Form 8-K



 Exhibit 10.68 

***Text Omitted and Filed Separately 

with the Securities and Exchange Commission. 

Confidential Treatment Requested 

Under 17 C.F.R. Sections 200.80(b)(4) 

and 240.24b-2. 

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 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. 

  
  

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 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. 

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 

  
  

					
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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 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 

  
  

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

  
  

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 2.5    Enzon shall prepare and effect the Product shipment in
accordance with explicit 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
explicitly set forth herein; in the event that Enzon neither accepts or rejects any forecast submitted by Savient within ten (10) days of receipt from Savient then the entire forecast as submitted by Savient shall be deemed accepted by Enzon. If
accepted, the forecast for the first [...***...] 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 

  
  

					
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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 [...***...] batch 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 provided with at least [...***...] of Bulk Product by Savient shall 

  
  

					
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not constitute a breach of this Agreement and that 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 [...***...] (specified 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 

  
  

					
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Components) which amount shall represent liquidated damages resulting from unused manufacturing capacity. Only with respect to 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 [...***...] per month, 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 

  
  

					
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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 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. 

  
  

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 5.5    Books and Records. Enzon shall maintain true
and accurate books, records, test and laboratory data, reports and all other information relating to manufacture of Product as 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
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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
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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 Section 7.3 then, anything to the contrary notwithstanding, 

  
  

					
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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 publicly available through no fault of Enzon; 

  
  

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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 Confidential Information shall reimburse the other Party for its
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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 NON-INFRINGEMENT OF INTELLECTUAL


  
  

					
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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: 
  

			
	To Enzon:	  	To Savient


  
  

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	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. 

15.12    Nonsolicitation. For the term of this Agreement, and for twelve (12) months following
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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
 EVP - Operations
	 		 		 	 Philip K. Yachmetz
 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
	 Activities
Included
 • Prepare Master Batch Records

• Materials to be packed with one vial and product insert per carton.

• Commercial Batch Prices are effective on 1 January 2008, and are effective through
31 December 2009.
 • Enzon reserves the right to increase prices pursuant to the terms of the
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.
  
	  	 $[...***...] per vial

 
 The minimum price per batch of $[...***...] shall
apply in accordance with the terms of Section 6.2(e) of the Agreement.


  

															
	 Puricase Final Drug
Product Stability test Schedule at [...***...]
 [...***...]

Price is per each lot tested

	Setup & initiation
Fee	 	Initial Test	 	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]	  	Total Cost
	$[...***...]	 	$[...***...]	 	[...***...]	  	[...***...]	  	$[...***...]	  	$[...***...]	  	$[...***...]	  	$[...***...]
	
Puricase Final Drug Product Stability test Schedule at [...***...]

Price is per each lot tested

	Setup & initiation
Fee	 	Initial Test	 	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]	  	 	  	Total Cost
	$[...***...]	 	 	 	$[...***...]	  	$[...***...]	  	$[...***...]	  	$[...***...]	  	 	  	$[...***...]

 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 postponed 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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 [...***...] 

  
  

					
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 Exhibit E 

Letter Agreement 
 (see
attached) 

  
  

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	 September 12, 2007
	  	                         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.../
... 







 
(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.../ ... 

  
 2 








 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/ Ralph del Campo


			
		
	Name:	 	     Ralph del Campo


			
		
	Title:	 	       EVP Technical Operations


			
		
	Date:	 	       9/17/07


  
 3 








 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. 

[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. QOP

	Title	  	Title
		
	     10/16/08
	  	     10/21/08

	Date	  	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:
  

•  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.
	 	 	 	 	 	X
	 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:
  
 •  All requested
data and information required per 21 CFR 211.180(e)
	 	 	 	 	 	X


  
  

					
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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 Applicable 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 DOS’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 disposition of Product to SAVIENT.
	 	 	 	 	 	X
	 10.2
	 	 	 	 Provide final QA disposition 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:
 •  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.
	 	 	 	 	 	X
	 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 Contact	  	Name/Title	  	Phone	  	Fax	  	E-mail
	 Quality Assurance
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]

	QA –
Product
Release	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]

	 Quality
Control Lab
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	
[...***...]



  
  

					
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	 Operations
	  	 Control
	  	 	  	 	  	 
	 Regulatory Affairs
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]

	Operations – Planning	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]


  

									
	Savient
Contact	  	Name/Title	  	Phone	  	Fax	  	E-mail
	 Quality Assurance 
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]

	Quality Assurance 	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]

	 QA — Product
Release
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]

	 Regulatory Affairs
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]

	 Manufacturing
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]

	Planning and
Logistics	  	 [...***...]
	  	 [...***...]
	  	 [...***...]
	  	 [...***...]



  
  

					
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 AMENDMENT NO. 1 

TO 

COMMERCIAL SUPPLY AGREEMENT 

DATED OCTOBER 16, 2008 

THIS AMENDMENT, effective as of Oct. 5, 2009, is entered into by and between SAVIENT PHARMACEUTICALS, INC.
(“SAVIENT”), and ENZON PHARMACEUTICALS, INC. (“ENZON”) hereinafter collectively referred to as the “Parties.” 

