Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
        Exhibit 10.1      

COMMERCIAL SUPPLY AGREEMENT

          This Commercial Supply Agreement (this “Agreement”) is entered into as
of October 16, 2008, (the “Effective Date”) by and between Enzon
Pharmaceuticals, Inc., a Delaware corporation with an address of 685 Route
202-206, Bridgewater, New Jersey 08807 (“Enzon”), and Savient Pharmaceuticals,
Inc., a Delaware corporation, having its principal place of business at One
Tower Center, 14th Floor, East Brunswick, New Jersey 08816 (“Savient”). Enzon
and Savient may be referred to individually as a “Party” or collectively as
“Parties.”

R E C I T A L S

          WHEREAS, Savient is engaged in the development and research of certain
biologic products and requires manufacture of such a product for commercial
distribution;

          WHEREAS, Enzon is a contract manufacturer that possesses the necessary
technical capabilities and operates facilities for the manufacture of
pharmaceutical and biological products for commercial distribution;

          WHEREAS, Savient desires Enzon to supply to it the Product on the
terms and conditions set forth herein; and

          WHEREAS, Enzon is willing to supply the Product to Savient on the
terms and conditions set forth below.

          NOW, THEREFORE, in consideration of the mutual promises contained
herein, and for other good and valuable consideration, the receipt and adequacy
of which each of the Parties does hereby acknowledge, the Parties, intending to
be legally bound, agree as follows:

               Section 1.                                                   
DEFINITIONS

          1.1     As used herein, the following terms shall have the following
meanings:

          1.2     “Affiliate” shall mean any business entity which directly or
indirectly controls, is controlled by, or is under common control with any Party
to this Agreement. A business entity shall be deemed to “control” another
business entity if (i) it owns, directly or indirectly, at least fifty percent
(50%) of the issued and outstanding voting securities, capital stock, or other
comparable equity or ownership interest of such business entity, or (ii) it has
the de facto ability to control or direct the management of such business
entity.

          1.3     “Applicable Laws” means all relevant federal, state and local
laws, statutes, rules, and regulations which are applicable to a Party's
activities hereunder, including, without

 

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limitation, the applicable regulations of the Regulatory Authority, European
Medicines Agency (EMEA) and United States and European Union cGMPs. The Parties
may amend this section in writing to include additional countries.

          1.4     “BLA” means a regulatory application filed with a governmental
agency in a the United States, the European Union, or any other country that the
Parties mutually agree upon in writing (e.g. FDA and EMEA) for the purpose of
lawfully marketing, selling, distributing, importing, exporting, manufacturing,
developing or using a therapeutic or prophylactic product for the treatment or
prevention of a disease or physical condition. As used herein, BLA shall
include, without limitation, a Marketing Authorization Application in the
European Union, a Biologics License Application in the United States.

          1.5     “Bulk Product” shall mean the bulk solution of [**] supplied
by Savient to Enzon pursuant to this Agreement.

          1.6     “Commercially Reasonable Efforts” shall mean efforts in
accordance with the standards of care and diligence Enzon practices with respect
to its own products.

          1.7     “cGMPs” shall mean current good manufacturing practices as
promulgated by the FDA under the United States Food, Drug and Cosmetic Act, 21
C.F.R. Part 210 et seq., as amended from time to time, and the European Union.

          1.8     “Field Alerts” shall have the definition of field alerts used
by the FDA irrespective of the jurisdiction in which the acts or circumstances
giving rise to such field alerts occur.

          1.9     “Process Consumables” means media, resins, raw materials,
filters, membranes, product contact materials or surfaces, disposable lab
supplies and similar materials used in the manufacture of Product. Provided,
however, that Process Consumables shall not include components of manufacture
supplied by third parties such as labels (hereinafter referred to as
“Manufacture Components”).

          1.10   “Product” means pegloticase, a PEGylated recombinant mammalian
uricase formulation in final drug product form ready for commercial sale.

          1.11   “Quality Agreement” shall mean that certain Quality Agreement
by and between the Parties hereto, dated as of the date hereof and attached to
this Agreement

          1.12   “Regulatory Authority” shall mean any governmental agency with
jurisdiction over the regulation of drug and biological agents for use in man,
including, but not limited to, the United States Food and Drug Administration
and any foreign equivalents thereto.

          1.13   “Savient-supplied Materials” shall mean those materials
including, but not limited to Bulk Product, supplied by Savient for use in
connection with the manufacture of the Product, as set forth in the Work Plan
which is attached hereto as Exhibit A or any subsequent Work Plan signed by both
parties.

 

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          1.14   “Savient Intellectual Property” shall mean (i) all valid patent
claims owned or licensed by Savient and all converted provisionals, divisions,
continuations, continuations-in-part, reissues, reexaminations or extensions
thereof, as well as any corresponding foreign counterparts and equivalents
thereof, whether issued or pending as of the Effective Date or thereafter; (ii)
trademarks which are owned, licensed or sublicensed by Savient and which are
registered in the United States and, where applicable, foreign jurisdictions for
use in association with the Product; and (iii) any Savient Know-How developed by
Savient or any of its Affiliates during the Term relating to (a) the Bulk
Product or the Product (including, without limitation, its pharmaceutical
utility) or (b) the Services provided hereunder

          1.15   “Savient Know-How” shall mean all technical information, data
(including, without limitation, regulatory data) patentable and unpatentable
inventions, developments, discoveries, methods and processes that are, in each
case, not disclosed in a published patent application or patent or otherwise
publicly available, which are developed or conceived of by Savient or any of its
Affiliates or which is licensed to Savient or any of its Affiliates.

          1.16   “Service” means those services described in any Work Plan which
is made a part of this Agreement and those services described in any Quality
Agreement pertaining to such services.

          1.17   “Specifications” means the written specifications for the
Product and Savient-supplied Materials attached hereto as Exhibit B, which may
be amended from time to time by the mutual written agreement of the parties.

          1.18   “Work Plan” means the schedule and detailed plans used to
prepare formulated Bulk Product, fill Bulk Product into vials and package the
resulting drug product thereby resulting in the ultimate deliverable which is
the Product. The definition of Work Plan shall also include subsequent change
orders to any Work Plan (as described in Section 3.3) . The first Work Plan is
attached hereto as Exhibit A.

Section 2.    SERVICES

          2.1     Enzon shall perform the Services described in this Agreement
and in the exhibits hereto, which are made part of this Agreement, or as
described in any Work Plan, the Specifications, or change order pursuant to
Section 3.3. Savient shall provide such Savient-supplied Materials and make such
payments as are set forth therein. The Parties mutually acknowledge and agree
that nothing contained in this Agreement or any Work Plan executed hereunder
shall create an exclusive manufacture or supply arrangement between the Parties.

          2.2     To the extent necessary to enable Enzon to provide the
Services, Savient hereby grants to Enzon a royalty-free, non-exclusive license
and, where appropriate, sublicense, to use the Savient Intellectual Property
which pertains to the Product or the Services hereunder; provided, however, that
any license, or sublicense, granted herein as the case may be, shall be

 

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used by Enzon or any permitted sublicensee solely for the purposes of carrying
out the Services and no rights or title in or to the Savient Intellectual
Property shall vest in Enzon. Upon the expiration or earlier termination of this
Agreement the license or sublicense granted to Enzon to use Savient Intellectual
Property shall immediately cease and Enzon shall make no further use thereof and
shall cause any permitted sublicensee to make no further use thereof.

          2.3     Enzon agrees to provide the Services outlined in the Work Plan
attached hereto as Exhibit A which is incorporated and made a part of this
Agreement and any other Services that may be described in any future Work Plan
or change order, or Quality Agreement which addresses the Services described in
this Section 2, which shall be incorporated into this Agreement upon execution
by both parties. Such Services shall be performed in accordance with Applicable
Laws. Savient agrees to make payments in accordance with this Agreement and all
Work Plans. In the event of a conflict between this Agreement and any Work Plan,
this Agreement shall control.

          2.4     Enzon shall provide Savient, at no additional charge, product
support services, at Savient’s reasonable request, for the activities listed
below:

 * Meetings with Regulatory Authorities, whether in person or by phone

 * Routine documentation provided to Regulatory Authorities on behalf of Savient

 * Annual product reviews for commercial products, as required by Regulatory
   Authorities.

 * All audit correspondence including Savient-requested revisions to Enzon’s
   audit response.

Savient may request from Enzon other product support services at its customary
rate, as set forth on Exhibit C, including but not limited to:

 * Preparation of documents in anticipation of a Pre-Approval Inspection.

 * Letters of reference from Enzon or Enzon’s vendors that are requested by
   Savient (e.g., Master file reference letters, rubber or glass vendor
   letters).

 * Documentation provided to Regulatory Authorities on behalf of Savient, other
   than routine documentation.

 * All time used for collecting and photocopying Savient documentation. One copy
   of a batch record is exempted from support charges.

 * Changes and revisions to artwork mandated by Regulatory Authorities or
   requested by Savient.

 * Any additional validation work requested by Savient beyond original Work Plan
   or outside current validation requirements.

 * Any analytical development and/or analyses beyond original Work Plan.

For all requests under this Section 2.4, Savient shall provide Enzon a written
request for product support services that describes the required services and/or
documents/work product required. Enzon shall provide Savient an estimate based
on its customary rate. Upon acceptance of such

 

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estimate by Savient, Savient shall issue a purchase order to Enzon and Enzon
shall perform such services in accordance with the terms hereof.

          2.5     Enzon shall prepare and effect the Product shipment in
accordance with explict written instructions issued by Savient, which shall
include the packaging instructions and Savient’s selected mode of
transportation. All transportation costs shall be borne by Savient in accordance
with the terms contained herein.

Section 3.    MANAGEMENT/FORECASTING/MATERIALS

          3.1     Account Management. Each party will appoint an account manager
who will be the party responsible for overseeing the activities hereunder.

          3.2     Content of Work Plans. Each Work Plan shall include a
reasonably detailed description of the Services to be provided, relevant
Specifications, a schedule for completion of the Work Plan, a fee and payment
schedule, and such other information as is necessary for Enzon to perform the
relevant Services.

          3.3     Change Orders. In the event that Enzon is requested to perform
services that are outside the scope of agreed-upon Work Plans such changes must
be mutually agreed upon by the parties in a written change order prior to the
provision of said services. Each such change order constitutes an amendment to
the applicable Work Plan (which shall be explicitly referenced in such change
order) and the services set forth therein shall be deemed to be part of such
Work Plan. After receipt of the reasonably detailed description of the
additional services from Savient, Enzon shall provide Savient with a cost
estimate for performing the changed or additional services. Each change order
shall be governed by the terms and conditions of this Agreement and by such
supplementary written amendments of this Agreement or Work Plans as may be, from
time to time, executed between the parties.

