1.29                        “Marketing Application” shall mean a
marketing authorization application filed by or under authority of Genzyme with
the requisite health regulatory authority of any country requesting approval
for commercialization of Aldurazyme for a particular indication in such
country, including as applicable, the MAA.

 

1.30                        “Marketing Application Approval” shall mean,
with respect to each country approval of the Marketing Application filed in
such country by the health regulatory authority in such country, including as applicable,
the MAA.

 

1.31                        “Marketing Costs” with respect to Aldurazyme shall mean the
sales and marketing costs and expenses incurred by Genzyme with respect to work
performed by Genzyme and its Affiliates and subcontractors in connection with
the performance of and in accordance with the marketing plan for Aldurazyme,
including without limitation, sales and marketing costs related to performing
market research, advertising, producing promotional literature, sponsoring
seminars and symposia, sales training meetings and seminars, originating sales,
providing reimbursement and other patient support services, recruitment costs
and salaries and associated expenses for sales and marketing personnel and
support staff, and distribution fees.

 

1.32                        “Master
Batch Record” shall mean a written description of the
procedure to be followed by BioMarin in processing of a Batch of Aldurazyme,
which description shall include, but not be limited to, a complete list of all
active and inactive ingredients, components, weights and measures and
procedures used in processing the Aldurazyme within the meaning of 21 CFR
part 211.186, or its successor as in effect from time to time.

 

1.33                        “Members
Agreement” shall have the meaning set forth in the recitals.

 

1.34                        “MPS-I” shall mean mucopolysaccharidosis I.

 

1.35                        “Multiple Products Sale” shall mean a sale of Aldurazyme by
Genzyme or its Affiliates to an independent Third Party customer that is
associated, by contract or course of dealing, with the use or sale or one or
more other products or services [**].  In
determining the consideration received for Aldurazyme, the following shall be
excluded: (i) Aldurazyme from the quantities provided to Genzyme pursuant
to Section 6.1(d)(i), and (ii) transfers
of Aldurazyme that are excluded from the definition of Net Sales under Section 1.36 below.

 

1.36                        “Net Sales” with respect to Aldurazyme shall
mean the gross invoiced sales price of Aldurazyme billed to independent Third
Party customers, including without limitation Third Party distributors, in fully
legitimate, arms length transactions, less: (a) credits
or allowances granted upon billing corrections, (b) credits or allowances
granted upon

 

[**] = 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

 

returns or rejections, provided that such Aldurazyme
shall be deemed to be unsold and treated in accordance with Section 6.7; (c) freight, shipping and insurance
costs (incurred in transporting Aldurazyme to such customers to the extent
separately billed); (d) quantity, cash and other trade discounts [**],
credits or allowances actually allowed and taken; (e) customs duties,
surcharges and taxes and other governmental charges incurred in connection with
the production, sale, transportation, delivery, use, exportation or importation
of Aldurazyme in final form; (f) amounts incurred resulting from
governmental mandated rebate or discount programs; and (g) Third Party
rebates and charge backs, hospital buying group/group purchasing organization
administration fees or managed care organization rebates; all in accordance
with standard allocation procedures, allowance methodologies and accounting
requirements consistently applied, which procedures, methodologies and
requirements are in accordance with GAAP. 
“Net Sales” with respect to Aldurazyme
sold in Multiple Products Sales shall be calculated by Genzyme in good faith
and shall equal a fair and equitable allocation of all consideration received
by Genzyme in connection with a Multiple Products Sale, considering the nature
and economic value of each component of the Multiple Products Sale.  The transfer of Aldurazyme by Genzyme or one
of its Affiliates to another Affiliate of Genzyme in furtherance of a sale to a
Third Party shall not be considered a sale; in such cases, Net Sales shall be
determined based on the invoiced sales price by the Affiliate to its customer,
less the deductions allowed under this Section 1.36.  “Net Sales”
shall not include transfers of Aldurazyme for use for clinical purposes, in
compassionate or expanded access programs, or in programs for patients paying a
nominal price for Aldurazyme.

 

1.37                        “Operating Agreement” shall mean that certain Operating
Agreement of BioMarin/Genzyme LLC dated as of September 4, 1998 entered
into by and among the BioMarin Companies and Genzyme.

 

1.38                        “Order” shall mean a firm purchase order originated by
Genzyme and sent to BioMarin which sets forth, at a minimum, the quantities of
Aldurazyme ordered, the delivery dates and other material information as set
forth in Section 3.3.

 

1.39                        “Original Collaboration Agreement” shall have the meaning set
forth in the recitals.

 

1.40                        “Party” shall mean BioMarin, Genzyme or
BioMarin/Genzyme LLC, as applicable, and “Parties”
shall mean BioMarin, Genzyme and BioMarin/Genzyme LLC, collectively.

 

1.41                        “Patent Rights” shall mean all US and foreign patents and
patent applications (including continuations, continuations-in-part,
divisionals, reissues, re-examinations, renewals, supplemental protection
certificates and extensions) which are or become owned or controlled by a Party
or to which such Party has, now or in the future, the right to grant licenses and
other rights, which generically or specifically claim Collaboration Products, a
process for manufacturing Collaboration Products, an intermediate used in such
process or a use of a Collaboration Product.

 

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

 

6

 

1.42                        “Patient” shall mean any person who is the
actual recipient of Aldurazyme for clinical or medical purposes.

 

1.43                        “Percentage Interest” shall have the meaning set forth in the
Operating Agreement.

 

1.44                        “Post-Marketing Studies” shall mean any
clinical trial using Aldurazyme performed by Genzyme or its Affiliates required
by regulatory authorities as a condition to the issuance, continuation, or
maintenance of a Marketing Application Approval.  Post-Marketing Studies shall not include
registries.

 

1.45                        “Regulatory Approvals” shall mean all approvals from
regulatory authorities in any country required lawfully to manufacture and
market Aldurazyme in any such country, including without limitation approval of
any BLA, any establishment license application filed with the FDA to obtain
approval of the facilities and equipment to be used to manufacture Aldurazyme,
any Marketing Application Approval and any product pricing approvals where
applicable.

 

1.46                        “Regulatory Scheme” shall mean the U.S. Food, Drug and
Cosmetics Act and the regulations, interpretations and guidelines promulgated
thereunder by the FDA or the regulatory scheme applicable to Aldurazyme in any
country other than the United States, as such statutes, regulations,
interpretations and guidelines or regulatory schemes may be amended from time
to time.

 

1.47                        “Related Agreements” shall mean the Amended and Restated
Collaboration Agreement, the Members Agreement, the Fill Agreement and the
Operating Agreement.

 

1.48                        “Serious
Adverse Experience” shall mean any Adverse Experience associated with the
use of any of Aldurazyme that results in one or more of the following outcomes:
death; a life-threatening experience; required or prolonged inpatient
hospitalization; persistent or significant disability or incapacity; a
congenital anomaly or defect; or the occurrence of an important medical event
that may jeopardize the health of a Patient or subject, and may require medical
or surgical intervention to prevent one of the outcomes listed above.

 

1.49                        “SOP” shall mean
standard operating procedure.

 

1.50                        “Specifications” shall mean the written
specifications for Aldurazyme set forth in Exhibit A
hereto; provided  that such
specifications shall at all times comply with the relevant Regulatory Scheme in
the country of sale and in the country of use. 
The Specifications with respect to any particular country shall
automatically be amended upon receipt of required Regulatory Approvals from the
regulatory authorities in such country for any changes thereto.  Copies of the then-current Specifications
shall be maintained by both BioMarin and Genzyme and shall become a part of
this Agreement as if incorporated herein.

 

1.51                        “Taxes” shall have the meaning set forth in Section 6.5.

 

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

 

7

 

1.52                        “Technology” shall mean inventions, trade secrets,
copyrights, know-how, data and other intellectual property of any kind (including
without limitation any proprietary biological or other materials, compounds or
reagents, but not including Patent Rights).

 

1.53                        “Technical
Agreement” shall have the meaning set forth in Section 3.18.

 

1.54                        “Territory”
shall mean the world.

 

1.55                        “Third Party” shall mean any entity other than
BioMarin/Genzyme LLC, BioMarin or Genzyme and their respective Affiliates.

 

1.56                        “Third Party Licenses” shall mean those licenses between
BioMarin/Genzyme LLC and Third Parties set forth on Schedule 1.56.  If after the Effective Date any Party enters
into an agreement to license or acquire rights from a Third Party with respect
to subject matter to be utilized in connection with Aldurazyme in accordance
with Section 3.1.4 of the Amended and
Restated Collaboration Agreement, such agreements shall also be included in the
definition of Third Party Licenses for purposes of this Agreement.

 

2.                                      EXCLUSIVE RELATIONSHIP.

 

2.1                               Non-Compete.  Except as otherwise expressly provided herein
or in the Amended and Restated Collaboration Agreement and the Fill Agreement,
during the term of this Agreement, neither BioMarin/Genzyme LLC, Genzyme nor
BioMarin, nor any of their respective Affiliates, shall independently, or with
or through a Third Party, conduct research or development activities regarding,
or engage in the manufacture, marketing, sale or distribution of, Collaboration
Products in the Field and in the Territory.

 

3.                                      MANUFACTURING.

 

3.1                               Manufacturing.  Subject to the terms and conditions of this Article 3, during the term of this
Agreement, BioMarin shall supply Genzyme with filled (but not labeled)
Aldurazyme, and Genzyme shall exclusively purchase its requirements from
BioMarin except as provided herein.  The
Aldurazyme supplied to Genzyme (i) shall conform in all respects to the
Specifications, (ii) will be manufactured under cGMP using the process
licensed or approved by regulatory authorities, (iii) shall have a
remaining shelf life at the time of delivery to Genzyme of at least [**] of the
total expiry of the product and (iv) shall not have experienced any
manufacturing process deviations that would require notice to any regulatory
authorities unless, prior to delivery to Genzyme, such regulatory authorities
have been notified and have approved the deviations.  BioMarin shall ensure that Genzyme has a
complete and accurate copy of the Master Batch Record (as it may be modified
from time to time pursuant to this Agreement). 
BioMarin and Genzyme shall be responsible for release testing as
provided in the Technical Agreement; provided, however, that
BioMarin agrees to complete all release testing for which is responsible under
the Technical Agreement and provide the testing and release documentation to
Genzyme within [**] of delivery of each such Lot.  Genzyme shall prepare all Aldurazyme in final
packaged form, including, without

 

[**] = 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

 

limitation, all product labeling and other package
inserts and materials required by applicable regulatory agencies (collectively,
“Labeling Materials”).

 

3.2                               Forecasts.

 

3.2.1                     Initial
Forecast and Initial Shipments.  Prior
to the Effective Date, Genzyme will provide to BioMarin a written initial
forecast of sales and estimates of forthcoming orders of Aldurazyme from
BioMarin that will cover the fifteen (15) month period commencing on the
Effective Date.  On the Effective Date,
BioMarin will deliver sufficient vials of Aldurazyme to Genzyme such that
Genzyme will hold at least [**] of filled Aldurazyme.  Thereafter, BioMarin will promptly deliver
all additional quantities of filled Aldurazyme as soon as each Lot is available
for delivery in accordance with the delivery schedule specified in the initial
forecast through September 30, 2008.

 

3.2.2                     Rolling
Forecasts.  Beginning on March 17,
2008, Genzyme will provide to BioMarin a rolling written
fifteen (15) month forecast of sales and estimates of forthcoming
orders of Aldurazyme from BioMarin that will cover the period commencing at the
beginning of the third (3rd) following calendar quarter.  For example, assuming that this Agreement is
effective as of January 1, 2008, the forecast delivered by March 17,
2008 would cover the period of October 1, 2008 through December 31,
2009.  Genzyme shall update such rolling
fifteen-month forecast every calendar quarter (such that each forecast shall
cover fifteen (15) months on a rolling basis), and such updates shall be
provided not later than fifteen (15) days prior to the commencement
of each quarterly period during the term hereof.  The first three (3) months of each
such forecast (i.e. October 1, 2008 through December 31, 2008 in the above
example) shall constitute a binding commitment to order the quantity of
Aldurazyme forecast for such period (the “Firm Period”).  Projections for months four (4) through
fifteen (15) (i.e., January 1, 2009 through December 31, 2009 in
the above example) shall constitute Genzyme’s reasonable best estimates of
future orders, but shall not be binding on Genzyme.  To the extent that any new quarterly forecast
calls for BioMarin to provide vials of Aldurazyme in quantities that exceed the
average quarterly volume sold by Genzyme for the previous [**] period by more
than [**], BioMarin shall not be required to provide such increased quantity of
Aldurazyme without its consent; provided, however, that BioMarin
will use its commercially reasonable and diligent efforts to supply the entire
quantity of Aldurazyme ordered by Genzyme during such period.  Additionally, BioMarin shall not be obligated
to supply vials of Aldurazyme in quantities that exceed [**] of Genzyme’s
estimate for vials of Aldurazyme for the relevant twelve-month non-binding
period (based on the lowest non-binding forecast for each respective calendar
quarter); provided, however, that BioMarin will use its
commercially reasonable and diligent efforts to supply the entire quantity of
Aldurazyme ordered 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.

 

9

 

during such period, provided further, that BioMarin
shall be under no obligation to alter its scheduled manufacturing of other
products.

 

3.3                               Orders.  Genzyme shall submit to BioMarin an Order
with each rolling fifteen-month forecast covering the Firm Period reflected in
each such forecast.  Each Order shall
specify the quantity ordered, the required delivery date (provided that
such delivery date is not earlier than [**] after the date of such Order), and
any special instructions or invoicing information.  For example, the forecast delivered by March 17,
2008 shall state a required delivery date no earlier than [**], 2008 for the
Order covering the Firm Period (i.e., the quarterly period running from October 1,
2008 through December 31, 2008) reflected in such forecast.  With respect to the quantity ordered, Genzyme
shall indicate in the Order the number of vials of Aldurazyme (specifying the
number of vials of Aldurazyme meeting each different Specification) to be used
for each of the following categories, based on Genzyme’s good faith estimates
at such time: (a) commercial sales, (b) compassionate use or expanded
access programs, (c) Post-Marketing Studies (other than Post-Marketing
Studies conducted under the Amended & Restated Collaboration
Agreement), and (d) acceptance and in-country testing, final Lot release
and regulatory requirements.  Each Order
issued shall be governed by the terms of this Agreement.  BioMarin shall accept and fill all properly
placed Orders that are consistent with the rolling forecasts and the
limitations set forth in Section 3.2.  BioMarin shall notify Genzyme (i) within
[**] business days of the date of the Order with respect to all Orders that
conform to this Agreement of its acceptance of such Order and (ii) within
[**] business days of the date of the Order with respect to all Orders that
BioMarin questions, in good faith, the consistency of such Order with the
rolling forecasts or the limitations set forth in Section 3.2,
whether or not it is accepting such Order. 
Any terms or conditions of any such Order that conflict or are
inconsistent with the terms of the Agreement are hereby rejected.  Genzyme agrees to use its commercially
reasonable and diligent efforts to manage the purchase and delivery cycle so
that Genzyme or its Affiliates is at all times after October 1, 2008
holding at least [**] of filled inventory of Aldurazyme, with the exact amount
being held in inventory to be determined based on anticipated demand as
determined by Genzyme in good faith.

 

3.4                               Safety
Stock.  Except as provided below,
BioMarin agrees to use its commercially reasonable and diligent efforts to hold
at least [**] inventory of Aldurazyme at all times after October 1, 2008,
with the exact amount being held in inventory to be determined based on anticipated
demand as reflected in Genzyme’s rolling forecasts.  In addition, in the event that there is a
proposed change in the facilities used to manufacture Aldurazyme pursuant to Section 3.10 below or a proposed modification of the
Specifications or the processes used to manufacture Aldurazyme pursuant to Section 3.11, BioMarin shall (i) hold ready for
immediate transfer to Genzyme sufficient additional inventory of filled
Aldurazyme (“Change Control Safety Stock”) to
reasonably ensure uninterrupted supply of such Aldurazyme in each country in
the Territory in which Aldurazyme is distributed, marketed and sold until the
necessary Regulatory Approvals for such change or modification are obtained in
such country; and (ii) ensure that all such Change Control Safety Stock
shall at all times be manufactured and produced using the facilities,
Specifications or processes approved by

 

[**] = 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

 

the appropriate government or regulatory authorities
in each country in the Territory as appropriate to enable sale of such Change
Control Safety Stock in such country until the necessary Regulatory Approvals
for such change or modification are obtained in such country.

 

3.5                               Shipping
of Aldurazyme.  BioMarin will deliver
Aldurazyme sold to Genzyme [**] by such means of transportation as shall be
reasonably determined by BioMarin from time to time.  BioMarin shall use its commercially
reasonable and diligent efforts to ship Aldurazyme so that it will arrive at
Genzyme’s facility on or within [**] business days of the date specified in the
relevant Order.  To the extent BioMarin
incurs any shipping charges, premiums for freight insurance, customs duties or
other import or export fees, or other transportation costs in connection with
shipments of Aldurazyme to Genzyme, BioMarin will be solely responsible for
such amounts.  Included with each
shipment or provided separately but concurrently with such shipment shall be
the Certificate of Analysis for the drug product, Certificate(s) of
Analysis for each Lot of drug substance or intermediate that went into the drug
product, and a certificate of cGMP compliance in a form reasonably agreed to by
BioMarin and Genzyme.  All other
obligations of BioMarin relating to the documents to be provided in connection
with each shipment of Aldurazyme shall be governed by the Technical Agreement.

 

3.6                               Compliance
with Laws.  BioMarin shall comply
with all applicable laws, rules and regulations applicable to the
manufacture, storage, handling and shipment of Aldurazyme.

 

3.7                               Direct
Shipment to Customers.  BioMarin
shall not be required to ship Aldurazyme directly to a customer of Genzyme
unless Genzyme first seeks and obtains BioMarin’s prior written approval for
such a shipment.  BioMarin shall not ship
Aldurazyme to any Third Party (other than bulk material to vendors for the sole
purpose of filling Aldurazyme on behalf of BioMarin), without Genzyme’s prior
written authorization.

 

3.8                               Risk
of Loss.  [**].

 

3.9                               Testing;
Rejection.

 

(a)                                  [**]

 

(b)                                  [**]

 

(c)                                  [**]

 

(d)                                  [**]

 

(e)                                  [**]

 

(f)                                    [**]

 

(g)                                 Genzyme
shall not be obligated under any circumstances to accept delivery of any Lot of
Aldurazyme unless it meets the Specifications and Regulatory

 

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

 

11

 

Approvals for the relevant country in the Territory
(as determined through the mechanism set forth in this Section 3.9)
and the applicable warranties set forth herein. 
Genzyme shall be entitled to return to BioMarin any Aldurazyme which the
Parties reasonably agree cannot or should not be sold due to a change in the
Specifications or Regulatory Approvals, and BioMarin shall promptly replace, at
no additional expense to Genzyme, such Aldurazyme with new Aldurazyme that does
conform with the approved Specifications and Regulatory Approvals for the
relevant country in the Territory.