WHEREAS, the Parties have entered into a certain Commercial Supply Agreement (hereinafter referred to as the
“Agreement”) with an effective date of October 16, 2008, which sets forth the terms and conditions for services performed by the Parties. 

WHEREAS, the Parties wish to amend the payment structure outlined in the Agreement. 

NOW, THEREFORE, notwithstanding anything to the contrary within the Agreement, for the duration of this Amendment set
forth below, the parties hereby agree as follows: 
  

	 	•	 	 All payments under the Agreement are to be made as follows: 



 

	 	-	 Savient shall pay the full amount for the Product upon Enzon’s receipt of Bulk Product. 



	 	-	 Payment in full due “net 15 days” from bulk receipt. Packaging will occur at Savient’s instructions; final batch cost reconciliation
will be calculated and billed at shipment (that payment also net 15 days.) Precise filling date will be confirmed by Enzon to accommodate Savient’s timelines. 



 

	 	•	 	 Upon FDA approval of a Biologics License Application for the Product, consistent with the original assumption of the Agreement, the Parties shall
repeal this Amendment by signed mutual agreement and thereby revert to the original terms of the Agreement in full. 


  

	 	•	 	 A cancellation in Purchase Order or specific Product line after the Project is initiated will not result in a refund. All payments are
considered final upon receipt. 


 Where there is any inconsistency between the provisions of the
Agreement and the Amendment, the provisions of this Amendment shall prevail. 
 All remaining terms and conditions of the
Statement shall remain unchanged and in full force and effect. 
 AGREED: 
  

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

	Date:	 	10/9	 	, 2009.	 		 	Date:	 	10/5/09	 	, 2009.








 ENZON Pharmaceuticals, Inc. 

Contract Manufacturing 
 Exhibit C
to the Commercial Supply Agreement Dated October 6, 2008 
 Revision dated October 22, 2009 – supersede prior Exhibit C 

[...***...] 

  
  

 

					
		 	 Enzon Pharmaceuticals, Inc.

Commercial Supply Agreement
 Page 1
of 3
	 	  
 Exhibit C

*** Confidential Treatment Requested










 [...***...] 

  
  

 

					
		 	 Enzon Pharmaceuticals, Inc.

Commercial Supply Agreement
 Page 2
of 3
	 	  
 Exhibit C

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 ENZON Pharmaceuticals, Inc. 

Contract Manufacturing 
 Exhibit C
to the Commercial Supply Agreement Dated October 16, 2008 
 Revision dated October 22, 2009 – supersede prior Exhibit C 

Terms: 

	 	•	 	 Terms and conditions of the Commercial Supply Agreement dated October 16, 2008 and subsequent amendments apply (October 5, 2009 –
Amendment No 1) 



	 	•	 	 Delivery terms are FCA Enzon’s Indianapolis, IN facility (Section 6.1) 



	 	•	 	 Purchase orders are required for all scheduled work 



	 	•	 	 Canceled or postponed batches will be billed in full. All payment are considered final 



The Parties have caused their duly authorized representatives to execute this supplemental Exhibit C to the Commercial Manufacturing
Agreement. 
  

					
	SAVIENT PHARMACEUTICALS, Inc.	 		 	ENZON PHARMACEUTICALS, Inc.
			
	/s/ Philip K. Yachmetz	 		 	/s/ Ralph del Campo
	 Signature
	 		 	 Signature

			
	 Philip K. Yachmetz
	 		 	 Ralph del Campo

	 Printed Name
	 		 	
			
	 SVP & General Counsel
	 		 	 EVP – Tech Ops

	 Title
	 		 	 Title

			
	 10-26-09
	 		 	 10/26/09

	 Date
	 		 	 Date



  
  

 

					
		 	 Enzon Pharmaceuticals, Inc.

Commercial Supply Agreement
 Page 1
of 3
	 	  
 Exhibit C










 AMENDMENT TO COMMERCIAL SUPPLY AGREEMENT 

This Amendment (“Amendment”) is entered into as of July 29, 2014 (the “Effective Date”), by and between
Sigma Tau PharmaSource, Inc., with its principal executive offices located at 6925 Guion Road, Indianapolis, IN, 46268 (“STPS”) and Crealta Pharmaceuticals LLC with its principal executive offices located at 500 W. Silver Spring Drive,
Suite K-200, Glendale, WI 53217 (“Crealta”). 
 WHEREAS, STPS and Crealta are parties to a certain Commercial Supply
Agreement dated October 16, 2008, (the “Agreement”); 
 The parties desire to amend the Agreement to expand the scope
of the Agreement. In consideration of the promises and of the mutual covenants and agreements set forth, the parties agree as follows: 
  

	 	1.	 Recitals. The following two recitals are hereby added to the RECITALS section of the Agreement: 



 

	 	    	 WHEREAS, on or about January 29, 2010, Enzon Pharmaceuticals, Inc. assigned its rights under this Agreement to Sigma-Tau PharmaSource,
Inc. (“STPS”); 


 WHEREAS, on or about January 9, 2014, Savient Pharmaceuticals, Inc.
assigned its rights under the Agreement to Crealta; and 
  

	 	2.	 Terms and Conditions. Except as herein amended, all other terms and conditions of Agreement shall remain unchanged and in full
force and effect. All defined terms used and not otherwise defined in this Amendment have the meanings ascribed to such terms in the Agreement. This Amendment may only be modified by a written document, signed by both parties. This
Amendment may be executed in counterparts, each of which is an original, but all of which together constitute one and the same instrument. The terms and conditions of this Amendment and any Exhibits are incorporated into and made a part of the
Agreement. 