          3.4     Forecasting And Savient-supplied Materials

                    (a)     Upon execution of this Agreement and on the first
day of each [**] thereafter, Savient shall deliver to Enzon’s account manager an
updated rolling forecast of Product requirements (in full-batch quantities) for
the [ *** ] period commencing on the first day of the immediately following
calendar month. Enzon shall, within ten (10) days of receipt of a forecast from
Savient, confirm its receipt thereof in writing and shall advise Savient of
whether such forecast is accepted in whole or in part; in the event that any
part of the forecast is not accepted by Enzon then Enzon shall detail in writing
the rationale for such non-acceptance. Within thirty (30) days of accepting each
forecast, Enzon will provide Savient a projected manufacturing schedule
indicating approximate dates of manufacturing which shall conform with the
delivery dates specified in the forecast supplied by Savient. The foregoing
notwithstanding, once a forecast (or any portion thereof) has been accepted by
Enzon it shall be binding on both parties except as otherwise may be explicity
set forth herein; in the event that Enzon neither accepts or rejects any
forecast submitted by Savient within ten (10) days of receipt

 

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from Savient then the entire forecast as submitted by Savient shall be deemed
accepted by Enzon. If accepted, the forecast for the [**] of each forecast
(“Firm Forecast”) shall be 100% binding on both parties and the forecast for the
next [**] (“Planning Forecast”) shall be binding on both parties as set forth in
the following sentence. Product requirements within the Planning Forecast shall
not be increased or decreased by Savient by more than [**] per [**] period, per
forecast, provided that no month may be reduced to [**] batches unless the
initial Planning Forecast for that particular month was initially set as [**]
batches; for purposes of clarification only, the parties agree that the
intention of this provision is to allow Savient, in each subsequent forecast, to
modify each [**] period of the most recently supplied Planning Forecast by [**]
as follows: the [**] period of the most recently provided Planning Forecast
(which becomes the [**] period of the Firm Forecast) may be modified by [**],
the [**] period of the Planning Forecast may be modified by [**], the [**]
period of the most recently provided Planning Forecast may be modified by [**]
and the [**] period of the most recently provided Planning Forecast may be
modified by [**]. Savient shall forecast Product requirements for the [**]
following the Planning Forecast, and the forecast for those [**] are non-binding
(“Non-Binding Forecast”) on Savient. Savient shall place firm purchase orders
for its requirement of the Product in full-batch quantities at least [**] prior
to the requested date of delivery. Each firm written purchase order, signed by
Savient’s duly authorized representative, shall authorize Enzon to manufacture
the number of batches of the Product as are set forth therein. The number of
purchase orders submitted by Savient shall not exceed [**] per calendar month,
unless otherwise agreed to by the parties in writing. Enzon shall have completed
any and all activities which are required by the applicable Work Plan and all
Applicable Laws so as to be able to deliver the Product on or before the
delivery dates specified by Savient in the subject purchase order but in any
event the Product shall not be delivered by Enzon more than [**] in advance of
any specified delivery date. Provided, however, that Enzon shall use
Commercially Reasonable Efforts to minimize the amount of time elapsing between
the completion of manufacturing activities and delivery of the completed Product
to Savient.

                    (b)     Starting from inception of the manufacture of the
Product, Savient shall supply to Enzon, and use Commercially Reasonable Efforts
to ensure that Enzon has on hand, a sufficient stock of Savient-supplied
Materials as is necessary to provide the Services. Enzon shall have no liability
for any failure to supply Product to Savient in accordance with the delivery
terms contained in a Savient purchase order if sufficient quantities of
Savient-supplied Materials in light of the forecasting described above have not
been supplied to Enzon at least four (4) weeks prior to the scheduled
manufacture date, as communicated to Savient pursuant to Section 3.4(a) . In
such case, manufacture of Product may be delayed until receipt of adequate
supplies of Savient-supplied Materials and the availability of an appropriate
manufacturing slot; provided, however, that Enzon shall use Commercially
Reasonable Efforts to schedule the manufacture of the Product as soon as is
possible subsequent to receiving the Savient-supplied Materials. If Savient
provides Enzon with insufficient Savient-supplied Materials to produce the
amount of Product requested in a particular purchase order, both sides may
nonetheless agree in writing to have Enzon produce a lesser amount based on the
amount of Savient-supplied Materials provided to Enzon, and all such batches
shall be subject to the pricing listed in Exhibit C, including the minimum batch
price, if applicable. Provided, however, that the Parties agree that any
shortfall on the part of Enzon to produce at least [**] vials of Product when
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least [**] of Bulk Product by Savient shall not constitute a breach of this
Agreement and that the the pricing for such shortfall below [**] vials) shall be
computed as set forth in Section 6.2(e) herein. Additionally, in the event that
any scheduled manufacture of the Product is delayed due to the unavailability of
adequate stores of Savient-supplied Materials, then any Firm Forecast then in
effect shall be carried forward until such a time as the manufacture and
delivery of the Product in accordance with the most recently supplied firm
purchase order have been completed. Savient shall be responsible for verifying
that all Savient-supplied Materials meet relevant Specifications. Title to
Savient-supplied Materials shall not be transferred to Enzon. Savient will
provide a signed, abbreviated Certificate of Analysis (“CofA”) which shall, at
minimum, certify that Savient-supplied Materials meet the Specifications for
such Savient-supplied Materials as defined on Exhibit B prior to the processing
of Savient-supplied Materials by Enzon. Enzon shall store all Savient-supplied
Materials and finished Product in accordance with instructions provided by
Savient in the Quality Agreement.

                    (c)     All costs associated with the selection and/or
qualification of alternative suppliers for any materials required to perform the
Services shall be borne by Savient. Any such activities will be defined by
Savient in writing an accompanied by an appropriate purchase order to Enzon.

                    (d)     Upon execution of this Agreement and along with
every [**] forecast, Savient shall pay Enzon a rolling, non-refundable
reservation fee equal to [**] (specifed on Exhibit C) price for batches included
in the Firm Forecast to secure manufacturing capacity slots corresponding to the
forecast provided. Savient shall pay such reservation fee to Enzon within ten
(10) days of Enzon’s provision to Savient of the manufacturing schedule, as set
forth in Section 3.4(a), which schedule sets forth the approximate dates of
manufacturing for the Product. Such reservation fee shall be credited towards
Product produced by Enzon on a batch-by-batch basis in a prorated amount.
Additionally, upon payment of the reservation fee by Savient, Enzon warrants
that manufacture of the Product shall occur on or before the dates specified in
the manufacturing schedule which conforms to the Firm Forecast for which the
reservation fee is paid. Upon shipment of each completed batch, Enzon will
invoice Savient at a rate equivalent to the applicable unit price multiplied by
the total number of vials produced less the applicable portion of any
reservation fees paid. No less than two weeks prior to each [**] update of the
Firm Forecast, Enzon and Savient will reconcile the invoices against the
above-mentioned reservation fee. In the event that Savient cancels any batch
within the Firm Forecast, Enzon will charge Savient, and Savient agrees to pay
to Enzon, a cancellation fee as set forth in the following sentence. For each
batch canceled by Savient, Savient will pay Enzon an amount equal to the minimum
batch price set forth on Exhibit C [**] representing unused Process Consumables
and Manufacturing Components), which amount shall represent liquidated damages
resulting from unused manufacturing capacity. In the event that Savient
postpones the manufacture of any batch scheduled during the Firm Forecast period
for a period of more than thirty (30) days, then Enzon will charge Savient, and
Savient agrees to pay to Enzon, a postponement fee as set forth in the following
sentence. For each batch postponed by Savient, Savient will pay Enzon an amount
equal to the minimum batch price set forth on Exhibit C [**] representing unused
Process Consumables and Manufacturing Components) which amount shall represent
liquidated damages resulting from unused manufacturing capacity. Only with
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batches which are postponed beyond the Firm Forecast, Savient will remit to
Enzon the amount drawn within 30 days, and that amount will be credited back to
the reservation fee. Enzon will draw the cancellation and postponement fee
amounts described above from the amounts previously remitted to Enzon as
reservation fees. In the event that any amounts owing to Enzon pursuant to this
Section exceed the amounts previously remitted to Enzon as reservation fees,
Enzon shall submit an invoice to Savient for the difference and Savient shall
submit payment for such invoiced amounts in accordance with the terms of this
Agreement.

Section 4.    COMPENSATION AND EXPENSES

          4.1     As compensation for rendering the Services hereunder, Savient
shall pay Enzon the amounts specified in Exhibit C and any subsequent additional
Work Plans executed in writing by both parties. Except as otherwise specifically
provided in the attached Work Plan or any subsequent additional Work Plan, all
payments by Savient shall be made within thirty (30) days of the date of its
receipt of the appropriate invoice from Enzon. Enzon will charge a late payment
fee of [**] per month, or the maximum amount permitted by law if less than [**],
for any payment not received within thirty (30) days of the date of Savient’s
receipt of the appropriate invoice from Enzon. Failure to invoice for interest
due shall not be a waiver of Enzon’s right to charge interest. Savient will pay
any sales, use, gross receipts or other taxes, licenses, or fees (excluding tax
based on Enzon’s net income) required to be paid by Enzon to any state or tax
jurisdiction in connection with the Services performed hereunder.

          4.2     All invoices and/or other requests for payment shall be
itemized with a reasonable degree of specificity to ensure accuracy in
accounting for services and/or goods provided and invoiced for. All invoices
and/or other requests for payment shall be sent to:

Accounts Payable
Savient Pharmaceuticals, Inc.
One Tower Center, 14th Floor
East Brunswick, New Jersey 08816

          4.3     Enzon will adjust prices not more often than annually,
commencing on January 1, 2010, based on normal and customary increases in costs,
not greater than the pharmaceutical Producer Price Index (as published by Bureau
of Labor Statistics, Industry Code 325412). Additionally, Enzon may revise the
prices provided in an attached Work Plan either upward or downward with
Savient’s prior written consent, such consent not to be unreasonably withheld,
if (i) any information which the parties reasonably agree is material to the
performance of the Services proves to be incomplete or inaccurate (including but
not limited to a material reduction in volume or a material change in prices of
Enzon’s raw materials), (ii) Savient revises Enzon’s manufacturing or packaging
responsibilities, procedures, or assumptions in a way that would impact the cost
of the Services, or (iii) unforeseen circumstances, which both parties
reasonably agree were unforeseeable at the time of contracting and which are not
directly attributable to Enzon, affect the activities required to complete the
Work Plan. Enzon will notify Savient immediately if the costs to complete
Services materially differ, either positively or negatively, from the prices
stated in the attached Work Plan. Enzon will not commence work involving

 

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charges in excess of those stated in the attached Work Plan without Savient’s
written approval unless such advance notice was not possible due to the
circumstances. Savient shall be responsible for all non-cancelable costs
incurred by Enzon as a direct result of any change order or other variation in
Services requested by Savient, including but not limited to, inventory rendered
unusable under the Work Plan; provided, however, that Enzon shall use
Commercially Reasonable Efforts to minimize any non-cancelable costs
contemplated herein including, but not limited to, by maintaining on hand only
such Manufacture Components which are reasonably required to manufacture such
quantities of Product as are specified in the Firm Forecast.