 

3.10                        Suppliers.  Without limiting BioMarin’s responsibility
under this Agreement, BioMarin shall have the right at any time to satisfy its
supply obligations to Genzyme hereunder, either in whole or in part, through
arrangements with Third Parties engaged to perform services or supply
facilities or goods in connection with the manufacture, testing, and/or
packaging of Aldurazyme.  BioMarin shall
ensure that all such facilities comply with applicable regulations and will
give Genzyme written notice at least [**] days in advance of any such
arrangement to determine whether such arrangement would require changes to a
Marketing Application Approval application filed in any country and, if so, whether
prior approval of any such changes is required by the regulatory authority in
such country.  To the extent that a
change is required, after receipt of all necessary data from BioMarin, Genzyme
shall, at BioMarin’s expense, use its commercially reasonable and diligent
efforts to prepare and make such filings and, if required, seek approval for
such change in such countries that Genzyme has responsibility for pursuant to Section 5.1.2(a); and BioMarin shall, at its own
expense, use its commercially reasonable and diligent efforts to make such
filings and, if required, seek approval for such change in the United
States.  BioMarin shall be required to
continue to supply drug product using materials or testing from previously
approved suppliers for each country in the Territory until such Regulatory
Approvals are received in such country and to clearly mark which Lots use the
new suppliers or testing laboratories at the time of shipment.

 

3.11                        Changes to
Aldurazyme.

 

(a)               BioMarin may, at
its election and in its sole discretion, modify the Specifications of or
processes used to manufacture Aldurazyme at any time, subject to (i) BioMarin
generating such data, including without limitation development, comparability,
stability and validation data, as may be necessary to obtain Regulatory
Approvals for such changes and (ii) such Regulatory Approvals being
obtained; provided, however, that to the extent that any such
modification would require clinical trials with MPS-I patients in order to
obtain the necessary Regulatory Approvals for such modification, BioMarin may
not implement such modification without the prior written consent of Genzyme,
which consent shall not be unreasonably withheld, delayed or conditioned.  BioMarin will give Genzyme written notice of
any such change at least [**] days prior to its implementation, together with a
proposed amendment to Exhibit A
reflecting and identifying such change.  Exhibit A shall not be amended to reflect any such
change unless and until any necessary amendments to any Marketing Applications

 

[**] = 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

 

and Regulatory Approvals to implement such changes are
approved by the appropriate regulatory authorities.

 

(b)              [**]

 

(c)               Additionally,
Genzyme may be required, as a result of negotiations with or directions from a
regulatory authority of a country in the Territory, to propose changes in the
Specifications as a condition to marketing or continuing to market Aldurazyme
in that country.  BioMarin shall use its
commercially reasonable and diligent efforts to accommodate such changes to the
Specifications for such country; provided that BioMarin may decide not
accommodate any such change to the extent that it would require a change to the
manufacturing process, if (i) historical data does not support such
proposed Specification changes, (ii) such change would increase BioMarin’s
cost of goods sold, or (iii) such change would jeopardize BioMarin’s
ability to manufacture Aldurazyme for global demand.  BioMarin recognizes that any such failure to
accommodate any changes required by a regulatory authority in the Territory (or
any delay in accommodating any such changes) may result in the prevention or
suspension of distribution and sales of Aldurazyme in that country.

 

(d)              Subject to Sections 3.2 and 3.3, BioMarin shall continue to supply
Genzyme with Aldurazyme for each country in the Territory conforming to the
then-approved Specifications or manufacturing process for such country as
requested by Genzyme until such time as any change in the Specifications or
manufacturing process, as applicable, is approved by the relevant regulatory
authority(ies) for such country.

 

3.12                        Responsibility
for Costs.  BioMarin shall be solely
responsible for all costs resulting from decisions made by BioMarin pursuant to
Sections 3.10 and 3.11 above, including
without limitation, Genzyme’s fully burdened costs incurred in accordance with
such Sections (including Genzyme’s FTE
costs, filing fees, translation costs, and the costs of any changes to Labeling
Materials resulting from decisions or changes made pursuant to such Sections) unless the
change is related to (a) updating filings for raw materials, reagents,
replacements for obsolete equipment or other material used in the manufacture
or testing of Aldurazyme that are no longer available on commercially
reasonable terms or (b) updating filings related to material used in the
manufacture, release or testing of Aldurazyme based on the process and
procedures included with then current Regulatory Approvals (such as validation
of quantities of reference material), in which cases Genzyme shall make such
filings and secure such Regulatory Approvals outside of the United States at
Genzyme’s sole expense and BioMarin shall make such filings and secure such
Regulatory Approvals in the United States at BioMarin’s sole expense.  Genzyme shall provide BioMarin with
quarterly, reasonably detailed invoices for all such costs, and BioMarin shall
reimburse Genzyme for such costs within forty-five (45) days after receipt
thereof.  Notwithstanding any of the
above, (i) any changes resulting from the request or direction of the FDA,
EMEA or any other regulatory authority other than as a direct result of a
change proposed or implemented by BioMarin pursuant to Section 3.10
or 3.11, (ii) those changes set forth on Schedule
3.12 and (iii) 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.

 

13

 

validation of a Third Party [**] pursuant to Section 3.8 of the Fill Agreement shall not be deemed
to be decisions made by BioMarin pursuant to Section 3.10
and 3.11 above and Genzyme shall bear all costs and expenses related
to making all filings and seeking approval for such changes in all countries
outside of the United States while BioMarin shall bear all costs and expenses
related to making all filings and seeking approval for such changes in the
United States; provided, however, that with respect to the
changes set forth in Schedule 3.12, priority
shall be given to those changes that fall into the categories described in clauses (a), (b) and (i) above; provided  further
that Genzyme’s responsibility under this Section 3.12 with
respect to the cost of making regulatory filings and securing Regulatory
Approvals outside of the United States (A) for the changes set forth in Schedule 3.12 shall end upon the earlier of (x) completion
of such regulatory activities or (y) such time as the costs incurred with
respect to such regulatory activities equal [**] and (B) related to the
validation of a Third Party pursuant to clause (iii) above
shall be for the first [**] of such costs (thereafter, BioMarin shall be
responsible for the next [**], of such costs and BioMarin and Genzyme shall
share equally any such costs in excess of [**] (with BioMarin reimbursing
Genzyme for BioMarin’s portion of all such costs within forty-five (45) days
after receipt of reasonably detailed invoices therefor)).

 

3.13                        Failure to
Supply.

 

(a)               In the event
that technical, regulatory or other reasons or events beyond BioMarin’s
reasonable control prevent BioMarin from producing Aldurazyme, BioMarin will
use its commercially reasonable and diligent efforts to secure a Third Party
contract manufacturer in a timely manner. 
All such contract manufacturing activities will be at BioMarin’s sole
cost and expense and BioMarin shall have full authority to direct and control
the contract manufacturer and Genzyme, except as provided below, shall continue
to purchase Aldurazyme from BioMarin. 
Notwithstanding the foregoing, during the technology transfer to and
validation of any Third Party contract manufacturer, Genzyme may, at its
election and expense, have technical representatives present for such activities
and BioMarin will consider, but will have no obligation to implement, any
suggestions or recommendations made by such representatives.

 

(b)               In the event
that BioMarin is unable to secure a Third Party contract manufacturer within
[**] days, then BioMarin shall offer Genzyme the opportunity to produce
Aldurazyme.  If Genzyme agrees to produce
Aldurazyme, then BioMarin and Genzyme shall promptly negotiate in good faith
commercially reasonable and diligent terms and conditions for such arrangement;
provided, however, BioMarin and Genzyme shall negotiate in good
faith for payment amounts and structures to compensate Genzyme for its out of
pocket and internal expenses incurred in the technology transfer and regulatory
process, cost of involvement to allow it to manufacture Aldurazyme and variable
costs associated with the actual production of Aldurazyme.  If BioMarin and Genzyme enter into such
arrangement, then BioMarin will promptly initiate a technology transfer process
during which BioMarin and its

 

[**] = 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

 

subcontractors, as appropriate, will provide Genzyme
or its designee with all know-how, data and information necessary or desirable
to enable Genzyme to manufacture or have manufactured Aldurazyme for the
Territory.  Additionally, BioMarin will
make such employees involved in the development, manufacture and release of
Aldurazyme available to ensure a complete technology transfer is achieved in a
timely fashion.

 

(c)               In the event
that BioMarin and Genzyme enter into an arrangement pursuant to clause (b) above and BioMarin is subsequently able to
resume production of Aldurazyme, BioMarin may elect, upon [**] days prior
written notice to Genzyme to reacquire such production responsibilities from
Genzyme.  If BioMarin elects to reacquire
production responsibilities from Genzyme, then BioMarin will promptly reimburse
Genzyme the total amount of costs incurred by Genzyme (including, without
limitation any and all capital expenditures) in connection with the technology
transfer process described in clause (b) above,
building or acquiring capacity and resources to manufacture Aldurazyme, filing
for and obtaining all necessary Regulatory Approvals to produce Aldurazyme, and
transferring such manufacturing responsibility back to BioMarin.  Such amounts to be reimbursed by BioMarin to
Genzyme pursuant to the previous sentence shall be offset by the amount such
costs have already been recovered by Genzyme pursuant to payments made by
BioMarin pursuant to clause (b) above.  BioMarin shall reimburse Genzyme for such
amounts within forty-five (45) days after receipt of reasonably detailed
invoices therefor.  Upon BioMarin
resuming production responsibilities from Genzyme with respect to Aldurazyme,
the royalty payable by Genzyme to BioMarin shall be increased to those levels
set forth in Section 6.1 for Aldurazyme
produced by BioMarin.

 

(d)               BioMarin will
use its commercially reasonable and diligent efforts to continue to produce
Aldurazyme for supply to such countries in the Territory where Aldurazyme is
used or sold until such time as this Third Party manufacturer or Genzyme, as
the case may be, has been approved in all countries in the Territory.  If BioMarin is not able to do so, then
Genzyme will not be held in breach of any of its obligations due to an
inability to supply Patients and commercialize Aldurazyme in such country
resulting from BioMarin’s failure to supply product that meets the regulatory
requirements in such country.

 

3.14                        Certificates
of Analysis.  BioMarin shall perform,
or cause its contract manufacturer(s) to perform, quality assurance,
control tests, and release on each Lot of Aldurazyme, to the extent specified
in and in compliance with the Technical Agreement, before delivery and shall
prepare, or cause its contract manufacturer(s) to prepare and deliver, a
written report of the results of such tests (for purposes of Sections 3.14 through 3.17 (inclusive), such contract
manufacturer(s) shall be included in the definition of the term “BioMarin”).  Each test report shall set forth for each Lot
delivered the items tested, specifications and results in a Certificate of Analysis
containing the types of information typical for such reports or required by the
FDA or other applicable regulatory authority. 
BioMarin shall maintain such certificates for a period of not less

 

[**] = 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

 

than five (5) years from the date of manufacture
or for such longer period as required under applicable requirements of the FDA
or other applicable regulatory authority.

 

3.15                        Certificates
of Manufacturing Compliance. 
BioMarin shall prepare, or cause to be prepared and delivered, and
maintain for a period of not less than five (5) years or for such longer
period as required under applicable requirements of the FDA or other applicable
regulatory authority for each Lot of Aldurazyme manufactured a certificate of
manufacturing compliance containing the types of information typical for such
reports or required by the FDA or other applicable regulatory authority, which
certificate will certify that the Lot of Aldurazyme was manufactured in
accordance with the Specifications and the cGMP Regulations as the same may be
amended from time to time.

 

3.16                        Regulatory
Inspections; Reports.  BioMarin shall
advise Genzyme immediately if an authorized agent of the FDA or other
regulatory authority visits any of manufacturing facilities used to produce
Aldurazyme, for an inspection with respect to the Aldurazyme, and of any
written or oral inquiries by any such authority about such facilities or the
procedures for the manufacture, storage or handling of Aldurazyme or the
packaging, labeling, marketing, distribution, promotion, commercialization for
sale and sale of Aldurazyme.  BioMarin
shall furnish to Genzyme the report and any and all correspondence issued by or
provided to such agency in connection with such visit or inquiry, to the extent
that such report or correspondence relates to Aldurazyme, within ten (10) business
days after BioMarin’s receipt of such report or correspondence, as the case may
be, and Genzyme shall have the right to comment on any response by BioMarin to
such inspecting agency.  Notwithstanding
the prior sentence, BioMarin shall be under no obligation to accept any
comments provided by Genzyme on any response by BioMarin to such inspecting
agency and all submissions to such agency by BioMarin shall be at its sole and
absolute discretion.

 

3.17                        Access to
BioMarin Facilities.  Genzyme shall
have the right to audit once annually each of those portions of the
manufacturing, finish processing or storage facilities where Aldurazyme is
being manufactured, finished or stored, or any subcontractor who is
manufacturing, finishing or storing Aldurazyme for BioMarin, at any time during
regular business hours and upon reasonable advance notice to ascertain
compliance with the cGMP Regulations, as the same may be amended from time to
time.  Subject to the terms and
conditions of Section 8.1 below,
confidential information disclosed to or otherwise gathered by Genzyme during
any such audit or provided by BioMarin shall be maintained as confidential.

 

3.18                        Technical
Agreement.  Within ninety (90) days
after the Effective Date, the Parties shall execute and deliver a new Technical
Agreement containing customary provisions consistent with the allocation of
responsibilities set forth in this Agreement. 
Until a new agreement is executed and delivered, the Parties shall
operate under the existing Technical Agreement.

 

3.19                        Hollister-Stier Agreement.  BioMarin shall have sole responsibility for
managing the relationship with Hollister-Stier Laboratories, LLC pursuant to
the Supply 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.

 

16

 

by and between Hollister-Stier Laboratories, LLC and
BioMarin/Genzyme LLC dated as of November 6, 2006, as it may be amended
from time to time (as amended, the “Hollister-Stier Agreement”)
and shall be solely responsible for all amounts payable to Hollister-Stier and
liabilities arising under such Agreement. 
As soon as practicable after the Effective Date, BioMarin shall use its
commercially reasonable and diligent efforts to cause the Hollister-Stier
Agreement to be assigned from BioMarin/Genzyme LLC to BioMarin.

 

4.                                      MARKETING AND SALES

 

4.1                               Exclusive
Right to Market, Sell and Distribute. 
Subject to the terms and conditions of this Article 4, Genzyme
shall have the exclusive right to distribute, market and sell Aldurazyme
throughout the world, including without limitation all pricing and
reimbursement activities.  Genzyme agrees
(by itself or through its Affiliates or Third Parties selected by Genzyme at
its election and in its sole discretion) to use its commercially reasonable and
diligent efforts to establish Aldurazyme in the markets, fulfill market demand
and meet the marketing and distribution goals for Aldurazyme determined by
Genzyme in its good faith, subject to the receipt of necessary Regulatory
Approvals and subject to BioMarin’s performance of its obligations under Article 3.

 

4.2                               Compliance
With Laws.  Genzyme shall comply with
applicable laws, rules and regulations in each country in which Aldurazyme
is licensed, marketed or sold relating to the marketing, sale and distribution
of Aldurazyme.  Without limiting the
foregoing, Genzyme shall comply with all U.S. federal and state laws pertaining
to price reporting and, except to the extent such compliance is BioMarin’s
responsibility as the holder of the BLA and subject to BioMarin’s compliance
with its obligations under Section 5.1.2,
marketing disclosure.

 

4.3                               Marketing
and Distribution Expenses.

 

4.3.1                     Genzyme
shall be solely responsible for payment of all Marketing Costs.

 

4.3.2                     Beginning
on January 1, 2008 and continuing so long as this Agreement remains in
force, Genzyme agrees to [**].

 

4.3.3                     Genzyme
shall keep complete and accurate books and records of all Marketing Costs
relating to Aldurazyme.  BioMarin shall
have the right, at BioMarin’s expense, through a certified independent public
accountant, to have reasonable access upon reasonable advance notice and during
normal business hours to such books and records for the purpose of verifying
the accuracy of such Marketing Costs; provided, however, that
BioMarin shall not have the right to perform any audit work pursuant to this Section 4.3.3 unless and until [**].  BioMarin and Genzyme shall agree in good
faith upon reasonable procedures before BioMarin’s auditors begin the audit
work pursuant to this Section 4.3.3.  The report issued by such auditor shall be
final, binding and conclusive upon each of BioMarin and Genzyme.  Such verifications may be conducted not more
than once in each 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.

 

17

 

The books and records for any particular calendar
quarter may not be examined under this Section 4.4.3
more than once.

 

4.3.4                     BioMarin
agrees that all information subject to review under this Section 4.3
(other than information directly related to Aldurazyme) is Genzyme’s
confidential information and that it shall cause its accounting firm to retain
all such information in confidence (even as to BioMarin) subject to the
confidentiality restrictions of Article 8 hereof.  Notwithstanding the prior sentence, Genzyme
acknowledges and agrees that such accounting firm’s obligation to retain all
such information in confidence from BioMarin shall not apply in the event that
BioMarin and Genzyme are involved in a dispute under Section 13.8
related to this Section 4.3 and such
information is necessary for BioMarin’s use in connection with such dispute; provided,
however, that BioMarin shall only use such information in connection
with such dispute and such information shall remain subject to the
confidentiality restrictions of Article 8.

 

4.4                               Medical
Information.  Genzyme shall have sole
responsibility for responding to all requests for medical information regarding
Aldurazyme.  If BioMarin receives any
such requests, it shall promptly direct such requests to Genzyme.  Notwithstanding the foregoing, BioMarin may
maintain a website or other informational resources where it may publish
general medical information relating to MPS I, so long as such website complies
in all respects with applicable laws, rules and regulations.  This Section 4.4
shall not prohibit BioMarin from publishing non-medical information
in its investor relations communications, including on BioMarin’s website, provided
that such publication is consistent with the terms and conditions of Article 8.

 

4.5                               Pharmacovigilance.

 

4.5.1                     Genzyme
and its Affiliates will be responsible for continuing all pharmacovigilance
activities with respect to Aldurazyme, including without limitation maintaining
Aldurazyme Core Safety Information. 
BioMarin shall have the right to audit, at any time during regular
business hours and upon reasonable advance notice to audit such
pharmacovigiliance activities with respect to Aldurazyme.  Such audit rights shall include the right to
review, inspect and/or audit any systems or processes involved or utilized in
such pharmacovigilance activities as well as the right to review, inspect or
audit all information or data necessary to be filed with any regulatory or
governmental authority.

 

4.5.2                     In the
event that the Aldurazyme Labeling Materials must be updated per new Core
Safety Information, after receipt of all necessary information and data from
Genzyme, BioMarin agrees to use its commercially reasonable and diligent
efforts make all necessary regulatory filings to FDA and obtain approvals in
order to ensure the content of Aldurazyme Labeling Materials in the United
States is in-line with the Core Safety Information.  Genzyme shall be responsible for using its
commercially reasonable and diligent efforts 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.

 

18

 

make such filings and obtain such approvals outside of
the United States.  Each of BioMarin and
Genzyme shall be given the opportunity to attend and participate in any
meetings or discussions that the other Party may have with any regulatory authorities
regarding any submissions or approvals and shall be provided with an
opportunity to review and comment upon any correspondence, submission or
communication that the other Party may have with any such regulatory authority
prior to such correspondence, submission or communication being made or
submitted to such regulatory authority.

 

4.5.3                     As of the
Effective Date and throughout the term of this Agreement, Genzyme shall
maintain one or more written SOP(s) to collect Adverse Experience
information.  The content of any SOP(s) shall
include, but not be limited to, specific instructions regarding the type of
Adverse Experience information collected, the time frame for collection,
provisions for secure transmissions, and inter-company processes to be used for
notification of said information.  In
addition to the foregoing, the Parties shall update the current guidelines and
procedures to govern receipt, processing, assessment and submission of
Aldurazyme Adverse Experience and Serious Adverse Experience reports to the
FDA, the European Commission and other regulatory authorities within sixty (60)
days after the Effective Date. 
Procedures described therein shall ensure compliance with all applicable
laws and regulations.  The Parties
acknowledge that Genzyme’s SOPs as they exist as of the Effective Date satisfy
the requirements of this Section 5.2.1 for
reports to the FDA.