  

	 	3.	 Section 2.4 of the Agreement is deleted in its entirety and replaced with the following: 



 

	 	    	 STPS shall provide Crealta, at no additional charge, product support services, at Crealta’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 Crealta 



 

	 	•	 	 Routine validation activities to support commercial production (e.g. Media fills, annual sterilization validations, or vial washing
requalifications). 


  

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



 

	 	•	 	 All audit correspondence including Crealta-requested revisions to STPS’s audit response. 



 

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



 

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


  

	 	•	 	 Documentation provided to Regulatory Authorities on behalf of Crealta, other than routine documentation. 



 

	 	•	 	 All time used for collecting and photocopying Crealta documentation. 



 

	 	•	 	 Changes and revisions to artwork mandated by Regulatory Authorities or requested by Crealta. 



 

	 	•	 	 Batch storage. 



  
 Page 1 









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



  

	 	•	 	 Any additional validation work requested by Crealta 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, Crealta shall provide STPS a written request for product support services that describes the required
services and/or documents/work product required. STPS shall provide Crealta an estimate based on its customary rate. Upon acceptance of such estimate by Crealta, Crealta shall issue a purchase order to STPS and STPS shall perform such
services in accordance with the terms hereof. 


  

	 	4.	 The first 2 sentences of Section 7.2 shall be deleted in their entirety and replaced with the following: 



 

	 	    	 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 thirty-six (36) 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 36-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, Crealta may place, and STPS shall accept
and fulfill, forecasts and purchase orders for the manufacture of Product, all in accordance with the terms and conditions of this Agreement. 


  

	 	5.	 Section 14.1 is deleted in its entirety and replaced with the following: 



 

	 	    	 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: 


  

			
	 To STPS:
	  	 To Crealta:

		
	 Sigma-Tau PharmaSource, Inc.
	  	 Crealta Pharmaceuticals LLC

		
	 6925 Guion Rd.
	  	 Attn: Richard Crowley

		
	 Indianapolis, IN 46268
	  	 150 S. Saunders Rd., Suite 130

		  	 Lake Forest, IL 60045

		
	 With a Copy to:
	  	 With a Copy to:

		
	 Sigma-Tau Pharmaceuticals, Inc.
	  	 Crealta Pharmaceuticals LLC

		
	 Attn: Legal Dept.
	  	 Attn: Edward Donovan

		
	 9841 Washingtonian Blvd., Suite 500
	  	 150 S. Saunders Rd., Suite 130

		
	 Gaithersburg, MD 20878
	  	 Lake Forest, IL 60045


  

	 	6.	 Exhibit C of the Agreement is deleted in its entirety and replaced with Attachment 1 of this Amendment. 



 

	 	7.	 Exhibit F is deleted in its entirety and incorporates by reference with the Quality Agreement between the Parties dated October 16, 2008. Such
new version is the new Exhibit F, which supersedes all prior versions of such Quality Agreement. 



  
 Page 2 









	 	8.	 The parties acknowledge that the revised pricing reflected herein is reasonable as of the Effective Date of this Amendment and that current
business conditions, as of the Effective Date, with respect thereto do not warrant any adjustment to the prices set forth herein pursuant to the second sentence of Section 4.3. Notwithstanding the foregoing, nothing in this Section 8 of this
Amendment shall alter, modify, diminish, or otherwise affect any of the Parties’ rights under Section 4.3 of the Agreement. 



The parties have executed this Amendment to be effective as of the Effective Date. 

 

									
	Sigma-Tau PharmaSource, Inc.	 		 	Crealta Pharmaceuticals LLC
					
	By:	 	/s/ Dave Lemus	 		 	By:	 	/s/ Richard Crowley
					
	Name:	 	Dave Lemus	 		 	Name:	 	Richard Crowley
					
	Title:	 	President	 		 	Title:	 	Senior VP, Operations & QA
					
	Date:	 	9-22-14	 		 	Date:	 	September 9, 2014


  
 Page 3 








 ATTACHMENT 1 

Exhibit C 

Product Price 

[...***...] 

  

					
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 [...***...] 

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 STPS’s manufacturing facility in Indianapolis, IN 



 

	 	•	 	 Cancelled and postponed batches shall be billed in accordance with Section 3.4(d) 



STPS and Crealta agree that the total price (costs, fees, and incentives, if any) for all work provided for under the Agreement, including the
work authorized under this Amendment, shall not exceed the new total contract price. All invoices must be presented to Company no later than 120 days after the completion of services. 

  

					
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