          4.4     Savient’s failure to pay for the amounts due under this
Agreement (including but not limited to payments under 3.4(d)) shall constitute
a material breach of this Agreement. Savient shall have 45 days from Enzon’s
written notice to cure such breach; provided, however, that Savient’s failure to
pay any amounts otherwise owing hereunder due to a good faith dispute relating
to such amounts shall not constitute a material breach only with respect to such
amounts. Upon the expiration of the stated cure period, Enzon shall have the
right to suspend any Services under this Agreement. Any batch cancellations
resulting from such actions will be billed to Savient in accordance with Section
3.4(d) .

Section 5.    CERTAIN REPRESENTATIONS, WARRANTIES, AND COVENANTS

OF ENZON:

          5.1     Authority. Enzon represents and warrants that it has full
authority to enter into this Agreement.

          5.2     Material/Supplies. Enzon shall use Savient-supplied Materials
only to perform the Services hereunder.

          5.3     Savient Intellectual Property. Enzon warrants that it shall
use Savient Intellectual Property only for the purpose of manufacturing the
Product on behalf of Savient in accordance with the terms of this Agreement.

          5.4     MVP Confidential Information. Enzon hereby represents and
warrants that, during the Term of this Agreement, it has not taken any action,
nor failed to take any action, which would violate or cause to be violated the
terms and conditions contained in the attached Exhibit E, which is incorporated
herein by reference. The warranty contained herein shall survive the termination
or expiration of the Agreement in accordance with the terms contained in the
attached Exhibit E. Anything to the contrary contained in this Agreement
notwithstanding, Enzon agrees that there shall be no limitation on the amount of
liability for which Enzon may be liable to either Savient or Mountain View
Pharmaceuticals, Inc., for breach of this Section 5.4.

          5.5     Books and Records. Enzon shall maintain true and accurate
books, records, test and laboratory data, reports and all other information
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required by regulation and in accord with current good manufacturing practices
(“cGMP”) and as set forth in the Quality Agreement.

          5.6     Regulatory Inspections. Enzon shall make its facilities and
all records relating to the Product manufacture available to the Regulatory
Authorities at times agreed with such authorities and shall notify Savient if
the Regulatory Authority begins or schedules an inspection of Enzon’s records,
facilities, or manufacturing processes related to the manufacture of Product and
provide Savient access to any documentation related to or resulting from the
inspection as described in the Quality Agreement.

          5.7     Debarment. Enzon hereby certifies it does not and shall not
employ, contract with or retain any person directly or indirectly to perform
services under this Agreement if such person is debarred under 21 U.S.C. 335a
(a) or (b) or other equivalent laws, rules, regulations or standards of any
other relevant jurisdiction.

          5.8     Regulatory Filings. Enzon will cooperate in providing to
Savient any non-confidential information in its control relating to this
Agreement or the Product that Savient may reasonably require in connection with
its regulatory or governmental filings, provided that such information shall be
provided in whatever form held by Enzon. If applicable, Enzon will provide a
letter permitting applicable Regulatory Authority to reference its relevant drug
master file.

          5.9     Product and Process. Enzon provides services to its customers
on a contractual fee-for-service basis. Enzon warrants that it will perform the
Services with due care and in accordance with agreed upon protocols and/or
specifications, the terms of this Agreement and any Work Plan hereunder,
generally prevailing industry standards and Applicable Laws. Enzon warrants that
its fill/finish process does not and will not infringe on the rights of any
third parties.

OF SAVIENT:

          5.10   Authority. Savient represents and warrants that it has full
authority to enter into this Agreement.

          5.11   Savient-supplied Materials. Savient represents, warrants and
covenants as follows: (i) all Savient-supplied Materials will be supplied not
later than four (4) weeks prior to a scheduled manufacturing date, as
communicated to Savient pursuant to Section 3.4(a), so as to enable Enzon to
complete manufacture and delivery of the Product in accordance with all
forecasts and firm purchase orders submitted by Savient and accepted by Enzon;
(ii) all Savient-supplied Materials shall meet all relevant specifications,
(iii) Savient shall take sole and exclusive responsibility for the quality and
sufficient supply of all such Savient-supplied Materials, including
responsibility for all testing and inspection of the same except to the extent
(if any) that Savient and Enzon agree that Enzon shall perform any such testing
and/or inspections in any Work Plan to this Agreement, and (iv) Enzon shall have
no liability for a loss of Savient-supplied Materials except as set forth in
Section 11.4.

 

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          5.12   IP Rights. Savient represents, warrants and covenants that
Savient has all the rights necessary, including the rights to the Savient
Trademarks, to permit Enzon to perform the Services hereunder without infringing
the intellectual property rights of any third party.

          5.13   Debarment. Savient hereby certifies it does not and shall not
employ, contract with or retain any person directly or indirectly to perform
services under this Agreement if such person is debarred under 21 U.S.C. 335a
(a) or (b) or other equivalent laws, rules, regulations or standards of any
other relevant jurisdiction.

Section 6.    ADDITIONAL PRODUCT SUPPLY TERMS

          6.1     Delivery. Delivery terms shall be FCA (Incoterms 2000) Enzon’s
manufacturing facility in Indianapolis, Indiana (or such other facility as the
Parties may agree upon); Product shall be delivered in accordance with the
timeframe set forth in the applicable purchase order. Title to Product and
Savient-supplied Materials shall remain vested with Savient at all times.

          6.2     Rejected Goods; Failure of Supply.

                    (a)     Except as provided for in Section 11.4, Savient’s
sole remedy for breach of Enzon’s warranty in Section 5.9 shall be to require
Enzon to re-perform the relevant services at Enzon’s cost.

                    (b)     Concurrent with Enzon’s delivery to Savient of any
Product contemplated hereunder, Enzon shall provide to Savient a written,
executed CofA demonstrating compliance of Product with all relevant
Specifications; such CofA may be transmitted to Savient via facsimile or
electronic mail. Promptly following receipt of Product, Savient shall have the
right but not the obligation to test such Product to determine compliance with
the Specifications. Savient shall notify Enzon in writing of any rejection of
Product based on any claim that the Product fails to meet Specifications within
thirty (30) days of delivery, after which point all unrejected Product shall be
deemed accepted. Any rightly rejected Product that does not meet the
Specifications shall, at Enzon’s sole discretion and expense, either (i) be
returned to Enzon within a reasonable period of time and relabeled or reworked
as permitted in the Marketing Authorizations and Specifications, if permitted by
the Applicable Laws, or (ii) be destroyed in accordance with Applicable Laws.

                    (c)     In the event that Enzon believes that Product has
been incorrectly rejected, Enzon may require that Savient provide to it Product
samples for testing. Enzon may retain and test the samples of Product retained
by it. In the event of a discrepancy between Savient’s and Enzon’s test results
such that one Party’s test results fall within relevant Specifications and the
other Party’s test results fall outside the relevant Specifications, or there
exists a dispute between the Parties over the extent to which such failure is
attributable to a given Party, the Parties shall cause an independent laboratory
or appropriate expert promptly to review records, test data and perform
comparative tests and/or analyses on samples of the alleged defective Product.
Such independent laboratory or expert shall be mutually agreed upon by the
Parties, and shall be of such national repute as to allow both Parties to
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or expert is sufficiently qualified to perform such analyses. The independent
laboratory’s results shall be in writing and shall be final and binding save for
manifest error. Unless otherwise agreed to by the Parties in writing, the costs
associated with such testing and review shall be borne by the Party against whom
the independent laboratory rules.

                    (d)     Enzon shall replace any rightly rejected Product as
promptly as practicable, using Commercially Reasonable Efforts to make available
manufacturing capacity, after the notice of such rejection, and in any case as
soon as reasonably possible after receiving such notice, provided that Savient
shall provide to Enzon sufficient quantities of Savient-supplied Materials at no
additional cost to Enzon. However, if the failure to meet Specifications is due
to defects in the Savient-supplied Materials (where such defects are not due to
any failure on the part of Enzon), or any other cause except Enzon’s failure to
perform the Services in accordance with this Agreement, Savient will pay the
full cost of the rejected batch.

                    (e)     The Parties agree that Savient shall supply variable
amounts of Bulk Product to Enzon for purposes of allowing Enzon to provide
Services to fill and finish such Bulk Product into Product; the Parties further
agree that.if Savient supplies to Enzon [**] or more of Bulk Product for a
single filling run that Enzon shall produce not less than [**] vials of Product;
if Enzon should fail to produce at least [**] vials of Product as indicated
herein, then Savient shall pay to Enzon an amount equal to the per-vial price
indicated on the attached Exhibit C multiplied by the actual number of vials
produced. In the event that Savient supplies less than [**] of Bulk Product to
Enzon for a single filling run, then Savient shall pay to Enzon the minimum
batch price indicated on Exhibit C attached hereto.

          6.3     Recall; Withdrawal; Modification; Complaints. Savient shall be
responsible for the cost of and all losses associated with any recall or product
withdrawal or modification; provided, however, that to the extent that any such
recall or product withdrawal is due to the gross negligence or willful
misconduct on the part of Enzon, then Enzon shall reimburse Savient for all
direct costs associated with such recall or withdrawal, in addition to any other
rights or remedies Savient may have, but in any case only to the extent
attributable to Enzon. Enzon shall reasonably cooperate with Savient in
connection with any recall, withdrawal, or modification, at the expense of
Savient except as otherwise provided for herein. Savient shall share with Enzon
all relevant information relating to any such recall, withdrawal, or
modification. In addition, Savient shall also promptly and fully detail for
Enzon any Product complaints or Field Alerts it receives insofar as any such
complaints relate to the Services rendered by Enzon hereunder. Enzon shall
cooperate with Savient to report any adverse events of which it becomes aware in
accordance with the terms of the Quality Agreement. Enzon shall only be
responsible for the testing and protocols set forth in the Work Plan and
Exhibits A and B, as applicable, and Savient is responsible for all other
testing and protocols.

Section 7.    TERM AND TERMINATION

          7.1     Term. This Agreement shall commence on the Effective Date and
shall remain in full force and effect unless terminated as provided herein.