 

4.5.4                     BioMarin
shall have responsibility for filing all 15-day alert reports, 15-day alert
follow-up reports and periodic adverse event reports to the FDA per 21 CFR
§600.80.  Genzyme or its designee shall
have responsibility for filing such reports outside of United States, including
EMEA and other regulatory authorities according to the local regulations.

 

4.6                               Complaints.  Within sixty (60) days after the Effective
Date, Genzyme and BioMarin shall develop a written protocol for exchanging
information on product complaints concerning Aldurazyme of which either Party
becomes aware, so as to allow each of Genzyme and BioMarin to comply with its
regulatory obligations.  At a minimum,
such protocol shall provide that the Party receiving such complaint or
information shall promptly, but in any event not later than twenty-four (24)
hours after receipt, advise the other Party (excluding, for purposes of this
Section, BioMarin/Genzyme LLC) in writing of the details of such complaint or
information, after learning of such information.  Promptly thereafter, Genzyme shall report
such incident to the appropriate regulatory authorities in the countries in
which Aldurazyme is being commercialized, in accordance with the appropriate
laws and regulations of the relevant countries and authorities; provided,
however, that with respect to reports that are to be made with the FDA,
BioMarin shall make such report using the information prepared by Genzyme.  Such reporting activities shall be
coordinated between Genzyme and BioMarin where time and law permit.  The Party initially receiving the complaint
or information shall provide the other Party with all follow-up information
related to such incident generated

 

[**] = 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 the receiving Party or required by the other Party
to satisfy its regulatory filing obligations.

 

4.7                               Registries;
Post-Marketing Studies.

 

4.7.1                     Registries.  Genzyme shall have the responsibility for
conducting the MPS-I registry program as it exists on the Effective Date at
Genzyme’s sole expense.  In the event
that the scope of the registry program is expanded to implement any
Post-Marketing Studies required by regulatory authorities to be conducted
through or as part of the registry program, such costs above the general cost
of maintaining the registry program as currently conducted will be funded by
BioMarin/Genzyme LLC pursuant to the terms of the Amended and Restated
Collaboration Agreement.

 

4.7.2                     Post-Marketing
Studies.  With respect to any Post
Marketing Studies required by a jurisdiction where Aldurazyme does not have
Regulatory Approval as of the Effective Date, Genzyme shall, at its sole
expense and in its sole discretion, have the responsibility for conducting any such
Post-Marketing Studies that are not funded by BioMarin/Genzyme LLC pursuant to
the terms of the Amended and Restated Collaboration Agreement.

 

4.8                               Use
of Trademarks.  Aldurazyme shall be
sold under trademarks determined by Genzyme and owned by or licensed to Genzyme
or BioMarin/Genzyme LLC.

 

4.9                               Records.  Genzyme shall maintain complete and accurate
records of all movements and transactions involving Aldurazyme by an
appropriate identifier and by customer so that all such movements and
transactions can be traced quickly and effectively.  Genzyme shall maintain such records for a
minimum period of five (5) years after the relevant movement or
transaction contained in such record. 
The records maintained by Genzyme pursuant to this Section 4.9 shall be Genzyme’s
confidential information under Article 8
and subject to BioMarin’s audit rights under Section 6.5.

 

4.10                        Regulatory
Inspections; Reports.  Genzyme shall
advise BioMarin immediately of any visit by an authorized agent of a regulatory
authority to, or written or oral inquiries by any such authority about, any
Genzyme facilities (or facilities of any subcontractors engaged by Genzyme)
used to package, label or store Aldurazyme or procedures for the filling,
manufacture, storage, or handling of Aldurazyme, or the packaging, labeling,
marketing, distribution, promotion, commercialization for sale and sale of
Aldurazyme.  Genzyme shall furnish to
BioMarin the report and any and all correspondence issued by or provided to
such authority in connection with such visit or inquiry to the extent such
report or correspondence relates to Aldurazyme, within ten (10) business
days after Genzyme’s receipt of such report or correspondence, as the case may
be, and BioMarin shall have the right to comment on any response by Genzyme to
such inspecting agency.  Notwithstanding
the prior sentence, Genzyme shall be under no obligation to accept any comments
provided by BioMarin on any response by Genzyme to such inspecting agency and
all submissions to such agency by Genzyme shall be at its sole and absolute
discretion.

 

[**] = 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

 

4.11        Access to Genzyme
Facilities.  BioMarin shall have the
right to audit once annually each of those portions of the distribution or
storage facilities of Genzyme or its Affiliates where Aldurazyme is being
stored, sold or distributed, or any subcontractor or other Third Party who is
storing, selling or distributing Aldurazyme for Genzyme, at any time during
regular business hours and upon reasonable advance notice to ascertain
compliance with cGMP Regulations, as the same may be amended from time to time.  Such audit rights shall include the right to
review, inspect and/or audit any systems or processes involved or utilized in
the storage, selling or distribution of Aldurazyme as well as the right to
review, inspect or audit all information or data necessary to be filed with any
regulatory authority (including the FDA) or related to the BLA.  Genzyme shall furnish to BioMarin any report
or correspondence issued by or provided to any governmental authority in
connection with any governmental visit or inquiry regarding the facilities at
which Genzyme, its Affiliates or any Third Party stores, sells or distributes
Aldurazyme or the procedures related thereto. 
Subject to the terms and conditions of Section 8.1
below, confidential information disclosed to or otherwise gathered by BioMarin
during any such audit or provided by Genzyme shall be maintained as
confidential.

 

4.12        Third Party Licenses.  Genzyme hereby agrees to pay any and all
royalties, sublicense fees and other costs owed by BioMarin/Genzyme LLC with
respect to the manufacture or sale of Aldurazyme to any Third Party pursuant to
the terms and conditions of the Third Party Licenses.  Genzyme further agrees to fulfill any and all
of the reporting obligations BioMarin/Genzyme LLC may have to any Third Party
related to Aldurazyme by virtue of the Third Party Licenses.

 

4.13        Suspension of Distribution.  Each Party shall notify the other promptly if
it becomes aware of a problem with the quality of Aldurazyme distributed in the
Territory, or a directive from the FDA, the EMEA or any other applicable
regulatory authority related to Aldurazyme distributed in the Territory.  Upon receipt of any such notice from
BioMarin, Genzyme may suspend sales and distribution of Aldurazyme in the
Territory, at its reasonable discretion. 
After any such suspension, BioMarin and Genzyme shall consult in good
faith to determine whether and when to resume sales and distribution of
Aldurazyme; provided, however, that no such
suspension shall be deemed to be a default by Genzyme hereunder except to the
extent that Genzyme does not resume sales and distribution of Aldurazyme within
fifteen (15) business days after the Parties agree that such quality problem
has been resolved.

 

5.             REGULATORY MATTERS.

 

5.1          Marketing and Regulatory
Approvals.

 

5.1.1       Marketing Applications.  Genzyme shall be responsible, in its
sole discretion and at its sole expense, for filing Marketing Applications for
Aldurazyme in each country, other than as expressly provided in Sections 3.10, 3.11, 3.12 and 5.1.2, in which Aldurazyme is
licensed, marketed or sold, up to and including Marketing Application Approval,
and for thereafter maintaining such Marketing Application Approvals.  In connection with Genzyme’s filing 

 

[**] = 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

 

of Marketing Applications, BioMarin shall provide
Genzyme with a copy, in English, of all necessary supporting information and
data when required, to prepare appropriate regulatory submissions affecting
approval and maintenance of market or of product pricing.  Nothing in this Article 5
shall be deemed to require Genzyme to file Marketing Applications
and obtain Marketing Application Approvals in each country in the Territory;
Genzyme shall determine in good faith where and when to file and maintain such
applications and approvals in a manner consistent with its obligation to use
its commercially reasonable and diligent efforts to commercialize Aldurazyme.

 

5.1.2       Regulatory Approvals.

 

(a)        Genzyme shall be
responsible at its sole expense: (i) for the filing of all reports,
documents or other information regarding Aldurazyme required by the EMEA or any
other governmental agency or body outside of the United States having
jurisdiction related to Aldurazyme and for securing all necessary Regulatory
Approvals and for ensuring that Aldurazyme remains in good standing with all
such governmental agencies or bodies and all other applicable jurisdictions
(other than the United States) for as long as Genzyme determines to market and
sell Aldurazyme in such jurisdictions; and (ii) for obtaining and
maintaining all permits and licenses necessary to enable Genzyme to distribute
Aldurazyme under this Agreement.  Genzyme
agrees to provide BioMarin with copies of all filings, reports, documents or
other information provided by it to any regulatory authority outside of the
United States related to Aldurazyme within thirty (30) days of making such
filing with such regulatory authority.

 

(b)        BioMarin shall be
responsible at its sole expense:  (i) for
the filing of all reports, documents or other information regarding Aldurazyme
required by the FDA or any other governmental agency in the United States
having jurisdiction related to Aldurazyme and for securing all necessary
Regulatory Approvals and for ensuring that Aldurazyme remains in good standing
with the FDA and such other governmental agencies; and (ii) for obtaining
and maintaining all permits and licenses to enable BioMarin to produce
Aldurazyme for the global market under this Agreement.  BioMarin agrees to provide Genzyme with
copies of all filings, reports, documents or other information provided by it
to any regulatory authority in the United States related to Aldurazyme within
thirty (30) days of making such filing with such regulatory authority.

 

(c)        All regulatory filings
for Aldurazyme in the United States will be filed by and in the name of
BioMarin.  BioMarin agrees that:  (i) it shall hold the licenses issued in
respect of such Regulatory Approval filings, and maintain control over the
manufacturing facilities, equipment and personnel, to the extent required by
the Regulatory Scheme; (ii) it shall maintain compliance with the
applicable Regulatory Scheme; (iii) each of the Parties shall have an
irrevocable right of access and reference to such Regulatory Approval filings,
licenses and facilities in connection with its exercise of its rights and
performance of its obligations under this Agreement, the Amended and Restated
Collaboration Agreement and 

 

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

 

22

 

the Fill Agreement; and (iv) it shall comply with
the provisions of Article 12
hereof with respect to the ownership and/or disposition of such Regulatory
Approvals in the event this Agreement is terminated and that it will provide
the level of cooperation described in this Agreement in connection therewith.

 

(d)        All regulatory filings
for Aldurazyme outside of the United States will be filed by and in the name of
Genzyme or its designee.  Genzyme agrees
that:  (i) it shall hold the
licenses issued in respect of such Regulatory Approval filings, maintain
control over the distribution facilities, equipment and personnel, and engage
in pharmacovigilence to the extent required by the Regulatory Scheme; (ii) it
shall maintain compliance with the applicable Regulatory Scheme; (iii) each
of the Parties shall have an irrevocable right of access and reference to such
Regulatory Approval filings, licenses and facilities in connection with its
exercise of its rights and performance of its obligations under this Agreement,
the Amended and Restated Collaboration Agreement and the Fill Agreement; and (iv) it
shall comply with the provisions of Article 12
hereof with respect to the ownership and/or disposition of such Regulatory
Approvals in the event this Agreement is terminated and that it will provide
the level of cooperation described in this Agreement in connection therewith.

 

(e)        No Party may assign or
otherwise transfer a Regulatory Approval for Aldurazyme without the prior
written consent of the other Parties; provided, however, that
either BioMarin or Genzyme may, without such consent, assign such Regulatory
Approvals (i) in connection with a corporate reorganization, to any member
of an affiliated group, all or substantially all of the equity interest of
which is owned and controlled by such Party or its direct or indirect parent
corporation or (ii) in connection with a merger, consolidation or sale of
substantially all of such Party’s assets to an unrelated Third Party; provided,
however, that such Regulatory Approvals shall not be transferred
separate from this Agreement and the Related Agreements and all or
substantially all of such Party’s other business assets, including without
limitation those business assets that are the subject of this Agreement.  Any purported assignment in violation of this
Section 5.1.2(e) shall be
void.

 

5.2          Recalls.

 

5.2.1       BioMarin may, in its
sole discretion, determine whether or when to initiate any recalls of
Aldurazyme in the United States and Genzyme may, in its sole discretion,
determine whether or when to initiate any recalls of Aldurazyme anywhere else
in the world.  As of the Effective Date
and throughout the term of this Agreement, BioMarin and Genzyme shall prepare
and maintain a written SOP, to handle any recalls of Aldurazyme.  Such SOP shall include, without limitation,
prior notice to and consultation with the other Party of any recall; provided,
however, that in no event shall such consultation be deemed to limit or
supersede the Parties’ ability to make recall decisions in their sole
discretion pursuant to the first sentence hereof.  Genzyme
shall transmit recall decision information to BioMarin to Vice President,

 

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

 

23

 

Regulatory Affairs, by phone
at (415) 506-6708 or facsimile at (415) 506-6306.  BioMarin shall transmit recall decision
information to Genzyme to Regulatory Affairs/QA, attention: Vice President,
Regulatory Affairs and Corporate Quality Compliance, by phone at (508) 661-6172
or facsimile at (508) 661-8851.  In
the event that (i) any regulatory authority or other governmental agency
or authority issues a request or directive or orders that Aldurazyme be
recalled or retrieved, (ii) a court of competent jurisdiction orders that
Aldurazyme be recalled or retrieved or (iii) a Party determines that
Aldurazyme should be recalled, retrieved or a “Dear Doctor” letter is required
relating to restrictions on use of Aldurazyme in a country for which it is
responsible, the Party responsible for the relevant country pursuant to the
first sentence hereof shall conduct such activity and the Parties shall take
all appropriate corrective actions and shall execute the steps detailed in the
SOP.  To the extent practicable, the
Parties shall coordinate the notices of any such recall to be delivered to
regulatory authorities (including the timing thereof).  Genzyme and BioMarin shall cooperate fully
with one another in conducting such action. 
Genzyme shall destroy units of Aldurazyme lawfully recalled only upon
BioMarin’s (or any regulatory authority’s) written instruction to destroy such
units of Aldurazyme, and only then in accordance with BioMarin’s procedures and
instructions.  Otherwise, Genzyme may
return the recalled units of Aldurazyme to BioMarin in accordance with BioMarin’s
instructions within thirty (30) days after completion of the action.  In the event that either BioMarin or Genzyme
becomes aware of circumstances that may necessitate a recall of Aldurazyme in
any country for which it is not responsible pursuant to this Section 5.2, it will promptly notify the other Party of
such circumstances.

 

5.2.2       In the event a recall
results from the manufacture of Aldurazyme (including without limitation
changes made pursuant Sections 3.11 and 3.12
hereof) or BioMarin’s negligence or willful misconduct, BioMarin shall be
responsible for the expenses thereof.  In
the event a recall results from Genzyme’s filling, packaging, labeling or
storage of Aldurazyme, or Genzyme’s negligence or willful misconduct (including
without limitation any negligence or willful misconduct resulting in
adulteration of Aldurazyme), Genzyme shall be responsible for the expenses
thereof.  Otherwise, the Parties shall
share equally the expenses of the action. 
For purposes of this Agreement, the expenses of the action shall be the
expenses of notification and return or destruction (if such destruction is
authorized by BioMarin or the applicable regulatory authority) of units of the
recalled Aldurazyme, the cost of replacement of the recalled Aldurazyme, and
any costs directly associated with the distribution of replacement
Aldurazyme.  For the avoidance of doubt,
amounts payable under Article 6
hereof shall only be payable on Aldurazyme used to replace the recalled
Aldurazyme (not on the returned Aldurazyme itself).

 

[**] = 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

 

6.             PAYMENTS.

 

6.1          Transfer Royalties.

 

(a)           For the Aldurazyme
supplied by BioMarin to Genzyme pursuant to Article 3,
Genzyme shall pay to BioMarin the following royalties based upon the Annual Net
Sales of Aldurazyme:

 

	
  Annual
  Net Sales

  	
   

  	
  Royalty Payment %

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  of between $0 and
  $130,000,000

  	
   

  	
  39.5

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  of between $130,000,001
  and $140,000,000

  	
   

  	
  40

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  of between $140,000,001
  and $155,000,000

  	
   

  	
  42

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  of between $155,000,001
  and $170,000,000

  	
   

  	
  44

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  of between $170,000,001
  and $185,000,000

  	
   

  	
  46

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  of between $185,000,001
  and $200,000,000

  	
   

  	
  48

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  of $200,000,001 and
  above

  	
   

  	
  50

  	
  %

  

 

As used herein, “Annual
Net Sales” shall mean total aggregate Net Sales of all Aldurazyme
sold in the particular calendar year.

 

(b)           It is expressly understood
that the royalty payment to be made by Genzyme to BioMarin pursuant to Section 6.1(a) shall be based on a tiered
structure.  For instance, if total Annual
Net Sales are $145,000,000, the royalty payable from Genzyme to BioMarin
pursuant to the methodology outlined in Section 6.1(a) would
be equal to $57,450,000, calculated as follows: 
($130,000,000 x 39.5%) + ($10,000,000 x 40%) + ($5,000,000 x 42%).

 

(c)           In the event that
the [**] Aldurazyme in any country in which Aldurazyme has received all necessary
Regulatory Approvals and, if applicable, pricing approvals as of the Effective
Date (“Existing Markets”) is [**] over any
calendar quarter, then [**].  The term
[**] for purposes of this clause (c) shall
mean a [**] of Aldurazyme.

 

(d)           Notwithstanding the
foregoing,

 

[**] = 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

 

(i)                            BioMarin
agrees to supply Genzyme’s requirements of Aldurazyme for compassionate use and
expanded access programs free of charge, concurrent with delivery of commercial
vials, in an amount equal to [**]. 
Thereafter, BioMarin agrees to supply additional vials to Genzyme during
the relevant calendar year for such compassionate use and expanded access
programs for [**] until it has provided an additional [**] of Aldurazyme.  Thereafter, any additional vials required by
Genzyme in the relevant calendar year for such compassionate use and expanded
access programs shall be provided by BioMarin at [**].  The term “vial” for purposes of this clause (d)(i) shall mean a 2.9 mg vial of Aldurazyme;
and

 

(ii)                           BioMarin
agrees that Genzyme may use up to [**] vials per Lot of Aldurazyme delivered to
Genzyme to supply Genzyme’s requirements of Aldurazyme for appropriate
acceptance testing and required in-country release testing and final Lot
testing free of charge.  Genzyme shall
account for any Aldurazyme so used in the quarterly report described in Section 6.4.

 

6.2          Quarterly Payments.  Genzyme shall pay all amounts owed to
BioMarin for Aldurazyme pursuant to Section 6.1
on a quarterly basis within forty-five (45) days after the end of each calendar
quarter.  In computing the royalty
payable for any quarter, the Parties shall take into account the aggregate Net
Sales to date from the beginning of the relevant calendar year.

 

6.3          Monthly
Reports.  Within [**] business days
after the end of each calendar month, Genzyme shall provide BioMarin with a
preliminary report of Net Sales of Aldurazyme for the immediately proceeding
month (a “Flash Report”).  As soon as practicable, but in no event later
than [**] business days after the end of each calendar month, Genzyme shall
provide BioMarin with a final report of Net Sales of Aldurazyme for the
immediately proceeding month.  Such
monthly reports shall not include inventory data.

 

6.4          Quarterly
Reports.  Within forty-five (45)
business days after the end of each calendar quarter, Genzyme shall provide
BioMarin with a true accounting of all payment obligations, if any, owed in
accordance with this Article 6,
together with a statement setting out all details necessary to calculate the
amounts actually due hereunder with respect to Net Sales made in that calendar
quarter, including vials of Aldurazyme sold on a country-by-country basis,
gross sales of Aldurazyme in that calendar quarter including vials of
Aldurazyme sold on a country-by-country basis, Net Sales in that calendar quarter
on a country-by-country basis, all relevant deductions, and all relevant
exchange rate conversions.  Any
additional payments owed by Genzyme to BioMarin shall accompany such statement.