 

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          7.2     Termination. Subsequent to the first (1st) anniversary of the
Effective Date of this Agreement, this Agreement may be terminated by either
party at any time by giving at least twenty-four (24) months prior written
notice to the other party as follows: either party may give notice to the other
party thirty (30) days prior to every such anniversary date. During the 24-month
period between the notice of termination and the effectiveness of such
termination, the Parties shall continue to cooperate with each other in good
faith to effectuate the purpose of this Agreement; specifically, and without
limitation, Savient may place, and Enzon shall accept and fulfill, forecasts and
purchase orders for the manufacture of Product, all in accordance with the terms
and conditions of this Agreement. During the pendency of the effective date of
the termination notice, Savient shall not reduce the final six (6) months of any
previously submitted forecast to [**] batches except if Enzon is the party which
is terminating this Agreement. For the purposes of clarification only, the
prohibition contained in the immediately preceding sentence shall not apply
where the final six (6) months of the most recently supplied forecast were
identified as having [**] batches at the time that the notice of termination was
provided. Except as provided for herein, if, at any time subsequent to the
tendering of a notice of termination pursuant to the terms herein, Savient
reduces any of the final six months of the forecast to [**] batches, Savient
shall pay Enzon a termination fee of $[**] per batch. Enzon shall use
Commercially Reasonable Efforts to minimize the incurrence of any additional
charges, fees or expenses which will not be utilized in the manufacture of the
Product on behalf of Savient prior to the effective date of termination of this
Agreement. Within thirty (30) days of the effective date of the termination of
this Agreement, Enzon shall provide to Savient any case reports, analyses and
other deliverables which were prepared by Enzon, if any, prior to the date of
termination and Enzon shall also provide Savient with a written itemized
statement of all Services performed by it hereunder and all costs incurred or
for which Enzon is obligated. In the event of termination pursuant to this
Section 7.2, Enzon shall be entitled to full payment for the Services actually
rendered by it hereunder and all non-cancelable costs incurred through the date
of termination. In addition to the foregoing, if Savient terminates this
Agreement or any Work Plan pursuant to this Section 7.2, Savient shall pay any
cancellation or postponement amounts set forth in Section 3.4(d); provided,
however, that Enzon shall use Commercially Reasonable Efforts to mitigate any
such cancellation or postponement amounts by scheduling, to the extent
practicable, additional third party manufacturing activities, with any such
mitigation accruing to the benefit of Savient and proportionately reducing any
cancellation or postponement amounts otherwise owing. If the amount already paid
by Savient to Enzon exceeds such amounts payable hereunder, Enzon shall refund
such excess to Savient and if such amounts payable are greater than the amounts
already paid by Savient to Enzon, then Savient shall pay the amount of such
shortfall to Enzon.

          7.3     This Agreement may also be terminated by either party upon
material default in performance of the other party, provided that any defaulting
party shall be given not less than ninety (90) days’ prior written notice of
default and the opportunity to cure the default during such period. In the event
this Agreement is terminated pursuant to this Section 7.3, Enzon shall be
entitled to full payment for the services provided by it hereunder (as set forth
in any Work Plan(s) made a part hereof) and all costs incurred through the date
of termination or for which Enzon is obligated as of the date of termination;
provided, however, that if Savient terminates this Agreement pursuant to this
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Enzon shall be entitled only to payment for such Services which it actually
rendered on behalf of Savient through the effective date of termination. In
addition to the foregoing, if Enzon terminates this Agreement or any Work Plan
pursuant to this Section 7.3, Savient shall pay any applicable cancellation or
postponement amounts set forth in Section 3.4(d); provided, however, that Enzon
shall use Commercially Reasonable Efforts to mitigate any such cancellation or
postponement amounts by scheduling, to the extent practicable, additional third
party manufacturing activities, with any such mitigation accruing to the benefit
of Savient and proportionately reducing any cancellation or postponement amounts
otherwise owing. If the amount previously paid by Savient exceeds such amount
payable hereunder, the excess shall be refunded to Savient and if such amounts
payable are greater than the amounts already paid by Savient to Enzon, then
Savient shall pay the amount of such shortfall to Enzon.

          7.4     In the event that Savient’s BLA for the Product is not
approved by the FDA, and where such disapproval is final or otherwise not
appealed by Savient, then either Party shall have the right, but not the
obligation, to terminate this Agreement upon the provision of thirty (30) days
notice to the other Party. In the event this Agreement is terminated pursuant to
this Section 7.4, Savient shall pay Enzon for packaging and labeling materials,
any unpaid amounts for manufactured batches, and any reservation fees or other
applicable cancellation or termination fees, provided that Enzon shall use
Commercially Reasonable Efforts to mitigate such fees.

          7.5     In the event that Savient’s BLA for the Product has not been
approved by April 2009, then this Agreement shall continue in force and effect
but any deliverables and obligations of the parties shall be held in abeyance
for up to 18 months so as to allow Savient to address any findings in such
approvable letter issued by the FDA and resubmit the subject BLA. Savient shall
pay any cancellation or postponement amounts set forth in Section 3; provided,
however, that Enzon shall use Commercially Reasonable Efforts to mitigate any
such postponement amounts by scheduling, to the extent practicable, additional
third party manufacturing activities, with any such mitigation accruing to the
benefit of Savient and proportionately reducing any cancellation or postponement
amounts otherwise owing. Savient shall provide to Enzon notice of its receipt of
an approvable letter from the FDA within five (5) business days of its receipt
of same. After said 18 months lapses, Enzon shall have the right to terminate
this agreement immediately and with no penalty, and Savient shall pay all
applicable cancellation and postponement amounts as set forth .

          7.6     This Agreement may be terminated immediately, upon written
notice, upon either party’s bankruptcy (voluntary or involuntary), insolvency,
or placing of either party’s business in the hands of a receiver.

          7.7     Survival. The rights and obligations of each Party which by
their nature survive the termination or expiration of this Agreement shall
survive the termination or expiration of this Agreement, including Sections 4,
6, 7, 8, 9, 10, 11, 14, and 15 (to the extent relevant). In addition, Enzon
hereby acknowledges that neither expiration nor termination of this Agreement
shall affect in any manner Savient’s right to manufacture and sell, or have
manufactured and sold, the Product.

 

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Section 8.    INTELLECTUAL PROPERTY

          8.1     Subject to Section 8.2, all Savient Intellectual Property
supplied to Enzon or developed by Enzon in the course of performing the Services
hereunder are owned by Savient. All information developed by Enzon and related
to the Bulk Product or the Product shall be disclosed to Savient promptly upon
discovery or development by Enzon. Savient shall have the right to make any use
of such information and Enzon agrees to execute any documents which may be
reasonably required to effectuate any assignment of inventorship contemplated by
this provision, at Savient’s expense. Following completion of the Services
outlined in any Work Plan, Enzon will insure the return of all client data or
other materials furnished to Enzon. Subject to Section 8.2, all intellectual
property rights subsisting in or relating to any calculations, data, methods,
specifications, papers, documents, and any other items, material or information
arising from the performance of the Services by Enzon under this Agreement are
vested in and are the sole property of Savient and Enzon shall execute any and
all documents reasonably requested by Savient in order to effectuate the intent
of this provision, at Savient’s expense.

          8.2     Enzon shall own all rights to any invention (whether or not
patentable) relating to manufacturing and analytical methods and processes
developed by Enzon in connection with Services performed hereunder that have
general use in biopharmaceutical manufacturing, to the extent not specific to
Savient’s Product, and to the extent not directed to or derived from any
pre-existing Savient Intellectual Property or MVP Confidential Information
(“Process Invention”); provided that the provisions of this Section 8.2 shall
not apply to manufacturing and analytical methods and processes developed by
Enzon at the direction of Savient. Except as specifically prohibited with
respect to MVP Confidential Information, Enzon reserves the right to use data
developed during the course of performing Services hereunder to support
applications, assignments or other instruments necessary to apply for and obtain
patent or other intellectual property protection with respect to Process
Inventions so long as no information which Enzon is required to keep
confidential under this Agreement or any other previously executed agreement
between the Parties relating to confidentiality of information is disclosed in
any such application, assignment, or other instrument without the prior consent
of Savient (not to be unreasonably withheld). For Process Inventions developed
by Enzon in connection with performing services hereunder, Enzon will grant to
Savient a perpetual, world-wide, royalty-free, non-exclusive license for Savient
to use such Process Inventions in the development and manufacture of the Savient
Products.

Section 9.    CONFIDENTIALITY

          9.1     For the duration of the Agreement and five (5) years
thereafter with respect to Savient Confidential Information (as defined below),
or, in the case of MVP Confidential Information (as defined below), for twenty
(20) years from the Effective Date of the Agreement, Enzon will not disclose,
without Savient’s written permission, any such Savient Confidential Information
or MVP Confidential Information, unless such disclosure: (i) is to an Affiliate,
agent, employee or consultant of Enzon that is under a similar obligation to
keep such information confidential and such disclosure is reasonably necessary
for the performance of the Services contemplated herein; (ii) is or becomes
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(iii) is disclosed by a third party entitled to disclose it; (iv) is already
known to Enzon as shown by its prior written records; or, (v) is required by any
law, rule, regulation, order, decision, decree, subpoena or other legal process
to be disclosed or in response to a request or order from a regulatory agency.
If such disclosure is requested by a regulatory agency or legal process, Enzon
will make all reasonable efforts to notify Savient of this request promptly
prior to any disclosure to permit Savient to oppose such disclosure by
appropriate legal action. Enzon shall use reasonable precautions to protect the
confidentiality of both Savient Confidential Information and MVP Confidential
Information in a manner that is comparable to precautions taken to protect is
own proprietary information. As used herein, “MVP Confidential Information”
means any Confidential Information that Savient provides, or has provided, to
Enzon which is specifically identified in writing as containing Mountain View
Pharmaceuticals, Inc.’s proprietary technology for the manufacture of PEGylated
uricase (Puricase®/pegloticase), specifically including the documents referenced
in Schedule A of the Second Amendment to the Agreement for Services between
Savient and Enzon dated October 31, 2006, which the Parties have agreed to in a
letter dated September 12, 2007, as containing Confidential Information
belonging to Mountain View Pharmaceuticals, Inc; “Savient Confidential
Information” means any Confidential Information provided by Savient to Enzon,
with the sole exception of MVP Confidential Information, during the term of the
Agreement.

          9.2     For the duration of the Agreement and five (5) years
thereafter with respect to Savient Confidential Information, or in the case of
MVP Confidential Information, for twenty (20) years from the Effective Date of
the Agreement, Enzon will not use such Confidential Information except in
connection with the performance of Services under the Agreement or any other
Agreement between Savient and Enzon related to Savient’s PEGylated uricase
(Puricase®/pegloticase) product and in particular represents and warrants that
it will not utilize such Confidential Information in the manufacturing of any
other product.

          9.3     For twenty (20) years from the Effective Date of the
Agreement, Savient will not disclose, without Enzon’s written permission, any
Confidential Information belonging to Enzon which is provided to Savient by
Enzon during the Term of the Agreement (“Enzon Confidential Information”) unless
such disclosure: (i) is to an affiliate, agent, employee or consultant of
Savient that is under a similar obligation to keep such information
confidential; (ii) is or becomes publicly available through no fault of Savient;
(iii) is disclosed by a third party entitled to disclose it; (iv) is already
known to Savient as shown by its prior written records; or, (v) is required by
any law, rule, regulation, order decision, decree, subpoena or other legal
process to be disclosed or in response to a request or order from a regulatory
agency. If such disclosure is requested by a regulatory agency or legal process,
Savient will make all reasonable efforts to notify Enzon of this request
promptly prior to any disclosure to permit Enzon to oppose such disclosure by
appropriate legal action. Savient shall use reasonable precautions to protect
the confidentiality of Enzon Confidential Information in a manner that is
comparable to precautions taken to protect its own proprietary information.

          9.4     If either Party shall be obliged to provide testimony or
records pertaining to the Confidential Information provided by the other in any
legal or administrative proceeding, then the Party which supplied the
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of-pocket costs therefore plus an hourly fee for its employees or
representatives equal to the internal fully burdened costs of such employee or
representative.

          9.5       For both Parties, “Confidential Information” shall mean and
include, without limitation, such types of information as: inventions, methods,
plans, processes, specifications, characteristics, raw data, analyses, equipment
design, trade secrets, costs, marketing, sales, and product performance
information, including patents and patent applications, grant applications,
notes, and memoranda, whether in writing or presented, stored or maintained
electronically, magnetically or by other means, which are disclosed by the
disclosing Party to the recipient Party in writing or in other tangible form and
marked "confidential" or, if disclosed orally (or in some other non-tangible
form), are identified as confidential to the recipient Party in writing within
sixty (60) days of such disclosure; provided, however, that failure to reduce
any verbal disclosure to writing shall not, in and of itself, vitiate the
confidential nature of such Confidential Information and provided, further, that
for the purposes of this Agreement, Confidential Information shall include any
and all such information exchanged between the Parties prior to the Effective
Date of this Agreement pursuant to the Confidentiality Agreement between the
Parties dated July 24, 2006.”

Section 10.    INSURANCE

          Each Party shall for the term of this Agreement and for two (2) years
after the last Product is delivered, obtain and maintain at its own cost and
expense from a qualified insurance company, comprehensive general liability
insurance including, but not limited to, contractual liability coverage and
standard product liability coverage in an amount commensurate with industry
standards. Savient shall for the term of this Agreement and for two (2) years
after the last Product is delivered, obtain and maintain at its own cost and
expense from a qualified insurance Savient, insurance coverage for losses of
inventory at Enzon’s facility prior to, and following manufacture of the
Product. At a Party’s request, the other Party shall provide it with proof of
such coverage.

Section 11.    INDEMNIFICATION AND LIMITS OF LIABILITY

          11.1     Without limiting Enzon’s rights under law or in equity,
Savient agrees to indemnify and hold harmless Enzon and its employees, directors
and agents from and against any loss, damage, cost and expense (including
without limitation attorneys’ fees and expenses) incurred in connection with any
claims, proceedings or investigations arising directly or indirectly from (a)
the manufacture, promotion, marketing, distribution or sale of the Product, (b)
use or exposure to Product or any material provided to Enzon by Savient, (c) use
of any Savient Intellectual Property provided by Savient to Enzon (but only in
cases where Savient has provided such Savient Intellectual Property for Enzon’s
use) or any infringement of the intellectual property rights of any third party
related to the Product, or (d) any breach of Savient’s representations and/or
warranties, except to the extent any such claim is the result of Enzon’s [**].

 

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          11.2     Without limiting Savient’s rights under law or in equity,
Enzon agrees to indemnify and hold harmless Savient and its employees, directors
and agents from and against any loss, damage, cost and expense (including
without limitation attorneys’ fees and expenses) incurred in connection with any
claims, proceedings or investigations arising out of or in connection with (a)
this Agreement and the Product produced and the Services rendered hereunder to
the extent that such claim, proceeding or investigation is based on the [**] of
Enzon or its employees, (b) any breach of Section 9.2 of this Agreement with
respect to MVP Confidential Information, (c) any breach of the representations
made by Enzon in the Letter Agreement between Enzon and Savient dated September
12, 2007, attached hereto as Exhibit E; but in any case only to the extent
attributable to Enzon.

          11.3     Any party seeking indemnification pursuant to this Section 11
(the “Indemnitee”) shall give notice within five (5) days to the party from whom
indemnification is sought (the “Indemnitor”) of any claim, proceeding or
investigation; provided, however, that any failure to notify the Indemnitor
within such five (5) day period shall not negate the rights of indemnification
granted hereunder except to the extent that the Indemnitor is actually
prejudiced by such delay in notification. The Indemnitee shall cooperate in the
defense of such claim, proceeding or investigation, subject to reimbursement by
the Indemnitor for all reasonable out-of-pocket expenses. The Indemnitor shall,
at its option, assume control of the defense of any such claim, proceeding or
investigation. The indemnities set forth in Sections 11.1 and 11.2 shall include
amounts paid in settlement provided, however, that no such settlement shall be
entered into without the Indemnitor’s consent, which consent shall not be
unreasonably withheld.

          11.4     As Savient’s sole remedy, Enzon agrees to reimburse Savient
up to a maximum of $[**] per batch, pro-rated over the usable portion of the
batch, if applicable, for any loss of Savient-supplied Materials for each batch
that does not meet Specifications or was not manufactured in accordance with the
Manufacturing Process or cGMP or the requirements of this Agreement, and
therefore cannot be released or otherwise utilized for its intended purpose;
provided that the loss of such materials can be shown after investigation to be
caused solely and directly by: (a) the failure of Enzon to follow its SOP’s; or
(b) Enzon’s negligence, gross negligence, willful misconduct, or breach of this
Agreement. In addition to this payment, if due to Enzon’s gross negligence,
willful misconduct, or breach of this Agreement, Enzon will re-perform the
Services as provided in Section 6.2(a) .

          11.5     SECTION 11.4 IS SAVIENT’S SOLE AND EXCLUSIVE REMEDY FOR ANY
LOSSES OF SAVIENT-SUPPLIED MATERIAL AS A RESULT OF PRODUCT THAT DOES NOT COMPLY
WITH THE SPECIFICATIONS OR THE OTHER REQUIRMENTS OF THIS AGREEMENT. UNDER NO
CIRCUMSTANCES SHALL ENZON BE LIABLE TO SAVIENT OR ANY THIRD PARTY FOR ANY
CONSEQUENTIAL, INDIRECT (INCLUDING LOST REVENUES OR PROFITS), SPECIAL, OR OTHER
DAMAGES, AND THE WARRANTY SET FORTH IN SECTION 5.9 IS THE SOLE AND EXCLUSIVE
WARRANTY AND IN LIEU OF ANY AND ALL OTHER WARRANTIES RELATING TO THE SERVICES TO
BE PERFORMED, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR FOR
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PROPERTY RIGHTS. ENZON’S MAXIMUM LIABILITY FOR DAMAGES IN CONNECTION WITH A
CLAIM RELATED TO THIS AGREEMENT, REGARDLESS OF THE CAUSE OF ACTION, WILL NOT
EXCEED THE SUM TOTAL OF THE AMOUNTS PAID BY SAVIENT TO ENZON IN THE PRECEEDING
TWELVE (12) MONTHS.

EXCEPT AS EXPRESSLY STATED HEREIN, NEITHER PARTY PROVIDES TO THE OTHER PARTY
HERETO ANY WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE SERVICES PROVIDED
HEREUNDER, AND ALL SUCH WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTIBILITY OR FITNESS FOR A PARTICULAR
PURPOSE ARE WAIVED, OTHER THAN AGREED HEREIN. WITHOUT LIMITING THE PROVISIONS OF
SECTION 5.9 AND 6.2(e), ENZON MAKES NO WARRANTIES THAT THE EXECUTION OF THIS
AGREEMENT WILL RESULT IN ANY SPECIFIC QUANTITY OR QUALITY OF PRODUCT.

Section 12.    PUBLICITY AND PUBLICATIONS

          Neither Savient nor Enzon shall make any news release or other public
statement, whether to the press or otherwise, disclosing the existence of this
Agreement, the terms thereof, or of any amendment thereto without the prior
written approval of the other Party, except as required by Applicable Laws
including, without limitation, those regulations promulgated by the United
States Securities and Exchange Commission.

Section 13.    FORCE MAJEURE AND CHANGE IN CIRCUMSTANCES

          If either Party shall be delayed or hindered in or prevented from the
performance of any act required hereunder by reason of strike, lockouts, labor
troubles, restrictive governmental or judicial orders or decrees, riots,
insurrection, war, terrorist acts, acts of God, inclement weather, or other
reason or cause reasonably beyond such Party’s control (each a “Force Majeure”),
then performance of such act shall be excused for the period of such Force
Majeure. The Party affected by the Force Majeure shall provide notice to the
other of the commencement and termination of the Force Majeure. Should a Force
Majeure continue for more than three (3) months, the Party unaffected by the
Force Majeure may terminate this Agreement upon prior written notice to the
affected Party. If the Force Majeure equally affects the ability of each Party
to perform under this Agreement, then such termination shall only be by mutual
written agreement. In the event of any other type of unforeseen material change
in circumstances (that does not qualify as force majeure), both parties agree to
negotiate in good faith to find a commercially reasonable solution.

Section 14.    NOTICES

          14.1     All administrative communications provided for in this
Agreement shall be sent via first class mail (subject to Section 14.2 below),
postage prepaid, addressed to the respective parties as follows:

 

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To Enzon:   To Savient   Executive Vice President, Operations   Vice President,
Technical Operations Enzon Pharmaceuticals, Inc.   Savient Pharmaceuticals, Inc.
685 Route 202/206   One Tower Center, 14th Floor Bridgewater, New Jersey 08807  
East Brunswick, NJ 08816 United States of America   United States of America  
With a copy to:       Legal Department   General Counsel Enzon Pharmaceuticals,
Inc.   Savient Pharmaceuticals, Inc. 685 Route 202/206   One Tower Center, 14th
Floor Bridgewater, New Jersey 08807   East Brunswick, NJ 08816 United States of
America   USA

          14.2     Original documents and other than routine correspondence
required under this Agreement shall be sent by certified mail and addressed to
the respective parties at the addresses set forth in Section 14.1. All legal
notices shall be in writing and sent by certified mail, return receipt
requested. Such notices shall be effective on receipt. All routine
correspondence between the Parties may be sent via electronic mail, facsimile or
by regular mail.

Section 15.    MISCELLANEOUS

          15.1     Amendments; Assignment. This Agreement, including any Work
Plans or other attachments, may not be altered, amended or modified except by a
written document signed by both Parties. Enzon will not assign this Agreement
without the prior written consent of Savient and any purported assignment in
contravention of this Section shall be null and void; provided, however, that
either Party may assign this Agreement in connection with the sale of all or
substantially all of its assets related to this Agreement or the Services to be
provided hereunder; provided, further, that any such successor or assignee
assumes and accepts in writing all obligations of the purported assigning party
hereunder.

          15.2     Subcontracting. Enzon may subcontract or delegate any of its
rights or obligations under this Agreement with the prior written authorization
of Savient, such authorization not to be unreasonably withheld. Enzon shall
cause any subcontractor to be subject by contract to the same restrictions,
exceptions, obligations, reports, termination provisions and other provisions
contained in this Agreement.