 

6.5          Sales
Records; Audit.

 

6.5.1       Genzyme shall keep
complete and accurate books and records of all Net Sales of Aldurazyme on a
country-by-country basis.  BioMarin shall
have the right, at BioMarin’s expense, through a certified independent public
accountant, to have reasonable access upon reasonable advance notice and during
normal business hours to such books and records for the sole purpose of
verifying the accuracy of the royalty report and payments under this 

 

[**] = 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

 

Article 6 in respect of any
calendar quarter ending not more than thirty-six (36) months prior to the date
of such notice.  BioMarin and Genzyme
shall agree in good faith upon reasonable procedures before BioMarin’s auditors
begin the audit work pursuant to this Section 6.5.1.  Such verifications may be conducted not more
than once in each calendar year during the term of this Agreement and once
during the three (3) year period following the expiration or termination
of this Agreement.  The records and
royalty reports for any particular calendar quarter may not be examined under
this Section 6.5.1 more than once.

 

6.5.2       In the event such audit
concludes that adjustments should be made in BioMarin’s favor, then any
appropriate payments (plus accrued interest as determined by Section 6.8) shall be paid by Genzyme within [**] days
after the date Genzyme receives BioMarin’s accounting firm’s written report so
concluding, unless Genzyme shall have a good faith dispute as to the
conclusions set forth in such written report in which case Genzyme shall
provide written notice to BioMarin within such [**] day period of the nature of
its disagreement with such written report. The Parties shall thereafter, for a
period of sixty (60) days, attempt in good faith to resolve such dispute and if
they are unable to do so then the matter will be submitted to dispute
resolution in accordance with Section 13.8
hereof.  Any overpayments by Genzyme will
be promptly refunded by BioMarin to Genzyme with interest calculated as
provided in Section 6.8 from the date
such overpayment was made.  If any such
examination reveals an underpayment to BioMarin in excess of [**] for the
examined period, then Genzyme shall promptly reimburse BioMarin for the costs
of such examination within forty-five (45) days after receipt of a reasonably
detailed invoice therefor unless Genzyme is disputing such conclusion as
provided above.

 

6.5.3       BioMarin agrees that
all information subject to review under this Section 6.5
(other than information directly related to Aldurazyme) is Genzyme’s
confidential information and that it shall cause its accounting firm to retain
all such information in confidence (even as to BioMarin) subject to the
confidentiality restrictions of Article 8 hereof. 
Notwithstanding the prior sentence, Genzyme acknowledges and agrees that such
accounting firm’s obligation to retain all such information in confidence from
BioMarin shall not apply in the event that BioMarin and Genzyme are involved in
a dispute under Section 13.8 related to this Section 6.5 and such information is necessary for
BioMarin’s use in connection with such dispute; provided, however,
that BioMarin shall only use such information in connection with such dispute
and such information shall remain subject to the confidentiality restrictions
of Article 8.

 

6.6          Taxes.  Any taxes, levies or similar governmental
charges, now in force or enacted in the future, however designated (“Taxes”) including related penalties and
interest, imposed by any governmental authority on or measured or incurred by
the sale or shipment of Aldurazyme by BioMarin to Genzyme or the sale of
Aldurazyme by Genzyme shall be 

 

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

 

27

 

paid by Genzyme. Notwithstanding anything to the contrary herein, each
Party shall be solely responsible with respect to its own income Taxes.

 

6.7          Payment
for Unsold Aldurazyme.  [**].

 

6.8          Payment
Terms.  All sums due under this
Agreement shall be payable in United States dollars.  Monetary conversion from the currency of a
foreign country in which Aldurazyme is sold into United States currency shall
be calculated in accordance with GAAP using the average of the relevant daily
exchange rates for each month of the calendar quarter based on rates published
by Bloomberg.  All payments to be made
under this Agreement shall be paid by check or wire transfer as selected by
paying Party, and shall be delivered to such address or wired to such account
or accounts as the Party owned such payment shall designate from time to time
in writing to the paying Party.  Any such
payment shall be deemed to have been paid when received with respect to check
payments or when recorded in the proper account with respect to wire transfer
payments.

 

6.9          Late
Fees; Collection Costs.  If any
amounts due under this Agreement
are not made when due, the Party from whom such payment was due will be charged
a late charge of [**] per month determined on a daily basis from the date due
until the date paid.  Payment of such
late charges alone (i.e., without the late payment itself) will not excuse or
cure the breach or default for late payment. 
If either BioMarin or Genzyme retains a collection agency, attorney or
other person or entity to collect overdue payments, all collection costs,
including but not limited to reasonable attorneys’ fees and expenses, will be
paid by the Party from whom such payment was due.

 

6.10        No
Deductions.  No part of any amount
payable by a Party may be reduced due to any counterclaim, set-off, adjustment
or other right that such Party may have against another Party, except with
respect to Aldurazyme that is returned to BioMarin in accordance with Section 3.9 or 5.2.

 

7.             RESEARCH AND DEVELOPMENT

 

7.1          Independent Research and
Development Activities.  Except as
otherwise provided herein or in the Amended and Restated Collaboration
Agreement, to the extent that the Steering Committee (as defined in the Amended
and Restated Collaboration Agreement) does not exercise the right of first
refusal granted to BioMarin/Genzyme LLC under Section 3.1.5
or Article 5 of the Amended and Restated Collaboration
Agreement, each of BioMarin and Genzyme shall have the right to independently
conduct, at its own expense, any research or development of Aldurazyme, including
without limitation Post-Marketing Studies and through investigator-initiated
studies.

 

7.2          Access to Data.  Each Party shall provide the other Party
will full access to the data generated in any research and development
activities conducted with Aldurazyme, and the other Party shall be free to use
such information to perform its obligations under this Agreement or any Related
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.

 

28

 

8.             CONFIDENTIALITY.

 

8.1          Nondisclosure
Obligations.  Except as otherwise
provided in this Article 8, during the term of
this Agreement and for a period of five (5) years thereafter, the
Parties shall maintain in confidence and use only for purposes specifically
authorized under this Agreement any information furnished to it by the other
Party hereto pursuant to this Agreement which if disclosed in tangible form is
marked “Confidential” or with other similar designation to indicate its
confidential or proprietary nature or if disclosed orally or by inspection is
indicated orally to be confidential or proprietary by the Party disclosing such
information at the time of such disclosure and is confirmed in writing as
confidential or proprietary by the disclosing Party (describing in reasonable
detail the information to be treated as confidential) within a reasonable time
after such disclosure (collectively, “Information”).

 

To the extent it is reasonably necessary or appropriate to fulfill its
obligations or exercise its rights under this Agreement, the Amended and
Restated Collaboration Agreement or the Fill Agreement, a Party may disclose
Information of the other Party it is otherwise obligated under this Section 8.1 not to disclose to its Affiliates,
permitted sublicensees, consultants, outside contractors and clinical
investigators, on a need-to-know basis and on the condition that such entities
or persons agree to keep the Information confidential for the same time periods
and to substantially the same extent as such Party is required to keep such
Information confidential; and a Party or its permitted sublicensees may
disclose such Information to government or other regulatory authorities to the
extent that such disclosure is reasonably necessary to obtain patents or
authorizations to conduct clinical trials or to file and maintain Regulatory
Approvals with and to market commercially Aldurazyme.  The obligation not to disclose Information
shall not apply to any part of such Information that: (i) is or becomes
patented, published or otherwise becomes publicly known other than by acts of
the Party obligated not to disclose such Information or its Affiliates or
sublicensees in contravention of this Agreement; (ii) can be shown by
written documents to have been disclosed to the receiving Party or its
Affiliates or sublicensees by a Third Party, provided that such
Information was not obtained by such Third Party directly or indirectly from
the disclosing Party under this Agreement; (iii) prior to disclosure under
this Agreement was already in the possession of the receiving Party or its
Affiliates or sublicensees, provided that such Information was not obtained
directly or indirectly from the disclosing Party under this Agreement; (iv) can
be shown by written documents to have been independently developed by the
receiving Party or its Affiliates without breach of any of the provisions of
this Agreement; or (v) is required to be disclosed by the receiving Party
to comply with applicable laws or regulations, or with a court or
administrative order, provided that the receiving Party notifies the
disclosing Party in writing prior to any such disclosure and agrees to use
reasonable efforts to secure confidential treatment thereof prior to its
disclosure (whether by protective order or otherwise).

 

8.2          Terms of this Agreement;
Press Releases.  The Parties agree to
seek confidential treatment for any filing of this Agreement with the
Securities and Exchange Commission and shall agree upon the content of the
request for confidential treatment 

 

[**] = 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

 

made by each Party in respect of such filing.  Except as permitted by the foregoing
provisions or as otherwise required by law, each of the Parties agrees not to
disclose any terms or conditions of this Agreement to any Third Party without
the prior consent of the other Parties; provided that each of BioMarin
and Genzyme shall be entitled to disclose the terms of this Agreement without
such consent to its advisors and potential investors or other financing sources
on the condition that such entities or persons agree to keep such terms
confidential for the same time periods and to the same extent as such Party is
required to keep such terms confidential. 
The Parties agree that all press releases related to Aldurazyme shall be
issued jointly by BioMarin and Genzyme and that the Party preparing any such
press release shall provide the other Party with a draft thereof reasonably in
advance of disclosure so as to permit the other Party to review and comment on
such press release.  Notwithstanding the
foregoing, the Parties shall agree upon a press release to announce the
execution of this Agreement, together with a corresponding Question &
Answer outline for use in responding to inquiries about the Agreement;
thereafter, BioMarin and Genzyme may each disclose to Third Parties the
information contained in such press release and Question & Answer
outline without the need for further approval by the other.

 

9.             REPRESENTATIONS AND WARRANTIES.

 

9.1          General Representations
and Warranties.  Each Party hereby
represents and warrants:

 

9.1.1       Duly Organized.  It is a corporation (or limited liability
company as the case may be) duly organized, validly existing and in good
standing under the laws of the jurisdiction of its incorporation (or
organization as the case may be), is qualified to do business and is in good
standing as a foreign corporation (or limited liability company as the case may
be) in each jurisdiction in which the conduct of its business or the ownership
of its properties requires such qualification and failure to have such would
prevent it from performing its obligations under this Agreement and has all
requisite corporate power (or limited liability power as the case may be) and
authority to conduct its business as now being conducted, to own, lease and
operate its properties and to execute, deliver and perform this Agreement.

 

9.1.2       Authorization.  It is duly authorized to execute and deliver
this Agreement and to perform its obligations hereunder.  The person executing this Agreement on its
behalf has been duly authorized to do so by all requisite corporate action.

 

9.1.3       No Third Party Approval.  No authorization, consent, approval, license,
exemption of, or filing or registration with, any court or governmental
authority or regulatory body (other than health regulatory authorities) is
required for the due execution, delivery or performance by it of this
Agreement, except as provided herein.

 

[**] = 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

 

9.1.4                     Enforceable
Agreement.  This Agreement has been
duly and validly executed and delivered, and assuming it is a legally
enforceable agreement of the other Parties hereto, constitutes the legal, valid
and binding obligation of such Party, enforceable against it in accordance with
its terms, subject to the effect of any applicable bankruptcy, insolvency,
reorganization, moratorium, or similar laws now or hereinafter in effect
relating to creditors’ rights generally or to general principles of equity.

 

9.1.5                     No Violation.  None of the execution, delivery or
performance of this Agreement by such Party, nor the consummation by such Party
of the transactions contemplated hereby will (i) result in a violation of
any provision of such Party’s charter documents or by-laws; or (ii) with
or without the giving of notice or the lapse of time, or both, conflict with,
or result in any violation or breach of, or constitute a default under, or
result in any right to accelerate or result in the creation of any lien, charge
or encumbrance pursuant to, or right of termination under, any provision of any
material agreement to which such Party is a party or by which such Party or any
of its assets or properties are bound or which is applicable to such Party or
any of its assets or properties.

 

9.1.6                     No Debarment.  It is not currently debarred, suspended, or
otherwise excluded by the FDA or any other regulatory authority from conducting
business and shall not knowingly use in connection with this Agreement the
services of any person debarred by the FDA.

 

9.1.7                     Accuracy of
Data.  All laboratory, scientific,
technical and/or other data submitted by or on behalf of such Party, as the
case may be, relating to Aldurazyme shall, to the best of its knowledge, be
true and correct and shall not contain any material falsification,
misrepresentations or omissions.

 

9.2                               Additional
Representations and Warranties.

 

9.2.1                     Genzyme
Warranties.  Genzyme warrants that
the Aldurazyme sold pursuant to Article 4
hereof will be marketed and sold in all material respects in accordance with
the conditions of any applicable Marketing Application Approvals, Regulatory
Approvals, any applicable labeling claims and any applicable requirements of
the Regulatory Scheme regarding the promotion, sale and marketing of Aldurazyme
(except to the extent any of the foregoing is the responsibility of BioMarin as
the holder of the BLA).

 

9.2.2                     BioMarin
Warranties.

 

(a)                        BioMarin
warrants that the Aldurazyme delivered by BioMarin pursuant to Article 3 hereof will conform in all material respects
to the Specifications, the conditions of any applicable Regulatory Approvals
regarding the manufacturing process and any applicable requirements of the
Regulatory Scheme regarding the manufacturing process.

 

[**] = 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

 

(b)                        When
each Lot of Aldurazyme leaves BioMarin’s facility, such Lot shall be of good,
merchantable and usable quality, free of defects in material and workmanship,
suitable for the purposes for which Aldurazyme is to be used, and shall not be
adulterated or misbranded due to any defect caused by BioMarin within the
meaning of the U.S. Regulatory Scheme and other substantially similar laws and
statutes in any country outside the United States in which Aldurazyme is to be
sold.

 

(c)                        The
manufacturing facilities for Aldurazyme shall conform in all material respects
to the standards of those Regulatory Authorities with jurisdiction over such
facilities, including, but not limited to, those set forth in the cGMP
Regulations.

 

9.2.3                     No
Representations or Warranties as to Safety of Aldurazyme or Specifications as
of the Effective Date.

 

(a)                        Each of
the Parties acknowledges that none of the other Parties nor their respective
personnel are obligated to engage in any refinement or development of
Aldurazyme pursuant to the terms of this Agreement other than with respect to
BioMarin, the production of Aldurazyme pursuant to the Specifications or as
approved by BioMarin and any refinement and development required as a result of
any changes to Aldurazyme made pursuant to Section 3.

 

(b)                        Each of
the Parties acknowledges that the Specifications as they exist as of the
Effective Date have been jointly developed by the Parties pursuant to the terms
of the Original Collaboration Agreement.

 

(c)                        BioMarin/Genzyme
LLC and Genzyme acknowledge that other than [**] each Lot of Aldurazyme by
BioMarin as required by the Specifications, the applicable Regulatory Approvals
and the applicable requirements of the Regulatory Scheme (including without
limitation cGMP Regulations) and/or the Technical Agreement, BioMarin shall not
be in any way responsible for [**].

 

9.3                               Disclaimer
of Representations and Warranties. 
EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT OR IN A
RELATED AGREEMENT, NONE OF BIOMARIN, GENZYME OR BIOMARIN/GENZYME LLC MAKES ANY
REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, AND THE NON-INFRINGEMENT OF ANY THIRD-PARTY PATENTS
OR PROPRIETARY RIGHTS.  ALL UNIFORM COMMERCIAL
CODE WARRANTIES ARE EXPRESSLY DISCLAIMED BY THE PARTIES.

 

9.4                               Limitation
of Liability.  EXCEPT WITH RESPECT TO
CLAIMS FOR INDEMNIFICATION UNDER ARTICLE 11
HEREOF AND AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, IT IS AGREED BY
THE PARTIES THAT NO PARTY SHALL BE LIABLE TO ANOTHER PARTY FOR 

 

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

 

 

32

 

ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY OR INCIDENTAL
DAMAGES (INCLUDING LOST OR ANTICIPATED REVENUES OR PROFITS RELATING TO THE
SAME), ARISING FROM ANY CLAIM RELATING TO THIS AGREEMENT, WHETHER SUCH CLAIM IS
BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EVEN IF AN
AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS ADVISED OF THE POSSIBILITY OR
LIKELIHOOD OF SAME.

 

10.                               LICENSE GRANTS: PATENT PROSECUTION AND
LITIGATION.

 

10.1                        License
Grants.  Pursuant to the terms and
conditions of Article 3 of the Amended and
Restated Collaboration Agreement, the Parties have granted each other licenses
with respect to all Patent Rights, Technology and Manufacturing Know-How owned
or Controlled by the Parties related to Collaboration Products in the Field.

 

10.2                        Rights and
Obligations of the Parties.  The
rights and obligation of the Parties with respect to filing, prosecution and
maintenance of all Patent Rights, defense of Third Party infringement claims
and enforcement of Patent Rights are set forth in Article 9
of the Amended and Restated Collaboration Agreement.

 

11.                               INDEMNITY.

 

11.1                        In Favor of BioMarin.  Genzyme shall defend, indemnify and hold
harmless each of BioMarin, its Affiliates and their respective officers,
directors and employees (collectively, the “BioMarin
Indemnified Parties”) from and against any and all claims, demands,
losses, damages, liabilities, settlement amounts, costs or expenses whatsoever
(including reasonable attorneys’ fees and costs) (collectively, “Losses”) (i) arising from or related to any claim,
action or proceeding asserted by a Third Party (a “Third Party
Claim”) against any BioMarin Indemnified Party arising from Genzyme’s
breach of this Agreement or negligence or willful misconduct in connection with
its performance of its obligations under this Agreement or (ii) allocated
to it in Section 11.3, except to the extent
(which shall reduce Genzyme’s indemnification obligation hereunder) in the case
of (i) and (ii) such Losses also arise from BioMarin’s breach of any
warranty or representation herein, BioMarin’s failure to perform any covenant
herein, or any negligent or willful act or omission of BioMarin in performing
its obligations under this Agreement.

 

11.2                        In Favor of Genzyme.  BioMarin shall defend, indemnify and hold
harmless each of Genzyme, its Affiliates and their respective officers,
directors and employees (collectively, the “Genzyme
Indemnified Parties”) from and against any and all Losses (i) arising
from or related to any Third Party Claim against any Genzyme Indemnified Party
arising from BioMarin’s breach of this Agreement or negligence or willful
misconduct in connection with its performance of its obligations hereunder, (ii) arising
from or related to any Third Party Claim against any Genzyme Indemnified Party
and lost profits of Genzyme, in each case, resulting from an interruption in
the supply of Aldurazyme due to changes implemented by BioMarin pursuant to Section 3.10 or 3.11 (other than any change made at the
request or direction of any regulatory 

 

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

 

33

 

authority) or (iii) allocated to it in Section 11.3, except to the extent (which shall reduce
BioMarin’s indemnification obligation hereunder), in each of case (i), (ii) and
(iii) such Losses also arise from Genzyme’s breach of any warranty or
representation herein, Genzyme’s failure to perform any covenant herein, or any
negligent or willful act or omission of Genzyme in performing its obligations
under this Agreement.

 

11.3                        Product Liability.  If any Party receives a Third Party Claim or
suffers any Losses relating to product liability, the other Party shall
contribute to such Losses to the extent set forth in this Section 11.3.