          15.3     Successors; Assigns. This Agreement shall be binding upon and
inure to the benefit of the Parties hereto and each of their respective
successors and permitted assigns.

          15.4     Severability. All agreements and covenants contained herein
are severable, and in the event any of them shall be held to be invalid by any
competent court, this Agreement shall be interpreted as if such invalid
agreements or covenants were not contained herein.

 

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          15.5     Entire Agreement. This Agreement, including the attached Work
Plans, constitutes the entire agreement between the Parties and supersedes all
prior communications, representations, or agreements, either verbal or written
between the Parties which are specifically related to the subject matter
contemplated herein; anything to the contrary notwithstanding, any previously
executed Confidentiality and Nondisclosure Agreement shall remain valid and
enforceable in accordance with its terms. Each Party confirms that it is not
relying on any representations or warranties of the other Party except as
specifically set forth herein.

          15.6     Independent Contractor. This Agreement shall not be deemed to
create any partnership, joint venture, or agency relationship between the
Parties. Each Party shall act hereunder as an independent contractor and its
agents and employees shall have no right or authority under this Agreement to
assume or create any obligation on behalf of, or in the name of, the other
Party. All persons employed by a Party shall be employees of such Party and not
of the other Party, and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such Party.

          15.7     Waiver. The waiver by either Party of any right hereunder
shall not be deemed a waiver of any other right hereunder.

          15.8     Counterparts. This Agreement may be executed in two (2) or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

          15.9     Headings. The headings used in this Agreement are for
convenience only and are not a part of this Agreement.

          15.10   Governing Law. This Agreement shall be construed and enforced
in accordance with the laws of the State of New Jersey, without application of
its principles of conflict of laws.

          15.11   Audits. Once each calendar year during the term of this
Agreement, Savient and its agents and designees shall have the right to audit
Enzon’s facilities, systems, records solely related to this Agreement or the
Product. Such audits may be conducted upon reasonable notice during the term of
this Agreement, so long as (i) all auditors have entered into confidentiality
agreements relating to the materials to be reviewed, (ii) no materials are
removed from the premises of Enzon, provided, however, that Savient may make and
retain copies of Enzon materials as may be reasonably necessary solely for
purposes of completing the contemplated audit and any such materials shall be
considered confidential, and (iii) a copy of all findings is provided to Enzon.
All costs for such audits shall be paid by Savient. For the avoidance of doubt,
pre-approval inspections shall be considered an audit under this Section 15.11.
Anything to the contrary notwithstanding, in the event that an audit is required
due to batch failures or because the Services are not rendered in accordance
with the terms of this Agreement (including any Work Plan), then such for-cause
audit shall not count towards the annual audit provided for herein.

 

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          15.12   Nonsolicitation. For the term of this Agreement, and for
twelve (12) months following termination of this Agreement, for any reason,
neither Savient nor Enzon nor any of their employees or agents shall, directly
or indirectly, solicit any employees of the other, who have been involved in the
Services, unless otherwise approved by the other party.

          IN WITNESS WHEREOF, each of the Parties hereto has caused this
Commercial Supply Agreement to be executed by its duly authorized representative
as of the date written above.

ENZON PHARMACEUTICALS, INC.   SAVIENT PHARMACEUTICALS, INC.     By:
  /s/ Ralph del Campo
  By:
 /s/ Philip K. Yachmetz
  Ralph del Campo     Philip K. Yachmetz   EVP - Operations     EVP & Chief
Business Officer

 

 

 

 

 

 

 

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Exhibit A

Work Plan

Enzon will fill, inspect, package and test the Product using the components
defined below and the process as outlined on the following Process Flow Diagram.

   [**]

 

   [**]

 

 

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[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

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Exhibit B

Final Product Release Specifications
 
Parameter
 
Test Method
 
Specification
  [**]   [**]   [**]   [**]   [**]   [**]   [**]   [**]   [**]     [**] [**]

 

In-Process Product Specifications
 
Parameter
 
Test Method
 
Specification
  [**]   [**]   [**]   [**]   [**]   [**]   [**]   [**]   [**]

 

 

 

 

 

 

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Exhibit C

Product Price

Commercial Manufacturing
  Price   Activitites Included   $[**]  per vial       •      Prepare Master
Batch Records     • Materials to be packed with one vial and product insert per
carton. The minimum price per batch of   • Commercial Batch Prices are effective
on 1 January 2008, and are $[**]  shall apply in accordance     effective
through 31 December 2009. with the terms of Section 6.2(e) of   • Enzon reserves
the right to increase prices pursuant to the terms of the the Agreement.    
Supply Agreement.     • Release testing of batches; provision of CoA     •
Supply temperature recorders to Drug Substance manufacturer for       shipping.
Download and provide temperature data to Savient.  

Puricase Final Drug Product Stability test Schedule at [**] [**] Price is per
each lot tested Setup &   Initial Test      

              Total Cost Initiation   [**] [**] [**] [**] [**]   Fee            
  $[**]   $[**]   [**]   [**]   $[**]   $[**]   $[**]   $[**] Puricase Final
Drug Product Stability test Schedule at [**] Price is per each lot tested Setup
&   Initial Test      

              Total Cost Initiation   [**] [**] [**] [**]     Fee              
$[**]       $[**]   $[**]   $[**]   $[**]       $[**]

Stability studies will be conducted on batches requested in advance by Savient.
Prices will be in effect for stability studies initiated on 2008 or 2009 and
subject to review at the end of 2009.

Professional Services Fee Structure
  Price       • One (1) man-hour   $[**]               Enzon to update prices on
or       about January 1 of every year

Terms: Purchase Orders are required for each scheduled batch.

 * Invoice for vials produced will be sent upon shipment of materials. Payment
   due net 30 days.

 * Delivery terms are FCA Enzon’s manufacturing facility in Indianapolis, IN

 * Cancelled and postoponed batches shall be billed in accordance with Section
   3.4(d).

 

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Exhibit D

Product Forecast

Savient has provided the following forecast for the [**]  period beginning
October 2008.

[**]

 

 

 

 

 

 

 

 

 

 

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Exhibit E

Letter Agreement

September 12, 2007

PHILIP K. YACHMETZ
Executive Vice President
Chief Business Officer

732-418-9300 Main
732-565-4705 Direct
732-418-9065 Fax
pyachmetz@savientpharma.com

Our Ref: pky/jmw

Enzon Pharmaceuticals, Inc.
Attn: Thomas J. Puskar
685 Route 202/206
Bridgewater, New Jersey 08807

            Re:      Second Amendment to Agreement for Services (“Agreement”)
between Savient     Pharmaceuticals, Inc. (“Savient”) and Enzon Pharmaceuticals,
Inc. (“Enzon”)     dated October 31, 2006 and as amended on June 15, 2007

Dear Mr. Puskar:

Pursuant to Section 13.01 of the Agreement, Savient and Enzon hereby agree to
amend the Agreement by repealing Section 4: Confidentiality and replacing it as
follows:

“4.01:      For the duration of the Agreement and five (5) years thereafter with
respect to Savient Confidential Information (as defined below), or, in the case
of MVP Confidential Information (as defined below), for twenty (20) years from
the Effective Date of the Agreement, Enzon will not disclose, without Savient’s
written permission, any such Savient Confidential Information or MVP
Confidential Information, unless such disclosure: (i) is to an affiliate, agent,
employee or consultant of Enzon that is under a similar obligation to keep such
information confidential and such disclosure is reasonably necessary for the
performance of the Services contemplated herein; (ii) is or becomes publicly
available through no fault of Enzon; (iii) is disclosed by a third party
entitled to disclose it; (iv) is already known to Enzon as shown by its prior
written records; or, (v) is required by any law, rule, regulation, order
decision, decree, subpoena or other legal process to be disclosed or in response
to a request or order from a regulatory agency. If such disclosure is requested
by a regulatory agency or legal process, Enzon will make all reasonable efforts
to notify Savient of this request promptly prior to any disclosure to permit
Savient to oppose such disclosure by appropriate legal action. Enzon shall use
reasonable precautions to protect the confidentiality of both Savient
Confidential Information and MVP Confidential Information in a manner that is
comparable to precautions taken to protect its own proprietary information. As
used herein, “MVP Confidential Information” means any Confidential Information
that Savient provides, or has provided, to Enzon which is specifically
identified in writing as containing Mountain View Pharmaceuticals, Inc.’s
proprietary technology for the manufacture of PEGylated uricase

Cont…/…

 

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Enzon Pharmaceuticals, Inc
September 12, 2007

(Puricase®/pegloticase), specifically including the documents referenced in the
attached Schedule A, which the Parties have agreed to in a letter dated
September 12, 2007, as containing Confidential Information belonging to Mountain
View Pharmaceuticals, Inc; “Savient Confidential Information” means any
Confidential Information provided by Savient to Enzon, with the sole exception
of MVP Confidential Information, during the Term of the Agreement.

4.02      For the duration of the Agreement and five (5) years thereafter with
respect to Savient Confidential Information, or in the case of MVP Confidential
Information, for twenty (20) years from the Effective Date of the Agreement,
Enzon will not use such Confidential Information except in connection with the
performance of Services under the Agreement or any other Agreement between
Savient and Enzon related to Savient’s PEGylated uricase (Puricase®/pegloticase)
product and in particular represents and warrants that it will not utilize such
Confidential Information in the manufacturing of any other product.

4.03      For twenty (20) years from the Effective Date of the Agreement,
Savient will not disclose, without Enzon’s written permission, any Confidential
Information belonging to Enzon which is provided to Savient by Enzon during the
Term of the Agreement (“Enzon Confidential Information”) unless such disclosure:
(i) is to an affiliate, agent, employee or consultant of Savient that is under a
similar obligation to keep such information confidential; (ii) is or becomes
publicly available through no fault of Savient; (iii) is disclosed by a third
party entitled to disclose it; (iv) is already known to Savient as shown by its
prior written records; or, (v) is required by any law, rule, regulation, order
decision, decree, subpoena or other legal process to be disclosed or in response
to a request or order from a regulatory agency. If such disclosure is requested
by a regulatory agency or legal process, Savient will make all reasonable
efforts to notify Enzon of this request promptly prior to any disclosure to
permit Enzon to oppose such disclosure by appropriate legal action. Savient
shall use reasonable precautions to protect the confidentiality of Enzon
Confidential Information in a manner that is comparable to precautions taken to
protect its own proprietary information.

          4.04     

If either Party shall be obliged to provide testimony or records pertaining to
the Confidential Information provided by the other in any legal or
administrative proceeding, then the Party which supplied the Confidential
Information shall reimburse the other Party for its out-of-pocket costs
therefore plus an hourly fee for its employees or representatives equal to the
internal fully burdened costs of such employee or representative.

Cont…/…

 

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Enzon Pharmaceuticals, Inc
September 12, 2007

4.05.      For both Parties, “Confidential Information” shall mean and include,
without limitation, such types of information as: inventions, methods, plans,
processes, specifications, characteristics, raw data, analyses, equipment
design, trade secrets, costs, marketing, sales, and product performance
information, including patents and patent applications, grant applications,
notes, and memoranda, whether in writing or presented, stored or maintained
electronically, magnetically or by other means, which are disclosed by the
disclosing Party to the recipient Party in writing or in other tangible form and
marked “confidential” or, if disclosed orally (or in some other non-tangible
form), are identified as confidential to the recipient Party in writing within
sixty (60) days of such disclosure; provided, however, that failure to reduce
any verbal disclosure to writing shall not, in and of itself, vitiate the
confidential nature of such Confidential Information and provided, further, that
for the purposes of this Agreement, Confidential Information shall include any
and all such information exchanged between the Parties prior to the effective
date of this Agreement pursuant to the Confidentiality Agreement between the
Parties dated July 24, 2006.”

To signify your acceptance of this Amendment, kindly countersign and return one
copy to my attention.

Should you have any questions, please do not hesitate to contact John Petrolino
at (732) 565-4655.

Very truly yours,

/s/ Philip K. Yachmetz

Philip K. Yachmetz
Executive Vice President
Chief Business Officer

I hereby agree to the terms and conditions
contained herein.
Enzon Pharmaceuticals, Inc.

 

By: /s/ Thomas J. Puskar Name:    Thomas J. Puskar Title: Associate Director
Business Development Date: 09/17/08

 

 

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Enzon Pharmaceuticals, Inc
September 12, 2007

SCHEDULE A

List of Confidential Documents identified pursuant to
Section 4.01 of this Agreement in the letter of September 12, 2007

1.)         [**] 2.) [**] 3.) [**] 4.) [**]

 

 

 

 

 

 

 

 

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Exhibit F

QUALITY AGREEMENT

Quality Technical Agreement for:

PRODUCT: Puricase® (PEG-Uricase)
DOSAGE/FORM: 8 mg/ml per vial

This Quality Agreement shall be read in conjunction with a commercial Supply
Agreement between ENZON and SAVIENT (“Supply Agreement”), dated as of October
16, 2008 and is incorporated into the Supply Agreement. Capitalized terms not
defined herein shall have the respective meanings set forth in the Supply
Agreement. The effective date of this Quality Agreement shall be the Effective
Date of the Supply Agreement.

This Quality Agreement defines the duties of ENZON and SAVIENT for the contract
pharmaceutical manufacture of Product. In particular this Quality Agreement
clearly states who is responsible for the cGMP aspects of manufacturing and
specifies the way in which the Party releasing Product for sale ensures that the
Product complies with the approved Product Specifications (defined below) and
the Marketing Authorizations (defined below).

          This Quality Agreement takes the form of a detailed checklist of all
the activities associated with pharmaceutical production, analysis, release, and
distribution. Responsibility for each activity is assigned to either ENZON or
SAVIENT in the appropriate box in the Delegation Responsibility Checklist which
follows.

In order to provide better quality assurance, ENZON will perform the activities
defined herein in accordance with its Standard Operating Procedures (defined
below) to the extent that a Standard Operating Procedure is applicable to such
activity.

This Agreement is subject to the terms of the Supply Agreement. A breach of this
Quality Agreement shall be deemed a breach of the Supply Agreement. In the event
of a conflict between this Quality Agreement and the Supply Agreement, the
Supply Agreement shall control.

This Quality Agreement is intended to comply with the guidance and directives
set forth in the current versions and effective amendments of (i) FDA Guidance
for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics,
August 1999; (ii) 21 CFR 210 & 211 and applicable portions of 21 CFR 600 through
610; and (iii) European Commission Directive 91/356 down the principles and
guidelines of good manufacturing practice for medicinal Products for human use.
This will be made accessible to relevant regulatory authorities if required by
them.

 

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[signature page follows]

 

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The Parties have caused their duly authorized representatives to executed this
Quality Agreement, effective as of October 16, 2008.

                     SAVIENT PHARMACEUTICALS, Inc.   ENZON PHARMACEUTICALS, Inc.
    /s/ Robert Lamm   /s/ Christian W. Dreyer Signature   Signature   Robert
Lamm    Christian W. Dreyer Printed Name   Printed Name   SVP, QA, RA    V.P. Q
Ops Title   Title   10/16/08    10/21/08 Date             10/16/08   Date

 

 

 

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For purposes of this Quality Agreement, the following definitions shall apply:

A.     

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

  B.     

“Marketing Application” shall mean an application for Product marketing
authorization which has not yet been approved by the FDA or other regulatory
authority, including, without limitation, FDA New Drug Application, FDA
Biologics License Application, and other similar marketing applications
promulgated by regulatory authorities.

  C.     

“Marketing Authorizations” shall mean any approved application for Product
marketing authorization, including, without limitation, FDA New Drug
Application, FDA Biologics License Application, and other similar marketing
authorizations promulgated by international regulatory authorities.

  D.     

"Process" or "Processing" shall mean the sterile compounding, filling, producing
and/or packaging of the raw materials into Product in accordance with the
Product Specifications and the terms and conditions set forth in the Supply
Agreement and this Quality Agreement.

  E.     

“Product Specifications” shall mean the procedures, requirements,
specifications, standards, quality control testing, other data and scope of
Supply related to the Product, as set forth in the Project Plan and/or attached
hereto. ENZON shall not release Product if these parameters are not met and
investigation shows the non-complying parameter to be a valid test result.

  F.     

“Standard Operating Procedures” or “SOPs” shall mean the standard operating
procedures in effect at ENZON which have been approved by ENZON Quality
Assurance department and which are applicable to the Processing; provided that
all Standard Operating Procedures applicable to the Processing or the Product
shall also be approved by SAVIENT.

  G.     

“Bulk Product” shall mean the bulk solution of [**] supplied by Savient to Enzon
pursuant to this agreement.

  H.     

“Business Day” shall mean Monday through Friday excluding government holidays.

  I.     

“Component” shall mean all packaging materials utilized during manufacture,
including all primary and secondary packaging materials.

  J.     

“Deviation” shall mean any planned or unplanned event or result that is
different from the expected event or result defined in existing procedures or
specifications.

 

 

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K.     

“Filled Product” shall mean in-process sterile Product that has been filled into
its final primary package for further labeling and packaging.

  L.     

“Product” shall mean sterile Product in its final packaged and labeled form that
is ready for disposition.

  M.     

“Manufacture” shall mean finished drug Product pooling, filling, packaging, and
associated in-process and stability testing, as applicable.

  N.     

“Master Production Control Record (MPCR)” shall mean a master document that
represents a detailed procedure and data record for the batch manufacturing
process, pursuant to CFR 21 §211.186.

  O.     

“Out of Specification (OOS)” shall mean any in-process, intermediate, or
finished Product test result that is outside of acceptable ranges defined in
approved specifications or analytical test methods.

  P.     

“cGMPs’ shall mean current good manufacturing practices as promulgated by the
FDA under the United States Food, Drug, and Cosmetic Act, 21 C.F.R. Part 210 et
seq., as amended from time to time, and the European Union.

 

The following Facilities shall be used by ENZON for Processing or provision of
Supply (“Facilities”):

Manufacturing, Packaging, Testing and Storage 6925 Guion Rd.
Indianapolis, IN 46268
USA

Section 16. RESPONSIBILITY DELEGATION CHECKLIST

  RESPONSIBILITIES SAVIENT ENZON 1. Regulatory Authorizations & cGMP Compliance
1.1 Maintain all licenses, registrations and other authorizations as are
required to operate a cGMP pharmaceutical manufacturing facility under the
Applicable Laws.   X 1.2 Maintain and operate the Facility in compliance with
the cGMPs, Applicable Laws and all other Product-specific instructions and
requirements agreed to by the Parties.   X

 

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  RESPONSIBILITIES SAVIENT ENZON 1.3 Process the Product in accordance with the
cGMPs, Applicable Laws and all other Product-specific instructions and
requirements agreed to by the Parties.   X 1.4 Prepare, maintain and update the
Marketing Authorizations in accordance with cGMPs, Applicable Laws and all other
Product-specific instructions and requirements agreed to by the Parties. X   1.5
Provide ENZON with copies of those portions of the Marketing Applications which
are applicable to the Processing, prior to submission of such Marketing
Applications to the applicable regulatory authorities. X   1.6 Provide ENZON
with copies of updates of those portions of the Marketing Authorizations which
are applicable to the Processing, prior to submission of such Marketing
Applications to the applicable regulatory authorities. X   1.7 Satisfy all drug
listing filing requirements for all Product and packaging configurations
processed at the Facilities.   X 1.8 Prepare and submit post-marketing annual
reports to the FDA and other applicable regulatory authorities in accordance
with cGMPs, Applicable Laws and all other Product-specific instructions and
requirements agreed to by the Parties. X   1.9 Provide SAVIENT within 30
business days of their request with the following information to be included in
the post- marketing annual reports:   X • Change control information for all
changes implemented during the preceding year relating to the Product. •
Applicable Product test data submitted in accordance with the requirements of
the Supply Agreement, including any non-conforming data. 1.10 Conduct Annual
Product Quality Review for the Product in accordance with cGMP’s, and Applicable
Laws. X   1.11 Provide SAVIENT with the following information to be included in
the Annual Product Quality Review:   X • All requested data and information
required per 21 CFR 211.180(e)

 

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  RESPONSIBILITIES SAVIENT ENZON 2. Regulatory Actions & Inspections 2.1
Promptly (within 24 hours of receiving notice) notify SAVIENT of any FDA or
other regulatory authority (a) notice of inspection or inspection of the
Facilities directly relating to the Product, or (b) inspection or investigation
relating to the Product; and promptly (within 3 days) notify SAVIENT of any
regulatory authority request for Product samples or Product batch records.   X
2.2 Promptly (within 24 hours of receiving notice) notify ENZON of any FDA or
other regulatory authority inspection or investigation relating to the Product;
and promptly (within 3 days) notify ENZON of any regulatory authority request
for Product samples or Product batch records. X   2.3 Provide SAVIENT copies of
any FDA Form 483's, warning letters or the like from applicable regulatory
authorities within 30 days of receipt and copies of all subsequent response(s)
relating to the Product or Quality Systems.   X 2.4 Approve inspection responses
to observations relevant to Product. X   2.5 Other than a request(s) delivered
in conjunction with an inspection, notify the other Party of any requests for
information, notices of violations or other communications from a regulatory
authority relating directly to the Product produced at the Facility. X   3.
Specifications & Change Control 3.1 Approve Product Specifications. X   3.2
Assume primary responsibility for ensuring that all Specifications (including
Product Specifications) and batch records that specifically relate to the
manufacture and release of Product comply with relevant portions of the
Marketing Applications and Marketing Authorizations, as amended from time to
time. X  

 