 

11.3.1              Alleged Design Defect Regarding Aldurazyme.  Each of the Parties acknowledge and agree
that Aldurazyme produced using the Specifications in effect as of the Effective
Date was produced through their joint efforts. 
To the extent that a Third Party Claim is asserted against any of the
Parties or any of their Affiliates related to a design defect in Aldurazyme
meeting the Specifications in effect as of the Effective Date, the Parties
acknowledge and agree that they shall each be responsible for fifty percent
(50%) of all Losses incurred by the Parties and their Affiliates arising from
such a Third Party Claim.  To the extent
that the Specifications are modified after the Effective Date pursuant to Sections 1.50 and 3.11 and any of the Parties is found to be
responsible for any claims related to a design defect in the production of
Aldurazyme pursuant to such modified Specifications, the Parties acknowledge
and agree that BioMarin shall be responsible for one hundred percent (100%) of
all Losses incurred by the Parties and their Affiliates arising from such a
Third Party Claim except to the extent such Losses also arise from Genzyme’s
breach of any warranty or representation herein, Genzyme’s failure to perform
any covenant herein, or the negligent or willful act or omission of Genzyme in
performing its obligations under this Agreement, in which case liability shall
be apportioned between BioMarin and Genzyme as appropriate.

 

11.3.2              Alleged Manufacturing Defect Regarding
Aldurazyme.  Notwithstanding Section 11.3.1, the Parties
acknowledge and agree that to the extent that a Third Party Claim is asserted
against Genzyme or any of its Affiliates related to the manufacturing, storing,
handling, delivery, US regulatory compliance of Aldurazyme by BioMarin or its
Affiliates or Third Parties engaged by or on behalf of BioMarin (including
without limitation Hollister-Stier), any and all Losses incurred by Genzyme or
its Affiliates arising from such Third Party Claim shall be the sole
responsibility of BioMarin except to the extent such Losses arise from Genzyme’s
breach of any warranty or representation herein, Genzyme’s failure to perform
any covenant herein, or the negligent or willful act or omission of Genzyme in
performing its obligations under this Agreement, in which case liability shall
be apportioned between BioMarin and Genzyme as appropriate.

 

11.3.3              Alleged Non-Manufacturing Defect Regarding
Aldurazyme. Notwithstanding Section 11.3.1,
the Parties acknowledge and agree that to the 

 

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

 

34

 

extent that a Third Party Claim is asserted against BioMarin or any of
its Affiliates related to the storage, handling, delivery, non-US regulatory
compliance, labeling, marketing, distribution or sale of Aldurazyme by Genzyme
or its Affiliates or Third Parties engaged by or on behalf of Genzyme, any and
all Losses incurred by BioMarin or its Affiliates arising from such Third Party
Claim shall be the sole responsibility of Genzyme except to the extent such
Losses arise from BioMarin’s breach of any warranty or representation herein,
BioMarin’s failure to perform any covenant herein, or the negligent or willful
act or omission of BioMarin in performing its obligations under this Agreement,
in which case liability shall be apportioned between BioMarin and Genzyme as
appropriate.

 

11.4                        Indemnification
and Contribution Procedures.

 

11.4.1              Indemnification
Procedure.  In a circumstance where
one Party is required to indemnify the other Party for one hundred percent
(100%) of the Losses arising from any Third Party Claim, a Party or any of its
Affiliates or their respective directors, officers, employees or agents (the “Indemnitee”) that intends to claim indemnification under
this Article 11 shall promptly notify
the other Party (the “Indemnitor”) of
any Losses in respect of which the Indemnitee intends to claim such
indemnification, and if the Indemnitor confirms in writing that it will
indemnify the Indemnitee for one hundred percent (100%) of such Loss, then the
Indemnitor shall have the right to assume the defense thereof with counsel of
its choice, subject to the consent of the non-Indemnifying Party, which consent
will not be unreasonably withheld, delayed or conditioned; provided, however,
that an Indemnitee shall have the right to retain its own counsel, with the
fees and expenses to be paid by the Indemnitor, if representation of such
Indemnitee by the counsel retained by the Indemnitor would be inappropriate due
to actual or potential conflicting interests between such Indemnitee and any
other Party represented by such counsel in such proceedings.  The Indemnitor shall not be responsible for
the fees and expenses of more than one counsel to all Indemnitees.  The indemnity in this Article 11
shall not apply to amounts paid in settlement of any Third Party Claim if such
settlement is effected without the prior written consent of any Indemnitor,
which consent shall not be unreasonably withheld, delayed or conditioned.  The failure to deliver notice to an
Indemnitor within a reasonable time after the commencement of any such Third
Party Claim shall not relieve such Indemnitor of any liability to the
Indemnitee under this Article 11
with respect to such action, except to the extent that such failure materially
prejudiced the Indemnitor’s ability to defend such action.  Each Indemnitee under this Article 11, its employees and agents, shall cooperate
fully with the Indemnitor and its legal representatives in the investigation of
any Claim or action covered by this indemnification.

 

11.4.2              Contribution
Procedure.  In a circumstance where
responsibility for Losses arising out of any Third Party Claim is to be
apportioned between Genzyme and BioMarin pursuant to Sections
11.1, 11.2, and 11.3, a Party that intends 

 

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

 

35

 

to seek partial indemnification or contribution from the other Party
for any such Losses must notify the other Party as promptly as practical.  The failure to deliver such notice within a
reasonable time will not relieve a Party of any obligations for indemnification
or contribution hereunder with respect to such Losses, except to the extent
that such failure materially prejudiced the Indemnitor’s ability to defend such
Third Party Claim.  If the Parties agree
that one Party will have responsibility for more than fifty percent (50%) of
the Losses arising out of a Third Party Claim, such Party shall have the right
to assume the defense of the Third Party Claim with counsel of its choice,
subject to the consent of the non-Indemnifying Party, which consent will not be
unreasonably withheld, delayed or conditioned; provided, however, the Party not
defending the Third Party Claim shall have the right to retain its own counsel
to participate in the defense of the Third Party Claim at its own expense.  In the absence of such agreement, each Party
seeking indemnification or contribution may defend the Third Party Claim with
counsel of its choosing at its own expense, and each Party’s counsel fees and
costs related to the Third Party Claim will be excluded from the Losses to be
apportioned in accordance with Section 11.1, 11.2,
and 11.3.  No Party shall be
required to contribute to or indemnify the other Party for any Losses arising
out of a Third Party Claim if the claim is settled without its written consent,
which consent shall not be unreasonably withheld, delayed or conditioned.  Each Party, its employees and agents, shall
cooperate fully with the other Party and its legal representatives in the
investigation of any Third Party Claim covered by this Section 11.4.2.  The Parties shall negotiate in good faith to
enter into a joint defense agreement with respect to the defense of any Third
Party Claim covered by this Section 11.4.2.

 

11.5                        Insurance.  Each Party shall, during the term of this
Agreement, maintain commercially reasonable amounts of insurance or
self-insurance given the size, nature and scope of its business from a
reputable insurance carrier to cover against liability risks, including product
liability insurance and business interruption insurance (for commercial value)
for the benefit of the other Party.  Each
Party shall provide the other Party with evidence of such insurance.

 

12.                               TERM AND TERMINATION.

 

12.1                        Term.  The term of this Agreement shall be perpetual
unless terminated pursuant to Section 12.2
below.

 

12.2                        Termination.  This Agreement may be terminated in the
following circumstances:

 

12.2.1              For Certain Material
Breaches.  If either BioMarin or
Genzyme fails to use commercially reasonable and diligent efforts to perform
any material duty imposed upon such Party under this Agreement and such failure
to perform is not cured within ninety (90) days of written notice thereof from
the non-breaching Party, the non-breaching Party may elect, in its sole
discretion, to terminate this Agreement with the consequences set forth in Section 12.3.1  

 

[**] = 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.

 

36

 

below.  Such 90-day period shall be extended to one
hundred eighty (180) days if the breaching Party has engaged in good faith
efforts to remedy such default within such 90-day period and indicated in
writing to the non-breaching Party prior to the expiration of such 90-day
period that it believes that it will be able to remedy the default within such
180-day period, but such extension shall apply only so long as the breaching
Party is engaging in good faith efforts to remedy such default.

 

12.2.2              For Convenience.  Either BioMarin or Genzyme may elect to
terminate this Agreement for any reason upon one (1) year prior written
notice to the other Party, during which one-year period the obligations of the
Parties shall continue in full force and effect.

 

12.2.3              Upon Change of
Control.  Either BioMarin or Genzyme
may terminate this Agreement in the event that the other Party is a party to a
transaction involving (a) a merger or consolidation in which such Party is
not the surviving entity or (b) the sale of all or substantially all of
the assets of such Party to a Third Party. 
Termination of this Agreement pursuant to this Section 12.2.3
shall be effective as of the effective date of such transaction.

 

12.2.4              Upon Bankruptcy.  Either BioMarin or Genzyme may terminate this
Agreement if: (a) the other Party fails to meet any material obligation
hereunder and (i) applies for or consents to the appointment of a
receiver, trustee, liquidation or custodian of itself or of all or a
substantial part of its property; (ii) becomes unable, or admits in
writing its inability, to pay its debts generally as they mature; (iii) makes
a general assignment for the benefit of its or any of its creditors; (iv) is
dissolved or liquidated in full or in part; (v) commences a voluntary case
or other proceeding seeking liquidation, reorganization or other relief with
respect to itself or its debts under any bankruptcy, insolvency or other
similar law now or hereafter in effect or consent to any such relief or to the
appointment of or taking possession of its property by any official in an
involuntary case or other proceeding commenced against it; or (vi) takes
any action for the purpose of effecting any of the foregoing; or (b) proceedings
for the appointment of a receiver, trustee, liquidator or custodian of the
other Party or of all or a substantial part of the property thereof, or an
involuntary case or other proceedings seeking liquidation, reorganization or
other relief with respect to the other Party or the debts thereof under any bankruptcy,
insolvency or other similar law now or hereafter in effect shall be commenced
and an order for relief entered or such proceeding shall not be dismissed or
discharged within sixty (60) calendar days of commencement.

 

12.3                        Effects of
Termination.

 

12.3.1              For Certain Material Breaches.  In
addition to the rights and duties set forth in Section 12.4
below, BioMarin and Genzyme shall have the following 

 

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

 

37

 

rights and duties upon
termination of this Agreement pursuant to Section 12.2.1
above:

 

(a)           the
non-breaching Party shall have an irrevocable right and license, with the right
to grant and authorize sublicenses, to develop, make, have made, use, offer for
sale, sell, have sold, import and export Aldurazyme and the breaching Party
shall execute such documents and take all action  as may be necessary or desirable to effect
the foregoing; provided,
that such license shall be for the same level of exclusivity as the rights
granted with respect thereto under Article 3
or Article 4 hereof, as the case may
be, immediately prior to such termination; provided  further that any license granted
hereunder shall be subject to the obligation of the non-breaching Party to use
commercially reasonable and diligent efforts to manufacture, develop and market
Aldurazyme pursuant to such license;

 

(b)           the
breaching Party shall assign and transfer all of its interest in
BioMarin/Genzyme LLC to the non-breaching Party, and the non-breaching Party
may dissolve BioMarin/Genzyme LLC in its sole discretion; provided that
in the event that BioMarin is the breaching Party, it shall also cause BioMarin
Genetics to assign and transfer all of its interest in BioMarin/Genzyme LLC to
Genzyme.

 

(c)           upon exercise of its license option by the
non-breaching party provided in paragraph (a) of this Section 12.3.1:  (i) all rights and licenses or rights
granted pursuant to Article 3
or Article 4, as the case may be,
shall be revoked; (ii) if 
BioMarin/Genzyme LLC is dissolved, any applicable Regulatory Approvals
(other than any Regulatory Approvals filed in the name of an entity other than
BioMarin/Genzyme LLC), “Orphan Drug” designations and clinical data owned or
licensed by BioMarin/Genzyme LLC and any trademarks owned or licensed by
BioMarin/Genzyme LLC (other than any trademarks registered in the name  of an entity other than BioMarin/Genzyme LLC pursuant to Section 9.1.2
of the Amended and Restated Collaboration Agreement) shall be assigned or  exclusively licensed to the non-breaching
Party; and (iii) any Regulatory Approvals filed and  any trademarks registered in the name of an
entity other  than BioMarin/Genzyme LLC
shall be (A) exclusively licensed to BioMarin/Genzyme LLC, the
non-breaching Party or  any Third Party
or Affiliate designated by the non-breaching Party until such time as
BioMarin/Genzyme LLC, the non-breaching Party or  its designee is qualified to hold such
Regulatory Approvals  or trademarks under
the applicable provisions of the Regulatory Scheme and (B) transferred  or assigned to BioMarin/Genzyme LLC, the
non-breaching Party or its designee, as appropriate, as soon as practicable
thereafter;

 

(d)           the non-breaching Party shall become
obligated  to pay the breaching Party an
amount equal to: [**] (iii) interest
thereon at the Base Rate of
interest declared from time to time by 
Bank of America, N.A. in Boston, Massachusetts from  

 

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

 

38

 

the date of termination to
the date payment is made (the “Breach Buyout Amount”),
payable as follows:

 

(i)                                    if
the non-breaching Party elects to sell or otherwise dispose of all or any
portion of its or its Affiliates’ right, title and interest in Aldurazyme, then
the non-breaching Party shall, upon any such sale or other disposition, pay the
breaching Party an amount equal to [**];

 

(ii)                                for
as long as the non-breaching Party (together, in the case of BioMarin with
BioMarin Genetics) has not sold or otherwise disposed of all or a portion of
its (together in the case of BioMarin, with BioMarin Genetics) right, title and
interest  in Aldurazyme which is equal to
or greater than the breaching Party’s (together in the case of BioMarin, with
BioMarin Genetics) Percentage Interest as of the date of termination, the
non-breaching Party shall pay the breaching Party (and, in the event that
BioMarin is the breaching Party, BioMarin Genetics) [**] as described in the
preceding paragraph; and

 

(iii)                                        on the [**] of the date of termination, the non-breaching Party shall pay the
breaching Party (and, in the event that BioMarin is the breaching Party,
BioMarin Genetics) the difference between the aggregate amounts paid pursuant
to clauses (i) and (ii) above and the Breach Buyout Amount; provided, that the aggregate
amount of all payments made under clauses (i), (ii) and (iii) shall
not exceed the Breach Buyout Amount.

 

12.3.2              For Convenience.  In addition to the rights and duties set
forth in Section 12.4 below, BioMarin and
Genzyme shall have the following rights and duties upon termination of this
Agreement pursuant to Section 12.2.2
above:

 

(a)                                  the
non-terminating Party shall have an option exercisable upon written notice to
the terminating Party within the one-year period provided in Section 12.2.2 hereof to obtain from the terminating
Party the irrevocable right and license, with the right to grant and authorize
sublicenses, to develop, make, have made, use, offer for sale, sell, have sold,
import and export Aldurazyme, and the terminating Party shall execute such
documents and take all action as may be necessary or desirable to affect the
foregoing; provided, that such license shall be for the same level of
exclusivity as the rights granted with respect thereto under Article 3 or Article 4
hereof, as the case may be; provided  further
that any license granted hereunder shall be subject to the obligation of the
non-terminating Party to use commercially reasonable and diligent efforts to
develop and market Aldurazyme pursuant to such license;

 

(b)                                  upon
exercise of its license option provided in paragraph (a) of this Section 12.3.2, the terminating Party shall assign and
transfer all of its interest 

 

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

 

39

 

in BioMarin/Genzyme LLC to the non-terminating Party,
and the non-terminating Party may dissolve BioMarin/Genzyme LLC in its sole
discretion;

 

(c)           upon
exercise of its license option provided in paragraph (a) of this Section 12.3.2, (i) all licenses granted pursuant
to Article 3 or Article 4,
as the case may be, shall be revoked, (ii) if BioMarin/Genzyme LLC is
dissolved, any applicable Regulatory Approvals (other than any Regulatory
Approvals filed in the name of an entity other than BioMarin/Genzyme LLC
pursuant to Section 5.3 of the Amended and Restated Collaboration
Agreement), “Orphan Drug” designations and clinical data owned or licensed by
BioMarin/Genzyme LLC and any trademarks owned or licensed by BioMarin/Genzyme
LLC (other than any trademarks registered in the name of an entity other than
BioMarin/Genzyme LLC pursuant to Section 9.1.2 of the Amended and Restated
Collaboration Agreement) shall be assigned to the non-terminating Party and (iii) any
Regulatory Approvals filed and any trademarks registered in the name of an
entity other than BioMarin/Genzyme LLC shall be (A) exclusively licensed
to BioMarin/Genzyme LLC, the non-terminating-Party or any Third Party or
Affiliate designated by such Party until such time as BioMarin/Genzyme LLC, the
non-terminating Party or its designee is qualified to hold such Regulatory
Approvals or trademarks under the applicable provisions of the Regulatory
Scheme and (B) transferred or assigned to BioMarin/Genzyme LLC, the
non-terminating Party or its designee, as appropriate, as soon as practicable
thereafter;

 

(d)           upon
the exercise of its license option provided in paragraph (a) of this Section 12.3.2, the non-terminating Party shall become
obligated to pay to the terminating Party an amount equal to: [**] (iii) interest
thereon at the Base Rate of interest declared from time to time by Bank of
America, N.A. in Boston, Massachusetts from the date of termination to the date
payment is made; payable on the terms and conditions and in accordance with the
schedule of payments set forth in Section 12.3.1(d),
mutatis mutandis; and

 

(e)           if
the license option provided in paragraph (a) of this Section 12.3.2
is not exercised, then all right, title and interest in Aldurazyme shall be
sold to the highest bidder within eighteen (18) months from the date of
termination and the proceeds shall be allocated between the Members in
proportion to their Percentage Interests in BioMarin/Genzyme LLC as of the date
of termination and BioMarin/Genzyme LLC shall be dissolved.

 

12.3.3                                 Upon
a Change of Control.  In addition to
the rights and duties set forth in Section 12.4
below, BioMarin and Genzyme shall have the following rights and duties upon
termination of this Agreement pursuant to Section 12.2.3
above:

 

(a)           the
terminating Party shall have the exclusive, irrevocable and, except as provided
in Section 12.3.3(d), royalty-free right
and license, with the right to grant sublicenses, to develop, make, have made,
use, offer for sale, sell, have

 

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

 

40

 

sold, import and export Aldurazyme, and the
non-terminating Party shall execute such documents and take all action as may
be necessary or desirable to effect the foregoing; provided, that any
license granted hereunder shall be subject to the obligation of the terminating
Party to use commercially reasonable and diligent efforts to develop and market
Collaboration Products pursuant to such license;

 

(b)                                 the
non-terminating Party shall assign and transfer all of its interest in
BioMarin/Genzyme LLC to the terminating Party, and the terminating Party may
dissolve BioMarin/Genzyme LLC in its sole discretion; provided that in
the event that BioMarin is the non-terminating Party, it shall also cause
BioMarin Genetics to assign and transfer all of its interest in BioMarin/Genzyme
LLC to Genzyme;

 

(c)                                  all
licenses or rights granted pursuant to Article 3 or
Article 4, as the case may be,
shall be revoked and, if BioMarin/Genzyme LLC is dissolved, any applicable
Regulatory Approval, “Orphan Drug” designations and clinical data owned or
licensed by BioMarin/Genzyme LLC and any trademarks owned or licensed by
BioMarin/Genzyme LLC shall be assigned or licensed to the terminating Party;
and

 

(d)                                 the
terminating Party (the “Offeror”)
shall, pursuant to the conditions set forth in this Section 12.3.3(d),
give the other Party (Genzyme in the case BioMarin is terminating or the
BioMarin Companies in the case Genzyme is terminating, in either case the “Offeree”) at the time of termination written notice of the
Offeror’s intention to purchase Offeree’s entire interest in and to (i) 
Aldurazyme as of the date of termination and (ii) the Percentage Interest
of the net asset value of BioMarin/Genzyme LLC as of the date of termination
(the “Notice of Offer”).  The Notice of Offer shall state therein the
specific price, terms and conditions under which the Offeror agrees to purchase
Offeree’s entire interest in and to (i) Aldurazyme as of the date of
termination and (ii) the Percentage Interest of the net asset value of
BioMarin/Genzyme LLC as of the date of termination; provided, however,
that the purchase price shall be paid in cash, publicly-traded and registered
securities or as the Parties otherwise agree. 
The Offeree shall then have ninety (90) days (the “Acceptance
Period”) from the receipt of the Notice of Offer to give notice (the
“Notice of Acceptance”) of the Offeree’s intention to accept the offer of the
Offeror and shall sell Offeree’s entire interest in and to (i) Aldurazyme
as of the date of termination and (ii) the Percentage Interest of the net
asset value of BioMarin/Genzyme LLC as of the date of termination to Offeror
for the price and upon such terms and conditions as set forth in the Notice of
Offer.  In the event the Offeree gives
such Notice of Acceptance, a closing shall be held within ninety (90) days of
the receipt of the Notice of Acceptance by the Offeror.  In the event the Offeree elects not to accept
the Offeror’s offer to purchase, by giving the Offeror written notice thereof,
or by failing to give the appropriate Notice of Acceptance within the
Acceptance Period, the Offeree shall thereby automatically be bound to purchase
Offeror’s entire interest in and to (i) Aldurazyme as of the date of 

 

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

 

41

 

termination and (ii) the Percentage Interest of
the net asset value of BioMarin/Genzyme LLC as of the date of termination for
the same price (as adjusted for Percentage Interest, if necessary) and upon
such terms and conditions as specified in the Notice of Offer.  In such event, a closing shall be held within
ninety (90) days of the earlier to occur of the expiration of the Acceptance
Period and the date of receipt of the written rejection, whichever is the first
to occur.  In addition to any other
remedies provided by this Agreement, in the event the Offeree rejects the offer
contained in the Notice of Offer, but thereafter fails for any reason to timely
close as provided herein above, the Offeree shall, by such failure to close, be
deemed to have accepted the original offer contained in the Notice of Offer,
and shall thereafter sell Offeree’s entire interest in and to
(i) Aldurazyme as of the date of termination and (ii) the Percentage
Interest of the net asset value of BioMarin/Genzyme LLC as of the date of
termination to the Offeror pursuant to the terms of the Notice of Offer.  For purposes of Sections
12.3.3 (a)-(c) above, the Party purchasing the other Party’s
interest in (i) Aldurazyme and (ii) the Percentage Interest of the
net asset value of BioMarin/Genzyme LLC shall be deemed to be the terminating
Party and the other Party shall be deemed to be the non-terminating Party.

 

12.3.4                                 Upon
Bankruptcy.  In addition to the
rights and duties set forth in Section 12.4
below, BioMarin and Genzyme shall have the following rights and duties upon
termination of this Agreement pursuant to Section 12.2.4
above:

 

(a)                                 the
terminating Party shall obtain from the non-terminating Party the irrevocable
right and license, with the right to grant sublicenses, under the
non-terminating Party’s Patent Rights, Technology and Manufacturing Know-How to
develop, make, have made, use, offer for sale, sell, have sold, import and
export Aldurazyme in the Field and in the Territory, and the non-terminating
Party shall execute such documents and take all action as may be necessary or
desirable to affect the foregoing; provided, that such license shall be
for the same level of exclusivity as the rights granted with respect thereto
under Article 3 or Article 4
hereof, as the case may be; provided  further that any license
granted hereunder shall be subject to the obligation of the terminating Party
to use commercially reasonable and diligent efforts to develop and market
Aldurazyme pursuant to such license;

 

(b)                                 the
non-terminating Party shall assign and transfer all of its interest in
BioMarin/Genzyme LLC to the terminating Party, and the terminating Party may
dissolve BioMarin/Genzyme LLC in its sole discretion; provided that in
the event that BioMarin is the non-terminating Party, it shall also cause
BioMarin Genetics to assign and transfer all of its interest in BioMarin/Genzyme
LLC to Genzyme.

 

(c)                                  all
licenses granted pursuant to Article 3
or Article 4, as the case may be,
shall be revoked and, if BioMarin/Genzyme LLC is dissolved, any applicable
Regulatory Approvals (other than any Regulatory Approvals filed in the name 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.

 

42

 

an entity other than BioMarin/Genzyme LLC pursuant to
Section 5.3 of the Amended and Restated Collaboration Agreement), “Orphan
Drug” designations and clinical data owned or licensed by BioMarin/Genzyme LLC
and any trademarks owned or licensed by BioMarin/Genzyme LLC (other than any
trademarks registered in the name of an entity other than BioMarin/Genzyme LLC
pursuant to Section 9.1.2 of the Amended and Restated Collaboration
Agreement) shall be assigned or licensed to the terminating Party and (iii) any
Regulatory Approvals filed and any trademarks registered in the name of an
entity other than BioMarin/Genzyme LLC shall be (A) exclusively licensed
to BioMarin/Genzyme LLC, the terminating Party or any Third Party or Affiliate
designated by such Party until such time as BioMarin/Genzyme LLC, the
terminating Party or its designee is qualified to hold such Regulatory
Approvals or trademarks under the applicable provisions of the Regulatory
Scheme and (B) transferred or assigned to BioMarin/Genzyme LLC, the
terminating Party or its designee, as appropriate, as soon as practicable
thereafter,

 

(d)                                 the
terminating Party shall become obligated to pay to the non-terminating Party an
amount equal to [**] from the date of termination to the date payment is made,
payable on the terms and conditions and in accordance with the schedule of
payments set forth in Section 12.3.1(d),
mutatis mutandis.

 

12.3.5                                 Fair
Value.  For purposes of this Section 12.3, the “Fair Value” of
a Party’s interest in Aldurazyme shall be [**], the Fair Value shall be
determined by an investment, banking firm selected by mutual agreement of
BioMarin and Genzyme, and the costs and expenses incurred in connection with
the engagement of such investment banking firm shall be shared equally by
BioMarin and Genzyme.

 

12.3.6                                 Other.  In the event that a Party (the “Purchasing Party”) purchases the other Party’s (or in the
case of BioMarin, the BioMarin Companies’, in each case the “Selling Party”) entire interest in and to (i) Aldurazyme
and (ii) the Percentage Interest of the net asset value of
BioMarin/Genzyme LLC pursuant to this Section 12.3,
the Purchasing Party shall be deemed to assume all of the liabilities inuring
to the Selling Party’s Percentage Interest being acquired.  At closing, the Parties shall execute any and
all documents necessary to effectuate such transfer, including an assignment of
all of the Selling Party’s Percentage Interest and mutual releases which shall
have the effect of releasing each Party from all claims or liabilities
pertaining to BioMarin/Genzyme LLC (except for any liabilities specifically
included in the terms of such sale).

 

12.4                        Cooperation.  If either BioMarin or Genzyme (the “Assuming Party”) shall assume Aldurazyme rights from the
other Party (the “Responsible Party”)
in accordance with the provisions of this Article 12,
the Responsible Party shall promptly provide to the Assuming Party (or any
Third Party or Affiliate designated by the Assuming Party) all Technology,
Manufacturing Know-How and access to regulatory filings filed hereunder
reasonably necessary to allow the Assuming Party to perform the duties assumed
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.

 

43

 

otherwise exercise the rights and licenses granted
hereunder.  The Responsible Party shall
further use its commercially reasonable and diligent efforts to provide
reasonable assistance required by the Assuming Party with respect to such
transfer so as to permit the Assuming Party to begin to perform such duties as
soon as possible to minimize any disruption in the continuity of supply or
marketing of Aldurazyme.  If the
Responsible Party is manufacturing Aldurazyme the Responsible Party shall, at
the option of the Assuming Party, supply Aldurazyme until the earlier of [**].

 

12.5                        Survival
of Rights and Duties.  No termination
of this Agreement shall eliminate any rights or duties of the Parties accrued
prior to such termination.  The
provisions of Article 1, Sections 4.9, 5.2.2,
6.5, 6.9, 6.10 and 9.4, Article 8, Article 11, Sections 12.3 through
12.5, 13.2, 13.3, 13.6 through 13.15 and the first sentence of Section 3.15 and the last sentence of Section 3.14 hereof shall survive any termination of
this Agreement.

 

13.                               MISCELLANEOUS

 

13.1                        Exchange
Controls.  All payments due hereunder
shall be paid in United States dollars. 
If at any time legal restrictions prevent the prompt remittance of part
or all payments with respect to any country in which Aldurazyme is sold,
payment shall be made through such lawful means or methods as the Parties may
determine in good faith.

 

13.2                        Withholding
Taxes.  If applicable laws or
regulations require that taxes be withheld from payments made hereunder, the
Party paying such taxes will (a) deduct such taxes, (b) timely pay
such taxes to the proper authority and (c) send written evidence of
payment to the Party from whom such taxes were withheld within sixty (60) days
after payment.  Each Party will assist
the other Party or Parties in claiming tax refunds, deductions or credits at
such other Party’s request and will cooperate to minimize the withholding tax,
if available, under various treaties applicable to any payment made hereunder.

 

13.3                        Force
Majeure.  Neither Party shall be held
liable or responsible to the other Party nor be deemed to have defaulted under
or breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected Party, including without
limitation fire, floods, embargoes, war, acts of war (whether war is declared
or not), insurrections, riots, civil commotions, strikes, lockouts or other
labor disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other Party; provided, however,
that the Party so affected shall use commercially reasonable and diligent
efforts to avoid or remove such causes of non-performance, and shall continue
performance hereunder with reasonable dispatch wherever such causes are
removed.  Each Party shall provide the
other Parties with prompt written notice of any delay or failure to perform
that occurs by reason of force majeure.  The Parties shall mutually seek a resolution
of the delay or the failure to perform in good faith.

 

13.4                        Assignment.  This Agreement may not be assigned or
otherwise transferred by any Party without the consent of the other Parties; provided, however, that either BioMarin 

 

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

 

44

 

or Genzyme may, without such consent, assign its
rights and obligations under this Agreement (a) in connection with a
corporate reorganization, to any member of an affiliated group, all or
substantially all of the equity interest of which is owned and controlled by
such Party or its direct or indirect parent corporation or (b) in
connection with a merger, consolidation or sale of substantially all of such
Party’s assets to an unrelated Third Party; provided, however,
that such Party’s rights and obligations under this Agreement shall be assumed
by its successor in interest in any such transaction and shall not be
transferred separate from all or substantially all of its other business
assets, including without limitation those business assets that are the subject
of this Agreement and the Related Agreements. 
Any permitted assignee shall assume all obligations of its assignor
under this Agreement; accordingly, all references herein to the assigning Party
shall be deemed references to the assignee to whom the Agreement is so
assigned.  Any purported assignment in
violation of this Section 13.4
shall be void.

 

13.5                        Severability.  Each Party hereby agrees that it does not
intend to violate any public policy, statutory or common laws, rules,
regulations, treaty or decision of any government agency or executive body
thereof of any country or community or association of countries.  Should one or more provisions of this
Agreement be or become invalid, the Parties hereto shall substitute, by mutual
consent, valid provisions for such invalid provisions which valid provisions in
their economic effect are sufficiently similar to the invalid provisions that
it can be reasonably assumed that the Parties would have entered into this Agreement
with such valid provisions.  In case such
valid provisions cannot be agreed upon, the invalidity of one or several
provisions of this Agreement shall not affect the validity of this Agreement as
a whole, unless the invalid provisions are of such essential importance to this
Agreement that it is to be reasonably assumed that the Parties would not have
entered into this Agreement without the invalid provisions.  In the event a Party seeks to avoid a
material provision of this Agreement upon an assertion that such provision is
invalid, illegal or otherwise unenforceable, the other Party shall have the
right to terminate this Agreement upon sixty (60) days prior written
notice to the asserting Party, unless such assertion is eliminated and cured
within such sixty (60) day period. 
Such a termination shall be deemed a termination by such Party for
breach pursuant to Section 12.2.1.

 

13.6                        Notices.  Any consent, notice or report required or
permitted to be given or made under this Agreement by one of the Parties hereto
to the other shall be in writing, delivered personally or by facsimile (and
promptly confirmed by personal delivery or courier), by a next business day
delivery service of a nationally recognized overnight courier service or by
courier, postage prepaid (where applicable), addressed to such other Party at
its address indicated below, or to such other address as the addressee shall
have last furnished in writing to the addressor in accordance with this Section 13.6 and shall be effective upon receipt by the
addressee.

 

	
  If to BioMarin:

  	
  BioMarin
  Pharmaceutical Inc.

  105 Digital Drive

  Novato, California 94949 

  Attention: Chief Executive Officer 

  Facsimile: (415) 382-7889

  

 

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

 

45

 

	
  with a copy to:

  	
  BioMarin
  Pharmaceutical Inc.

  105 Digital Drive

  Novato, California 94949 

  Attention: General Counsel 

  Facsimile: (415) 382-7889

  
	
   

  	
   

  
	
  If to Genzyme:

  	
  Genzyme
  Corporation

  500 Kendall Street

  Cambridge, Massachusetts 02142 

  Attention: President, LSD Therapeutics 

  Facsimile: (617) 768-6419

  
	
   

  	
   

  
	
  with a copy to:

  	
  Genzyme Corporation

  500 Kendall Street

  Cambridge, Massachusetts 02142

  Attention: General Counsel 

  Facsimile: (617) 252-7553

  
	
   

  	
   

  
	
  If to

  BioMarin/Genzyme LLC

  (if such notice is

  sent by BioMarin):

  	
  BioMarin/Genzyme LLC

  c/o Genzyme Corporation

  500 Kendall Street

  Cambridge, Massachusetts 02142 

  Attention: President, LSD Therapeutics 

  Facsimile: (617) 768-6419

  
	
   

  	
   

  
	
  with a copy to:

  	
  Genzyme
  Corporation

  500 Kendall Street

  Cambridge, Massachusetts 02142

  Attention: General Counsel 

  Facsimile: (617) 252-7553

  
	
   

  	
   

  
	
  If to

  BioMarin/Genzyme

  LLC (if such notice is

  sent by Genzyme):

  	
  BioMarin/Genzyme
  LLC

  c/o BioMarin Pharmaceutical Inc.

  105 Digital Drive

  Novato, California 94949 

  Attention: Chief Executive Officer 

  Facsimile: (415) 382-7889

  
	
   

  	
   

  
	
  with a copy to:

  	
  BioMarin
  Pharmaceutical Inc.

  105 Digital Drive

  Novato, California 94949 

  Attention: General Counsel 

  Facsimile: (415) 382-7889

  

 

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

 

46

 

13.7                        Applicable
Law.  This Agreement shall be
governed by and construed in accordance with the laws of the State of Delaware
without regard to any choice of law principle that would dictate the
application of the laws of another jurisdiction.

 

13.8                        Arbitrate.  Any disputes arising between the Parties
relating to, arising out of or in any way connected with this Agreement or any
term or condition hereof, or the performance by either Party of its obligations
hereunder, whether before or after termination of this Agreement (a “Dispute”) shall be finally resolved by binding arbitration
as herein provided.

 

13.8.1              General.  Except as otherwise provided in this Section 13.8, any arbitration hereunder shall be
conducted under the commercial rules of the American Arbitration
Association.  Each such arbitration shall
be conducted in the English language by a single arbitrator appointed in
accordance with such rules, provided that if either Party requests the
arbitration shall be conducted by a panel of three (3) arbitrators
(the “Arbitration Panel”).  In the case of three (3) arbitrators,
each of BioMarin and Genzyme shall appoint one (1) arbitrator to the
Arbitration Panel and the third arbitrator shall be appointed by the two (2) arbitrators
appointed by BioMarin and Genzyme.  The
Arbitration Panel shall be convened upon delivery of the Notice of Arbitration
(as herein defined).  Any such
arbitration shall be held in Chicago, Illinois. 
The Arbitration Panel shall have the authority to grant specific
performance, and to allocate between the Parties the costs of arbitration in
such equitable manner as it shall determine. 
Judgment upon the award so rendered may be entered in any court having
jurisdiction or application may be made to such court for judicial acceptance
of any award and an order of enforcement, as the case may be.

 

13.8.2              Procedure.

 

(a)                                 Whenever
a Party (the “Claimant”) shall decide to
institute arbitration proceedings, it shall give written notice to that effect
(the “Notice of Arbitration”) to the other
Party (the “Respondent”).  The Notice of Arbitration shall set forth in
detail the nature of the Dispute, the facts upon which the Claimant relies and
the issues to be arbitrated (collectively, the “Arbitration
Issues”).  Within
fifteen (15) days of its receipt of the Notice of Arbitration, the
Respondent shall send the Claimant and the Arbitration Panel a written Response
(the “Response”).  The Response shall set forth in detail the
facts upon which the Respondent relies. 
In addition, the Response shall contain all counterclaims which the
Respondent may have against the Claimant which are within the Arbitration
Issues, whether or not such claims have previously been identified.  If the Response sets forth a counterclaim,
the Claimant may, within fifteen (15) days of the receipt of the
Response, deliver to the

 

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

 

47

 

Respondent and the Arbitration Panel a rejoinder
answering such counterclaim.

 

(b)                                 Within
fifteen (15) days after the later of (i) the expiration of the
period provided in Section 13.8.2(a) above
for the Claimant to deliver a rejoinder or (ii) the completion of any
discovery proceedings authorized by the Arbitration Panel:  (A) the Claimant shall send to the
Arbitration Panel a proposed resolution of the Arbitration Issues and a
proposed resolution of any counterclaims set forth in the Response, including
without limitation the amount of monetary damages, if any, or other relief
sought (the “Claimant’s Proposal”); and
(B) the Respondent shall send to the Arbitration Panel a proposed
resolution of the Arbitration Issues, a proposed resolution of any
counterclaims set forth in the Response and a proposed resolution of any
rejoinder submitted by the Claimant, including without limitation the amount of
monetary damages, if any, or other relief sought (the “Respondent’s
Proposal”).  Once both the
Claimant’s Proposal and the Respondent’s Proposal have been submitted, the
Arbitration Panel shall deliver to each Party a copy of the other Party’s
proposal.

 

(c)                                  The
Arbitration Panel shall issue an opinion with respect to any Dispute, which
opinion shall explicitly accept either the Claimant’s Proposal or the
Respondent’s Proposal in its entirety (the “Final
Decision”).  The Arbitration
Panel shall not have the authority to reach a Final Decision that provides
remedies or requires payments other than those set forth in the Claimant’s
Proposal or the Respondent’s Proposal. 
The concurrence of two (2) arbitrators shall be sufficient for
the entry of a Final Decision.  The
arbitrators shall issue a Final Decision within one (1) month from
the later of (i) the last day for submission of proposals under Section 13.8.2(b) above or (ii) the date of
the final hearing on any Dispute held by the Arbitration Panel.  A Final Decision shall be binding on both
Parties.

 

13.9                        Injunctive
Relief.  The Parties hereby
acknowledge that a breach of their respective obligations under Article 8 hereof may cause irreparable harm and that
the remedy or remedies at law for any such breach may be inadequate.  The Parties hereby agree that, in the event
of any such breach, in addition to all other available remedies hereunder, the
non-breaching Party or Parties shall have the right to seek equitable relief to
enforce Article 8 hereof.

 

13.10                 Entire Agreement.  This Agreement, together with the Related
Agreements, contains the entire understanding of the Parties with respect to
the subject matter hereof.  All express
or implied agreements and understandings, either oral or written, heretofore made
are expressly merged in and made a part of this Agreement.  This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by both Parties
hereto.  Each of the Parties hereby
acknowledges that this Agreement is

 

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

 

48

 

the result of mutual negotiation and therefore any
ambiguity in their respective terms shall not be construed against the drafting
Party.