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3.3 Assume secondary responsibility for ensuring that all Specifications
(including Product Specifications) and batch records that specifically relate to
the manufacture and release of Product comply with relevant portions of the
Marketing Applications and Marketing Authorizations, as amended from time to
time.   X   RESPONSIBILITIES SAVIENT ENZON 3.4 Submit any proposed changes to
the Specifications to SAVIENT for review and approval, prior to the
implementation of such changes by ENZON.   X 3.5 Submit any proposed changes to
the Specifications to ENZON for review and comment, prior to the submission of
any such changes by SAVIENT to the regulatory authorities. X   3.6 Discuss and
reach agreement with SAVIENT regarding any proposed changes to the Facilities or
the Processing that may impact the Product, prior to implementation of such
proposed changes.   X 3.7 Serve as sole communicator with regulatory authorities
for the approval and any revisions of Product Specifications in the Market
Applications and Marketing Authorizations. X   4. Materials 4.1 Maintain Bulk
Product according to cGMPs and Appplicable Laws X   4.2 Retain reference samples
of Bulk Product, including samples for periodic re-tests, for 6 years beyond
Product expiry date. X   4.3 Provide Bulk Product meeting the Specifications and
cGMPs for manufacture, as well as a certificate of analysis for Bulk Product. X
  4.4 Perform identification testing of Bulk Product.   X 4.5 Source and qualify
raw materials (excluding Bulk Product) used in Processing. X   4.6 Maintain
Specifications for Components and procure, store, sample, test and release raw
materials.   X 4.7 Audit suppliers that provide Components and Process
Consumables used in Processing in accordance with applicable SOPs to ensure full
compliance with cGMPs and Applicable Laws.   X

 

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4.8 Store Bulk Product and Components in accordance with the Specifications,
SOPs, cGMPs and Applicable Laws while at the Facilities.   X   RESPONSIBILITIES
SAVIENT ENZON 4.9 Retain reference samples of raw materials in a quantity
sufficient to perform periodic re-tests, for 1 year beyond Product expiry date
in accordance with Specifications, SOPs, cGMPs and Applicable Laws.   X 4.10
Notify SAVIENT of intent to dispose of material retains.   X 4.11 At SAVIENT’s
option, ship material retains to SAVIENT (at SAVIENT’s expense) or destroy.   X
4.12 Dispose of Product waste and any special waste related to the Processing of
the Product in accordance with Applicable Laws.   X 5. Production,
Investigations & Validations 5.1 Provide personnel with appropriate education,
training and/or experience for manufacturing, testing and disposition of Product
that is suitable for human use, and for provision of Supply hereunder.   X 5.2
Provide premises that are maintained and able to meet design and cleanliness
requirements in accordance with Applicable Laws and industry standards.   X 5.3
Test and maintain utilities and environment to the appropriate compendia or
environmental standard to assure appropriateness for use in connection with
Processing and the Product.   X 5.4 Maintain, qualify and validate the Facility,
equipment, utilities (air and water) and processes associated with Processing
the Product in accordance with Applicable Laws and industry standards.   X 5.5
Manufacture and test the Product at the Facilities in accordance with the
Product master Production control record, the SOPs referenced therein, and the
Specifications.   X 5.6 Perform visual inspection of finished Product in
accordance with the Product master Production control record, the SOPs
referenced therein, and the Specifications.   X 5.7 Label Product in accordance
with the Product master Production control record, the SOPs referenced therein,
and the Specifications.   X

 

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5.8 Prepare and approve all artwork, inserts, labeling and packaging in
connection with the Product. X   5.9 Package the Product in accordance with the
Product master Production control record, the SOPs referenced therein, and the
Specifications.   X   RESPONSIBILITIES SAVIENT ENZON 5.10 Perform finished
Product testing in accordance with the supply agreement and supply a certificate
of analysis and a Certificate of Compliance to SAVIENT.   X 5.11 Final release
Product in accordance with the Product Specifications. X   5.12 Investigate,
resolve and document deviations from the Master Production Control Record and
OOS test results in accordance with the cGMPs. Investigations should be
completed with 30 calendar days. Interim status reports must be provided to
Savient periodically in writing for investigations remaining open beyond 30
business days.   X 5.13 Obtain Quality Assurance approval of all investigations
and corrective and preventive action plans.   X 5.14 Provide equipment
maintained and able to meet design and cleanliness requirements in accordance
with Applicable Laws and industry standards, as applicable.   X 5.15 Establish a
validation master plan and maintain the validation program in accordance with
plan requirements.   X 5.16 Prepare and execute all Product related validation
protocols, and complete validation reports.   X 5.17 Review and approve
validation protocols related to Product. X   5.18 Provide Quality Assurance
review and approval of all validation packages.   X 6. Audits 6.1 SAVIENT will
schedule and audit ENZON Facilities, records and documentation related to the
Product manufactured by ENZON at a time mutually agreed by Enzon with a minimum
advanced notice of 3 months and at a frequency of not more than once every 12
months. SAVIENT may request for- cause audits as needed. X   6.2 Conduct
internal audits of Facilities, processes and quality systems, in accordance with
cGMPs and applicable SOPs.   X

 

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6.3 SAVIENT shall provide ENZON with a written audit report containing audit
observations within 30 business days of the audit. X   6.4 ENZON will respond to
Savient audit report in writing within 15 business days.   X 6.5 SAVIENT is
entitled to inspect and audit suppliers, vendors and contractors used by ENZON
in connection with the Product. X   7. Lot Codes & Expiration Dating 7.1
Establish Product lot code.   X 7.2 Establish Product expiry dating as per
approved Product License/Marketing Authorization. X   8. Samples 8.1 Perform
Product sampling in accordance with the Supply Agreement, cGMP’s, and as
otherwise agreed to by the Parties in the master Production control record for
the Product.   X 8.2 Retain Finished Product samples including Stability samples
in accordance with cGMP’s and the Supply Agreement.   X 9. Testing & Analysis
9.1 Perform all applicable Product testing according to the Supply Agreement. X
X 9.2 Track and investigate all deviations (including OOS’s) associated with the
Product, and notify SAVIENT Quality and Manufacturing within 24 hours of
discovery of any significant deviations (those that may affect the identity,
strength, quality, or purity of the Product).   X 9.3 Notify ENZON of any
Product recall that might be attributed to Processing the Product. X   9.4
Notify SAVIENT Quality and Manufacturing via email within the business day
followed by signed documents of any confirmed failure of the Product that might
be attributed to Processing the Product.   X 10. Release 10.1 Provide initial QA
dispostion of Product to SAVIENT.   X 10.2 Provide final QA dispostion of
Product. X   11. Records

 

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11.1 Review and approve the executed batch records. X X   RESPONSIBILITIES
SAVIENT ENZON 11.2 Provide the released, executed batch record documentation for
each batch of Product, which shall include the following:   X • A statement that
the lot was manufactured, packaged and tested in accordance with cGMPs,
identifies the master batch Record documents, and lists any incident reports and
investigations associated with the batch. • A certificate of analysis covering
all regulatory authority and compendial tests, and a Certificate of Compliance.
• The signature of the QA Representative who released the batch. • Copies of
significant deviations (those that may materially affect the identify, strength,
quality or purity of the Product). • A list of other deviations that may affect
the Product. • A list of change control records that could impact the Product. •
Copies of summary Quality Assurance reviewed release test records. 11.3 Store
the master record, batch records, manufacturing documentation and all other
documentation related to the Product for the minimum period required by all
Applicable Laws.   X 11.4 Provide copies of all documentation necessary for
SAVIENT to respond to inquiries by regulatory authorities.   X 12. Storage 12.1
Store and ship the Bulk Product in accordance with the Bulk Product
Specifications, SOPs, cGMPs and Applicable Laws until manufacture of the
Product. X   12.2 Receive and store the Bulk Product. Intermediates, and
finished Product in accordance with the Specifications, SOPs, cGMPs and
Applicable Laws pending release of the Product.   X 12.3 Provide written
instructions for shipping prior to Product release and shipment. X   13. Safety
13.1 Maintain safety/hazard and handling data on the Product and Bulk Product. X
X

 

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  RESPONSIBILITIES SAVIENT ENZON 13.2 Maintain safety/hazard and handling data
on the raw materials. X X 14. Complaints 14.1 Upon request of SAVIENT, assist
SAVIENT in investigating and resolving all medical, adverse events, and
non-medical Product complaints.   X 14.2 Collect and log all information
relating to Product complaints and adverse drug events. X X 14.3 Investigate all
Product complaints and adverse drug events. X X 14.4 Issue all reports and
conduct follow up corrective action relating to Product complaints and adverse
drug events. X X 15. Recall, Field Alerts and Product Withdrawal 15.1 Inform the
Quality Assurance contact from the other Party within 24 hours upon knowledge of
all quality issues which might compromise the other Party’s quality requirements
for Products already shipped, or about to be shipped. X X 15.2 Issue any
decision to initiate Product recall or Product withdrawal. X   15.3 Communicate
decision to initiate Product recall to ENZON. X   15.4 Notify appropriate
regulatory authorities of any Product recall or Product withdrawal. X   15.5
Manage any Product recall or Product withdrawal. X   15.6 Reconcile returned
Product following Product recall or Product withdrawal. X X 15.7 Issue and
follow up on FDA Field Alerts (or other similar processes of other regulatory
authorities). X   15.8 Perform mock recall and recall effectiveness checks. X  
16 Quality Agreement Review 16.1 On an as-needed basis (or once every two
years), conduct a review to ensure that the Quality Agreement is in alignment
with the current scope of the Project Plan and the then- current Supply
Agreement. Update by mutual agreement of the Parties (if necessary). X X 17 Key
Contacts

 

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17.1 Either party may change the following contact information by issuing a memo
to the other party. Each party shall attach the memo to this original signed
agreement. The updated information shall be incorporated into the next
controlled revision of this agreement. X X

Savient Pharmaceuticals Inc.

For All Product Concerns:
Savient Pharmaceutical’s Inc.
One Tower Center
14th Floor
East Brunswick, New Jersey 08816
USA

Enzon Pharmaceuticals, Inc.

For Manufacturing, Quality Assurance and Quality Control:
Enzon Pharmaceuticals, Inc.
6925 Guion Road
Indianapolis, Indiana 46268
USA

For Regulatory Affairs:   For Operations, Planning & Logistics:   Enzon
Pharmaceuticals, Inc.   Enzon Pharmaceuticals, Inc. 685 Route 202/206   685
Route 202/206 Bridgewater, New Jersey 08854   Bridgewater, New Jersey 08807 USA
  USA

Enzon   Name/Title   Phone   Fax   E-mail Contact                 Quality      
          Assurance                                                     QA –
Product                 Release                                                
    Quality                 Control Lab                

 

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Operations   Control             Regulatory                 Affairs            
                                                          Operations –          
      Planning                                                                  
   

Savient   Name/Title   Phone   Fax   E-mail Contact                 Quality
Assurance                                                     Quality Assurance
                                  QA – Product                 Release          
      Regulatory Affairs                                                    
Manufacturing                                                                  
    Planning and                 Logistics                                      
             

 

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