 

13.11                 Bankruptcy
Provision.  All rights and licenses
now or hereafter granted under or pursuant to this Agreement, including Sections 12.3 and 12.4, are rights to “intellectual
property” (as defined in Section 101(35A) of Title 11 of the United States
Code, as amended (such Title 11, the “Bankruptcy Code”)).  The licensing Party hereby grants to the
licensee Party a right of access and to obtain possession of and to benefit
from (i) copies of research data, (ii) laboratory samples, (iii) product
samples, (iv) formulas, (v) laboratory notes and notebooks, (vi) data
and results related to clinical trials, (vii) regulatory filings and
approvals, (viii) rights of reference in respect of regulatory filings and
approvals, (ix) manufacturing procedure documentation and manufacturing
records, (x) marketing, advertising and promotional materials, and (xi)
all other embodiments of such intellectual property, that are in the licensing
Party’s possession or control, freely licenseable without further payment or
restriction by the licensing Party, and necessary for the licensee Party’s
exercise of the rights and licenses to such intellectual property, all of which
constitute “embodiments” of intellectual property pursuant to Section 365(n) of
the Bankruptcy Code.  The licensing Party
agrees not to interfere with the licensee’s exercise of rights and licenses to
intellectual property licensed under this Agreement and embodiments thereof in
accordance with this Agreement and agrees to use commercially reasonable and
diligent efforts to assist the licensee Party to obtain such intellectual
property and embodiments thereof in the possession or control of Third Parties
as reasonably necessary or desirable for the licensee Party to exercise such
rights and licenses in accordance with this Agreement.  The Parties acknowledge and agree that only
the payments due under Section 6.1,
as adjusted pursuant to this Agreement, constitute “royalties” within the
meaning of Bankruptcy Code §365(n).

 

13.12                 Headings.  The captions to the several Articles and
Sections hereof are not a part of this Agreement, but are merely guides or
labels to assist in locating and reading the several Articles and Sections
hereof.

 

13.13                 Independent
Contractors.  It is expressly agreed
that BioMarin and Genzyme shall be independent contractors and that the
relationship between the two Parties shall not constitute a partnership, joint
venture or agency.  Neither BioMarin nor
Genzyme shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the
other, without the prior consent of the other Party to do so.

 

13.14                 Waiver.  Except as expressly provided herein, the
waiver by either Party hereto of any right hereunder or of any failure to
perform or any breach by the other Party shall not be deemed a waiver of any
other right hereunder or of any other failure to perform or breach by said
other Party, whether of a similar nature or otherwise, nor shall any singular
or partial exercise of such right preclude any further exercise thereof or the
exercise of any other such right.

 

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

 

49

 

13.15                 Counterparts.  This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.  Signature pages may be exchanged by
facsimile.

 

[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.

 

50

 

IN WITNESS WHEREOF, the Parties have executed this
Agreement effective as of the date first set forth above.

 

	
   

  	
  GENZYME CORPORATION

  
	
   

  	
   

  
	
   

  	
  By:

  	
      /s/
  David P. Meeker

  
	
   

  	
   

  	
   

  
	
   

  	
  Print
  Name: David P. Meeker

  
	
   

  	
   

  
	
   

  	
  Title:
  President LSD Therapeutics

  
	
   

  	
   

  
	
   

  	
  Date:
  12/31/07

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  BIOMARIN PHARMACEUTICAL INC.

  
	
   

  	
   

  
	
   

  	
  By:

  	
      /s/
  G. Eric Davis

  
	
   

  	
   

  	
   

  
	
   

  	
  Print
  Name: G. Eric Davis

  
	
   

  	
   

  
	
   

  	
  Title:
  Vice President, General Counsel

  
	
   

  	
   

  
	
   

  	
  Date:
  12/31/07

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  BIOMARIN/GENZYME LLC

  
	
   

  	
   

  
	
   

  	
  By:

  	
  BIOMARIN
  PHARMACEUTICAL INC.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
      /s/
  G. Eric Davis

  
	
   

  	
   

  
	
   

  	
  Print
  Name: G. Eric Davis

  
	
   

  	
   

  
	
   

  	
  Title:
  Vice President, General Counsel

  
	
   

  	
   

  
	
   

  	
  Date:
  12/31/07

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  GENZYME
  CORPORATION

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
      /s/
  David P. Meeker

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Print
  Name: David P. Meeker

  
	
   

  	
   

  
	
   

  	
  Title:
  President LSD Therapeutics

  
	
   

  	
   

  
	
   

  	
  Date:
  12/31/07

  

 

[**] = 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
1.56

 

Third
Party Licenses

 

1.) License Agreement
effective as of September 4, 1998 entered into by and between the
University of Iowa Research Foundation, an Iowa corporation and
BioMarin/Genzyme LLC, a Delaware limited liability company.

 

2.) License Agreement
effective as of September 4, 1998 entered into by and between Research
Corporation Technologies, Inc., a Delaware nonprofit corporation and
BioMarin/Genzyme LLC, a Delaware limited liability company.

 

3.) Grant Terms and
Conditions Agreement dated April 1, 1997 entered into by and among
BioMarin Pharmaceuticals, Harbor-UCLA Research and Education Institute and Emil
D. Kakkis, as amended through the Effective Date.

 

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

 

 

Schedule
3.12

 

[**]

 

[**] = 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 A

 

[**]

 

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

 

 

Exhibit 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.Exhibit 10.3

 

	
  Notice
  of Grant of Award

  	
  GENZYME
  CORPORATION

  
	
  and
  Award Agreement

  	
  ID:
  06-1047163

  
	
   

  	
  500
  Kendall Street

  
	
   

  	
  Cambridge,
  MA 02142

  

 

 

	
  [First
  Name][Last Name]

  	
  Award
  Number:

  	
  [Grant
  Number]

  
	
  [Address
  Line 1]

  	
  Plan:

  	
  [Plan
  Number]

  
	
  [City],
  [State] [Zip][Country]

  	
  ID:

  	
  [Social
  Security]

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  

 

Effective
[Grant Date], you have been granted an award of [Share Number] restricted stock
units.  These units are restricted until
the vest date(s) shown below, at which time you will receive shares of
GENZYME CORPORATION (the Company) common stock.

 

The
current total value of the award is $[Dollar Amount].

 

The
award will vest in increments on the date(s) shown.

 

	
  Shares

  	
   

  	
  Full
  Vest

  
	
  [Share
  Number]

  	
   

  	
  [Grant
  Date]

  

 

These
awards are granted under and governed by the terms and conditions of the
Company’s Equity Plan as

amended
and the Award Agreement, all of which are attached and made a part of this
document.

 

 

GENZYME CORPORATION 2004 EQUITY INCENTIVE PLAN

Restricted Stock Unit Award Agreement

Tier I Retirement Eligible

 

                1.  Plan Incorporated by Reference. This
Restricted Stock Unit is issued pursuant to the terms of the Plan, as amended
or may be amended, and this Restricted Stock Unit Award Agreement (“Award
Agreement”), and may be amended as provided in the Plan. Capitalized terms used
and not otherwise defined in this Award Agreement have the meanings given to
them in the Plan. This Award Agreement does not set forth all of the terms and
conditions of the Plan, which are incorporated herein by reference. Copies of the
Plan may be obtained upon written request without charge from the Shareholder
Relations Department of the Company.

 

                2.  Vesting Schedule. The Participant
qualifies for a retirement eligible vesting schedule because the Participant
has reached, or by December 31, 2008 can reach, at least 60 years of age
and 5 years of service with the Company or its Affiliates.  Accordingly, the Participant’s right to
receive the number of shares of Stock set forth in the Notice of Grant of Award
associated with this Award Agreement (“Notice”) shall vest with respect to
one-third of such number of shares of Stock on each of the first three
anniversaries of the date of grant set forth in the Notice, provided that on
each such anniversary the Participant is then, and since the date of grant has
been continuously, employed by the Company or its Affiliates, unless otherwise
specified herein (each such anniversary, a “Vesting Date”).  Notwithstanding the preceding sentence, all
unvested shares of Stock subject to this Restricted Stock Unit shall vest, if
applicable, on such date as prescribed by sections 4 and 6 below and the
earliest of any such date to occur shall be the “Full Vesting Date.”

 

                3.  Delivery of Shares. As soon as
practicable after each respective Vesting Date for this Restricted Stock Unit,
and in no event later than March 15th of the calendar year following the
calendar year in which the respective Vesting Date occurs, the Company shall
deliver to the Participant, subject to sections 4 and 7 below, one-third of the
number of shares of Stock set forth in the Notice.  As soon as practicable after the Full Vesting
Date for this Restricted Stock Unit, and in no event later than March 15th
of the calendar year following the calendar year in which the Full Vesting Date
occurs, the Company shall deliver to Participant, subject to sections 4 and 7
below, all shares of Stock subject to this Award that vested on the Full
Vesting Date.  The provisions of this
section 3 and of section 2 shall not be construed as limiting the Administrator’s
right to accelerate the vesting for, and therefore the Vesting Date in respect
of, any portion of this Restricted Stock Unit or of the delivery of shares in
respect of any vested portion of this Restricted Stock Unit for any reason.

 

                4.  Recapitalization, Mergers, Etc. In the
event of a Covered Transaction, the Administrator may upon written notice to
the Participant provide that this Restricted Stock Unit shall terminate on a
date not less than 20 days after the date of such notice unless theretofore
vested. In connection with such notice, the Administrator may in its sole
discretion accelerate or waive any deferred vesting period.  Notwithstanding the foregoing, in the event
of a Change in Control of the Company (as defined in Participant’s employment
agreement) during Participant’s employment with the Company or its Affiliates,
this Restricted Stock Unit shall immediately vest as to all unvested shares
without regard to any deferred vesting period under section 2 above.  With respect to any portion of this
Restricted Stock Unit the vesting of which is accelerated under the immediately
preceding sentence, the date referred to in the last sentence of section 2
above shall be the date of the consummation of such Change in Control.

 

                5.  Restricted Stock Unit Not Transferable.
This Restricted Stock Unit is not transferable by the Participant otherwise
than by will or the laws of descent and distribution. The naming of a
Designated Beneficiary does not constitute a transfer.  A “Designated Beneficiary” means the
beneficiary designated by the Participant, in a manner determined by the
Administrator, to receive

 

 

amounts
due or vesting rights of the Participant in the event of the Participant’s
death.  In the absence of an effective
designation by the Participant, “Designated Beneficiary” means the Participant’s
estate.

 

                6.  Termination of Employment. If the
Participant’s employment with (a) the Company, (b) an Affiliate, or (c) a
corporation or other entity (or parent or subsidiary thereof) assuming this
Award or issuing a substitute equity-based award pursuant to the Plan
(collectively, “Group”), is terminated for any reason other than due to death,
as result of disability, or by the Group without cause, the Participant shall
not be entitled to any shares under this Restricted Stock Unit unless
theretofore vested, and the remainder of this Restricted Stock Unit shall be
immediately forfeited.  If Participant’s
employment is terminated upon Participant’s death or by the Group without cause
(as defined in Participant’s employment agreement), this Restricted Stock Unit
shall immediately vest as to all unvested shares without regard to any deferred
vesting period under section 2 above. 
With respect to any portion of this Restricted Stock Unit the vesting of
which is accelerated under the immediately preceding sentence, the date
referred to in the last sentence of section 2 above shall be the date of the
Participant’s death or termination of employment, as the case may be.  If Participant’s employment is terminated by
the Group as a result of disability (as defined in his employment agreement),
this Restricted Stock Unit shall vest as to all unvested shares on the earlier
of such termination and March 15th of the calendar year following the date
the Participant is determined by the Administrator to have such a disability,
all without regard to any deferred vesting period under section 2 above.  With respect to any portion of this
Restricted Stock Unit the vesting of which is accelerated under the immediately
preceding sentence, the date referred to in the last sentence of section 2
above shall be the earlier of the two dates described in the immediately
preceding sentence.

 

                7.  Tax Matters.

 

                (a) Withholding.  The Participant shall pay to the Company, or make
provision satisfactory to the Company for payment of any taxes required by law
to be withheld with respect to the vesting of this Restricted Stock Unit or the
delivery of shares hereunder.  The
Administrator may, in its sole discretion, require that a portion of the shares
of Stock that would have otherwise been delivered to the Participant upon
vesting of this Restricted Stock Unit be sold by the Participant or retained by
the Company to satisfy tax withholding and payment obligations, or in the case of
any taxes due upon vesting and prior to distribution that the number of shares
subject to this Restricted Stock Unit may be reduced to satisfy the tax
withholding and payment obligations. 
Such shares shall be valued at the Fair Market Value on the date of sale
if sold, or vesting if retained or reduced. 
All other terms of the sale or retention shall be determined by the
Administrator in its sole discretion. 
The Administrator may, in its sole discretion, require any other
federal, state or local taxes imposed on the sale of the shares to be paid by
the Participant.  In the Administrator’s
sole discretion, such additional tax obligations may be paid in whole or in
part in shares of Stock, including shares sold upon or retained from the
vesting of this Restricted Stock Unit, valued at their Fair Market Value on the
date of sale if sold, or of vesting if retained.  Any cash proceeds resulting from a sale of
Stock pursuant to this section 7 that are in excess of the taxes due shall be
paid to the Participant. The Company and its Affiliates may, to the extent
permitted by law, deduct any tax obligations from any payment of any kind
otherwise due to the Participant.

 

                (b) Section 409A.  The Participant acknowledges that the
Restricted Stock Unit is intended to qualify for the “short-term deferral”
exemption from Section 409A and shall be construed by the Administrator
accordingly.  Notwithstanding the
preceding sentence, neither the Group, nor the Administrator, nor any person
acting on behalf of any of them, shall be liable to the Participant by reason
of any acceleration of income, or any tax or additional tax, asserted by reason
of any failure of the Award or any portion thereof to

 

2

 

satisfy
the requirements for exemption from, or compliance with, Section 409A of
the Code.

 

(c) Section 4999.  Neither the Group, nor the Administrator, nor
any person acting on behalf of any of them, shall be liable to the Participant
by reason of any tax asserted under Section 4999 of the Code.

 

                8. Notice of Sale of Stock
Required.  The Participant agrees to
notify the Company in writing within 30 days of the disposition of any shares
of Stock received upon vesting of this Restricted Stock Unit if such
disposition occurs within two years of the date of the grant of this Restricted
Stock Unit or within one year after such vesting.

 

9.  Rights Limited.  The Administrator, in its sole discretion,
shall determine from the group of eligible persons whether an individual shall
be a Participant under the Plan.  Any
grant made under the Plan shall be made in the sole discretion of the
Administrator and no prior grant shall entitle a person to any future
grant.  Nothing in the Plan or any
Restricted Stock Unit grant will be construed as giving any person the right to
continued employment or service with the Group, or any rights as a shareholder
except as to shares of Stock actually issued under the Plan.  In no event shall the Plan, or any grant made
under the Plan, form a part of an employee’s or consultant’s contract of
employment or service, if any.  The loss
of existing or potential profit in Restricted Stock Units will not constitute
an element of damages in the event of termination of employment or service for
any reason, even if the termination is in violation of an obligation of the
Group to the Participant.

 

10.  Acceptance.  Failure of the Participant to accept the
terms and conditions of this Restricted Stock Unit in accordance with the
requirements of the Administrator can result in adverse consequences to the
Participant, including cancellation of the Restricted Stock Unit.

 

	
  ACKNOWLEDGED
  AND AGREED:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Participant
  Signature

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Participant
  Name (Print)

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Date

  	
   

  

 

3

 

GENZYME CORPORATION 2004 EQUITY INCENTIVE PLAN

Restricted Stock Unit Award Agreement

Tier I Not Retirement Eligible

 

1.  Plan Incorporated by Reference. This
Restricted Stock Unit is issued pursuant to the terms of the Plan, as amended
or may be amended, and this Restricted Stock Unit Award Agreement (“Award
Agreement”), and may be amended as provided in the Plan. Capitalized terms used
and not otherwise defined in this Award Agreement have the meanings given to
them in the Plan. This Award Agreement does not set forth all of the terms and
conditions of the Plan, which are incorporated herein by reference. Copies of
the Plan may be obtained upon written request without charge from the
Shareholder Relations Department of the Company.

 

2.  Vesting Schedule. The Participant’s
right to receive the number of shares of Stock set forth in the Notice of Grant
of Award associated with this Award Agreement (“Notice”) shall vest on the
earlier of (a) the third anniversary of the date of grant set forth in the
Notice or (b) if applicable, the earliest to occur of the dates prescribed
by sections 4 and 6 below, provided that the Participant is then, and since the
date of grant has been continuously, employed by the Company or its Affiliates,
unless otherwise specified herein (the earlier of the dates specified in (a) and
(b) shall be the “Vesting Date”).

 

3.  Delivery of Shares. As soon as
practicable after the Vesting Date for this Restricted Stock Unit, and in no
event later than March 15th of the calendar year following the calendar
year in which the respective Vesting Date occurs, the Company shall deliver to
the Participant, subject to sections 4 and 7 below, the number of shares of
Stock set forth in the Notice.  The
provisions of this section 3 and of section 2 shall not be construed as
limiting the Administrator’s right to accelerate the vesting for, and therefore
the Vesting Date in respect of, any portion of this Restricted Stock Unit or of
the delivery of shares in respect of any vested portion of this Restricted Stock
Unit for any reason.

 

4.  Recapitalization, Mergers, Etc. In the
event of a Covered Transaction, the Administrator may upon written notice to
the Participant provide that this Restricted Stock Unit shall terminate on a
date not less than 20 days after the date of such notice unless theretofore
vested.  In connection with such notice,
the Administrator may in its sole discretion accelerate or waive any deferred
vesting period.  Notwithstanding the
foregoing, in the event of a Change in Control of the Company (as defined in
Participant’s employment agreement) during Participant’s employment with the
Company or its Affiliates, this Restricted Stock Unit shall immediately vest as
to all shares without regard to any deferred vesting period under section 2 above,
and the date referred to in clause (b) of such section shall be the date
of the consummation of such Change in Control.

 

5.
 Restricted Stock Unit Not
Transferable. This Restricted Stock Unit is not transferable by the
Participant otherwise than by will or the laws of descent and distribution. The
naming of a Designated Beneficiary does not constitute a transfer.  A “Designated Beneficiary” means the
beneficiary designated by the Participant, in a manner determined by the
Administrator, to receive amounts due or vesting rights of the Participant in
the event of the Participant’s death.  In
the absence of an effective designation by the Participant, “Designated
Beneficiary” means the Participant’s estate.

 

6.  Termination of Employment. If the
Participant’s employment with (a) the Company, (b) an Affiliate, or (c) a
corporation or other entity (or parent or subsidiary thereof) assuming this
Award or issuing a substitute equity-based award pursuant to the Plan
(collectively, “Group”), is terminated for any reason other than due to death,
as result of disability, or by the Group without cause, the Participant shall
not be entitled to any shares under this Restricted Stock Unit unless
theretofore vested, and the remainder of this Restricted Stock Unit shall

 

 

 

be
immediately forfeited.  If Participant’s
employment is terminated upon Participant’s death or by the Group without cause
(as defined in Participant’s employment agreement), this Restricted Stock Unit
shall immediately vest as to all shares without regard to any deferred vesting
period under section 2 above, and the date referred to in clause (b) of
such section shall be the date of Participant’s death or termination of
employment, as the case may be.  If
Participant’s employment is terminated by the Group as a result of disability
(as defined in his employment agreement), this Restricted Stock Unit shall vest
as to all shares on the earlier of such termination and March 15th of the
calendar year following the date the Participant is determined by the
Administrator to have such a disability, all without regard to any deferred
vesting period under section 2 above, and the date referred to in clause (b) of
such section shall be the earlier of the two dates described in this sentence.

 

7.  Tax Matters.

 

(a) Withholding.  The Participant shall pay to the Company, or
make provision satisfactory to the Company for payment of any taxes required by
law to be withheld with respect to the vesting of this Restricted Stock Unit or
the delivery of shares hereunder.  The
Administrator may, in its sole discretion, require that a portion of the shares
of Stock that would have otherwise been delivered to the Participant upon
vesting of this Restricted Stock Unit be sold by the Participant or retained by
the Company to satisfy tax withholding and payment obligations, or in the case
of any taxes due upon vesting and prior to distribution that the number of
shares subject to this Restricted Stock Unit may be reduced to satisfy the tax
withholding and payment obligations.  Such
shares shall be valued at the Fair Market Value on the date of sale if sold, or
vesting if retained or reduced.  All
other terms of the sale or retention shall be determined by the Administrator
in its sole discretion.  The
Administrator may, in its sole discretion, require any other federal, state or
local taxes imposed on the sale of the shares to be paid by the
Participant.  In the Administrator’s sole
discretion, such additional tax obligations may be paid in whole or in part in
shares of Stock, including shares sold upon or retained from the vesting of
this Restricted Stock Unit, valued at their Fair Market Value on the date of
sale if sold, or of vesting if retained. 
Any cash proceeds resulting from a sale of Stock pursuant to this
section 7 that are in excess of the taxes due shall be paid to the Participant.
The Company and its Affiliates may, to the extent permitted by law, deduct any
tax obligations from any payment of any kind otherwise due to the Participant.

 

(b) Section 409A.  The Participant acknowledges that the
Restricted Stock Unit is intended to qualify for the “short-term deferral”
exemption from Section 409A and shall be construed by the Administrator
accordingly.  Notwithstanding the
preceding sentence, neither the Group, nor the Administrator, nor any person
acting on behalf of any of them, shall be liable to the Participant by reason
of any acceleration of income, or any tax or additional tax, asserted by reason
of any failure of the Award or any portion thereof to satisfy the requirements
for exemption from, or compliance with, Section 409A of the Code.

 

(c) Section 4999.  Neither the Group, nor the Administrator, nor
any person acting on behalf of any of them, shall be liable to the Participant
by reason of any tax asserted under Section 4999 of the Code.

 

8.
Notice of Sale of Stock Required. 
The Participant agrees to notify the Company in writing within 30 days
of the disposition of any shares of Stock received upon vesting of this
Restricted Stock Unit if such disposition occurs within two years of the date
of the grant of this Restricted Stock Unit or within one year after such
vesting.

 

9.  Rights Limited.  The Administrator, in its sole discretion,
shall determine from the group of eligible persons whether an individual shall
be a Participant under the Plan.  Any
grant made under the Plan shall be made in the sole discretion of the
Administrator and no prior grant shall entitle a person to any future
grant.  Nothing in the Plan or any
Restricted Stock Unit grant will be construed as giving any person the right to
continued

 

2

 

employment
or service with the Group, or any rights as a shareholder except as to shares
of Stock actually issued under the Plan. 
In no event shall the Plan, or any grant made under the Plan, form a
part of an employee’s or consultant’s contract of employment or service, if
any.  The loss of existing or potential
profit in Restricted Stock Units will not constitute an element of damages in
the event of termination of employment or service for any reason, even if the
termination is in violation of an obligation of the Group to the Participant.

 

10.  Acceptance.  Failure of the Participant to accept the
terms and conditions of this Restricted Stock Unit in accordance with the
requirements of the Administrator can result in adverse consequences to the
Participant, including cancellation of the Restricted Stock Unit.

 

	
  ACKNOWLEDGED
  AND AGREED:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Participant
  Signature

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Participant
  Name (Print)

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Date

  	
   

  

 

3

 

GENZYME CORPORATION 2004 EQUITY INCENTIVE PLAN

Restricted Stock Unit Award Agreement

Tier II Retirement Eligible

 

1.  Plan Incorporated by Reference. This
Restricted Stock Unit is issued pursuant to the terms of the Plan, as amended
or may be amended, and this Restricted Stock Unit Award Agreement (“Award
Agreement”), and may be amended as provided in the Plan. Capitalized terms used
and not otherwise defined in this Award Agreement have the meanings given to
them in the Plan. This Award Agreement does not set forth all of the terms and
conditions of the Plan, which are incorporated herein by reference. Copies of
the Plan may be obtained upon written request without charge from the
Shareholder Relations Department of the Company.

 

2.  Vesting Schedule. The Participant
qualifies for a retirement eligible vesting schedule because the Participant
has reached, or by December 31, 2008 can reach, at least 60 years of age
and 5 years of service with the Company or its Affiliates.  Accordingly, the Participant’s right to
receive the number of shares of Stock set forth in the Notice of Grant of Award
associated with this Award Agreement (“Notice”) shall vest with respect to
one-third of such number of shares of Stock on each of the first three
anniversaries of the date of grant set forth in the Notice, provided that on
each such anniversary, the Participant is then, and since the date of grant has
been continuously, employed by the Company or its Affiliates, unless otherwise
specified herein (each such anniversary, a “Vesting Date”).  Notwithstanding the preceding sentence, all
unvested shares of Stock subject to this Restricted Stock Unit shall vest, if
applicable, on the earlier to occur of the dates prescribed by sections 4 and 6
below (the earlier of these two dates shall be the “Full Vesting Date”).

 

3.  Delivery of Shares. As soon as
practicable after each respective Vesting Date for this Restricted Stock Unit,
and in no event later than March 15th of the calendar year following the
calendar year in which the respective Vesting Date occurs, the Company shall
deliver to the Participant, subject to sections 4 and 7 below, one-third of the
number of shares of Stock set forth in the Notice.  As soon as practicable after the Full Vesting
Date for this Restricted Stock Unit, and in no event later than March 15th
of the calendar year following the calendar year in which the Full Vesting Date
occurs, the Company shall deliver to Participant, subject to sections 4 and 7
below, all shares of Stock subject to this Award that vested on the Full
Vesting Date.  The provisions of this
section 3 and of section 2 shall not be construed as limiting the Administrator’s
right to accelerate the vesting for, and therefore the Vesting Date in respect
of, any portion of this Restricted Stock Unit or of the delivery of shares in
respect of any vested portion of this Restricted Stock Unit for any reason.

 

4.  Recapitalization, Mergers, Etc. In the
event of a Covered Transaction, the Administrator may upon written notice to
the Participant provide that this Restricted Stock Unit shall terminate on a
date not less than 20 days after the date of such notice unless theretofore
vested. In connection with such notice, the Administrator may in its sole
discretion accelerate or waive any deferred vesting period.  Notwithstanding the foregoing, in the event
of a Change in Control of the Company (as defined in a vote of the Compensation
Committee adopted May 29, 2002) during Participant’s employment with the
Company or its Affiliates, this Restricted Stock Unit shall immediately vest as
to all unvested shares without regard to any deferred vesting period under
section 2 above.  With respect to any
portion of this Restricted Stock Unit the vesting of which is accelerated under
the immediately preceding sentence, the date referred to in the last sentence
of section 2 above shall be the date of the consummation of such Change in
Control.

 

5.
 Restricted Stock Unit Not
Transferable. This Restricted Stock Unit is not transferable by the
Participant otherwise than by will or the laws of descent and distribution. The
naming of a Designated Beneficiary does not constitute a

 

 

 

transfer.  A “Designated Beneficiary” means the
beneficiary designated by the Participant, in a manner determined by the
Administrator, to receive amounts due or vesting rights of the Participant in
the event of the Participant’s death.  In
the absence of an effective designation by the Participant, “Designated
Beneficiary” means the Participant’s estate.

 

6.  Termination of Employment. If the
Participant’s employment with (a) the Company, (b) an Affiliate, or (c) a
corporation or other entity (or parent or subsidiary thereof) assuming this
Award or issuing a substitute equity-based award pursuant to the Plan
(collectively, “Group”), is terminated for any reason other than death, the
Participant shall not be entitled to any shares under this Restricted Stock
Unit unless theretofore vested and the remainder of this Restricted Stock Unit
shall be immediately forfeited.  Upon
Participant’s death during employment with the Group, this Restricted Stock
Unit shall immediately vest as to all unvested shares without regard to any
deferred vesting period under section 2 above. 
With respect to any portion of this Restricted Stock Unit the vesting of
which is accelerated under the immediately preceding sentence, the date
referred to in the last sentence of section 2 above shall be the date of
Participant’s death.

 

7.  Tax Matters.

 

(a) Withholding.  The Participant shall pay to the Company, or
make provision satisfactory to the Company for payment of any taxes required by
law to be withheld with respect to the vesting of this Restricted Stock Unit or
the delivery of shares hereunder.  The
Administrator may, in its sole discretion, require that a portion of the shares
of Stock that would have otherwise been delivered to the Participant upon
vesting of this Restricted Stock Unit be sold by the Participant or retained by
the Company to satisfy tax withholding and payment obligations, or in the case
of any taxes due upon vesting and prior to distribution that the number of
shares subject to this Restricted Stock Unit may be reduced to satisfy the tax
withholding and payment obligations. 
Such shares shall be valued at the Fair Market Value on the date of sale
if sold, or vesting if retained or reduced. 
All other terms of the sale or retention shall be determined by the
Administrator in its sole discretion. 
The Administrator may, in its sole discretion, require any other
federal, state or local taxes imposed on the sale of the shares to be paid by
the Participant.  In the Administrator’s
sole discretion, such additional tax obligations may be paid in whole or in
part in shares of Stock, including shares sold upon or retained from the
vesting of this Restricted Stock Unit, valued at their Fair Market Value on the
date of sale if sold, or of vesting if retained.  Any cash proceeds resulting from a sale of
Stock pursuant to this section 7 that are in excess of the taxes due shall be
paid to the Participant. The Company and its Affiliates may, to the extent
permitted by law, deduct any tax obligations from any payment of any kind
otherwise due to the Participant.

 

(b) Section 409A.  The Participant acknowledges that the
Restricted Stock Unit is intended to qualify for the “short-term deferral”
exemption from Section 409A and shall be construed by the Administrator
accordingly.  Notwithstanding the
preceding sentence, neither the Group, nor the Administrator, nor any person
acting on behalf of any of them, shall be liable to the Participant by reason
of any acceleration of income, or any tax or additional tax, asserted by reason
of any failure of the Award or any portion thereof to satisfy the requirements
for exemption from, or compliance with, Section 409A of the Code.

 

(c) Section 4999.  Neither the Group, nor the Administrator, nor
any person acting on behalf of any of them, shall be liable to the Participant
by reason of any tax asserted under Section 4999 of the Code.

 

8.
Notice of Sale of Stock Required. 
The Participant agrees to notify the Company in writing within 30 days
of the disposition of any shares of Stock received upon vesting of this
Restricted Stock Unit if such disposition occurs within two years of the date
of the grant of this Restricted Stock Unit or within one year after the date of
such vesting.

 

2

 

9.  Rights Limited.  The Administrator, in its sole discretion,
shall determine from the group of eligible persons whether an individual shall
be a Participant under the Plan.  Any
grant made under the Plan shall be made in the sole discretion of the
Administrator and no prior grant shall entitle a person to any future
grant.  Nothing in the Plan or any
Restricted Stock Unit grant will be construed as giving any person the right to
continued employment or service with the Group, or any rights as a shareholder
except as to shares of Stock actually issued under the Plan.  In no event shall the Plan, or any grant made
under the Plan, form a part of an employee’s or consultant’s contract of
employment or service, if any.  The loss
of existing or potential profit in Restricted Stock Units will not constitute
an element of damages in the event of termination of employment or service for
any reason, even if the termination is in violation of an obligation of the
Group to the Participant.

 

10.  Acceptance.  Failure of the Participant to accept the
terms and conditions of this Restricted Stock Unit in accordance with the
requirements of the Administrator can result in adverse consequences to the
Participant, including cancellation of the Restricted Stock Unit.

 

	
  ACKNOWLEDGED
  AND AGREED:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Participant
  Signature

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Participant
  Name (Print)

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Date

  	
   

  

 

3

 

GENZYME CORPORATION 2004 EQUITY INCENTIVE PLAN

Restricted Stock Unit Award Agreement

Tier II Not Retirement Eligible

 

1.  Plan Incorporated by Reference. This
Restricted Stock Unit is issued pursuant to the terms of the Plan, as amended
or may be amended, and this Restricted Stock Unit Award Agreement (“Award
Agreement”), and may be amended as provided in the Plan. Capitalized terms used
and not otherwise defined in this Award Agreement have the meanings given to
them in the Plan. This Award Agreement does not set forth all of the terms and
conditions of the Plan, which are incorporated herein by reference. Copies of
the Plan may be obtained upon written request without charge from the
Shareholder Relations Department of the Company.

 

2.  Vesting Schedule. The Participant’s
right to receive the number of shares of Stock set forth in the Notice of Grant
of Award associated with this Award Agreement (“Notice”) shall vest on the
earlier of (a) the third anniversary of the date of grant set forth in the
Notice or (b) if applicable, the earlier to occur of the dates prescribed
by sections 4 and 6 below, provided that the Participant is then, and since the
date of grant has been continuously, employed by the Company or its Affiliates,
unless otherwise specified herein (the earlier of the dates specified in (a) and
(b) shall be the “Vesting Date”).

 

3.  Delivery of Shares. As soon as
practicable after the Vesting Date for this Restricted Stock Unit, and in no
event later than March 15th of the calendar year following the calendar
year in which the respective Vesting Date occurs, the Company shall deliver to
the Participant, subject to sections 4 and 7 below, the number of shares of
Stock set forth in the Notice.  The
provisions of this section 3 and of section 2 shall not be construed as
limiting the Administrator’s right to accelerate the vesting for, and therefore
the Vesting Date in respect of, any portion of this Restricted Stock Unit or of
the delivery of shares in respect of any vested portion of this Restricted
Stock Unit for any reason.

 

4.  Recapitalization, Mergers, Etc. In the
event of a Covered Transaction, the Administrator may upon written notice to
the Participant provide that this Restricted Stock Unit shall terminate on a
date not less than 20 days after the date of such notice unless theretofore
vested.  In connection with such notice,
the Administrator may in its sole discretion accelerate or waive any deferred
vesting period.  Notwithstanding the
foregoing, in the event of a Change in Control of the Company (as defined in a
vote of the Compensation Committee adopted May 29, 2002) during
Participant’s employment with the Company or its Affiliates, this Restricted
Stock Unit shall immediately vest as to all shares without regard to any
deferred vesting period under section 2 above, and the date referred to in
clause (b) of such section shall be the date of the consummation of such
Change in Control.

 

5.
 Restricted Stock Unit Not
Transferable. This Restricted Stock Unit is not transferable by the
Participant otherwise than by will or the laws of descent and distribution. The
naming of a Designated Beneficiary does not constitute a transfer.  A “Designated Beneficiary” means the
beneficiary designated by the Participant, in a manner determined by the
Administrator, to receive amounts due or vesting rights of the Participant in
the event of the Participant’s death.  In
the absence of an effective designation by the Participant, “Designated
Beneficiary” means the Participant’s estate.

 

6.  Termination of Employment. If the
Participant’s employment with (a) the Company, (b) an Affiliate, or (c) a
corporation or other entity (or parent or subsidiary thereof) assuming this
Award or issuing a substitute equity-based award pursuant to the Plan
(collectively, “Group”), is terminated for any reason other than death, the
Participant shall not be entitled to any shares under this Restricted Stock
Unit unless theretofore vested and the remainder of this Restricted Stock Unit
shall be immediately forfeited.  Upon
Participant’s death during

 

 

 

employment
with the Group, this Restricted Stock Unit shall immediately vest as to all
unvested shares without regard to any deferred vesting period under section 2
above, and the date referred to in clause (b) of such section shall be the
date of Participant’s death.

 

7.  Tax Matters.

 

(a) Withholding.  The Participant shall pay to the Company, or
make provision satisfactory to the Company for payment of any taxes required by
law to be withheld with respect to the vesting of this Restricted Stock Unit or
the delivery of shares hereunder.  The
Administrator may, in its sole discretion, require that a portion of the shares
of Stock that would have otherwise been delivered to the Participant upon
vesting of this Restricted Stock Unit be sold by the Participant or retained by
the Company to satisfy tax withholding and payment obligations, or in the case
of any taxes due upon vesting and prior to distribution that the number of
shares subject to this Restricted Stock Unit may be reduced to satisfy the tax
withholding and payment obligations. 
Such shares shall be valued at the Fair Market Value on the date of sale
if sold, or vesting if retained or reduced. 
All other terms of the sale or retention shall be determined by the
Administrator in its sole discretion. 
The Administrator may, in its sole discretion, require any other
federal, state or local taxes imposed on the sale of the shares to be paid by
the Participant.  In the Administrator’s
sole discretion, such additional tax obligations may be paid in whole or in
part in shares of Stock, including shares sold upon or retained from the
vesting of this Restricted Stock Unit, valued at their Fair Market Value on the
date of sale if sold, or of vesting if retained.  Any cash proceeds resulting from a sale of
Stock pursuant to this section 7 that are in excess of the taxes due shall be
paid to the Participant. The Company and its Affiliates may, to the extent
permitted by law, deduct any tax obligations from any payment of any kind
otherwise due to the Participant.

 

(b) Section 409A.  The Participant acknowledges that the
Restricted Stock Unit is intended to qualify for the “short-term deferral”
exemption from Section 409A and shall be construed by the Administrator
accordingly.  Notwithstanding the preceding
sentence, neither the Group, nor the Administrator, nor any person acting on
behalf of any of them, shall be liable to the Participant by reason of any
acceleration of income, or any tax or additional tax, asserted by reason of any
failure of the Award or any portion thereof to satisfy the requirements for
exemption from, or compliance with, Section 409A of the Code.

 

(c) Section 4999.  Neither the Group, nor the Administrator, nor
any person acting on behalf of any of them, shall be liable to the Participant
by reason of any tax asserted under Section 4999 of the Code.

 

8.
Notice of Sale of Stock Required. 
The Participant agrees to notify the Company in writing within 30 days
of the disposition of any shares of Stock received upon vesting of this Restricted
Stock Unit if such disposition occurs within two years of the date of the grant
of this Restricted Stock Unit or within one year after the date of such
vesting.

 

9.  Rights Limited.  The Administrator, in its sole discretion,
shall determine from the group of eligible persons whether an individual shall
be a Participant under the Plan.  Any
grant made under the Plan shall be made in the sole discretion of the
Administrator and no prior grant shall entitle a person to any future
grant.  Nothing in the Plan or any
Restricted Stock Unit grant will be construed as giving any person the right to
continued employment or service with the Group, or any rights as a shareholder
except as to shares of Stock actually issued under the Plan.  In no event shall the Plan, or any grant made
under the Plan, form a part of an employee’s or consultant’s contract of
employment or service, if any.  The loss
of existing or potential profit in Restricted Stock Units will not constitute
an element of damages in the event of termination of employment or service for
any reason, even if the termination is in violation of an obligation of the
Group to the Participant.

 

10.  Acceptance.  Failure of the Participant to accept the
terms and conditions of this Restricted

 

2

 

Stock
Unit in accordance with the requirements of the Administrator can result in
adverse consequences to the Participant, including cancellation of the
Restricted Stock Unit.

 

	
  ACKNOWLEDGED
  AND AGREED:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Participant
  Signature

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Participant
  Name (Print)

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Date

  	
   

  

 

3

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